FIELD
The present disclosure generally relates to components for medical systems for
conveying gases to and/or from a patient. In one particular aspect, the disclosure relates to patient
interfaces that form a part of a breathing system.
BACKGROUND
[0002] In assisted breathing, respiratory gases are supplied to a patient through a patient
interface via one or more flexible breathing tubes. The patient interface can be a nasal cannula, nasal
mask, full face or oro-nasal mask, endotracheal tube, or other known types of interfaces. The gases
expired by the patient may be channeled through a similar breathing tube to other equipment (valves,
ventilators, pressure devices, or the like) or expelled to the patient's surroundings.
[0003] In medical applications, such as assisted breathing, the gases inhaled by a patient
are preferably delivered close to body temperature (usually between 33°C and 37°C) and with a high
relative humidity (commonly near saturation). In other medical applications, such as continuous
positive airway pressure (CPAP) systems or positive pressure ventilations systems that provide
patient's suffering obstructive sleep apnea (OSA) with positive pressure breathing gases, the breathing
gases may be heated and/or humidified to varying levels to improve user comfort or supplied without
heating or humidification.
[0004] In the specification where reference has been made to patent specifications, other
external documents, or other sources of information, this is generally for the purpose of providing a
context for discussing the features of the disclosure. Unless specifically stated otherwise, reference to
such external documents is not to be construed as an admission that such documents, or such sources
of information, in any jurisdiction, are prior art, or form part of the common general knowledge in the
art.
[0005] Further aspects and advantages of the present disclosure will become apparent from
the ensuing description which is given by way of example only.
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SUMMARY
[0006] It would be advantageous to provide a system for gas delivery treatment with
interchangeable patient interface, such as a nasal cannula, nasal mask, or oro-nasal mask. Such an
alternative or improved system may further assist with improved compliance and flexibility of gas
delivery treatment.
[0007] An aspect of the present disclosure involves a patient interface assembly including
a first interface body, a second interface body, and a housing configured to detachably couple with
the first interface body or the second interface body. The first interface body and the second interface
body are interchangeable, such that the first interface body is coupled to the housing in a first
configuration, and the second interface body is coupled to the housing in a second configuration.
[0008]
[0009]
[0010]
In some configurations, the first interface body is a cannula body.
In some configurations, the cannula body comprises one or more nasal prongs.
In some configurations, the one or more prongs are configured to be inserted into
nares of a user and form a seal.
[0011] In some configurations, the second interface body is a mask body.
[0012]
[0013]
[0014]
In some configurations, the second interface body is a nasal mask.
In some configurations, the second interface body is an oro- nasal mask.
In some configurations, the mask defines a breathing chamber and having a usercontacting
surface configured to contact a face of the user and surround at least the nares of the user.
[0015]
[0016]
symmetrical.
[0017]
housing.
In some configurations, the housing comprises an upper edge and a lower edge.
In some configurations, the upper edge and the lower edge of the housing are
In some configurations, the lower edge of the housing is curved inwardly to the
[0018] In some configurations, each of the first interface body and the second interface
body comprises a manifold, wherein the manifold is configured to be at least partially received by the
housing when the first interface body or the second interface body is detachably coupled to the
housing.
[0019] In some configurations, the manifold compnses a housing coupling portion
configured to be received within the housing when the first interface body or the second interface
body is detachably coupled to the housing.
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[0020] In some configurations, the manifold further comprises a raised portion adjacent
the housing coupling portion, wherein the raised portion is configured to inhibit rotation of the
manifold about the housing when the first interface body or the second interface body is detachably
coupled to the housing.
[0021] In some configurations, the housing and/or the manifold comprises a feedback
mechanism to provide a visual or audible feedback when the first interface body or the second
interface body is detachably coupled to the housing.
[0022] In some configurations, the patient interface assembly further includes one or more
interface tubes.
[0023] In some configurations, the housing compnses one or more tube engagmg
receiving portions configured to receive interface tubes.
[0024] In some configurations, the patient interface assembly further includes a
securement member configured to be attached to the housing.
[0025] In some configurations, the first interface body can comprise a mask or nasal
prongs of a first size and the second interface body comprises a mask or nasal prongs of a second size,
wherein the first size is different from the second size.
[0026] An aspect of the present disclosure involves a patient interface including, an
interface body, a housing, one or more interface tubes, a first securement member and a second
securement member extending vertically for providing vertical stability to the patient interface.
[0027] In some configurations, the interface body is configured to be engaged on the
patient's face and form a seal.
[0028]
[0029]
housing.
[0030]
housing.
[0031]
gnp.
In some configurations, the interface body is a mask body or a cannula body.
In some configurations, the one or more tubes are configured to be coupled to the
In some configurations, the one or more tubes are formed as a single piece with the
In some configurations, each of the one or more tubes comprises an overmoulded
[0032] In some configurations, the first securement member includes a central portion, a
pair of support pads and a pair ofbridging portions. Each of the support pads are configured to engage
a securing mechanism at the face of a user on opposing sides of the central portion. Each of the
bridging portions connects the central portion and a respective one of the support pads.
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[0033] In some configurations, the first securement member further comprises a patch
assembly coupled to each of the support pads for securing the support pads to the user.
[0034] In some configurations, the second securement member is coupled to the housing.
[0035] In some configurations, the second securement member is configured to engage the
forehead of a user.
[0036]
material
[0037]
In some configurations, the second securement member is constructed from a fabric
In some configurations, the second securement member further comprises a patch
assembly for securing the second securement member to the user.
[0038] In some configurations, the interface body has a Shore hardness between 20AIOOA.
[0039]
one end.
[0040]
In some configurations, each of the one or more interface tubes is tapered toward
An aspect of the present disclosure involves a patient interface including an
interface body. The interface body includes one or more prongs extending from a base region at the
interface body, and one or more openings to allow the flow of respiratory gases into and from the
interface body. The one or more prongs are configured to flex at the base region while maintaining
seal with the nares of the user.
[0041] In some configurations, the interface body comprises a right prong and a left prong.
[0042] In some configurations, a thickness of the one or more prongs varies along the
length of the one or more prongs.
[0043] In some configurations, a thickness of the one or more prongs maintains a constant
thickness along the length of the one or more prongs.
[0044] In some configurations, the base region has a thickness smaller than the rest of the
interface body.
[0045] In some configurations, the base region has a surface recessed relative to the
adjacent region of the interface body.
[0046] In some configurations, the base region has a recessed surface around the one or
more prongs.
[0047]
two prongs.
[0048]
In some configurations, the base region has a recessed surface extending around
In some configurations, the one or more prongs are configured to flex in forward
and rear directions.
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[0049]
left directions.
In some configurations, the one or more prongs are configured to flex in right and
[0050]
left directions.
In some configurations, the one or more prongs are configured to flex in right and
[0051] In some configurations, the one or more prongs have a circular cross-section
adjacent at a top end of the prongs.
[0052] In some configurations, the one or more prongs are configured to flex while
maintaining their diameter and cross-sectional shape along their lengths.
[0053] In some configurations, the one or more prongs are configured to flex while
maintaining their resistance to flow (RTF).
[0054] An aspect of the present disclosure involves a respiratory system including a gas
flow source, an inspiratory conduit fluidically connected to the gas flow source, and a patient interface.
The patient interface includes an interface body, a housing, one or more interface tubes; and a first
securement member.
[0055] In some configurations, the respiratory system further includes an expiratory
conduit configured to receive gases from the patient interface.
[0056] In some configurations, the respiratory system further includes a bubbler device.
[0057]
[0058]
In some configurations, the respiratory system further includes a humidifier.
In some configurations, the housing is configured to receive each of a plurality of
interface bodies, such that the interface bodies are interchangeable.
[0059] In some configurations, the interface body is a mask body or a cannula body.
[0060] In some configurations, the one or more interface tubes are configured to be
coupled to the housing.
[0061] In some configurations, one of the one or more interface tubes is configured to be
connected to the inspiratory conduit.
[0062]
housing.
[0063]
gnp.
In some configurations, the one or more tubes are formed as a single piece with the
In some configurations, each of the one or more tubes comprises an overmoulded
[0064] In some configurations, the first securement member comprises a central portion,
a pair of support pads and a pair of bridging portions. Each of the support pads is configured to engage
the face of a user on opposing sides of the central portion. Each of the bridging portions connects the
central portion and a respective one of the support pads.
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[0065] In some configurations, the first securement member further comprises a patch
assembly coupled to each of the support pads for securing the support pads to the user.
[0066] In some configurations, the patient interface further comprises a second securement
member is coupled to the housing.
[0067] In some configurations, the second securement member is configured to engage the
forehead of a user.
[0068]
material
In some configurations, the second securement member is constructed from a fabric
[0069] In some configurations, the second securement member further comprises a patch
assembly for securing the second securement member to the user.
[0070] In some configurations, the respiratory system further incudes a headgear or a
bonnet.
[0071] In aspect of the present disclosure involves a securement member for a patient
interface of a respiratory system including a soft, flexible barb for detachably coupling with a housing
of the patient interface.
[0072] In some configurations, the barb comprises one or more tabs.
[0073] In some configurations, the housing comprises an opening, wherein the one or more
tabs are configured to catch on the housing at the opening of the housing.
[0074] In some configurations, the barb includes a cutout. The cutout is configured to aid
in collapsing of the barb.
[0075] In some configurations, the barb compnses an extended top portion that 1s
configured to prevent the barb from being over inserted into the opening of the housing.
[0076] In some configurations, the barb is overmoulded onto the securement member.
[0077] In aspect of the present disclosure involves a securement member for a patient
interface of a respiratory system including a support pad that secures to a patch assembly on a patient,
wherein the support pad is hinged relative to the rest of the securement member.
[0078] In some configurations, the support pad is flexible.
[0079] In some configurations, the securement member further compnsmg a hinge
between the support pad and a portion of the securement member.
[0080]
member.
[0081]
In some configurations, the support pad is overmoulded onto the securement
In some configurations, the hinge is a 180-degree hinge.
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[0082] An aspect of the present disclosure involves a securement member for a patient
interface of a respiratory system including a first flexible portion connectable with a patient interface
component, a second flexible portion connectable to a patient's forehead, and a third rigid portion
extending between the first and second portions.
[0083]
[0084]
In some configurations, the first flexible portion is a barb.
In some configurations, the second flexible portion is a support pad.
[0085] In some configurations, the first and/or second flexible portions are overmoulded
onto the third rigid portion.
[0086] In some configurations, the second flexible portion is hinged relative to the third
rigid portion.
[0087] In some configurations, the securement member is detachably connectable to
housing of the patient interface.
[0088]
[0089]
In some configurations, the component is a housing or interface body.
An aspect of the present disclosure involves a patient interface assembly including
an interface body comprising a manifold comprising a front side configured to contact the patient and
a rear side opposite the front side, wherein the manifold comprises a raised portion of a housing
coupling portion positioned between the rear side of the manifold and the front side of the manifold,
the manifold comprising a width that runs along an inner lumen of the manifold and a horizontal axis
that runs along the width, wherein the raised portion is angled with respect to the horizontal axis,
wherein the angled raised portion of the housing coupling portion is configured to improve the
assembly and alignment of the interface body when it detachably couples with a housing via the
manifold; a housing comprising a front patient facing side and a rear side opposite the front side,
wherein the housing comprises a width that extends from a first tube engaging portion on one end of
the housing to a second tube engaging portion on an opposite end of the housing and a horizontal axis
that runs along the width, wherein the housing comprises an interface body receiving portion between
the front side of the housing and the rear side of the housing, wherein the interface body receiving
portion is angled with respect to the horizontal axis, wherein the angled interface body receiving
portion is configured to improve the assembly and alignment when the manifold is detachably coupled
and received by the housing.
[0090] In some configurations, the raised portion of the manifold comprises a first width
on the front side of manifold that is greater than a second width on the rear side of the manifold.
[0091] In some configurations, the raised portion of the manifold comprises a first width
on the front side of manifold that is less than a second width on the rear side of the manifold.
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[0092] In some configurations, the angled raised portion of the housing coupling portion
of the manifold extends at an angle of 120 degrees from the rear side ofthe manifold.
[0093] In some configurations, the angled raised portion of the housing coupling portion
of the manifold extends at an angle of 60 degrees from the rear side of the manifold.
[0094] In some configurations, the angled raised portion of the housing coupling portion
of the manifold extends at an angle of between 30 degrees and 170 degrees from the rear side of the
manifold.
[0095] In some configurations, the patient interface assembly further compnsmg an
engagement surface where the raised portion of the housing coupling portion and the interface body
receiving portion contact each other, wherein a portion of the raised portion of the manifold at the
engagement surface is higher relative to the engagement surface of the housing.
[0096] In some configurations, the manifold comprises a portion on either side of manifold
that is configured to extend within the housing, wherein the portion that extends within the housing
has a ridge configured to seal to the housing.
[0097] In some configurations, the ridge is an annular ridge.
[0098] In some configurations, the ridge is configured to seal with the internal surface of
housing.
[0099] In some configurations, the manifold has a first distance between the front side of
the engagement surface and the annular ridge and a second distance between the rear side of the
engagement surface and the annular ridge, wherein the second distance is greater than the first
distance.
[0100] In some configurations, the front side of the manifold has a first wall thickness and
the rear side of the manifold has a second wall thickness, wherein the first wall thickness is thicker
than the second wall thickness.
[0101] An aspect of the present disclosure involves a patient interface assembly involving
a housing that detachably couples with a manifold of an interface body, wherein the housing comprises
a side protrusion and a central protrusion, wherein the side protrusion comprises features for coupling
a first securement member to the housing and wherein the central protrusion comprises one or more
features for coupling a second securement member to the housing.
[0102]
[0103]
In some configurations, the housing is a rigid housing.
In some configurations, the one or more features for coupling with a second
securement member to the housing are one or more openings.
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[0104]
the housing.
[0105]
In some configurations, the second securement member is detachably coupled with
In some configurations, the one or more openings comprise a lip configured to
catch a complementary fitting portion of the second securement member.
[0106] In some configurations, the features of the side protrusion comprise an enlarged
head and a stem for a push-fit coupling.
[0107] In some configurations, the first securement member is detachably coupled with
the housing.
[0108] In some configurations, the patient interface assembly further comprising a tubing,
wherein the tubing is integral with the housing.
[0109] In some configurations, the patient interface assembly further comprising a tubing,
wherein the tubing is detachably coupled with the housing.
[0110] An aspect of the present disclosure involves a securement member for a patient
interface of a respiratory system including a central portion, a pair of support pads, each of the support
pads configured to engage the face of a user on opposing sides of the central portion, and a pair of
bridging portions, each of the bridging portions connecting the central portion and a respective one of
the support pads, wherein the bridging portions comprise cutouts for receiving a housing, wherein the
bridging portions comprise a thickened portion surrounding the cutouts.
[0111] In some configurations, the securement member further compnses a patch
assembly coupled to each of the support pads for securing the support pads to the user.
[0112] In some configurations, the securement member further comprises opemngs
configured to detachably couple the securement member to protrusions on a housing, wherein the first
securement member is push-fit over the protrusions on the housing.
[0113] In some configurations, the securement member further comprises a recess on the
rear side of the securement member, wherein the recess is configured to accommodate for a central
protrusion on the housing when the securement member is coupled to the housing.
[0114] An aspect of the present disclosure involves a patient interface assembly of a
respiratory system including an interface body; and a housing, wherein the interface body is
detachably coupled to the housing; and a feature that limits rotation of the interface body relative to
the housing.
[0115] In some configurations, the interface body comprises a manifold and the feature
comprises a shoulder portion on the rear of the manifold.
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[0116]
rotation.
[0117]
housing.
[0118]
[0119]
[0120]
10
In some configurations, the shoulder portion abuts against the housing to limit
In some configurations, the feature comprises a keyed feature on manifold and
In some configurations, the interface body comprises a cannula body.
In some configurations, the interface body comprises a mask body.
In some configurations, the housing comprises one or more tube engagmg
receiving portions configured to receive interface tubes.
[0121] An aspect of the present disclosure involves a patient interface assembly of a
respiratory system including a housing, an inspiratory conduit with a first end and a second end, the
first end configured to connect the housing and deliver incoming flow of gases and the second end
with locking fingers, and an expiratory conduit with first end and second end, the first end configured
to connect a housing and receive flow of expiratory gases and the second end with locking fingers.
[0122] In some configurations, the locking fingers at the second end of the expiratory
conduit are configured to couple to a downstream component.
[0123] In some configurations, the downstream component comprises a bubbler.
[0124] In some configurations, the locking fingers at the second end of the inspiratory
conduit are configured to couple to an upstream component.
[0125]
[0126]
In some configurations, the upstream component comprises a flow source.
In some configurations, the locking fingers extend away from a connector, the
locking fingers being spaced apart and narrowing along their length away from the connector.
[0127] In some configurations, the locking fingers comprising locking recesses that are
formed at least on outer surfaces of each of the locking fingers, the locking recesses being configured
to lock with portions of a gas delivery tube connector, the locking fingers being configured to interact
with recesses of the gas delivery tube connector to align the connector and the gas delivery tube
connector.
[0128] An aspect of the present disclosure involves a patient interface assembly of a
respiratory system including an interface body, and a housing, wherein at least a portion of an external
surface of the housing and/or the interface body comprises a low friction surface coating or finish.
[0129]
[0130]
In some configurations, the interface body comprises a cannula body.
In some configurations, the interface body comprises a mask body.
[0131] In some configurations, the low friction surface coating or finish is a parylene
coating or achieved by a blasting process, such as bead blasting.
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[0132] In some configurations, the interface body comprises a rear side comprising patient
contacting surface and a front side opposite the rear side, wherein the rear side has a low friction
surface coating or finish.
[0133] In some configurations, the interface body is detachable with the housing and the
interface body comprises a manifold with a low friction surface coating or finish that engages with
the housing.
[0134] An aspect of the present disclosure involves a manufacturing process for a patient
interface assembly for a respiratory system including manufacturing an interface body and coating an
external surface of the interface body in a low friction surface coating or finish.
[0135] In some configurations, the interface body comprises a cannula body.
[0136] In some configurations, the interface body comprises a mask body.
[0137] In some configurations, the interface body is detachable with a housing.
[0138] In some configurations, substantially an entire external surface of the interface
body is coated.
[0139] In some configurations, a portion of the interface body is coated, wherein the
interface body comprises a rear patient facing side of the interface body and a front side opposite the
rear side, wherein the coated portion is a rear portion of a manifold of the interface body.
[0140] In some configurations, a portion of the interface body is coated, wherein the
interface body comprises a rear patient facing side of the interface body and a front side opposite
the rear side, wherein the coated portion is a front portion of a manifold of the interface body.
[0141] An aspect of the present disclosure involves a patient interface assembly including
an interface body including a manifold comprising a front side configured to contact the patient and a
rear side opposite the front side, wherein the manifold comprises a raised portion of a housing coupling
portion positioned between the rear side of the manifold and the front side of the manifold, wherein
the manifold comprising a width that runs along an inner lumen of the manifold and a horizontal axis
that runs along the width, wherein the raised portion is angled with respect to the horizontal axis,
wherein the angled raised portion of the housing coupling portion is configured to improve the
assembly and alignment of the interface body when it detachably couples with a housing via the
manifold, and a feature that limits rotation of the interface body relative to the housing, and the
housing including a front patient facing side, a rear side opposite the front side, wherein the housing
comprises a width that extends from a first tube engaging portion on one end of the housing to a
second tube engaging portion on an opposite end of the housing and a horizontal axis that runs along
the width, wherein the housing comprises an interface body receiving portion between the front side
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of the housing and the rear side of the housing, wherein the interface body receiving portion is angled
with respect to the horizontal axis, wherein the angled interface body receiving portion is configured
to improve the assembly and alignment when the manifold is detachably coupled and received by the
housing, a first securement member comprising a central portion, a pair of support pads, each of the
support pads configured to engage the face of a user on opposing sides of the central portion, and a
pair of bridging portions, each of the bridging portions connecting the central portion and a respective
one of the support pads wherein the bridging portions comprise cutouts for receiving the housing,
wherein the bridging portions comprise a thickened portion surrounding the cutouts, a second
securement member comprising a first flexible portion connectable with a patient interface
component, a second flexible portion connectable to a patient's forehead, and a third rigid portion
extending between the first and second portions, an inspiratory conduit with a first end and a second
end, the first end configured to connect to the housing and deliver incoming flow of gases and the
second end with locking fingers, and an expiratory conduit with first end and second end, the first
end configured to connect to the housing and receive flow of expiratory gases and the second end with
locking fingers.
[0142]
[0143]
[0144]
housing.
In some configurations, the interface body comprises a cannula body.
In some configurations, the interface body comprises a mask body.
In some configurations, the inspiratory and expiratory conduit are integral with the
[0145] In some configurations, the first and second securement members are
connectable with the housing.
[0146] In some configurations, the second securement member is connectable with a patch
assembly or headgear of a patient.
[0147] In some configurations, the second securement member is detachably coupled to
the housing.
[0148] In some configurations, the interface body is detachably coupled to the housing.
[0149] An aspect of the present disclosure involves a patient interface assembly
comprising an interface body, and a housing configured to detachably couple with the interface body,
the housing comprises one or more tube engaging portions at lateral entry points on opposite ends of
the housing, wherein the tube engaging portions are configured to receive interface tubes.
[0150] In some configurations, the interface body can comprise a cannula body.
[0151] In some configurations, the interface body can comprise a mask body.
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[0152] An aspect of the present disclosure involves a patient interface assembly
comprising a first interface body, a second interface body, and a housing configured to detachably
couple with the first interface body or the second interface body, the housing comprises one or more
tube engaging portions at lateral entry points of the housing, wherein the tube engaging portions are
configured to receive interface tubes, wherein the first interface body and the second interface body
are interchangeable, such that the first interface body is coupled to the housing in a first configuration,
and the second interface body is coupled to the housing in a second configuration.
[0153] An aspect of the present disclosure involves an interface body comprising a mask
comprising a breathing chamber and having a user-contacting surface configured to contact a face of
the user and surround at least the nares of the user, and a manifold in fluid communication with the
breathing chamber, the manifold comprising a first opening on a first lateral side of the manifold and
a second opening on the second lateral side of the manifold, wherein the first and second openings
permit gas flow into and out of the breathing chamber.
[0154] In some configurations, the first and second openings can be configured to be in
communication with interface tubes configured to deliver a flow of gas entering and exiting the mask
and the first and second lateral side of the manifold.
[0155] An aspect of the present disclosure involves an interface body comprising a mask,
wherein the mask defines a breathing chamber and having a user-contacting surface configured to
contact a face of the user and surround at least the nares of the user, the mask comprising a mask seal,
wherein at least part of the mask seal comprises a region of reduced stiffness, wherein the region of
reduced stiffness is positioned between a first stiffer region and a second stiffer region, wherein the
first and second stiffer regions have a stiffness greater than the stiffness of the region of reduced
stiffness, wherein when the first stiffer region is moved toward the second stiffer region, the region of
reduced stiffness buckles in a single direction as the first stiffer region continues to move towards the
second stiffer region.
[0156] In some configurations, the first stiffer region can comprise a structural support
portion extending partially around the circumference of the mask.
[0157]
[0158]
In some configurations, the second stiffer region can be a front portion of the mask.
An aspect of the present disclosure involves a patient interface assembly
comprising an interface body comprising a housing coupling portion, the housing coupling portion
comprise a first patient facing side and an opposite second side, wherein the housing coupling portion
comprises a shape defined between the first side and the second side of the housing coupling portion,
and a housing comprising an interface body receiving portion, wherein the interface body receiving
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portion is a complementary shape to the shape of the housing coupling portion of the interface body,
wherein the housing is configured to detachably coupled with the interface body.
[0159] In some configurations, the shape of the housing coupling portion can comprise a
trapezoidal shape.
[0160] In some configurations, the housing coupling portion of the interface body can
comprise a wider base of the trapezoid proximal to the front portion of the housing.
[0161] In some configurations, the housing coupling portion of the interface body can
comprise a wider base of the trapezoid proximal to the rear portion of the housing.
[0162] An aspect of the present disclosure involves an interface body comprising one or
more prongs extending from a base region and one or more openings to allow the flow of respiratory
gases into and from the prongs, wherein the one or more prongs are configured to flex at the base
region while maintaining seal with the nares of the user.
[0163] In some configurations, the one or more prongs can comprise a thickness that varies
along the length of the one or more prongs.
[0164] In some configurations, the one or more prongs can maintain a constant thickness
along the length of the one or more prongs.
[0165] An aspect of the present disclosure involves an interface body, wherein the
interface body can comprise one or more prongs extending from a base region at the interface body,
and one or more openings to allow the flow of respiratory gases into and from the interface body,
wherein the one or more prongs are configured to flex at the base region while maintaining seal with
the nares of the user.
BRIEF DESCRIPTION OF THE DRAWINGS
[0166] Throughout the drawings, reference numbers can be reused to indicate general
correspondence between reference elements. The drawings are provided to illustrate example
embodiments described herein and are not intended to limit the scope of the disclosure.
[0167]
can be used.
[0168]
can be used.
[0169]
[0170]
[0171]
FIG. 1 shows an example of a system in which embodiments of the patient interface
FIG. 2 shows an example of a system in which embodiments of the patient interface
FIG. 3 is a front, top and side perspective view of a patient interface.
FIG. 4 is a front, top and side perspective view of the patient interface of FIG. 3.
FIG. 5 is a front, top and side perspective view of a patient interface.
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[0172]
[0173]
[0174]
[0175]
[0176]
[0177]
[0178]
[0179]
[0180]
[0181]
[0182]
thickness analysis.
[0183]
[0184]
[0185]
[0186]
[0187]
[0188]
[0189]
[0190]
[0191]
[0192]
[0193]
[0194]
[0195]
[0196]
[0197]
[0198]
[0199]
[0200]
[0201]
[0202]
[0203]
15
FIG. 6 is a front, top and side perspective view of the patient interface of FIG. 5.
FIG. 7 is a front, top and side perspective view of a housing.
FIG. 8 is a front view of the housing of FIG. 7.
FIG. 9 is a rear view of the housing of FIG. 7
FIG. 10 is a front, top and side perspective view of a nasal interface.
FIG. 11 is a front view of the nasal interface ofFIG. 10.
FIG. 12A is a top view of the nasal interface of FIG. 10.
FIG. 12B is a rear view of the nasal interface of FIG. 10.
FIGS. 13A-13D representation ofthe nasal prongs of a cannula body.
FIGS. 13E-13I illustrate views of nasal prongs of a cannula body.
FIG. 14A is a schematic drawing of the nasal interface of FIG. 10 showing a
FIG. 14B is a schematic drawing of a nasal interface showing a thickness analysis.
FIG. 14C is a cross-sectional view of a nasal prong of a cannula body.
FIG. 15 is a rear, top and side perspective view of a patient interface.
FIG. 16 is a front, top and side perspective view of a patient interface.
FIG. 17 is a front view of the patient interface of FIG. 16.
FIG. 18 is a top view of the patient interface of FIG. 16.
FIG. 19 is a rear view of the patient interface of FIG. 16.
FIGS. 20-21 are schematic drawings of the patient interface of FIG. 16.
FIG. 22A is a front, top and side perspective view of a nasal interface.
FIG. 22B is a rear, top and side perspective view of the nasal interface ofFIG. 22A.
FIG. 23 is a schematic drawing of the nasal interface of FIG. 22A.
FIG. 24A is a rear, top and side perspective view of a nasal interface.
FIG. 24B is a top, cross-sectional view of a nasal interface.
FIG. 24C is a side, cross-sectional view of a nasal interface.
FIG. 24D is a schematic of a top cross-section of a nasal interface.
FIG. 24E is a schematic of a side cross-section of a nasal interface.
FIG. 25 is a front, top and side perspective view of a patient interface.
FIG. 26 is a top view of the patient interface of FIG. 25.
FIG. 27 is a front, top and side perspective view of a securement member.
FIG. 28 is a front view of the securement member of FIG. 27.
FIG. 29 is a front, top and side view of a securement member and a housing.
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[0204]
[0205]
[0206]
[0207]
[0208]
[0209]
[0210]
[0211]
[0212]
[0213]
[0214]
[0215]
[0216]
[0217]
[0218]
[0219]
[0220]
[0221]
[0222]
[0223]
[0224]
[0225]
[0226]
[0227]
[0228]
[0229]
[0230]
[0231]
[0232]
[0233]
[0234]
[0235]
[0236]
16
FIG. 30 is a rear view of the securement member and the housing of FIG. 29.
FIG. 31 is a schematic drawing of a securement member.
FIG. 32 is a schematic drawing of a securement member.
FIG. 33 is a front, top and side view of a securement member.
FIG. 34 is a front view of the securement member of FIG. 33.
FIG. 35 is a rear view of the securement member of FIG. 33.
FIG. 36 is a front, top, side perspective view of a patient interface assembly.
FIG. 37 is a top view of a housing.
FIG. 38 is a top perspective view of an interface housing.
FIG. 39A is a front perspective view of a securement member.
FIG. 39B is a rear perspective view of a securement member.
FIG. 39C is a top view of a securement member.
FIGS. 40-42 are front perspective views of a securement member.
FIG. 43A is a front view of a securement member and a housing.
FIG. 43B is a top view of a housing.
FIG. 44 is a front, side perspective view of a securement member.
FIG. 45 is a view of a securement member.
FIG. 46A-46B is a front and rear side perspective view of a securement member.
FIG. 47 is a front side perspective view of a securement member and housing.
FIG. 48A is a rear view of a cannula body.
FIG. 48B is a front view of a mask body.
FIG. 48C is a front view of a schematic of a mask body.
FIG. 48D is a front, side perspective view of a schematic of a mask body.
FIG. 48E is a top view of a schematic of a mask body.
FIG. 49 is a top view of a nasal interface and housing.
FIG. 50 is a partial top view of a nasal interface and housing.
FIGS. 51A-51B is a partial top view of a nasal interface and housing.
FIG. 52A is a top view of a nasal interface and housing.
FIG. 52B is a rear view of the nasal interface and housing of FIG. 52A.
FIG. 53 A is a top view of a nasal interface and housing.
FIG. 53B is a partial top view of the nasal interface and housing of FIG. 53A.
FIG. 53C is a partial top view of the nasal interface and housing of FIG. 53A.
FIG. 53D is a partial top view of the nasal interface and housing of FIG. 53A.
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[0237]
[0238]
[0239]
[0240]
assembly.
[0241]
[0242]
17
FIG. 54 is a side cross section view of an interface body.
FIG. 55 is a side cross section view of an interface body.
FIGS. 56A-56D are views of an interface body and housing.
FIGS. 56E-56F are views of an interface body, housing, and tubing of the interface
FIG. 57 is a front perspective view of an interface tubing and connector.
DETAILED DESCRIPTION
Embodiments of systems, components and methods of assembly and manufacture
will now be described with reference to the accompanying figures, wherein like numerals refer to like
or similar elements throughout. Although several embodiments, examples and illustrations are
disclosed below, it will be understood by those of ordinary skill in the art that the inventions described
herein extends beyond the specifically disclosed embodiments, examples and illustrations, and can
include other uses of the inventions and obvious modifications and equivalents thereof The
terminology used in the description presented herein is not intended to be interpreted in any limited
or restrictive manner simply because it is being used in conjunction with a detailed description of
certain specific embodiments of the inventions. In addition, embodiments of the inventions can
comprise several novel features and no single feature is solely responsible for its desirable attributes
or is essential to practicing the inventions herein described.
[0243] Certain terminology may be used in the following description for the purpose of
reference only, and thus are not intended to be limiting. For example, terms such as "above" and
"below" refer to directions in the drawings to which reference is made or directions relative to an
orientation of the device as used with the user in an upright position. Terms such as "front," "back,"
"left," "right," "rear," and "side" describe the orientation and/or location of portions of the
components or elements within a consistent but arbitrary frame of reference which is made clear by
reference to the text and the associated drawings describing the components or elements under
discussion or relative to an orientation of the device as used with the user in an upright position.
Respiratory System
[0244] FIG. 1 shows an example respiratory system 1000 in which embodiments of a
patient interface 3000 can be used. In the illustrated arrangement, the patient interface 3000 receives
an inspiratory flow of gases via an inspiratory conduit 201a. A flow of the expiratory gases can be
directed from the interface 3 000 via an expiratory conduit 201 b to a resistance device, which in the
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illustrated arrangement is a bubbler device 70. An optional humidifier system 30 is provided to
humidify the inspiratory flow of gases. The humidifier system 30 typically includes a chamber sitting
atop a heater base, the chamber of which is fed with a source of gases flow from, for example, a
hospital or other supply source 300. The humidified inspiratory flow of gases is delivered to the
airway of the patient by inspiratory conduit 201a and the patient interface 3000. Excess and expired
gases are evacuated from the patient interface 3000 by the expiratory conduit 201 b. The resistance
device 70 provides resistance to the expiratory flow of the gases exiting the system 1000 to the
atmosphere to provide a desirable peak end expiratory pressure (PEEP). One of skill in the art will
understand that such a system may include additional and/or replacement components as are known
in the art. In some embodiments, the patient interface 3000 includes a nasal cannula. In other
embodiments, the patient interface 3000 includes a mask. For example, the patient interface 3000 may
include a nasal mask, an oro-nasal mask, an oral mask or a full-face mask. In some embodiments, the
resistance device and/or the humidifier is integrated into the supply source 300. Although a waterbased
resistance device is shown in FIG. 1, it should be appreciated by one of skill that the resistance
device may be any other mechanical or electrical resistance device as is known in the art.
[0245] Referring now to FIG. 2, another example of a respiratory system including a
bubbler device and humidifier is depicted. A humidified Positive End Expiratory Pressure (PEEP)
system is shown in which a patient 119 is receiving humidified and pressurized gases through the
patient interface 3000 connected to an inspiratory or inhalatory conduit 201a. It should be understood
that the present disclosure, however, is not limited to the delivery of PEEP gases but is also applicable
to other types of gases delivery systems and may not necessarily involve humidification. Inspiratory
conduit 201a is connected to the outlet 112 of a humidification chamber 110, which contains a volume
of water 115. Inspiratory conduit 201 a may contain heating means or heater wires 120 that heat the
walls of the conduit to ensure a constant humidity profile along the conduit and therefore reduce
condensation of humidified gases within the conduit. As the volume of water 115 within
humidification chamber 11 0 is heated, water vapour begins to fill the volume of the chamber above
the water's surface and is passed out of the humidification chamber 110 outlet 112 with the flow of
gases (for example air) provided from a gases supply means or blower 118 which enters the chamber
110 through inlet 116. The humidified gases pass through the inspiratory conduit 201a to an interface
3000 being worn by the patient 119. The excess gases then flow through an expiratory or exhalatory
conduit 201 b to a pressure regulator 40.
[0246] In some embodiments, the pressure regulator 40 takes the form of discharging the
flow of exhalatory gases into a chamber 204 containing a column of water13 8. The gases flowing
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through the expiratory conduit 201 b are discharged into the body of water 13 8 from a short conduit
136 which extends from the expiratory conduit 201 b into the chamber 204. This results in a bubbling
effect, whereby the gases eventually exit the chamber 204 via the outlet port, which can also be used
to initially fill the chamber 204 with water. The outlet port includes shielding to prevents liquid
aerosols created by the vigorous bubbling on the surface of the water from being expelled. It will be
appreciated that the short conduit 136, could equally be integrated into the end of the expiratory
conduit 201 b.
Patient Interface Assembly
[0247] FIGS. 3-6 illustrate embodiments of the patient interface 3000. As shown in FIGS.
3-6, the patient interface 3000 includes an interface body which can form a seal with a user's face and
allow gas flow from and to the user, and the interface body can be coupled to a housing 3400. In some
embodiments, the housing 3400 can be a frame that can receive a portion of the interface body. In
some embodiments, the interface body is a cannula body 3200a that can mate with the housing 3400
to form a nasal cannula 3200, such as illustrated in FIGS. 3-4. The cannula body 3200a can form a
seal with nares of the user's nose. In some embodiments, the interface body is a mask body, such as
the mask body 3200b illustrated in FIGS. 5-6. The mask body 3200b has a mask or mask cushion that
can form a seal with the face of the user. The illustrated embodiment of the patient interface 3000 also
includes a first securement member 3600, one or more interface tubes 3800, and a second securement
member 3900.
[0248] In some embodiments, the housing 3400 can be detachably coupled to the cannula
body 3200a, the mask body 3200b, or any other type of interface bodies. The housing 3400 can be
detachably coupled with an interface body, for example using mechanisms to be described in further
detail herein, such that a user or a clinician can swap between different types of interface bodies (e.g.
between the cannula body 3200a and the mask body 3200b) and/or different sizes of interface body.
This may assist with better fitting while reusing the same housing without disassembling or removing
the entire patient interface 3000 during treatment. For example, the interface body may be coupled
to and/or decoupled from the housing 3400 while the first securement member 3600, the interface
tubes 3800 and/or the forehead support member 3900 are kept coupled to the housing 3400. In some
occasions, a mask body and a cannula body may need to be used alternately during treatment, for
example to reduce or prevent skin irritation or damage. The interface body could be swapped while
maintaining the housing 3400 connected to a headgear, a bonnet, a chinstrap, or the face of the user.
Further, detachable coupling of the interface body and the housing 3400 may be advantageous for
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cleaning and maintenance. In some embodiments, a kit for treating a patient includes one or more
cannula bodies and/or one or more mask bodies compatible with the housing 3400, such that a user or
a clinician can choose and use an appropriate interface body. In some embodiments, the kit includes
cannula bodies with different sizes and/or mask bodies with different sizes. The different sizes of
mask bodies and/or cannula bodies may be indicated by different colours or other means, such as
letters and/or symbols. The letters and/or symbols may be moulded, laser marked, printed or otherwise
displayed on the mask bodies and/or cannula bodies.
[0249] In some embodiments, the housing 3400 may be permanently coupled to the
cannula body 3200a, the mask body 3200b, or any other type of interface bodies. A user or a clinician
can swap between different types of interface bodies (e.g. between the cannula body 3200a and the
mask body 3200b) or the interface body of different sizes for better fitting, by interchanging the
assembly with the housing and the interface body. For example, the interface body and the housing
3400 may be coupled to and/or decoupled with the interface tubes 3800. In some embodiments, a kit
for treating a patient includes one or more cannula bodies and/or one or more mask bodies attached
with the housing 3400, such that a user or a clinician can choose and use an appropriate interface body
attached to the housing 3400.
[0250] The first securement member 3600 may secure or support the patient interface 3000
relative to the user. The first securement member 3600 may be coupled to the housing 3400 and
facilitate securement of the interface body to the user's face and thereby help the interface body to
form and maintain a seal with the user's face. In some embodiments, the first securement member
3600 includes means to attach and secure the patient interface 3000 on a headgear, a chinstrap, a
patient interface patch or a dermal patch on the patient's face, or otherwise on the patient's face by
any suitable mechanisms. For example, the first securement member 3600 may include hook and
loop material or adhesive on the user facing side as described in further detail herein. Even though
the first securement member 3600 is coupled with the housing 3400 in the illustrated embodiments,
the patient interface 3000 may be used without the first securement member 3600. For example, the
housing 3400 may be secured on the user's face, for example on cheeks, directly or with other
securement means, such as a headgear or chinstrap. As illustrated in FIGS. 3-6, the first securement
member 3600 may extend horizontally or substantially horizontally. However, the first securement
member 3600 may be positioned in any suitable orientation.
[0251] The patient interface 3000 may further include other securement means in addition
to or instead of the first securement member 3600. For example, in the illustrated embodiment, the
patient interface 3000 includes the second securement member 3900. In some embodiments, the
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patient interface 3000 includes both the first securement member 3600 and the second securement
member 3900. In some embodiments, the patient interface includes one of the first securement
member 3600 and the second securement member 3900. As illustrated in FIGS. 3-6, the second
securement member 3900 may extend vertically or substantially vertically. However, the second
securement member 3900 may be positioned in any suitable orientation.
[0252] The patient interface 3000 may further include one or more interface tubes 3800.
In some embodiments, the walls of the interface tubes can be made of a material that can allow for the
passage of moisture vapor through the walls of the interface tubes. In some embodiments, the one or
more interface tubes 3800 are at least partially insulated. The interface tubes 3800 may be coupled to
the housing 3400 at one end, and may connect to a CP AP therapy delivering device, for example
through the tubes 201 a and 201 b, at the other end, and allow gas from and to the user to flow through
the housing 3400 and the interface body. Each of the interface tubes 3800 may include a connector
3860 for the connection to the respiratory component, such as tubes 201a and 201b. The connector
3860 may be overmoulded to the tube 3800. The connector 3860 may be or comprise a silicone or
elastomer material. The connector 3 860 may have similar or greater stiffness than the interface tubes
3800. The connector 3860 may be or comprise the same material as a component of the tube 3800,
such as a bead of the interface tube 3800, provided in a stiffer geometry relative to the tube 3800. In
some embodiments, the connector 3860 includes one or more ports to monitor gas properties such as
pressure. In some embodiments, the patient interface 3000 may include one or more sensors to
monitor gas properties such as pressure at the one or more ports or any other suitable locations. The
connector 3860 may be suitable for receiving a clip, which may be used to clip to bed sheets or clothing
to provide additional securement of the patient interface 3000 and the tubes 3800. In some
embodiments, each of the interface tubes 3800 further include a grip 3850. The grip 3850 may be
directly or indirectly overmoulded to the tube 3800, for example over both the tube 3800 and the
connector 3860. In some embodiments, the tube 3800 may be attached with adhesives or threadably
attached to the connector 3860 or other regions of the grip 3850. The clinician or the user may hold
the grip 3850 to connect or plug-in the connector 3860 to the respiratory component, such as tubes
201 a and 201 b. In some embodiments, one or more components of the interface tubes 3 800 can rotate
relative to the other components of the interface tubes 3800. For example, the grip 3850 can rotate
relative to the connector 3860, such that the torsion or movement caused by holding of the grip 3850
may not be translated through the rest of the tubes 3800 to the housing 3400 and the interface body.
[0253] In some embodiments, the tubes 3800 can be detachably coupled to the housing
3400. In some embodiments, the one or more of interface tubes 3800 are permanently attached to the
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housing 3400. For example, the one or more of interface tubes 3800 may be directly or indirectly
overmoulded to the housing 3400, thereby forming an integral piece. In some embodiments, the tubes
3800 may be attached with an adhesive or threadably attached with the housing 3400. In some
embodiments, the tube 3800 can rotate or swivel relative to the housing 3400, such that the torsion or
movement of the tubes 3800 may not conduct to the housing 3400 and the interface body. In some
embodiments, the interface tubes 3800 have a varying diameter and/or thickness along the length of
the interface tubes 3800. For example, each of the interface tubes 3800 may be tapered toward one
end. In some embodiments, the interface tubes 3800 have a constant diameter and/or thickness along
their lengths. In some embodiments, the interface tubes 3800 may have a circular, semicircular, or Dshaped
cross-sectional shape. When the semicircular or D-shaped cross-sectional shape is used, a flat
side of the interface tubes 3800 can be patient facing.
Housing
[0254] FIGS. 7-9 illustrate an embodiment of the housing 3400. In the illustrated
embodiment, the housing 3400 has a front portion 3430 and a rear portion 3450. The rear portion 3450
may be oriented to face the user's face when the patient interface 3000 is applied on the user's face,
and the front portion 3430 may be oriented to be opposite the user's face when the patient interface
3000 is applied on the user's face.
[0255] In the illustrated embodiment, the front portion 3430 includes one or more
attachment elements. The one or more attachment elements may extend outwardly from the front
portion 3430. In the embodiment illustrated in FIGS. 7-9, the one or more attachment elements can
include a central protrusion 3440 and a front extension 3420. In some embodiments, such as shown
in FIGS. 7-9, the one or more attachment elements includes a central protrusion 3440 with a pair of
front extensions 3420. Each of the pair of front extensions 3420 can be located laterally on opposing
sides of the central protrusion 3440. In other embodiments, the one or more attachment elements can
include any arrangement of protrusions or extensions. For example, in some cases, a single attachment
element can be used.
[0256] In some embodiments, such as shown in FIG. 7, the front extension 3420 can be
raised toward a front direction. The front extension 3420 may form a ridge 3422. A channel 3424
may be at least partially defined by the ridge 3422. In some embodiments, the first securement member
3600 can be positioned around the front extension 3420 and secured at the channel3424, such that the
first securement member 3600 can be detachably coupled to the housing 3400 when the patient
interface 3000 is assembled.
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[0257] The central protrusion and front extension can be used to secure one or more
securement members to the housing 3400. The central protrusion and front extension can be shaped
to receive the complementary portion of a securement member. As shown in FIGS. 7-9, in some
embodiments, the central protrusion 3440 may include an enlarged head 3442 and a stem 3444. In
other embodiments, such as shown in FIGS. 37 and 38, the central protrusion 4440 can have an
opening to receive the securement member as described herein with reference to FIGS. 37-38.
[0258] As illustrated in FIGS. 7-9, the central protrusion 3440 can receive and retain one
or more components with a hole which fits to the enlarged head 3442, for example by push-fit. For
example, the second securement member 3900 can be detachably coupled to the housing 3400 at the
central protrusion 3440. In some embodiments, the central protrusion 3440 is positioned in the middle
or substantially in the middle of the front portion 3430 and between the front extensions 3420.
[0259] In some embodiments, the front extensions 3420 can be positioned on either side
of the central protrusion 3440 as shown in FIGS. 7-9. The front extensions can have a shape to receive
the complementary securement member. As illustrated in FIGS. 7-9, the front extension 3420 may be
recessed around the central protrusion 3440, such that the central protrusion 3440 can have a greater
height to receive a thicker component, such as the second securement member 3900 without
excessively protruding out of the housing 3400. In some embodiments, the front extension 3420 may
not be recessed around the central protrusion 3440. In other embodiments, as shown in FIGS. 37 and
38, the front protrusion 4420 can be circular to receive the securement member as described herein
with reference to FIGS. 37-38.
[0260] In the illustrated embodiment, the rear portion 3450 of the housing 3400 includes
an interface body receiving portion 3480 for receiving an interface body, such as the cannula body
3200a or the mask body 3200b. At the interface body receiving portion 3480, an inner surface of the
housing 3400 is exposed. The interface body receiving portion 3480 and the inner surface of the
housing 3400 may be shaped and/or sized to match the shape and/or size of the interface body, and to
allow removal and interchangeability of the interface body relative to the housing 3400. For example,
the inner surface of the housing 3400 may have a cylindrical shape, such that it can receive and fit
with a cylindrical shaped portion of the interface body.
[0261] The housing 3400 may further include one or more tube engaging portions 3460 to
receive one or more interface tubes, such as the one or more interface tubes 3800. The tube engaging
portions 3460 may be sized and/or shaped to match the shape and/or size of the interface tubes, such
that the interface tubes can be coupled to the tube engaging portions 3460 without a leak The tube
engaging portion 3460 may be positioned such that the housing 3400 can receive a gas from the
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interface tubes through the tube engaging portion 3460, and allow the gas to flow to the interface body
coupled to the interface body receiving portion 3480.
[0262] The housing 3400 further includes an upper edge 3470 and a lower edge 3490
opposite the upper edge 3470. In some embodiments, the upper edge 3470 and the lower edge 3490
are symmetrical, such that a user or a clinician can orient the housing 3400 in either direction when
assembling the interface 3000. As shown in FIGS. 8-9, the upper edge 3470 and/or the lower edge
3490 may have an inwardly curved profile. The inwardly curved profiles of the upper edge 3470
and/or the lower edge 3490 can allow the user's mouth to be exposed even when the user is wearing
the patient interface 3000, for the comfort of the user. If the user is an infant, a pacifier may be used
or the user can be breastfed during the treatment. Further, an oro gastric tube may be introduced to the
patient, and the mouth of the user would be able to be cleaned easily.
[0263] In some embodiments, the housing 3400 is constructed from a material having
greater stiffness than the interface body, such as the cannula body 3200a and the mask body 3200b,
such that the housing 3400 can provide structural stability to the patient interface 3000. For example,
the housing 3400 may be constructed from a material having Young's modulus of0.1 GPa -7 GPa,
0.5 GPa -7 GPa, 0.5 GPa- 6 GPa, 0.8 GPa- 6 GPa, 1 GPa- 6 GPa, 1.8 GPa- 6 GPa, 2 GPa- 5
GPa, or 3 GPa- 5GPa. The thickness of the housing 3400 may be then altered to achieve the desired
stiffness of each regions of the housing 3400. The housing 3400 may be constructed from
thermoplastic elastomers, such as polycarbonate, thermoplastic polyurethane (TPU), polyamide,
nylons. The front extension 3420 forms a raised portion with greater thickness as described herein,
such that the front extension 3420 contributes to the stiffness of the housing 3400. The size and/or
thickness of the front extension 3420 may be adjusted to adjust the rigidity of the housing 3400.
Interface Body
[0264] As described herein, the patient interface 3000 includes an interface body which
can form a seal with a user's face and allow gas flow from and to the user. The interface body can be
coupled to a housing 3400. In some embodiments, the interface body is a cannula body 3200a that can
mate with the housing 3400 and form a nasal cannula that can form a seal with nares of the user's
nose. In other embodiments, the interface body is a mask body, such as the mask body 3200b.
Cannula Body
[0265] FIGS. 1 0-12B illustrate an embodiment of the cannula body 3200a. The cannula
body described herein in other embodiments can have similar features as described with reference to
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FIGS. 10-12B. For example, the embodiments of the cannula body described with reference to FIGS.
21, 48A, 49, 52A-B, 53A, and 55 can include features described herein with reference to the cannula
body 3200a and nasal prongs described herein. As shown in FIGS. 10-12B, the cannula body 3200a
may have at least one nasal prong 3220, such as a pair of prongs 3220. The prongs 3220 may extend
from a rear portion 3243 of a manifold 3240 facing the patient. The nasal prongs 3220 can form a seal
with nares of a user's nose and allow gas flow from and to the user. The nasal prongs 3220 of the
patient interface shown and described herein are shaped for sealing in a patient's nares. In some
embodiments, the nasal prongs are shaped for sealing in an infant's nares. However, it should be
appreciated that the prongs may be suitable for any patient population with similar nares geometry,
and that the prongs may be provided in different absolute sizes for various patient populations. The
prongs 3220 can be shaped and formed to minimize tissue compression and kinking of one or more
of the prongs 3220 during insertion into a patient's nares.
[0266] In the illustrated embodiment, the manifold 3240 defines one or more openings
3246, such as a pair of openings 3246 which can be coupled to the tube engaging portion 3460 of the
housing 3400 to receive the interface tubes, and allow gas flow from and to the patient via the manifold
3240 and the nasal prongs 3220. The openings 3246 may be in fluid communication with each other
via the manifold 3240. Except for the openings 3246 and the lumens of the nasal prongs 3220, the
manifold 3240 may be sealed. The openings 3246 can be positioned on the side of the manifold 3240.
As shown in FIGS. 10-12B, the manifold 3240 can have two openings 3246 and the openings 3246
can be on opposing sides of the manifold 3240. The placement of the openings 3246 on the side of
the manifold allows for lateral flow of fluid into and out of the manifold 3240 through the openings
3246 when the manifold 3240 is coupled to the tube engaging portion 3460 of the housing 3400.
Prongs of the Cannula Body
[0267] The cannula body 3200a can include nasal prongs with an orientation and/or
geometry that may assist with gas flow and delivery of gas to the patient. For example, FIGS. 13A-
13D illustrate a geometry of an embodiment of the prongs 105 that can be similar to or the same as
the nasal prongs on the cannula body as described herein, such as the nasal prongs 3220 and 4220.
[0268] As shown in FIGS. 13A-13B, the prongs 105 may taper inwardly from or between
the gases inlet 106 to the gases outlet 108. The cross-sectional area of the gases inlet 106 may be
larger than the cross-sectional area of the gases outlet 108. The prong cross-sectional area may
gradually diminish from or between the inlet 106 to the outlet 108. This prong tapering may aid in the
sealing function of the prongs 105. When the prongs 105 are pushed into the patient's nares, they may
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seal somewhere along the length of the prong 105 due to tapering in which the prongs 105 widen
towards the inlet 106. The tapering may aid in insertion of the prongs 105, as opposed to prongs which
are of a constant cross-sectional area, or prongs which widen towards the outlet.
[0269] The lumen of the nasal prong 105 may have an internal cross-section that varies
along the length of the nasal prong 105. For example, as shown in and described with reference to
FIGS. 13A-13D, the internal cross-section of the prong may vary in shape and/or diameter along its
length.
[0270] As described in more detail herein, the nasal prong 105 may be shaped to
substantially align the flow of breathing gas through the gas outlet with a user's upper airways.
[0271] The nasal prong 105 may be shaped to extend generally upwardly and rearwardly
into a user's nares, the nasal prong 105 having a curvature that includes at least two inflection points,
for example, as shown in FIGS. 13A-13D and described herein.
[0272] The prongs 105 may extend from the cannula body or manifold, toward the user's
septum and curve around the corners of a user's nostrils upwardly and rearwardly into the user's nares.
Each prong 105 may extend along a generally inclined posterior trajectory, passing through two
mediolateral points of inflection. This geometry may assist to orientate the gas outlet 1 08 with respect
to the user's upper airway passages.
[0273] The at least one prong 105 may have a shaped trajectory fitting or comparable with
the anatomical shape of the user's nostril. In a first portion (or phase) of the prong 105, the trajectory
may move horizontally towards the midline of the face. In a second portion (or phase) of the prong
105, the trajectory may curve upwards into the nostril towards the crown of the head. In a third portion
(or phase) of the prong 105, the trajectory may roll backwards into the head, generally following the
anatomical curvature of the nostril. In a fourth portion (or phase) of the prong 105, the trajectory may
tilt horizontally towards the center of the interface assembly to align the outlet 108 with the user's
upper mrway.
[0274] The prong 105 may have a cross-section that varies along the central trajectory,
such as described above. For example, the cross-section may be generally circular at the base of the
trajectory and become generally circular or oval or elliptical towards the end of the trajectory or prong
105. The cross-section may be generally circular or oval or elliptical at the base of the trajectory,
becoming generally circular towards the end of the trajectory or prong 105.
[0275] The cross-sectional diameter may generally decrease along the trajectory from the
first portion (or phase) to the end of the fourth portion (or phase).
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[0276] The geometry of the prongs, such as shown in FIGS. 10-12B as well as FIGS. 48A,
49, 52A-52B, and 53 described herein may be substantially as illustrated in FIGS. 13A-13D, wherein
the curved lines represent the prong trajectory, and ellipses 1135 primarily represent the orientation
of the lumen within each prong at a particular trajectory (and also show one potential cross-sectional
lumen shape). In some embodiments, the ellipses 1135 can be circular or substantially circular. Each
prong may generally follow a curved path that is shaped to follow the anatomical geometry/ curvature/
contours of a user's nare. The prongs 105 may be moulded or formed to substantially follow the
anatomical shape and curvature of a user's nare.
[0277] The prongs 105 may be premoulded or preformed according to the anatomical
shape of a nare. In some embodiments, the prongs 105 may include at least one thinned wall section
which is conformable so as to limit pressure on the patient's septum. In other embodiments, the prong
wall thickness can be uniform throughout.
[0278] From a base 1415, each prong 105 may curve generally upwardly or superiorly
toward the crown of the user's head (away from the transverse plane) and generally rearwardly or
posteriorly (toward the user's coronal plane) with respect to the user's upper lip. Between the ellipses
1131 and 1133 (the second phase) the lumen of the prongs 105 may transition from a generally
mediolateral orientation along the user's upper lip to a predominantly inclined posterior orientation.
This configuration may direct gas flow toward an upper portion of the back of a user's head. The
lumen of the prong 105 may reduce slightly during this phase. The lumen may also become more
elliptical, which may utilize the space available within the nare.
[0279] In the third phase (between the ellipses 1133 and 1134) the prongs 105 may
continue along an inclined posterior trajectory toward the upper back of a user's head (away from the
transverse plane and toward the coronal plane). There may be a smooth reduction in the rate of incline
in the superior component of the prongs trajectory 1420, which may cause the lumen to move away
from the transverse plane. During this phase, the prongs 105 may have negligible or minimal
convergence (or mediolateral component) toward the sagittal plane. The prong lumen may reduce
further during this phase and may become increasingly elliptical.
[0280] In the final phase (between ellipses 1134 and 1135) the prongs 105 may continue
along an inclined posterior trajectory with some mediolateral convergence toward the sagittal plane.
The mediolateral convergence of the prongs 105 may begin at the illustrated trajectory inflection point
1 07a at the start of the fourth phase (or slightly prior) adjacent the ellipse 1134.
[0281] A second inflection point 107b may be adjacent the final ellipse 1135. The second
inflection point may reduce convergence of the prongs 105 and orientate the prong outlet 1411
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generally posteriorly (toward the coronal plane) with a slight mediolateral component toward the
sagittal plane (represented by the orientation of the final ellipse 1135 in FIG. 13A).
[0282] The incline rate of the prong trajectories 1420 may continue to decrease during the
fourth phase, until the respective trajectories 1420 are substantially parallel with the transverse plane
at the prong outlet 1411 (represented by ellipse 1135). The mediolateral and superior-inferior
adjustments of the prong trajectories 1420 adjacent the final ellipse 1135 may position the prong outlet
1411 generally in alignment with the passage of the upper airway. This may assist to reduce soft
tissue irritation caused by exiting breathing gases.
[0283] The prong lumen may be elliptical at the outlet 1411. The major elliptical axis may
be arranged in a generally transverse plane. The prong lumen may be circular or substantially circular
at the outlet 1411. The outlet 1411 may direct breathing gases upwardly or superiorly toward the
crown of the user's head (away from the transverse plane) and rearwardly or posteriorly (toward the
user's coronal plane).
[0284]
quadrilateral.
[0285]
In alternative embodiments the cross-section of the lumens may be triangular, or
As shown in FIGS. 13C-13D, the nasal prongs may have a sealing region 1109 that
is longer compared to a sealing region 109 of the earlier described embodiment described with
reference to FIGS. 13A-13B. The longer sealing region 1109 may cause the overall length of the nasal
prong of this embodiment to be longer than the overall prong length of previously described
embodiments. This may have the additional benefit of the prong being less likely to flick out or
otherwise disengage from the patient's nare. With reference to the curved lines that represent the prong
trajectory, and the ellipses ofFIGS. 13C-13D, a prong sealing region 1109 is between ellipses 1134a
and 1135. The prong sealing region 1109 may comprise a tapered region. A cross-section of the
exterior surface of the prong 1 05 near the gas inlet 106 may be larger than a cross-section of the
exterior surface of the prong 105 near the gas outlet 108.
[0286] In the illustrative embodiment shown, the prong sealing region 1109 tapers from
about 5 mm to about 4 mm, for example. The measurements of the prong ( 5mm and 4mm) refer to an
equivalent diameter of an oval. The equivalent diameter may be a diameter calculated from the
perimeter of the prong (circular and ovular prongs may have the same equivalent diameter) or it may
be the largest width dimension of the prong (circular and ovular prongs may have a different
equivalent diameter). The tapered sealing region 1109 may allow the patient interface 1101 to be used
for a patient having a nare size that is anywhere between about 4mm and about 5mm. For example, if
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a patient's nare size is 4.5mm, the prongs 1105 may be inserted in the nares such that the section of
the sealing region 1109 having a diameter of 4. 5mm seals with their nares.
[0287] The prong sealing region 1109 may have different dimensions. and/or different
amounts of taper. The length range for the sealing region may be between about 1 mm to about 10
mm. The length of the sealing region may be about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm,
8 mm, 9 mm, or 10 mm. The diameter of the sealing region may be between about 2 mm and about
1 0 mm. The diameter of the sealing range may be about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8
mm, 9 mm, or 10 mm.
[0288] The ratio of the taper from the wider portion to the narrower portion may be about
1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1, 1.6:1, 1.7:1, 1.8:1, 1.9:1, or 2:1.
[0289] For example, the prong sealing region may taper from 10mm to 9mm, 9 mm to
8mm, 8mm to 7mm, 7mm to 6mm, 6mm to 5mm, 5mm to 4mm, or 4mm to 3mm, 3mm to 2 mm, for
example. The taper may be steeper, for example, the prong sealing region may taper from 1 Omm to
8mm, 9mm to 7mm, 8mm to 6mm, 7mm to 5mm, 6mm to 4mm, 5mm to 3mm, or 4mm to 2mm, for
example. The taper may be less steep, for example, the prong sealing region may taper from 1 Omm to
9.5mm, 9.5mm to 9mm, 9mm to 8.5mm, 8.5mm to 8mm, 8mm to 7.5mm, 7.5mm to 7mm, 7mm to
6.5mm, 6.5mm to 6mm, 6mm to 5.5mm, 5.5mm to 5mm, 5mm to 4.5mm, 4.5mm to 4mm, or 4mm to
3.5mm, 3.5mm to 3mm, 3mm to 2.5mm, or 2.5mm to 2mm for example.
[0290] Different sizes of the patient interface 101, 11 01 may be provided, for which
different prong sealing region dimensions may be utilized.
[0291] The outlet of the prong lumen can be substantially circular. In some embodiments,
the outlet of the prong lumen can be substantially elliptical. It should be appreciated by one of skill in
the art that any suitable shape of outlet may be used.
[0292] The nasal prong lumen may be flared out at or near the outlet of the lumen. An
example of a nasal prong lumen with flared out portions at the outlet or alternative outlet shapes are
shown in FIGS. 13E and 13H. As shown in FIG. 13E, ends of the prongs 305 adjacent the prong outlet
308 may be shaped to reduce the resistance to flow of the prongs 305. For example, the prongs 305
may be cut off horizontally or at an angle. This may lower flow resistance in the prong 305.
Additionally, or alternatively, when viewing the prongs 305 from above the interface 300 in a same
or similar perspective as FIG. 13F, the prong outlet 308 may have a substantially U-shape, as shown
in FIG. 13G. These features may assist to provide a lower resistance to flow in use, and/or prevent
accidental sealing of the prong outlet 308, which may cause a user or a clinician to falsely determine
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that the CP AP therapy is delivered to the user. In some embodiments, the nasal prongs may have a
thickness that varies in a circumferential direction.
Base of Nasal Prong
[0293] The cannula body can have a base region at and/or adjacent the base of the nasal
prong. The base region can form a portion of the cannula body where the base of the nasal prong
meets the manifold. The base region can be configured to allow movement of the manifold and/or
housing while maintaining the nasal prongs within the patient's nares. The base region may assist to
provide comfort and conformability to the patient while also ensuring the flow path is maintained
between the manifold and nasal prongs.
[0294] In some embodiments, the base region can allow the nasal prongs to bend in
different directions without compromising the gas flow path from manifold to prong outlet. For
example, the base region can allow the prongs to move relative to the housing/manifold without the
prongs kinking. The base region may function to decouple the position of the or each prong from the
position of the manifold/housing. In this manner, the housing/manifold can move, e.g. from forces
applied to the interface by pulling on tubes, facial movements and/or grasping of the interface, whilst
retaining the prongs in position in the nares. The base region may also provide a spring mechanism
which may operate to assist in compensating external forces applied to or experienced by the interface.
The spring mechanism may also allow for movement of the housing/manifold whilst assisting the
prongs to remain in an operational, i.e. sealed position in the nares. In some cases, the base region can
include a groove, dip, channel or any other mechanism between the prongs to provide for adequate
clearance of the septum.
[0295] This portion of the cannula body can be an alternation in the material at or adjacent
the base of the prong and/or a specific shape of the base of the prong. For example, the base region
can be a groove, sunken or recessed region, a thinning of the nasal prong wall, base or surrounding
region of the manifold, a shape of the nasal prong and/or manifold, and/or any other feature that may
provide elasticity or conformability. Embodiments of the base region described herein can be used
with any of the cannula body embodiments and/or nasal prong embodiments described herein.
[0296] In some embodiments, the manifold 3240 may have a base region that can be a
sunken or recessed region under the prongs 3220 and/or adjacent the base of the prongs 3220. For
example, in the illustrated embodiment of FIGS. 1 0-12B, the manifold 3240 includes one or more
grooves 3222 located under the prongs 3220. The one or more grooves 3222 may support the prongs
3220 relative to a surrounding portion of the manifold 3240. The grooves 3222 as shown in FIGS. 10-
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12B, can extend substantially around the base of each prong 3220 or at least partially around the base
of each prong 3220. The grooves 3222 may assist the prongs 3220 to pivot and move about or relative
to the surrounding portion of the manifold 3240.The ability of the prongs 3220 to pivot at or adjacent
their base may enable more effective fitting and sealing of the prongs 3220 in the nares of a patient
without compromising gas flow. The ability for the prongs 3220 to bend or move relative to the
manifold 3240 may decouple the position or orientation of the prongs 3220 from the position of the
manifold/housing. In other words, the housing/manifold can move while the prongs 3220 remain in
a sealing position in the nares.
[0297] The grooves 3222 may allow one size of prongs to fit a wider range of nare sizes.
The groove 3222 around each prong 3220 may allow the prong 3220 to move or flex forward and
backward when inserting and fitting the prongs 3220 into the patient's nares. This movement can
adjust for variation in face and philtrum size of patients. The groove 3222 may also allow for sideways
movement to adjust for variation in septum size and/or to assist accommodating movement of the
interface 3000, for example caused by cheek movement of the user. The sunken or recessed region
such as the grooves 3222 may further make the effective length of the prongs 3222 greater, such that
the prongs 3222 can have greater degree of adjustability.
[0298] The manifold 3240 may have varying thicknesses at different regions. For example,
at least a portion of the grooves 3222 may be thinner relative to the prongs 3220 and the rest of the
manifold 3240, as illustrated in FIG. 14A (with the thinner region of material of the prongs shown
with darker shading in FIG. 14A and 14B). The grooves 3222 may facilitate movement of the prongs
3220 to assist to maintain seal with the patient's nares. The grooves 3222 may also assist to ensure
that the prongs 3220 collapse into the manifold 3240 by the grooves 3222 being folded, bending or
flexing, rather than one or more of the prongs kinking, thereby maintaining the diameter and crosssectional
shape of the prongs 3220, and/or maintaining the resistance to flow (RTF) of the prongs
3220.
[0299] As illustrated in FIG. 14A, the manifold 3240 may further include a thickened
region 3249 adjacent the grooves 3222 shown with the lighter shaded region adjacent the grooves
3222. When the prongs 3220 are placed in the nares of the user, the grooves 3222 having thinner
walls, may allow preferential movement or bending of the prongs 3220 into the manifold 3240. In
other words, when the prongs 3220 are inserted into the nares, at least part of the thinner walls of the
grooves 3222 may flex or deflect inwardly to the manifold 3240. While in the flexed or deflected
position, the grooves 3222 may provide an upwards force into the nares of the user to maintain sealing
position. On the other hand, the thickened region 3249 may prevent collapse of the manifold 3240 at
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a region around the grooves 3222, thereby maintaining the structural integrity of the cannula body
3200a. In the illustrated embodiment, the grooves 3222 are separately formed around each prong 3220,
being spaced apart from each other.
[0300] In some embodiments, the groove or sunken region at the base of the prongs 3220
can be continuous. FIG. 14B illustrates the cannula body 3200a having a sunken region 3223
continuously extending around the bases of the both prongs 3220. Similarly, with the grooves 3222,
the sunken region 3223 may have a reduced thickness relative to the prongs 3220 and the rest of the
manifold 3240, as illustrated in FIG. 14B. The sunken regions 3223 may provide the prongs 3220
greater flexibility than the grooves 3222, because of the lack of stiffer part between the prongs 3220
which exists between the grooves 3222. Additionally, the sunken regions 3223 may have greater
clearance from the septum, such that the cannula body 3200a has smaller chance to interfere and/or
damage the septum. The sunken regions 3223 may also make cleaning of the cannula body 3200a
easier due to the relative lack of small cavities or spaces. The groove or sunken region may partially
or wholly surround the base of the prong. For example, the groove or sunken region can be on one or
both sides of each prong to allow adjustment for septum width. The grooves or sunken regions 3222
at the base of the prongs 3220 may allow for a spring-like movement at the base of the prongs to
decouple movement of the nasal prong from the movement of the housing and/or manifold and to
retain the nasal prongs in the correct sealing position in the nares.

WHAT IS CLAIMED IS:
body.
1. A patient interface assembly comprising: a
first interface body;
a second interface body; and
a housing configured to detachably couple with the first interface body or the
second interface body,
wherein the first interface body and the second interface body are interchangeable,
such that the first interface body is coupled to the housing in a first configuration, and the
second interface body is coupled to the housing in a second configuration.
2. The patient interface assembly of Claim 1, wherein the first interface body is a cannula
3. The patient interface assembly of Claim 2, wherein the cannula body comprises one or
more nasal prongs.
4. The patient interface assembly of Claim 3, wherein the one or more prongs are
configured to be inserted into nares of a user and form a seal.
5. The patient interface assembly of any one of the preceding claims, wherein the second
interface body is a mask body.
6. The patient interface assembly of Claim 5, wherein the second interface body is a nasal
mask
7. The patient interface assembly of Claim 5 or 6, wherein the second interface body is an
oro- nasal mask
8. The patient interface assembly of any one of Claims 5-7, wherein the mask defines a
breathing chamber and having a user-contacting surface configured to contact a face of the user and
surround at least the nares of the user.
9. The patient interface assembly of any one of the preceding claims, wherein the housing
comprises an upper edge and a lower edge.
10. The patient interface assembly of Claim 9, wherein the upper edge and the lower edge of
the housing are symmetrical.
11. The patient interface assembly of Claim 9 or 1 0, wherein the lower edge of the housing
is curved inwardly to the housing.
12. The patient interface assembly of any one of the preceding claims, wherein each of the
first interface body and the second interface body comprises a manifold, wherein the manifold is
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configured to be at least partially received by the housing when the first interface body or the
second interface body is detachably coupled to the housing.
13. The patient interface assembly of Claim 12, wherein the manifold comprises a housing
coupling portion configured to be received within the housing when the first interface body or the
second interface body is detachable coupled to the housing.
14. The patient interface assembly of Claim 13, wherein the manifold further comprises a
raised portion adjacent the housing coupling portion, wherein the raised portion is configured to
inhibit rotation of the manifold about the housing when the first interface body or the second
interface body is detachably coupled to the housing.
15. The patient interface assembly of any one of the preceding claims, wherein the housing
and/or the manifold comprises a feedback mechanism to provide a visual or audible feedback when
the first interface body or the second interface body is detachable coupled to the housing.
16. The patient interface assembly of any one of the preceding claims, further comprising
one or more interface tubes.
17. The patient interface assembly of any one of the preceding claims, wherein the housing
comprises one or more tube engaging portions configured to receive interface tubes.
18. The patient interface assembly of any one of the preceding claims, further comprising
a securement member configured to be attached to the housing.
19. The patient interface assembly of Claim 1, wherein the first interface body comprises
a mask or nasal prongs of a first size and the second interface body comprises a mask or nasal
prongs of a second size, wherein the first size is different from the second size.
20. A patient interface comprising: an
interface body;
a housing;
one or more interface tubes;
a first securement member; and
a second securement member extending vertically for providing vertical stability
to the patient interface.
21. The patient interface of Claim 20, wherein the interface body is configured to be
engaged on the patient's face and form a seal.
22. The patient interface of Claim 20 or 21, wherein the interface body is a mask body or a
cannula body.
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23. The patient interface of any one of Claims 20-22, wherein the one or more tubes are
configured to be coupled to the housing.
24. The patient interface of any one of Claims 20-23, wherein the one or more tubes are
formed as a single piece with the housing.
25. The patient interface of any one of Claims 20-24, wherein each of the one or more
tubes comprises an overmoulded grip.
26. The patient interface of any one of Claims 20-25, wherein the first securement member
compnses:
a central portion;
a pair of support pads, each of the support pads configured to engage a securing
mechanism at on opposing sides of the central portion; and
a pair of bridging portions, each of the bridging portions connecting the central
portion and a respective one of the support pads.
27. The patient interface of Claim 26, wherein the first securement member further
comprises a patch assembly coupled to each of the support pads for securing the support pads to
the user.
28. The patient interface of any one of Claims 20-27, wherein the second securement
member is coupled to the housing.
29. The patient interface of any one of Claims 20-28, wherein the second securement
member is configured to engage the forehead of a user.
30. The patient interface of any one of Claims 20-29, wherein the second securement
member is constructed from a fabric material
31. The patient interface of any one of Claims 20-30, wherein the second securement
member further comprises a patch assembly for securing the second securement member to the
user.
32. The patient interface of any one of Claims 20-31, wherein the interface body has a
Shore hardness between 20A-100A.
3 3. The patient interface of any one of Claims 20-3 2, wherein each of the one or more
interface tubes is tapered toward one end.
34. A patient interface comprising an interface body, wherein the interface body
compnses:
one or more prongs extending from a base region at the interface body;
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one or more openings to allow the flow of respiratory gases into and from the
interface body,
wherein the one or more prongs are configured to flex at the base region while
maintaining seal with the nares of the user.
35. The patient interface of Claim 34, wherein the interface body comprises a right prong
and a left prong.
36. The patient interface of Claim 34 or 35, wherein a thickness of the one or more
prongs varies along the length of the one or more prongs or maintains a constant thickness along
the length of the one or more prongs.
37. The patient interface of any one of Claims 34-36, wherein the base region has a
thickness smaller than the rest of the interface body.
38. The patient interface of any of Claims 34-36, wherein the base region has a surface
recessed relative to the adjacent region of the interface body.
39. The patient interface of any of Claims 34-38, wherein the base region has a recessed
surface around the one or more prongs.
40. The patient interface of any of Claims 34-39, wherein the base region has a
recessed surface extending around two prongs.
41. The patient interface of any of Claims 34-40, wherein the one or more prongs are
configured to flex in forward and rear directions.
42. The patient interface of any of Claims 34-41, wherein the one or more prongs are
configured to flex in right and left directions.
43. The patient interface of any of Claims 34-42, wherein the one or more prongs have a
circular cross-section adjacent at a top end of the prongs.
44. The patient interface of any of Claims 34-43, wherein the one or more prongs are
configured to flex while maintaining their diameter and cross-sectional shape along their lengths.
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45. The patient interface of any of Claims 34-44, wherein the one or more prongs are
configured to flex while maintaining their resistance to flow (RTF).
46. A respiratory system comprising: a
gas flow source;
an inspiratory conduit fluidically connected to the gas flow source; and a
patient interface comprising:
an interface body; a
housing;
one or more interface tubes; and a
first securement member.
47. The respiratory system of Claim 46, further compnsmg an expiratory conduit
configured to receive gases from the patient interface.
48. The respiratory system of Claim 46 or 47, further comprising a bubbler device.
49. The respiratory system of any one of Claims 46-48, further comprising a humidifier.
50. The respiratory system of any one of Claims 46-49, wherein the housing is configured to
receive each of a plurality of interface bodies, such that the interface bodies are interchangeable.
51. The respiratory system of any one of Claims 46-50, wherein the interface body is a mask
body or a cannula body.
52. The respiratory system of any one of Claims 46-51, wherein the one or more interface
tubes are configured to be coupled to the housing.
53. The respiratory system of any one of Claims 46-52, wherein one of the one or more
interface tubes is configured to be connected to the inspiratory conduit.
54. The respiratory system of any one of Claims 46-53, wherein the one or more tubes are
formed as a single piece with the housing.
55. The respiratory system of any one of Claims 46-54, wherein each of the one or more
tubes comprises an overmoulded grip.
56. The respiratory system of any one of Claims 46-55, wherein the first securement
member comprises:
a central portion;
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a pair of support pads, each of the support pads configured to engage the face of a
user on opposing sides of the central portion; and
a pair of bridging portions, each of the bridging portions connecting the central
portion and a respective one of the support pads.
57. The respiratory system of any one of Claims 46-56, wherein the first securement
member further comprises a patch assembly coupled to each of the support pads for securing the
support pads to the user.
58. The respiratory system of any one of Claims 46-57, wherein the patient interface
further comprises a second securement member coupled to the housing.
59. The respiratory system of Claim 58, wherein the second securement member is
configured to engage the forehead of a user.
60. The respiratory system of Claim 58 or 59, wherein the second securement member
is constructed from a fabric material
61. The respiratory system of any one of Claims 58-60, wherein the second securement
member further comprises a patch assembly for securing the second securement member to the
user.
62. The respiratory system of any one of Claims 46-61, further comprising a headgear or
a bonnet.
63. A securement member for a patient interface of a respiratory system comprising:
a soft, flexible barb for detachably coupling with a housing of the patient interface.
64. The securement member of Claim 63, wherein the barb comprises one or more tabs.
65. The securement member of Claim 64, wherein the housing comprises an opening,
wherein the one or more tabs are configured to catch on the housing at the opening of the housing.
66. The securement member of any one of Claims 63-65, wherein the barb comprises
a cutout, wherein the cutout is configured to aid in collapsing of the barb.
67. The securement member of any one of Claims 63-66, wherein the barb comprises
an extended top portion that is configured to prevent the barb from being over inserted into the
opening of the housing.
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68. The securement member of any one of Claims 63-67, wherein the barb is
overmoulded onto the securement member.
69. A securement member for a patient interface of a respiratory system comprising:
a support pad that secures to a patch assembly on a patient, wherein the support
pad is hinged relative to the rest of the securement member.
70. The securement member of Claim 69, wherein the support pad is flexible.
71. The securement member of any one of Claims 69-70, further comprising a hinge
between the support pad and a portion of the securement member.
72. The securement member of any one of Claims 69-71, wherein the support pad is
overmoulded onto the securement member.
73. The securement member of Claim 71, wherein the hinge is a 180 degree
hinge.
74. A securement member for a patient interface of a respiratory system
compnsmg:
barb.
a first flexible portion connectable with a patient interface component;
a second flexible portion connectable to a patient's forehead; and
a third rigid portion extending between the first and second portions.
75. The securement member of Claim 74, wherein the first flexible portion is a
76. The securement member of any one of Claims 74-75, wherein the second
flexible portion is a support pad.
77. The securement member of any one of Claims 74-76, wherein the first and/or
second flexible portions are overmoulded onto the third rigid portion.
78. The securement member of any one of Claims 74-77, wherein the second flexible
portion is hinged relative to the third rigid portion.
79. The securement member of any one of Claims 7 4-78, wherein the securement
member is detachably connectable to housing of the patient interface.
80. The securement member of any one of Claims 7 4-79, wherein the component is a
housing or interface body.
81. A patient interface assembly comprising:
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an interface body comprising a manifold comprising a front side configured to
contact the patient and a rear side opposite the front side, wherein the manifold comprises
a raised portion of a housing coupling portion positioned between the rear side of the
manifold and the front side of the manifold,
the manifold comprising a width that runs along an inner lumen of the manifold
and a horizontal axis that runs along the width, wherein the raised portion is angled with
respect to the horizontal axis, wherein the angled raised portion of the housing coupling
portion is configured to improve the assembly and alignment of the interface body when it
detachably couples with a housing via the manifold;
a housing comprising a front patient facing side and a rear side opposite the front
side, wherein the housing comprises a width that extends from a first tube engaging portion
on one end of the housing to a second tube engaging portion on an opposite end of the
housing and a horizontal axis that runs along the width, wherein the housing comprises an
interface body receiving portion between the front side of the housing and the rear side of
the housing, wherein the interface body receiving portion is angled with respect to the
horizontal axis, wherein the angled interface body receiving portion is configured to
improve the assembly and alignment when the manifold is detachably coupled and received
by the housing.
82. The patient interface assembly of Claim 81, wherein the raised portion of the
manifold comprises a first width on the front side of manifold that is greater than a second width
on the rear side of the manifold.
83. The patient interface assembly of Claim 81, wherein the raised portion of the
manifold comprises a first width on the front side of manifold that is less than a second width on
the rear side of the manifold.
84. The patient interface assembly of any one of Claims 81-83, wherein the angled raised
portion of the housing coupling portion of the manifold extends at an angle of 120 degrees from the
rear side of the manifold.
85. The patient interface assembly of any one of Claims 81-83, wherein the angled raised
portion of the housing coupling portion of the manifold extends at an angle of 60 degrees from the
rear side of the manifold.
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86. The patient interface assembly of any one of Claims 81-83, wherein the angled raised
portion of the housing coupling portion of the manifold extends at an angle of between 30 degrees
and 170 degrees from the rear side of the manifold.
87. The patient interface assembly of any one of Claims 81-86, further comprising an
engagement surface where the raised portion of the housing coupling portion and the interface
body receiving portion contact each other, wherein a portion of the raised portion of the manifold
at the engagement surface is higher relative to the engagement surface of the housing.
88. The patient interface assembly of any one of Claims 81-87, wherein the manifold
comprises a portion on either side of manifold that is configured to extend within the housing,
wherein the portion that extends within the housing has a ridge configured to seal to the housing.
89. The patient interface assembly of Claim 88, wherein the ridge is an annular
ridge.
90. The patient interface assembly of Claims 88 or 89, wherein the ridge is
configured to seal with the internal surface of housing.
91. The patient interface assembly of any one of Claims 81-90, wherein the manifold
has a first distance between the front side of the engagement surface and the annular ridge and a
second distance between the rear side of the engagement surface and the annular ridge, wherein
the second distance is greater than the first distance.
92. The patient interface assembly of any one of Claims 81- 91, wherein the front side
of the manifold has a first wall thickness and the rear side of the manifold has a second wall
thickness, wherein the first wall thickness is thicker than the second wall thickness.
93. A patient interface assembly comprising:
a housing that detachably couples with a manifold of an interface body, wherein
the housing comprises a side protrusion and a central protrusion, wherein the side
protrusion comprises features for coupling a first securement member to the housing and
wherein the central protrusion comprises one or more features for coupling a second
securement member to the housing.
94. The patient interface assembly of Claim 93, wherein the housing is a rigid housing.
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95. The patient interface assembly of any one of Claims 93 or 94, wherein the one or
more features for coupling with a second securement member to the housing are one or more
opemngs.
96. The patient interface assembly of any one of Claims 93-95, wherein the second
securement member is detachably coupled with the housing.
97. The patient interface assembly of any one of Claims 93-96, wherein the one or more
openings comprise a lip configured to catch a complementary fitting portion of the second
securement member.
98. The patient interface assembly of any one of Claims 93-97, wherein the features of
the side protrusion comprise an enlarged head and a stem for a push-fit coupling.
99. The patient interface assembly of any one of Claims 93-98, wherein the first
securement member is detachably coupled with the housing.
100. The patient interface assembly of any one of Claims 93-99, further comprising a
tubing, wherein the tubing is integral with the housing.
101. The patient interface assembly of any one of Claims 93-99, further comprising a
tubing, wherein the tubing is detachably coupled with the housing.
102. A securement member for a patient interface of a respiratory system comprising:
a central portion;
a pair of support pads, each of the support pads configured to engage the face of a
user on opposing sides of the central portion; and
a pair of bridging portions, each of the bridging portions connecting the central
portion and a respective one of the support pads;
wherein the bridging portions comprise cutouts for receiving a housing, wherein
the bridging portions comprise a thickened portion surrounding the cutouts.
103. The securement member of Claim 1 02, wherein the securement member further
comprises a patch assembly coupled to each of the support pads for securing the support pads to
the user.
104. The securement member of any one of Claims 102 or 103, wherein the securement
member further comprises openings configured to detachably couple the
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securement member to protrusions on a housing, wherein the first securement member is push-fit
over the protrusions on the housing.
105. The securement member of Claim 104, wherein the securement member further
comprises a recess on the rear side of the securement member, wherein the recess is configured to
accommodate for a central protrusion on the housing when the securement member is coupled to the
housing.
106.
and
A patient interface assembly of a respiratory system comprising: an
interface body; and
a housing, wherein the interface body is detachably coupled to the housing;
a feature that limits rotation of the interface body relative to the housing.
107. The patient interface assembly of Claim 106, wherein the interface body comprises
a manifold and the feature comprises a shoulder portion on the rear of the manifold.
108. The patient interface assembly of Claim 107, wherein the shoulder portion abuts
against the housing to limit rotation.
109. The patient interface assembly of Claim 106, wherein the feature comprises a keyed
feature on manifold and housing.
110. The patient interface assembly of any one of Claims 106-109, wherein the interface
body comprises a cannula body.
111. The patient interface assembly of any one of Claims 106-109, wherein the interface
body comprises a mask body.
112. The patient interface assembly of any one of Claims 106-111, wherein the housing
comprises one or more tube engaging receiving portions configured to receive interface tubes.
113. A patient interface assembly of a respiratory system comprising: a
housing;
an inspiratory conduit with a first end and a second end, the first end configured to
connect the housing and deliver incoming flow of gases and the second end with locking
fingers; and
an expiratory conduit with first end and second end, the first end configured to
connect a housing and receive flow of expiratory gases and the second end with locking
fingers.
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114. The patient interface assembly of Claim 113, wherein the locking fingers at the
second end of the expiratory conduit are configured to couple to a downstream component.
115. The patient interface assembly of Claim 114, wherein the downstream component
comprises a bubbler.
116. The patient interface assembly of any one of Claims 113-115, wherein the locking
fingers at the second end of the inspiratory conduit are configured to couple to an upstream
component.
117. The patient interface assembly of Claim 116, wherein the upstream component
comprises a flow source.
118. The patient interface assembly of any one of Claims 113-117, wherein the locking
fingers extend away from a connector, the locking fingers being spaced apart and narrowing along
their length away from the connector.
119. The patient interface assembly of Claim 118, the locking fingers compnsmg
locking recesses that are formed at least on outer surfaces of each of the locking fingers, the locking
recesses being configured to lock with portions of a gas delivery tube connector, the locking
fingers being configured to interact with recesses of the gas delivery tube connector to align the
connector and the gas delivery tube connector.
120. A patient interface assembly of a respiratory system comprising: an
interface body; and
a housing, wherein at least a portion of an external surface of the housing and/ or
the interface body comprises a low friction surface.
121. The patient interface assembly of Claim 120, wherein the interface body comprises
a cannula body.
122. The patient interface assembly of Claim 120, wherein the interface body comprises
a mask body.
123. The patient interface assembly of any one of Claims 120-122, wherein the low
friction surface is provided by a parylene coating and/or a blasting process.
124. The patient interface assembly of any one of Claims 120-123, wherein the interface
body comprises a rear side comprising patient contacting surface and a front side opposite the rear
side, wherein the rear side has a low friction surface.
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125. The patient interface assembly of any one of Claims 120-124, wherein the interface
body is detachable with the housing and the interface body comprises a manifold with a low
friction surface that engages with the housing.
126. A manufacturing process for a patient interface assembly for a respiratory system
compnsmg:
manufacturing an interface body; and
treating an external surface of the interface body to provide a low friction surface.
127. The manufacturing process of Claim 126, wherein the interface body comprises a
cannula body.
128. The manufacturing process of Claim 126, wherein the interface body comprises a
mask body.
129. The manufacturing process of any of the Claims 126-128, wherein the interface
body is detachable with a housing.
130. The manufacturing process of any of claims 126-129, wherein the low friction
surface is provided by a surface coating or a surface blasting process.
131. The manufacturing process of claim 13 0, wherein the surface coating is a pary lene
coating.
132. The manufacturing process of claim 130, wherein the surface blasting process is a
bead blasting process.
133. The manufacturing process of any ofthe Claims 126-132, wherein substantially an
entire external surface of the interface body is a low friction surface.
134. The manufacturing process of any of the Claims 126-133, wherein a portion of the
interface body is a low friction surface, wherein the interface body comprises a rear patient facing
side of the interface body and a front side opposite the rear side, wherein the low friction portion is
a rear portion of a manifold of the interface body.
135. The manufacturing process of any ofthe Claims 126-134, wherein a portion ofthe
interface body is a low friction surface, wherein the interface body comprises a rear patient facing
side of the interface body and a front side opposite the rear side, wherein the low friction portion is
a front portion of a manifold of the interface body.
136. A patient interface assembly comprising: an
interface body comprising:
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a manifold comprising a front side configured to contact the patient and a
rear side opposite the front side, wherein the manifold comprises a raised portion
of a housing coupling portion positioned between the rear side of the manifold and
the front side of the manifold;
wherein the manifold comprising a width that runs along an inner lumen of
the manifold and a horizontal axis that runs along the width, wherein the raised
portion is angled with respect to the horizontal axis, wherein the angled raised
portion of the housing coupling portion is configured to improve the assembly and
alignment of the interface body when it detachably couples with a housing via the
manifold; and
a feature that limits rotation of the interface body relative to the housing;
and the housing comprising:
a front patient facing side;
a rear side opposite the front side;
wherein the housing comprises a width that extends from a first tube
engaging portion on one end of the housing to a second tube engaging portion on
an opposite end of the housing and a horizontal axis that runs along the width,
wherein the housing comprises an interface body receiving portion between the
front side of the housing and the rear side of the housing, wherein the interface
body receiving portion is angled with respect to the horizontal axis, wherein the
angled interface body receiving portion is configured to improve the assembly and
alignment when the manifold is detachably coupled and received by the housing;
a first securement member comprising: a
central portion;
a pair of support pads, each of the support pads configured to engage the
face of a user on opposing sides of the central portion; and
a pair of bridging portions, each of the bridging portions connecting the
central portion and a respective one of the support pads;
wherein the bridging portions comprise cutouts for receiving the housing,
wherein the bridging portions comprise a thickened portion surrounding the
cutouts;
a second securement member comprising:
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a first flexible portion connectable with a patient interface component; a
second flexible portion connectable to a patient's forehead; and
a third rigid portion extending between the first and second portions; an
inspiratory conduit with a first end and a second end, the first end
configured to connect to the housing and deliver incoming flow of gases and the second
end with locking fingers; and
an expiratory conduit with first end and second end, the first end configured to
connect to the housing and receive flow of expiratory gases and the second end with
locking fingers.
137. The patient interface assembly of Claim 136, wherein the interface body comprises
a cannula body.
138. The patient interface assembly of Claim 136, wherein the interface body comprises
a mask body.
139. The patient interface assembly of any one of Claims 136-138, wherein the
inspiratory and expiratory conduit are integral with the housing.
140. The patient interface assembly of any one of Claims 136-139, wherein the first
and second securement members are connectable with the housing.
141. The patient interface assembly of any one of Claims 136-140, wherein the second
securement member is connectable with a patch assembly or headgear of a patient.
142. The patient interface assembly of any one of Claims 136-141, wherein the second
securement member is detachably coupled to the housing.
143. The patient interface assembly of any one of Claims 136-142, wherein the
interface body is detachably coupled to the housing.
144. A patient interface assembly comprising:
an interface body; and
a housing configured to detachably couple with the interface body, the housing
comprises one or more tube engaging portions at lateral entry points on opposite ends of
the housing, wherein the tube engaging portions are configured to receive interface tubes.
145. The patient interface assembly of Claim 144, wherein the interface body
comprises a cannula body.
146. The patient interface assembly of Claim 144, wherein the interface body
comprises a mask body.
147. A patient interface assembly comprising:
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a first interface body;
a second interface body; and
a housing configured to detachably couple with the first interface body or the
second interface body, the housing comprises one or more tube engaging portions at lateral
entry points of the housing, wherein the tube engaging portions are configured to receive
interface tubes;
wherein the first interface body and the second interface body are interchangeable,
such that the first interface body is coupled to the housing in a first configuration, and the
second interface body is coupled to the housing in a second configuration.
148. An interface body comprising:
a mask comprising a breathing chamber and having a user-contacting surface
configured to contact a face of the user and surround at least the nares of the user;
a manifold in fluid communication with the breathing chamber, the manifold
comprising a first opening on a first lateral side of the manifold and a second opening on
the second lateral side of the manifold, wherein the first and second openings permit gas
flow into and out of the breathing chamber.
149. The mask body of Claim 148, wherein the first and second openings are
configured to be in communication with interface tubes configured to deliver a flow of gas
entering and exiting the mask and the first and second lateral side of the manifold.
150. An interface body comprising:
a mask, wherein the mask defines a breathing chamber and having a user-contacting
surface configured to contact a face of the user and surround at least the nares of the user,
the mask comprising:
a mask seal, wherein at least part of the mask seal comprises a region of
reduced stiffness, wherein the region of reduced stiffness is positioned between a
first stiffer region and a second stiffer region, wherein the first and second stiffer
regions have a stiffness greater than the stiffness of the region of reduced stiffness;
wherein when the first stiffer region is moved toward the second stiffer
region, the region of reduced stiffness buckles in a single direction as the first stiffer
region continues to move towards the second stiffer region.
151. The mask body of Claim 150, wherein the first stiffer region comprises a
structural support portion extending partially around the circumference of the mask.
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152. The mask body of Claim 150, wherein the second stiffer region is a front portion
of the mask
153. A patient interface assembly comprising:
an interface body comprising a housing coupling portion, the housing coupling
portion comprise a first patient facing side and an opposite second side, wherein the
housing coupling portion comprises a shape defined between the first side and the second
side of the housing coupling portion; and
a housing comprising an interface body receiving portion, wherein the interface
body receiving portion is a complementary shape to the shape of the housing coupling
portion of the interface body, wherein the housing is configured to detachably coupled with
the interface body.
154. The patient interface assembly of Claim 153, wherein the shape of the housing
coupling portion comprises a trapezoidal shape.
155. The patient interface assembly of Claim 154, wherein the housing coupling portion
of the interface body comprises a wider base of the trapezoid proximal to the front portion of the
housing.
156. The patient interface assembly of Claim 154, wherein the housing coupling portion
of the interface body comprises a wider base of the trapezoid proximal to the rear portion of the
housing.
157. An interface body comprising:
one or more prongs extending from a base region;
one or more openings to allow the flow of respiratory gases into and from the prongs,
wherein the one or more prongs are configured to flex at the base region while
maintaining seal with the nares of the user.
158. The patient interface assembly of Claim 157, wherein the one or more prongs
comprise a thickness that varies along the length of the one or more prongs.
159. The patient interface assembly of Claim 157, wherein the one or more prongs
maintains a constant thickness along the length of the one or more prongs.
160. An interface body, wherein the interface body comprises:
one or more prongs extending from a base region at the interface body;
one or more openings to allow the flow of respiratory gases into and from the
interface body,
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wherein the one or more prongs are configured to flex at the base region while
maintaining seal with the nares of the user.