EP4724127A1 - Patient interface - Google Patents

Patient interface

Info

Publication number
EP4724127A1
EP4724127A1 EP25811513.8A EP25811513A EP4724127A1 EP 4724127 A1 EP4724127 A1 EP 4724127A1 EP 25811513 A EP25811513 A EP 25811513A EP 4724127 A1 EP4724127 A1 EP 4724127A1
Authority
EP
European Patent Office
Prior art keywords
gases
nasal
interface
delivery element
interface according
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
EP25811513.8A
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 EP4724127A1 publication Critical patent/EP4724127A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
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    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A—HUMAN NECESSITIES
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    • A61M16/10—Preparation of respiratory gases or vapours
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    • A61M16/106—Filters in a path
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    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
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    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
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    • A61M2210/00—Anatomical parts of the body
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    • A61M2210/0618—Nose
    • A—HUMAN NECESSITIES
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    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0625—Mouth

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (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) comprising a gases flow channel (125), a first nasal delivery element (111), a second nasal delivery element (112), and a first gases port (121) in the interface body (110). The first nasal delivery element (111) and second nasal delivery element (112) being a non-sealing nasal delivery element. A bias flow vent (340) for enabling exhaled gases to be expelled out of the interface body (110). Wherein the nasal interface (100) is configured to create an asymmetric flow of gases at a patient's nasal airways.

Description

PATIENT INTERFACE
[0001] This application claims priority from United States Provisional Application No. 63/686581 filed on 23 August 2024, entitled 'Patient Interface', and from United States Provisional Application No. 63/782682 filed on 3 April 2025, 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 with a nasal interface for delivering respiratory gases to patient airways.
BACKGROUND
[0003] Respiratory gases can be provided to a patient. The respiratory gases are delivered through a patient interface. The patient interface may take numerous forms, for instance, where masks are used, these can be a mask over the nose and mouth, a mask exclusively for the nose or a mask exclusively for the mouth, or a combination of nose and mouth masks. Separate nasal and oral masks can also be used together. Rather than having a mask that surrounds an airway, an interface may be used such as nasal or oral cannula. These too may be combined with the various masks.
[0004] When using a nasal interface of a patient interface, the respiratory gases may be delivered using nasal delivery elements. A nasal delivery element is inserted into the nose of a patient to deliver the required therapy. Pairs of nasal delivery elements may be used, one for each naris. Some nasal delivery elements may be required to seal or semi-seal at the nose, or may not be required to seal at the nose, to deliver the therapy. [0005] Non-sealing patient interfaces have benefits such as preventing barotrauma effects (e.g., tissue damage to the airways and/or lungs due to differences in pressure relative to standard atmospheric pressure). There is a desire to provide improvements in patient interfaces.
SUMMARY
[0006] A respiratory interface and respiratory therapy system are disclosed that use nasal flow, e.g. through nasal delivery elements, in a nasal interface of a patient interface to deliver respiratory gases to a patient. This delivery may be via asymmetrical flow. Asymmetrical flow provides the patient with increased dead space clearance in the upper airways. Noise can also be reduced due to a decrease in peak expiratory pressure. [0007] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, and a bias flow vent for enabling exhaled gases to be expelled out of the interface body, the bias flow vent positioned downstream of the first nasal delivery element, wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[0008] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways. [0009] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body.
[0010] In some configurations, the bias flow vent positioned downstream of the first nasal delivery element.
[0011] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use. [0012] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0013] In some configurations, the gases inlet port comprises two or a plurality of gases inlet ports.
[0014] In some configurations, the bias flow vent is downstream of the second nasal delivery element.
[0015] In some configurations, the bias flow vent is more proximal the second nasal delivery element.
[0016] In some configurations, the bias flow vent is between the first and second nasal delivery elements.
[0017] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element wherein the gases inlet port points substantially toward or is substantially directed toward the first nasal delivery element.
[0018] In some configurations, the gases inlet is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
[0019] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and net pressure.
[0020] In some configurations, the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow.
[0021] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0022] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0023] In some configurations, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
[0024] In some configurations, the first nasal delivery element and the second nasal delivery element are symmetrical about the 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 nasal delivery element and the second nasal delivery element are each substantially straight.
[0026] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements.
[0027] In some configurations, the first nasal delivery element is larger than the second nasal delivery element.
[0028] In some configurations, the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
[0029] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions.
[0030] In some configurations the pair of side arms are configured to be moveable to follow the contours of the face.
[0031] In some configurations, the side arms are formed of a flexible material.
[0032] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[0033] In some configurations, a headgear comprises the button hole for connection to the attachment button.
[0034] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button. [0035] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[0036] 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 to a portion of a headgear. [0037] In some configurations, the ball portion comprises at least one protrusion to limit the range of articulation between the ball portion and the socket portion.
[0038] In some configurations, at least one side arm comprises a buckle.
[0039] In some configurations, the buckle is formed as a figure of eight.
[0040] In some configurations, the bias flow vent comprises an aperture or an aperture and a diffuser.
[0041] In some configurations, the nasal interface 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 bias flow vent.
[0042] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[0043] In some configurations, there are a plurality of the spaced apart baffles extending along the gases flow channel.
[0044] In some configurations, the at least one baffle extend across the interface body, a frame portion, or both an interface body and a frame portion of the nasal interface. [0045] In some configurations, at least one of the nasal delivery elements has a tapering wall portion.
[0046] In some configurations, the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
[0047] In some configurations, a base of at least one of the nasal delivery elements has an angled portion.
[0048] In some configurations, the base has a frustoconical shape.
[0049] In some configurations, the nasal interface comprises a connector coupled to, or defining, the gases inlet port.
[0050] In some configurations, the connector comprises a gases delivery portion to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion configured to receive incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion.
[0051] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet port. [0052] 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 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.
[0053] In some configurations, the second direction is a laterally outward direction.
[0054] In some configurations, the elbow may be configured to redirect the gases flow by more than 30 degrees, by more than 60 degrees or by approximately 90 degrees. [0055] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines a second axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other.
[0056] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0057] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0058] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0059] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0060] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. The first axis and the inlet axis may be aligned with each other. Accordingly, an angle between the first axis and the inlet axis may be 0 degrees.
[0061] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0062] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other. [0063] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0064] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0065] In some configurations, the nasal interface comprises a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
[0066] In some configurations, the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
[0067] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0068] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0069] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0070] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0071] In some configurations, the annular portion of the conduit retainer is C- shaped.
[0072] In some configurations, the conduit retainer comprises a pair of inwardly facing arms forming a channel for a strap or arm to pass therethrough.
[0073] In some configurations, the pair of inwardly facing arms maintain a space or gap in-between them.
[0074] In some configurations, the interface body comprises an external gases channel in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external gases channel.
[0075] In some configurations, the external gases channel extends along at least part of the main body portion.
[0076] In some configurations, the external gases channel extends from at or adjacent a base of the at least one of the nasal delivery elements, away from the at least one of the nasal delivery elements. [0077] In some configurations, the interface body comprises a frame portion, and wherein the interface body comprises the main body portion.
[0078] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements, and wherein the external gases channel is adjacent a smaller one of the nasal delivery elements.
[0079] In some configurations, the external gases channel extends along at least part of the main body portion and along at least part of the at least one of the nasal delivery elements.
[0080] In some configurations, the external gases channel extends to a tip of the at least one of the nasal delivery elements that comprises a gases outlet.
[0081] In some configurations, the nasal interface comprises a plurality of the external gases channels adjacent the at least one of the nasal delivery elements.
[0082] In some configurations, at least one of the external gases channels is adjacent each of the nasal delivery elements.
[0083] In some configurations, a plurality of the external gases channels is adjacent each of the nasal delivery elements.
[0084] In some configurations, the external gases channel has an expanding or bifurcated configuration in region distal from the at least one of the nasal delivery elements, to enable gases flow away from the frame.
[0085] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0086] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body.
[0087] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements.
[0088] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[0089] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[0090] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion. [0091] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[0092] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[0093] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
[0094] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
[0095] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0096] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0097] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0098] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
[0099] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove.
[0100] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0101] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[0102] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion. [0103] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0104] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0105] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0106] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0107] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0108] In some configurations, the frame member comprises substantially straight upper and lower edges.
[0109] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0110] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0111] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0112] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0113] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0114] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[0115] In some configurations, the side arms are formed of a flexible material.
[0116] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge. [0117] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hinged ly articulate along the lines of the X-shape.
[0118] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[0119] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[0120] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[0121] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[0122] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[0123] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0124] 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.
[0125] In some configurations, side arms or headgear arms comprise cheek pads.
[0126] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0127] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[0128] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0129] In some configurations, the cheek pad is formed as a hollow body. [0130] 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.
[0131] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0132] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[0133] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[0134] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[0135] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[0136] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[0137] In some configurations, the loops comprise webbing.
[0138] In some configurations, the struts have a uniform length.
[0139] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end (lateral end) of the securing member.
[0140] In some configurations, the securing member is flexible to allow a circumferential expansion.
[0141] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[0142] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. The first axis and the inlet axis may be aligned with each other. Accordingly, an angle between the first axis and the inlet axis may be 0 degrees.
[0143] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0144] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0145] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0146] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0147] In some configurations, the second nasal delivery element comprises a second gases outlet, wherein the second gases outlet defines a second axis corresponding to a direction of gases flow through the second gases outlet. The first axis, the second axis and the inlet axis may all lie within the plane of the interface body that is transverse to the first midline plane.
[0148] In some configurations, the first axis and the second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
[0149] In some configurations, the bias flow vent defines an outlet axis corresponding to a direction of gases flow through the bias flow vent. The second axis and the outlet axis may be aligned with each other. Accordingly, an angle between the second axis and the outlet axis may be 0 degrees. The outlet axis and the second axis may be at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
[0150] In some configurations, the gases inlet port and the bias flow vent are provided on opposite sides of the midline plane. The gases inlet port and the bias flow vent may be symmetrical about the midline plane.
[0151] In some configurations, the interface body comprises a first side at which the first and second nasal delivery elements are provided and an opposite second side at which the inlet port as well as the bias flow vent 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. [0152] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the gases inlet port is arranged to direct the incoming respiratory gases towards the first nasal delivery element, and wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[0153] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use.
[0154] In some configurations, the gases inlet port points substantially toward the first nasal delivery element.
[0155] In some configurations, the gases inlet port is substantially directed toward the first nasal delivery element.
[0156] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0157] In some configurations, the gases inlet is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
[0158] In some configurations, the gases inlet port comprises two or a plurality of gases inlet ports.
[0159] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines a second axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. [0160] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0161] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0162] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0163] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0164] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. The first axis and the inlet axis may be aligned with each other. Accordingly, an angle between the first axis and the inlet axis may be 0 degrees.
[0165] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0166] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0167] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0168] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0169] In some configurations, the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow.
[0170] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and net pressure.
[0171] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0172] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0173] In some configurations, the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
[0174] In some configurations, the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
[0175] In some configurations, the first nasal delivery element and the second nasal delivery element are each substantially straight.
[0176] In some configurations, the one of the nasal delivery elements is larger than the other of the nasal delivery elements.
[0177] In some configurations, the first nasal delivery element is larger than the second nasal delivery element.
[0178] In some configurations, the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
[0179] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions.
[0180] In some configurations the pair of side arms are configured to be moveable to follow the contours of the face.
[0181] In some configurations, the side arms are formed of a flexible material.
[0182] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[0183] In some configurations, a headgear comprises the button hole for connection to the attachment button. [0184] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button. [0185] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[0186] 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.
[0187] In some configurations, the ball portion comprises at least one protrusion to limit the range of articulation between the ball portion and the socket portion.
[0188] In some configurations, at least one side arm comprises a buckle.
[0189] In some configurations, the buckle is formed as a figure of eight.
[0190] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body.
[0191] In some configurations, the bias flow vent positioned downstream of the first nasal delivery element.
[0192] In some configurations, the bias flow vent is downstream of the second nasal delivery element.
[0193] In some configurations, the bias flow vent is more proximal the second nasal delivery element.
[0194] In some configurations, the bias flow vent is between the first and second nasal delivery elements.
[0195] In some configurations, the bias flow vent comprises an aperture or an aperture and a diffuser.
[0196] In some configurations, 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 bias flow vent.
[0197] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[0198] In some configurations, there are a plurality of the spaced apart baffles extending along the gases flow channel. [0199] In some configurations, the at least one baffle extends across the interface body, a frame portion, or both the interface body and a frame portion of the nasal interface.
[0200] In some configurations, at least one of the nasal delivery elements has a tapering wall portion wherein the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
[0201] In some configurations, a base of at least one of the nasal delivery elements has an angled portion.
[0202] In some configurations, the base has a frustoconical shape.
[0203] In some configurations, the nasal interface comprising a connector coupled to, or defining, the gases inlet port.
[0204] In some configurations, the connector comprises a gases delivery portion to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion configured to receive incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion.
[0205] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[0206] 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.
[0207] In some configurations, wherein the second direction is a laterally outward direction.
[0208] In some configurations, the nasal interface comprises a cap configured to at least partly cover the bias flow vent in use.
[0209] In some configurations, the cap is configured to substantially cover the bias flow vent in use.
[0210] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use. [0211] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0212] In some configurations, the cap comprises at least one opening to enable gases flow from the bias flow vent through the cap.
[0213] In some configurations, the cap comprises an annular configuration comprising a peripheral frame surrounding the opening.
[0214] In some configurations, the interface body comprises a frame portion, and wherein the bias flow vent is located in the frame portion.
[0215] In some configurations, the cap is tethered to the frame portion.
[0216] In some configurations, the cap is removably attached to the frame.
[0217] In some configurations, the interface body comprises an external gases channel in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external gases channel.
[0218] In some configurations, the external gases channel extends along at least part of the main body portion.
[0219] In some configurations, the external gases channel extends from at or adjacent a base of the at least one of the nasal delivery elements, away from the at least one of the nasal delivery elements.
[0220] In some configurations, the interface body comprises a frame portion, and wherein the interface body comprises the main body portion.
[0221] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements, and wherein the external gases channel is adjacent a smaller one of the nasal delivery elements.
[0222] In some configurations, the external gases channel extends along at least part of the main body portion and along at least part of the at least one of the nasal delivery elements.
[0223] In some configurations, the external gases channel extends to a tip of the at least one of the nasal delivery elements that comprises a gases outlet.
[0224] In some configurations, the nasal interface comprises a plurality of the external gases channels adjacent the at least one of the nasal delivery elements.
[0225] In some configurations, at least one of the external gases channels adjacent each of the nasal delivery elements.
[0226] In some configurations, a plurality of the external gases channels adjacent each of the nasal delivery elements. [0227] In some configurations, the external gases channel has an expanding or bifurcated configuration in region distal from the at least one of the nasal delivery elements, to enable gases flow away from the frame.
[0228] In some configurations, the nasal interface comprises a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
[0229] In some configurations, the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
[0230] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0231] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0232] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0233] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0234] In some configurations, the annular portion of the conduit retainer is C- shaped.
[0235] In some configurations, the conduit retainer comprises a pair of inwardly facing arms forming a channel for a strap or arm to pass therethrough.
[0236] some configurations, the pair of inwardly facing arms maintain a space or gap in-between them.
[0237] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0238] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body.
[0239] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements. [0240] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[0241] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[0242] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
[0243] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[0244] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[0245] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
[0246] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
[0247] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0248] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0249] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0250] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
[0251] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove. [0252] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0253] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[0254] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[0255] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0256] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0257] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0258] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0259] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0260] In some configurations, the frame member comprises substantially straight upper and lower edges.
[0261] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0262] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0263] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0264] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0265] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0266] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[0267] In some configurations, the side arms are formed of a flexible material. [0268] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
[0269] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hingedly articulate along the lines of the X-shape.
[0270] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[0271] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[0272] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[0273] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[0274] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[0275] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0276] 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.
[0277] In some configurations, side arms or headgear arms comprise cheek pads.
[0278] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0279] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm. [0280] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0281] In some configurations, the cheek pad is formed as a hollow body.
[0282] 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.
[0283] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0284] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[0285] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[0286] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[0287] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[0288] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[0289] In some configurations, the loops comprise webbing.
[0290] In some configurations, the struts have a uniform length.
[0291] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[0292] In some configurations, the securing member is flexible to allow a circumferential (i.e. horizontal) expansion.
[0293] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[0294] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, and a connector for coupling the gases supply conduit to the interface body and to enable the passage of the incoming respiratory gases from the gases supply conduit to the gases flow channel.
[0295] In some configurations, the connector is configured to reduce the turbulence of the flow of gases when entering the interface body.
[0296] In some configurations, the reduction in turbulence is compared to a nasal interface excluding a connector.
[0297] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, and an elbow for coupling the gases supply conduit to the interface body and to enable the passage of the incoming respiratory gases from the gases supply conduit to the gases flow channel.
[0298] In some configurations, the elbow is configured to reduce the turbulence of the flow of gases when entering the interface body.
[0299] In some configurations, the reduction in turbulence is compared to a nasal interface excluding the elbow.
[0300] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use. [0301] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0302] In some configurations, the gases inlet port comprises two or a plurality of gases inlet ports.
[0303] In some configurations, the elbow is coupled to or defines the gases inlet port.
[0304] In some configurations, the interface body comprises a frame portion.
[0305] In some configurations, the interface body comprises a frame portion and a cushion portion.
[0306] In some configurations, the frame portion comprises the gases inlet port, and wherein the interface body comprises the first nasal delivery element and the second nasal delivery element.
[0307] In some configurations, the frame portion comprises the gases inlet port, and wherein the cushion portion comprises the first nasal delivery element and the second nasal delivery element.
[0308] In some configurations, the elbow is integrally formed with the frame portion of the interface body.
[0309] In some configurations, the connector is integrally formed with the frame portion of the interface body.
[0310] In some configurations, the nasal interface comprises a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
[0311] In some configurations, the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
[0312] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0313] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0314] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body. [0315] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0316] In some configurations, the annular portion of the conduit retainer is C- shaped.
[0317] In some configurations, the conduit retainer comprises a pair of inwardly facing arms forming a channel for a strap or arm to pass therethrough.
[0318] some configurations, the pair of inwardly facing arms maintain a space or gap in-between them.
[0319] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[0320] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and net pressure.
[0321] In some configurations, the gases inlet port points substantially toward the first nasal delivery element.
[0322] In some configurations, the gases inlet port is substantially directed toward the first nasal delivery element.
[0323] In some configurations, the gases inlet port is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
[0324] In some configurations, the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow.
[0325] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0326] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0327] In some configurations, the first nasal delivery element and the second nasal delivery element lie in a plane of the interface body that is transverse to 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.
[0328] In some configurations, the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
[0329] In some configurations, the first nasal delivery element and the second nasal delivery element are each substantially straight.
[0330] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements.
[0331] In some configurations, the first nasal delivery element is larger than the second nasal delivery element.
[0332] In some configurations, the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
[0333] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions.
[0334] In some configurations the pair of side arms are configured to be moveable to follow the contours of the face.
[0335] In some configurations, the side arms are formed of a flexible material.
[0336] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[0337] In some configurations, a headgear comprises the button hole for connection to the attachment button.
[0338] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button. [0339] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[0340] 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. [0341] In some configurations, the ball portion comprises at least one protrusion to limit the range of articulation between the ball portion and the socket portion.
[0342] In some configurations, at least one side arm comprises a buckle.
[0343] In some configurations, the buckle is formed as a figure of eight.
[0344] In some configurations, the nasal interface comprising a bias flow vent for enabling exhaled gases to be expelled out of the interface body.
[0345] In some configurations, the bias flow vent positioned downstream of the first nasal delivery element.
[0346] In some configurations, the nasal interface 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 bias flow vent.
[0347] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[0348] In some configurations, the nasal interface comprising a plurality of the spaced apart baffles extending along the gases flow channel.
[0349] In some configurations, the at least one baffle extends across the interface body, a frame portion, or both the interface body and a frame portion of the nasal interface.
[0350] In some configurations, at least one of the nasal delivery elements has a tapering wall portion wherein the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
[0351] In some configurations, a base of at least one of the nasal delivery elements has an angled portion.
[0352] In some configurations, the base has a frustoconical shape.
[0353] In some configurations, the connector comprises a gases delivery portion to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion configured to receive incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion.
[0354] 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 portion 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 deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[0355] In some configurations, the second direction is a laterally outward direction. [0356] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines a second axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other.
[0357] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0358] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0359] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0360] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0361] In some configurations, the nasal interface comprises a cap configured to at least partly cover the bias flow vent in use.
[0362] In some configurations, the cap is configured to substantially cover the bias flow vent in use.
[0363] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use.
[0364] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0365] In some configurations, the cap comprises at least one opening to enable gases flow from the bias flow vent through the cap.
[0366] In some configurations, the cap comprises an annular configuration comprising a peripheral frame surrounding the opening.
[0367] In some configurations, the interface body comprises a frame portion, and wherein the bias flow vent is located in the frame portion.
[0368] In some configurations, the cap is tethered to the frame portion. [0369] In some configurations, the cap is removably attached to the frame.
[0370] In some configurations, the interface body comprises an external gases channel in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external gases channel.
[0371] In some configurations, the external gases channel extends along at least part of the main body portion.
[0372] In some configurations, the external gases channel extends from at or adjacent a base of the at least one of the nasal delivery elements, away from the at least one of the nasal delivery elements.
[0373] In some configurations, the interface body comprises a frame portion, and wherein the interface body comprises the main body portion.
[0374] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements, and wherein the external gases channel is adjacent a smaller one of the nasal delivery elements.
[0375] In some configurations, the external gases channel extends along at least part of the main body portion and along at least part of the at least one of the nasal delivery elements.
[0376] In some configurations, the external gases channel extends to a tip of the at least one of the nasal delivery elements that comprises a gases outlet.
[0377] In some configurations, the nasal interface comprises a plurality of the external gases channels adjacent the at least one of the nasal delivery elements.
[0378] In some configurations, at least one of the external gases channels is adjacent each of the nasal delivery elements.
[0379] In some configurations, a plurality of the external gases channels is adjacent each of the nasal delivery elements.
[0380] In some configurations, the external gases channel has an expanding or bifurcated configuration in region distal from the at least one of the nasal delivery elements, to enable gases flow away from the frame.
[0381] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0382] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body. [0383] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements.
[0384] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[0385] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[0386] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
[0387] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[0388] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[0389] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
[0390] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
[0391] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0392] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0393] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0394] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body. [0395] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove.
[0396] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0397] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[0398] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[0399] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0400] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0401] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0402] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0403] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0404] In some configurations, the frame member comprises substantially straight upper and lower edges.
[0405] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0406] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0407] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0408] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0409] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout. [0410] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[0411] In some configurations, the side arms are formed of a flexible material.
[0412] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
[0413] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hingedly articulate along the lines of the X-shape.
[0414] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[0415] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[0416] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[0417] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[0418] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[0419] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0420] 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.
[0421] In some configurations, side arms or headgear arms comprise cheek pads. [0422] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0423] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[0424] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0425] In some configurations, the cheek pad is formed as a hollow body.
[0426] 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.
[0427] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0428] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[0429] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[0430] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[0431] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[0432] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[0433] In some configurations, the loops comprise webbing.
[0434] In some configurations, the struts have a uniform length.
[0435] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[0436] In some configurations, the securing member is flexible to allow a circumferential expansion.
[0437] In some configurations, the securing member comprises buckles at each of its circumferential ends. [0438] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions.
[0439] In some configurations the pair of side arms are configured to be moveable to follow the contours of the face.
[0440] In some configurations, the side arms are formed of a flexible material.
[0441] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[0442] In some configurations, a headgear comprises the button hole for connection to the attachment button.
[0443] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button. [0444] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[0445] In some configurations, each side arm comprises a headgear connection feature to movably connect to either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to respective connectors on first and second ends of a headgear.
[0446] In some configurations, the ball portion comprises at least one protrusion to limit the range of articulation between the ball portion and the socket portion.
[0447] In some configurations, at least one side arm comprises a buckle.
[0448] In some configurations, the buckle is formed as a figure of eight.
[0449] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use. [0450] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0451] In some configurations, a first one of the side arms comprises either a ball portion or a socket portion of the ball and socket joint configured to moveably connect to a corresponding ball or socket portion on the respective headgear connecting portion.
[0452] In some configurations, a second one of the side arms comprises either a ball portion or a socket portion of the ball and socket joint configured to moveably connect to a corresponding ball or socket portion on the respective headgear connecting portion.
[0453] 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.
[0454] In some configurations, the at least one protrusion limits the maximum pivot angle to 45 degrees relative to the side arm.
[0455] In some configurations, each headgear connection feature is moveably connectable to either of the connectors on the first and second ends of the headgear.
[0456] In some configurations, the gases inlet port comprises two or a plurality of gases inlet ports.
[0457] In some configurations, the gases inlet port points substantially toward the first nasal delivery element.
[0458] In some configurations, the gases inlet port is substantially directed toward the first nasal delivery element.
[0459] In some configurations, the gases inlet is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
[0460] In some configurations, the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow.
[0461] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow. [0462] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0463] In some configurations, the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
[0464] In some configurations, the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
[0465] In some configurations, the first nasal delivery element and the second nasal delivery element are each substantially straight.
[0466] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements.
[0467] In some configurations, the first nasal delivery element is larger than the second nasal delivery element.
[0468] In some configurations, the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
[0469] In some configurations, the nasal interface comprising a bias flow vent for enabling exhaled gases to be expelled out of the interface body.
[0470] In some configurations, the bias flow vent positioned downstream of the first nasal delivery element.
[0471] In some configurations, the bias flow vent comprises an aperture or an aperture and a diffuser.
[0472] In some configurations, the nasal interface 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 bias flow vent.
[0473] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[0474] In some configurations, the interface comprises a plurality of the spaced apart baffles extending along the gases flow channel.
[0475] In some configurations, the at least one baffle extends across the interface body, a frame portion, or both an interface body and a frame portion of the nasal interface. [0476] In some configurations, at least one of the nasal delivery elements has a tapering wall portion.
[0477] In some configurations, the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
[0478] In some configurations, a base of at least one of the nasal delivery elements has an angled portion.
[0479] In some configurations, the base has a frustoconical shape.
[0480] In some configurations, the nasal interface comprises a gases delivery connector coupled to, or defining, the gases inlet port.
[0481] In some configurations, the connector comprises a gases delivery portion to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion configured to receive incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion.
[0482] In some configurations, the nasal interface comprises an elbow coupled to, or defining, the gases inlet port.
[0483] 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 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.
[0484] In some configurations, the second direction is a laterally outward direction.
[0485] In some configurations, the interface body comprises a single inlet comprising the gases inlet port.
[0486] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines a second axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other.
[0487] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0488] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0489] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0490] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0491] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. The first axis and the inlet axis may be aligned with each other. Accordingly, an angle between the first axis and the inlet axis may be 0 degrees.
[0492] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0493] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0494] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0495] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0496] In some configurations, the nasal interface comprises a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
[0497] In some configurations, the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
[0498] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body. [0499] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0500] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0501] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0502] In some configurations, the annular portion of the conduit retainer is C- shaped.
[0503] In some configurations, the conduit retainer comprises a pair of inwardly facing arms forming a channel for a strap or arm to pass therethrough.
[0504] some configurations, the pair of inwardly facing arms maintain a space or gap in-between them.
[0505] In some configurations, the nasal interface comprises a cap configured to at least partly cover the bias flow vent in use.
[0506] In some configurations, the cap is configured to substantially cover the bias flow vent in use.
[0507] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use.
[0508] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0509] In some configurations, the cap comprises at least one opening to enable gases flow from the bias flow vent through the cap.
[0510] In some configurations, the cap comprises an annular configuration comprising a peripheral frame surrounding the opening.
[0511] In some configurations, the interface body comprises a frame portion, and wherein the bias flow vent is located in the frame portion.
[0512] In some configurations, the cap is tethered to the frame portion.
[0513] In some configurations, the cap is removably attached to the frame. [0514] In some configurations, the interface body comprises an external gases channel in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external gases channel.
[0515] In some configurations, the external gases channel extends along at least part of the main body portion.
[0516] In some configurations, the external gases channel extends from at or adjacent a base of the at least one of the nasal delivery elements, away from the at least one of the nasal delivery elements.
[0517] In some configurations, the interface body comprises a frame portion, and wherein the interface body comprises the main body portion.
[0518] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements, and wherein the external gases channel is adjacent a smaller one of the nasal delivery elements.
[0519] In some configurations, the external gases channel extends along at least part of the main body portion and along at least part of the at least one of the nasal delivery elements.
[0520] In some configurations, the external gases channel extends to a tip of the at least one of the nasal delivery elements that comprises a gases outlet.
[0521] In some configurations, the nasal interface comprises a plurality of the external gases channels adjacent the at least one of the nasal delivery elements.
[0522] In some configurations, at least one of the external gases channels is adjacent each of the nasal delivery elements.
[0523] In some configurations, a plurality of the external gases channels is adjacent each of the nasal delivery elements.
[0524] In some configurations, the external gases channel has an expanding or bifurcated configuration in region distal from the at least one of the nasal delivery elements, to enable gases flow away from the frame.
[0525] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0526] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body. [0527] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements.
[0528] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[0529] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[0530] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
[0531] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[0532] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[0533] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
[0534] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
[0535] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0536] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0537] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0538] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body. [0539] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove.
[0540] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0541] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[0542] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[0543] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0544] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0545] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0546] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0547] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0548] In some configurations, the frame member comprises substantially straight upper and lower edges.
[0549] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0550] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0551] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0552] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0553] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout. [0554] 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.
[0555] In some configurations, side arms or headgear arms comprise cheek pads.
[0556] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0557] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[0558] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0559] In some configurations, the cheek pad is formed as a hollow body.
[0560] 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.
[0561] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0562] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[0563] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[0564] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[0565] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[0566] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[0567] In some configurations, the loops comprise webbing.
[0568] In some configurations, the struts have a uniform length.
[0569] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member. [0570] In some configurations, the securing member is flexible to allow a circumferential expansion.
[0571] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[0572] 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 (as described herein) and a pair of the headgear connecting portions each moveably connected to one of the side arms, a first one of the side arms comprising either the ball or socket portion and a first headgear connecting portion comprising the corresponding socket or ball portion, and a second one of the side arms comprising either the ball or socket portion and a second headgear connecting portion comprising the corresponding socket or ball portion.
[0573] In some configurations, the patient interface comprises a headgear comprising the headgear connecting portions.
[0574] In some configurations, the patient interface comprises flexible cheek contacting portions.
[0575] In some configurations, the headgear is symmetric 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.
[0576] 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 (as described 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.
[0577] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, a bias flow vent for enabling exhaled gases to be expelled out of the interface body, the bias flow vent positioned downstream of the first nasal delivery element, and a cap configured to at least partly cover the bias flow vent in use.
[0578] In some configurations, at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element.
[0579] In some configurations, the cap is configured to substantially cover the bias flow vent in use.
[0580] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use.
[0581] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0582] In some configurations, the cap comprises at least one opening to enable gases flow from the bias flow vent through the cap.
[0583] In some configurations, the cap comprises an annular configuration comprising a peripheral frame surrounding the opening.
[0584] In some configurations, the interface body comprises a frame portion, and wherein the bias flow vent is located in the frame portion.
[0585] In some configurations, the cap is tethered to the frame portion.
[0586] In some configurations, the cap is removably attached to the frame.
[0587] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[0588] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions.
[0589] In some configurations the pair of side arms are configured to be moveable to follow the contours of the face.
[0590] In some configurations, the side arms are formed of a flexible material.
[0591] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[0592] In some configurations, a headgear comprises the button hole for connection to the attachment button.
[0593] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button. [0594] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[0595] In some configurations, each side arm comprises a headgear connection feature to movably connect to either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to respective connectors on first and second ends of a headgear.
[0596] In some configurations, a first one of the side arms comprises either a ball portion or a socket portion of the ball and socket joint configured to moveably connect to a corresponding ball or socket portion on the respective headgear connecting portion.
[0597] In some configurations, a second one of the side arms comprises either a ball portion or a socket portion of the ball and socket joint configured to moveably connect to a corresponding ball or socket portion on the respective headgear connecting portion.
[0598] 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.
[0599] In some configurations, the ball portion comprises at least one protrusion to limit the range of articulation between the ball portion and the socket portion.
[0600] In some configurations, the at least one protrusion limits the maximum pivot angle to 45 degrees relative to the side arm.
[0601] In some configurations, at least one side arm comprises a buckle.
[0602] In some configurations, the buckle is formed as a figure of eight.
[0603] In some configurations, each headgear connection feature is moveably connectable to either of the connectors on the first and second ends of the headgear.
[0604] In some configurations, the gases inlet port comprises two or a plurality of gases inlet ports.
[0605] In some configurations, the gases inlet port points substantially toward the first nasal delivery element.
[0606] In some configurations, the gases inlet port is substantially directed toward the first nasal delivery element.
[0607] In some configurations, the gases inlet is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
[0608] In some configurations, the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow. [0609] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0610] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0611] In some configurations, the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
[0612] In some configurations, the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
[0613] In some configurations, the first nasal delivery element and the second nasal delivery element are each substantially straight.
[0614] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements.
[0615] In some configurations, the first nasal delivery element is larger than the second nasal delivery element.
[0616] In some configurations, the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
[0617] In some configurations, the nasal interface comprising a bias flow vent for enabling exhaled gases to be expelled out of the interface body.
[0618] In some configurations, the bias flow vent positioned downstream of the first nasal delivery element. [0619] In some configurations, the bias flow vent comprises an aperture or an aperture and a diffuser.
[0620] In some configurations, the nasal interface 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 bias flow vent.
[0621] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[0622] In some configurations, the interface comprises a plurality of the spaced apart baffles extending along the gases flow channel.
[0623] In some configurations, the at least one baffle extends across the interface body, a frame portion, or both an interface body and a frame portion of the nasal interface. [0624] In some configurations, at least one of the nasal delivery elements has a tapering wall portion.
[0625] In some configurations, the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
[0626] In some configurations, a base of at least one of the nasal delivery elements has an angled portion.
[0627] In some configurations, the base has a frustoconical shape.
[0628] In some configurations, the nasal interface comprises a gases delivery connector coupled to, or defining, the gases inlet port.
[0629] In some configurations, the connector comprises a gases delivery portion to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion configured to receive incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion.
[0630] In some configurations, the nasal interface comprises an elbow coupled to, or defining, the gases inlet port.
[0631] 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 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.
[0632] In some configurations, the second direction is a laterally outward direction.
[0633] In some configurations, the interface body comprises a single inlet comprising the gases inlet port.
[0634] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines a second axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other.
[0635] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0636] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0637] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0638] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0639] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. The first axis and the inlet axis may be aligned with each other. Accordingly, an angle between the first axis and the inlet axis may be 0 degrees.
[0640] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0641] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0642] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0643] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other. [0644] In some configurations, the nasal interface comprises a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
[0645] In some configurations, the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
[0646] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0647] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0648] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0649] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0650] In some configurations, the annular portion of the conduit retainer is C- shaped.
[0651] In some configurations, the conduit retainer comprises a pair of inwardly facing arms forming a channel for a strap or arm to pass therethrough.
[0652] some configurations, the pair of inwardly facing arms maintain a space or gap in-between them.
[0653] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0654] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body.
[0655] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements.
[0656] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[0657] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion. [0658] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
[0659] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[0660] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[0661] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
[0662] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
[0663] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0664] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0665] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0666] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
[0667] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove.
[0668] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0669] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion. [0670] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[0671] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0672] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0673] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0674] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0675] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0676] In some configurations, the frame member comprises substantially straight upper and lower edges.
[0677] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0678] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0679] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0680] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0681] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0682] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[0683] In some configurations, the side arms are formed of a flexible material.
[0684] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge. [0685] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hinged ly articulate along the lines of the X-shape.
[0686] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[0687] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[0688] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[0689] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[0690] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[0691] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0692] 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.
[0693] In some configurations, side arms or headgear arms comprise cheek pads.
[0694] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0695] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[0696] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0697] In some configurations, the cheek pad is formed as a hollow body. [0698] 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.
[0699] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0700] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[0701] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[0702] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[0703] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[0704] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[0705] In some configurations, the loops comprise webbing.
[0706] In some configurations, the struts have a uniform length.
[0707] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[0708] In some configurations, the securing member is flexible to allow a circumferential expansion.
[0709] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[0710] 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 in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises an external gases channel in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external gases channel.
[0711] In some configurations, the external gases channel extends along at least part of the main body portion.
[0712] In some configurations, the external gases channel extends from at or adjacent a base of the at least one of the nasal delivery elements, away from the at least one of the nasal delivery elements.
[0713] In some configurations, the interface body comprises a frame portion, and wherein the interface body comprises the main body portion.
[0714] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements, and wherein the external gases channel is adjacent a smaller one of the nasal delivery elements.
[0715] In some configurations, the external gases channel extends along at least part of the main body portion and along at least part of the at least one of the nasal delivery elements.
[0716] In some configurations, the external gases channel extends to a tip of the at least one of the nasal delivery elements that comprises a gases outlet.
[0717] In some configurations, the nasal interface comprises a plurality of the external gases channels adjacent the at least one of the nasal delivery elements.
[0718] In some configurations, at least one of the external gases channels is adjacent each of the nasal delivery elements.
[0719] In some configurations, a plurality of the external gases channels is adjacent each of the nasal delivery elements.
[0720] In some configurations, the external gases channel has an expanding or bifurcated configuration in region distal from the at least one of the nasal delivery elements, to enable gases flow away from the frame.
[0721] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use. [0722] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0723] In some configurations, the gases inlet port comprises two or a plurality of gases inlet ports.
[0724] In some configurations, the bias flow vent is downstream of the second nasal delivery element.
[0725] In some configurations, the bias flow vent is more proximal the second nasal delivery element.
[0726] In some configurations, the bias flow vent is between the first and second nasal delivery elements.
[0727] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element wherein the gases inlet port points substantially toward the first nasal delivery element.
[0728] In some configurations, the gases inlet port is substantially directed toward the first nasal delivery element.
[0729] In some configurations, the gases inlet is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
[0730] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and net pressure.
[0731] In some configurations, the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow.
[0732] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0733] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0734] In some configurations, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
[0735] In some configurations, the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
[0736] In some configurations, the first nasal delivery element and the second nasal delivery element are each substantially straight.
[0737] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements.
[0738] In some configurations, the first nasal delivery element is larger than the second nasal delivery element.
[0739] In some configurations, the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
[0740] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions.
[0741] In some configurations the pair of side arms are configured to be moveable to follow the contours of the face.
[0742] In some configurations, the side arms are formed of a flexible material.
[0743] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[0744] In some configurations, a headgear comprises the button hole for connection to the attachment button.
[0745] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button.
[0746] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[0747] 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 to a portion of a headgear.
[0748] In some configurations, the ball portion comprises at least one protrusion to limit the range of articulation between the ball portion and the socket portion.
[0749] In some configurations, at least one side arm comprises a buckle.
[0750] In some configurations, the buckle is formed as a figure of eight.
[0751] In some configurations, the bias flow vent comprises an aperture or an aperture and a diffuser.
[0752] In some configurations, the nasal interface 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 bias flow vent.
[0753] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[0754] In some configurations, there are a plurality of the spaced apart baffles extending along the gases flow channel.
[0755] In some configurations, the at least one baffle extend across the interface body, a frame portion, or both an interface body and a frame portion of the nasal interface. [0756] In some configurations, at least one of the nasal delivery elements has a tapering wall portion.
[0757] In some configurations, the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
[0758] In some configurations, a base of at least one of the nasal delivery elements has an angled portion.
[0759] In some configurations, the base has a frustoconical shape.
[0760] In some configurations, the nasal interface comprises a connector coupled to, or defining, the gases inlet port.
[0761] In some configurations, the connector comprises a gases delivery portion to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion configured to receive incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion. [0762] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet port.
[0763] 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 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.
[0764] In some configurations, the second direction is a laterally outward direction. [0765] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines a second axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other.
[0766] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0767] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0768] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0769] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0770] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. The first axis and the inlet axis may be aligned with each other. Accordingly, an angle between the first axis and the inlet axis may be 0 degrees.
[0771] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0772] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other. [0773] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0774] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0775] In some configurations, the nasal interface comprises a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
[0776] In some configurations, the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
[0777] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0778] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0779] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0780] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0781] In some configurations, the annular portion of the conduit retainer is C- shaped.
[0782] In some configurations, the conduit retainer comprises a pair of inwardly facing arms forming a channel for a strap or arm to pass therethrough.
[0783] some configurations, the pair of inwardly facing arms maintain a space or gap in-between them.
[0784] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0785] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body.
[0786] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements. [0787] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[0788] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[0789] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
[0790] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[0791] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[0792] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
[0793] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
[0794] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0795] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0796] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0797] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
[0798] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove. [0799] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0800] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[0801] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[0802] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0803] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0804] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0805] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0806] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0807] In some configurations, the frame member comprises substantially straight upper and lower edges.
[0808] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0809] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0810] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0811] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0812] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0813] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[0814] In some configurations, the side arms are formed of a flexible material. [0815] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
[0816] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hingedly articulate along the lines of the X-shape.
[0817] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[0818] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[0819] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[0820] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[0821] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[0822] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0823] 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.
[0824] In some configurations, side arms or headgear arms comprise cheek pads.
[0825] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0826] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm. [0827] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0828] In some configurations, the cheek pad is formed as a hollow body.
[0829] 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.
[0830] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0831] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[0832] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[0833] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[0834] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[0835] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[0836] In some configurations, the loops comprise webbing.
[0837] In some configurations, the struts have a uniform length.
[0838] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[0839] In some configurations, the securing member is flexible to allow a circumferential expansion.
[0840] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[0841] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, to provide an articulating connection of the headgear with the nasal interface. [0842] In some configurations, each side arm comprises a headgear connection feature to movably connect to either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to respective connectors on first and second ends of a headgear.
[0843] In some configurations, the headgear connection feature on a first one of the side arms 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 the headgear connecting portion for connecting the headgear end portion of a headgear, and wherein a second one of the side arms 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. [0844] In some configurations, each headgear connection feature is moveably connectable to either of the connectors on the first and second ends of the headgear.
[0845] 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.
[0846] In some configurations, the ball portion comprises at least one protrusion to limit the range of articulation between the ball portion and the socket portion.
[0847] In some configurations, the at least one protrusion limits the maximum pivot angle to 45 degrees relative to the side arm.
[0848] In some configurations, at least one side arm comprises a buckle.
[0849] In some configurations, the buckle is formed as a figure of eight. [0850] In some configurations, the first and second nasal delivery elements are non-sealing.
[0851] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is the non-sealing nasal delivery element and is configured to not form a seal with the respective naris of the patient in use.
[0852] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element is exclusive of sealing with the respective naris of the patient.
[0853] In some configurations, the bias flow vent is downstream of the second nasal delivery element.
[0854] In some configurations, the bias flow vent is more proximal the second nasal delivery element.
[0855] In some configurations, the bias flow vent is between the first and second nasal delivery elements.
[0856] In some configurations, the gases inlet port comprises two or a plurality of gases inlet ports.
[0857] In some configurations, the at least one of the first nasal delivery element and the second nasal delivery element wherein the gases inlet port points substantially toward the first nasal delivery element.
[0858] In some configurations, the gases inlet port is substantially directed toward the first nasal delivery element.
[0859] In some configurations, the gases inlet is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
[0860] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and net pressure.
[0861] In some configurations, the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow.
[0862] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0863] In some configurations, the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
[0864] In some configurations, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
[0865] In some configurations, the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
[0866] In some configurations, the first nasal delivery element and the second nasal delivery element are each substantially straight.
[0867] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements.
[0868] In some configurations, the first nasal delivery element is larger than the second nasal delivery element.
[0869] In some configurations, the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
[0870] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions.
[0871] In some configurations the pair of side arms are configured to be moveable to follow the contours of the face.
[0872] In some configurations, the side arms are formed of a flexible material.
[0873] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[0874] In some configurations, a head gear strap comprises the button hole for connection to the attachment button. [0875] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[0876] 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 to a portion of a headgear.
[0877] In some configurations, the bias flow vent comprises an aperture or an aperture and a diffuser.
[0878] In some configurations, the nasal interface 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 bias flow vent.
[0879] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[0880] In some configurations, there are a plurality of the spaced apart baffles extending along the gases flow channel.
[0881] In some configurations, the at least one baffle extend across the interface body, a frame portion, or both an interface body and a frame portion of the nasal interface. [0882] In some configurations, at least one of the nasal delivery elements has a tapering wall portion.
[0883] In some configurations, the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
[0884] In some configurations, a base of at least one of the nasal delivery elements has an angled portion.
[0885] In some configurations, the base has a frustoconical shape.
[0886] In some configurations, the nasal interface comprises a connector coupled to, or defining, the gases inlet port.
[0887] In some configurations, the connector comprises a gases delivery portion to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion configured to receive incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion. [0888] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet port.
[0889] 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 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.
[0890] In some configurations, the second direction is a laterally outward direction. [0891] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines a second axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other.
[0892] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0893] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
[0894] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0895] In some configurations, the first axis and second axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0896] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other. The first axis and the inlet axis may be aligned with each other. Accordingly, an angle between the first axis and the inlet axis may be 0 degrees.
[0897] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
[0898] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other. [0899] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
[0900] In some configurations, the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
[0901] In some configurations, the nasal interface comprises a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
[0902] In some configurations, the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
[0903] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0904] In some configurations, the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0905] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a headgear strap adjacent to a coupling of the headgear strap with a side arm of the interface body.
[0906] In some configurations, the conduit retainer is positioned laterally outward of the connector and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
[0907] In some configurations, the annular portion of the conduit retainer is C- shaped.
[0908] In some configurations, the conduit retainer comprises a pair of inwardly facing arms forming a channel for a strap or arm to pass therethrough.
[0909] some configurations, the pair of inwardly facing arms maintain a space or gap in-between them.
[0910] In some configurations, the interface body comprises an external gases channel in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external gases channel.
[0911] In some configurations, the external gases channel extends along at least part of the main body portion.
[0912] In some configurations, the external gases channel extends from at or adjacent a base of the at least one of the nasal delivery elements, away from the at least one of the nasal delivery elements. [0913] In some configurations, the interface body comprises a frame portion, and wherein the interface body comprises the main body portion.
[0914] In some configurations, one of the nasal delivery elements is larger than the other of the nasal delivery elements, and wherein the external gases channel is adjacent a smaller one of the nasal delivery elements.
[0915] In some configurations, the the external gases channel extends along at least part of the main body portion and along at least part of the at least one of the nasal delivery elements.
[0916] In some configurations, the external gases channel extends to a tip of the at least one of the nasal delivery elements that comprises a gases outlet.
[0917] In some configurations, the nasal interface comprises a plurality of the external gases channels is adjacent the at least one of the nasal delivery elements.
[0918] In some configurations, at least one of the external gases channels is adjacent each of the nasal delivery elements.
[0919] In some configurations, a plurality of the external gases channels adjacent each of the nasal delivery elements.
[0920] In some configurations, the external gases channel comprises an expanding or bifurcated configuration in region distal from the at least one of the nasal delivery elements, to enable gases flow away from the frame.
[0921] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0922] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0923] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0924] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
[0925] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove. [0926] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0927] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[0928] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[0929] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0930] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0931] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0932] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0933] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0934] In some configurations, the frame member comprises substantially straight upper and lower edges.
[0935] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0936] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0937] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0938] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0939] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0940] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[0941] In some configurations, the side arms are formed of a flexible material. [0942] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
[0943] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hingedly articulate along the lines of the X-shape.
[0944] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[0945] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[0946] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[0947] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[0948] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[0949] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0950] 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.
[0951] In some configurations, side arms or headgear arms comprise cheek pads.
[0952] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0953] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm. [0954] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0955] In some configurations, the cheek pad is formed as a hollow body.
[0956] 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.
[0957] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0958] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[0959] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[0960] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[0961] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[0962] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[0963] In some configurations, the loops comprise webbing.
[0964] In some configurations, the struts have a uniform length.
[0965] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[0966] In some configurations, the securing member is flexible to allow a circumferential expansion.
[0967] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[0968] 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 in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0969] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body.
[0970] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements.
[0971] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[0972] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[0973] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
[0974] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[0975] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[0976] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
[0977] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use. [0978] In some configurations, wherein the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[0979] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[0980] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[0981] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
[0982] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove.
[0983] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[0984] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[0985] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[0986] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[0987] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion. [0988] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[0989] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[0990] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[0991] In some configurations, the frame member comprises substantially straight upper and lower edges. [0992] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline.
[0993] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[0994] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[0995] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[0996] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[0997] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[0998] In some configurations, the side arms are formed of a flexible material.
[0999] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[1000] In some configurations, a headgear comprises the button hole for connection to the attachment button.
[1001] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button.
[1002] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[1003] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
[1004] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hingedly articulate along the lines of the X-shape.
[1005] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line. [1006] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[1007] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[1008] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[1009] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[1010] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[1011] 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.
[1012] In some configurations, side arms or headgear arms comprise cheek pads.
[1013] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[1014] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[1015] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[1016] In some configurations, the cheek pad is formed as a hollow body.
[1017] 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.
[1018] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[1019] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps. [1020] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[1021] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[1022] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1023] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[1024] In some configurations, the loops comprise webbing.
[1025] In some configurations, the struts have a uniform length.
[1026] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[1027] In some configurations, the securing member is flexible to allow a circumferential expansion.
[1028] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[1029] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[1030] 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 in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
[1031] In some configurations, the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
[1032] In some configurations, the nasal interface comprises a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
[1033] In some configurations, the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
[1034] In some configurations, the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove.
[1035] In some configurations, a surface of the frame portion encompassed by its periphery is substantially planar.
[1036] In some configurations, the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
[1037] In some configurations, the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
[1038] In some configurations, the surface of the frame portion has a substantially hour-glass shaped outline.
[1039] In some configurations, the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion.
[1040] In some configurations, the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
[1041] In some configurations, the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
[1042] In some configurations, the surface of the frame portion has a substantially elongated circle segment shaped outline.
[1043] In some configurations, the frame member comprises substantially straight upper and lower edges.
[1044] In some configurations, the surface of the frame portion has a substantially stadium-shaped outline. [1045] In some configurations, the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
[1046] In some configurations, the frame portion, first side arm and second side arm are formed as a unitary member.
[1047] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[1048] In some configurations, the nasal interface comprises an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[1049] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
[1050] In some configurations, the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body.
[1051] In some configurations, the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements.
[1052] In some configurations, the external cutout is a recess in the main body portion of the interface body.
[1053] In some configurations, walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[1054] In some configurations, walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
[1055] In some configurations, the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
[1056] In some configurations, the arc of the external cutout shares a central axis with the at least one nasal delivery element.
[1057] In some configurations, the nasal interface comprises a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body. [1058] In some configurations, the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
[1059] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[1060] In some configurations, the side arms are formed of a flexible material.
[1061] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
[1062] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hingedly articulate along the lines of the X-shape.
[1063] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[1064] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[1065] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[1066] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[1067] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[1068] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use. [1069] 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.
[1070] In some configurations, side arms or headgear arms comprise cheek pads.
[1071] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[1072] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[1073] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[1074] In some configurations, the cheek pad is formed as a hollow body.
[1075] 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.
[1076] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[1077] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[1078] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[1079] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[1080] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1081] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[1082] In some configurations, the loops comprise webbing.
[1083] In some configurations, the struts have a uniform length.
[1084] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member. [1085] In some configurations, the securing member is flexible to allow a circumferential expansion.
[1086] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[1087] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[1088] 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 in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face.
[1089] In some configurations, the side arms are formed of a flexible material.
[1090] In some configurations, the side arms comprise an attachment button configured to selectively connect to a corresponding button hole.
[1091] In some configurations, a headgear comprises the button hole for connection to the attachment button.
[1092] In some configurations, a headgear strap or headgear connecting portion part of the headgear comprises the button hole for connection to the attachment button.
[1093] In some configurations, the attachment button is radially pivotable about the axis of the button hole.
[1094] In some configurations, each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge. [1095] In some configurations, the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hinged ly articulate along the lines of the X-shape.
[1096] In some configurations, the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
[1097] In some configurations, the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
[1098] In some configurations, the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
[1099] In some configurations, the living hinge is formed on the patient facing side of the side arms of when in use.
[1100] In some configurations, the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
[HOI] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
[1102] 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.
[1103] In some configurations, side arms or headgear arms comprise cheek pads.
[1104] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[1105] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[1106] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[1107] In some configurations, the cheek pad is formed as a hollow body. [1108] 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.
[1109] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[1110] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[1111] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[1112] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[1113] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1114] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[1115] In some configurations, the loops comprise webbing.
[1116] In some configurations, the struts have a uniform length.
[1117] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[1118] In some configurations, the securing member is flexible to allow a circumferential expansion.
[1119] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[1120] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[1121] 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 (as described herein) is disclosed, the method comprising articulating the hinge of the living hinge, 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 articulating the hinge the change from first configuration to second configuration.
[1122] 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 in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein 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.
[1123] In some configurations, side arms or headgear comprise cheek pads.
[1124] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[1125] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[1126] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[1127] In some configurations, the cheek pad is formed as a hollow body.
[1128] 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.
[1129] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[1130] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[1131] In some configurations, the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[1132] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[1133] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1134] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[1135] In some configurations, the loops comprise webbing.
[1136] In some configurations, the struts have a uniform length.
[1137] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[1138] In some configurations, the securing member is flexible to allow a circumferential expansion.
[1139] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[1140] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[1141] 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 in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms comprise buckles at their distal ends for connecting to straps.
[1142] 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 in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[1143] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
[1144] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1145] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[1146] In some configurations, the loops comprise webbing.
[1147] In some configurations, the struts have a uniform length.
[1148] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[1149] In some configurations, the securing member is flexible to allow a circumferential expansion.
[1150] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[1151] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[1152] 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: 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.
[1153] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a headgear is disclosed, the headgear comprising : a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
[1154] In some configurations, the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive the patient's hair.
[1155] In some configurations, adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1156] In some configurations, the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
[1157] In some configurations, the loops comprise webbing.
[1158] In some configurations, the struts have a uniform length.
[1159] In some configurations, the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
[1160] In some configurations, the securing member is flexible to allow a circumferential expansion.
[1161] In some configurations, the securing member comprises buckles at each of its circumferential ends.
[1162] 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 headgear according to any of the configurations above; and a nasal interface for delivering respiratory gases to a patient, wherein the headgear is configured to support the nasal interface on a patient's head.
[1163] In some configurations, the nasal interface comprises an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient. [1164] In some configurations, at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element.
[1165] In some configurations, the nasal interface comprises a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body.
[1166] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
[1167] In some configurations, the gases inlet port is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element to create or contribute to an asymmetric flow, wherein the gases inlet port is optionally substantially directed toward the first nasal delivery element and/or proximal to the first nasal delivery element and distal from the second nasal delivery element.
[1168] In some configurations, the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse, optionally orthogonal, to 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, the first nasal delivery element and the second nasal delivery element optionally being symmetrical about said midline plane of the interface body.
[1169] In some configurations, the interface body comprises a first side at which the first and second nasal delivery elements are provided and an opposite second side at which the inlet port as well as the bias flow vent 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.
[1170] In some configurations, the first nasal delivery element is larger than the second nasal delivery element, optionally the cross section of the internal flow area of the larger nasal delivery element being greater than that of the other nasal delivery element.
[1171] In some configurations, the nasal interface comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the gases inlet port toward a region corresponding generally to the bias flow vent, wherein the at least one baffle is optionally arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent. [1172] In some configurations, the nasal interface comprises a connector for coupling the gases supply conduit to the interface body to enable the passage of the incoming respiratory gases from the gases supply conduit to the gases flow channel, the connector being coupled to or defining the gases inlet port, wherein the connector optionally is an elbow, which is optionally configured to redirect the gas flow by more than 30 degrees, more than 60 degrees or by approximately 90 degrees.
[1173] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein optionally, the pair of side arms are configured to be moveable to follow the contours of the face, optionally, the side arms being formed of a flexible material, optionally, 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.
[1174] 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 in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, and a bias flow vent 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.
[1175] In some configurations, the gases inlet port is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element to create or contribute to the asymmetric flow, wherein the gases inlet port is optionally substantially directed toward the first nasal delivery element and/or proximal to the first nasal delivery element and distal from the second nasal delivery element.
[1176] In some configurations, the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and the inlet axis are aligned with each other or at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
[1177] In some configurations, the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse, optionally orthogonal, to 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, the first nasal delivery element and the second nasal delivery element optionally being symmetrical about said midline plane of the interface body.
[1178] In some configurations, the second nasal delivery element comprises a second gases outlet, wherein the second gases outlet defines a second axis corresponding to a direction of gases flow through the second gases outlet, wherein the first axis, the second axis and the inlet axis all lie within the plane of the interface body that is transverse to said first midline plane.
[1179] In some configurations, the first axis and the second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
[1180] In some configurations, the bias flow vent defines an outlet axis corresponding to a direction of gases flow through the bias flow vent, wherein the second axis and the outlet axis are aligned with each other or at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
[1181] In some configurations, the gases inlet port and the bias flow vent are provided on opposite sides of said midline plane, the gases inlet port and the bias flow vent optionally being symmetrical about said midline plane.
[1182] In some configurations, the interface body comprises a first side at which the first and second nasal delivery elements are provided and an opposite second side at which the inlet port as well as the bias flow vent 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.
[1183] In some configurations, the first nasal delivery element is larger than the second nasal delivery element, optionally the cross section of the internal flow area of the larger nasal delivery element being greater than that of the other nasal delivery element.
[1184] In some configurations, the bias flow vent comprises an aperture or an aperture and a diffuser. [1185] In some configurations, the nasal interface comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the gases inlet port toward a region corresponding generally to the bias flow vent, wherein the at least one baffle is optionally arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
[1186] In some configurations, the nasal interface comprises a connector for coupling the gases supply conduit to the interface body to enable the passage of the incoming respiratory gases from the gases supply conduit to the gases flow channel, the connector being coupled to or defining the gases inlet port, wherein the connector optionally is an elbow, which is optionally configured to redirect the gas flow by more than 30 degrees, more than 60 degrees or by approximately 90 degrees.
[1187] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein optionally, the pair of side arms are configured to be moveable to follow the contours of the face, optionally, the side arms being formed of a flexible material, optionally, 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.
[1188] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hinged ly articulate to follow the contours of the face, and optionally wherein each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
[1189] In some configurations, the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable, and optionally wherein the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove, and which optionally a surface of the frame portion encompassed by its periphery is substantially planar.
[1190] 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 and optionally the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek, and which optionally 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.
[1191] In some configurations, the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout, and optionally wherein the external cutout is a recess in the main body portion of the interface body, and which optionally walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
[1192] In some configurations, nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb, and optionally comprising a plurality of substantially vertically arranged struts, and which adjacent struts optionally are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1193] In some configurations, the headgear comprises a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb, and optionally comprising a plurality of substantially vertically arranged struts, and which adjacent struts optionally are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
[1194] 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 headgear according to any configuration above and a nasal interface according to any configuration above, wherein the headgear is configured to support the nasal interface on a patient's head.
[1195] 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: a nasal interface according to any configuration above and a headgear comprising first and second ends with ball or socket portions that are configured to connect to the ball or socket portions on the side arms. [1196] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a respiratory therapy apparatus is disclosed, the respiratory therapy apparatus comprising : a controller; an ambient air inlet; a gases outlet; and a nasal interface according to any configuration above or a patient interface according to configuration above.
[1197] 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 outlined above or herein is disclosed and a headgear comprising first and second ends with connectors that are configured to connect to the headgear connection features on the side arms.
[1198] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a respiratory therapy apparatus is disclosed, the respiratory therapy apparatus comprising : a controller; an ambient air inlet; a gases outlet; and a nasal interface outlined above or herein is disclosed.
[1199] In some configurations, the apparatus 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.
[1200] 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.
[1201] As used herein a feature referred to as "a" feature means a singular and/or plurality and/or at least one of said feature.
[1202] As used herein the term "(s)" following a noun means the plural and/or singular form of that noun.
[1203] As used herein the term "and/or" means "and" or "or", or where the context allows both.
[1204] 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. [1205] 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.
[1206] 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.
[1207] The disclosure consists in the foregoing and also envisages constructions of which the following gives examples only.
BRIEF DESCRIPTION OF THE DRAWINGS
[1208] 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:
[1209] Figure 1 is a perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface.
[1210] Figure 2 shows an elevated front perspective view of the nasal interface of Figure 1.
[1211] Figure 3 shows a top perspective view of the nasal interface of Figure 1.
[1212] Figure 4 shows a rear perspective view (i.e. from the patient direction) of the nasal interface of Figure 1.
[1213] Figure 5 shows a top section perspective view of the nasal interface of Figure 1.
[1214] Figure 6 shows a top section perspective view of the nasal interface of Figure 1 with flow annotations.
[1215] Figure 7 shows an enhanced top section perspective view of the nasal interface of Figure 1. [1216] Figure 8 shows a top perspective view of an exemplary configuration of a nasal interface of the present disclosure which may be the nasal interface of or for use with any of the features of the figures herein.
[1217] Figure 9 shows a rear perspective view of an interface body of an arrangement of the nasal interface of the present disclosure which may be the nasal interface of or for use with any of the features of the figures herein.
[1218] Figure 10 shows a top perspective view of the interface body of Figure 9.
[1219] Figure 11 shows a rear perspective view of the interface body of the nasal interface the present disclosure which may be the nasal interface of or for use with any of the features of the figures herein.
[1220] Figure 12 shows a top perspective view of the interface body of Figure 11.
[1221] Figure 13 shows a front perspective view (i.e. toward the patient) of the nasal interface of Figure 1 or may be a nasal interface of or for use with any of the features of the other figures herein.
[1222] Figure 14 shows a front perspective view of an exemplary configuration of a patient interface having a nasal interface of the present disclosure which may be the nasal interface of or for use with any of the features of the figures herein.
[1223] Figure 15 shows a front perspective view of a frame of the nasal interface of Figure 1 or may be a frame of a nasal interface of or for use with a nasal interface of any of the features of the other figures herein.
[1224] Figure 16 shows a rear perspective view of the frame of Figure 15.
[1225] Figure 17 shows a rear perspective view of an exemplary configuration of a nasal interface of the present disclosure which may be the nasal interface of or for use with any of the features of the figures herein and having the frame of Figures 15 or 16.
[1226] Figure 18 shows a front section perspective view of the nasal interface of Figure 1 or may be a nasal interface of or for use with any of the features of the other figures herein.
[1227] Figure 19 shows a front perspective detailed view the side arm of the nasal interface such as shown in Figures 14 to 17, or for use with any of the features of the other figures herein.
[1228] Figure 20 shows a front perspective detailed view the side arm of Figure 19.
[1229] Figure 21 shows a side perspective detailed view the side arm of Figure 19.
[1230] Figure 22 shows a side perspective detailed view the side arm of Figure 19.
[1231] Figure 23 shows a side perspective detailed view the side arm of Figure 19.
[1232] Figure 24 shows a top plan detailed view the side arm of Figure 19. [1233] Figure 25 shows a top section perspective view of an alternative side arm of the nasal interface of Figure 1 or for use with a nasal interface of any of the features of the other figures herein.
[1234] Figure 26 shows a bottom angled transparent perspective view of the side arm of the nasal interface of Figure 25.
[1235] Figure 27 shows a top perspective view of the side arm of the nasal interface of Figure 25.
[1236] Figure 28 shows a rear transparent perspective view of the side arm of the nasal interface of Figure 25.
[1237] Figure 29 shows a top perspective view of the nasal interface of Figure 1, which may also be the nasal interface of or used with any of the features of the other figures herein.
[1238] Figure 30 shows an exemplary configuration of an alternative arrangement of a patient interface of the present disclosure which may be for use with any of the features of the figures herein.
[1239] Figure 31 shows rear perspective view of the nasal interface of the patient interface of Figure 30.
[1240] Figure 32 shows a front perspective view of the nasal interface of Figure 1 with a cap or for use with a nasal interface of any of the features of the other figures herein.
[1241] Figure 33 shows top perspective section view of the nasal interface of Figure 32.
[1242] Figure 34 shows a top perspective view of the nasal interface of Figure 1 with a cap or for use with a nasal interface of any of the features of the other figures herein.
[1243] Figure 35 shows top perspective section view of the nasal interface of Figure 34.
[1244] Figure 36 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1245] Figure 37 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein. [1246] Figure 38 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1247] Figure 39 shows a front perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1248] Figure 40 shows a top section view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1249] Figure 41 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1250] Figure 42 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1251] Figure 43 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1252] Figure 44 shows a top perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1253] Figure 45 shows a bottom perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1254] Figure 46 shows a top perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1255] Figure 47 shows a rear view of the nasal interface of Figure 1 with external cutouts or for use with a nasal interface of any of the features of the other figures herein.
[1256] Figure 48 shows a top view of the nasal interface of Figure 47.
[1257] Figure 49 shows a rear view of the nasal interface of Figure 1 with alternative external cutouts or for use with a nasal interface of any of the features of the other figures herein.
[1258] Figure 50 shows a rear perspective view of the nasal interface of Figure 1 with alternative external cutouts or for use with a nasal interface of any of the features of the other figures herein. [1259] Figure 51 shows a rear perspective view of the nasal interface of Figure 50 with a single external cutout.
[1260] Figure 52 shows a rear perspective view of the nasal interface of Figure 1 with alternative external cutouts or for use with a nasal interface of any of the features of the other figures herein.
[1261] Figure 53 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1262] Figure 54 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1263] Figure 55 shows a rear perspective view of the nasal interface of Figure 1 with channels or for use with a nasal interface of any of the features of the other figures herein.
[1264] Figure 56 shows a top perspective view of the nasal interface of Figure 1 with a cutout or for use with a nasal interface of any of the features of the other figures herein.
[1265] Figure 57 shows a rear perspective view of the nasal interface of Figure 56.
[1266] Figure 58 shows a top perspective view of the nasal interface of Figure 1 with a tube or for use with a nasal interface of any of the features of the other figures herein.
[1267] Figure 59 shows a front perspective view of the nasal interface of Figure 1 with a tube or for use with a nasal interface of any of the features of the other figures herein.
[1268] Figure 60 shows a side cross-sectional view of an exemplary configuration of a nasal interface of the present disclosure which may be the nasal interface of or for use with any of the features of the figures herein.
[1269] Figure 61 shows a top perspective view of the nasal interface of Figure 60.
[1270] Figure 62 shows a cross-sectional view of the nasal interface of Figure 61 .
[1271] Figure 63 shows a side cross-sectional view of the nasal interface of Figure
62 in use.
[1272] Figure 64 shows a rear perspective view of an exemplary configuration of a nasal interface of the present disclosure which may be the nasal interface of or for use with any of the features of the figures herein.
[1273] Figure 65 shows a top perspective view of the nasal interface of Figure 64. [1274] Figure 66 shows a side cross-sectional view of the nasal interface of Figure 64.
[1275] Figure 67 shows a rear perspective view of an exemplary configuration of a nasal interface of the present disclosure with a raised portion which may be the nasal interface of or for use with any of the features of the figures herein.
[1276] Figure 68 shows a rear perspective view of an exemplary configuration of a nasal interface of of the present disclosure with a recessed portion or for use with a nasal interface of any of the features of the other figures herein.
[1277] Figure 69 shows a top cross-sectional view of the nasal interface of Figure 68.
[1278] Figure 70 shows a top perspective view of an exemplary configuration of a nasal interface of the present disclosure or for use with a nasal interface of any of the features of the other figures herein.
[1279] Figure 71 shows a rear perspective view of the nasal interface of Figure 70.
[1280] Figure 72 shows a bottom perspective view of an exemplary configuration of a nasal interface of the present disclosure or for use with a nasal interface of any of the features of the other figures herein.
[1281] Figure 73 shows a rear perspective view of the nasal interface of Figure 72.
[1282] Figure 74 shows a side perspective view of an exemplary configuration of a nasal interface of the present disclosure or for use with a nasal interface of any of the features of the other figures herein.
[1283] Figure 75 shows a top cross-sectional view of an exemplary configuration of a nasal interface of the present disclosure or for use with a nasal interface of any of the features of the other figures herein.
[1284] Figure 76 shows a bottom perspective view of an exemplary configuration of a nasal interface of the present disclosure or for use with a nasal interface of any of the features of the other figures herein.
[1285] Figure 77 shows a front view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1286] Figure 78 shows a top plan view of a frame of Figure 77.
[1287] Figure 79 shows a front perspective view of a frame of Figure 77.
[1288] Figure 80 shows a front perspective view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein. [1289] Figure 81 shows a top rear perspective view of a frame of Figure 80.
[1290] Figure 82 shows a rear perspective view of the interface body of Figure 80.
[1291] Figure 83 shows a side sectional view of the interface body of Figure 80.
[1292] Figure 84 shows a front view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1293] Figure 85 shows a side sectional view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1294] Figure 86 shows a rear perspective view of the interface body of Figure 85.
[1295] Figure 87 shows a bottom cross-sectional view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1296] Figure 88 shows a rear perspective view of the nasal interface of Figure 87.
[1297] Figure 89 shows a front perspective view of the nasal interface of Figure 87.
[1298] Figure 90 shows a side cross-sectional view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1299] Figure 91 shows a rear perspective view of the nasal interface of Figure 90.
[1300] Figure 92 shows a front perspective view of an exemplary configuration of a nasal interface of the present disclosure with a living hinge for use with a nasal interface of any of the features of the other figures herein.
[1301] Figure 93 shows a detailed rear view of a configuration of a living hinge of Figure 92.
[1302] Figure 94 shows a detailed rear view of a configuration of a living hinge of Figure 92.
[1303] Figure 95 shows a detailed rear view of a configuration of a living hinge of Figure 92.
[1304] Figure 96 shows a top view of a configuration of the nasal interface of Figure 92.
[1305] Figure 97 shows a top perspective view of a configuration of a living hinge of Figure 92. [1306] Figure 98 shows a perspective view of a headgear connecting portion for use with the nasal interface of Figure 1 or for use with a nasal interface of any of the features of the other figures herein.
[1307] Figure 99 shows a detailed perspective view of the headgear connecting portion of Figure 98 connected to a nasal interface of any of the features of the other figures herein.
[1308] Figure 100 shows a perspective view of an alternative headgear connecting portion to that of Figure 98 and Figure 99 comprising a tube retainer.
[1309] Figure 101 shows a top view of the nasal interface of the present disclosure comprising attachment buttons for use with a nasal interface of any of the features of the other figures herein.
[1310] Figure 102 shows a front perspective detailed view of a configuration of the attachment button of Figure 101 engaging with a button hole of a headgear.
[1311] Figure 103 shows a side perspective view of a configuration of the attachment button of Figure 101 engaging with a button hole of a headgear.
[1312] Figure 104 shows a bottom perspective view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1313] Figure 105 shows a top perspective view of t an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1314] Figure 106 shows a top perspective view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1315] Figure 107 shows a top view of an exemplary configuration of a nasal interface of the present disclosure including cheek pads for use with a nasal interface of any of the features of the other figures herein.
[1316] Figure 108 shows a detailed top perspective view of the cheek pads of Figure 107.
[1317] Figure 109 shows a side schematic view of an alternative cheek pad to Figure 107.
[1318] Figure 110 shows a side schematic view of an alternative cheek pad to Figure 107 with a hooking portion.
[1319] Figure 111 shows a side schematic view of an alternative cheek pad to Figure 107. [1320] Figure 112 shows a top perspective view of an alternative hooking portion to Figure 110.
[1321] Figure 113 shows a top perspective view of an alternative hooking portion to Figure 110.
[1322] Figure 114 shows a front view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1323] Figure 115 shows a top perspective view of an exemplary configuration of a patient interface of the present disclosure comprising a nasal interface and including a securing member for use with a patient interface of any of the features of the other figures herein.
[1324] Figure 116 shows a front view of the securing member of Figure 115.
[1325] Figure 117 shows a front view of an alternative securing member of Figure
115.
[1326] Figure 118 shows a front view of an alternative securing member of Figure 115.
[1327] Figure 119 shows a front view of an alternative securing member of Figure 115.
[1328] Figure 120 shows a front view of an alternative securing member of Figure 115.
[1329] Figure 121 shows a top perspective view of the patient interface including the securing member of Figure 120.
[1330] Figure 122 shows a front view of an alternative securing member of Figure 115.
[1331] Figure 123 shows a front view of buckles for use with the patient interface of Figure 1 or for use with a patient interface of any of the features of the other figures herein.
[1332] Figure 124 shows a front perspective view of an exemplary configuration of a nasal interface of the present disclosure including a recess for use with a nasal interface of any of the features of the other figures herein.
[1333] Figure 125 shows a front perspective view of the nasal interface of Figure 124 including a cap for the recess.
[1334] Figure 126 shows a front perspective view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein. [1335] Figure 127 shows a bottom cross-sectional view of the nasal interface of Figure 126.
[1336] Figure 128 shows a partial front perspective view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1337] Figure 129 shows a front perspective view of an exemplary configuration of a nasal interface of the present disclosure with an alternative configuration for use with a nasal interface of any of the features of the other figures herein.
[1338] Figure 130 shows a front perspective view of the nasal interface of Figure 129.
[1339] Figure 131 shows a front perspective view of a tube retainer for use with the nasal interface of Figure 1 or for use with a nasal interface of any of the features of the other figures herein.
[1340] Figure 132 shows a front cross-sectional view of an exemplary configuration of a nasal interface of the present disclosure including a structural support for use with a nasal interface of any of the features of the other figures herein.
[1341] Figure 133 shows a front cross-sectional view of an exemplary configuration of a nasal interface of the present disclosure including a structural support for use with a nasal interface of any of the features of the other figures herein..
[1342] Figure 134 shows a lower front cross-sectional view of an exemplary configuration of a nasal interface of the present disclosure including a structural support for use with a nasal interface of any of the features of the other figures herein..
[1343] Figure 135 shows a front perspective view of an exemplary configuration of a nasal interface of the present disclosure including lateral protrusions for use with a nasal interface of any of the features of the other figures herein.
[1344] Figure 136 shows a rear perspective view of an exemplary configuration of a nasal interface of the present disclosure including lateral notches and tabs for use with a nasal interface of any of the features of the other figures herein.
[1345] Figure 137 shows a top perspective sectional view of an exemplary configuration of a nasal interface of the present disclosure including a polarised groove for use with a nasal interface of any of the features of the other figures herein.
[1346] Figure 138 shows a top perspective sectional view of an exemplary configuration of a nasal interface of the present disclosure including a polarised groove for use with a nasal interface of any of the features of the other figures herein. [1347] Figure 139 shows a front view of an interface body of the nasal interfaces of Figures 137 and 138.
[1348] Figure 140 shows schematically a respiratory therapy system configured to provide a respiratory therapy to a patient.
[1349] Figure 141 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
[1350] Patient interfaces are used for delivering respiratory gases to airways of a patient. The patient interfaces of the present disclosure comprise a nasal interface that delivers a flow of gases to a patient. In some arrangements, nasal delivery elements, such as nasal prongs, are inserted into the nose of a patient to deliver the required gases. The nasal delivery elements of the present disclosure are non-sealing at the nose to deliver the respiratory gases. A non-sealing nasal delivery element allows for some movement of respiratory gases between the respective nasal passageway and the outside environment, along an exterior of the nasal delivery element. In some arrangements, the non-sealing nasal delivery element is substantially spaced from the internal skin of the naris or has minimal contact with the naris. The non-sealing nasal interface may also be exclusive of sealing with the respective naris of the patient in use. A nasal interface with non-sealing nasal delivery elements reduces the pressure difference in the patient's respiratory tract and lungs relative to standard atmospheric pressure. This can prevent tissue damage to the airways and/or lungs due to pressure differences. A non-sealing interface may also be more comfortable to a patient. Further a non-sealing interface may be used where a patient is being moved to self-breathing after high-flow therapy, for instance. The nonsealing nasal interface is such that there is no occlusion or, in some arrangements, partial occlusion of the nares by the nasal delivery elements. In some arrangements, at least one of the nasal delivery elements may partly occlude the nasal passage through the naris, but will still allow the flow of gases between the respective nasal passageway and the outside environment, along an exterior of the nasal delivery element.
[1351] Disclosed is a system to deliver gases to a patient through a nasal interface.
[1352] In some arrangements, an asymmetric flow of respiratory gases is provided to the patient. That is, a 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.
[1353] A nasal interface that provides 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.
[1354] Total unidirectional flow is where all flow enters one naris by a nasal delivery element and exiting via the other naris via a nasal delivery element or venting to the atmosphere. Partial unidirectional flow is where flow enters the nose via both nares and leaves the nose from one naris, flow that enters the nose through one naris and leave the nose via both nares, or different proportions of flow that enter the nose through both nares and/or different proportions of flow that may leave the nose through both nares (and optionally the mouth). In non-sealing interfaces, the asymmetric flow with likely be partial unidirectional flow as inhalation or expiration includes atmospheric air. 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. The partially unidirectional flow may reduce turbulence in the patient's nasal cavity, which could also improve comfort. A reduction in turbulence can also reduce noise in the nasal cannula providing a quieter interface.
[1355] 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.
[1356] 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.
[1357] Figure 1 shows 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. The nasal interface 100 is shown in Figures 1 to 139 and the present description applies.
[1358] The nasal interface 100 provides a patient with a delivery of flow-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 - I l l - wide flow range (e.g. about 8 Ipm, 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.
[1359] 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.
[1360] The nasal interface 100 comprises a face mount part or interface body 110 (or 110a) part including the pair of hollow nasal delivery elements 111 and 112, integrally moulded with or removably attached to a main body of the interface body 110. The nasal interface 100 comprises a gases manifold 120 part or frame 120 (or 120a) that comprises a gases inlet port 121 (or gases port 121 I gases inlet 121). The frame 120 may be removably attached or integrally moulded to a respiratory conduit 300.
[1361] The interface body 110 may be connectable to or engageable with the frame 120, or may be integrally formed or permanently engaged with the frame 120. The interface body 110 may refer to the interface body 110 including the frame 120 in some arrangements. The connecting or engaging of the interface body 110 with the frame 120 brings the first nasal delivery element 111 and the second nasal delivery element 112 into fluid communication with the gases inlet port 121 such that the first nasal delivery element
111 is more proximal the gases inlet port 121 and the second nasal delivery 112 element is more distal the gases inlet port 121.
[1362] In Figure 1, the frame 120 is partially positioned within the interface body 110 and thus obscured.
[1363] The interface body 110 may be formed from a soft, flexible material such as silicone, thermoplastic elastomers, or other polymers known in the art. In some arrangements it may be referred to as a cushion. 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. [1364] The frame 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 frame 120 fluidly couples the respiratory conduit 300 to the nasal delivery elements 111 and 112 of the interface body 110.
[1365] The nasal delivery elements 111 and 112 are substantially hollow.
[1366] In the arrangement of Figure 1, the first and second nasal delivery elements 111, 112 have a different shape and/or configuration from each other, i.e. may be asymmetrical. In some arrangements described herein, the first and second nasal delivery elements 111, 112 have the same shape and configuration as each other, i.e. may be symmetrical.
[1367] 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.
[1368] The interface body 110 comprises a base portion 118 from which the nasal delivery elements 111 and 112 extend. The base portion 118 is part of the main body of the interface body 110.
[1369] The base portion 118 is arranged to locate between a patient's face and the frame 120 in use. The base portion 118 may act as a cushion to avoid the frame 120 from touching the patient's face.
[1370] In the arrangement 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.
[1371] In the arrangement shown in Figure 1, the side arms 101, 102 are integrally formed with the frame 120. One side arm 101 is formed as part of the frame 120 where the gases inlet port 121 is formed. Part of the frame 120 forms a feature that sits external to the interface body 120 and surrounds the gases inlet port 121 and extends laterally to form the side arm 101.
[1372] The other side arm 102 is formed as part of the frame 120 where the other gases port 122 is formed. Part of the frame 120 forms a feature that sits external to the interface body 120 and at the gases port 122 (and as described with reference to Figure 2 below, forms or is the bias flow vent 340) and extends laterally to form the other side arm 102.
[1373] The side arms 101, 102 may alternatively be formed as part of the base portion 118 or interface body 110 but may alternatively be separate parts.
[1374] Whilst one arrangement of side arms 101, 102 is shown in Figure 1, other arrangements are described herein.
[1375] The nasal interface 100 comprises respective headgear connecting portions 1005, 1006. The headgear connecting portions 1005, 1006 are intermediary connectors between the headgear 200 and the side arms 101, 102. Therefore, in some arrangements, each headgear connecting portion 1005, 1006 connects at one end to the side arm 101, 102 and at its other end to the headgear 200.
[1376] In some configurations, the nasal delivery elements 111, 112 extend generally rearwardly from the frame interface body 110 or base portion 118.
[1377] Whilst a single feature may be shown in the figures, it will be appreciated that "at least one" of these features may be present. In some arrangements, at least one or a plurality of features may be present to provide the overall feature. In particular, whilst the gases inlet 121 is shown in the figures, a plurality of gases inlet ports 121 (and outlet ports 122) may be provided or a plurality of inlets forming a common inlet port 121 may be provided. Therefore, reference to "a" or "the" inlet port 121 is not intended to be limited to the singular and may be taken to be at least one inlet port 121. In some arrangements, two inlet gases ports 121 are provided.
[1378] The interface body 110 is generally tubular in shape comprising a gases port 121, 122 proximal at least one side thereof, and generally extending from a front of the nasal interface 100. At least one of the gases ports 121, 122 may be the gases inlet port 121 described herein. 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 121 for the interface body 110 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.
[1379] Flow enters the nasal interface 100 through the gases port 111, 112 and travels through the interface body 110 in a direction that is transverse to the direction the flow is intended to travel into the first and second nasal delivery elements 111, 112. This forms the gases flow channel.
[1380] The gases inlet is in fluid communication with the respiratory conduit 300.
[1381] 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.
[1382] Referring to Figure 2, a detailed view of the nasal interface of Figure 1 is shown. The headgear connecting portions 1005, 1006 and headgear 200 are omitted for the explanation. Otherwise, the description provided in reference to Figure 1 applies for features with like reference signs.
[1383] The conduit 300 is connected to the gases inlet port 121 via a connector. The connector may be configured to reduce turbulent flow of gases passing through the conduit 300 into the gases inlet port 121.
[1384] In some arrangements, the connector is a gases delivery elbow 351. The gases delivery elbow 351 forms an angled interface between the conduit 300 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.
[1385] 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.
[1386] 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.
[1387] 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.
[1388] As shown, the nasal interface 100 comprises an interface body 110 comprising a gases flow channel (125, see Figure 6), a first nasal delivery element 111 in fluid communication with the gases flow channel 125 and configured to deliver gases to a first naris of the patient, a second nasal delivery element 112 in fluid communication with the gases flow channel 125 and configured to deliver gases to a second naris of the patient, a gases inlet port 121 in the interface body 110 and in fluid communication with the gases flow channel 125, the gases inlet port 110 for receiving incoming respiratory gases from a gases supply conduit 300 and enabling the incoming respiratory gases to be delivered into the interface body 110, wherein the nasal interface 110 is configured to create an asymmetric flow of gases at a patient's nasal airways. The nasal interface 100 optionally includes or comprises any of the features described herein with reference to Figures 1 to 139.
[1389] In some arrangements, at least one of the first nasal delivery element 111 and the second nasal delivery element 112 is a non-sealing nasal delivery element 111, 112.
[1390] Referring to Figure 2, the nasal interface 100 comprises a bias flow vent 340. The bias flow vent 340 is more proximal to the second nasal delivery element 112 and more distal to the first nasal delivery element 111. In some arrangements the bias flow vent 340 is approximately in a mirror position to the gases inlet port 121 (with a sagittal or parasagittal plane of symmetry).
[1391] The bias flow vent 340 enables gases to leave the interface body 110 through the bias flow vent 340. In some arrangements, the gases include expiratory gases expelled from the patient which pass through the first and second nasal delivery elements 111, 112.
[1392] The bias flow vent 340 is downstream from the first nasal delivery element 111. The upstream end of the interface body 110 corresponds to the position of the gases inlet 121. The respiratory gases delivered to the interface body 110 passes the first delivery element 111 (where some gases are delivered therethrough) and the second gases delivery element 112 and to the bias flow vent 340. This forms the gases flow channel 125.
[1393] In some arrangements, the bias flow vent 340 may comprise apertures 342 where the apertures 342 are formed to allow an expiratory gas flow therethrough. In addition, in some arrangements, the bias flow vent 340 comprises a diffuser 341 to diffuse gases flowing through the bias flow vent 340. The diffuser may mitigate respiratory contaminants being released through the bias flow vent 340.
[1394] The bias flow vent 340 may be formed as part of the nasal interface 100, and in some arrangements as part of frame 120. The bias flow vent 340 is formed over the gases outlet port 122 as previously described herein. In some arrangements, the bias flow vent 340 is the gases outlet port 122. However, for purposes of explanation, the gases outlet port 122 is considered the region of the interface body 110 where gases pass to the bias flow vent 340. However, the bias flow vent 340 may be formed with or attached to the frame 120 such that the bias flow vent 340 is irremovably attached. This may result in there being no gases outlet port 122 in use.
[1395] In the arrangement of Figure 2, one side arm 102 is formed as part of the bias flow vent 340. Therefore, the bias flow vent 340 is part of the frame 120 that sits external to the interface body 120 and extends laterally to form the side arm 102.
[1396] A benefit of the bias flow vent 340 is to reduce noise by allowing the air to travel through this on expiration, reducing the noise generated at the nostril openings.
[1397] As described herein, the nasal delivery elements 111, 112 are non-sealing. This may be termed as expiratory air or gases may pass around the nasal delivery elements 111, 112 and not necessarily through the interface body 110. However, the bias flow vent 340 may provide a safety benefit to ensure that gases are able to escape from the interface body 110 in the case of high pressure created in the interface body (such as the nasal delivery elements 111, 112 being improperly positioned).
[1398] The bias flow vent 340 may also reduce expiratory pressure. The expiratory pressure may be altered by changing the flow permitted through the bias flow vent 340 by variation the area of the apertures 342 or diffuser 341.
[1399] Where a diffuser 341 is used, the diffuser 341 may comprise a diffuser material. The diffuser material 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 may be used in the diffuser 341, it may be beneficial to not use a filter material to reduce or avoid liquid build-up in the diffuser 341. In some configurations, the diffuser 341 may have an antimicrobial material to reduce bacteria in the exhaled air.
[1400] The aperture 342 and diffuser 341 may be combined.
[1401] Referring to Figure 3, a top view of the nasal interface of Figure 2 is shown.
Referring to Figure 4, a view from the patient direction of the nasal interface 100 of Figure 2 is shown. As with Figure 2, the headgear connecting portions 1005, 1006 and headgear 200 are omitted for the explanation. Otherwise, the description provided in reference to Figure 1 and Figure 2 applies for features with like reference signs in Figures 3 and 4.
[1402] As described, the interface body 110 comprises the first delivery element 111 (or a first delivery element portion) in fluid communication with the gases flow channel (125 - see Figure 6). The first delivery element 111 is configured to substantially deliver gases to or from the first naris of the patient. The first delivery element 111 is non-sealing. This may result in the non-sealing first delivery element 111 allowing for some movement of respiratory gases between the outside of the first delivery element 111 and the nasal passageways.
[1403] The interface body 110 comprises the second delivery element 112 (or a second delivery element portion) in fluid communication with the gases flow channel. The second delivery element 112 is configured to substantially deliver gases to or from the second naris of the patient. The second delivery element 112 is non-sealing. This may result in the non-sealing second delivery element 112 allowing for some movement of respiratory gases between the outside of the first delivery element 112 and the nasal passageways.
[1404] Whilst the first delivery element 111 and second delivery element 112 are described with reference to the positioning in the figures, e.g., from left or from right, in some arrangements, the order is interchangeable and the description of said features are interchangeable.
[1405] Whilst the term 'deliver' or '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.
[1406] Referring to Figure 3, the first delivery element 111 and the second delivery element 112 are different sizes. In particular, the first delivery element 111 is relatively larger than the second delivery element 112. Referring to Figure 4, the relatively larger first delivery element 111 has a larger cross-sectional area than the cross-sectional area of the second delivery element 112. A flow of gases is directly related to the cross-sectional area. In some arrangements, the larger relative cross-sectional area of the first delivery element 111 encourages a larger proportion of the respiratory flow delivered to the interface body 110 from the conduit 300 to pass through the first delivery element 111. This larger flow contributes to an asymmetrical flow at the patient's nasal airways. The larger proportion maybe be more than 50% of the total flow. In some arrangements, the larger proportion may be more than 60% of the total flow. In some arrangements the larger proportion is more than 70% of the total flow.
[1407] First illustrated and labelled in Figure 4, the first nasal delivery element 111 comprises a first outlet 1111a (or first gases outlet 1111a). The first outlet 1111a is 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 comprises 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.
[1408] The first outlet 1111a has a larger diameter than the second outlet 1112a.
[1409] Whilst it is noted that as the nasal delivery elements 111, 112 are nonsealing such that a patient may drawn air from external to the nasal interface 100, as respiratory gases are delivered to the interface body 110, this promotes the inhalation of the delivered respiratory gases. Further, the asymmetric flow, such as due to the relatively larger cross-section of the first delivery element 111, is encouraged by the nasal interface 100.
[1410] Referring to Figure 5, a top-sectional view of the nasal interface of Figure 3 is shown. The headgear connecting portions 1005, 1006, headgear 200 and conduit 300 are omitted for the explanation. Otherwise, the description provided in reference to Figures 1 to 4 applies for features with like reference signs in Figure 5.
[1411] The inlet gases port 121 defines an inlet axis 167. Likewise, the gases delivery portion 352 defines the same axis. The inlet axis 167 corresponds to a gases flow direction through the inlet gases port 121 1 gases delivery portion 352. This inlet axis 167 is congruent with the first direction described above with reference to the gases delivery portion 352. This may result in the inlet axis 167 passing through the opening of the first gases port 121. [1412] The first delivery element 111 defines a first axis which aligns with the inlet axis 167 in the present embodiment. Therefore, an angle between the inlet axis and the first axis may be 0 degrees. Accordingly, the first delivery element 111 sits along the same inlet axis 167. This may result in the first axis 167 passes through the opening of the first delivery element 111 in some arrangements. This may also be termed a co-axial arrangement.
[1413] In some configurations, such an arrangement may be beneficial as the gases flow from the inlet gases port 121 is primarily directed toward a first naris of the patient via the first delivery element 111. This may create or contribute to asymmetric flow in some arrangements.
[1414] In some alternative arrangements, the gases inlet port 121 is arranged to (at least substantially) direct the incoming respiratory gases towards the first nasal delivery element 111. Additionally, or alternatively, the gases flow from the inlet gases port 121 substantially points toward the first delivery element 111. Alternatively, or additionally, in some arrangements, the gases flow from the inlet gases port 121 is directed or arranged such that flow therethrough is directed substantially toward the first delivery element 111. In either or all arrangements, the gases flow from the inlet gases port 121 may be primarily directed toward a first naris of the patient via the first delivery element 111.
[1415] Such an arrangement may be additional or alternative to the co-axial arrangement of the first axis 167. The co-axial arrangement may (substantially) direct the incoming respiratory gases towards the first nasal delivery element 111.
[1416] Whilst the terms "substantially points" or "substantially directs" are used, other terms such as "substantially aims", "guides" or "is orientated towards" may be used to define the various arrangements. Where appropriate, in some arrangements, the term may mean there is a direct overlap with the outlet of the inlet gases port 121 and the opening of the first delivery element 111 (or bias flow vent 340 and second delivery element 112). Such an overlap may mean the perimeter of the inlet gases port 121 (or bias flow vent 340) overlaps with the perimeter of the opening of the first delivery element 111 (or second delivery element 112) when viewed along an axis line of either one. This definition may be applied to this feature throughout the description.
[1417] In some arrangements, the inlet gases port 121 and first delivery element 111 are not aligned on the same first axis 167. However, as described above, the inlet gases port 121 substantially points, directs or is arranged such that flow therethrough is directed substantially toward the first delivery element 111. [1418] The first axis 167 is defined with reference to the first delivery element 111 or the first gases outlet 1111a. Therefore, this may also be termed as the first gases outlet 1111a defines a first axis 167.
[1419] In Figure 5, the outlet gases port 122 defines an outlet axis 168. As noted, outlet gases port 122 may not be present in use. Therefore, bias flow vent 340 defines the same axis 168. The outlet axis 168 corresponds to a gases flow direction through the bias flow vent 340.
[1420] The second delivery element 112 defines a second axis, which is aligned with the outlet axis 168 in the present embodiment. Therefore, the angle between the outlet axis 168 and the second axis may be 0 degrees. Accordingly, the second delivery element 112 sits along the same second axis 168. Therefore, the second axis 168 passes through the opening of the second delivery element 112. This may be termed co-axial as defined above.
[1421] Note that references to the first axis 167 and second axis 168 in this specification are to the aligned axis of the present embodiment.
[1422] In some alternative arrangements, as described with reference to the first nasal delivery element 111, the second delivery element 112 is arranged to direct flow therethrough toward the bias flow vent 340. This may be an alternative or additional arrangement to the co-axial arrangement.
[1423] In some configurations, such an arrangement may be beneficial as the gases flow from the second naris of a patient is primarily directed toward out of the interface body 110 through the bias flow vent 340.
[1424] As with the first axis 167, in some arrangements, the bias flow vent 340 and second delivery element 112 are not aligned on the same second axis 168. However, as described above with reference to the first axis 167, the second delivery element 112 substantially points, directs or is arranged such that flow therethrough is directed substantially toward the bias flow vent 340.
[1425] The second axis 168 is defined with reference to the second delivery element 112 or the second gases outlet 1112a. Therefore, this may be termed as, the second gases outlet 1112a defines a second axis 168.
[1426] In view of the above axis lines, it will be appreciated that if the first axis 167 and second axis 168 were parallel, then the first and second delivery elements 111, 112 must be aligned on the same plane as they are parallel with the first axis 167 and second axis 168 (assuming no stepped arrangement in the interface body 100, i.e. the planes are non-intersecting). In the arrangement shown in Figure 5, the first axis 167 and second axis 168 intersect. Therefore, first and second delivery elements 111, 112 are nonparallel and/or arranged on different or separate intersecting planes. That is, the nasal interface 100 is angled.
[1427] 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.
[1428] 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 actions of eating or drinking when the nasal interface 100 is in use.
[1429] 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 nasal 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 nasal 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 nasal delivery elements 111, 112. In some arrangements, the opposite configuration may be used.
[1430] Referring to Figure 6, a further top-sectional view of the nasal interface similar to Figure 5 is shown. The headgear connecting portions 1005, 1006, headgear 200 and conduit 300 are omitted for the explanation. Otherwise, the description provided in reference to Figures 1 to 5 applies for like-features in Figure 6.
[1431] As discussed with reference to Figure 5, the first gases port 121 is arranged such that flow therethrough is directed substantially toward the first nasal delivery element 111. Referring to Figure 6, the flow channel 125 is formed within the interface body 110. The inlet gases port 121 is substantially aligned with the first nasal delivery element 111 as illustrated by an arrow indicating an inlet gases flow 171. This line partially aligns with the first axis 167 in this arrangement. Further, the arrow indicating the indicating an inlet gases flow 171 also shows that the flow turns as it passes through the gases delivery elbow 351. This is shown as substantially right angle turn that is then directed toward the inlet gases port 121. Such an arrangement may be beneficial as the gases flow from the inlet gases port 121 is primarily directed toward a first naris of the patient via the first nasal delivery element 111. This may create or contribute to asymmetric flow, when such a flow is present, referred to above.
[1432] The second nasal delivery element 112 is arranged such that flow therethrough is directed substantially toward the bias flow vent 340. The second nasal delivery element 112 is substantially aligned with the bias flow vent 340 as illustrated by an arrow indicating an 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 bias flow element 340 via the second nasal delivery element 112.
[1433] In some arrangements, the opening of the first gases port 121 is concentric with the first outlet 1111a. Additionally, in some arrangements, the opening of the second gases port 122 is concentric with the second outlet 1112a.
[1434] The first nasal delivery element 111 and second nasal delivery element 112 are non-sealing. There is the possibility for a gases flow to be between the nares and the environment external to the nasal interface 100. In particular, the gases flow between the patient's first naris and the environment external to the first delivery element 111 is illustrated by an arrow indicating a first external gases flow 178. The gases flow between the patient's second naris and the environment external to the second delivery element 112 is illustrated by an arrow indicating a second external gases flow 179.
[1435] The first external gases flow 178 may include respiratory gases from the inlet gases flow 171 that are not inhaled by the patient but pass to the environment due to the non-sealing of the first nasal element 111.
[1436] Whilst the inlet gases port 121 points or directs substantially toward the first nasal delivery element 111 and the second nasal delivery element 112 points or directs substantially toward the bias flow vent 340, the flow path may be restricted. For instance, the inlet gases flow 171 or the outlet gases flow 172 does not directly follow the arrows as indicated in Figure 6. That said, in some arrangements, the resultant flow may be in the direction of the arrow 171, 172 as described.
[1437] Additionally, in some arrangements, the gases may bypass through the interface body 110. A bypass flow 173 is formed by the respiratory gases (such as shown by the inlet gases flow 171) passing through the gases flow channel of the interface body 110 and bypassing the patient's first naris. Therefore, the respiratory gases pass from the inlet gases port 121 toward the region of the bias flow vent 340.
[1438] The bypass flow 173 then may either travel toward the second naris as a bypass inhalation flow 174 or may travel out of the interface body 110 through the bias flow vent 340 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.
[1439] The second external gases flow 179 may include respiratory gases from the bypass inhalation flow 174 that are not inhaled by the patient but pass to the environment due to the non-sealing of the second nasal delivery element 112.
[1440] Additionally, in some arrangements, there may be an exhalation bypass flow 176. The exhalation bypass flow 176 is formed by the exhalation gases (such as shown by the outlet gases flow 172) passing back through the gases flow channel of the interface body 110 after being exhaled from the second naris. Therefore, the exhalation gases pass from the second nasal delivery element 112 toward the inlet gases port 121.
[1441] 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 caused by a turbulent area in the interface body 110.
[1442] Whilst the inlet gases flow 171, outlet gases flow 172, bypass flow 173, bypass inhalation flow 174, bypass exhaust flow 175, exhalation bypass flow 176, recirculated flow 177, first external gases flow 178 and second external gases flow 179 are shown by arrows in Figure 6, it will be appreciated that in some configurations, the direction of the flow indicated by the arrows may be varied according to the respiratory gases inlet.
[1443] Referring to Figure 7, a further sectional view of the nasal interface similar to Figure 5 and Figure 6 is shown. However, the image is shown from the bottom such that the first nasal delivery element 111 is on the left of the image. The view is enlarged so that the features of the headgear connecting portions 1005, 1006, side arms 101, 102, headgear 200 and conduit 300 are not visible or not shown. Otherwise, the description provided in reference to Figures 1 to 6 applies for like-features in Figure 7.
[1444] As described above with reference to Figure 4, in Figure 7 the first nasal delivery element 111 and second nasal delivery element 112 extend in an outward direction from the base portion 118 of the interface body 110. The first nasal delivery element 111 comprises the first outlet 1111a. The first outlet 1111a allows gases into and out of the nasal interface 100 and, in use, the gases flow through the patent's first naris. The first outlet 1111a is at the patent's naris end of the first nasal delivery element 111. Likewise, the second nasal delivery element 112 comprises the second outlet 1112a for allowing gases into and out of the nasal interface 100 and, in use, the gases flow through the patent's second naris. The second outlet 1112a is at the patent's naris end of the second nasal delivery element 112.
[1445] At the opposing end of the nasal delivery elements 111, 112 to the first and second outlets 1111a, 1112a there is provided a first base 1111c and a second base 1112c. More specifically, the first nasal delivery element 111 extends from the base portion 118 of the interface body 110 from the first base 1111c of the first nasal delivery element 111. The second nasal delivery element 112 extends from the base portion 118 of the interface body 110 from the second base 1112c of the second nasal delivery element 112. Therefore, when applicable, a respiratory gas flow flows from the first base 1111c from the interface body 110 through the first nasal 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 nasal delivery element 111 then the first base 1111c into the interface body 110.
[1446] Likewise, from the second naris perspective, when applicable, a respiratory gas flow flows from the second base 1112c from the interface body 110 through the second nasal 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 nasal delivery element 112 then the second base 1112c into the interface body 110.
[1447] As discussed earlier, for an asymmetric flow, the actual flow of gases to provide the asymmetric flow a variation of the flows described above. Asymmetric flow may be provided by the nasal interface 100 by more flow being directed to the first naris/first outlet 1111a than to the second naris/second outlet 1112a. That may be termed as flow directionality.
[1448] As shown in Figure 7, a base 1111c, 1112c of each first 111 and second 112 nasal delivery elements are thicker than an outlet 1111a, 1112a (or tip) of the first 111 and second 112 nasal delivery elements. The variation in thickness is shown by the first taper m id in Figure 7 for the first nasal delivery element 111 and the second taper 1112d for the second nasal delivery element 112. A portion of the base 1111c, 1112c of each first 111 and second 112 nasal delivery elements may be considered to be frustoconical in shape.
[1449] The thickness may be a wall thickness. Therefore, in such an arrangement, the first nasal delivery element 111 and the second nasal delivery element 112 have a wall thickness at the 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. This may result in the first and second tapers mid, 1112d being shown as a triangle that narrows in the first and second outlets 1111a, 1112a direction.
[1450] The decrease in wall thickness in the outlet direction allows greater compliance in the nasal delivery elements. For instance, to allow comfort when inserting into the naris whilst being rigid enough at the base to maintain the position and shape. This can prevent the nasal delivery elements 111, 112 from folding.
[1451] 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.
[1452] 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.
[1453] In some arrangements additional to or alternative to the first and second tapers mid, 1112d, the first 111 and second 112 nasal delivery elements comprise an angled base lllle, 1112e. The angled base lllle, 1112e is the junction of the wall where the first and second bases lllle, 1112c are attached to the base portion 118. The angled base lllle, 1112e is formed as a curved camber (rather than a right angle). This results in the angled base lllle, 1112e being wider than the remainder of the first 111 and second 112 nasal delivery elements.
[1454] The angled base (or angled portion) lllle, 1112e may assist in ensuring that the nasal delivery elements 111, 112 are non-sealing as they cannot occlude with the patient's naris.
[1455] The nasal delivery elements 111, 112 may also be referred to as prongs. The generally shape of the nasal delivery elements 111, 112 is shown as being elongate or, in some arrangements, tubular. They are generally shown as being straight walled or substantially straight. However, different arrangements are possible. However, the illustrated prong arrangement of the nasal delivery elements 111, 112 assist with the nonsealing. [1456] Referring to Figure 8, a top view of the nasal interface similar to Figure 3 is shown. The headgear connecting portions 1005, 1006, and headgear 200 are omitted for the explanation. Otherwise, the description provided in reference to Figures 1 to 7 applies for like-features in Figure 8.
[1457] The arrangement of Figure 8 differs from Figures 1 to 7 in that the first nasal delivery element 111 and second nasal delivery element 112 are sized the same. Therefore, the first outlet 1111a in the first nasal delivery element 111 and the second outlet 1112a in the second nasal delivery element 112 are substantially the same shape. Where the first outlet 1111a and second outlet 1112a are circular in shape, the first outlet 1111a and second outlet 1112a have the same diameter.
[1458] The same sized first nasal delivery element 111 and second nasal delivery element 112 may have the same cross-sectional area. However, asymmetric flow may be provided in the manner described elsewhere in this document. For instance, the gases inlet port 121 substantially points or directs at the first nasal delivery element 111. The same sized first nasal delivery element 111 and second nasal delivery element 112 allows for functions such as rotation of the nasal interface 100. The rotation, or side-swapping, or inverting upside-down is described in detail with reference to the following Figures 9 to 12.
[1459] Referring to Figures 9 to 12, schematical views of the interface body 110 of the nasal interface 100 are shown. Specifically, Figures 9 and 11 are rear views and Figures 10 and 12 are top views. However, Figures 9 and 10 illustrate a nasal interface 100 having different sized (asymmetrically sized) nasal delivery elements 111, 112, whereas Figures 11 and 12 illustrate a nasal interface 100 having the same sized (symmetrically sized) nasal delivery elements 111, 112. The illustrations omit features such as the frame 120 and connected parts. Otherwise, the description provided in reference to Figures 1 to 8 applies for like-features in Figures 9 to 12. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1460] Referring to Figure 9, the interface body 110 comprises a second midline plane 166. The second midline plane 166 is transverse to a first midline plane 165 (see Figure 10) 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. The second midline plane 166 bisects the interface body 110 when viewed from the rear or front. The second midline plane 166 equally bisects the pair of first and second delivery elements 111, 112, or the pair of first and second outlets 1111a, 1112a, or the pair of first and second bases 1111c, 1112c.
[1461] 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.
[1462] The symmetry described herein may exclude the features such as the gases inlet port 121 and bias flow vent 340 and may be directed at the patient facing side of the interface body 110.
[1463] As shown in Figure 9, the first nasal delivery element 111 and second nasal delivery element 112 have different sizes. However, as the second midline plane 166 bisects these, they remain symmetrical in the described plane.
[1464] The interface body 110 being symmetrical about the second midline plane 166 allows the switching of nares to nasal delivery elements 111, 112. This allows the patient interface 1 to be positioned with the first nasal delivery element 111 proximal with the patient's second naris, and the second nasal delivery element 112 proximal with the patient's first naris. Such a side-swapping for an asymmetric flow interface allows for the respiratory gases to be directed at the alternative naris without the need for extensive disconnection and reconnection of conduits. Where the conduits 300 remain on the same side, this side swapping reduces the effort or errors in ensuring the orientation of wearing the nasal interface 100.
[1465] Referring to Figure 10, the first nasal delivery element 111 and the second nasal delivery element 112 are sized differently. A first 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. The interface body 110 exclusive of the nasal delivery elements 111, 112 is symmetrical about the first midline plane 165.
[1466] As seen in Figure 10, the midline plane 165 equally bisects the interface body 110 in a vertical direction when viewing from the top. Further, the midline plane 165 equally bisects the interface body 110 in a front to back direction. It may also be termed that the interface body 110 has symmetry about the first midline plane 165. The symmetry about the first midline plane 165 allows the nasal interface 100 to be placed on a patient "upside down", such that the first nasal delivery element 111 is in contact with the first naris and the second nasal delivery element 112 is in contact with the second naris, or the nasal interface 100 is flipped and the first nasal delivery element 111 is in contact with the second naris and the second nasal 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 likelihood of incorrect wearing of the nasal interface 100. It also allows for easy switching of the inlet gases port 121 side for the asymmetric delivery of respiratory gases.
[1467] Referring to Figure 11, the second midline plane 166 as described above with reference to Figure 9 is shown. Therefore, the second midline plane 166 is transverse to the first midline plane 165 (see Figure 10) 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. The second midline plane 166 bisects the interface body 110 when viewed from the rear or front. Therefore, the second midline plane 166 equally bisects the pair of first and second nasal delivery elements 111, 112, or the pair of first and second outlets 1111a, 1112a, or the pair of first and second bases 1111c, 1112c.
[1468] The first nasal delivery element 111 and second nasal delivery element 112 have the same size. The first midline plane 165 is also shown in Figure 11 as the interface body 110 including the first nasal delivery element 111 and second nasal delivery element 112 are symmetrical about the first midline plane 165 (the sagittal or parasagittal plane when in use).
[1469] The first midline plane 165 is also shown in Figure 12 for a nasal interface 100 comprising the same sized (or symmetrical) first and second nasal delivery elements 111, 112. The first 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. The interface body is symmetrical about the first midline plane 165.
[1470] The first midline plane 165 equally bisects the interface body 110 in a vertical direction when viewing from the top. Further, the midline plane 165 equally bisects the interface body 110 in a front to back direction. It may also be termed that the interface body 110 has symmetry about the first midline plane 165. The symmetry about the first midline plane 165 allows the nasal interface 100 to be placed on a patient 'upside down', such that the first nasal delivery element 111 is in contact with the first naris and the second nasal delivery element 112 is in contact with the second naris, or the nasal interface 100 is flipped and the first nasal delivery element 111 is in contact with the second naris and the second nasal 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. It also allows for easy switching or side-swapping of the inlet gases port 121 side for the asymmetric delivery of respiratory gases. [1471] The interface body 110 being symmetrical about the second midline plane 166 allows the switching of nares to nasal delivery elements 111, 112. This allows the patient interface 1 to be placed with the first nasal delivery element 111 proximal with the patient's second naris, and the second nasal delivery element 112 proximal with the patient's first naris. Such a side-swapping for an asymmetric flow interface allows for the respiratory gases to be directed at the alternative naris without the need for extensive disconnection and reconnection of conduits. Where the conduits 300 remain on the same side, this side swapping reduces the effort or errors in ensuring the orientation of wearing the nasal interface 100.
[1472] The symmetry of the interface body 110, whether nasal delivery elements 111, 112 are also symmetrical about the first plane 165 or not, assists with simplifying the side-swapping of the nasal interface 100 such that the gases inlet port 121 and bias flow vent 340 sides are swapped by inverting the nasal interface 100. This allows nonmedical staff, e.g. patients, to side-swap the nasal interface 100 themselves. This is advantageous for patients at home, such as patients with chronic illnesses requiring nasal interfaces.
[1473] The nasal interface 100 may also be angled along the first midline plane
165 such as described with reference to Figure 5.
[1474] 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 11) may be termed as the centrosymmetric point 164. In some arrangements, 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 11. The centrosymmetry excludes features such as inlet gases port 121 and the bias flow vent 340.
[1475] Referring to Figure 13, a front view of the interface body 110 of the nasal interface 100 is shown. The figure is as previous Figures 9 to 12 but includes the frame 120 along with side arms 101, 102, gases delivery elbow 351 and bias flow vent 340. The description provided in reference to Figures 1 to 12 applies for like-features in Figure 13.
[1476] The second midline plane 166 is shown, where the second midline plane
166 is transverse to the sagittal plane of a patient when the nasal interface 100 is in use (or transverse to a first midline plane 165 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). The frame 120 comprising the bias flow vent 340, gases inlet port 121 (and connected gases delivery elbow 351), first side arm 101 and second side arm 102 is also shown where the second midline plane 166 bisects these. Therefore, in such an arrangement, the bias flow vent 340, gases delivery elbow 351, first side arm 101 and second side arm 102 are symmetrical along the second midline plane 166.
[1477] The symmetry of the interface body 110, including the frame 120, assists with simplifying the side-swapping of the nasal interface 100 such that the interface body 110 including the frame 120 have the same arrangement regardless of the orientation of the mask. Notably, the side arms 101, 102 are at the same position regardless of whether the nasal interface 100 is placed with the first nasal delivery element 111 proximal with the patient's first naris or second naris. This may result in the side arms 101, 102 being symmetrical about the second midline plane 166 of the interface body 110. This means that the side arms 101, 102 are not angled in a particular direction to conform with a patient's face in this plane 166.
[1478] In some arrangements as a result of at least some of the symmetrical features, the nasal interface 100 may be inverted without the headgear 200 having a resultant different position or needing further adjustment. This ensures that the nasal interface 100 may be attached in the same manner using the headgear 200 to the patient whether side-swapped or not. Likewise, the gases delivery elbow 351 extends in the same direction, transversely outward in the (opposing) cheek direction when the nasal interface 100 is side-swapped. This ensures that the conduit 300 may be similarly directed away from the patient.
[1479] Whilst not shown in Figure 13, the frame comprises features positioned internal to the interface body 110. For instance, features of the frame 120 will be described with reference to baffles 180 in the following figures. In some arrangements, the frame 120, including the baffles 180, comprises symmetry along the second midline plane 166 for all aspects of the frame 120.
[1480] Referring to Figures 14 to 18, a baffle 180 feature of the nasal interface 100 is described. The patient interface 1 and nasal interface 100 is as the previously described in Figures 1 to 13. Therefore, the description provided applies for like-features.
[1481] In Figure 14, a front view of patient interface 1 is provided. The nasal interface 100 is shown without the gases delivery elbow 351 or the bias flow vent 340 to allow the frame 120 portion positioned internal to the interface body 110 to be visible. Through the openings of the gases inlet port 121 and the other gases port 122 (which is the opening over which the bias flow vent 340 is positioned), the baffle 180 is visible. Therefore, the nasal interface 100 comprises at least one baffle 180 extending along the gases flow channel 125 (see Figure 6) from a region corresponding generally to the first gases port 121 toward a region corresponding generally to the bias flow vent 340.
[1482] The baffle 180 is an elongate planar member. The baffle 180 is arranged perpendicular to the openings of gases ports 121, 122, i.e. the baffle intersects the openings of the gases ports 121, 121 when viewed from the front, such as illustrated in Figure 14.
[1483] In Figures 15 and 16, the frame 120 is shown without the interface body 110. Therefore, the baffle 180 is clearly visible. The frame 120 of Figure 15 is shown from the front and the frame 120 of Figure 16 is shown from the rear.
[1484] The baffle 180 comprises a leading edge 181 and a trailing edge 182. In the illustrated configuration, particularly as seen in Figures 15 and 16, 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 inlet gases port 121 and the other gases port 122 (or bias flow vent 340 when in use). The baffle 180 is arranged such that the trailing edge
182 is positioned at or proximal the first and second delivery elements 111, 112.
[1485] In some configurations, the 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 a surface of the baffle 180 to the first delivery element 111 and along the baffle 180 to the second delivery element 112 or the second delivery element portion.
[1486] The baffle 180 may provide a directional arrangement for respiratory flow passing through the interface body 110 to a patient. This may be considered a channel for the delivery of gases. In some configurations, the baffle 180 may direct the respiratory gases to a single delivery element, e.g. the first delivery element 111.
[1487] In some configurations, the baffle 180 is arranged such that exhaled gases pass along the baffle 180 to the other gases port 112 (or bias flow vent 340 when in use). The baffle may provide a directional arrangement for exhalation flow from a patient through the interface body 110.
[1488] The baffle 180 has the benefit of reducing turbulence of gases flow and also reducing noise. The baffle 180 also directs the flow of gases.
[1489] A plurality of the baffles 180 may be provided as shown in Figures 15 to 18. The plurality of baffles 180 are arranged in parallel with a gap formed between each baffle. In such an arrangement, each baffle 180 retains a leading edge 181 closer to the inlet gases port 121 and the other gases port 122 (or bias flow vent 340 when in use) than the first and second nasal delivery elements 111, 112.
[1490] The number of baffles 180 may be between 1 and 7, such as 1, 2, 3, 4, 5, 6 or 7 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 seven baffles 180 is stated as one limit, it could be envisaged that additional baffles 180 be provided in some situations where space allows.
[1491] In some configurations, the frame 120 comprises a plurality of the baffles 180, wherein the baffles 180 are spaced apart from each other and extend along the gases flow channel 125. In some configurations, the baffles 180 extend across the gases flow channel of the interface body 110, the frame portion 120, or both the interface body 110 and the frame portion 120 of the nasal interface 100.
[1492] In some arrangements, 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. This may result in each baffle 180 being attached (or in contact with) at their ends to internal surfaces of the interface body 110. When attached, the baffle 180 may be molded as part of the interface body 110, or may be affixed such as by welding or adhesive.
[1493] The baffles 180 extending the width of the interface body 110 (i.e. the length of the flow channel) ensures that gases flow does not pass around the edge causing turbulence and also risking an increase in sound.
[1494] In some configurations such as shown in Figures 15 and 16, 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 transversely along the baffle 180.
[1495] In some arrangements such as shown in Figure 18, the baffle 180 has a varying thickness along its length. Figure 18 is a sectional view cut vertically through the frame 120 and interface body 110 when viewed from the rear. In this view, it can be seen that the baffle 180 is thicker at around its centre. This may alternatively be termed as the baffles 180 have a thickened portion 184. The baffle 180 may have the thickened portion 184 at a position between the inlet gases port 121 and the other gases port 122 (or bias flow vent 340 when in use). The thickening to the thickened portion 184 may be gradual from the sides to the centre of the baffle 180.
[1496] The thickening in the middle I centre of the baffles 180 restricts the flow in the flow channel. This increases asymmetrical flow, when present, as gases flow cannot easily bypass the first nasal delivery element 111 by flowing to the second nasal delivery element 112.
[1497] A thicker thickened portion 184 promotes more asymmetrical flow. This may provide effects such as additional flushing in the nasal airways. This may be adopted in hospital settings. A thicker thickened portion 184 may also result in more sound than a relatively smaller thickened portion 184. 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 centre of the flow channel 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 centre 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.
[1498] Figure 17 provides a rear view of the nasal interface 100 with the frame 120 and interface body 110 present and the baffle 180 visible through the first nasal delivery element 111. In this arrangement, the baffle 180 (or one of the baffles 180) is positioned at the centre of the prong outlet 1111a, 1112a. 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 respective nasal delivery element 111, 112.
[1499] In the illustrated configurations, the baffle 180 is formed as part of the frame portion 120. In such an arrangement, 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.
[1500] In some configurations, the baffle 180 may be formed as part of the interface body 110.
[1501] Referring once again to Figures 14 to 17, the nasal interface 100 comprises the headgear connecting portions 1005, 1006. The headgear connecting portion 1005, 1006 is an intermediary connector between the headgear 200 and the side arms 101, 102. The headgear connecting portion 1005, 1006 may connect at one end to the side arms 101, 102 and at its other end to a portion of the headgear 200. The headgear connecting portion 1005, 1006 may have a slot for portion of the headgear 200 to slot around there. However, other connection means may be used.
[1502] In some arrangements, the portion of the headgear 200 may comprise end portions of headgear strap(s). In other configurations, the portion of the headgear 200 comprise sleeves or other features that are connected to the headgear strap(s). [1503] 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 comprised by the patient interface 1 comprising a headgear 200 and a nasal interface 100.
[1504] In addition to Figures 14 to 17, reference is also made to Figures 19 to 22 in the following description. Each side arm 101, 102 comprises either a ball portion 1007 or a socket portion 1008 of a ball and socket joint 191. In the Figures of 14 to 17, presently described, each side arm 101, 102 comprises the ball portion 1007 of the ball and socket joint 191. Figures 25 to 28, described below, provide details of the opposite arrangement.
[1505] 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.
[1506] The movement of the ball portion 1007 and the socket portion 1008 is a rotatable connection as the socket portion 1008 rotates or pivots around the ball portion
1007 when connected. Figures 19 to 22 show the ball portion 1007 and socket portion
1008 in detail.
[1507] The ball and socket joint 191 is a removably engageable connection. Therefore, the ball portion 1007 is removably engaged with the socket portion 1008. However, in some arrangements, the ball and socket joint 191 may be permanently attached or may be attached in a manner that is not freely disconnectable - for instance, a tool may be required to disconnect the ball 1007 from the socket 1008. This is to prevent accidental dislodgement of the connected ball and socket joint 191.
[1508] Referring to Figure 15 with overall reference to Figures 14 to 17, each side arm 101, 102 extends laterally outwardly from the interface body 110. The lateral extension can be termed a distal end 1016 that is distal to the interface body 110. The ball portion 1007 positioned at the distal end 1016. This may result in the ball portion 1007 being 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. The distal end 1016 is shown in detail in Figures 19 to 22.
[1509] 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.
[1510] As shown in Figure 15 and Figures 19 and 20, 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.
[1511] 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.
[1512] Whilst a ball-shaped ball portion 1007 is described, other shapes could be contemplated that are not fully spherical.
[1513] The socket portion 1008 is formed as a hook-shaped portion 1008. Therefore, the socket portion 1008 is shaped to have a curved portion at its distal end with an inner hook.
[1514] The hook-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 hook-shaped portion 1008 passes through the aperture 1017 and around the ball portion 1007. The hook-shaped portion 1008 may have an outer body that conforms with the curve of the D-shape 1007 to ensures it maximizes the space whilst retaining a gap for movement.
[1515] In some arrangements, such as shown in Figure 24, an end of the hookshaped portion 1008 (or hooked portion) is formed with an undercut profile 1018. The undercut profile 1018 shaped to allow the hook-shaped portion 1008 to engage with the ball portion 1007 by having a corresponding profile to the shape of the ball portion 1007. 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 hook-shaped portion
1008 partially surround the ball portion 1007 to ensure a secure connection.
[1516] The ball and socket joint 191 is a moveable connection comprising multipleaxis 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.
[1517] 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 19 and 20. Referring to Figure 19 and 21, 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 14 to 17, and Figures 20, 22 and 23 the ball and socket joint 191 is shown in a different orientation. [1518] As shown in the comparison between Figures 19 to 23, 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. 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.
[1519] 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. This may allow the position required for a patient to be at any angle required therebetween.
[1520] 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 19. Therefore, the connecting portion axis 1024 is angled.
[1521] 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. This may allow for the position required for a patient to be at any angle required therebetween.
[1522] Whilst two planes of movement are described, as the ball and socket joint 191 has freedom of movement, from the position described above, i.e. the neutral or central position, 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. [1523] 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.
[1524] 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 plane 165 and or second midline plane 166 as described with reference to Figures 9 to 13. In such a configuration, as discussed with reference to Figure 13, 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.
[1525] A method of side-swapping or changing the configuration or direction of a gases inlet of the nasal interface 100 can be provided by the described configuration. The method comprises rotating the ball portion 1007 in the socket portion 1008 of the ball and socket joint 191, such that nasal interface 100 changes from a first configuration where the gases inlet (e.g. gases inlet port 121) is on a left side of the nasal interface 100 to a second configuration where gases inlet (e.g. gases inlet port 121) is on a right side of the nasal interface 100. Rotating the ball portion 1007 in the socket portion 1008 of the ball and socket joint 191 causes the change from first configuration to second configuration.
[1526] The method may comprise rotating the ball portions 1007 in the socket portions 1008 in both sides of the nasal interface 100.
[1527] As discussed above, the ball portion 1007 and socket portion 1008 may be reversed such that the socket portion 1008 is formed in the respective side arm 101, 102. Referring to Figures 25 to 28, such an arrangement is shown.
[1528] When referring to Figures 25 to 28, the patient interface 1 and nasal interface 100 illustrated is as previously described. Therefore, the description provided applies for like-features. Further, whilst the ball portion 1007 and socket portion 1008 are reversed (and reference numerals changed), the arrangement is applicable to any description herein, for instance, Figure 1 has the inverted socket portion 1008/1038 and ball portion 1007/1037 and associated headgear connecting portions 1005/1035, 1006/1036. Whilst reference to a particular headgear connecting portion or ball and socket joint 191 may be given, it will be appreciated that these are fully interchangeable in the connection of the patient interface 1. Therefore, with the exception of the description in Figures 18 to 28, reference to any ball and socket joint 191 or headgear connecting portions is reference to all.
[1529] In Figures 26 to 28, the headgear connecting portions 1035, 1036 are omitted completely or partially. For instance, in Figures 27 and 28, the ball portion 1037 is shown without being connected to any headgear connecting portion 1035, 1036.
[1530] Referring firstly to Figure 25, a top sectional view of the nasal interface 100 is shown with a ball and socket joint 191. Each side arm 101, 102 comprises the socket portion 1038 of the ball and socket joint 191.
[1531] As previously described, the ball and socket joint 191 is configured to be a moveable connection. Therefore, the ball portion 1037 moves relative to the socket portion 1038 when connected or engaged.
[1532] The movement of the ball portion 1037 and the socket portion 1038 is a rotatable connection as the ball portion 1037 rotates or pivots within the socket portion 1038 when connected. Figures 25 to 28 show the ball portion 1037 and socket portion 1038 in detail where the socket portion 1038 is housed on the side arms 101, 102.
[1533] Each side arm 101, 102 extends laterally outwardly from the interface body 110. The socket portion 1038 is positioned at a lateral end of the side arm 101, 102. Therefore, the socket portion 1038 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. The socket portion 1038 is formed as a substantially C-shape when viewed from above.
[1534] Referring particularly to Figures 26 to 28, the C-shape of the socket portion 1038 is angled back toward the patient's face at an angle of approximately between 60 and 30 degrees and more preferably 40 to 50 degrees. Therefore, the ball portion 1037 of Figure 28 is more visible when viewed from the rear of the nasal interface 100. The rearward angling ensures that the option portion of the C-shaped socket portion 1038 is directed toward the required articulation, for instance, in the direction along a patient's cheeks.
[1535] The C-shape of the socket portion 1038 is arranged so that is does not extend further in a rearwards direction than the interface body 110. This may result in the socket portion 1038 not interfering with a patient's face when the nasal interface 100 is positioned on a patient.
[1536] The side arms 101, 102 are connected in a central region of the back of the C-shaped socket portion 1038. Therefore, rather than forming a hook-like connection, the side arm 101, 102 is more aligned with the headgear connecting portion 1035, 1036. That is, they may form a semi-continuous elongate line.
[1537] The headgear connecting portion 1035, 1036 comprises the ball portion 1037, as shown in Figure 25. The ball portion 1037 is positioned at an end of a substantially elongate headgear connecting portion 1035, 1036. Therefore, in some arrangements, the ball portion 1037 is in-line or straight with the headgear connecting portion 1035, 1036.
[1538] The headgear connecting portion 1035, 1036 comprises a notch 1039 in the area where the ball portion 1037 connects to the headgear connecting portion 1035, 1036. This allows the increased articulation of ball portion 1037 within the socket portion 1038 before the headgear connecting portion 1035, 1036 comes into contact with the socket portion 1038.
[1539] The arrangement of the ball and socket joint 191 of Figures 25 to 28 ensures that the headgear connecting portion 1035, 1036 and the associated headgear 200 and straps are positioned flush along a patient's face, such as their cheeks. Therefore, there is a minimized gap formed between the headgear connecting portion 1005, 1006 and the cheeks by the positioning of the ball portion 1037 on this part. The rearwardly directing of the ball and socket joint 191 is via the side arms 101, 102.
[1540] The arrangement of the ball and socket joint 191 of Figures 25 to 28 also allows for an increased range of motion. This makes the nasal interface 100 more flexible, for better positioning in the patient's nose and more compliant with the patient's face.
[1541] Referring to Figure 29, the patient interface 1 and nasal interface 100 illustrated is as previously described. Therefore, the description provided applies for like- features. The headgear connecting portion 1035 of Figures 25 to 28 is shown. However, the following description may apply to the headgear connecting portion 1005 of Figures 18 to 24.
[1542] The headgear connecting portion 1035 comprises a tube retainer 348 (also called a conduit retainer 348). The tube retainer 348 is removably attached to the conduit 300. Therefore, the tube retainer 348 couples the conduit 300 to the headgear 200. The tube retainer 348 holds the conduit in position 300.
[1543] The tube retainer 348 may have an annular portion for receiving the conduit 300 therethrough. The conduit 300 is moveably received in the tube retainer 248. The tube retainer may be C-shaped or a closed channel. [1544] The tube retainer 348 is positioned to extend in a perpendicular direction outwardly from the nasal interface 100, i.e. away from the patent's face. This ensures that the conduit 300 does not interfere with the patient such as sitting on the patient's cheeks.
[1545] As discussed above, particularly with reference to Figure 2, a gases delivery elbow 351 may be provided at the gases inlet port 121. The tube retainer 348 is positioned laterally outward from the gases delivery elbow 351. The gases delivery elbow 351 directs the conduit 300 along the patient's cheek. Therefore, the gases receiving portion 353 is directed toward the opening of the tube retainer 348. That is, the tube retainer 348 and gases receiving portion 353 I gases delivery elbow 351 are aligned such that a conduit 300 may pass between them in a substantially straight line.
[1546] In some arrangements, the tube retainer 348 is positioned on a strap of the headgear 200 instead of the headgear connecting portion 1035 or side arms 101, 102. Figure 131 illustrated a stand-alone tube retainer 348 (described below).
[1547] The tube retainer 348, in combination with the gases delivery elbow 351 when present, ensure that the conduit 300 is directed away from the patient's face and mouth as not to interfere with actions such as eating or drinking when the nasal interface 100 is in use.
[1548] The tube retainer 348 is also shown in Figures 32 to 35, however, it may optionally not be combined with the cap 346 features described therein.
[1549] In an arrangement shown in Figures 30 and 31, the gases delivery elbow 351 is omitted. Otherwise, the patient interface 1 and nasal interface 100 illustrated in these Figures 30 and 31 is as previously described. Therefore, the description provided applies for like-features.
[1550] The conduit 300 is directly connected to the gases inlet port 121. In the illustrated arrangement, the gases inlet port 121 substantially points or directs toward the first nasal delivery element 111, as described above. Additionally or alternatively, the conduit 300 directs a gases flow toward the first nasal delivery element 111 and contributes toward an asymmetric flow. In Figures 30 and 31, the interface body 110 is angled as described with reference to Figure 5. Therefore, at least a portion of the first conduit 300 follows the axis line 167 when connected directly to the gases inlet port. This may result in the first conduit 300 being angled slightly outwardly from the sagittal plane (when the nasal interface 100 is in use). This is opposite to the first and second delivery elements 111, 112 that are angled to converge, i.e. toward the sagittal plane.
[1551] Referring to Figures 32 to 35, schematical views of the interface body 110 of the nasal interface 100 are shown. Specifically, Figures 32 and 34 are perspective views and Figures 33 and 35 are top sectional views. Figures 32 and 33 illustrate a nasal interface 100 comprising a vent cap 346, and Figures 34 and 35 illustrate a nasal interface 100 comprising an annular vent cap 346. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features in Figures 32 to 35. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1552] In Figures 32 and 33, a vent cap 346 is provided. The vent cap 346 is removably positionable over the bias flow vent 340 to substantially cover the bias flow vent 340. In some arrangements, the vent cap 346 is positioned on an outer portion of the interface body 110.
[1553] The sectional view of Figure 33 shows the apertures 342 of the bias flow vent 340 in this arrangement. The vent cap 346 occludes or covers the apertures 342. The vent cap 346 may be clippable around the frame 120 of the nasal interface 100 to retain the cap 346 in position. In some arrangements, the cap 346 extends at least partially in a lateral outward direction, i.e. over the side arm 102. In some arrangements, the cap 346 may have a tether 345 to the frame 120 to allow it to be removed but avoid it being lost or misplaced.
[1554] The vent cap 346 may increase the positive end-expiratory pressure of the nasal interface 100 by preventing the expiratory gases escaping from the interface body 110 through the bias flow vent 340. A higher positive end-expiratory pressure assists with keeping patient airways open during therapy. The vent cap 346 can optionally be applied when therapy is required. As the nasal delivery elements 111, 112 are non-sealing and, in particular, the second nasal delivery element 112 has a relatively smaller outlet than the first nasal delivery element 111, the expiratory gases may leave by flowing around the nasal delivery element 112 and not through the nasal interface 100. However, as a portion of expiratory gases are still directed through the interface body 110, the positive end-expiratory pressure will still increase with the vent cap 346.
[1555] In Figures 34 and 35, the vent cap 346 comprises an aperture 347. The vent cap 346 has an annular configuration where the aperture 347 is formed centrally to the cap 346. The arrangement of the vent cap 346 may be termed that the cap aperture 347 is an opening with a peripheral frame forming the cap 346. The vent cap 346 with cap aperture 347 (annular cap) is removably positionable over the bias flow vent 340 to substantially cover the bias flow vent 340 but leaving a portion of the bias flow vent 340 uncovered. [1556] The sectional view of Figure 35 shows the apertures 342 of the bias flow vent 340 in this arrangement where an outer portion are occluded by the vent cap 346 and an inner portion are positioned at the cap aperture 347 and thus uncovered. The vent cap 346 partially occludes or covers the apertures 342. The vent cap 346 may otherwise be attachable and connected by a tether 345 as described above.
[1557] Whilst the cap aperture 347 is described as being centrally positioned, in some configurations, the cap aperture 347 may be positioned at a side or off-centre, such that the peripheral frame does not fully surround the cap aperture 347.
[1558] The vent cap 346 with cap aperture 347 can increase the positive end- expiratory pressure of the nasal interface 100 by preventing the expiratory gases escaping from the interface body 110 through the bias flow vent 340. However, some portion of the gas flow is able to pass through the central cap aperture 347. In some arrangements, this may result in a higher positive end-expiratory pressure being generated, but at a smaller peak than that of the fully occluded cap 346. Again, as the nasal delivery elements 111, 112 are non-sealing the expiratory gases may also leave the patient's airways by flowing around the nasal delivery element 112 and not through the interface body 110.
[1559] Referring to Figures 36 to 42, schematical views of the interface body 110 and frame 120 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1560] As illustrated in Figure 36, the interface body 110 comprises at least one external gases channel 144. The external gases channel 144 extends along an exterior of the interface body 110. The external gases channel 144 allows for the flow of gases through the channel 144.
[1561] In some arrangements, the interface body 110 is defined as having or comprising a main body portion, this being the portion from which the nasal delivery elements 111, 112 extend. The main body portion may be referred to as the base portion 118. However, the more general term of main body portion is optionally used herein as to allow for the channels to be on either side of the interface body 110 where appropriate. However, where appropriate, the term base portion 118 may instead be used. The external gases channel 144 extends along at least a part of the main body portion or base portion 118 of the interface body 110. This may also be termed as the gases channel 144 extends along the interface body 110 exclusive to the nasal delivery elements 111, 112. [1562] The gases channel 144 may be formed as a substantially U- or C-shaped channel. The channel may also be formed to be concave along its length such that it has a deepest portion at a substantially central point.
[1563] The gases channel 144 is formed on the patient side of the interface body 110 (when in use), i.e. the base portion 118. However, in some arrangements, the gases channel 144 may extend to the side of the interface body 110 that faces away from the patient. The gases channel 144 extends laterally outwardly from the nasal delivery elements 111, 112. Therefore, the gases channel 144 extends toward the side arms 101, 102 and are adjacent to the nasal delivery elements 111, 112.
[1564] A gases channel 144 may be formed adjacent to each nasal delivery element 111, 112. Therefore, the gases channel 144 is symmetrical about the first midline plane 165 (see Figures 10 and 11), i.e. symmetrical along a plane arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface 100 is in use.
[1565] The gases channel 144 prevents occlusion of the nasal interface 110 with the user's nares by ensuring there is a channel for the gases to flow through. This ensures that the nasal interface 100 is non-sealing. The gases channel 144 also allows for the directing of gases away from the patient's face. This may have the effect of any expiratory gases that do not pass through the nasal delivery elements 111, 112, (or any inspiratory gases that do not pass through the nares) are directed through the gases channel 144 around the nasal interface 110 rather than deflecting back to the patient's face. This provides additional comfort for the patient.
[1566] Referring to Figure 37, the external gases channel 144 is bifurcated. The bifurcated channel 145, 146 forms a first external gases channel 145 and a second external gases channel 146.
[1567] The first external gases channel 145 and second external gases channel 146 are arranged on either side of the second midline plane 166 (see Figure 11), i.e. either side of and/or symmetrical to a plane that is transverse to a first midline plane 165 (see Figure 10) 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.
[1568] The first external gases channel 145 and second external gases channel 146 allows for gases passing through the channel to be further directed away from the patient as required.
[1569] Referring to Figure 38, the external gases channel 144 extends along at least part of the adjacent nasal delivery element 111, 112. Further, in the illustrated arrangement, the external gases channel 144 extends to the tip of the adjacent nasal delivery element 111, 112 (i.e. to the nasal delivery element outlet 1111a, 1112a). Therefore, the external gases channel 144 extends from the lateral direction on the patient side of the main body portion I base portion 118 of the interface body 110, to the nasal delivery element outlet 1111a, 1112a. This provides the external gases channel 144 for gases to pass through from a position within the naris. This may assist with directing the gases flow.
[1570] The illustrated arrangement of Figure 38 also has the channel bifurcated into the first external gases channel 145 and second external gases channel 146 as described above. However, in some arrangements, the external gases channel 144 is a single channel.
[1571] The external gases channel 144 may have a same depth along its length. However, in the illustrated arrangement, the external gases channel 144 has a constant depth in the portion that is arranged external to the nasal delivery element 111, 112, and a concave depth in the portion that is arranged external to the main body portion I base portion 118.
[1572] Referring to Figures 39 and 40, the external channel gases flow 147 is shown where arrows illustrate the flow path of external channel gases flow 147 that is directed along the associated external gases channel 144. The arrangement of Figure 38 is used for this explanation where the external gases channel is bifurcated and extends along the nasal delivery elements 111, 112. However, the external channel gases flow 147 is relevant to all arrangements.
[1573] The external channel gases flow 147 is shown to follow the external gases channel 144 from the nasal delivery elements 111, 112. The external channel gases flow 147 is directed in a respective lateral outward direction toward the respective side arms 101, 102. This directs the flow away from the patient's face and avoid flow circulating back onto the patient. Further, where the channel 144 is bifurcated, the external channel gases flow 147 splits into an upward or downward direction relative to a patient's face. Therefore, rather than a flow colliding with side arms 101, 102 or the headgear 200, portions of external channel gases flow 147 are directed upwardly or downwardly depending on whether is passes through the first external gases channel 145 or second external gases channel 146.
[1574] The sectional view of Figure 40 in particular illustrates that the external channel gases flow 147 is directed outwardly away from the patient's face toward the lateral position of the external gases channel 144. A single external channel gases flow 147 is illustrated adjacent to the second nasal delivery element 112. However, the same flow occurs at the first nasal delivery element 111 when the external gases channel 144 is present.
[1575] Referring to Figure 41, the external gases channel 144 further extends along at least part of the second nasal delivery element 112 in addition to extending along the main body portion I base portion 118 adjacent the second nasal delivery element 112. However, no external gases channel 144 is present adjacent the first nasal delivery element 111. Therefore, there is a single external gases channel 144 (that is bifurcated into the first external gases channel 145 and second external gases channel 146 in the illustrated arrangement). Therefore, the interface body 110 is not symmetrical about the first midline plane 165 (but still symmetrical about the second midline plane 166).
[1576] Referring to Figure 42, the external gases channel 144 is provided extending along at least a part of the main body portion I base portion 118 of the interface body 110 in a similar manner to that described with reference to Figures 36 or 37 above. A plurality of channels 144 may be provided. A plurality of channels may be at least bifurcated channels 145, 146 or may be additional individual channels 144 extending parallel to one another. As with the arrangements of Figures 36 or 37, the channels 144 may extend along the interface body 110 exclusive to the nasal delivery elements 111, 112.
[1577] In some arrangements, the external gases channels 144 may be undercut such that they extend around an edge or side of the main body portion I base portion 118 of the interface body 110. An extension of the external gases channels 144 are such that the external gases channels 144 are at least partially formed on a rear portion of the main body (i.e. the nasal delivery elements 111, 112 side) and the front portion of the main body (i.e. the gases inlet 121 side or base portion 118). The undercut may further direct the flow of gases, such as expiratory gases, to a front portion of the nasal interface 100 away from the user's face.
[1578] Referring to Figures 43 to 46, schematical views of the interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1579] As illustrated in the configuration of Figure 43, the interface body 110 comprises a plurality of external gases channels 148. The plurality of external body gases channels 148 are located on the rear portion of the main body (i.e. the nasal delivery elements 111, 112 side or base portion 118). The plurality of external body gases channels 148 extend along an exterior of the interface body 110 in a lateral direction.
[1580] The external body gases channels 148 may be similar in shape and/or functionality to the gases channels 144, e.g. the external body gases channels 148 may be formed as a substantially U- or C-shaped channels. The channels may also be formed to be concave along their length such that they have a deepest portion at a substantially central point. The external body gases channels 148 substantially direct or allow a gas flow along the channels.
[1581] In the configuration shown, the plurality of external body gases channels 148 are parallel to each other. The plurality of external body gases channels 148 may also be parallel to an axis extending between the nasal delivery elements 111, 112. The plurality of external body gases channels 148 allow for the flow of gases through the channels 148.
[1582] The plurality of external body gases channels 148 extend from an edge or side of the interface body 110 to an opposite edge or side of the interface body 110. The external body gases channels 148 may be continuous or discontinuous. The plurality of external body gases channels 148 extend to or near the bases 1111c, 1112c of the nasal delivery elements 111, 112. In some configurations, apart from the bases 1111c, 1112c, the nasal delivery elements 111, 112 have a smooth external surface without channels. Each channel of the plurality 148 that stops at the base 1111c, 1112c of a nasal delivery element 111, 112 continues from the base 1111c, 1112c of the nasal delivery element 111, 112 on the other side of said nasal delivery element. In other configurations, some or part of the external body gases channels 148 may extend along the outer surface of one or each nasal delivery element 111, 112, such as forming gases channels 144 as described above.
[1583] In some configurations, such as the configuration illustrated in Figure 43, there is an additional channel 186 that is arranged substantially perpendicular to the plurality of external body gases channels 148. The additional channel is located (substantially) at the midpoint of the interface body, i.e. half way between the nasal delivery elements. The additional channel 186 extends from the uppermost channel of the plurality of external body gases channels 148 to the lowermost channel of the plurality of external body gases channels 148. The additional channel 186 may be formed as a discontinuity of the external body gases channels 148. In some arrangements, the discontinuity that forms the additional channel 186 may not be present in all external body channels 148. [1584] In some configurations, the channels of the plurality of external body gases channels 148 have the same width and equal spacing. In the illustrated configuration there are eight channels in the plurality of external body gases channels 148. In alternative configurations there may be greater or fewer channels 148 than eight, such as two, three, four, five, six, seven, nine, or ten channels for example. In alternative configurations the channels 148 may have different widths and unequal spacing.
[1585] Referring to Figure 44, the external body gases channels 148 are provided as described above with reference to Figure 43, but where the external body gases channels 148 extend perpendicular to that arrangement, i.e. from a top to a bottom of the rear of the interface body 110. The description above, may be applied here. As illustrated in the configuration of Figure 44, the plurality of external body gases channels 148 are located on the rear portion of the main body of the interface body 110 (i.e. the nasal delivery elements 111, 112 side or base portion 118). The plurality of external body gases channels 148 extend along an exterior of the interface body 110. The plurality of external body gases channels 148 extend from an edge or side of the interface body 110 to an opposite edge or side of the interface body 110. The plurality of external body gases channels 148 are formed by a plurality of ridges that extend across the rear portion of the main body and also extend from the rear portion of the main body in a direction toward gases outlets of the nasal delivery elements.
[1586] In the configuration shown, the plurality of external body gases channels 148 are parallel to each other and perpendicular to an axis extending between the nasal delivery elements 111, 112. The plurality of external body gases channels 148 allow for the flow of gases through the channels 148.
[1587] The plurality of external body gases channels 148 may be continuous or discontinuous. Some of the plurality of external body gases channels 148 are in contact with the bases 1111c, 1112c of the nasal delivery elements 111, 112. Apart from the bases 1111c, 1112c, the nasal delivery elements 111, 112 have a smooth external surface without channels. Each channel of the plurality of body gases channels 148 that stops at the base 1111c, 1112c of a nasal delivery element 111, 112 continues from the base 1111c, 1112c of the nasal delivery element 111, 112 on the other side of said element.
[1588] As illustrated in the configuration of Figure 45, the plurality of external body gases channels 148 are located on the rear portion of the main body (i.e. the nasal delivery elements 111, 112 side or base portion 118). The plurality of external body gases channels 148 are defined by the spaces between protrusions on the rear portion of the main body. [1589] The protrusions may be circular. In the configuration shown, the protrusions have uniform diameter and are spaced uniformly on a hexagonal grid. The protrusions protrude in a uniform direction. The distal or outermost surfaces of the protrusions may be curved, and may collectively define a curved surface for contacting a patient's face (in use). With the exception of the nasal delivery elements 111, 112 and the spaces between the protrusions, the protrusions may cover the entirety of the rear portion of the main body.
[1590] As illustrated in the configuration of Figure 46, the plurality of external body gases channels 148 are located on the rear portion of the main body (i.e. the nasal delivery elements 111, 112 side or base portion 118). The plurality of external body gases channels 148 is defined by the spaces between hexagonal protrusions on the rear portion of the main body.
[1591] In the configuration shown, the protrusions are regular hexagons with equal dimensions and are spaced uniformly on a hexagonal grid. The protrusions protrude in a uniform direction. The top surfaces of the protrusions may be curved, and may collectively define a curved surface for contacting a patients face (in use). With the exception of the nasal delivery elements 111, 112 and the spaces between the protrusions, the protrusions cover the entirety of the rear portion of the main body.
[1592] Referring to Figures 47 to 52, schematical views of the interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the frame 120 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1593] The interface body 110 comprises a first cutout 158 and second cut out 159. The base portion 118 (or rear of the main body of the interface body 110) comprises the first cutout 158 and the second cutout 159. These may also be collectively referred to as a pair of cutouts 158, 159.
[1594] Referring to Figure 47, the first cutout 158 is formed as an indent or recess in the base portion 118. The first cutout 158 extends from the edge of the base portion 118. The first cutout 158 may be a recess, indent or dip in the otherwise smooth or continuous surface of the interface body 110.
[1595] The first cutout 158 may be formed with a relative wide portion at the edge narrowing to a relatively narrow portion at the nasal delivery element 111. The wide portion may extend along approximately 50% of the lateral edge. However, other sizes are possible. In some arrangements, the first cutout 158 may be formed as a substantially triangular-shaped or trapezoid-shaped cutout. The wide base of the triangle or trapezoid shape is formed at the edge of the base portion 118. The opposing apex or narrow base of the shape is formed at the nasal delivery element 111. In some arrangements, the opposing apex or narrow base of the shape is formed at the base of the 1111c of the nasal delivery element 111.
[1596] The edge of the base portion 118 from which the wide base of the triangle or trapezoid shape is formed is at the effective lateral side or edge of the interface body 110, that is the edge closest to the corresponding side arm 101. However, in some configurations, the first cutout 158 may have its edge positioned at any radial point relative to the nasal element 111.
[1597] The first cutout 158 forms an effective channel along the surface of the base portion 118 toward the edge. The relatively narrow portion may direct a flow of gases, such as exhalation gases from a user's naris through the cutout 158 toward the relatively wide portion and outwardly from the interface body 110 in a relatively lateral direction. This may be beneficial in ensuring gases are directed away from a patient rather than toward the eyes or mouth.
[1598] The second cutout 159 is formed in a similar manner at the opposing lateral side - that is at the side of the nasal interface 110 positioned at the opposing I second side arm 102.
[1599] Referring to Figure 47, the second cutout 159 is formed as an indent or recess in the base portion 118. The second cutout 159 extends from the edge of the base portion 118 that is opposed to the edge from which the first cutout 157 extends. The second cutout 159 may be a recess, indent or dip formed in or below the otherwise smooth or continuous surface of the interface body 110.
[1600] The second cutout 159 may be formed with a relative wide portion at the edge narrowing to a relatively narrow portion at the second nasal delivery element 112. The wide portion may extend along approximately 50% of the lateral edge. However, other sizes are possible. In some arrangements, the second cutout 159 may be formed as a substantially triangular-shaped or trapezoid-shaped cutout. The wide base of the triangle or trapezoid shape is formed at the lateral side or edge of the base portion 118. The opposing apex or narrow base of the shape is formed at the second nasal delivery element 112. In some arrangements, the opposing apex or narrow base of the shape is formed at the base of the 1112c of the second nasal delivery element 112.
[1601] The edge of the base portion 118 from which the wide base of the triangle or trapezoid shape is formed is at the lateral side or edge of the interface body 110, that is the edge closest to the corresponding side arm 102. However, in some configurations, the second cutout 159 may have its edge positioned at any radial point relative to the nasal element 111. The first and second cutouts 158, 159 may be positioned at non- symmetrical positions.
[1602] The second cutout 159 forms an effective channel along the surface of the base portion 118 toward the edge. The relatively narrow portion may direct a flow of gases, such as exhalation gases from a user's naris through the cutout 159 toward the relatively wide portion and outwardly from the interface body 110 in a relatively lateral direction. This may be beneficial in ensuring gases are directed away from a patient rather than toward the eyes or mouth.
[1603] Whilst two cutouts 158, 159 are shown, in some configurations, a single cutout 158, 159 may be present.
[1604] The first and second cutouts 158, 159 are separate. Between the first and second cutouts 158, 159 there is a portion of the interface body 110 that is not recessed.
[1605] Referring to Figure 48, a schematical top or plan view of the interface body 110 is shown. The shape of the cutouts 158, 159 form a concave shape relative to the remaining non-cutout portions of the interface body 110. The cutouts 158, 159 do not vary the shape of the front side, i.e. the size of the interface body 110 having the gases ports 121, 122.
[1606] As shown in Figures 47 and 48, the first cutout 158 and second cutout 159 are different sizes. This is primarily a result of the first nasal element 111 and second nasal element 112 have different outer diameters. Therefore, the distance from the edge to the corresponding edge of the base 1111c, 1112c are different. This results in the first cutout 158 and second cutout 159 having a different shape. In some arrangements, the different shape is provided for by the angle of the sides or arms of the first cutout 158 and second cutout 159 being different. For instance, the first cutout 158 may have a shaper angle for the sides or arms of the shape of the cutout relative to the second cutout 159. The arrangement may be referred to as having non-symmetrical cutouts 158. 159.
[1607] Referring to Figure 49, an interface body 110 of the nasal interface 100 with a pair of cutouts 160, 161 is shown. The cutouts 160 are substantially similar to those described above with reference to Figures 47 and 48. However, in the configuration of Figure 49, the cutouts 160, 161 are symmetrical. For ease of description, the symmetrical cutouts 160, 161 are referred to as a third cutout 160 and fourth cutout 161 to distinguish from the cutouts 158, 159 of Figures 47, 48. However, the third and fourth cutouts 160, 161 may be termed first and second cutouts. [1608] The third and fourth cutouts 160, 161 are formed as an indent or recess in the base portion 118. The third and fourth cutouts 160, 161 extend from the respective (lateral) edges of the base portion 118. The third and fourth cutouts 160, 161 may be recesses, indents or dips in the otherwise smooth or continuous surface of the interface body 110.
[1609] The third and fourth cutouts 160, 161 may be formed with a relative wide portion at the edge narrowing to a relatively narrow portion at the corresponding nasal delivery elements 111, 112. The wide portion may extend along approximately 50% of the lateral edge. However, other sizes are possible. In some arrangements, the third and fourth cutouts 160, 161 are be formed as having relatively straight sides which narrow to a curved apex or arc. The wide base of the shape is formed at the edge of the base portion 118. The opposing apex or arc of the shape is formed around the nasal delivery elements 111, 112. In some arrangements, the opposing apex or arc of the shape is formed around the base of the 1111c, 1112c of the nasal delivery elements 111, 112.
[1610] The apex or arc of the shape of the third and fourth cutouts 160, 161 may be formed radially around the corresponding nasal delivery elements 111, 112. Therefore, the nasal delivery elements 111, 112 are the axis of curvature.
[1611] As described above, the third and fourth cutouts 160, 161 are symmetrical about the first midline plane 165 (see Figure 10). The third cutout 160 is positioned around the first nasal element 111 and its wall passes relatively close to the perimeter of the base 1111c. The fourth cutout 161 is positioned around the second nasal element 112 and its wall passes relatively distant to the perimeter of the base 1112c. The distance between the third and fourth cutouts 160, 161 and the relative nasal elements 111, 112 may be varied depending on design requirements.
[1612] The third and fourth cutouts 160, 161 form an effective channel along the surface of the base portion 118 toward the edge of the interface bodies 110. As the third and fourth cutouts 160, 161 circumscribe the nasal elements 111, 112, gases which flow down on all sides of the nasal elements 111, 112 may be directed through the third and fourth cutouts 160, 161. The shape of the third and fourth cutouts 160, 161 may direct a flow of gases, such as exhalation gases from a user's naris through the third and fourth cutouts 160, 161 toward the relatively wide portion and outwardly from the interface body 110 in a relatively lateral direction. This may be beneficial in ensuring gases are directed away from a patient rather than toward the eyes or mouth.
[1613] The edge of the base portion 118 from which the wide base of the third and fourth cutouts 160, 161 is formed is at the effective side of the interface body 110, that is the edge closest to the corresponding side arms 101, 102. However, in some configurations, the third and fourth cutouts 160, 161 may have their edges positioned at any radial point relative to the nasal elements 111, 112.
[1614] Referring to Figure 50, an interface body 110 of the nasal interface 100 with the pair of cutouts 160, 161 is shown. The cutouts 160, 161 are substantially similar to those described above with reference to Figure 49, in that the cutouts 160, 161 are symmetrical and encircle the corresponding nasal elements 111, 112. However, in the configuration of Figure 50, the shape of cutouts 160, 161 is different as described below.
[1615] The third and fourth cutouts 160, 161 of the configuration of Figure 50 are formed as an indent or recess in the base portion 118. When viewed from the top or a plan view of the interface body 110, the sides or walls of the indent are substantially transverse to a planar tangent along the surface of the base portion 118. The sides or walls of the indents of the third and fourth cutouts 160, 161 have a depth that extends up to 10% of the total thickness of the interface body 110, where the thickness is the distance between the surface of the base portion 118 to the surface of the interface body 110 having the gases ports 121, 122. The walls of the third and fourth cutouts 160, 161 extend from the respective (lateral) edges of the base portion 118. The third and fourth cutouts 160, 161 may be recesses, indents or dips in the otherwise smooth or continuous surface of the interface body 110 / base portion 118.
[1616] The third and fourth cutouts 160, 161 may be formed with an opening portion at the edge extending in toward the corresponding nasal delivery elements 111, 112. The opening portion may extend along approximately 50% of the lateral edge. However, other sizes are possible. The third and fourth cutouts 160, 161 are formed as having relatively straight and parallel sides 162 which extend to a curved apex or arc 163. The parallel sides 162 extends in a direction that is generally parallel to an axis extending between the nasal delivery elements 111, 112. The opening portion of the shape is formed at the edge of the base portion 118. The opposing apex or arc 163 of the shape is formed around the nasal delivery elements 111, 112. In some arrangements, the opposing apex or arc 163 of the shape is formed around the base of the 1111c, 1112c of the nasal delivery elements 111, 112.
[1617] The apex or arc 163 of the shape of the third and fourth cutouts 160, 161 may be formed radially around the corresponding nasal delivery elements 111, 112. Therefore, the nasal delivery elements 111, 112 form an axis of curvature for the apex or arc 163. [1618] The third and fourth cutouts 160, 161 are symmetrical about the first midline plane 165 (see Figure 10). The third cutout 160 is positioned around the first nasal element 111 and its apex walls pass relatively close to the perimeter of the base 1111c. The fourth cutout 161 is positioned around the second nasal element 112 and its apex walls pass relatively distant to the perimeter of the base 1112c. The distance between the third and fourth cutouts 160, 161 and the relative nasal elements 111, 112 may be varied depending on design requirements.
[1619] The third and fourth cutouts 160, 161 are separate. Between third and fourth cutouts 160, 161 there is a portion of the interface body 110 that is not recessed.
[1620] The third and fourth cutouts 160, 161 form an effective channel along the surface of the base portion 118 toward the edge of the interface bodies 110. As the third and fourth cutouts 160, 161 circumscribe the nasal elements 111, 112 and have straight sides 162, gases which flow down on all sides of the nasal elements 111, 112 may be directed through the third and fourth cutouts 160, 161 to the edges in a focused direction. The shape of the third and fourth cutouts 160, 161 may direct a flow of gases, such as exhalation gases from user's nares through the respective third and fourth cutouts 160, 161 toward the open portion and outwardly from the interface body 110 in a relatively lateral direction. This may be beneficial in ensuring gases are directed away from a patient rather than toward the eyes or mouth.
[1621] The edge of the base portion 118 from which the opening portion of the third and fourth cutouts 160, 161 is formed is at the effective side of the interface body 110, that is the edge closest to the corresponding side arms 101, 102. However, in some configurations, the third and fourth cutouts 160, 161 may have their edges positioned at any radial point relative to the nasal elements 111, 112.
[1622] Referring to Figure 51, the configuration of Figure 50 is shown with a single fourth cutout 161, i.e. the third cutout 161 is not present. The fourth cutout 161 encircles the second nasal interface 112. The arc or apex 163 may still be relatively distant from the base 1112c of the nasal element 112 as if symmetrical with a third cutout 161. Otherwise, the description for the above configuration of Figure 50 applies here.
[1623] As described above, the larger nasal delivery element 111 may occlude or partially occlude the naris of the patient compared to the smaller nasal delivery element 112. Therefore, exhalation gases may be more directed through the naris in contact with the smaller nasal delivery element 112. In view of this, in the present configuration, it may not be necessary to have a pair of cutouts 160, 161 as only the cutout 161 corresponding to the smaller nasal delivery element 112 needs to direct gases. [1624] In some alternative configurations, the single cutout 160, 161 may be the third cutout 160 which corresponds to the first or larger nasal delivery element 111.
[1625] Referring to Figure 52, an interface body 110 of the nasal interface 100 with a pair of cutouts 160, 161 is shown. The cutouts 160, 161 are substantially similar to those described above with reference to Figure 50, in that the cutouts 160, 161 are symmetrical and encircle the corresponding nasal elements 111, 112 and have substantially parallel sides 162.
[1626] The third and fourth cutouts 160, 161 of the configuration of Figure 52 are formed as an indent or recess in the base portion 118. When viewed from the top or a plan view of the interface body 110, the walls of the indent are substantially angled to a planar tangent along the surface of the base portion 118. The angle of the walls are angled between approximately 30 degrees and 60 degrees.
[1627] The angled walls provide a smoother transition between the base portion 118 (or main body portion) and the third and fourth cutout 160, 161. This may provide additional patient comfort.
[1628] The sides or walls of the indents of the third and fourth cutouts 160, 161 have a depth that extends up to 10% of the total thickness of the interface body 110, where the thickness is the distance between the surface of the base portion 118 to the surface of the interface body 110 having the gases ports 121, 122. The sides of the third and fourth cutouts 160, 161 extend from the respective (lateral) edges of the base portion 118. The third and fourth cutouts 160, 161 may be recesses, indents or dips in the otherwise smooth or continuous surface of the interface body 110 / base portion 118.
[1629] The third and fourth cutouts 160, 161 may be formed with an opening portion at the edge extending toward the corresponding nasal delivery elements 111, 112. The opening portion may extend along approximately 50% of the lateral edge. However, other sizes are possible.
[1630] The third and fourth cutouts 160, 161 are formed as having relatively straight and parallel sides 162 which extend to a curved apex or arc 163. The parallel sides 162 extends in a direction that is generally parallel to an axis extending between the nasal delivery elements 111, 112. The opening portion of the shape is formed at the edge of the base portion 118. The opposing apex or arc 163 of the shape is formed around the nasal delivery elements 111, 112. In some arrangements, the opposing apex or arc 163 of the shape is formed around the base of the 1111c, 1112c of the nasal delivery elements 111, 112. [1631] The apex or arc 163 of the shape of the third and fourth cutouts 160, 161 may be formed radially around the corresponding nasal delivery elements 111, 112. Therefore, the nasal delivery elements 111, 112 form an axis of curvature for the apex or arc 163.
[1632] The third and fourth cutouts 160, 161 are symmetrical about the first midline plane 165 (see Figure 10). The third cutout 160 is positioned around the first nasal element 111 and its apex walls pass relatively close to the perimeter of the base 1111c. The fourth cutout 161 is positioned around the second nasal element 112 and its apex walls pass relatively distant to the perimeter of the base 1112c. The distance between the third and fourth cutouts 160, 161 and the relative nasal elements 111, 112 may be varied depending on design requirements.
[1633] The third and fourth cutouts 160, 161 are separate. Between third and fourth cutouts 160, 161 there is a portion of the interface body 110 that is not recessed.
[1634] The third and fourth cutouts 160, 161 form an effective channel along the surface of the base portion 118 toward the edge of the interface bodies 110. As the third and fourth cutouts 160, 161 circumscribe the nasal elements 111, 112 and have straight sides 162, gases which flow down on all sides of the nasal elements 111, 112 may be directed through the third and fourth cutouts 160, 161 to the edges in a focused direction. The shape of the third and fourth cutouts 160, 161 may direct a flow of gases, such as exhalation gases from user's nares through the respective third and fourth cutouts 160, 161 toward the open portion and outwardly from the interface body 110 in a relatively lateral direction. This may be beneficial in ensuring gases are directed away from a patient rather than toward the eyes or mouth.
[1635] The edge of the base portion 118 from which the opening portion of the third and fourth cutouts 160, 161 is formed is at the effective side of the interface body 110, that is the edge closest to the corresponding side arms 101, 102. However, in some configurations, the third and fourth cutouts 160, 161 may have their edges positioned at any radial point relative to the nasal elements 111, 112.
[1636] Referring to Figures 53 to 55, schematical views of the interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1637] As illustrated in the configuration of Figure 53, the interface body 110 comprises two external gases channels 144. Each external gases channel 144 is located on the rear portion of the main body (i.e. the base portion 118 of the nasal delivery elements 111, 112 side). The external gases channels 144 allow for the flow of gases through the channels 144.
[1638] Each of the external gases channels 144 surround a respective nasal delivery element 111, 112. The shape of the portion of the external gases channel 144 surrounding the respective nasal delivery element 111, 112 is approximately circular, and the centre of the circular portion of the external gases channel 144 is aligned with the centre of the base of the respective nasal delivery element 111, 112. This is similar to that described with reference to Figures 50 to 52 above.
[1639] The diameters of the circular portions of each of the two external gases channels 144 are equal. This means that the width of the circular potion of the channel 144 surrounding the smaller of the nasal delivery elements 112 is greater than the width of the circular portion of the channel 144 surrounding the larger of the two nasal delivery elements 111.
[1640] The circular portions of each of the two external gases channels 144 are separate. Between the two channels 144 there is a portion of the interface body 110 that is not recessed.
[1641] Each of the external gases channels 144 has a lateral portion that extends outwardly from the circular portion to the edge or side of the interface body 110 in a lateral direction at least to lateral edges or sides of the interface body 110. Each lateral portion extends in a direction that is generally parallel to an axis extending between the nasal delivery elements 111, 112.
[1642] The lateral portion of each external gases channel 144 has a width that is less than the diameter of the circular portion of the external gases channel 144. The width of each lateral portion may be equal.
[1643] In the configuration shown, each external gases channel 144 has an undercut. The width of the channel at an upper part of the channel is narrower than the width of the channel at a lower part of the channel. The undercut may extend along all of the edges of the channel. In alternative configurations, the undercut may extend along only a portion of the channel, such as the lateral portion, or the circular portion, or some of the lateral portion, or some of the circular portion, or some of both the lateral and circular portions.
[1644] The gases channels 144 are formed on the patient side of the interface body 110 (when in use). However, in some arrangements, the lateral portion of each gases channels 144 may extend to the side of the interface body 110 that faces away from the patient.
[1645] Each external gases channel 144 is smoothly curved at the point that the lateral portion meets the circular portion.
[1646] The two external gases channels 144 are symmetrical about a midline plane that equally bisects the interface body 110 either vertically or horizontally with reference to a sagittal plane of a patient when the nasal interface 100 is in use (i.e. both about the first midline plane 165 (see Figure 10) and the second midline plane 166 (see Figure 9).
[1647] As illustrated in the configuration of Figure 54, the interface body 110 comprises an external gases channel 144. Each external gases channel 144 is located on the rear portion of the main body (i.e. the base portion 118 side with the nasal delivery elements 111, 112). The external gases channels 144 allow for the flow of gases through the channels 144.
[1648] The external gases channel 144 surrounds both nasal delivery elements 111, 112. The shape of each of the portions of the external gasses channel 144 that surrounds the nasal delivery elements 111, 112 is approximately circular, and the centre of the circular portions of the external gases channel 144 is aligned with the centre of the base of the respective nasal delivery element 111, 112.
[1649] The diameters of the circular portions of the external gases channel 144 are equal. This means that the width of the circular potion of the channel 144 surrounding the smaller of the nasal delivery elements 112 is greater than the width of the circular portion of the channel 144 surrounding the larger of the two nasal delivery elements 111.
[1650] The external gases channel 144 has lateral portions that extend outwardly from the circular portions to the edge or side of the interface body 110 in a lateral direction at least to the outer side edges of the interface body. Each lateral portion extends in a direction that is generally parallel to an axis extending between the nasal delivery elements 111, 112.
[1651] The lateral portions each have a width that is less than the diameter of the circular portions of the external gases channel 144. The width of each lateral portion may be equal.
[1652] In the configuration shown, the external gases channel 144 has an undercut. The width of the channel at the top of the channel is narrower than the width of the channel at a lower part of the channel. The undercut may extend along all of the edges of the channel. In alternative configurations, the undercut may extend along only a portion of the channel, such as the lateral portion, or the circular portion, or some of the lateral portion, or some of the circular portion, or some of both the lateral and circular portions.
[1653] The gases channels 144 are formed on the rear, patient side of the interface body 110 (i.e. the base portion 118). However, in some arrangements, the lateral portion of each gases channels 144 may extend to the side of the interface body 110 that faces away from the patient.
[1654] The external gases channel 144 has a central portion that extends between the two nasal delivery elements 111, 112. The central portion is aligned with the lateral portions. The width of the central portion is less than the width of the lateral portions.
[1655] The external gases channel 144 is smoothly curved at the points where the lateral portions meet the circular portions, and at the point where the central portion meets the circular portions.
[1656] As illustrated in the configuration of Figure 55, the interface body 110 comprises two external gases channels 144. Each external gases channel 144 is located on the rear portion of the main body (i.e. the base portion 118 side with the nasal delivery elements 111, 112). The external gases channels 144 allow for the flow of gases through the channels 144.
[1657] Each of the external gases channels 144 surround a respective nasal delivery element 111, 112. The shape of the portion of the external gases channel 144 surrounding the respective nasal delivery element 111, 112 is generally circular, and the centre of the circular portion of the external gases channel 144 is aligned with the centre of the base of the respective nasal delivery element 111, 112.
[1658] The diameters of the circular portions of each of the two external gases channels 144 are equal. This means that the width of the circular portion of the channel 144 surrounding the smaller of the nasal delivery elements 112 is greater than the width of the circular portion of the channel 144 surrounding the larger of the two nasal delivery elements 111.
[1659] The circular portions of each of the two external gases channels 144 are separate. Between the two channels 144 there is a portion of the interface body 110 that is not recessed.
[1660] Each of the external gases channels 144 has an upper portion that extends from the circular portion to the top edge or side 152 of the interface body 110. Each of the external gases channels 144 has a lower portion that extends from the circular portion to the bottom edge or side 153 of the interface body 110. In the configuration shown, the upper portion and lower portion of each channel are aligned. In the configuration shown, the upper portion and lower portion of each channel are parallel with the corresponding portion of the other channel.
[1661] The upper and lower portions of each external gases channel 144 has a width that is less than the diameter of the circular portion of the external gases channel 144. The width of each upper or lower portion may be equal.
[1662] Referring to Figures 56 to 57, schematical views of the interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1663] As illustrated in the configuration of Figures 56 and 57, the interface body 110 comprises a septum contacting region in the form of a bridge 149 extending between the nasal delivery elements 111, 112. The bridge 149 is spaced from an underlying portion of the body beneath the bridge. The underlying body is the base portion 118.
[1664] There is a cutout or through channel in the interface body 110 between the nasal delivery elements 111, 112. The bridge 149 is closer to the patient's nose (in use) than the cutout. The main body portion of the interface body 110 is further from the patient's nose (in use) than the cutout.
[1665] The interface body 110 is continuous around the cutout such that no gases can flow through the wall of the interface body 110 in the region of the cutout.
[1666] In the configuration shown, the bridge 149 has an approximately constant width between the nasal delivery elements 111, 112. The width of the bridge 149 is approximately the same as the diameter of the larger of the two nasal delivery elements 111.
[1667] In some configurations, the bridge 149 can flex upon contact with the patient's septum. In other configurations, the bridge 149 can be substantially rigid to provide support to the patient's septum.
[1668] As described, the nasal interface 100 delivers an asymmetric flow at the patient's nares. Therefore, the first nasal delivery element 111 may be primarily for inspiratory flow and the second nasal delivery element 112 may be primarily for expiratory flow. In such a situation, the external gases channel 144 may be more required at the second nasal delivery element 112 as this is where flow is required to be directed. However, such locations may be reversed in some arrangements.
[1669] Referring to Figures 58 and 59, schematical views of the interface body 110 and frame 120 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1670] A portion of the bias flow vent 340 comprises a tube notch 195. The tube notch 195 is shaped around a tube 196 passing through the notch and along the side of the nasal delivery element 112.
[1671] Whilst the tube 196 is shown passing proximal to the second nasal delivery element 112 so that the second nasal delivery element 112 and tube 196 pass through the same naris of the patient, in some arrangements, the tube 196 may pass proximal to the first nasal delivery element 111. However, as in some arrangements, the second nasal delivery element 112 is relatively smaller, there may be more room in a patient's naris to accommodate both the nasal delivery element 112 and the tube 196.
[1672] The tube notch 195 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 bias flow vent 340 is formed around the tube 196 in the form of the tube notch 195. The tube notch 195 is formed in an upward and downward direction with reference to the patent's face. Therefore, if the nasal interface 100 is inverted, the tube 196 may be repositioned at the same side, which in the illustrated arrangement is at the top of the bias flow vent 340. This reduces any discomfort for the patient.
[1673] In some arrangements, the tube notch 195 is shaped to closely conform with the shape of the tube 196 to assist with holding it in position on the frame 120 so it is directed away from the patent's cheeks.
[1674] Where the tube 196 is a nasogastric tube (NG tube), this is a type of medical catheter that's inserted through the patient's nose into the stomach. It's used for limited periods to deliver substances such as food or medications to the patient's stomach or to draw substances out. There are many situations where an NG tube need to be inserted while the respiratory mask is still on. The tube notch 195 being symmetric in the second midline plane 196 allows the nasal interface 100 to accommodate the NG tube and still support side-swapping.
[1675] The tube notch 195 may also be arranged on the gases delivery portion 352 of the gases inlet port 121. As with the tube notch 195 of the bias flow vent 340, this may be arranged such that the exterior of the gases delivery portion 352 is formed around the tube 196 in the form of the tube notch 195. The tube notch 195 of the gases delivery portion 352 is formed in an upward and downward direction with reference to the patent's face. Therefore, if the nasal interface 100 is rotated, the tube 196 may be repositioned at the same location. This reduces any discomfort for the patient.
[1676] The interface body 110 is soft and compliant and combines with the tube notches 195 to allow the nasal interface 100 to sit on the patient's face without pressing the tube 196 hard against the patient's face, reducing the pressure and adding to comfort.
[1677] Referring to Figures 60 to 66, schematical views of the interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1678] As illustrated in the configuration shown in Figures 60 to 63, the interface body 110 comprises a shape that slopes away from a septum contacting region 149 of the interface body 110, and that slopes away from the base of each nasal delivery element 111, 112. The sloped shape of the interface body 110 results in reduced noise when a patient who is using the interface exhales.
[1679] As illustrated in Figure 60, the interface body comprises an upper portion
150 that is sloped from the septum contacting region 149 to the top edge or side 152 of the interface body 110, and a lower portion 151 that is sloped from the septum contacting region 149 to the bottom edge or side 153 of the interface body 110. The septum contacting region 149 is a curved portion of the interface body 110 that connects the upper sloped portion 150 and the lower sloped portion 151. The top and bottom edges or sides 152, 153 of the interface body 110 are curved portions of the interface body 110 that connect the rear portion of the main body (i.e. the nasal delivery elements 111, 112 side) to the front portion of the main body (i.e. the gases inlet 121 side).
[1680] The thickness of the septum contacting region 149 of the interface body 110 is greater than the thickness of the sloped portions 150, 151 of the interface body 110. The thickness of the septum contacting region 149 may gradually increase from the point where the septum contacting region 149 meets with one of the sloped portions 150,
151 to the middle of the septum contacting region 149.
[1681] In the configuration shown, the top and bottom sloped portions of the interface body 110 have (substantially) no curvature in the first midline plane 165 (see Figure 10).
[1682] In the configuration shown, the angle of each of the sloped portions 150, 151 to the second midline plane 166 (see Figure 9) is approximately 55 degrees. In alternative configurations, this angle may be greater or lesser. For instance, the angle may be between 35 degrees and 75 degrees, or between 40 degrees and 70 degrees, or between 45 degrees and 65 degrees, or between 50 degrees and 60 degrees. The angle of the upper sloped portion 150 and the angle of the lower sloped portion 151 may be equal. The angles of the upper sloped portion 150 and the lower sloped portion 151 may be different, with each of the angles coming from the aforementioned range.
[1683] As illustrated in Figure 61, the septum contacting region 149 is saddle shaped. The septum contacting region 149 is convex in the first midline plane 165 (see Figure 10). The septum contacting region 149 is concave in the second midline plane 166 (see Figure 9).
[1684] The septum contacting region 149 extends between the bases of the nasal delivery elements 111, 112.
[1685] The portion of the interface body 110 that partially surrounds the base of each nasal delivery element 111, 112 has a generally frustoconical shape. The generally frustoconical portions surround top, bottom, and lateral sides of the nasal delivery elements 111, 112.
[1686] In the configuration shown, the slopes of the generally frustoconical portions are different to each other, and to the sloped portions 150, 151. The slope of the generally frustoconical portions may be between 35 degrees and 75 degrees, or between 40 degrees and 70 degrees, or between 45 degrees and 65 degrees, or between 50 degrees and 60 degrees.
[1687] The generally frustoconical portions may have regions which are concave, convex, saddle shaped, flat, or curved in only one axis. In the illustrated configuration the generally frustoconical portion that partially surrounds the larger of the two nasal delivery elements 111 has a convex portion located lateral to the nasal delivery element 111. The generally frustoconical portions connect smoothly to the nasal delivery elements 111, 112, the sloped portions 150, 151, and to the septum contacting region 149. The generally frustoconical portions extend to the edge or side of the interface body 110.
[1688] As illustrated in Figure 63, in use the septum contacting region 149 is in contact with a septum of the patient. When the patient exhales through their nose, gases flow along the sloped surfaces of the interface body 110. The shape of the interface body 110 is such that the gases flow is minimally disturbed, reducing noise related to exhalation.
[1689] As illustrated in the configuration shown in Figures 64 to 66 the interface body 110 comprises a bulbous or rounded septum contacting region 149 of the interface body 110. The interface body 110 is sloped away from the base of each nasal delivery element 111, 112. The rounded septum contacting region 149 provides improved comfort. The sloped shape of the interface body 110 results in reduced noise when a patient who is using the interface exhales.
[1690] As illustrated in Figure 64, the septum contacting region 149 has a cross section that approximates a circle segment in the first midline plane 165 (see Figure 10). The radius of this circular segment is greater that the radius of the larger of the two nasal delivery elements 111. In alternative configurations this radius may be the same as or smaller than the radius of the larger nasal delivery element 111. The circular segment smoothly connects to the top and bottom edges or sides 152, 153 of the interface body
110.
[1691] As illustrated in Figure 65, the septum contacting region 149 comprises a central portion 149a of the rear portion of the main body (i.e. the nasal delivery elements
111, 112 side). The central portion 149a is raised relative to the surrounding portions of the interface body 110. The central portion 149a is located between the two nasal delivery elements 111, 112. In the configuration shown, the central portion 149a extends to the bases of the nasal delivery elements 111, 112. In the configuration shown, the central portion 149a extends part way to the top and bottom edges or sides 152, 153 of the interface body 110. The central portion 149a may be generally symmetrical in one of or both the first midline plane 165 (see Figure 10) and the second midline plane 166 (see Figure 9). The central portion 149a may have a generally circular or ovate shape when viewed in a direction from the outlets of the nasal delivery elements 111, 112.
[1692] The central portion 149a connects to the surrounding portions of the interface body 110 smoothly. The region where the central portion 149a connects to the surrounding portions of the interface body 110 is recessed relative to the central portion 149a. The recessed regions define four external gases channels 144 through which exhaled gases can flow. Each external gases channel 144 extends from the intersection of the base of the nasal delivery elements 111, 112 and the central portion 149a, and extends to the top or bottom edge or side 152, 153 of the interface body 110.
[1693] As illustrated in Figure 66, the septum contacting region 149 is saddle shaped. In the first midline plane 165 (see Figure 10) the septum contacting region 149 is convex. In the second midline plane 166 (see Figure 9) the septum contacting region is concave.
[1694] The septum contacting region 149 extends between the bases of the nasal delivery elements 111, 112. [1695] The portion of the interface body 110 that partially surrounds the base of each nasal delivery element 111, 112 has a generally frustoconical shape. The generally frustoconical portions surround top, bottom, and lateral sides of the nasal delivery elements 111, 112.
[1696] In the configuration shown, the slopes of the generally frustoconical portions are different to each other. The slope of the generally frustoconical portions may be between 35 degrees and 75 degrees, or between 40 degrees and 70 degrees, or between 45 degrees and 65 degrees, or between 50 degrees and 60 degrees.
[1697] The generally frustoconical portions may have regions which are concave, convex, saddle shaped, flat, or curved in only one axis. In the illustrated configuration the generally frustoconical portion that partially surrounds the larger of the two nasal delivery elements 111 has a convex portion located lateral to the nasal delivery element 111. The generally frustoconical portions connect smoothly to the nasal delivery elements 111, 112, the sloped portions, and to the septum contacting region 149. The generally frustoconical portions extend to the edge or side of the interface body 110.
[1698] Referring to Figures 67 to 69, schematical views of the interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1699] As illustrated in the configuration shown in Figure 67. the interface body 110 comprises a raised septum contacting region 149, and external gases channels 144 defined on either side of the raised septum contacting region 149. The raised septum contacting region 149 improves patient comfort while the external gases channels 144 help prevent the interface body 110 from sealing against the patient's nares (in use).
[1700] The raised septum contacting region 149 is located generally at the midpoint between the nasal delivery elements 111, 112. The raised septum contacting region 149 extends part way between the nasal delivery elements. The external gases channels 144 are located between edges of the raised septum contacting region 149 and the bases of the nasal delivery elements 111, 112.
[1701] The raised septum contacting region 149 extends continuously into raised upper and lower portions 150, 151 of the interface body 110. The raised upper and lower portions 150, 151 extend to top and bottom edges or sides 152, 153 of the interface body 110. The external gases channels 144 extend to top and bottom edges or sides 152, 153 of the interface body 110 along edges of the raised upper and lower portions 150, 151. [1702] The raised septum contacting region 149 and raised upper and lower portions 150, 151 increase in width from their narrowest point between the nasal delivery elements 111, 112 to their widest point where they connect with the top or bottom edge or side 152, 153 of the interface body 110. In the configuration shown, the raised septum contacting region 149 and raised upper and lower portions 150, 151 are generally symmetric about the first midline plane 165 (see Figure 10). In alternative configurations, the raised septum contacting region 149 and raised upper and lower portions 150, 151 may have a constant width, or a width that does not continually increase towards the top and bottom edge or side 152, 153 of the interface body 110. In alternative configurations, the raised septum contacting region 149 and raised upper and lower portions 150, 151 may not be symmetric.
[1703] As illustrated in the configuration shown in Figures 68 and 69. The interface body 110 comprises a recessed portion between the nasal delivery elements 111, 112. The recessed portion provides more space for a patient's septum (in use).
[1704] The recessed portion extends between the bases of the nasal delivery elements 111, 112. The interface body 110 comprises ridges at the point where the recessed potion connects with the main body portion. The recessed portion is widest at the midpoint between the nasal delivery elements 111, 112. The recessed portion tapers towards the nasal delivery elements 111, 112 to a width that is less than the diameter of the respective nasal delivery element 111, 112. The recessed portion is wider at the point where it connects with the base of the larger of the two nasal delivery elements 111 than it is at the point where it connects with the base of the narrower of the two nasal delivery elements 112.
[1705] In the configuration shown, the bases of the nasal delivery elements 111, 112 are curved outwardly to connect to the main body portion of the interface body 110. There is a ridge surrounding at least a portion of each nasal delivery element 111, 112 at the point where the outwardly curved base meets the main body portion.
[1706] The thickness of the walls of the main body portion of the interface body 110 may be (substantially) greater than the thickness of the walls of the nasal delivery elements, for instance more than 1.5 times greater, or more than 2 times greater, or more than 3 times greater, or more than 4 times greater, or more than 5 times greater. In alternative configurations the thickness of the walls of the main body portion may be equal to the thickness of the walls of nasal delivery elements 111, 112. The thickness of the wall of the main body portion may vary or be constant. [1707] Referring to Figures 70 to 75, schematical views of the interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[1708] As illustrated in the configuration shown in Figures 70 and 71, the rear portion of the main body (i.e. the nasal delivery elements 111, 112 side) is curved and convex in the second midline plane 166 (see Figure 9), and has a central section that is flat in a direction perpendicular to this plane. The interface body 110 comprises two lateral raised portions 155, 156 that extend from the rear portion of the main body in (substantially) the same direction as respective nasal delivery elements 111, 112. The nasal delivery elements 111, 112 extend from respective lateral raised portions 155, 156. The lateral raised portions 155, 156 are located at or adjacent lateral edges or sides of the interface body 110. The lateral raised portions 155, 156 may be termed as pillows.
[1709] The bases of the nasal delivery elements 111, 112 are curved outwardly to connect to a rear face of the respective lateral raised portions 155, 156. Each rear face may be curved. The outer, top, and bottom edges of the rear face of the lateral raised portions 155, 156 connect smoothly to sides of the lateral raised portions 155, 156. The sides of the lateral raised portions 155, 156 are generally parallel to the respective nasal delivery elements 111, 112. The top and bottom sides of the lateral raised portions 155, 156 connect to the curved rear portion of the main body. The outer sides of the lateral raised portions 155, 156 connect to respective lateral edges or sides of the interface body 110. The inner edges of the rear face of each lateral raised portion 155, 156 connects to the curved rear portion of the main body.
[1710] An external gases channel 144 is provided around each lateral raised portion 155, 156 at the intersection of the lateral raised portion 155, 156 and the curved rear portion of the main body. Exhaled gases pass through these external gases channels 144.
[1711] In the illustrated configuration, the curved rear portion of the main body has an hourglass shape. The curved rear portion of the main body is narrowest at the midpoint between the nasal delivery elements 111, 112, and widest at points approximately in line with the middle of each lateral raised portion 155, 156.
[1712] The thickness of the walls of the interface body 110 may not be constant. The thickness of the rear portion of the main body between the lateral raised portions 155, 156 may be (substantially) greater than the thickness of the nasal delivery elements Il l, 112. The thickness of the walls of the lateral raised portions 155, 156 may be (substantially) greater than the thickness of the nasal delivery elements 111, 112.
[1713] As illustrated in the configuration shown in Figures 72 to 74, the rear portion of the main body (i.e. the nasal delivery elements 111, 112 side) is curved and convex in both the second midline plane 166 (see Figure 9), and has a central section that is curved and convex in a direction perpendicular to this plane. The interface body 110 comprises two lateral raised portions 155, 156 that extend from the rear portion of the main body in (substantially) the same direction as respective nasal delivery elements 111, 112. The nasal delivery elements 111, 112 extend from respective lateral raised portions 155, 156. The lateral raised portions 155, 156 are located at or adjacent lateral edges or sides of the interface body 110. The lateral raised portions 155, 156 may be termed as pillows.
[1714] The bases of the nasal delivery elements 111, 112 connect smoothly to a rear face of the respective lateral raised portions 155, 156. The rear face may be curved. The outer, top, and bottom edges of the rear face of the lateral raised portions 155, 156 connect smoothly to sides of the lateral raised portions 155, 156. The outer sides of the lateral raised portions 155, 156 are generally parallel to the respective nasal delivery elements 111, 112. The top and bottom sides of the lateral raised portions 155, 156 connect to the curved rear portion of the main body. The outer sides of the lateral raised portions 155, 156 connect to respective lateral edges of the interface body 110. The inner edges of the rear face of each lateral raised portion 155, 156 connects to the curved rear portion of the main body.
[1715] The top and bottom sides of the lateral raised portions 155, 156 are tapered, so that the lateral raised person 155, 156 is wider at the point where it connects to the rear portion of the main body than it is at the rear face of the lateral raised portion 155, 156. The rear face of the lateral raised portion 155 that corresponds to the larger nasal delivery element 111 is approximately the same width as the larger nasal delivery element 111 in a direction from the top edge or side 152 of the interface body 110 to the bottom edge or side 153 of the interface body 110. The rear face of the lateral raised portion 156 that corresponds to the smaller nasal delivery element 112 is approximately the same width as the smaller nasal delivery element 112 in a direction from the top edge or side 152 of the interface body 110 to the bottom edge or side 153 of the interface body 110. In alternative configurations the rear faces of the lateral raised portions 155, 156 may be wider than their respective nasal delivery elements 111, 112 in a direction from the top edge or side 152 of the interface body 110 to the bottom edge or side 153 of the interface body 110, for instance 10% wider or 20% wider or 30% wider or 40% wider or 50% wider or 60% wider or 70% wider or 80% wider or 90% wider or 100% wider or more than 100% wider.
[1716] An external gases channel 144 is provided around each lateral raised portion 155, 156 at the intersection of the lateral raised portion 155, 156 and the curved rear portion of the main body. Exhaled gases pass through these channels.
[1717] In the illustrated configuration, the curved rear portion of the main body has an hourglass shape. The curved rear portion of the main body is narrowest at the midpoint between the nasal delivery elements 111, 112, and widest at points approximately in line with the nasal delivery elements 111, 112.
[1718] The thickness of the walls of the interface body 110 may not be constant. The thickness of the rear portion of the main body between the lateral raised portions may be (substantially) greater than the thickness of the nasal delivery elements 111, 112. The thickness of the walls of the lateral raised portions may be (substantially) greater than the thickness of the nasal delivery elements 111, 112.
[1719] As illustrated in the configuration shown in Figure 75, the interface body 110 comprises two lateral raised portions 155, 156 that extend from the rear portion of the main body in (substantially) the same direction as respective nasal delivery elements 111, 112. The nasal delivery elements 111, 112 extend from respective lateral raised portions 155, 156. The lateral raised portions 155, 156 may be termed as pillows.
[1720] The interface body 110 comprises a septum contacting region 149 between the nasal delivery elements 111, 112. The septum contacting region 149 may be located at the midpoint between the nasal delivery elements 111,112. The septum contacting region 149 has a generally semi-circular cross section in the second midline plane 166 (see Figure 9). The septum contacting region 149 is narrower than the distance between the nasal delivery elements 111, 112. Between the septum contacting region 149 and each of the nasal delivery elements 111, 112 is an external gases channel 144 through which exhaled air can flow.
[1721] The septum contacting region 149 extends continuously into raised upper and lower portions of the interface body 110. The raised upper and lower portions may extend to top and bottom edges or sides of the interface body 110. The external gases channels 144 extend to top and bottom edges or sides 152, 153 of the interface body 110 along edges of the raised upper and lower portions.
[1722] In some configurations the raised upper and lower portions are wider towards the respective edge or side 152, 153 of the interface body 110. In some configurations the raised upper and lower portions may bifurcate towards the respective edge or side 152, 153 of the interface body 110.
[1723] The bases 1111c, 1112c of the nasal delivery elements 111, 112 are curved outwardly to connect to a rear face of the respective lateral raised portions 155, 156. Each rear face may be curved. The outer, top, and bottom edges of the rear face of the lateral raised portions 155, 156 connect smoothly to sides of the lateral raised portions 155, 156. The sides of the lateral raised portions 155, 156 are generally parallel to the respective nasal delivery elements 111, 112. The top and bottom sides of the lateral raised portions 155, 156 connect to the rear portion of the main body. The outer sides of the lateral raised portions 155, 156 connect to respective lateral edges of the interface body 110. The inner edges of the rear face of each lateral raised portion 155, 156 connects to the rear portion of the main body.
[1724] The thickness of the walls of the interface body 110 may not be constant. The thickness of the rare portion of the main body between the lateral raised portions 155, 156 may be (substantially) greater than the thickness of the nasal delivery elements 111, 112. The thickness of the walls of the lateral raised portions 155, 156 may be (substantially) greater than the thickness of the nasal delivery elements 111, 112.
[1725] Referring to Figure 76, a schematical view of the interface body 110 of the nasal interface 100 is shown. The illustration omits features such as the headgear 200 for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figure may be applied to any arrangement described herein.
[1726] As illustrated in the configuration shown in Figure 76, the interface body 110 comprises an external gases channel 144 located between the nasal delivery elements 111, 112 and closer to the larger nasal delivery element 111. The external gases channel 144 extends towards top and bottom edges or sides 155, 156 of the interface body 110. The external gases channel 144 (substantially) prevents or limits sealing around the later nasal delivery element 111.
[1727] The interface body 110 has a septum contacting region 149 that extends from the base 1112c of the smaller of the two nasal delivery elements 112 to the external gases channel 144. In the configuration shown the septum contacting region 149 is parallel to the axis extending between the nasal delivery elements 111, 112. In alternative configurations the septum contacting region 149 may be curved.
[1728] The external gases channel 144 is recessed relative to the septum contacting region 149, i.e. it is closer to the front portion of the main body (i.e. the gases inlet 121 side) than the septum contacting region 149. The external gases channel 144 has sides that are curved to smoothly connect to the septum contacting region 144 and to the base 1111c of the larger nasal delivery element 111. In the configuration shown, the sides of the external gases channel 144 meet at a sharp angle at a most recessed point of the external gases channel 144. In alternative configurations the sides of the external gases channel 144 may be connected smoothly. In alternative configurations the external gases channel 144 may have a flat or curved most recessed point.
[1729] The interface body 110 slopes away from the septum contacting region 149 to the top and bottom edges or sides of the interface body 110.
[1730] The interface body 110 is formed from a flexible material and shaped to generally follow the contours of a patient's face around the upper lip area. In some arrangements, the interface body 110 is a cushion portion. The interface body comprises the cushion portion and the frame portion 120.
[1731] Referring to the earlier figures and description, such as Figure 33, the gases inlet port 121 is formed as a first cushion opening in the interface body 110 (or cushion portion) and a first frame opening is formed in the frame portion 120.
[1732] The gases outlet port 122 is formed as a second cushion opening in the interface body 110 (or cushion portion) and a second frame opening is formed in the frame portion 120.
[1733] The openings are such that they are formed as apertures in frame portion 120 and interface body 110 (or cushion portion) respectively.
[1734] The first cushion opening and first frame opening are inter-engageable to attach the interface body 110 (or cushion portion) to the frame portion 120. The second cushion opening and second frame opening are inter-engageable to attach the interface body 110 to the frame portion 120.
[1735] The inter-engageability enables the frame portion 120 to be connected to the interface body 110 (or cushion portion) through the openings. This provides the benefit of providing various ways for the frame portion 120 and the interface body 110 (or cushion portion) 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 interface body 110 (or cushion portion).
[1736] The frame portion 120 and interface body 110 (or cushion portion) may be engaged by protrusions on one portion that engage with apertures on the corresponding portion. [1737] The frame portion 120 forms the internal portion of the combined interface body 110 when engaged. Therefore, the interface body 110 (or cushion portion) is stretched over the frame portion 120 when engaged. However, in some configurations, the frame portion 120 is primarily external to the interface body 110 (or cushion portion). 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.
[1738] The frame portion 120 provides the structure of the interface body 110 (or cushion portion) 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 avoids direct contact with the patient's face. This provides comfort for the patient whose face is primarily in contact with the flexible material of the interface body 110 (or cushion portion). The front part of the frame 120 is shown in Figure 15 as the gases ports 121, 122. Where present, the baffles 180 of the frame portion 120 are internal to interface body 110 (or cushion portion).
[1739] Referring to Figures 77 to 86, schematical views of the frame 120 and/or interface body 110 of the nasal interface 100 are shown. The illustrations omit some features for means of explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the frame 120 and/or interface body 110 of the presently described figures may be applied to any arrangement described herein. The description for the frame 120 in reference to Figures 1 to 76 likewise applies here with reference to the frame portion 120a for Figures 77 to 86 and the terms are interchangeable.
[1740] The nasal interface 100 as illustrated in figures 77 to 79 comprises an interface body 110a and a frame portion 120a. As with the above, the interface body 110a maybe be referred as comprising a cushion portion 110a and the frame portion 120a.
[1741] The frame portion 120a comprises the gases inlet port 121 (or gases port 121 1 gases inlet 121). The frame 120a may be removably attached or integrally moulded to the respiratory conduit 300.
[1742] The interface body or cushion portion 110a may be connectable to or engageable with the frame portion 120a or may be integrally formed or permanently engaged with the frame portion 120a. The interface body 110a may refer to the interface body 110a including the frame portion 120a in some arrangements. The connecting or engaging of the interface body 110a with the frame portion 120a brings the first nasal delivery element 111 and the second nasal delivery element 112 into fluid communication with the gases inlet port 121 such that the first nasal delivery element 111 is more proximal the gases inlet port 121 and the second nasal delivery 112 element is more distal the gases inlet port 121.
[1743] The interface body 110a may be formed from a soft, flexible material such as silicone, thermoplastic elastomers, or other polymers known in the art. In some arrangements it may be referred to as a cushion portion. 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 110a 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.
[1744] The frame portion 120a 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 110a 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 frame portion 120a fluidly couples the respiratory conduit 300 to the nasal delivery elements 111 and 112 of the interface body 110a.
[1745] The interface body 110a is shaped to generally follow the contours of a patient's face around the upper lip area. The interface body 110a 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.
[1746] The interface body 110a comprises a base portion 118 (not visible in Figures 77 to 79) from which the nasal delivery elements 111 and 112 extend. The base portion 118 is part of the main body of the interface body 110a.
[1747] The base portion 118 is arranged to locate between a patient's face and the frame 120a in use. The base portion 118 may act as a cushion to avoid the frame 120a from touching the patient's face.
[1748] In the arrangement shown, the interface body 110a comprises the two side arms 101, 102 extending laterally from either side of the frame portion 120a. In some arrangements, the frame portion 120a, first side arm 101 and second arm 102 are formed as a unitary member. [1749] In use, the frame 120a is generally positioned in a direction facing away from the patient and the nasal interface 110 is generally positioned in a direction facing the patient.
[1750] The frame portion 120a comprises the gases inlet port 121 and the gases outlet port 122 (which may be the bias flow vent 340).
[1751] The interface body 110a comprises an opening for receiving at least a portion of the frame portion 120a. The interface body 110a is engageable with the frame portion 120a.
[1752] The frame portion 120a extends between the inlet gases port 121 and the outlet gases port 122 I bias flow vent 340 and forming at least part of an outer surface of the interface body 110a.
[1753] The frame portion 120a comprises a top edge 126, a bottom edge 127 extending between a pair of lateral edges 128, 129. The lateral edges 128, 129 are respectively connected to the side arms 101, 102. The first lateral edge 128 is proximal the gases inlet port 121 and first side arm 102. The second lateral edge 129 is proximal the outlet gases port 122 and second side arm 102.
[1754] The top edge 126 and bottom edge 127 are elongate relative to the lateral edges 128, 129. Referring to Figure 78, the frame portion 120a has a relatively planar or flat shape when viewed from above. A slight curvature may be present in the shape of the frame portion 120a. The slight curvature curves toward the patent's face when in use. This may provide additional comfort.
[1755] The top and bottom edges 126, 127 of the frame portion 120a have a sinusoidal shape when viewed from the front. The top and bottom edges 126, 127 are bulbous at portions around the gases inlet port 121 and gases outlet port 122. The top and bottom edges 126, 127 of the frame portion 120a have a narrowed portion in between the gases inlet port 121 and gases outlet port 122. The overall shape of the frame portion 120a is substantially an hourglass shape.
[1756] The periphery of the frame portion 120a generally tapers between the narrow substantially laterally central position to the enlarged lateral portions.
[1757] The frame portion 120a is continuous between the gases inlet port 121 and gases outlet port 122. The frame portion 120a is outwardly facing. Therefore, the portion 120a forms an outer surface of the combined frame portion 120a and interface body 110a.
[1758] Excluding the gases inlet port 121 and the gases outlet port 122, the frame 120a is generally symmetrical in the first midline plane 165 (see Figure 10). The frame 120a is generally symmetrical in the second midline plane 166 (see Figure 9). [1759] Excluding any differences in the first and second nasal elements 111, 112, the interface body 110a is generally symmetrical in the first midline plane 165 (see Figure 10). The interface body 110a is generally symmetrical in the second midline plane 166 (see Figure 9).
[1760] The edges or sides 126, 127, 128, 129 of the frame portion 120a comprise a groove 124 extending around the entire perimeter of the frame portion 120a. A portion of the interface body 110a is received in the groove 124. The interaction between the interface body 110a in the groove 124 secures the interface body 110a to the frame portion 120a.
[1761] In some arrangements, the interface body 110a comprises a single opening for engaging with and receiving the frame portion 120a.
[1762] When viewed from the front, the interface body 110a has a similar shape to the frame portion 120a. The perimeter of the interface body 110a has a substantially hourglass shape.
[1763] The nasal interface 100 as illustrated in figures 80 to 83 comprises an interface body 110a and a frame portion 120a. As with the above, the interface body 110a maybe be referred as comprising a cushion portion 110a and the frame portion 120a.
[1764] The frame portion 120a comprises the gases inlet port 121 (or gases port 121 1 gases inlet 121). The frame 120a may be removably attached or integrally moulded to the respiratory conduit 300.
[1765] The interface body or cushion portion 110a may be connectable to or engageable with the frame portion 120a or may be integrally formed or permanently engaged with the frame portion 120a. The interface body 110a may refer to the interface body 110a including the frame portion 120a in some arrangements. The connecting or engaging of the interface body 110a with the frame portion 120a brings the first nasal delivery element 111 and the second nasal delivery element 112 into fluid communication with the gases inlet port 121 such that the first nasal delivery element 111 is more proximal the gases inlet port 121 and the second nasal delivery 112 element is more distal the gases inlet port 121.
[1766] The interface body 110a may be formed from a soft, flexible material such as silicone, thermoplastic elastomers, or other polymers known in the art. In some arrangements it may be referred to as a cushion portion. 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 110a 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.
[1767] The frame portion 120a 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 110a 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 frame portion 120a fluidly couples the respiratory conduit 300 to the nasal delivery elements 111 and 112 of the interface body 110a.
[1768] The interface body 110a is shaped to generally follow the contours of a patient's face around the upper lip area. The interface body 110a 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.
[1769] The interface body 110a comprises a base portion 118 from which the nasal delivery elements 111 and 112 extend. The base portion 118 is part of the main body of the interface body 110a.
[1770] The base portion 118 is arranged to locate between a patient's face and the frame 120a in use. The base portion 118 may act as a cushion to avoid the frame 120a from touching the patient's face.
[1771] In the arrangement shown, the interface body 110a comprises the two side arms 101, 102 extending laterally from either side of the frame portion 120a. In some arrangements, the frame portion 120a, first side arm 101 and second arm 102 are formed as a unitary member.
[1772] In use, the frame 120a is generally positioned in a direction facing away from the patient and the nasal interface 110 is generally positioned in a direction facing the patient.
[1773] The frame portion 120a comprises the gases inlet port 121 and the gases outlet port 122 (which may be the bias flow vent 340 as shown in the figures).
[1774] The interface body 110a comprises an opening for receiving at least a portion of the frame portion 120a. The interface body 110a is engageable with the frame portion 120a.
[1775] The frame portion 120a extends between the inlet gases port 121 and the outlet gases port 122 I bias flow vent 340 and forming at least part of an outer surface of the interface body 110a. [1776] The frame portion 120a comprises a top edge 126, a bottom edge 127 extending between a pair of lateral edges 128, 129. The lateral edges 128, 129 are respectively connected to the side arms 101, 102. The first lateral edge 128 is proximal the gases inlet port 121 and first side arm 102. The second lateral edge 129 is proximal the outlet gases port 122 and second side arm 102.
[1777] The top edge 126 and bottom edge 127 are elongate relative to the lateral edges 128, 129. Referring to Figure 81, the frame portion 120a has a relatively planar or flat shape when viewed from above. A slight curvature may be present in the shape of the frame portion 120a. The slight curvature curves toward the patent's face when in use. This may provide additional comfort.
[1778] The top edge 126 of the frame portion 120a is relatively straight. The bottom edge 127 of the frame portion 120a is relatively curved or convex with reference to the frame portion 120a. The curvature of the bottom edge 127 narrows to the lateral edges 128, 129. Therefore, the centre portion of frame portion 120a has a relatively widened portion narrowing to the lateral edges 128, 129. The overall shape of the frame portion 120a is substantially rectangular with a convex edge. The convex edge may be a circle or oval segment. The overall shape may also be an elongated circle segment shape.
[1779] In some arrangements, the top edge 126 may be curved additionally or alternatively to the bottom edge 127.
[1780] The periphery of the frame portion 120a generally tapers between the enlarged substantially laterally central position to the narrowed lateral portions.
[1781] The frame portion 120a is continuous between the gases inlet port 121 and gases outlet port 122. The frame portion 120a is outwardly facing. Therefore, the portion 120a forms an outer surface of the combined frame portion 120a and interface body 110a.
[1782] Excluding the gases inlet port 121 and the gases outlet port 122, the frame 120a is generally symmetrical in the first midline plane 165 (see Figure 10). The frame 120a is generally symmetrical in the second midline plane 166 (see Figure 9).
[1783] Excluding any differences in the first and second nasal elements 111, 112, the interface body 110a is generally symmetrical in the first midline plane 165 (see Figure 10). The interface body 110a is generally symmetrical in the second midline plane 166 (see Figure 9).
[1784] The edges or sides 126, 127, 128, 129 of the frame portion 120a comprise a groove 124 extending around the entire perimeter of the frame portion 120a. A portion of the interface body 110a is received in the groove 124. The groove 124 is generally U- shaped. The interaction between the interface body 110a in the groove 124 secures the interface body 110a to the frame portion 120a.
[1785] In some arrangements, the interface body 110a comprises a single opening for engaging with and receiving the frame portion 120a.
[1786] When viewed from the front, the interface body 110a has a similar shape to the frame portion 120a. The perimeter of the interface body 110a has a substantially ovate shape.
[1787] The cushion portion 110a and frame portion 120a of Figures 77 to 83 provides a compact interface body. This provides additional comfort toa patient when in use.
[1788] The nasal interface 100 as illustrated in Figure 84 comprises a frame 120a as described with reference to Figures 77 to 83 above having an alternative shape. The description for the frame 120a and associated interface body / cushion portion 110a above likewise applies here where appropriate.
[1789] The frame portion 120a comprises a top edge 126, a bottom edge 127 extending between a pair of lateral edges 128, 129. The lateral edges 128, 129 may optionally be respectively connected to the side arms 101, 102. The first lateral edge 128 is proximal the gases inlet port 121 and first side arm 102. The second lateral edge 129 is proximal the outlet gases port 122 and second side arm 102.
[1790] The top edge 126 and bottom edge 127 are elongate relative to the lateral edges 128, 129. The top and bottom edges 126, 127 of the frame portion 120a are relatively straight. The lateral edges 128, 129 are relatively straight. In the illustrated arrangement, the frame portion 120a comprises tapered corners between the edges 126, 127, 128, 129. The overall shape of the frame portion 120a is substantially rectangular. The shape may also comprise tapered corners.
[1791] The shape of the frame 120a of Figure 84 provides a compact frame whilst may provide additional ease for size swapping given the unform rectangular-like shape.
[1792] Referring to Figures 85 and 86, a nasal interface 100 is illustrated combining the features of Figures 77 to 84 comprising a compact, substantially planar frame 120a, the features of Figures 60 to 76 comprising a cavernous body, and the features of Figures 47 to 52 comprising cutouts 160, 161. Whilst the combined features are shown in these figures, the combination of configurations is not limited to only illustrated combinations. Instead, the configurations may be combined as discussed throughout this document. The description of these configurations may be applied to the present configuration. [1793] Referring to Figures 85 and 86, the interface body or cushion portion 110a may be connectable to or engageable with the frame portion 120a or may be integrally formed or permanently engaged with the frame portion 120a as described above.
[1794] The interface body 110a may be formed from a soft, flexible material such as silicone, thermoplastic elastomers, or other polymers known in the art. In some arrangements it may be referred to as a cushion portion. 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 110a 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.
[1795] The frame portion 120a 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 110a 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 frame portion 120a fluidly couples the respiratory conduit 300 to the nasal delivery elements 111 and 112 of the interface body 110a.
[1796] The interface body 110a is shaped to generally follow the contours of a patient's face around the upper lip area. The interface body 110a 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.
[1797] The interface body 110a comprises a base portion from which the nasal delivery elements 111 and 112 extend. The base portion 118 is part of the main body of the interface body 110a.
[1798] The base portion 118 is arranged to locate between a patient's face and the frame 120a in use. The base portion 118 may act as a cushion to avoid the frame 120a from touching the patient's face.
[1799] In some configurations, the side arms 101, 102 extend laterally from either side of the frame portion 120a. In some arrangements, the frame portion 120a, first side arm 101 and second arm 102 are formed as a unitary member.
[1800] In use, the frame 120a is generally positioned in a direction facing away from the patient and the nasal interface 110 is generally positioned in a direction facing the patient. [1801] The frame portion 120a comprises the gases inlet port 121 and the gases outlet port 122 (which may be the bias flow vent 340).
[1802] The interface body 110a comprises an opening for receiving at least a portion of the frame portion 120a. The interface body 110a is engageable with the frame portion 120a.
[1803] The frame portion 120a extends between the inlet gases port 121 and the outlet gases port 122 I bias flow vent 340 and forming at least part of an outer surface of the interface body 110a.
[1804] The frame portion 120a comprises a top edge 126, a bottom edge 127 extending between a pair of lateral edges 128, 129. The shape of the frame 120a may be as any of the configurations described above with reference to Figures 77 to 84 to provide a compact frame. As seen in Figure 85, the shape of the frame 120a and interface body 110a provides more cavernous space compared to some other configurations. This may aside with gases flow and noise.
[1805] The edges or sides 126, 127, 128, 129 of the frame portion 120a comprise a groove 124 extending around the entire perimeter of the frame portion 120a. A portion of the interface body 110a is received in the groove 124. The interaction between the interface body 110a in the groove 124 secures the interface body 110a to the frame portion 120a.
[1806] As illustrated in Figure 86, the interface body 110a of the nasal interface 100 comprises a pair of cutouts 160, 161. The cutouts 160 are substantially similar to those described above with reference to Figures 47 to 52 and the cutouts 160, 161 are symmetrical.
[1807] The cutouts 160, 161 are formed as an indent or recess in the base portion 118. The cutouts 160, 161 extend from the respective (lateral) edges of the base portion 118. The cutouts 160, 161 may be recesses, indents or dips in the otherwise smooth or continuous surface of the interface body 110a.
[1808] The cutouts 160, 161 are formed as having relatively straight sides which narrow to a curved apex or arc. The wide base of the shape is formed at the edge of the base portion 118. The opposing apex or arc of the shape is formed around the nasal delivery elements 111, 112. However, in some arrangements, the cutouts 160, 161 may narrow.
[1809] The apex or arc of the shape of the cutouts 160, 161 may be formed radially around the corresponding nasal delivery elements 111, 112. Therefore, the nasal delivery elements 111, 112 are the axis of curvature. [1810] As described above, the cutouts 160, 161 are symmetrical about the first midline plane 165 (see Figure 10).
[1811] Excluding the gases inlet port 121 and the gases outlet port 122, the frame 120a is generally symmetrical in the first midline plane 165 (see Figure 10). The frame 120a is generally symmetrical in the second midline plane 166 (see Figure 9).
[1812] Excluding any differences in the first and second nasal elements 111, 112, the interface body 110a is generally symmetrical in the first midline plane 165 (see Figure 10). The interface body 110a is generally symmetrical in the second midline plane 166 (see Figure 9).
[1813] Referring to Figures 87 to 89, schematical views of the frame 120a and interface body 110a of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, the frame 120a of the presently described figures may be applied to any arrangement described herein. The frame 120a has the substantially planar shape as illustrated in Figures 77 to 84. Therefore, the same reference numeral is used for the frame 120a and interface body 110a I cushion portion 110a as used above.
[1814] As illustrated in the configuration shown in Figures 87 to 89, the frame 120a comprises a curved shape in the second midline plane 166 (see Figure 9), the inner side of the curved shape facing the nasal delivery elements 111, 112 of the interface body 110a. The frame 120a comprises a gases inlet port 121. The frame 120a may comprise a gases outlet port 122 or a bias flow vent 340 (not illustrated).
[1815] The frame 120a comprises top and bottom edges 126, 127. The top and bottom edges 126, 127 of the frame 120a each have a shape that is a segment of an ellipse when viewed in a direction from the gases inlet 121 side. The lateral edges 128, 129 of the frame 120a each have a shape that is a segment of an ellipse when viewed in a direction from the gases inlet 121 side. The dimensions of the elliptic shape of the top and bottom edges 126, 127 are different from the dimensions of the elliptic shape of the lateral edges 128, 129. The widest portion of the frame 120a in a direction from the top edge 126 to the bottom edge 127 is at a midpoint of the frame 120a. The widest portion of the frame 120a in a direction between the lateral edges 128, 129 is at a midpoint of the frame 120a.
[1816] The top and bottom edges 126, 127 of the frame 120a are connected to the lateral edges 128, 129 of the frame 120a in a smooth curve. [1817] The widest portion of the frame 120a in a direction from the top edge 126 to the bottom edge 127 is narrower than the widest portion of the frame 120a in a direction between the lateral edges 128, 129.
[1818] Excluding the gases inlet port 121 and the gases outlet port 122 (or bias flow vent 340), the frame 120 is generally symmetric in the first midline plane 165 (see Figure 10). The frame 120 is generally symmetric in the second midline plane 166 (see Figure 9).
[1819] The edges 126, 127, 128, 129 of the frame 120a comprise a groove 124 extending around at least a portion of the perimeter of the frame 120a. A portion of the interface body 110a is received in the groove 124, which secures the interface body 110a to the frame 120a.
[1820] In some configurations, not illustrated in Figures 87-89, the gases delivery portion 352 of the gases delivery elbow 351 extends through the gases inlet port 121 towards the larger of the nasal delivery elements 111. The gases delivery portion 352 may extend past the inner side of the frame 120a. The gases delivery portion 352 may extend a substantial portion of the distance between the frame 120a and the base 1111c of the nasal delivery element 111, for instance more than half of the distance. The gases delivery portion 352 may extend into the base 1111c of the nasal delivery element 111. The gases delivery portion 352 may be in contact with the interface body 110a at or near the base 1111c of the nasal delivery element 111. This extension provides or contributes to an asymmetric flow of gases.
[1821] Referring to Figures 90 to 91, schematical views of the frame 120a and interface body 110a of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, the frame 120a of the presently described figures may be applied to any arrangement described herein. The frame 120a has the substantially outer positioning as illustrated in Figures 77 to 84. Therefore, the same reference numeral is used for the frame 120a and interface body 110a I cushion portion 110a as used above. However, the features of Figures 90 and 91 may be applied to any configuration disclosed herein.
[1822] As illustrated in the configuration shown in Figures 90 to 91, the frame 120a comprises an elongate member that extends in a direction that is generally parallel to an axis extending between the nasal delivery elements 111, 112. The elongate member has a trapezoidal cross section, with the wider side of the elongate member facing the nasal delivery elements 111, 112. Some of the edges of the elongate member may be rounded. The front portion of the main body (i.e. the gases inlet 121 side) has a groove with a shape that corresponds to the shape of the elongate member. The elongate member is located within the groove. The flexibility of the elongate member improves comfort for the septum of the patient, in use.
[1823] The elongate member is continuous with a constant cross section, except for the gases inlet port 121.
[1824] The elongate member is contiguous with side arms 101, 102. The side arms 101, 102 curve towards the rear side of the nasal interface 100a (i.e. the nasal delivery elements 111, 112 side). The side arms 101, 102 comprise features for connecting to the headgear 200. Alternatively, the side arms 101,102 may be configured to detachably connect with extension arms (not shown) that are configured to detachably connect with headgear 200.
[1825] Referring to Figures 92 to 96 a schematical views of the nasal interface 100 are shown. The illustrations omit some features for explanation, for example, whilst the frame 120a is shown, the cushion portion 110a (e.g. interface body 110a) is omitted. Otherwise, the description provided in reference to figures elsewhere applies for like- features. As will be clear, nasal interface 100 of the presently described figures may be applied to any arrangement described herein. The frame 120a has the substantially planar shape as illustrated in Figures 77 to 84. Therefore, the same reference numeral is used for the frame 120a and interface body 110a I cushion portion 110a as used above. However, the present embodiment may be applied to the frame 120 and interface body 110 of the nasal interface 100 throughout the description.
[1826] Referring firstly to Figure 92, a front perspective view of a patient interface 1 is shown comprises the nasal interface 100 with side arms 101, 102. In the present configuration, the side arms 101, 102 are extended and are used to mean the entirety of the arms which extend from the interface body 110a I frame 120a. In some arrangements the side arms 101, 102 may form part of the headgear 200, in other arrangements, the side arms 101, 102 further attach to the headgear 200 (not shown).
[1827] The side arms 101, 102 respectively comprise living hinges 1301, 1302. The living hinges 1301, 1302 are intermediary portions of the side arms 101, 102 connecting at one end to a respective lateral edge of the interface body 110a I frame 120a.
[1828] The side arms 101, 102 respectively comprise connecting arm portions 1311, 1312. The living hinges 1301, 1302 may connect at their respective opposing ends to the connecting arm portions 1311, 1312. The connecting arm portions 1311, 1312 may connect to a portion of the headgear 200. However, in some arrangements, the connecting arm portions 1311, 1312 are omitted and the side arms 101, 102 connect directly to the headgear 200.
[1829] In some arrangements, the portion of the headgear 200 may comprise end portions of headgear strap(s). In other configurations, the portion of the headgear 200 comprise sleeves or other features that are connected to the headgear strap(s).
[1830] Further, whilst the living hinges 1301, 1302 is described as being comprised by the side arms 101, 102 of the nasal interface 100, in some configurations, they may be comprised by the nasal interface 100, the headgear 200 or be comprised by the patient interface 1 comprising a headgear 200 and a nasal interface 100.
[1831] In addition to Figure 92, reference is also made to Figure 93 in the following description. Figure 93 is a detailed view of the living hinge 1302 at the bias flow vent 340 side of the nasal interface 100. However, the description hereafter likewise applies to the opposing living hinge 1301 and may be used interchangeably.
[1832] The living hinge 1302 is configured to be a moveable connection. Therefore, the living hinge 1302 may move relative to the interface body 110 when engaged. The living hinge 1302 is configured to allow the side arm 102 to be vertically moveable (upwardly or downwardly).
[1833] The living hinge 1302 comprises a first cross hinge 1321 and a second cross hinge 1322. The first cross hinge 1321 extends diagonally across the height of the side arm 102, i.e. between a bottom edge to a top edge. The second cross hinge 1322 extends diagonally across the height of the side arm 102, i.e. between a top edge to a bottom edge. The first cross hinge 1321 and a second cross hinge 1322 cross over one another.
[1834] The first cross hinge 1321 and a second cross hinge 1322 are formed as an indent, groove or line of thinning in the surface of the side arm 102. The indent, groove or line of thinning allows the side arm 102 to bend and form a hinge along the respective first cross hinge 1321 and a second cross hinge 1322. The side arm 102 is hingedly moveable about the living hinge 1301.
[1835] The first cross hinge 1321 and a second cross hinge 1322 extend in opposing directions across the height of the side arm 102. Therefore, the first cross hinge 1321 and a second cross hinge 1322 form an X-shape on the side arm 102. The first cross hinge 1321 enables the side arm 102 to hinge downwardly relative to the interface body 110a. The second cross hinge 1322 enables the side arm 102 to hinge upwardly relative to the interface body 110a. [1836] The angle of the first cross hinge 1321 and second cross hinge 1322 relative to the horizonal (i.e. the edge of the side arm 102), is between about 25 and 60 degrees, or between 35 and 55 degrees.
[1837] The side arm 102 is formed as strap-like arm to comprise the living hinge 1302.
[1838] As discussed above, the same description applies for the opposing side arm 101 with its living hinge 1301.
[1839] At their centre point, the living hinges 1301, 1302 are generally symmetric about a vertical or horizontal plane.
[1840] The living hinges 1301, 1302 accommodate the nasal interface 100 symmetry. Interfaces known in the art are unidirectional, so do not need to account for upside-down or inverted use. However, human faces are not vertically symmetrical. Therefore, the side arms 101, 102 of the present disclosure allow adjustment of the nasal interface 100. Such adjustment using the side arm 101, 102 of the present disclosure is done automatically as the nasal interface 100 is put on for the first time by the patient. The living hinges 1301, 1302 advantageously enable the nasal interface 100 to be oriented in only the relevant directions, instead of as a freely moving member. Therefore, the correct orientation of the nasal interface 100 on the patient is more readily achieved.
[1841] Referring to Figure 94, a schematic of a front view of an alternative configuration of a living hinge 1302 is shown. As with the above, whilst a living hinge 1302 at the bias flow vent 340 side of the nasal interface 100 is shown, this description likewise applies to the opposing living hinge 1301.
[1842] The living hinge 1302 comprises a first cross hinge 1321 and a second cross hinge 1322 as described with reference to Figure 92. Additionally, the living hinge 1302 comprises a first vertical hinge 1325.
[1843] The first vertical hinge 1325 extends substantially vertically across the height of the side arm 102, i.e. between a bottom edge to a top edge. The first vertical hinge 1325 is positioned between the first cross hinge 1321 and the second cross hinge 1322, and the interface body 110a I frame 120a. The first vertical hinge 1325 does not overlap with either of the first cross hinge 1321 and the second cross hinge 1322.
[1844] The first vertical hinge 1325 is formed as an indent, groove or line of thinning in the surface of the side arm 102. The indent, groove or line of thinning allows the side arm 102 to bend and form a hinge along the first vertical hinge 1325. The side arm 102 is hingedly moveable about the living hinge 1301. [1845] The first vertical hinge 1325 extends in a substantially vertical direction across the height of the side arm 102. Therefore, the first vertical hinge 1325 enables the side arm 102 to hinge in a left or right direction relative to the interface body 110a. This allows the living hinge 1302 to angle around a patient's face in a horizontal manner.
[1846] The second vertical hinge 1326 extends substantially vertically across the height of the side arm 102, i.e. between a bottom edge to a top edge. The second vertical hinge 1326 is positioned between the first cross hinge 1321 and the second cross hinge 1322, and the second connecting arm portion 1312. The second vertical hinge 1326 does not overlap with either of the first cross hinge 1321 and the second cross hinge 1322. The first vertical hinge 1325 and second vertical hinge 1326 are positioned on either side of the first cross hinge 1321 and the second cross hinge 1322. The first cross hinge 1321 and the second cross hinge 1322 are positioned on the side arm 102 between the first vertical hinge 1325 and second vertical hinge 1326.
[1847] The second vertical hinge 1326 is formed as an indent, groove or line of thinning in the surface of the side arm 102. The indent, groove or line of thinning allows the side arm 102 to bend and form a hinge along the second vertical hinge 1326. The side arm 102 is hingedly moveable about the living hinge 1301.
[1848] The second vertical hinge 1326 extends in a substantially vertical direction across the height of the side arm 102. Therefore, the second vertical hinge 1326 enables the side arm 102 to hinge in a left or right direction relative to the interface body 110a. This allows the living hinge 1302 to angle around a patient's face in a horizontal manner.
[1849] The combination of the first vertical hinge 1325 and the second vertical hinge 1326 provide two hinges for horizontal hinged movement. This provides additional freedom in the movement of the side arm 102 when conforming to the contours of a patient's face.
[1850] As discussed above, the same description applies for the opposing side arm 101 with its living hinge 1301.
[1851] Whilst a first vertical hinge 1325 and a second vertical hinge 1326 are described, in some configurations, a single one of the first vertical hinge 1325 and the second vertical hinge 1326 may be used. For instance, as shown in Figure 92, only the second vertical hinge 1326 is present.
[1852] The X-shaped living hinge, which provides some rotation of the nasal interface 100 in relation to the nares along with at least one vertical hinge 1325, 1326 allows the nasal interface to move into or away from the nose of the patient providing additional comfort. [1853] Referring to Figure 95, a schematic of a perspective view of an alternative configuration of a living hinge 1302 is shown. As with the above, whilst a living hinge 1302 at the bias flow vent 340 side of the nasal interface 100 is shown, this description likewise applies to the opposing living hinge 1301.
[1854] The living hinge 1302 comprises thinned upper and lower portions 1327, 1328.
[1855] The thinner upper portion 1327 is a triangular shaped portion of thinned material. The thinner upper portion 1327 extends from the upper edge of the side arm 102 to approximately half-way along the height of the side arm 102. The thinner upper portion 1327 has the base of the triangle at the upper edge of the side arm 102 and extends to an apex at approximately half-way along the height of the side arm 102.
[1856] The thinner lower portion 1328 is a triangular shaped portion of thinned material. The lower portion 1328 extends from the lower edge of the side arm 102 to approximately half-way along the height of the side arm 102. The lower portion 1328 has the base of the triangle at the lower edge of the side arm 102 and extends to an apex at approximately half-way along the height of the side arm 102.
[1857] The thinner upper portion 1327 and thinner lower portion 1328 are vertically opposed such that their apices meet at an approximately half-way point in the height of the side arm 102. The thinner upper portion 1327 and thinner lower portion 1328 may extend slightly further in each vertical direction than half-way such that they overlap at the half-way point. Alternatively, the shape of thinner upper portion 1327 and thinner lower portion 1328 may be a trapezoid shape.
[1858] The living hinge may also be described as having a first cross hinge 1321 and a second cross hinge 1322 as described with reference to Figure 92 with the material between the hinges 1321, 1322 also thinned.
[1859] The remaining unthinned or relatively thicker material forms a horizontal chevron shape at either lateral side of the living hinge 1302.
[1860] The thinning thinner upper portion 1327 and thinner lower portion 1328 allows the side arm 102 to bend and form a hinge along a range extending from the diagonal edges of the triangular shapes of the thinner upper portion 1327 and thinner lower portion 1328 and any position in between.
[1861] The side arm 102 is hingedly moveable about the living hinge 1301.
[1862] As discussed above, the same description applies for the opposing side arm
101 with its living hinge 1301. [1863] The X-shaped living hinge permits diagonal folding, but may prevent the vertical hinges 1325, 1326 from bending at the same time. By removing the top and bottom 'triangle' and leaving thinner material, this leaves two triangular flat sections where the side arms 101, 102 are free to bend in any of these directions simultaneously. This provides additional flexibility.
[1864] Additionally in some arrangements, the living hinge 1301, 1302 may comprise at least one of the first vertical hinge 1325 and second vertical hinge 1326 to provide additional flexibility.
[1865] Referring back to Figure 92, additional living hinges 1331, 1332 may be provided according to any of the configurations described with reference to Figures 92 to 95. Such additional living hinges 1331, 1332 may be positioned on the connecting arm portions 1311, 1312. Such additional living hinges 1331, 1332 may provide additional flexibility in the side arms 101, 102 for conforming to patent's faces.
[1866] The living hinges 1301, 1302 described herein provide a semi rigid side arm 101, 102 whilst maintaining flexibility, particularly for vertical inverting of the nasal interface 100. This ensures a tight fit of the nasal interface 100 for the patient whilst allowing for adaptability.
[1867] Referring to Figure 96, a nasal interface 100 comprises a frame 102a having the side arms 101, 102 and living hinges 1301, 1032 as hereinbefore described is shown. The shape of the side arms 101, 102 is substantially convex with reference to the patient's face. Therefore, the side arms 101, 102 curve away from the patent's face. Such curvature may assist in providing a force to hold the nasal interface 100 closer to the patient's face when positioned on the patient, such as using headgear 200.
[1868] Whilst an X-shaped living hinge 1301, 1302 is described, other shapes could be contemplated such as V-shaped or W-shaped. In some arrangements, such as shown in Figure 97, the living hinge 1301, 1302 is formed by a thinned area of material, such as along a portion of the side arms 101, 102. Such a shape may be rectangular.
[1869] In some configurations, the living hinge 1301, 1302 is formed on the patient facing side of the side arms 101, 102. This provides the maximum articulation in the patient facing direction.
[1870] In some configurations, the living hinge 1301, 1302 is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees, or a maximum of 60 degrees or a maximum of 45 degrees.
[1871] In reference to Figures 98 to 100, schematical views of the nasal interface 100 describing a configuration comprising a modification of the ball and socket joint 191 are provided. The illustrations omit some features for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, nasal interface 100 of the presently described figures may be applied to any arrangement described herein. In particular, the ball and socket joint 191 described in reference to Figures 14 to 29 are applicable to the following described configurations.
[1872] Figures 98 to 100 illustrate a headgear connecting portion 1035, 1036 as previously described. For conciseness, the figures and following description refer to the inlet gases port 121 headgear connecting portion 1035. However, this description likewise applies to the bias flow vent 340 headgear connecting portion 1036. The headgear connecting portion 1035, 1036 refers to the inverted socket portion 1038 and ball portion 1037 where the headgear connecting portion 1035 comprises the ball portion 1037.
[1873] The headgear connecting portion 1035 comprises a ball portion 1037, as described above. The ball portion 1037 is positioned at an end of a substantially elongate headgear connecting portion 1035. Therefore, in some arrangements, the ball portion 1037 is in-line or straight with the headgear connecting portion 1035. The movement of the ball portion 1037 and the socket portion 1038 is a rotatable connection as the ball portion 1037 rotates or pivots about the socket portion 1038 when connected.
[1874] The ball portion 1037 comprises a protrusion 1040. The protrusion 1040 is positioned on at least a part of the surface of the ball portion 1037. The protrusion 1040 may be substantially elongated. The elongated shape extending in the elongate direction of the headgear connecting portion 1035.
[1875] In some configurations, the protrusion 1040 is substantially wedge shaped. An elongate part of the wedge shape co-extending the elongate direction of the headgear connecting portion 1035. The narrow part of the wedge positioned at the end of the substantially elongate headgear connecting portion 1035.
[1876] The protrusion 1040 extends outwardly from the otherwise spherical shape of the ball portion 1037.
[1877] The protrusion 1040 obstructs or collides with the sides of the opening of the socket portion 1038. Therefore, the range of movement of the ball portion 1037 is limited by the protrusion 1040.
[1878] The protrusion 1040 limits the movement of the ball and socket joint 191 to prevent twisting of the headgear 200 such as when the ball portion 1037 is able to fully rotate in the earlier described configurations. Instead, the ball portion 1037 may be limited in sideways movement (i.e., in the upward 1026 or downward 1027 directions of Figure 19). In such a movement, the connecting portion axis angle is positionable at any point between 0 and about 60 degrees, or between 0 and about 45 degrees, or between 0 and about 30 degrees. The angle may also be limited to any point in between these. It will be appreciated that these are maximum points of movement. This may allow for the position required for a patient to be at any angle required therebetween.
[1879] Likewise, the ball portion 1037 may be limited in other directions of movement to the same angular limitation as above.
[1880] Whilst a ball-shaped ball portion 1037 is described, other shapes could be contemplated that are not fully spherical.
[1881] Optionally, as illustrated in Figure 98 and 99, in some configurations, the headgear connecting portion comprises a buckle 1042 at the opposing end to the ball portion 1037. The buckle 1042 may be formed as a flat eyelet or a pair of flat eyelets in a figure of eight configuration for receiving a strap. Such a strap may be part of the headgear 200.
[1882] The use of a buckle 1040 in combination with the protrusion 1040 may ensure that any connected strap does not twist. This ensures that if a patient is required to turn the nasal interface 100 up-side-down that the headgear 200 does not become unnecessarily twisted thus complicating the process.
[1883] Referring to Figure 100, the tube retainer 348 is formed as part of the headgear connecting portion 1035. This is similar to the arrangement of Figure 29. Additionally, the buckle 1042 is positioned between the end of the headgear connecting portion 1035 (i.e. with the ball portion 1037) and the tube retainer 348. As with the above, the buckle 1042 may be a single buckle 1042 or a multiple buckle 1042 such as a figure of eight. The headgear connecting portion 1035 may have a substantially elongate portion between the buckle 1042 and the tube retainer 348. In some optional configurations, the headgear connecting portion 1035 may comprise a further buckle 1044 at its opposing end. The buckles 1042, 1044 may be for use with a strap as described above.
[1884] Whilst the configuration comprising the ball portion 1037 on the headgear connecting portion 1035 is described, in some configurations, the protrusion 1040, tube retainer 348, and/or buckles 1042, 1044 may be applied to a configuration where the socket portion 1008 is positioned on the headgear connecting portion 1005, 1006.
[1885] As stated above, the description likewise applies for the headgear connecting portion 1006, 1036.
[1886] Referring to Figures 101 to 103, schematical views of the nasal interface 100 describing a configuration of the side arms 101, 102 are provided. The illustrations omit some features for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, nasal interface 100 of the presently described figures may be applied to any arrangement described herein. In particular, any side arm 101, 102 connection, including headgear connecting portions 1005, 1006, 1035, 1036 are arrangeable with the presently described configuration.
[1887] The term side arm 101, 102 is generally used to mean a lateral arm extending directly from the nasal interface 100, such as the body 110 or frame 120. Where such an arm 101, 102 has a connection, the term side arm 101, 102 is generally complemented with a further connecting feature, such as the headgear connecting portions 1005, 1006, 1035, 1036 of Figures 14 to 29. For the purposes of explanation, side arm 101, 102 may be used interchangeably to describe any feature directly or indirectly connected to the nasal interface 100 and the headgear 200 as appropriate.
[1888] Referring to Figure 101, a nasal interface 100 comprising a frame 120, 120a is illustrated. The cushion portion 100a I interface body 110 is omitted for purposes of explanation.
[1889] The nasal interface 100 comprises side arms 101, 102 extending laterally. Each side arm 101, 102 comprises an attachment button 1340. The attachment button is formed as a protruding feature on the side arm 101, 102. The attachment button 1340 may comprise a bulbous head and narrow neck. In some configurations, the attachment button 1340 is positioned at or near the end of the side arm 101, 102 opposed to the frame 120a, 120. At least one button attachment 1340 is provided on each side arm 101, 102.
[1890] The attachment button 1340 is for attaching to a corresponding button hole 1342. The attachment button 1340 allows for the easier connection of the nasal interface 100 to the corresponding features such as the headgear 200.
[1891] The nasal interface 100 illustrated in Figure 101 comprising elongate side arm 101, 102 having connecting arm portions 1311, 1312 described above in reference to Figure 92. The connecting arm portions 1311, 1312 may conform to the shape of a patient's face. The attachment button 1340 is may be used for connecting to the headgear 200.
[1892] In some configurations, such as that illustrated in Figure 102, the side arms 101, 102 are relatively short, or do not conform to a patient's face. The side arms 101, 102 comprise the attachment buttons 1340 described. A headgear arm 202 (or headgear connecting portion 1005, 1006, 1035, 1036) comprises a button hole 1342 for engaging with the attachment button 1340. [1893] In some configurations, the button hole 1342 may be slotted to allow lateral movement of the attachment button 1340. In other configurations, the button hole 1342 is shaped to correspond closely to the neck of the attachment button 1340 to prevent lateral movement.
[1894] The connection between the attachment button 1340 and the button hole 1342 may allow for some rotational movement. The button hole 1342 may be pivotable about a central axis of the attachment button 1340. Conversely, attachment button 1340 may be pivotable about a central axis of the button hole 1342. The headgear connecting portion 1005, 1006, 1035, 1036 or the headgear arm 202 may be pivotable about the attachment button 1340 and button hole 1342 connection.
[1895] Referring to Figure 103, the headgear connecting portion 1005, 1006, 1035, 1036 or the headgear arm 202 may comprise button hole 1342 at or near one end and a and a further attachment button 1344 at or near the opposing end. The button hole 1342 may be for connecting to an attachment button 1340 of the side arm 101, 102. The further attachment button 1344 may be for connecting to a further button hole connection of the headgear 200, such as headgear strap or a further strap or connection of the nasal interface 100. Such multiple button hole connections may provide additional articulation or may compliment a connection described herein, such as a ball and socket connection 191 or a living hinge connection 1301, 1302.
[1896] Referring to Figures 104 to 106, schematical views of the frame 120a and interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, the frame 120a of the presently described figures may be applied to any arrangement described herein including all configurations of the frame 120.
[1897] As illustrated in the configuration shown in Figure 104, the frame 120a comprises side arms 101, 102 which curve towards the rear side of the nasal interface 100 (i.e. the nasal delivery elements 111, 112 side). The side arms 101, 102 have a first portion 101a, 102a which flares outwardly away from the frame 120 to connector portions 103 of the side arms 101, 102. The connector portions 103 of the side arms 101, 102 each comprise a cylindrical recess (not shown) extending into the connector portions from their free ends. In the configuration shown, the side arms 101, 102 are integral with the frame 120a.
[1898] The connector portions 103 are configured to detachably connect to the headgear 200. When connected, the connector portions 103 may rotate relative to the headgear 200. Alternatively, the side arms 101,102 may be configured to detachably connect with extension arms (not shown) that are configured to detachably connect with headgear 200. In some configurations the connector portions 103 may be able to freely rotate through 360 degrees. In some configurations the connector portions 103 may be limited to rotate through an angle of less than 360 degrees.
[1899] The headgear 200 (or extension arms) comprises a cylindrical protrusion (not shown) that is received by the cylindrical recess of the connector portion 103 of the side arms 101, 102. In alternative configurations, the connector portions 103 may comprise cylindrical protrusions rather than cylindrical recesses. The headgear 200 (or extension arms) may comprise cylindrical recesses rather than cylindrical protrusions. In such a configuration, the cylindrical protrusions of the connector portions 103 are received by the cylindrical recesses of the headgear 200 (or extension arms).
[1900] As illustrated in the configuration shown in Figure 105, the frame 120a comprises side arms 101, 102. The side arms 101, 102 each have a first portion 101a, 102a, a second portion 101b, 102b, and a connector portion 103. The first portion 101a, 102a is connected to the frame 120a and to the second portion 101b, 102b. The second portion 101b, 102b is connected to the first portion 101a, 102a and the connector portion 103. In the configuration shown the first and second portions 101a, 102a, 101b, 102b are generally cylindrical, and have a constant diameter less than a diameter of the connector portion 103. In the configuration shown, the side arms 101, 102 are integral with the frame 120a.
[1901] An end of the first portion 101a, 102a of each side arm 101, 102 which is connected to the frame 120a is generally aligned with the frame 120a. The first portion 101a, 102a is curved towards the rear side of the nasal interface 100 (i.e. the nasal delivery elements 111, 112 side). The second portion 101b, 102b of each side arm 101, 102 is generally aligned with a central axis 164 defined by the intersection of the first and second midline planes 165, 166 (See Figures 9 and 10). The second portion 101b, 102b is generally straight. In use, the second portion 101b, 102b extends from the first portion 101a, 102a towards the face of the patient. In the configuration shown, the second portion 101b, 102b of each side arm 101, 102 deviates from the central axis 164 by less than 10 degrees. In alternative configurations, the second portion 101b, 102b of each side arm 101, 102 may be parallel with the central axis 164. In alternative configurations the second portion 101b, 102b of each side arm 101, 102 may deviate from the central axis 164 by more than 10 degrees. [1902] The connector portions 103 are configured to detachably connect to the headgear 200. When connected, the connector portions 103 may rotate relative to the headgear 200. Alternatively, the side arms 101,102 may be configured to detachably connect with extension arms (not shown) that are configured to detachably connect with headgear. In some configurations the connector portions 103 may be able to freely rotate through 360 degrees. In some configurations the connector portions 103 may be limited to rotate through an angle of less than 360 degrees.
[1903] In the configuration shown, the headgear 200 (or extension arms) comprises a cylindrical recess that receives the connector portion 103 of the side arms 101, 102. Alternatively, the connector portion 103 may comprise a cylindrical recess that receives a protrusion on the headgear 200 (or extension arms).
[1904] As illustrated in the configuration shown in Figure 106, the frame 120a comprises side arms 101, 102. The side arms 101, 102 each have a first portion 101a, 102a, a second portion 101b, 102b, and a connector portion 103. The first portion 101a, 102a is connected to the frame 120 and to the second portion 101b, 102b. The second portion 101b, 102b is connected to the first portion 101a, 102a and the connector portion 103. In the configuration shown the second portion 101b, 102b is generally cylindrical, and has a diameter less than a diameter of the connector portion 103. In the configuration shown, the side arms 101, 102 are integral with the frame 120a.
[1905] The first portion 101a, 102a of each side arm 101, 102 is generally aligned with the frame 120a. The first portion 101a, 102a is generally straight. The second portion 101b, 102b of each side arm 101, 102 is parallel with the central axis 164 defined by the intersection of the first and second midline planes 165, 166 (See Figures 9 and 10). The second portion 101b, 102b is generally straight. In use, the second portion 101b, 102b extends from the first portion 101a, 102a towards the face of the patient.
[1906] The connector portions 103 are configured to detachably connect to the headgear 200. In the illustrated configuration, the connector portions 103 connect to headgear arms 202. The headgear arms 202 comprise further attachment buttons 1344 as described above. Alternatively, the connector portions 103 connect to headgear connecting portion 1005, 1006, 1035, 1036.
[1907] When connected, the connector portions 103 may rotate relative to the headgear 200. Alternatively, the side arms 101,102 may be configured to detachably connect with extension arms (not shown) that are configured to detachably connect with headgear 200. In some configurations the connector portions 103 may be able to freely rotate through 360 degrees. In some configurations the connector portions 103 may be limited to rotate through an angle of less than 360 degrees.
[1908] In the configuration shown, the headgear 200 (or extension arms) comprises a cylindrical recess that receives the connector portion 103 of the side arms 101, 102. Alternatively, the connector portion 103 may comprise a cylindrical recess that receives a protrusion on the headgear 200 (or extension arms).
[1909] Referring to Figures 107 to 108 schematical views of the patient interface 1 comprising the nasal interface 100 describing a configuration of cheek pads are shown. The illustrations omit some features for explanation such as the interface body 110. 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.
[1910] The patient interface 1 comprises cheek pads 210. In the illustrated configurations of Figures 107 and 108, the cheek pad 210 forms part of the headgear 200. However, the cheek pad 210 may also be present on the side arms 101, 102, or intermediary elements such as extension arms or the headgear connecting portion 1005, 1006, 1035, 1036. Any of these features may comprise the cheek pads 210. In some configurations, the cheek pads 210 are present on headgear arms 202.
[1911] The headgear 200 comprises cheek pads 210. The cheek pads 210 are positioned on arms or straps of the headgear 200.
[1912] In some configurations, the headgear may be formed of neoprene, knitted, wider knitted, or brevida headgear. By having 3D elements, such as the cheek pads 210, these may be positioned on the cheeks to improve stability and absorb any excess tension and prevent septum injury. The cheek pads 210 may be molded from TF3 or silicone, with the option to overmold the headgear, such as knitted headgear.
[1913] The cheek pads 210 are present on each lateral portion of the headgear 200 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.
[1914] The cheek pads 210 have a bulbous shape extending from the patient facing side of the straps of the headgear 200. The cheek pads 210 comprise an outer body 212 extending substantially radially between a top and bottom edge of the straps of the headgear 200. The outer body 212 has an elongate shape extending along a part of the strap of the headgear 200. The cheek pads have an open channel 214 passing laterally through them. [1915] The outer body 212 has a wall thickness to provide rigidity of to maintain a shape, but to be conformable such as when pressed against a patient's cheek.
[1916] The cheek pads 210 have a substantially semi-oval shape when viewed from the top.
[1917] The outer body 212 of the cheek pads 210 comprise a front face 216. The front face 216 extends substantially perpendicularly away from the strap of the headgear 200 in a patient facing direction.
[1918] The outer body 212 comprises an upper face 218 connected to the front face 216. The upper face 218 extends laterally along the strap of the headgear 200. The upper face 218 provide the oval-shape. The upper face 218 is curved along its length the upper face 218 has an irregular concave shape extending in the patient direction. The apex of the oval or concave shape is closer to the front face 216 than a mid-point of the upper face 218.
[1919] The outer body of the cheek pads 210 comprises a rear face 220. The rear face 220 extends toward the face of the strap of the headgear 200. The rear face 220 connects to the upper face 218 and the strap of the headgear 200. The rear face 220 is angled relative to the strap of the headgear 200. The angle of the rear face is approximately between 30 and 60 degrees relative to the strap of the headgear 200.
[1920] The material of the cheek pad 210 is flexible to conform to a patient's cheeks when in use.
[1921] The open channel 214 may be used to accommodate a further strap.
[1922] In the illustrated configuration of Figures 107 and 108, the side arms 101,
102 may be contained within the headgear 200, such as within the straps.
[1923] Referring to Figures 109 to 111, a further configuration of the cheek pads 210 is provided.
[1924] In the illustrated configurations, the cheek pad 210 forms part of the side arms 101, 102. However, the cheek pad 210 may also be on the headgear 200, or intermediary elements such as extension arms or the headgear connecting portion 1005, 1006, 1035, 1036. Any of these features may comprise the cheek pads 210. In some configurations, the cheek pads 210 are present on headgear arms 202.
[1925] The side arm 101, 102 comprises a cheek pada 210. The cheek pad 210 is positioned on arms or straps of the side arm 101, 102.
[1926] Cheek pads 210 are present on each side arm 101, 102 (only one side arm 101 is illustrated). 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.
[1927] 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.
[1928] Referring to Figure 110, a sectional top view of the cheek pad 210 of the patient interface 1 is provided.
[1929] 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.
[1930] 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.
[1931] The hook portion 1334 comprises a peripheral groove 1336 for engaging with the walls of the pad opening 222.
[1932] Referring to Figure 111, a sectional top view of the cheek pad 210 of the patient interface 1 is provided. 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.
[1933] In some configurations, the cheek pad 210 of Figures 109 to 111 may comprise an open channel 214. In some configurations, the cheek pad 210 of Figures 107 and 108 may comprise a pad opening 222.
[1934] Optionally, in some configurations, a living hinge 1301, 1302 may be present in conjunction with the cheek pad 210. As illustrated in Figure 110, the living hinge 1301, 1302 may be positioned between the frame 120a and the cheek pad 210. Alternatively, as illustrated in Figure 11, the living hinge 1301, 1302 may be positioned on the opposing side of the cheek pad 210 distal to the frame 120. Alternatively, in some configurations, multiple living hinges 1301, 1302 positioned on either side of the cheek pad 210 may be provided.
[1935] Referring to Figure 112, a detailed view of a hook portion 1334 positioned on a side arm 101, 102 as described above is shown. The hook portion 1334 comprises a peripheral groove 1336 for receiving a wall of a cheek pad 210 as described. [1936] The hook portion 1334 comprises buckle openings 1338 passing through its body. The buckle openings also pass through the side arm 101. The buckle openings 1338 are formed as slots, such as to allow a strap to be secured therethrough. A plurality of buckle openings 1338 are provided to allow a strap to be fed up (i.e. into the cheek pad 210) and back down through the hook portion 1336. Additional buckle openings 1338 may be provided to allow further straps to be secured.
[1937] In some configurations, the hook portion 1334 may be an individual component and a strap of a side arm 101 and a strap of a headgear 200 may connect to the buckle openings 1338.
[1938] Referring to Figure 113, a detailed view of a hook portion 1334 positioned on a side arm 101, 102 as described above is shown. The hook portion 1334 comprises a peripheral groove 1336 for receiving a wall of a cheek pad 210 as described.
[1939] A strap clip 230 is provided. The headgear 200 comprises a strap clip 230. The strap clip 230 is configured to attach to a strap of the headgear 200. The strap clip 230 may allow the strap of the headgear 200 to be secured therethrough. The strap clip 230 is configured to engage with the peripheral groove 1336 of the hook portion 1334 such that it is secured on the hook portion 1334. The hook portion 1334 may additionally be securable to the cheek pad 210.
[1940] The hook portions 1334 of Figures 112 and 113 may likewise be positioned on a strap of the headgear 200 and engageable with straps of the side arm 101, 102 or other nasal interface straps.
[1941] Referring to Figure 114, a schematical view of the patient interface 1 comprising the nasal interface 100 is shown. The illustrations omit some features for explanation such as the interface body 110. 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.
[1942] The nasal interface comprises side arms 101, 102 as described elsewhere. The side arms comprise buckles 1050 positioned at the ends of each side arm 101, 102 distal to the frame 120a. The buckles 1050 may be formed as a flat eyelet or a pair of flat eyelets in a figure of eight configuration for receiving a strap. Such a strap may be part of the headgear 200.
[1943] The buckle 1050 may be positioned distal from the frame 120a such that when in use, the buckle 1050 is positioned past a patient's cheek. This allows the side arms 101, 102 to have face conforming features, such as the cheek pads 210, living hinges 1301, 1302, ball and socket connection 191 or any other feature described herein without the buckle 1050 interfering.
[1944] The buckle 1050 provides a simple way to attach the headgear 200 to the nasal interface 100. This also allows for adjustment of the headgear 200 to be on the front side of the nasal interface 100 at the buckles 1050. Headgear 200 may optionally include Velcro to secure the ends after they are looped through the buckle 1050. This method may be more cost effective and easier to manufacture than overmolding, sowing or welding.
[1945] Referring to Figures 115 to 122 schematical views of the patient interface 1 comprising the nasal interface 100 are shown. The illustrations omit some features for explanation such as the nasal interface 100. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the features of the patient interface 1 of the presently described figures may be applied to any arrangement described herein.
[1946] In Figure 115 a patient interface 1 is shown. The patient interface 1 comprises a nasal interface 100 as hereinbefore described with reference to any configuration. The patient interface 1 comprises headgear 200. The headgear 200 secures the nasal interface 100 on the head of a patient.
[1947] Headgear 200 may be a loop for securing around the patient's head. For instance, the headgear 200 may attach to the side arms 101, 102 and from a loop around the patient's head. The headgear may comprise straps made from materials described above. For instance, the headgear 200 may be elasticated. The headgear may be secured with adjustable clips or buckles. The headgear 200 may have multiple loops. The headgear 200 may also be formed from multiple components.
[1948] In the configuration illustrated in Figure 115, the headgear 200 comprises a securing member 240. The securing member 240 further secures or attaches the headgear 200 to a patient's head when in use.
[1949] The headgear 200 comprising the securing member 240 may optionally not be limited to the nasal interface 100 described herein. In some configurations, the headgear 200 comprising the securing member 240 may be used with any patient interface, these are not limited to a nasal or oral cannula, but may also include a mask over the nose and mouth, a mask exclusively for the nose or a mask exclusively for the mouth, or a combination of nose and mouth masks.
[1950] The securing member 240 may form at least part of a loop of the headgear 200. The securing member 240 may be positionable on the headgear 200 to sit at the rear of a patient's head when in use. The securing member 240 may connect between a loop in the headgear 200 (e.g. headgear arms 202).
[1951] Referring to Figure 116, a detailed view of the securing member 240 is shown. The securing member 240 is substantially comb-shaped. The securing member 240 is configured to be anti-slip. The securing member 240 is configured to grip several layers of hair. The increased surface area of the securing member 240 also increases the anti-slip properties in patient's with short or no hair. The securing member is not noticeable nor uncomfortable on patients regardless of hair length. The securing member 240 prevents or reduces the likelihood for the back of the headgear 200 to slip upwardly or downwardly from its original position on a patient's head. This avoids the headgear 200 from coming loose or resting on patient's ears.
[1952] The securing member 240 is economically manufacturable and may be cheaper than known headgear 200 materials.
[1953] Figures 116 to 121 are front views of the securing member 240 in a two- dimensional (2-D) view and laid out flat. In use, the securing member 240 is arranged to follow the curvature of a patient's head in a cylindrical manner. Therefore, references to a cylinder are made to describe the orientation.
[1954] The securing member 240 comprises a first end 251 and a second end 252, the securing member 240 extending circumferentially (or along the horizontal plane of the patient) therebetween.
[1955] The securing member 240 includes a plurality of longitudinally oriented struts 242. The longitudinal direction may also be referred to as an upward/downward or vertical direction with reference to the patient interface 1. Further the direction of the struts 242 may also be termed as being perpendicular to the horizontal plane of the patient. The plurality of struts 242 are arranged circumferentially.
[1956] The struts 242 are connected by loops 244. The loops 244 are substantially circumferentially oriented. Adjacent struts 242 are connected at their opposite ends by the loops 244. The struts 242 and loops 244 form a substantially S- or Z- shaped sinusoidal pattern.
[1957] The struts 242 and loops 244 have a uniform length such that the longitudinal length of the securing member 240 remains constant.
[1958] Optionally, at the first end 251 the end-most strut 242 and adjacent strut 242 (i.e. adjacently inward) are connected at both longitudinal ends by loops 244. Optionally, at the second end 252 the end-most strut 242 and adjacent strut 242 (i.e. adjacently inward) are connected at both longitudinal ends by loops 244. Therefore, the end struts 242 form a substantially O-shape or elongated O-shape.
[1959] The space formed between each adjacent strut 242 forms a channel 246 accessible in a longitudinal direction opposite to the position of the connecting loop 244. The channel 246 is configured to gather hair, like the teeth of a comb. In some arrangements, the securing members 240 described herein may be referred to French comb's as they remain in a patient's hair or on a patient's head when in use.
[1960] In some arrangements, the channel 246 is a closed channel such that it is biased to maintain a minimal channel width or no channel width. Where a patient's hair enters the closed channel 246, the channel 246 opens slightly to allow the hair to pass through. This also provides gripping of the hair. The expansion or stretching of the securing member 240 described below may open the channels 246 to receive hair. The mouths of the channels may be tapered to direct hair into a smaller or closed channel 246.
[1961] The securing member 240 has a circumferential length to extend along approximately 30% to 80% of the back of a patient's head.
[1962] The securing member 240 may comprise between 5 and 40 struts. In some configurations, the securing member 240 may comprise between 10 and 30 struts. In some configurations, the securing member 240 may comprise an odd number of struts to provide an equal number of channels 246.
[1963] The loops 244 may be flexible or ductile to allow a circumferential expansion of the securing member 240. Circumferential expansion may result in adjacent struts 242 being angled away from one another in the non-connected un-looped ends. The shape of the struts 242 in an expanded state may be W-shaped.
[1964] The expansion or stretching of the securing member 240 further prevents the risk of overtightening and septum injury. The expansion or stretching of the securing member 240 also allows for hair to be gathered in the channels 246 without risking damage to the securing member 240.
[1965] The securing member 240 comprises a buckle at the first end 251 and at the second end 252. The buckle 248 is configured to attach to a strap or arm of the headgear 200 or of the nasal interface 100.
[1966] The buckle 248 may be formed as an elongate slot. In some configurations, the buckle 248 is formed as an adjacent buckle strut with a reduced longitudinal length to the relative end strut 242. The buckle strut is connected to the end strut 242 by loops at either longitudinal end of the buckle strut connecting to a mid-portion of the strut 242. [1967] In some configurations, the buckle 248 may be formed as a figure of eight buckle (see Figures 117 to 119). Therefore, two adjacent elongate slots are provided. In some configurations, the further slot is formed as a further adjacent buckle strut connected by loops to the first buckle strut.
[1968] A figure of eight buckle 248 more readily allows loose ends of straps to be secured and adjusted. This may prevent the need for Velcro or other fasteners on the headgear 200.
[1969] The struts 242 and loops 244 of the securing member 240 may be formed of members having a uniform cross-sectional shape. In some arrangements, the struts 242 and loops 244 are substantially tubular in shape.
[1970] Referring to Figure 117, a detailed view of a securing member 240 is shown. The description for the securing member 240 with reference to Figures 115 and 116 likewise applies here.
[1971] The securing member 240 includes the plurality of longitudinally oriented struts 242. Adjacent struts 242 in a central portion of the securing member 240 are connected at their opposite ends by the loops 244. The struts 242 and loops 244 of a central portion form a substantially S- or Z- shaped sinusoidal pattern. The space formed between each adjacent strut 242 in the central portion forms a channel 246 accessible in a longitudinal direction opposite to the position of the connecting loop 244. At end portions of the securing member 240, i.e. at first and second ends 251, 252, the end-most struts 242 and adjacent strut 242 are connected at both longitudinal ends by loops 244. The end struts 242 form a substantially O-shape or elongated O-shape.
[1972] The securing member 240 comprises webbing 254 extending between adjacent struts 242 and the loops 244. The webbing 254 extends a portion into the channel 246.
[1973] The webbing 254 has a reduced thickness relative to the cross-sectional thickness of the struts 242 and/or loops 244.
[1974] In some configurations, the webbing 254 extends up to 25% of the total channel length. In other configurations, the webbing 254 extends up to 10% of the total channel length.
[1975] The webbing 254 is present between struts 242 having channels 246. The webbing is not present between the end struts 242 which form an O-shape.
[1976] The web 254 provides additional strength to prevent damage occurring at the loops 244 from stretching or expansion of the securing member 240. [1977] Referring to Figure 118, a detailed view of a securing member 240 is shown. The description for the securing member 240 with reference to Figures 115 and 116 likewise applies here.
[1978] The securing member 240 includes the plurality of longitudinally oriented struts 242. Adjacent struts 242 in a central portion of the securing member 240 are connected at their opposite ends by thickened loops 244a. The struts 242 and thickened loops 244a of a central portion form a substantially S- or Z- shaped sinusoidal pattern. The space formed between each adjacent strut 242 in the central portion forms a channel 246 accessible in a longitudinal direction opposite to the position of the connecting loop 244. At end portions of the securing member 240, i.e. at first and second ends 251, 252, the end-most struts 242 and adjacent strut 242 are connected at both longitudinal ends by loops 244. The end struts 242 form a substantially O-shape or elongated O-shape.
[1979] The thickened loops 244a are the same as the loops 244 but where the cross-sectional thickness of the thickened loops 244a of the securing member 240 are greater than that of the struts 242. In some arrangements, the thickened loops 242a comprise a cross-sectional thickness that gradually increases from the cross-sectional thickness of the struts 242 to a maximum thickness at the apex of the thickened loop 244a joining two adjacent struts 242. In some arrangements, the struts 242 and thickened loops 244a are substantially tubular in shape.
[1980] In some configurations, the cross-sectional thickness of the thickened loop 244a is between 1.5 and 4 times the cross-sectional thickness of the struts 242.
[1981] The thickened loops 244a are present between struts 242 having channels 246. The thickened loops 244a are not present between the end struts 242 which form an O-shape, i.e. the end struts are joined with loops 244.
[1982] In some arrangements, a combination of loops 244 and thickened loops 244a are used.
[1983] The thickened loops 244a provide additional strength to prevent damage occurring at the loops 244a from stretching or expansion of the securing member 240.
[1984] In some arrangements, the webs 254 may be used with the thickened loops 244a.
[1985] Referring to Figure 119, a detailed view of a securing member 240 is shown. The description for the securing member 240 with reference to Figures 115 and 116 likewise applies here.
[1986] The securing member 240 includes the plurality of longitudinally oriented struts 242. Adjacent struts 242 in a central portion of the securing member 240 are connected at their opposite ends by the loops 244. The struts 242 and loops 244 of a central portion form a substantially S- or Z- shaped sinusoidal pattern. The space formed between each adjacent strut 242 in the central portion forms a channel 246 accessible in a longitudinal direction opposite to the position of the connecting loop 244. At end portions of the securing member 240, i.e. at first and second ends 251, 252, the end-most struts 242 and adjacent strut 242 are connected at both longitudinal ends by loops 244. The end struts 242 form a substantially O-shape or elongated O-shape.
[1987] The securing member 240 comprises secondary loops 250. Secondary loops 250 are looped-shaped connectors connecting adjacent struts 242. Secondary loops 250 are positioned in the channels 246 and effectively reduce the length of the channel 246. Secondary loops 250 are distributed throughout the securing member 240 for structural stability.
[1988] Adjacent secondary loops 250 face opposing direction forming a substantially S- or Z- shaped sinusoidal pattern with a portion of the strut 242.
[1989] The secondary loops 250 are positioned more proximal to the end of the longitudinal end of the strut 242 having the loop 244 connecting to the same adjacent strut 242 than the opposing end. The secondary loops 250 are spaced apart from the loops 244.
[1990] The curvature of the secondary loop 250 may be the same or similar to the curvature of the loop 244 in the same channel 246.
[1991] The secondary loops 250 may have a reduced cross-sectional thickness relative to the cross-sectional thickness of the struts 242 and/or loops 244.
[1992] The secondary loops 250 are present between struts 242 having channels 246. The secondary loops 250 are not present between the end struts 242 which form an O-shape.
[1993] The secondary loops provide additional strength to prevent damage occurring at the loops 244 from stretching or expansion of the securing member 240.
[1994] The secondary loops 250 may be combined with the webbing 254 and/or the thickened loops 244a.
[1995] Referring to Figure 120, a detailed view of a securing member 240 is shown. The description for the securing member 240 with reference to Figures 115 and 116 likewise applies here.
[1996] The securing member 240 includes the plurality of longitudinally oriented struts 242. Adjacent struts 242 in a central portion of the securing member 240 are connected at their opposite ends by the loops 244. The struts 242 and loops 244 of a central portion form a substantially S- or Z- shaped sinusoidal pattern. The space formed between each adjacent strut 242 in the central portion forms a channel 246 accessible in a longitudinal direction opposite to the position of the connecting loop 244. At end portions of the securing member 240, i.e. at first and second ends 251, 252, the end-most struts 242 and adjacent strut 242 are connected at both longitudinal ends by loops 244. The end struts 242 form a substantially O-shape or elongated O-shape.
[1997] The longitudinal length of the struts 242 reduces between the mid-point between the two ends 251, 252 and the ends 251, 252. In some configurations, the reduction in longitudinal length of the struts 242 may be gradual. In some configurations, the reduction in longitudinal length of the struts 242 is the same from a mid-point to the first end 152 as the mid-point to the second end 252. In some configurations, a centre portion of the securing member 240 has an area of uniform longitudinal length struts 242.
[1998] The longitudinal length of the struts 242 may reduce in length to match the longitudinal length of the buckles 248. Referring to Figure 121, a patient interface 1 is shown with the securing member 240 where the longitudinal length of the buckles 248 matches or is slightly larger than the width of a strap of the headgear 200 or strap of the side arms 101, 102.
[1999] The reduction in longitudinal length of the struts 242 to match the buckles 248 ensures that there is no sudden change in longitudinal length which may result in stress concentration areas. It may also prevent any areas where hear may become caught from a sudden change in longitudinal length.
[2000] The change in longitudinal length of the struts 242 may be combined with any configuration of the securing member 240 described herein.
[2001] Referring to Figure 122, a detailed view of a securing member 240 is shown. The description for the securing member 240 with reference to Figures 115 and 116 likewise applies here. The longitudinal length of the struts 242 reduces between the midpoint between the two ends 251, 252 and the ends 251, 252. Therefore, the description with reference to Figures 120 and 121 also applies here.
[2002] The circumferential length (patient horizontal plane length) of the securing member 240 is extended. The length is extended by including more struts 242. For instance, between 20 and 50 struts 242 may be used. The increase in circumferential length increases the stretch or expansion of the securing member 240.
[2003] Optionally, the two looped ends of the end struts 242 may instead use a single loop 244. This further increases the stretch or expansion of the securing member 240. [2004] Referring to Figure 122, smaller buckles 248 may be used. This may accommodate smaller straps. The buckle 248 may optionally have curved slots The curved slots may more securely hold a strap of headgear 200 as the strap is force against the corners of the curved slot when in use.
[2005] Referring to Figure 123, schematical views of a buckle is shown. As will be clear, the buckle of the presently described figures may be applied to any arrangement described herein.
[2006] A buckle 260 for securing straps of the headgear 200 is illustrated. The buckle 260 is formed as two figure of eight arrangements positioned on each side of the buckle 260. This allows two straps to be attached on each figure of eight such that they extend in opposing directions. The buckle 260 may also be described as the buckles 248 of the securing member 240 described above, with the struts 242 and loops 244 removed. Therefore, the buckle 260 may be an alternative to the securing member 240.
[2007] Two buckles 260 are shown in Figure 123, one having an elongated vertical height, i.e. the slots are longer. This allows the buckle 260 to accommodate wider straps of the headgear 200. Optionally, the slots of the buckle 260 may be curved to increase the securing strength.
[2008] Referring to Figures 124 and 125, schematical views of the frame 120a and of the nasal interface 100 are shown. The illustrations omit features such as the interface body 110 and headgear 200 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the frame 120a of the presently described figures may be applied to any arrangement described herein.
[2009] The front of the frame 120a, i.e. the part of the frame 120a facing away from the patient comprises a recessed portion 338 surrounding the bias flow vent 340. The recessed portion 338 is oval or stadium shaped. The bias flow vent 340 is contained within a part of the indent. The bias flow vent 340 may be positioned eccentrically within the recessed portion 338. The frame 120a may comprise an integral bias flow vent 340.
[2010] As illustrated in Figure 125, the nasal interface 100 comprises a vent cap 346. The vent cap 346 is shaped to correspond with the shape of the recess portion 338. The vent cap 346 may fully occlude or block the recessed portion 338 and thus bias flow vent 340, or may allow a portion of gases flow therethrough to increase pressure.
[2011] Referring to Figures 126 to 130, schematical views of the frame 120 and interface body 110 of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. Otherwise, the description provided in reference to Figures elsewhere applies for like-features. As will be clear, the frame 120 of the presently described figures may be applied to any arrangement described herein.
[2012] As illustrated in the configuration shown in Figures 126 and 127, the frame 120 comprises an integral bias flow vent 340. The frame 120 comprises a recessed portion 338. The bias flow vent 340 is located in the recessed portion 338 of the frame 120. The frame 120 comprises a lip 339 at an opening of the recessed portion 338, such that a diameter of the recessed portion 338 at the opening is less than a diameter of the recessed portion 338 at a base of the recessed portion 338. The recessed portion 338 may be generally cylindrical. The recessed portion 338 may be frustoconical, with the diameter of the recessed portion tapering inwards towards the base of the recessed portion 338.
[2013] The bias flow vent 340 comprises apertures 342 in the base of the recessed portion 338. In the illustrated configuration, the apertures 342 are arranged in a spiral shape. The spiral shape may have a constant gap between adjacent loops of the spiral. In the configurations shown, each aperture 342 is an elongate aperture 342 that extends along the spiral shape and has a constant width. The apertures may be discontinuous.
[2014] A rotatable vent cover 343 is connected to the frame. The rotatable vent cover 343 may be detachably connected to the frame 120 by being inserted into the recessed portion 338. The rotatable vent cover 343 has a shape that corresponds to the shape of the recessed portion 338. The rotatable vent cover 343 has a groove that corresponds to the lip 339 of the recessed portion 338. When connected to the frame 120, the rotatable vent cover 343 is held in place by the lip 339. The rotatable vent cover 343 may be connected to the frame 120 by pressing the rotatable vent cover 343 into the recessed portion 338 such that the lip 339 and groove clip together.
[2015] The rotatable vent cover 343 has a front portion. When connected to the frame, the front portion of the rotatable vent cover 343 rests on the front side of the frame 120 (i.e. the gases inlet 121 side) in the area immediately surrounding the recessed portion 338 of the frame 120. The front portion of the rotatable vent cover 343 is generally circular in shape and flat. The front portion of the rotatable vent cover 343 has a diameter greater than the diameter of the recessed portion 338 of the frame 120 at the opening of the recessed portion 338. In the configuration shown, the front portion of the rotatable vent cover 343 has a diameter greater than the diameter of the recessed portion 338 of the frame 120 at the base of the recessed portion 338.
[2016] The rotatable vent cover 343 has a tab 344 protruding from an edge of the front portion in a direction radially outwards from the generally circular front portion. In the configuration shown the tab 344 is raised relative to the front portion. The tab 344 allows the rotatable vent cover 343 to be rotated easily.
[2017] In the configuration shown, the frame 120 has a tab 349 located proximal to the side arm 102. The tab 349 of the frame 120 engages with the tab 344 of the rotatable vent cover 343 to hold the rotatable vent cover 343 in a first position. The engagement reduces the likelihood of the rotatable vent cover 343 being accidentally rotated away from the first position. The tabs 344, 349 may be disengaged by manually rotating the rotatable vent cover 343.
[2018] The rotatable vent cover 343 has cutouts that correspond to the apertures 342 of the bias flow vent 340. When the rotatable vent cover 343 is rotated the proportion of the apertures 342 that align with the cutouts changes. This allows adjustment of expiratory pressure. The first position where the tab 344 of the rotatable vent cover 343 is engaged with the tab 349 of the frame 120 may correspond to the cutouts being completely aligned with the apertures 342. The first position may correspond to the apertures 342 being completely covered by the rotatable vent cover 343.
[2019] As illustrated in the configuration shown in Figure 128, the apertures 342 of the bias flow vent 340 are circular apertures 342. The apertures are arranged in a spiral shape. The spiral shape may have a constant gap between adjacent loops of the spiral.
[2020] The rotatable vent cover 343 has cutouts that are arranged in a spiral shape. The spiral shape of the cutouts of the rotatable vent cover 343 (substantially) corresponds to the spiral shape of the apertures 342. Each cutout is an elongate cutout that extends along the spiral shape and has a constant width. The width of the cutouts is equal to the diameter of the circular apertures 342. When the rotatable vent cover 343 is rotated the proportion of the apertures 342 that align with the cutouts changes. This allows adjustment of expiratory pressure.
[2021] The rotatable vent cover 343 has a tab 344 protruding from an edge of the front portion in a direction radially outwards from the generally circular front portion. In the configuration shown the tab 344 is flush with the front portion. The tab 344 allows the rotatable vent cover 343 to be rotated easily.
[2022] As illustrated in the configuration shown in Figures 129 and 130, the apertures 342 of the bias flow vent 340 are circular apertures 342. The apertures are arranged in a spiral shape. The spiral shape may have a constant gap between adjacent loops of the spiral.
[2023] The rotatable vent cover 343 has cutouts that are arranged in a spiral shape. Each cutout corresponds to an aperture 342. The spiral shape of the cutouts of the rotatable vent cover 343 (substantially) corresponds to the spiral shape of the apertures 342. Each cutout is a circular cutout. The diameter of the cutouts is equal to the diameter of the circular apertures 342. When the rotatable vent cover 343 is rotated the proportion of the apertures 342 that align with the cutouts changes. This allows the adjustment of expiratory pressure.
[2024] The rotatable vent cover 343 has a tab 344 protruding from an edge of the front portion in a direction radially outwards from the generally circular front portion. In the configuration shown the tab 344 is raised relative to the front portion. The tab 344 allows the rotatable vent cover 343 to be rotated easily.
[2025] The frame 120 has a tab 349 located proximal to the side arm 102. The tab 349 of the frame 120 engages with the tab 344 of the rotatable vent cover 343 to hold the rotatable vent cover 343 in a first position. The engagement reduces the likelihood of the rotatable vent cover 343 being accidentally rotated away from the first position. The tabs 344, 349 may be disengaged by manually rotating the rotatable vent cover 343. The first position where the tab 344 of the rotatable vent cover 343 is engaged with the tab 349 of the frame 120 corresponds to the apertures 342 being completely covered by the rotatable vent cover 343.
[2026] Referring to Figure 131, a schematical view of the tube retainer 348 of the nasal interface 100 is shown. The description provided in reference to Figures 29 to 36 applies for like-features. As will be clear, tube retainer 348 of the presently described figure may be applied to any arrangement described herein.
[2027] The tube retainer 348 of Figure 131 is a stand-alone feature. Therefore, the nasal interface 100 (or headgear 200) comprises the tube retainer 348. The tube retainer 348 is removably attached to the conduit 300. The tube retainer 348 couples the conduit 300 to the headgear 200. The tube retainer 348 holds the conduit 300 in position.
[2028] The tube retainer 348 comprises an annular portion 354 for receiving the conduit 300 therethrough. The conduit 300 is moveably received in the tube retainer 348. The annular portion 354 is C-shaped in the illustrated configuration, but may also be a closed channel.
[2029] The tube retainer 348 comprises clip arms 355. The clip arms 355 comprise a pair of arms that face one another through which a strap, such as a strap of the headgear 200 or side arms 101, 102 may pass. The tube retainer 348 is retained on any such strap via the clip arms 355. The arms of the clip arms 355 are spaced apart to allow a strap to pass therethrough. Therefore, the tube retainer 348 may be attached to a strap at any location without the need to feed the tube retainer 348 from an end of a strap. [2030] The clip arms 355 are positioned on an opposite side of a body of the tube retainer 348 to the opening in the C-shaped annular portion 354. Referring to Figures 132 to 134, schematical views of the interface body 110 are shown. The illustrations omit features such as the frame 120 for explanation. Otherwise, the description provided in reference to figures elsewhere applies for like-features. As will be clear, the interface body 110 of the presently described figures may be applied to any arrangement described herein.
[2031] The nasal interface 100 comprises a flow channel 125 to allow the flow of gases therethrough, such as from a gases inlet port 121 (not shown) to the first and/or second nasal elements 111, 112. The assembled interface body 110 and frame 120 house the flow channel 125. The interface body 110 comprises a structural support 2110 extending into the flow channel 125. The structural support may be formed of the same material as the interface body 110. 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. 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.
[2032] Referring to Figure 132, the structural support 2110 is formed in the shape of a dome or semi-disc shape extending from the inner wall of the base portion 118.
[2033] Referring to Figures 133 and 134, the structural support 2110 is formed as tubular or teardrop shaped extensions to the first and second nasal elements 111, 112 extending downwardly into the flow channel 125. The structural support 2110 each having an aperture that aligns with the channel of the first and/or second nasal elements 111, 112
[2034] Referring to Figures 135 and 136, schematical views of the frame 120a and interface body 110a of the nasal interface 100 are shown. The illustrations omit features such as the headgear 200 for explanation. 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.
[2035] As illustrated in Figure 135, the frame 120a comprises lateral protrusions 2112. The lateral protrusions 2112 extend outwardly at the lateral portions of the frame 120a. The side arms 101, 102 are positioned out of contact with the lateral protrusions 2112 in a frontward direction, i.e. away from the patient side. The lateral protrusions 2112 are formed as tabs. [2036] As illustrated in Figure 136, the interface body 110a comprises lateral notches 2114. The lateral notches 2114 extend outwardly at the lateral portions of the interface body 110a. The lateral notches 2114 are extensions or protrusions in the shape or molding of the interface body 110a. The lateral notches 2114 are shaped to correspond and receive the lateral protrusions 2112 of the frame 120a. The lateral notches 2114 and the lateral protrusions 2112 assist in the securing of the frame 120a to the nasal interface 110a.
[2037] The interface body 110a comprises lateral tabs 2116. The lateral tabs 2116 extend outwardly at the lateral portions of the interface body 110 and are positioned at or near the lateral notches 2114. The lateral tabs 2116 provide area to grip or hold when assembling or disassembling the attachment of the interface body 110a to the frame 120a.
[2038] Referring to Figures 137 to 139, schematical views of the frame 120a and interface body 110a of the nasal interface 100 are shown. Figures 137 and 138 illustrate schematical section views of variations of the frame 120a. Figure 139 illustrates an interface body 110a compatible with the frames 120a of Figures 137 and 138. The illustrations omit features such as the headgear 200 for explanation. 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.
[2039] The nasal interface 100 of Figure 137 comprises the lateral tabs 2116 and structural support 2110 as described above with reference to Figures 132 to 134 and 136. No lateral protrusions 2112 I notches 2114 are present in the configuration of Figure 137. However, in some optional configurations, these may be present.
[2040] The interface body 110 comprises a structural support 2110 extending into the flow channel 125 as described above. The structural support 2110 is formed in a cuboid shape extending from the inner wall of the base portion 118. The structural support 2110 does not extend so far to be in contact with the frame 120a. The structural support 2110 maintains a gap between its end and the frame 120a. The gap may be sized to restrict flow through the flow channel 125, i.e. between the first nasal delivery element 111 and the second nasal delivery element 112.
[2041] The nasal interface 100 of Figure 138 comprises a single lateral tab 2116 on the gases inlet port side 121 of the interface body 110a. However, a single lateral tab 2116 may optionally be positioned on either lateral side or any edge of the nasal interface 100 in some configurations. No lateral protrusions 2112, lateral notches 2114 or structural support 2110 are present in the configuration of Figure 138, but may optionally be present.
[2042] Referring to both Figures 137 and 138, a groove 124 (not shown in view of groove elements below) is formed in the periphery of the frame 120a similar to the groove 124 described above with first reference to Figure 77. Therefore, edges or sides 126, 127, 128, 129 of the frame portion 120a comprise a groove 124 extending around the entire perimeter of the frame portion 120a. A portion of the interface body 110a is received in the groove 124. The groove 124 is generally U-shaped. The interaction between the interface body 110a in the groove 124 secures the interface body 110a to the frame portion 120a.
[2043] The portion of the interface body 110a received in the groove 124 is a circumferential lip 131. The circumferential lip 131 is shown in Figure 139. The circumferential lip 131 is arranged circumferentially around the opposite face of the interface body 110a to the patient facing side (in use). The circumferential lip 131 forms a partial face of the interface body 110a on the side facing away from the patient (in use). The circumferential lip 131 surrounds an opening of the interface body 110a for receiving the frame 120a.
[2044] The circumferential lip 131 is sized to be received in the groove 124. The circumferential lip corresponds to the groove 124. In some arrangements, the circumferential lip 131 forms a sealing connection with the groove 124.
[2045] The size of the groove 124 varies around the circumference or edges or sides 126, 127, 128, 129 of the frame portion 120a. At least a portion of the groove 124 comprises a deeper and/or thicker channel relative to a further portion of the groove 124.
[2046] The groove 124 comprises a standard groove 124a and a deep groove 124b. In some configurations, the deep groove 124b extends from an edge of the frame 120a further toward a mid-point of the frame 120a than the standard groove 124a. The deep groove 124b may extend between 1.5 times to 4 times the depth of the standard groove 124a.
[2047] The deep groove 124b may have a greater thickness than the standard groove 124a. The deep groove 124b may extend further in a front to back direction relative nasal interface 100 in use. The deep groove 124b may extend further in a substantially sagittal plane direction of the patient in use. The deep groove 124b may extend between 1.2 times to 3 times the width of the standard groove 124a. [2048] Referring to Figures 137 to 139, the portion of the circumferential lip 131 received in the standard groove 124a is the standard lip 132. The portion of the circumferential lip 131 received in the deep groove 124b is the enlarged lip 133.
[2049] The standard lip 132 is sized to be received in the standard groove 124a. The enlarged lip 133 is sized to be received in the deep groove 124b. The standard lip 132 is too large to be receivable in the standard groove 124a. In some arrangements, the circumferential lip 131 forms a sealing connection with the groove 124.
[2050] The enlarged lip 133 extends from an edge of the interface body 110a further toward a mid-point of the interface body 110a than the standard lip 132. The enlarged lip 133 may extend between 1.5 times to 4 times the depth of the standard lip 132.
[2051] The enlarged lip 133 may have a greater thickness than the standard lip 132. The enlarged lip 133 may extend further in a front to back direction relative nasal interface 100 in use. The enlarged lip 133 may extend further in a substantially sagittal plane direction of the patient in use. The enlarged lip 133 may extend between 1.2 times to 3 times the width of the standard lip 132.
[2052] The groove 124 and circumferential lip 131 are orientated such that the standard lip 132 is positioned to be received in the standard groove 124a and the enlarged lip 133 is positioned to be received in the deep groove 124b when the frame 120a and interface body 110a are in the desired orientation.
[2053] The deep groove 124b may be positioned on the edge 129 at or near the outlet gases port 122 I bias flow vent 340. Such a position ensures that the deep groove 124b does not interfere or overlap with the inlet gases port 121. This has the advantage of ensuring that the inlet gases port 121 may maintain the common axis or be substantially directed at the first delivery element 111. Likewise, the enlarged lip 133 on the inner circumferential edge of the interface body 110a at or near the second nasal delivery element 112.
[2054] Optionally, as shown in Figures 137 and 138, in some configurations, the outlet gases port 122 I bias flow vent 340 may be positioned more distal to the edge 129 where the deep groove 124b is positioned than the inlet gases port 121 is relative to the proximal edge 128. The outlet gases port 122 I bias flow vent 340 may not be on a common axis or be substantially directed at the second delivery element 112.
[2055] As shown in Figure 139, the enlarged lip 133 may be positioned more closely to the axis (168 - see Figure 5) of the second delivery element 112 than the standard lip 132 to the axis (167 - see Figure 5) of the first delivery element 111. [2056] The groove 124 and circumferential lip 131 comprising a varied size ensures that the interface body 110a may only be positioned or connected to the frame 120a in a single orientation. Given the symmetrical or very similar mirrored features of the nasal interface 100, there is a risk that the frame 120a and interface body 110a be orientated incorrectly. This may result in the inlet gases port 121 being directed at the incorrect nasal delivery element 111, 112. The varied size of the groove 124 and corresponding lip 131 provides a key or polarisation to the connection.
[2057] Whilst the deep groove 124b and enlarged lip 133 are illustrated as being positioned on one edge 129 of the nasal interface 100 with the three remaining edges having a standard groove and lip 124a, 132, in some optional arrangements, the deep groove 124b and enlarged lip 133 may be positioned on any of the edges and may be positioned on more than one edge.
[2058] Whilst the deep groove 124b and enlarged lip 133 are illustrated as being positioned at the edge 129 of the nasal interface 100 proximal the second nasal interface 112 and bias flow vent 340, the nasal interface 100 may be arranged such that the positioned of first and second nasal delivery elements 111, 112 are switched relative to the inlet gases port 121.
[2059] 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.
[2060] In some configurations, the patient may be spontaneously breathing.
[2061] 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.
[2062] 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.
[2063] 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 [2064] 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.
[2065] Usability advantages are provided by the nasal interfaces 100 and patient interfaces 30 comprising the ball and socket configurations for connecting the headgear to the nasal interface 100, the nasal interfaces 100 comprising 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.
[2066] 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.
[2067] 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.
[2068] In some configurations, the respiratory therapy system 1000 comprises a respiratory therapy apparatus 1100 and a patient interface comprising a nasal interface 100.
[2069] A schematic representation of an example respiratory therapy system 1000 is provided by Figure 140. 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.
[2070] An exemplary breathing assistance apparatus will now be described, with reference to Figures 140 and 141. 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. [2071] Breathing assistance apparatus 10 is configured or operable to provide respiratory therapy via the supply conduit 20 and the patient interface 1.
[2072] 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.
[2073] 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.
[2074] With reference to Figure 140, 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.
[2075] 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 140, in some embodiments the inlet module 1010 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.
[2076] With reference to Figure 140, 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.
[2077] 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.
[2078] 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.
[2079] The respiratory therapy system 1000 and breathing assistance apparatus 10 will now be described in more detail.
[2080] 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.
[2081] 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.
[2082] The blower/sensor module 1114 may further comprise a sensor module
1112. With reference to Figure 140, 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.
[2083] One or more sensors (for example, Hall Effect sensors) may be used to measure a motor speed of the blower motor.
[2084] 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.
[2085] 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.
[2086] The patient interface 1 described herein in is a non-sealing interface, where the nasal delivery elements 111, 112, which may be prongs, allow for some movement of gases between the outside environment and the nasal passageways. Non-sealing patient interfaces may help to prevent barotrauma effects (e.g., tissue damage to the airways and/or lungs due to differences in pressure relative to standard atmospheric pressure).
[2087] The patient respiratory interface 30 may instead be a tracheostomy interface or any other suitable type of patient interface, depending on the type of therapy being provided and/or the patient's needs.
[2088] 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.
[2089] 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
[2090] 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.
[2091] 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).
[2092] 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.
[2093] 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.
[2094] 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.
[2095] 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. [2096] 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.
[2097] 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.
[2098] 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).
[2099] 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.
[2100] 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.
[2101] 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.
[2102] 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.
[2103] 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.
[2104] 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).
[2105] 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.
[2106] 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). [2107] Figure 141 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.
[2108] With continued reference to Figure 140, 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, such as a non-sealing interface (for example, a non-sealing nasal cannula) at another end.
[2109] 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.
[2110] 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.
[2111] 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.
[2112] 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.
[2113] 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 comprising 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; positioning 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.
[2114] 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; positioning 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.
[2115] 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.
[2116] 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.
[2117] 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.
[2118] The nasal interface may be any one of the nasal interfaces 100, disclosed herein.
[2119] 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.
[2120] 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.
[2121] 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 leaking (due to control of pressure).
[2122] 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.
[2123] 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.
REFERENCE NUMERALS
I patient interface
10 breathing assistance apparatus
II flow generator
12 humidifier
13 outlet
14 controller
15 battery pack
16 breathing tube
20 supply conduit
21 sensor
30 patient interfaces
40 pulse oximetry sensor
100 nasal interface
101 side arm
101a first portion of the side arm
101b second portion of the side arm
102 side arm
102a first portion of the side arm
102b second portion of the side arm
103 connector portions
110 interface body
II I nasal delivery element
112 nasal delivery element
113 flow generator outlet
118 base portion
120 frame
121 gases inlet port
122 gases outlet port
123 sensor
124 groove
124a standard groove
124b deep groove
125 flow channel
126 top edge or side bottom edge or side lateral edge or side (corresponds to gas inlet port) lateral edge or side (corresponds to gas outlet port) sensor circumferential lip standard lip enlarged lip communication modules display and I/O
Gases channel first bifurcated channel second bifurcated channel external gases flow channel plurality of external gases channels septum contacting region (bridge) a central region upper (sloped) portion lower (sloped) portion top edge or side bottom edge or side lateral raised portion (corresponds to 111) lateral raised portion (corresponds to 112) first cutout second cutout first (symmetrical) cutout second (symmetrical) cutout parallel walls apex central axis first midline plane second midline plane first axis second axis angle between inlet gases flow outlet gases flow bypass flow bypass inhalation flow bypass exhaust flow exhalation bypass flow recirculated flow first external gases flow second external gases flow baffle leading edge trailing edge thickened portion additional channel socket joint tube notch tube headgear headgear arm cheek pad outer body open channel front face upper face rear face pad opening headgear clip securing member strut loop a thickened loop channel buckle secondary loops first end second end 254 web
260 double buckle
300 Conduit
310 control system
311 pressure sensor input
312 temperature sensor input
313 flow rate sensor input
315 gas fraction sensor input
316 humidity sensor input
317 pulse oximetry sensor input
318 parameter input
319 PWM input
320 voltage input
338 recessed portion
339 lip
340 bias flow vent
341 diffuser
342 aperture
343 rotatable vent cover
344 rotatable vent cover tab
345 tether
346 cap
347 cap aperture
348 tube retainer
349 frame tab
351 gases delivery elbow
352 gases delivery portion
353 gases receiving portion
354 annular portion
355 clip arms
1000 respiratory therapy system
1005 headgear connecting portion
1006 headgear connecting portion
1007 ball portion
1008 socket portion 1010 inlet module
1011 gases source
1016 distal end
1017 aperture
1018 undercut
1024 connection portion axis
1025 angle of twisting
1026 upward direction
1027 downward direction
1035 headgear connection portion
1036 headgear connection portion
1037 ball portion
1038 socket portion
1039 notch
1040 protrusion
1042 arm buckle
1044 further arm buckle
1101 ambient air inlet
1102 low-pressure gas inlet
1103 high-pressure gas inlet
1104 filter
1105 valve
1106 single filter
1107 sensor
1108 sensor
1109 sensor
1111 blower
1111a first outlet
1111c first base lllld first taper lllle first angled base
1112 sensor module
1112a second outlet
1112c second base
1112d second taper 1112e second angled base
1113 sensor
1114 blower/sensor module
1122 non-return valve
1205 humidification chamber
1216 heater plate
1226 heating element
1301 living hinge (inlet side)
1302 living hinge (outlet side)
1311 connecting arm portion (inlet side)
1312 connecting arm portion (outlet side)
1321 first cross hinge
1322 second cross hinge
1325 first vertical hinge
1326 second vertical hinge
1327 thinner upper portion
1328 thinner lower portion
1331 additional living hinge (inlet side)
1332 additional living hinge (outlet side)
1334 hook portion
1336 peripheral groove
1338 buckle opening
1340 attachment button
1342 button hole
1344 further attachment buttons
2110 structural support
2112 lateral protrusions
2114 lateral notches
2116 lateral tabs
3211 current input

Claims

CLAIMS:
1. A nasal interface comprising: an interface body comprising a gases flow channel, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, and a bias flow vent 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.
2. The nasal interface according to claim 1, wherein the gases inlet port is substantially directed toward the first nasal delivery element.
3. The nasal interface according to claim 1 or claim 2, wherein the gases inlet port is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
4. The nasal interface according to any preceding claim, wherein the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to create or contribute to the asymmetric flow.
5. The nasal interface according to any preceding claim, wherein the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory gases, a first flow stream of gases configured to be substantially provided to the first nasal delivery element and a second flow stream of gases configured to be substantially provided to the second nasal delivery element, and is configured to direct more of the incoming respiratory gases to the first flow stream of gases than to the second flow stream of gases to contribute to the asymmetric flow.
6. The nasal interface according to any preceding claim, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
7. The nasal interface according to any preceding claim, wherein the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
8. The nasal interface according to any preceding claim, wherein the first nasal delivery element and the second nasal delivery element are each substantially straight.
9. The nasal interface according to any preceding claim, wherein one of the nasal delivery elements is larger than the other of the nasal delivery elements.
10. The nasal interface according to claim 9, wherein the first nasal delivery element is larger than the second nasal delivery element.
11. The nasal interface according to claim 9 or claim 10, wherein the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
12. The nasal interface according to any preceding claim, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, optionally, the pair of side arms are configured to be moveable to follow the contours of the face, optionally, the side arms are formed of a flexible material, optionally, 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 to a portion of a headgear.
13. The nasal interface according to any preceding claim, wherein the bias flow vent comprises an aperture or an aperture and a diffuser.
14. The nasal interface according to any preceding claim, the nasal interface comprising at least one baffle extending along the gases flow channel from a region corresponding generally to the inlet gases port toward a region corresponding generally to the bias flow vent.
15. The nasal interface according to claim 14, wherein the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
16. The nasal interface according to claim 14 or claim 15, comprising a plurality of the spaced apart baffles extending along the gases flow channel.
17. The nasal interface according to any one of claims 14 to 16, wherein the at least one baffle extends across the interface body, a frame portion, or both an interface body and a frame portion of the nasal interface.
18. The nasal interface according to any preceding claim, wherein at least one of the nasal delivery elements has a tapering wall portion.
19. The nasal interface according to claim 18, wherein the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
20. The nasal interface according to claim 18 or claim 19, wherein a base of at least one of the nasal delivery elements has an angled portion.
21. The nasal interface according to any one of claims 18 to 20, wherein the base has a frustoconical shape.
22. The nasal interface according to any preceding claim, wherein the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet port.
23. The nasal interface according to claim 22, wherein 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 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.
24. The nasal interface according to claim 22, wherein the second direction is a laterally outward direction.
25. A nasal interface comprising: an interface body comprising a gases flow channel, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the gases inlet port is arranged to direct the incoming respiratory gases towards the first nasal delivery element, and wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
26. The nasal interface according to claim 25, wherein the gases inlet is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
27. The nasal interface according to claim 25 or claims 26, wherein the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other.
28. The nasal interface according to claim 27, wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 60 degrees relative to each other.
29. The nasal interface according to claim 27, wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 45 degrees relative to each other.
30. The nasal interface according to claim 27, wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 30 degrees relative to each other.
31. The nasal interface according to claim 27, wherein the first axis and inlet axis are at an angle of between 0 degrees and up to but less than 15 degrees relative to each other.
32. The nasal interface according to any one of claims 25 to 31, wherein the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to contribute to the asymmetric flow.
33. The nasal interface according to any one of claims 25 to 32, wherein the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to contribute to the asymmetric flow.
34. The nasal interface according to any one of claims 25 to 33, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
35. The nasal interface according to any one of claims 25 to 33, wherein the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
36. The nasal interface according to any one of claims 25 to 35, wherein the first nasal delivery element and the second nasal delivery element are each substantially straight.
37. The nasal interface according to any one of claims 25 to 36, wherein one of the nasal delivery elements is larger than the other of the nasal delivery elements.
38. The nasal interface according to claim 37, wherein the first nasal delivery element is larger than the second nasal delivery element.
39. The nasal interface according to claim 37 or claim 38, wherein the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
40. The nasal interface according to any one of claims 25 to 39, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, optionally, the pair of side arms are configured to be moveable to follow the contours of the face, optionally, the side arms are formed of a flexible material, optionally, 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.
41. The nasal interface according to any one of claims 25 to 40, the nasal interface comprising a bias flow vent for enabling exhaled gases to be expelled out of the interface body, the bias flow vent positioned downstream of the first nasal delivery element.
42. The nasal interface according to claim 41, wherein the bias flow vent comprises an aperture or an aperture and a diffuser.
43. The nasal interface according to claim 41 or claim 42, comprising at least one baffle extending along the gases flow channel from a region corresponding generally to the inlet gases port toward a region corresponding generally to the bias flow vent.
44. The nasal interface according to claim 43, wherein the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
45. The nasal interface according to claim 43 or claim 44, wherein a plurality of the spaced apart baffles extending along the gases flow channel.
46. The nasal interface according to any one of claims 43 to 45, wherein the at least one baffle extends across the interface body, a frame portion, or both the interface body and a frame portion of the nasal interface.
47. The nasal interface according to any one of claims 25 to 46, wherein at least one of the nasal delivery elements has a tapering wall portion wherein the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
48. The nasal interface according to claim 47, wherein a base of at least one of the nasal delivery elements has an angled portion.
49. The nasal interface according to claim 47, wherein the base has a frustoconical shape.
50. The nasal interface according to any one of claims 25 to 49, the nasal interface comprising a gases delivery elbow coupled to, or defining, the gases inlet portion.
51. The nasal interface according to claim 50, wherein 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.
52. The nasal interface according to claim 51, wherein the second direction is a laterally outward direction.
53. A nasal interface comprising: an interface body comprising a gases flow channel, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, and a connector for coupling the gases supply conduit to the interface body and to enable the passage of the incoming respiratory gases from the gases supply conduit to the gases flow channel.
54. The nasal interface according to claim 53, wherein the connector is configured to reduce the turbulence of the flow of gases when entering the interface body.
55. The nasal interface according to claim 53 or claim 54, wherein the connector is coupled to or defines the gases inlet port.
56. The nasal interface according to any one of claims 53 to 55, wherein the interface body comprises a frame portion.
57. The nasal interface according to claim 56, wherein the frame portion comprises the gases inlet port, and wherein the interface body comprises the first nasal delivery element and the second nasal delivery element.
58. The nasal interface according to claim 56 or claim 57, wherein the connector is integrally formed with the frame portion of the interface body.
59. The nasal interface according to any one of claims 53 to 58, wherein the connector is an elbow.
60. The nasal interface according to any one of claims 53 to 59, the nasal interface comprising a conduit retainer to couple the gases supply conduit to a headgear of the nasal interface.
61. The nasal interface according to claim 60, wherein the conduit retainer comprises an annular portion to moveably receive the gases supply conduit.
62. The nasal interface according to claim 60 or claim 61, wherein the conduit retainer is positioned laterally outward of the elbow and on a side arm adjacent to a coupling of a headgear strap with the side arm of the interface body.
63. The nasal interface according to any one of claims 53 to 62, wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
64. The nasal interface according to any one of claims 53 to 63, wherein the gases inlet port is substantially directed toward the first nasal delivery element, and optionally wherein the gases inlet port is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element.
65. The nasal interface according to claim 63, wherein the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to contribute to the asymmetric flow.
66. The nasal interface according to any one of claims 53 to 65, wherein the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to contribute to the asymmetric flow.
67. The nasal interface according to any one of claims 53 to 66, wherein the first nasal delivery element and the second nasal delivery element lie in a plane of the interface body that is transverse to 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.
68. The nasal interface according to any one of claims 53 to 67, wherein the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
69. The nasal interface according to any one of claims 53 to 68, wherein the first nasal delivery element and the second nasal delivery element are each substantially straight.
70. The nasal interface according to any one of claims 53 to 69, wherein one of the nasal delivery elements is larger than the other of the nasal delivery elements, optionally, wherein the first nasal delivery element is larger than the second nasal delivery element.
71. The nasal interface according to claim 70, wherein the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
12. The nasal interface according to any one of claims 53 to 71, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, optionally, the pair of side arms are configured to be moveable to follow the contours of the face, optionally, the side arms are formed of a flexible material, optionally, 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.
73. The nasal interface according to any one of claims 53 to 72, the nasal interface comprising a bias flow vent for enabling exhaled gases to be expelled out of the interface body, the bias flow vent positioned downstream of the first nasal delivery element.
74. The nasal interface according to claim 73, the nasal interface comprising at least one baffle extending along the gases flow channel from a region corresponding generally to the inlet gases port toward a region corresponding generally to the bias flow vent.
75. The nasal interface according to claim 74, wherein the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
76. The nasal interface according to claim 73 or claim 74, the nasal interface comprising a plurality of the spaced apart baffles extending along the gases flow channel.
77. The nasal interface according to any one of claims 74 to 76, wherein the at least one baffle extends across the interface body, a frame portion, or both the interface body and a frame portion of the nasal interface.
78. The nasal interface according to any one of claims 53 to 77, wherein at least one of the nasal delivery elements has a tapering wall portion wherein the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
79. The nasal interface according to claim 78, wherein a base of at least one of the nasal delivery elements has an angled portion.
80. The nasal interface according to claim 78, wherein the base has a frustoconical shape.
81. The nasal interface according to any one of claims 53 to 80, wherein the retainer elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet portion 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 deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
82. The nasal interface according to claim 81, wherein the second direction is a laterally outward direction.
83. A nasal interface comprising: an interface body comprising a gases flow channel, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to be moveable to follow the contours of the face.
84. The nasal interface according to claim 83, wherein the side arms are formed of a flexible material.
85. The nasal interface according to claim 83 or claim 84, wherein each side arm comprises a headgear connection feature to movably connect to either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to respective connectors on first and second ends of a headgear.
86. The nasal interface according to claim 85, wherein a first one of the side arms comprises either a ball portion or a socket portion of the ball and socket joint configured to moveably connect to a corresponding ball or socket portion on the respective headgear connecting portion.
87. The nasal interface according to claim 85 or claim 86, wherein a second one of the side arms comprises either a ball portion or a socket portion of the ball and socket joint configured to moveably connect to a corresponding ball or socket portion on the respective headgear connecting portion.
88. The nasal interface according to any one of claims 85 to 87, 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.
89. The nasal interface according to any one of claims 85 to 88, wherein each headgear connection feature is moveably connectable to either of the connectors on the first and second ends of the headgear.
90. The nasal interface according to any one of claims 83 to 89, wherein the gases inlet port is proximal to the first nasal delivery element and distal from the second nasal delivery element to contribute to the asymmetric flow.
91. The nasal interface according to any one of claims 83 to 90, wherein the nasal interface is configured to receive the incoming respiratory gases from the gases inlet port and to provide, from the incoming respiratory 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 respiratory gases to the first flow stream of gases than to the second flow stream of gases to contribute to the asymmetric flow.
92. The nasal interface according to any one of claims 83 to 91, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse to 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.
93. The nasal interface according to any one of claims 83 to 92, wherein the first nasal delivery element and the second nasal delivery element are symmetrical about the 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.
94. The nasal interface according to any one of claims 83 to 93, wherein the first nasal delivery element and the second nasal delivery element are each substantially straight.
95. The nasal interface according to any one of claims 83 to 94, wherein one of the nasal delivery elements is larger than the other of the nasal delivery elements.
96. The nasal interface according to claim 95, wherein the first nasal delivery element is larger than the second nasal delivery element.
97. The nasal interface according to claim 95 or claim 96, wherein the cross section of the internal flow area of the larger nasal delivery element is greater than that of the other nasal delivery element.
98. The nasal interface according to any one of claims 83 to 97, the nasal interface comprising a bias flow vent for enabling exhaled gases to be expelled out of the interface body, the bias flow vent positioned downstream of the first nasal delivery element.
99. The nasal interface according to claim 98, wherein the bias flow vent comprises an aperture or an aperture and a diffuser.
100. The nasal interface according to claim 98 or claim 99, the nasal interface comprising at least one baffle extending along the gases flow channel from a region corresponding generally to the inlet gases port toward a region corresponding generally to the bias flow vent.
101. The nasal interface according to claim 100, wherein the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
102. The nasal interface according to claim 100 or claim 101, comprising a plurality of the spaced apart baffles extending along the gases flow channel.
103. The nasal interface according to any one of claims 100 to 102, wherein the at least one baffle extends across the interface body, a frame portion, or both an interface body and a frame portion of the nasal interface.
104. The nasal interface according to any one of claims 83 to 103, wherein at least one of the nasal delivery elements has a tapering wall portion.
105. The nasal interface according to claim 104, wherein the tapering wall portion in a region proximal to the gases flow channel is thicker than the tapering wall portion in a region proximal to a gases outlet of the at least one of the nasal delivery elements.
106. The nasal interface according to claim 104 or claim 105, wherein a base of at least one of the nasal delivery elements has an angled portion.
107. The nasal interface according to any one of claims 104 to 106, wherein the base has a frustoconical shape.
108. The nasal interface according to any one of claims 83 to 107, wherein the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet port.
109. The nasal interface according to claim 108, wherein 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 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.
110. The nasal interface according to claim 109, wherein the second direction is a laterally outward direction.
111. The nasal interface according to any one of claims 83 to 110, wherein the interface body comprises a single inlet comprising the gases inlet port.
112. A patient interface comprising the nasal interface of any one of claims 83 to 111 and a pair of the headgear connecting portions each moveably connected to one of the side arms, a first one of the side arms comprising either the ball or socket portion and a first headgear connecting portion comprising the corresponding socket or ball portion, and a second one of the side arms comprising either the ball or socket portion and a second headgear connecting portion comprising the corresponding socket or ball portion.
113. The patient interface according to claim 112, wherein the patient interface comprises a headgear comprising the headgear connecting portions.
114. The patient interface according to claim 112 or claim 113, wherein the patient interface comprises flexible cheek contacting portions.
115. The patient interface according to any one of claims 112 to 114, wherein the headgear is symmetric 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.
116. A method of changing the configuration or direction of a gases inlet of a nasal interface according to any one of claims 83 to 111, 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.
117. A nasal interface comprising: an interface body comprising a gases flow channel, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, a bias flow vent for enabling exhaled gases to be expelled out of the interface body, the bias flow vent positioned downstream of the first nasal delivery element, and a cap configured to at least partly cover the bias flow vent in use.
118. The nasal interface according to claim 117, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element.
119. The nasal interface according to claim 117 or claim 118, wherein the cap is configured to substantially cover the bias flow vent in use.
120. The nasal interface according to claim 119, wherein the cap comprises at least one opening to enable gases flow from the bias flow vent through the cap.
121. The nasal interface according to claim 120, wherein the cap comprises an annular configuration comprising a peripheral frame surrounding the opening.
122. The nasal interface according to any one of claims 119 to 121, wherein the interface body comprises a frame portion, and wherein the bias flow vent is located in the frame portion.
123. The nasal interface according to claim 120, wherein the cap is tethered to the frame portion.
124. The nasal interface according to claim 120, wherein the cap is removably attached to the frame.
125. The nasal interface according to any one of claims 117 to 124, wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
126. A nasal interface comprising: an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises an external gases channel in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external gases channel.
127. The nasal interface according to claim 126, wherein the external gases channel extends along at least part of the main body portion.
128. The nasal interface according to claim 126 or claim 127, wherein the external gases channel extends from at or adjacent a base of the at least one of the nasal delivery elements, away from the at least one of the nasal delivery elements.
129. The nasal interface according to claim 127 or claim 128, wherein the interface body comprises a frame portion, and wherein the interface body comprises the main body portion.
130. The nasal interface according to claim 129, wherein one of the nasal delivery elements is larger than the other of the nasal delivery elements, and wherein the external gases channel is adjacent a smaller one of the nasal delivery elements.
131. The nasal interface according to claim 129 or claim 130, wherein the external gases channel extends along at least part of the main body portion and along at least part of the at least one of the nasal delivery elements.
132. The nasal interface according to any one of claims 129 to 131, wherein the external gases channel extends to a tip of the at least one of the nasal delivery elements that comprises a gases outlet.
133. The nasal interface according to any one of claims 129 to 132, comprising a plurality of the external gases channels adjacent the at least one of the nasal delivery elements.
134. The nasal interface according to any one of claims 129 to 132, comprising at least one of the external gases channels is adjacent each of the nasal delivery elements.
135. The nasal interface according to any one of claims 129 to 134, comprising a plurality of the external gases channels are adjacent each of the nasal delivery elements.
136. The nasal interface according to any one of claims 129 to 135, wherein the external gases channel comprises an expanding or bifurcated configuration in region distal from the at least one of the nasal delivery elements, to enable gases flow away from the frame.
137. A nasal interface comprising: an interface body comprising a gases flow channel, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, to provide an articulating connection of the headgear with the nasal interface.
138. The nasal interface according to claim 137, wherein each side arm comprises a headgear connection feature to movably connect to either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to respective connectors on first and second ends of a headgear.
139. The nasal interface according to claim 138, wherein the headgear connection feature on a first one of the side arms 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 the headgear connecting portion for connecting the headgear end portion of a headgear, and wherein a second one of the side arms 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.
140. The nasal interface according to claim 138 or claim 139, wherein each headgear connection feature is moveably connectable to either of the connectors on the first and second ends of the headgear.
141. The nasal interface according to any one of claims 138 to 140, 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.
142. A method of changing the configuration or direction of a gases inlet of a nasal interface according to any one of claims 138 to 141, 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.
143. A patient interface comprising a nasal interface according to any one of 138 to 142, and a headgear comprising first and second ends with connectors that are configured to connect to the headgear connection features on the side arms.
144. 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 111 or claims 117 to 141.
145. A respiratory therapy system according to claim 144, 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.
146. A nasal interface comprising : an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
147. The nasal interface according to claim 146, wherein the external cutout extends from or adjacently from at least one of the nasal delivery elements along part of a main body portion of the interface body to a lateral edge of the interface body.
148. The nasal interface according to claim 146 or claim 147, wherein the external cutout extends around or adjacently around a base of the at least one of the nasal delivery elements, and away from the at least one of the nasal delivery elements.
149. The nasal interface according to any one of claims 146 to 148, wherein the external cutout is a recess in the main body portion of the interface body.
150. The nasal interface according to claim 149, wherein walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
151. The nasal interface according to claim 149, wherein walls of the recess are formed at an angle between about 35 and 60 degrees relative to the surface of the main body portion.
152. The nasal interface according to any one of claims 146 to 151, wherein the external cutout comprises parallel sides extending between the lateral edge to an arc extending around the base of the at least one of the nasal delivery elements.
153. The nasal interface according to claim 152, wherein the arc of the external cutout shares a central axis with the at least one nasal delivery element.
154. The nasal interface according to any one of claims 146 to 153, comprising a second external cutout extending from or adjacently from the other one of the nasal delivery elements along part of a main body portion of the interface body to the opposing lateral edge of the interface body.
155. The nasal interface according to claim 154, wherein the first and second external cutouts are symmetrical about a midline plane through the interface body, wherein the midline plane is parallel to a sagittal plane of a patient when the nasal interface is in use.
156. A nasal interface comprising: an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable.
157. The nasal interface according to claim 156, wherein the frame portion comprises the inlet gases port, and wherein the cushion portion comprises the first delivery element and the second delivery element.
158. The nasal interface according to claim 156 or claim 157, comprising a bias flow vent for enabling exhaled gases to be expelled out of the interface body, wherein the frame portion comprises the bias flow vent.
159. The nasal interface according to claim 158, wherein the frame portion extends between the inlet gases port and the bias flow vent and forming at least part of an outer surface of the interface body.
160. The nasal interface according to any one of claims 156 to 159, wherein the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove.
161. The nasal interface according to any one of claims 156 to 160, wherein a surface of the frame portion encompassed by its periphery is substantially planar.
162. The nasal interface according to any one of claims 156 to 161, wherein the frame portion comprises enlarged lateral portions relative to a substantially narrowed central portion of the frame portion.
163. The nasal interface according to claim 162, wherein the frame member tapers toward the enlarged lateral portions from a substantially laterally central position of the frame portion.
164. The nasal interface according to any one of claims 156 to 163, wherein the surface of the frame portion has a substantially hour-glass shaped outline.
165. The nasal interface according to any one of claims 156 to 161, wherein the frame portion comprises narrowed lateral portions relative to a substantially enlarged laterally central portion of the frame portion.
166. The nasal interface according to claim 165, wherein the frame member tapers toward the narrowed lateral portions from a substantially laterally central position of the frame portion.
167. The nasal interface according to claim 165 or claim 166, wherein the frame member comprises a substantially straight upper edge and a substantially curved lower edge.
168. The nasal interface according to any one of claims 165 to 167, wherein the surface of the frame portion has a substantially elongated circle segment shaped outline.
169. The nasal interface according to claim 165 or claim 166, wherein the frame member comprises substantially straight upper and lower edges.
170. The nasal interface according to claim 169, wherein the surface of the frame portion has a substantially stadium-shaped outline.
171. The nasal interface according to any one of claims 156 to 170, wherein the frame portion comprises a first side arm and a second side arm connected at its respective lateral edges.
172. The nasal interface according to claim 171, wherein frame portion, first side arm and second arm are formed as a unitary member.
173. The nasal interface according to any one of claims 156 to 172, wherein the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
174. The nasal interface according to any one of claims 156 to 172, comprising an external cutout in an exterior of the cushion portion and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout.
175. A nasal interface comprising: an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hingedly articulate to follow the contours of the face.
176. The nasal interface according to claim 175, wherein the side arms are formed of a flexible material.
177. The nasal interface according to claim 175 or claim 176, wherein each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
178. The nasal interface according to claim 177, wherein the living hinge comprises two intersecting lines of thinned material forming an X-shape on the side arm, the living hinge configured to hingedly articulate along the lines of the X-shape.
179. The nasal interface according to claim 177 or claim 178, wherein the living hinge comprises at least one line of thinned material extending substantially vertically across the side arm, the living hinge configured to hingedly articulate along the at least one line.
180. The nasal interface according to claim 179, wherein the living hinge further comprises a further line of thinned material extending substantially vertically across the side arm, the one line is separated from the further line and the living hinge configured to hingedly articulate along the one line and/or further line.
181. The nasal interface according to claim 177, wherein the living hinge comprises an area of thinned material, the area of thinner material formed of two opposing triangular shapes with their respective apices meeting at the vertical midpoint of the side arm, the living hinge configured to hingedly articulate along any line passing through the thinned material.
182. The nasal interface according to any one of claims 177 to 181, wherein the living hinge is formed on the patient facing side of the side arms of when in use.
183. The nasal interface according to any one of claims 177 to 182, wherein the living hinge is configured hingedly articulate along the hinge direction with a maximum angle of 90 degrees relative to the side arm.
184. The nasal interface according to any one of claims 175 to 183, wherein the interface body is symmetrical about a second midline plane of the interface body that is transverse to a first midline plane of the interface body that is arranged to be parallel to or coplanar to a sagittal plane of a patient when the nasal interface is in use.
185. A nasal interface comprising: an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein 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.
186. The nasal interface according to claim 185, wherein the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
187. The nasal interface according to claim 185 or claim 186, wherein the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
188. The nasal interface according to any one of claims 185 to 187, wherein the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
189. The nasal interface according to any one of claims 185 to 187, wherein the cheek pad is formed as a hollow body.
190. The nasal interface according to claim 189, wherein 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.
191. The nasal interface according to claim 190, wherein the hooking connection comprises slot openings for securing at least one strap.
192. A nasal interface comprising: an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, and a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, wherein nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
193. The nasal interface according to claim 192, wherein the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive a patient's hair.
194. The nasal interface according to claim 193, wherein adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
195. The nasal interface according to claim 194, wherein the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
196. The nasal interface according to claim 194 or claim 195, wherein the loops comprise webbing.
197. The nasal interface according to any one of claims 193 to 196, wherein the struts have a uniform length.
198. The nasal interface according to any one of claims 193 to 196, wherein the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
199. The nasal interface according to any one of claims 192 to 198, wherein the securing member is flexible to allow a circumferential expansion.
200. The nasal interface according to any one of claims 192 to 199, wherein the securing member comprises buckles at each of its circumferential ends.
201. A headgear for supporting a patient interface, the headgear comprising : a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb.
202. The headgear according to claim 201, wherein the securing member comprises a plurality of substantially vertically arranged struts, the channels between the struts configured to receive the patient's hair.
203. The headgear according to claim 202, wherein adjacent struts are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
204. The headgear according to claim 203, wherein the securing member comprises secondary loops arranged between the adjacent struts vertically separated from the loops.
205. The headgear according to claim 203 or claim 204, wherein the loops comprise webbing.
206. The headgear according to any one of claims 202 to 205, wherein the struts have a uniform length.
207. The headgear according to any one of claims 202 to 206, wherein the length of the struts reduces from a mid-point of the securing member to each end of the securing member.
208. The headgear according to any one of claims 201 to 207, wherein the securing member is flexible to allow a circumferential expansion.
209. The headgear according to any one of claims 201 to 208, wherein the securing member comprises buckles at each of its circumferential ends.
210. A patient interface comprising: a headgear according to any one of claims 201 to 209; and a nasal interface for delivering respiratory gases to a patient, wherein the headgear is configured to support the nasal interface on a patient's head.
211. The patient interface according to claim 210, wherein the nasal interface comprises an interface body comprising a gases flow channel in a main body portion of the interface body, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient.
212. The patient interface according to claim 211, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element.
213. The patient interface according to claim 211 or claim 212, wherein the nasal interface comprises a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body.
214. The patient interface according to any one of claims 210 to 213, wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways.
215. The patient interface according to claim 213, wherein the gases inlet port is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element to create or contribute to an asymmetric flow, wherein the gases inlet port is optionally substantially directed toward the first nasal delivery element and/or proximal to the first nasal delivery element and distal from the second nasal delivery element.
216. The patient interface according to claim 213 or claim 215, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse, optionally orthogonal, to 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, the first nasal delivery element and the second nasal delivery element optionally being symmetrical about said midline plane of the interface body.
217. The patient interface according to claim 213 or any one of claims 215 to 216, wherein the interface body comprises a first side at which the first and second nasal delivery elements are provided and an opposite second side at which the inlet port as well as the bias flow vent 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.
218. The patient interface according to claim 213 or any one of claims 215 to 217, wherein the first nasal delivery element is larger than the second nasal delivery element, optionally the cross section of the internal flow area of the larger nasal delivery element being greater than that of the other nasal delivery element.
219. The patient interface according to claim 213 or any one of claims 215 to 218, wherein the nasal interface comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the gases inlet port toward a region corresponding generally to the bias flow vent, wherein the at least one baffle is optionally arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
220. The patient interface according to claim 213 or any one of claims 215 to 219, wherein the nasal interface comprises a connector for coupling the gases supply conduit to the interface body to enable the passage of the incoming respiratory gases from the gases supply conduit to the gases flow channel, the connector being coupled to or defining the gases inlet port, wherein the connector optionally is an elbow, which is optionally configured to redirect the gas flow by more than 30 degrees, more than 60 degrees or by approximately 90 degrees.
221. The patient interface according to claim 213 or any one of claims 215 to 220, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein optionally, the pair of side arms are configured to be moveable to follow the contours of the face, optionally, the side arms being formed of a flexible material, optionally, 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.
222. A nasal interface comprising : an interface body comprising a gases flow channel, a first nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a first naris of the patient, a second nasal delivery element in fluid communication with the gases flow channel and configured to deliver gases to a second naris of the patient, wherein at least one of the first nasal delivery element and the second nasal delivery element is a non-sealing nasal delivery element, a gases inlet port in the interface body and in fluid communication with the gases flow channel, the gases inlet port for receiving incoming respiratory gases from a gases supply conduit and enabling the incoming respiratory gases to be delivered into the interface body, and a bias flow vent 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.
223. The nasal interface according to claim 222, wherein the gases inlet port is arranged to direct a larger proportion of the incoming respiratory gases towards the first nasal delivery element than the second nasal delivery element to create or contribute to the asymmetric flow, wherein the gases inlet port is optionally substantially directed toward the first nasal delivery element and/or proximal to the first nasal delivery element and distal from the second nasal delivery element.
224. The nasal interface according to claim 223, wherein the first nasal delivery element comprises a first gases outlet, wherein the first gases outlet defines a first axis corresponding to a direction of gases flow through the first gases outlet, and wherein the gases inlet port defines an inlet axis corresponding to a direction of gases flow through the gases inlet, and wherein the first axis and the inlet axis are aligned with each other or at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
225. The nasal interface according to any one of claims 222 to 224, wherein the first nasal delivery element and the second nasal delivery element lie substantially in a plane of the interface body that is transverse, optionally orthogonal, to 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, the first nasal delivery element and the second nasal delivery element optionally being symmetrical about said midline plane of the interface body.
226. The nasal interface according to claim 224 or claim 225, wherein the second nasal delivery element comprises a second gases outlet, wherein the second gases outlet defines a second axis corresponding to a direction of gases flow through the second gases outlet, wherein the first axis, the second axis and the inlet axis all lie within the plane of the interface body that is transverse to said first midline plane.
227. The nasal interface according to claim 226, wherein the first axis and the second axis are at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
228. The nasal interface according to claim 226 or claim 227, wherein the bias flow vent defines an outlet axis corresponding to a direction of gases flow through the bias flow vent, wherein the second axis and the outlet axis are aligned with each other or at an angle of between 0 degrees and up to but less than 90 degrees relative to each other, optionally less than 60 degrees, 45 degrees, 30 degrees or 15 degrees relative to each other.
229. The nasal interface according to any one of claims 225 to 228, wherein the gases inlet port and the bias flow vent are provided on opposite sides of said midline plane, the gases inlet port and the bias flow vent optionally being symmetrical about said midline plane.
230. The nasal interface according to any one of claims 222 to 229, wherein the interface body comprises a first side at which the first and second nasal delivery elements are provided and an opposite second side at which the inlet port as well as the bias flow vent 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.
231. The nasal interface according to any one of claim 222 to 230, wherein the first nasal delivery element is larger than the second nasal delivery element, optionally the cross section of the internal flow area of the larger nasal delivery element being greater than that of the other nasal delivery element.
232. The nasal interface according to any one of claims 222 to 231, wherein the bias flow vent comprises an aperture or an aperture and a diffuser.
233. The nasal interface according to any one of claims 222 to 232, the nasal interface comprising at least one baffle extending along the gases flow channel from a region corresponding generally to the gases inlet port toward a region corresponding generally to the bias flow vent, wherein the at least one baffle is optionally arranged such that when respiratory gases are delivered into the interface body through the gases inlet port, they pass along the baffle to the first nasal delivery element and along the baffle to the second nasal delivery element, and such that exhaled gases substantially pass along the baffle to the bias flow vent.
234. The nasal interface according to any one of claims 222 to 233, the nasal interface comprising a connector for coupling the gases supply conduit to the interface body to enable the passage of the incoming respiratory gases from the gases supply conduit to the gases flow channel, the connector being coupled to or defining the gases inlet port, wherein the connector optionally is an elbow, which is optionally configured to redirect the gas flow by more than 30 degrees, more than 60 degrees or by approximately 90 degrees.
235. The nasal interface according to any one of claims 222 to 234, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein optionally, the pair of side arms are configured to be moveable to follow the contours of the face, optionally, the side arms being formed of a flexible material, optionally, 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.
236. The nasal interface according to any one of claims 222 to 234, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein the pair of side arms are configured to hingedly articulate to follow the contours of the face, and optionally wherein each side arm comprises at least one living hinge comprising an area or line of thinned material relative to the remaining material of the side arm, the thinned material being more flexible relative to the remaining material of the side arm and the side arm configured to hingedly articulate at the living hinge.
237. The nasal interface according to any one of claims 222 to 236, wherein the interface body comprises a frame portion and a cushion portion, the cushion portion comprising an opening for receiving at least a portion of a frame for supporting the nasal interface, wherein the frame portion and cushion portion are inter-engageable, and optionally wherein the frame portion comprises a groove arranged around at least a portion of its periphery, at least a portion of an edge of the opening of the cushion portion receivable in the groove, and which optionally a surface of the frame portion encompassed by its periphery is substantially planar.
238. The nasal interface according to any one of claims 222 to 237, wherein 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 and optionally the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek, and which optionally 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.
239. The nasal interface according to any one of claims 222 to 238, wherein the interface body comprises an external cutout in an exterior of the interface body and adjacent at least one of the nasal delivery elements and configured to enable a flow of gases through the external cutout, and optionally wherein the external cutout is a recess in the main body portion of the interface body, and which optionally walls of the recess are formed at a substantially transverse angle relative to the surface of the main body portion.
240. The nasal interface according to any one of claims 222 to 236, wherein the nasal interface is configured to be supported on a patient's head via headgear, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb, and optionally comprising a plurality of substantially vertically arranged struts, and which adjacent struts optionally are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
241. A headgear for supporting a nasal interface, the headgear comprising a securing member positionable at a rear of a patient's head, the securing member configured to extend around a portion of a circumference of the patient's head and configured to be secured in the hair of a patient in the manner of a comb, and optionally comprising a plurality of substantially vertically arranged struts, and which adjacent struts optionally are connected by loops at opposing vertical ends of the struts forming a substantially S- or Z-shaped sinusoidal pattern.
242. A patient interface comprising : a headgear according to claim 241; and a nasal interface according to any one of claims 222 to 239 wherein the headgear is configured to support the nasal interface on a patient's head.
243. A patient interface with a nasal interface according to claim 235 and a headgear comprising first and second ends with ball or socket portions that are configured to connect to the ball or socket portions on the side arms.
244. 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 222 to 240 or a patient interface according to claim 242 or claim 243.
EP25811513.8A 2024-08-23 2025-08-22 Patient interface Pending EP4724127A1 (en)

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US202463686581P 2024-08-23 2024-08-23
US202563782682P 2025-04-03 2025-04-03
PCT/IB2025/058460 WO2026042041A1 (en) 2024-08-23 2025-08-22 Patient interface

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