CN117042826A

CN117042826A - Patient interface

Info

Publication number: CN117042826A
Application number: CN202280017996.XA
Authority: CN
Inventors: 詹姆斯·亚历山大·戈登; 萨沙·克里斯托弗·佐尔纳; 约瑟夫·朱尔斯·尼霍特; 阿沙尼·梅利莎·佩雷拉; 维基·丹·高; 尼尔·格雷·达西; 萨奇·沙赫里; 弗雷德里克·沃尔特·威廉森·施特劳斯; 克里斯托弗·沃姆比; 瑞安·安东尼·格拉哈姆; 安德烈·范·施哈尔克维克
Original assignee: Fisher and Paykel Healthcare Ltd
Current assignee: Fisher and Paykel Healthcare Ltd
Priority date: 2021-01-19
Filing date: 2022-01-12
Publication date: 2023-11-10

Abstract

The present disclosure relates to a patient interface for non-invasive ventilation. The patient interface is configured to seal around a mouth and nostrils of a patient and includes an outer wall defining an interior volume comprising a first chamber having one or more oral openings to communicate with the mouth gas and a second chamber having one or more nostril openings to communicate with the nostrils gas. The patient interface further includes a dividing wall separating the first chamber from the second chamber. The patient interface further includes one or more flow directors that enable gas to flow from the first chamber into the second chamber or from the second chamber into the first chamber. The one or more flow directors are configured to direct the gas flow through the one or more nostril openings.

Description

Patient interface

Technical Field

The present invention relates to a patient interface for delivering respiratory gases to a patient. In particular, the present invention relates to a non-invasive patient interface.

Background

One current treatment for respiratory diseases such as chest-limited diseases, acute respiratory failure, advanced neuromuscular diseases, chronic obstructive pulmonary disease (COPD, including emphysema, refractory asthma, and chronic bronchitis) is non-invasive ventilation (NIV). There is some evidence that NIV therapy can be used for assisted breathing after intubation, including reducing the chance of re-intubation. NIV therapy applies positive airway pressure to the lungs throughout the inhalation and exhalation cycles to keep the airways open. This improves the flow of breathing gas into and out of the lungs.

However, one side effect of the positive pressure applied in current NIV therapies is that the applied therapeutic pressure may be uncomfortable for the patient and thus less likely to receive treatment. The subsequent effect of the positive pressure is that it requires that the patient interface be securely fastened to the patient to avoid leakage and thereby ensure that the pressure in the patient interface and respiratory system is maintained. This firm application of the interface can cause pressure sores, particularly for such patients: they are semi-conscious or unconscious and therefore cannot provide feedback on any pain caused by the pressure of the patient interface on their skin.

NIV therapy presents two challenges, namely compliance (the extent to which a patient is willing to follow treatment) and pressure sores. In addition to these challenges, a further challenge for obstructive respiratory disease patients is flushing carbon dioxide from anatomical dead spaces. In particular, the end of an exhalation cycle is characterized by a pressure decrease of the exhaled breathing gas. This means that the carbon dioxide laden respiratory gas remains in the patient's throat, nose and mouth and is pulled back into the lungs at the beginning of the inhalation cycle. Thus, replacing the carbon dioxide laden respiratory gas in these areas with respiratory gas containing higher levels of oxygen than the carbon dioxide laden respiratory gas will assist the patient in achieving adequate respiration.

It is desirable to provide a patient interface that improves patient comfort and reduces pressure sores.

It is also desirable to provide a patient interface that assists in flushing anatomical dead space.

Disclosure of Invention

The invention will now be described by way of a set of embodiments. However, it is to be understood that the invention may be defined by a combination of features of two or more of these embodiments.

According to a first aspect, there is provided a non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising:

(a) An outer wall defining an interior volume, the interior volume comprising a first chamber having one or more oral openings to communicate with the mouth gas and a second chamber having one or more nostril openings to communicate with the nostrils gas; and

(b) A partition wall that separates the first chamber from the second chamber; and

(c) One or more flow directors that enable gas to flow from the first chamber into the second chamber, and configured to direct the gas through the one or more nostril openings.

The one or more flow directors may extend from the dividing wall.

The one or more flow directors may be located in a central region of the dividing wall such that each flow director is spaced apart from a perimeter of the dividing wall.

The one or more flow directors may extend from the dividing wall into the first chamber or into the second chamber, or into both the first chamber and the second chamber.

The one or more flow directors may extend toward the one or more nostril openings.

A partition wall may be coupled to the outer wall to separate the first chamber from the second chamber.

The partition wall may be joined to the outer wall at a location spaced apart from the one or more nostril openings.

The partition wall may be joined to the outer wall over the entire width.

The partition wall may be coupled to the outer wall between the at least one or more nostril openings and the at least one or more oral openings.

The partition wall may be joined to the outer wall at a location closer to the one or more oral openings than to the one or more nostril openings.

The outer wall may comprise a wall portion between the at least one or more nostril openings and the at least one or more oral openings, and the connection between the dividing wall and the wall portion may be located in a lower half of the wall portion. The width of the wall portion may be defined between laterally outermost ends of the one or more nostril openings.

The one or more flow directors may define a gas flow path from the first chamber to the second chamber, and the flow directors encircle the gas flow path.

The one or more flow directors may be sealingly coupled to the dividing wall.

Each of the one or more flow directors may have a second opening in the second chamber recessed from the one or more nostril openings.

Each of the one or more flow directors may have a second opening within the second chamber, and the second opening is spaced apart from the one or more nostril openings.

The second opening is defined by a rim, the rim may be contoured such that at least a portion of the rim has a substantially uniform spacing from the one or more nostril openings.

The portion of the rim that may be substantially consistently spaced apart from the one or more nostril openings is adjacent to an outer wall between the at least one or more nostril openings and the at least one or more oral openings.

The rim of each second opening may extend from the partition wall a greater distance at the laterally outer side of the deflector than the rim extends from the partition wall at the laterally inner side of the deflector.

The rim of each second opening may be recessed from the nostril opening to a greater depth at the lateral inner side of the deflector than the rim is recessed at the lateral outer side of the deflector.

The rim of each second opening may be recessed deepest from the nostril opening at a point between the lateral inboard side of the deflector and the lateral outboard side of the deflector.

At least a portion of the rim of the second opening may be concentric with at least a portion of the rim of the nostril opening.

The patient interface may include at least two flow directors spaced apart by a void through which breathing gas from the first chamber and breathing gas exhaled from the nostrils may flow into the second chamber.

The distance that the rim of each deflector extends from the partition wall on the same side as the void may be smaller than the distance that the rim extends on the side remote from the void.

The flow director may be configured such that a lateral outer side of the rim is adjacent to a lateral rim of the nostril opening, taking into account the direction of gas flow from the flow director.

The or each deflector may be configured such that the laterally outer side of the respective rim is adjacent to the lateral rim of the nostril opening, taking into account the direction of gas flow from the respective deflector.

The flow director may be configured such that the lateral outside of the rim is aligned with the lateral rim of the nostril opening, taking into account the direction of gas flow from the flow director.

Alternatively, each of the one or more flow directors may have a second opening that is flush with the one or more nostril openings.

The one or more flow directors may be spaced apart from the outer wall.

The one or more deflectors may be linked to the outer wall.

According to a second aspect, there is provided a non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising:

(a) An outer wall defining an interior volume of the patient interface, the outer wall having a patient-engaging surface including one or more oral openings in gaseous communication with the mouth and one or more nostril openings in gaseous communication with the nostrils; and

(b) A dividing wall dividing the internal volume into a first chamber having the one or more oral openings and a second chamber having the one or more nostril openings; and

(c) One or more flow directors extending from the dividing wall, the one or more flow directors enabling gas to flow from the first chamber into the second chamber, and the one or more flow directors configured to direct the gas to flow through the one or more nostril openings; and is also provided with

Wherein the deflectors are spaced apart by a spacing element which maintains the spacing between the deflectors.

Each deflector may have a second opening defined by a second opening rim, and wherein the second opening rim is spaced apart from the patient engagement surface.

The second opening edge may be recessed from the patient engagement surface.

Each flow director may include a body defining a flow passage extending between a second opening of the second chamber and an inlet opening to the first chamber, and wherein the body is spaced apart from the patient engagement surface.

The spacer element may be arranged between the flow directors.

The spacer element may be linked to the partition wall.

The spacer element may link the flow directors to each other.

The spacer element may comprise a rib or web.

The spacer element may be spaced apart from an outer wall of the patient interface.

The spacer element may comprise a concave curved surface extending between the flow directors.

Features of the first aspect disclosed in relation to the dividing wall and the deflector are equally applicable to this aspect.

In a third aspect, there is provided a non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising:

(a) An outer wall defining an interior volume of the patient interface, the outer wall having one or more oral openings in gaseous communication with the mouth and one or more nostril openings in gaseous communication with the nostrils;

(b) A dividing wall dividing the internal volume into a first chamber having the one or more oral openings and a second chamber having the one or more nostril openings; and is also provided with

Wherein the dividing wall comprises one or more spaced apart deflectors which enable gas to flow from the first chamber into the second chamber, and the deflectors are configured to direct the gas flow through the nostril openings.

The one or more spaced apart deflectors may be linked to the outer wall.

Each of the one or more flow directors may have a second opening within the second chamber and a first opening to the first chamber.

Each flow director may define an independent gas flow path.

Wherein the body of one or more deflectors may be linked to the outer wall such that the gas flow path is defined in part by the body and in part by the outer wall.

The one or more flow directors may be linked to the outer wall at or near the one or more nostril openings.

The one or more flow directors may be linked to the outer wall laterally outboard of the one or more nostril openings.

The one or more deflectors may be linked to the outer wall distally of the one or more nostril openings.

The one or more deflectors may be linked to the outer wall in the first chamber.

The one or more flow directors may be linked to the outer wall in the first chamber and the second chamber.

The body of the one or more deflectors may be linked to the outer wall between the at least one or more nostril openings and the at least one or more oral openings.

Wherein the body of the one or more flow directors may be linked to the outer wall on a side of the one or more nostril openings opposite the wall portion.

Wherein the body of the one or more flow directors may be linked to the outer wall at or near the one or more nostril openings.

The patient interface may include at least two spaced apart flow directors, and a portion of each flow director body may be joined to the outer wall on a laterally outer side of the lateral edge of the one or more nostril openings, and another portion of each flow director body may be joined to the outer wall on a laterally inner side of the lateral edge of the one or more nostril openings.

Each body may have a side wall and an inner side wall, both extending from spaced apart locations at the wall portion and meeting one another away from the wall portion.

The side walls and the inner side walls may extend from the partition wall to meet the outer wall.

The sidewall may be joined to the outer wall on a laterally outer side of a lateral edge of the one or more nostril openings such that the edge of the at least one or more nostril openings forms part of the edge of the deflector.

The inner side wall may be joined to the outer wall on a laterally inner side of a lateral edge of the one or more nostril openings such that a portion of the inner side wall forms a portion of the edge of the deflector.

The second opening edge formed by the inner side wall may be closer to the dividing wall than the second opening edge formed by the lateral edge of the one or more nostril openings.

The body may be linked to the outer wall by a linking element.

The second opening of the one or more flow directors may be defined in part by the at least one or more nostril openings.

The second opening of each flow director may be configured to direct breathing gas laterally inwardly.

Features disclosed in relation to the first aspect are equally applicable to the second and third aspects. In addition, features disclosed in relation to the second aspect are equally applicable to the third aspect. Furthermore, the applicable features of one aspect do not exclude the applicable features of another aspect.

The following disclosure applies to each of the first, second and third aspects disclosed above.

The separation wall may include one or more preferential deformation regions to accommodate at least some of the deformation forces generated by the patient's contact with the patient-engaging surface in preference to deformation of the flow director.

The deflector may be spaced apart from the one or more preferential deformation zones.

The one or more preferential deformation areas may disengage one portion of the dividing wall from another portion of the dividing wall such that a force applied to one portion is greater than a force experienced by the disengaged portion.

The preferential deformation zone may disengage one portion of the dividing wall from another portion of the dividing wall, enabling the two portions to move relative to one another.

The two parts of the partition wall may be shaped to resist deformation.

The outer wall or the partition wall may comprise deformation-resistant sections which translate the deformation forces into preferential deformation zones, such that the deformation of the partition wall is substantially limited to these preferential deformation zones.

The one or more preferential deformation areas may be interposed between the deflector and the elastic area.

The one or more preferential deformation zones may include a first elastic zone and a deformation panel disposed between the first elastic zone and the deflector.

The thickness of the deformed panel may be less than the thickness of the first elastic region.

The deformable panel may include a first wall extending from the first elastic region and a second wall connecting the first wall with a second elastic region of the dividing wall including the one or more flow directors, and wherein the first wall and the second wall meet along a link line.

The first wall and the second wall may be adapted to deform in a predetermined order.

The predetermined sequence may include the first wall folding toward the first elastic region.

The predetermined sequence may include buckling of the second wall to accommodate a decrease in spacing between the first elastic region and a region of the dividing wall that includes the one or more flow directors.

The second wall may be configured to cause buckling when a distance between a region of the partition wall including the one or more flow directors and the link line is less than a length of the second wall.

The second wall may have a curved profile from the link line to the region of the dividing wall including the one or more flow directors to cause buckling of the second wall.

The thickness of the second wall may increase from the connecting portion to the second elastic region to cause initial folding of the first wall during deformation and subsequent buckling of the second wall.

The wall thickness of the deformation panel may be selected to cause the deformation panel to deform in preference to the first and second elastic regions.

The thickness of the first elastic region may be at least three times the thickness of the first wall.

The second wall may have a profile from the first wall to the region of the dividing wall comprising the one or more flow directors for causing a rolling movement of the second wall in order to accommodate deformation of the deformed region.

The thickness of the second wall may increase from the first wall to the deflector region to cause initial folding of the first wall during deformation and subsequent rolling of the second wall from the intersection between the second wall and the first wall.

An imaginary line extending from the intersection line between the first elastic region and the first wall may converge at the pivot point with another imaginary line extending along the line of linkage between the first wall and the second wall.

The first elastic region may comprise a first thickened region of the dividing wall.

The first thickened region may comprise an elastic lip adjacent the deformable panel.

The deformation of the one or more preferential deformation areas may involve a reduction in the spacing between the first elastic area and the area of the dividing wall comprising the one or more flow directors, and may involve an associated deformation of the deformation panel to accommodate the reduction in spacing.

The patient interface may include one or more deformation resistant sections configured to withstand at least some deformation forces applied to the patient engagement surface such that the one or more flow directors withstand less deformation forces than the deformation resistant sections.

The one or more deformation resistant sections may be configured to reduce the extent to which the flow director is deformed by a deforming force applied to the patient engagement surface.

The deflector or the dividing wall may comprise one or more deformation resistant sections.

The one or more deformation resistant sections may increase the resistance to deformation of the region of the dividing wall that includes the one or more flow directors.

The partition wall may include one or more deformation resistant sections between the patient engagement surface and the preferential deformation zone.

The one or more deformation resistant sections may be located in a region of the dividing wall that includes the one or more flow directors.

Wherein one or more of the deformation resistant sections may include a rib associated with the dividing wall.

Wherein one or more of the deformation resistant sections may be integrally formed with the dividing wall.

Wherein the one or more deformation resistant sections may comprise a portion of the dividing wall having a wall thickness that is greater than the wall thickness of the other portions of the dividing wall.

Wherein the one or more deformation resistant sections may be configured to direct a deformation force applied to the patient engagement surface into the preferential deformation zone.

Wherein one or more deformation resistant sections may extend from or adjacent to the patient engagement surface and within a region of the dividing wall including the one or more flow directors to direct deformation forces into the preferential deformation zone.

Wherein the one or more deformation resistant sections may be wider at the end at or adjacent to the patient engagement surface than at the end remote from the patient engagement surface.

Wherein the one or more deformation resistant sections may include deformation translating ribs formed on the bottom side of the dividing wall.

Wherein the one or more deformation resistant sections may be configured to cause the deflector to track deformation of the patient engagement surface.

Wherein one or more deformation resistant sections may be configured on the bottom side and the top side of the partition wall to at least partially overlap.

Wherein one or more deformation resistant sections may be located where the deflector is joined to the dividing wall.

One or more deformation resistant sections located where the deflector joins the dividing wall may be linked to the patient engagement surface.

One or more deformation resistant sections located where the flow director joins the dividing wall may be linked to the patient engagement surface by one or more other deformation resistant sections.

The one or more deformation resistant sections located where the flow director joins the partition wall may strengthen the region of the partition wall that includes the one or more flow directors such that at least some of the deformation forces applied to the patient engagement surface are transferred to the preferential deformation region.

One or more deformation resistant sections located where the flow director joins the partition wall may be provided on the top or bottom side of the partition wall and may be linked to the patient engagement surface by one or more other deformation resistant sections provided on the bottom or top side, respectively.

Wherein the one or more deformation resistant sections may overlap the spacer element such that the deflector tracks movement of the one or more deformation resistant sections overlapping the spacer element.

The deformation-resistant sections overlapping the spacer elements may extend substantially orthogonal to each other.

Wherein one or more deformation resistant sections may be configured on the bottom side and the top side of the partition wall to transfer deformation of the patient engagement surface into deformation of the preferential deformation area.

The deformation resistant section may be configured to at least partially overlap with another of the one or more deformation resistant sections located at the intersection of the deflector and the dividing wall.

The flow director may be configured to accelerate the breathing gas from the first opening to the second opening.

The second opening of the deflector may have a combined area that is less than the area of the one or more nostril openings.

The second opening of the deflector may be disposed laterally outboard of the one or more nostril openings.

Each deflector may comprise a body having a cross-sectional area that decreases in a direction from the inlet to the outlet.

Each deflector may comprise a body having a substantially constant cross-sectional area from the inlet to the outlet.

The body may include a lower body portion and an upper body portion, and wherein the upper body portion has a cross-sectional area that is smaller than a cross-sectional profile of the lower body portion.

The lower body portion may have a tapered profile.

The lower body portion may have a constant profile.

The upper body portion may have a tapered profile.

The upper body portion may have a circular, elliptical or oval profile in a cross-section generally parallel to the dividing wall in which the flow director is located.

The body may have a tapered or stepped profile in a cross section generally orthogonal to the dividing wall in which the deflector is located.

The body may have a tapered profile in a cross section generally orthogonal to the dividing wall in which the deflector is located.

The patient interface may have an inlet for breathing gas to the first chamber.

The patient interface may have an exhaust port configured to communicate breathing gas from the patient interface to an exterior of the patient interface.

The exhaust port may be configured to communicate breathing gas from the second chamber to an exterior of the patient interface.

The exhaust port may be configured to communicate breathing gas from the first chamber and the second chamber to an exterior of the patient interface.

The outer wall may be provided by a cushion module comprising a resilient sealing member and a housing, and wherein the sealing member and the housing together form a first chamber and a second chamber.

The sealing member may include a patient engagement surface.

The inlet may be formed in the housing.

The exhaust port may be formed in the housing.

A partition wall may be provided between the inlet and the exhaust port.

A separation wall may be disposed between the one or more oral openings and the one or more nostril openings.

The sealing member may include a nostril sealing portion that includes the one or more nostril openings, and the sealing member further includes a mouth sealing portion that includes the one or more oral openings.

The sealing member may be an elastic material and may be connected to the casing body to form a unitary structure.

The sealing member may be an elastic material and may be mechanically locked to the cap housing to form a unitary structure.

The sealing member may be over-molded onto the cap housing to mechanically lock and/or chemically bond with the cap housing.

The patient interface may further comprise a mask frame.

The cover frame may be removably connectable to the cover housing.

The cover frame may be removably connectable by a cooperable snap-fit formation on the cover housing and on the cover frame.

The cover frame may be permanently connectable to the housing by cooperable formations on the cover housing and the cover frame.

The cover frame may be permanently connectable to the housing by ultrasonic welding of the cover housing and the cover frame.

The cover frame and the cover housing may be integrally formed.

The mask frame or mask housing may further include headgear connectors for connecting headgear to the patient interface.

The patient interface may further include a conduit connector and a shoulder sleeve rotatably linking the conduit connector to the mask frame to form a flow path for the breathing gas from the conduit to the first chamber.

In a fourth aspect, there is provided a non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising:

(c) One or more flow directors that enable gas to flow from the first chamber into the second chamber or from the second chamber into the first chamber.

The one or more flow directors enable gas to flow from the first chamber into the second chamber and are configured to direct the gas flow through the one or more nostril openings.

The dividing wall is configured to reduce movement of the flow directors toward each other.

The dividing wall is configured to reduce collapse of the deflector.

The dividing wall is configured to reduce buckling of the deflector.

The dividing walls are configured to reduce collapse or buckling of the flow directors inwardly toward each other.

The partition wall includes a lateral side portion disposed laterally outward of the deflector and joined to the outer wall.

The lateral side portions are joined to the outer wall at a location spaced from the top of the outer wall.

With the patient interface in an upright orientation, the lateral side portions are joined with the outer wall at a level below the lowest level of the one or more nasal orifices.

With the patient interface in an upright orientation, the lateral side portions are joined with the outer wall along the line extending at least partially above and partially below the lowest level of the one or more nasal orifices and not extending above the highest level of the one or more nasal orifices.

With the patient interface in an upright orientation, a portion of the lateral side portion is joined with the outer wall along a line that extends between and does not extend above the highest level of the one or more nasal orifices.

With the patient interface in an upright orientation, a portion of the lateral side portion is joined with the outer wall along a line extending above a highest level of the one or more nostrils.

With the patient interface in an upright orientation, the lateral side portions are joined to the outer wall at a level that is lower than or substantially equal to an uppermost level of the deflector.

The dividing wall includes a deformation region configured to deform in preference to the deflector.

The deformation zone is configured to deform also in preference to the lateral side portions.

The partition wall is configured to reduce laterally inward travel of the lateral side portions when the deformation region is deformed.

The flow director is arranged between the patient contacting portion of the outer wall and the deformation zone, and the lateral side portion is arranged laterally outside the flow director.

The lateral side portion includes a portion of the deformation region disposed laterally outboard of the deflector.

The lateral side portions are adjacent to the deformation zone.

The lateral side portion is at least partially joined with a portion of the outer wall having a wall thickness that is greater than a wall thickness of the patient contacting portion of the outer wall.

The lateral side portion is at least partially joined with a portion of the outer wall, the wall thickness of the outer wall portion being selected to resist deformation of the outer wall.

The outer wall includes a housing and a sealing member, the housing forming at least a portion of a coupling with the gas supply source, and wherein, in view of the upright orientation of the patient interface, the dividing wall extends at least partially along an imaginary line that abuts a line extending across a top of the housing.

The inclination of the lateral side portions at their junction with the outer wall is horizontal or at an acute angle relative to the horizontal, taking into account the upright orientation of the patient interface.

The inclination of the lateral side portions at their junction with the outer wall is horizontal or less than 45 ° with respect to the horizontal, taking into account the upright orientation of the patient interface.

The inclination of the lateral side portions at their junction with the outer wall is horizontal or less than 30 ° relative to the horizontal, taking into account the upright orientation of the patient interface.

The inclination of the lateral side portions at their junction with the outer wall is horizontal or less than 15 ° relative to the horizontal, taking into account the upright orientation of the patient interface.

The lateral side wall joins the outer wall at an obtuse angle in the second chamber.

Each deflector has a first opening to the first chamber and a second opening to the second chamber.

The first opening is shaped such that its long axis is longer than the orthogonal short axis.

The long axis lies in the plane of the dividing wall and is oriented at least 45 ° from a vertical mid-plane through the patient interface.

The long axes of the respective first openings intersect at a point on the proximal side of an imaginary straight line passing through the center of the first opening.

The long axes of the respective first openings intersect at a point proximal to the patient contacting portion of the outer wall.

The angle between the long axes when they intersect is less than 180 °.

The angle between the long axes when they intersect is in the range of 45 ° to less than 180 °.

The angle between the long axes when they intersect is in the range of 90 ° to 150 °.

The angle between the long axes when they intersect is in the range of 110 ° to 150 °.

The long axes of the respective first openings intersect at a point on the distal side of an imaginary straight line passing through the center of the first opening.

The first opening is disposed between the deformation region and the patient contacting portion of the outer wall and extends a distance less than a distance between the patient contacting portion of the outer wall portion and the deformation region.

The first opening is disposed between the deformation region and a patient-contacting portion of the outer wall (which is between the one or more nostril openings and the one or more oral openings) and extends a distance that is less than a distance between the patient-contacting portion of the outer wall portion and the deformation region.

The first opening is provided on the partition wall.

The flow directors forming each first opening are spaced apart from the deformation region.

Each first opening has an oval shape.

The orientation of the major and minor axes remains unchanged throughout the deflector.

The major axis, or the minor axis, or both the major and minor axes at the second opening are different in size than the major axis, or the minor axis, or both the major and minor axes at the first opening.

The major axis, or the minor axis, or both the major and minor axes at the second opening are smaller in size than the major axis, or the minor axis, or both the major and minor axes at the first opening.

The dimensions of the major axis, or the minor axis, or both the major and minor axes, vary across the deflector.

The major axis, or the minor axis, or both the major and minor axes decrease in size from the first opening to the second opening.

The major axis, or the minor axis, or both the major and minor axes are varied in size to define the constriction.

The second opening of each deflector is spaced apart from the outer wall to enable gas flow between the first chamber and the second chamber, and wherein the second opening is positioned such that a flow of gas from the first chamber through the deflector into the second chamber will at least partially impinge the outer wall when the patient interface is not mounted to the patient.

The area, shape, or both the shape and area of the nostril opening changes when the patient interface is fitted to a patient.

When the patient interface is fitted to a patient, the area, shape, or both the one or more nostril openings change such that the flow of gas through the deflector will be directed through the one or more nostril openings without striking the outer wall.

The deflector and the outer wall are arranged such that the outer wall extends over a portion of each second opening when the patient interface is not assembled.

The outer wall extends over a portion of the second opening when viewed vertically above a midpoint between the second openings, taking into account an upright orientation of the patient interface when the patient interface is not mounted to the patient.

The second opening portion on which the outer wall extends is a side-out portion of the second opening.

With the patient interface in its upright orientation when not mounted to a patient, at least a portion of each second opening is located outside of an imaginary cylindrical volume having the outline of and extending vertically through the one or more nostril openings.

In view of the upright orientation of the patient interface when the patient interface is not assembled to the patient, at least a portion of each second opening is obscured by the outer wall when the patient interface is viewed vertically from above a midpoint between the second openings.

The lateral outer edges of the one or more nostril openings are disposed laterally outward of the second opening of the respective deflector when the patient interface is assembled to a patient.

The outer wall is configured such that the one or more nostril openings may extend laterally outward.

The outer wall is configured such that the one or more nostril openings are capable of extending laterally outwardly such that, when the patient interface is viewed vertically from above a midpoint between the second openings, the outer wall does not extend over a portion of each second opening, taking into account the upright orientation of the patient interface when the patient interface is assembled onto a patient.

The patient contacting surface of the outer wall is configured such that the outer wall extending over the second opening of the deflector is movable laterally outward such that the outer wall no longer extends over the second opening when the patient interface is fitted to a patient.

The patient contact surface is curved to receive the underside of the patient's nose when the patient interface is assembled to the patient and the curvature decreases when the patient interface is assembled.

The patient contact surface includes a valley shape configured to receive an underside of a nose of a patient, and a bottom of the valley shape including the one or more nostril openings adopts a flatter valley shape when the patient interface is assembled to the patient.

The partition wall includes flow directors that enable gas to flow between the first chamber and the second chamber, each flow director having a base, a body extending from the base, a rim remote from the base, the base being joined with the partition wall and defining a first opening to the first chamber, and a gas flow passage defining a second opening to the second chamber, the gas flow passage extending from the first opening to the second opening in the base.

The body includes a reinforced section configured to resist deformation of the shape of the outlet under the force of the deformation.

The reinforced section extends completely or partially around the body.

The wall thickness of the reinforced section is greater than the wall thickness of the other portions of the body.

The reinforced section includes ribs.

The body is formed of a first material and the reinforced section is formed of a second material, the second material being different from the first material and being less compliant than the first material.

The reinforced section extends around at least a portion of the distal side of the body.

The reinforced section is generally parallel to the dividing wall on one side of the long axis of the deflector profile.

The reinforced section is disposed at a set spacing from the rim around the body.

The reinforced section is disposed at a set spacing around the body from the base.

The reinforced sections are disposed at different spacings from the rim around the body.

The enhancement section is disposed adjacent the rim.

The reinforcing section is disposed on an exterior of the body.

The body includes a lower body portion and an upper body portion.

The reinforced section extends completely or partially around the lower body portion.

The reinforced section extends completely or partially around the upper portion of the body.

The reinforced section extends from the lower body portion and at least partially surrounds the upper body portion.

The wall thickness of the upper portion of the body is less than the wall thickness of the lower portion of the body.

The base of each deflector is elongate in a lateral direction away from a vertical mid-plane passing through the patient interface, the body being offset from a lateral centerline passing through the base such that the body is closer to a lateral inner side of the base than to a lateral outer side of the base, taking into account the upright orientation of the patient interface.

The laterally outer side of the base extends laterally outwardly from the body a greater distance than the laterally inner side of the base extends laterally inwardly from the body.

The laterally outer side of the base extends laterally outwardly from the body at least two, at least three, at least four, or at least five times more than the laterally inner side of the base extends laterally inwardly from the body.

The base has a footprint that extends laterally through corresponding lateral edges of the one or more nostril openings.

The gas flow channel has a longitudinal axis that diverges laterally inward from a lateral centerline through the base (the centerline being parallel to a vertical midplane through the patient interface) such that the gas flow channel is closer to a lateral inner side of the base than to a lateral outer side of the base.

The wall thickness of the base is greater than the wall thickness of the partition wall adjacent to the base.

The base includes a thickened pad extending laterally outwardly from the body.

The wall thickness of the thickened cushion decreases away from the body.

The thickened pad has a wedge-shaped profile in a laterally outward direction.

The base at least partially encloses the body.

The base includes a laterally outer side configured to resist displacement of the outlets toward each other.

The laterally outer side of the base is configured as a reinforced link between the partition wall and the body to resist deflection of the partition wall that causes displacement and change in orientation of the body.

The laterally outer side of the base tapers from the dividing wall to the body.

The taper of the laterally outer side of the base has rounded corners.

The laterally outer side of the base comprises a radial wall thickness relative to the longitudinal axis of the gas flow channel that is greater than the radial wall thickness at any point on the remainder of the body.

The base of each deflector comprises a block comprising an airflow channel and having a thickness that resists deformation of the body.

The base is configured to resist displacement and orientation changes of the body by transmitting a deforming force exerted on the outer wall to the deforming region.

The bases of the deflectors are linked together to form a common block from which the individual bodies extend.

The common block has a footprint that extends laterally through corresponding lateral edges of the one or more nostril openings.

The common block has an inclined side extending from a lateral side portion of the partition wall to the body.

The region of the common block defined by the sloped sides tapers downwardly in the distal direction.

The region is tapered to be substantially parallel to the one or more nostril openings.

The inclined sides of the common blocks include rounded corner shapes.

The rounded shape is continuous with respect to the sides of the common block.

The rounded shape is continuous with respect to the proximal and distal sides of the common block.

The rounded shape is continuous with respect to the proximal and distal sides (including the spacer portion) of the common block.

The wall thickness of the deflector decreases from the base towards the rim.

The body includes a transition intermediate the base and the rim.

The transition portion defines a body upper portion from the body lower portion.

The wall thickness of the lower body portion is constant while the wall thickness of the upper body portion decreases from the transition to the rim.

The wall thickness of the body varies from the transition to the rim.

The wall thickness of the body decreases from the transition to the rim.

The decrease in wall thickness of the body from the transition to the rim is constant.

The decrease in wall thickness of the body from the transition to the rim is not constant.

The transition portion is inclined with respect to the partition wall.

The transition is sloped such that the distal side of the lower body portion extends from the base a greater distance than the proximal side of the lower body portion extends from the base.

With the patient interface in an upright orientation, a plane defined by the transition is generally parallel to the one or more nostril openings, or the outer wall above the deflector, or both the one or more nostril openings and the outer wall above the deflector.

With the patient interface in an upright orientation, the rim of the upper body portion is generally parallel to the one or more nostril openings, or the outer wall above the deflector, or both the one or more nostril openings and the outer wall above the deflector.

The wall thickness of the lower body portion is selected to be more resistant to deformation than the deformation zone to resist deformation such that the deformation zone preferentially deforms in response to a deformation force applied to the patient contacting portion of the sealing member.

The distal outer surface of the flow director has a curved profile in the direction of the longitudinal axis of the flow director.

The decrease in wall thickness of the deflector from the transition to the rim is due to the fact that the outer surface of the deflector tapers inwardly towards the inner surface of the deflector.

The transition portion includes, at least in part, a step intermediate the base portion and the rim.

The body has a first wall thickness below the step and the body has a second wall thickness above the step, and wherein the second wall thickness is less than the first wall thickness.

The step extends around at least the distal side of the deflector.

The step extends around the distal and laterally outboard sides of the deflector.

The step extends substantially entirely around the deflector.

The step extends completely around the deflector.

The step includes an inclined surface connecting the lower body portion to the upper body portion.

The stepped portion is formed on an outer portion of the deflector.

The radial wall thickness of the lower body portion relative to the longitudinal axis of the deflector varies with respect to the deflector.

The radial wall thickness of the lower body portion relative to the longitudinal axis of the deflector varies with the spacing of the rim from the base.

The radial wall thickness of the lower body portion relative to the longitudinal axis of the deflector is greater where the rim is farther from the base than where the rim is closer to the base.

The radial wall thickness of the lower body portion relative to the longitudinal axis of the deflector is minimal where the spacing between the rim and the base is minimal and increases as the spacing between the rim and the base increases.

The radial wall thickness of the lower body portion is constant around the deflector.

The radial wall thickness of the upper portion of the body is constant around the deflector.

The partition wall includes a spacing rib disposed between the bodies of the flow directors.

The spacer rib is coupled to the body at a location spaced from the rim.

The spacer rib is coupled to the base and the body of the deflector at a location spaced from the rim.

The spacer ribs are attached only to the base and lower body portions of the deflector.

The deflector includes a step portion between the lower body portion and the upper body portion and a spacer rib coupled to the step portion.

The spacer rib has a flattened upper surface connected to the step portion.

The spacer rib is coupled only to the base and the lower body portion of the deflector and the stepped portion.

The spacer rib includes a rounded transition coupled to the deflector.

The spacer ribs are disposed in a plane intersecting the longitudinal axis of the deflector.

The wall thickness of the spacer ribs in the distal-proximal direction is 5% to 20% of the dimension of the deflector in the distal-proximal direction.

The wall thickness of the spacer ribs in the distal-proximal direction is 20% to 40% of the dimension of the deflector in the distal-proximal direction.

The wall thickness of the spacer ribs in the distal-proximal direction is 40% to 60% of the dimension of the deflector in the distal-proximal direction.

The spacer rib overlaps a reinforcing section of the partition wall, which reinforcing section is arranged to transfer a deformation force applied to the patient contacting portion of the outer wall to the deformation region.

The partition wall includes a respective support member disposed between each deflector and the outer wall, and the support member maintains a spacing between the outer wall and the respective deflector.

Each support member is coupled to the outer wall at an outer wall portion between the one or more nostril openings and the one or more oral openings.

Each support member is coupled only with the outer wall portion and the lower body portion.

Each support member is coupled only with the outer wall portion and the body lower portion and the stepped portion.

Each support member is coupled to the outer wall portion and the common block.

Each support member is coupled to the outer wall portion and to the corresponding deflector block.

The lateral width of each support member is 20% to 70% of the lateral width of the deflector.

The support member has a polygonal profile.

The support member has a trapezoidal profile.

The support member has a semi-circular profile.

The support member has a circular arc profile.

The support member has a curved profile.

The wall thickness of the partition wall proximal portion between the partition rib and the wall portion of the seal and between the lateral side portions of the partition wall may be greater than the wall thickness of the lateral side portions of the partition wall.

The wall thickness of the proximal portion may be at least 1.5 times the wall thickness of the lateral side portion.

The wall thickness of the proximal portion may be in the range of 1.5 to 8 times the wall thickness of the lateral side portion.

The wall thickness of the proximal portion may be in the range of 1.5 to 3 times the wall thickness of the lateral side portion.

The wall thickness of the proximal portion may be greater than the wall thickness of the distal portion of the partition wall between the partition rib and the deformation panel and between the lateral side portions of the partition wall.

The wall thickness of the proximal portion may be different at different locations. The wall thickness of the proximal portion may vary across the proximal portion in a proximal-distal direction or in a lateral direction or both.

The spacer rib may be positioned distally of the center of the second opening of the deflector.

The spacer rib may be aligned in a proximal-distal direction with a distal portion of the rim defining the second opening.

The main portion of the partition wall may have a curved profile in the proximal-distal direction.

The curved profile may extend across substantially the entire lateral dimension of the main portion of the partition wall.

The curved profile may extend through the proximal and distal portions of the dividing wall.

The curved profile may be concave in the proximal-distal direction and relative to the nostril opening.

The proximal and distal portions may have profiles that are inclined relative to each other in the proximal-distal direction such that they sandwich an angle of less than 180 ° at the side of the partition wall within the second chamber.

The profile of the proximal portion may be curved.

The profile of the distal portion may be curved.

The profile of the proximal portion may be concave relative to the nostril opening.

The profile of the distal portion may be concave relative to the nostril opening.

The wall thickness of the distal portion of the partition wall between the partition rib and the deformation region and between the lateral side portions of the partition wall may be greater than the wall thickness of the lateral side portions of the partition wall.

The wall thickness of the distal portion may be at least 1.5 times the wall thickness of the lateral side portion.

The wall thickness of the distal portion may be in the range of 1.5 to 8 times the wall thickness of the lateral side portion.

The wall thickness of the distal portion may be in the range of 1.5 to 3 times the wall thickness of the lateral side portion.

The wall thickness of the distal portion may vary in the proximal-distal direction.

The wall thickness of the distal portion may vary in the lateral direction.

The wall thickness of the distal portion may be the same as the wall thickness of the proximal portion.

The wall thickness of the distal portion may be greater than the wall thickness of the proximal portion.

The distal portion may comprise one or more tapered regions, wherein the wall thickness of the distal portion decreases to the same thickness as the respective adjacent lateral side portion or adjacent deformation panel in the direction of the adjacent lateral side portion or in the direction of the adjacent deformation panel.

Wherein one or more tapered regions may be provided on the side of the partition wall facing the first chamber.

Wherein one or more tapered regions may be provided on the side of the partition wall facing the second chamber.

Wherein one or more tapered regions may be provided on the side of the partition wall facing the second chamber and wherein one or more tapered regions may be provided on the side of the partition wall facing the first chamber.

The spacer rib may include a tapered region disposed between the proximal portion and the distal portion.

The base of the or each deflector may comprise a tapered region in which the wall thickness of the distal portion is reduced to a thickness that matches the wall thickness of the body portion of the or each deflector.

The distal portion may have a lateral width tapering inwardly in a distal direction.

The patient interface may include tethers between the body and the partition wall of the respective fluid director.

The tether may be configured to resist a change in orientation between the body and the dividing wall of the respective deflector.

The tether may link the body to the distal portion at a location on the body and distal portion that is spaced apart from the base of the respective deflector.

The tether may be coupled to the deflector along the body and the base and to the distal portion from the base to a location spaced from the base.

The tether may be a rib extending between the body and the distal portion of the respective deflector.

The tether may be positioned on the distal side of the deflector.

The tether may be oriented in a proximal-distal direction.

The tether may be an extension of the body in the distal direction and the wall thickness of the extension in the proximal-distal direction is greater than the wall thickness of the other portion of the body.

The extension may taper inwardly in the distal direction in a cross-section parallel to the plane of the distal portion.

The patient interface may include one or more tethers connecting the deformable panel to the first elastic region.

The deformable panel may extend from the first elastic region to define a void into which the main portion travels when the deformable panel is deformed, and wherein the or each respective tie extends across the void and joins the first elastic region and the deformable panel.

A void may be formed between the main portion and the first elastic region.

The or each respective tie may be configured to resist movement of the distal portion towards the nostril sealing portion of the outer wall.

The or each respective tie may be configured to limit travel of the dividing wall away from the first elastic region.

The or each respective tie may be a panel connected to the deformable panel and the first elastic region.

The panel may be configured to collapse under compression and be configured to resist extension under tension.

The panel may be configured to collapse under compression in a proximal-distal direction and to resist extension under tension in the proximal-distal direction and/or in a direction toward the nostril sealing portion.

The wall thickness of the panel may be the same as the wall thickness of the first wall of the deformed panel.

The wall thickness of the panel may be less than the wall thickness of the first wall of the deformed panel.

The or each tie may be perpendicular to the first wall of the deformable panel.

The or each respective strap may connect the distal portion and the first elastic region.

The or each respective strap may be joined with the distal portion, the deformation panel and the first elastic region.

The or each respective tie may connect the first elastic region and the reinforcing section associated with the distal portion.

The or each respective strap may connect the deformable panel and the first elastic region.

The ligament may include a free edge that is exposed to the oral cavity.

The free edge may be a straight line extending between the first elastic region and the deformation panel or the distal portion or the reinforcing section associated with the distal portion.

The or each respective strap may include a point of weakness to cause collapse of the strap at that point under compressive force.

The or each respective strap may comprise a point of weakness to cause collapse of the strap at that point as the distal portion is advanced towards the first elastic region.

The point of weakness may be a reduction in wall thickness of the or each connector.

The free edge may extend between the first elastic region and the deformation panel or the distal portion or the reinforcing rib associated with the distal portion, and the free edge comprises a weak point.

The weak point in the free edge may be a notch provided between the deformed panel and the first elastic region.

The recess has a V-shape.

The patient interface may include two tethers, and each tether is aligned with the distal portion in a proximal-distal direction.

The patient interface may include two tethers, and each tether is aligned with a respective lateral side portion in a proximal-distal direction.

The two tethers may be parallel to each other in the proximal-distal direction.

The two laces may diverge from each other in the distal direction.

The two tethers may converge toward each other in a distal direction.

The free edge of the or each respective tie may extend to the respective deflector.

The free edge of the or each respective tie may be incorporated with a respective deflector.

The free edges may merge with the base of the respective deflector.

The separation wall may include a reinforcing structure extending across at least a distal portion of the separation wall and adjacent to the deformation panel.

The reinforcing structure may extend across the distal and lateral side portions of the partition wall and adjacent to the deformation panel.

The reinforcing structure may be configured to resist deformation of the distal portion and the lateral side portion.

The reinforcing structure may be a lateral reinforcing rib extending across the distal portion and the lateral side portion at a location on the distal side of the or each deflector.

The reinforcing structure may be arranged with a spacing between the reinforcing structure and the deformed panel, and the spacing is constant along the reinforcing structure.

The spacing may vary along the reinforcing structure.

The spacing between the reinforcing structure and the deformable panel on the distal portion may be greater than the spacing between the reinforcing structure and the deformable panel on the lateral portion.

The spacing between the reinforcing structure and the deformation panel may decrease in the lateral direction.

The spacing between the reinforcing structure and the deformed panel may be greatest at the central location.

The lateral stiffening rib may be located on the side of the partition wall exposed to the second chamber or may be located on the side of the partition wall exposed to the first chamber.

The reinforcing structure may comprise a first lateral reinforcing rib on the side of the partition wall exposed to the second chamber and a second lateral reinforcing rib on the side of the partition wall exposed to the first chamber.

The first reinforcing rib and the second reinforcing rib may be aligned in a near-far direction on each side of the partition wall.

The first reinforcing rib and the second reinforcing rib may be offset in a near-far direction on each side of the partition wall.

The first reinforcing rib may be spaced from the deformed panel at a different distance than the second reinforcing rib.

The spacing of the first reinforcing ribs from the deformed panel may be constant while the spacing of the second reinforcing ribs from the deformed panel varies.

The spacing of the second reinforcing ribs from the deformed panel may be constant while the spacing of the first reinforcing ribs from the deformed panel varies.

The lateral reinforcing ribs may have a uniform profile along the length of the lateral reinforcing ribs.

The lateral reinforcing ribs may have a profile that varies along the length of the lateral reinforcing ribs.

The lateral reinforcing rib may have a profile in which the height above the partition wall is tapered in the lateral direction.

The lateral stiffening rib may be spaced apart from the or each respective deflector.

The lateral stiffening ribs may be linked to the or each respective deflector.

The patient interface may include one or more deformation zone tethers located in the first chamber and connecting the distal portion to the outer wall.

The one or more deformation zone tethers may be configured to inhibit tipping of the partition wall.

The or each respective deformation zone tie may extend between the side of the partition wall exposed to the first chamber and the outer wall of the sealing member.

The or each respective deformation zone ligament may extend from the outer wall to the distal portion.

The or each respective deformation zone tie may be connected to the dividing wall between the deformation panel and the or a respective one of the deflectors.

The or each respective deformation zone ligament may be spaced apart from the deformation panel.

The or each respective deformation zone ligament may be spaced apart from the deflector.

The or each respective deformation zone tie may be connected to the dividing wall between the deflector and the deformation panel.

Each respective deformation zone ligament may be incorporated with a respective one of the flow directors.

The or each respective deformation zone ligament may extend from the partition wall and the outer wall and have a free edge in the first chamber.

The free edge of the or each deformation zone strap may be straight.

The or each respective deformation zone ligament may have a planar structure.

The interface may include two deformed region ligaments, and each respective deformed region ligament has an angle greater than 140 ° between proximal surfaces of the proximal side.

The angle of each respective deformation zone ligament between the proximal surfaces of the proximal sides may be greater than 160 °.

The two deformation zone tethers may extend toward each other to spaced apart locations on the distal portion.

The two deformation zone tethers may extend to the same location on the distal portion.

The two deformation zone tethers may extend toward each other on the distal portion.

The two deformation zone tethers may extend to the reinforcement section.

The or each respective deformation zone ligament may comprise a first portion connected to the outer wall and a second portion extending to and connected to the main portion.

The or each respective deformation zone strap may have two connection points, one connection point being connected to the main portion and the other connection point being connected to the outer wall at a level below the distal portion, taking into account the upstanding orientation of the patient interface.

The or each respective deformation zone tie may be a rope or wire or cable.

The first portion has a flat planar structure and the second portion may be curved such that on the proximal side the angle between the tangents at the respective locations to which the second portion extends is between 140 ° and 180 °.

The or each respective deformation zone tie may extend to a level below the lowest level of the dividing wall, taking into account the upright orientation of the patient interface.

The or each respective deformation zone ligament may extend to a level below the uppermost level of the oral opening, taking into account the upstanding orientation of the patient interface.

The deformation zone tethers may extend from the distal portion to the outer wall at a location distal to a proximal-most portion of the one or more nostril openings.

The free edge may extend from the outer wall at a location distal to the reinforcing section.

The free edge may extend from the outer wall at a location distal to the one or more oral openings.

The free edge may extend from the outer wall at a location distal to the spacer element.

The deformation zone tethers may be configured to permit the main portion of the separation wall to travel in the proximal-distal direction and inhibit tipping of the separation wall.

The flow directors may be configured such that the flow of gas provided through one flow director is greater than the flow of gas through the other flow director.

One of the respective flow directors may be configured to have a first gas flow resistance and the other of the respective flow directors is configured to have a second gas flow resistance, and the first gas flow resistance is lower than the second gas flow resistance.

The first opening, or the second opening, or both the first opening and the second opening, of one of the respective flow directors may be larger than the first opening, or the second opening, or both the first opening and the second opening, of the other of the respective flow directors.

The ratio of the area of the first opening of one of the respective flow directors to the area of the first opening of the other of the respective flow directors may be in the range of 1:1 to 1:0.1.

The ratio of the area of the second opening of one of the respective flow directors to the area of the second opening of the other of the respective flow directors may be in the range of 1:1 to 1:0.1.

The ratio of the area of the second opening of one of the respective flow directors to the area of the second opening of the other of the respective flow directors may be 1:0.33.

The ratio of the area of the second opening of one of the respective flow directors to the area of the second opening of the other of the respective flow directors may be in the range of 1:0.5 to 1:0.2.

The ratio of the combined area of the first opening and the second opening of one of the respective flow directors to the combined area of the first opening and the second opening of the other of the respective flow directors may be in the range of 1:1 to 1:0.1.

The patient interface may include only one flow director.

The one flow director may be configured to deliver a flow of breathing gas to one naris.

The one flow director may be configured to deliver an accelerated flow of breathing gas to produce a flushing flow.

The one deflector may be configured to be capable of flushing the nasal dead space by delivering a flushing flow to one nostril.

The deflector may be in the form of any of the deflectors disclosed above.

The flow director may be configured to direct a flow of gas through the nostril openings and into one nostril of the patient.

The second opening of the deflector may be laterally offset from a midplane through the patient interface.

The second opening of the deflector may be laterally spaced from a midplane passing through the patient interface.

The first opening of the deflector may be laterally offset from a midplane through the patient interface.

The first opening of the deflector may be laterally spaced from a midplane passing through the patient interface.

The partition wall may include a first lateral portion adjacent the midplane on an opposite side of the midplane and a second lateral portion extending laterally outward from the first lateral portion, the first lateral portion having a first wall thickness, the second lateral portion having a second wall thickness, and wherein the first wall thickness is greater than the second wall thickness.

The transition between the first lateral portion and the second lateral portion may be laterally spaced from the midplane by a distance substantially equivalent to the distance that the most laterally positioned portion of the deflector is spaced from the midplane.

The transition between the first and second lateral portions may be laterally spaced from the midplane by a distance greater than the distance that the most laterally positioned portion of the deflector is spaced from the midplane.

The transition between the first and second lateral portions may be laterally spaced from the midplane by a distance less than the distance that the most laterally positioned portion of the deflector is spaced from the midplane.

The patient interface may include one or more nostril openings sealed around the patient's nostril and include a passageway extending from the first chamber to one of the nostril openings or the nostril opening and configured to align with one nostril of the patient and the remainder of the one or the other nostril opening is configured to align with the other nostril of the patient.

The passageway may be configured to enable gas to flow from the other naris of the patient into the second chamber.

The channel may be configured to enable gas to flow from the channel into the second chamber.

The channel may be configured to deliver a flow of gas to only one nostril of the patient.

The channel may be configured to deliver a flow of gas to both nostrils of the patient.

The channel may be configured to deliver a first gas flow and a second gas flow to respective nostrils of the patient, and the first gas flow and the second gas flow are unequal.

The first gas flow rate may be greater than the second gas flow rate.

The passage may be defined in part by a perimeter wall extending between the dividing wall and the nostril opening or to one nostril opening and in part by a baffle extending between the dividing wall and a location recessed from the nostril opening.

The recessed location of the baffle from the nostril opening may enable gas to flow from the passageway into the second chamber when the patient interface is fitted to a patient.

The cross-sectional area of the channel may decrease from the divider wall to the nostril opening or to one nostril opening to accelerate the gas as it travels through the channel.

The channel may taper from the divider wall to the nostril opening or one nostril opening to accelerate the gas as it travels through the channel.

The profile of the passage is constant from the dividing wall to the nostril opening or to one nostril opening.

The channel and the one or more nostril openings may be configured to deliver a flow of irrigation gas to the first nostril when the interface is fitted to the patient, and the flow of irrigation gas to flush the nasal cavity and gas flushed through the nasal cavity flows through the other nostril and through the one nostril opening or the remainder of the other nostril opening and into the second chamber.

Each deformation zone ligament may be a panel with a wall thickness that decreases from the dividing wall to the free edge.

The or each respective deflector may comprise a base, a lower body portion, a rim forming a second opening to the second chamber, and a transition extending between the lower body portion and the rim.

The lower body portion may have a wall thickness and the rim has another wall thickness that is less than the wall thickness of the lower body portion, and wherein the transition comprises a tapered wall thickness.

The spacer rib may be joined to the body lower portion and the transition at a location spaced from the rim.

The spacer rib may be disposed distally of an imaginary line connecting centers of the second openings of the respective flow directors.

The base or lower body portion of the one or more deflectors may be joined with the wall portion.

The inner wall of the deflector may taper inwardly toward the second opening to form an inwardly tapered channel between the first opening and the second opening.

The wall thickness of the rim may be greater than the wall thickness of the lateral side, distal or proximal portions of the divider wall.

The patient interface may include:

(a) One or more deformation zone tethers extending between the side of the partition wall exposed to the first chamber and the outer wall of the sealing member;

(b) The main portion of the partition wall has a concave profile in a proximal-distal direction relative to the nostril opening; and

(c) The or each respective deflector comprises a base, a lower body portion, a rim forming a second opening to the second chamber, and a transition extending between the lower body portion and the rim.

Throughout the above disclosure, the following description and claims, the terms "proximal" and "distal" and grammatical variations thereof refer to respective proximal and distal directions. The reference to proximal direction indicates what would be the direction toward the patient if the patient interface were mounted to the patient. The distal reference indicates what would be the direction away from the patient if the patient interface were mounted to the patient. These directions are shown in fig. 4, 34 and 40. The same directionality applies to all figures and all embodiments disclosed in this specification. The use of the terms "proximal" and "distal" should not be considered to indicate a state of the patient interface when assembled onto a patient unless the context indicates otherwise.

The deflector of the fourth aspect may comprise any one or more features of the deflector outlined in relation to the first, second and third aspects. The deflector of the fourth aspect may also be combined with the cushion module disclosed above in relation to the first, second and third aspects. The following description includes embodiments of the first, second, third and fourth aspects disclosed above. It will be appreciated that embodiments of the deflector relating to the fourth aspect may be combined with embodiments of the cushion module associated with the first, second and third aspects. Further, the deflector of the fourth aspect may comprise any one or more features of the deflector outlined in relation to the first, second and third aspects. The same applies to all other features described in the following description, i.e. an embodiment described below in association with one of the above disclosed aspects may be combined with any other embodiment described below in relation to the same or different disclosed aspects.

Throughout the above disclosure, the following description and the claims, the term "chamber" is considered to mean a structure of the patient interface enclosing a volume, and having one or more breathing gas inlets and one or more breathing gas outlets.

Throughout the above disclosure, the following description and the claims, the term "upright orientation" is considered to mean the orientation of the patient interface when the midplane between the lateral sides of the patient interface is oriented vertically and when the most distal point of the wall portion on the midplane is vertically aligned with the mouth-below point of the oral opening on the midplane. The midplane is the plane of section line A-A in FIG. 1 and is also the plane of section line U-U in FIG. 30.

While various features are disclosed above in relation to one or more aspects, it will be appreciated that one or more features of one aspect may be combined with other aspects to obtain further embodiments. The features disclosed in the foregoing statements are not to be construed as meaning that the application of these features is limited to the aspects disclosed in relation to them. For example, the deformation region may be incorporated into a patient interface of any of the aspects described above. As a further example, the housing disclosed above may be incorporated into the patient interface of any of the previous aspects.

Ordinal numbers are used to mention the above disclosed aspects (e.g., first, second, third) merely to distinguish the aspects from each other. Such ordinal references should not be construed as order of importance of the aspects.

Drawings

Various aspects of the patient interface disclosed above are described in detail below by reference to embodiments, which are intended to be exemplary only, and to the accompanying drawings, in which:

FIG. 1 is an oblique view of a patient interface and a gas conduit connector according to one embodiment;

FIG. 2 is an exploded perspective view of the patient interface and gas conduit connector of FIG. 1;

FIG. 3 is a rear view of the patient interface and gas conduit connector of FIG. 1;

FIG. 4 is a cross-sectional side view of the patient interface and gas conduit connector taken along line A-A of FIG. 1;

FIG. 5 is a cross-section of the gas conduit connector taken along line B-B of FIG. 4;

FIG. 6 is a front plan view of a housing forming part of the patient interface of FIG. 1;

FIG. 7 is a front perspective view of a cushion module of the patient interface of FIG. 1;

FIG. 8 is a cross-sectional oblique side view of the cushion-only module of the patient interface taken along line C-C of FIG. 7;

FIG. 9 is an enlarged view of the area labeled D in the cross-sectional view of FIG. 8;

FIG. 10 is a cross-sectional oblique view of the cushion module taken along line E-E in FIG. 7;

FIG. 11 is a cross-sectional view of the cushion module taken along line F-F in FIG. 7;

FIG. 12 is a rear perspective view of an alternative cushion module;

FIG. 13 is a cross-sectional side view taken along line G-G in FIG. 12;

FIG. 14 is an enlarged oblique view of the area labeled H in the cross-sectional view of FIG. 13;

FIG. 15 is a bottom view of a partition wall in the cushion module of FIG. 12;

FIG. 16 is a rear perspective view of an additional alternative cushion module;

FIG. 17 is a cross-sectional side view of the cushion module of FIG. 16 taken along line J-J;

FIG. 18 is an enlarged oblique view of the region labeled K in the cross-sectional view of FIG. 17;

FIG. 19 is another cross-sectional side view of the cushion module of FIG. 16 taken along line L-L;

FIG. 20 is a front cross-sectional view of the cushion module of FIG. 16 taken along line M-M;

FIG. 21 is a bottom view of a partition wall in the cushion module of FIG. 16;

FIG. 22 is an enlarged oblique view of the bottom side of the divider wall in the direction labeled N in FIG. 21;

FIG. 23 is a top cross-sectional view of the cushion module of FIG. 16 along line P-P;

FIG. 24 is a rear perspective view of an additional alternative cushion module;

FIG. 25 is a top cross-sectional view of the cushion module of FIG. 24 taken along line Q-Q;

FIG. 26 is a cross-sectional side view of the cushion module of FIG. 24 taken along line R-R;

FIG. 27 is an enlarged oblique view of the area labeled S in the cross-sectional view of FIG. 26;

FIG. 28 is a bottom view of a partition wall in the cushion module of FIG. 24;

fig. 29 is an enlarged oblique view of the bottom side of the partition wall in the direction marked T in fig. 21;

FIG. 30 is a plan front view of a further alternative cushion module;

FIG. 31 is a plan side view of the alternative cushion module shown in FIG. 30;

FIG. 32 is a top plan view of the alternative cushion module shown in FIG. 30;

FIG. 33 is a rear plan view of the alternative cushion module shown in FIG. 30;

FIG. 34 is a cross-sectional view taken along line U-U in FIG. 30;

FIG. 35 is an enlarged view of the area labeled W in the cross-sectional view of FIG. 34;

FIG. 36 is an enlarged view of a cross-sectional view taken along line X-X in FIG. 32;

FIG. 37 is a cross-sectional oblique view taken along line Y-Y in FIG. 30;

FIG. 38 is a cross-sectional oblique view taken along line Z-Z in FIG. 30;

fig. 39 is a sectional view taken along line Aa-Aa in fig. 30;

FIG. 40 is a bottom view of a section taken along line BB-BB in FIG. 30;

FIG. 41 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with alternative flow directors and spacer ribs;

FIG. 42 is an enlarged view of FIG. 32 with a deflector and spacer rib in the form of the alternative deflector of FIG. 41;

FIG. 43 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with another alternative deflector and another alternative spacer rib;

FIG. 44 is an enlarged cross-sectional view taken along line AA-AA of FIG. 30 with the alternative flow director and spacing rib of FIG. 43;

FIG. 45 is an enlarged cross-sectional oblique view of the cushion module of FIG. 30 taken along line U-U and seen from above with alternative flow directors and spacer ribs;

FIG. 46 is an enlarged cross-sectional oblique view of FIG. 30 taken along line AA-AA with the alternative flow director of FIG. 45;

FIG. 47 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with another alternative deflector, spacer ribs and reinforcing section;

FIG. 48 is an enlarged cross-sectional view taken along line BB-BB of FIG. 30 with the deflector, spacer ribs and reinforcing section of FIG. 47;

FIG. 49 is an enlarged cross-sectional view of FIG. 30 taken along line Y-Y with the deflector, spacer ribs and reinforcing section of FIG. 47;

FIG. 50 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with another alternative deflector and another alternative spacer rib;

FIG. 51 is an enlarged cross-sectional view of FIG. 30 taken along line AA-AA with the alternative flow director and spacing rib of FIG. 50;

FIGS. 52-54 are enlarged cross-sectional views of the cushion module of FIG. 30 taken along line U-U with alternative proximal and distal portions of the partition wall;

FIG. 55 is an enlarged oblique view of the cross-section of the cushion module of FIG. 31 taken along line CC-CC with the deflector, spacer ribs and with the proximal and distal portions of FIG. 54;

FIG. 56 is an enlarged cross-sectional view of the cushion module of FIG. 31 taken along line DD-DD and with additional alternative flow directors;

FIG. 57 is an enlarged cross-sectional view of the cushion module of FIG. 33 taken along line EE-EE with the alternative deflector of FIG. 56;

FIG. 58 is an enlarged oblique view of the cushion module of FIG. 33 taken in section along line EE-EE and with additional alternative flow directors;

FIG. 59 is an enlarged cross-sectional view of the cushion module of FIG. 31 taken along line CC-CC with the deflector of FIG. 58;

FIG. 60 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with the deflector of FIG. 58;

FIG. 61 is an enlarged oblique view of the cushion module of FIG. 33 taken in section along line EE-EE and with additional alternative flow directors;

FIG. 62 is an enlarged oblique view of a cross-section of the cushion module of FIG. 30 taken along line FF-FF and with the alternative deflector of FIG. 61;

FIG. 63 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with the deflector of FIG. 61.

FIG. 64 is a top plan view of the cross-sectional view taken along line Y-Y of FIG. 30 with additional alternative flow directors;

FIGS. 65A and 65B are enlarged cross-sectional views of the cushion module of FIG. 30 taken along line U-U with the alternative deflector and spacer ribs of FIG. 64 and with an alternative proximal portion of the dividing wall;

FIG. 66 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U in an alternative configuration with the alternative flow director and spacing rib of FIG. 64 and with the proximal and distal portions of the dividing wall;

FIG. 67 is an enlarged cross-sectional view of the seal member alone of FIG. 30 taken along line HH-HH and with an alternative distal portion of the deflector of FIG. 64 and with a dividing wall;

FIG. 68 is an enlarged cross-section of the seal member alone of FIG. 30 taken along line HH-HH and seen from below with the deflector of FIG. 64 and with the alternative distal portion of FIG. 67;

FIG. 69 is an enlarged cross-sectional view of the seal member alone of FIG. 30 taken along line U-U and with the deflector of FIG. 64 and with an alternative distal portion of the partition wall of FIG. 67;

FIG. 70 is a top plan view of a section taken along line Y-Y of FIG. 30 with the alternative deflector of FIG. 64 and with a deflector tether;

FIG. 71 is an enlarged cross-section of the cushion module of FIG. 30 taken along line U-U and seen from above with the deflector of FIG. 64 and with the deflector tether of FIG. 70;

FIG. 72 is an enlarged cross-sectional view of the seal member alone of FIG. 30 taken along line U-U and with the deflector of FIG. 64 and with the tether extending from the deformation panel;

FIG. 73 is a bottom oblique view of the sealing member of FIG. 30 taken along line BB-BB alone and with the tether of FIG. 72;

FIG. 74 is an enlarged bottom plan view of the sealing member alone of FIG. 30 taken along line BB-BB and with the tether of FIG. 72;

FIG. 75 is an enlarged cross-sectional view of the sealing member alone of FIG. 30 taken along line U-U and with the deflector of FIG. 64 and with an alternative tether arrangement;

FIG. 76 is a bottom oblique view of the cross-section of FIG. 30 taken along line BB-BB only of the sealing member and with the alternative tether arrangement of FIG. 75;

FIG. 77 is an enlarged bottom plan view of the cross-section of only the sealing member of FIG. 30 taken along line BB-BB and with the alternative tether arrangement of FIG. 75;

FIG. 78 is a top plan view of a cross-section of the cushion module taken along line Y-Y of FIG. 30 with the alternative flow director of FIG. 64 and with reinforcing structure;

FIG. 79 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with the deflector of FIG. 64 and with the reinforcement structure of FIG. 78;

FIG. 80 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with the deflector of FIG. 64 and with the deformation zone tethers;

FIG. 81 is a bottom plan view of the cushion module of FIG. 30 taken along line GG-GG and with the deformation zone tethers of FIG. 80;

FIG. 82 is a bottom oblique view of the seal member of FIG. 30 taken along line GG-GG and with the deformed region of FIG. 80 being laced;

FIG. 83 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line AA-AA and with an alternative deflector and with an alternative deformation zone tether;

FIG. 84 is an enlarged cross-sectional view of the cushion module of FIG. 30 taken along line U-U and with the deflector and deformation zone tethers of FIG. 83;

FIG. 85 is a top plan view of the cross-section of the cushion module of FIG. 30 taken along line Y-Y with an alternative arrangement of flow directors;

FIG. 86 is a bottom plan view of the cushion module of FIG. 30 taken along line GG-GG and with the deflector arrangement of FIG. 85;

FIG. 87 is an oblique view from above of the cross-section of the cushion module of FIG. 30 taken along line Y-Y with the alternative deflector arrangement of FIG. 85;

FIG. 88 is a top plan view of the cushion module of FIG. 30 taken along line Y-Y in cross section with a single deflector arrangement;

FIG. 89 is a bottom plan view of the cushion module of FIG. 30 taken along line GG-GG and with the single deflector arrangement of FIG. 88;

FIG. 90 is an oblique view from above of the cross-section of the cushion module of FIG. 30 taken along line Y-Y with the single deflector arrangement of FIG. 88;

FIG. 91 is an oblique view from above of the cushion module of FIG. 33 taken along line LL-LL and with a passageway from the mouth to the nostril opening;

FIG. 92 is an enlarged view of a section of the cushion module of FIG. 33 taken along line KK-KK and with the channel of FIG. 91; and is also provided with

FIG. 93 is a bottom plan view of the cushion module of FIG. 30 taken along line BB-BB and with the channel of FIG. 91.

Detailed Description

Preferred embodiments of the present invention will now be described hereinafter, including reference numerals corresponding to the features shown in the drawings. Wherever possible, the same reference numbers have been used to identify the same or substantially similar features in different embodiments. However, not all reference numerals are included in each figure in order to maintain clarity of the drawings.

Various aspects of the patient interface disclosed above will be described in detail below with reference to the embodiments of the patient interface shown in fig. 1-4 in a general form. The embodiments described below are variations on this general form. However, it will be appreciated that the scope of these aspects should not be limited by reference to this general form or to the specific embodiments described below, but rather that these aspects should be construed as related to other forms of patient interface that also deliver pressurized breathing gas to a patient, including patient interfaces that extend across the bridge of the nose, full face masks, and full head helmets.

As used throughout this specification, the term "breathing gas" is understood to mean a gas used for human breathing. As used throughout this specification, the term "inhaled breathing gas" is understood to mean breathing gas inhaled during the inspiratory phase of the breathing cycle. The term includes within its scope ambient air or air conditioned for treating a patient, such as having an elevated humidity or oxygen level or both as compared to ambient air. As used throughout this specification, the term "exhaled breath" is understood to mean the breathing gas exhaled from the lungs and airways of a patient. Thus, it includes respiratory gases from the lungs, and the gases occupy anatomical dead spaces at the end of the expiratory phase of the respiratory cycle.

Referring to fig. 1-4, a general form includes a patient interface 10 that includes a cushion module 20, a frame 30, and a conduit connector 40. The conduit connector 40 includes structural components for connecting the cushion module to a source of breathing gas (e.g., a ventilator, humidifier, flow generator, or wall source). In this embodiment, the patient interface 10 is in the form of a subnasal mask, wherein the cushion module 20 includes a resilient sealing member 230 and a housing 210. The resilient sealing member 230 and the housing 210 together form an outer wall 288 of the cushion module 20.

Without the sealing member 230, the housing 210 is formed of a substantially rigid plastic material as shown in fig. 6 to provide structural support to the sealing member 230. In addition, the housing 210 provides an interface for connecting the sealing member 230 to the frame 30 and the catheter connector 40.

The housing 210 includes a sleeve 220 sized and shaped to couple with the frame 30. The sleeve 220 forms an inlet opening 292 through which breathing gas may be transferred from the conduit connector 40 to the interior of the cushion module 20. The sleeve includes a key structure 222 that interacts with the frame 30 to ensure proper alignment of the frame with the housing when the frame 30 is assembled with the housing 210.

The housing 210 includes a series of tabs 212 extending outwardly around its perimeter. The outer ends of the tabs 212 are linked to a bead 214 that extends continuously across all of the tabs 212, thereby forming a series of discrete overmolded outer windows 216 between the tabs 212 and the bead 214. The sealing member 230 is integrally formed with the housing 210 by over-molding an elastomeric material over the housing to fill the series of windows. Thus, the tab 212 and the bead 214 are embedded in the resilient material and mechanically interlocked with the sealing member 230. Thus, the sealing member 230 and the housing 210 form a unitary cushion module 20 structure.

The housing 210 further includes a set of offset vents 226 through the housing 210. The housing further includes a series of overmolded inner windows 218 through which the sealing member 230 is also overmolded with the housing 210. The overmolded inner window 218 is located in an area of the housing 210 within the perimeter formed by the overmolded outer window 216. The offset vent 226 is defined on one side by the overmolded outer window 216 and on the other side by the overmolded inner window 218. As shown in fig. 6, the offset vent 226 is surrounded by the overmolded outer window 216 and the overmolded inner window 218. The material used to form the sealing member 230 flows through the overmolded inner window 218 and the overmolded outer window 216 during molding such that the material conforms to the shape of the housing 210 and windows 216, 218 prior to solidification or curing. Extending material through the windows 216, 218 will effect a mechanical connection with the housing. The windows 216, 218 may take the form of apertures extending completely through the housing 210.

The sealing member 230 is formed of a soft, resilient material (e.g., silicone) and includes an oral opening 232 and a nostril opening 234. When assembled to a patient, the oral opening 232 circumferentially surrounds the patient's mouth, and the patient contacting surface 290 of the outer wall forms a seal around the mouth. Accordingly, high pressure breathing gas may be delivered to the patient via the oral opening 232. The sealing member 230 is formed with a nostril sealing portion 236 in the valley of which the nostril opening 234 is located. The patient contact surface 290 includes a nostril sealing portion 236, and a wall portion 276 located between the oral opening 232 and the nostril opening 234. The naris seal portion 236 is arranged to contact the underside of the patient's nose and form a seal with the patient's naris such that high pressure breathing gas may be delivered to the patient via the naris opening 234. The nostril openings 234 are positioned to align with the nostrils of the patient when the mask 10 is assembled.

While this embodiment of the cushion module 20 includes a single oral opening 232 and a single nostril opening 234, it should be appreciated that other embodiments may include more than one oral opening, more than one nostril opening, or multiple oral openings and multiple nostril openings. In another embodiment, not shown, the cushion module includes a single oral opening 232 and two nostril openings 234.

The cushion module 20 defines an interior volume that includes a first chamber 238 and a second chamber 240. The second chamber 240 is located in an upper portion of the interior volume of the sealing member 230. The first chamber 238 includes a lower portion of the interior volume of the cushion module 20. The first chamber 238 and the second chamber 240 are separated by a partition wall 242. The first cavity is a first chamber 238 and the second cavity is a second chamber 240. As shown in fig. 3 and 4, the oral opening 232 is associated with the first chamber 238 to enable the breathing gas to pass between the first chamber 238 and the patient's mouth. An inlet opening 292 of the sleeve 220 is also associated with the first chamber 238. The nostril openings 234 are associated with the second chamber to enable breathing gas to be transferred between the second chamber 240 and the patient's nostrils. A bias vent 226 is also associated with the second chamber 240. Thus, the offset vent 226 enables breathing gas to be exhausted from the cushion module to the external environment. In this embodiment, the offset vent 226 vents the breathing gas to the surrounding atmosphere.

The partition wall 242 divides the interior of the cushion module 20 to define a first chamber 238 and a second chamber 240. The partition wall 242 separates the first chamber 238 from the second chamber 240 by extending all the way across the interior volume of the cushion module 20. In other words, the perimeter of the divider wall 242 seals with the outer wall 288. An intersection line 282 is shown in fig. 3 and 7, conceptually illustrating the location where the divider wall 242 intersects the outer wall 288. In particular, the intersection line extends all the way between the first chamber 238 and the second chamber 240. Sealing the first chamber from the second chamber means that the only flow of breathing gas between the first chamber and the second chamber is through the flow director 246. In this way, while the partition wall 242 seals the first chamber 238 from the second chamber 240, the partition wall 242 permits respiratory gases to flow from the first chamber 238 to the second chamber 240 via only the pair of flow directors 246 (see fig. 8-11).

The partition wall 242 of the cushion module 20 has a wide U-shaped transverse profile. This is illustrated by the intersection line 282 in fig. 3 and 7 which extends across the ridge on each side of the nostril sealing portion 236 and across the wall portion 276 below the offset vent 226. The U-shaped profile allows some vertical travel of the dividing wall 242 (and the flow director 246), which helps to maintain the spacing between the flow director 246 and the nostril opening 234 (and also vertically when the nostril sealing portion 236 is subjected to deforming forces) to reduce the risk of the flow director contacting the patient. The wide U-shaped profile of the dividing wall 242 is replaced with a flatter profile in subsequent embodiments described below.

Figures 8 and 9 illustrate that the divider wall 242 seals against the outer wall 288 between the nostril opening 234 and the oral opening 232. By wall portion 276, this means that the divider wall 242 seals with the wall portion 276 across the width of the wall portion 276. In other words, the divider wall 242 seals with the outer wall 288 at a location spaced from the nostril opening 234. As can also be seen in fig. 8 and 9, the divider wall 242 seals against the outer wall 288 at a location closer to the oral opening 232 than to the nostril opening 234. In other words, the seal between the divider wall 242 and the wall portion 276 is located in the lower half of the wall portion 276.

One design consideration of the sealing member 230 involves balancing patient comfort with therapeutic performance. Therapeutic performance is improved by ensuring that the flow structure (e.g., the flow director 246 in this embodiment) that directs the breathing gas into the nostrils maintains its shape and remains properly oriented when the patient interface is fitted to a patient. Some patient interfaces link these structures to the patient contact surface 290. Typically, the links are located in the nasal contact area, i.e., the nasal contact surface, of the patient contact surface 290. In this embodiment, the partition wall 242 moves downward within the interior volume of the cushion module 20. The lower positioning of the divider wall 242 moves the connection between the divider wall 242 and the outer wall 288 away from the nose contact surface. This is expected to improve patient comfort. However, it is contemplated that therapeutic performance may be maintained because the dividing wall 242 may be formed with additional support structures that assist in maintaining the shape and orientation of the flow director 246. This means that these structures are supported less dependent on the connection to the outer wall 288, which is why the deflector 246 in the cushion module 20 has only a small contact area with the outer wall 288. While the additional support structure incorporated into the divider wall 246 will increase the flexibility of the divider wall 242 and increase the flexibility of the connection with the outer wall, the lower position of the divider wall 242 keeps the connection between the divider wall 242 and the outer wall 288 away from the highly sensitive nasal contact region. This movement of the location where the divider wall 242 is joined with the outer wall 288 increases patient comfort compared to the joining and linking in the nasal contact region. That is, reducing the links between the structures, such as the flow director 246, and the outer wall 288 increases patient comfort because there are fewer structural points of contact with the outer wall 288 that may create pressure points on the patient's face. In use, the facial contact points affected by the patient interface 10 include areas of high sensitivity, such as the septum and the person. It is contemplated that patient comfort is enhanced by employing a divider wall 242 in a lower position between the nostril opening 234 and the oral opening 232. It is also contemplated to increase by reducing contact between the internal structure of cushion module 20 and patient contact surface 290. In addition, the larger volume of the second chamber 240 enables structures within the second chamber 240 (such as the flow director 246) to be further supported and enhanced by the dividing wall 242. As described above, other embodiments are contemplated having the deflector spaced from the outer wall 288 such that the dividing wall 242 is the only link between the deflector and the cushion module 20.

A flow director 246 extends from the dividing wall 242 into the second chamber 240. In other embodiments, the flow director 246 may extend from the dividing wall 242 into the first and second chambers 238, 240 or into the first chamber 238 only. In another embodiment, the flow directors 246 may not extend from either side of the divider wall 242. For example, the wall thickness of the dividing wall 242 may be sufficient to include a flow director 246 between the surfaces of the dividing wall 242 that are exposed to the first and second chambers 238, 240, respectively.

The flow director 246 defines a gas flow path from the first chamber 238 to the second chamber 240 and the flow director 246 surrounds the gas flow path. Each flow director 246 includes a body 248 having a first opening 250 and a second opening 252. The first opening 250 opens into the first chamber and the second opening 252 opens into the second chamber 240. This means that the flow director 246 is the only channel through which the breathing gas flows between the first chamber 238 and the second chamber 240.

A deflector 246 is disposed in the main portion 244 of the divider wall 242. In this embodiment, the body 248 of each flow director 246 is coupled to the divider wall 242. A small section of the body 248 joins with the outer wall 288 at the wall portion 276. Thus, the first and second chambers 238, 240 are coupled to the outer wall 288 by the partition 242 and to the flow director 246 and are separated by the flow director 246 being coupled to the outer wall 288. In other embodiments, the body 248 of each deflector 246 may be spaced apart from the outer wall 288 such that the entire perimeter of the dividing wall 242 is joined with the outer wall 288. In other words, the body 248 of each flow director 246 may be located in a central region of the dividing wall 242 such that each flow director 246 is spaced apart from the perimeter of the dividing wall 242. The central region may coincide with the center of the partition wall, or may be offset from the center of the partition wall. However, in each embodiment, the first chamber 238 is separated from the second chamber 240 by a dividing wall 242 and a flow director 246.

In this embodiment, the entire sealing member 230 is integrally formed and over-molded onto the housing 210. The integral molding of the divider wall 242 with the outer wall 288 forms an airtight joint. The same applies to the coupling of the flow director 246 to the dividing wall 242.

The second opening 252 is positioned to direct breathing gas toward and through the nostril opening 234. This directs the breathing gas from the first chamber 238 to the patient's nostrils via the second openings 252 and through the nostril openings 234. This directed breathing gas aids in breathing during the breathing cycle and aids in anatomical dead space irrigation in the patient's nasal cavity. It should be appreciated that while at least a portion of the gas flow directed by the flow director 246 toward the nostril opening 234 generally flows through the nostril opening 234, some directed gas may not flow through the nostril opening 234. Furthermore, sometimes during use of the patient interface, the directed breathing gas may not flow through the nostril openings 234 at all. The flow of gas through the nostril openings 234 will depend on the gas flow, gas pressure, and points in the breathing cycle. Any directed flow of breathing gas from the flow director 246 that does not flow through the nostril openings 234 will flow through the second chamber 240 to the offset vent 226.

The location and shape of the second opening 252 affects the flow of breathing gas into the second chamber and through the nostril openings 234. In the embodiment shown in fig. 8-10, each flow director 246 has a second opening 252 within the second chamber 240, and the second openings 252 are spaced apart from the nostril openings 234. The second opening 252 is defined by a rim 254 that is contoured such that at least a portion of the rim 254 is substantially uniformly spaced from the nostril opening 234. The portion of the rim 254 that is substantially uniformly spaced from the nostril opening 234 is adjacent to the outer wall 288 between the at least nostril opening 234 and the oral opening 232. The rim 254 of each second opening 252 extends a greater distance from the divider wall 242 at a laterally outer side of the flow director 246 than the rim 252 extends from the divider wall 242 at a laterally inner side of the flow director 246. This means that the rim 254 is recessed from the nostril opening 234 at the laterally inner side of the deflector 246 to a greater depth than the rim 254 is recessed from the nostril opening 234 at the laterally outer side of the deflector 246. The lower height of the rim relative to the dividing wall 242 laterally inboard of each flow director 246 assists in the flow of breathing gas from the first chamber 238 into the second chamber 240. The higher height of the rim relative to the dividing wall 242 laterally outboard of each flow director 246 assists in directing the breathing gas from the first chamber 238 through the second chamber 240 and the nostril openings 234. In another embodiment, the rim 254 is recessed deepest from the nostril opening 234 at a point between the laterally outboard side of the deflector 246 and the laterally inboard side of the deflector 246 such that, in cross-section, the rim 254 is concave or curved inwardly.

The recessed position of the second opening 252 relative to the nostril opening 234 enables excess breathing gas from the first chamber 238 (including breathing gas exhaled from the mouth) to enter the second chamber 240 and be expelled through the offset vent 226 to the exterior of the patient interface 10. The nostril opening 234 is defined by a rim 286 at the outer wall 288 of the sealing member 230. However, given that the second opening 252 is recessed from the rim 254, the spacing between the second opening 252 and the rim 286 enables breathing gas to flow from the first chamber 238 to the second chamber 240 and then out through the offset vent 226 to the surrounding atmosphere. This typically occurs during a portion of the expiratory phase of the respiratory cycle. For example, when the patient exhales through their nose (excess breathing gas delivered from the source to the first chamber 238 flows into the second chamber 240). In another example, this also occurs when the patient exhales through their mouth (the exhaled gas flows from the mouth into the first chamber and then flows into the second chamber with the excess respiratory gas delivered from the source). At times, during inspiration through the nose or during flushing of the dead space of the nasal cavity, breathing gas may flow from the first chamber 238 into the second chamber 240 and then through the nostril openings 234 and into the patient's nostrils.

The body 248 of each deflector 246 includes a lower body portion 256 and an upper body portion 258. The overall profile of the body 248 has a cross-sectional area that decreases in a direction between the first opening 250 and the second opening 252. In this embodiment, the body 248 includes a lower body portion 256 and an upper body portion 258. The lower body portion 256 is substantially tapered from the first opening 250 to the upper body portion 258, and the upper body portion 258 is slightly tapered from the lower body portion 256 to the second opening 252. However, in other embodiments, the cross-sectional area of the upper body portion 258 may be smaller than the cross-sectional profile of the lower body portion 256. This may be implemented as a stepped profile of the body 248. The reduction in cross-sectional area between the first opening 250 and the second opening 252 has the effect of accelerating the flow of breathing gas to the nostril openings 234 to deliver the accelerated flow of breathing gas to the nostrils. In another embodiment, the cross-sectional area of the body 248 of each deflector may be constant between the first opening 250 and the second opening 252.

In this embodiment, the lower body portion 256 and the upper body portion 258 have tapered profiles. In alternative embodiments, the body upper portion 258 may have a circular, elliptical, or oval profile in a cross-section generally parallel to the dividing wall in which the deflector is located. Further, the body 248 may have a tapered profile, or a stepped profile in a cross-section generally orthogonal to the divider wall 242 where the flow director 246 is located.

In the embodiment shown in fig. 8-19, the patient interface 10 includes two spaced apart flow directors 246. That is, the two flow directors 246 comprise two separate structures. They do not share a common wall defining a flow path through each flow director 246. The flow director 246 is spaced apart by a gap through which respiratory gases from the first chamber 238 and respiratory gases exhaled from the nostrils into the second chamber via the nostril openings 234 may flow into the second chamber. The rim 254 of each flow director 246 extends from the divider wall 242 on the same side of the flow director 246 as the void a distance less than the distance the rim 254 extends on the side of the flow director 246 remote from the void. In this embodiment, the flow director 246 is configured such that the laterally outer side of the rim 254 is adjacent to the laterally outer edge 286 of the nostril opening 234, taking into account the direction of gas flow from the flow director 246. More specifically, the rim 254 is located laterally inboard of the laterally outer edge 286 of the nostril opening 234. However, in other embodiments, the rim 254 may be laterally outboard of the lateral outer edge 286 of the nostril opening 234, or the laterally outboard of the rim 254 may be aligned with the lateral outer edge 286 of the nostril opening 234, taking into account the direction of gas flow from the deflector 246.

The lateral outward spacing of the deflector 246 from the nostril opening 234 is expected to increase patient comfort due to the reduced contact point with the outer wall 288. As described above, a reduction in the contact points will reduce the number or size of pressure points on the patient's face. In addition, the lateral spacing of the contact points will distance the contact points from the sensitive septal and personal areas. The expected increase in comfort should help to increase treatment compliance and reduce pressure sores. Further, it is believed that the lateral position of each of the two flow directors 246 relative to the nostril opening 234 will increase the likelihood that the flow directors 246 will align with the patient's nostrils and thus deliver adequate flow. This is because the laterally spaced apart locations of the flow director 246 reduce the chance that a patient having a broad or large septum (which is centered relative to the nostril opening 234) will impede flow out of the flow director 246.

The bead 262 circumferentially surrounds the rim 286 on the inner surface of the sealing member 230. In this embodiment, the bead 262 includes an area of increased wall thickness, as shown in fig. 4. The increased thickness of the rim 286 increases the resistance of the rim 286 to excessive outward deformation (otherwise known as bursting) that may occur when the patient interface 10 receives high levels of pressurized breathing gas from a gas source. The increased thickness of the rim 286 also increases the resistance of the rim 286 to undesired deformation that may occur when the patient interface 10 is assembled to a patient.

The partition 242 is configured to preferentially deform in a manner to reduce the likelihood of the second chamber 240 and the nostril opening 234 becoming blocked.

In this embodiment, the partition wall 242 includes a main portion 244 and a first resilient region 268 linked by a deformation panel 294. In this embodiment, the first resilient region 268 has the form of a lip. The deformation panel 294 includes a first wall 270 and a second wall 272. A first wall 270 extends from the first resilient region 268 (see fig. 9), and a second wall 272 extends from the main portion 244 between the deflector 246 and the second wall 272 and joins with the first wall 270. The second wall 272 has a curved profile extending from the first wall 270 to the main portion 244. Fig. 9 shows an undeformed configuration of the first wall 270 and the second wall 272.

The deformation panel 294 structurally decouples the first resilient region 268 from the main portion 244. Detachment occurs because the deformation panel 294 accommodates a decrease in the distance between the first elastic region 268 and the main portion 244.

The deformation of the deformation panel 294 occurs in two stages. The main portion 244 includes the flow director 246 and is therefore relatively resistant to deformation in the region of the flow director 246 as compared to the first wall 270 and the second wall 272. Accordingly, the deformation panel 294 is more easily deformed than the rest of the main portion 244. The first stage of deformation involves applying a force to the patient contact surface 290 such that the main portion 244 is displaced toward the first elastic region 268. This causes the first wall 270 to fold about its line of attachment to the first elastic region 268 until it contacts or is located near the bottom side of the first elastic region 268. In the second stage of deformation, as the main portion 244 continues to displace toward the first elastic region 268, the second wall 272 and main portion 244 sections flex and translate over the first wall 270 until the deflector 246 contacts or is positioned adjacent the first elastic region 268. Such flexion and translation movements may be referred to as "scrolling". Buckling occurs due to the curvature of the second wall 272. This deflection sequence is shown and described in international patent application PCT/NZ 202/050072, with particular reference to fig. 59A to 59D and related descriptions. The contents of this international application are incorporated into the present specification by reference so that they are considered as a single disclosure.

In alternative embodiments, the divider wall 242 may be configured such that deformation of the deformed panel 294 is limited to the first stage of deformation described above. For example, the second wall 272 may be omitted, or the size of the second wall may be reduced, or the second wall may have a shape that is altered to avoid "rolling" movement. In a further alternative, the first wall 270 may extend further from the first elastic region 268 such that the first stage of deformation occurs for all displacement of the main portion 244 toward the first elastic region 268.

During use, when the mask 10 is assembled, the patient contact surface 290 will be forced to accommodate different facial geometries, headgear preferences, and pressure settings. These forces and the locations at which they are applied will vary. However, the configuration described above concentrates forces and deflections into the deformation panel 294 to provide predictable collapse and rebound movement. The predictable buckling pattern achieved via the preferred deformable region allows the cover 10 to be designed in a manner such that when the seal is forced, the deformation and compression that occurs in the elastomeric material forming the sealing member 230 occurs in a manner such that the nostril openings 234 and the second openings 252 of the flow directors 246 may remain unobstructed. Furthermore, the positioning of the nostril openings 234 and the second openings 252 relative to one another is substantially maintained during deformation. Without such preferential deformation, collapse of the divider wall 242 is unpredictable, potentially resulting in inconsistent flow through the second opening 252, or inconsistent positioning of the second opening 252 relative to the nostril opening 234 and/or the patient's nostril. This will cause inconsistencies in the overall performance of the achieved therapy, comfort, fitting procedure aspects, and both between uses for the same patient and between different patients.

In a variation of this embodiment, the sealing member 230 may have more than one preferential deformation zone. For example, additional preferential deformation areas may be incorporated into the dividing wall 242, or may be incorporated into the sealing member 230 at other locations that enable the second chamber 240 and/or the nostril opening 234 and the second opening 252 to substantially retain their shape.

The geometry of the first wall 270 and the second wall 272, as well as their thickness, are selected such that the cushion module 20 can accommodate a wide range of facial geometries and deformation forces associated with the application and use of the patient interface. However, it is possible to produce different cushion modules to fit face geometries that fall into a specific range of extremes of the facial geometry spectrum.

Although the first resilient region 268 is formed with a greater wall thickness than the deformed panel 294 to provide greater resilience, doing so allows for the use of a single material to form the sealing member 230. However, it will be appreciated that the first resilient region 268 may be hardened by alternative means, so long as the deformation panel 294 preferentially deforms upon application of force to the sealing member 230. For example, the first elastic region 268 may be formed from a more elastic material (such as a different grade of silicone or plastic material), or may have a different structure.

The transmission of the deforming force into the deforming panel 294 is facilitated by one or more reinforcing sections 264 formed in the dividing wall 242. In this embodiment, the reinforcing section 264 comprises a thickened wall section on the underside of the dividing wall 242, as shown in fig. 11 and in cross-section in fig. 8 and 9. The reinforcing section 264 takes the form of a rib having a force dispersing end 266 that is connected to the wall portion 276 of the outer wall 288. The force dispersing end 266 tapers outwardly in the direction of the wall portion 276. This dispersion distributes the contact area of the reinforcing section 264 over a larger area of the wall portion 276. This creates a large contact point at which the force is dispersed. By providing hard localized contact points in the patient contact surface 290, reducing the flexibility of the wall portion 276 can affect patient comfort. However, dispersing the contact points reduces the contact pressure, thereby increasing patient comfort. The reinforcing section 264 directs the force applied to the wall portion 276 into the partition wall 242 where the deflection force is absorbed by the deforming panel 294. In so doing, the reinforcing section 264 substantially maintains the position of the dividing wall 242 (and the deflector 246) relative to the nostril opening 234. Another way to understand the function of the enhancement section 264 is to understand that it supports the main portion 244 in place relative to the wall portion 276. This allows patient treatment to continue during deformation of the patient-contacting portion of the outer wall 288 with little disturbance to the flow of breathing gas (a) through the flow director 246, (b) through the nostril openings 234 and (c) through the second chamber 240.

The function of the reinforcing section 264 is facilitated by the spacer ribs 260 (fig. 10). In this embodiment, the spacer rib 260 has the form of a rib connecting the two flow directors 246 and to the main portion 244 at a location overlapping the reinforcing section 264 (see fig. 9). A spacer rib 260 extends partially upward along each deflector 246. In this embodiment, the spacer extends from the dividing wall and up to the body lower portion 256. The connection of the spacer ribs 260 to the flow director 246 strengthens the flow director 246 and causes it to deform more elastically. The connection of the spacer ribs 260 to each flow director 246 also ensures that any force applied to one flow director 246 is transferred and dispersed to the other flow director 246, which may reduce localized deformation. The connection of the spacer ribs 260 to the flow director 246 also reduces the likelihood of the flow director 246 buckling inwardly or outwardly. Reducing the likelihood of buckling assists in maintaining the alignment of the flow director 246 in the following directions: in use, the flow of breathing gas is directed towards the nostril openings 234.

In addition, the location of the spacer ribs 260 and the reinforcing section 264 means that the deflection of the wall portion 276 translates through the reinforcing section 264 and the spacer ribs 260 and, thus, causes the deflector 246 to follow the movement of the wall portion 276 and the nostril opening 234. The spacer ribs 260 also serve to maintain the position of the second openings 252 relative to each other and reduce the likelihood of the second openings 252 collapsing inwardly or outwardly during deformation. In this embodiment, the spacer ribs 260 are integrally formed with the body 248 of the deflector 246. However, in other embodiments, the spacer ribs 260 may be located between, but not coupled to, the flow directors 246. Alternatively, the spacer ribs 260 may join the flow director 246, but may not be linked to the main portion 244. Although this arrangement does not overlap the reinforcing section 264, the spacing ribs 260 still serve to maintain the relative spacing of the second openings 252. In another alternative, the spacer ribs 260 or the reinforcing section 264 may be omitted. The structure of the deflector and the spacing rib 260 or reinforcing section 264 serves to more elastically deform the main portion such that the deformation force is expected to be transferred into the preferential deformation zone without one or the other of the spacing rib 260 or reinforcing section 264. Accordingly, it is contemplated that the flow director 246 maintains its shape and position relative to the nostril opening 234 when subjected to deforming forces.

The manner in which the cushion module 20 delivers breathing gas to the patient and removes excess breathing gas and removes exhaled breathing gas is similar to the method described in international patent application PCT/NZ 202/050072, with particular reference to fig. 45-47 and the associated description. By way of overview about cushion module 20, respiratory gases are supplied to a patient as follows. The accelerated flow of breathing gas is delivered to the patient to provide anatomical dead zone irrigation. This involves delivering an elevated pressure of breathing gas to the first chamber 238 of the cushion module 20. The first chamber 238 supplies respiratory gas to the patient's mouth via the oral opening 232 and to the second chamber 240 via the flow director 246. The second chamber 240 supplies breathing gas to the patient's nares via the nares opening 234. The breathing gas flowing to the nostrils is accelerated through the flow director 246. The cross-sectional area of the flow director 246 decreases toward the nostril opening 234. The accelerated breathing gas may then be delivered to the nostrils of the patient. The accelerated flow of breathing gas occurs concurrently with the breathing gas being available for delivery from the first chamber 238 to the mouth.

In further embodiments, the cross-sectional area of the flow director 246 does not decrease toward the second opening 252, but, because the gas is restricted from entering the flow director 246 from the first chamber 238, the flow director 246 still accelerates the gas from the first opening 250 toward the second opening 252.

In general terms, the patient interface 10 operates such that when the patient interface 10 is fitted to a patient and the patient's mouth is open, there is:

a first flow path from the first chamber 238 through the oral opening 232 into the patient's mouth and then into their oral and then nasal cavities, out of one or both nostrils and into the second chamber 240 via the one or more nostril openings 234 and out of the patient interface via the offset vent 226; and

a second flow path from the first chamber 238 through the flow director 246 into the second chamber 240 and out of the patient interface through the offset vent 226.

When the patient interface 10 is fitted to a patient and a flow of pressurized gas is supplied to the patient interface 10, a first pressure P1 is generated in the first chamber 238 and a second pressure P2 is generated in the second chamber 240. Due to the combination of the flow restriction in the second flow path and the offset vent 226 in the second chamber 240, a pressure differential is created between the pressure P1 in the first chamber 238 and the pressure P2 in the second chamber 240, wherein the pressure P2 in the second chamber 240 is lower than the pressure P1 in the first chamber 238. This pressure differential means that pressurized gas supplied to the first chamber 238 will flow through both the first flow path and the second flow path in order to exit the patient interface via the offset vent 226 in the second chamber 240.

The balance of flow resistance through the first flow path and flow resistance through the second flow path determines the proportion of pressurized gas supplied to the patient interface 10 that travels through each path.

The second flow path is configured to have a sufficiently high flow resistance due to flow restriction in the second flow path such that at least a desired minimum portion of the pressurized flow of air supplied to the patient interface 10 flows away from the patient interface 10 along the first flow path. This enables irrigation of anatomical dead spaces of the patient, at least in the throat and nasal cavity. In some embodiments, the flow restriction (and thus the desired flow resistance) of the second flow path is achieved due to the restricted cross-section of the flow director 246. In other embodiments, a restriction may be provided at another location along the second flow path to create a desired flow resistance of the second flow path.

The patient interface 10 is also typically operated such that when the patient's mouth is closed, there is only a single flow path from the first chamber 238 through the flow director 246, through the one or more nostril openings 234, into one or both nostrils of the patient and into the nasal cavity, after which the flow of gas is slowed down and the direction of flow reversed, and the gas flows through the one or both nostrils of the patient, through the one or more nostril openings 234, into the second chamber 240 and out of the patient interface 10 through the offset vent 226. Because of the restricted cross-section of the flow directors 246 and the large volume of gas flowing through the flow directors due to the single flow path through the patient interface 10, the flow accelerates through the flow directors, creating a jet effect directed toward the patient's nostrils and into the patient's nostrils via the one or more nostril openings 234. This jet effect into one or both nostrils enables irrigation of the patient's anatomical dead.

It should be appreciated that the above description describes certain flow paths that are formed during use of the patient interface 10. If patient interface 10 is fitted to an anatomical model where no breathing occurs, it is believed that this will be observed. However, other flow paths may be formed, particularly during breathing through the mouth or nostrils. The following description provides some additional details regarding specific conditions during the respiratory cycle.

When breathing through the mouth, a substantial portion of the breathing gas supplied to the first chamber 238 is inhaled by the patient via the oral opening 232. Some of the breathing gas supplied to the first chamber 238 that exceeds the tidal flow requirement flows from the first chamber 238 through the flow director 246. The portion of the gas flowing through the flow director 246 may then flow through the nostril openings 234 and into the nostrils to flush the anatomical nasal dead space of the patient, while the remaining flow enters the second chamber 240 and exits the cushion module 20 via the offset vent holes 226. In addition to, or in lieu of, flowing through the flow director 246 as discussed above, the portion of the breathing gas supplied to the first chamber 238 that exceeds the tidal flow requirement may flow through the oral opening 232 into the patient's mouth, through the oral and nasal cavities and out through the nostrils thereof and into the second chamber 240 via the one or more nostril openings 234, and then out of the patient interface 10 via the offset vent 226, thereby effecting some irrigation of anatomical dead spaces. This is achieved due to the pressure difference created between the first and second chambers as discussed above. During exhalation, exhaled breathing gas flows from the mouth into the first chamber 238, where it mixes with fresh breathing gas supplied to the first chamber 238. This mixture of exhaled and fresh breathing gases then flows through the flow director 246, with the portion of the gases flowing through the flow director 246 flowing through the one or more nostril openings 234 and into the nostril to flush the anatomical nasal dead space of the patient, while a substantial portion of the exhaled and excess breathing gases will flow into the second chamber 240 via the flow director 246. The flow of breathing gas into the second chamber 240 is facilitated by the recessed position of the second opening 252 relative to the rim 286 of the one or more nostril openings 234. The exhaled and excess breathing gas then flows out of the second chamber 240 of the patient interface 10 via the offset vent 226. In most cases, the majority of the washout of the mouth and upper throat occurs near the end of the expiration and/or inspiration cycle when the pressure within the patient's mouth and throat is lower than the pressure of the breathing gas supplied to the first chamber, at which point the flow enters the patient's mouth via the oral opening 232, travels through the nasal cavity of the patient out of the nostrils, and into the second chamber 240 via the one or more nostril openings 234, thereby flushing the nasal cavity, mouth, and upper throat of the patient with fresh breathing gas.

When breathing through the nose with the mouth closed, the breathing gas supplied to the first chamber 238 flows through the flow director 246 and is directed to the nostrils. The breathing gas is inhaled through the nostrils. Respiratory gases that exceed the tidal flow requirements flow from the flow director 246 into the second chamber 240 and then out of the patient interface 10 via the offset vent 226. During most of the exhalation phase, because the pressure within the patient's nares is higher than the pressure of the supplied breathing gas, the breathing gas cannot enter the nares, and thus, the breathing gas flows into the second chamber 240 and then out of the patient interface 10 via the offset vent 226. Exhaled breathing gas flows into the second chamber 240 via the gap between the flow director 246 and the nostril openings 234 and merges with the flow of breathing gas exiting through the offset vent 226. However, near the end of the exhalation phase, when the pressure in the nasal cavity drops below the pressure of the supplied breathing gas, the accelerated flow of breathing gas from flow director 246 penetrates the nostrils, causing anatomical dead spaces and upper throat in the nasal cavity to be flushed with fresh breathing gas.

When breathing through the nose with the mouth open, the breathing gas supplied to the first chamber 238 flows through the flow director 246 and is directed to the nostrils. Respiratory gases are inhaled through the nostrils via the nostril openings 234. Some of the breathing gas exceeding the tidal flow requirement flows from the flow director 246 into the second chamber 240 and then out of the patient interface 10 via the offset vent 226. During exhalation through the nose with the mouth open, exhaled breathing gases enter the second chamber 240 via the nostril openings 234 and exit the patient interface 10 via the offset holes 226. At the same time, fresh breathing gas supplied to the first chamber enters the patient's mouth, travels through the patient's nasal cavity out of the nostrils, and enters the second chamber 240 via the nostril opening 234. This irrigates anatomical dead spaces in the patient's mouth, upper throat, and nasal cavity with fresh breathing gas. Further, near the end of the exhalation phase, when the pressure within the nasal cavity drops below the pressure of the breathing gas exiting the flow director 246, a portion of the supplied breathing gas may flow through the flow director 246 and into the nostrils such that anatomical dead spaces and upper throat within the nasal cavity are flushed with fresh breathing gas.

The above-described dead space flushing is the replacement of low oxygen content breathing gas in the patient's anatomical dead space with higher oxygen content breathing gas inhaled into the lungs at the beginning of the next inhalation cycle. The low oxygen content respiratory gas is pushed out of the dead space and into the second chamber 240 where it exits the patient interface 10 via the bias flow orifice 226. Will have a low oxygen content (or in other words, a high CO ₂ Content) of the respiratory gas into the patient interface 10 means that the low oxygen content respiratory gas is not available for inhalation at the beginning of the next respiratory cycle. This is achieved in part by: the first chamber 238 is supplied with pressurized breathing gas in combination with the offset vent 226 located in the second chamber 240 such that there is a constant unidirectional flow through the patient interface 10 to remove low oxygen content breathing gas from the patient interface 10 by pushing any low oxygen content breathing gas out of the second chamber 240 via the offset vent 226.

In other words, the above-described dead space flushing is the replacement of high carbon dioxide content respiratory gases in the patient's anatomical dead space with lower carbon dioxide content respiratory gases inhaled into the lungs at the beginning of the next inhalation cycle. The high carbon dioxide content respiratory gas is pushed out of the anatomical dead space and into the second chamber 240 where it exits the patient interface 10 via the bias flow orifice 226. Flushing high carbon dioxide content respiratory gas into patient interface 10 means that the high carbon dioxide content respiratory gas is not inhaled at the beginning of the next respiratory cycle.

Although providing supplemental oxygen to the patient increases the oxygen concentration, it does not necessarily reduce the presence in anatomical dead space as does flushing the anatomical dead space with ambient airCO in ₂ Horizontal. Thus, an advantage of this approach is that improved results are achieved without the need to supplement the breathing gas supplied to the patient interface 10 with oxygen. This is particularly advantageous in case of a shortage of supplemental oxygen. An additional advantage is that the potential risks associated with supplying supplemental oxygen to a patient may be avoided by eliminating or reducing the need for supplemental oxygen. Furthermore, this approach may provide improved results not achievable by supplementing oxygen alone, as removal of high carbon dioxide content respiratory gases from the patient's dead space may improve gas exchange within the lungs.

Alternative embodiments of cushion module 20 are described below. These alternative embodiments function in the same manner as described above for cushion module 20 in delivering breathing gas to a patient, removing excess breathing gas, and removing exhaled breathing gas.

The above-described embodiments relate to supplying breathing gas from a gas source to the first chamber 238 and exhausting the breathing gas from at least the second chamber. This configuration of supply and exhaust of breathing gas involves the flow of breathing gas from the first chamber 238 to the second chamber 240. However, in alternative embodiments, the housing 210 may be reconfigured to receive the breathing gas supplied from the gas source to the second chamber 240 and to exhaust the breathing gas from the first chamber 238. This configuration involves the flow of breathing gas from the second chamber 240 to the first chamber 238 via the flow director 246. While the embodiments of the cushion module described below are performed in the context of gas flowing from the first chamber 238 to the second chamber 240, the same applies to various cushion module embodiments, including variations of those embodiments described below. That is, those cushion module embodiments may be used in the direction of gas flow from the first chamber 238 to the second chamber 240 or the direction of gas flow from the second chamber 240 to the first chamber 238.

Although the above description of the sealing member 230 is in the context of features that are integrally formed by a molding process, any one or more of the features may be formed separately and then assembled with the sealing member 230. For example, the main portion 244 may be formed with an opening adapted to receive a preformed deflector unit comprising two spaced apart deflectors. One reason for this assembly method may be to form certain features from different materials. Referring to an example of a deflector unit, the unit may be formed of a hard plastic material having a significantly higher resistance to deformation than the same structure formed of silicone. In further examples, the spacer ribs 260 and/or the reinforcing section 264 may be formed separately from the sealing member 230 and joined at a later stage.

Another variation of the cushion module 20 is shown in fig. 12-15 as cushion module 1020. Features of the cushion module 1020 that are identical to features of the cushion module 20 are identified by identical reference numerals. Features that differ from those of the cushion module 20 are represented by like reference numerals preceded by the numeral "1".

The cushion module 1020 may be used with the same housing 210, frame 30 and conduit connector 40 as respectively disclosed in the cushion module 10. However, the cushion module 1020 differs from the cushion module 20 in that the flow directors 1246 have a larger cross-sectional area of the body to reduce the flow resistance of the breathing gas through these flow directors. In addition, the body 1248 is formed to have a funnel-shaped body lower portion 1256 (see fig. 13 and 14). The lower body portion 1256 includes more than 50% of the extent to which the deflector 1246 protrudes from the divider wall 242.

The spacing ribs 1260 between the deflectors 1246 are formed with concave bridges connecting the deflectors 1246. This shape reduces the risk of contact with the patient's nose, especially the patient's septum, which is a known highly sensitive area. The concave shape allows the spacers to extend further up the sides of each deflector 1246 and thus contribute more stabilizing effect to the deflector 1246. The spacer ribs 260 of the cushion module 20 are offset from the center of the distance spanned by the deflector 246 between the wall portion 276 and the second wall 272. Instead, the spacer ribs 1260 are located at or near the center of the span of the dimension. The more central position of the spacing rib 1260 assists in maintaining the spacing of the second openings 1252. More specifically, the more central location reduces the tendency of the deflectors 1246 to collapse toward each other when the wall portions 276 are subjected to a deforming force.

Another difference is that the reinforcing section 1264 is spaced apart from the wall portion 276 (fig. 14 and 15). Removing the contact point between the reinforcing section 264 and the wall portion 276 (as in the cushion module 20) reduces the local wall thickness of the wall portion 1276 and thus increases patient comfort. The body lower portion 256 of each deflector 246 sufficiently reinforces the main portion 244 such that deformation forces are directed from the wall portion 276 through the main portion 244 and into the deformation panel 294. The reinforcement of the main portion 244 avoids the need for the reinforcing section 264 to be connected to the wall portion 276 or for the reinforcing section 264 to have a force dispersing end 266.

Another variation of the cushion module 20 is shown in fig. 16-23 as cushion module 2020. Features of the cushion module 2020 that are identical to features of the cushion module 20 are identified by identical reference numerals. Features that differ from those of the cushion module 20 are represented by like reference numerals including the numeral "2".

The cushion module 2020 differs from the cushion module 20 in that the deflector 2246 is linked to the outer wall 288 in the second chamber 240, see fig. 19, 20 and 22. This means that the breathing gas flows through the passage formed in part by the body 2248 and in part by the outer wall 288. The junction of body 2248 with outer wall 288 is shown conceptually in fig. 16 and 17 by intersection line 2280. Intersection line 282 between partition wall 242 and outer wall 288 is also shown in fig. 16 and 17, where intersection line 2280 can be seen intersecting intersection line 282.

The deflector 2246 has a second opening 2252 defined in part by the rim 286 of the nostril opening 234 and in part by the rim 2254. The rim 2254 extends from the outer wall 288 and is recessed from the nostril opening 234, as shown in figures 17, 18 and 20. The edge 2254 may extend from the edge 286 or may be recessed back from the edge 286 such that the edge 2254 and the edge 286 are not in direct contact. Accordingly, a second opening 2252 defined by rims 2254 and 286 is recessed from the nostril opening 234. This provides the same breathing gas flow effect as described above with respect to cushion module 20, i.e., breathing gas from first chamber 238 may flow into the nostrils or into second chamber 240 via deflector 2246.

In this embodiment, the deflectors 2246 are spaced farther apart than the deflectors 246 and 1246 in the cushion modules 20 and 1020, respectively. The additional spacing lines the second opening 2252 with the lateral outside of the patient's nostril and provides a wider contact point spacing where the body 2248 meets the outer wall 288. By spacing the contact points away from the patient's septum, a wider spacing of the contact points is expected to increase patient comfort. Furthermore, when the deflectors 2246 are linked to the outer wall, they do not require the equivalent of the spacing ribs 260 or 1260 (as in the embodiments described above) because the deflectors are less likely to collapse laterally inward.

The body 2248 of each deflector 2246 is linked to the outer wall 288 between the nostril opening 234 and the oral opening 232. More specifically, the body 2248 of each deflector 2246 is linked to the outer wall 288 at or near the nostril opening 234.

The deflector 2246 is spaced apart and a portion of the body 2248 is joined with the outer wall 288 on the laterally outer side of the lateral rim 286 of the nostril opening 234 and another portion of the body 2246 is joined with the laterally inner side of the lateral rim 286 of the nostril opening 234. In this form, each body 2248 has a side wall 274a and an inner side wall 274b, both extending from the wall section 276 and meeting one another away from the wall section 276. In addition, side walls 274a and inner side walls 274b extend from partition wall 242 to meet outer wall 288. The sidewall 274a joins with the outer wall 288 on a laterally outer side of the lateral rim 286 of the nostril opening 234 such that the rim 286 of the nostril opening 234 forms part of the rim 2254 of the deflector 2246. The inner sidewall 274b joins the outer wall 288 on a laterally inward side of the lateral rim 286 of the nostril opening 234 such that a portion of the inner sidewall 274b forms a portion of the rim 2254 of the deflector.

The second opening 2252 rim 2254 formed by the inner sidewall 274b is closer to the divider wall 242 than the second opening 2252 rim 286 formed by the lateral rim 286 of the nostril opening 234. Thus, the second opening of the deflector 2246 is defined in part by the nostril opening 234. Such a configuration of the second opening 2252 may have the effect of directing the breathing gas laterally inwardly as it flows from the deflector 2246 into the second chamber 240.

In alternative embodiments, the deflector 2246 may be linked to the outer wall 288 in the first and second chambers 238, 240. In further alternative embodiments, the body 2248 may be linked to the outer wall 288 on the side of the nostril opening 234 opposite the wall portion 276.

The cushion module 2020 includes a reinforcement section 264 having a force dispersing end 266. Accordingly, the primary and secondary deformation effects described above with respect to cushion module 20 apply to cushion module 2020 in the same manner.

The cushion module 2020 includes an additional reinforcing section 2264 where the body 2248 of the deflector 2246 meets the partition wall 242, see fig. 17, 18 and 19. The reinforcing section 2264 is a thickened rounded corner where the respective body 2248 meets the divider wall 242. Accordingly, the reinforcing section 2264 extends from the outer wall 288 on one side of the body 2248 and returns to the outer wall 288 on the other side of the body 2248. The location of the reinforcing section 2264 serves to guide the deforming force applied to the wall portion 276 through the main portion 244 and into the deforming panel 294. Thus, the deforming forces are directed through the reinforcing section 2264 and around the base of the deflector 2246 such that they may retain their shape when the deforming forces are applied. In this configuration, reinforcing section 264 does not overlap reinforcing section 2264.

Another variation of cushion module 20 is shown in fig. 24-29 as cushion module 3020. Features of the cushion module 3020 that are identical to features of the cushion module 20 are identified by the same reference numerals. Features that differ from those of the cushion module 20 are represented by like reference numerals including the numeral "3".

The cushion module 3020 is similar to the cushion module 2020 in that the deflector 3246 is linked to the outer wall 288, see fig. 25 and 29. This means that the breathing gas flows through the channel formed in part by the body 3248 and in part by the outer wall 288. The junction of body 3248 with outer wall 288 is shown conceptually in fig. 24 by junction line 3280. Intersection line 282 between partition wall 242 and outer wall 288 is also shown in fig. 26, where intersection line 3280 can be seen intersecting intersection line 282.

The cushion module 3020 includes flow directors 3246 having second openings 3252 defined in part by the rim 286 of the nostril opening 234 and in part by the rim 3254. Rim 3254 extends from outer wall 288 and is recessed from nostril opening 234, as shown in figures 26 and 27. Edge 3254 is recessed back from edge 286. In this embodiment, edge 3254 joins bead 262. However, in other embodiments, the rim may be further retracted rearward by joining with the outer wall 288 adjacent to the bead 262. As shown in fig. 27, the rim 3254 extends away from the outer wall 288. In this way, the second opening 2252 defined by the rims 2254 and 286 is recessed from the nostril opening 234. This provides the same breathing gas flow effect as described above with respect to cushion module 20, i.e., breathing gas from first chamber 238 flows into nostril or second chamber 240.

The cushion module 3020 further differs from the cushion module 2020 in that the reinforcing section 264 (shown in fig. 28 and 29) has a bifurcated force dispersing end 3266. The force dispersing end 3266 is spaced from the wall section 276. This is expected to reduce the pressure felt by the patient through the wall section 276. Bifurcated force-dispersing end 3266 is formed to disperse slightly wider than the human and/or septum of most patients. (it should be appreciated that a set of different sized patient interfaces may accommodate a wide range of facial geometries). For a given patient interface size, force-dispersing end 3266 is formed to disperse slightly wider than the person of the majority of patients for whom the patient interface 10 is sized. When patient interface 10 is assembled and therapy is applied, bifurcation is expected to relieve pressure exerted on the patient by wall portion 276. Additionally, it should be appreciated that by having two points of contact due to bifurcation, the force applied through each point of contact may be halved. This means that the wall thickness of the wall section 276 may be reduced due to the reduced point load of the reinforcing section 264. In this embodiment, the wall thickness of the wall section 276 is 0.7mm. Other embodiments may involve the body 3248 and the wall section 276 having different wall thicknesses.

Additional reinforcing sections 3264 are included where the body 3248 meets the divider wall 242, see fig. 26 and 27. While in this embodiment the reinforcing sections 3264 do not extend to the outer wall 288, in other embodiments they may extend to the outer wall. The location of the reinforcing section 3264 serves to guide the deforming force applied to the wall portion 276 through the main portion 244 and into the deforming panel 294. Accordingly, the deforming force is directed through the bifurcated force-dispersing end 3266 which overlaps the reinforcing section 3264. This means that the deforming forces are transmitted through the reinforcing section 3264 and around the base of the deflector 3246 so that they may retain their shape when the deforming forces are applied.

Another variation of the cushion module 20 is shown in fig. 30-40 as cushion module 4020. Features of the cushion module 4020 that are identical to features of the cushion module 20 are identified by the same reference numerals. Features that differ from those of the cushion module 20 are represented by like reference numerals including the numeral "4".

In this embodiment, the cushion module 4020 includes a dividing wall 4242, a deflector 4246, and a deformation region similar to the deformation region described above with respect to the cushion module 20. All will be described in more detail below.

The dividing wall 4242 divides the interior of the cushion module 4020 to define a first chamber 238 and a second chamber 240. The dividing wall 4242 separates the first chamber 238 from the second chamber 240 by extending all the way across the interior volume of the cushion module. In other words, the perimeter of the divider wall 4242 seals with the outer wall 288.

The divider wall 4242 has a flatter but still curved profile as compared to the divider wall 242 of the cushion module 20, which joins with the laterally positioned reinforcement portion 804 of the outer wall 288. The flatter profile reduces movement of the deflectors 4246 toward each other. Accordingly, the divider wall 4242 is configured to reduce collapse or buckling of the deflector 4246. In each case, the divider walls 4242 are configured to reduce collapse or buckling of the flow directors 4246 inwardly toward each other.

More specifically, the partition wall 4242 has a flatter lateral profile than the partition wall 242 in this embodiment. As shown in fig. 30, 31 and 33, the location where the divider wall 4242 joins the outer wall 288 is indicated by the intersection line 4282. The intersection line 4282 extends below the offset vent 226 and across the wall portion 276 and around the sides of the cushion module 4020 along an imaginary line contiguous with the line extending across the top of the housing 210.

As can be seen in fig. 34, the partition wall 4242 includes a deflector 4246 disposed away from the wall portion 276, and the deformation panel 294 is disposed away from the deflector 4246. The deformation panel 294 is identical to the deformation panel 294 described above with respect to the cushion module 20 and operates in the same manner in terms of controlled collapse under the influence of a deforming force applied to the wall portion 276. This means that the deformation panel 294 in the cushion module 4020 is configured to deform in preference to the deflector 4246 and the main portion 244. The divider wall 4242 includes a lateral side portion 800 disposed laterally outboard of the deflector 4246 and joined with the outer wall 288. The lateral side portions 800 are adjacent to the deformation region. In this embodiment, the deformation region is configured to deform in preference to the lateral side portion 800 as well. As shown in fig. 36, the lateral side portion 800 joins the outer wall 288 at a location spaced from the top of the outer wall 288. In this particular embodiment, the level at which the lateral side portions 800 join the outer wall 288 is significantly lower than the level at the top of the outer wall 288. More specifically, with the patient interface 10 in mind the upright orientation, the lateral side portions 800 are joined with the outer wall 288 along a line extending at least partially above and partially below the lowest level of the nostril openings 234 (i.e., the intersection line 4282), and the intersection line 4282 does not extend above the highest level of the nostril openings 234.

However, in another embodiment, the lateral side portion 800 may be joined with the outer wall 288 at a level below the lowest level of the nostril opening 234. In further embodiments, a portion of the lateral side portion 800 is joined with the outer wall 288 along a line that extends between the highest level and the lowest level of the nostril opening 234 and does not extend above the highest level of the nostril opening 234, in view of the upright orientation of the patient interface 10. In further alternative embodiments, a portion of the lateral side portion 800 is joined with the outer wall 288 along a line extending above the highest level of the nostril opening 234, taking into account the upright orientation of the patient interface 10. In another alternative embodiment, lateral side portion 800 joins outer wall 288 at a level that is lower than or substantially equal to the uppermost level of deflector 4246, given the upright orientation of patient interface 10.

Due to the flatter transverse profile of the dividing wall, the inclination of the lateral side portion 800 at its junction with the outer wall 288 is horizontal, or at an acute angle relative to the horizontal, taking into account the upright orientation of the patient interface 10. More specifically, considering the upright orientation of the patient interface 10, the inclination of the lateral side portion 800 at its junction with the outer wall 288 is less than 45 °, less than 30 °, or less than 15 ° relative to the horizontal. In most embodiments, the lateral side portions 800 will join with the outer wall 288 to form an obtuse angle with the inner surface of the outer wall in the second chamber 240.

The sealing member 4230 includes reinforcing portions 804 (fig. 36) that resist deformation of the sealing member 4230 and thereby assist in maintaining the shape of the sealing member 4230. The reinforcing section 804 includes a portion having a wall thickness that is greater than the wall thickness of the other portions of the outer wall 288. The lateral side portions 800 are at least partially joined with reinforcing portions 804 of the outer wall 288 having a wall thickness that is greater than the wall thickness of the patient contacting surface 290 of the outer wall 288. For example, the lateral side portion 800 is joined with a reinforcing portion 804 of a sealing member 4230 that is over-molded with the housing 210. The joining of the lateral side portion 800 with the overmolded reinforcing section 804 of the sealing member 4230 assists in maintaining the shape of the separation wall 4242 by transmitting deformation forces applied to the patient contact surface 290 to the reinforcing section 804 (such as the overmolded reinforcing section 804 of the sealing member 4230).

As with the other embodiments, the cushion module 4020 defines an interior volume including a first chamber 238 and a second chamber 240. The second chamber 240 is located in an upper portion of the interior volume of the seal member 4230. With the patient interface 10 in an upright orientation, the first resilient region 268 is positioned at a level greater than or equal to the offset vent 226. The dividing wall 4242 is joined with the wall portion 276 at a substantially middle between the nostril opening 234 and the oral opening 232. Alternatively, the partition wall 4242 may be joined with the wall portion 276 in the upper half of the wall portion 276.

Fig. 34 to 40 show a deflector 4246. The flow director 4246 enables gas to flow between the first chamber 238 and the second chamber 240. Each deflector 4246 has: a base 806 (which is joined to the dividing wall 4242 and defines a first opening 4250 into the first chamber 238); a body 4248 extending from the base 806; and a rim 4254 remote from the base 806. The rim 4254 defines a second opening 4252 open to the second chamber 240. As with the other embodiments, the gas flow passage 812 extends from a first opening 4250 in the base 806 to a second opening 4252 of the rim 4254.

While this and other embodiments show the body 4248 extending from the divider wall 4242 into the second chamber 240, it should be appreciated that other configurations of the flow director 4246 may be employed. An example of one such configuration involves at least a portion of the body 4248 extending into the first chamber 238. In other words, the body 4248 extends partially downward from the divider wall 4242 and into the first chamber 238, and also extends partially upward from the divider wall 4242 and into the second chamber 240. In this configuration, the base 806 joins the body 4248 to the divider wall 4242. The dividing wall has an annular form from which the body lower portion 4256 extends into the first chamber 238. The lower body portion 4256 includes a first opening 4250 in the first chamber. The upper body portion 4258 extends from the base 806 into the second chamber 240 and includes a second opening 4252. This configuration may be combined with any of the features described in the above embodiments and the following embodiments. In another embodiment, the flow directors 4246 may not extend from either side of the dividing wall 4242. For example, the wall thickness of the divider wall 4242 may be sufficient to include a deflector 4246 between the surfaces of the divider wall 4242 that are exposed to the first and second chambers 238, 240, respectively.

Fig. 34, 35, and 39 illustrate that the body 4248 of each deflector 4246 includes a transition intermediate the base 806 and the rim 4254. The transition 802 defines a lower body portion 4256 from the upper body portion 4258. The lower body portion 4256 extends from the base to the transition. The upper body portion extends from the transition to the rim 4254. In this embodiment, the transition portion includes, at least in part, a step portion 802, and the upper body portion 4258 extends from the step portion 802 to the rim 4254. A step 802 is formed on the exterior of the deflector 4246. The wall thickness of the upper body portion 4258 is less than the wall thickness of the lower body portion 4256. Thus, the step 802 joins the different wall thicknesses of the upper body portion 4258 and the lower body portion 4256. The step 802 extends completely around the deflector 4246. Accordingly, there is a step change in the wall thickness of the deflector 4246 from the lower body portion 4256 to the upper body portion 4258. The step change in wall thickness of the deflector 4246 occurs on the outer surface of the deflector 4246 such that the inner surface of the deflector 4246 is smooth. The body upper portion 4258 extends from the step 802. The upper body portion 4258 terminates in a rim 4254 spaced from the nostril opening 234. The wall thickness of the upper body portion 4258 is less than the wall thickness of the lower body portion 4256. The thinner wall thickness of the upper body portion 4258 makes it easier to deform, and therefore, less uncomfortable for the patient if the upper body portion 4258 is in contact with the patient's nose. The greater wall thickness of the lower body portion 4256 increases the resistance of the deflector 4246 to collapse or buckling under the influence of the deforming force. The wall thickness is selected to increase the resistance to deformation such that the deforming force applied to the wall portion 276 is transferred through the dividing wall 4242 around the deflector 4246 into the deforming panel 294. As such, the deformation panel 294 deforms in preference to the flow director 4246, and thus, the flow director 4246 is more likely to retain its shape when a deforming force is applied and retain the ability to transfer a desired gas flow rate between the first and second chambers 238, 240. In other words, the deflector 4246 is less likely to clog when a deforming force is applied.

As shown in fig. 35 and 36, the step 802 is inclined with respect to the partition wall 4242. The step 802 is farther from the divider wall 4242 distally of the flow director 4246 and nearer to the divider wall 4242 proximally of the flow director 4246. Additionally, given the upright orientation of patient interface 10, step 802 also slopes downward in a laterally inward direction toward a vertical midplane passing through patient interface 10. This means that the step 802 is further from the partition wall 4242 laterally outside the deflector 4246 than the step is from the partition wall 4242 laterally inside the deflector 4246. The lateral and proximal inclination of the stepped portion 802 provides a substantially constant spacing between the stepped portion 802 and the nostril opening 234.

The upper body portion 4258 extends a constant distance from the step 802 with respect to the deflector 4246. This means that the edge 4254 has the same inclination as the step. That is, the rim 4254, and thus the second opening 4252, has an inclination that provides a substantially constant spacing between the rim 4254 and the nostril opening 234. However, the rim 4254 is further retracted rearwardly from the nostril opening 234 as compared to other embodiments previously disclosed. The increased rearward indentation further facilitates the flow of gas (such as breathing gas exhaled by the patient orally) from the first chamber 238 to the second chamber 240. It also facilitates the flow of gas (such as breathing gas exhaled through the patient's nostrils) from the nostrils into the second chamber 240 via the nostril openings 234.

In the illustrated embodiment, the step 802 extends substantially entirely around the deflector 4246. However, the transition may include a step 802 in only a portion of the deflector 4246. For example, in some embodiments, the step 802 may extend around at least a distal side of the deflector 4246. In other embodiments, the step 802 may extend around the distal and lateral sides of the deflector 4246.

In this embodiment, the radial wall thickness of the lower body portion 4256 is constant in the circumferential direction around the deflector 4246. The radial wall thickness of the upper body portion 4258 is also constant in the circumferential direction around the deflector 4246. This means that the step 802 has a constant wall thickness variation around the deflector 4246 from the lower body portion 4256 to the upper body portion 4258. However, in other embodiments, the radial wall thickness of the lower body portion 4256 relative to the longitudinal axis of the deflector 4246 may vary with respect to the deflector 4246. In further embodiments, the radial wall thickness of the lower body portion 4256 may vary in a circumferential direction around the deflector 4246. Alternatively, the radial wall thickness of the lower body portion 4256 may vary with the spacing of the rim 4254 from the base 806. For example, the radial wall thickness of the lower body portion 4256 may be greater where the rim 4254 is spaced farther from the base 806 than where the rim 4254 is spaced less from the base 806. As another example, the radial wall thickness of the lower body portion 4256 is smallest where the spacing between the rim 4254 and the base 806 is smallest, and increases as the spacing between the rim 4254 and the base 806 increases. The reduced radial wall thickness of the upper body portion 4258 relative to the lower body portion 4256 makes it more compliant and, therefore, less uncomfortable for the patient with the patient's nose contacting the upper body portion 4258.

The divider wall 4242 further includes spacer ribs 4260 disposed between the bodies 4248 of the flow directors 4246, as shown in fig. 34-36. The spacer rib 4260 is joined to the body 4248 at a location spaced from the rim 4254. In this embodiment, spacer ribs 4260 extend from the divider wall 4242 between the deflectors 4246 and join the base 806, the lower body portion 4256, the step 802, and the upper body portion 4258, but are spaced from the rim 4254. Spacing the spacing rib 4260 from the rim 4254, and thus further from the nostril opening than the rim 4254, reduces the chance of the patient's nose coming into contact with the spacing rib 4254 during use. The spacer ribs 4260 are disposed in a plane intersecting the longitudinal axis of the deflector 4246. Accordingly, a spacer rib 4260 is disposed intermediate between the proximal and distal sides of the deflector 4246.

As shown in fig. 35, the spacer ribs 4260 have an inverted U-shaped profile. The spacer ribs 4260 strengthen the flow directors 4246 and make them more resilient to flex inwardly or outwardly. Reducing the likelihood of buckling assists in maintaining the alignment of the flow director 246 in the following directions: in use, the flow of breathing gas is directed towards the nostril openings 234. Further, the location of the spacer ribs 4260 and the reinforcing sections 4264 means that deflection of the wall portion 276 is transmitted through the spacer ribs 4260 and the reinforcing sections 4264 and thus causes the deflector 4246 to track movement of the wall portion 276 and the nostril openings 234.

With the patient interface 10 in an upright orientation, the spacer ribs 4260 have a generally upright orientation. Assuming that the partition wall 4242 is inclined downward from the wall portion 276 to the deformation panel 294, the partition rib 4260 is inclined with respect to the partition wall 4242. That is, the partition rib 4260 joins the partition wall 4242 at an acute angle at the proximal side thereof. The spacer ribs 4260 comprise rounded transitions that join the flow directors 4246. This provides a smooth transition 802 from the spacer ribs 4260 to the base 806 and to the body 4248 of the deflector 4246.

The thickness of the spacer ribs 4260 in the proximal-distal direction is significantly greater than the wall thickness of the deflector 4246. More specifically, the wall thickness of the spacing rib 4260 in the distal-proximal direction is 5% to 20%, 20% to 40%, or 40% to 60% of the maximum width dimension of the deflector 4246.

The spacer ribs 4260 in fig. 35, 36 and 38 overlap the reinforcing sections 4264 on the bottom side of the partition wall 4242 disposed between the respective first openings 4250 of the flow directors 4246. The reinforcing section 4264 comprises a thickened section of the divider wall 4242. The enhancement section 4264 extends in the proximal-distal direction. Further, the reinforcing section is spaced apart from the wall portion 276 and the deformation panel 294. The reinforcing section 4264 increases the stiffness of the dividing wall 4242 in the region between the wall portion 276 and the deformation panel 294, and thus helps transfer the deformation force applied to the wall portion 276 around the deflector 4246 to the deformation panel 294. Accordingly, the reinforcing section 4264 assists in maintaining the position of the divider wall 4242 (and the deflector 4246) relative to the nostril opening 234. In other words, the reinforcing section 4264 assists in supporting the divider wall in position relative to the wall portion 276. This allows patient treatment to continue during deformation of the patient contacting surface 290 of the outer wall 288 with minimal disturbance to the flow of breathing gas (a) through the flow director 4246, (b) through the nostril openings 234 and (c) through the second chamber 240.

The reinforcing section 4264 transmits the deforming force from the wall portion 276 to the deforming panel 294 by means of portions 808, 810 of the dividing wall 4242 having a wall thickness greater than the wall thickness of the other portions of the dividing wall 4242. Portions 808, 810 are located proximal and distal, respectively, of the deflector 4246. In some embodiments, the proximal portion 808 and the distal portion 810 are located proximal and distal, respectively, of the spacer rib 4260. In some embodiments, the proximal portion 808 and the distal portion 810 include respective portions of the divider wall 4242 proximal and distal, respectively, of the deflector 4246. The proximal portion 808 is located between the lateral side portions 800 of the divider walls 4242. Alternatively, the proximal portion may be located between the deflectors 4246. The distal portion 810 is located between the lateral side portions 800 of the divider wall 4242. For embodiments that do not include the spacer ribs 4260, the proximal portion 808 and the distal portion 810 are located proximal and distal, respectively, of an imaginary line passing through the center of the respective second opening 4252 of the deflector 4246. The wall thickness of the distal portion is represented by a wall thickness that does not include the wall thickness of the reinforcing section 4264. Fig. 36 shows a distal portion 810 having a wall thickness greater than that of the lateral side portion 800. The distal portion 810 extends from the spacer rib 4260 around the base 806 of the deflector 4246. The distal portion 810 also extends toward the deflection panel but is spaced apart from the second wall 272 of the deformation panel 294. Accordingly, the distal portion 810 overlaps the reinforcing section 4264. The same applies to the proximal portion 808 as shown in fig. 35 and 38. The proximal portion 808 joins with the spacer ribs 4260 and overlaps with the reinforcing section 264. The proximal portion 808 extends proximally from the spacer rib 4260 about the base 806 of the deflector 4246. The proximal portion 808 is coupled to the wall portion 276.

These portions 808, 810 have greater resistance to deformation due to their greater wall thickness than the wall thickness of the other portions of the divider wall. Thus, the deforming force exerted on the wall portion 276 is transferred through the divider wall 4242 to the deforming panel 294, which will deform in preference to the portions 808, 810. The presence of the portions 808, 810, along with the reinforcing section 276 and the spacing ribs 4260, resists undesired deformation of the divider wall 4242 by improving the transmission of deformation forces into the deformation panel 294. Thus, the deflector 4246 is less likely to collapse or buckle due to buckling of the partition wall 4242. However, the wall thicknesses of the portions 808, 810 are limited because increasing the wall thicknesses of these portions has the effect of localizing the pressure experienced by the patient at the wall portion 276. In other words, the increased wall thickness of the portion increases the likelihood of pressure sores. Conversely, making the wall thickness too small will result in buckling of the divider wall 4242 and possible buckling of the deflector 4246, as deformation forces cannot be transferred to the deformation panel 294.

The larger wall thickness of the portions 808, 810 means that the reinforcing section 4264 need not extend all the way to the wall portion 276 or all the way to the deformation panel 294 to transfer deformation forces from the wall portion 276 into the deformation panel 294.

By employing a larger first opening 4250 and a larger second opening 4252, the flow resistance through the deflector 4246 is reduced compared to the deflector 246 of the cushion module 20. A comparison between the first opening 250 of the cushion module 20 in fig. 11 and the first opening 4250 of the cushion module 4020 in fig. 40 provides an example of the size difference between the fluid director 4246 and the fluid director 246. To accommodate the larger size of the first opening 4250, the shape and orientation of the first opening 4250 is different to allow the deflector 4246 to fit between the wall portion 276 and the deformation panel 294. The shape shown in fig. 40 is employed such that the deflector 4246 is spaced apart from the wall portion 276 and the deformation panel 294. This reduces the extent to which the wall portion 276 is reinforced by the base 806. The stiffening of the wall portion 276 may reduce patient comfort by creating localized pressure points that may cause patient soreness over time. Spacing the deflector 4246 from the deformation panel 294 provides additional displacement travel for deformation of the deflection panel 204, thereby absorbing deformation forces. That is, limiting the extent of travel of the deformation panel 294 limits the amount of deformation force that can be absorbed before other features of the seal member 4230 (e.g., the divider wall 4242 or the deflector 4246) begin to flex under the influence of the deformation force. Such uncontrolled buckling is undesirable because it may cause misalignment of the flow director with the nostril openings, obstruct gas flow through the flow director, or even block gas flow through the flow director.

As shown in fig. 40, the first opening 4250 is shaped such that its long axis U1 is longer than the orthogonal short axis U2. In this embodiment, the first opening 4250 has an elliptical shape. However, it should be appreciated that alternative shapes having a major axis U1 and an orthogonal minor axis U2 may be employed instead of the oval shape. To assist in fitting the first opening 4250 between the wall portion 276 and the deformation panel 294, the long axis U1 is located in the plane of the dividing wall 4242 and is oriented at least 45 ° from a vertical mid-plane through the patient interface 10. Therefore, the size of the first opening in the near-far direction is reduced as compared with the case where the long axis U1 is parallel to the vertical midplane. In the embodiment shown in fig. 40, the long axes U1 of the respective first openings 4250 intersect at a point on the proximal side of an imaginary straight line 814 (fig. 40) passing through the center of the first opening 4250. In some embodiments, the long axis U1 of the respective first opening 4250 may intersect at a point proximal to the patient contacting portion 290 of the outer wall 288. In either case, the angle (V) between the long axes U1 when they intersect is less than 180 °. The angle V may be in the range of 45 ° to less than 180 °, in the range of 90 ° to 150 °, or in the range of 110 ° to 150 °. In other embodiments, the long axes U1 of the respective first openings 4250 may intersect at a point on the distal side of a straight line passing through the center of the first opening 4250. In this alternative, the angle V between the long axes U1 falls within the range described above.

The orientation of the major and minor axes U1, U2 remains unchanged throughout the deflector 4246. However, the dimensions of the flow director 4246 along the major axis U1 and the minor axis U2 at the second opening 4252 are different than the dimensions of the flow director 4246 along the major axis U1 and the minor axis U2 at the first opening 4250. Specifically, in this embodiment, the dimensions of the flow director 4246 at the second opening 4252 along both the major axis U1 and the minor axis U2 are smaller than the dimensions of the flow director 4246 at the first opening 4250 along the respective major axis U1 and minor axis U2. In other embodiments, the orientation of the major axis U1 and the minor axis U2 at the second opening 4252 is different than the orientation of the major axis U1 and the minor axis U2 at the first opening 4250. Alternatively, the orientation of the major and minor axes U1, U2 may vary from the first opening 4250 to the second opening 4252 through the flow director 4246. In other embodiments, the dimensions of the flow director 4246 along one of the major axis U1 or the minor axis U2 at the second opening 4252 may be different than the dimensions of the flow director 4246 along the corresponding axis at the first opening 4250. For example, the size of the flow director 4246 at the second opening 4252 along only one of the major axis U1 or the minor axis U2 is less than the size of the flow director 4246 at the first opening 4250 along the corresponding axis. Alternatively, the dimensions of the deflector 4246 along the major axis U1 or the minor axis U2, or both the major axis U1 and the minor axis U2, vary across the deflector 4246 from the first opening 4250 to the second opening 4252. In other embodiments, the orientation and dimensions of the fluid director 4246 at the second opening 4252 along the major axis U1 and the minor axis U2 are different than the orientation and dimensions of the fluid director 4246 at the first opening 4250 along the major axis U1 and the minor axis U2.

The positioning of the second opening 4252 relative to a vertical midplane passing through the patient interface 10 is selected to direct gas flowing from the first chamber 238 to the second chamber 240 through the nostril opening 234 and into the patient's nostrils. However, there is a risk that if the second opening 4252 is placed too close, the flow of gas may be directed into the patient's septum. This can lead to patient discomfort, undesirable turbulence, and problems with delivering adequate flow to the nostrils. Accordingly, the second openings 4252 are sufficiently spaced apart to direct the flow of gas into the nostrils and to substantially avoid directing the flow of gas into the patient's septum. In this embodiment, due to the orientation of the major and minor axes U1, U2 and the spacing of the second openings 4252, the outer wall 288 extends over a portion of the second openings 4252 when the patient interface 10 is not fitted to a patient. This can be seen in fig. 32 and 40, wherein a laterally outer portion of the rim 286 of the nostril opening 234 extends over a portion of each second opening 4252 when the patient interface 10 is not assembled. That is, with the cushion module 4020 in view of its upright orientation, the portion of the outer wall 288 surrounding the nostril opening 234 extends laterally outwardly of the respective second opening 4252 when viewed vertically from above the cushion module 4020.

In the view shown in fig. 32, at least a portion of each second opening 4252 is obscured by outer wall 288 when patient interface 10 is viewed vertically from above a midpoint between second openings 4252, taking into account the upright orientation of patient interface 10 when patient interface 10 is not assembled. However, the outer wall 288 is configured to enable the nostril opening 234 to extend laterally outward when fitted to a patient. This is primarily due to the fact that the nostril sealing portion 236 flexes to receive the underside of the patient's nose when the patient interface 10 is assembled to the patient, such that the curvature decreases when the patient interface 10 is assembled. However, this is facilitated by the outer wall 288 being formed of an elastic material. The nostril sealing portion 236 has a relatively thin wall thickness as compared to the other portions of the outer wall 288, such that the resilient material forming the outer wall 288 enables the nostril opening 234 to expand laterally outwardly when fitted to a patient. In other words, the patient contact surface 290 includes a valley-shaped naris seal portion 236 configured to receive the underside of the patient's nose. The valley-shaped bottom portion, including the nostril openings 234, adopts a flatter valley-shape when the patient interface 10 is fitted to a patient. Thus, when the patient interface 10 is assembled to a patient, the laterally outer edges of the nostril openings 234 are laterally displaced outwardly from the second openings 4252. Thus, when the patient interface 10 is assembled, the flow of gas through the flow director 4246 will be directed through the nostril openings 234 without impinging on the outer wall 288.

The curvature of the outer wall 288 and the outer wall being formed of a resilient material facilitate the change in the area, shape, or shape and area of the nostril opening 234 when the patient interface 10 is assembled to a patient. This variation enables the flow of gas through the deflector to be directed through the nostril openings 234 without impinging on the outer wall 288.

Alternative forms of deflectors, spacing ribs, reinforcing sections, distal portions, and proximal portions may be utilized in place of the deflectors, spacing ribs, reinforcing sections, distal portions, and proximal portions described above with respect to cushion module 4020. Some alternative embodiments of these components are discussed below. It should be appreciated that different alternative embodiments may be combined together in the cushion module 4020. For example, any of the alternative flow directors 246, 1246, 2246, 3246, and 4246 discussed above or any of the flow directors 820, 830, 840, 850, 860, 870, 880, or 890 described below may be combined at the cushion module 4020 with any of the alternative spacing ribs 260, 1260 discussed above or any of the spacing ribs 828, 838, 848, 888, 898 discussed below.

Features of the following embodiments that are identical to features of the cushion module 4020 are identified by the same reference numerals.

An alternative flow director 820 is shown in fig. 41. Deflector 820 has the same general form as deflector 4246, with the former deflector comprising a base 821, a body 822 extending from base 821, and a rim 823. Base 821 joins body 822 to divider wall 4242. Base 821 forms a smooth transition surface between body 822 and divider wall 4242. Similar to the deflector 4246, a portion of the outer wall 288 extends laterally outboard of the second opening 824 defined by the rim 823. This is shown in fig. 42. As explained above with respect to cushion module 4020, when patient interface 10 is assembled, nostril openings 234 laterally expand such that nostril openings 234 extend laterally outward such that outer wall 288 does not extend over second opening 824.

The deflector 820 differs from the deflector 4246 in that it has a differently shaped body 822 and differently shaped spacer ribs 828. Body 822 includes a transition 825 that defines a body lower portion 826 from body upper portion 827. The body lower portion 826 has a reduced wall thickness from the base 821 to the transition 825. The upper body portion 827 has the same wall thickness from the transition to the rim 823. The body lower portion 826 is angled in the proximal direction such that a proximal side of the body lower portion 826 extending from the base 821 to the transition 825 is shorter than a distal side of the wall lower portion 826 extending from the base 821 to the transition 825. The body upper portion 827 is angled proximally and laterally inwardly. In other words, the rim 823 is sloped such that it is spaced farther from the divider wall 4242 distally laterally outboard of the deflector than the rim 823 is spaced from the divider wall 4242 proximally laterally inboard of the deflector 4246. The transition 825 occupies a plane that is inclined in the same manner as the lower body portion 826. The same angular direction exists in the deflector 4246. The angulation of the lower body portion 826 and the upper body portion 827, as well as the lateral positioning of the flow director 820, help direct the breathing gas from the flow director 820 through the one or more nostril openings and into the nostrils.

The base 821 of each deflector is joined at a vertical midplane passing through the cushion module 4020 (as shown in fig. 42). The spacing ribs 828 span the gaps between the flow directors 820. A spacing rib 828 extends from the base 821 of each deflector 820 to the transition 825. The tops of the spacing ribs 828 form straight lines between the flow directors 820. The spacing ribs 828 overlap the reinforcing sections 4264 on the bottom side of the divider wall 4242. The proximal portion 808 and distal portion 810 of the divider wall 4242 have the same wall thickness as the lateral side portion 800.

Another alternative flow director 830 is shown in fig. 43. The deflector 830 has the same general form as deflector 820, with the former deflector having a base 831, a body 832, and a rim 833. The body includes a transition 835 that defines a body lower portion 836 from a body upper portion 837. However, the deflector 830 differs in that the body lower portion 836 has a substantially constant wall thickness from the base to the transition. The transition 835 is sloped in the proximal direction such that it is adjacent to the base 831 proximal to the body 832. In another embodiment, transition 835 is coupled with base 831 proximal to body 832. The inclination of the transition 825 means that with the wall portion 276 pressed against the deflector 830, the body lower portion 836 proximal to the body 832 will exert less pressure against the wall portion 276.

The wall thickness of the upper body portion 837 tapers inwardly from the transition 835 to the rim 833. This is shown in the cross-sectional view of fig. 44. In this particular embodiment, the outer wall of the body 832 tapers inwardly toward the inner wall of the body 832. This provides a curved outer profile for body 832.

The deflector 830 includes spacing ribs 838 that are the same size and shape as the spacing ribs 828 of the deflector 820. However, because transition 835 on body 832 is lower than transition 825 on body 822, spacer ribs 838 extend from base 831 to a point between transition 835 and rim 833.

Fig. 45 shows a further alternative deflector 840. Deflector 840 has the same general form as deflector 820, with the former deflector having a base 841, a body 842, and a rim 843. Body 842 includes a transition 845 defining a body lower portion 846 from a body upper portion 847. The transition portion 845 includes, in part, a stepped portion 844 intermediate the base 841 and the rim 843. However, due to the inclination of the step 844, the step 844 joins the body upper portion 847 with the base 841 proximal to the body 842. The proximal side of the deflector 840 is near an imaginary center line in the lateral direction. The body lower portion 846 below the step 844 has a first wall thickness and the body upper portion 847 above the step 844 has a second wall thickness. The first wall thickness may vary with respect to the body lower portion 846. The second wall thickness is less than the first wall thickness. The greater wall thickness of the lower body portion 846 provides deformation resistance to the deflector 840 in the event that a deforming force is applied to the wall portion 276. The deformation resistance helps to direct the deforming force applied to the wall portion 276 through the dividing wall into the deforming panel 294. The smaller wall thickness of the body upper portion 847 makes it more compliant and softer to the touch in the event that the rim 843 contacts the patient.

The radial wall thickness of the upper body portion 847 relative to the longitudinal axis of the deflector 840 is constant about the deflector 840. However, the radial wall thickness of the body lower portion 846 varies with respect to the deflector. In this embodiment, the radial wall thickness of the body lower portion 846 varies with the spacing of the rim 843 from the base 841. More specifically, the radial wall thickness of the body lower portion 846 is greater where the rim 843 is spaced farther from the base 841 than where the rim 843 is spaced less from the base 841. In this embodiment, the wall thickness distal of the body lower portion 846 is greater than the wall thickness proximal of the body lower portion 846. In an alternative embodiment, the radial wall thickness of the body lower portion 846 is minimal where the spacing between the rim 843 and the base 841 is minimal, and increases as the spacing between the rim 843 and the base 841 increases. In another alternative embodiment, the wall thickness of the body lower portion 846 is constant around the deflector 840.

The step 844 extends at least about the distal side of the deflector 840. Referring to fig. 45, the step 844 includes an inclined surface that joins the body lower portion 846 with the body upper portion 847. The inclination of the step 844 varies with respect to the deflector 840. More specifically, the slope is steeper proximal of the body 842 and less slope distal of the body 842. Thus, the profile of the stepped portion 844 varies depending on the location around the body 842. This can be seen in fig. 45, where the proximal side of body 842 has a steep step 844 and the distal side of body 842 has a less steep step 844. In this particular embodiment, the step 844 extends completely around the body 842 and joins the base 841 with the body upper portion 847 proximal to the deflector 840.

The spacing ribs 828 and 838 associated with the flow directors 820 and 830, respectively, are identical. However, the spacer ribs 848 associated with the deflector 840 have a square or rounded square cross-sectional profile. The spacer ribs extend from the divider wall 4242 and bridge the gaps between the deflectors 840. The spacer ribs 848 extend up the base 841 and the body lower portion 846 to the stepped portion 844. That is, the spacer rib 848 terminates at the top of the body lower portion 846 where the spacer rib 844 meets the step 844. The top surface of the spacing rib 848 is flat and sloped such that the distal side of the spacing rib 848 extends a greater distance from the divider wall 4242 than the proximal side of the spacing rib 848 extends from the divider wall 4242. The inclination of the spacer rib 848 follows the proximal and distal inclination of the step 844, with the spacer rib 848 meeting the step 844.

An alternative embodiment of a spacer rib 848 and the same deflector 840 is shown in fig. 47. In this embodiment, the spacer rib 848 is identical to the spacer rib shown in fig. 45, but is joined to the base 841, the body lower portion 846, and the stepped portion 844. As can be seen in fig. 47, the spacer ribs 848 include rounded transitions that join the deflector 840.

As with the other embodiments, the spacer ribs 848 overlap the reinforcing section 849. This arrangement helps to transfer the deforming force applied to the wall portion 276 to the deforming panel 294. In the embodiments described above for flow directors 820 and 830, the same configuration exists. Those flow directors 820, 830 are associated with the same enhancement section 4264 that is present in the cushion module 4020. However, the effect is the same because the deforming force is transferred through the respective lower body portions 826, 836 to the associated spacer ribs 828, 838 and then through the reinforcing section 4264 to the deforming panel 294.

However, embodiments of the deflector 840 have an alternative reinforcing section 849. Although fig. 48 shows the reinforcing section 849 having the same elongated form as the reinforcing section 4264, the reinforcing section 849 extends from the bottom side of the spacing rib 848 to the deformation panel 294. This is in contrast to the reinforcing section 4264 which extends from the spacer ribs 4262 to a location spaced from the deformation panel 294. Extending the reinforcing section 849 to the deformation panel 294 may assist in controlling the deformation of the deformation panel 294. More specifically, the reinforcing section 849 facilitates the rolling action of the second wall 272 under the first resilient section 268.

Embodiments of deflectors 820, 830, and 840 are associated with proximal portion 808 and distal portion 810 of divider wall 4242 having the same wall thickness as lateral side portion 800. In different embodiments, the wall thicknesses of the proximal portion 808 and the distal portion 810 may be different. For example, fig. 52-54 illustrate the deflector 4246 and its associated spacer ribs 4260, as described above with respect to the cushion module 4020. These figures also illustrate different embodiments in which the proximal portion 808 and the distal portion 810 have different wall thicknesses. In comparison to the deflectors 820, 830 and 840, fig. 50 and 51 show the deflector 4246 and the spacing ribs 828 and the proximal 808 and distal 810 portions having the same wall thickness as the lateral side portions 800. In the embodiment shown in fig. 52, the proximal portion 808 is thickened. This thickening of the proximal portion 808 increases the resistance to deformation of the proximal portion 808, thereby increasing the stability of the deflector 4246. Stability is increased as the deforming force is directed through the proximal portion 808 and into the reinforcing section 4264. This facilitates controlled deformation of the deformation panel 294, rather than buckling of the proximal portion 808, which might otherwise buckle or collapse the deflector 4246.

A variation of the embodiment shown in fig. 52 is shown in fig. 53, where the flow directors 4246 are identical and the spacing ribs 4260 are identical. This embodiment differs in that the proximal portion 808 is further thickened than the proximal portion 808 shown in fig. 52. It also differs in that the distal portion 810 is thickened compared to the distal portion 810 shown in fig. 52. Thickening of the proximal portion 808 and distal portion 810 has the same effect as increasing the stability of the deflector 4246 described above with respect to the embodiment shown in fig. 52.

A variation of the alternative embodiment shown in fig. 52 is shown in fig. 54 and 55, where the flow directors 4246 are identical and the spacing ribs 4260 are identical. In this embodiment, distal portion 810 is thickened in the same manner as in the embodiment shown in fig. 53. This embodiment differs in that the proximal portion 808 has the same wall thickness in the proximal region of the spacer ribs 4260 as the lateral side portion 800. The proximal portion 808 includes a support member 818 disposed between each deflector 4246 and the outer wall 288. The support member 818 maintains a spacing between the outer wall 288 and each of the respective deflectors 4246.

Each support member 818 is joined to the outer wall 288 at an outer wall portion between the nostril opening 234 and the oral opening 232. In this embodiment, each support member 818 is coupled only with the base 806 and the lower body portion 4256 (fig. 54). In other embodiments, support member 818 may be coupled with base 806, lower body portion 4256, and step 802. In another embodiment, support member 818 may be coupled only with base 806. In each of these embodiments, the lateral width of the support member may be 20% to 70% of the lateral width of the deflector 4246.

In this embodiment, support member 818 has a trapezoidal profile. However, the base member is not limited to this profile. For example, support member 818 may have a polygonal profile, a semi-circular profile, a circular arc profile, or a curved profile.

An alternative embodiment of a deflector 850 for a cushion module 4020 is shown in fig. 56 and 57. The deflector 850 has a portion of the same general form as the deflector 820, with the former deflector having a base 851, a body 852, and a rim 853. The base 851 includes an outwardly directed laterally thickened pad 854 having a thickness that decreases from the body 852 to the laterally outermost portion of the base 851. The base 851 wraps around the body 852 at a level where the thickened liner 854 joins the body 852. Body 852 extends upwardly from base 851 and terminates in rim 853.

In other words, the base 851 of each deflector 850 is elongated in a lateral direction away from a vertical midplane passing through the patient interface 10, taking into account the upright orientation of the patient interface 10. Further, the body 852 is offset from a lateral centerline (denoted as Z in fig. 57) through the base 851 such that the body 852 is closer to the lateral inside of the base 851 than to the lateral outside of the base 851. The laterally outer side of the base 851 extends laterally outwardly from the body 852 a greater distance than the laterally inner side of the base 851 extends laterally inwardly from the body 852. This is evident in fig. 57, which shows the gas flow passage 812 offset laterally inward from a lateral centerline through the base 851 that is parallel to a vertical midplane through the patient interface 10. Accordingly, the gas flow passage 812 is closer to the laterally inner side of the base 851 than to the laterally outer side of the base 851. In this embodiment, the base 851 has a footprint that extends laterally beyond the corresponding lateral edge of the nostril opening 234. However, in different embodiments, the laterally outer sides of the base 851 may extend different distances. In this regard, the laterally outer side of the base 851 extends laterally outwardly from the body 851 at least two, at least three, at least four, or at least five times more than the laterally inner side of the base 851 extends laterally inwardly from the body 851.

The function of the thickened pad 854 is to stabilize the body 852. More specifically, thickening the liner 854 increases resistance to buckling or collapsing of the deflector 850 because localized buckling of the divider wall 4242 is resisted. This increases the lateral stability of the flow directors 850 and helps resist inward deflection of the flow directors 850 toward each other. Thus, the thickened cushion assists in maintaining the orientation of the deflector 850 in directing the breathing gas through the nostril openings 234 and into the nostrils of the patient in use.

An additional factor that helps resist buckling or collapse of the deflector is the increased wall thickness of the body 852. For patient comfort reasons, the wall thickness of the body 852 cannot be too thick, as the body 852 would cause patient discomfort when in contact with the patient. Alternatively, the body 852 may include a transition portion in the form of any of the bodies 248, 1248, 2248, 3248, 822, 832, or 842, and an upper body portion and a lower body portion. In those alternatives, the transition may take the form of a step 802. In those alternative embodiments, the step may extend completely or partially around the body.

Another feature that may be used in any of the embodiments disclosed herein is a reinforced section 855 (fig. 56) on the body 852 or on the body of any other embodiment. In this embodiment, the reinforced section 855 includes ribs. The reinforced section 855 in the form of a rib or other form may be used in combination with other features disclosed in this specification to stabilize the deflector and transfer deformation forces to the deformation region. Accordingly, it should be understood that the enhanced section 855 is not limited to this embodiment and may be used in combination with other flow directors, such as flow directors 246, 1246, 2246, 3246, 820, 830, 840 and flow directors 860 and 870, 880 or 890 (described below).

The reinforced section 855 shown in fig. 56 and 57 is configured to resist deformation of the shape of the second opening 856 under the deforming force. The reinforced section 855 may extend completely or partially around the body 852. In this embodiment, the reinforced section 855 extends partially around the body 852 distally of the body 852. However, in other embodiments, the reinforced section 855 may extend around the distal side of the body 852, the proximal side of the body 852, or the lateral sides of the body 852, or a combination of these sides (e.g., proximal and lateral sides or lateral and distal sides).

In this embodiment, the reinforced section 852 is integrally formed with the body 852. The wall thickness of the reinforcing section is greater than the wall thickness of the other portions of the body 852. In another embodiment, the body 852 is formed of a first material and the reinforced section 855 is formed of a second material different from the first material. Further, the second material is less compliant than the first material such that the reinforced section 852 reinforces the body 852 by structural and material properties.

The reinforced section 855 is disposed a set distance from the edge 853. In an alternative embodiment, the reinforced section 855 may be disposed a set distance from the base 851. Alternatively, the reinforced section 855 may be disposed at different spacing from the rim 853 around the body 852. The reinforcing section 855 may be combined with the body of other flow directors described or claimed in this specification. This includes a deflector having a body including a lower body portion and an upper body portion. In these embodiments, the reinforced section may extend completely or partially around the lower body portion. Alternatively, the reinforced section may extend completely or partially around the upper portion of the body. In a further alternative, the reinforced section may extend from the lower body portion and extend at least partially around the upper body portion.

Another embodiment of a deflector 860 is shown in fig. 58-60, which may replace the deflector 4246 in the cushion module 4020. In this embodiment, deflector 860 has a base 861 and a body 862 extending upwardly from base 861 and terminating in a rim 863. The base 861 of each deflector is a region of increased thickness compared to the wall thickness of the divider wall 4242. In this embodiment, the base 861 takes the form of an island extending from the dividing wall 4242 into the second chamber 240. In other words, in this embodiment, the base 861 takes the form of a localized area of increased wall thickness as compared to the wall thickness of the divider wall 4242. This embodiment differs in that the bases 861 of the deflector 860 are linked together to form a common block 865 from which the individual bodies 862 extend. The common block 865 has a footprint that extends laterally beyond the corresponding lateral edges of the nostril openings 234. The common block 865 is a solid structure except for a gas flow passage 812 extending through the common block 865. The common block 865 is presented as a unitary structure such that deforming forces exerted on the wall portion 276 will be transferred through the common block 865 into the deforming panel 294. As the deforming force is transferred into the deflection panel 294, the gas flow channels 812 within the common block 865 are protected from buckling or collapsing when the deforming force is applied to the wall portion 276. The common block 865 has the advantage of spreading the deforming force over a laterally wider area of the deflection panel. This provides a more even distribution of the deforming force across the width of the deforming panel 294 and thus a more controlled deformation of the deforming panel 294. Another advantage is that the deforming force applied to one body 862 will be transmitted at least partially through the common block 865 to another body 862 (or other bodies 862, depending on the number of bodies 862 incorporated into the cushion module 4020). The force transfer increases the overall resistance to buckling of deflector 860.

As shown in fig. 60, the common block 865 is inclined upward from the partition wall 4242 on the proximal and distal sides of the common block 865 and the lateral sides of the common block 865. The sloped sides of the common block 865 may take the form of rounded corners or may be chamfered in other embodiments. The top surface of the common block 865 is inclined with respect to the partition wall 4242. The relative tilt is downward in the proximal direction. That is, the proximal side of the top surface is spaced from the divider wall 4242 a distance less than the spacing of the top surface from the divider wall 4242 distal of the common block 865.

A variation of deflector 860 is shown in fig. 61-63 as another embodiment of deflector 870 that may replace deflector 4246 in cushion module 4020. The deflector 870 has a base 871, a body 872, and a rim 873 in the same form as the deflector 860. That is, the base 871 is in the form of a common block 875. However, the deflector 870 differs from the deflector 860 in that the perimeter walls of the common block 875 are more steeply sloped. Thus, the distal side of the common block 875 forms the proximal edge of the deformation panel 294. This means that the deforming force transmitted through the common block 875 is transmitted directly into the deforming panel 294, rather than through the distal portion 810 or distal tapered wall of the common block 865.

Bodies 862 and 872 have constant wall thicknesses from their respective bases 861, 871 to their rims 863, 873. In alternative embodiments, the bodies 862, 872 may include a transition defining a body upper portion and a body lower portion. The transition may take the form of a step (such as step 844 in deflector 840). The step may form a transition between a lower body portion and an upper body portion, the lower body portion having a wall thickness greater than a wall thickness of the upper body portion. For example, the bodies 862, 872 can be replaced with any of the bodies 822, 832, 842 (including different wall thicknesses for the upper and lower body portions). The body may also be replaced with a body 852 that includes a reinforcing section.

In further variations, the bases 861 and 871 may be combined with any of the bodies 248, 1248, 2248, 3248.

Other features may be combined with the bodies 862 and 872. These features include, for example, the enhanced section 855 from the deflector 850 described above.

An alternative flow director 880 that may form part of a cushion module 4020 is shown in fig. 64 and 65A and 65B. Deflector 880 has the same general form as deflector 4246, with the former deflector including a base 881, a body 882 extending from base 881, and a rim 883. The base 881 joins the body 882 to the divider wall 4242. The base 881 forms a smooth transition surface between the body 882 and the divider wall 4242. Similar to the deflector 4246, a portion of the outer wall 288 extends laterally outboard of the second opening 884 defined by the rim 883. As explained above with respect to the cushion module 4020, in use, when the patient interface 10 is assembled, the nostril openings 234 laterally expand such that the nostril openings 234 extend laterally outward such that the outer wall 288 does not extend over the second opening 884.

The body 882 includes a transition 885 that defines a body lower portion 886 from a body upper portion 887. The body lower portion 886 has a reduced wall thickness from the base 881 to the transition 885. The upper body portion 887 has the same wall thickness from the transition 885 to the rim 883. The body lower portion 886 is angled in the proximal direction such that a proximal side of the body lower portion 886 extending from the base 881 to the transition 885 is shorter than a distal side of the wall lower portion 886 extending from the base 881 to the transition 885. The body upper portion 887 angles proximally and laterally inwardly. The transition 885 occupies a plane that is inclined in the same manner as the body lower portion 886. However, the inclination of the body lower portion 886 and transition 885 is less than the inclination present in the deflector 4246. The angulation of the lower body portion 886 and the upper body portion 887, as well as the lateral positioning of the deflector 880, help direct the breathing gas from the deflector 880 through the one or more nostril openings 234 and into the nostrils. Deflector 880 also differs from deflector 4246 in that transition 885 is closer to the dividing wall than transition 802 of deflector 4246.

The flow directors 880 further differ from the flow directors 4246 in that the base of the or each respective flow director 880 is joined to the outer wall 288 at the wall portion 276. In this arrangement, the proximal portion 808 is located between the flow directors 880 and between the spacing ribs 888 and the wall portion 276. In other embodiments, the deflector 888 is spaced apart from the wall portion 276 such that the proximal portion 808 is positioned between the lateral side portions 800.

The base 821 of each deflector is spaced apart from a vertical midplane passing through the cushion module 4020 (as shown in fig. 64). The spacer ribs 888 span the gaps between the flow directors 880. The spacer ribs 888 extend from the base 881 of each deflector 880 to a location below the transition 885. The tops of the spacing ribs 888 form straight lines between the flow directors 880. The spacing ribs 828 overlap the reinforcing sections 4264 on the bottom side of the divider wall 4242. The spacer ribs 888 are aligned in the proximal-distal direction with the distal portion of the rim 883 defining the second opening.

The wall thickness of the proximal portion 808 of the divider wall 4242 between the spacer rib 888 and the wall portion 276 of the sealing member 4230 and between the lateral side portions 800 of the divider wall 4242 is greater than the wall thickness of the lateral side portions 800 of the divider wall 4242. In this embodiment, the wall thickness of the proximal portion 808 is at least 1.5 times the wall thickness of the lateral side portion 800. The wall thickness of the proximal portion 808 may be up to 3 times the wall thickness of the lateral side portion 800. In other embodiments, the wall thickness of the proximal portion 808 may be up to 8 times the wall thickness of the lateral side portion 800.

The wall thickness of the proximal portion 800 may be different at different locations. In other words, the wall thickness of the proximal portion 808 may vary across the proximal portion 808 in the proximal-distal direction or in the lateral direction or both.

In the embodiment shown in fig. 65B, the wall thickness of the proximal portion 808 is greater than the wall thickness of the distal portion 810 of the divider wall 4242 between the spacer ribs 888 and the deformation panel 294 and between the lateral side portions 800 of the divider wall 4242. Fig. 65A shows a profile of a portion of distal portion 810 that overlaps reinforcing section 4264. Accordingly, in fig. 65A, the wall thickness of the distal portion is represented by a wall thickness that does not include the wall thickness of the reinforcing section 4264.

In this and other embodiments, the divider 4242 has a curved profile in the proximal-distal direction. The curved profile extends across substantially the entire lateral dimension of the main portion 244 of the divider wall 4242. Optionally, the curved profile extends through the proximal and distal portions of the dividing wall.

The main portion 244 of the divider wall 4242 is convex in the proximal-distal direction and with respect to the nostril openings 234. This convex curvature can be seen in the curved alignment of the proximal portion 808 relative to the distal portion 810 in fig. 35, 50, 52, 53, 54 and 65B. The convex curvature is highlighted by the dashed line CX in fig. 65B.

In an alternative embodiment shown in figure 66, the curved profile is concave in the proximal-distal direction and relative to the nostril opening 234. The concave curvature is highlighted in fig. 66 by a dashed line CV. In one embodiment shown in fig. 66, the proximal portion 808 and the distal portion 810 have profiles that are inclined relative to each other in the proximal-distal direction such that they sandwich an angle of less than 180 ° on the side of the dividing wall within the second chamber.

In an alternative embodiment, the profile of the proximal portion 808 is curved. The profile of the proximal portion 808 is concave relative to the nostril opening 234. However, it should be appreciated that for convex curvature, the proximal portion 808 is concave relative to the first chamber 238. Optionally, the profile of distal portion 810 is curved. For the concave curvature of the divider wall 4242, the profile of the distal portion 810 may be concave relative to the nostril opening 234. However, for convex curvature, the distal portion 810 is concave relative to the first chamber 238.

Fig. 67 to 69 show a variation of the embodiment shown in fig. 66. This variation involves the wall thickness of the distal portion 810 being greater than the wall thickness of the lateral side portion 800 of the divider wall 4242. The wall thickness of the distal portion is at least 1.5 times the wall thickness of the lateral side portion. The wall thickness of the distal portion 810 may be up to 3 times the wall thickness of the lateral side portion 800. In other embodiments, the wall thickness of the distal portion 810 may be up to 8 times the wall thickness of the lateral side portion 800.

The wall thickness of distal portion 810 may vary in the proximal-distal direction. In addition, the wall thickness of the distal portion 810 may vary in the lateral direction. In this embodiment, the distal portion 810 includes one or more tapered regions 900, wherein the wall thickness of the distal portion 810 decreases to the same thickness as the respective adjacent lateral side portion 800 or adjacent deformation panel 294 in the direction of the adjacent lateral side portion 800 or in the direction of the adjacent deformation panel 294.

Wherein one or more tapered regions 900 may be provided on the side of the dividing wall facing the first chamber 238. This is shown in fig. 68 as tapered region 900 on the distal and lateral sides of distal portion 810 adjacent to the junction of distal portion 810 with deformation panel 294 and lateral side portion 800. In this embodiment, the surface of the divider wall 4242 spanning the intersection of the distal portion 810 and the lateral side portion 800 comprises a continuous curve associated with the overall curvature of the divider wall 4242. In other words, the side of the distal portion 810 that is exposed to the second chamber 240 does not include adjustments that consider the tapered region 900.

However, in other embodiments, one or more of the tapered regions 900 are disposed on the side of the divider wall 4242 facing the second chamber 240. In another embodiment, the tapered regions may be provided on both sides of the divider wall 4242.

The spacer rib 888 includes a tapered region 900 disposed between the proximal portion 808 and the distal portion 810.

In addition, the base 881 of the or each deflector 880 includes a tapered region 900 in which the wall thickness of the distal portion 810 is reduced to a thickness that matches the wall thickness of the lower body portion 886 of the one or more deflectors 880.

The wall thickness of the distal portion 810 may be the same as the wall thickness of the proximal portion 808. However, in another embodiment, the wall thickness of the distal portion 810 is greater than the wall thickness of the proximal portion 808.

In this and other embodiments, the distal portion 810 has a lateral width that tapers inwardly in the distal direction. However, in alternative embodiments, there may be no laterally inward taper of the distal portion 810.

In a variation of the embodiment shown in fig. 64, the patient interface 10 includes a tether 902 configured to resist a change in orientation between the lower body portion 886 of the respective deflector 880 and the divider wall 4242. The tether 902 links the lower body portion 886 to the distal portion 810 at a location on the lower body portion 886 and distal portion 810 that is spaced apart from the base 821 of the respective deflector 880. In this particular embodiment, tether 902 is coupled to deflector 800 along body lower portion 886 and base 881, and to distal portion 810 from base 810 to a location spaced from base 881.

Tether 902 may take a variety of forms. In this embodiment, the tethers 902 are ribs extending between the lower body portion 886 and the distal portion 810 of the respective deflector 800.

Tether 902 is positioned on the distal side of the flow director 800. Tether 902 is oriented in the proximal-distal direction.

In alternative embodiments, the tether 902 may be oriented in other directions. In further alternative embodiments, the tether 902 may be an extension of the lower body portion 886 in the distal direction and the wall thickness of the extension in the proximal-distal direction is greater than the wall thickness of the other portions 886 of the lower body portion. The extension may taper inwardly in the distal direction in a cross-section parallel to the plane of the distal portion.

Fig. 72 to 74 show another variant of the embodiment shown in fig. 66. In this embodiment, the patient interface 10 includes one or more tethers 904 configured to resist movement of the distal portion 810 toward the nostril sealing portion 236 of the outer wall 288.

Referring to fig. 72, the first resilient region 268 includes a support wall 906 and a depending lip 908 extending proximally from the support wall 906. The first wall 270 of the deformation panel 296 extends away from the nose seal portion and proximally from the depending lip 908 to define a void 910 between the deformation panel and the support wall 906. When the wall portion 276 is subjected to a deforming force, the main portion 244 of the divider wall 4242 travels distally as the deforming panel deforms. In so doing, the distal edge of the main portion 244 travels into the void 910. Permitting such travel enables the patient interface to absorb deformation forces and substantially avoid buckling of the flow director 870 and the main portion 244. As shown in fig. 72-74, the strap 904 helps maintain the shape of the main portion when the main portion is subjected to a deforming force, such as: the deforming force applied to the wall portion 276, or the deforming force created by the gas pressure differential between the first chamber 238 and the second chamber 240, or the deforming force created by the gas pressure differential between the ambient gas pressure outside the patient interface 10 and the gas pressure within the patient interface 10.

The tethers 904 are configured to collapse when subjected to compressive forces in the proximal-distal direction, such as due to deforming forces applied to the wall portion 276. Such collapse permits the main portion 244 to travel into the void 910. However, the tie 904 is also configured to inhibit movement of the main portion 244 toward the nostril sealing portion 236. In other words, any tendency of the main portion 244 to flex by moving toward the naris seal portion 236 is resisted by the tie 904 tying the main portion to the support wall 906. This cinching places the strap 904 under tension, thereby resisting displacement of the main portion 244 toward the nostril sealing portion 236.

In this embodiment, the tie 904 is configured to limit travel of the divider wall away from the first elastic region 268. The tie 904 is a panel that connects the deformation panel 294, the main portion 244, and the first elastic region 268. In this embodiment, the tether 904 connects the distal portion 810 and the first elastic region 268. In connection with the first elastic region 268, the tie strap 904 is connected with the deformation panel 294, the depending lip 908, and the support wall 906. As shown particularly in fig. 73 and 74, the lacing 904 connects the first elastic region 268 and the reinforcing section 4264 associated with the distal portion 810. However, in other embodiments, the tie 904 may be coupled to the deformation panel 294, the main portion 244, and the support wall 906. That is, the tie 904 may not be connected to the depending lip 908. In other embodiments, the tethers may be connected only to the divider wall 4242 and the first support wall 906.

The tethers 904 are configured to collapse under compressive forces in the proximal-distal direction and are configured to resist extension under tension in the proximal-distal direction and in a direction toward the nostril sealing portion 236. In this embodiment, the strap 904 is a panel.

The thickness of the walls of the tie 904 is the same as the thickness of the wall of the first wall 270 of the deformable panel 294. Optionally, the wall thickness of the tie 904 is less than the wall thickness of the first wall 270 of the deformation panel 294.

The tie 904 is perpendicular to the first wall 270 of the deformation panel 294, as shown in fig. 74. In this embodiment, the strap 904 is disposed in a vertical midplane through the patient interface 10, taking into account the upright orientation of the patient interface 10. However, other embodiments may include a strap 904 that is oriented obliquely with respect to the proximal-distal direction.

The strap 904 includes a free edge 912 exposed to the first chamber 238. The free edge 912 is a straight line extending between the first elastic region 268 and the deformation panel 294 or the distal portion 810 or the reinforcing section 4264 associated with the distal portion 810.

The tether 904 includes a weak point to cause collapse of the tether 904 at that point as the distal portion 810 advances toward the first elastic region 268. Optionally, the weak point is a localized reduction in the wall thickness of the strap 904. However, in this embodiment, the weak point in the free edge 912 is a notch 914 disposed between the deformed panel 294 and the first elastic region 268. The recess 914 has a V-shape. Other shapes for the recess 914 may be selected as long as the recess 914 is capable of functioning as a weak point.

In the embodiment shown in fig. 72-74, the patient interface includes a strap 904. However, it should be appreciated that other embodiments may include more than one strap. Fig. 75-77 illustrate one embodiment that includes more than one strap 904.

In this embodiment, the patient interface 10 includes two tethers, and each tether is aligned with the distal portion in the proximal-distal direction. However, the tethers 904 may be further laterally spaced apart. For example, the patient interface may include two tethers 904, and each tether 904 may be aligned with a respective lateral side portion in a proximal-distal direction.

For the embodiment shown in fig. 75-77, the two tethers 904 are parallel to each other in the proximal-distal direction. However, the two laces 904 may diverge from each other in the distal direction. Alternatively, the two tethers 904 may converge toward each other in the distal direction.

The free edge 914 of each tie 904 extends to a respective deflector 880. Alternatively, the free edge 914 of each tie 904 merges with a respective deflector 880. The free edge 914 of each tie 904 merges with the base 881 of the corresponding deflector 880. However, one strap 904 of the plurality of straps 904 may extend to or merge with a respective deflector 880.

The divider wall 4242 includes a reinforcing structure 916 extending across the distal portion 810 and lateral side portion 800 of the divider wall 4242 and adjacent to the deformation panel 294. The reinforcing structure 816 is configured to resist deformation of the distal portion 810 and the lateral side portion 800. In this embodiment, the reinforcing structure 916 is a lateral reinforcing rib extending across the distal portion 810 and the lateral side portion 800 at a location on the distal side of the or each deflector 880. The additional wall thickness associated with the reinforcing structure 916 provides elasticity to the deformation of the partition walls 4242 along the line of the reinforcing structure 916. This helps to preferentially deform the partition wall 4242 in the deformation panel 294, and thus helps to maintain the shape of the partition wall 4242 when subjected to a deforming force applied through the wall portion 276.

The reinforcement structure 916 is disposed with a spacing between the reinforcement structure 916 and the deformation panel 294, and optionally the spacing is constant along the reinforcement structure 916. In this embodiment, the spacing varies along the reinforcing structure. The spacing between the reinforcing structures 916 on the distal portion 810 and the deformation panel 294 is greater than the spacing between the reinforcing structures 916 on the lateral side portion 800 and the deformation panel 294. The spacing between the reinforcing structure and the deformation panel decreases in the lateral direction. The decrease in spacing may be continuous, stepwise or discontinuous. Furthermore, in other embodiments, the spacing may vary differently. In this embodiment, the spacing between the reinforcing structure 916 and the deformed panel 294 is greatest at the center location.

In the embodiment shown in fig. 78 and 79, the reinforcing structure 916 is a lateral reinforcing rib and is located on the side of the partition wall 4242 exposed to the second chamber 240. In other embodiments, the reinforcement structure 916 may be a lateral reinforcement rib and may be located on the side of the divider wall 4242 exposed to the first chamber 238.

In other embodiments, the reinforcing structure 916 includes a first lateral reinforcing rib on the side of the divider wall 4242 exposed to the second chamber 240, and includes a second lateral reinforcing rib on the side of the divider wall 4242 exposed to the first chamber 238. The first and second lateral stiffening ribs may be aligned in a proximal-distal direction on each side of the divider wall 4242. Alternatively, the first reinforcing rib and the second reinforcing rib are offset in a near-far direction on each side of the partition wall. Alternatively, the first reinforcing rib and the second reinforcing rib may be aligned in the near-far direction at one or more locations on each side of the partition wall 4242, and may be offset in the near-far direction at other locations on each side of the partition wall 4242.

Other embodiments may be variations of the configurations of the first and second reinforcing ribs described above. For example, the first reinforcing rib is spaced from the deformation panel 294 at a different distance than the second reinforcing rib is spaced from the deformation panel 294. In another example, the spacing of the first reinforcing ribs from the deformable panel 294 is constant, while the spacing of the second reinforcing ribs from the deformable panel 294 is variable. In another example, the spacing of the second reinforcing ribs from the deformable panel 294 is constant while the spacing of the first reinforcing ribs from the deformable panel 294 is variable.

In the embodiment shown in fig. 78 and 79, the reinforcing structure 916 has a uniform profile along the length of the reinforcing structure 916. In other embodiments, the reinforcing structure 916 has a profile that varies along the length of the reinforcing structure 916. Alternatively, the reinforcing structure 916 may have a profile tapered in a lateral direction at a height above the partition wall 4242. The reinforcing structure may have a polygonal profile, a rectangular profile, a trapezoidal profile, a semicircular profile or a circular arc profile.

In this embodiment, the reinforcing structure 916 is spaced apart from the or each respective deflector 880. However, the reinforcing structure 916 may be linked to the or each respective deflector 880.

The patient interface 10 includes one or more deformation zone tethers 918 (fig. 80-82) configured to inhibit tipping of the divider wall 4242. The or each respective deformation zone tie 918 extends between the side of the dividing wall 4242 exposed to the first chamber 238 and the outer wall 288 of the sealing member 4230. As shown particularly in fig. 81 and 82, the sealing member includes two deformation zone tethers 918. Each deformation zone tether 918 extends from the outer wall to the distal portion 810. While the following description is made in the context of a sealing member having two deformed region tethers 918, it should be appreciated that the sealing member 4230 may have only one deformed region tether 918. Accordingly, the following description of the different configurations of the deformation zone tethers 918 should be understood to apply equally to embodiments of the patient interface 10 that include only one deformation zone tethers 918.

The deformation zone tethers 918 are connected to the divider wall 4242 between the deformation panel 294 and the deflector 880 or a respective one of the deflectors 880. In the embodiment shown in fig. 80-82, the deformation zone tethers 918 are spaced apart from the deformation panel 294. The deformation zone tethers 918 are spaced apart from the deflector 880. Alternatively, each respective deformation zone tether 918 may be incorporated with a respective one of the deflectors. For example, each respective deformation zone tether 918 may be incorporated with the base 881 of a respective deflector 880.

As shown in fig. 81 and 82, each respective deformation zone tether 918 extends from the divider wall 4242 and the outer wall 288 and has a free edge 920 in the first chamber 238. The free edge 920 is a straight line. In this embodiment, the deformed region tether 918 has a flat planar configuration.

The patient interface 10 includes two deformed region tethers, and each respective deformed region tether 918 has an angle greater than 140 ° between proximal surfaces 922. Alternatively, the angle between each respective deformation zone tether 918 between the proximal side surfaces 922 is greater than 160 °.

In the embodiment shown in fig. 81 and 82, the two deformation zone tethers 918 extend to the same location on the distal portion 810. The two deformation zone tethers 918 extend to the reinforcing section 4264. However, in alternative embodiments, the two deformation zone tethers 918 extend toward each other to spaced apart locations on the distal portion 810. In another embodiment, the deformation zone tethers 918 may extend to spaced apart locations on the distal portion, but the deformation zone tethers 918 may not extend toward each other.

The deformation zone tether 918 includes a first portion 924 connected with the outer wall and a second portion 926 extending to the main portion 244. In an alternative embodiment, one connection point is connected to the main portion 244 and the other connection point is connected to the outer wall 288 at a level below the distal portion 810, taking into account the upright orientation of the patient interface. In such embodiments, the deformation zone tethers 918 may be cords or wires or cables. In another alternative embodiment, the first portion 924 has a flat planar configuration and the second portion 926 is curved such that, on the proximal side, the angle between the tangents at the respective locations to which the second portion 926 extends is between 140 ° and 180 °.

The deformation zone tethers 918 are arranged to permit the main portion 244 of the divider wall 4242 to travel when the wall portion 276 is applied with a deforming force, and are arranged to inhibit deformation or eversion of the main portion toward the nostril sealing portion 236. Accordingly, the location of the deformation zone tethers 918 within the first chamber 238 enables them to act as pull-resists to prevent deflection or tipping of the main portion 244 toward the nostril sealing portion 236. The large angle between the proximal surfaces 922 reduces the extent to which the deformation zone tethers 918 exert a tensile or compressive effect on the travel of the main portion 244. The deformation zone tethers 918 may be configured to apply a substantially constant pulling force to the divider wall 4242 through the range of travel of the divider wall 4242 under the influence of the deformation force applied to the wall portion 276. This is facilitated by orienting the flat panel form of the deformation zone tethers 918 substantially orthogonal to the direction of travel of the main portion 244.

The tensile resistance exerted by the deformed region tether 918 may be attributed to the connection to the outer wall being lower than the point of connection to the main portion 244. In the embodiment shown in fig. 80-82, the deformation zone tethers 918 extend to a level below the lowest level of the divider wall 4242, taking into account the upright orientation of the patient interface. With the patient interface in an upright orientation, the deformation zone tethers 918 extend to a level below the uppermost level of the oral opening. Further, the deformation zone tethers 918 extend from the distal portion 810 to the outer wall 288 at a location distal to the proximal-most portion of the one or more nostril openings 234.

The free edge 920 extends from the outer wall 288 at a location proximal to the reinforcing section 4264. Alternatively, the free edge 920 extends from the outer wall 288 at a location distal to the one or more oral openings 232. Alternatively, the free edge 920 extends from the outer wall 920 at a location distal to the spacer rib 888.

In alternative embodiments, the free edge 920 may be curved. The curve may be a convex curve or a concave curve.

The embodiment shown in fig. 80-82 involves deformation zone tethers 918 that always have the same wall thickness. The alternative embodiment shown in fig. 83 involves deformed zone tethers 918 of the same flat panel formed as described above but differing in wall thickness. In particular, the deformation zone tie 918 in fig. 83 is a panel with a wall thickness that decreases from the dividing wall to the free edge.

Fig. 85-87 illustrate alternative deflector 880 configurations for cushion module 4020. In this embodiment, the deflector 880 is the same as the deflector 880 described above with respect to fig. 64 and 65A. In this embodiment, the flow directors 880 are the same size and thus provide the same gas flow rate. The flow directors 880 in fig. 85-87 differ in that they are configured such that the flow of gas provided through one flow director 880 is greater than the flow of gas through the other flow director 880. In other words, one of the respective flow directors 880 is configured to have a first gas flow resistance and the other of the respective flow directors 880 is configured to have a second gas flow resistance, and the first gas flow resistance is lower than the second gas flow resistance.

As can be seen from fig. 86 and 87, the first opening 889A and the second opening 884A of one of the respective flow directors 880A are larger than the first opening 889B and the second opening 884B of the other of the respective flow directors 880B, respectively. In an alternative embodiment, the first opening 889A or the second opening 884A of the deflector 880A is larger than the corresponding first opening 889B or second opening 884B of the deflector 880B.

In other words, the asymmetry in flow between the flow directors 880A and 880B is a result of the different opening sizes of the flow directors 880A and 880B. For example, the ratio of the area of the first opening 889A of the deflector 880A to the area of the first opening 889B of the other deflector 880B is in the range of 1:1 to 1:0.1. Alternatively, the ratio of the area of the second opening 884A of the deflector 880A to the area of the second opening 884B of the other deflector 880B is in the range of 1:1 to 1:0.1. Further alternatively, the ratio of the combined area of the first opening 889A and the second opening 884A of the deflector 880A to the combined area of the first opening 889B and the second opening 884B of the other deflector 880B is in the range of 1:1 to 1:0.1. Alternatively, the ratio of the area of the second opening of one of the respective deflectors to the area of the second opening of the other of the respective deflectors is in the range of 1:0.5 to 1:0.2. Alternatively, the ratio of the area of the second opening of one of the respective deflectors to the area of the second opening of the other of the respective deflectors is 1:0.33. In another alternative, the two flow directors 880A and 880B have the same shape, and the ratio of the size of flow director 880A to the size of flow director 880B is in the range of 1:0.5 to 1:0.2. The ratio of the size of deflector 880A to the size of deflector 880B may be 1:0.33.

Although there is a size difference between the flow directors 880A and 880B, the orientation and position of the flow directors 880A and 880B and the spacing ribs 888 remain the same as the flow directors 880 in the embodiment shown in fig. 64.

The flow director 880A, which has a larger area for the first and second openings 889A, 884B, has less resistance to gas flow and thus a greater gas flow rate than the flow rate of gas through the flow director 880B. The higher flow of gas through the flow director 880A directs more gas flow to one naris of the patient than to the other naris. In other words, the irrigation flow provided to both nostrils is asymmetric. It is contemplated that the higher flow of gas to one naris promotes unidirectional irrigation of dead nasal cavities by flowing a flow of breathing gas to one naris and out of the other naris. Although irrigation flow is provided from the respective flow directors 880A and 880B to both nostrils, less flow enters the nostril associated with flow director 880B and therefore the irrigation flow through the nostril and nasal cavity is asymmetric. Outflow through the other naris is believed to be facilitated by relatively less gas flow through the flow director 880B associated with that naris. That is, the smaller flow of gas directed to the other naris provides less resistance to gas flow from the same naris. It is believed that unidirectional irrigation of the nasal cavity dead space may improve anatomical dead space irrigation when the patient's mouth is closed. However, unidirectional irrigation is still effective, at least to some extent, when the patient's mouth is open.

An alternative to having two different sized flow directors 880A and 880B involves a patient interface that includes only one flow director 880, as shown in fig. 88-90.

In this embodiment, one deflector 880 is configured to deliver an irrigation flow of respiratory gases to one naris. That is, the flow director 880 is configured to direct a flow of gas through the nostril openings and into one nostril of the patient. One deflector 880 is configured to be able to flush the nasal cavity dead space by delivering an irrigation flow to one nostril. It is contemplated that delivering the flow of irrigation gas to one nostril via one deflector 880 may achieve unidirectional irrigation of the dead nasal cavity by flowing the irrigation flow through the nasal cavity and out through the other nostril into the second chamber 240.

Although the deflector 880 shown in fig. 88 to 90 has the form of the deflector 880 described above with respect to fig. 64, 65A and 65B, the deflector may be in the form of any of the deflectors disclosed above. That is, the deflector may be in the form of any of the deflectors 246, 1246, 2246, 3246, 4246, 820, 830, 840, 850, 860, or 870.

In fig. 88-90, the midplane between the second opening 884 of the deflector 880 and the lateral side of the patient interface 10 is laterally offset. And, a second opening 884 of the deflector 880 is laterally spaced from the midplane. Similarly, the first opening 889 of the deflector 880 is laterally offset from a midplane passing through the patient interface 10. Also, the first opening 889 of the deflector 880 is laterally spaced from a midplane passing through the patient interface 10.

The dividing wall 4242 comprises a first lateral portion 928 adjacent the midplane on the side of the midplane opposite the flow director 880. The first lateral portion 928 coincides with the location of the second deflector of the pair of deflectors 880. The first lateral portion 928 has a first wall thickness. The dividing wall 4242 further comprises one of the lateral side portions 800 extending laterally outwardly from the first lateral portion 928. The lateral side portion 800 has a second wall thickness, and the first wall thickness of the first lateral portion 928 is the same as the second wall thickness. In an alternative embodiment, the first wall thickness of the first lateral portion 928 is greater than the second wall thickness.

According to this alternative embodiment, the transition 930 between the first lateral portion 928 and the lateral side portion 800 is laterally spaced from the midplane by a distance substantially equivalent to the distance that the most laterally positioned portion of the deflector 880 is spaced from the midplane. Alternatively, the transition 930 between the first lateral portion and the lateral side portion 800 is laterally spaced from the midplane by a distance greater than the distance that the most laterally positioned portion of the deflector 880 is spaced from the midplane. In another alternative embodiment, the transition 930 between the first lateral portion and the lateral side portion 800 is laterally spaced from the midplane a distance less than the distance that the most laterally positioned portion of the deflector 880 is spaced from the midplane.

Fig. 91 to 93 show variants of the embodiment shown in fig. 88 to 90. In fig. 91-93, the patient interface 10 includes the nostril opening 234 and includes a passage 930 extending from the first chamber 238 to the nostril opening 234 that seals around the nostril of the patient and that is configured to align with one nostril of the patient. The remainder of the nostril opening 234 is configured to align with another nostril of the patient. This embodiment is expected to operate in the same manner as the embodiment described above with only one deflector (fig. 88-90). That is, the channel 934 and the nostril opening 234 are configured to deliver a flow of irrigation gas to the first nostril when the interface is fitted to a patient, and the flow of irrigation gas that irrigates the nasal cavity and that irrigates through the nasal cavity flows through the other nostril and through the remainder of the nostril opening 234 and into the second chamber 240. In this way, this embodiment is expected to provide a unidirectional irrigation of the nasal cavity.

In this embodiment, the channel 930 is configured to enable gas to flow from the other naris of the patient into the second chamber 240. In addition, the channel 930 is configured to enable gas to flow from the channel 930 into the second chamber 240.

The channel 930 may be configured to deliver a flow of gas to only one naris of the patient. However, in this embodiment, the channel 930 is configured to deliver a flow of gas to both nostrils of the patient. The flow of gas to the nostrils of the patient includes a first flow of gas and a second flow of gas from the passageways 930, and the first flow of gas and the second flow of gas are unequal. The first gas flow is greater than the second gas flow. The first flow of gas to the first naris is a flow of irrigation gas. Although both nostrils are clean, the flow of irrigation gas supplied to one nostril enables one-way anatomic dead space irrigation of the nasal cavity and upper throat as described above. If the nostril to which the flow of flushing gas is supplied is blocked, the second flow of gas supplies breathing gas to the patient to continue the breathing cycle.

The diversion of the gas flow from the channel 930 is achieved by the configuration of the channel 930. The channel 930 is defined in part by a perimeter wall 932 extending between the divider wall 4242 and the nostril opening 234 and in part by a partition wall 934 extending between the divider wall and a location recessed from the nostril opening 234 to form the channel 930 with the perimeter wall 932. The partition wall terminates at the outlet end of the channel with a partition edge 936. While the blocking edge 936 links the rim 286 on the proximal and distal sides of the rim 386 of the nostril opening 234, the blocking edge 936 has a curved shape recessed from the nostril opening 234. The recessed location of the partition wall 934 from the nostril opening 234 enables gas to flow from the passage 234 into the second chamber 240 when the patient interface 10 is assembled to a patient. The partition wall 934 is recessed from the nostril opening to avoid contact with the patient. That is, the partition wall 934 is sufficiently recessed from the nostril opening 234 such that when the patient interface 10 is fitted to a patient, a void exists between the end of the partition wall 934 and the patient's septum for gas flow.

The channel 934 tapers from the divider wall 4242 to the nostril openings 234 to accelerate the gas as it travels through the channel 934. In other embodiments, the profile of the channel 934 is constant from the divider wall 4242 to the nostril opening 234.

Fig. 83 and 84 illustrate another alternative flow director 890. The deflector 890 has the same general form as the deflector 880, with the former deflector including a base 891, a body 892 extending from the base 891, and a rim 893. The base 891 joins the body 892 to the divider wall 4242. The base 891 forms a smooth transition surface between the body 892 and the divider wall 4242. Similar to the deflector 880, a portion of the outer wall 288 extends on a laterally outer side of the second opening 894 defined by the rim 893. As explained above with respect to the cushion module 4020, in use, when the patient interface 10 is assembled, the nostril openings 234 laterally expand such that the nostril openings 234 extend laterally outward such that the outer wall 288 does not extend over the second opening 894.

Body 892 includes a transition 895 that defines a body lower portion 896 from rim 893. Unlike deflector 880, deflector 890 does not include an upper body portion. The body lower portion 896 has a reduced wall thickness from the base 891 to the transition 895. The body lower portion 896 is angled in the proximal direction such that a proximal side of the body lower portion 896 extending from the base 891 to the transition 895 is shorter than a distal side of the body lower portion 896 extending from the base 891 to the transition 895. The transition 895 occupies a plane that is inclined in the same manner as the lower body portion 896. However, the inclination of the lower body portion 896 and the transition 895 is less than the inclination present in the deflector 4246. The angulation of the body lower portion 896 and the lateral positioning of the flow director 890 help direct the breathing gas from the flow director 890 through the nostril opening 234 and into the nostril. The flow director 890 also differs from the flow director 4246 in that the transition 895 is closer to the divider wall 4242 than the transition 802 of the flow director 4246.

The lower body portion 896 has a wall thickness and the rim 893 has another wall thickness that is less than the wall thickness of the lower body portion such that the transition 895 has a tapered wall thickness.

In this embodiment, the spacer rib 898 joins the body lower portion 896 and the transition 895 at a location spaced from the rim 893. The spacer ribs 898 are disposed distally of an imaginary line connecting the centers of the second openings 894 of the respective flow directors 890. The base 891 or lower body portion 896 of the deflector 890 is joined to the wall portion 276.

The inner wall of the deflector 890 tapers inwardly from the first opening 899 toward the second opening 894 to form an inwardly tapered channel 930 between the first opening 899 and the second opening 894. In this embodiment, the wall thickness of rim 893 is greater than the wall thickness of lateral side portion 800, distal portion 810, or proximal portion 808 of the divider wall.

In this embodiment, the patient interface 10 includes one or more deformation zone tethers 918 extending between the side of the divider wall 4242 exposed to the first chamber 238 and the outer wall 288 of the sealing member 4230, the main portion 244 of the divider wall 4242 having a concave profile in a proximal-distal direction relative to the nostril opening 234, and the or each respective deflector 890 including a base 891, a body lower portion 896, a rim 893, and a transition 895 forming a second opening 894 open to the second chamber 240 extending between the body lower portion 896 and the rim 893.

For all embodiments of the deflector described above, the area of the second opening is between 20 and 160mm ² Or 40 to 140mm ² Or 40 to 100mm ² Or 40 to 80mm ² Or 40 to 60mm ² Or 30 to 80mm ² Or 30 to 60mm ² Or 20 to 60mm ² Within a range of (2). The only exception to this range is for the case of the embodiment of the deflector 880B shown in fig. 85-87 and having a smaller size, especially with respect to the two asymmetrically sized deflectors 880A and 880B. The smaller flow guideThe second opening 884B of the device may have an area smaller than the above-described range.

For all embodiments of the above-described flow director, the gas velocity through the flow director is in the range of 1 to 40 m/s. It will be appreciated that the speed may be different for a given gas pressure supplied to the patient interface, but is contemplated to fall within the ranges described above. The expected gas velocity is based on the patient interface being fitted to the patient and the first chamber 238, the second chamber 240, or the flow directors 246, 1246, 2246, 3246, 4246, 820, 830, 840, 850, 860, 870, 880, or 890 not being occluded.

As previously described, patient interface 10 further includes frame 30 and catheter connector 40.

The frame 30 includes a central body portion 302 that includes one or more channels for delivering breathing gas from a gas source to the cushion module 20 and thus to the patient. The frame 30 includes wings 304 extending from the central body portion 302. Each side flap 74 includes a pair of openings 308 that are arranged to cooperate with a headgear (e.g., an elastic strap) to fit the patient interface onto a patient. The headgear operates by pulling the mask 10 into contact with the patient's face to form a substantially airtight seal when breathing gas at an elevated gas pressure is delivered to the patient via the mask 10. One opening 308 on each side flap 304 includes a lever 306 for connection with the headgear clip to allow easier connection and disconnection with the headgear.

While this embodiment includes a frame 30, in alternative embodiments the headgear connection points may be integral with or connected to the housing 210. If so, the frame 30 is not necessary and may be omitted from such embodiments.

The frame 30 further includes a connector sleeve 310 that includes four arcuate fingers 312. The connector sleeve 312 has an inner wall 314 that includes a concave profile having the shape of a spherical segment. The outer wall of the connector sleeve 310 is shaped to fit within the sleeve 220 of the housing 210. The arcuate fingers 312 are spaced apart by detents that are shaped to mate with the key structure 222. The location of the key structure 222 and detents ensures that the frame is properly aligned with the housing 210 when assembled therewith.

Each arcuate finger 312 has an end with an arcuate flange portion 318 that forms a snap fit with the radially inwardly projecting lip 298 of the sleeve 220. The snap fit holds the frame 30 to the housing 210. The snap fit may be releasable or may be a permanent fit between the frame 30 and the housing 210.

In view of the comments above regarding the variation of the general form shown in fig. 1, one such variation of the general form (and which applies to the aspects and embodiments described below) is that the housing 210 and the frame 30 are integrally formed. In other words, patient interface 10 may include an integral structure that performs the same function of housing 210 and frame 30. Although the housing 210 and the frame 30 are described as separate components of the patient interface 10, the description should be read as including the option of integrally formed components that function in the same manner as the housing 210 and the frame 30. Alternatively, the frame 30 may be attached to the housing 210 by any conventional means, such as by adhesive or welding. For example, the frame 30 may be permanently connected to the housing 210 by ultrasonic welding the housing 210 and the frame 30.

The conduit connector 40 includes an elbow 60 and a socket insert 50 that couples the elbow 60 to the frame 30. The conduit connector 40 further includes a swivel connector 80 that connects to a conduit that delivers breathing gas from a source such as a ventilator, humidifier, or wall source. The swivel connector 80, elbow 60 and socket insert 50 form a flow path for breathing gas from the conduit into the cushion module 20, 1020, 2020, 3020.

The socket insert 50 has an outer wall 502 that includes a convex spherical section. The shape of the spherical section matches the shape of the concave spherical section of the inner wall 314 of the frame 30. One end of the outer wall 502 is coupled to the inner wall 504. The inner wall 504 includes an inner surface 506 that includes a radially inwardly extending shoulder 508. The socket insert 50 is snap-fit with the frame 30 such that the outer wall 502 sits in the concave section of the inner wall 314 of the frame 30 (fig. 4). The connection forms a ball-and-socket connection to allow the socket to rotate within the spherical section of the inner wall 314 of the frame 30.

Elbow 60 includes a first conduit portion 602 and a second conduit portion 608. The longitudinal axes of the first conduit portion 602 and the second conduit portion 608 are set at an oblique angle. Accordingly, the breathing gas flowing through elbow 60 undergoes a change in direction from first conduit portion 602 to second conduit portion 608. The conduit portion 602 includes a radially extending flange 606. Elbow 60 is connected to socket insert 50 by snap-fit of flange 606 with shoulder 508. However, in other embodiments, the elbow 60 may be connected to the socket insert 50 by welding or by adhesive, in which case the shoulder 508 and flange may be omitted.

The second conduit portion 608 includes an inlet 610 for breathing gas. An inlet 610 is located at the distal end of the second conduit portion 608. The second conduit portion 608 further includes the following structure (see fig. 5): this structure cooperates with an anti-asphyxia valve 70 (fig. 2, 4 and 5) to admit ambient air into the patient interface in the event of a failure of the source of breathing gas, or in the event of a blockage of the conduit for delivering gas from the source to the patient interface 10. More specifically, the second conduit portion 608 includes an opening 612. The opening is located in a lower portion of the second conduit portion 608. A ridge 614 is disposed adjacent to the opening 612 and supports a faceplate 616 spaced from the opening 612. The panel and the open clamp form a void 618 through which ambient air may enter the opening.

The anti-asphyxia valve 70 includes a valve seat 702 and a valve seal 714. Valve seat 702 includes a sealing surface 704 against which valve seal 714 seals the valve 70. Valve seat 702 further includes a sleeve 708 having a radially outwardly extending bead 710. The bead 710 is located at the end of the sleeve 708. Valve seat 702 further includes a plug 712 for coupling with a valve seal 714.

The valve seal 714 includes a flap 720 that is switchable between an open position in which the elbow 60 is open to flow of breathing gas from the source and a closed position in which the elbow 60 is closed to flow of breathing gas from the source. In the open position, ambient air is inhibited from entering the interior of elbow 60, and in the closed position, ambient air is admitted to the interior of elbow 60. In this embodiment, the petals 720 are formed of a flexible material. Flap 720 is coupled to tab 716 by hinge 722. Hinge 722 includes a section of flexible material having a reduced wall thickness. The lugs 716 are configured to assist in positioning the valve seal 714 within an end of the second conduit portion 608. In addition, the tab 716 includes a recess 718 adapted to receive the plug 712. The fitting of plug 712 within recess 718 properly orients valve seal 714 on valve seat 702.

When supplied with pressurized breathing gas from a source, the pressurized breathing gas flows through elbow 60 and into cushion module 20, 1020, 2020, 3020. The elevated pressure of the breathing gas causes the flaps to swing about the hinge 722 to cover the opening 612 in the second conduit portion. This represents the "open position" described above, wherein the flaps 720 prevent ambient air from entering the elbow 60 via the void 618 and the opening 612. In the event that the source of breathing gas fails or the conduit connected to the source is blocked, the anti-asphyxia valve 70 closes because the gas pressure in elbow 60 is equal to the gas pressure outside elbow 60, causing the flaps 720 to transition to the "closed" position described above due to the inherent elasticity of the flexible material forming hinge 722. In the closed position, the opening 612 emerges into the interior of the elbow 60 such that the patient's natural breathing cycle draws air into the elbow 60 and cushion module 20, 1020, 2020, 3020 via one or more openings as shown by the flow arrows in fig. 5.

Valve seat 702 includes a radially protruding step configured to couple with elbow 60. In particular, the step 724 is configured to mate with an end of the second conduit portion 608. The coupling may comprise a snap fit connection, or may comprise a permanent fixation, such as welding or fixation with an adhesive.

Valve seat 702 is coupled to swivel connector 80, which is configured to connect with a conduit from a source of respiratory gases. The swivel connector 80 includes a radially inwardly extending shoulder 82 that may cooperate with a step 724 of the valve seat 714 to connect the valve seat 714 to the swivel connector 80. The connection is a snap fit connection. However, in other embodiments, the connection may include permanent fixation, such as welding or fixation with an adhesive.

Those skilled in the art to which the invention relates will appreciate that many changes and modifications can be made to the preferred embodiments without departing from the spirit and scope of the invention.

In the claims that follow and in the preceding description, except where the context requires otherwise due to express language or necessary implication, the words "comprise" and variations such as "comprises" or "comprising" are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the apparatus and methods as disclosed herein.

In the foregoing description of the preferred embodiment, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar technical purpose. Terms such as "front" and "rear", "inner" and "outer", "above", "below", "upper" and "lower", "bottom" and "top", "vertical" and "horizontal" are used as words of convenience to provide reference points and are not to be construed as limiting terms. These terms are used throughout the specification (including the claims) in reference to a patient interface referring to an orientation relative to a normal operating orientation (i.e., when the interface is fitted to a patient and the patient's head is upright).

Throughout the specification and claims, terms such as "connected," "linked," and "connected" should not be interpreted as requiring that two separate elements be linked together. These terms should be interpreted in the context of including an option that means that integrally formed features intersect. For example, in the above embodiments the partition walls are joined to the outer wall, but in those embodiments they are integrally formed.

Furthermore, while the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. In addition, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to implement the other embodiments. Furthermore, each individual feature or component of any given assembly may constitute a further embodiment.

Claims

1. A non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising:

2. A non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising:

3. A non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising:

Wherein the dividing wall comprises one or more spaced apart flow directors, said flow directors enabling gas to flow from the first chamber into the second chamber, and said flow directors being configured to direct the gas to flow through the nostril openings.

4. A non-invasive patient interface configured for sealing around a mouth and nostrils of a patient, the patient interface comprising: