Patient interface system

Abstract

A patient interface for respiratory therapy includes an interface body and a housing for receiving the interface body. The patient interface also includes a fixation member having a pair of support pads, each of the support pads configured to engage a face of a user. In some configurations, the interface body may be a cannula body or a mask body. In some configurations, the housing may receive different interface bodies, and the interface bodies are interchangeable.

Description

[0001] This application is a divisional application of the application filed on March 2, 2021, with application number 2021800187317 and invention title "Patient Interface System". Technical Field

[0002] This disclosure generally relates to components of medical systems used for the intake and / or exhaust of gases for patients. In one particular aspect, this disclosure relates to patient interfaces that form part of a respiratory system. Background Technology

[0003] In assisted ventilation, breathing gas is supplied to the patient via one or more flexible breathing tubes through a patient interface. The patient interface can be a nasal cannula, nasal mask, full face mask or oronasal mask, endotracheal tube, or other known types of interface. Exhaled gas from the patient can be directed to other devices (valve, ventilator, pressure device, etc.) or discharged into the patient's surrounding environment through similar breathing tubes.

[0004] In medical applications such as assisted breathing, the gas inhaled by the patient is preferably delivered at near body temperature (typically between 33°C and 37°C) and with high relative humidity (commonly close to saturation). In other medical applications such as continuous positive airway pressure (CPAP) systems or positive pressure ventilation systems that provide positive pressure breathing gases for patients with obstructive sleep apnea (OSA), these breathing gases may be heated and / or humidified to different levels to improve user comfort or supplied without heating or humidification.

[0005] References to patent specifications, other external documents, or other sources of information in this specification are generally made to provide context for discussing the features of this disclosure. Unless otherwise expressly stated, references to these external documents should not be construed as an admission that such documents, or such sources, are prior art or part of common general knowledge in any jurisdiction.

[0006] Other aspects and advantages of this disclosure will become clear from the following description, given only by way of example. Summary of the Invention

[0007] It would be advantageous to provide a system for gas delivery therapy using interchangeable patient interfaces, such as nasal cannulas, nasal masks, or oronasal masks. Such alternative or improved systems could further enhance the compliance and flexibility of gas delivery therapy.

[0008] One aspect of this disclosure relates to a patient interface assembly including a first interface body, a second interface body, and a housing configured for detachable connection to either the first interface body or the second interface body. The first interface body and the second interface body are interchangeable such that, in a first configuration, the first interface body is connected to the housing, and in a second configuration, the second interface body is connected to the housing.

[0009] In some configurations, the first interface body is the cannula body.

[0010] In some configurations, the cannula body includes one or more nose forks.

[0011] In some configurations, the one or more forks are configured to be inserted into the user's nostrils and form a seal.

[0012] In some configurations, the second interface body is the mask body.

[0013] In some configurations, the main body of this second interface is a nose mask.

[0014] In some configurations, the second interface body is a mouth and nose mask.

[0015] In some configurations, the mask defines a breathing chamber and has a user contact surface configured to contact the user's face and at least surround the user's nostrils.

[0016] In some configurations, the housing includes a top edge and a bottom edge.

[0017] In some configurations, the upper and lower edges of the housing are symmetrical.

[0018] In some configurations, the lower edge of the housing curves inward toward the housing.

[0019] In some configurations, each of the first interface body and the second interface body includes a manifold, wherein the manifold is configured to be received at least partially by the housing when the first interface body or the second interface body is detachably coupled to the housing.

[0020] In some configurations, the manifold includes a housing connection portion configured to be received within the housing when the first interface body or the second interface body is detachably connected to the housing.

[0021] In some configurations, the manifold further includes a protrusion adjacent to the housing connection portion, wherein the protrusion is configured to suppress rotation of the manifold around the housing when the first interface body or the second interface body is detachably connected to the housing.

[0022] In some configurations, the housing and / or the manifold includes a feedback mechanism to provide visual or auditory feedback when the first interface body or the second interface body is detachably coupled to the housing.

[0023] In some configurations, the patient interface component further includes one or more interface tubes.

[0024] In some configurations, the housing includes one or more tube engagement receiving portions configured to receive interface tubes.

[0025] In some configurations, the patient interface component further includes a fixing member configured to be attached to the housing.

[0026] In some configurations, the first interface body may include a mask or nose fork of a first size, and the second interface body may include a mask or nose fork of a second size, wherein the first size is different from the second size.

[0027] One aspect of this disclosure relates to a patient interface including an interface body, a housing, one or more interface tubes, a first fixing member, and a second fixing member that extends vertically to provide vertical stability to the patient interface.

[0028] In some configurations, the interface body is configured to engage with the patient's face and form a seal.

[0029] In some configurations, the interface body is either the mask body or the cannula body.

[0030] In some configurations, the one or more tubes are configured to be connected to the housing.

[0031] In some configurations, the one or more tubes are formed as a single piece with the housing.

[0032] In some configurations, each of the one or more tubes includes an overmolded grip.

[0033] In some configurations, the first fixing member includes a central portion, a pair of support pads, and a pair of bridging portions. Each of the support pads is configured to engage a fixing mechanism on the opposite side of the central portion at the user's face. Each of the bridging portions connects the central portion to a corresponding support pad among the support pads.

[0034] In some configurations, the first fixing member further includes a patch assembly that is attached to each of the support pads to secure the support pads to the user.

[0035] In some configurations, the second fixing member is attached to the housing.

[0036] In some configurations, the second fixing member is configured to engage the user's forehead.

[0037] In some configurations, the second fixing member is constructed of fabric material.

[0038] In some configurations, the second fixing member further includes a patch assembly for securing the second fixing member to the user.

[0039] In some configurations, the interface body has a Shore hardness between 20A and 100A.

[0040] In some configurations, each of the one or more interface tubes is tapered towards one end.

[0041] One aspect of this disclosure relates to a patient interface including an interface body. The interface body includes: one or more forks extending from a base region at the interface body; and one or more openings for allowing respiratory gas flow into and out of the interface body. The one or more forks are configured to flex at the base region while maintaining a seal with the user's nostrils.

[0042] In some configurations, the interface body includes a right fork and a left fork.

[0043] In some configurations, the thickness of the one or more forks varies along the length of the one or more forks.

[0044] In some configurations, the thickness of the one or more forks is maintained at a constant thickness along the length of the one or more forks.

[0045] In some configurations, the base region has a thickness smaller than the rest of the interface body.

[0046] In some configurations, the base region has a surface that is recessed relative to the adjacent region of the interface body.

[0047] In some configurations, the base region has a recessed surface surrounding the one or more forks.

[0048] In some configurations, the base region has a recessed surface extending around the two forks.

[0049] In some configurations, the one or more forks are configured to flex in the forward and backward directions.

[0050] In some configurations, the one or more forks are configured to flex in the left-right direction.

[0051] In some configurations, the one or more forks are configured to flex in the left-right direction.

[0052] In some configurations, the one or more forks have a circular cross-section near the tips of these forks.

[0053] In some configurations, the one or more forks are configured to flex while maintaining their diameter and cross-sectional shape along their length.

[0054] In some configurations, the one or more forks are configured to flex while maintaining their flow resistance (RTF).

[0055] One aspect of this disclosure relates to a respiratory system comprising: a gas flow source; an inspiratory conduit fluidly 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 fixing member.

[0056] In some configurations, the respiratory system further includes an expiratory tubing configured to receive gas from the patient interface.

[0057] In some configurations, the respiratory system further includes an bubbling device.

[0058] In some configurations, the respiratory system further includes a humidifier.

[0059] In some configurations, the housing is configured to receive each of a plurality of interface bodies, making these interface bodies interchangeable.

[0060] In some configurations, the interface body is either the mask body or the cannula body.

[0061] In some configurations, the one or more interface tubes are configured to be connected to the housing.

[0062] In some configurations, one of the one or more interface tubes is configured to be connected to the inhalation conduit.

[0063] In some configurations, the one or more tubes are formed as a single piece with the housing.

[0064] In some configurations, each of the one or more tubes includes an overmolded grip.

[0065] In some configurations, the first fixing member includes a central portion, a pair of support pads, and a pair of bridging portions. Each of the support pads is configured to engage the user's face on the opposite side of the central portion. Each of the bridging portions connects the central portion to a corresponding support pad among the support pads.

[0066] In some configurations, the first fixing member further includes a patch assembly that is attached to each of the support pads to secure the support pads to the user.

[0067] In some configurations, the patient interface further includes a second fixation member that is coupled to the housing.

[0068] In some configurations, the second fixing member is configured to engage the user's forehead.

[0069] In some configurations, the second fixing member is constructed of fabric material.

[0070] In some configurations, the second fixing member further includes a patch assembly for securing the second fixing member to the user.

[0071] In some configurations, the respiratory system further includes a headgear or cap.

[0072] In one aspect of this disclosure, there is a fixation member for a patient interface for a respiratory system, the fixation member including a soft, flexible barb for detachably engaging with the housing of the patient interface.

[0073] In some configurations, the barb includes one or more tabs.

[0074] In some configurations, the housing includes an opening, wherein one or more tabs are configured to engage with the housing at the opening.

[0075] In some configurations, the barb includes a notch. This notch is configured to facilitate the collapse of the barb.

[0076] In some configurations, the barb includes an extended top portion configured to prevent the barb from being over-inserted into the opening of the housing.

[0077] In some configurations, the barb is overmolded onto the fixing member.

[0078] In one aspect of this disclosure, there is a fixation member for a patient interface of a respiratory system, the fixation member including a support pad that is fixed to a patch assembly on a patient, wherein the support pad is hinged relative to the rest of the fixation member.

[0079] In some configurations, the support pad is flexible.

[0080] In some configurations, the fixing member further includes a hinge between the support pad and a portion of the fixing member.

[0081] In some configurations, the support pad is overmolded onto the fixing member.

[0082] In some configurations, the hinge is a 180-degree hinge.

[0083] One aspect of this disclosure relates to a fixation member for a patient interface for a respiratory system, the fixation member comprising: a first flexible portion connectable to a patient interface component; a second flexible portion connectable to a patient's forehead; and a third rigid portion extending between the first portion and the second portion.

[0084] In some configurations, the first flexible part is a barb.

[0085] In some configurations, this second flexible part is a support pad.

[0086] In some configurations, the first flexible portion and / or the second flexible portion are overmolded onto the third rigid portion.

[0087] In some configurations, the second flexible portion is hinged relative to the third rigid portion.

[0088] In some configurations, the fixing member can be detachably attached to the housing of the patient interface.

[0089] In some configurations, this component is the housing or interface body.

[0090] One aspect of this disclosure relates to a patient interface assembly comprising: an interface body including a manifold, the manifold including a front side configured to contact a patient and a rear side opposite to the front side, wherein the manifold includes a protrusion of a housing connection portion located between the rear side and the front side of the manifold, the manifold including a width extending along an inner lumen of the manifold and a horizontal axis extending along the width, wherein the protrusion is angled relative to the horizontal axis, and wherein the angled protrusion of the housing connection portion is configured for detachable connection of the interface body to a housing via the manifold. Improved assembly and alignment of the interface body; housing, the housing including a patient-facing front side and a rear side opposite to the front side, wherein the housing includes a width extending from a first tube engagement portion at one end of the housing to a second tube engagement portion at the opposite end of the housing and a horizontal axis extending along the width, wherein the housing includes an interface body receiving portion between the front side and the rear side of the housing, wherein the interface body receiving portion is angled relative to the horizontal axis, wherein the angled interface body receiving portion is configured to improve assembly and alignment when the manifold is detachably connected to and received by the housing.

[0091] In some configurations, the protrusion of the manifold includes a first width on the front side of the manifold, which is greater than a second width on the rear side of the manifold.

[0092] In some configurations, the protrusion of the manifold includes a first width on the front side of the manifold, which is smaller than a second width on the rear side of the manifold.

[0093] In some configurations, the angled protrusions of the manifold housing connection extend from the rear side of the manifold at an angle of 120 degrees.

[0094] In some configurations, the angled protrusions of the manifold housing connection extend from the rear side of the manifold at a 60-degree angle.

[0095] In some configurations, the angled protrusions of the manifold housing connection extend from the rear side of the manifold at an angle between 30 and 170 degrees.

[0096] In some configurations, the patient interface assembly further includes a mating surface, wherein a protruding portion of the housing connection portion and the interface body receiving portion contact each other, wherein a portion of the manifold protrusion at the mating surface is higher than the mating surface of the housing.

[0097] In some configurations, the manifold includes a portion on either side of the manifold configured to extend within the housing, wherein the portion extending within the housing has a ridge configured to seal to the housing.

[0098] In some configurations, the ridge is a ring-shaped ridge.

[0099] In some configurations, the ridge is configured to seal against the inner surface of the housing.

[0100] 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.

[0101] In some configurations, the manifold has a first wall thickness on its front side and a second wall thickness on its rear side, wherein the first wall thickness is thicker than the second wall thickness.

[0102] One aspect of this disclosure relates to a patient interface assembly including a housing detachably connected to a manifold of an interface body, wherein the housing includes side protrusions and a central protrusion, wherein the side protrusions include features for attaching a first fixing member to the housing, and wherein the central protrusion includes one or more features for attaching a second fixing member to the housing.

[0103] In some configurations, the housing is a rigid housing.

[0104] In some configurations, one or more features used to attach the second fixing member to the housing are one or more openings.

[0105] In some configurations, the second fixing member is detachably connected to the housing.

[0106] In some configurations, the one or more openings include a lip that is configured to engage a complementary assembly portion of the second fixing member.

[0107] In some configurations, the side protrusion features an enlarged head and a rod for pushing into the mating connection.

[0108] In some configurations, the first fixing member is detachably connected to the housing.

[0109] In some configurations, the patient interface component further includes a conduit, which is integrated with the housing.

[0110] In some configurations, the patient interface component further includes a conduit that is detachably connected to the housing.

[0111] One aspect of this disclosure relates to a fixation member for a patient interface of a respiratory system, the fixation member comprising: a central portion; a pair of support pads, each of which is configured to engage a user’s face on the opposite side of the central portion; and a pair of bridging portions, each of which connects the central portion and a corresponding support pad among the support pads, wherein the bridging portions include cutouts for receiving a housing, and wherein the bridging portions include thickened portions surrounding the cutouts.

[0112] In some configurations, the fastening member further includes a patch assembly that is attached to each of the support pads to secure the support pads to the user.

[0113] In some configurations, the retaining member further includes openings configured to detachably attach the retaining member to a protrusion on the housing, wherein the first retaining member is pushed into the protrusion that engages with the housing.

[0114] In some configurations, the fixing member further includes a recess on the rear side of the fixing member, wherein the recess is configured to receive a central protrusion on the housing when the fixing member is attached to the housing.

[0115] One aspect of this disclosure relates to a patient interface assembly for a respiratory system, the patient interface assembly comprising: an interface body; and a housing, wherein the interface body is detachably coupled to the housing; and a feature that restricts rotation of the interface body relative to the housing.

[0116] In some configurations, the interface body includes a manifold, and the feature includes a shoulder portion on the rear of the manifold.

[0117] In some configurations, the shoulder portion abuts against the housing to limit rotation.

[0118] In some configurations, this feature includes keyed features on the manifold and housing.

[0119] In some configurations, the interface body includes the cannula body.

[0120] In some configurations, the interface body includes the mask body.

[0121] In some configurations, the housing includes one or more tube engagement receiving portions configured to receive interface tubes.

[0122] One aspect of this disclosure relates to a patient interface component for a respiratory system, the patient interface component comprising: a housing; an inspiratory conduit having a first end and a second end, the first end being configured to connect to the housing and deliver an incoming gas flow, and the second end having locking fingers; and an expiratory conduit having a first end and a second end, the first end being configured to connect to the housing and receive an expiratory gas flow, and the second end having locking fingers.

[0123] In some configurations, a locking finger at the second end of the expiratory tube is configured to connect to a downstream component.

[0124] In some configurations, this downstream component includes a bubbler.

[0125] In some configurations, the locking finger at the second end of the inhalation duct is configured to connect to the upstream component.

[0126] In some configurations, this upstream component includes a flow source.

[0127] In some configurations, these locking fingers extend away from the connector, are spaced apart, and narrow along their length away from the connector.

[0128] In some configurations, these locking fingers include locking recesses formed on the outer surface of at least each of the locking fingers, the locking recesses being configured to partially lock with a gas delivery pipe connector, the locking fingers being configured to interact with the recesses of the gas delivery pipe connector to align the connector and the gas delivery pipe connector.

[0129] One aspect of this disclosure relates to a patient interface component for a respiratory system, the patient interface component including an interface body and a housing, wherein at least a portion of the outer surface of the housing and / or the interface body includes a low-friction surface coating or finish.

[0130] In some configurations, the interface body includes the cannula body.

[0131] In some configurations, the interface body includes the mask body.

[0132] In some configurations, the low-friction surface coating or finish is a parylene coating or is achieved through a sandblasting process (such as bead blasting).

[0133] In some configurations, the interface body includes a rear side containing a patient contact surface and a front side opposite to the rear side, wherein the rear side has a low-friction surface coating or finish.

[0134] In some configurations, the interface body is detachable from the housing, and the interface body includes a manifold having a low-friction surface coating or finish that engages with the housing.

[0135] One aspect of this disclosure relates to a manufacturing process for a patient interface component for a respiratory system, the manufacturing process including manufacturing an interface body and coating the outer surface of the interface body with a low-friction surface coating or finish.

[0136] In some configurations, the interface body includes the cannula body.

[0137] In some configurations, the interface body includes the mask body.

[0138] In some configurations, the interface body can be detached from the housing.

[0139] In some configurations, the entire outer surface of the interface body is coated.

[0140] In some configurations, a portion of the interface body is coated, wherein the interface body includes a patient-facing posterior side of the interface body and a front side opposite to the posterior side, wherein the coated portion is the rear portion of the manifold of the interface body.

[0141] In some configurations, a portion of the interface body is coated, wherein the interface body includes a patient-facing posterior side of the interface body and a front side opposite to the posterior side, wherein the coated portion is the anterior portion of the manifold of the interface body.

[0142] One aspect of this disclosure relates to a patient interface assembly comprising: an interface body including a manifold, the manifold including a front side configured for contacting a patient and a rear side opposite to the front side, wherein the manifold includes a protrusion of a housing connection portion located between the rear side and the front side of the manifold, wherein the manifold includes a width extending along an inner lumen of the manifold and a horizontal axis extending along the width, wherein the protrusion is angled relative to the horizontal axis, and wherein the angled protrusion of the housing connection portion is configured for contact between the interface body and the housing via the manifold. The assembly and alignment of the interface body are improved during disassembly and connection; and the feature restricts the rotation of the interface body relative to the housing, wherein the housing includes a patient-facing front side and a rear side opposite to the front side, wherein the housing includes a width extending from a first tube engagement portion at one end of the housing to a second tube engagement portion at the opposite end of the housing, and a horizontal axis extending along the width, wherein the housing includes an interface body receiving portion between the front side and the rear side of the housing, wherein the interface body receiving portion is angled relative to the horizontal axis, wherein the angled interface body receiving portion... The manifold is configured to improve assembly and alignment when it is detachably connected to and received by the housing; a first fixing member comprising: a central portion; a pair of support pads, each of which is configured to engage a user's face on the opposite side of the central portion; and a pair of bridging portions, each of which connects the central portion and a corresponding support pad among the support pads, wherein the bridging portions include cutouts for receiving the housing, and wherein the bridging portions include thickened portions surrounding the cutouts; a second fixing member comprising: The device comprises: a first flexible portion that can be connected to a patient interface component; a second flexible portion that can be connected to the patient's forehead; and a third rigid portion that extends between the first portion and the second portion; an inhalation conduit having a first end and a second end, the first end being configured to connect to the housing and deliver an incoming gas flow, and the second end having a locking finger; and an expiratory conduit having a first end and a second end, the first end being configured to connect to the housing and receive an expiratory gas flow, and the second end having a locking finger.

[0143] In some configurations, the interface body includes the cannula body.

[0144] In some configurations, the interface body includes the mask body.

[0145] In some configurations, the inhalation tube and the exhalation tube are integrated with the housing.

[0146] In some configurations, the first fixing member and the second fixing member can be connected to the housing.

[0147] In some configurations, the second fixation component can be connected to the patient's patch assembly or headgear.

[0148] In some configurations, the second fixing member is detachably attached to the housing.

[0149] In some configurations, the interface body is detachably attached to the housing.

[0150] One aspect of this disclosure relates to a patient interface assembly including an interface body and a housing configured for detachable connection to the interface body, the housing including one or more tube engagement portions at a lateral access point on an opposite end of the housing, wherein these tube engagement portions are configured to receive an interface tube.

[0151] In some configurations, the interface body may include the cannula body.

[0152] In some configurations, the interface body may include the mask body.

[0153] One aspect of this disclosure relates to a patient interface assembly including a first interface body, a second interface body, and a housing configured for detachable connection to either the first or second interface body. The housing includes one or more tube engagement portions at a lateral entry point of the housing, wherein these tube engagement portions are configured to receive an interface tube. The first and second interface bodies are interchangeable such that, in a first configuration, the first interface body is connected to the housing, and in a second configuration, the second interface body is connected to the housing.

[0154] One aspect of this disclosure relates to an interface body comprising: a face mask including a breathing chamber and having a user contact surface configured to contact a user's face and at least surround the user's nostrils; and a manifold in fluid communication with the breathing chamber, the manifold including a first opening on a first lateral side of the manifold and a second opening on a second lateral side of the manifold, wherein the first opening and the second opening allow gas flow into and out of the breathing chamber.

[0155] In some configurations, the first opening and the second opening may be configured to communicate with interface tubes configured to deliver gas flows into and out of the mask and the manifold on the first and second lateral sides.

[0156] One aspect of this disclosure relates to an interface body including a face mask defining a breathing chamber and having a user contact surface configured to contact a user's face and at least surround the user's nostrils. The face mask includes a face mask seal, wherein at least a portion of the face mask seal includes a stiffness-reduced region positioned between a first stiffer region and a second stiffer region, wherein the first and second stiffer regions have a stiffness greater than that of the stiffness-reduced region, and wherein the stiffness-reduced region buckles in a unidirectional direction as the first stiffer region moves toward the second stiffer region.

[0157] In some configurations, the first rigider region may include a structural support portion that extends partially around the circumference of the mask.

[0158] In some configurations, the second, harder area can be the front portion of the mask.

[0159] One aspect of this disclosure relates to a patient interface assembly comprising: an interface body including a housing coupling portion having a first side facing a patient and an opposite second side, wherein the housing coupling portion includes a shape defined between the first and second sides of the housing coupling portion; and a housing including an interface body receiving portion having a shape complementary to the shape of the housing coupling portion of the interface body, wherein the housing is configured for detachably coupling to the interface body.

[0160] In some configurations, the shape of the housing connection portion may include a trapezoidal shape.

[0161] In some configurations, the housing connection portion of the interface body may include a wider trapezoidal base near the front portion of the housing.

[0162] In some configurations, the housing connection portion of the interface body may include a wider trapezoidal base near the rear portion of the housing.

[0163] One aspect of this disclosure relates to an interface body comprising: one or more forks extending from a base region; and one or more openings for allowing a flow of breathing gas into and out of the forks, wherein the one or more forks are configured to flex at the base region while maintaining a seal with the user's nostrils.

[0164] In some configurations, the one or more forks may include a thickness that varies along the length of the one or more forks.

[0165] In some configurations, the one or more forks can maintain a constant thickness along the length of the one or more forks.

[0166] One aspect of this disclosure relates to an interface body, wherein the interface body may include: one or more forks extending from a base region at the interface body; and one or more openings for allowing a flow of breathing gas into and out of the interface body, wherein the one or more forks are configured to flex at the base region while maintaining a seal with the user's nostrils. Attached Figure Description

[0167] Reference numerals may be used repeatedly throughout the accompanying drawings to indicate general correspondences between referenced elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of this disclosure.

[0168] Figure 1 An example of a system that can use a patient interface is shown.

[0169] Figure 2 An example of a system that can use a patient interface is shown.

[0170] Figure 3 It is a stereoscopic view of the patient interface from the front, top, and sides.

[0171] Figure 4 yes Figure 3 Stereoscopic views of the patient interface, including frontal, top, and lateral views.

[0172] Figure 5 It is a stereoscopic view of the patient interface from the front, top, and sides.

[0173] Figure 6 yes Figure 5 Stereoscopic views of the patient interface, including frontal, top, and lateral views.

[0174] Figure 7 These are front, top, and side perspective views of the shell.

[0175] Figure 8 yes Figure 7 Front view of the housing.

[0176] Figure 9 yes Figure 7 Rear view of the housing.

[0177] Figure 10 It is a stereoscopic view of the nasal interface from the front, top, and side.

[0178] Figure 11 yes Figure 10 Front view of the nose interface.

[0179] Figure 12A yes Figure 10 A top view of the nose connector.

[0180] Figure 12B yes Figure 10 Rear view of the nose connector.

[0181] Figures 13A to 13D It represents the nose fork of the intubation tube.

[0182] Figures 13E to 13I A view showing the nose fork of the intubation body.

[0183] Figure 14A yes Figure 10 A schematic diagram of the nose interface is shown, illustrating thickness analysis.

[0184] Figure 14B This is a schematic diagram of the nose connector, showing a thickness analysis.

[0185] Figure 14C This is a cross-sectional view of the nose fork of the intubation tube.

[0186] Figure 15 It is a stereoscopic view of the patient interface from the rear, top, and side.

[0187] Figure 16 It is a stereoscopic view of the patient interface from the front, top, and sides.

[0188] Figure 17 yes Figure 16 The front view of the patient interface.

[0189] Figure 18 yes Figure 16 A top view of the patient interface.

[0190] Figure 19 yes Figure 16 The rear view of the patient interface.

[0191] Figures 20 to 21 yes Figure 16 A schematic diagram of the patient interface.

[0192] Figure 22A It is a stereoscopic view of the nasal interface from the front, top, and side.

[0193] Figure 22B yes Figure 22A Rear, top, and side stereoscopic views of the nasal inlet.

[0194] Figure 23 yes Figure 22A A schematic diagram of the nose connector.

[0195] Figure 24A These are rear, top, and side stereoscopic views of the nasal inlet.

[0196] Figure 24B This is a top cross-sectional view of the nose connector.

[0197] Figure 24C This is a side cross-sectional view of the nose connector.

[0198] Figure 24D This is a schematic diagram of the top cross-section of the nasal inlet.

[0199] Figure 24E This is a schematic diagram of the side cross-section of the nasal connector.

[0200] Figure 25 It is a stereoscopic view of the patient interface from the front, top, and sides.

[0201] Figure 26 yes Figure 25 A top view of the patient interface.

[0202] Figure 27 It is a three-dimensional view of the fixed component, including the front view, top view, and side view.

[0203] Figure 28 yes Figure 27 Front view of the fixed component.

[0204] Figure 29 These are the front, top, and side views of the fixed components and the shell.

[0205] Figure 30 yes Figure 29 Rear view of the fixed components and the housing.

[0206] Figure 31 This is a schematic diagram of the fixed component.

[0207] Figure 32 This is a schematic diagram of the fixed component.

[0208] Figure 33 These are the front view, top view, and side view of the fixed component.

[0209] Figure 34 yes Figure 33Front view of the fixed component.

[0210] Figure 35 yes Figure 33 Rear view of the fixed component.

[0211] Figure 36 It is a stereoscopic view of the patient interface component from the front, top, and side views.

[0212] Figure 37 This is a top view of the casing.

[0213] Figure 38 This is a top-view perspective of the interface housing.

[0214] Figure 39A It is a front-view perspective view of the fixed component.

[0215] Figure 39B It is a rear-view perspective view of the fixed component.

[0216] Figure 39C This is a top view of the fixed component.

[0217] Figures 40 to 42 It is a front-view perspective view of the fixed component.

[0218] Figure 43A This is a front view of the fixed components and the housing.

[0219] Figure 43B This is a top view of the casing.

[0220] Figure 44 These are front and side perspective views of the fixed components.

[0221] Figure 45 This is a view of the fixed component.

[0222] Figures 46A to 46B It is a three-dimensional view of the front and rear sides of the fixed component.

[0223] Figure 47 It is a three-dimensional view of the front side of the fixed components and the shell.

[0224] Figure 48A This is a rear view of the intubation tube body.

[0225] Figure 48B This is a front view of the main body of the mask.

[0226] Figure 48C This is a front view of a schematic diagram of the main body of the mask.

[0227] Figure 48D These are front and side perspective views of the main body of the mask.

[0228] Figure 48EThis is a top view of a schematic diagram of the main body of the mask.

[0229] Figure 49 This is a top view of the nose connector and the housing.

[0230] Figure 50 This is a partial top view of the nose inlet and the housing.

[0231] Figure 51 This is a partial top view of the nose inlet and the housing.

[0232] Figure 52A This is a top view of the nose connector and the housing.

[0233] Figure 52B yes Figure 52A The nose port and rear view of the housing.

[0234] Figure 53A This is a top view of the nose connector and the housing.

[0235] Figure 53B yes Figure 53A A partial top view of the nose interface and the housing.

[0236] Figure 53C yes Figure 53A A partial top view of the nose interface and the housing.

[0237] Figure 53D yes Figure 53A A partial top view of the nose interface and the housing.

[0238] Figure 54 This is a side cross-sectional view of the interface body.

[0239] Figure 55 This is a side cross-sectional view of the interface body.

[0240] Figures 56A to 56D This is a view of the interface body and the shell.

[0241] Figures 56E to 56F It is a view of the interface body, shell, and pipes of the interface component.

[0242] Figure 57 This is a front-view perspective view of the interface pipes and connectors. Detailed Implementation

[0243] Embodiments of systems, components, and methods of assembly and manufacture will now be described with reference to the accompanying drawings, wherein similar reference numerals refer to similar or analogous elements throughout. Although several embodiments, examples, and illustrations are disclosed below, it will be understood by those skilled in the art that the invention described herein extends beyond the specifically disclosed embodiments, examples, and illustrations, and may include other uses of the invention and its obvious modifications and equivalents. The terminology used in the description presented herein is not intended to be interpreted in any limiting or restrictive manner merely because the terminology is used in conjunction with the detailed description of certain particular embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature alone is essential to achieving its desired properties or to practicing the invention described herein.

[0244] Certain terms used in the following description may be for illustrative purposes only and are therefore not intended to be limiting. For example, terms such as “above” and “below” refer to orientations in the referenced figures or orientations relative to the orientation of the device used by a user in an upright position. Terms such as “front,” “back,” “left,” “right,” “rear,” and “side” describe the orientation and / or position of portions of a component or element within a consistent but arbitrary frame of reference or relative to the orientation of the device used by a user in an upright position, which will become clear from the text describing the component or element in question and the associated figures.

[0245] Respiratory system

[0246] Figure 1An exemplary respiratory system 1000 is illustrated, in which an embodiment of a patient interface 3000 can be used. In the illustrated arrangement, the patient interface 3000 receives an inspiratory gas flow via an inspiratory conduit 201a. An expiratory gas flow may be directed from the interface 3000 to a resistance device via an expiratory conduit 201b, which, in the illustrated arrangement, is an evaporator device 70. An optional humidifier system 30 is provided to humidify the inspiratory gas flow. The humidifier system 30 typically includes a chamber located on top of a heater base, which is supplied with an airflow source, for example, from a hospital or other supply source 300. The humidified inspiratory gas flow is delivered to the patient's airway via the inspiratory conduit 201a and the patient interface 3000. Excess and exhaled gas is expelled from the patient interface 3000 via the expiratory conduit 201b. The resistance device 70 provides resistance to the expiratory gas flow leaving the system 1000 to the atmosphere to provide a desired peak end-expiratory pressure (PEEP). Those skilled in the art will understand that such a system may include additional and / or replacement components as known in the art. In some embodiments, the patient interface 3000 includes a nasal cannula. In other embodiments, the patient interface 3000 includes a face mask. For example, the patient interface 3000 may include a nasal mask, an oronasal mask, a face mask, or a full-face mask. In some embodiments, a resistance device and / or a humidifier are integrated into the supply source 300. Although in Figure 1 The diagram illustrates a water-based resistance device, but those skilled in the art will understand that the resistance device can be any other mechanical or resistive device as known in the art.

[0247] Now for reference Figure 2 Another example of a respiratory system including an evaporator device and a humidifier is depicted. A humidified positive end-expiratory pressure (PEEP) system is shown, in which a patient 119 is receiving humidified and pressurized gas through a patient interface 3000 connected to an inspiratory or inhalation conduit 201a. However, it should be understood that this disclosure is not limited to the delivery of PEEP gas, but can also be applied to other types of gas delivery systems and may not necessarily involve humidification. The inspiratory conduit 201a is connected to an outlet 112 of a humidification chamber 110 containing a certain amount of water 115. The inspiratory conduit 201a may include a heating device or heating wire 120 that heats the walls of the conduit to ensure a constant humidity distribution along the conduit and thus reduce condensation of the humidified gas within the conduit. When a certain amount of water 115 within the humidification chamber 110 is heated, water vapor begins to fill the volume of the chamber above the water surface and dissipates from the outlet 112 of the humidification chamber 110, where a gas flow (e.g., air) supplied from a gas supply device or blower 118 enters the chamber 110 through inlet 116. The humidified gas travels through inhalation tubing 201a to the interface 3000 worn by the patient 119. Excess gas then flows through exhalation or expiratory tubing 201b to the pressure regulator 40.

[0248] In some embodiments, the pressure regulator 40 takes the form of discharging an exhaled gas stream into a chamber 204 containing a column of water 138. Gas flowing through the exhalation conduit 201b is discharged into the water body 138 via a short conduit 136 extending from the exhalation conduit 201b into the chamber 204. This creates a foaming effect, whereby the gas eventually exits the chamber 204 via an outlet port, which can also be used for initially filling the chamber 204 with water. The outlet port includes a barrier to prevent the expulsion of liquid aerosols generated by vigorous foaming on the water surface. It should be understood that the short conduit 136 can also be integrated into the end of the exhalation conduit 201b.

[0249] Patient Interface Component

[0250] Figures 3 to 6 An embodiment of the patient interface 3000 is shown. For example... Figures 3 to 6 As shown, the patient interface 3000 includes an interface body that can form a seal with the user's face and allow gas to flow out of and to the user, and the interface body can be coupled to a housing 3400. In some embodiments, the housing 3400 may 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... Figures 3 to 4 As shown. The cannula body 3200a can form a seal with the user's nostrils. In some embodiments, the interface body is a mask body, such as... Figures 5 to 6 The mask body 3200b is shown. The mask body 3200b has a mask or mask cushion that can form a seal with the user's face. The illustrated embodiment of the patient interface 3000 also includes a first fixing member 3600, one or more interface tubes 3800, and a second fixing member 3900.

[0251] In some embodiments, the housing 3400 may be detachably coupled to the cannula body 3200a, the mask body 3200b, or any other type of interface body. The housing 3400 may be detachably coupled to the interface body, for example using a mechanism described in further detail herein, allowing the user or clinician to interchange different types of interface bodies (e.g., cannula body 3200a and mask body 3200b) and / or different sizes of interface bodies. This can facilitate better assembly when reusing the same housing without requiring disassembly or removal of the entire patient interface 3000 during treatment. For example, the interface body may be coupled to and / or detached from the housing 3400, while the first fixation member 3600, the interface tube 3800, and / or the forehead support member 3900 remain coupled to the housing 3400. In some situations, the mask body and the cannula body may need to be used alternately during treatment, for example, to reduce or prevent skin irritation or injury. The interface body can be interchanged while maintaining the housing 3400 connected to a headgear, cap, chin strap, or the user's face. Furthermore, the detachable connection between the interface body and the housing 3400 may be advantageous for cleaning and maintenance. In some embodiments, the kit for treating a patient includes one or more cannula bodies and / or one or more mask bodies compatible with the housing 3400, allowing the user or clinician to select and use an appropriate interface body. In some embodiments, the kit includes cannula bodies and / or mask bodies of different sizes. Different sized mask bodies and / or cannula bodies may be indicated by different colors or other means, such as letters and / or symbols. Letters and / or symbols may be molded, laser-marked, printed, or otherwise displayed on the mask bodies and / or cannula bodies.

[0252] 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 body. Users or clinicians can interchange different types of interface bodies (e.g., cannula body 3200a and mask body 3200b) or different sizes of interface bodies by swapping the components with the housing and interface bodies for better fit. For example, the interface body and housing 3400 may be coupled to and / or detached from the interface tube 3800. In some embodiments, a kit for treating a patient includes one or more cannula bodies and / or one or more mask bodies attached to the housing 3400, allowing the user or clinician to select and use the appropriate interface body attached to the housing 3400.

[0253] The first fixing member 3600 can secure or support the patient interface 3000 relative to the user. The first fixing member 3600 can be coupled to the housing 3400 and helps secure the interface body to the user's face, thereby helping the interface body form and maintain a seal with the user's face. In some embodiments, the first fixing member 3600 includes means for attaching and securing the patient interface 3000 to a headgear, chin strap, patient interface patch, or skin patch on the patient's face, or otherwise, via any suitable mechanism. For example, the first fixing member 3600 may include a hook-and-loop material or adhesive on the user-facing side, as described in further detail herein. Even in the illustrated embodiments where the first fixing member 3600 is coupled to the housing 3400, the patient interface 3000 can be used without the first fixing member 3600. For example, the housing 3400 can be secured directly to the user's face, such as on the cheek, either directly or via other securing means such as a headgear or chin strap. Figures 3 to 6 As shown, the first fixing member 3600 may extend horizontally or substantially horizontally. However, the first fixing member 3600 may be positioned in any suitable orientation.

[0254] In addition to or in place of the first fixation member 3600, the patient interface 3000 may further include other fixation devices. For example, in the illustrated embodiment, the patient interface 3000 includes a second fixation member 3900. In some embodiments, the patient interface 3000 includes both the first fixation member 3600 and the second fixation member 3900. In some embodiments, the patient interface includes one of the first fixation member 3600 and the second fixation member 3900. Figures 3 to 6 As shown, the second fixing member 3900 may extend vertically or substantially vertically. However, the second fixing member 3900 may be positioned in any suitable orientation.

[0255] The patient interface 3000 may further include one or more interface tubes 3800. In some embodiments, the walls of the interface tubes may be made of a material that allows wet vapor to pass through the walls of the interface tubes. In some embodiments, 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 be connected to the CPAP therapy delivery device at the other end, for example, via tubes 201a and 201b, 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, such as tubes 201a and 201b, for connection to a breathing component. The connector 3860 may be overmolded to the tube 3800. The connector 3860 may be or include a silicone or elastomeric material. The connector 3860 may have a stiffness similar to or greater than that of the interface tubes 3800. Connector 3860 may be or include the same material as components of tube 3800 provided with a geometry that is more rigid than tube 3800, such as beads of interface tube 3800. In some embodiments, connector 3860 includes one or more ports for monitoring gas properties, such as pressure. In some embodiments, patient interface 3000 may include one or more sensors for monitoring gas properties, such as pressure at one or more ports or any other suitable location. Connector 3860 may be adapted to receive a clamp that can be used to clip onto sheets or clothing to provide additional fixation to patient interface 3000 and tube 3800. In some embodiments, each of interface tubes 3800 further includes a grip 3850. Grip 3850 may be directly or indirectly overmolded to tube 3800, for example, overmolded to both tube 3800 and connector 3860. In some embodiments, tube 3800 may be adhesively or threadedly attached to other areas of connector 3860 or grip 3850. Clinicians or users can grasp the grip 3850 to connect or insert the connector 3860 into respiratory components, such as tubes 201a and 201b. In some embodiments, one or more components of the interface tube 3800 can rotate relative to other components of the interface tube 3800. For example, the grip 3850 can rotate relative to the connector 3860 such that torsion or movement caused by grasping the grip 3850 can be transmitted to the housing 3400 and the interface body without passing through the rest of the tube 3800.

[0256] In some embodiments, the tube 3800 may be detachably coupled to the housing 3400. In some embodiments, one or more of the interface tubes 3800 are permanently attached to the housing 3400. For example, one or more of the interface tubes 3800 may be directly or indirectly overmolded to the housing 3400 to form a monolithic piece. In some embodiments, the tube 3800 may be attached to the housing 3400 with an adhesive or threaded to the housing. In some embodiments, the tube 3800 may be rotatable or revolute relative to the housing 3400 such that torsion or movement of the tube 3800 may not be transmitted to the housing 3400 and the interface body. In some embodiments, the interface tube 3800 has a varying diameter and / or thickness along its length. For example, each of the interface tubes 3800 may be tapered toward one end. In some embodiments, the interface tube 3800 has a constant diameter and / or thickness along its length. In some embodiments, the interface tube 3800 may have a circular, semi-circular, or D-shaped cross-section. When a semi-circular or D-shaped cross-section is used, the flat side of the interface tube 3800 may face the patient.

[0257] case

[0258] Figures 7 to 9 An embodiment of the housing 3400 is shown. In the illustrated embodiment, the housing 3400 has a front portion 3430 and a rear portion 3450. The rear portion 3450 can be oriented to face the user's face when the patient interface 3000 is applied to the user's face, and the front portion 3430 can be oriented to face away from the user's face when the patient interface 3000 is applied to the user's face.

[0259] In the illustrated embodiment, the front portion 3430 includes one or more attachment elements. One or more attachment elements may extend outward from the front portion 3430. Figures 7 to 9 In the illustrated embodiment, one or more attachment elements may include a central protrusion 3440 and a front extension 3420. In some embodiments, such as Figures 7 to 9 As shown, one or more attachment elements include a central protrusion 3440 having a pair of front extensions 3420. Each of the pair of front extensions 3420 may be laterally located on opposite sides of the central protrusion 3440. In other embodiments, the one or more attachment elements may include any arrangement of protrusions or extensions. For example, in some cases, a single attachment element may be used.

[0260] In some embodiments, such as Figure 7As shown, the front extension 3420 may protrude in a forward direction. The front extension 3420 may form a ridge 3422. The channel 3424 may be at least partially defined by the ridge 3422. In some embodiments, the first fixing member 3600 may be positioned around the front extension 3420 and fixed at the channel 3424 such that the first fixing member 3600 may be detachably coupled to the housing 3400 when the patient interface 3000 is assembled.

[0261] The central protrusion and front extension can be used to secure one or more fixing members to the housing 3400. The central protrusion and front extension can be shaped as complementary portions for receiving the fixing members. For example... Figures 7 to 9 As shown, in some embodiments, the central protrusion 3440 may include an enlarged head 3442 and a rod 3444. In other embodiments, such as Figure 37 and Figure 38 As shown, the central protrusion 4440 may have an opening to receive a fixing member, as referenced herein. Figures 37 to 38 As stated above.

[0262] like Figures 7 to 9 As shown, the central protrusion 3440 can receive and retain one or more components having holes, which are fitted into the enlarged head 3442, for example, by a push-fit. For example, a second retaining member 3900 can be detachably coupled to the housing 3400 at the central protrusion 3440. In some embodiments, the central protrusion 3440 is positioned at the middle or substantially the middle of the front portion 3430 and between the front extensions 3420.

[0263] In some embodiments, the front extension 3420 can be positioned on either side of the central protrusion 3440, such as... Figures 7 to 9 As shown. The front extension may have a shape to receive complementary fixing members. For example... Figures 7 to 9 As shown, the front extension 3420 may be recessed around the central protrusion 3440, allowing the central protrusion 3440 to have a greater height to receive thicker components, such as the second fixing member 3900, without excessively protruding beyond the housing 3400. In some embodiments, the front extension 3420 may not be recessed around the central protrusion 3440. In other embodiments, such as Figure 37 and Figure 38 As shown, the front protrusion 4420 may be circular to receive the fixing member, as referenced herein. Figures 37 to 38 As stated above.

[0264] 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 a cannula body 3200a or a mask body 3200b). At the interface body receiving portion 3480, the inner surface of the housing 3400 is exposed. The interface body receiving portion 3480 and the inner surface of the housing 3400 can be shaped and / or sized to match the shape and / or size of the interface body, allowing for removal and interchangeability of the interface body relative to the housing 3400. For example, the inner surface of the housing 3400 can have a cylindrical shape, allowing it to receive and mate with a cylindrical portion of the interface body.

[0265] The housing 3400 may further include one or more pipe engagement portions 3460 to receive one or more interface pipes, such as one or more interface pipes 3800. The pipe engagement portions 3460 may be sized and / or shaped to match the shape and / or size of the interface pipes, such that the interface pipes can be connected to the pipe engagement portions 3460 without leakage. The pipe engagement portions 3460 may be positioned such that the housing 3400 can receive gas from the interface pipes through the pipe engagement portions 3460, and allow gas flow to the interface body connected to the interface body receiving portion 3480.

[0266] The housing 3400 further includes an upper edge 3470 and a lower edge 3490 opposite to the upper edge 3470. In some embodiments, the upper edge 3470 and the lower edge 3490 are symmetrical, such that when the interface 3000 is assembled, a user or clinician can orient the housing 3400 in either direction. Figures 8 to 9 As shown, the upper edge 3470 and / or the lower edge 3490 may have an inwardly curved profile. The inwardly curved profile of the upper edge 3470 and / or the lower edge 3490 allows the user's mouth to be exposed, even when the user is wearing the patient interface 3000, for the user's comfort. If the user is an infant, a pacifier can be used during treatment, or the user can be breastfed. Furthermore, a nasogastric tube can be introduced into the patient, and it will be possible to easily clean the user's mouth.

[0267] In some embodiments, the housing 3400 is constructed of a material with greater stiffness than the interface bodies (such as the cannula body 3200a and the mask body 3200b), such that the housing 3400 can provide structural stability for the patient interface 3000. For example, the housing 3400 can be constructed of a material with a Young's modulus of 0.1 GPa to 7 GPa, 0.5 GPa to 7 GPa, 0.5 GPa to 6 GPa, 0.8 GPa to 6 GPa, 1 GPa to 6 GPa, 1.8 GPa to 6 GPa, 2 GPa to 5 GPa, or 3 GPa to 5 GPa. The thickness of the housing 3400 can then be varied to achieve the desired stiffness in each region of the housing 3400. The housing 3400 can be constructed of a thermoplastic elastomer, such as polycarbonate, thermoplastic polyurethane (TPU), polyamide, or nylon. The front extension 3420 forms a protrusion 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 can be adjusted to adjust the rigidity of the housing 3400.

[0268] Interface main body

[0269] As described herein, the patient interface 3000 includes an interface body that can form a seal with a user's face and allow gas to flow out of 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 to form a nasal cannula that can form a seal with the user's nostrils. In other embodiments, the interface body is a mask body, such as a mask body 3200b.

[0270] Intubation body

[0271] Figures 10 to 12B An embodiment of the cannula body 3200a is shown. In other embodiments, the cannula body described herein may have the features described in the reference document. Figures 10 to 12B Similar features as described above. For example, refer to Figure 21 , Figure 48A , Figure 49 , Figures 52A to 52B , Figure 53A and Figure 55 Embodiments of the described cannula body may include the features described herein with reference to the cannula body 3200a and the nose fork. For example... Figures 10 to 12BAs shown, the cannula body 3200a may have at least one nasal fork 3220, such as a pair of forks 3220. The forks 3220 may extend from the patient-facing rear portion 3243 of the manifold 3240. The nasal fork 3220 may form a seal with the user's nostril and allow gas to flow out of and to the user. The nasal fork 3220 of the patient interface shown and described herein is shaped for sealing in a patient's nostril. In some embodiments, the nasal fork is shaped for sealing in the nostril of an infant. However, it should be understood that the fork can be adapted to any patient group having similar nostril geometry, and forks of different absolute sizes can be provided for various patient groups. The forks 3220 may be shaped and configured to minimize tissue compression and kinking of one or more forks 3220 during insertion into the patient's nostril.

[0272] In the illustrated embodiment, manifold 3240 defines one or more openings 3246, such as a pair of openings 3246, which can be coupled to a tube engagement portion 3460 of housing 3400 to receive an interface tube and allow gas to flow from and to the patient via manifold 3240 and nose fork 3220. The openings 3246 can be in fluid communication with each other via manifold 3240. Manifold 3240 can be sealed except for the lumens of openings 3246 and nose fork 3220. Openings 3246 can be positioned on the sides of manifold 3240. Figures 10 to 12B As shown, manifold 3240 may have two openings 3246, and the openings 3246 may be on opposite sides of manifold 3240. When manifold 3240 is connected to pipe engagement portion 3460 of housing 3400, the openings 3246 are positioned on the side of the manifold to allow lateral fluid flow to enter and exit manifold 3240 through the openings 3246.

[0273] fork of the cannula body

[0274] The cannula body 3200a may include nasal forks, the orientation and / or geometry of which may facilitate gas flow and gas delivery to the patient. For example, Figures 13A to 13D The geometry of embodiments of forks 105 is shown, which may be similar to or the same as the nose forks (such as nose forks 3220 and 4220) on the cannula body described herein.

[0275] like Figures 13A to 13BAs shown, the fork 105 can taper inward from the gas inlet 106 to the gas outlet 108 or between the gas inlet and the gas outlet. The cross-sectional area of ​​the gas inlet 106 can be larger than the cross-sectional area of ​​the gas outlet 108. The cross-sectional area of ​​the fork can gradually decrease from the inlet 106 to the outlet 108 or between the inlet and the outlet. This tapering of the fork can help the sealing function of the fork 105. When the fork 105 is pushed into the patient's nostril, it may seal at some point along the length of the fork 105 due to the taper (where the fork 105 widens towards the inlet 106). In contrast to forks with a constant cross-sectional area or forks that widen towards the outlet, tapering can facilitate the insertion of the fork 105.

[0276] The inner cavity of the nose fork 105 may have an internal cross-section that varies along the length of the nose fork 105. For example, as Figures 13A to 13D As shown and referred to herein, the shape and / or diameter of the internal cross-section of the fork may vary along its length.

[0277] As described in more detail herein, the nose fork 105 can be shaped to substantially align the flow of breathing gas through the gas outlet with the user's upper respiratory tract.

[0278] The nose fork 105 can be shaped to extend generally upward and backward into the user's nostril, and the nose fork 105 has a curvature including at least two inflection points, for example, as Figures 13A to 13D As shown and described in this article.

[0279] Forks 105 can extend from the intubation body or manifold toward the user's nasal septum and curve upward and backward around the corners of the user's nostrils into the user's nostrils. Each fork 105 can extend along a generally sloping rearward trajectory, thus passing through two intermediate lateral bends. This geometry can help orient the gas outlet 108 relative to the user's upper airway.

[0280] At least one fork 105 may have a shaped trajectory that conforms to or corresponds to the anatomical shape of the user's nostrils. In a first portion (or stage) of the fork 105, the trajectory may move horizontally toward the midline of the face. In a second portion (or stage) of the fork 105, the trajectory may curve upward toward the top of the head into the nostrils. In a third portion (or stage) of the fork 105, the trajectory may roll backward toward the head, generally following the anatomical curvature of the nostrils. In a fourth portion (or stage) of the fork 105, the trajectory may be horizontally inclined toward the center of the interface assembly to align the outlet 108 with the user's upper respiratory tract.

[0281] Fork 105 may have a cross-section that varies along the central trajectory, as described above. For example, the cross-section may be generally circular at the base of the trajectory and become generally circular, oval, or elliptical towards the ends of the trajectory or fork 105.

[0282] The cross-sectional diameter can generally decrease along the trajectory from the end of the first part (or stage) to the end of the fourth part (or stage).

[0283] The geometry of the fork described in this article (such as...) Figures 10 to 12B as well as Figure 48A , Figure 49 , Figures 52A to 52B As shown in Figure 53, it can be substantially as follows Figures 13A to 13D As shown, the curve represents the fork trajectory, and the ellipse 1135 primarily represents the orientation of the cavity within each fork at a particular trajectory (and also illustrates a potential cross-sectional cavity shape). In some embodiments, the ellipse 1135 may be circular or substantially circular. Each fork may generally follow a curved path shaped to conform to the anatomical geometry / curvature / contour of the user's nostrils. Forks 105 may be molded or formed to substantially conform to the anatomical shape and curvature of the user's nostrils.

[0284] The fork 105 can be pre-molded or pre-shaped according to the anatomical shape of the nostrils. In some embodiments, the fork 105 may include at least one thinned wall portion that is adaptable to limit pressure on the patient's nasal septum. In other embodiments, the fork wall thickness may always be uniform.

[0285] From the base 1415, each fork 105 can be generally upward or high toward the top of the user's head (away from the transverse plane) and generally backward or back (toward the user's coronal plane) relative to the user's upper lip. Between ellipses 1131 and 1133 (second stage), the inner cavity of the fork 105 can transition from a generally middle-outer orientation along the user's upper lip to a predominantly sloping rearward orientation. This configuration can direct airflow toward the upper portion of the back of the user's head. During this stage, the inner cavity of the fork 105 can be slightly reduced. The inner cavity can also become more elliptical, which can utilize the space available within the nostrils.

[0286] In the third stage (between ellipses 1133 and 1134), fork 105 may continue along the inclined rear trajectory toward the upper back of the user's head (away from the lateral plane and toward the coronal plane). The slope of the upper component of fork trajectory 1420 may decrease smoothly, which may cause the lumen to move away from the lateral plane. During this stage, fork 105 may have negligible or minimal convergence (or a mid-lateral component) toward the sagittal plane. The fork lumen may further decrease during this stage and may become increasingly elliptical.

[0287] In the final stage (between ellipses 1134 and 1135), fork 105 can continue along the inclined rear trajectory, where some intermediate-outer convergence toward the sagittal plane occurs. The intermediate-outer convergence of fork 105 can begin at the trajectory inflection point 107a shown, at the start of the fourth stage adjacent to ellipse 1134 (or slightly earlier).

[0288] The second inflection point 107b can be adjacent to the final ellipse 1135. The second inflection point can reduce the convergence of the fork 105 and make the fork exit 1411 generally oriented dorsally (towards the coronal plane), with the orientation towards the sagittal plane (by...) Figure 13A The final ellipse 1135 in the orientation representation has a component that is slightly outward from the center.

[0289] During the fourth stage, the inclination rate of the fork trajectory 1420 can continue to decrease until the corresponding trajectory 1420 is substantially parallel to the transverse plane at the fork exit 1411 (represented by ellipse 1135). Mid-lateral and up-down adjustments of the fork trajectory 1420 adjacent to the final ellipse 1135 can position the fork exit 1411 generally aligned with the upper respiratory tract pathway. This can help reduce soft tissue irritation caused by exhaled respiratory gases.

[0290] The fork cavity at outlet 1411 may be elliptical. The major axis of the ellipse may be arranged in a generally transverse plane. The fork cavity at outlet 1411 may be circular or substantially circular. Outlet 1411 may be directed upward or upward toward the top of the user's head (away from the transverse plane) and backward or backward (towards the user's coronal plane) to guide breathing air.

[0291] In alternative embodiments, the cross-section of the cavity may be triangular or quadrilateral.

[0292] like Figures 13C to 13D As shown, the nose fork may have a sealing region 1109, which is larger than the reference... Figures 13A to 13BThe sealing region 109 of the earlier described embodiment is longer. The longer sealing region 1109 can cause the total length of the nasal fork in this embodiment to be longer than the total nasal fork length of the previously described embodiment. This may have the additional benefit of making the fork less likely to protrude from or otherwise separate from the patient's nostril. (Refer to the curve representing the fork trajectory and...) Figures 13C to 13D The ellipse-shaped fork sealing region 1109 lies between ellipses 1134a and 1135. The fork sealing region 1109 may include a conical region. The cross-section of the outer surface of the fork 105 near the gas inlet 106 may be larger than the cross-section of the outer surface of the fork 105 near the gas outlet 108.

[0293] In the illustrative embodiment shown, the fork sealing region 1109 is tapered from approximately 5 mm to approximately 4 mm, for example. The measurements of the fork (5 mm and 4 mm) refer to the equivalent diameter of the oval shape. The equivalent diameter can be the diameter calculated from the circumference of the fork (circular and oval forks can have the same equivalent diameter), or it can be the maximum width dimension of the fork (circular and oval forks can have different equivalent diameters). The tapered sealing region 1109 allows the patient interface 1101 to be used for patients with nostril sizes anywhere between approximately 4 mm and approximately 5 mm. For example, if the patient's nostril size is 4.5 mm, the fork 1105 can be inserted into the nostril such that the cross-section of the sealing region 1109 with a diameter of 4.5 mm seals with its nostril.

[0294] The fork sealing region 1109 can have different dimensions and / or different taper amounts. The length of the sealing region can range from about 1 mm to about 10 mm. The length of the sealing region can 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 can be between about 2 mm and about 10 mm. The diameter of the sealing region can be about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.

[0295] The tapering ratio from the wider to the narrower section can be approximately 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.

[0296] For example, the fork seal area can be tapered from 10 mm to 9 mm, from 9 mm to 8 mm, from 8 mm to 7 mm, from 7 mm to 6 mm, from 6 mm to 5 mm, from 5 mm to 4 mm, or from 4 mm to 3 mm, or from 3 mm to 2 mm. The tapering can be steeper; for example, the fork seal area can be tapered from 10 mm to 8 mm, from 9 mm to 7 mm, from 8 mm to 6 mm, from 7 mm to 5 mm, from 6 mm to 4 mm, from 5 mm to 3 mm, or from 4 mm to 2 mm. The taper can be relatively gentle; for example, the fork seal area can taper from 10 mm to 9.5 mm, from 9.5 mm to 9 mm, from 9 mm to 8.5 mm, from 8.5 mm to 8 mm, from 8 mm to 7.5 mm, from 7.5 mm to 7 mm, from 7 mm to 6.5 mm, from 6.5 mm to 6 mm, from 6 mm to 5.5 mm, from 5.5 mm to 5 mm, from 5 mm to 4.5 mm, from 4.5 mm to 4 mm, or from 4 mm to 3.5 mm, from 3.5 mm to 3 mm, from 3 mm to 2.5 mm, or from 2.5 mm to 2 mm.

[0297] Patient interfaces 101 and 1101 of different sizes can be provided, and different fork sealing area sizes can be used for them.

[0298] The outlet of the fork cavity can be substantially circular. In some embodiments, the outlet of the fork cavity can be substantially elliptical. Those skilled in the art will understand that any suitable outlet shape can be used.

[0299] The nasal fork cavity may open outward at or near the cavity outlet. Examples of nasal fork cavities having an outwardly flared portion or alternative outlet shape at the outlet are shown in... Figure 13E and Figure 13H As shown in the image. Figure 13E As shown, the end of the fork 305 adjacent to the fork outlet 308 can be shaped to reduce the flow resistance of the fork 305. For example, the fork 305 can be cut horizontally or at an angle. This can reduce the flow resistance in the fork 305. Alternatively or additionally, when used with... Figure 13F When viewed from above interface 300 at the same or similar angle, fork exit 308 may have a roughly U-shape, such as Figure 13GAs shown. These features can help provide lower flow resistance during use and / or prevent accidental sealing of the fork outlet 308, which could lead to the user or clinician mistakenly determining that CPAP therapy should be delivered to the user. In some embodiments, the nose fork may have a thickness that varies circumferentially.

[0300] Base of the nose fork

[0301] The cannula body may have a basal region at and / or near the base of the nasal fork. This basal region may form part of the cannula body, where the base of the nasal fork intersects with the manifold. The basal region may be configured to allow movement of the manifold and / or housing while maintaining the nasal fork within the patient's nostril. The basal region helps provide patient comfort and compliance while also ensuring a flow path is maintained between the manifold and the nasal fork.

[0302] In some embodiments, the base region may allow the nose fork to bend in different directions without disrupting the gas flow path from the manifold to the fork outlet. For example, the base region may allow the fork to move relative to the housing / manifold without kinking. The base region may be used to separate the position of the fork, or each fork, from the position of the manifold / housing. In this way, the housing / manifold may be moved, for example, by forces applied to the interface by pulling the tube, facial movements, and / or gripping the interface, while securing the fork in the proper position within the nostril. The base region may also provide a spring mechanism that can operate to help compensate for external forces applied to or borne by the interface. The spring mechanism may also allow movement of the housing / manifold while helping to hold the fork in an operable (i.e., sealed) position within the nostril. In some cases, the base region may include grooves, recesses, channels, or any other mechanisms between the forks to provide sufficient clearance for the nasal septum.

[0303] This portion of the cannula body can be an alternation of material at or near the base of the fork and / or a specific shape of the base of the fork. For example, the base region can be a groove, a recessed or sunken area, a thinning of the nasal fork wall, the base or surrounding area of ​​the manifold, the shape of the nasal fork and / or manifold, and / or any other feature that can provide elasticity or compliance. Embodiments of the base region described herein can be used with any of the cannula body embodiments and / or nasal fork embodiments described herein.

[0304] In some embodiments, the manifold 3240 may have a base region, which may be a recessed or sunken region below and / or adjacent to the base of the fork 3220. For example, in Figures 10 to 12B In the illustrated embodiment, the manifold 3240 includes one or more recesses 3222 located below the fork 3220. The one or more recesses 3222 may support the fork 3220 relative to a surrounding portion of the manifold 3240. Figures 10 to 12B As shown, the groove 3222 may extend substantially around the base of each fork 3220 or at least partially around the base of each fork 3220. The groove 3222 facilitates the pivoting and movement of the forks 3220 around or relative to a portion of the manifold 3240. The ability of the forks 3220 to pivot at or near their base allows for a more efficient fitting and sealing of the forks 3220 into the patient's nostrils without disrupting airflow. The ability of the forks 3220 to bend or move relative to the manifold 3240 allows for separation of the position or orientation of the forks 3220 from the position of the manifold / housing. In other words, the housing / manifold can move while the forks 3220 are held in a sealed position in the nostrils.

[0305] The groove 3222 allows a single-sized fork to accommodate a wider range of nostril sizes. When the fork 3220 is inserted and fitted into the patient's nostril, the groove 3222 around each fork 3220 allows the fork 3220 to move back and forth or flex. This movement can be adjusted to accommodate changes in the size of the patient's face and philtrum. The groove 3222 also allows for lateral movement to accommodate changes in the size of the nasal septum and / or to help accommodate movements of the interface 3000, such as those caused by movement of the user's cheek. The recessed or recessed areas (such as the groove 3222) can further increase the effective length of the fork 3222, allowing for a greater degree of adjustability.

[0306] The manifold 3240 may have varying thicknesses in different areas. For example, at least a portion of the groove 3222 may be thinner relative to the fork 3220 and the rest of the manifold 3240, such as... Figure 14A As shown (where in Figure 14A and Figure 14B (The thinner material area of ​​the fork is shown in dark shading). The groove 3222 facilitates the movement of the fork 3220 to help maintain a seal with the patient's nostril. The groove 3222 also helps ensure that the fork 3220 is folded, bent, or flexed through the groove 3222 rather than collapsed into the manifold 3240 by one or more kinks in the fork, thereby maintaining the diameter and cross-sectional shape of the fork 3220 and / or maintaining the flow resistance (RTF) of the fork 3220.

[0307] like Figure 14AAs shown, the manifold 3240 may further include a thickened region 3249 adjacent to the groove 3222, shown by a lighter shaded region adjacent to the groove 3222. When the fork 3220 is placed in the user's nostril, the groove 3222, with its thinner wall, allows the fork 3220 to preferentially move or bend into the manifold 3240. In other words, when the fork 3220 is inserted into the nostril, at least a portion of the thinner wall of the groove 3222 can flex or deflect inward toward the manifold 3240. When in the flexed or deflected position, the groove 3222 can provide an upward force toward the user's nostril to maintain a sealed position. On the other hand, the thickened region 3249 can prevent the manifold 3240 from collapsing in the area surrounding the groove 3222, thereby maintaining the structural integrity of the cannula body 3200a. In the illustrated embodiment, the grooves 3222 are individually formed spaced apart from each other around each fork 3220.

[0308] In some embodiments, the groove or recessed area at the base of the fork 3220 may be continuous. Figure 14B A cannula body 3200a is shown, which has a recessed region 3223 extending continuously around the base of the two forks 3220. Similarly, using the groove 3222, the recessed region 3223 can have a reduced thickness relative to the forks 3220 and the rest of the manifold 3240, such as... Figure 14B As shown. The recessed area 3223 can provide greater flexibility to the forks 3220 than the grooves 3222 because there is no harder portion present between the forks 3220 as there is between the grooves 3222. Additionally, the recessed area 3223 can have a larger gap with the nasal septum, giving the cannula body 3200a a less chance of interfering with and / or damaging the nasal septum. The recessed area 3223 also makes cleaning of the cannula body 3200a easier due to the relatively absence of small cavities or spaces. The grooves or recessed areas can partially or completely surround the base of the forks. For example, the grooves or recessed areas can be on one or both sides of each fork to allow adjustment for the width of the nasal septum. The grooves or recessed areas 3222 at the base of the forks 3220 can allow spring-like movement at the base of the forks to separate the movement of the nose forks from the movement of the housing and / or manifold, and to secure the nose forks in the correct sealing position within the nostrils.

[0309] In some embodiments, the base region includes a thinner material region at and / or near the base of the nose fork. In some embodiments, the groove or recessed region may be absent. The thinner material region may surround or partially surround the base of each nose fork. The thinner material region may be formed partially or entirely in the base of the nose fork.

[0310] The wall thickness of the nose fork can vary from the base of the fork 309 to the outlet 308. For example... Figure 14CAs shown, when extending from the manifold, the wall at the base of the fork 309 may have a first thickness t1. As extending toward the outlet, the wall of the fork may have a second thickness t2. The first thickness t1 may be thinner than the second thickness t2. The first thickness t1 may be thinner than the material of the manifold surrounding the base of the fork 309. The thinner wall section t1 at the base of the fork 309, compared to the rest of the fork 309 and the manifold, allows for fork movement and patient compliance of the nasal fork. The thinner wall section at the base of the fork can achieve the same benefits described with reference to a groove or recessed area, but without the groove.

[0311] The cannula body 3200a can be constructed from a single material or a combination of materials. The cannula body 3200a can be constructed from a material with a Shore hardness between 20A and 100A. For example, the cannula body 3200a can have a Shore hardness between 20A and 90A, 40A and 100A, 40A and 90A, 50A and 80A, or 60A and 70A. The cannula body 3200a can be constructed from a silicone resin material. As described herein, the thickness ratio of this material can then be varied to achieve the desired stiffness in each region of the cannula body 3200a, such as the fork 3220, the groove 3222, and the recessed region 3223. The groove 3222 and the recessed region 3223 may have a thickness between 0.1 mm and 1.5 mm, 0.2 mm and 1.5 mm, 0.2 mm and 1.3 mm, 0.3 mm and 1.3 mm, 0.5 mm and 1.2 mm, or 0.5 mm and 1.0 mm. The walls of the fork 3220 and the thickened region 3249 may have a thickness greater than that of the groove 3222 and the recessed region 3223. For example, the walls of the fork 3220 and the thickened region 3249 may have a thickness between 0.3 mm and 2.0 mm, 0.5 mm and 2.0 mm, 0.6 mm and 2.0 mm, 0.3 mm and 1.8 mm, 0.5 mm and 1.8 mm, 0.6 mm and 1.8 mm, 0.7 mm and 1.8 mm, 0.6 mm and 1.5 mm, or 0.7 mm and 1.5 mm.

[0312] The fork 3220 extends from the manifold 3240 and can be shaped and configured to minimize tissue compression and kinking during insertion into the user's nostril. Figure 10As shown, each of the nose forks 3220 has a gas outlet 3224 configured to direct a flow of gas toward a user's nostrils. Each of the nose forks 3220 further includes an outer surface 3225. At least a portion of the outer surface 3225 is a sealing surface 3226. The sealing surface 3226 is configured to seal the user's nostrils. In one embodiment, the sealing surface 3226 is configured to seal against a nasal valve of the user's nose. The sealing surface 3226 may be configured to seal at or near the entrance of the user's nostrils. In another embodiment, the sealing surface 3226 is configured to seal between the nostril entrance and the nasal valve.

[0313] In some embodiments, the forks 3220 have a constant or substantially constant cross-sectional shape along their length. For example, each of the forks 3220 may have a circular or oval cross-sectional shape along its length. When the forks 3220 have a constant cross-section in the region at their distal end (i.e., the end adjacent to the outlet), the forks 3220 can compensate for minor movement in and out of the nostril, which can help maintain a seal. In some embodiments, the forks 3220 may have a varying shape along their length. For example, the forks 3200 may have a circular cross-section in the portion closer to the base, while the forks 3200 may have an oval cross-section in the portion closer to the top of the fork. The varying cross-sections at the portions of the fork may be similar to those referenced herein. Figures 13A to 13D The shape of the change described.

[0314] Figure 15A cannula body 3200a with a base region 3228 is shown, which can provide a spring-like action or mechanism at the base of the fork 3220. The base region 3228 can help separate the movement of the housing and / or manifold from the movement of the nose fork. The base region 3228 can provide the fork 3220 with the ability to flex around the base region 3228 while preventing kinking of the fork 3220. The fork 3220 can flex while maintaining its position in the nostril. For example, the base region 3228 can provide spring-like movement at the base of the fork 3220 and / or in the region surrounding the base of the fork 3220. The base region 3228 can apply a spring load to the fork to absorb some interface movement while maintaining the fork 3220 in proper position in the nostril. As an example, the base region can initially be in a neutral / relaxed position (i.e., the natural state of the cannula body) without any force applied to any part. When inserted into the nostril, the action of pushing the fork into place (and sealing it) can cause the base region 3228 to flex downwards or deflect into the manifold. The position of the fork in the nostril can remain constant, especially once the fork is in the sealed position. If the housing and / or manifold are pulled downwards and / or away from the face during use (e.g., by pulling the tube), the base region 3228 can move toward a neutral position. Sufficient elasticity can still be maintained in the base region 3228 to maintain the position of the fork in the nostril. For example, spring loads from the base region 3228 can absorb interface movements, such as cheek movements, patient movements, or headgear movements. The base region 3228 can assist the movement of the fork or each fork 3220 from right to left.

[0315] The base region 3228 can help accommodate changing nasal septal septum. The base region 3228 can allow one or both forks 3220 to flex back and forth to adjust for different facial geometries. Alternatively or additionally, the base region 3228 can provide upward pushing into the nostril to maintain a constant seal.

[0316] In some embodiments, the base region 3228 may be a region with reduced thickness. A region with reduced thickness may allow a spring at the base of the fork. The base region 3228 may have a reduced thickness relative to the rest of the fork 3220 and manifold 3240. The region with reduced thickness may be used in conjunction with or as an alternative to other base regions. For example, the base region 3228 may be a bellows region, which may allow a spring at the base of the fork by providing a bellows-like structure or construction at the base region. In another embodiment, as previously described, the nose fork may have a recessed or sunken region at the base of the fork 3220 to allow spring-like movement at the base of the fork.

[0317] Figure 15An embodiment of a base region 3228 at the base of the fork 3220 is shown. The fork 3220 may have a constant wall section of constant thickness that transitions to the base region 3228 around the fork, which allows for spring-like movement of the base of the fork. The fork may have a constant wall thickness throughout the fork up to the base region 3228. The constant wall thickness of the fork helps prevent kinking because the base region 3228 can absorb movement and deflection can be localized to the base region 3228.

[0318] In some embodiments, the fork 3220 may have a constant wall section of constant thickness that transitions toward a base region 3228 surrounding the fork. The base region 3228 may be thinner than the constant wall thickness of the fork 3220. The base region 3228 may also have a substantially constant thickness throughout the region. In some embodiments, the thickness of the fork 3220 may be between 0.3 mm and 2.0 mm, 0.5 mm and 2.0 mm, 0.6 mm and 2.0 mm, 0.3 mm and 1.8 mm, 0.5 mm and 1.8 mm, 0.6 mm and 1.8 mm, 0.7 mm and 1.8 mm, 0.6 mm and 1.5 mm, or 0.7 mm and 1.5 mm. The thickness of the base region 3228 can be between 0.1 mm and 1.5 mm, 0.2 mm and 1.5 mm, 0.2 mm and 1.3 mm, 0.3 mm and 1.3 mm, 0.5 mm and 1.2 mm, or 0.5 mm and 1.0 mm. For example, in one embodiment, the thickness of the fork 3220 can be 0.6 mm, and the thickness of the base region 3228 can be 0.3 mm. In this embodiment, the thickness ratio between the fork 3220 and the base region 3228 can be 1:0.5. The thickness ratio between the fork 3220 and the base region 3228 can be any other ratio that provides the desired transition therebetween.

[0319] As described herein, the thickness ratio of this material can be varied to achieve the desired stiffness of each region of the cannula body 3200a, such as the fork 3220, base regions 3223 and 3228, and the groove 3222 of the base region (described with reference to 14A) . For example, the base region 3228 may have a thickness between 0.1 mm and 1.5 mm, 0.2 mm and 1.5 mm, 0.2 mm and 1.3 mm, 0.3 mm and 1.3 mm, 0.5 mm and 1.2 mm, or 0.5 mm and 1.0 mm. The wall of the fork 3220, having a constant wall thickness, may have a greater thickness than that of the base region 3228. For example, the wall of the fork 3220 may have a section in which the fork transitions to a base region with a constant wall thickness, the section having a thickness between 0.3 mm and 2.0 mm, 0.5 mm and 2.0 mm, 0.6 mm and 2.0 mm, 0.3 mm and 1.8 mm, 0.5 mm and 1.8 mm, 0.6 mm and 1.8 mm, 0.7 mm and 1.8 mm, 0.6 mm and 1.5 mm, or 0.7 mm and 1.5 mm.

[0320] The base region 3228 may be a thin, localized area at the base of the fork that allows movement of the manifold and / or housing relative to the nasal fork. For example, when movement from the patient or external forces apply pressure to the fork, the base region 3228 may at least partially absorb the movement and / or force of the fork. The base region 3228 may accommodate or at least partially absorb the movement and / or force of the fork by flexing or deflecting inward. In some embodiments, the base region 3228 may have a larger gap with the nasal septum than the recess 3222, thus reducing the chance of the cannula body 3200a interfering with and / or damaging the nasal septum. The base region 3228 may also facilitate cleaning of the cannula body 3200a due to the relatively absence of small cavities or spaces.

[0321] Connection between the interface body and the housing

[0322] return Figures 10 to 12B The manifold 3240 may include a front portion 3241 opposite to the rear portion 3243. The front portion 3241 may include a housing connection portion 3244, which may be received by an interface body receiving portion 3480 of the housing 3240. The housing connection portion 3244 and the remainder of the manifold 3240 may be shaped and / or sized to be inserted into and received by the housing 3400 and to form an hermetically sealed connection. For example, the manifold 3240 may include ridges 3248 at each of the openings 3246. The ridges may be annular ridges 3248. The annular ridges 3248 may provide interference with the housing 3400, thereby forming an hermetically sealed connection with the housing 3400.

[0323] In the illustrated embodiment, manifold 3240 includes a protrusion 3242 that defines a raised surface relative to housing connection portion 3244 and the remainder of manifold 3240. The raised surface defined by protrusion 3242 may be discontinuous with the surface of housing connection portion 3244. In some embodiments, protrusion 3242 is formed at both an upper and lower portion of manifold 3240 such that housing connection portion 3244 is surrounded by protrusion 3242. In some embodiments, protrusion 3242 may be formed only at the upper or lower portion of manifold 3240. In some embodiments, protrusion 3242 may inhibit or prevent rotation of cannula body 3200a about housing 3400 when cannula body 3200a and housing 3400 are assembled, as described in further detail herein. In some embodiments, manifold 3240 may not include protrusion 3242 and may have a generally continuous outer surface adjacent to housing connection portion 3244. In some embodiments, manifold 3240 may include a strip or reinforcing member to increase the structural integrity of manifold 3240. For example, the strip or reinforcing member may be formed at least partially by a region that is significantly thicker than the rest of manifold 3240.

[0324] As discussed herein, the cannula body 3200a can be connected to the housing 3400 by inserting the housing connection portion 3244 of the manifold 3240 into the interface body receiving portion 3480. Figures 16 to 19 An embodiment of the cannula body 3200a assembled with the housing 3400 is shown. (See example...) Figures 16 to 17As shown, when the cannula body 3200a is connected to the housing 3400, the protrusion 3242 of the cannula body 3200a can be exposed. In the illustrated embodiment, the protrusion 3242 mates with the upper edge 3470 and / or the lower edge 3490 such that there is no gap between the protrusion 3242 and the upper edge 3470 and / or the lower edge 3490 when the cannula body 3200a is assembled with the housing 3400. In this embodiment, rotation of the cannula body 3200a around the housing 3400 can be prevented. In some embodiments, the protrusion 3242 and the upper edge 3470 and / or the lower edge 3490 can be shaped such that there is a certain amount of gap between them during assembly to allow a certain degree of rotation of the cannula body 3200a around the housing 3400. In some embodiments, the manifold 3240 does not include the protrusion 3242 to allow the cannula body 3200a to rotate more freely around the housing 3400, thereby enabling a greater degree of adjustment. In some embodiments, the protrusion 3242 may have a thickness similar to that of the housing 3400, such that the protrusion 3242 can form a continuous surface with the housing 3400. In some embodiments, the protrusion 3242 may have a thickness greater than or less than that of the housing 3400, such that the protrusion 3242 may protrude relative to the surface of the housing 3400 or be recessed relative to the surface of the housing 3400.

[0325] The protrusion 3242 can also aid in the visual alignment of the manifold 3240 relative to the housing 3400. For example, a user or clinician can align the protrusion 3242 with the upper edge 3470 and lower edge 3490 of the housing 3400 to assemble the manifold 3240 in the correct position. In some embodiments, the manifold 3240 and / or housing 3400 may include auditory and / or tactile indicators to provide feedback when the manifold 3240 and housing 3400 are in the correct position. For example, the manifold 3420 and / or housing 3400 may emit a “click” sound when it is correctly positioned and properly assembled. In some embodiments, the manifold 3420 and / or housing 3400 may include a visual indicator that indicates when the manifold 3420 and / or housing 3400 are correctly positioned and properly assembled. In some cases, the visual indicator may be a color indicator. Color indicators can be used with transparent parts of the manifold and / or housing. Examples of color indicators are referenced in this article. Figures 56A to 56F Further description.

[0326] When assembling the housing 3400 and the manifold 3420, the housing 3400 may only contact the manifold 3420 and may not interfere with the fork 3220. In some embodiments, the recessed area 3223 or the groove 3222 may be fully or partially exposed, and the movement of the fork 3220 may not be interfered with by the housing 3400.

[0327] Figure 20 A to Figure 20 B demonstrates how the manifold 3240 can be secured within the housing 3400. For example... Figure 20 A to Figure 20 As shown in Figure B, the inner surface of the housing 3400 can mate with the manifold 3240, thereby securing the manifold 3240 within the housing 3400. Figure 20 A to Figure 20 As shown in Figure B, the opening 3246 of the manifold 3240 can be secured within the pipe engagement portion 3460 of the housing 3400 to receive the interface pipe. In some embodiments, an annular ridge 3248 at each opening 3246 of the manifold 3240 can provide interference with the housing 3400, thereby forming an airtight seal with the inner surface of the housing 3400.

[0328] mask body

[0329] Figures 22A to 22B An embodiment of the mask body 3200b is shown. In the illustrated embodiment, the mask body 3200b includes a manifold 3240, which is identical or similar to the manifold 3240 of the cannula body 3200a. For example, the manifold 3240 includes a combination... Figures 10 to 1 3 describes the protrusion 3242, the housing connection portion 3244, the opening 3246, and the annular ridge 3248. The manifold 3240 can be connected to the housing 3400 in substantially the same manner as described with respect to the manifold 3240 of the cannula body 3200a. As described herein, the mask body 3200b, including a manifold identical or similar to that of the cannula body 3200a, allows for the interchange of the cannula body 3200a and the mask body 3200b while keeping the housing 3400 unchanged.

[0330] In the illustrated embodiment, the mask body 3200b further includes a mask 3232 or mask cushion extending rearward from the manifold 3240. The mask 3232 can be applied to the patient's face. In the illustrated embodiment, the mask 3232 is a nasal mask. The nasal mask can form a nasal seal applied to the patient's nose. The nasal mask can surround the patient's nostrils to form a seal on or around the nose. In some embodiments, the mask 3232 can cover both the patient's nose and mouth.

[0331] The face mask 3232 or face mask cushion includes a facial contact surface 3234. The facial contact surface 3234 may have an inner peripheral edge 3235 that defines a nasal receiving opening through the face mask cavity 3236 for receiving the user's nose in use. In some embodiments, the facial contact surface 3234 is positioned substantially opposite to the manifold 3240. In use, the contact surface 3234 of the face mask 3232 may enclose or restrict a portion of a defined nostril of the user's nose. The contact surface 3234 may sealably engage around the user's nose, such as a cheek surface and / or lateral side surface abutting the user's nose, an upper lip region below the user's nose, and one or more of a region across the bridge of the nose or the tip of the user's nose.

[0332] The mask 3232 may be substantially hollow and is generally shaped to provide or define a mask cavity 3236. The mask cavity 3236 may receive a gas flow from the manifold 3240. The mask cavity 3236 may be fluidly connected to the manifold 3240 and the opening 3246, such that gas from and to the patient flows through the mask cavity 3236.

[0333] Figure 23 A schematic diagram of the face mask body 3200b is shown from the face contact side or rear side. In some embodiments, such as Figure 23 As shown in the striped area, a region 3237 (“roll-up region”) can be provided for the face mask 3232. Region 3237 can be designed such that at least a portion of region 3237 is configured to roll up onto the outer surface of the face mask 3232. The roll-up region 3237 may extend at the upper and / or side portions of the face mask 3232. The roll-up region 3237 may include at least a portion of or work in conjunction with the facial contact surface 3234. The roll-up region 3237 can help relieve pressure applied to the user’s nose and / or face, which is required to provide a seal sufficient for therapeutic delivery.

[0334] To facilitate the roll-up of region 3237, region 3237 may have varying thickness or varying stiffness. Region 3237 may be formed by and / or coexist with regions of reduced stiffness. In some embodiments, the wall thickness of mask 3232 may be substantially constant over the entire roll-up region 3237. In some embodiments, the wall thickness of mask 3232 may vary or alternate between relatively thick and relatively thin regions. The wall thickness of mask 3232 may be relatively thick along other portions of the mask, thereby providing support for the structure of mask 3232. However, other arrangements may also be used to induce or facilitate the roll-up of roll-up region 3237. Examples of mask seals including roll-up portions are disclosed in WO 2014 / 062070, the entire contents of which are incorporated herein by reference.

[0335] In some embodiments, the lower or base portion 3256 of the face mask 3232 may have a region with greater thickness / stiffness, which may allow for greater structural stability of the face mask. For example, the base or a portion thereof may be formed at least partially by a region with significantly increased thickness relative to the region with reduced stiffness. This base portion 3256 may have a greater thickness relative to the face contact portion of the face mask.

[0336] The base portion 3256 may be formed of the same material as the material forming the face mask 3232. A region of the base portion with increased thickness may be configured as a thickened band. The base portion 3256 may be positioned on the lower or bottom portion of the face mask below the roll-up region 3237. When the face mask is applied to a patient's face, the face mask may pivot at or around the base portion or the thickened band as the roll-up region is rolled up under force. In other arrangements, the base portion may be or include a component formed of a material with increased stiffness relative to the silicone or other material forming the face mask 3232. This can aid in inserting and removing the face mask 3232 into and from the housing 3400 during use and maintain a seal.

[0337] The face mask body 3200b can be constructed from a single material or from two or more different materials. The face mask body 3200b can be constructed from silicone resin. The face mask body 3200b can be constructed from a material with a Shore hardness between 15A and 80A. For example, the face mask body 3200b can have a Shore hardness between 15A and 80A, 20A and 80A, 30A and 80A, 40A and 70A, or 40A and 60A. As described herein, the thickness ratio of this material can then be varied to achieve the desired stiffness in each region of the face mask body 3200b.

[0338] In some embodiments, masks 3232a of various or alternative shapes or sizes may be provided to achieve the desired fit to achieve comfort, compliance and / or efficient delivery of therapy. Figure 24A The mask 3232a shown is related to Figures 22A to 23 The mask 3232 is similar to the one described; however, the mask 3232a can have a different shape. The mask 3232a can have a first end 3252 extending from the first annular ridge 3246 to the second end 3254 extending from the second annular ridge 3246 (in...). Figure 22A The width is measured (as shown in Figure 24). The mask 3232a may have a horizontal axis extending along this width and a vertical axis perpendicular to the horizontal axis. As shown in Figure 24, the mask 3232a may be longer in the vertical direction than the mask 3232 described herein. This shape allows the mask 3232a to be longer than those shown in Figures 22 to 24. Figure 23The mask 3232 shown provides a further upward seal on the user's nose bridge. This configuration may be more comfortable for the patient. Additionally, a higher seal on the user's nose bridge minimizes the risk of obstructing the patient's airway or otherwise affecting the flow of air in or out of the patient's airway, particularly in infants. For example, by configuring the mask to seal higher on the bridge of the user's nose or on a firmer part of the nose rather than on a softer, fleshier part closer to the tip of the nose, the risk of obstructing or affecting the flow of air in or out of the patient's airway can be minimized.

[0339] Mask roll-up area

[0340] When the mask 3232 is placed on the user's face during use, the contact surface 3234 may be located on the bridge of the nose, the sides of the nose, and above the user's upper lip. With a positive pressure air supply, the contact surface 3234 may expand and seal against the user's face. Leakage may occur if the sealing contact pressure between the contact surface 3234 and the user's face is less than the pressure of the supplied air. For successful delivery of the therapy, the pressure of the mask contact surface 3234 should be higher than the air pressure around the periphery of the contact surface 3234 forming the mask seal.

[0341] Face mask 3232a may include, as per the above Figures 22A to 23 The described roll-up area 3237. In some embodiments, the roll-up area may roll up or bend to allow the mask to adapt to facial movement or apply force to the mask. For example, roll-up aspects at the sides of the mask and pivot points at the base of the mask may allow the mask to adapt to facial movement or apply force to the mask. This may allow the mask to maintain the integrity of the seal between the mask and the patient. The thickness of the roll-up area 3237 is designed to reduce pressure on the bridge of the nose. In some embodiments, the roll-up area 3237 is present at the sides of the mask and may allow the mask to compress into the nasolabial folds to increase contact between the patient and the mask to form a seal around the nose. For example, this may be used to accommodate cheek movement. In some embodiments, even if the cheek is compressed, the roll-up area 3237 may also allow the mask to form a seal in the folds between the nose and cheek. For example, the cheek may be compressed during side sleeping or lateral positioning, such as during chin strap use.

[0342] To facilitate rolling or bending, region 3237 can have varying thickness or varying stiffness. For example... Figures 24B to 24E In the configuration shown, region 3237 includes a thin / thick / thin configuration. Figures 24B to 24EA face mask body 3200b is shown, wherein the face mask 3232b has reduced or thinner regions 3237b and 3237c, which allow the face mask 3232b to be rolled up, bent, or folded. In the illustrated embodiment, the thin region 3237c is configured to be rolled up or bent over the relatively thicker or stiffer front portion 3238 of the face mask 3232b.

[0343] Figures 24B to 24E A mask body 3200b is shown, wherein the mask 3232b has thin regions 3237b and 3237c that allow the mask 3232b to bend or fold. The mask 3232b may have a region 3237b with reduced stiffness at the patient contact surface to conform to the patient's face. Alternatively or additionally, the mask 3232b may have a region 3237c with reduced stiffness and / or thickness at the roll-up regions (top and sides of the mask) to enable roll-up movement with a flat force-displacement curve. Figure 24B and Figure 24C The crosshairs in the diagram show regions 3237b and 3237c, which are segments of the mask 3232b with reduced stiffness. Reduced stiffness can be provided by decreasing the thickness or thinning of these regions relative to adjacent or other parts of the mask. Therefore, these regions 3237b and 3237c allow for greater bending and flexibility relative to thicker or stiffer portions of the material.

[0344] The reduced stiffness of regions 3237b and 3237c can be achieved by forming a thin material in these sections. The patient contact surfaces of regions 3237b and 3237c are... Figure 24B and Figure 24C As shown in the diagram, the varying stiffness of the region can create hinge points or pivot points that can guide the movement of the mask 3232b. In the illustrated embodiment, the hinge point or pivot point is located at or near the base of the mask 3232. When the mask cushioning is compressed, such as when the mask 3232 is pushed toward the patient's face during use, region 3237c can roll forward from the pivot point or hinge point at or near the base of the mask 3232. Region 3237c can roll up or bend over the relatively thicker or stiffer front portion 3238 of the mask 3232b. Therefore, region 3237c can be referred to as roll-up region 3237c. When the mask is used with or without a midline fixing member, the pivot point or hinge point can remain at the base of the mask.

[0345] The face shield 3232b may have a reinforcing structural portion 310 between the two regions 3237b and 3237c. The reinforcing structural portion 310 may be stiffer or formed of a thicker material than regions 3237b and 3237c. The structural portion 310 may be continuous or uninterrupted around the circumference of the face shield. The structural portion 310 may extend partially around the circumference of the face shield. In, for example... Figure 24C In the illustrated embodiment, structural portion 310 may extend around the sides and top of the face mask. Structural portion 310 may be a strap. The strap may be located around the sides and top of the face mask.

[0346] A stiffer or thicker structural portion 310 or band may gradually transition into the remainder of the rolled-up area. In other words, the structural portion 310 or band may gradually transition into areas 3237b and / or 3237c. This can improve comfort because it reduces the likelihood of the band or other relatively stiff sections coming into contact with the user's skin and / or bridge of the nose, which could occur if the thickened sections did not have a gradual transition. In some embodiments, the gradual transition of the structural portion 310 into the remainder of the rolled-up area 3237 may also improve ease of cleaning. In some embodiments, the structural portion 310 may gradually transition into the remainder of the rolled-up area 3237.

[0347] In some situations, such as under higher pressure, structural portion 310 can help prevent the mask from inflating. Structural portion 310 can also help prevent folds or creases in the thin material sections of regions 3237b and 3237c, which helps keep region 3237b conforming to the patient. In some embodiments, structural portion 310 can make cleaning of mask 3232b easier.

[0348] The mask 3232b and area 3237c can be designed to roll up or bend at the top and sides of the mask. Rolling up at the top is designed to reduce pressure on the bridge of the nose and better accommodate a range of patient facial geometries. Rolling up at the sides is designed to allow the mask to sink down into the cheek (nasolabial fold) crease and achieve sufficient contact to form a seal. Rolling up at the sides allows the mask to sway from side to side while maintaining a seal, thereby reducing the likelihood of lateral forces dislodging the seal (e.g., in a lateral position). In some cases, cheek creases can be increased by patient positioning, the use of a chin strap, and / or tension applied to other patient fixation mechanisms or devices.

[0349] Structural portion 310 may blend at the front or patient-facing side of the face mask 3232b, such that the area 3237b in contact with the patient buckle should not have a hard edge. Blending on the opposite or non-patient-facing side of structural portion 310 may be less necessary. However, in some cases, structural portion 310 may blend on both sides of structural portion 310. Structural portion 310 may be positioned to influence the force-displacement curve of the rolled-up area at the top and / or sides. For example, the force curve may be relatively flat as thin material rolls up in a section with decreasing stiffness until the thickness of the rolled-up material begins to increase (suddenly or gradually). The increase in the thickness of the rolled-up material can then cause the force-displacement curve to slope upwards. Gradual thinning or decreasing stiffness of structural portion 310 can be used to allow the rolled-up area to roll up a certain distance before slowly resisting displacement, rather than transitioning from low to high force when the rolled-up area stops rolling up.

[0350] The mask 3232b can be rolled up at the side and pivoted at or near the base of the mask. For example... Figure 24B As shown, the rolled-up area 3237c can be positioned around point 312 at the base of the mask 3232b. The material thickness of the wall at the base of the mask 3232b can increase or decrease as it moves away from point 312 toward the rear of the mask. Figure 24B As shown, a region 3237c with reduced stiffness can extend inward and rearward from point 312, allowing the face mask 3232b to roll up at point 312 and further inward hinge. This configuration allows the sides of the face mask 3232b to be displaced or rolled up more easily when a force is applied to it. In some embodiments, the face mask may have a rolled-up region or region 3237c that extends around the entire circumference of the face mask 3232b. In some embodiments, the face mask may have a thickened or stiffened base that may add structure to, for example, prevent the face mask from folding laterally.

[0351] To aid stability, it may be useful to attach an interface retention or stabilization device (e.g., a headgear) near the pivot point. Figures 24B to 24C As shown, the base of region 3237c is slightly triangular, but in some embodiments, the rolled-up region can be more rounded.

[0352] In some embodiments, the stiffness-reducing section of the material may have a thickness of approximately 0.5 mm or less. The stiffness-reducing section may have a thickness of 0.8 mm or less, 0.7 mm or less, 0.6 mm or less, 0.5 mm or less, 0.4 mm or less, or 0.3 mm or less. In some embodiments, the thickness ratio of the structural portion 310 to the stiffness-reducing section may be approximately 20:1, 15:1, 10:1, 5:1, 2:1, or 1.5:1.

[0353] The mask 3232b can help create a seal, and the sealing contact pressure between the face contact surface 3234 and the patient is sufficient to prevent leakage. The sealing contact pressure can be applied to the skin at the nasal bone, and the area 3237b at the top of the mask 3232b can contact the patient's skin.

[0354] The face mask 3232a can be used in conjunction with one or more fixation members to provide stability of the face mask on the user. The face mask 3232b can be used with a midline fixation member applied to the patient's forehead (e.g., reference...). Figures 33 to 35 and Figures 40 to 47 The described retaining member is used in conjunction with the mask. When the mask is sealed, this retaining member can compress the rolled-up area, and the contact pressure can be higher than the delivered air pressure. Regions 3237b and 3237c can reduce compression on the bridge and / or sides of the nose while still achieving a proper seal and stability of the mask 3232b.

[0355] The roll-up area of ​​the mask 3232b can be rolled up on the sides and at the top. Figure 24D and Figure 24E The movement of the mask 3232b as it is rolled up at the sides and top is shown. Figure 24D This is a top cross-sectional view of the nose connector. Figure 24D The top cross-sectional view of the nose interface shown illustrates the side roll-up of the mask 3232b (indicated by dashed lines and moving in the direction of the arrows). Figure 24D As shown, when regions 3237b and 3237c are compressed by a force acting on one side of the mask 3232b, the mask 3232b pivots at point 312. During the pivoting of the mask, region 3237c bends or rolls up on the front surface 3238 of the mask. Figure 24E This is a side cross-sectional view of the nose connector. Figure 24E The side cross-sectional view of the nose interface shown illustrates the top roll-up of the mask 3232b (indicated by dashed lines and moving in the direction of the arrows). Figure 24E As shown, when region 3237c bends or rolls forward by a force acting on the front top portion of mask 3232b (as indicated by the arrow), mask 3232b is hinged at the base of the mask.

[0356] The side rolls of the mask allow for a compliant seal at the sides by letting the mask settle into the nasolabial folds. The side rolls also help accommodate cheek movement.

[0357] Entry and exit points

[0358] In some embodiments, the interface body may have lateral inlet and outlet points to the mask chamber or nose fork, allowing gas flow to enter the interface body from conduits at each end of the housing. Lateral gas flow into and out of the interface body can result in greater CO2 removal compared to a mask or fluid interface with inlet and outlet points located in the middle or top of the mask. Additionally, lateral inlet and outlet points for gas flow can reduce inefficient space outside the flow path within the interface body. In some embodiments, the housing is configured such that gas can enter and / or exit the interface body substantially in a straight line with the horizontal axis of the housing and / or interface body. In some embodiments, the ends of the housing at or near the inlet / outlet points may be substantially bent downwards or extended. In this embodiment, the inlet / outlet points can guide gas laterally but at an angle offset from the horizontal into the interface body.

[0359] Fixed components

[0360] Figure 25 and Figure 26 An embodiment of a patient interface 3000 assembled to form a nasal cannula interface is shown. In the illustrated embodiment, the patient interface 3000 includes a cannula body 3200a, a housing 3400, a first fixing member 3600, and an interface tube 3800. Figure 25 As shown, the first fixing member 3600 includes a central portion 3610, a support pad 3660, and a bridging portion 3630 extending between the central portion 3610 and the support pad 3660. Figure 25 and Figure 26 As shown, the bridging portion 3630 can be positioned on the opposite side of the central portion 3610. A support pad 3660 can extend laterally outward from the bridging portion 3630. In some embodiments, the first fixing member 3600 may include a single support pad 3660 extending from a single bridging portion 3630. In some embodiments, the first fixing member 3600 may include more than one support pad 3660 extending from the bridging portion 3630 on the outer periphery of the central portion 3610. In some embodiments, the first fixing member 3600 may include a pair of support pads 3660. Each support pad 3660 in the pair may extend from the bridging portion 3630 at the opposite end of the central portion 3610, as shown... Figure 25 and Figure 26 As shown.

[0361] like Figures 25 to 26As shown, the central portion 3610 may have a generally low profile. The central portion 3610 may have a small thickness to allow it to extend outward from the patient's face with minimal deviation. In some embodiments, the central portion 3610 may have a generally planar shape. In some embodiments, the central portion 3610 may have a generally rectangular shape. In some embodiments, the central portion 3610 may be generally curved. In some embodiments, the central portion 3610 may bend outward from the patient's face generally during use. In some embodiments, the central portion 3610 is permanently or semi-permanently connected to the bridging portion 3630. In some embodiments, the central portion 3610 and the bridging portion 3630 are integrally formed as a single piece. In some embodiments, the central portion 3610, the bridging portion 3630, and the support pad 3660 may be integrally formed as a single piece. For example, the central portion 3610, the bridging portion 3630, and the support pad 3660 can be molded as a single piece from a single material, co-molded or overmolded as a single piece from different materials, welded (e.g., ultrasonic welding, thermal welding), or otherwise attached by any suitable method to form a single piece. In some cases, ease of manufacture can be improved if the central portion 3610 and the bridging portion 3630 are formed separately and then assembled or joined. In some embodiments, the first fixing member 3600 and the second fixing member 3900 can be integrally formed.

[0362] When the patient interface ( For example When the patient interface 3000 is worn by the user, the support pad ( For example The support pad 3660 can be placed directly or indirectly on the user's face. For example, the support pad 3660 can be secured to the user's face directly or indirectly by external force, such as using adhesive bonding, headgear arrangement, hook or loop connections as discussed above, or another suitable support structure, such as any of those described herein. In some arrangements, the support pad 3660 can be attached to a headgear and / or chin strap to secure the interface body. In some embodiments, the support pad 3660 can be attached to one or more face pads or skin patches. The face pads or skin patches can have a patient side and an interface side. The interface side can have a first fastening element. The first fastening element can be removably coupled or attached to a complementary fastening element on the patient side of the support pad 3660. In some embodiments, the support pad 3660 can include a tab 3666 at either end of the support pad 3660 to aid in positioning and / or removing the support pad 3660 and / or the first fixation member 3600.

[0363] Therefore, when the user's face moves, the bridging portion (e.g., bridging portion 3630) connected to the support pad can move or deflect. For example, when a portion of the user's face on which the support pad rests moves, this external force or movement can be transmitted to the bridging portion 3630, then to the central portion (e.g., central portion 3610), and finally to the housing (e.g., housing 3400) and the interface body (e.g., cannula body 3200a, mask body 3200b). In some cases, the bridging portion itself can move or deflect when an external force is applied to it. Therefore, it is desirable that the bridging portion be configured such that the interface body maintains its seal with the user even when the user's face and / or the support pad moves. In some configurations, a deformable configuration of the bridging portion 3630 provides a degree of separation between the support pad 3660 and the interface body. Preferably, the deformation of the bridging portion 3630 at least reduces or may eliminate the disruption of the seal between the interface body and the user's face due to movement of the user's cheeks or external forces applied to the user's face. Additionally, the deformation of the bridging portion of the fixing member can work in conjunction with the roll-up area of ​​the mask to maintain the seal between the interface body and the user's face.

[0364] In some embodiments, the first fixing member 3600 can adapt to movement of the patient's face, wherein one or more hinge points are located further outward from the surface of the patient's face compared to the position of the support pad 3660. Figure 25 and Figure 26 As shown, hinge point 3662 may be located at the portion of the first fixing member 3600 where the first fixing member 3600 is connected to the housing 3400. In some cases, hinge point may be located at the connection between bridging portion 3630 and the central portion 3610 of the first fixing member 3600. In some embodiments, such as shown in FIG. 39, bridging portion 3630 may help maintain torsional stability and prevent or minimize movement of the central portion 3610 and the manifold relative to each other.

[0365] In some embodiments, the bridging portion 3630 or the entire first fixation member 3600 is made of a flexible material, such that the bridging portion 3630 is flexible or deformable, as described above. In some embodiments, the bridging portion 3630 is made of the same material as the central portion 3610, which is assembled or integrally constructed. In some embodiments, the first fixation member 3600 may be made of one or more elastomeric materials, such as silicone, rubber, polyethylene, etc. In some embodiments, the first fixation member 3600 may be made of a single material. In some embodiments, the first fixation member 3600 may be made of two or more materials, such that regions of the bridging portion 3630 have different flexibility relative to other regions. In some embodiments, at least one region of the bridging portion 3630 may be made of a flexible but stretchable material, such that the bridging portion 3630 is sufficiently rigid to resist torsional forces while being compressible. This can help minimize the translation of force and / or movement from the patient's cheek to the sealing area. In some embodiments, the first fixing member 3600 may be constructed of the same material as the interface body (e.g., cannula body 3200a, mask body 3200b) and / or housing 3400.

[0366] The patient-facing side of the support pad 3660 may have fastener elements to allow direct attachment to the face (e.g., adhesive) or indirect attachment to a headgear or patient interface patch or skin patch that may have complementary fastener elements on the non-patient-facing side. The user-facing surface 3680 of the support pad 3660 may initially be provided without a user interface patch or skin patch. Surface 3680 may receive or retain the patient interface patch or skin patch. Such a patient interface patch may be attached to surface 3680 by adhesive or other suitable connections as known in the art, such as by hook-and-loop fasteners, ultrasonic welding, and / or co-molding or overmolding. Once the support pad patch is in place, it can be attached to or receive the skin patch. Alternatively, the patient interface patch may be assembled to surface 3680 of the support pad 3660 using the same operation as molding a face pad. In some embodiments, the user-facing surface 3680 is configured such that it does not cause excessive abrasion or disturbance on the patient's face. For example, the user-facing surface 3680 will include a ring material of a hook-and-loop mechanism, while the user interface patch or skin patch will include a hook material of a hook-and-loop mechanism. In some embodiments, the user-facing surface 3680 engages a fastening mechanism other than a skin patch, such as a headgear, chin strap, or hat.

[0367] In some embodiments, the first retaining member 3600 may be coupled to the housing 3400 by coupling a central portion 3610 to the housing 3400. The first retaining member 3600 may have a mechanism or attachment portion that can be held in place by the housing 3400. For example, the first retaining member 3600 may include a central opening 3620. The central opening 3620 may be coupled to one or more attachment elements of the housing 3400. For example, the central opening 3620 may be coupled to one or more front extensions 3420 and / or a central protrusion 6440 of the housing 3400. The central opening 3620 may be sized and shaped to receive and hold one or more attachment elements of the housing 3400, such as the front extensions 3420. For example, the central opening 3620 may be sized and shaped to hold at or around a ridge 3422. In some embodiments, the first retaining member 3600 may be detachably coupled to the housing 3400. In some embodiments, the first retaining member 3600 may be coupled to the housing 3400 using a clamp. In some embodiments, the first fixing member 3600 may be permanently coupled to the housing 3400. In some embodiments, the first fixing member may not have a central portion 3610 and / or a bridging portion 3630, and may include a support pad 3600 that is detachably or permanently coupled directly to the housing 3400 or the interface body.

[0368] In some embodiments, the bridging portion 3630 may include a cutout 3640. The cutout 3640 may be positioned to allow an interface tube (such as interface tube 3800) to pass through the first retaining member 3600. In some embodiments, the bridging portion 3630 or any other area of ​​the first retaining member 3600 may include mechanisms for further securing the interface tube 3800 to facilitate or assist in the management of the interface tube 3800. For example, the bridging portion 3630 may include a hook-and-loop fastener or adhesive at the cutout 3640, which may be detachably attached to the interface tube 3800.

[0369] In some embodiments, the first fixing member 3600 may be constructed of a fabric material. Figures 27 to 28 An embodiment of a first fastening member 3600 constructed of fabric material is shown. In addition to those described herein, the first fastening member 3600 constructed of fabric material can be used with respect to… Figures 25 to 26 The first fixing member 3600 described is similar. For example, the first fixing member 3600 may include a central opening 3620 for engagement with the housing 3400. The first fixing member 3600 may include one or more cutouts 3640 to allow the interface tube 3800 to pass through. Figures 29 to 30 The first fixing member 3600 connected to the housing 3400 is shown.

[0370] Figures 31 to 32A schematic cross-sectional view of the fabric of the first fixation member 3600 is shown, illustrating its multilayer structure. The multilayer structure may include one or more mechanical fastener substrates sandwiched between a pair of membrane layers. In the illustrated embodiment, an uninterrupted ring material 3695 and a nylon ring material 3696 may be sandwiched between two outer thin laminated membranes 3694, 3697. Laminated membranes 3694, 3697 may allow for easier cleaning and maintenance of the first fixation member 3600. Laminated membranes 3694, 3697 may help reduce the amount of moisture and other materials that the fabric of the first fixation member 3600 may absorb. In some embodiments, the laminated membrane 3694 on the patient-facing side may be interrupted at the exposed area 3691 to expose a portion of the uninterrupted ring material 3695. Figure 30 The diagram also shows an exposed area 3691. The exposed uninterrupted ring material 3695 at the exposed area 3691 can be attached to a corresponding hook material on a user's face, headgear, or chin strap to secure the patient interface 3000. In some embodiments, the molded uninterrupted ring material 3695 and nylon ring material 3696 can be overlaid with an elastomeric layer (e.g., thermoplastic elastomer) instead of being laminated with nylon membranes 3694, 3697. Nylon membranes 3694, 3697 can provide stiffness to the first fixation member 3600. Nylon membranes 3694, 3697 can form a non-stretchable area 3692, which can contribute to the stability and support of the patient interface. In some embodiments, the first fixation member 3600 may include a tab 3693 at either end of the first fixation member 3600 to aid in positioning and / or removing the first fixation member 3600. The tab 3693 may be located near the exposed portion 3691. In some embodiments, the first fixing member 3600 may further include foam material 3698, such as Figure 32 As shown. Foam material 3698 may be located between uninterrupted ring material 3695 and nylon ring material 3696. In some embodiments, the first fixation member 3600 may be cut from a prefabricated multilayer fabric, for example, by punching. In some embodiments, the first fixation member 3600 may include perforated tape, such that the first fixation member 3600 can be cut or torn at certain locations to size the first fixation member 3600 for the patient.

[0371] Figures 33 to 35 An embodiment of the second fixation member 3900 is shown. In the illustrated embodiment, the second fixation member 3900 includes a connecting portion 3910, a support pad 3980, and a bridging portion 3930 extending between the connecting portion 3910 and the support pad 3980. The support pad 3980 may be a forehead support pad. When the patient interface 3000 is used on the user's face, the second fixation member 3900 may extend substantially vertically.

[0372] The connecting portion 3910 may be attached to or be attached to the housing 3400 to connect the second fixation member 3900 to the patient interface 3000. In some embodiments, the connecting portion 3910 includes a hole or recess 3912. The hole or recess 3912 may be configured to receive a central protrusion 3440 such that the connecting portion 3910 is attached to the housing 3400. In some embodiments, the connecting portion 3910 and / or the housing 3400 may be configured such that rotation of the second fixation member 3900 about the housing 3400 is suppressed. For example, the outer periphery of the connecting portion 3910 may be polygonal and embedded between the central protrusion 3440 and the front extension 3420 such that the front extension 3420 suppresses rotation of the connecting portion 3910. In some embodiments, the second fixation member 3900 may be configured such that it can rotate about the housing 3400. In some embodiments, the central protrusion 3400 may be symmetrical such that the housing 3400 may be symmetrical, as described herein. In some embodiments, the second fixing member 3900 may be coupled to the housing in an upward or downward direction. In some embodiments, the second fixing member 3900 may be applied in other orientations, such as lateral or any angled orientation.

[0373] In some embodiments, the second fixation member 3900 may be detachably attached to the housing 3400. In some embodiments, the second fixation member 3900 may be permanently attached to the housing 3400. The second fixation member 3900 may be overmolded and / or formed integrally with the housing 3400. In some embodiments, the second fixation member 3900 may be detachably or permanently coupled to an interface body, such as a cannula body 3200a and a mask body 3200b. In some embodiments, the second fixation member 3900 may be detachably or permanently coupled to the first fixation member 3600. In some embodiments where the second fixation member 3900 is integral with the first fixation member 3600, the second fixation member 3900 may include a perforated band such that the second fixation member 3900 can be cut or torn from the first fixation member 3600. In some embodiments, the first fixation member and / or the second fixation member may be integral with a patient's headgear.

[0374] The support pad 3980 can be configured to rest directly or indirectly on the user's face. For example, when the patient interface 3000 is worn by the user, the support pad 3980 can be positioned at or on the forehead. For example, the support pad 3980 can be secured to the user's forehead directly or indirectly by external force, such as using adhesive bonding, headgear arrangement, hook or loop connections as discussed above, or another suitable support structure, such as any of those described herein. In some arrangements, the support pad 3980 can be attached to the headgear and / or chin strap to secure the interface body.

[0375] In some embodiments, the second fixing member 3980 may be constructed of a fabric material. The fabric material may be related to... Figures 31 to 32 The fabric material described. In some embodiments, the second fixation member 3980 may be constructed of a rigid material, such as thermoplastic or a combination of materials. In some embodiments, for example, if the second fixation member 3980 is integrally formed with the housing, the second fixation member 3980 may be constructed of the same material as the housing. In some embodiments, the second fixation member 3980 may be constructed of one or more elastomeric materials, such as silicone, rubber, polyethylene, etc. In some embodiments, the second fixation member 3900 may include perforated straps, allowing the second fixation member 3900 to be cut or torn at certain locations to adjust the size of the second fixation member 3900 for the patient.

[0376] Additional examples of patient interface components

[0377] Figure 36 An embodiment of the patient interface component 4000 is shown. For example... Figure 36 As shown, the patient interface assembly 4000 includes: an interface body 4200 that can form a seal with at least a portion of a user's airway and allow gas to flow out of and to the user; and a housing 4400 that can be coupled to the interface body 4200. In some embodiments, the interface body 4200 is an intubation body, such as... Figures 3 to 4 and Figures 10 to 21 The cannula body 3200a shown, or the mask body, such as Figures 5 to 6 The mask body 3200b is shown in Figures 22 to 24. The cannula body 3200a can form a seal with one or both nostrils of the user's nose. The mask body 3200b can form a seal with the user's nose, mouth, or both nose and mouth. Figure 36 In the illustrated embodiment, the mask body 3200b is a nasal mask. The cannula body 3200a and the mask body 3200b can be interchangeably coupled to the housing. The illustrated embodiment of the patient interface 4000 also includes a first fixation member 4600, one or more interface tubes 4800, and a second fixation member 4900. The components and features described in these embodiments of the patient interface assembly 4000 can be used with any embodiment of the patient interface assembly and the components of the previously described patient interface assembly.

[0378] In some embodiments, the interface housing includes a horizontal axis extending from a first tube engagement portion to a second tube engagement portion on the opposite end of the housing. In some embodiments, the interface tube may engage with the housing at the tube engagement portion and may extend laterally outward from the tube engagement portion along the horizontal axis, such as... Figure 36 As shown. In other embodiments, the interface tube may engage with the housing at the tube joint and may be offset downwards or angled away from the horizontal axis of the housing. In this embodiment, the first fixing member may be positioned above the tube, in contrast to the tube passing through it.

[0379] In some embodiments, the first fixing member 4600 and / or the second fixing member 4900 may be coupled to or connected to the housing 4400. In some embodiments, the first fixing member 4600 and / or the second fixing member 4900 may be integral with the housing 4400 and / or the interface body. Figure 37 and 38 A housing 4400 is shown, featuring attachment for a first fixing member 4600 and / or a second fixing member 4900. Figure 37 and Figure 38 In the illustrated embodiment, the attachment feature is located on the front side or front portion 4430 of the housing 4400. The attachment feature may include one or more attachment elements. The one or more attachment elements may be similar to those previously mentioned, such as those concerning... Figures 7 to 9 The attached element is described in the embodiment shown.

[0380] In some embodiments, housing 4400 may be formed of a rigid material. Housing 4400 may be detachably coupled to an interface body, as described herein. Housing 4400 may be detachably coupled to a manifold of the interface body. In the illustrated embodiment, front portion 4430 includes one or more attachment elements in the form of one or more protrusions. The protrusions may include one or more side protrusions 4420 and a central protrusion 4440. Side protrusions 4420 may project forward. Side protrusions 4420 may extend outward from front portion 4430. Side protrusions may have enlarged heads 4422 and rods 4424. Heads 4422 may have a larger cross-section than rods 4424. Side protrusions 4420 may be received and engaged by one or more complementary or receiving components. For example, each or every side protrusion 4420 may be received and engaged by a hole or recess, which is fitted to the enlarged head 4422, for example, by a push-fit. For example, the first fixing member 4600 may be detachably attached to the housing 4400 at the side protrusion 4420. The first fixing member 4600 may have one or more holes or recesses configured to receive or engage with the side protrusion 4420.

[0381] The central protrusion 4440 may include features for attaching the second fixing member 4900 to the housing 4400. The central protrusion 4440 may include an opening 4442. In some embodiments, the second fixing member 4900 may be attached to the housing 4400 through the opening 4442 in the central protrusion 4440. In some embodiments, the opening 4442 may have one or more channels 4443 for inserting the second fixing member 4900. In some embodiments, the central protrusion 4440 may include two channels in the opening 4442, such as... Figure 37 and Figure 38 As shown. In some embodiments, such as Figure 38 As shown, the central protrusion 4440 may include a lip 4446. The lip 4446 may engage with a complementary fitting portion of the second fixation member 4900 (not shown), as described in more detail herein. Features on the housing 4400 facilitate securing the first fixation member 4600 and / or the second fixation member 4900 to the housing 4400. This can position the fixation members for subsequent attachment to the patient via suitable mechanisms (such as patient interface patches, skin patches on the patient's face, adhesives, or any other suitable mechanisms) or via other suitable means (such as headgear, chin straps, or caps) to stabilize the seal between the mask body or cannula body and the patient. Features on the housing for securing the first fixation member 4600 and / or the second fixation member 4900 to the housing may have a low profile to minimize the outward extension of the features from the patient's face. This arrangement minimizes the volume or profile of the patient interface on the patient.

[0382] First fixing component

[0383] Figures 39A to 39B A view showing an embodiment of the first fixing member 4600 is provided. Figures 39A to 39B As shown, the first fixing member 4600 includes a central portion 4610, a support pad 4660, and a bridging portion 4630 extending between the central portion 4610 and the support pad 4660. In addition to what is described herein, the first fixing member 4600 having the central portion 4610, the support pad 4660, and the bridging portion 4630 can be used with respect to… Figure 25 and Figure 26 The first fixing member 3600, which has a central portion 3610, a support pad 3660, and a bridging portion 3630, is similar to and formed and used in the same manner. (See example...) Figure 39A and Figure 39BAs shown, the bridging portion 4630 can be positioned on the opposite side of the central portion 4610. Support pads 4660 can extend laterally outward from the bridging portion 4630. In some embodiments, the first fixing member 4600 may include a single support pad 4660 extending from the single bridging portion 4630. In some embodiments, the first fixing member 4600 may include more than one support pad 4660 extending from the bridging portion 4630 on the outer periphery of the central portion 4610. In some embodiments, the first fixing member 4600 may include a pair of support pads 4660 extending from the bridging portion 4630 at opposite ends of the central portion 4610, as shown... Figure 39A and Figure 39B As shown.

[0384] The first fixation member 4600 may include a pair of support pads 4660 on the opposite side of the central portion 4610, the pair of support pads being configured to rest on or engage with the user's face. In some embodiments, the first fixation member 4600 includes means for attaching and securing the patient interface to, or otherwise attaching it to, the patient's face via any suitable mechanism, a headband, chin strap, patient interface patch, or skin patch.

[0385] In some embodiments, the first fixing member 4600 may include a notch 4640 and two arms 4642 bridging the central portion 4610 and the support pad 4660. The notch 4640 allows the interface tube 4800 to pass between the two arms 4642 and through the notch 4640. The notch 4640 can be used to receive the interface tube 4800. The notch 4640 can be fitted onto the interface tube 4800 and secured in place. In some embodiments, the arms 4642 can be positioned around the interface tube 4800 as the tube 4800 extends through the notch 4640. In some embodiments, the arms 4642 can flex or fit around the tube 4800. The arms 4642 can be configured to "fit" against or be located near the tube 4800. This configuration can help reduce the thickness or volume of the interface assembly while still allowing the bridging portion 4630 to freely hinge or flex. The cutout 4640 of the bridging portion 4630 provides a channel for the interface tube 4800 to pass through the cutout 4640 and connect to the housing 4400. In some cases, the interface tube 4800 may be integral with the housing 4400. In some cases, the interface tube 4800 may be detachably connected to the housing 4400.

[0386] like Figure 39A and Figure 39BAs shown, the first fixing member 4600 can be bent 4634, wherein the bridging portion 4630 intersects with the central portion 4610. This bending can help accommodate the tubular shape of the tube 4800 and / or the housing 4400. Figure 39C A top view of the first fixing member 4600 is shown. The arm 4642 of the bridging portion 4630 may have a first end 4644 that contacts the support pad 4660 and a second end 4646 that contacts the center portion 4610. The arm 4642 may have a horizontal axis extending from the first end 4644 to the second end 4646. (As shown from...) Figure 39C As shown in the top view, the arm 4642 of the bridging portion 4630 can be wider at the second end 4646. The arm 4642 can taper inward as it extends along the horizontal axis toward the first end 4644. However, in some embodiments, the first end 4644 of the bridging portion 4630, which connects to the support pad 4660, can have a thickened region 4632. The thickened region 4632 can be provided with or have a reinforced material area to provide additional support, such as... Figures 39A to 39B As shown. Figure 39A A front view of the first fixing member 4600 is shown. (See image.) Figures 39A to 39B As shown, when viewed from the front view, the thickened region 4632 of the first end 4644 can be thicker than the second end 4646 of the arm 4642.

[0387] In some embodiments, the cutout 4640 of the bridging portion 4630 may allow an interface tube (such as interface tube 4800) to pass through the first fixing member 4600, such as... Figure 36 As shown. In some embodiments, any other area of ​​the bridging portion 4630 or the first fixing member 4600 may include mechanisms for further securing the interface tube 4800 to facilitate management of the interface tube 4800. For example, the bridging portion 4630 may include a hook-and-loop fastener or adhesive at the cutout 4640, which may be detachably attached to the interface tube 4800.

[0388] exist Figures 39A to 39C In the illustrated embodiment, the first fixation member 4600 includes an opening 4640 formed through the bridging portion 4630. When the user interface patch is applied to the patient-facing surface of the support liner 4660, the opening 4640 exposes the user interface patch from a front side opposite to the rear side of the first fixation member 4600. Therefore, if a double-sided adhesive or double-sided hook-and-loop fastener is used to attach the patient interface patch to the rear side of the support liner 4660, such adhesive or hook-and-loop fastener will be exposed from a front side opposite to the rear or user side. In some configurations, this adhesive or hook-and-loop fastener exposed through the opening 4640 can be used as a tube fastener or otherwise to organize an interface tube or catheter.

[0389] In some cases, the arm of the bridging portion 4630 may have a recessed area with hook-and-loop fasteners, which can also help manage the interface tube or catheter. In some situations, a way to hold and manage the interface tube 4800 of the patient interface assembly 4000 may be desired. In this arrangement, the tube 4800 can be flexible enough to facilitate tube movement and fixation by the clinician or user. The ability to move and fix the tube 4800 as needed allows for greater patient comfort, such as when sleeping on their side.

[0390] In some embodiments, the bridging portion 4630 of the first fixation member 4600 may have a cut-out or recessed area for receiving the tube 4800, as described herein. The cut-out or recessed area may further include hook or loop material for attachment to a corresponding material on the tube 4800. In some embodiments, one or more cut-out or recessed areas may be present on the bridging portion 4630 or the support pad 4660. The cut-out areas may be located at any suitable location along the bridging portion 4630 or the support pad 4660. In some embodiments, a cut-out or recessed area with hooks or loops may be present on the front side (non-patient-facing side) of each support pad 4660 or bridging portion 4630. In some embodiments, the hook or loop material may be overmolded onto the bridging portion 4630 or the support pad 4660, or attached by adhesive.

[0391] In some embodiments, the rear-side and patient-facing hook or loop material sheet can be formed as a single piece to form a double-sided hook or loop material, which can be overmolded into the cutouts or openings in the support pad 4660. Using a double-sided hook or loop material may be advantageous because it can be more easily overmolded onto the first fixation member 4600 compared to individual hook or loop pieces on each side. Furthermore, when using a single double-sided hook or loop material sheet, the support pad 4660 can be more flexible, thus better conforming to the user's face, in contrast to multiple hook or loop material sheets.

[0392] The tube 4800 may have a hook or loop material strip for attachment to a corresponding material on the patient interface assembly 4000. For example, the hook or loop strip may be wrapped around the outside of the tube 4800 or attached to a portion of the tube 4800. In some embodiments, the tube 4800 may include an engagement portion 4840 to which a hook or loop strip or any other attachment mechanism is attached. The engagement portion 4840 may be wrapped, molded, or placed around the outside of the tube 4800. A loop material sheet may be attached to a corresponding hook material on a bridging portion 4630 of the patient interface assembly 4000 to secure the tube 4800. Alternatively or additionally, a covered molded portion may be present on the tube, a portion of which includes loop material.

[0393] In some embodiments, a magnet may be used to retain the catheter or tube 4800 on the patient interface assembly 4000. For example, a magnet may be present on the support liner 4660 or bridging portion 4630, or the magnet may be placed on a sheet of material wound around or overlaid into the tube 4800. This magnet may interact with a corresponding ferromagnetic material on another component to secure the tube 4800 and the patient interface assembly 4000. Any other suitable detachable coupling mechanism (such as those described elsewhere herein regarding attachment of the fixation member and interface body) may be used to attach the tube 4800 to the first fixation member 4600.

[0394] The first fixing member 4600 may have a mechanism for being secured to or otherwise coupled to the housing 4400. The first fixing member 4600 may be coupled to the housing 4400 by coupling a central portion 4610 to the housing 4400. The first fixing member 4600 may be coupled to the housing 4400 by coupling with one or more attachment elements on the housing 4400. For example, the first fixing member 4600 may include an opening 4426 for coupling the first fixing member 4600 to the housing 4400 at an attachment element. The opening 4426 may be coupled to the housing 4400 at a side protrusion 4420. In some embodiments, the first fixing member 4600 may be detachably coupled to the housing 4400. The first fixing member 4600 may have a mechanism for being secured to or coupled to the housing 4400. The opening 4426 may be sized and shaped to be received and secured to or engaged with the side protrusion 4420. For example, the opening 4426 can be sized and shaped to be fixed at the rod 4424 of the side protrusion 4420.

[0395] In some embodiments, the first fixing member 4600 may be made of a soft, flexible material (e.g., TPE / silicone) or any other material described herein for fixing members. In some embodiments, the first fixing member 4600 may have one or more openings or recesses 4426. The first fixing member 4600 may have two openings or recesses 4426. The openings or recesses 4426 may be located in the central portion of the first fixing member 4600. The openings or recesses 4426 may be pushed onto or otherwise engaged with the two side protrusions 4420 of the housing 4400 to secure the first fixing member 4600 in place. In some embodiments, the openings 4426 and the side protrusions 4420 may allow the first fixing member 4600 and the housing to be secured by a push-fit mechanism. The openings 4426 of the first fixing member 4600 may be pushed onto the enlarged heads 4422 of the side protrusions 4420. When the first fixing member 4600 is positioned on the housing 4400, the inner diameter of the opening 4426 of the first fixing member 4600 can sit around the rod 4424 of the side protrusion 4420. The rod 4424 always surrounds the uniform indentation of the side protrusion 4420 to prevent the first fixing member 4600 from separating from the housing 4400.

[0396] Figure 39B A rear view of the first fixing member 4600 is shown. Figure 39B As shown, the first fixing member 4600 may include a recess 4428 on the rear side 4645 of the central portion 4610. When the first fixing member 4600 is properly positioned on the housing 4400, the recess 4428 can accommodate the presence of the central protrusion 4440 on the housing 4400 without increasing the volume of the interface assembly. Although two side protrusions are used, the housing 4400 may include only one side protrusion for fixing the first fixing member 4600. In other cases, more than two side protrusions may be used. For example, the first fixing member 4600 may be fixed using one or more protrusions on the housing 4400 and corresponding openings on the first fixing member 4600.

[0397] In some embodiments, the first retaining member 4600 may be attached to the housing 4400 by any other mechanism, wherein the side protrusion 4420 may receive and retain or otherwise engage one or more complementary components. For example, the side protrusion 4420 may engage with a hole fitted into an enlarged head of the side protrusion 4420. In some embodiments, the first retaining member 4600 may be detachably coupled to the housing 4400. In some embodiments, the first retaining member 4600 may be coupled to the housing 4400 using a clamp. In some embodiments, the first retaining member 4600 may be permanently coupled to the housing 4400. In some embodiments, the first retaining member may not have a central portion 4610 and / or a bridging portion 4630, and may include a support pad 4660 that is detachably or permanently coupled directly to the housing 4400 or the interface body.

[0398] In some embodiments, the bridging portion 4630 or the entire first fixation member 4600 is made of a flexible material, such that the bridging portion 4630 is flexible or deformable, as described above. In some embodiments, the bridging portion 4630 is made of the same material as the central portion 4610, which is assembled or integrally constructed. In some embodiments, the first fixation member 4600 may be made of one or more elastomeric materials, such as silicone, rubber, polyethylene, or any other flexible material. In some embodiments, the first fixation member 4600 may be made of a single material. In some embodiments, the first fixation member 4600 may be made of two or more materials, such that a region of the bridging portion 4630 has a different flexibility relative to another region of the first fixation member 4600. In some embodiments, at least one region of the bridging portion 4630 may be made of a flexible but stretchable material, such that the bridging portion 4630 is sufficiently rigid to resist torsional forces and prevent the central portion from rotating relative to the housing, while being able to hinge or flex to help minimize force and / or movement translating from the patient's cheek to the sealing area. In some embodiments, the first fixing member 4600 may be constructed of the same material as the interface body (e.g., cannula body 3200a, mask body 3200b) and / or housing 4400.

[0399] The first fixing member 4600 may have a material thickness, which can be defined as the distance from the rear side 4645 of the first fixing member 4600 to the front side 4647 of the first fixing member 4600. The first fixing member 4600 may have different thicknesses in different regions. In some embodiments, the first fixing member 4600 may have a thickened region at the bridging portion 4632, wherein the material thickness at the bridging portion 4632 is greater than the material thickness at other portions of the first fixing member 4600. For example, the material thickness at the bridging portion 4632 may be greater than the material thickness at one or more of the support pad 4660, other portions of the arm of the bridging portion 4630, and / or the central portion 4610, as previously discussed. Figures 39A to 39C The thickened bridging portion 4632 can be located at the arm 4642 surrounding the cutout 4640 of the bridging portion 4632 to improve torsional stability in that region. In some cases, the thickened bridging portion 4632 can be located at the first end 4644, such as... Figure 39A As shown.

[0400] When force is applied to the interface, for example by pulling the tube or touching the housing and / or interface body, the torsional stiffness of the first fixing member 4600 can resist movement of the seal and thus damage to the seal. The torsional stiffness of the first fixing member 4600 can also help resist vertical rotation or movement of the interface body seal, thereby minimizing the effect on the seal when force is applied.

[0401] The portion of the first fixation member 4600 having or connected to the support pad 4660 may be flexible for attaching the first fixation member 4600 to the patient. The flexure of the support pad 4660 may also adapt to the contours of the patient's face.

[0402] In some embodiments, the first fixation member 4600 may include a perforated area or indicator, wherein a clinician may cut off a portion of the support pad 4660 to change the size of the support pad 4660, for example, to achieve a smaller size support pad for a smaller patient.

[0403] Second fixing component

[0404] Figures 40 to 42 and Figures 44 to 47An embodiment of a second fixation member 4900 is illustrated. The second fixation member 4900 may include an attachment portion 4910, a support pad 4980, and a central portion 4920 connecting the attachment portion 4910 to the support pad 4980. The support pad 4980 may be a soft, connected pad that can rest directly or indirectly on a user's face. For example, the support pad 4980 may be configured to rest on the forehead when the patient interface 4000 is worn by the user. In some embodiments, the support pad 4980 is a flexible material. For example, the support pad 4980 may be secured directly or indirectly to the user's forehead by external force, such as using a skin patch on the patient's face or any suitable mechanism (such as adhesive bonding, headgear arrangement, hook or loop connections as discussed above) or another suitable support structure, such as any of those described herein. In some arrangements, the support pad 4980 may be connected to a headgear and / or chin strap to secure the interface body.

[0405] The attachment portion 4910 can be used to attach the second fixing member 4900 to the housing 4400. The attachment portion 4910 is formed to connect with a corresponding structure on the housing 4400. In some embodiments, the corresponding structure may be located on the central portion of the housing 4400. The central portion of the housing 4400 may have a central protrusion 4440, such as Figure 43A and Figure 43B As shown. The attachment portion 4910 can be formed as an opening 4442 connected to the central protrusion 4440 (in Figure 43A and Figure 43B (As shown in the reference). Figures 40 to 47 The second fixing member 4900 is described as being coupled to the housing 4400, but the second fixing member 4900 may be used in conjunction with any of the housing or patient interface component parts and embodiments described herein.

[0406] In one embodiment, the attachment portion 4910 may be a soft, deformable, or flexible material that can be attached to or detached from the housing 4400. This may be desirable, for example, when switching between different interface bodies. The attachment portion 4910 may be a flexible barb 4912. The flexible barb 4912 may have a pair of tabs 4914 on opposite sides of the barb 4912. The pair of tabs 4914 may be configured to engage or otherwise engage with an opening 4442 in the housing 4400. The pair of tabs 4914 may be a pair of lower laterally projecting tabs 4914. The flexible barb 4912 may include a pair of lower laterally projecting tabs 4914 and an extending top portion 4918 and a connecting portion 4915 therebetween. The connecting portion 4915 may include a cutout 4916 at the center of the connecting portion 4915. The cutout 4916 may allow at least a portion of the flexible barb 4912 to compress or deform during attachment and detachment. The flexible barb 4912 can be compressed or deformed, and the connecting portion 4915 can move inward toward each other. The compressed flexible barb 4912 can pass through the opening 4442 in the housing 4400. Then, as the laterally protruding tabs 4914 pass through the opening 4442, the flexible barb 4912 can be allowed to relax and the connecting portion 4915 can move back to its extended rest position. After insertion, a pair of lower laterally protruding tabs 4914 can be located on one side of the central protrusion 4440, and the extended top portion 4918 can be located on the other side of the central protrusion 4440, as... Figure 43A As shown.

[0407] Unless the flexible barb is intentionally removed from its attachment, the flexible material of the flexible barb 4912 allows for low insertion force and strong separation force. The flexible barb 4912 can be easily compressed and collapsed or otherwise deformed to be pushed through the opening 4442 for assembly, and then return to its original configuration as it passes through the opening 4442. A central notch 4916 in the flexible barb 4912 facilitates this compression and collapse. In some cases, the attachment portion 4910 can be made of a soft or flexible material; for example, the attachment portion 4910 can be made of TPE or silicone.

[0408] Figure 43A An embodiment of the second fixing member 4900 is shown, demonstrating the interconnection between it and the housing 4400. The flexible barb 4912 can be fitted into the opening 4442 of the central protrusion 4440 of the housing 4400. Figure 43BAs shown in Figure 43, the flexible barb 4912 can be fitted within the central protrusion 4440 by engaging the tabs 4914 of each transverse protrusion with the lower edge of the central protrusion 4440 of the housing 4400. The flexible barb 4912 can collapse or otherwise temporarily deform to fit through the opening 4442. The flexible barb 4912 can be designed to collapse or deform to fit through the opening 4442 and does not necessarily have to be an interference fit. In other embodiments, the flexible barb 4912 can be fitted using an interference fit. Although Figure 43B It does not have a central projection with a lip, but in some embodiments, the central projection 4440 may include a... Figure 38 The lip shown is similar to the lip 4446. In this embodiment, the lip can engage the lateral protrusion 4914 of the second fixing member 4900.

[0409] In some embodiments, the flexible barb 4912 may have low insertion force and strong separation force. The flexible barb 4912 can be easily removed from the housing 4400. The flexible barb 4912 can be removed by moving or pivoting the second fixing member 4900 to one side or laterally and pulling the second fixing member 4900 and the flexible barb 4912 away from the housing 4400. In some embodiments, the flexible barb 4912 can be removed by collapsing in a manner similar to but opposite to insertion. In some embodiments, the length, size, and / or configuration of the protruding tab 4914 may be selected such that the tab 4914 can fold and allow the second fixing member 4900 to be removed when the second fixing member 4900 is moved laterally to a certain extent. In some embodiments, the protruding tab 4914 may have a length of 1.5 mm (approximately 1.5 mm). In some embodiments, the protruding tab 4914 may have a length between 0.5 mm and 10.0 mm, 1.0 mm and 5.0 mm, 1.0 mm and 2.5 mm, 1.0 mm and 2.0 mm, 1.5 mm and 5.0 mm, 1.5 mm and 2.5 mm, or 1.5 mm and 2.0 mm.

[0410] The flexible barb 4912 may have an extended top portion 4918 extending outward from the flexible barb 4912. The extended top portion 4918 prevents the flexible barb 4912 from being over-inserted into the opening 4442 of the housing 4400. The extended top portion 4918 may extend outward from the connecting portion 4915 of the flexible barb 4912 and may be located above the opening in the housing 4400, as shown in FIG. 43. The extended top portion 4918 prevents the second fixing member 4900 from being over-inserted into the opening 4442. The width of the housing opening 4442 may be less than the width of the extended top portion 4918 measured from one end of the extended top portion to the other end of the extended top portion 4918. The width of the housing opening 4442 may be less than the width between a pair of tabs 4914 measured from one end of a tab 4914 to the end of an opposite tab 4914.

[0411] In some cases, the flexible barb 4912 can be beneficial because it prevents rigid, sharp, or potentially damaging parts from interacting with the patient. Additionally, the flexible barb 4912 can withstand compressive forces used for assembly and disassembly without breaking.

[0412] The central portion 4920 may be a rigid central portion for attaching the attachment portion 4910 to the support pad 4980. In some embodiments, the attachment portion 4910 may be integrally formed with or molded as a single piece with the central portion 4910. In other embodiments, the attachment portion 4910 may be formed separately and attached to the central portion 4920. In some embodiments, the attachment portion 4910 may be overmolded onto the central portion 4920 of the second fixing member 4900. In some embodiments, the attachment portion 4910 may be attached to the central portion 4920 by curling or deforming one or both of these portions to join them together. Additionally, in some embodiments, the support pad 4980 may also be overmolded. In some embodiments, the support pad 4980 may be flexible. In some embodiments, the support pad 4980 may be rigid. The rigid central portion may have a Shore hardness between 30A and 100D. In some embodiments, the attachment portion 4910 and / or the support pad 4980 may have a Shore hardness between 20A and 80A. In some embodiments, the Shore hardness of the central portion 4920 may be equal to or greater than (or even lower than) the Shore hardness of the attachment portion 4910 and / or the support pad 4980.

[0413] Figure 41 and 42 Other embodiments of the interface between the attachment portion 4910 and the center portion 4920 are shown. Figure 41 and Figure 42The attachment portion 4910 and the center portion 4920 are shown being combined. In some embodiments, the attachment portion 4910 may be overmolded onto the center portion 4920. Figure 41 The portion of the central portion 4920 that is covered by a molded attachment portion 4910 is shown. Figure 42 The resulting portion of the second fixing member is shown after the attachment portion 4910 is overmolded onto the central portion 4920. Although in Figure 41 The diagram shows a specific structure extending from the central portion 4920 on which a molded attachment portion is covered, but any structure or geometry can be used.

[0414] In some embodiments, the central portion 4920 can operate under tension and compression. In some embodiments, compared to the flexible second fixation member, the central portion 4920 can prevent excessive upward rotation of the interface body and housing 4400, which could further increase additional pressure on the nose. In some embodiments, the central portion 4920 can be formed of an optically clear or transparent material, which can help allow visibility of the patient's face. In some embodiments, the profile of the second fixation member 4900 can be shaped to avoid the interface body in use, which allows the second fixation member 4900, and especially the central portion 4920, to undergo some slight bending. However, the central portion 4920 can be generally relatively straight. In some embodiments, the central portion 4920 can be rigid. In other cases, the central portion 4920 can be flexible.

[0415] Figure 44 An embodiment of a support pad 4980 and a central portion 4920 of a second fixing member 4900 is shown. The support pad 4980 can be connected to the central portion 4920 by a hinged or pivotal connection 4982. In some embodiments, the central portion 4920 may be hinged relative to the attachment portion 4910 due to differences in material hardness and / or thickness, or may have a hinged connection similar to the hinged connection 4982 between the support pad 4980 and the central portion 4920.

[0416] The pivoting of the support pad 4980 relative to the central portion 4920 can help provide the desired vertical stability of the second fixation member 4900 by allowing adjustment of the position of the support pad 4980. This adjustment may be important because the support pad 4980 may be attached to the patient, for example, at the patient's forehead, or may be attached to different devices (e.g., headgear) that can position the support pad 4980 at different heights relative to the patient's forehead. Therefore, the second fixation member 4900 can be adapted to these different heights (e.g., headgear volume) and different forehead angles via a hinged or pivotal connection 4982 having the support pad 4980. Compensation for different heights and / or forehead angles can help minimize the impact on the seal between the interface body and the patient. In some embodiments, the support pad 4980 may be flexible. The support pad 4980 may have means for attaching and securing to a headgear, chin strap, patient interface patch, or skin patch, or otherwise, on the patient's face via any suitable mechanism.

[0417] The second fixation member 4900 may have a hinged connection between the support pad 4980 and the remainder of the second fixation member 4900. In some embodiments, the hinged or pivotal connection 4982 may allow 180-degree pivoting, greater than 180-degree pivoting, or any other pivoting angle, which allows the second fixation member 4900 to be held on the patient (and also on the remainder of the assembly) when a caregiver or clinician is caring for the patient or removing / moving the component (e.g., cleaning the patient's nostrils). For example, the housing 4400 and interface body may be flipped upward and over the support pad 4980 via the pivot or hinge 4982 to remove it. With this configuration, it is not necessary to completely remove the assembly of the housing 4400 and interface body. This can be advantageous because the assembly of the housing 4400 and interface body can be easily flipped up and down. For example, if the patient begins to lose saturation during care and needs therapy again, the mask can be easily flipped down back into place.

[0418] In other embodiments, the second fixing member 4900 may not have a pivotable connection. The support pad 4980 may alternatively be integral with the second fixing member 4900, as per [reference to...]. Figures 33 to 35 As described. In some embodiments, the support pad 4980 is overmolded onto the central portion 4920.

[0419] Figure 45An embodiment of a second fixing member 4900a is shown. The second fixing member 4900a may have a pivoting or hinged handle 4984 for attachment to a support pad (not shown). In addition to those described herein, the second fixing member 4900a may include an attachment portion 4910, a support pad (not shown), and a central portion 4920, similar to those described herein. Figures 40 to 44 The second fixing member 4900 is described. The attachment portion 4910 may be formed of a rigid material and may have a wide base 4986, a cutout profile 4972 in the wide base 4986, a barbed finger 4987, and a barbed clip 4988.

[0420] The wide base 4986 can be compressed to bring the barbed finger 4987 closer together. The cutout profile 4972 of the wide base 4986 can facilitate deformation of the base 4986 when compressed. The barbed clip 4988 can engage with the central protrusion 4440 and / or the lip of the central protrusion 4440 of the housing 4400. The wide base 4986 above the barbed finger 4987 can be clamped to compress the attachment portion 4910 and assemble the barbed finger 4987 into the opening 4442 (or multiple openings) of the housing 4400. The attachment portion 4910 can provide tactile feedback to the user.

[0421] Similar to the attachment of the second fixing member 4900, the second fixing member 4900a can be attached by compression of the barbs and subsequent expansion. Once compressed and assembled through the opening, the compressive force is released, and the barbed finger 4987 can pop out and lock onto the central protrusion 4440 of the housing 4400 and remain in place.

[0422] A similar mechanism can be used to remove the second fixation member 4900a. The attachment portion 4910 can have a low insertion force but a high removal force. Removal of the attachment portion 4910 can require the user to actively compress the barbs for easy removal. The second fixation member 4900a has an attachment rod 4984 that allows connection of a support pad or any other pad or patch that can be attached to a device for securing the component to the patient, similar to the one mentioned above. Figure 44 The attachment is described. In some embodiments, the attachment rod 4984 may allow connection to a skin patch that helps secure the component to the patient. In other embodiments, the second fixation member 4900a may not have a pivotable connection, and the support pad may instead be integral with the second fixation member 4900, as described above. Figures 33 to 35 As described.

[0423] Figure 46A and Figure 46B An embodiment of the second fixing member 4900b is shown. Figure 46A A front view of the second fixing member 4900b is shown. Figure 46B A rear view of the second fixing member 4900b is shown. Except as described herein, similar to the descriptions... Figure 45 The second fixing member 4900a and 4900b described may include an attachment portion 4910, a support pad (not shown), and a central portion 4920. The second fixing member 4900b may have the attachment portion 4910 having two barbed fingers 4987 and tabs 4989. When the attachment portion 4910 is pushed through one or more openings 4442 in the central protrusion 4440 of the housing 4400, the barbed fingers 4987 can move and compress together. Once received in one or more openings, the tabs 4989 of the barbed fingers 4987 can engage on one side of the central protrusion 4440.

[0424] Additionally, the second fixing member 4900b may have a protrusion 4985 on the rear side of each barbed finger 4987, which can provide a locking mechanism by engaging the lip 4446 (in... Figure 38 (as shown in the diagram) to secure the second fixing member 4900b to the housing (e.g., regarding...). Figures 37 to 38 Additional locking in the central protrusion 4440 of the described housing 4400.

[0425] Figure 47 Another embodiment of the attachment portion 4910 of the second fixing member 4900b is shown. In this embodiment, the attachment portion 4910 includes one or more front barb portions 4950. The one or more front barb portions 4950 can be positioned and extend outward from the front surface of the attachment portion 4910. A first or lower front barb portion 4950a can be located at the lowest or distal end of the attachment portion 4910. In the illustrated embodiment, the first front barb portion 4950a includes an upwardly extending hook portion 4951. The hook portion 4951 can be flexible or elastically deformable, allowing it to be inserted into a corresponding attachment feature on the housing 4400. In the illustrated embodiment, the hook portion 4951 engages with an opening 4442 in the central projection 4440 of the housing 4400.

[0426] The second or upper front barb portion 4950b may be located on the attachment portion 4910, above the first front barb portion 4950a. In the illustrated embodiment, the second barb portion 4950b includes a protrusion extending outward from the front surface of the attachment portion 4910. The protrusion may be configured such that it cannot pass through the opening 4442. Therefore, the second barb portion 4950b prevents the attachment portion 4910 and thus the second fastening member 4900 from being over-inserted into the opening 4442.

[0427] In some embodiments, the housing may have an opening in a central protrusion at the front side of the housing 4400 (in Figure 43B (as shown in the image) so as to receive two barbed finger-shaped pieces 4987, or may have two openings (as shown in the image). Figures 37 to 38 As shown), each finger has an opening (4987).

[0428] The attachment portion 4910 can provide tactile feedback to the user. Using the tactile feedback of the attachment portion 4910, the user can know when the attachment portion 4910 is correctly inserted into the housing 4400 or under the first fixation member 4600. In some cases, the attachment portion 4910 can control the angle between the second fixation member 4900 and the sealing assembly and the patient.

[0429] In some embodiments, the attachment portion 4910 may be rigid. In some embodiments, the attachment portion 4910 may be made of a flexible material.

[0430] about Figures 40 to 47 The described embodiment of the second fixing member 4900 can be inserted into the housing 4400 by a vertical force by the user pushing the attachment portion downward into the opening of the central protrusion of the housing 4400 until it is received within the opening. This is more suitable for... Figures 33 to 35 The described second fixation member 3900 is preferred because it can be attached by applying a force pushing it into the patient's face, which is then attached to the central protrusion of the housing 3400 via a push-in engagement. This force may cause discomfort to the patient, therefore it is necessary to first remove the component to attach this second fixation member 3900.

[0431] Seal between housing and interface body

[0432] The patient interface assembly includes: an interface body that can form a seal with at least a portion of a user's airway and allow gas to flow out of and to the user; and a housing that can be coupled to the interface body. The housing and interface body can be coupled in various configurations. The fit between these two components can be optimized for the functionality of the patient interface assembly and / or ease of use for caregivers. The interface body can be sealingly engaged with the housing to allow gas to flow out of and to the user.

[0433] In some embodiments, the connection between the interface body and the housing may be complementary, as described herein. The connection between the interface body and the housing allows for the assembly and disassembly of the patient interface and switching between different interface bodies. The connection is configured to also help prevent accidental disconnection of the interface body from the housing. The housing and interface body may be complementary, making incorrect assembly difficult and / or providing visual indications of incorrect and correct assembly. The interface body may have a manifold 4240 that connects to the internal cavity of the housing 4400 at a tube engagement portion 4460.

[0434] Figure 48A An embodiment of the interface body of the cannula body 4200a is shown. The cannula body 4200a may have a manifold 4240 and at least one nasal fork 4220, such as a pair of forks 4220. The forks 4220 may extend from the rear portion of the manifold 4240 facing the patient in use. Except as described herein, the cannula body 4200a may be similar to the embodiments described herein. Figures 10 to 1 3 and Figure 21 The main body of the intubation tube is described. Figure 21 and Figure 48A The manifold 4240 shown can be similar to the one described above. Figures 10 to 1 The manifold described in section 3, however, manifold 4240 and annular ridge 4248 are positioned closer to the bottom side of the interface body. This can be achieved, for example, by positioning the manifold and annular ridge closer to the bottom side of the interface body (as described in section 3). Figures 10 to 1 This alignment is achieved by (or essentially by reversing the centerline of the interface body as described in section 3). This alignment can help improve the stability of the patient interface.

[0435] The manifold 4240 may include a housing connection portion 4244 on its rear side. The housing connection portion 4244 may be received by the interface body receiving portion 4480 of the housing. Figures 37 to 38 (As shown in the diagram) The housing connection portion 4244 may have a protrusion 4247. When the manifold 4240 and the housing are connected, the protrusion 4247 may be adjacent to the interface body receiving portion 4480 of the housing 4400. The remaining portions of the housing connection portion 4244 and the manifold 4240 may be shaped and / or sized for insertion into and reception by the housing 4400 and to form an hermetically tight seal. For example, the manifold 4240 may include an annular ridge 4248 at each of the openings 4246. The annular ridge 4248 may provide interference with the inner surface of the housing at or near the opening in the housing 4400, thereby forming an hermetically tight seal with the housing 4400, such as... Figures 49 to 53DAs shown. The annular ridge 4248 of the manifold 4240 contacts the inner surface of the housing 4400. All other features of the manifold have gaps to reduce friction when assembling the manifold 4240 to the housing 4400. Lower friction can facilitate assembly of the components and reduce the risk of rotational misalignment between the two components.

[0436] The interface body and housing may have mating surfaces 4889 (in Figure 50 As shown in the diagram, the interface body and the housing intersect after assembly. The mating surface 4889 of the interface body may include a protrusion 4247 of the housing connection portion 4244, such as... Figure 49 As shown. When assembling the housing 4400 and the interface body, the protrusion 4247 of the housing connecting portion 4244 may be adjacent to the interface body receiving portion 4480. The mating surface 4889 may continue around the entire periphery of the protrusion 4247. In other embodiments, the mating surface 4889 may include only a portion of the protrusion.

[0437] Figures 48B to 48E The interface body of the face mask body 4200b is shown. The face mask body 4200b is similar to the face mask body 3200b described herein, but it includes reference numerals. Figure 48A The manifold features described.

[0438] The manifold 4240 of the cannula body 4200a and the mask body 4200a may define one or more openings 4246 (in Figures 48A to 48E As shown in the diagram), such as a pair of openings 4246. Openings 4246 can be connected to the tube engagement portion 4460 of the housing 4400 (in...). Figures 37 to 38 (As shown in the diagram) to receive the interface tube and allow gas to flow from and to the patient via the manifold 4240 and the interface body. Openings 4246, located at both ends of the housing 4400, create lateral entry points for gas to flow into and out of the interface. Lateral entry points help remove CO2 and create less dead space outside the flow path, as described herein with reference to the lateral entry and exit points of the interface body. For example, lateral gas flow into and out of the interface body (such as the mask cavity of the mask body) can result in greater CO2 removal compared to a mask or fluid interface with entry and exit points located in the middle or top of the mask. Additionally, lateral entry and exit points for gas flow can reduce dead space outside the flow path in the interface body.

[0439] The lateral openings 4246 can be in fluid communication with each other via the manifold 4240. When the cannula body is engaged with the housing, the manifold 4240 can be sealed when connected to the housing, except for the cavities of the openings 4246 and the nose fork 4220. When the mask body is engaged with the housing, the manifold can be sealed when connected to the housing, except for the openings in the manifold and the mask cavity.

[0440] like Figure 49 As shown, the housing 4400 may include a width w, which is measured from a first tube joint 4460 at a first end of the housing 4400 to a second tube joint 4460 at a second end of the housing 4400. The interface body may have a width a, which extends along or can be measured along the lumen of the manifold 4240, and is measured from a first annular ridge 4248 at a first end of the manifold 4240 to a second annular ridge 4248 at a second end of the manifold 4240. In some embodiments, it may be advantageous to reduce the housing profile and minimize the overall volume of the interface. In some embodiments, a single housing size and style can be used for all sizes of cannula bodies or mask bodies. This allows a single, constant housing or frame to be used with multiple interface bodies. The interface bodies can be of different types, such as using both cannula bodies and mask bodies. Different interface bodies can be used with different sized masks on different mask bodies, or with different sized nose forks on different cannula bodies. This avoids waste and makes it possible to change and adapt the interface bodies as needed by the clinician.

[0441] Figures 49 to 50 An embodiment of a housing connection portion 4244 of a manifold 4240 located within an interface body receiving portion 4480 of a housing 3400 is shown. Figures 49 to 5 3. The housing 4400 is shown as transparent, which allows the manifold 4240 to be visible within the housing 4400. The housing 4400 and manifold 4240 may have mating surfaces 4889, wherein a protrusion 4247 of the housing connection portion 4244 of the manifold 4240 mates with or abuts against the interface body receiving portion 4480 of the housing 4400. The housing 4400 may have a width w that extends from one pipe connection portion 4460 to a second pipe connection portion 4460, or can be measured from one pipe connection portion to a second pipe connection portion, such as... Figure 49 As indicated by the line "w" in the diagram. The interface body receiving portion 4480 may include an opening. This opening may be an angled opening 4845, such as... Figure 43B The design shown in the diagram does not include an attached manifold, and as... Figure 49 Another design is shown where the manifold 4240 is located within the housing 4400. The embodiment shown in Figure 43D and... Figure 49The embodiments described have different angled openings that can mate with manifolds of different shapes in the interface body. An angled opening 4845 may include a portion of a manifold 4240 of the housing 4400 that can receive the interface body. An angled opening 3845 may be an angle extending along an opening in the housing, extending along the top of the housing from a front portion 4841 to a rear portion 4843, such as... Figure 49 As shown. In some embodiments, the housing connection portion 4244 of the manifold 4240 may have a protrusion 4247 having an angled surface that complements the angled opening 4845 of the interface body receiving portion 4480. The angled surface of the protrusion 4247 may extend at an angle along the top of the manifold from the front portion 4241 of the manifold 4240 to the rear portion 4243 of the manifold 4240, as shown. Figure 49 As shown. When the manifold 4240 is detachably connected to and received by the housing 4400, the complementary engagement of the angled interface body receiving portion 4480 and the angled protrusion 4247 of the housing connecting portion 4244 can improve assembly and alignment.

[0442] In some embodiments, the housing connection portion 4244 and the manifold 4240 of the interface body may have a width measured along the inner cavity of the manifold 4240 from one end of the protrusion 4247 of the housing connection portion 4244 to the second end of the protrusion 4247 of the housing connection portion 4244. When the protrusion 4247 of the housing connection portion 4244 is an angled protrusion 4247, such as Figure 49 As shown, the protrusion 4247 of the housing connection portion 4244 can have a varying width. For example, the protrusion 4247 of the housing connection portion 4244 can have a first width b on the front portion 4841 of the manifold 4240 and a second width c on the rear portion 4843 of the manifold 4240. In some cases, the first width b on the front portion of the manifold 4240 is smaller than the second width c on the rear portion of the manifold 4240, such as... Figure 49 As shown. In some cases, the first width b on the front portion of the manifold 4240 is greater than the second width c on the rear portion of the manifold 4240.

[0443] The angle 4847 of the opening 4845 can be balanced with the width w of the housing. The angled opening 4845 can prevent and stop the manifold 4240 from being misaligned within the housing 4400. For example... Figure 49 As shown, the angled opening does not have straight edges, but rather the shape and configuration of the opening can have curved or trapezoidal sides. In other embodiments, the angled opening may have straight edges. In other embodiments, the angled opening may have one or more curved edges.

[0444] In some embodiments, the angled opening 4845 can facilitate the alignment and removal of the manifold 4240 from and from the housing 4400. In some embodiments, a narrow or smaller angle (e.g., from 0 to 30 degrees, from 0 to 45 degrees, or from 0 to 60 degrees) at the angled opening can prevent incorrect assembly. Smaller angles may require increasing the width of the housing due to, for example, the fixed position of the fork on the interface body. In some embodiments, the angled opening 4845 and the protrusion 4247 of the housing connection portion 4244 with larger angles (e.g., from 30 to 180 degrees, from 45 to 180 degrees, from 60 to 180 degrees) can allow for a shorter housing width. However, larger angles may lose the advantage of preventing or preventing incorrect orientation. In some embodiments, at a 90-degree angle, the orientation assistance from that angle may be lost. Therefore, it may be desirable to make the housing 4400 as narrow as possible to improve patient comfort when lying on their side, and to reduce volume and improve aesthetics. However, the width of the housing 4400 is ideally balanced with an angle that helps prevent incorrect orientation of the manifold 4240 within the housing 4400. In some embodiments, the protrusion 4247 of the housing connection portion 4244 may have an angled opening having a 60-degree angle 4847 measured from the rear portion 4843 of the manifold 4240, such as... Figure 49 As shown. In some embodiments, the angled protrusion 4247 of the housing connection portion 4244 may extend from the rear side of the manifold at an angle between 30 degrees and 170 degrees. In some embodiments, the angled protrusion of the housing connection portion may extend from the rear side of the manifold at an angle between 60 degrees and 120 degrees. In some embodiments, the angled protrusion of the housing connection portion may extend from the rear side of the manifold at an angle between 30 degrees and 90 degrees. In some embodiments, the angled protrusion of the housing connection portion may extend from the rear side of the manifold at an angle between 90 degrees and 170 degrees.

[0445] Figure 50 The connection of manifold 4240 to a portion of housing 4400 is shown. Figure 50 The housing connection portion 4244 of the interface body, which is connected to the interface body receiving portion 4480 of the housing 4400, is shown. (See diagram below.) Figure 50As shown, manifold 4240 is positioned off-center from the horizontal axis h2, which extends from the first pipe joint 4460 through the center of the cavity of housing 4400 to the second pipe joint 4460. This alignment of manifold 4240 relative to housing 4400 allows for a larger manifold inner diameter, which reduces flow resistance within housing 4400 and manifold 4240. This offset arrangement allows for a thicker front portion 4841 of housing 4400, which increases the rigidity of housing 4400. The increased thickness of the front portion 4841 of housing 4400 improves stability and increases the ease of assembly and / or disassembly of the interface body from housing 4400. This arrangement also improves the structural integrity of housing 4400.

[0446] In some embodiments, manifold 4240 may have a horizontal axis h1 extending through the center of the inner cavity of manifold 4240. Housing 4400 may have a horizontal axis h2 extending through the center of the pipe engagement portion 4460 on each side of housing 4400. In some cases, horizontal axis h1 may be the same as horizontal axis h2. In other embodiments, horizontal axis h1 may be offset or off-center relative to the horizontal axis h2 of housing 4400. Thus, the annular ridge 4248 of manifold 4240 may be off-center from the center of horizontal axis h2. The annular ridge 4248 of manifold 4240 may be substantially the same size as or smaller than the inner diameter of housing 4400.

[0447] Figure 51 A portion of another embodiment of a manifold 4240 coupled to a housing 4400 is shown, along with an enlarged view of the ends of the manifold 4240 and the housing 4400. The manifold 4240 may include extensions 4288 extending outwardly from each opening 4246 of the manifold 4240. Each extension 4288 may extend beyond the annular ridge 4248 by a certain distance. The extension 4288 may have a diameter smaller than the outer diameter of the annular ridge 4248. The extension 4288 may have an outer diameter comparable to the inner diameter of the interface tube 4800. The extension 4288 may be configured to extend from the manifold 4240 into the tube 4800 during use. The extension 4288 may extend within the tube engagement portion 4460 of the housing 4400. In some embodiments, the extension 4288 may extend within the interface tube 4800 of a patient interface assembly. The extension 4288 may increase the necessary manifold removal force to remove the manifold from the housing 4400. When the user assembles the two components, the extension 4288 reduces the likelihood that the annular ridge 4248 (e.g., an annular ridge including an O-ring) will get stuck on the housing 4400. When the extension 4288 is used, misalignment between the manifold and the housing 4400 becomes more noticeable and apparent.

[0448] Figures 52A to 52B An embodiment of a manifold 4240 coupled to a housing 4400 is shown, the manifold having features designed to prevent or limit rotation of the interface body within the housing. The manifold / housing interface may include a key feature 4286. The key feature 4286 may include a protrusion 4287 on the manifold and a recess 4289 on the housing. The protrusion 4287 and the recess 4289 may have complementary shapes, such that the protrusion 4287 can engage with the recess 4289 in a complementary fit, as... Figures 52A to 52B As shown. In some embodiments, key feature 4286 can prevent misalignment between the manifold and housing 4400. Key feature 4286 can prevent rotation between the two sides of the manifold, as... Figure 52B As shown. This can be beneficial because manifold rotation can affect the geometry of the fork or mask. Restricting or preventing manifold rotation allows for a more consistent sealing surface between the manifold and the housing, which can improve the assembly's ability to maintain a seal between the two components.

[0449] Key feature 4286 is shown on the rear side (or patient-facing side) of housing 4400. However, key feature 4286 can be positioned on the front or rear side of housing 4400 or at any location that allows for complementary engagement between the protrusion and the corresponding recess. Alternatively, although the manifold is shown with a protrusion and housing 4400 is shown with a recess, a key feature can be used where the protrusion is present on the housing and the recess is present on the manifold. Figures 52A to 52B The key feature shown is rectangular in shape; however, the key feature can be any shape, such as a square, rectangle, circle, or any part of these shapes or an irregular shape.

[0450] Figures 53A to 53D Another embodiment of a manifold 4240 connected to a housing 4400 is shown. The protrusion 4247 of the housing connection portion 4244 of the manifold 4240 may have an angled surface 4849 that complements an angled opening 4284 of the interface body receiving portion 4480 of the housing 4400. Except as described herein, the angled opening 4284 and the protrusion 4247 may be similar to those described above. Figure 49 The angled opening is described. When measured in the same manner, the angled opening 4384 of the housing can be greater than that described above. Figure 49 The angled opening described is at a larger angle. The angled opening 4284 can have a shape and configuration that helps form a self-aligning geometry with the housing connection portion 4244 of the manifold 4240. For example... Figures 53A to 53B The angled opening 4284 shown has the same Figure 37 and Figure 38The angled openings of the interface body receiving portion 3480 of the housing 4400 shown have similar or identical geometries. The angled protrusions 4247 and 4480 of the housing connection portion 4244 can control the orientation between the manifold and the housing, and reduce the possibility of incorrect placement of the manifold within the housing. The angled protrusions 4247 and 4480 of the housing connection portion 4244 can also reduce the chance of rotational misalignment between the manifold and the housing.

[0451] When viewed from a top view of the housing 4400 and the manifold 4240, the angled protrusions 4247 of the manifold can be configured in a substantially trapezoidal shape, such as... Figure 53A As shown in the top view. Figure 53A As shown, the trapezoidal configuration of the angled protrusion 4247 causes the wider base of the trapezoid to be close to the front portion of the housing 4400. In other embodiments, the protrusion of the interface body includes a wider trapezoidal base near the rear portion of the housing.

[0452] The housing 4400 may have complementary, angled interface body receiving portions 4480, such as... Figure 37 , Figure 37 and Figure 53A As shown. Figure 53A As shown in the top view of the interface component, when viewed from above, the angled protrusion 4247 can be trapezoidal in shape. When viewed from above... Figure 53A When viewed from the top view shown, the trapezoidal shape depicted by the angled protrusion 4247 of the housing connection portion 4244 and the angled interface body receiving portion 4480 can have four corners, which have angles other than 90 degrees.

[0453] like Figure 53A The angled protrusion 4247 of the housing connection portion 4244 and the angled interface body receiving portion 4480 shown may have an angle greater than 90 degrees in one of the two corners 4482 formed by the rear side of the manifold. Figure 53A The angled protrusion 4247 of the housing connection portion 4244 and the angled interface body receiving portion 4480 shown may have an angle less than 90 degrees in the corner 4484 on the front side of the protrusion of the housing manifold and the interface body receiving portion. For example, as Figure 53A The angled protrusion 4247 of the housing connection portion 4244 and the angled interface body receiving portion 4480 shown can have an angle of 120 degrees at two opposite corners on the rear side of the manifold.

[0454] like Figure 53A and Figure 53BAs shown, when measured from the rear portion of the manifold, the angle 4482 of the angled protrusion 4247 has an angle greater than 90 degrees. When measured from the rear portion of the manifold, in Figure 49 The embodiments of housing 4400 shown exhibit angles less than 90 degrees. However, any angled opening can also be used to allow for proper attachment assessment and prevent misalignment during component rotation. In some embodiments, the angled protrusion 4247 of the housing connection portion 4244 may extend from the rear side of the manifold at an angle between 30 and 170 degrees. In some embodiments, the angled protrusion of the housing connection portion may extend from the rear side of the manifold at an angle between 60 and 120 degrees. In some embodiments, the angled protrusion of the housing connection portion may extend from the rear side of the manifold at an angle between 90 and 120 degrees. In some embodiments, the angled protrusion of the housing connection portion may extend from the rear side of the manifold at an angle between 90 and 170 degrees.

[0455] The manifold 4240 can be folded, flexed, bent, or otherwise suitably manipulated when inserted into the housing 4400. For example, during insertion, the manifold 4240 can be folded through the center of the housing 4400 to manipulate the annular ridge 4248 through the narrowest point of the housing 4400. Once the annular ridge 4248 is concentrically positioned within the housing, the manifold can be straightened and returned to its resting shape. During this process, the angled face 4849 and the angled opening 4284 can be used to properly align the manifold 4240 relative to the housing 4400.

[0456] Figure 53B It shows Figure 53A The diagram shows a portion of manifold 4240 and housing 4400. An annular ridge 4248 of manifold 4240 may contact housing 4400. The annular ridge 4248 may contact the inner surface of housing 4400 to create a gas seal. Other features on manifold 4240 may avoid contact with the housing or have minimal contact with the housing to reduce friction during assembly of the two components. Lower friction helps the user during assembly and reduces the risk of misalignment during rotation between the two components. In some cases, the annular ridge 4248 may have an interference fit to prevent leakage.

[0457] Figure 53C It shows Figure 53AThe manifold 4240 and a portion of the housing 4400 are shown. The manifold 4240 and housing 4400 of the interface body may each have a mating surface 4889, wherein the manifold 4240 and housing 4400 intersect or are otherwise continuous during assembly. The sidewall of the protrusion 3247 of the housing connection portion 3244 may form at least a portion of the mating surface 4889 of the interface body. A portion of the protrusion 4247 on the manifold 4240 may be higher relative to the mating surface 4889 on the housing 4400. This arrangement results in a portion of the protrusion 4247 of the manifold 4240 remaining uncontacted with the housing, as... Figure 53C As shown. For example, as Figure 53C As shown, the rearward protrusion 4247 of the manifold 4240 extends beyond the rearward side of the housing 4400 at the engagement surface 4889. This difference in the rearward (or patient-facing) extension of these components allows the relatively soft manifold material of the interface body to contact the user's face before or prior to the relatively hard or more rigid housing material.

[0458] Figure 53D A portion of manifold 4240 and housing 4400 in an assembled configuration is shown. Disassembly of manifold 4240 from housing 4400 can be managed or optimized, at least in part, based on the materials and / or configuration of the manifold and housing. The disassembly force required to disassemble the components can be controlled, at least in part, by a distance “x”, such as... Figure 53D As shown, this is the horizontal distance between the outer edge of the annular ridge 4248 and the sealing or mating surface 4889 of the manifold 4240. When the annular ridge 4248 moves past the mating surface 4889 of the housing 4400, disassembly of the manifold 4240 from the housing 4400 can occur, thereby disengaging the manifold 4240 from the interface body receiving portion 4480 of the housing. The user can overcome this force to replace the interface body, for example, a face shield, a fork, or to change to a different size.

[0459] In some embodiments, when the annular ridge 4248 moves beyond a distance "y", the seal between the manifold 4240 and the housing 4400 may be compromised, such as... Figure 53D As shown, distance "y" is the distance between the outer edge of the annular ridge 4248 and the protrusion 4247 of the manifold. When the annular ridge 4248 is at or beyond this point, a clear flow path can exist between the housing and the annular ridge 4248, leading to leakage, which may be unacceptable for therapies delivery. In some embodiments, angled openings can affect both dimensions ("x" and "y"), and also the overall width of the housing.

[0460] Figures 54 to 55 The diagram shows a side cross-sectional view of the main interface component. Figure 54A side cross-sectional view of the interface body with the cannula is shown. Figure 55 A side cross-sectional view of the interface body with the face mask body is shown. Except as described herein, the manifold 4240, the cannula body, and the face mask body are similar to those described above. Figures 10 to 2 4 describes the manifold and cannula body, as well as the mask body. The manifold 4240 may have an inner diameter of the inner surface 4851 of the manifold wall and an outer diameter of the outer surface 4853 of the manifold wall, with a wall thickness therebetween. The rear portion 4243 or patient-facing portion of the manifold 4240 may have a thinner wall thickness compared to the wall thickness on the front portion 4241 of the manifold 4240. A thinner wall thickness allows for greater flexibility, which can make the patient more comfortable. The wall thickness of the front portion 4241 of the manifold 4240, received by the housing, can generally be thicker than the rest of the manifold 4240. This can help the user or clinician assemble or remove the interface body from the housing. For example, when assembling the interface assembly or removing the interface body, the interface body can fold inward when force is applied to its side. This folding is achieved at least in part by the wall thickness on the rear portion 4243 of the manifold 4240 being thinner than that on the front portion 4241 of the manifold 4240. During the insertion and removal of the interface body, the thinner material can collapse inward when force is applied to one or both sides of the manifold 4240.

[0461] Both the mask body and the cannula body have manifolds 4240 with annular ridges 4248 on both sides. The annular ridges 4248 can be integral sealing O-ring portions. These annular ridges 4248 of the manifold 4240 can be fitted into and sealed to the housing 4400, such that each side is in fluid communication with a tube. The annular ridges 4248 are the intended contact points between the manifold 4240 and the housing 4400. Having a single contact point reduces friction between the manifold 4240 and the housing 4400, making it easier for the interface body to slide in and self-align when fitted into the housing. The amount of rotation of each side of the interface body or each annular ridge relative to each other can be controlled by the amount of interference between the components (e.g., the amount of interference between the housing 4400 and the manifold 4240). Since even a small amount of rotation on one side can deform the seal between the housing 4400 and the manifold 4240, this rotation (and thus the resulting interference) is ideally minimized. Therefore, it may be important to ensure and verify the correct alignment of the manifold 4240 within the housing 4400. The manifold 4240 may include self-aligning features to help prevent such rotation and maintain each side of the manifold 4240 in the same position relative to the other side within the housing 4400.

[0462] Figures 54 to 55A manifold is shown, which features a characteristic that prevents or at least minimizes rotation of the interface body within the housing. In some cases, this feature may be a shoulder portion 4628. The shoulder portion 4628 may be any structure having a sufficiently large surface area to engage with the bottom edge (not shown) of the opening in the housing and to prevent or reduce rotation. For example, the shoulder portion 4628 may be a thickened portion of the wall of the manifold 4240, such as... Figure 54 and Figure 55 As shown. The shoulder portion 4628 helps the manifold 4240 self-align within the housing. (As shown...) Figure 54 and Figure 55 As shown, the shoulder portion 4628 can be a thickened portion at the bottom of the housing attachment portion of the manifold. Once assembled, the shoulder portion 4628 can be suspended on the housing. In other cases, the shoulder portion is not suspended on the housing but can abut against the surface of an opening in the housing. The shoulder portion 4628 engages with and abuts against the edge of the housing, and can prevent or limit rotation and movement of the interface body relative to the housing. Limiting or preventing rotation of the manifold allows for a more consistent sealing surface between the manifold and the housing, which can improve the ability to maintain a seal between the two components. The shoulder portion 4628 can be a thickened portion of the manifold, which can help prevent the interface body from being improperly inserted into the housing. The shoulder portion 4628 allows for visual assessment of incorrect or incorrect configuration of the interface body within the housing. The user can visually observe manifold misalignment and correct the alignment of the manifold with the housing.

[0463] like Figure 54 As shown, the distance "d" indicates the width at 4628 in the shoulder section, which is wider than the rest of the manifold wall. The thickness "t" of the manifold wall is... Figure 54 As shown in the diagram, the width of the shoulder portion 4628 is thinner by a distance “d” than the width of the region of the manifold having the shoulder portion 4628. In some embodiments, the width “d” of the shoulder portion may be 2.5 mm, and the wall thickness “t” of the manifold is 1.0 mm. The width “d” of the shoulder portion may be between 1.5 mm and 3.5 mm, 1.5 mm and 2.5 mm thick, 2.5 mm and 3.5 mm thick, and 2.0 mm and 3.0 mm.

[0464] The width at the shoulder portion 4628 can form an area at the base of the interface body, which, once assembled, can be used to prevent the manifold from rotating within the housing. In some embodiments, the shoulder portion 4628 extends only along a portion of the manifold. In some embodiments, the shoulder portion 4628 can extend the width of the manifold from one side to the other. The shoulder portion 4628 can also provide some structure or rigidity to the nose fork or mask, which can aid in the insertion of devices as previously described. Additionally, the increased thickness at the shoulder portion 4628 can increase the necessary removal force, thereby reducing the chance of accidental disassembly.

[0465] In some embodiments, the surface finish of the materials of the housing and interface body or manifold can facilitate placement of the manifold within the housing, thereby improving the assembly of the manifold with the housing. In some embodiments, to achieve this, the surface finish of the housing and manifold or interface body can create a low-friction or smooth surface. In some embodiments, the low-friction surface of the housing or interface body can be a feature of the material forming the housing or interface body or a portion thereof. In some embodiments, the low-friction surface can be achieved during manufacturing. For example, a material coating can be added to the material of the housing or interface body. For example, a parylene coating can be applied to the outer surface of the housing or interface body to achieve a low-friction surface. Alternatively, the surface can be treated by a process such as sandblasting (e.g., bead blasting) to provide a low-friction surface. Coatings or treatments can reduce friction and adhesion between the housing or interface body and other materials, which can improve the sliding of the interface body into the housing. Furthermore, a low-friction surface reduces friction on the portion of the interface body that contacts the patient's face and can improve comfort. In some embodiments, other components of the patient interface assembly may also have low-friction surfaces or be formed of low-friction materials.

[0466] Figures 56A to 56F A manifold 5420 connected to housing 5400 is shown, which uses visual indicators to indicate the correct positioning and alignment of components. The visual indicators may be color indicators or indicator lines indicating the correct placement of components.

[0467] Figures 56A to 56D A visual indicator is shown, which may be a colored ring 5604 located on or around the annular ridge of manifold 5420. The colored ring 5604 can be observed through a transparent or translucent portion of housing 5400. Users or clinicians can observe the position and configuration of the colored ring 5604 through the transparent or translucent portion. In the illustrated embodiment, correct component positioning is indicated by observing that the colored ring 5604 is axially aligned with housing 5400 and forms a circle. Incorrect component positioning is indicated by observing, for example, deformation of the colored ring 5604 or misalignment with housing 5400.

[0468] The color ring 5604 can be disposed on two opposite annular ridges of the manifold. In some embodiments, the color indicator can be disposed only on the manifold, only on the housing, or on both the manifold and the housing.

[0469] Alternatively or additionally, the interface components may include a second visual indicator, such as a second color indicator, at an angled corner of the housing 5400 and / or manifold 5420. Figures 56C to 56D A color indicator 5606 is shown at the angled edges of manifold 5420 and housing 5400. The color indicator 5606 provides a visual indication of when the angled edges of the two components are correctly aligned. When the two components are not correctly aligned, the user can see the misalignment of the color indicator on the component.

[0470] Another embodiment of the visual indicator is in Figures 56E to 56F As shown in the diagram. In this embodiment, the visual indicator is provided as a colored or contrasting bar or line 5608. The colored bar 5608 may be located on the surface of the interface body manifold 5420. In the illustrated embodiment, the colored bar 5608 is located on or near the surface or edge of the manifold 5420 that mates with or is adjacent to the housing 5400. If the manifold 5240 and the housing 5400 are not properly aligned, the colored bar 5608 may be observed to have a non-linear configuration, such as... Figure 56E As shown. If the parts are correctly assembled and aligned, the color stripe 5608 can be observed to have a linear or straight configuration, such as Figure 56F As shown.

[0471] In some embodiments, color indicators on the housing and / or manifold can serve as both size and alignment indicators. For example, housings and manifolds of various sizes can be provided, and different sizes can use different color indicators, allowing the correct size housing to be matched with the correct size manifold. This helps the user correctly align the housing and manifold components. (See reference...) Figures 56A to 56F The color indicator shown is positioned at the ends of the manifold, where it mates with the housing or the angled edge of the manifold and housing. However, the color indicator can be positioned on any component of the manifold and / or housing, such as any portion of the manifold that mates with the housing, to provide visual indication of proper positioning and alignment. In some embodiments, any part or component of the interface assembly, or the entire assembly, can be transparent or translucent to allow the visibility of the visual alignment indicator. Transparent or translucent materials can allow the colored portions of components to be visible; for example, transparent or translucent materials can allow the visibility of the colored portions on the annular ridge of the manifold within the housing.

[0472] Pipes and connectors

[0473] One or more interface tubes and connectors of the patient interface assembly allow fluid communication to and from the patient from external devices or airflow sources. Figure 57 A conduit 4800 and a connector 4820 at the end of the conduit are shown. In some embodiments, the wall of the interface conduit 4800 may be made of a material that allows wet vapor to pass through the wall of the conduit 4800. The connector 4820 may be any type of interlocking or mating connector to connect the conduit to another device or additional conduit. Figure 57 As shown, the connector may have locking fingers 4822 to connect and secure the tubing to another device or additional tubing. Examples of connectors and / or connector assemblies can be found in International Application No. PCT / NZ2012 / 000142, filed August 10, 2012, entitled "CONDUIT CONNECTOR FOR A PATIENT BREATHING DEVICE," the entire contents of which are incorporated herein by reference. In other embodiments, the connector may have a tapered fit for connection to another device or additional tubing.

[0474] The housing can be connected to the pipe at the pipe joint (in Figure 36 (As shown in the diagram). In some embodiments, conduit 4800 may include an inhalation conduit, wherein a first end may be connected to the housing and deliver an incoming gas flow, and a second end has a locking finger 4822. In some embodiments, conduit 4800 may include an exhalation conduit, wherein a first end may be connected to the housing and receive an exhaled gas flow, and a second end has a locking finger 4822. In some embodiments, the conduit may include both an inhalation conduit and an exhalation conduit. In some cases, the locking finger 4822 at the second end may be coupled to a downstream component, such as an efflorescent device. In some embodiments, the locking finger 4822 at the second end of the inhalation conduit may be coupled to an upstream component, such as a flow source.

[0475] In some embodiments, locking fingers 4822 may extend away from connector 4820. Locking fingers 4822 may be spaced apart and narrow along their length away from the connector. Locking fingers may have locking recesses formed at least on the outer surface of each locking finger. Locking recesses may lock partially with a gas delivery tube connector or other connector. Locking fingers may interact with the recesses of the gas delivery tube connector or other connector to align connector 4820 and the gas delivery tube connector or other connector.

[0476] the term

[0477] Unless the context explicitly requires otherwise, throughout the specification and claims, the terms "comprise," "comprising," etc., shall be understood to mean inclusive, not exclusive or exhaustive; that is, in the sense of "including but not limited to." Otherwise, conditional language used herein, such as "can," "could," "might," "may," "for example," etc., shall be understood to mean inclusive, not exclusive, not exhaustive. e.g. Unless specifically stated otherwise, or otherwise understood in the context as used, such conditional language is generally intended to convey that certain embodiments include certain features, elements, and / or states while other embodiments do not. Therefore, such conditional language is generally not intended to imply that features, elements, and / or states are in any manner required by one or more embodiments, or to imply that one or more embodiments necessarily include logic for determining (with or without author input or prompting) whether such features, elements, and / or states are included in any particular embodiment or to be performed in any particular embodiment.

[0478] The term "multiple" refers to two or more items. The enumeration of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should be understood as preceding the terms "about" or "approximately." The terms "about" or "approximately" mean that quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics need not be precise, but may be approximate and / or larger or smaller as needed, reflecting acceptable tolerances, conversion factors, rounding, measurement errors, and other factors known to those skilled in the art. The enumeration of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should also be understood as preceding the term "substantially." As used herein, the terms "approximately," "about," and "substantially" represent quantities close to the stated quantity and still performing the desired function or achieving the desired result. For example, in some embodiments, as the context may indicate, the terms "approximately," "about," and "substantially" may refer to quantities less than or equal to 10% of the stated quantity. As used herein, the term “generally” means that a value, quantity, or characteristic primarily includes or tends to include a particular value, quantity, or characteristic. For example, as the context may indicate, the term “generally linear” may mean approximately deviating from exact parallelism by less than or equal to 15°.

[0479] Numerical data may be expressed or presented in range format in this document. It should be understood that this range format is used merely for convenience and brevity, and therefore should be flexibly interpreted to include not only the numerical values ​​explicitly listed as the limits of the range, but also all individual numerical values ​​or subranges covered within the range, as if each numerical value and subrange were explicitly listed. For example, the numerical range “1 to 5” should be understood to include not only the explicitly listed values ​​of approximately 1 to approximately 5, but also the individual values ​​and subranges within the indicated range. Therefore, included within the numerical range are individual values ​​such as 2, 3, and 4, and subranges such as “1 to 3”, “2 to 4”, and “3 to 5”. The same principle applies to ranges that list only one numerical value (…). For example "Greater than 1"), and should apply regardless of whether the range or breadth of the property is described.

[0480] For convenience, multiple items may be presented in a common list. However, such lists should be interpreted as if each member of the list were independently identified as a separate and unique member. Therefore, unless otherwise indicated, individual members of such lists should not be considered solely based on their actual equivalent to any other member in the same group that is interpreted as being in the same list. Furthermore, when the terms “and” and “or” are used in conjunction with a list of items, they should be interpreted broadly, as any one or more of the listed items can be used individually or in combination with other listed items. Unless the context explicitly indicates otherwise, the term “alternatively” means selecting one of two or more alternatives and is not intended to limit the selection to only the listed alternatives or to only one of the listed alternatives at a time.

[0481] Any reference to prior art in this specification is not and should not be construed as an admission or in any way implying that such prior art is part of common general knowledge in the relevant field in any country of the world.

[0482] The invention can also be broadly defined as any or all combinations of the parts, elements, and features individually or jointly mentioned or indicated in the specification of this application, as well as two or more of the said parts, elements, or features.

[0483] In the above description, reference has been made to components in whole or in part having known equivalents thereof, which are incorporated herein as if described separately.

[0484] It should be noted that various variations and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its advantages. For example, various components may be repositioned as needed. Therefore, such variations and modifications are contemplated to be included within the scope of the invention. Furthermore, not all features, aspects, and advantages are necessary for practicing the invention. Therefore, the scope of the invention is intended to be defined solely by the following claims.

Claims

1. A patient interface component (3000, 4000), comprising: First interface main body; Second interface main body; A housing configured for detachable connection to either the first interface body or the second interface body, the housing comprising: a pair of tube engagement portions, each of the pair of tube engagement portions having a lateral entry point at opposite ends of the housing; and A pair of interface tubes, each of which is connected to one of the paired tube joints, and when detachably connected to the housing, allows gas to flow to and from the user through the first interface body or the second interface body. The first interface body and the second interface body are interchangeable, such that in the first configuration, the first interface body is connected to the housing, while in the second configuration, the second interface body is connected to the housing. Each of the first interface body and the second interface body includes a manifold configured to be received at least partially by the housing when the first interface body or the second interface body is detachably coupled to the housing. The manifold includes a first opening and a second opening that communicate with the interface tube when the first interface body or the second interface body is detachably coupled to the housing. The positions of the first opening and the second opening define lateral entry points for gas flowing into and out of each of the first interface body and the second interface body.

2. The patient interface component as described in claim 1, wherein, The first opening and the second opening are in fluid communication with each other via the manifold.

3. The patient interface component as described in claim 1 or 2, wherein, The first interface tube of the paired interface tubes includes an inspiratory conduit, while the second interface tube of the paired interface tubes includes an expiratory conduit.

4. The patient interface component as described in any of the preceding claims, wherein, The first opening and the second opening are on opposite sides of the manifold.

5. The patient interface component as described in any of the preceding claims, wherein, The first interface body is the cannula body, while the second interface body is the mask body.

6. The patient interface component as described in any of the preceding claims, wherein, The first interface body has a first size, while the second interface body has a second size, wherein the first size and the second size are different.

7. The patient interface component as described in any of the preceding claims, wherein, Each of the first interface body and the second interface body is configured to form a seal with the user's face.

8. The patient interface component as described in any of the preceding claims, wherein, The upper and lower edges of the shell are symmetrical.

9. The patient interface component as described in any of the preceding claims, wherein, The manifold includes a housing connection portion configured to be received within the housing when the first interface body or the second interface body is detachably connected to the housing.

10. The patient interface component of claim 9, wherein, The manifold also includes a protrusion adjacent to the housing connection portion, wherein the protrusion is configured to suppress rotation of the manifold around the housing when the first interface body or the second interface body is detachably connected to the housing.

11. The patient interface component as claimed in claim 9 or 10, wherein, The housing connection portion and the manifold are configured to be inserted into and received by the housing, and to form an airtight seal with the housing.

12. The patient interface component as claimed in any one of claims 9 to 11, wherein, The housing connection portion includes a trapezoidal shape defined between a first side facing the patient and an opposite second side of the housing connection portion, and the housing includes a shape complementary to the trapezoidal shape of the housing connection portion.

13. The patient interface component as described in any of the preceding claims, wherein, The manifold includes a ridge at each of the first opening and the second opening, the ridge being configured to form an airtight seal with the housing.

14. The patient interface assembly of claim 13, wherein the spine is a ring-shaped spine.

15. The patient interface component as described in any of the preceding claims, wherein, The manifold includes visual indicators for indicating correct positioning and proper alignment with the housing.

16. The patient interface component as described in claim 15 when dependent on claim 13 or 14, wherein, The visual indicator includes a colored ring located on or around the ridge of the manifold.

17. The patient interface assembly as claimed in any of the preceding claims further includes a fixing member coupled to the housing, the fixing member including a support pad for attachment to a user's face or headgear.

18. The patient interface assembly as claimed in any of the preceding claims, further comprising a midline fixation member, the midline fixation member being connectable to the housing at a first end and having a support pad at a second end, wherein, The support pad can be attached to the user's face or headgear.

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