Oral cavity interface for providing respiratory support

Abstract

An oral interface for providing respiratory support to a patient includes at least one gas inlet for receiving a flow of gas; at least one gas outlet for providing the flow of gas to the patient; a flow path defined between the at least one gas inlet and the at least one gas outlet; and a main body. The main body includes an oral engaging portion configured to engage with an oral cavity of the patient; a first end opening and a second end opening disposed on opposite sides of the main body. The first end opening and the second end opening define a passageway for providing access to the oral cavity. The at least one gas outlet includes a restriction device configured to increase an average velocity of the flow of gas as the flow of gas exits the at least one gas outlet.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 590,144, filed October 13, 2023, the contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to a patient interface in a system for providing respiratory support to a patient. More specifically, embodiments of this disclosure relate to an oral interface for providing respiratory support to a patient and a system including such an oral interface. Background Technology

[0004] Respiratory support can be provided to patients in a variety of settings, including but not limited to intensive care units, hospital wards, or operating rooms. Respiratory support may be required for patients undergoing certain medical procedures. For example, surgical procedures may require anesthesia or sedation. During anesthesia procedures, respiratory support, such as high-flow nasal delivery, can be provided to patients throughout the procedure via nasal intubation, especially during pre-oxygenation, intubation, and / or extubation.

[0005] Some medical procedures do not require closing the mouth, while others require opening the mouth to access the patient's airway. However, when the mouth is exposed to the atmosphere, the pressure within the airway decreases (even with high-flow respiratory support delivered via the nose), increasing the risk of airway collapse and / or atelectasis.

[0006] There is a need to provide an oral interface to reduce the risks encountered in procedures involving opening the patient's mouth. Therefore, there is a need to provide an oral interface that can improve or maintain airway pressure when the patient's mouth is open.

[0007] The discussion of the background art included herein, including references to documents, actions, materials, devices, articles, etc., is for the purpose of explaining the context of the invention. This should not be construed as an admission or implication that any material cited has been disclosed, is known, or is part of the general common sense. Summary of the Invention

[0008] According to one aspect of this disclosure, an oral interface for providing respiratory support to a patient is provided, the oral interface comprising: at least one gas inlet for receiving airflow; at least one gas outlet for providing airflow to the patient; an airflow path defined between the at least one gas inlet and the at least one gas outlet; and a body comprising: an oral engagement portion configured to engage with the patient's oral cavity; a first end opening and a second end opening disposed on opposite sides of the body, the first end opening and the second end opening defining a passage for providing access to the oral cavity; wherein the at least one gas outlet includes a limiting device configured to increase the average velocity of the airflow as it exits the at least one gas outlet.

[0009] At least one gas outlet may be located at any of the following positions: at or near the first end opening, between the first end opening and the second end opening, or at or near the second end opening. The channel extends between the first end opening and the second end opening.

[0010] The limiting device may be a nozzle configured to generate a jet of airflow. In some examples, the limiting device may be located in the airflow path upstream of at least one gas outlet.

[0011] At least a portion of the airflow path may extend, for example, circumferentially around the channel. At least a portion of the airflow path may be defined by structural features of the body. In some examples, at least a portion of the airflow path may be defined between an outer wall portion and an inner wall portion of the body. In some examples, the oral cavity junction may include the outer wall portion of the body. In some examples, at least a portion of the airflow path may be arranged concentrically with the channel, such that the airflow path at least partially surrounds the channel. The airflow path may extend longitudinally for a portion or all of its length around the channel between a first end opening and a second end opening. The airflow path may be arranged outside the channel. In some examples, one or more gas outlets may be arranged such that gas flowing from the airflow path through one or more gas outlets is provided to the patient through the channel during use.

[0012] At least one gas outlet may be provided along the perimeter of the channel. The channel may have an elliptical, oblong, circular, oval, or other cross-sectional shape.

[0013] In some embodiments, the average velocity of the airflow around the channel can be substantially uniform.

[0014] At least one gas outlet can have a substantially uniform width around the channel.

[0015] At least one gas outlet can be configured to direct the gas flow in a direction substantially parallel to the axis of the body extending between the first end opening and the second end opening.

[0016] In some embodiments, at least one gas outlet may be configured to guide airflow from a first end opening toward a second end opening by means of one or both of the angle of the limiting device and the cross-sectional width of the airflow path.

[0017] In some embodiments, at least one gas outlet may be configured to direct airflow toward a line converging near the second end opening. This line may be substantially orthogonal to the axis of the body extending between the first and second end openings.

[0018] In some embodiments, at least one gas outlet may be configured to direct airflow toward a point near the second end opening. The location of this point may be determined based on one or more of the angle of at least one gas outlet, the shape of at least one gas outlet, the cross-sectional width of the airflow path, the shape of at least one gas inlet, and the average velocity of the airflow.

[0019] At least one gas outlet may be further configured to provide airflow such that the patient's airway pressure is at least about 0.1 cmH2O or about 0.2 cmH2O, or about 0.3 cmH2O, or about 0.4 cmH2O, or about 0.5 cmH2O, or about 0.6 cmH2O, or about 0.7 cmH2O, or about 0.8 cmH2O, or about 0.9 cmH2O, or about 1 cmH2O, or about 2 cmH2O, or about 3 cmH2O, or about 4 cmH2O, or about 5 cmH2O, or about 6 cmH2O, or about 7 cmH2O, or about 8 cmH2O, or about 9 cmH2O, or about 10 cmH2O.

[0020] In some embodiments, at least one gas outlet may be configured to provide an airflow such that the patient’s airway pressure is between about 0.1 cmH2O and about 10 cmH2O, or between about 0.2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and 10 cmH2O.

[0021] The airflow rate can be between approximately 0 LPM and approximately 200 LPM. In some embodiments, the airflow rate can be between approximately 20 LPM and approximately 200 LPM.

[0022] The average speed of the airflow can be approximately 100 m / sec.

[0023] The body of the oral cavity interface may have a cross-section having a first dimension and a second dimension perpendicular to the first dimension, wherein the first dimension is larger than the second dimension.

[0024] In some embodiments, at least a portion of the body may have an elliptical, oblong, circular, oval, or other cross-sectional shape transverse to an axis extending from the first end opening to the second end opening.

[0025] The cross-sectional width of the airflow path around the channel may be non-uniform. The width of at least one gas outlet may be non-uniform around the channel.

[0026] At least one gas outlet may include two or more gas outlets arranged around the channel.

[0027] At least one gas inlet may include a first gas inlet and a second gas inlet. The cross-sectional area of ​​the first gas inlet may be substantially equal to the cross-sectional area of ​​the second gas inlet.

[0028] Furthermore, in some embodiments, one of the first gas inlet and the second gas inlet may be configured to be close to the patient's nose during use.

[0029] In some embodiments, the first gas inlet and the second gas inlet may be arranged opposite to each other.

[0030] The oral interface may include a cap disposed around an oral engagement portion of the body. In some embodiments, the cap may be disposed around a portion of the oral engagement portion configured to be located within the patient's oral cavity and configured to provide a substantial seal around the oral interface and the patient's oral cavity, allowing fluid to enter the patient's oral cavity substantially through a channel.

[0031] The oral interface may further include a headband connector configured to detachably connect to a patient-wearable headband to stabilize the oral interface during use.

[0032] According to another aspect of this disclosure, an oral interface for providing respiratory support to a patient is provided, the oral interface comprising: at least one gas inlet for receiving airflow; at least one gas outlet for providing airflow toward the posterior part of the patient's oral cavity; an airflow path defined between the at least one gas inlet and the at least one gas outlet; and a body comprising: a first end opening and a second end opening disposed on opposite sides of the body, the first end opening and the second end opening defining a channel for providing access to the patient's oral cavity, wherein the at least one gas outlet is circumferentially disposed around the channel and configured as a jet to provide airflow toward the posterior part of the patient's oral cavity.

[0033] In some embodiments, at least one gas outlet may be located at any of the following positions: at or near the first end opening, between the first end opening and the second end opening, or at or near the second end opening.

[0034] At least one gas outlet can be configured to provide gas flow into the channel in the form of a jet.

[0035] At least one gas outlet may include a nozzle configured to provide a jet.

[0036] At least one gas outlet may be located along the perimeter of the channel.

[0037] At least one gas outlet may include a slit arranged around the periphery of a body that defines the gas flow path.

[0038] In some embodiments, at least one gas outlet may be configured to guide airflow in a direction substantially parallel to an axis extending between a first end opening and a second end opening.

[0039] In some embodiments, at least one gas outlet may be configured to guide airflow from a first end opening toward a second end opening by means of one or more of the angle of the limiting device, the angle of at least one gas outlet, the shape of at least one gas outlet, and the cross-sectional width of the airflow path.

[0040] In some embodiments, at least one gas outlet may be configured to direct airflow toward a line converging near the second end opening. This line may be substantially orthogonal to the axis of the body extending between the first and second end openings.

[0041] In some embodiments, at least one gas outlet may be configured to direct airflow toward a point near the second end opening. The location of this point may be based on one or more of the following: the angle of the limiting device, the angle of at least one gas outlet, the shape of at least one gas outlet, the cross-sectional width of the airflow path, the shape of at least one gas inlet, and the average velocity of the airflow.

[0042] In some embodiments, at least one gas outlet may be configured to direct the gas flow toward the second end opening.

[0043] The average velocity of the airflow around the channel near at least one gas outlet can be substantially uniform.

[0044] In some embodiments, at least one gas outlet may be configured to provide an airflow such that the patient's airway pressure is at least about 0.1 cmH2O or about 0.2 cmH2O, or about 0.3 cmH2O, or about 0.4 cmH2O, or about 0.5 cmH2O, or about 0.6 cmH2O, or about 0.7 cmH2O, or about 0.8 cmH2O, or about 0.9 cmH2O, or about 1 cmH2O, or about 2 cmH2O, or about 3 cmH2O, or about 4 cmH2O, or about 5 cmH2O, or about 6 cmH2O, or about 7 cmH2O, or about 8 cmH2O, or about 9 cmH2O, or about 10 cmH2O.

[0045] In some embodiments, at least one gas outlet may be configured to provide an airflow such that the patient’s airway pressure is between about 0.1 cmH2O and about 10 cmH2O, or between about 0.2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and 10 cmH2O.

[0046] The airflow rate can be, for example, between approximately 0 LPM and approximately 200 LPM. For example, the airflow rate can be between approximately 20 LPM and approximately 200 LPM.

[0047] The average speed of the airflow can be approximately 100 m / sec.

[0048] In some embodiments, the body may have a cross-section having a first dimension and a second dimension perpendicular to the first dimension, wherein the first dimension is larger than the second dimension.

[0049] In some embodiments, at least a portion of the body may have an elliptical, oblong, circular, oval, or other cross-sectional shape transverse to an axis extending from the first end opening to the second end opening.

[0050] In some embodiments, the cross-sectional width of the airflow path may be non-uniform around the channel.

[0051] In some embodiments, at least one gas outlet may include two or more gas outlets arranged around the channel.

[0052] In some embodiments, at least one gas inlet may include a first gas inlet and a second gas inlet.

[0053] In some embodiments, the cross-sectional area of ​​the first gas inlet may be substantially equal to the cross-sectional area of ​​the second gas inlet.

[0054] In some embodiments, one of the first gas inlet and the second gas inlet may be configured to be close to the patient's nose during use.

[0055] In some embodiments, the first gas inlet and the second gas inlet may be arranged opposite to each other.

[0056] The oral interface may include a cap disposed around a body. In some embodiments, the cap may be disposed around a portion of the body configured to be located within the patient's oral cavity and further configured to provide a substantially sealed space between the oral engagement portion and the patient's teeth and / or lips, for example, allowing fluid to enter the patient's oral cavity substantially through a channel.

[0057] In some embodiments, the oral interface includes one or more headband connectors configured to detachably connect to a patient-wearable headband to stabilize the oral interface during use.

[0058] According to another aspect, an oral interface for providing respiratory support to a patient is provided, the oral interface comprising: at least one gas inlet for receiving airflow; at least one gas outlet for providing airflow to the patient; an airflow path between the at least one gas inlet and the at least one gas outlet; and a body comprising: an oral engagement portion configured to engage with the patient's oral cavity; a first end opening and a second end opening disposed on opposite sides of the body, the first end opening and the second end opening defining a passage for providing access to the oral cavity; wherein the airflow path includes a limiting device configured to increase the average velocity of the airflow as it exits the at least one gas outlet.

[0059] According to a further aspect of this disclosure, an oral interface for providing respiratory support to a patient is provided, the oral interface comprising: at least one gas inlet for receiving airflow; at least one gas outlet for providing airflow to the patient; an airflow path between the at least one gas inlet and the at least one gas outlet; and a body comprising: a first end opening and a second end opening disposed on opposite sides of the body, the first end opening and the second end opening defining a passage for providing access to the patient's oral cavity, wherein the at least one gas outlet is configured such that the average velocity of airflow exiting the at least one gas outlet is up to approximately 110 m / s.

[0060] In some embodiments, the average velocity of the gas flow exiting at least one gas outlet may be between approximately 10 m / s and approximately 110 m / s.

[0061] In some embodiments, the average velocity of the gas flow exiting at least one gas outlet may be between approximately 40 m / s and approximately 110 m / s.

[0062] In some embodiments, the average velocity of the airflow may be approximately 100 m / sec.

[0063] In some embodiments, the airflow path may extend circumferentially, for example, around at least a portion of the channel.

[0064] In some embodiments, at least one gas outlet may be disposed around the periphery of the channel. The channel may have an elliptical, oblong, circular, oval, or other cross-sectional shape. Thus, at least one gas outlet may be disposed, for example, around the circumference of the channel, although it is not necessarily required, at least one gas outlet may also be disposed, for example, in a spiral or other arrangement around the periphery (or boundary) of the channel.

[0065] In some embodiments, the average velocity of the airflow around the channel can be substantially uniform.

[0066] In some embodiments, the width of at least one gas outlet surrounding the channel may be substantially uniform.

[0067] In some embodiments, at least one gas outlet may be configured to guide airflow in a direction substantially parallel to an axis extending between a first end opening and a second end opening.

[0068] In some embodiments, at least one gas outlet may be configured to guide airflow from a first end opening toward a second end opening by means of one or both of the angle of the limiting device and the cross-sectional width of the airflow path.

[0069] In some embodiments, at least one gas outlet may be configured to direct airflow toward a line converging near the second end opening. This line may be substantially orthogonal to the axis of the body extending between the first and second end openings.

[0070] In some embodiments, at least one gas outlet is configured to guide the airflow toward a point near the second end opening. The location of this point within the channel may be based on one or more of the following: the angle of the limiting device, the angle of at least one gas outlet, the shape of at least one gas outlet, the cross-sectional width of the airflow path, the shape of at least one gas inlet, and the average velocity of the airflow.

[0071] In some embodiments, at least one gas outlet may be configured to provide an airflow such that the patient's airway pressure is at least about 0.1 cmH2O or about 0.2 cmH2O, or about 0.3 cmH2O, or about 0.4 cmH2O, or about 0.5 cmH2O, or about 0.6 cmH2O, or about 0.7 cmH2O, or about 0.8 cmH2O, or about 0.9 cmH2O, or about 1 cmH2O, or about 2 cmH2O, or about 3 cmH2O, or about 4 cmH2O, or about 5 cmH2O, or about 6 cmH2O, or about 7 cmH2O, or about 8 cmH2O, or about 9 cmH2O, or about 10 cmH2O.

[0072] In some embodiments, at least one gas outlet may be configured to provide an airflow such that the patient’s airway pressure is between about 0.1 cmH2O and about 10 cmH2O, or between about 0.2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and 10 cmH2O.

[0073] In some embodiments, the airflow rate can be between approximately 0 LPM and approximately 200 LPM. For example, the airflow rate can be between approximately 20 LPM and approximately 200 LPM.

[0074] In some embodiments, the body may have a cross-section having a first dimension and a second dimension perpendicular to the first dimension, wherein the first dimension is larger than the second dimension.

[0075] In some embodiments, at least a portion of the body may have an elliptical or oblong, circular, oval, or other cross-sectional shape transverse to an axis extending from the first end opening to the second end opening.

[0076] In some embodiments, the cross-sectional width of the airflow path may be non-uniform around the channel. The width of at least one gas outlet may be non-uniform around the channel.

[0077] In some embodiments, at least one gas outlet may include two or more gas outlets arranged around the channel.

[0078] In some embodiments, at least one gas inlet may include a first gas inlet and a second gas inlet.

[0079] In some embodiments, the cross-sectional area of ​​the first gas inlet may be substantially equal to the cross-sectional area of ​​the second gas inlet.

[0080] In some embodiments, one of the first gas inlet or the second gas inlet may be configured to be close to the patient's nose during use.

[0081] In some embodiments, the first gas inlet and the second gas inlet may be arranged opposite to each other.

[0082] According to another aspect of this disclosure, a patient interface component is provided, including: a nasal interface; and an oral interface according to any of the foregoing aspects.

[0083] In some embodiments, the nasal and oral interfaces can be configured to receive airflow from a common airflow source.

[0084] In other embodiments, the nasal and oral interfaces can be configured to receive airflow from separate airflow sources.

[0085] The nasal interface can provide a first airflow to the patient at a first flow rate, and the oral interface can provide a second airflow to the patient at a second flow rate.

[0086] In some embodiments, the first traffic flow may be different from the second traffic flow.

[0087] In some embodiments, the first flow rate and the second flow rate can be between approximately 0 LPM and approximately 100 LPM.

[0088] For example, the first and second flows can be between approximately 20 LPM and approximately 100 LPM.

[0089] In some embodiments, the sum of the first flow and the second flow can be between approximately 0 LPM and approximately 200 LPM.

[0090] The nasal and oral interfaces can be fluidly connected.

[0091] The bottom of the nasal interface may include an interface connector to allow fluid communication with the airflow path in the oral cavity interface.

[0092] The nasal interface may include a nasal cannula. In some embodiments, the nasal cannula may be unsealed.

[0093] In some embodiments, the nasal interface can form a seal with the patient's nostrils. A sealed nasal interface may include a nasal cannula, a nasal mask, or a nasal pillow. A sealed interface may also include a nasal clip.

[0094] According to a further aspect of this disclosure, a system for providing respiratory support to a patient is provided, the system comprising: at least one airflow source for generating airflow; at least one humidifier configured to deliver humidified airflow to a patient interface; and a patient interface component according to the foregoing aspect.

[0095] According to a further aspect of this disclosure, a system for providing respiratory support to a patient is provided, the system comprising: at least one airflow source for generating airflow; and a patient interface component according to the foregoing aspect.

[0096] It is understood that each aspect described herein may be combined with one or more features, modifications, and alternatives described in the context of one or more other aspects, and may, as appropriate, include one or more features, modifications, and alternatives of any embodiment described below. For efficiency, while those skilled in the art will recognize that combinations of these features, modifications, and alternatives disclosed for some aspects and embodiments are equally applicable to other aspects and are within and constitute a part of the subject matter of this disclosure, these features, modifications, and alternatives are not disclosed repeatedly for each aspect. Attached Figure Description

[0097] Embodiments of this disclosure will be described by way of example only and with reference to the accompanying drawings, wherein:

[0098] Figure 1 A system for providing high-flow respiratory support according to an embodiment of the present disclosure is shown;

[0099] Figure 2 a illustrates an embodiment of the present disclosure with Figure 1 A cross-sectional side view of the oral cavity interface used in the system; Figure 2 b is Figure 2 The first enlarged part of a; Figure 2 c is Figure 2 The second enlarged portion of a;

[0100] Figure 3 Another embodiment of the present disclosure is shown. Figure 1 A cross-sectional side view of the oral cavity interface used in the system;

[0101] Figure 4 A perspective side view of the oral cavity interface is shown;

[0102] Figure 5 The front view shows Figure 4 The oral cavity interface (which is away from the patient during use);

[0103] Figure 6 Shown from the rear view Figure 4 and Figure 5 The oral cavity interface (facing the patient when in use);

[0104] Figure 7 The top view shows Figures 4 to 6 Oral interface;

[0105] Figure 8 An oral cavity interface with a single gas inlet is shown according to an embodiment of the present disclosure;

[0106] Figure 9 An oral cavity interface with two gas inlets is shown according to an embodiment of the present disclosure;

[0107] Figures 10 to 12 Various orientations of at least one gas inlet of an oral cavity interface according to various embodiments of the present disclosure are shown;

[0108] Figure 13 A nozzle for an oral cavity interface according to an embodiment of the present disclosure is shown, which is oriented at approximately 0 degrees to the longitudinal axis of the oral cavity interface;

[0109] Figure 14 It shows Figure 13 The airflow pattern of the airflow exiting the nozzle of the oral cavity interface;

[0110] Figure 15 A nozzle for an oral cavity interface according to an embodiment of the present disclosure is shown, which is oriented at approximately 45 degrees to the longitudinal axis of the oral cavity interface;

[0111] Figure 16 It shows Figure 15 The airflow pattern of the airflow exiting the nozzle of the oral cavity interface;

[0112] Figure 17 A nozzle for an oral cavity interface according to an embodiment of the present disclosure is shown, which is oriented at approximately 90 degrees;

[0113] Figure 18 It shows Figure 17 The airflow pattern of the airflow exiting the nozzle of the oral cavity interface;

[0114] Figures 19 to 21 This is a cross-sectional perspective view according to various embodiments of the present disclosure, showing different contours of airflow convergence within the oral cavity interface when the nozzle is oriented at an angle of approximately 45 degrees to the axis of the oral cavity interface, having a non-circular (e.g., oblong) shape.

[0115] Figure 22 This is a side cross-sectional view according to an embodiment of the present disclosure, showing the gas flow profile within the oral cavity interface when the nozzle is oriented at approximately a 45-degree angle to the axis of the oral cavity interface having a circular shape.

[0116] Figure 23 A patient interface component including an oral interface and a nasal interface is shown according to an embodiment of the present disclosure;

[0117] Figure 24 It shows the flow from a common airflow source Figure 23Airflow through the oral and nasal interfaces;

[0118] Figure 25 A nose interface according to an embodiment of the present disclosure is shown to be fluidly connected to an oral cavity interface at the bottom of the nose interface;

[0119] Figure 26 It shows when the nose interface is like Figure 25 The airflow is shown when the nasal inlet is fluidly connected to the oral inlet at the bottom.

[0120] Figure 27 Alternative embodiments including a nasal interface and a mouth interface connected via an interface connector are shown;

[0121] Figure 28 A patient interface assembly including an oral interface 20 and a nasal interface, according to an embodiment of the present disclosure, is shown, each interface receiving airflow from an independent airflow source;

[0122] Figure 29 A patient wearing a patient assembly is shown, the patient assembly having an oral interface and a nasal interface as well as a face mask applied to the top of the patient assembly;

[0123] Figure 30 Cross-sections of a substantially foldable portion of a patient interface or catheter are shown in substantially open and substantially folded states, respectively.

[0124] Figure 31 It shows the relationship with Figure 23 The corresponding patient interface component has a foldable portion in each air supply conduit from the common airflow source to the nasal and oral interfaces.

[0125] Figure 32 It shows the relationship with Figure 26 The corresponding patient interface component has a foldable portion in the conduit that supplies air from a common airflow source to the nasal interface (and subsequently to the oral interface);

[0126] Figure 33 It shows the relationship with Figure 27 The corresponding patient interface component includes a foldable portion in the conduit supplying air from a common airflow source to the oral interface (and subsequently to the nasal interface); and

[0127] Figure 34 It shows the relationship with Figure 28 The corresponding patient interface component has a foldable portion in each air supply conduit from an independent airflow source to the oral and nasal interfaces, for airflow at the nasal interface. Detailed Implementation

[0128] Throughout the accompanying drawings and description, similar reference numerals may be used to refer to the same or similar parts, and redundant descriptions of these parts may be omitted.

[0129] As previously mentioned, a respiratory system delivers gas or a combination of gases to a patient. Respiratory systems can take many forms, such as positive airway pressure systems (PAP) and high-flow-rate breathing gas systems (e.g., high-flow therapy used in respiratory support and anesthesia procedures).

[0130] In this specification, "high flow rate" means, but is not limited to, any flow rate higher than the usual / normal flow rate, such as higher than the normal inspiratory flow rate of a healthy patient. It can be provided through an unsealed breathing system, where uncontrolled and often significant leakage occurs at the patient's airway inlet due to the use of an unsealed patient interface (e.g., an unsealed nasal plug). It can also be provided by humidification to improve patient comfort, compliance, and safety. Alternatively or additionally, it can be higher than other context-dependent threshold flow rates. For example, providing an airflow to a patient at a flow rate to meet inspiratory needs (e.g., instantaneous inspiratory needs or peak inspiratory needs). This can be the inspiratory needs of a patient receiving respiratory support, or representative inspiratory needs, such as representative needs of patients based on, for example, empirical data. This flow rate may be considered "high flow rate" because it is higher than the nominal flow rate that could otherwise be provided. Therefore, "high flow rate" depends on the context, and the factors constituting "high flow rate" depend on many factors, such as the patient's health status, the type of procedure / treatment / support provided, the patient's nature (tall, short, adult, child), etc. Those skilled in the art can understand what "high flow rate" means from the context. It is a traffic volume that exceeds or is higher than the traffic that could have been provided.

[0131] However, this is not the only indication; some high-flow indicators can be shown below.

[0132] In some configurations, the flow rate of gas delivered to the patient can be greater than or equal to approximately 5 or 10 liters per minute (5 or 10 LPM or L / min).

[0133] In some configurations, the flow rate of gas supplied to the patient can be from about 5 or 10 LPM to about 150 LPM, or from about 15 LPM to about 95 LPM, or from about 20 LPM to about 90 LPM, or from about 25 LPM to about 85 LPM, or from about 30 LPM to about 80 LPM, or from about 35 LPM to about 75 LPM, or from about 40 LPM to about 70 LPM, or from about 45 LPM to about 65 LPM, or from about 50 LPM to about 60 LPM. For example, according to the various embodiments and configurations described herein, the gas flow rate supplied by the system or from a gas flow source or flow regulator to the interface may include, but is not limited to, flow rates of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 LPM or more, and the useful range that can be selected may be any of these values ​​(e.g., about 20 LPM to about 90 LPM, about 40 LPM to about 70 LPM, about 40 LPM to about 80 LPM, about 50 LPM to about 80 LPM, about 60 LPM to about 80 LPM, about 70 LPM to about 100 LPM, about 70 LPM to about 80 LPM).

[0134] In the "high flow" configuration, the gas or multiple gases delivered will be selected depending on the intended use, such as treatment. The delivered gas may include a specific proportion of oxygen. In some configurations, the proportion of oxygen in the delivered gas may be approximately 15% to approximately 100%, 20% to approximately 100%, or approximately 30% to approximately 100%, or approximately 40% to approximately 100%, or approximately 50% to approximately 100%, or approximately 60% to approximately 100%, or approximately 70% to approximately 100%, or approximately 80% to approximately 100%, or approximately 90% to approximately 100%, or approximately 100%, or 100%.

[0135] In some embodiments, the delivered gas may include a proportion of carbon dioxide. In some configurations, the proportion of carbon dioxide in the delivered gas may be greater than 0%, from about 0.3% to about 100%, from about 1% to about 100%, from about 5% to about 100%, from about 10% to about 100%, from about 20% to about 100%, or from about 30% to about 100%, or from about 40% to about 100%, or from about 50% to about 100%, or from about 60% to about 100%, or from about 70% to about 100%, or from about 80% to about 100%, or from about 90% to about 100%, or about 100%, or 100%.

[0136] In some embodiments, at least one gas outlet is configured to provide an airflow such that the airway pressure in the patient's airway is at least about 0.1 cmH2O, or about 0.2 cmH2O, or about 0.3 cmH2O, or about 0.4 cmH2O, or about 0.5 cmH2O, or about 0.6 cmH2O, or about 0.7 cmH2O, or about 0.8 cmH2O, or about 0.9 cmH2O, or about 1 cmH2O, or about 2 cmH2O, or about 3 cmH2O, or about 4 cmH2O, or about 5 cmH2O, or about 6 cmH2O, or about 7 cmH2O, or about 8 cmH2O, or about 9 cmH2O, or about 10 cmH2O. In some embodiments, at least one gas outlet is configured to provide an airflow such that the patient’s airway pressure is at least about 0.1 cmH2O to about 10 cmH2O or about 0.2 cmH2O to about 7 cmH2O, or about 2 cmH2O to about 7 cmH2O, or about 2 cmH2O to 10 cmH2O.

[0137] The flow rate for "high flow" in premature infants / pediatricians (weighing approximately 1 to approximately 30 kg) can vary. The flow rate can be set from 0.4 to 8 L / min / kg, with a minimum of approximately 0.5 L / min and a maximum of approximately 70 L / min. For patients weighing less than 2 kg, the maximum flow rate can be set to 8 L / min.

[0138] High-flow-rate inhalation has been found to effectively reach or exceed a patient's normal inspiratory flow rate to increase oxygenation and / or reduce the work of breathing. Additionally, high-flow-rate therapy can create a flushing effect in the nasopharynx, flushing the anatomical dead space of the upper airway with a high inspiratory flow. This creates a reservoir of fresh gas for each breath while minimizing the re-inhalation of carbon dioxide, nitrogen, etc.

[0139] As an example, refer to Figure 1 The text describes a system 10 for high-flow respiratory support. High-flow respiratory therapy can promote gas exchange and / or provide respiratory support by delivering oxygen and / or other gases and by removing carbon dioxide from the patient's airway.

[0140] High-flow ventilator therapy may be particularly useful before, during, or after medical and / or anesthesia procedures.

[0141] When used before medical procedures, high-flow respiratory support pre-oxygenates patients, resulting in higher blood oxygen saturation levels and more oxygen in their lungs, thus providing an oxygen buffer if the patient experiences apnea during the medical procedure.

[0142] During medical procedures such as anesthesia, a continuous supply of oxygen to the patient's airway is crucial for maintaining healthy respiratory function when respiratory function may be impaired (e.g., weakened or stopped). When this supply is impaired, hypoxia, hypoxemia, and / or hypercapnia may occur. Patients are monitored for this condition during medical procedures where they are unconscious or may become unconscious (such as anesthesia and / or sedation). If oxygen supply and / or carbon dioxide removal are impaired, clinicians will stop the procedure and promote oxygen supply and / or carbon dioxide removal. This can be achieved by manually ventilating the patient, such as through a bag mask, or by using a high-flow-rate breathing system to deliver a high flow of gas to the patient's airway.

[0143] Further advantages of high airflow include increased pressure in the patient's airways, providing pressure support to open the airways, trachea, lungs / alveoli, and bronchioles. This opening of structures enhances oxygenation and may contribute to carbon dioxide removal to some extent.

[0144] After humidification, high airflow can also prevent airway dryness, reduce mucociliary damage, and decrease the risk of laryngospasm and associated risks of airway dryness, such as nasal bleeding, aspiration (due to nasal bleeding), and airway obstruction, swelling, and bleeding. Another advantage of high airflow is that the flow rate can clear fumes generated in the airway during surgery. For example, fumes can be generated by lasers and / or cauterization devices.

[0145] refer to Figure 1 System 10 may include integrated or stand-alone component-based arrangements, typically such as Figure 1As shown in dashed box 11. In some configurations, system 10 can include a modular component arrangement. System 10 may include an airflow source 12, such as an in-wall oxygen source, oxygen tank, blower, flow therapy device, or any other source of oxygen, air, or other gases or combinations thereof. In some embodiments, airflow source 12 includes a flow regulator, and in some embodiments, the flow regulator includes a flow generator, such as a blower, bellows, and / or piston. In some embodiments, the flow regulator includes a flow generator and a proportional valve that can be used to control the oxygen concentration in the flow rate of a mixed gas (such as air (preferably filtered air) and oxygen) delivered to the patient. In some embodiments, the flow regulator includes a proportional valve, and in these embodiments, the flow regulator may not include a flow generator. In other embodiments, airflow source 12 does not need to include a flow generator, and in these embodiments, airflow source 12 may include an in-wall gas source and / or a mixed gas or other gas supply. In some embodiments, airflow source 12 may include a compressed gas source (e.g., an in-wall gas source, oxygen tank supply, etc.) and a blower. In some embodiments, the airflow source 12 may include a compressed gas source (e.g., an in-wall gas source, an oxygen tank supply, etc.) and a proportional valve or other flow valve to control the airflow from the compressed gas source.

[0146] In some embodiments, the airflow source 12 includes or is part of an anesthesia machine. System 10 may also include an auxiliary gas source 12A, which includes one or more other gases capable of being combined with the gas from the airflow source 12. The airflow source 12 is capable of providing an airflow 13, which can be delivered via a delivery conduit 14 to the patient 16 and the patient interface assembly 15 (such as an oral interface, as will be described in more detail below, for use with or without a nasal cannula). The patient depicted is an adult. However, the patient may be an infant, child, or adolescent. In the foregoing context, the airflow 13 may deliver a high flow rate to the patient. Controller 19 controls the airflow source 12 and the auxiliary gas source 12A via valves, etc., to control the flow rate and other characteristics of the airflow 13, such as flow rate, pressure, composition, concentration, and volume, any one or more of these. Optionally, a humidifier 17 is also provided, capable of humidifying the gas and / or controlling the gas temperature, for example, under the control of controller 19. The humidifier 17 may be a separate component that can be provided with fluid communication with the airflow source 12. One or more sensors 18a, 18b, 18c, 18d (such as flow rate, oxygen, pressure, humidity, temperature, respiratory plethysmography tape, or other sensors) can be placed throughout the system and / or on or near the patient 16. Sensors may include a pulse oximeter 18d on the patient for measuring the oxygen concentration in the blood.

[0147] Controller 19 can be operatively coupled to one or more components of system 10 in various ways, including wired or wireless coupling. For example, controller 19 can be operatively coupled to one or more of the following: airflow source 12, auxiliary gas source 12A, humidifier 17, sensors 18a-18d, and input / output (I / O) interface 20. As an example, controller 19 can be located on or within a high-flow-rate device, as a standalone component and / or integrated into or used with other devices, such as an anesthesia machine or ventilator, or it can be part of system 10 and communicate with one or more separate controllers that control the operation of separate components of system 10 used to provide respiratory support to a patient. Controllers can include microcontrollers, PID (proportional-integral-derivative) controllers or variations of PID controllers (where the proportional, integral, and derivative elements of the controller can be turned on or off as needed (such as P, PI, or I controllers)), or other architectures configured to operate via algorithms stored in memory that communicates with the controller to guide the operation of controllable components of the respiratory system. Therefore, controller 19 can control airflow source 12 and system 10, or other components used with system 10, to provide the patient with airflow having specific characteristics such as required flow rate, pressure, composition (when more than one gas is provided), volume, and / or other parameters, based on feedback from one or more sensors 18a-18d. Controller 19 is also capable of controlling any other suitable parameters of the airflow source to meet the patient's oxygenation, airway pressure, and / or flow requirements, and / or the system's system pressure and / or flow requirements (e.g., preset or set by the user via interface 20). Controller 19 is also capable of controlling humidifier 17, and this control can be based on feedback from one or more sensors 18a-18d. Using the sensor inputs, the controller can determine the operational changes required to meet oxygenation requirements and, as needed, change the control parameters of airflow source 12 and / or humidifier 17 and / or other additional gas sources 12A and / or other system components.

[0148] An input / output (I / O) interface 20 (such as a display and / or input device) may be provided. Interface 20 is capable of receiving information and input from a user (such as a clinician or patient) (such as required patient respiratory support parameters), which can be used to determine oxygenation, pressure, flow rate requirements, and / or other system settings for controlling one or more of the airflow source 12, the auxiliary gas source 12A, and other components of system 10 to achieve an airflow 13 with the characteristics required to provide the desired respiratory support. In some embodiments, the system may not have a controller and / or I / O interface. Medical professionals such as nurses or technicians may provide the necessary control functions based on observation of the patient or the use of other monitoring devices. In some embodiments, system 10 has a controller 19 but no I / O interface, which can be operated by a user such as a medical professional. In some embodiments, system 10 may not have a controller 19, and a user can manually operate one or more other components of system 10, such as airflow source 12, humidifier 17, auxiliary gas source 12A, and I / O interface 20.

[0149] As described above, a high airflow (optionally humidified) can be delivered to the patient 16 via the delivery catheter 14 and the patient interface assembly 15 or an "interface" (such as an oral interface, nasal cannula, mask, or a combination thereof). In some embodiments, the high airflow (optionally humidified) can be delivered to the patient 16 for surgical purposes, such as surgical inflation.

[0150] In some embodiments, system 10 includes a pressure relief valve or pressure relief device. System 10 may include such a pressure relief or regulating device, or pressure limiting device 100 (e.g., a pressure relief valve or PRV). The pressure limiting device 100 may be a valve having the features described in WO2018 / 033863, the entire contents of which are incorporated herein by reference. In some embodiments, system 10 does not include or excludes a pressure relief valve or pressure relief device. In some embodiments, system 10 does not include or excludes a flow-compensated pressure relief valve or pressure relief device, such as a flow-compensated pressure relief valve having the features described in WO2018 / 033863. Pressure relief and pressure control are particularly desirable for applications in respiratory support systems, such as system 10, for providing high-flow respiratory support including a non-sealed patient interface 15, to set an upper limit on the downstream pressure generated from the airflow source 12, which in turn affects the patient's airway pressure (also known as patient pressure). Importantly, the upper limit pressure can be configured to provide a safety threshold to ensure patient pressure safety and / or prevent damage to piping, fluid connections, or other components in system 10 due to overpressure.

[0151] Figure 2 A cross-sectional side view of the oral cavity interface 200 is shown. The oral cavity interface 200 can be configured as follows: Figure 1This is part of the patient interface component 15, used to provide respiratory support to the patient 16. Figure 2 b and Figure 2 c shows the gas outlet 220. Figure 2 The enlarged portion of a. The oral interface 200 includes at least one gas inlet 210 for receiving airflow 13 from the airflow source 12 via a gas delivery conduit 14. The oral interface 200 further includes at least one gas outlet 220 for providing airflow 13 to the patient 16. Figure 2 b and Figure 2 c shows the gas outlet 220. Figure 2 The enlarged portion of a. A gas flow path 230 is defined between at least one gas inlet 210 and at least one gas outlet 220. The gas flow path 230 provides a path for gas to flow from at least one gas inlet 210 to at least one gas outlet 220. In other words, at least one gas inlet 210 and at least one gas outlet 220 are fluidly connected via the gas flow path 230.

[0152] The oral interface 200 further includes a body 240 having an oral engagement portion 250 that engages with the oral cavity of the patient 16. The body 240 has a first end opening 260 and a second end opening 270 disposed on opposite sides of the body 240. The body 240 may include an integral part or may include constituent parts that, when assembled, form the body. In use, the second end opening 270 is located within the oral cavity of the patient 16 and close to the airway of the patient 16, while the first end opening 260 is located away from the patient's airway and is generally located outside the oral cavity of the patient 16. The first end opening 260 and the second end opening 270 define a channel 280 therebetween, which allows access into the oral cavity of the patient 16 (e.g., through which a medical instrument can enter the oral cavity).

[0153] An airflow path 230 between at least one gas inlet 210 and at least one gas outlet 220 may be defined by structural features of the body 240. A portion of the airflow path 230, toward at least one gas outlet 220, may be defined between an outer wall portion 244 and an inner wall portion 242 of the body 240, corresponding to at least a portion of the channel 280. In some examples, an oral engagement portion 250 defines the outer wall portion of the body 240. The inner wall portion 242 may terminate at a second end opening 270 or closer to a first end opening 260. In some examples, the inner wall portion 242 and the outer wall portion 244 include limiting devices. More specifically, the surfaces of the inner wall portion 242 and the outer wall portion 244 in fluid communication with the airflow path 230 may include limiting devices. The limiting devices may include all or part of the length of the wall portion corresponding to the channel 280. The limiting devices may include a narrowing between the wall portions, which may be defined by a taper, flange, protrusion, or other structural feature between the wall portions. One or both of the inner wall portion 242 and the outer wall portion 244 defining a portion of the airflow path 230 may be tapered. A taper may be provided on one or both of the inner wall portion 242 and the outer wall portion 244 facing away from the airflow path 230. Alternatively or additionally, a taper may be provided on one or both of the inner wall portion 242 and the outer wall portion 244 facing away from the airflow path 230. For example, as... Figure 2 a to Figure 2 As shown in Figure c, the inner wall portion 242 facing the channel 280 may be tapered. The airflow path 230 provides a path for gas to flow from at least one gas inlet 210 to at least one gas outlet 220. In other words, at least one gas inlet 210 and at least one gas outlet 220 are fluidly connected via the airflow path 230. In some examples, at least a portion of the airflow path 230 may be arranged concentrically with the channel 280, such that the airflow path 230 at least partially surrounds the channel 280.

[0154] In some examples, at least one gas outlet 220 may be located between a first end opening 260 and a second end opening 270. In use, airflow exiting from at least one gas outlet 220 may enter a channel 280, flow within the channel, and then exit through the second end opening 270. In some examples, gas exiting from at least one gas outlet 220 may adhere to the inner wall of the body 240 defining the channel 280. In some examples, at least one gas outlet 220 may be located near the second end opening 270, such that gas exiting from at least one gas outlet 220 may flow directly into the airway of the patient 16 from the second end opening 270. In some examples, if at least one gas outlet 220 is located at or near the first end opening 260, or between the first end opening 260 and the second end opening 270, gas exiting from at least one gas outlet 220 may enter the channel 280, flow within the channel, and then exit through the second end opening 270 into the airway of the patient 16. However, if at least one gas outlet 220 is located at or near the second end opening 270, gas flowing from at least one gas outlet 220 can flow directly into the airway of the patient 16 from the second end opening 270.

[0155] The body 240 may have a first dimension and a second dimension perpendicular to the first dimension, wherein the first dimension is larger than the second dimension. The first dimension “c” may be the distance between the first end opening 260 and the second end opening 270. In some examples, the first dimension “c” represents the length of the oral cavity interface 200. The first dimension “c” may be measured along an axis substantially parallel to the longitudinal axis 290 of the oral cavity interface 200. The second dimension “a” may be measured along an axis substantially perpendicular to the axis 290 of the oral cavity interface 200. In some examples, the second dimension “a” represents the height or diameter (in the case of a circular cross-section) of the body 240 defining the channel 280. Figure 2 Schematic diagram 240 shows a first dimension “c” that is larger than a second dimension “a”. A third dimension “b” may be the distance between the cap 310 (when provided) and the second end opening 270. In some examples, the third dimension “b” represents the length of the oral cavity engagement portion 250. The third dimension “b” may be measured along an axis substantially parallel to the axis 290 of the oral cavity interface 200. In some embodiments, such as Figure 2As shown in Figure a, the second dimension “a” can be larger than the third dimension “b”. As shown, the third dimension “b” can be a distance measured between the outer edge of the second end opening 270 and the cover 310, intended to be away from the patient during use. Alternatively, the third dimension “b” can be a shorter distance measured between the inner edge of the second end opening 270 and the cover 310, intended to be facing the patient during use. In some embodiments, the second dimension “a” (e.g., the height of the oral interface channel 280) can be greater than or less than the third dimension “b” (e.g., the length of the oral engagement portion 250). In some embodiments, the third dimension “b” is sized such that the oral engagement portion 250 protrudes into the patient’s oral cavity without obstructing the posterior part of the oral cavity or the airway of the patient 16. It is understood that dimensions “a”, “b”, and “c” can be selected as necessary based on different patient demographics and groups, and their relative dimensions are not required in all cases.

[0156] As explained in further detail below, the oral interface 200 may include a cap 310 disposed around an oral engagement portion 250. The oral engagement portion 250 is a substantially tubular portion of the body 240 that is received in the patient's oral cavity when the oral interface 200 is in use. The oral engagement portion 250 defines a portion of a channel 280. It will be understood that, in various embodiments, the cap 310 may be located inside (between the lips and gums, behind the teeth, etc.) or outside the patient's oral cavity 16 to provide a substantially sealing effect around the oral interface 200 and the patient's oral cavity 16, allowing fluid to enter the patient's oral cavity substantially through the channel 280. Therefore, the dimension "b" may vary depending on the position of the cap 310 relative to the patient. In some examples, part or all of the cap 310 may be formed of a flexible material that can conform to the shape of the inner and / or outer surfaces of the patient's oral cavity. In some examples, the cap 310 may have a convex shape with its apex facing a first end opening 260.

[0157] In some embodiments, at least a portion of the body 240 may have a non-circular cross-section transverse to axis 290. As an example, at least a portion of the body may be oblong, elliptical, oval, circular, rounded square, peanut-shaped, or kidney-shaped. In one embodiment, at least a portion of the body 240 may have an elliptical or oblong cross-section transverse to axis 290. In another embodiment, at least a portion of the body 240 may have an oval cross-section transverse to axis 290. In some embodiments, the body 240 may taper such that opposing wall portions of the body are not parallel and taper together (or separately) toward the oral cavity engagement portion 250. In some examples, the body 240 may have an irregular / non-uniform cross-section along and / or perpendicular to axis 290. For example, the body 240 may taper such that the cross-sectional area of ​​adjacent portions perpendicular to axis 290 may increase or decrease toward the first end opening 260 and / or the second end opening 270. In various embodiments, the oral cavity engagement portion 250 or the exterior of the oral cavity engagement portion 250 may or may not have the same shape as the body 240 in one or both directions, namely, the transverse direction and the direction parallel to the axis 290.

[0158] At least one gas outlet 220 may be disposed between the first end opening 260 and the second end opening 270. In some embodiments, at least one gas outlet 220 may be disposed at or near the first end opening 260 and away from the second end opening 270. For example, at least one gas outlet 220 may be disposed between the first end opening 260 and the second end opening 270, closer to the first end opening 260. At least one gas outlet 220 may include a limiting device configured to increase the average velocity of the airflow 13 entering the channel 280 from the airflow path 230. In embodiments, the limiting device in at least one gas outlet 220 may provide a gas jet through the channel 280 toward the airway of the patient 16. In some embodiments, the limiting device may be angled such that the airflow is angled relative to, for example, the longitudinal axis 290 described elsewhere herein. In some examples, the wall portion of the body 240 may be angled such that the airflow 13 enters the channel 280 in a desired direction. In some examples, the limiting device may be disposed in the airflow path 230 upstream of at least one gas outlet 220. In such an example, the speed at which airflow 13 flows out of the limiting device may be slowed down before flowing out of at least one gas outlet.

[0159] The gas jet can be a high-speed region of gas. The gas jet can have greater momentum and / or pressure and / or velocity than the medium into which the gas jet enters. The gas jet can include an airflow exiting from at least one gas outlet 220, with a dynamic pressure higher than that of ambient air surrounding the oral cavity interface 200. It is understood that, during use, the gas exiting from at least one gas outlet will be affected by the patient's breathing. However, during use, providing a high flow rate of gas with a higher dynamic pressure than ambient air can help clear carbon dioxide from the patient's airways. The gas jet can include a velocity capable of achieving a target patient pressure of at least 1 cmH2O. This pressure can be provided near the outlet of at least one gas outlet 220. For example, downstream of at least one gas outlet 220, this can be within the body 240 or downstream of the second end opening 270. The velocity of the gas jet can be greater than, less than, or equal to the velocity of the airflow 13 provided or generated by the airflow source 12. The velocity of the gas jet can be greater than the velocity of the airflow 13 provided or generated by the airflow source 12. Additionally or alternatively, the velocity of the gas jet can be greater than or less than the velocity of the airflow 13 at other locations in the system 10. In an embodiment, the velocity of the gas jet may be greater than the velocity of the airflow 13 at other locations in system 10. The gas jet may include velocities ranging from approximately 5 m / s to approximately 100 m / s. When the selected flow rate of the airflow provided by airflow source 12 is approximately 20 L / min to approximately 100 L / min, the gas jet may include velocities ranging from approximately 5 m / s to approximately 60 m / s. When the selected flow rate of the airflow provided by airflow source 12 is approximately 20 L / min to approximately 90 L / min, the gas jet may include velocities ranging from approximately 5 m / s to approximately 60 m / s.

[0160] In one or more embodiments of this disclosure, the limiting device may be a nozzle. In other embodiments, the limiting device may be an orifice plate (e.g., a plate including one or more discrete outlets, such as in a honeycomb pattern), a venturi tube, etc. In further embodiments, the limiting device may be a single outlet surrounding the entire periphery of channel 280, i.e., an annular outlet. In some examples, the limiting device may be disposed between an inner wall portion and an outer wall portion of the body, as described elsewhere in this disclosure. The shape and size of the limiting device may cause the average velocity of the airflow 13 to increase as it passes through the limiting device 220, and to have the highest average velocity at the outlet point of at least one gas outlet 220, and then decrease as the airflow moves toward the back of the patient's mouth or into the airway of the patient 16.

[0161] If at least one gas outlet 220 is located within the channel 280, for example at or near the first end opening 260, or between the first end opening 260 and the second end opening 270, then airflow 13 may exit from at least one gas outlet 220 and enter the channel 280. If at least one gas outlet 220 is located at or near the second end opening 270 (which is adjacent to the airway of the patient 16), then airflow may exit from at least one gas outlet 220 near the second end opening 270. The average velocity of the airflow 13 may be as high as about 110 m / s, between about 10 m / s and about 110 m / s, and may be between about 40 m / s and about 110 m / s. When the average velocity of the airflow 13 is about 40 m / s, an airway pressure of about 1 cmH2O can be generated in the oral cavity of the patient 16, which may be the minimum required airway pressure. In some embodiments, the average velocity of the airflow 13 may be about 100 m / s. In some embodiments, the average velocity of the airflow 13 is 100 m / s, which can be achieved at the limiting device and / or minimum portion (e.g., nozzle 830) of the gas outlet 220.

[0162] In one or more embodiments, at least one gas outlet 220 may be configured to provide an airflow 13 such that the airway pressure of the patient 16 is at least about 0.1 cmH2O or about 0.2 cmH2O, or about 0.3 cmH2O, or about 0.4 cmH2O, or about 0.5 cmH2O, or about 0.6 cmH2O, or about 0.7 cmH2O, or about 0.8 cmH2O, or about 0.9 cmH2O, or about 1 cmH2O, or about 2 cmH2O, or about 3 cmH2O, or about 4 cmH2O, or about 5 cmH2O, or about 6 cmH2O, or about 7 cmH2O, or about 8 cmH2O, or about 9 cmH2O, or about 10 cmH2O. In other embodiments, at least one gas outlet 220 may be configured to provide an airflow 13 such that the airway pressure of the patient 16 is between about 0.1 cmH2O and about 10 cmH2O, or between about 0.2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and about 7 cmH2O, or between about 2 cmH2O and 10 cmH2O.

[0163] In one or more embodiments, at least one gas outlet 220 may be disposed along an inner wall portion of the body that defines the periphery of the channel 280. For example, when disposed along the inner wall of the body 240 defining the channel 280, at least one gas outlet 220 may be oblong / elliptical / oval / circular / rounded square / peanut-shaped / kidney-shaped. In one or more embodiments, the airflow path 230 surrounding the channel 280 may be circumferential. Furthermore, in some embodiments, at least one gas outlet 220 may be provided as a slit along the periphery of the inner wall of the body 240 defining the channel 280. See, for example, [link to relevant documentation]. Figure 2 a to Figure 2 c. In yet another embodiment, at least one gas outlet 220 may be provided as a slit or opening around the circumference of the end face of the body portion 240. See, for example, [link to example]. Figure 3 The airflow 13 from airflow path 230 can directly reach the patient's airway without first passing through channel 280. It is understood that airflow path 230 and / or at least one gas outlet 220 around channel 280 may be non-circular, but in operation, airflow path 230 together with at least one gas outlet 220 may provide annular airflow 13 into or at the end of channel 280 via a configuration at a second end opening 270. In some embodiments, one or more of the shape, size, and configuration (e.g., angle and position) of at least one gas outlet 220 may such that the average velocity of airflow 13 around channel 280 is substantially uniform. It is understood that in different embodiments, at least one gas outlet 220 may be annular and non-circular (e.g., oblong, elliptical, oval, circular, rounded square, peanut-shaped, kidney-shaped, etc.) or annular and circular.

[0164] Figure 3 Another embodiment of the present disclosure is shown for use as Figure 1 A cross-sectional side view of an oral interface 200, a portion of the patient interface assembly 15, for providing respiratory support to a patient 16. The oral interface 200 includes at least one gas inlet 210 for receiving airflow 130 from an airflow source 12 (not shown) via a gas delivery conduit 14 (not shown). The oral interface 200 further includes at least one gas outlet 220 for providing airflow 13 to the patient 16. While the composition of the airflow 130 at the gas inlet 210 will remain the same as the composition of the airflow 13 at the at least one gas outlet 220, the airflow characteristics of airflow 130 and airflow 13 will differ because the at least one gas outlet includes a limiting device configured to increase the average velocity of the gas in the airflow path 230. In some examples, the limiting device produces a gas jet as described above.

[0165] The oral interface 200 further includes a body 240 having an oral engagement portion 250 that engages with the oral cavity of the patient 16. The body 240 has a first end opening 260 and a second end opening 270 disposed on opposite sides of the body 240. In use, the second end opening 270 is located inside the oral cavity of the patient 16 and close to the airway of the patient 16, while the first end opening 260 is located away from the patient's airway and is generally located outside the oral cavity of the patient 16. The first end opening 260 and the second end opening 270 define a channel 280 (not shown) therebetween, which allows access into the oral cavity of the patient 16 (e.g., through which a medical instrument can enter the oral cavity).

[0166] Figure 3 At least one gas outlet 220 may be located at or near the second end opening 270 and away from the first end opening 260. In other words, at least one gas outlet 220 may be located on or near the same plane as the second end opening 270. The airflow path 230 and at least one gas outlet 220 may be defined by the structural features of the body 240 as described above.

[0167] Figure 4 A perspective side view of the oral cavity interface 200 as observed from the patient's end during use is shown. Gas or multiple gases from the airflow source 12 flow into at least one gas inlet 210 via a gas delivery conduit 14. The gas then flows through an airflow path 230 to at least one gas outlet 220, and from there enters a channel 280 defined by a first end opening 260 and a second end opening 270. Figure 4 The main body 240 of the oral cavity interface 200 can also be seen.

[0168] Figure 5 A front view illustrates some embodiments according to this disclosure. Figure 4 The oral cavity interface 200 (16 away from the patient when in use). Figure 6 A rear view illustrates some embodiments according to this disclosure. Figure 4 and Figure 5 The oral interface 200 (facing the patient 16 when in use). Figure 7 A top view illustrates some embodiments according to this disclosure. Figures 4 to 6The oral interface 200 may include a cap 310 disposed around an oral engagement portion 250 surrounding a body 240. In use, the oral engagement portion 250 is configured to be located within the oral cavity of a patient 16. The cap 310 may be disposed around a portion of the oral engagement portion 250, located between or behind the lips and teeth of the patient 16. The cap 310 may be substantially flexible and provides a substantially tight seal around the oral engagement portion 250 of the oral interface 200 to prevent or reduce any fluid leakage in the oral cavity of the patient 16, such as leakage from between the teeth and lips of the patient 16. The cap 310 also helps to ensure that fluid entering the oral cavity of the patient 16 can substantially pass through a channel 280. In use, the oral engagement portion 250 has an elongated structure and is located within the oral cavity of the patient 16, configured as a bite block to help prevent the patient 16's mouth from closing and / or the patient 16's teeth from biting the tongue.

[0169] The oral interface 200 may also include a headband connector 320, which can be detachably connected to a headband worn by the patient 16 via an attachment ring 330. In use, when the oral interface 200 is placed in the mouth of the patient 16, the headband connector 320 helps to secure the oral interface 200 in place by passing through the attachment ring 330 and connecting to a strap that can be placed on or around the head of the patient 16. The headband connector 320 may also be configured to form a basic seal with, for example, a cap 310 on the lateral corner of the patient 16's mouth. It is understood that other types of connectors or spacers may be used in use to help secure and hold the oral interface 200 in place.

[0170] Air entrainment may occur through channel 280 when the pressure in channel 280 is lower than the pressure of the external environment (e.g., ambient air). Low-pressure areas may occur when the airflow travels at a speed greater than that of the ambient gas near the outlet of channel 280, or when the patient inhales and the inhaled airflow is greater than the airflow delivered through oral cavity interface 200. When a gas with a composition greater than 21% oxygen is supplied to the patient, air entrainment may or may not cause a pressure drop and may result in dilution of the gas supplied to the patient.

[0171] Figure 8 and Figure 9 The oral cavity interface 200 is shown with airflow paths 230 having both asymmetrical and constant cross-sectional areas. The internal shape of the airflow path 230 can help establish a constant pressure around the airflow path 230. Figure 8 An oral cavity interface 200 with a single gas inlet 210 is shown. In this embodiment, the cross-sectional area of ​​the airflow path 230 farther from the gas inlet 210 is ( Figure 8(shown as 610) can be smaller than the cross-sectional area of ​​the airflow path 230 closest to the gas inlet 210. Figure 8 (Shown as 620). Therefore, the static pressure in the airflow path 230 can be equalized by the non-uniform cross-sectional area of ​​the airflow path 230. It is understood that if the cross-sectional area of ​​the airflow path 230 were constant, the gas might exit the oral cavity interface 200 at at least one gas outlet 220 at unequal speeds. Since such non-uniformity in the airflow can lead to pressure differences in the oral cavity, which in turn can cause difficulties associated with increasing airway pressure and / or air entrainment, this non-uniformity may be undesirable.

[0172] Figure 9 An oral cavity interface 200 with two gas inlets 210A, 210B and a constant cross-sectional area is shown. In an embodiment, the oral cavity interface 200 includes two or more gas inlets 210 surrounding an airflow path 230, which may have a constant cross-sectional area and be capable of delivering gas with consistent airflow parameters such as flow rate, velocity, pressure, etc. In other words, Figure 9 The cross-sectional areas at points 610 and 620 are equal. Therefore, when gas enters through the two gas inlets 210A and 210B, the pressure within the gas flow path 230 may be relatively more uniform when the gas flow path 230 has a uniform cross-sectional area.

[0173] Figures 10 to 12 Various possible orientations of at least one gas inlet 210 relative to the longitudinal axis 290 of the oral cavity interface 200 are shown. Axis 290 extends longitudinally along the channel 280. Figure 10 In this configuration, the longitudinal axis 291 of at least one gas inlet 210 along its length may be substantially parallel to the longitudinal axis 290 of the oral cavity interface 200. Figure 11 In this configuration, the longitudinal axis 292 of the gas inlet 210 can form an acute angle α with the longitudinal axis 290 of the oral cavity interface 200. Figure 12 In this embodiment, the longitudinal axis 293 of the gas inlet 210 can be substantially perpendicular to the axis 290 of the oral interface 200, i.e., α = 90°. In some cases, the angle α can be greater than 90°. In various embodiments, axes 291, 292, and 293 can be angled along any of the x-axis, y-axis, or z-axis of the body 240, depending on one or more factors such as the application of the oral interface 200 and the user comfort of the patient 16. It is understood that the above orientations should not be considered limiting, and other orientations are possible without departing from the scope of this disclosure.

[0174] The longitudinal axis 293 of the gas inlet 210 is substantially perpendicular to the longitudinal axis 290 of the oral cavity interface 200 (e.g., Figure 12As shown), and in some embodiments, positioning the coupling of the gas inlet 210 at a greater distance from the oral cavity interface 200 may be advantageous because this avoids the gas inlet 210 being too close to the patient 16's mouth and reduces the space near or around the patient's mouth available for accessing / performing medical procedures. In some embodiments, the gas inlet 210 may be located next to the patient 16's cheek during use and is generally oriented rearward to connect with the coupling that supplies airflow 130 to the airflow path 230. In a non-limiting example, α may be approximately 135°, and the gas inlet 210 may be located in a plane intersecting the longitudinal axis 290. This plane may be orthogonal to the longitudinal axis 290. In other examples, this plane may not be orthogonal to the longitudinal axis 290, and the gas inlet 210 may be oriented to provide a low profile relative to the patient's facial anatomy such that, during use, the conduit of the gas inlet 210 conforms closely to the contour of the patient's face. In some examples, the conduit of the gas inlet 210 may be pre-formed or flexible to conform to the contour of the patient's face during use. This can be advantageous because it minimizes disruption to clinicians' contact with patients.

[0175] Figures 13 to 18 An example of a limiting device is shown at at least one gas outlet 220 configured at various angles relative to the horizontal longitudinal axis 290. Figures 19 to 21 Examples of gas outlet 220 at different locations relative to the plane of the first end opening are shown. The angle and / or position of at least one gas outlet 220 may affect the direction of airflow into the channel 280, which will be explained in more detail below. In some embodiments, the limiting device in the gas outlet 220 may be a nozzle. In some embodiments, the nozzle may be configured to taper gradually toward the outlet end of the gas inflow channel 280.

[0176] Figure 13 The nozzle 820 according to an embodiment of the present disclosure is shown with respect to the longitudinal axis 290 of the body 240 (e.g., Figure 2 As shown, axis 290 extends between the first end opening 260 and the second end opening 270 at an angle of approximately 0 degrees. Figure 14 It shows the use of Figure 13 When the oral cavity interface is used, the airflow within the channel 280 of the main body 240. For example... Figure 14 The illustrated airflow pattern indicates that as airflow 13 exits from nozzle 820 (without affecting patient breathing), it travels further into channel 280 and toward the mouth of patient 16. In this embodiment, at least one gas outlet 220, including nozzle 820, can be configured to direct airflow 13 in a direction substantially parallel to axis 290. Figure 14As can be seen, most (if not all) of the gas flowing out of the airflow path 230 through the nozzle 820 and into the channel 280 travels toward or toward the second end opening 270 (towards the airway of the patient 16) before turning toward the first end opening 260 and flowing out of the oral cavity interface 200.

[0177] exist Figure 14 In the middle, streamlines represent Figure 13 The approximation of the airflow 13 exiting from nozzle 820 during operation of the oral interface 200 is when gas inlet 210 is coupled to airflow 130 from, for example, a blower or other gas source. This approximation is derived without the influence of patient breathing. The airflow 13 will travel deeper into channel 280 depending on the total pressure of the airflow as it exits nozzle 820. For example, the higher the dynamic pressure, the farther the airflow 13 will travel into channel 280. In some cases, the airflow 13 will travel through channel 280. In use, the gas traveling through the channel enters the patient's airway. A higher-pressure airflow 13 may stagnate deeper in channel 280 and closer to the second end opening 270. In some examples, the airflow 13 may stagnate at a point where the airflow 13 stops completely (whether temporarily or otherwise).

[0178] Figure 15 This shows that the nozzle 830 is oriented or pointed at approximately a 45-degree angle relative to the longitudinal axis 290 of the body 240. From Figure 2 As can be seen, axis 290 extends between the first end opening 260 and the second end opening 270. Figure 16 In the middle, streamlines represent Figure 15 The approximation is based on the airflow 13 within the channel 280 of the body 240 during operation of the oral cavity interface, i.e., when the gas inlet 210 is coupled to the airflow 130 from, for example, a blower or a high-pressure gas supply or other gas source. This approximation is derived without the influence of patient breathing. In this embodiment, at least one gas outlet 220, including a nozzle 830, can be configured to converge the airflow 13 from the first end opening 260 toward the second end opening 270. Figure 16 As can be seen, the nozzle 830 is oriented or pointed at approximately a 45-degree angle (β) relative to the axis 290 of the body 240. Gas flowing from the airflow path 230 through the nozzle 830 initially travels substantially along the axis 294 and toward the center portion of the channel 280 upon entering the channel 280. Then, some gas travels toward or along the second end opening 270, which is closer to the patient 16's airway, before turning toward the first end opening 260. The remaining gas travels toward the first end opening 260 and exits the oral cavity interface 200.

[0179] Figure 17This shows the nozzle 840 oriented at approximately a 90-degree angle to the longitudinal axis 290 of the body 240. From Figure 2 As can be seen, axis 290 extends between the first end opening 260 and the second end opening 270. Figure 18 In the middle, streamlines represent Figure 17 The approximation is based on the airflow 13 within the channel 280 of the body 240 during operation of the oral cavity interface, specifically when the gas inlet 210 is coupled to the airflow 130 from, for example, a blower, a high-pressure gas supply, or another gas source. This approximation is derived without the influence of patient breathing. Figure 18 As can be seen, since the nozzle 840 is oriented or pointed at approximately a 90-degree angle (β2) to the axis 290 of the body 240, most (if not all) of the gas flowing out of the airflow path 230 and into the channel 280 through the nozzle 840 initially travels substantially perpendicular to the axis 290 of the body 240 into the channel 280. Then, some of the gas travels toward or along the direction of the second end opening 270, and then turns toward the first end opening 260. The remaining gas travels toward the first end opening 260 and then flows out from the oral cavity interface 200 into the ambient air. Figure 18 In this process, the gas flowing from nozzle 840 may stagnate closer to the first end opening 260, which could cause the air to travel towards a lower pressure area (ambient air). Understandably, Figure 14 , 16 The airflow pattern 13 shown in Figure 18 only represents the main airflow characteristics of airflow 13 and may not be to scale or accurately proportional. It can be further understood that... Figure 14 , 16 The airflow pattern 13 shown in 18 is not a simulation result or a depiction of an accurate airflow pattern, but rather a predicted approximation.

[0180] Figure 19This is a cross-sectional perspective view of a body 240 having a non-circular (e.g., oblong) shape, and at least one gas outlet 220 (e.g., nozzle 830) is disposed around an inner wall portion 242 of the body 240, having a substantially constant 45° outlet angle relative to the longitudinal axis 290 of the oral cavity interface 200. The dashed line 410 schematically indicates the direction of airflow exiting the gas outlet 220. In some embodiments, it may be desirable to guide the airflow to converge at a single point. In the illustrated example, the airflow convergence, indicated by the dashed line 410, is directed toward point 920, which can be considered to lie in a first reference plane RF1, orthogonally intersecting the longitudinal axis 290. The nozzle 830 is disposed around the body 240 having a non-circular cross-sectional shape. Therefore, to achieve gas convergence at point 920 with a substantially constant 45° outlet angle, the distance between the nozzle 830 and the convergence point 920 varies along a path 930 on the inner wall portion 242 of the body 240. In other words, if nozzle 830 provides a substantially constant exit angle for the gas exiting from airflow path 230, then the position of nozzle 830 within the inner wall portion 242 of body 240 (i.e., its relative distance to the converging point) must vary. In the example shown, this variation is substantially continuous. This is represented in the figure by reference planes designated "RF," which intersect the longitudinal plane 290 orthogonally, but for simplicity, are shown as a single dashed line. In this example, the converging point of the airflow 13 exiting the nozzle is located at RF1. The shortest distance between nozzle 830 and the converging point 920 lies between RF1 and a second reference plane RF2, which intersects the longitudinal axis 290 orthogonally. RF2 is located at the position where the distance between opposing portions of body 240, including the nozzle, is minimal. The maximum distance between nozzle 830 and the converging point 920 lies between RF1 and RF3. RF3 also intersects the longitudinal axis 290 orthogonally and is located at the position where the distance between opposing portions of body 240, including the nozzle, is maximum (i.e., the widest portion of body 240). At the midpoint of path 930, the distance between nozzle 830 and convergence point 920 lies between reference planes RF2 and RF3. It can be understood that by positioning the nozzle closer to inlet 260 or closer to outlet 270, while keeping the nozzle exit angle substantially constant, convergence point 920 can be closer to inlet 260 or closer to outlet 270. In some cases, when the gas velocity exiting nozzle 830 is low, the gas flow may not be able to converge to point 920. However, low-velocity gas may still converge toward point 920 along the path shown by dashed line 410, although it may not converge completely to point 920.

[0181] Figure 20This is a cross-sectional perspective view of a body 240 having a non-circular (e.g., oblong) shape, wherein at least one gas outlet 220 (e.g., nozzle 830) is arranged around an inner portion 242 of the body 240 in a reference frame RF7 orthogonally intersecting the longitudinal axis 290. The dashed line 410 schematically indicates the direction of airflow from the gas outlet 220. In the example shown, the airflow converges toward a single point 920, which can be considered to lie in a reference plane RF6 orthogonally intersecting the longitudinal axis 290. Since the nozzle 830 is arranged around the body 240 having a non-circular cross-sectional shape, and the distance between the reference planes RF6 and RF7 is substantially constant, the outlet angle β of the gas outlet 220 must vary along a path 930 on the inner surface of the body 240 to achieve convergence toward point 920. In the example shown, the variation is substantially continuous. In the example shown, the exit angle β can be a first angle at the location where the distance between the opposite portions of the nozzles 830 on path 930 is greatest (i.e., the widest part of body 240), and a second angle at the location where the distance between the opposite portions of the nozzles 830 on path 930 is smallest (i.e., the narrowest part of body 240), where the first angle is greater than the second angle. In one example, the first angle can be approximately 56°, and the second angle can be approximately 45°. To direct the airflow toward the convergence point 920, the exit angle of the nozzles 830 at the midpoint of path 930 varies between the first and second angles. It is understood that the distance between the gas outlet of the nozzles 830 and the convergence point 920 remains substantially constant. In some cases, when the gas velocity flowing from the nozzles 830 is low, it may not be possible for the airflow to converge toward point 920. However, low-velocity gas can still converge toward point 920 along the path shown by dashed line 410, although it may not converge completely to point 920.

[0182] It is understood that, in some embodiments, the distance from nozzle 830 to convergence point 920 may be variable. The location of point 920 may be based on one or more parameters, such as angle, and / or the size and / or shape and / or location of the limiting device and / or gas outlet 220 (when the limiting device is located upstream of gas outlet 220), the cross-sectional width of airflow path 230, the shape of at least one gas inlet 210, and the average velocity of airflow 13.

[0183] Figure 21This is a cross-sectional perspective view of a body 240 having a non-circular (e.g., oblong) shape, wherein at least one gas outlet 220 (e.g., nozzle 830) is disposed around the interior of the body 240. In this figure, the gas outlet angle β is substantially constant, and the gas outlet 220 is located in the inner wall portion 242 of the body 240 in a single plane orthogonally intersecting the longitudinal axis 290, so that the gas converges to line 950. In other words, the nozzle 830 is disposed with a substantially constant gas outlet angle of approximately 45° relative to the longitudinal axis 290 of the oral cavity interface 200. In the example shown, due to the non-circular (e.g., oblong) shape of the body 240, the airflow represented by line 410 converges toward line 950, which can be considered to be located in a reference plane RF8 orthogonally intersecting the longitudinal axis 290. Given that the gas outlet angle is substantially constant at 45° and the body 240 surrounding the gas outlet 220 is non-circular, the distance between the nozzle 830 and the converging line 950 is substantially constant.

[0184] Figure 22 This is a side cross-sectional view of a body 240 having a substantially circular shape, wherein at least one gas outlet 220 (e.g., nozzle 830) is positioned around the interior of the body 240 at a substantially constant 45° angle relative to the longitudinal axis 290 of the oral cavity interface 200. In this figure, the gas outlet angle β is substantially constant, and the gas outlet 220 is located in the inner wall portion 242 of the body 240 in a single plane orthogonally intersecting the longitudinal axis 290. Since the inner wall portion 242 of the body 240 is substantially circular, the gas converges toward point 920. The dashed line 410 schematically indicates the direction of airflow from the gas outlet 220. In the example shown, the airflow convergence indicated by the dashed line 410 toward point 920 can be considered to be located in a reference plane RF4 orthogonally intersecting the longitudinal axis 290. Given that the gas outlet angle is substantially constant at 45° and the body 240 around the gas outlet 220 is circular, the distance between the nozzle 830 and the convergence point 920 is substantially constant. Understandably, by positioning the nozzle closer to inlet 260 or closer to outlet 270, while keeping the nozzle exit angle substantially constant, the convergence point 920 can be closer to inlet 260 or closer to outlet 270. In some examples, the outlet angle β of the gas outlet can be decreased to bring the convergence point 920 closer to outlet 270, or increased to bring the convergence point closer to inlet 260. In some cases, when the gas velocity exiting nozzle 830 is low, the gas flow may not be able to converge to point 920. However, low-velocity gas can still move towards point 920 along the path shown by dashed line 410, although it will not converge completely at point 920. In some examples, to achieve substantially convergence along axis 290 and closer to outlet 270, the outlet angle β of the gas outlet can be close to zero, making the gas flow substantially parallel to axis 290.

[0185] Figures 13 to 22 Examples demonstrate that the location and / or orientation of at least one gas outlet 220 can be selected to control the location and outlet angle of the airflow, thereby achieving different airflow patterns within the channel 280 and / or the patient's airway. However, it is understood that, in use, the convergence of the airflow can also be affected by patient breathing and other factors. In some examples, controlling the location and outlet angle of the gas outlet 220 to converge it towards a point or line closer to the patient's airway can help the gas travel deeper into the channel 280. When the outlet angle is very small, such as close to or approximately 0 degrees to the axis 290 (see...), Figure 14 When the airflow is directed towards the channel 280, it can travel deeper into the channel but remain closer to the wall. This can be advantageous because when the airflow is directed essentially along the channel wall rather than the center of the channel 280, the interference of instruments inserted into the channel 280 on the airflow may be less. In another example, when the exit angle is larger, such as close to or approximately 90 degrees to axis 290 (see [reference needed]), the airflow can travel deeper into the channel 280 but remain closer to the wall. Figure 18 When the airflow is in the airway, it can act as a curtain, reducing the amount of surrounding air entering the patient's airway through channel 280.

[0186] In some embodiments, the gas can flow out of the oral cavity interface at a speed of approximately 80 m / s to 100 m / s. The gas may have the highest dynamic pressure at or near the point of exit from the nozzle (820, 830, or 840). As the airflow passes through channel 280 toward the patient's airway, the airflow may slow down, and the dynamic pressure may be converted into static pressure. The location where the gas is turned within the oral cavity may be referred to as the momentary stagnation zone.

[0187] A limiting device formed by nozzles (820, 830, 840) creates a jet within the oral cavity interface 200. In some embodiments, the nozzles (820, 830, or 840) may be circumferential nozzles surrounding channel 280, creating a circumferential (or “annular”) jet within the oral cavity interface 200. This can be advantageous in creating a high-pressure region covering a large cross-sectional area within the patient’s oral cavity. In open-mouth procedures, this will provide additional pressure to prevent airway collapse. Advantageously, this also helps to clear carbon dioxide from the patient’s airway. It is understood that the jet need not be perfectly circumferential. Therefore, the nozzle need not be formed by a single continuous slit or opening. However, one or more gaps in the circumferential jet profile can create a low-resistance region for the airflow. One or more gaps in the circumferential jet profile can facilitate the flow of air out of the patient 16’s oral cavity. This can subsequently reduce the pressure generated within the oral cavity interface 200 and within the patient 16’s oral cavity, which may help to reduce the patient 16’s expiratory effort.

[0188] During inhalation, the gas supplied through the airflow path 230 of the oral interface 200 can further travel into the airway of the patient 16. During exhalation, the exhaled gas can collide with the airflow 13 from the oral interface 200 and encounter high resistance provided by the static pressure generated by the jet (and any momentary stagnation pressure). The pressure and airflow generated by the patient can simultaneously push the airflow 13 supplied through the oral interface 200 toward the first end opening 260.

[0189] In some embodiments, the flow rate of airflow 13 may be between approximately 0 LPM and approximately 120 LPM, such as between approximately 20 LPM and approximately 120 LPM.

[0190] In one or more embodiments of this disclosure, at least one gas outlet 220 (e.g., a slit configured circumferentially) can provide an outlet angle of approximately 0 degrees relative to the axis 290 of the oral cavity interface 200, and the width of at least one gas outlet 220 can be approximately 0.15 mm. In such an example, the static pressure or stagnation pressure at the posterior aspect of the patient's mouth 16 can be approximately 3.6 cmH2O when the flow rate is 70 LPM, and the static pressure or stagnation pressure at the posterior aspect of the patient's mouth 16 can be approximately 0.6 cmH2O when the flow rate is 30 LPM.

[0191] In one or more embodiments of this disclosure, at least one gas outlet 220 (e.g., a slit configured circumferentially) may be at an angle of approximately 45 degrees relative to the axis 290 of the oral cavity interface 200, and the width of at least one gas outlet may be 0.2 mm. In such an example, when the flow rate is 70 LPM, the static pressure or stagnation pressure at the posterior aspect of the patient's mouth 16 may be approximately 2.6 cmH2O, while when the flow rate is 30 LPM, the static pressure or stagnation pressure at the posterior aspect of the patient's mouth 16 may be approximately 0.4 cmH2O.

[0192] In one or more embodiments of this disclosure, at least one gas outlet 220 (e.g., a slit configured as a circumference) may be at an angle of approximately 45 degrees relative to the axis 290 of the oral cavity interface 200, and the width of at least one gas outlet may be approximately 0.1 mm. In such an example, when the flow rate is 30 LPM, the static pressure or stagnation pressure at the posterior part of the patient's mouth 16 may be approximately 0.2 cmH2O.

[0193] In one or more embodiments of this disclosure, at least one gas outlet 220 (e.g., a slit configured as a circumference) may be at an angle of approximately 90 degrees relative to the axis 290 of the oral cavity interface 200, and the width of at least one gas outlet may be approximately 0.5 mm. In such an example, when the flow rate is 30 LPM, the static pressure or stagnant pressure at the posterior part of the patient's mouth 16 may be approximately 0.1 cmH2O.

[0194] The scope referenced in the provided examples relates to bench testing of the oral interface 200 on a non-human 3D rigid airway model with mandibular protraction and apnea / choking, and can be determined by such testing.

[0195] Therefore, it is understandable that when the jet enters the channel 280 at an angle 290 perpendicular to the axis 240 of the body 240, most of the airflow 13 will travel into the outside atmosphere, resulting in little or no pressure at the back of the patient's mouth 16. It is also understandable that the higher the jet velocity (depending on the driving pressure), the greater the static pressure in the upper airway of the patient 16.

[0196] It is understood that the convergence of airflow to an imaginary line, plane, or point may not be strictly achievable or necessary. Changing one or more of the following parameters—the nozzle angle, the distance between the nozzle and the first end opening 260, the width of the gas outlet 220, or others—may affect the convergence profile of the airflow. It is also understood that the distance from the nozzle to the convergence point / line may depend on the geometry of the airflow path 230 and the exit angle β of the nozzle 830. It is also understood that changing the width of one or more gas outlets 220 (i.e., defining the location where opposite portions of the gas outlets 220 are separated by the shortest distance, which may be located at the opening of the gas outlet 220 into the channel 280) can change the gas profile entering the channel 280.

[0197] Figure 23 A patient interface assembly 15 is shown, comprising an oral interface 200 and a nasal interface 1010. The patient interface assembly 15 can be configured as a non-hermetic mask. The nasal interface 1010 and the oral interface 200 can receive airflow 13 from a common airflow source 12. The airflow 13 from the common airflow source 12 enters the oral interface 200 through at least one gas inlet 210. The airflow 13 from the common airflow source 12 also enters the nasal interface 1010 through a nasal cannula 1012 and enters the nostrils of the patient 16 through nasal prongs 1014. Figure 24 It shows the flow from the common airflow source 12 Figure 23 Airflow 13 from the oral cavity interface 200 and the nasal interface 1010. Airflow 13 from the common airflow source 12 enters the oral cavity interface 200 through at least one gas inlet 210, flows through the airflow path 230, and then enters the channel 280 through at least one gas outlet 220. Figure 24 The diagram illustrates airflow 13 flowing through airflow path 230 and exiting from one or more gas outlets 220 of oral cavity interface 200, either at or near second end opening 270, or at or near first end opening 260, or between first end opening 260 and second end opening 270, before flowing into channel 280 and subsequently towards the posterior part of the oral cavity of patient 16. While the airflow direction into channel 280 appears to originate from seven discrete openings 220, it is understood that this is merely illustrative, and gas outlets 220 may comprise a continuous slit surrounding channel 280, or any suitable number of discrete openings 220 as would be understood by a person skilled in the art based on this disclosure.

[0198] In an alternative embodiment, the nose interface 1010 and the mouth interface 200 may receive airflow 13 from a separate airflow source.

[0199] In alternative embodiments, the nasal interface 1010 can form a seal with the patient's face. For example, the sealing interface can include a nasal cannula, a nasal pillow, or a nasal mask. The sealing interface does not require supplying gas to the patient. For example, the sealing nasal interface can include a nose clip. A nose clip can block or prevent airflow (e.g., ambient air) between the patient's nasal passage and the outside of the patient's nasal passage.

[0200] As used herein, nasal interface 1010 refers to a device such as a cannula, nasal mask, nasal pillow or other type of nasal device or combination thereof, which in some embodiments is configured to direct airflow to one or both nostrils of a patient.

[0201] A nasal cannula is a nasal interface that may include one or more pins 1014 configured for insertion into one or both nasal passages of a patient. A mask is an interface that covers a patient's nasal passages and / or oral cavity.

[0202] The patient interface assembly 15 may further include mounting elements and / or supports, such as a cheek support, for attaching and / or supporting the gas delivery conduit 14 or a catheter to the patient's face. Alternatively or additionally, such as Figures 4 to 6 As shown, the patient interface component 15 can be secured by one or more straps or headbands.

[0203] The nasal interface 1010 can provide a first airflow to the patient 16 at a first flow rate, and the oral interface 200 can provide a second airflow to the patient 16 at a second flow rate. In an embodiment, the first flow rate is different from the second flow rate. In an embodiment, the first flow rate and the second flow rate can be between approximately 0 LPM and approximately 120 LPM, such as between approximately 20 LPM and approximately 120 LPM. In another embodiment, the combined flow rate of the first and second airflows can be between approximately 0 LPM and approximately 120 LPM.

[0204] The airflow path in the nasal interface 1010 can be fluidly connected to the oral interface 200. Figure 25 The nose interface 1010 is shown to be fluidly connected to the oral interface 200 at its bottom via an interface connector 1110. The interface connector 1110 allows the nose interface 1010 to be detachably attached to the oral interface 200.

[0205] Figure 26 This shows when the nose interface 1010 is as follows Figure 25 The airflow 13 is shown when the nasal interface 1010 is fluidly connected to the oral interface 200 at the bottom via the interface connector 1110. The airflow 13 can be received from the airflow source 12 into the nasal interface 1010 and flows into the nose of the patient 16 through the nasal pin 1014, while flowing into the airflow path 230 through the interface connector 1110 and exiting from one or more gas outlets 220 of the oral interface 200, which are located at or near the second end opening 270, or at or near the first end opening 260, or between the first end opening 260 and the second end opening 270, then flowing into the channel 280 and subsequently into the posterior part of the patient 16's mouth.

[0206] Figure 27 An alternative embodiment is shown, comprising a nasal interface 1010 and an oral interface 200 connected via an interface connector 1110. In this embodiment, airflow 13 may be received from airflow source 12 into gas inlet 210 and flows through airflow path 230 into channel 280 or second end opening 270 via one or more gas outlets 220, depending on the location of the one or more gas outlets 220. Further, airflow 13 travels from airflow path 230 in oral interface 200 through interface connector 1110 to nasal interface 1010 and through nasal pin 1014 into the nose of patient 16. It will be understood that, as Figure 24 As shown, Figure 25 , Figure 27 , Figure 28 The arrows indicating the direction of airflow only indicate that there is airflow in the nose interface 1010 and the mouth interface 200 when connected to the airflow source 12, and do not indicate the actual direction or distribution of airflow.

[0207] Figure 28 Another embodiment of a patient interface assembly 15 is shown, including an oral interface 200 and a nasal interface 1010. The oral interface 200 can receive airflow 13 from an airflow source 12a into a gas inlet 210, and flow through an airflow path 230 into a channel 280 via one or more gas outlets 220. The nasal interface 1010 can receive airflow 13 from another airflow source 12b.

[0208] Figures 25 to 27 The configuration shown facilitates the selective delivery of individual treatment or support modes to patients using different patient interfaces. Alternatively or additionally, Figures 25 to 27 The configuration shown can facilitate stopping the delivery of treatment from the interface. Advantageously, Figures 25 to 27 The configuration is particularly useful for emergency resuscitation and / or intubation of patients receiving high-flow therapy, during ear, nose and throat (ENT) surgery, assisting in conditioning / pre-oxygenation of patients in their preoperative state before anesthesia administration, and after extubation and during sedation (e.g., gastroscopy and recovery).

[0209] Using the oral interface 200 in combination with the unsealed nasal interface 1010 (which supplies high-flow-rate gas) can provide greater pressure support to patient 16 compared to using the oral interface 200 alone or the unsealed nasal interface 1010 alone. This is because supplying airflow to both the nose and mouth of patient 16 may result in higher resistance to exhaled air. A synergistic effect can occur when high-flow-rate respiratory support is provided simultaneously through the high-flow nasal interface 1010 (such as a nasal cannula) and the oral interface 200.

[0210] In some examples, it may be necessary to use different patient interfaces to provide selective delivery of independent treatments to a patient. This may be desirable in specific applications such as emergency resuscitation, intubation of patients receiving high-flow-rate treatment, ear, nose, and throat (ENT) surgery, assisting in the conditioning of patients in their preoperative state before anesthesia administration, and during extubation and recovery. In some cases, particularly involving ENT surgery, an oral interface 200 may be provided according to this disclosure, optionally in conjunction with a nasal interface 1010, to provide primary respiratory support. The mask assembly 300 may be used as or in conjunction with a secondary respiratory support subsystem, and / or for delivering one or more substances other than those delivered by the oral interface 200, such as anesthetics or oxygen, or delivering the same substance at different flow rates and / or pressure levels.

[0211] Figure 29The illustrated embodiment allows for the delivery of gas from multiple sources via two respiratory support subsystems. Additionally, this configuration allows the oral interface 200 to remain on the patient throughout the surgical procedure and / or recovery period (regardless of whether the patient continues to receive flow therapy through the oral interface 200 throughout the procedure, whether or not it is used in conjunction with the nasal interface 1010). In the illustrated embodiment, the mask assembly 300 includes a full-face mask 302 configured to cover the patient's nose and mouth. In other configurations, the mask 300 may be a nasal mask or a face mask positioned above the oral interface 200, covering only the patient's nasal region or only the patient's mouth, respectively. As shown, the mask 302 includes a sealing region 304 adapted to seal against the patient's face. The mask assembly 300 is connected to a second gas source that supplies one or more other gases to the patient through the mask. In other words, the second gas source is preferably different from the airflow source 12 supplying gas to the oral interface 200. For example, the mask assembly 300 can be connected to a separate gas source or a separate respiratory support device, such as a ventilator, continuous positive airway pressure (CPAP), a high-flow therapy device, or a manual resuscitator (e.g., a handheld mask with a bag). Alternatively, the mask assembly 300 can be connected to an anesthesia device, and anesthetic gas, or air, or oxygen, or a combination of gases can be delivered through the mask 302.

[0212] In some examples, the same respiratory support system can supply gas to both the oral cavity interface 200 and the mask 300.

[0213] A filter element 400 may be present between the mask 300 and the second gas source.

[0214] Figure 29 The illustrated embodiments allow for the delivery of gas from multiple sources through at least two different respiratory support modes, and further allow physicians, clinicians, or medical professionals to quickly and easily change the type of respiratory support mode.

[0215] In one specific application, high-flow-rate oxygen can be delivered via the nasal cannula 1010 for pre-oxygenation of a patient preparing for anesthesia. The oral interface 200 can also be placed on the patient to prepare for procedures requiring oral instruments. In some cases, the anesthesiologist managing the sedation of patient 16 may wish to switch between delivering airflow from one patient interface (such as the nasal cannula 1010) and from another patient interface (such as via a mask 300). Simultaneous delivery of gas from the nasal cannula and mask, or even delivery of gas from the cannula with the mask covering it, can lead to increased pressure, potentially damaging the patient's lungs. Anesthesiologists also use cuffed masks to deliver oxygen to patients, which can be more comfortable in some cases if a patient's vital signs begin to decline. In such cases, delivering airflow via the cannula 1010 and / or oral interface 200, as well as pulsatile airflow via the cuffed mask 300, can lead to excessive lung pressure and potential lung injury. In some examples, the risk of the aforementioned lung injury can be mitigated by “switching” between respiratory support modes, for example, using a catheter with one or more sections configured to switch between different conditions to change airflow, as described below. Therefore, in some cases, healthcare professionals may wish to switch between different respiratory systems or support modes. In a first mode, respiratory support may be provided by a first respiratory support system (e.g., via oral interface 200, with or without nasal intubation 1010), while in a second mode, respiratory support may be provided by a second respiratory support system (e.g., via mask 300), while reducing or shutting off support from the first system. In some cases, additional airflow from oral interface 200 and / or nasal intubation 1010 can also alter the intended behavior of the anesthesia circuit; therefore, the ability to shut off additional airflow from the first respiratory system may be advantageous. In some cases, in response to switching, the airflow from oral interface 200 and / or nasal intubation 1010 can be adjusted to a very low flow rate and / or pressure.

[0216] In some configurations, the structure of the gas delivery conduit 14 supplying the oral cavity interface 200 and / or the nasal cannula 1012 supplying the nasal cannula 1010 can facilitate switching between two respiratory support modes or subsystems. Such a structure may include a portion 204 configured to transition from a first condition (where a first level of gas can pass through this portion 204) to a second condition (where a second level of gas can pass through this portion 204). Preferably, portion 204 is configured to be more easily foldable or better adapted to altering the airflow through this portion 204 (thus reducing the airflow through the respective conduit and reaching the patient) than other portions of the gas delivery conduit 14 and / or the nasal cannula 1012. In some examples, the first condition of portion 204 is a substantially open condition, and the second condition is a substantially closed condition. In other words, the gas delivery conduit 14 and / or the nasal cannula 1012 is configured to be more easily foldable, deformable, or better adapted to completely shut off the airflow at portion 204 than other portions of the conduit 14 and / or the nasal cannula 1012.

[0217] Figure 30 An example is shown where, at section 204, a catheter (e.g.) Figure 29 The gas delivery conduit 14 in the mask 302 is substantially closed by the seal 304. In this embodiment, the length of the foldable portion 204 of the gas delivery conduit 14 (i.e., the portion that is more easily foldable or deformable) should be greater than the width of the portion of the mask seal that covers the portion 204 of the gas delivery conduit 14. This ensures that the mask seal does not cover the non-foldable portion of the gas delivery conduit 14. For example, the portion 204 may extend from a distance of 35 mm or less from the center of the user's nose to a distance of at least 50 mm from the center of the user's nose, and the length of the portion 204 may be at least 15 mm. In some embodiments, the length of the portion 204 may be at least 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, or longer.

[0218] Part 204 can be determined based on the relative force level applied to its outer wall or the force level felt by its inner wall between a first condition and a second condition. For example, as Figure 29As shown, this force can be applied by the seal 304 of the mask 302. In this example, the portion 204 is configured to be positioned below the seal 304 of the mask 302. Alternatively, force can be applied to the portion 204 in other ways, such as using a clamp (not shown). In some embodiments, the seal of the mask acting on the portion 204 of the gas delivery conduit causes the portion 204 to form a seal or at least a partial seal between the oral cavity interface 200 (with or without the nasal cannula 1010) and the airflow generator. Additionally, the seal of the mask forms a seal or at least a partial seal on the portion 204 of the gas delivery conduit 14 and / or the nasal cannula 1012. Therefore, by applying the mask to the patient's face, the mask's seal (partially or completely) folds the portion 204 of the gas delivery conduit 14 to "close" or reduce treatment supplied through the oral interface 200 (with or without the nasal interface 1010), while also providing a seal between the outer surfaces of the mask 300 and the portion 204, a simple switching between respiratory support treatments can be achieved, allowing treatment to be delivered solely through the mask or at least primarily through the mask. In some embodiments, removing the mask from the patient's face allows treatment supplied by the first interface to resume. Figures 31 to 34 This is an example of a patient assembly having an oral interface 200 and a nasal cannula 1010, and schematically shows the placement of a portion 204 that can be configured to switch between different conditions (e.g., substantially foldable) to change airflow, thereby facilitating switching between two respiratory support modes or subsystems as described above.

[0219] The configuration of a convertible or substantially foldable portion 204 of the catheter may be due to its cross-sectional shape. In other words, the portion may contain predefined thinning areas that facilitate easy conversion or folding of the catheter portion 204. In other examples, the cross-section of portion 204 may be thinner than that of other catheter portions in fluid communication with it.

[0220] exist Figure 31 In this assembly, the nasal interface 1010 and the oral interface 200 can receive airflow from a common airflow source 12. The nasal interface 1010 can be supplied by a nasal cannula 1012 having a portion 204, and the oral interface 200 can be supplied by a gas delivery conduit 14 having an independent portion 204. Each portion can switch between a first (substantially open) condition and a second (substantially closed) condition when sufficient pressure is applied to substantially stop the flow to its respective interface. The portions 204 can be located on conduits 1012 and 14 such that, during use, when the mask is applied to the patient interface assembly, these portions are located below the mask pouch. However, this is not always the case; the mask pouch may be applied to only one portion 204, and sufficient pressure may be applied to the other portion 204 using a clamp, hand, or other means.

[0221] exist Figure 32 and Figure 33 In the middle, the nasal interface 1010 is fluidly connected to the oral interface 200 at its bottom via an interface connector 1110 to form a shape as shown in the image. Figures 25 to 27 The patient interface component is shown. Airflow can be received from the common airflow source 12 via the gas delivery conduit 14, first flowing into the nasal interface 1010, and then... Figure 32 The airflow is shown as flowing into the oral cavity interface 200. Alternatively, the airflow can be received from the common airflow source 12 via the gas delivery conduit 14, first flowing into the oral cavity interface 200, and then... Figure 33 The inflow nasal interface 1010 is shown. The gas delivery conduit 14 has a portion 204 that, when sufficient pressure is applied, can switch between a first (substantially open) condition and a second (substantially closed) condition to substantially stop the flow to the patient interface assembly. In either case, the portion 204 may be located on the conduit 14 such that, during use, when the mask is applied to the patient interface assembly, the portion is located below the mask pouch. However, this is not necessarily the case, as sufficient pressure may be applied to the portion 204 using a clamp, hand, or other means. Figure 32 and Figure 33 The arrangement in the middle may be advantageous because a single part 204 can be used to switch between respiratory support provided by the patient interface component through the mouth and nose via a first respiratory support mode and, for example, a mask provided via a second respiratory support mode.

[0222] exist Figure 34 In this configuration, the nasal interface 1010 and the oral interface 200 receive independent airflows from independent airflow sources 12a and 12b, respectively. The nasal cannula 1012 and the gas delivery conduit 14 may each have a portion 204 that, when sufficient pressure is applied, can switch between a first (substantially open) condition and a second (substantially closed) condition to substantially stop the flow of gas into the patient interface assembly. The portion 204 may be located on the gas delivery conduit 14 and the nasal cannula 1012 such that, during use, when the mask is applied to the patient interface assembly, the portion 204 is located below the mask pouch. However, this is not always the case; sufficient pressure may be applied to one or both portions 204 using a clamp, hand, or other means.

[0223] In some examples, switching (e.g., stopping or reducing flow from airflow sources 12, 12a, 12b) can be performed electronically under the instruction of controller 19 (which may include a microcontroller). For example, conditions under which the mask 300 is positioned on the oral cavity interface 200 and optionally the nasal interface 1010 can be detected by one or more sensors 18a, 18b, 18c, 18d. For example, one or more sensors may be pressure sensors. One or more sensors can detect a pressure rise in the conduit 14, which, upon electronic communication with controller 19, causes a signal to be sent to airflow source 12 to reduce or stop airflow to interface 200.

[0224] High-flow-rate oral respiratory support can increase mean airway pressure by 3-5 cmH2O per 100 L / min of airflow, with or without separate high-flow-rate nasal respiratory support. This is applicable to both mandibular and non-mandibular airways, regardless of whether breathing is occurring.

[0225] In some examples, using the unsealed nasal cannula 1010 alone at a flow rate of approximately 70 L / min can provide a static pressure of 0.18 cmH2O. In some examples, using the oral cannula 200 alone at a flow rate of 70 L / min can provide a static pressure of 0.8 cmH2O. However, simulations (e.g., bench tests on a rigid airway model with mandibular protraction) show that using the nasal cannula 1010 to generate a flow rate of 70 L / min, and simultaneously using the oral cannula 200 to generate a flow rate of 70 L / min, can provide a static pressure of 1.4 cmH2O.

[0226] Similarly, in some examples, using the unsealed nasal cannula 1010 alone at a flow rate of 100 L / min can provide a static pressure of approximately 0.5 cmH2O. In some examples, using the oral cannula 200 alone at a flow rate of 100 L / min can provide a static pressure of approximately 2 cmH2O. However, simulations (e.g., bench tests on a rigid airway model with mandibular protraction) show that using the nasal cannula 1010 to generate a flow rate of 100 L / min, and simultaneously using the oral cannula 200 to generate a flow rate of 100 L / min, can provide a static pressure of approximately 4 cmH2O.

[0227] Therefore, the simultaneous use of nasal and oral interfaces to deliver high-flow-rate gas may have synergistic benefits. When nasal and oral interfaces are used simultaneously, the pressure generated within the patient's body is higher than that generated when they are used individually, potentially resulting in a synergistic effect. For example, using the nasal interface without the oral interface can generate an airflow of x cmH2O, while using the oral interface without the nasal interface can generate an airflow of y cmH2O. Simultaneous use of the nasal and oral interfaces 200 may generate a pressure greater than or equal to the sum of x and y cmH2O. This is because the patient experiences greater airflow resistance when both the nasal and oral interfaces are in place simultaneously. This increased airflow resistance may be due to the jet colliding with the patient's breathing and / or increased structural obstruction provided by the patient interface in the airway. The jet may originate from the oral interface 200 or the nasal interface 1010, or simultaneously from both the oral interface 200 and the nasal interface 1010.

[0228] The pressure generated by using both the nasal and oral interfaces 200 may be between 0 cmH2O and 20 cmH2O. More specifically, the pressure generated may be between 0.1 cmH2O and 10 cmH2O.

[0229] It is understood that, according to the embodiments disclosed herein, a system for providing respiratory support to a patient 16 using the patient interface component 15 may include at least one airflow source 12 for generating airflow 13, and at least one humidifier 17 optionally for humidifying and / or heating the airflow to deliver humidified airflow to the patient 16.

[0230] Applications of the oral interface 200 may include anesthesia procedures or procedures involving sedation of patient 16, where patient 16 is breathing spontaneously or involuntarily and requires access to their oral cavity. The oral interface 200 may be particularly suitable for patients with OSA (obstructive sleep apnea) who are at higher risk of upper airway collapse, or for patients with a high BMI (body mass index) who may have a higher risk of atelectasis. The oral interface 200 may also provide improved airway clearance and / or increase the patient's FiO2 (fraction of inspired oxygen), which is useful at least during the pre-oxygenation phase. This can also be useful in procedures where patient 16 is experiencing apnea and needs to remain still, such as diagnostic and / or interventional radiology imaging, to obtain better scanning results.

[0231] The oral interface 200, via channel 280, can be configured to allow simultaneous access to other medical instruments / devices into the patient's mouth, for example, for shared airway procedures, while also providing gas delivery. The oral interface 200 can also enhance the respiratory support or therapy provided by the nasal interface 1010 (low or high flow). Advantageously, the airflow can be delivered substantially annularly or circumferentially around the inner wall portion 242 of the body 240 in the end face of the body portion facing the second end opening 270. This makes the airflow less susceptible to disturbance or obstruction during procedures, such as due to the positioning of the clinician's hands and / or instruments in channel 280. Depending on the location of at least one gas outlet 220, the body 240 facing the first end opening 260 can provide further protection against obstruction of the gas outlet 220. Specifically, a portion of the inner wall portion 242 forming the gas outlet 220 can prevent obstruction of the gas outlet 220.

[0232] The oral interface 200 can be used to control airway pressure while keeping the airway unsealed, thereby allowing the provision of treatment modes such as non-invasive ventilation (NIV) or basic periodic pressure changes to generate small tidal airflows in and out of the lungs that would otherwise be in a state of apnea, without losing the shared airway access.

[0233] This specification, including the claims, is intended to be interpreted as follows:

[0234] The embodiments or examples described in this specification are intended to illustrate the invention and not to limit its scope. The invention can be implemented with various modifications and additions readily apparent to those skilled in the art. Therefore, it is understood that the scope of the invention is not limited to the precise construction and operation described or shown, but is defined only by the following claims. It is understood that the terms "embodiment" and "example" do not supersede the following claims.

[0235] Unless expressly stated otherwise or clearly stated in the claims, the disclosure of method steps or product elements in this specification should not be construed as essential to the content claimed in this invention.

[0236] The terms in the claims have the broadest meaning as assigned to those skilled in the art at the relevant date.

[0237] Unless explicitly specified, the terms “a” and “one” mean “one or more”.

[0238] Neither the title nor the abstract of this application shall be construed in any way as a limitation on the scope of the claimed invention.

[0239] If the preamble of a claim states the purpose, benefit, or possible use of the claimed invention, it does not limit the scope of the claimed invention to having only that purpose, benefit, or possible use.

[0240] It should be noted that degree terms such as “usually,” “basically,” “approximately,” and “approximately” used in this article refer to a reasonable amount of deviation from the modified term so that the final result does not change significantly. If the deviation of these degree terms does not negate the meaning of the term they modify, they should be interpreted as including the deviation of the modified term.

[0241] In this specification (including the claims), the term "circumferential" and its variations (such as "circumferential" and "circumferentially") are used to refer to the enclosing boundary of a closed geometry, including but not limited to a circle.

[0242] In this specification (including the claims), the term “comprise” and variations thereof (such as “comprises” or “comprising”) are used to mean “including but not limited to”, unless otherwise expressly stated or required by the context or usage to be exclusively interpreted.

[0243] Furthermore, any numerical range stated via endpoints in this document includes all numbers and fractions within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also understood that all numbers and fractions are assumed to be modified by the term "approximately," which means that the variation in the final result reaches a specific amount of the number mentioned, if no significant change is made.

[0244] As used herein, the term “and / or” is intended to indicate inclusion or. That is, for example, “X and / or Y” is intended to mean X or Y or both. As a further example, “X, Y and / or Z” is intended to mean X or Y or Z or any combination thereof.

[0245] The disclosures of any documents mentioned herein are incorporated by reference into this patent application as part of this disclosure, but only for the purpose of written description and illustration, and should in no way be used to limit, define, or otherwise interpret any terminology of this application if it would not fail to provide a definite meaning without such incorporated references. Any incorporated references in themselves do not constitute an endorsement or approval of any statements, opinions, or arguments contained in the incorporated documents.

Claims

1. An oral interface for providing respiratory support to a patient, the oral interface comprising: At least one gas inlet for receiving gas flow; At least one gas outlet for providing the airflow to the patient; An airflow path, which is defined between the at least one gas inlet and the at least one gas outlet; as well as The main body includes: The oral cavity junction is configured to engage with the patient's oral cavity; A first end opening and a second end opening are disposed on opposite sides of the body, the first end opening and the second end opening defining a passage for providing access to the oral cavity; The at least one gas outlet includes a limiting device configured to increase the average velocity of the gas flow as it exits the at least one gas outlet.

2. The oral cavity interface according to claim 1, wherein, The at least one gas outlet is located at any of the following positions: at or near the first end opening, between the first end opening and the second end opening, or at or near the second end opening.

3. The oral cavity interface according to claim 1 or 2, wherein, The at least one gas outlet includes the limiting device, and the limiting device includes a nozzle configured to provide a jet of gas flow.

4. The oral interface according to any one of claims 1 to 3, wherein, At least a portion of the airflow path is circumferential around the channel.

5. The oral interface according to any one of claims 1 to 4, wherein, The at least one gas outlet is disposed along the periphery of the channel.

6. The oral interface according to any one of claims 1 to 5, wherein, The average velocity of the airflow around the channel is substantially uniform.

7. The oral cavity interface according to claim 6, wherein, The width of the at least one gas outlet surrounding the channel is substantially uniform.

8. The oral interface according to any one of claims 1 to 7, wherein, The at least one gas outlet is configured to direct the gas flow in a direction substantially parallel to the axis of the body extending between the first end opening and the second end opening.

9. The oral interface according to any one of claims 1 to 7, wherein, The at least one gas outlet is configured based on one or both of the angle of the limiting device and the cross-sectional width of the airflow path to guide the airflow from the first end opening toward the second end opening.

10. The oral interface according to any one of claims 1 to 7, wherein, The at least one gas outlet is configured to guide the gas flow toward a line converging near the second end opening.

11. The oral cavity interface according to claim 10, wherein, The line is substantially orthogonal to the axis of the body extending between the first end opening and the second end opening.

12. The oral interface according to any one of claims 1 to 7, wherein, The at least one gas outlet is configured to guide the gas flow toward a point close to the second end opening.

13. The oral cavity interface according to claim 12, wherein, The location of the point is determined based on one or more of the following: the angle of the limiting device, the angle of the at least one gas outlet, the shape of the at least one gas outlet, the cross-sectional width of the airflow path, the shape of the at least one gas inlet, and the average velocity of the airflow.

14. The oral interface according to any one of claims 1 to 13, wherein, The at least one gas outlet is configured to provide the airflow such that the patient's airway pressure is at least about 0.1 cmH2O.

15. The oral interface according to any one of claims 1 to 14, wherein, The at least one gas outlet is configured to provide the airflow such that the patient's airway pressure is between approximately 0.1 cmH2O and approximately 10 cmH2O.

16. The oral interface according to any one of claims 1 to 15, wherein, The flow rate of the airflow is between approximately 0 LPM and approximately 200 LPM.

17. The oral interface according to any one of claims 1 to 16, wherein, The airflow rate is between approximately 20 LPM and approximately 200 LPM.

18. The oral interface according to any one of claims 1 to 17, wherein, The average velocity of the airflow is approximately 100 m / sec.

19. The oral interface according to any one of claims 1 to 18, wherein, The body has a cross-section, the cross-section having a first dimension and a second dimension perpendicular to the first dimension, wherein the first dimension is larger than the second dimension.

20. The oral interface according to any one of claims 1 to 19, wherein, At least a portion of the body has an elliptical, oblong, circular, oval, or other cross-sectional shape that is transverse to an axis extending from the first end opening to the second end opening.

21. The oral interface according to any one of claims 1 to 20, wherein, The cross-sectional width of the airflow path is non-uniform around the channel, and / or the width of the at least one gas outlet is non-uniform around the channel.

22. The oral interface according to any one of claims 1 to 21, wherein, The at least one gas outlet includes two or more gas outlets arranged around the channel.

23. The oral interface according to any one of claims 1 to 22, wherein, The at least one gas inlet includes a first gas inlet and a second gas inlet.

24. The oral cavity interface according to claim 23, wherein, The cross-sectional area of ​​the first gas inlet is substantially equal to the cross-sectional area of ​​the second gas inlet.

25. The oral cavity interface according to claim 23 or 24, wherein, One of the first gas inlet and the second gas inlet is configured to be close to the patient's nose during use.

26. The oral interface according to any one of claims 23 to 25, wherein, The first gas inlet and the second gas inlet are positioned opposite each other.

27. The oral interface according to any one of claims 1 to 26, further comprising a cover disposed around the oral engagement portion of the body.

28. The oral cavity interface according to claim 27, wherein, The cover is disposed around a portion of the oral cavity interface, the portion being configured to be located within the patient's oral cavity, and configured to provide a substantial seal around the oral cavity interface and the patient's oral cavity, such that fluid enters the patient's oral cavity substantially through the channel.

29. The oral interface according to any one of claims 1 to 28, further comprising a headband connector configured to be detachably connected to the patient-wearable headband to stabilize the oral interface during use.

30. An oral interface for providing respiratory support to a patient, the oral interface comprising: At least one gas inlet for receiving gas flow; At least one gas outlet for providing the airflow toward the back of the patient's mouth; An airflow path defined between the at least one gas inlet and the at least one gas outlet; as well as The main body includes: A first end opening and a second end opening are disposed on opposite sides of the body, the first end opening and the second end opening defining a passage for providing access to the patient's oral cavity. The at least one gas outlet is arranged circumferentially around the channel and configured to provide the airflow toward the back of the patient's mouth as a jet.

31. The oral cavity interface according to claim 30, wherein, The at least one gas outlet is located at any of the following positions: at or near the first end opening, between the first end opening and the second end opening, or at or near the second end opening.

32. The oral cavity interface according to claim 30 or 31, wherein, The at least one gas outlet is configured to provide the gas flow into the channel in the form of a jet.

33. The oral interface according to any one of claims 30 to 32, wherein, The at least one gas outlet includes a nozzle configured to provide the jet.

34. The oral cavity interface according to any one of claims 30 to 33, wherein, The at least one gas outlet is disposed along the periphery of the channel.

35. The oral cavity interface according to any one of claims 30 to 34, wherein, The at least one gas outlet includes a slit surrounding a circumference that defines the periphery of the body surrounding the gas flow path.

36. The oral cavity interface according to any one of claims 30 to 35, wherein, The at least one gas outlet is further configured to guide the airflow in a direction substantially parallel to an axis extending between the first end opening and the second end opening.

37. The oral interface according to any one of claims 30 to 35, wherein, The at least one gas outlet is further configured to guide the airflow from the first end opening toward the second end opening based on one or more of the angle of the limiting device, the angle of the at least one gas outlet, the shape of the at least one gas outlet, and the cross-sectional width of the airflow path.

38. The oral interface according to any one of claims 30 to 35, wherein, The at least one gas outlet is configured to guide the gas flow toward a line converging near the second end opening.

39. The oral cavity interface according to claim 38, wherein, The line is substantially orthogonal to the axis of the body extending between the first end opening and the second end opening.

40. The oral cavity interface according to any one of claims 30 to 35, wherein, The at least one gas outlet is configured to guide the gas flow toward a point close to the second end opening.

41. The oral cavity interface according to claim 40, wherein, The location of the point is based on one or more of the following: the angle of the limiting device, the angle of the at least one gas outlet, the shape of the at least one gas outlet, the cross-sectional width of the airflow path, the shape of the at least one gas inlet, and the average velocity of the airflow.

42. The oral cavity interface according to any one of claims 30 to 41, wherein, The at least one gas outlet is configured to direct the gas flow toward the second end opening.

43. The oral cavity interface according to any one of claims 30 to 42, wherein, The average velocity of the airflow near the at least one gas outlet around the channel is substantially uniform.

44. The oral cavity interface according to any one of claims 30 to 43, wherein, The at least one gas outlet is configured to provide the airflow such that the patient's airway pressure is at least about 0.1 cmH2O.

45. The oral cavity interface according to any one of claims 30 to 44, wherein, The at least one gas outlet is configured to provide the airflow such that the patient's airway pressure is between approximately 0.1 cmH2O and approximately 10 cmH2O.

46. ​​The oral cavity interface according to any one of claims 30 to 45, wherein, The airflow rate is between approximately 0 LPM and approximately 200 LPM.

47. The oral cavity interface according to any one of claims 30 to 46, wherein, The airflow rate is between approximately 20 LPM and approximately 200 LPM.

48. The oral cavity interface according to any one of claims 30 to 47, wherein, The average velocity of the airflow is approximately 100 m / sec.

49. The oral cavity interface according to any one of claims 30 to 48, wherein, The body has a cross-section, the cross-section having a first dimension and a second dimension perpendicular to the first dimension, wherein the first dimension is larger than the second dimension.

50. The oral interface according to any one of claims 30 to 49, wherein, At least a portion of the body has an elliptical, oblong, circular, oval, or other cross-sectional shape that is transverse to an axis extending from the first end opening to the second end opening.

51. The oral interface according to any one of claims 30 to 50, wherein, The cross-sectional width of the airflow path is non-uniform around the channel.

52. The oral interface according to any one of claims 30 to 51, wherein, The at least one gas outlet includes two or more gas outlets arranged around the channel.

53. The oral interface according to any one of claims 30 to 52, wherein, The at least one gas inlet includes a first gas inlet and a second gas inlet.

54. The oral cavity interface according to claim 53, wherein, The cross-sectional area of ​​the first gas inlet is substantially equal to the cross-sectional area of ​​the second gas inlet.

55. The oral interface according to any one of claims 53 or 54, wherein, One of the first gas inlet and the second gas inlet is configured to be close to the patient's nose during use.

56. The oral interface according to any one of claims 54 to 55, wherein, The first gas inlet and the second gas inlet are positioned opposite each other.

57. The oral cavity interface according to any one of claims 30 to 56, further comprising a cover disposed around the body.

58. The oral cavity interface according to claim 57, wherein, The cover is disposed around a portion of the body, the portion being configured to be located within the patient's oral cavity, and further configured to provide a substantial seal between the oral cavity junction and the patient's teeth and / or lips.

59. The oral interface according to any one of claims 30 to 58, further comprising one or more headband connectors configured to be detachably connected to the patient-wearable headband to stabilize the oral interface in use.

60. An oral interface for providing respiratory support to a patient, the oral interface comprising: At least one gas inlet for receiving gas flow; At least one gas outlet for providing the airflow to the patient; An airflow path defined between the at least one gas inlet and the at least one gas outlet; as well as The main body includes: A first end opening and a second end opening are disposed on opposite sides of the body, the first end opening and the second end opening defining a passage for providing access to the patient's oral cavity; The at least one gas outlet is configured such that the average velocity of the gas flow out of the at least one gas outlet is up to approximately 110 m / s.

61. The oral cavity interface according to claim 60, wherein, The average velocity of the gas flow exiting the at least one gas outlet is between approximately 10 m / s and approximately 110 m / s.

62. The oral cavity interface according to claim 60 or 61, wherein, The average velocity of the gas flow exiting the at least one gas outlet is between approximately 40 m / s and approximately 110 m / s.

63. The oral interface according to any one of claims 60 to 62, wherein, The average velocity of the airflow is approximately 100 m / sec.

64. The oral cavity interface according to any one of claims 60 to 63, wherein, The airflow path extends circumferentially around at least a portion of the channel.

65. The oral interface according to any one of claims 60 to 64, wherein, The at least one gas outlet is arranged around the periphery of the channel.

66. The oral interface according to any one of claims 60 to 65, wherein, The average velocity of the airflow around the channel is substantially uniform.

67. The oral interface according to any one of claims 60 to 66, wherein, The width of the at least one gas outlet surrounding the channel is substantially uniform.

68. The oral interface according to any one of claims 60 to 67, wherein, The at least one gas outlet is configured to direct the gas flow in a direction substantially parallel to the axis of the body extending between the first end opening and the second end opening.

69. The oral interface according to any one of claims 60 to 67, wherein, The at least one gas outlet is configured based on one or both of the angle of the limiting device and the cross-sectional width of the airflow path to guide the airflow from the first end opening toward the second end opening.

70. The oral interface according to any one of claims 60 to 67, wherein, The at least one gas outlet is configured to guide the gas flow toward a line converging near the second end opening.

71. The oral cavity interface according to claim 70, wherein, The line is substantially orthogonal to the axis of the body extending between the first end opening and the second end opening.

72. The oral interface according to any one of claims 60 to 67, wherein, The at least one gas outlet is configured to guide the gas flow toward a point close to the second end opening.

73. The oral cavity interface according to claim 72, wherein, The position of the point within the channel is based on one or more of the following: the angle of the limiting device, the angle of the at least one gas outlet, the shape of the at least one gas outlet, the cross-sectional width of the airflow path, the shape of the at least one gas inlet, and the average velocity of the airflow.

74. The oral cavity interface according to any one of claims 60 to 73, wherein, The at least one gas outlet is configured to provide the airflow such that the patient's airway pressure is at least about 0.1 cmH2O.

75. The oral interface according to any one of claims 60 to 74, wherein, The at least one gas outlet is configured to provide the airflow such that the patient's airway pressure is between approximately 0.1 cmH2O and approximately 10 cmH2O.

76. The oral interface according to any one of claims 60 to 75, wherein, The airflow rate is between approximately 0 LPM and approximately 200 LPM.

77. The oral interface according to any one of claims 60 to 76, wherein, The airflow rate is between approximately 20 LPM and approximately 200 LPM.

78. The oral interface according to any one of claims 60 to 77, wherein, The body has a cross-section, the cross-section having a first dimension and a second dimension perpendicular to the first dimension, wherein the first dimension is larger than the second dimension.

79. The oral cavity interface according to any one of claims 60 to 78, wherein, At least a portion of the body has an elliptical or oblong, circular, oval, or other cross-sectional shape transverse to an axis extending from the first end opening to the second end opening.

80. The oral interface according to any one of claims 60 to 79, wherein, The cross-sectional width of the airflow path is non-uniform around the channel, and / or the width of the at least one gas outlet is non-uniform around the channel.

81. The oral interface according to any one of claims 60 to 80, wherein, The at least one gas outlet includes two or more gas outlets arranged around the channel.

82. The oral interface according to any one of claims 60 to 81, wherein, The at least one gas inlet includes a first gas inlet and a second gas inlet.

83. The oral cavity interface according to claim 82, wherein, The cross-sectional area of ​​the first gas inlet is substantially equal to the cross-sectional area of ​​the second gas inlet.

84. The oral cavity interface according to claim 82 or 83, wherein, One of the first gas inlet or the second gas inlet is configured to be close to the patient's nose during use.

85. The oral cavity interface according to any one of claims 82 to 84, wherein, The first gas inlet and the second gas inlet are positioned opposite each other.

86. A patient interface component, comprising: Nose connector; And the oral interface according to any one of claims 1 to 85.

87. The patient interface component according to claim 86, wherein, The nasal interface and the oral interface are configured to receive airflow from a common airflow source.

88. The patient interface component according to claim 86, wherein, The nasal interface and the oral interface are configured to receive airflow from independent airflow sources.

89. The patient interface component according to any one of claims 86 to 88, wherein, The nasal interface provides a first airflow to the patient at a first flow rate, and the oral interface provides a second airflow to the patient at a second flow rate.

90. The patient interface component according to claim 89, wherein, The first flow rate is different from the second flow rate.

91. The patient interface component according to claim 89 or 90, wherein, The first and second flows are between approximately 0 LPM and approximately 100 LPM.

92. The patient interface component according to any one of claims 89 to 91, wherein, The first and second flows are between approximately 20 LPM and approximately 100 LPM.

93. The patient interface component according to claim 92, wherein, The sum of the first flow and the second flow is between approximately 0 LPM and approximately 200 LPM.

94. The patient interface component according to any one of claims 86 to 93, wherein, The nasal interface and the oral interface are fluidly connected.

95. The patient interface component according to any one of claims 86 to 94, wherein, The bottom of the nasal interface includes an interface connector to allow fluid communication with the airflow path in the oral cavity interface.

96. The patient interface component according to any one of claims 86 to 95, wherein, The nasal interface includes a nasal cannula.

97. The patient interface component according to claim 96, wherein, The nasal cannula is not sealed.

98. A system for providing respiratory support to a patient, the system comprising: At least one airflow source for generating airflow; At least one humidifier configured to humidify the airflow for delivering humidified airflow to a patient interface; as well as The patient interface component according to any one of claims 1 to 97.

99. A system for providing respiratory support to a patient, the system comprising: At least one airflow source for generating airflow; as well as The patient interface according to any one of claims 1 to 85 or the patient interface component according to any one of claims 86 to 97.

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