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 fixing member having a pair of support pads, each of which is configured to engage with a user's face. In some configurations, the interface body may be an intubation cannula body or a mask body. In some configurations, the housing may receive different interface bodies, and these interface bodies are interchangeable.

Description

Technical Field

[0001] This disclosure generally relates to components of medical systems used for the intake and / or exhaust of gases into and out of a patient. In a specific aspect, this disclosure relates to the patient interface that forms part of the respiratory system. Prior Technology

[0002] In assisted ventilation, breathing gases are 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 gases can be directed to other devices (valve, ventilator, pressure device, etc.) or discharged into the patient's surrounding environment through similar breathing tubes.

[0003] 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.

[0004] References to patent specifications, other external documents, or other sources of information have been made in this specification, typically to provide context for discussing the features of this disclosure. Unless otherwise expressly stated, references to such external documents should not be construed as an admission that such documents or sources of information are prior art or part of common general knowledge in any jurisdiction.

[0005] Other aspects and advantages of this disclosure will become clear from the following description, given only by way of example. Summary of the Invention

[0006] 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.

[0007] 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 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.

[0008] In some configurations, the first interface main system cannula body.

[0009] In some configurations, the cannula body includes one or more nose forks.

[0010] In some configurations, the one or more forks are configured to be inserted into the user's nostrils and form a seal.

[0011] In some configurations, this second interface main system mask body.

[0012] In some configurations, this second interface is the main system nose mask.

[0013] In some configurations, the second interface main system is a mouth and nose mask.

[0014] 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.

[0015] In some configurations, the housing includes a top edge and a bottom edge.

[0016] In some configurations, the upper and lower edges of the housing are symmetrical.

[0017] In some configurations, the lower edge of the housing curves inward toward the housing.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] In some configurations, the patient interface component further includes one or more interface tubes.

[0023] In some configurations, the housing includes one or more tube engagement receiving portions configured to receive interface tubes.

[0024] In some configurations, the patient interface assembly further includes a fixing member configured to attach to the housing.

[0025] 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.

[0026] 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.

[0027] In some configurations, the interface body is configured to engage with the patient's face and form a seal.

[0028] In some configurations, this interface is the main body of the mask or the cannula.

[0029] In some configurations, the one or more tubes are configured to be connected to the housing.

[0030] In some configurations, the one or more tubes are formed as a single piece with the housing.

[0031] In some configurations, each of the one or more tubes includes an overmolded grip.

[0032] 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.

[0033] In some configurations, the first fixing member further includes a patch assembly that is coupled to each of the support pads to secure the support pads to the user.

[0034] In some configurations, the second fixing member is attached to the housing.

[0035] In some configurations, the second fixing member is configured to engage the user's forehead.

[0036] In some configurations, the second fixing member is constructed of fabric material.

[0037] In some configurations, the second fixing member further includes a patch assembly for securing the second fixing member to the user.

[0038] In some configurations, the interface body has a Shore hardness between 20A and 100A.

[0039] In some configurations, each of the one or more interface tubes is tapered toward one end.

[0040] One aspect of this disclosure relates to a patient interface comprising an interface body. The interface body includes: one or more forks extending from a base region therefrom; and one or more openings for allowing a flow of breathing gas 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.

[0041] In some configurations, the interface body includes a right fork and a left fork.

[0042] In some configurations, the thickness of the one or more forks varies along the length of the one or more forks.

[0043] 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.

[0044] In some configurations, the base region has a thickness smaller than that of the rest of the interface body.

[0045] In some configurations, the base region has a surface that is recessed relative to the adjacent region of the interface body.

[0046] In some configurations, the base region has a recessed surface surrounding the one or more forks.

[0047] In some configurations, the base region has a recessed surface extending around the two forks.

[0048] In some configurations, the one or more forks are configured to flex in the forward and backward directions.

[0049] In some configurations, the one or more forks are configured to flex in the left-right direction.

[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 have a circular cross-section near the tip of the fork.

[0052] In some configurations, the one or more forks are configured to flex while maintaining the diameter and cross-sectional shape along their length.

[0053] In some configurations, the one or more forks are configured to flex while maintaining their flow resistance (RTF).

[0054] 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.

[0055] In some configurations, the respiratory system further includes an expiratory conduit configured to receive gas from the patient interface.

[0056] In some configurations, the respiratory system further includes an bubbling device.

[0057] In some configurations, the respiratory system further includes a humidifier.

[0058] In some configurations, the housing is configured to receive each of a plurality of interface bodies, such that the interface bodies are interchangeable.

[0059] In some configurations, this interface is the main body of the mask or the cannula.

[0060] In some configurations, the one or more interface tubes are configured to be connected to the housing.

[0061] In some configurations, one of the one or more interface tubes is configured to be connected to the inhalation conduit.

[0062] In some configurations, the one or more tubes are formed as a single piece with the housing.

[0063] In some configurations, each of the one or more tubes includes an overmolded grip.

[0064] 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.

[0065] In some configurations, the first fixing member further includes a patch assembly that is coupled to each of the support pads to secure the support pads to the user.

[0066] In some configurations, the patient interface further includes a second fixation member that is coupled to the housing.

[0067] In some configurations, the second fixing member is configured to engage the user's forehead.

[0068] In some configurations, the second fixing member is constructed of fabric material.

[0069] In some configurations, the second fixing member further includes a patch assembly for securing the second fixing member to the user.

[0070] In some configurations, the respiratory system further includes a headgear or cap.

[0071] In one aspect of this disclosure, with respect to a fixation member for a patient interface for a respiratory system, the fixation member includes a soft, flexible barb for detachably engaging with the housing of the patient interface.

[0072] In some configurations, the barb includes one or more tabs.

[0073] In some configurations, the housing includes an opening, wherein one or more tabs are configured to engage with the housing at the opening.

[0074] In some configurations, the barb includes a notch. This notch is configured to facilitate the collapse of the barb.

[0075] 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.

[0076] In some configurations, the barb is overmolded onto the fixing member.

[0077] In one aspect of this disclosure, regarding a fixation member for a patient interface of a respiratory system, the fixation member includes 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.

[0078] In some configurations, the support pad is flexible.

[0079] In some configurations, the fixing member further includes a hinge between the support pad and a portion of the fixing member.

[0080] In some configurations, the support pad is overmolded onto the fixing member.

[0081] In some configurations, the hinge is a 180-degree hinge.

[0082] One aspect of this disclosure relates to a fixation member for a patient interface of 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.

[0083] In some configurations, the first flexible part is a barb.

[0084] In some configurations, the second flexible portion serves as a support pad.

[0085] In some configurations, the first flexible portion and / or the second flexible portion are overmolded onto the third rigid portion.

[0086] In some configurations, the second flexible portion is hinged relative to the third rigid portion.

[0087] In some configurations, the fixing member can be detachably attached to the housing of the patient interface.

[0088] In some configurations, this component is the housing or interface body.

[0089] 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 cavity 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] In some configurations, the angled protrusions of the manifold housing connection extend from the rear side of the manifold at a 60-degree angle.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] In some configurations, the ridge is a ring-shaped ridge.

[0098] In some configurations, the ridge is configured to seal against the inner surface of the housing.

[0099] In some configurations, the manifold has a first distance between the front side of the engagement surface and the annular ridge and a second distance between the rear side of the engagement surface and the annular ridge, wherein the second distance is greater than the first distance.

[0100] In some configurations, the 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.

[0101] 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.

[0102] In some configurations, the shell system is a rigid shell.

[0103] In some configurations, one or more features or openings are used to attach a second fixing member to the housing.

[0104] In some configurations, the second fixing member is detachably connected to the housing.

[0105] 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.

[0106] In some configurations, the side protrusion features an enlarged head and a rod for pushing into the mating connection.

[0107] In some configurations, the first fixing member is detachably connected to the housing.

[0108] In some configurations, the patient interface assembly further includes conduits that are integral with the housing.

[0109] In some configurations, the patient interface assembly further includes conduits, which are detachably connected to the housing.

[0110] 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 of the support pads, wherein the bridging portions include cutouts for receiving a housing, and wherein the bridging portions include thickened portions surrounding the cutouts.

[0111] In some configurations, the fixing member further includes a patch assembly that is attached to each of the support pads to secure the support pads to the user.

[0112] In some configurations, the retaining member further includes openings configured for detachably attaching the retaining member to protrusions on the housing, wherein the first retaining member is pushed into the protrusions that engage with the housing.

[0113] 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.

[0114] 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.

[0115] In some configurations, the interface body includes a manifold, and the feature includes a shoulder portion on the rear of the manifold.

[0116] In some configurations, the shoulder portion abuts against the housing to limit rotation.

[0117] In some configurations, this feature includes keyed features on the manifold and housing.

[0118] In some configurations, the interface body includes the cannula body.

[0119] In some configurations, the interface body includes a face mask body.

[0120] In some configurations, the housing includes one or more tube engagement receiving portions configured to receive interface tubes.

[0121] One aspect of this disclosure relates to a patient interface assembly for a respiratory system, the patient interface assembly 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.

[0122] In some configurations, the locking finger at the second end of the expiratory tubing is configured to connect to a downstream component.

[0123] In some configurations, this downstream component includes a bubbler.

[0124] In some configurations, the locking finger at the second end of the inhalation duct is configured to connect to the upstream component.

[0125] In some configurations, this upstream component includes a flow source.

[0126] In some configurations, the locking fingers extend away from the connector, are spaced apart, and narrow along their length away from the connector.

[0127] In some configurations, the 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, and 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.

[0128] One aspect of this disclosure relates to a patient interface assembly for a respiratory system, the patient interface assembly 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.

[0129] In some configurations, the interface body includes the cannula body.

[0130] In some configurations, the interface body includes a face mask body.

[0131] In some configurations, the low-friction surface coating or finish is achieved either by a parylene coating or by a sandblasting process (such as beading).

[0132] 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.

[0133] 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.

[0134] One aspect of this disclosure relates to a manufacturing process for a patient interface component for a respiratory system, the manufacturing process comprising manufacturing an interface body and coating the outer surface of the interface body with a low-friction surface coating or finish.

[0135] In some configurations, the interface body includes the cannula body.

[0136] In some configurations, the interface body includes a face mask body.

[0137] In some configurations, the interface body can be detached from the housing.

[0138] In some configurations, the entire outer surface of the interface body is coated.

[0139] In some configurations, a portion of the interface body is coated, wherein the interface body includes a patient-facing rear side of the interface body and a front side opposite to the rear side, wherein the coated portion is the rear portion of the manifold of the interface body.

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

[0141] One aspect of this disclosure relates to a patient interface assembly, the 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 the 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. When disassembling and connecting, the assembly and alignment of the interface body are improved; and the feature restricts the rotation of the interface body relative to the housing, and 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 of 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.

[0142] In some configurations, the interface body includes the cannula body.

[0143] In some configurations, the interface body includes a face mask body.

[0144] In some configurations, the inhalation tube and the exhalation tube are integrated with the housing.

[0145] In some configurations, the first fixing member and the second fixing member can be connected to the housing.

[0146] In some configurations, the second fixation component can be connected to the patient's patch assembly or headgear.

[0147] In some configurations, the second fixing member is detachably attached to the housing.

[0148] In some configurations, the interface body is detachably attached to the housing.

[0149] 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 opposite ends of the housing, wherein the tube engagement portions are configured to receive interface tubes.

[0150] In some configurations, the interface body may include a cannula body.

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

[0152] 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 the tube engagement portions are configured to receive interface tubes. 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.

[0153] 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.

[0154] In some configurations, the first opening and the second opening may be configured to communicate with interface tubes, which are configured to deliver gas flows into and out of the mask and the manifold on the first lateral side and the second lateral side.

[0155] One aspect of this disclosure relates to an interface body comprising a face mask, wherein the face mask defines a breathing chamber and has a user contact surface configured to contact a user's face and at least surround the user's nostrils, the face mask comprising a face mask seal, wherein at least a portion of the face mask seal includes a stiffness-reduced region, wherein the stiffness-reduced region is positioned between a first stiffer region and a second stiffer region, wherein the first stiffer region and the second stiffer region have a stiffness greater than that of the stiffness-reduced region, wherein as the first stiffer region moves toward the second stiffer region, the stiffness-reduced region buckles in a unidirectional direction as the first stiffer region continues to move toward the second stiffer region.

[0156] In some configurations, the first rigider region may include a structural support portion that extends partially around the circumference of the mask.

[0157] In some configurations, the second, harder area can be the front portion of the mask.

[0158] One aspect of this disclosure relates to a patient interface assembly comprising: an interface body including a housing connection portion having a first side facing the patient and an opposite second side, wherein the housing connection portion includes a shape defined between the first and second sides of the housing connection portion; and a housing including an interface body receiving portion having a shape complementary to the shape of the housing connection portion of the interface body, wherein the housing is configured for detachably connecting to the interface body.

[0159] In some configurations, the shape of the housing connection portion may include a trapezoidal shape.

[0160] In some configurations, the housing connection portion of the interface body may include a wider trapezoidal base near the front portion of the housing.

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

[0162] 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.

[0163] In some configurations, the one or more forks may include a thickness that varies along the length of the one or more forks.

[0164] In some configurations, the one or more forks can maintain a constant thickness along the length of the one or more forks.

[0165] 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. Simple Explanation of the Diagram

[0166] 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.

[0167] [Figure 1] shows an example of a system that can be implemented using a patient interface.

[0168] [Figure 2] shows an example of a system that can be implemented using a patient interface.

[0169] [Figure 3] shows the anterior, apex and lateral stereoscopic views of the patient interface.

[0170] [Figure 4] is a stereoscopic view of the patient interface in Figure 3, showing the frontal, top, and side views.

[0171] [Figure 5] shows the anterior, apex and lateral stereoscopic views of the patient interface.

[0172] [Figure 6] is a stereoscopic view of the patient interface in Figure 5, showing the frontal, top, and side views.

[0173] [Figure 7] Front, top and side perspective views of the shell.

[0174] [Figure 8] is a front view of the housing in Figure 7.

[0175] [Figure 9] is a rear view of the housing in Figure 7.

[0176] [Figure 10] Front, top and side views of the main body of the intubation tube.

[0177] [Figure 11] is a front view of the cannula body in Figure 10.

[0178] [Figure 12A] is a top view of the cannula body in Figure 10.

[0179] [Figure 12B] is a rear view of the cannula body in Figure 10.

[0180] [Figures 13A to 13D] represent the nose fork of the intubation tube body.

[0181] [Figures 13E to 13I] show a view of the nasal fork of the cannula body.

[0182] [Figure 14A] is a schematic diagram of the nose interface in Figure 10, showing the thickness analysis.

[0183] [Figure 14B] is a schematic diagram of the nose interface, showing the thickness analysis.

[0184] [Figure 14C] is a cross-sectional view of the nose fork of the cannula body.

[0185] [Figure 15] shows the stereoscopic views of the patient interface from the rear, top, and sides.

[0186] [Figure 16] shows the anterior, apex and lateral stereoscopic views of the patient interface.

[0187] [Figure 17] is a front view of the patient interface in Figure 16.

[0188] [Figure 18] is a top view of the patient interface in Figure 16.

[0189] [Figure 19] is a rear view of the patient interface in Figure 16.

[0190] [Figures 20 and 21] are schematic diagrams of the patient interface in Figure 16.

[0191] [Figure 22A] shows the front, top, and side perspective views of the main body of the mask.

[0192] [Fig. 22B] is a rear, top, and side perspective view of the main body of the mask in Fig. 22A.

[0193] [Figure 23] is a schematic diagram of the main body of the mask in Figure 22A.

[0194] [Figure 24A] is a three-dimensional view of the main body of the mask, including rear view, top view, and side view.

[0195] [Figure 24B] is a top cross-sectional view of the main body of the mask.

[0196] [Figure 24C] is a side cross-sectional view of the main body of the mask.

[0197] [Figure 24D] is a schematic diagram of the top cross-section of the main body of the mask.

[0198] [Figure 24E] is a schematic diagram of the side cross-section of the main body of the mask.

[0199] [Figure 25] shows the anterior, apex and lateral stereoscopic views of the patient interface.

[0200] [Figure 26] is a top view of the patient interface in Figure 25.

[0201] [Figure 27] shows the front, top, and side perspective views of the fixed component.

[0202] [Figure 28] is a front view of the fixed component in Figure 27.

[0203] [Figure 29] shows the front, top, and side views of the fixed components and the shell.

[0204] [Figure 30] is a rear view of the fixing components and housing in Figure 29.

[0205] [Figure 31] is a schematic diagram of the fixed component.

[0206] [Figure 32] is a schematic diagram of the fixed component.

[0207] [Figure 33] shows the front view, top view, and side view of the fixed component.

[0208] [Figure 34] is the front view of the fixed component in Figure 33.

[0209] [Figure 35] is a rear view of the fixed component in Figure 33.

[0210] [Figure 36] shows the front, top, and side views of the patient interface component.

[0211] [Figure 37] is a top view of the shell.

[0212] [Figure 38] is a top perspective view of the interface shell.

[0213] [Figure 39A] is a front perspective view of the fixed component.

[0214] [Figure 39B] is a rear perspective view of the fixed component.

[0215] [Figure 39C] is a top view of the fixed component.

[0216] [Figures 40 to 42] are front perspective views of the fixed components.

[0217] [Figure 43A] is a front view of the fixed components and the shell.

[0218] [Figure 43B] is a top view of the shell.

[0219] [Figure 44] shows the front and side perspective views of the fixed component.

[0220] [Figure 45] is a view of the fixed component.

[0221] [Figures 46A to 46B] are perspective views of the front and rear sides of the fixed component.

[0222] [Figure 47] is a front perspective view of the fixed components and the shell.

[0223] [Figure 48A] is a rear view of the cannula body.

[0224] [Figure 48B] is a front view of the main body of the face mask.

[0225] [Figure 48C] is a schematic diagram of the main body of the mask, front view.

[0226] [Figure 48D] is a schematic diagram of the main body of the mask, including front and side perspective views.

[0227] [Figure 48E] is a top view of the main body of the mask.

[0228] [Figure 49] is a top view of the nose interface and the shell.

[0229] [Figure 50] is a partial top view of the nose interface and the shell.

[0230] [Figures 51A to 51B] are partial top views of the nose interface and the shell.

[0231] [Fig. 52A] is a top view of the nose interface and the shell.

[0232] [Fig. 52B] is a rear view of the nose interface and housing in Fig. 52A.

[0233] [Fig. 53A] is a top view of the nose interface and the shell.

[0234] [Fig. 53B] is a partial top view of the nose interface and shell of Fig. 53A.

[0235] [Fig. 53C] is a partial top view of the nose interface and shell of Fig. 53A.

[0236] [Fig. 53D] is a partial top view of the nose interface and shell of Fig. 53A.

[0237] [Figure 54] is a side cross-sectional view of the main body of the interface.

[0238] [Figure 55] is a side cross-sectional view of the interface body.

[0239] [Figures 56A to 56D] are views of the interface body and the shell.

[0240] [Figures 56E to 56F] are views of the interface body, housing, and pipes of the interface assembly.

[0241] [Figure 57] Front perspective view of the interface pipes and connectors. Implementation

[0242] 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, those skilled in the art will understand 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.

[0243] 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 under discussion and the associated figures. Respiratory system

[0244] Figure 1 illustrates an exemplary respiratory system 1000 in which 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 can be directed from the interface 3000 to a resistance device, 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 a water-based resistance device is shown in Figure 1, those skilled in the art will understand that the resistance device may be any other mechanical or resistive device as known in the art.

[0245] Referring now to Figure 2, another example of a respiratory system including an evaporator 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 exhalation catheter 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 pertain to humidification. The inspiratory catheter 201a is connected to the outlet 112 of a humidification chamber 110, which contains a certain amount of water 115. The inspiratory catheter 201a may include a heating device or heating wire 120 that heats the walls of the catheter to ensure a constant humidity distribution along the catheter and thus reduce condensation of the humidified gas within the catheter. 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, while 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.

[0246] 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. Patient interface components

[0247] Figures 3 through 6 illustrate embodiments of the patient interface 3000. As shown in Figures 3 through 6, 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, as shown in Figures 3 and 4. 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 the mask body 3200b shown in Figures 5 and 6. The mask body 3200b has a mask or mask cushion that can form a seal with the user's face. The illustrated embodiments of the patient interface 3000 also include a first fixing member 3600, one or more interface tubes 3800, and a second fixing member 3900.

[0248] 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 swapped while maintaining the housing 3400 connected to a headgear, cap, chin strap, or 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 of different sizes 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.

[0249] In some embodiments, the housing 3400 may be permanently attached 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 attached to and / or detached from the interface tube 3800. In some embodiments, the 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.

[0250] 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 facilitates securing the interface body to the user's face, thereby forming and maintaining a seal between the interface body and 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, by 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 by other securing means such as a headgear or chin strap. As shown in Figures 3 to 6, the first fixing member 3600 may extend horizontally or substantially horizontally. However, the first fixing member 3600 may be positioned in any suitable orientation.

[0251] 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. As shown in Figures 3 through 6, the second fixation member 3900 may extend vertically or substantially vertically. However, the second fixation member 3900 may be positioned in any suitable orientation.

[0252] The patient interface 3000 may further include one or more interface tubes 3800. In some embodiments, the walls of the interface tubes 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 coupled 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 connectors 3860, such as tubes 201a and 201b, for connection to a breathing component. The connectors 3860 may be overmolded to the tubes 3800. The connectors 3860 may be or include silicone or elastomeric materials. The connectors 3860 may have similar or greater stiffness than 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 attached 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.

[0253] In some embodiments, the tube 3800 may be detachably connected 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 component. 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 using a semi-circular or D-shaped cross-section, the flat side of the interface tube 3800 can face the patient. case

[0254] Figures 7 to 9 illustrate embodiments of the housing 3400. In the illustrated embodiments, 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.

[0255] In the illustrated embodiment, the front portion 3430 includes one or more attachment elements. The one or more attachment elements may extend outwardly from the front portion 3430. In the embodiments shown in Figures 7 through 9, the one or more attachment elements may include a central protrusion 3440 and a front extension 3420. In some embodiments, such as those shown in Figures 7 through 9, the 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.

[0256] In some embodiments, such as shown in FIG7, the front extension 3420 may project forward. 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, a 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 can be detachably coupled to the housing 3400 when the patient interface 3000 is assembled.

[0257] The central protrusion and the front extension can be used to secure one or more fastening members to the housing 3400. The central protrusion and the front extension can be shaped as complementary portions for receiving the fastening members. As shown in Figures 7 through 9, in some embodiments, the central protrusion 3440 may include an enlarged head 3442 and a rod 3444. In other embodiments, such as those shown in Figures 37 and 38, the central protrusion 3440 may have an opening to receive the fastening member, as described herein with reference to Figures 37 through 38.

[0258] As shown in Figures 7 to 9, 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 attached to the housing 3400 at the central protrusion 3440. In some embodiments, the central protrusion 3440 is positioned in the middle or substantially in the middle of the front portion 3430 and between the front extensions 3420.

[0259] In some embodiments, the front extension 3420 may be positioned on either side of the central protrusion 3440, as shown in Figures 7 through 9. The front extension may have a shape for receiving complementary fastening members. As shown in Figures 7 through 9, 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 fastening 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, as shown in Figures 37 and 38, the front protrusion 3420 may be circular to receive fastening members, as described herein with reference to Figures 37 through 38.

[0260] In the illustrated embodiment, the rear portion 3450 of the housing 3400 includes an interface body receiving portion 3480 for receiving an interface body (such as 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.

[0261] 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.

[0262] 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, the user or clinician can orient the housing 3400 in either direction. As shown in Figures 8 and 9, 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, an oropharyngeal tube can be introduced into the patient, and the user's mouth will be easily cleaned.

[0263] 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), allowing the housing 3400 to provide structural stability for the patient interface 3000. For example, the housing 3400 may 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 may 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 rigidity 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. Interface main body

[0264] As described herein, 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. 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. Intubation body

[0265] Figures 10 through 12B illustrate embodiments of the cannula body 3200a. In other embodiments, the cannula body described herein may have similar features as described with reference to Figures 10 through 12B. For example, embodiments of the cannula body described with reference to Figures 21, 48A, 49, 52A through 52B, 53A, and 55 may include the features described herein with reference to the cannula body 3200a and the nose fork. As shown in Figures 10 through 12B, the cannula body 3200a may have at least one nose 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 nose forks 3220 may form a seal with the user's nostrils and allow gas to flow out of and to the user. The nose forks 3220 of the patient interface shown and described herein are shaped for sealing in the patient's nostrils. In some embodiments, the nose forks are shaped for sealing in the nostrils of an infant. However, it should be understood that the fork can be adapted to any patient group with similar nostril geometry, and forks of different absolute sizes can be provided for various patient groups. The fork 3220 can be shaped and formed to minimize tissue compression and kinking of one or more forks 3220 during insertion into the patient's nostril.

[0266] In the illustrated embodiment, manifold 3240 defines one or more openings 3246, such as a pair of openings 3246, which can be coupled to the 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. Except for the lumens of the openings 3246 and nose fork 3220, manifold 3240 can be sealed. The openings 3246 can be positioned on the sides of manifold 3240. As shown in Figures 10 through 12B, manifold 3240 can have two openings 3246, and the openings 3246 can be on opposite sides of manifold 3240. When manifold 3240 is coupled to the tube engagement portion 3460 of housing 3400, the openings 3246 positioned on the sides of the manifold allow lateral fluid flow to enter and exit manifold 3240 through the openings 3246. fork of the cannula body

[0267] 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 show the geometry of embodiments of forks 105, which may be similar to or the same as nasal forks (such as nasal forks 3220 and 4220) on the cannula body described herein.

[0268] As shown in Figures 13A and 13B, 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 forks 105 are pushed into the patient's nostril, they 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.

[0269] 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 shown and referred to in Figures 13A to 13D, the shape and / or diameter of the internal cross-section of the fork may vary along its length.

[0270] 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.

[0271] The nose fork 105 can be shaped to extend generally upward and backward into the user's nostrils, and the nose fork 105 has a curvature including at least two inflection points, for example, as shown in Figures 13A to 13D and described herein.

[0272] The fork 105 can extend from the intubation body or manifold toward the user's nasal septum and curves upward and backward around the corner of the user's nostril into the user's nostril. 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.

[0273] 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.

[0274] 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 toward the ends of the trajectory or fork 105.

[0275] 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).

[0276] The geometry of the forks described herein (such as those shown in Figures 10 to 12B, and Figures 48A, 49, 52A to 52B, and 53) can be substantially as shown in Figures 13A to 13D, where the curves represent the fork trajectory, and the ellipse 1135 primarily represents the orientation of the cavity within each fork at a particular trajectory (and also shows 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.

[0277] 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 conformable to limit pressure on the patient's nasal septum. In other embodiments, the fork wall thickness may always be uniform.

[0278] From the base 1415, each fork 105 can be generally upward or high toward the top of the user's head (away from the lateral 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.

[0279] 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 middle lateral component) toward the sagittal plane. The fork lumen may further decrease during this stage and may become increasingly elliptical.

[0280] 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).

[0281] 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 back (towards the coronal plane), with a slightly middle-outer component toward the sagittal plane (represented by the orientation of the final ellipse 1135 in FIG. 13A).

[0282] 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.

[0283] 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 direct breathing air upward or upward toward the top of the user's head (away from the transverse plane) and backward or backward (toward the user's coronal plane).

[0284] In an alternative embodiment, the cross-section of the cavity may be triangular or quadrilateral.

[0285] As shown in Figures 13C to 13D, the nasal fork may have a sealing region 1109 that is longer than the sealing region 109 of the earlier described embodiments with reference to Figures 13A to 13B. The longer sealing region 1109 can result in a longer overall length of the nasal fork in this embodiment compared to the previously described embodiments. This may have the additional benefit of making the fork less likely to protrude from or otherwise separate from the patient's nostril. Referring to the curve representing the fork trajectory and the ellipse in Figures 13C to 13D, the fork sealing region 1109 lies between ellipses 1134a and 1135. The fork sealing region 1109 may include a tapered 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.

[0286] 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 3000 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 105 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.

[0287] 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.

[0288] 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.

[0289] 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 not too steep; 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.

[0290] Patient interfaces of different sizes (3000) can be provided, and different fork seal area sizes can be used for them.

[0291] 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.

[0292] The nose fork lumen may flare outward at or near the lumen outlet. Examples of nose fork lumens with an outwardly flared portion or alternative outlet shape are shown in Figures 13E and 13H. As shown in Figure 13E, the end of the fork 305 adjacent to the fork outlet 308 may be shaped to reduce flow resistance in the fork 305. For example, the fork 305 may be cut horizontally or at an angle. This can reduce flow resistance in the fork 305. Alternatively or additionally, when the fork 305 is viewed from above the interface 300 at the same or similar angle as in Figure 13F, the fork outlet 308 may have a generally U-shape, as shown in Figure 13G. 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. Base of the nose fork

[0293] The cannula body may have a basal region at and / or near the base of the nasal fork. The basal region may form part of the cannula body, wherein 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 may be designed to provide patient comfort and compliance while also ensuring a flow path is maintained between the manifold and the nasal fork.

[0294] 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 can 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 can be moved, for example, by forces applied to the interface by pulling the tube, facial movements, and / or gripping the interface, while simultaneously securing the fork in the proper position within the nostril. The base region may also provide a spring mechanism that can operate to compensate for external forces applied to or exerted on 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.

[0295] 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 in conjunction with any of the cannula body embodiments and / or nasal fork embodiments described herein.

[0296] In some embodiments, manifold 3240 may have a base region that may be a recessed or sunken area below and / or adjacent to the base of fork 3220. For example, in the embodiments shown in Figures 10-12B, manifold 3240 includes one or more recesses 3222 located below fork 3220. The one or more recesses 3222 may support fork 3220 relative to a peripheral portion of manifold 3240. As shown in Figures 10-12B, recesses 3222 may extend substantially around or at least partially around the base of each fork 3220. Recesses 3222 may facilitate pivoting and movement of fork 3220 around or relative to a peripheral portion of manifold 3240. The ability of fork 3220 to pivot at or near its base allows for more efficient fitting and sealing of fork 3220 into the patient's nostril without disrupting airflow. The fork 3220 can be bent or moved relative to the manifold 3240, which can separate the position or orientation of the fork 3220 from the position of the manifold / housing. In other words, the housing / manifold can move when the fork 3220 is held in the sealed position in the nostril.

[0297] 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 lateral movement to accommodate changes in the size of the nasal septum and / or helps 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 3220, allowing for a greater degree of adjustability.

[0298] The manifold 3240 may have varying thicknesses in different regions. For example, at least a portion of the groove 3222 may be thinner relative to the fork 3220 and the remainder of the manifold 3240, as shown in Figure 14A (wherein in Figures 14A and 14B, the thinner material area of ​​the fork is shown in dark shading). The groove 3222 may facilitate movement of the fork 3220 to help maintain a seal with the patient's nostril. The groove 3222 may also help ensure that the fork 3220 is folded, bent, or flexed into the manifold 3240 by the groove 3222 rather than collapsing 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.

[0299] As shown in Figure 14A, the manifold 3240 may further include a thickened region 3249 adjacent to the groove 3222, shown by a lighter shaded area adjacent to the groove 3222. When the fork 3220 is placed in the user's nostril, the thinner-walled groove 3222 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 inwards into the manifold 3240. When in the flexed or deflected position, the groove 3222 can provide an upward force into 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.

[0300] In some embodiments, the groove or recessed area at the base of the fork 3220 can be continuous. Figure 14B shows a cannula body 3200a having a recessed area 3223 extending continuously around the base of the two forks 3220. Similarly, utilizing the groove 3222, the recessed area 3223 can have a reduced thickness relative to the rest of the forks 3220 and manifold 3240, as shown in Figure 14B. The recessed area 3223 can provide greater flexibility to the forks 3220 than the groove 3222, because there is no harder portion present between the forks 3220 and the groove 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 the cannula body 3200a easier due to the relatively absence of small cavities or spaces. The groove or recessed area can partially or completely surround the base of the fork. For example, a groove or recessed area may be on one or both sides of each fork to allow adjustment for the width of the nasal septum. The groove or recessed area 3222 at the base of the fork 3220 may allow spring-like movement at the base of the fork to separate the movement of the nose fork from the movement of the housing and / or manifold, and to secure the nose fork in the correct sealing position in the nostril.

[0301] 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.

[0302] The wall thickness of the nasal fork can vary from the base of the fork 309 to the outlet 308. As shown in Figure 14C, the wall at the base of the fork 309 can have a first thickness t1 when extending from the manifold. When extending toward the outlet, the wall of the fork can have a second thickness t2. The first thickness t1 can be thinner than the second thickness t2. The first thickness t1 can 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 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 the groove or sunken area, but without the groove.

[0303] 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.

[0304] 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. As shown in FIG10, each of the nose forks 3220 has a gas outlet 3224 configured to direct a flow of gas toward the user's nostril. 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 nostril. 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 to the user's nostril. In another embodiment, the sealing surface 3226 is configured to seal between the nostril entrance and the nasal valve.

[0305] 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 movements 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 3220 may have a circular cross-section in the portion closer to the base, while the forks 3220 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 resemble the varying shapes described herein with reference to Figures 13A through 13D.

[0306] Figure 15 illustrates a cannula body 3200a with a base region 3228 that can provide a spring-like action or mechanism at the base of the fork 3220. The base region 3228 can be used to 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 of the interfacial 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 is 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 movement, patient movement, or headgear movement. The base region 3228 can indicate that the fork, or each fork 3220, moves from right to left.

[0307] The basal region 3228 can accommodate varying nasal septal septum ...

[0308] In some embodiments, the base region 3228 may be a region with reduced thickness. A region with reduced thickness can 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 a replacement for other base regions. For example, the base region 3228 may be a bellows region, which can 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.

[0309] Figure 15 illustrates an embodiment of the base region 3228 at the base of the fork 3220. The fork 3220 may have a constant wall section of constant thickness that transitions to the base region 3228 around the fork, allowing 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.

[0310] 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.

[0311] 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 (refer 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.

[0312] 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 inward flexion or deflection. 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 relative absence of small cavities or spaces. Connection between the interface body and the housing

[0313] Referring back to Figures 10 through 12B, 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 housing 3400. Housing connection portion 3244 and the remainder of manifold 3240 may be shaped and / or sized for insertion into and reception by housing 3400, forming an hermetically tight seal. For example, 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 housing 3400, thereby forming an hermetically tight seal with housing 3400.

[0314] 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 the upper and lower portions 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 does 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 relative to the rest of manifold 3240.

[0315] As discussed herein, the cannula body 3200a can be coupled 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 illustrate an embodiment of the cannula body 3200a assembled with the housing 3400. As shown in Figures 16 and 17, when the cannula body 3200a is coupled 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 lower edge 3490 may be shaped such that a certain amount of clearance exists between them during assembly to allow for a 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 or less than that of the housing 3400, such that the protrusion 3242 may protrude or be recessed relative to the surface of the housing 3400.

[0316] The protrusion 3242 can also indicate 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 3240 and / or housing 3400 may emit a "click" sound when it is correctly positioned and properly assembled. In some embodiments, the manifold 3240 and / or housing 3400 may include a visual indicator that indicates when the manifold 3240 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 further described herein with reference to Figures 56A through 56F.

[0317] When assembling the housing 3400 and the manifold 3240, the housing 3400 may only contact the manifold 3240 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.

[0318] Figures 20A and 20B illustrate how the manifold 3240 can be secured within the housing 3400. As shown in Figures 20A and 20B, the inner surface of the housing 3400 can mate with the manifold 3240, thereby securing the manifold 3240 within the housing 3400. As shown in Figures 20A and 20B, 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 hermetically tight seal with the inner surface of the housing 3400. mask body

[0319] Figures 22A and 22B illustrate an embodiment of the mask body 3200b. In the illustrated embodiment, the mask body 3200b includes a manifold 3240 that is identical or similar to the manifold 3240 of the cannula body 3200a. For example, the manifold 3240 includes a protrusion 3242, a housing connection portion 3244, an opening 3246, and an annular ridge 3248, as described in conjunction with Figures 10 to 13. 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, which includes 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.

[0320] 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.

[0321] The mask 3232 or 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 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 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 against 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.

[0322] 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.

[0323] Figure 23 shows a schematic diagram of the face mask body 3200b from the face contact side or rear side. In some embodiments, as shown by the striped area in Figure 23, a region 3237 ("roll-up region") of the face mask 3232 may be provided. The region 3237 may be designed such that at least a portion of the 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 face contact surface 3234. The roll-up region 3237 may be intended to alleviate pressure applied to the user's nose and / or face, which is required to provide a seal sufficient for the delivery of treatment.

[0324] To illustrate the roll-up of region 3237, region 3237 may have varying thickness or varying stiffness. Region 3237 may be formed by and / or extend co-located with regions of reduced stiffness. In some embodiments, the wall thickness of the mask 3232 may be substantially constant over the entire roll-up region 3237. In some embodiments, the wall thickness of the mask 3232 may vary or alternate between relatively thick and relatively thin regions. The wall thickness of the mask 3232 may be relatively thick along other portions of the mask, thereby providing support for the structure of the mask 3232. However, other arrangements may also be used to induce or facilitate the roll-up of 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.

[0325] In some embodiments, the lower or base portion 3256 of the face mask 3232 may have a region with greater thickness / stiffness, which can 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 a 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.

[0326] 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.

[0327] 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.

[0328] In some embodiments, various or alternative shapes or sizes of the mask 3232a may be provided to achieve a desired fit for comfort, compliance, and / or efficient delivery of therapy. The mask 3232a shown in FIG. 24A is similar to the mask 3232 described with respect to FIGS. 22A-23; however, the mask 3232a may have a different shape. The mask 3232a may have a width measured from a first end 3252 at a first annular ridge 3246 to a second end 3254 at a second annular ridge 3246 (shown in FIG. 22A). The mask 3232a may have a horizontal axis extending along this width and a vertical axis perpendicular to the horizontal axis. As shown in FIG. 24, the mask 3232a may be longer in the vertical direction than the mask 3232 described herein. This shape may allow the mask 3232a to seal further upwards over the user's nose than the mask 3232 shown in FIGS. 22-23. This configuration may be more comfortable for the patient. Additionally, a higher seal on the user's nose minimizes the risk of obstructing the patient's airway or otherwise affecting the flow of air in or out of the patient's airway, especially in infants. For example, by configuring the mask so that it seals higher on the bridge of the user's nose or on a harder 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. Mask roll-up area

[0329] 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 delivered 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 that forms the mask seal.

[0330] The mask 3232a may include a roll-up region 3237 as described with respect to Figures 22A-23. In some embodiments, the roll-up region may be rolled up or bent to allow the mask to adapt to facial movement or apply force to the mask. For example, a roll-up aspect at the side of the mask and a pivot point 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 region 3237 is designed to reduce pressure on the bridge of the nose. In some embodiments, the roll-up region 3237 is present at the side 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 adapt to cheek movement. In some embodiments, even if the cheek is compressed, the roll-up region 3227 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).

[0331] To illustrate rolling or bending, region 3237 can have varying thickness or varying stiffness. In configurations such as those shown in Figures 24B to 24E, region 3237 includes a thin / thick / thin configuration. Figures 24B to 24E show a mask body 3200b, in which mask 3232b has reduced thickness or thin regions 3237b and 3237c, which allow for rolling, bending, or folding of mask 3232b. In the illustrated embodiment, thin region 3237c is configured for rolling or bending over the relatively thicker or stiffer front portion 3238 of mask 3232b.

[0332] Figures 24B to 24E illustrate the mask body 3200b, wherein the mask 3232b has thin regions 3237b and 3237c, which 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. The crosshairs in Figures 24B and 24C illustrate regions 3237b and 3237c, which are segments of the mask 3232b with reduced stiffness. Reduced stiffness can be provided via reduced 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 compared to thicker or stiffer material portions.

[0333] 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 shown in Figures 24B and 24C. The varying stiffness of the regions 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 using a face mask with or without a centerline fixing member, the pivot point or hinge point can be retained at the base of the face mask.

[0334] 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 an embodiment, for example, shown in FIG. 24C, the structural portion 310 may extend around the sides and top of the face shield. The structural portion 310 may be a band. The band may be located around the sides and top of the face shield.

[0335] 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.

[0336] In some cases, such as under higher pressure, structural portion 310 can prevent the mask from inflating. Structural portion 310 can also prevent folds or creases in the thin material sections of regions 3237b and 3237c, which can help maintain the shape of region 3237b for the patient. In some embodiments, structural portion 310 can make cleaning of the mask 3232b easier.

[0337] 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.

[0338] 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 sections 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.

[0339] The face mask 3232b can be rolled up at the side and pivoted at or near the base of the face mask. As shown in FIG24B, the rolled-up area 3237c can be positioned around point 312 at the base of the face mask 3232b. The material thickness of the wall at the base of the face mask 3232b can become thicker or stiffer as it moves away from point 312 toward the rear of the face mask. As shown in FIG24B, the area 3237c with reduced stiffness can extend inward and rearward from point 312, which allows the face mask 3232b to be rolled up at point 312 and further inwardly hinged. This configuration allows the side of the face mask 3232b to be displaced or rolled up more easily when a force is applied to the face mask 3232b. In some embodiments, the face mask may have a rolled-up area or area 3237c that extends around the entire circumference of the face mask 3232b. In some implementations, the mask may have a thickened or stiffened base, which may be structurally enhanced to, for example, prevent the mask from folding laterally.

[0340] To aid stability, it may be useful to attach an interface holding or stabilizing device (e.g., a headgear) near the pivot point. As shown in Figures 24B to 24C, the base of region 3237c is slightly triangular, but in some embodiments, the rolled-up region may be more rounded.

[0341] 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.

[0342] 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.

[0343] The mask 3232a can be used in conjunction with one or more fixation members to provide stability of the mask on the user. The mask 3232b can be used in conjunction with a midline fixation member applied to the patient's forehead (e.g., the fixation member described with reference to Figures 33-35 and 40-47). When the mask is sealed, this fixation 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.

[0344] The roll-up area of ​​the mask 3232b can roll up at the side and at the top. Figures 24D and 24E show the movement of the mask 3232b when rolled up at the side and top. Figure 24D is a top cross-sectional view of the mask body. The top cross-sectional view of the mask body 3200b shown in Figure 24D shows the side roll-up of the mask 3232b (shown in dashed lines and moving in the direction of the arrows). As shown in Figure 24D, 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 is a side cross-sectional view of the mask body. The side cross-sectional view of the mask body shown in Figure 24E shows the top roll-up of the mask 3232b (shown in dashed lines and moving in the direction of the arrows). As shown in Figure 24E, 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.

[0345] 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 movements. Entry and exit points

[0346] In some embodiments, the interface body may have lateral entry and exit 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 entry and exit points located in the middle or at the top of the mask. Additionally, lateral entry and exit points for the gas flow can reduce inefficient space outside the flow path in 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 the interface body. In some embodiments, the ends of the housing at or near the entry / exit points may be substantially downwardly curved or extended. In this embodiment, the entry / exit points can guide gas laterally, but at an angle offset from the horizontal, into the interface body. Fixed components

[0347] Figures 25 and 26 illustrate embodiments of a patient interface 3000 assembled to form a nasal cannula interface. In the illustrated embodiment, the patient interface 3000 includes a cannula body 3200a, a housing 3400, a first fixation member 3600, and an interface tube 3800. As shown in Figure 25, the first fixation 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. As shown in Figures 25 and 26, the bridging portion 3630 may be positioned on the opposite side of the central portion 3610. The support pad 3660 may extend laterally outward from the bridging portion 3630. In some embodiments, the first fixation 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 a 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 of the support pads 3660 in the pair may extend from the bridging portion 3630 at the opposite end of the central portion 3610, as shown in Figures 25 and 26.

[0348] As shown in Figures 25 and 26, the central portion 3610 may have a generally low profile. The central portion 3610 may have a small thickness to allow it to extend outwards from the patient's face to a minimum. 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, during use, the central portion 3610 may curve outwards from the patient's face. 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 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.

[0349] When the patient interface (e.g., patient interface 3000) is worn by a user, a support pad (e.g., support pad 3660) may rest directly or indirectly on the user's face. For example, the support pad 3660 may be secured to the user's face directly or indirectly by external force, such as using adhesive bonding, headgear arrangements, 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 may be connected to a headgear and / or chin strap to secure the interface body. In some embodiments, the support pad 3660 may be connected to one or more face pads or skin patches. The face pads or skin patches may have a patient side and an interface side. The interface side may have a first fastening element. The first fastening element may be removably coupled to or attached to a complementary fastening element on the patient side of the support pad 3660. In some embodiments, the support pad 3660 may include a tab 3666 at either end of the support pad 3660 to help position and / or remove the support pad 3660 and / or the first fixing member 3600.

[0350] 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 rolled-up area of ​​the mask to maintain the seal between the interface body and the user's face.

[0351] In some embodiments, the first fixation 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. As shown in Figures 25 and 26, hinge point 3662 may be located at the portion of the first fixation member 3600 where the first fixation member 3600 is connected to the housing 3400. In some cases, the hinge point may be located at the connection between the bridging portion 3630 and the central portion 3610 of the first fixation member 3600. In some embodiments, such as shown in Figure 39, the bridging portion 3630 may be used to maintain torsional stability and prevent or minimize movement of the central portion 3610 and the manifold relative to each other.

[0352] 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 forces 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.

[0353] The patient-facing side of the support liner 3660 may have fastener elements to allow direct attachment to the face (e.g., adhesive), or indirect attachment to a headband 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 lining 3660 can be initially provided in the absence of a user interface patch or skin patch. Surface 3680 may receive or retain a patient interface patch or skin patch. Such patient interface patches may be connected 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 cladding molding). Once the support lining patch is in the proper position, it can connect to or receive the skin patch. Alternatively, the patient interface patch can be assembled to the surface 3680 of the support liner 3660 in the same operation as the molded face liner. In some embodiments, the user-facing surface 3680 is configured such that the user-facing surface 3680 may not cause excessive wear or interference on the patient's face. For example, the user-facing surface 3680 will include the ring material of the hook-and-loop mechanism, and the user interface patch or skin patch includes the hook material of the hook-and-loop mechanism. In some embodiments, a fixing mechanism other than a skin patch, such as a headgear, girdle, or hat, is engaged facing the user surface 3680 .

[0354] In some embodiments, the first fixed member 3600 may be coupled to the housing 3400 by coupling the center portion 3610 to the housing 3400 . The first fixed member 3600 may have a mechanism or attachment portion that can be held by the housing 3400 . For example, the first fixed member 3600 may include a center opening 3620 . The center opening 3620 may be coupled to one or more attachment elements of the housing 3400 . For example, the center opening 3620 may be coupled to one or more anterior extensions 3420 of the shell 3400 and / or the center protrusion 3440 . The center opening 3620 may be sized and shaped to receive and hold one or more attachment elements of the housing 3400 , such as the front extension 3420 . For example, the center opening 3620 may be sized and shaped to be anchored at or around the ridge 3422 . In some embodiments, the first fixing member 3600 may be removably coupled to the housing 3400 . In some embodiments, the first fixed member 3600 may be coupled to the housing 3400 utilizing a clamp. In some embodiments, the first fixing member 3600 may be permanently coupled to the shell 3400 . In some embodiments, the first fixing member may not have a center portion 3610 and / or a bridging portion 3630 and may include a support liner 3660 removably or permanently directly coupled to the shell 3400 or the interface body.

[0355] 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 indicate 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.

[0356] In some embodiments, the first fastening member 3600 may be constructed of a fabric material. Figures 27 and 28 illustrate embodiments of the first fastening member 3600 constructed of a fabric material. In addition to those described herein, the first fastening member 3600 constructed of a fabric material may be similar to the first fastening member 3600 described with respect to Figures 25 and 26. For example, the first fastening member 3600 may include a central opening 3620 for attachment to the housing 3400. The first fastening member 3600 may include one or more cutouts 3640 to allow the interface tube 3800 to pass through. Figures 29 and 30 illustrate the first fastening member 3600 attached to the housing 3400.

[0357] Figures 31 and 32 show schematic cross-sectional views of the fabric of the first fixation member 3600, 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 films 3694 and 3697. Laminated films 3694 and 3697 allow for easier cleaning and maintenance of the first fixation member 3600. Laminated films 3694 and 3697 can 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 film 3694 on the patient-facing side may be interrupted at the exposed area 3691 to expose a portion of the uninterrupted ring material 3695. The exposed area 3691 is also shown in Figure 30. The exposed uninterrupted ring material 3695 at the exposed area 3691 can be attached to corresponding hook material on the 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-stretched 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 fixation member 3600 may further include a foam material 3698, as shown in FIG32. The foam material 3698 may be located between an uninterrupted ring material 3695 and a 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, allowing the first fixation member 3600 to be cut or torn at certain locations to sized the first fixation member 3600 for the patient.

[0358] Figures 33 to 35 illustrate embodiments of the second fixation member 3900. 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.

[0359] The connecting portion 3910 may be attached to or be coupled 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 3440 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.

[0360] 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 perforated straps 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 the patient's headgear.

[0361] 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 connections, headband arrangements, hook or loop connections as discussed above, or other suitable support structures, such as any of those described herein. In some arrangements, the support pad 3980 can be connected to the headband and / or chin strap to secure the interface body.

[0362] In some embodiments, the second fixation member 3900 may be constructed of a fabric material. The fabric material may be the fabric material described with respect to Figures 31 and 32. In some embodiments, the second fixation member 3900 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 3900 is integrally formed with the housing, the second fixation member 3900 may be constructed of the same material as the housing. In some embodiments, the second fixation member 3900 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 strips, 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. Additional examples of patient interface components

[0363] Figure 36 illustrates an embodiment of the patient interface assembly 4000. As shown in Figure 36, 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 the intubation body 3200a shown in Figures 3-4 and 10-21, or a mask body, such as the mask body 3200b shown in Figures 5-6 and 22-24. The intubation 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. In the embodiment shown in Figure 36, the mask body 3200b is a nasal mask. The intubation 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 fixing member 4600, one or more interface tubes 4800, and a second fixing 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.

[0364] 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, as shown in FIG36. In other embodiments, the interface tube may engage with the housing at the tube engagement portion and may be offset downward or at an angle away from the horizontal axis of the housing. In this embodiment, the first fixing member may be positioned above the tube, opposite to the tube passing through it.

[0365] 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. Figures 37 and 38 illustrate a housing 4400 having features for attaching the first fixing member 4600 and / or the second fixing member 4900. In the embodiments shown in Figures 37 and 38, the attachment features are located on the front side or front portion 4430 of the housing 4400. The attachment features may include one or more attachment elements. The one or more attachment elements may be similar to the attachment elements previously described, such as those with respect to the embodiments shown in Figures 7 through 9.

[0366] In some embodiments, the housing 4400 may be formed of a rigid material. The housing 4400 may be detachably coupled to the interface body, as described herein. The housing 4400 may be detachably coupled to a manifold of the interface body. In the illustrated embodiment, the 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. The side protrusions 4420 may project forward. The side protrusions 4420 may extend outward from the front portion 4430. The side protrusions may have an enlarged head 4422 and a rod 4424. The head 4422 may have a larger cross-section than the rod 4424. The side protrusions 4420 may be received and engaged by one or more complementary or receiving components. For example, the side protrusion 4420 may be received and engaged by a hole or recess, which, for example, is fitted to the enlarged head 4422 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.

[0367] The central protrusion 4440 may include features for engaging the second retaining member 4900 to the housing 4400. The central protrusion 4440 may include an opening 4442. In some embodiments, the second retaining member 4900 may be engaged 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 retaining member 4900. In some embodiments, the central protrusion 4440 may include two channels in the opening 4442, as shown in Figures 37 and 38. In some embodiments, such as shown in Figure 38, the central protrusion 4440 may include a lip 4446. The lip 4446 may engage with a complementary fitting portion of the second retaining member 4900 (not shown), as described in more detail herein. Features on the housing 4400 facilitate securing the first retaining member 4600 and / or the second retaining member 4900 to the housing 4400. This allows the fixation members to be positioned for subsequent attachment to the patient via a suitable mechanism (such as a patient interface patch, a skin patch on the patient's face, an adhesive, or any other suitable mechanism) or by other suitable devices (such as a headgear, chin strap, or cap) 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. First fixing component

[0368] Figures 39A and 39B show views of an embodiment of the first fixing member 4600. As shown in Figures 39A and 39B, 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 similar to and formed and used in the same manner as the first fixing member 3600 having the central portion 3610, the support pad 3660, and the bridging portion 3630 described with respect to Figures 25 and 26. As shown in Figures 39A and 39B, the bridging portion 4630 can be positioned on the opposite side of the central portion 4610. The support pad 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 a 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 in Figures 39A and 39B.

[0369] 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 by any suitable mechanism, a headband, chin strap, patient interface patch, or skin patch.

[0370] In some embodiments, the first fixing member 4600 may include a cutout 4640 and two arms 4642 bridging the central portion 4610 and the support pad 4660. The cutout 4640 allows the interface tube 4800 to pass between the two arms 4642 and through the cutout 4640. The cutout 4640 can be used to receive the interface tube 4800. The cutout 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 cutout 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 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.

[0371] As shown in Figures 39A and 39B, the first fixing member 4600 can be bent 4634, wherein the bridging portion 4630 intersects the central portion 4610. This bending helps to accommodate the tubular shape of the tube 4800 and / or the housing 4400. Figure 39C shows a top view of the first fixing member 4600. The arm 4642 of the bridging portion 4630 can have a first end 4644 that contacts the support pad 4660 and a second end 4646 that contacts the central portion 4610. The arm 4642 can have a horizontal axis extending from the first end 4644 to the second end 4646. As shown in the top view of Figure 39C, 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 connected to the support pad 4660 may have a thickened region 4632. The thickened region 4632 may be provided with or have a reinforced material area to provide additional support, as shown in Figures 39A and 39B. Figure 39A shows a front view of the first fixing member 4600. As shown in Figures 39A and 39B, when viewed from the front view, the thickened region 4632 of the first end 4644 may be thicker than the second end 4646 of the arm 4642.

[0372] 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, as shown in FIG36. 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 the 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.

[0373] In the embodiments shown in Figures 39A to 39C, 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 the patient interface patch is attached to the rear side of the support liner 4660 using double-sided adhesive or double-sided hook-and-loop fasteners, such adhesives or hook-and-loop fasteners will be exposed from a front side opposite to the rear or user side. In some configurations, such adhesives or hook-and-loop fasteners exposed through the opening 4640 can be used as tube fasteners or otherwise to organize interface tubes or catheters.

[0374] In some cases, the arm of the bridging portion 4630 may have a recessed area with hook-and-loop fasteners, which may also indicate the management of the interface tube or catheter. In some situations, it may be desirable to have a way to hold and manage the interface tube 4800 of the patient interface assembly 4000. In this arrangement, the tube 4800 may 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 one's side.

[0375] 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.

[0376] 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.

[0377] 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.

[0378] In some embodiments, a magnet may be used to hold the catheter or tube 4800 onto 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.

[0379] 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 receive and secure or engage 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.

[0380] 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.

[0381] Figure 39B shows a rear view of the first fixing member 4600. As shown in Figure 39B, 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.

[0382] In some embodiments, the first fixing 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 parts. 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 fixing member 4600 may be detachably coupled to the housing 4400. In some embodiments, the first fixing member 4600 may be coupled to the housing 4400 using a clamp. In some embodiments, the first fixing member 4600 may be permanently coupled to the housing 4400. In some embodiments, the first fixing 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.

[0383] 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.

[0384] 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 described with respect to Figures 39A to 39C. This thickened bridging portion 4632 may be located at the arm 4642 surrounding the cutout 4640 of the bridging portion 4632 to improve the torsional stability of that region. In some cases, the thickened bridging portion 4632 may be located at the first end 4644, as shown in Figure 39A.

[0385] 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 help resist vertical rotation or movement of the interface body seal, thereby minimizing the effect on the seal when force is applied.

[0386] 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.

[0387] 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. Second fixing component

[0388] Figures 40-42 and 44-47 illustrate embodiments of the second fixation member 4900. 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 be placed directly or indirectly on the 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 made of 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 an adhesive connection, headgear arrangement, hook or loop connection as discussed above) or another suitable support structure, such as any of those described herein. In some configurations, the support pad 4980 can be attached to the headgear and / or chin strap to secure the interface body.

[0389] The attachment portion 4910 can be used to attach the second fixation member 4900 to the housing 4400. The attachment portion 4910 is formed to engage with a corresponding structure on the housing 4400. In some embodiments, the corresponding structure may be located on a central portion of the housing 4400. The central portion of the housing 4400 may have a central protrusion 4440, as shown in Figures 43A and 43B. The attachment portion 4910 may be formed to engage with an opening 4442 (shown in Figures 43A and 43B) of the central protrusion 4440. Although the second fixation member 4900 described with reference to Figures 40 through 47 is described as being engaged with the housing 4400, the second fixation member 4900 may be used in conjunction with any of the housing or patient interface assembly components and embodiments described herein.

[0390] 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 shown in Figure 43A.

[0391] 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 and assembled through the opening 4442, 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.

[0392] Figure 43A illustrates the interconnection between an embodiment of the second fixing member 4900 and the housing 4400. A flexible barb 4912 can be fitted into the opening 4442 (shown in Figure 43B) of the central protrusion 4440 of the housing 4400. The flexible barb 4912 can be fitted into the central protrusion 4440 by means of tabs 4914 on each transverse protrusion engaging the lower edge of the central protrusion 4440 of the housing 4400, as shown in Figure 43. 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 does not have a central protrusion with a lip, in some embodiments, the central protrusion 4440 may include a lip similar to the lip 4446 shown in Figure 38. In this embodiment, the lip edge can engage the lateral protrusion 4914 of the second fixing member 4900.

[0393] 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 when the second fixing member 4900 is moved laterally to a certain extent, the tab 4914 can fold and allow the second fixing member 4900 to be removed. 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.

[0394] 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 4918 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.

[0395] 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.

[0396] 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 4920. 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.

[0397] Figures 41 and 42 illustrate other embodiments of the interface between the attachment portion 4910 and the central portion 4920. Figures 41 and 42 illustrate the joining of the attachment portion 4910 and the central portion 4920. In some embodiments, the attachment portion 4910 may be overmolded onto the central portion 4920. Figure 41 shows a portion of the central portion 4920 overmolded with the attachment portion 4910. Figure 42 shows the resulting portion of the second fastening member after the attachment portion 4910 has been overmolded onto the central portion 4920. Although a specific structure extending from the central portion 4920 overmolded with the attachment portion is shown in Figure 41, any structure or geometry can be used.

[0398] In some embodiments, the central portion 4920 can operate under tension and compression. In some embodiments, compared to a flexible second fixation member, the central portion 4920 can prevent the interface body and housing 4400 from excessively rotating upwards, 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 during use, which can cause some slight bending of the second fixation member 4900, and especially the central portion 4920. 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.

[0399] Figure 44 illustrates an embodiment of the support pad 4980 and the central portion 4920 of the second fixing member 4900. The support pad 4980 may 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.

[0400] 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 from the patient's forehead. Therefore, the second fixation member 4900 can be adapted to such different heights (e.g., headgear volume) and different forehead angles by means of a hinged or pivotal connection 4982 having the support pad 4980. Compensation for different heights and / or forehead angles can 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 a headgear, chin strap, patient interface patch or skin patch or otherwise attached to the patient’s face by any suitable means.

[0401] 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.

[0402] 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 described with respect to Figures 33-35. In some embodiments, the support pad 4980 is overmolded onto the central portion 4920.

[0403] Figure 45 illustrates an embodiment of the second fixing member 4900a. The second fixing member 4900a may have a pivoting or hinged handle 4984 for connection 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 the second fixing member 4900 described with respect to Figures 40-44. 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, barbed fingers 4987, and barbed clips 4988.

[0404] 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.

[0405] 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 through the opening assembly, 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.

[0406] 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 may require the user to actively compress the barbs to easily remove it. The second fixation member 4900a has an attachment rod 4984 that allows connection to a support pad or any other pad or patch that can be attached to a device for securing the component to a patient (such as a headgear or patch), similar to the attachment described with respect to Figure 44. In some embodiments, the attachment rod 4984 may allow connection to a skin patch that can exemplify securing the component to a 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 with respect to Figures 33-35.

[0407] Figures 46A and 46B illustrate an embodiment of the second fixing member 4900b. Figure 46A shows a front view of the second fixing member 4900b. Figure 46B shows a rear view of the second fixing member 4900b. Similar to the second fixing member 4900a described with respect to Figure 45, except as described herein, the second fixing member 4900b 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.

[0408] Additionally, the second fixing member 4900b may have a protrusion 4985 on the rear side of each barbed finger 4987, which can provide additional locking by engaging with the lip 4446 (shown in FIG. 38) in the central protrusion 4440 of the housing (e.g., housing 4400 described with respect to FIG. 37-38).

[0409] Figure 47 illustrates another embodiment of the attachment portion 4910 of the second fixing member 4900b. In this embodiment, the attachment portion 4910 includes one or more front barb portions 4950. One or more front barb portions 4950 may be positioned and extend outward from the front surface of the attachment portion 4910. A first or lower front barb portion 4950a may 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 may 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 protrusion 4440 of the housing 4400.

[0410] 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 fixing member 4900 from being over-inserted into the opening 4442.

[0411] In some embodiments, the housing may have an opening in a central protrusion at the front side of the housing 4400 (shown in FIG. 43B) to receive two barbed fingers 4987, or it may have two openings (as shown in FIG. 37 to FIG. 38), one opening for each finger 4987.

[0412] 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.

[0413] In some embodiments, the attachment portion 4910 may be rigid. In some embodiments, the attachment portion 4910 may be made of a flexible material.

[0414] The embodiment of the second fixation member 4900 described in Figures 40 to 47 can be inserted into the housing 4400 by a vertical force, whereby the user pushes the attachment portion downward into the opening of the central protrusion of the housing 4400 until it is received within the opening. This may be preferable to the second fixation member 3900 described in Figures 33 to 35, because the second fixation member 3900 can be attached by providing a force that pushes it into the patient's face, and the second fixation member is attached to the central protrusion of the housing 3400 by pushing and engaging. This force may cause discomfort to the patient, therefore it is necessary to remove the component first to attach this second fixation member 3900. Seal between housing and interface body

[0415] 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 hermetically engaged with the housing to allow gas to flow out of and to the user.

[0416] In some embodiments, the connection between the interface body and the housing can 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 prevent accidental disconnection of the interface body from the housing. The housing and interface body can be complementaryly matched to prevent incorrect assembly and / or to provide 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.

[0417] Figure 48A illustrates an embodiment of the interface body 4200a. 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, which is facing the patient in use. Apart from what is described herein, the cannula body 4200a may be similar to the cannula body described with respect to Figures 10-13 and Figure 21. The manifold 4240 shown in Figures 21 and 48A may be similar to the manifold described with respect to Figures 10-13, but the manifold 4240 and the 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 the annular ridge closer to the bottom side of the interface body (opposite to the centerline or substantially the center of the interface body described with respect to Figures 10-13). This alignment can improve the stability of the patient interface.

[0418] Manifold 4240 may include a housing connection portion 4244 on its rear side. The housing connection portion 4244 may be received by an interface body receiving portion 4480 of the housing (shown in Figures 37-38). 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 housing connection portion 4244 and the remainder of the manifold 4240 may be shaped and / or sized for insertion into and reception by the housing 4400 and to form an hermetically sealed connection. 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 sealed connection with the housing 4400, as shown in Figures 49-53D. 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.

[0419] The interface body and housing may have a mating surface 4889 (shown in FIG. 50) where the interface body and housing intersect after assembly. The mating surface 4889 of the interface body may include a protrusion 4247 of the housing connection portion 4244, as shown in FIG. 49. When the housing 4400 and the interface body are assembled, the protrusion 4247 of the housing connection 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.

[0420] Figures 48B to 48E illustrate the interface body of the mask body 4200b. The mask body 4200b is similar to the mask body 3200b described herein, but it includes the manifold features described with reference to Figure 48A.

[0421] The manifold 4240 of the cannula body 4200a and the mask body 4200b may define one or more openings 4246 (shown in Figures 48A-48E), such as a pair of openings 4246. The openings 4246 may be coupled to a tube engagement portion 4460 of the housing 4400 (shown in Figures 37-38) to receive the interface tube and allow gas to flow out of and to the patient via the manifold 4240 and the interface body. The openings 4246, located at both ends of the housing 4400, can create lateral entry points for gas to flow to and from the interface. Lateral entry points can 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 an interface body (such as the mask cavity of the mask body) can result in greater CO2 removal compared to a mask or fluid interface having entry and exit points located in the middle or at the top of the mask. Additionally, the lateral entry and exit points for the gas flow can reduce the unused space outside the flow path in the interface body.

[0422] 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.

[0423] As shown in Figure 49, 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 different sized nose forks on different cannula bodies. This avoids waste and allows the interface body to be changed and adapted at any time according to the requirements of clinicians.

[0424] Figures 49 and 50 illustrate an embodiment of the housing connection portion 4244 of a manifold 4240 positioned within the interface body receiving portion 4480 of a housing 3400. Figures 49 to 53 show the housing 4400 as transparent, allowing the manifold 4240 to be visible within the housing 4400. The housing 4400 and the 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 extending from one pipe connection portion 4460 to a second pipe connection portion 4460, or measurable from one pipe connection portion to a second pipe connection portion, as indicated by line "w" in Figure 49. The interface body receiving portion 4480 may include an opening. The opening can be an angled opening 4845, as shown in one design without an attached manifold in FIG. 43B, and in another design where the manifold 4240 is located in the housing 4400 in FIG. 49. The embodiments in FIG. 43D and FIG. 49 have different angled openings that can mate with manifolds of different shapes for the interface body. The angled opening 4845 can include a portion of the manifold 4240 of the housing 4400 that can receive the interface body. The angled opening 4845 can be an angle extending along an opening in the housing from a front portion 4841 to a rear portion 4843 along the top of the housing, as shown in FIG. 49. In some embodiments, the housing connection portion 4244 of the manifold 4240 can 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 can 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 in FIG49. When the manifold 4240 is detachably connected to and received by the housing 4400, the complementary fit of the angled protrusion 4247 of the angled interface body receiving portion 4480 and the housing connecting portion 4244 can improve assembly and alignment.

[0425] 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, as shown in FIG49, the protrusion 4247 of the housing connection portion 4244 may have a varying width. For example, the protrusion 4247 of the housing connection portion 4244 may 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, as shown in FIG49. 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.

[0426] 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. As shown in Figure 49, the angled opening is not a straight edge, but rather the shape and configuration of the opening can have curved or trapezoidal sides. In other embodiments, the angled opening can have a straight edge. In other embodiments, the angled opening can have one or more curved edges.

[0427] 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 a fork on the interface body. In some embodiments, the angled opening 4845 and 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 stopping 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, as shown in FIG49. 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.

[0428] Figure 50 shows a portion of the manifold 4240 connected to the housing 4400. Figure 50 also shows the housing connection portion 4244 of the interface body connected to the interface body receiving portion 4480 of the housing 4400. As shown in Figure 50, the manifold 4240 is positioned off-center from the center of the horizontal axis h2, which extends from the first pipe engagement portion 4460 through the center of the inner cavity of the housing 4400 to the second pipe engagement portion 4460. This alignment of the manifold 4240 relative to the housing 4400 allows for a larger manifold inner diameter, which reduces flow resistance within the housing 4400 and the manifold 4240. This offset arrangement allows for a thicker front portion 4841 of the housing 4400, which increases the rigidity of the housing 4400. The increased thickness of the front portion 4841 of the housing 4400 improves stability and increases the ease of assembly and / or disassembly of the interface body from the housing 4400. This arrangement also improves the structural integrity of the housing 4400.

[0429] In some embodiments, manifold 4240 may have a horizontal axis h1 that extends through the center of the inner cavity of manifold 4240. Housing 4400 may have a horizontal axis h2 that extends 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.

[0430] Figures 51A and 51B illustrate a portion of another embodiment of the manifold 4240 coupled to the housing 4400. Figure 51B is an enlarged view of the ends of the manifold 4240 and the housing 4400 (indicated by boxes in Figure 51A). 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 in 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 the patient interface assembly. The extension 4288 can increase the necessary manifold removal force to remove the manifold from the housing 4400. When the user assembles the two parts, the extension 4288 can reduce 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 will be more noticeable and apparent.

[0431] Figures 52A and 52B illustrate embodiments of a manifold 4240 coupled to a housing 4400, 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 shown in Figures 52A and 52B. In some embodiments, the key feature 4286 can prevent misalignment between the manifold and the housing 4400. The key feature 4286 can prevent rotation between the two sides of the manifold, as shown in Figure 52B. This can be advantageous because rotation of the manifold can affect the geometry of the fork or face mask. Limiting or preventing rotation of the manifold can allow 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.

[0432] 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. Additionally, although the manifold is shown with a protrusion and housing 4400 is shown with a recess, key features can be used where the protrusion is present on the housing and the recess is present on the manifold. The key features shown in Figures 52A and 52B are rectangular in shape; however, key features can be any shape, such as square, rectangular, circular, or any portion of such shapes or irregular shapes.

[0433] Figures 53A to 53D illustrate another embodiment of the manifold 4240 connected to the housing 4400. The protrusion 4247 of the housing connection portion 4244 of the manifold 4240 may have an angled face 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 the angled opening described with respect to Figure 49. When measured in the same manner, the angled opening 4384 of the housing may have a larger angle than the angled opening described with respect to Figure 49. The angled opening 4284 may have a shape and configuration that facilitates a self-aligned geometry with the housing connection portion 4244 of the manifold 4240. As shown in Figures 53A and 53B, the angled opening 4284 has a geometry similar to or the same as the angled opening of the interface body receiving portion 3480 of the housing 4400 shown in Figures 37 and 38. The angled protrusion 4247 of the housing connection portion 4244 and the angled interface body receiving portion 4480 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 protrusion 4247 of the housing connection portion 4244 and the angled interface body receiving portion 4480 can also reduce the chance of rotational misalignment between the manifold and the housing.

[0434] When viewed from a top view of the housing 4400 and the manifold 4240, the angled protrusion 4247 of the manifold can be configured substantially trapezoidally, as shown in the top view of FIG53A. As shown in FIG53A, the trapezoidal configuration of the angled protrusion 4247 such that the wider base of the trapezoid is closer to the front portion of the housing 4400. In other embodiments, the protrusion of the interface body includes a wider trapezoidal base closer to the rear portion of the housing.

[0435] The housing 4400 may have complementary angled interface body receiving portions 4480, as shown in Figures 37 and 53A. As shown in the top view of the interface assembly in Figure 53A, when viewed from the top, the angled protrusion 4247 may be trapezoidal in shape. When viewed from the top view shown in Figure 53A, the trapezoidal shape defined by the angled protrusion 4247 of the housing connecting portion 4244 and the angled interface body receiving portion 4480 may have four corners, which have angles other than 90 degrees.

[0436] As shown in Figure 53A, the angled protrusion 4247 and the angled interface body receiving portion 4480 of the housing connection portion 4244 can have an angle greater than 90 degrees in one of the two corners 4482 formed by the rear side of the manifold. As shown in Figure 53A, the angled protrusion 4247 and the angled interface body receiving portion 4480 of the housing connection portion 4244 can have an angle less than 90 degrees in the corners 4484 on the front side of the protrusion of the manifold and the interface body receiving portion. For example, as shown in Figure 53A, the angled protrusion 4247 and the angled interface body receiving portion 4480 of the housing connection portion 4244 can have an angle of 120 degrees at two opposite corners on the rear side of the manifold.

[0437] As shown in Figures 53A and 53B, 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, the angle shown in the embodiment of housing 4400 shown in Figure 49 has an angle less than 90 degrees. However, any angled opening can also be used to allow assessment of proper attachment and prevent misalignment of components during 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.

[0438] 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.

[0439] Figure 53B shows a portion of the manifold 4240 and housing 4400 shown in Figure 53A. An annular ridge 4248 of the manifold 4240 can contact the housing 4400. The annular ridge 4248 can contact the inner surface of the housing 4400 to create a gas seal. Other features on the manifold 4240 can 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 can have an interference fit to prevent leakage.

[0440] Figure 53C shows a portion of the manifold 4240 and housing 4400 shown in Figure 53A. 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 4247 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 shown in Figure 53C. For example, as shown in Figure 53C, the rear protrusion 4247 of the manifold 4240 extends beyond the rear side of the housing 4400 at the mating 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 shell material.

[0441] Figure 53D shows a portion of the manifold 4240 and housing 4400 in an assembled configuration. The removal of the manifold 4240 from the housing 4400 can be managed or optimized, at least in part, based on the materials and / or configuration of the manifold and housing. The removal force required to remove the component can be controlled, at least in part, by a distance "x", as shown in Figure 53D, which is the horizontal distance between the outer edge of the annular ridge 4248 and the sealing or mating surface 4889 of the manifold 4240. Removal of the manifold 4240 from the housing 4400 can occur as the annular ridge 4248 moves past the mating surface 4889 of the housing 4400, thereby displacing 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.

[0442] 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, as shown in FIG53D, where 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 free flow path may exist between the housing and the annular ridge 4248, leading to leakage, which may be unacceptable for the delivery of therapies. In some embodiments, angled openings can affect both dimensions ("x" and "y"), and also the overall width of the housing.

[0443] Figures 54 and 55 show side cross-sectional views of the interface body. Figure 54 shows a side cross-sectional view of the interface body with the cannula body. Figure 55 shows a side cross-sectional view of the interface body with the mask body. Except as described herein, the manifold 4240, the cannula body, and the mask body are similar to the manifold and cannula body and the mask body described with respect to Figures 10 through 24. 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, and 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 that of the rest of the manifold 4240. This illustrates how users or clinicians 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 fact that the wall thickness on the rear portion 4243 of the manifold 4240 is thinner than that on the front portion 4241 of the manifold 4240. During 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.

[0444] 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 components (e.g., the amount of interference between the housing 4400 and the manifold 4240). Since 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 prevent such rotation and to maintain each side of the manifold 4240 in the same position within the housing 4400 relative to the other side.

[0445] Figures 54 and 55 illustrate a manifold having features that prevent or at least minimize 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 prevent or reduce rotation. For example, the shoulder portion 4628 may be a thickened portion of the wall of the manifold 4240, as shown in Figures 54 and 55. The shoulder portion 4628 may illustrate the self-alignment of the manifold 4240 within the housing. As shown in Figures 54 and 55, the shoulder portion 4628 may be a thickened portion at the bottom of the housing attachment portion of the manifold. Once assembled, the shoulder portion 4628 may be suspended on the housing. In other cases, the shoulder portion is not suspended on the housing but may abut against the surface of the opening in the housing. The shoulder portion 4628 engages with and abuts against the edge of the housing and may prevent or limit rotation and movement of the interface body relative to the housing. Restricting or preventing manifold rotation allows for a more consistent sealing surface between the manifold and the housing, which improves the ability to maintain a seal between the two components. The shoulder portion 4628 can be a thickened section of the manifold, which can prevent improper insertion of the interface body 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 and housing.

[0446] As shown in Figure 54, the distance "d" indicates the width at the shoulder portion 4628, which is wider than the rest of the manifold wall. The thickness "t" of the manifold wall is shown in Figure 54 and is thinner than the distance "d" of the width of the area of ​​the manifold having the shoulder portion 4628. In some embodiments, the width "d" of the shoulder portion can be 2.5 mm, and the wall thickness "t" of the manifold is 1.0 mm. The width "d" of the shoulder portion can 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.

[0447] The width of 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 the device 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.

[0448] 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, low-friction surfaces reduce 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.

[0449] Figures 56A to 56F show a manifold 5420 connected to housing 5400, 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.

[0450] Figures 56A to 56D illustrate a visual indicator, 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 arrangement 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.

[0451] 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.

[0452] Alternatively or additionally, the interface assembly may include a second visual indicator, such as a second color indicator, at the angled corners of the housing 5400 and / or manifold 5420. Figures 56C to 56D illustrate a color indicator 5606 at the angled edges of the manifold 5420 and housing 5400. The color indicator 5606 can provide 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.

[0453] Another embodiment of the visual indicator is shown in Figures 56E to 56F. 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 5420 and the housing 5400 are not properly aligned, the colored bar 5608 may be observed to have a non-linear configuration, as shown in Figure 56E. If the components are properly assembled and aligned, the colored bar 5608 may be observed to have a linear or straight configuration, as shown in Figure 56F.

[0454] 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 to correctly align the housing and manifold components. While the color indicator shown with reference to Figures 56A-56F is positioned at the end of the manifold where it mates with the angled edge of the housing or manifold, 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 correct positioning and alignment. In some embodiments, any part or component of the interface assembly, or the entire component, 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. Pipes and connectors

[0455] One or more interface tubes and connectors of the patient interface assembly allow fluid communication to and from the patient from an external device or airflow source. Figure 57 illustrates tube 4800 and connector 4820 at the end of tube. In some embodiments, the wall of interface tube 4800 may be made of a material that allows wet vapor to pass through the wall of tube 4800. Connector 4820 may be any type of interlocking or mating connector to connect tube to another device or additional tube. As shown in Figure 57, connector may have locking fingers 4822 to connect and secure tube to another device or additional tube. 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, connector may have a tapered mating connection to another device or additional tube.

[0456] The housing can be connected to the conduit at a tube joint (shown in Figure 36). In some embodiments, the conduit 4800 may include an inhalation conduit, wherein a first end can be connected to the housing and deliver an incoming gas flow, and a second end has a locking finger 4822. In some embodiments, the conduit 4800 may include an expiratory conduit, wherein a first end can be connected to the housing and receive an expiratory gas flow, and a second end has a locking finger 4822. In some embodiments, the conduit may include both an inhalation conduit and an expiratory 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.

[0457] 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 with portions of the 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.

[0458] From the above discussion, it will be understood that the present invention can be embodied in various forms, including but not limited to the following: Example 1. A patient interface component, comprising: First interface main body; The second interface main body; and A housing configured for detachable connection with either 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, and in the second configuration, the second interface body is connected to the housing. Example 2. The patient interface assembly as described in Example 1, wherein the first interface main system is the cannula body. Example 3. The patient interface assembly as described in Example 2, wherein the cannula body includes one or more nasal forks. Example 4. A patient interface assembly as described in Example 3, wherein the one or more forks are configured to insert into the user's nostrils and form a seal. Example 5. A patient interface assembly as described in any of the preceding examples, wherein the second interface host is a mask body. Example 6. The patient interface assembly as described in Example 5, wherein the second interface host is a nasal mask. Example 7. A patient interface assembly as described in Example 5 or 6, wherein the second interface host is an oral-nasal mask. Example 8. A patient interface assembly as described in any one of Examples 5 to 7, wherein 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. Example 9. A patient interface assembly as described in any of the foregoing examples, wherein the housing includes an upper edge and a lower edge. Example 10. The patient interface assembly as described in Example 9, wherein the upper and lower edges of the housing are symmetrical. Example 11. A patient interface assembly as described in Example 9 or 10, wherein the lower edge of the housing is bent inward toward the housing. Example 12. A patient interface assembly as described in any of the preceding embodiments, wherein 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. Example 13. A patient interface assembly as described in Example 12, 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. Example 14. The patient interface assembly as described in Example 13, wherein the manifold further includes a protrusion adjacent to the housing connection portion, wherein the protrusion is configured to suppress rotation of the manifold about the housing when the first interface body or the second interface body is detachably connected to the housing. Example 15. A patient interface assembly as described in any of the preceding embodiments, wherein 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. Example 16. The patient interface assembly as described in any of the foregoing examples further includes one or more interface tubes. Example 17. A patient interface assembly as described in any of the preceding embodiments, wherein the housing includes one or more tube engagement portions configured to receive an interface tube. Example 18. The patient interface assembly as described in any of the foregoing embodiments further includes a fixing member configured to be attached to the housing. Example 19. The patient interface assembly as described in Example 1, wherein the first interface body includes a mask or nose fork of a first size, and the second interface body includes a mask or nose fork of a second size, wherein the first size is different from the second size. Example 20. A patient interface, comprising: Interface main body; case; One or more interface tubes; First fixed component; and A second fixing member extends vertically to provide vertical stability to the patient interface. Example 21. A patient interface as described in Example 20, wherein the interface body is configured to engage with the patient’s face and form a seal. Example 22. A patient interface as described in Example 20 or 21, wherein the main body of the interface is a mask body or a cannula body. Example 23. A patient interface as described in any one of Examples 20 to 22, wherein the one or more tubes are configured to be connected to the housing. Example 24. A patient interface as described in any one of Examples 20 to 23, wherein the one or more tubes are formed as a single piece with the housing. Example 25. A patient interface as described in any one of Examples 20 to 24, wherein each of the one or more tubes includes an overmolded grip. Example 26. A patient interface as described in any one of Examples 20 to 25, wherein the first fixation member comprises: Central part; A pair of support pads, each of which is configured to engage a fixing mechanism 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 in the support pads. Example 27. The patient interface as described in Example 26, wherein the first fixation member further includes a patch assembly connected to each of the support pads to secure the support pads to the user. Example 28. A patient interface as described in any one of Examples 20 to 27, wherein the second fixing member is connected to the housing. Example 29. A patient interface as described in any one of Examples 20 to 28, wherein the second fixation member is configured to engage the user's forehead. Example 30. A patient interface as described in any one of Examples 20 to 29, wherein the second fixation member is constructed of a fabric material. Example 31. A patient interface as described in any one of Examples 20 to 30, wherein the second fixation member further includes a patch assembly for securing the second fixation member to the user. Example 32. A patient interface as described in any one of Examples 20 to 31, wherein the interface body has a Shore hardness between 20A and 100A. Example 33. A patient interface as described in any one of Examples 20 to 32, wherein each of the one or more interface tubes is tapered toward one end. Example 34. A patient interface, comprising an interface body, wherein the interface body includes: One or more forks, which extend from the base region of the interface body; One or more openings are provided to allow breathing gas to enter and exit 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. Example 35. The patient interface as described in Example 34, wherein the interface body includes a right fork and a left fork. Example 36. A patient interface as described in Example 34 or 35, wherein the thickness of the one or more forks varies along the length of the one or more forks, or maintains a constant thickness along the length of the one or more forks. Example 37. A patient interface as described in any one of Examples 34 to 36, wherein the base region has a thickness less than the rest of the interface body. Example 38. A patient interface as described in any one of Examples 34 to 36, wherein the base region has a surface recessed relative to an adjacent region of the interface body. Example 39. A patient interface as described in any one of Examples 34 to 38, wherein the base region has a recessed surface surrounding the one or more forks. Example 40. A patient interface as described in any one of Examples 34 to 39, wherein the base region has a recessed surface extending around the two forks. Example 41. A patient interface as described in any one of Examples 34 to 40, wherein the one or more forks are configured to flex in the anterior-posterior direction. Example 42. A patient interface as described in any one of Examples 34 to 41, wherein the one or more forks are configured to flex in the left-right direction. Example 43. A patient interface as described in any one of Examples 34 to 42, wherein the one or more forks have a circular cross section near the apex of the forks. Example 44. A patient interface as described in any one of Examples 34 to 43, wherein the one or more forks are configured to flex while maintaining the diameter and cross-sectional shape along their length. Example 45. A patient interface as described in any one of Examples 34 to 44, wherein the one or more forks are configured to flex while maintaining their flow resistance (RTF). Example 46. A respiratory system, comprising: Gas flow source; Inspiratory conduit, fluidly connected to the gas flow source; and patient interface, comprising: Interface main body; case; One or more interface tubes; and First fixed component. Example 47. The respiratory system as described in Example 46 further includes an expiratory conduit configured to receive gas from the patient interface. Example 48. The respiratory system as described in Example 46 or 47 further includes a bubbler device. Example 49. The respiratory system as described in any one of Examples 46 to 48, further comprising a humidifier. Example 50. A respiratory system as described in any one of Examples 46 to 49, wherein the housing is configured to receive each of a plurality of interface bodies such that the interface bodies are interchangeable. Example 51. A respiratory system as described in any one of Examples 46 to 50, wherein the interface host is a mask body or a cannula body. Example 52. A respiratory system as described in any one of Examples 46 to 51, wherein the one or more interface tubes are configured to be connected to the housing. Example 53. A respiratory system as described in any one of Examples 46 to 52, wherein one of the one or more interface tubes is configured to be connected to the inspiratory conduit. Example 54. A respiratory system as described in any one of Examples 46 to 53, wherein the one or more tubes are formed as a single piece with the housing. Example 55. A respiratory system as described in any one of Examples 46 to 54, wherein each of the one or more tubes includes a molded grip portion. Example 56. A respiratory system as described in any one of Examples 46 to 55, wherein the first fixation member comprises: Central part; A pair of support pads, each of which is configured to engage the 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 in the support pads. Example 57. A respiratory system as described in any one of Examples 46 to 56, wherein the first fixation member further includes a patch assembly coupled to each of the support pads to secure the support pads to the user. Example 58. A respiratory system as described in any one of Examples 46 to 57, wherein the patient interface further includes a second fixation member connected to the housing. Example 59. A respiratory system as described in Example 58, wherein the second fixation member is configured to engage with the user's forehead. Example 60. A respiratory system as described in Example 58 or 59, wherein the second fixing member is constructed of a fabric material. Example 61. A respiratory system as described in any one of Examples 58 to 60, wherein the second fixation member further includes a patch assembly for securing the second fixation member to the user. Example 62. The respiratory system as described in any one of Examples 46 to 61, further comprising a headgear or cap. Example 63. A fixation component for a patient interface in a respiratory system, comprising: A soft, flexible barb is used for detachable connection to the housing of the patient interface. Example 64. The fixing member as described in Example 63, wherein the barb includes one or more tabs. Example 65. A fixing member as described in Example 64, wherein the housing includes an opening, wherein one or more tabs are configured to engage with the housing at the opening. Example 66. A fixing member as described in any one of Examples 63 to 65, wherein the barb includes a cut, wherein the cut is configured to facilitate the collapse of the barb. Example 67. A fixing member as described in any one of Examples 63 to 66, wherein the barb includes an extended top portion configured to prevent the barb from being over-inserted into the opening of the housing. Example 68. A fixing member as described in any one of Examples 63 to 67, wherein the barb is overmolded onto the fixing member. Example 69. A fixation component for a patient interface in a respiratory system, comprising: A support pad is attached to a patch assembly on the patient, wherein the support pad is hinged relative to the rest of the attachment member. Example 70. The fixing member as described in Example 69, wherein the support pad is flexible. Example 71. The fixing member as described in any one of Examples 69 to 70 further includes a hinge between the support pad and a portion of the fixing member. Example 72. A fixing member as described in any one of Examples 69 to 71, wherein the support pad is overmolded onto the fixing member. Example 73. The fixing member as described in Example 71, wherein the hinge is a 180-degree hinge. Example 74. A fixation component for a patient interface in a respiratory system, comprising: A first flexible portion, which is capable of connecting to a patient interface component; A second flexible portion, which is capable of connecting to the patient's forehead; and The third rigid portion extends between the first portion and the second portion. Example 75. The fixing member as described in Example 74, wherein the first flexible part is a barb. Example 76. A fixing member as described in any one of Examples 74 to 75, wherein the second flexible portion is a support pad. Example 77. A fixing member as described in any one of Examples 74 to 76, wherein the first flexible portion and / or the second flexible portion is overmolded onto the third rigid portion. Example 78. A fixing member as described in any one of Examples 74 to 77, wherein the second flexible portion is hinged relative to the third rigid portion. Example 79. A fixation member as described in any one of Examples 74 to 78, wherein the fixation member is detachably connected to the housing of the patient interface. Example 80. A fixing member as described in any one of Examples 74 to 79, wherein the member is a housing or interface body. Example 81. A patient interface component, comprising: An interface body includes a manifold comprising a front side configured to contact the patient and a rear side opposite to the front side, wherein the manifold includes a protruding portion of a housing connection portion located between the rear side and the front side of the manifold. The manifold includes a width extending along the inner cavity of the manifold and a horizontal axis extending along the width, wherein the protruding portion is angled relative to the horizontal axis, and wherein the angled protruding portion of the housing connection portion is configured to improve the assembly and alignment of the interface body when the interface body is detachably connected to the housing via the manifold; A housing comprising 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. Example 82. The patient interface assembly as described in Example 81, wherein the protruding portion of the manifold includes a first width on the front side of the manifold, the first width being greater than a second width on the rear side of the manifold. Example 83. The patient interface assembly as described in Example 81, wherein the protruding portion of the manifold includes a first width on the front side of the manifold, the first width being smaller than a second width on the rear side of the manifold. Example 84. A patient interface assembly as described in any one of Examples 81 to 83, wherein an angled protrusion of the housing connection portion of the manifold extends from the rear side of the manifold at an angle of 120 degrees. Example 85. A patient interface assembly as described in any one of Examples 81 to 83, wherein an angled protrusion of the housing connection portion of the manifold extends from the rear side of the manifold at an angle of 60 degrees. Example 86. A patient interface assembly as described in any one of Examples 81 to 83, wherein an angled protrusion of the housing connection portion of the manifold extends from the rear side of the manifold at an angle between 30 degrees and 170 degrees. Example 87. A patient interface assembly as described in any one of Examples 81 to 86, further comprising a mating surface, wherein a protruding portion of the housing connection portion and the interface body receiving portion are in contact with each other, wherein a portion of the protruding portion of the manifold at the mating surface is higher than the mating surface of the housing. Example 88. A patient interface assembly as described in any one of Examples 81 to 87, wherein 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. Example 89. The patient interface assembly as described in Example 88, wherein the spine is a ring-shaped spine. Example 90. A patient interface assembly as described in Example 88 or 89, wherein the ridge is configured to seal with the inner surface of the housing. Example 91. A patient interface assembly as described in any one of Examples 81 to 90, wherein the manifold has a first distance between the front side of the engagement surface and the annular ridge and a second distance between the rear side of the engagement surface and the annular ridge, wherein the second distance is greater than the first distance. Example 92. A patient interface assembly as described in any one of Examples 81 to 91, wherein 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. Example 93. A patient interface component, comprising: 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. Example 94. The patient interface assembly as described in Example 93, wherein the shell system is a rigid shell. Example 95. A patient interface assembly as described in any of Examples 93 or 94, wherein the one or more features for attaching the second fixation member to the housing are one or more openings. Example 96. A patient interface assembly as described in any one of Examples 93 to 95, wherein the second fixing member is detachably connected to the housing. Example 97. A patient interface assembly as described in any one of Examples 93 to 96, wherein the one or more openings include a lip configured to engage a complementary assembly portion of the second fixation member. Example 98. A patient interface assembly as described in any one of Examples 93 to 97, wherein the side protrusion is characterized by an enlarged head and a rod for pushing into a mating connection. Example 99. A patient interface assembly as described in any one of Examples 93 to 98, wherein the first fixing member is detachably connected to the housing. Example 100. The patient interface assembly as described in any one of Examples 93 to 99 further includes a conduit, wherein the conduit is integral with the housing. Example 101. The patient interface assembly as described in any one of Examples 93 to 99 further includes a conduit, wherein the conduit is detachably connected to the housing. Example 102. A fixing member for a patient interface in a respiratory system, comprising: Central part; A pair of support pads, each of which is configured to engage the 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 in the support pads; The bridging portions include cutouts for receiving the housing, and the bridging portions include thickened portions surrounding the cutouts. Example 103. The fixing member as described in Example 102, wherein the fixing member further includes a patch assembly connected to each of the support pads to secure the support pads to the user. Example 104. A fixing member as described in any one of Examples 102 or 103, wherein the fixing member further includes openings configured for detachably attaching the fixing member to a protrusion on the housing, wherein the first fixing member is pushed into the protrusion engaging with the housing. Example 105. A fixing member as described in Example 104, wherein 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. Example 106. A patient interface component for a respiratory system, comprising: Interface main body; and A housing, wherein the interface body is detachably connected to the housing; as well as This feature restricts the rotation of the interface body relative to the housing. Example 107. A patient interface assembly as described in Example 106, wherein the interface body includes a manifold, and the feature includes a shoulder portion on the rear of the manifold. Example 108. The patient interface assembly as described in Example 107, wherein the shoulder portion abuts against the housing to restrict rotation. Example 109. A patient interface assembly as described in Example 106, wherein the feature includes keyed features on the manifold and housing. Example 110. A patient interface assembly as described in any one of Examples 106 to 109, wherein the interface body includes a cannula body. Example 111. A patient interface assembly as described in any one of Examples 106 to 109, wherein the interface body includes a mask body. Example 112. A patient interface assembly as described in any one of Examples 106 to 111, wherein the housing includes one or more tube engagement receiving portions configured to receive an interface tube. Example 113. A patient interface component for a respiratory system, comprising: case; 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 locking fingers; and An exhalation cannula having a first end and a second end, the first end being configured to connect to a housing and receive an exhaled gas flow, and the second end having locking fingers. Example 114. The patient interface assembly as described in Example 113, wherein a locking finger at the second end of the expiratory conduit is configured to connect to a downstream component. Example 115. The patient interface assembly as described in Example 114, wherein the downstream component includes a bubbler. Example 116. A patient interface assembly as described in any one of Examples 113 to 115, wherein a locking finger at the second end of the inhalation conduit is configured to connect to an upstream component. Example 117. The patient interface assembly as described in Example 116, wherein the upstream component includes a flow source. Example 118. A patient interface assembly as described in any one of Examples 113 to 117, wherein the locking fingers extend away from the connector, the locking fingers are spaced apart and narrow along their length away from the connector. Example 119. The patient interface assembly as described in Example 118, wherein the locking fingers include a locking recess formed on the outer surface of at least each of the locking fingers, the locking recess being configured for partial locking with a gas delivery tube connector, the locking fingers being configured to interact with the recess of the gas delivery tube connector to align the connector and the gas delivery tube connector. Example 120. A patient interface component for a respiratory system, comprising: Interface main body; and A housing, wherein at least a portion of the outer surface of the housing and / or the interface body comprises a low-friction surface. Example 121. The patient interface assembly as described in Example 120, wherein the interface body includes an intubation body. Example 122. The patient interface assembly as described in Example 120, wherein the interface body includes a mask body. Example 123. A patient interface assembly as described in any one of Examples 120 to 122, wherein the low-friction surface is provided by a parylene coating and / or a sandblasting process. Example 124. A patient interface assembly as described in any one of Examples 120 to 123, wherein 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. Example 125. A patient interface assembly as described in any one of Examples 120 to 124, wherein the interface body is detachable from the housing, and the interface body includes a manifold having a low-friction surface that engages with the housing. Example 126. A method for manufacturing a patient interface component for a respiratory system, comprising: Manufacturing interface body; and The outer surface of the interface body is treated to provide a low-friction surface. Example 127. The manufacturing method as described in Example 126, wherein the interface body includes a cannula body. Example 128. The manufacturing method as described in Example 126, wherein the interface body includes a mask body. Example 129. A manufacturing method as described in any one of Examples 126 to 128, wherein the interface body is detachable from the housing. Example 130. A manufacturing method as described in any one of Examples 126 to 129, wherein the low-friction surface is provided by a surface coating or a surface sandblasting process. Example 131. The manufacturing method as described in Example 130, wherein the surface coating is a parylene coating. Example 132. The manufacturing method as described in Example 130, wherein the surface sandblasting process is a bead-blasting process. Example 133. A manufacturing method as described in any one of Examples 126 to 132, wherein substantially the entire outer surface of the interface body is a low-friction surface. Example 134. A manufacturing method as described in any one of Examples 126 to 133, wherein a portion of the interface body is a low-friction surface, wherein the interface body includes a patient-facing rear side of the interface body and a front side opposite to the rear side, wherein the low-friction portion is the rear portion of the manifold of the interface body. Example 135. A manufacturing method as described in any one of Examples 126 to 134, wherein a portion of the interface body is a low-friction surface, wherein the interface body includes a patient-facing rear side of the interface body and a front side opposite to the rear side, wherein the low-friction portion is the front portion of the manifold of the interface body. Example 136. A patient interface component, comprising: Interface body, the interface body includes: A manifold including a front side configured to contact a patient and a rear side opposite to the front side, wherein the manifold includes a protruding portion of a housing connection portion located between the rear side and the front side of the manifold; The manifold includes a width extending along its inner cavity and a horizontal axis extending along the width, wherein the protruding portion is angled relative to the horizontal axis, and wherein the angled protruding portion of the housing connection portion is configured to improve the assembly and alignment of the interface body when the interface body is detachably connected to the housing via the manifold; and Features that restrict the rotation of the interface body relative to the housing; and the housing includes: Facing the patient's front side; The rear side, opposite to the front side; The housing includes a width extending from a first pipe engagement portion at one end of the housing to a second pipe engagement portion at the opposite end of the housing, and a horizontal axis extending along the width. The housing also includes an interface body receiving portion between the front and rear sides of the housing, wherein the interface body receiving portion is angled relative to the horizontal axis. This angled interface body receiving portion is configured to improve assembly and alignment when the manifold is detachably connected to and received by the housing. A first fixing member, the first fixing member comprising: Central part; A pair of support pads, each of which is configured to engage the 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 in the support pads; The bridging portions include cutouts for receiving the housing, and the bridging portions include thickened portions surrounding the cutouts; The second fixing member includes: A first flexible portion, which is capable of connecting to a patient interface component; A second flexible portion, which is capable of connecting to the patient's forehead; and A third rigid portion extending between the first and second portions; an intake conduit having a first end and a second end, the first end configured to connect to the housing and deliver an incoming gas flow, and the second end having locking fingers; and An exhalation cannula having a first end and a second end, the first end being configured to connect to the housing and receive an exhaled gas flow, and the second end having locking fingers. Example 137. The patient interface assembly as described in Example 136, wherein the interface body includes an intubation body. Example 138. The patient interface assembly as described in Example 136, wherein the interface body includes a mask body. Example 139. A patient interface assembly as described in any one of Examples 136 to 138, wherein the inspiratory conduit and the expiratory conduit are integral with the housing. Example 140. A patient interface assembly as described in any one of Examples 136 to 139, wherein the first fixation member and the second fixation member are connectable to the housing. Example 141. A patient interface assembly as described in any one of Examples 136 to 140, wherein the second fixing member is capable of being connected to a patient patch assembly or headgear. Example 142. A patient interface assembly as described in any one of Examples 136 to 141, wherein the second fixing member is detachably connected to the housing. Example 143. A patient interface assembly as described in any one of Examples 136 to 142, wherein the interface body is detachably connected to the housing. Example 144. A patient interface component, comprising: Interface main body; and A housing configured to be detachably connected to the interface body, the housing including one or more tube engagement portions at a lateral entry point on opposite ends of the housing, wherein such tube engagement portions are configured to receive interface tubes. Example 145. The patient interface assembly as described in Example 144, wherein the interface body includes a cannula body. Example 146. The patient interface assembly as described in Example 144, wherein the interface body includes a mask body. Example 147. A patient interface component, comprising: First interface main body; The second interface main body; and A housing configured to be detachably connected to the first interface body or the second interface body, the housing including one or more tube engagement portions at a lateral entry point of the housing, wherein the tube engagement portions are configured to receive an interface tube; 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, and in the second configuration, the second interface body is connected to the housing. Example 148. 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; The manifold is in fluid communication with the breathing chamber and includes 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 to enter and exit the breathing chamber. Example 149. A mask body as described in Example 148, wherein the first opening and the second opening are configured to communicate with interface tubes, the interface tubes being configured to deliver gas flows into and out of the mask and the first and second lateral sides of the manifold. Example 150. An interface body, comprising: A face mask, wherein the face 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, the face mask comprising: A face mask seal, wherein at least a portion of the face mask seal includes a region of reduced stiffness, wherein the region of reduced stiffness is positioned between a first harder region and a second harder region, wherein the first harder region and the second harder region have a stiffness greater than that of the region of reduced stiffness; As the first stiffer region moves toward the second stiffer region, the region with reduced stiffness buckles in a single direction as it continues to move toward the second stiffer region. Example 151. The mask body as described in Example 150, wherein the first rigid region includes a structural support portion that extends partially around the circumference of the mask. Example 152. The mask body as described in Example 150, wherein the second harder region is the front portion of the mask. Example 153. A patient interface component, comprising: Interface body, the interface body including a housing connection portion including a first side facing the patient and an opposite second side, wherein the housing connection portion includes a shape defined between the first side and the second side of the housing connection portion; and A housing, the housing including an interface body receiving portion, wherein the interface body receiving portion has a shape complementary to the shape of a housing connection portion of the interface body, wherein the housing is configured to be detachably connected to the interface body. Example 154. The patient interface assembly as described in Example 153, wherein the shape of the housing connection portion includes a trapezoidal shape. Example 155. A patient interface assembly as described in Example 154, wherein the housing connection portion of the interface body includes a wider trapezoidal base near the front portion of the housing. Example 156. A patient interface assembly as described in Example 154, wherein the housing connection portion of the interface body includes a wider trapezoidal base near the rear portion of the housing. Example 157. An interface body, comprising: One or more forks, which extend from the base region; One or more openings, which allow breathing gas to enter and exit the fork. The one or more forks are configured to flex at the base region while maintaining a seal with the user's nostrils. Example 158. A patient interface assembly as described in Example 157, wherein the one or more forks include a thickness that varies along the length of the one or more forks. Example 159. A patient interface assembly as described in Example 157, wherein the one or more forks maintain a constant thickness along the length of the one or more forks. Example 160. An interface body, wherein the interface body comprises: One or more forks, which extend from the base region of the interface body; One or more openings are provided to allow breathing gas to enter and exit 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.

[0459] the term Unless the context explicitly requires otherwise, throughout the specification and scope of the claims, the terms "comprise," "comprising," etc., shall be understood to have an inclusive meaning, rather than an exclusive or exhaustive meaning; that is, to be understood in the sense of "including but not limited to." Otherwise, conditional language used herein, such as "can," "could," "might," "may," "e.g.," etc., unless specifically stated otherwise, or otherwise understood as used in the context, 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.

[0460] 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 "approximately" or "about". The terms "approximately" or "about" mean that quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics need not be precise, but can 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 while still performing the desired function or achieving the desired result. For example, in some implementations, as the context may indicate, the terms "about", "approximately", 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 "approximately linear" may mean approximately deviating from exact parallelism by less than or equal to 15°.

[0461] 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 values ​​explicitly listed as limits of the range, but also all individual values ​​or subranges covered within the range, as if each 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. Thus, 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 value (e.g., "greater than 1"), and should apply regardless of whether the range or the breadth of the characteristic is described.

[0462] 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 clearly 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.

[0463] 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 constitutes part of the common general knowledge in the relevant field in any country of the world.

[0464] The invention can also be broadly defined as any part, element, and feature individually or jointly mentioned or indicated in the specification of this application, as well as any or all combinations of two or more of the said parts, elements, or features.

[0465] In the foregoing description, reference has been made to components in whole or in part having known equivalents thereof, which are incorporated herein as if described separately.

[0466] It should be noted that various variations and modifications to the presently 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 intended 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 only by the following claims.

[0467] 30: Humidifier System 40: Pressure Regulator 70: Aerator device; resistance device 105,3220,4220: nose fork; fork 106: Gas inlet; inlet 107a: Trajectory Inflection Point 107b: Second Inflection Point 108: Gas outlet; outlet 109, 1109: Sealed area 110: Humidification chamber; chamber 112: Export 115: Water 116: Entrance 118: Blower 119: Patient 120: Heating wire 136: Short catheter 138: Water Column 201a: Inspiratory catheter 201b: Expiratory tube 204: Chamber 300: Supply source; Interface 305, 309: Fork 308,1411: Forklift exit; Exit 310: Structural Part 312: point 1000: Exemplary Respiratory System 1131, 1133, 1134, 1134a, 1135: Ellipse 1415: Base 1420: Fork trajectory; trajectory 3000: Interface; Patient Interface 3200a, 4200a: Intubation body 3200b, 4200b: Main body of the mask 3222: Groove; sunken area 3223: Subsidence area; base area 3224: Gas outlet 3225,4853: Outer surface 3226: Sealing surface 3228: Base Area 3232, 3232a, 3232b: Face mask 3234: Contact surface 3235: Inner peripheral edge 3236: Mask cavity 3237: Area; Roll up area 3237b, 3237c: Thin region; region 3238: Front portion; front surface 3240, 4240, 5420: manifold 3241,3430,4241,4430,4841: Front part 3242, 4247: Protruding parts 3243,3450,4243,4843: Rear section 3244, 4244: Housing connection part 3246: Opening; First annular ridge 3248, 3422: Spine 3249: Thickened Area 3252,4644: First end 3254,4646: Second end 3256: Base portion 3400, 4400, 5400: Housing 3420: Forward extension 3424: Channel 3440, 4440: Central protrusion 3442,4422: Head 3444, 4424: Rod 3460, 4460: Pipe joint portion 3470: Upper edge 3480: Interface main receiving part 3490: Lower edge 3600, 4600: First fixed component 3610, 4610, 4920: Central part 3620: Center Opening 3630, 3930, 4630: Bridging section 3640,4916: Incision 3660, 3980, 4660, 4980: Support pads 3662: Hinge point 3666,3693,4914,4989: convex plates 3680: Surface 3691: Exposed area; exposed part 3692: Non-stretched area 3694, 3697: Laminated film; Nylon film 3695: Ring Materials 3696: Nylon Ring Material 3698: Foam Materials 3800: Interface tube 3845,4246,4284,4426,4442,4845: Opening 3850: Grip section 3860, 4820: Connectors 3900, 4900, 4900a, 4900b: Second fixed components 3910: Connecting part 3912,4428: concave part 4000: Patient Interface Component; Patient Interface 4200: Interface Main Body 4248: Circular ridge 4286: Key Features 4287: Protrusion 4288: Extension 4289: Dent 4420: Lateral protrusion; anterior protrusion 4443: Channel 4446: Lip border 4480: Interface Main Receiving Section 4482: Angle; Corner 4484: Corner 4628: Shoulder area 4632: Thickened area; bridging section 4634: Bending 4640: Incision; Opening 4642: Arm 4645: Rear side 4647: Front side 4800: Interface tube; Adaptor tube 4822, 4987: Finger-shaped parts 4840: Joint portion 4847: Angle 4849: Noodles 4851: Inner surface 4889: Joint surface 4910: Attachment 4912: Flexible barb 4915: Connection part 4918: Top section 4950, 4950a, 4950b: Front barb section 4951: Hook section 4972: Cut Outline 4982: Pivot Connection 4984: Hinged handle; attachment rod 4986: wide base; base 4988: Barbed Clip 5604: Coloring ring 5606: Color Indicator 5608: Line; Colored bar b: First width c: Second width h1, h2: Horizontal axes t1: First thickness t2: Second thickness a,w: width

Claims

1. A cannula body for a breathing interface for delivering breathable gas to a user's nostrils, the cannula body comprising: a manifold having a pair of openings on opposite lateral sides of the manifold, the openings assembling to allow gas flow into and out of the cannula body; a pair of prongs extending from the manifold, each prong defining an inner lumen and having a wall having a first thickness; and wherein, The manifold has a base region surrounding the junction between the forks and the manifold, the base region having a wall thickness less than the first thickness.

2. The cannula body as described in claim 1, wherein, The base region includes a thinned material portion extending around the base of each fork.

3. The cannula body as described in claim 1, wherein, The basal region extends around one base of the fork.

4. The cannula body as described in claim 1, wherein, The basal region is continuous and extends around the two forks.

5. The cannula body as described in claim 1, wherein, The base region is thinner than the rest of the manifold.

6. The cannula body as described in claim 1, wherein, The base region is configured to allow the forks to move independently of the manifold.

7. The cannula body as described in claim 1, wherein, These forks are configured to maintain the fork diameter and cross-sectional shape along the length of each fork while flexing relative to the manifold.

8. The cannula body as described in claim 1, wherein, These forks are configured to flex relative to the manifold while maintaining their flow resistance.

9. The cannula body as described in claim 1, wherein, These forks are designed to flex in the front-to-back direction.

10. The cannula body as described in claim 1, wherein, These forks are designed to flex in the left and right directions.

11. The cannula body as described in claim 1, wherein, These forks are designed to seal against the user's nostrils.

12. The cannula body as described in claim 1, wherein, The base area is assembled to provide a gap with the user's nasal septum.

13. The cannula body as described in claim 1, wherein, The base region is formed by a local reduction in the material thickness at the base of each fork.

14. The cannula body as described in claim 1, wherein, The base region is located where the base of the fork connects with the manifold, and the fork extends outward substantially perpendicular to the base region.

15. The cannula body as described in claim 1, wherein, The base region has a wall thickness between 0.2 mm and 1.3 mm.

16. The cannula body as described in claim 1, wherein, The manifold includes an annular ridge in each of the adjacent pairs of openings, the annular ridges assembling to form a seal with a housing.

17. The cannula body as described in claim 1, wherein, At least a portion of the manifold is assembled to be received by a housing of a patient interface component.

18. The cannula body as described in claim 17, wherein, The manifold includes a housing connection portion that includes a protrusion that is configured to suppress rotation of the cannula body relative to the housing.

19. The cannula body as described in claim 1, wherein, Except for the openings of the fork and the openings on the lateral side of the manifold, the main cannulation system is closed.

20. A patient interface comprising a housing configured to connect to a cannula body, the cannula body being the cannula body as described in claim 1, the patient interface further comprising a first tube connected to a first side of the housing and a second tube connected to the housing on a second side of the housing.

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