Patient interface

Abstract

The invention relates to a patient interface. A nasal interface (100) has a cannula body (118) with a first prong (111) and a second prong (112). The first fork (111) and the second fork (112) are asymmetrical to each other. The gas manifold (120) has a gas inlet (121). The first fork (111) and the second fork (112) are in fluid communication with the gas inlet (121). The gas manifold (120) is reconfigurable relative to the cannula body (118) between a first configuration and a second configuration. The first configuration corresponds to insertion of the gas manifold (120) into the cannula body (118) from a first side. The second configuration corresponds to insertion of the gas manifold (120) into the cannula body (118) from the second side.

Description

[0001] This application is a divisional application of invention patent application 202210471764.3, filed on April 29, 2022, and entitled “PATIENT INTERFACE”. Technical Field

[0002] The present disclosure generally relates to a patient interface for delivering breathing gases to the airway of a patient. Background Art

[0003] A humidifier is used to provide humidified breathing gases to the patient. The gases are delivered to the patient via a patient interface. Examples of patient interfaces include a mouth mask, a nasal mask, a nasal cannula, a combination of a mouth mask and a nasal mask, and the like.

[0004] Patient interfaces including nasal interfaces can be used to deliver high flow gases to a patient. A nasal delivery element is inserted into the patient's nose to deliver the desired therapy. The nasal delivery element may need to be sealed or semi-sealed at the nose, or may not need to be sealed at the nose, to deliver therapy. Nasal high flow is typically a non-sealed therapy that delivers a relatively high volume flow to a patient through a nasal interface, which may be sufficient to meet or exceed the patient's inspiratory flow. Summary of the invention

[0005] While there are prongs for nasal interfaces in the art, one aspect of at least one configuration disclosed herein includes recognizing that there are problems inserting some prior art prongs into a patient's nose. Prongs in the art require a high motor speed of a flow generating device to deliver a desired flow to the patient. A flow generating device is a device that delivers a flow of gas to a patient.

[0006] If the interface suddenly becomes blocked, the static pressure may increase to equal the back pressure in the system, which may potentially reach undesirable levels. Undesirably high static pressures are exacerbated for child and infant prongs because the reduced prong diameter required to fit the nares of a child or infant may increase the resistance to flow through the interface to the patient.

[0007] Currently, nasal delivery elements of different sizes are rarely available to better fit the patient, and it may be difficult to optimize dead space clearance and pressure delivered to the patient. Some options may use supplemental oxygen, require more heating, more water, and may not provide a high level of patient comfort. Undesirably high flow or too high a flow is provided to the patient through existing interfaces to achieve the desired pressure effect. Nasal delivery elements with smaller diameter nasal interfaces may have high leakage and therefore will deliver lower pressure to the patient. Large diameters may not effectively clear the anatomical dead space of the patient's airway.

[0008] A nasal interface and respiratory therapy system are disclosed that can combine nasal high flow with an asymmetric nasal delivery element for use in a nasal interface to deliver respiratory gases to a patient via an asymmetric flow. The asymmetric nasal delivery element can provide increased dead space clearance to the patient's upper airway. Since the peak expiratory pressure is reduced, noise can be reduced, and the asymmetric nasal delivery element can provide a more desirable therapy for infants due to the reduced risk of completely sealing the patient's airway. The asymmetry of the nasal delivery element can reduce the resistance to flow through the nasal interface, which can achieve the desired flow rate by using a lower back pressure and / or a lower motor speed of the flow generating device. A nasal interface with an asymmetric nasal delivery element can reduce the risk of both nostrils of a patient being completely blocked due to an improperly sized nasal interface.

[0009] In one aspect of the present disclosure, in accordance with certain features, aspects, and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0010] A first fork and a second fork that are asymmetrical to each other;

[0011] and a gas manifold comprising a gas inlet,

[0012] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0013] And wherein the nasal interface is configured such that at least about 60% of the total volumetric flow of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0014] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0015] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0016] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0017] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0018] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0019] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0020] In some configurations, the inner diameter and / or inner cross-sectional area of ​​the first fork in a direction transverse to gas flow through the first fork is larger than the corresponding inner diameter and / or inner cross-sectional area of ​​the second fork in a direction transverse to gas flow through the second fork.

[0021] In some configurations, the direction transverse to the gas flow is substantially perpendicular or orthogonal to the gas flow through the corresponding prong.

[0022] In some configurations, the inner diameter and / or inner cross-sectional area is at the outlet of the first tine and the second tine.

[0023] In some configurations, the nasal interface is configured such that about 60% to about 90% of the total volumetric flow of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0024] In some configurations, the nasal interface is configured such that about 60% to about 80% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0025] In some configurations, the nasal interface is configured such that about 65% to about 80% of the total volumetric flow of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0026] In some configurations, the nasal interface is configured such that about 70% to about 80% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0027] In some configurations, the nasal interface is configured such that about 70% to about 75% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0028] In some configurations, the nasal interface is configured such that approximately 70% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0029] In some configurations, the nasal interface is configured such that about 75% to about 80% of the total volumetric flow of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0030] In some configurations, the nasal interface is configured such that approximately 75% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0031] In some configurations, the nasal interface is configured such that approximately 80% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0032] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, optionally between about 5 mm and about 9 mm, optionally between about 6 mm and about 8 mm, optionally about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or any diameter between any two of these diameters.

[0033] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, optionally between about 3 mm and about 7 mm, optionally between about 4 mm and about 6 mm, optionally about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, or any diameter between any two of these diameters.

[0034] In some configurations, the wall thickness of the first prong and / or the second prong is between about 0.1 mm and about 0.5 mm.

[0035] In some configurations, the inner cross-sectional area of ​​the first fork is about 15 mm 2 To about 80mm 2 between, optionally between about 20 mm 2 To about 75mm 2 between, optionally between about 25 mm 2 To about 70mm 2 between, optionally between about 30 mm 2 To about 65mm 2 between, optionally between about 35 mm 2 To about 60mm 2 between, optionally between about 40 mm 2 To about 55mm 2 between, optionally between about 45 mm 2 To about 50mm 2 between, optionally about 15 mm 2 , about 16mm 2 、Approx. 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 , about 30mm 2 、Approx. 31mm 2、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 、About 50mm 2 、Approx. 51mm 2 、Approx. 52mm 2 、Approx. 53mm 2 、Approx. 54mm 2 、Approx. 55mm 2 、Approx. 56mm 2 、Approx. 57mm 2 、Approx. 58mm 2 、Approx. 59mm 2 、Approx. 60mm 2 、Approx. 61mm 2 、Approx. 62mm 2 、Approx. 63mm 2 、Approx. 64mm 2 、Approx. 65mm 2 、Approx. 66mm 2 、Approx. 67mm 2 、Approx. 68mm 2 、Approx. 69mm 2 、Approx. 70mm 2 、Approx. 71mm 2 、Approx. 72mm 2 、Approx. 73mm 2 、Approx. 74mm 2 、Approx. 75mm 2 、Approx. 76mm 2 、Approx. 77mm 2 、Approx. 78mm 2 、Approx. 79mm 2 、Approx. 80mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0036] In some configurations, the inner cross-sectional area of ​​the second fork is about 5 mm2 To about 50mm 2 between, optionally between about 10 mm 2 To about 45mm 2 between, optionally between about 15 mm 2 To about 40mm 2 between, optionally between about 20 mm 2 To about 35mm 2 between, optionally between about 25 mm 2 To about 30mm 2 between, optionally about 5 mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 、About 9mm 2 , about 10mm 2 , about 11mm 2 , about 12mm 2 , about 13mm 2 , about 14mm 2 , about 15mm 2 , about 16mm 2 、Approx. 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 , about 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 , about 50mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0037] In some configurations, the combined inner cross-sectional area of ​​the first fork and the second fork is about 20 mm 2 To about 130mm 2 between, optionally between about 30 mm 2 About 120mm 2 between, optionally between about 40 mm 2 To about 110mm 2 between, optionally between about 50 mm 2 To about 100mm 2 between, optionally between about 60 mm 2 To about 90mm 2 between, optionally between about 70 mm 2 To about 80mm 2 between, optionally about 20 mm 2 , about 25mm 2 、About 30mm 2 、Approx. 35mm 2 、Approx. 40mm 2 、Approx. 45mm 2 , about 50mm 2 、Approx. 55mm 2 、Approx. 60mm 2 、Approx. 65mm 2 、Approx. 70mm 2 、Approx. 75mm 2 、Approx. 80mm 2 、Approx. 85mm 2 、Approx. 90mm 2 、Approx. 95mm 2 , about 100mm 2 、Approx. 105mm 2 、Approx. 110mm 2 、Approx. 115mm 2 , about 120mm 2 , about 125mm 2 、Approx. 130mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0038] In some configurations, the ratio of the inner cross-sectional area of ​​the first fork to the inner cross-sectional area of ​​the second fork is between about 60:40 and about 80:20, optionally between about 65:35 and about 80:20, optionally between about 70:30 and about 80:20, optionally between about 70:30 and about 75:25, optionally about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, optionally between about 75:25 and 80:20, optionally about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20.

[0039] In some configurations, the gap between adjacent outer surfaces of the first prong and the second prong, adjacent to the base of the first prong and the second prong, is between about 5 mm and about 15 mm, optionally between about 6 mm and about 14 mm, optionally between about 7 mm and about 13 mm, optionally between about 8 mm and about 12 mm, optionally between about 9 mm and about 11 mm, optionally about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, or any value between any two of these values.

[0040] In some configurations, the gas inlet is in fluid communication with the gas permeable tube.

[0041] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0042] In some configurations, the nasal interface includes a cannula body including a first prong and a second prong, wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and such that the second prong is closer to the gas inlet and the first prong is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body such that the first prong is closer to the gas inlet and the second prong is farther away from the gas inlet.

[0043] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0044] A first fork and a second fork that are asymmetrical to each other;

[0045] and a gas manifold comprising a gas inlet,

[0046] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0047] wherein the nasal interface is configured to achieve an asymmetric gas flow at the patient's nostrils,

[0048] And wherein the nasal interface is configured such that when the total volumetric flow rate of gas flow into the gas inlet is between about 5 liters per minute (lpm) and about 70 lpm, about 60% to about 80% of the total volumetric flow rate of gas flow into the gas inlet is delivered out of the nasal interface through the first fork.

[0049] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0050] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0051] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0052] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0053] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0054] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0055] In some configurations, the nasal interface is configured such that when the total flow rate of gas flow into the gas inlet is between about 5 lpm and about 70 lpm, about 70% to about 80% of the total volumetric flow rate of gas flow into the gas inlet is delivered out of the nasal interface through the first prong.

[0056] In some configurations, the nasal interface is configured such that when the total flow rate of gas flow into the gas inlet is between about 5 lpm and about 70 lpm, about 70% to about 75% of the total volumetric flow rate of gas flow into the gas inlet is delivered out of the nasal interface through the first prong.

[0057] In some configurations, the nasal interface is configured such that when the total flow rate of gas flow into the gas inlet is between about 5 lpm and about 70 lpm, about 75% to about 80% of the total volume flow rate of gas flow into the gas inlet is delivered out of the nasal interface through the first prong.

[0058] In some configurations, the nasal interface is configured such that when the total flow rate of gas flow into the gas inlet is between about 5 lpm and about 70 lpm, about 75% of the total volumetric flow rate of gas flow into the gas inlet is delivered out of the nasal interface through the first prong.

[0059] In some configurations, the nasal interface is configured such that the amount of asymmetry in flow from the first prong and the second prong varies as a function of the total flow of gas into the gas inlet.

[0060] In some configurations, the nasal interface is configured such that a higher total volumetric flow rate of gas flow into the gas inlet causes a larger portion of the total volumetric flow rate of gas flow to be delivered out of the nasal interface through the first prong, and wherein a lower total flow rate of gas flow into the gas inlet causes a smaller portion of the total volumetric flow rate of gas flow to be delivered out of the nasal interface through the first prong.

[0061] In some configurations, the gas inlet is in fluid communication with the gas permeable tube.

[0062] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0063] In some configurations, the nasal interface includes a cannula body including a first prong and a second prong, wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and such that the second prong is closer to the gas inlet and the first prong is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body such that the first prong is closer to the gas inlet and the second prong is farther away from the gas inlet.

[0064] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0065] Gas inlet;

[0066] A first fork and a second fork that are asymmetrical to each other;

[0067] and a gas manifold comprising a gas inlet,

[0068] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0069] The inner diameter and / or inner cross-sectional area of ​​the first fork in a direction transverse to the gas flow passing through the first fork is larger than the corresponding inner diameter and / or inner cross-sectional area of ​​the second fork in a direction transverse to the gas flow passing through the second fork.

[0070] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0071] In some configurations, the direction transverse to the gas flow is substantially perpendicular or orthogonal to the gas flow through the corresponding prong.

[0072] In some configurations, the inner diameter and / or inner cross-sectional area is at the outlet of the first tine and the second tine.

[0073] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0074] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0075] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0076] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0077] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, optionally between about 5 mm and about 9 mm, optionally between about 6 mm and about 8 mm, optionally about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or any diameter between any two of these values.

[0078] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, optionally between about 3 mm and about 7 mm, optionally between about 4 mm and about 6 mm, optionally about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, or any diameter between any two of these values.

[0079] In some configurations, the inner cross-sectional area of ​​the first fork is about 15 mm 2 To about 80mm 2 between, optionally between about 20 mm 2 To about 75mm 2 between, optionally between about 25 mm 2 To about 70mm 2 between, optionally between about 30 mm 2 To about 65mm 2 between, optionally between about 35 mm 2 To about 60mm 2 between, optionally between about 40 mm2 To about 55mm 2 between, optionally between about 45 mm 2 To about 50mm 2 between, optionally about 15 mm 2 , about 16mm 2 、Approx. 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 , about 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 、About 50mm 2 、Approx. 51mm 2 、Approx. 52mm 2 、Approx. 53mm 2 、Approx. 54mm 2 、Approx. 55mm 2 、Approx. 56mm 2 、Approx. 57mm 2 、Approx. 58mm 2 、Approx. 59mm 2 、Approx. 60mm 2 、Approx. 61mm 2 、Approx. 62mm 2 、Approx. 63mm2 、Approx. 64mm 2 、Approx. 65mm 2 、Approx. 66mm 2 、Approx. 67mm 2 、Approx. 68mm 2 、Approx. 69mm 2 、Approx. 70mm 2 、Approx. 71mm 2 、Approx. 72mm 2 、Approx. 73mm 2 、Approx. 74mm 2 、Approx. 75mm 2 、Approx. 76mm 2 、Approx. 77mm 2 、Approx. 78mm 2 、Approx. 79mm 2 、Approx. 80mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0080] In some configurations, the inner cross-sectional area of ​​the second fork is about 5 mm 2 To about 50mm 2 between, optionally between about 10 mm 2 To about 45mm 2 between, optionally between about 15 mm 2 To about 40mm 2 between, optionally between about 20 mm 2 To about 35mm 2 between, optionally between about 25 mm 2 To about 30mm 2 between, optionally about 5 mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 、About 9mm 2 , about 10mm 2 , about 11mm 2 , about 12mm 2 , about 13mm 2 , about 14mm 2 , about 15mm 2 , about 16mm 2 , about 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 、About 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 , about 50mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0081] In some configurations, the combined inner cross-sectional area of ​​the first fork and the second fork is about 20 mm 2 To about 130mm 2 between, optionally between about 30 mm 2 About 120mm 2 between, optionally between about 40 mm 2 To about 110mm 2 between, optionally between about 50 mm 2 To about 100mm 2 between, optionally between about 60 mm 2 To about 90mm 2 between, optionally between about 70 mm 2 To about 80mm 2 between, optionally about 20 mm 2 , about 25mm 2 、About 30mm 2 、Approx. 35mm 2 、Approx. 40mm 2 、Approx. 45mm 2 , about 50mm 2 、Approx. 55mm 2 、Approx. 60mm 2 、Approx. 65mm2 、Approx. 70mm 2 、Approx. 75mm 2 、Approx. 80mm 2 、Approx. 85mm 2 、Approx. 90mm 2 、Approx. 95mm 2 , about 100mm 2 、Approx. 105mm 2 、Approx. 110mm 2 、Approx. 115mm 2 , about 120mm 2 , about 125mm 2 、Approx. 130mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0082] In some configurations, the ratio of the inner cross-sectional area of ​​the first fork to the inner cross-sectional area of ​​the second fork is between about 60:40 and about 80:20, optionally between about 65:35 and about 80:20, optionally between about 70:30 and about 80:20, optionally between about 70:30 and about 75:25, optionally about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, optionally between about 75:25 and 80:20, optionally about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20.

[0083] In some configurations, the gap between adjacent outer surfaces of the first prong and the second prong, adjacent to the base of the first prong and the second prong, is between about 5 mm and about 15 mm, optionally between about 6 mm and about 14 mm, optionally between about 7 mm and about 13 mm, optionally between about 8 mm and about 12 mm, optionally between about 9 mm and about 11 mm, optionally about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, or any value between any two of these values.

[0084] In some configurations, the nasal interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 60% to about 90% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 60% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 65% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 70% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, Delivered out of the nasal interface through the first prong, optionally so that about 70% to about 75% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 70% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 75% to about 80% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 75% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 80% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0085] In some configurations, the gas inlet is in fluid communication with the gas permeable tube.

[0086] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0087] In some configurations, the nasal interface includes a cannula body including a first prong and a second prong, wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and such that the second prong is closer to the gas inlet and the first prong is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body such that the first prong is closer to the gas inlet and the second prong is farther away from the gas inlet.

[0088] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0089] A first fork and a second fork that are asymmetrical to each other;

[0090] and a gas manifold comprising a gas inlet,

[0091] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0092] wherein the inner cross-sectional area of ​​the first fork in a direction transverse to the gas flow passing through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork in a direction transverse to the gas flow passing through the second fork,

[0093] wherein the second prong has a substantially oval or substantially elliptical cross-sectional shape in a direction transverse to a gas flow through the second prong, the substantially oval or substantially elliptical cross-sectional shape having a first ratio of a widest dimension to a narrowest dimension,

[0094] And wherein the first fork has an indistinct oval or indistinct elliptical cross-sectional shape in a direction transverse to the gas flow passing through the first fork, the indistinct oval or indistinct elliptical cross-sectional shape having a second ratio of the widest dimension to the narrowest dimension that is smaller than the first ratio, or having a substantially circular cross-sectional shape.

[0095] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0096] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0097] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0098] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0099] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0100] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0101] In some configurations, the direction transverse to the gas flow is substantially perpendicular or orthogonal to the gas flow through the corresponding prong.

[0102] In some configurations, the inner cross-sectional area and the inner cross-sectional shape of the first fork and the second fork are at the outlets of the first fork and the second fork.

[0103] In some configurations, the first prong is more flexible than the second prong.

[0104] In some configurations, the first prong has a generally circular shape.

[0105] In some configurations, the first prong has a first terminal end, and wherein the second prong has a second terminal end, wherein the first terminal end includes a generally scalloped surface.

[0106] In some configurations, the second terminal end has a substantially planar face.

[0107] In some configurations, the gas inlet is in fluid communication with the gas permeable tube.

[0108] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0109] In some configurations, the nasal interface includes a cannula body including a first prong and a second prong, wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and such that the second prong is closer to the gas inlet and the first prong is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body such that the first prong is closer to the gas inlet and the second prong is farther away from the gas inlet.

[0110] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0111] Gas inlet;

[0112] A first fork and a second fork that are asymmetrical to each other;

[0113] and a gas flow path from the gas inlet to the first fork and the second fork,

[0114] In some configurations, the inner cross-sectional area of ​​the first fork in a direction transverse to the gas flow through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork,

[0115] And wherein the first fork is downstream of the gas flow path of the second fork.

[0116] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0117] In some configurations, the direction transverse to the gas flow is substantially perpendicular or orthogonal to the gas flow through the corresponding prong.

[0118] In some configurations, the inner cross-sectional area is at the outlet of the first prong and the second prong.

[0119] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0120] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0121] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0122] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0123] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0124] In some configurations, the gas flow path is defined by a flow channel having a gas flow direction substantially perpendicular to a gas flow path through the first and second prongs, and wherein the first prong is farther from the gas inlet and the second prong is closer to the gas inlet.

[0125] In some configurations, the nasal interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 60% to about 90% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 60% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 65% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 70% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, The first prong is delivered out of the nasal interface, optionally so that about 70% to about 75% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 70% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 75% to about 80% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 75% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 80% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0126] In some configurations, the gas inlet is in fluid communication with the gas permeable tube.

[0127] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0128] In some configurations, the nasal interface includes a cannula body including a first prong and a second prong, wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and such that the second prong is closer to the gas inlet and the first prong is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body such that the first prong is closer to the gas inlet and the second prong is farther away from the gas inlet.

[0129] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0130] First fork and second fork;

[0131] and a gas manifold comprising a gas inlet,

[0132] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0133] wherein the nasal interface is configured to achieve an asymmetric gas flow at the patient's nostrils,

[0134] And wherein the gas inlet is in fluid communication with the gas permeable tube.

[0135] In some configurations, the first and second prongs are asymmetrical to each other, or are not symmetrical to each other, and / or are different in shape and configuration from each other, or are asymmetrical when compared to each other.

[0136] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0137] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0138] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0139] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0140] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0141] In some configurations, the gas manifold is integrally formed with or coupled to the gas tube.

[0142] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0143] In some configurations, the nasal interface includes a cannula body including the first prong and the second prong, wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body so that the first prong is closer to the gas inlet and the second prong is farther away from the gas inlet.

[0144] In some configurations, the nasal interface includes a cannula body including the first prong and the second prong, and wherein an outer surface of the cannula body between the first prong and the second prong includes a recess to accommodate a portion of the patient's nose and reduce pressure on the bottom side of the accommodated portion.

[0145] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0146] A cannula body comprising a first fork and a second fork, wherein the first fork and the second fork are asymmetrical to each other,

[0147] and a gas manifold comprising a gas inlet,

[0148] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0149] wherein the nasal interface is configured to achieve an asymmetric gas flow at the patient's nostrils,

[0150] And wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and such that the second fork is closer to the gas inlet and the first fork is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body such that the first fork is closer to the gas inlet and the second fork is farther away from the gas inlet.

[0151] In some configurations, the first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0152] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0153] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0154] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0155] In some configurations, the gas manifold includes a flow channel having a gas flow direction substantially perpendicular to a gas flow path through the first prong and the second prong.

[0156] In some configurations, the gas inlet is in fluid communication with the gas permeable tube.

[0157] In some configurations, the gas manifold is integrally formed with or coupled to the gas tube.

[0158] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0159] A cannula body including a first fork and a second fork that are asymmetric to each other;

[0160] and a gas manifold comprising a gas inlet,

[0161] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0162] And wherein the outer surface of the cannula body between the first prong and the second prong includes a recess.

[0163] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0164] In some configurations, the recess is arranged to receive a portion of the patient's nose and reduce pressure on the underside of the received portion.

[0165] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0166] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0167] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0168] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0169] In some configurations, a portion of the gas manifold is complementary to the recess.

[0170] In some configurations, the portion of the gas manifold that is complementary to the recess is an outlet of the gas manifold, and optionally a periphery of the outlet of the gas manifold.

[0171] In some configurations, the cannula body and / or the gas manifold include retention features(s) to removably retain the gas manifold in engagement with the cannula body.

[0172] In some configurations, the retaining features include a resilient annular portion of the cannula body that is received in a complementary recess of the gas manifold.

[0173] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0174] A cannula body including a first fork and a second fork that are asymmetric to each other;

[0175] and a gas manifold comprising a gas inlet,

[0176] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0177] The nasal interface further includes two side arms including wing portions extending laterally from one side of the cannula body,

[0178] The nasal interface includes or is provided in conjunction with a tube retaining clamp.

[0179] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0180] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0181] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0182] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0183] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0184] In some configurations, the tube retaining clamp is configured to support a patient conduit or other gas supply tube.

[0185] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0186] a first prong having a shape and a second prong having a shape;

[0187] and a gas manifold comprising a gas inlet,

[0188] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0189] wherein the inner cross-sectional area of ​​the first fork in a direction transverse to the gas flow passing through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork in a direction transverse to the gas flow passing through the second fork, and

[0190] Wherein, at least the first prong is made of an elastomeric material so that the first prong can deform and set its shape in response to temperature and contact with the patient's nostril during use.

[0191] In some configurations, the temperature may be between about 20°C and about 41°C, optionally exceeding 20°C and up to about 41°C, optionally between about 31°C and about 41°C, optionally between about 36°C and about 39°C, optionally about 37°C.

[0192] In some configurations, the first prong is configured to deform and set its shape to substantially match the internal shape of the patient's nostril during use.

[0193] In some configurations, the elastomeric material enables the first prong to deform and set its shape to substantially match the internal shape of the patient's nostril at a therapy temperature between about 31°C and about 41°C, optionally between about 36°C and about 39°C, and optionally about 37°C.

[0194] In some configurations, the first prong is not made of silicone.

[0195] In some configurations, at least the first prong is made of a thermoplastic elastomer.

[0196] In some configurations, the material exhibits a compression set of between about 10% and about 50% after 72 hours at a temperature of between about 20°C and about 40°C when tested according to Method A of ISO 815-1:2014.

[0197] In some configurations, the elastomeric material exhibits a compression set of between about 10% and about 45%, optionally between about 10% and about 40%, optionally between about 10% and about 35%, optionally between about 10% and about 30%, optionally between about 10% and about 25%, optionally between about 10% and about 20%, optionally between about 11% and about 19%, optionally between about 12% and about 18%, optionally between about 13% and about 17%, optionally between about 14% and about 16%, optionally about 15% at a temperature between about 20°C and about 40°C after 72 hours when tested in accordance with Method A of ISO 815-1:2014.

[0198] In some configurations, the elastomeric material is 815-1:2014, method A, exhibits a compression set of between about 10% to about 45%, optionally between about 10% to about 40%, optionally between about 10% to about 35%, optionally between about 10% to about 30%, optionally between about 10% to about 25%, optionally between about 10% to about 20%, optionally between about 11% to about 19%, optionally between about 12% to about 18%, optionally between about 13% to about 17%, optionally between about 14% to about 16%, optionally about 15% after 72 hours at a temperature above about 20°C up to about 35°C, optionally at a temperature of about 21°C or about 22°C or about 23°C or about 24°C or about 25°C or more.

[0199] In some configurations, both the first prong and the second prong are made of an elastomeric material.

[0200] In some configurations, the second fork has a distinct oval or distinct elliptical cross-sectional shape in a direction transverse to the gas flow passing through the second fork, the distinct oval or distinct elliptical cross-sectional shape having a first ratio of the widest dimension to the narrowest dimension, and wherein the first fork has a less distinct oval or less distinct elliptical cross-sectional shape in a direction transverse to the gas flow passing through the first fork, the less distinct oval or less distinct elliptical cross-sectional shape having a second ratio of the widest dimension to the narrowest dimension that is less than the first ratio, or has a substantially circular cross-sectional shape.

[0201] In some configurations, the first prong has a generally circular shape.

[0202] In some configurations, the first prong has a first terminal end, and wherein the second prong has a second terminal end, wherein the first terminal end includes a generally scalloped surface.

[0203] In some configurations, the second terminal end has a substantially planar face.

[0204] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, optionally between about 5 mm and about 9 mm, optionally between about 6 mm and about 8 mm, optionally about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or any diameter between any two of these values.

[0205] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, optionally between about 3 mm and about 7 mm, optionally between about 4 mm and about 6 mm, optionally about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, or any diameter between any two of these values.

[0206] In some configurations, the wall thickness of the first prong and / or the second prong is between about 0.1 mm and about 0.5 mm.

[0207] In some configurations, the inner cross-sectional area of ​​the first fork is about 15 mm 2 To about 80mm 2 between, optionally between about 20 mm 2 To about 75mm 2 between, optionally between about 25 mm 2 To about 70mm 2 between, optionally between about 30 mm 2 To about 65mm 2 between, optionally between about 35 mm 2 To about 60mm 2 between, optionally between about 40 mm 2 To about 55mm 2 between, optionally between about 45 mm 2 To about 50mm 2 between, optionally about 15 mm 2 , about 16mm 2 , about 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm2 、About 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 , about 50mm 2 、Approx. 51mm 2 、Approx. 52mm 2 、Approx. 53mm 2 、Approx. 54mm 2 、Approx. 55mm 2 、Approx. 56mm 2 、Approx. 57mm 2 、Approx. 58mm 2 、Approx. 59mm 2 、Approx. 60mm 2 、Approx. 61mm 2 、Approx. 62mm 2 、Approx. 63mm 2 、Approx. 64mm 2 、Approx. 65mm 2 、Approx. 66mm 2 、Approx. 67mm 2 、Approx. 68mm 2 、Approx. 69mm 2 、Approx. 70mm 2 、Approx. 71mm 2 、Approx. 72mm 2 、Approx. 73mm 2 、Approx. 74mm 2 、Approx. 75mm 2 、Approx. 76mm 2 、Approx. 77mm 2 、Approx. 78mm 2 、Approx. 79mm 2 、Approx. 80mm 2, or any cross-sectional area between any two of these cross-sectional areas.

[0208] In some configurations, the inner cross-sectional area of ​​the second fork is about 5 mm 2 To about 50mm 2 between, optionally between about 10 mm 2 To about 45mm 2 between, optionally between about 15 mm 2 To about 40mm 2 between, optionally between about 20 mm 2 To about 35mm 2 between, optionally between about 25 mm 2 To about 30mm 2 between, optionally about 5 mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 、About 9mm 2 , about 10mm 2 , about 11mm 2 , about 12mm 2 , about 13mm 2 , about 14mm 2 , about 15mm 2 , about 16mm 2 、Approx. 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 、Approx. 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 , about 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 , about 50mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0209] In some configurations, the combined inner cross-sectional area of ​​the first fork and the second fork is about 20 mm 2 To about 130mm 2 between, optionally between about 30 mm 2 About 120mm 2 between, optionally between about 40 mm 2 To about 110mm 2 between, optionally between about 50 mm 2 To about 100mm 2 between, optionally between about 60 mm 2 To about 90mm 2 between, optionally between about 70 mm 2 To about 80mm 2 between, optionally about 20 mm 2 , about 25mm 2 、About 30mm 2 、Approx. 35mm 2 、Approx. 40mm 2 、Approx. 45mm 2 , about 50mm 2 、Approx. 55mm 2 、Approx. 60mm 2 、Approx. 65mm 2 、Approx. 70mm 2 、Approx. 75mm 2 、Approx. 80mm 2 、Approx. 85mm 2 、Approx. 90mm 2 、Approx. 95mm 2 , about 100mm 2 、Approx. 105mm 2 、Approx. 110mm 2 、Approx. 115mm 2 , about 120mm 2 , about 125mm 2 、Approx. 130mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0210] In some configurations, the ratio of the inner cross-sectional area of ​​the first fork to the inner cross-sectional area of ​​the second fork is between about 60:40 and about 80:20, optionally between about 65:35 and about 80:20, optionally between about 70:30 and about 80:20, optionally between about 70:30 and about 75:25, optionally about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, optionally between about 75:25 and 80:20, optionally about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20.

[0211] In some configurations, the gas inlet is in fluid communication with the gas permeable tube.

[0212] In some configurations, the nasal interface includes a cannula body including a first prong and a second prong, wherein the gas manifold is reconfigurable relative to the cannula body between a first configuration and a second configuration, wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body and such that the second prong is closer to the gas inlet and the first prong is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body such that the first prong is closer to the gas inlet and the second prong is farther away from the gas inlet.

[0213] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0214] A first fork and a second fork that are asymmetrical to each other;

[0215] and a gas manifold comprising a gas inlet,

[0216] wherein the first fork and the second fork are in fluid communication with the gas inlet,

[0217] wherein the nasal interface is configured to achieve an asymmetric gas flow at the patient's nostrils,

[0218] Among them, the inner cross-sectional area of ​​the first fork is about 15mm 2 To about 80mm 2 The inner cross-sectional area of ​​the second fork is about 5 mm 2 To about 50mm 2 The combined cross-sectional area of ​​the first fork and the second fork is about 20 mm 2 To about 130mm 2 and wherein a ratio of an inner cross-sectional area of ​​the first fork to an inner cross-sectional area of ​​the second fork is between about 60:40 and about 80:20.

[0219] In some configurations, the inner cross-sectional area of ​​the first fork is about 20 mm 2 To about 75mm 2 between, optionally between about 25 mm 2 To about 70mm 2 between, optionally between about 30 mm 2 To about 65mm 2 between, optionally between about 35 mm 2 To about 60mm 2 between, optionally between about 40 mm 2 To about 55mm 2 between, optionally between about 45 mm 2 To about 50mm 2 between, optionally about 15 mm 2 , about 16mm2, about 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 、About 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 , about 50mm 2 、Approx. 51mm 2 、Approx. 52mm 2、Approx. 53mm 2 、Approx. 54mm 2 、Approx. 55mm 2 、Approx. 56mm 2 、Approx. 57mm 2 、Approx. 58mm 2 、Approx. 59mm 2 、Approx. 60mm 2 、Approx. 61mm 2 、Approx. 62mm 2 、Approx. 63mm 2 、Approx. 64mm 2 、Approx. 65mm 2 、Approx. 66mm 2 、Approx. 67mm 2 、Approx. 68mm 2 、Approx. 69mm 2 、Approx. 70mm 2 、Approx. 71mm 2 、Approx. 72mm 2 、Approx. 73mm 2 、Approx. 74mm 2 、Approx. 75mm 2 、Approx. 76mm 2 、Approx. 77mm 2 、Approx. 78mm 2 、Approx. 79mm 2 、Approx. 80mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0220] In some configurations, the inner cross-sectional area of ​​the second fork is about 10 mm 2 To about 45mm 2 between, optionally between about 15 mm 2 To about 40mm 2 between, optionally between about 20 mm 2 To about 35mm 2 between, optionally between about 25 mm 2 To about 30mm 2 between, optionally about 5 mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 、About 9mm 2 , about 10mm 2 , about 11mm 2 , about 12mm 2 , about 13mm 2 , about 14mm 2 , about 15mm 2 , about 16mm 2 , about 17mm2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 、Approx. 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 , about 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 、About 50mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0221] In some configurations, the combined inner cross-sectional area of ​​the first fork and the second fork is about 30 mm 2 About 120mm 2 between, optionally between about 40 mm 2 To about 110mm 2 between, optionally between about 50 mm 2 To about 100mm 2 between, optionally between about 60 mm 2 To about 90mm 2 between, optionally between about 70 mm 2 To about 80mm 2 Between, optionally about 20mm 2 , about 25mm 2 , about 30mm 2 、Approx. 35mm2 、Approx. 40mm 2 、Approx. 45mm 2 、About 50mm 2 、Approx. 55mm 2 、Approx. 60mm 2 、Approx. 65mm 2 、Approx. 70mm 2 、Approx. 75mm 2 、Approx. 80mm 2 、Approx. 85mm 2 、Approx. 90mm 2 、Approx. 95mm 2 , about 100mm 2 、Approx. 105mm 2 、Approx. 110mm 2 、Approx. 115mm 2 , about 120mm 2 , about 125mm 2 、Approx. 130mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0222] In some configurations, the ratio of the inner cross-sectional area of ​​the first fork to the inner cross-sectional area of ​​the second fork is between about 65:35 and about 80:20, optionally between about 70:30 and about 80:20, optionally between about 70:30 and about 75:25, optionally about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, optionally between about 75:25 and 80:20, optionally about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20.

[0223] In some configurations, the inner cross-sectional area of ​​the first prong is about 24 mm 2 Up to 25mm 2 and the inner cross-sectional area of ​​the second fork is about 6 mm 2 To about 17mm 2 between.

[0224] In some configurations, the inner cross-sectional area of ​​the first prong is about 44 mm 2 To about 45mm 2 and the inner cross-sectional area of ​​the second fork is about 11 mm 2 To about 30mm 2 between.

[0225] In some configurations, the inner cross-sectional area of ​​the first fork is about 69 mm 2 To about 70mm 2 and the inner cross-sectional area of ​​the second fork is about 17 mm 2To about 47mm 2 between.

[0226] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, the nasal interface comprising:

[0227] Gas inlet;

[0228] A first fork and a second fork that are asymmetric to each other, and wherein the first fork has a first fork outlet and the second fork has a second fork outlet;

[0229] and a gas flow path from the gas inlet to the first fork and the second fork,

[0230] In some configurations, the inner cross-sectional area of ​​the first fork in a direction transverse to the gas flow through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork,

[0231] Wherein, for a given gas flow rate at the gas inlet in use, different gas flow rates are provided through the first prong and the second prong, and the velocities of the gas exiting the first prong outlet and the second prong outlet are substantially similar.

[0232] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0233] In some configurations, the velocity of the gas exiting the first prong outlet is within about 20% of the velocity of the gas exiting the second prong outlet.

[0234] In some configurations, the velocity of the gas exiting the first prong outlet is within about 16% of the velocity of the gas exiting the second prong outlet.

[0235] In some configurations, at flow rates above about 40 lpm, the velocity of gas exiting the first prong outlet is about 10% of the velocity of gas exiting the second prong outlet.

[0236] In some configurations, at flow rates above about 42 lpm, the velocity of gas exiting the first prong outlet is about 10% of the velocity of gas exiting the second prong outlet.

[0237] In some configurations, for a total volumetric flow rate of gas flow into the gas inlet greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of the first and second forked outlets is greater than 0 m / s and less than about 32 m / s.

[0238] In some configurations, for a total volumetric flow rate of gas flow into the gas inlet greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of the first and second forked outlets is greater than 0 m / s and less than 32 m / s.

[0239] In some configurations, for a total volumetric flow rate of gas flow greater than 9 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first fork outlet and the second fork outlet is greater than about 2 m / s and less than about 32 m / s, optionally greater than about 2 m / s and less than 32 m / s, optionally greater than about 2 m / s and up to about 25 m / s, and optionally greater than about 2.5 m / s and up to about 20 m / s.

[0240] In some configurations, the nasal interface is configured such that the total volumetric flow of gas into the gas inlet is at least about 5 liters per minute (lpm).

[0241] In some configurations, the nasal interface is configured such that the total volumetric flow of gas into the gas inlet is between about 5 lpm and about 120 lpm.

[0242] In some configurations, the nasal interface is configured such that the total volumetric flow of gas into the gas inlet is between about 5 lpm and about 70 lpm.

[0243] In some configurations, the nasal interface is configured such that at least about 60% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0244] In some configurations, the nasal interface is configured such that about 60% to about 90% of the total volumetric flow of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0245] In some configurations, the nasal interface is configured such that about 60% to about 80% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0246] In some configurations, the nasal interface is configured such that about 65% to about 80% of the total volumetric flow of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0247] In some configurations, the nasal interface is configured such that about 70% to about 80% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0248] In some configurations, the nasal interface is configured such that about 70% to about 75% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0249] In some configurations, the nasal interface is configured such that approximately 70% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0250] In some configurations, the nasal interface is configured such that about 75% to about 80% of the total volumetric flow of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0251] In some configurations, the nasal interface is configured such that approximately 75% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0252] In some configurations, the nasal interface is configured such that approximately 80% of the total volumetric flow of gas into the gas inlet is delivered out of the nasal interface through the first prong.

[0253] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, optionally between about 5 mm and about 9 mm, optionally between about 6 mm and about 8 mm, optionally about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or any diameter between any two of these diameters.

[0254] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, optionally between about 3 mm and about 7 mm, optionally between about 4 mm and about 6 mm, optionally about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, or any diameter between any two of these diameters.

[0255] In some configurations, the inner cross-sectional area of ​​the first fork is about 15 mm 2 To about 80mm 2 between, optionally between about 20 mm 2 To about 75mm 2 between, optionally between about 25 mm 2 To about 70mm 2 between, optionally between about 30 mm 2 To about 65mm 2 between, optionally between about 35 mm 2 To about 60mm 2 between, optionally between about 40 mm 2 To about 55mm 2 between, optionally between about 45 mm 2 To about 50mm 2 between, optionally about 15 mm 2 , about 16mm 2 , about 17mm 2, about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 、About 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 , about 50mm 2 、Approx. 51mm 2 、Approx. 52mm 2 、Approx. 53mm 2 、Approx. 54mm 2 、Approx. 55mm 2 、Approx. 56mm 2 、Approx. 57mm 2 、Approx. 58mm 2 、Approx. 59mm 2 、Approx. 60mm 2 、Approx. 61mm 2 、Approx. 62mm 2 、Approx. 63mm 2 、Approx. 64mm 2 、Approx. 65mm 2 、Approx. 66mm 2 、Approx. 67mm 2 、Approx. 68mm 2 、Approx. 69mm 2 、Approx. 70mm2 、Approx. 71mm 2 、Approx. 72mm 2 、Approx. 73mm 2 、Approx. 74mm 2 、Approx. 75mm 2 、Approx. 76mm 2 、Approx. 77mm 2 、Approx. 78mm 2 、Approx. 79mm 2 、Approx. 80mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0256] In some configurations, the inner cross-sectional area of ​​the second fork is about 5 mm 2 To about 50mm 2 between, optionally between about 10 mm 2 To about 45mm 2 between, optionally between about 15 mm 2 To about 40mm 2 between, optionally between about 20 mm 2 To about 35mm 2 between, optionally between about 25 mm 2 To about 30mm 2 between, optionally about 5 mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 、About 9mm 2 , about 10mm 2 , about 11mm 2 , about 12mm 2 , about 13mm 2 , about 14mm 2 , about 15mm 2 , about 16mm 2 , about 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 , about 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 、About 30mm 2 、Approx. 31mm 2 、Approx. 32mm2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 , about 50mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0257] In some configurations, the combined inner cross-sectional area of ​​the first fork and the second fork is about 20 mm 2 To about 130mm 2 between, optionally between about 30 mm 2 About 120mm 2 between, optionally between about 40 mm 2 To about 110mm 2 between, optionally between about 50 mm 2 To about 100mm 2 between, optionally between about 60 mm 2 To about 90mm 2 between, optionally between about 70 mm 2 To about 80mm 2 between, optionally about 20 mm 2 , about 25mm 2 、About 30mm 2 、Approx. 35mm 2 、Approx. 40mm 2 、Approx. 45mm 2 , about 50mm 2 、Approx. 55mm 2 、Approx. 60mm 2 、Approx. 65mm 2 、Approx. 70mm 2 、Approx. 75mm 2 、Approx. 80mm 2 、Approx. 85mm 2 、Approx. 90mm 2 、Approx. 95mm 2 , about 100mm2 、Approx. 105mm 2 、Approx. 110mm 2 、Approx. 115mm 2 , about 120mm 2 , about 125mm 2 、Approx. 130mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0258] In some configurations, the ratio of the inner cross-sectional area of ​​the first fork to the inner cross-sectional area of ​​the second fork is between about 60:40 and about 80:20, optionally between about 65:35 and about 80:20, optionally between about 70:30 and about 80:20, optionally between about 70:30 and about 75:25, optionally about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, optionally between about 75:25 and 80:20, optionally about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20.

[0259] In some configurations, the inner diameters and / or inner cross-sectional areas of the first prong and the second prong are measured along the same plane (ie, a common plane).

[0260] In some configurations, the direction transverse to the gas flow is substantially perpendicular or orthogonal to the gas flow through the corresponding prong.

[0261] In some configurations, the inner diameters and / or inner cross-sectional areas are at the first prong outlet and the second prong outlet.

[0262] In some configurations, the nasal interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 60% to about 90% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 60% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 65% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally such that about 70% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, Delivered out of the nasal interface through the first prong, optionally so that about 70% to about 75% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 70% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 75% to about 80% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 75% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally so that about 80% of the total volumetric flow rate of gas flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0263] In some configurations, the nasal interface is configured such that approximately 7 lpm is delivered out of the nasal interface through the first prong at a volumetric flow rate of approximately 9.5 lpm at the gas inlet, and / or approximately 13.5 lpm is delivered out of the nasal interface through the first prong at a volumetric flow rate of approximately 19 lpm at the gas inlet, and / or approximately 21 lpm is delivered out of the nasal interface through the first prong at a volumetric flow rate of approximately 29 lpm at the gas inlet, and / or approximately 28 lpm is delivered out of the nasal interface through the first prong at a volumetric flow rate of approximately 38.5 lpm at the gas inlet, and / or approximately 35 lpm is delivered out of the nasal interface through the first prong at a volumetric flow rate of approximately 47.5 lpm at the gas inlet, and / or approximately 44 lpm is delivered out of the nasal interface through the first prong at a volumetric flow rate of approximately 58 lpm at the gas inlet, and / or approximately 48.5 lpm is delivered out of the nasal interface through the first prong at a volumetric flow rate of approximately 64 lpm at the gas inlet.

[0264] In some configurations, the nasal interface includes a gas manifold comprising a gas inlet.

[0265] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0266] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0267] In some configurations, the gas inlet is at a side of the gas manifold 120 .

[0268] In some configurations, the gas manifold includes one or more internal angled walls to direct the flow of gas into the first prong and / or the second prong.

[0269] In some configurations, the nasal interface is a non-sealing nasal interface.

[0270] In accordance with at least one certain features, aspects, and advantages disclosed herein, a patient interface is disclosed, the patient interface comprising a nasal interface as described above or as generally described herein.

[0271] In some configurations, the patient interface further includes a headgear to secure the nasal interface to the patient's face.

[0272] In some configurations, the patient interface further includes a tube in fluid communication with the gas inlet.

[0273] In some configurations, the tube is a breathable tube.

[0274] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0275] In some configurations, the gas manifold is integrally formed with or coupled to the gas tube.

[0276] In some configurations, the patient interface further includes a tube retaining clamp.

[0277] In another aspect of the present disclosure, according to at least one of the certain features, aspects, and advantages disclosed herein, a respiratory therapy system is disclosed, the respiratory therapy system comprising:

[0278] Respiratory therapy equipment, the respiratory therapy equipment comprising:

[0279] Controller;

[0280] Blood oxygen saturation sensor;

[0281] Ambient air inlet;

[0282] Oxygen inlet;

[0283] a valve in fluid communication with the oxygen inlet to control a flow of oxygen through the oxygen inlet; and

[0284] Gas outlet;

[0285] wherein the controller is configured to control the valve based on at least one oxygen saturation measurement from the blood oxygen saturation sensor; and

[0286] A patient interface, the patient interface comprising a nasal interface, wherein the nasal interface comprises:

[0287] A first fork and a second fork that are asymmetrical to each other;

[0288] and a gas manifold comprising a gas inlet, wherein the first prong and the second prong are in fluid communication with the gas inlet,

[0289] Wherein, the nasal interface is configured to achieve asymmetric gas flow at the patient's nostrils.

[0290] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0291] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0292] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0293] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0294] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0295] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0296] In some configurations, the nasal interface is as described above or generally herein.

[0297] In some configurations, the respiratory therapy device includes a flow generator and a humidifier.

[0298] In some configurations, the respiratory therapy system includes a patient conduit having a heater.

[0299] In some configurations, the patient interface includes a vent tube in fluid communication with the gas inlet, and wherein the patient interface further includes a headgear to hold the nasal interface on the patient's face.

[0300] In some configurations, the walls of the tube are permeable to water vapor, but impermeable to liquid water and bulk gases.

[0301] In some configurations, the gas manifold is integrally formed with or coupled to the gas tube.

[0302] In some configurations, the patient interface further includes a tube retaining clamp.

[0303] In some configurations, the patient interface is as described above or generally herein.

[0304] In another aspect of the present disclosure, according to at least one of the certain features, aspects, and advantages disclosed herein, a respiratory therapy system is disclosed, the respiratory therapy system comprising:

[0305] Respiratory therapy equipment, the respiratory therapy equipment comprising:

[0306] Gas inlet;

[0307] Gas outlet;

[0308] an atomizer that delivers one or more substances into a gas stream; and

[0309] A patient interface, the patient interface comprising a nasal interface, wherein the nasal interface comprises:

[0310] A first fork and a second fork that are asymmetrical to each other;

[0311] a gas manifold comprising a gas inlet, wherein the first prong and the second prong are in fluid communication with the gas inlet, wherein the gas inlet is in fluid communication with the gas outlet to receive gas and one or more substances from the respiratory therapy device;

[0312] Wherein, the nasal interface is configured to achieve asymmetric gas flow at the patient's nostrils.

[0313] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0314] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0315] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0316] In some configurations, the first and second prongs are configured to engage the nasal passage in a non-sealing manner.

[0317] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0318] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0319] In some configurations, the respiratory therapy system includes a conduit for receiving gas and one or more substances from the respiratory therapy device and delivering the gas and the one or more substances to the gas inlet of the nasal interface.

[0320] In some configurations, the catheter includes a smooth bore heating tube.

[0321] In some configurations, the nasal interface is as described above or generally herein.

[0322] In some configurations, the patient interface is as described above or generally herein.

[0323] In another aspect of the present disclosure, according to at least one of the certain features, aspects, and advantages disclosed herein, a respiratory therapy system is disclosed, the respiratory therapy system comprising:

[0324] Respiratory therapy equipment, the respiratory therapy equipment comprising:

[0325] at least one gas inlet;

[0326] a humidifier for humidifying the gas; and

[0327] Gas outlet;

[0328] and a patient interface, the patient interface comprising a nasal interface, wherein the nasal interface comprises:

[0329] A first fork and a second fork that are asymmetric to each other, and wherein the first fork has a first fork outlet and the second fork has a second fork outlet;

[0330] and a gas manifold comprising a gas inlet, wherein the first prong and the second prong are in fluid communication with the gas inlet,

[0331] wherein the nasal interface is configured to achieve asymmetric gas flow at the patient's nostrils;

[0332] Wherein, the respiratory therapy system is configured to deliver gas through the first fork outlet and the second fork outlet at a temperature range of between about 27°C-37°C, at a relative humidity greater than about 33 mg / l, and / or at a velocity greater than 0 m / s and less than about 32 m / s for a total volume flow rate of gas flow greater than 0 lpm and up to about 70 lpm into the gas inlet.

[0333] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0334] In some configurations, the respiratory therapy system is configured to deliver gas through the first prong outlet and the second prong outlet at a temperature range of between approximately 31°C-37°C.

[0335] In some configurations, the respiratory therapy system is configured to deliver gas through the first prong outlet and the second prong outlet at a relative humidity of up to about 44 mg / l.

[0336] In some configurations, the respiratory therapy system is configured to provide a total volumetric flow rate of gas flow to the gas inlet of at least about 5 liters per minute (lpm), optionally between about 5 plm to about 120 lpm, and optionally between about 5 lpm to about 70 lpm.

[0337] In some configurations, the respiratory therapy system is configured to deliver at least about 60% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally about 60% to about 90% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally about 60% to about 80% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally about 65% to about 80% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally about 70% to about 80% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, % is delivered out of the nasal interface through the first prong, optionally about 70% to about 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 70% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 75% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0338] In some configurations, the respiratory therapy system is configured to provide different gas flow rates through the first prong and the second prong, and to deliver substantially similar velocities of gas through the first prong outlet and the second prong outlet.

[0339] In some configurations, the velocity of gas leaving the first fork outlet is within about 20% of the velocity of gas leaving the second fork outlet, optionally within about 16% of the velocity of gas leaving the second fork outlet, and optionally within about 10% of the velocity of gas leaving the second fork outlet at flow rates above about 40 lpm, and optionally within about 10% of the velocity of gas leaving the second fork outlet at flow rates above about 42 lpm.

[0340] In some configurations, for a total volumetric flow rate of gas flow into the gas inlet greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of the first and second forked outlets is greater than 0 m / s and less than 32 m / s.

[0341] In some configurations, for a total volumetric flow rate of gas flow greater than 9 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first fork outlet and the second fork outlet is greater than about 2 m / s and less than about 32 m / s, optionally greater than about 2 m / s and less than 32 m / s, optionally greater than about 2 m / s and up to about 25 m / s, and optionally greater than about 2.5 m / s and up to about 20 m / s.

[0342] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0343] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0344] In some configurations, the first and second prongs are configured to engage the nasal passage in an unsealed (non-sealing) manner.

[0345] In some configurations, the first and second prongs allow exhaled gas to escape around the first and second prongs.

[0346] In some configurations, the first and second prongs are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0347] In some configurations, the first and second prongs are configured to provide gas to the patient independent of the patient's breathing.

[0348] In some configurations, the respiratory therapy system includes a conduit for receiving gas from the respiratory therapy device and delivering the gas to the gas inlet of the nasal interface.

[0349] In some configurations, the catheter includes a smooth bore heating tube.

[0350] In some configurations, the nasal interface is as described above or generally herein.

[0351] In another aspect of the present disclosure, according to certain features, aspects and advantages of at least one of the embodiments disclosed herein, there is provided a method for providing respiratory support to a patient, the method comprising:

[0352] A respiratory therapy system is provided, the respiratory therapy system comprising:

[0353] Respiratory therapy equipment, the respiratory therapy equipment comprising:

[0354] at least one gas inlet;

[0355] Traffic generator; and

[0356] Gas outlet;

[0357] and a patient interface, the patient interface comprising a nasal interface, wherein the nasal interface comprises:

[0358] A first fork and a second fork that pass through the first fork outlet and the second fork outlet and are asymmetrical to each other;

[0359] and a gas manifold comprising a gas inlet, wherein the first prong and the second prong are in fluid communication with the gas inlet;

[0360] operating the respiratory therapy device to provide a flow of gas to the nasal interface; and

[0361] An asymmetric flow of gas from the respiratory therapy device is delivered at a nares of a patient through a first prong outlet and a second prong outlet.

[0362] The first and second prongs are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0363] In some configurations, the method includes delivering an asymmetric gas flow through a first fork outlet and a second fork outlet at a temperature range between about 27°C-37°C, at a relative humidity greater than about 33 mg / l, and / or at a velocity greater than 0 m / s and less than about 32 m / s for a total volumetric flow rate of gas flow greater than 0 lpm and up to about 70 lpm flowing into the gas inlet.

[0364] In some configurations, the method includes delivering an asymmetric gas flow at a temperature range between about 31°C-37°C.

[0365] In some configurations, the method includes providing a total volumetric flow rate of gas flow of at least about 5 liters per minute (lpm) to the gas inlet, optionally providing a total volumetric flow rate of gas flow between about 5 lpm and about 120 lpm to the gas inlet, and optionally providing a total volumetric flow rate of gas flow between about 5 lpm and about 70 lpm to the gas inlet.

[0366] In some configurations, the method includes delivering at least about 60% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally delivering about 60% to about 90% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally delivering about 60% to about 80% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally delivering about 65% to about 80% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, optionally delivering about 70% to about 80% of the total volumetric flow of gas flowing into the gas inlet out of the nasal interface through the first prong, The first prong delivers out of the nasal interface, optionally about 70% to about 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 70% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 75% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong, optionally about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first prong.

[0367] In some configurations, the method includes delivering the gas through the first prong outlet and the second prong outlet at a relative humidity of up to about 44 mg / l.

[0368] In some configurations, the method includes providing different gas flow rates through the first prong and the second prong, and delivering substantially similar velocities of gas through the first prong outlet and the second prong outlet.

[0369] In some configurations, the velocity of gas exiting the first fork outlet is within about 20% of the velocity of gas exiting the second fork outlet, optionally within about 16% of the velocity of gas exiting the second fork outlet, and optionally at flow rates above about 42 lpm within about 10% of the velocity of gas exiting the second fork outlet.

[0370] In some configurations, for a total volumetric flow rate of gas flow into the gas inlet greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of the first and second forked outlets is greater than 0 m / s and less than 32 m / s.

[0371] In some configurations, for a total volumetric flow rate of gas flow greater than 9 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first fork outlet and the second fork outlet is greater than about 2 m / s and less than about 32 m / s, optionally greater than about 2 m / s and less than 32 m / s, optionally greater than about 2 m / s and up to about 25 m / s, and optionally greater than about 2.5 m / s and up to about 20 m / s.

[0372] In some configurations, the nasal interface includes a cannula body comprising a first prong and a second prong.

[0373] In some configurations, the gas manifold is integral to the cannula body, or is separate from and coupleable to the cannula body.

[0374] In some configurations, the method includes engaging the first and second prongs with the nasal passage in an unsealed (non-sealing) manner.

[0375] In some configurations, the method includes allowing exhaled gas to escape around the first prong and the second prong.

[0376] In some configurations, the method includes providing gas to the patient without interfering with the patient's spontaneous breathing.

[0377] In some configurations, the method includes providing gas to the patient independent of the patient's breathing.

[0378] In some configurations, the nasal interface is as described above or generally herein.

[0379] In some configurations, the respiratory therapy device includes a humidifier, and the method includes using the humidifier to humidify the flow of gas.

[0380] In some configurations, the respiratory therapy system includes a patient conduit having a heater, and the method includes operating the heater.

[0381] In some configurations, the patient interface includes a gas permeable tube in fluid communication with the gas inlet, and the method includes allowing water vapor to pass through a wall of the tube, but preventing liquid water and bulk gas from flowing through the wall of the tube.

[0382] Features from one or more embodiments or configurations may be combined with features of one or more other embodiments or configurations. In addition, more than one embodiment or configuration may be used together in a respiratory support system during a respiratory support procedure for a patient.

[0383] As used herein, the word "(s)" following a noun refers to the plural and / or singular forms of that noun.

[0384] As used herein, the term "and / or" means "and" or "or" or both.

[0385] The term "comprising" as used in this specification means "consisting at least in part of..." When interpreting each statement in this specification containing the term "comprising", there may also be features other than the one or those features following the term. Related terms such as "comprise" and "comprises" are to be interpreted in the same manner.

[0386] It is intended that reference to a numerical range disclosed herein (e.g., 1 to 10) also includes reference to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) as well as any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and thus all subranges of all ranges explicitly disclosed herein are explicitly disclosed herein. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between the recited minimum and maximum values ​​should be considered to be explicitly stated in this application in a similar manner.

[0387] The present disclosure may also be broadly stated as referring to the parts, elements and features referred to or indicated in the specification of the present application, either individually or collectively, and any or all combinations of any two or more of said parts, elements or features.

[0388] Where reference is made herein to specific integers that have known equivalents in the art to which the present disclosure relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

[0389] The present disclosure includes the foregoing and also contemplates a variety of configurations, only examples of which are given below. BRIEF DESCRIPTION OF THE DRAWINGS

[0390] Certain embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein by reference to the following drawings, in which:

[0391] Figure 1A is a left front perspective view of a patient interface of an exemplary configuration of the present disclosure, the patient interface comprising a nasal interface having an asymmetric nasal delivery element.

[0392] Figure 1B is a right front stereoscopic view of the patient interface.

[0393] Figure 1C is a front left exploded perspective view of the patient interface.

[0394] Figure 2 A nasal interface is shown, wherein Figure 2 (a) is the top view, Figure 2 (b) is the front view, and Figure 2 (c) is a bottom view.

[0395] Figure 3 is a front schematic diagram of a nasal interface of the present disclosure inserted into a nostril of a user.

[0396] Figure 4A is a rear view of the small nasal interface of the present disclosure.

[0397] Figure 4B is a rear view of the medium nasal interface of the present disclosure.

[0398] Figure 4C is a rear view of the large nasal interface of the present disclosure.

[0399] Figure 5 A rear view of the small, medium, and large nosepieces stacked on top of each other.

[0400] Figure 6 The results of desktop testing of the nasal interface are shown, where Figure 6 (a) Figure 6 (b) and Figure 6 (c) shows the dead space clearance of the larger upper airway at 25, 35 and 45 breaths per minute, respectively, and Figure 6 (d) and Figure 6 (e) shows dead space clearance of the smaller upper airway at 15 and 25 breaths per minute, respectively, where I:E is the ratio of inspiration time to expiration time.

[0401] Figure 7 The test results of the nasal interface are shown, where Figure 7 (a) shows the Optiflow from Fisher & Paykel Healthcare Limited TM +OPT944+nasal interface results, Figure 7 (b) shows the results of the nasal interface of the present disclosure, and Figure 7 (c) shows the comparison result.

[0402] Figure 8 Exemplary septum spacing and nasal prong heights for (a) a small nasal interface, (b) a medium nasal interface, and (c) a large nasal interface of the present disclosure are shown.

[0403] Fig. 9 An exemplary gas manifold for use in a small nasal interface is shown, wherein Fig. 9 (a) shows a top view, and Fig. 9 (b) shows the Fig. 9 (a) A front cross-sectional view obtained along line bb.

[0404] Fig.10An exemplary gas manifold for use in a medium or large nasal interface is shown, wherein Fig.10 (a) shows a top view, and Fig.10 (b) shows the Fig.10 (a) A front cross-sectional view obtained along line bb.

[0405] Fig.11 The effect of the orientation of the prongs relative to the gas inlet is shown for a nasal interface of the present disclosure.

[0406] Figure 12(a)-Figure 12(d) Possible configurations of the gas manifold relative to the cannula body are shown, wherein Figure 12(a) shows a first insertion direction of the gas manifold into the cannula body, and Figure 12(b) shows the gas manifold connected to the cannula body in a first configuration, and wherein Figure 12(c) shows a second insertion direction of the gas manifold into the cannula body, and Figure 12(d) shows the gas manifold connected to the cannula body in a second configuration.

[0407] Fig.13 Details of the fork geometry of the outlet of the nasal fork of the nasal interface of the present disclosure are shown.

[0408] Fig.14 Details of the terminal end of the prongs of the nasal interface of the present disclosure are shown, wherein Fig.14 (a) shows a left side cross-sectional view of the nasal interface, showing an exemplary geometry of the outlet of a large nasal prong, Fig.14 (b) shows a right side cross-sectional view of the nasal interface, showing an exemplary geometry of the outlet of the small nasal prong, and Fig.14 (c) shows a comparison of outlet geometries.

[0409] Fig.15 A respiratory therapy system incorporating a patient interface and a nasal interface of the present disclosure is shown.

[0410] Fig.16 A control loop for closed-loop blood oxygen saturation (SpO2) control of a respiratory therapy system is shown.

[0411] Fig.17 An alternative respiratory therapy system incorporating a patient interface and a nasal interface of the present disclosure is shown.

[0412] Fig.18 Shown is a cross-sectional view of a patient conduit that may be used in a respiratory therapy system and / or with a nasal interface of the present disclosure.

[0413] Fig.19 Shown is a cross-sectional view of an alternative patient conduit that may be used in a respiratory therapy system and / or with the nasal interface of the present disclosure.

[0414] Fig. 20 The test results of the nasal interface are shown, where Fig. 20 (a) shows how a nasal interface of the present disclosure may be used to achieve an increased obstruction area while still maintaining safe clearance in one nostril, Fig. 20 (b) shows test data showing increased positive end-expiratory pressure (PEEP) and reduced rebreathing using a nasal interface with asymmetric prongs of the present disclosure compared to a nasal interface with symmetric prongs when applying a nasal high flow of 30 liters / minute, and Fig. 20 (c) shows a similar Fig. 20 (b) but for test data at a nasal high flow rate of 60 L / min.

[0415] Fig.21 Shown are the maximum airway pressures that can be achieved with each size of nasal interface of the present disclosure when the larger prong completely blocks one of the patient's nostrils.

[0416] Fig.22A and Fig. 22B is a schematic cross-sectional view of an exemplary configuration of a single-walled gas permeable patient conduit. DETAILED DESCRIPTION

[0417] The patient interface can be used to deliver breathing gases to the patient's airway. The patient interface can include a nasal interface that can be used to deliver high-flow gases to the patient. A nasal delivery element (such as a nasal prong that can optionally include a nasal pillow) is inserted into the patient's nose to deliver the desired therapy. The nasal delivery element may be expected to seal or partially block the nose, or may not need to seal at the nose, to deliver the therapy. Nasal prongs typically refer to nasal delivery elements that are designed to be unsealed or only partially blocked at the nose. When one or more nasal prongs include nasal pillows, the nasal delivery element is designed to seal at the nose. Nasal high flow (NHF) therapy is typically a non-sealing therapy that delivers a relatively high volume of flow to a patient through a patient interface, such as a nasal interface. The nasal interface as described herein may refer to, but is not limited to, a nasal cannula.

[0418] A system for delivering gas to a patient via an asymmetric nasal cannula or nasal interface is disclosed. An asymmetric interface or asymmetric nasal delivery element as described herein refers to an interface in which the size of the nasal delivery element (e.g., internal and / or external transverse dimensions or diameters and / or internal and / or external cross-sectional areas) is different. The external cross-sectional area is the cross-sectional area defined by the outer wall of the nasal delivery element. For non-circular cross-sections, the diameters mentioned herein may be interpreted as transverse dimensions. In some configurations, the diameters mentioned herein include, but are not limited to, hydraulic diameters.

[0419] The system allows for asymmetric flow to be delivered to both nostrils or to either nostril through the interface. Asymmetric flow as described herein refers to different flow in the interface, or in the nose, or in the interface and the nose. In this way, each nasal delivery element can deliver a different flow, or the flow between inspiration and exhalation can be different, or the delivered flow can be a combination of the above. Asymmetric flow can also include partial unidirectional flow.

[0420] Delivering an asymmetric flow can improve clearance of dead space in the upper airway, reduce peak expiratory pressure, improve the safety of therapy, especially for children and infants, and reduce flow resistance in the interface. Asymmetric nasal interfaces and / or nasal delivery elements as described herein include interfaces or systems configured to produce such an asymmetric flow through an asymmetric nasal delivery element.

[0421] The pressure produced by NHF depends on the flow through the nasal interface, the size of the nasal delivery element and / or the patient's nostrils, and the breathing cycle. If during breathing, the flow through the nasal interface, leakage, or a combination of flow and leakage is asymmetric, the flow through the nose may be asymmetric. Partial unidirectional flow and total unidirectional flow can be types of asymmetric flow. Partial unidirectional flow or total unidirectional flow can provide improved removal of anatomical dead space when air is continuously flushed from the upper airway. Partial unidirectional flow can be more comfortable than total unidirectional flow. Total unidirectional flow as described herein includes flow entering one nostril through the nasal delivery element and leaving through the other nostril via the nasal delivery element, flow discharged into the atmosphere due to the absence of a nasal delivery element, etc. Partial unidirectional flow as described herein includes flow that can enter the nose via both nostrils and exit the nose from one nostril, flow that can enter the nose through one nostril and exit the nose via both nostrils, or different ratios of flow that can enter the nose through both nostrils and different ratios of flow that can exit the nose through both nostrils, and can be flow that can enter the nose via both nostrils and exit the nose from one or both nostrils and optionally exit via the mouth.

[0422] NHF delivered through an asymmetric nasal interface can involve making an interface in which the nasal delivery elements have different sizes, such as different lengths, and / or inner diameters or cross-sectional areas and / or outer diameters or cross-sectional areas. Especially for children or infants, the nasal delivery element has a small inner diameter and therefore has a higher gas flow resistance. By using nasal delivery elements of different lengths, each nasal delivery element can have a different inner diameter (e.g., a minimum inner diameter or area). A longer nasal delivery element can have a smaller inner diameter and a higher gas flow resistance; a shorter nasal delivery element can have a larger inner diameter (e.g., a larger minimum diameter), and therefore has a lower gas flow resistance at the interface. The reduced flow resistance allows the use of a lower back pressure, or a lower motor speed of the gas generating device, or a combination of the two to achieve the desired flow rate.

[0423] Asymmetric nasal delivery elements can reduce peak expiratory pressure due to the different cross-sectional areas of the nasal delivery elements at the nose, which can provide a different inner diameter for each nasal delivery element.

[0424] The pressure during exhalation with an asymmetric nasal interface can be higher than that with a symmetric interface, which is beneficial because higher positive end-expiratory pressure (PEEP) is part of the treatment of COPD (pressure here refers to intrathoracic pressure). The expiratory pressure depends on the combined cross-sectional area of ​​the two prongs. Increasing the cross-sectional area of ​​the symmetric prongs carries the risk of complete obstruction of the patient's nares. Using an asymmetric prong allows the total cross-sectional area to be increased without the risk of obstruction. Partial unidirectional flow can reduce turbulence in the patient's nasal cavity, which can improve comfort.

[0425] In an example, a gas generating device, such as the AIRVO from Fisher & Paykel Healthcare Ltd. TM An asymmetric nasal interface used with a flow generator (e.g., connected via a catheter or breathing tube) reduces flow resistance. TM The motor speed of the nasal delivery element can be reduced from a range of 18,000-22,000 RPM to a range of 14,000-18,000 RPM while continuing to achieve a suitable flow rate, such as about 8 liters per minute (lpm), for the desired therapy (e.g., NHF). For example, if an incorrectly sized prong does not form a seal with the patient's nostrils, the asymmetric nasal delivery element may reduce the back pressure generated in the system.

[0426] For smaller patients, such as infants or children, when the nostrils are too small relative to the two prongs, the use of an asymmetric nasal delivery element can reduce over-insertion of the prongs into the nostrils, which can result in an undesirable semi-seal or seal. An asymmetric flow can be delivered to the patient even if only one prong is tightly positioned in the nose. The asymmetric interface improves the performance of therapy for infants because compressed gas can be used in systems without pressure control.

[0427] Figures 1A to 1C and Figure 2 An exemplary patient interface 1 is shown that includes a nasal cannula or nasal interface 100 having asymmetric nasal delivery elements 111 , 112 .

[0428] The nasal interface 100 provides a patient interface suitable for delivering a high flow, high humidity gas flow to the patient's nasal cavity / nostril. In some configurations, the nasal interface 100 is adapted to deliver high flow gas over a wide flow range (e.g., about 8 plm or higher, depending on other therapeutic applications, approximately 10-50 lpm or higher). In some configurations, the nasal interface 100 is adapted to deliver relatively low pressure gas.

[0429] The nasal interface 100 includes a face mounting portion 110 including a pair of asymmetric tubular nasal prongs 111 and 112 integrally molded with or removably attached to the face mounting portion 110 and a gas manifold 120 portion removably attached to or integrally molded with the conduit 300.

[0430] The gas manifold 120 is insertable into the face mount 110. The face mount 110 may include at least one substantially horizontal side access passage 118a, 118b leading to the interior of the base portion of the face mount 110 or the cannula body 118 to releasably receive the outlet of the gas manifold 120 therethrough.

[0431] The gas manifold 120 is optionally insertable into the facial mount 110 from one of two opposing horizontal directions, i.e., from the left or right side. In this way, the position or location of the gas manifold 120 is reconfigurable relative to the facial mount 110. In other words, the user can choose to have the manifold portion 120 (and the conduits 300 extending therefrom) extend from the left or right side of the facial mount 110 of the nasal interface 100, depending on what is most convenient, e.g., depending on which side of the user the gas source or ventilator is positioned. In an alternative configuration, the gas manifold 120 is not reconfigurable relative to the facial mount 110.

[0432] The face mount 110 may include a pair of opposed side access passages 118a, 118b leading to the interior of a base portion or cannula body 118, each side access passage being adapted to releasably receive an outlet of a gas manifold 120 therethrough.

[0433] The face mount 100 is formed of a soft, flexible material, such as silicone or other cannula materials known in the art. The nose prongs 111 and 112 are preferably flexible and can be formed of a sufficiently thin layer of silicone to achieve this property.

[0434] The gas manifold 120 is formed of a relatively rigid material, such as polycarbonate, high density polyethylene (HDPE), or any other suitable plastic material known in the art. The facial mount 110 provides a soft interface for the patient to comfortably deliver the gas flow through the nasal prongs 111 and 112, while the gas manifold 120 fluidly couples the conduit 300 to the nasal prongs 111 and 112 of the facial mount 110.

[0435] The nasal prongs 111 and 112 are curved and extend into the patient's nostrils during use and provide a smooth flow path for gas to flow through. The inner surfaces of the prongs 111 and 112 can be contoured to reduce noise. The base of the prongs 111 and 112 can include a curved surface to provide a smoother gas flow. This can reduce the noise level during operation.

[0436] The nose prongs 111 and 112 are substantially hollow and substantially tubular in shape.

[0437] The diameter of the nasal prongs 111 and 112 can be consistent along their length, or alternatively can be shaped to fit the contour of the nostrils.

[0438] The facial mount 110 is shaped to generally follow the contours of the patient's face around the upper lip region. The facial mount 110 is molded or preformed so as to be able to conform to the contours of the user's face and / or is flexible so as to adapt, accommodate and / or correspond to the contours of the user's face in the area of ​​the face where the cannula is positioned.

[0439] The asymmetry of the nasal prongs 111 and 112 can reduce the chance of accidental blockage of both nostrils. Therefore, at least one of the nasal prongs 111 and 112 is sized to maintain sufficient clearance between the outer surface of the prongs 111 and 112 and the patient's skin to avoid a gas path between the nasal interface 100 and the patient. It should be understood that in the context of the present disclosure, the nasal prongs 111 and 112 are asymmetric, as described below.

[0440] The face mount 110 includes a base portion or cannula body 118 from which nose prongs 111 and 112 extend, and two side arms including wing portions 113 and 114 extending laterally from one side of the cannula body 118. The wing portions 113 and 114 are integrally formed with the cannula body 118, but may alternatively be separate parts.

[0441] An adhesive pad 113a, 114a ( Figure 4A ) to facilitate connection of cannula 100 to a patient, particularly for younger children (eg, under 5 years old).

[0442] The gas manifold 120 is generally tubular in shape, with a generally annular gas inlet 121 at one end and an opposite end that curves into an elongated oval outlet 123 ( Fig. 9 and Fig.10 ). The inlet 121 may be removably attached to the conduit 300, such as via a threaded engagement, but alternatively via a snap fit or any other type of coupling known in the art. Alternatively, the inlet is fixedly coupled to the conduit 300 or formed integrally therewith.

[0443] The outlet 123 is shaped to correspond with the cannula body 118 and fits into the cannula body, such as by a friction fit or snap fit engagement, so that significant or at least targeted force applied by the user or caregiver is required to separate the manifold 120 from the facial mount 110.

[0444] When the outlet 123 engages the cannula body 118, an effective seal is formed between the two parts 118 and 120. As discussed below, Figure 3 As shown, the gas manifold 120 may include a retaining flange 120b around its face that is removably received in a complementary resilient rim 118d of the cannula body 118. The engagement of the retaining flange 120b with the complementary resilient rim 118d of the cannula body 118 helps to form a seal between the gas manifold 120 and the cannula body 118.

[0445] The nasal prongs 111 , 112 align with corresponding holes extending through the upper surface of the cannula body 118 to fluidly connect them when the manifold outlet 123 is coupled to the nasal prongs 111 and 112 .

[0446] A headgear may be used to hold the nasal interface 100 on the patient's face. The headgear includes a head strap 200. The head strap 200 may be a single continuous length and adapted to extend along the patient's cheeks, over the ears and around the back of the head in use, may be adjustable, and / or may extend around other portions of the patient's head.

[0447] In the exemplary configuration shown, main end portions 201 and 202 of head strap 200 are adapted to releasably connect to corresponding formations 101 and 102 on a side of nasal interface 100 to hold nasal interface 100 in place during use.

[0448] In one configuration, a clamp component is provided at each end portion 201, 202, which can be received and retained within the corresponding structure 101, 102. The clamp component can be connected to the corresponding main end portion of the strap. In addition, the length of the head strap 200 is adjustable to help customize the strap to the wearer's head. The strap 200 can be formed of a soft and stretchable / elastic material (such as an elastic, textile material / fabric that is comfortable for the wearer). Alternatively, the strap 200 can be formed of a substantially harder, or less flexible material (such as a hard plastic material).

[0449] The headgear may further include additional straps or connecting straps 200 to extend over other headgear components over the top of the patient's head in use. The top strap or top component may have the following benefits: the straps 200 are pulled upwards and over the patient's ears in use to improve fit and comfort.

[0450] In general, but also refer to Figures 1A to 1C In one exemplary configuration of the adjustable strap 200 , an adjustment mechanism is provided in the form of one or more insertable / removable strap segments or strap extensions 220 .

[0451] A strap segment 220 having a fixed length can be releasably connected to the main strap 210 to extend its length. In this configuration, the main strap 210 includes a pair of intermediate or secondary end portions 203, 204 that are releasably connected to each other and to respective end portions 221 and 222 of the strap segment 220. When the secondary end portions 203 and 204 are connected to each other, the main strap 210 has a continuous starting length / size for the wearer. In order to extend the length of the strap 200 beyond this starting length, the main strap 210 can be disconnected at the secondary end portions 203 / 204 and one or more additional strap segments 220 are connected therebetween.

[0452] A plurality of cinch band segments 220 having varying predetermined lengths may be provided to provide a plurality of alternative adjustment lengths. For example, one or more cinch band segments 220 may be provided with a length in the range of about 1 cm to about 10 cm, or in the range of about 2 cm to about 6 cm. These cinch band segments 220 have a length of, for example, about 2 cm, about 4 cm, or about 6 cm. It should be understood that these examples are not intended to be limiting and that the length of each cinch band segment may be of any size, as this depends on the user and / or application.

[0453] In addition, each end 221, 222 of each strap segment 220 can be connectable to the corresponding end 221, 222 of another strap segment 220 and / or the corresponding secondary end portion 203, 204 of the main strap 210, thereby enabling the user to combine one or more strap segments 220 of the same or varying lengths in order to customize the overall length of the extension as desired.

[0454] These additional strap segments can be formed of soft and stretchable / elastic materials (such as elastic, textile materials / fabrics that are comfortable for the wearer). For example, a tubular knit type head strap or multiple segments of head strap 210 can be used over the user's ears, especially for comfort.

[0455] It should be appreciated that particular comfort may be achieved with a head strap that is capable of providing suitable positioning of the nasal interface 100 in a relatively stable position on the user's face while also providing a relatively loose fit or low tension fit around the user's head.

[0456] Alternatively, the further strap segments may be formed from a substantially rigid material, such as a hard plastics material.

[0457] A belt connector 230 is provided at each of the secondary end portions 203 , 204 of the main belt 210 and the corresponding end portions 203 , 204 of the belt segment 220 .

[0458] Each connector 230 has one end provided with a strap connection mechanism that couples to the strap material and an opposite end provided with a connection mechanism that releasably couples to a corresponding end of a similar connector 230 .

[0459] In the alternative, the connector 230 may be various different forms of adjustable buckles suitable for adjusting the length or tension of the head strap segments 210 that hold the patient interface in place around the user's head.

[0460] It should also be understood that the connector 230 can be positioned away from the midpoint of the back of the user's head, or can be offset to one side of the user's head. This may be advantageous to avoid bumping into a portion of the user's head that may otherwise make the user uncomfortable in certain positions (such as sleeping).

[0461] In yet other configurations, the strap segments may have different lengths to provide asymmetry or to aid in operability with offset connector 230 positions. Additionally, the two strap segments 210 may also be such that one of the straps may be adjustable in length while the other is not. For example, one strap segment 210 may have a permanent length or be permanently connected to connector 230.

[0462] In an exemplary configuration, the strap connection mechanism may include a series of internal teeth positioned within the connector body for establishing a friction fit engagement with an opposite end of the strap. An articulated clamp of the body is provided and closed on the teeth so as to securely retain one end of the strap on the teeth. The releasable coupling mechanism on the other end includes a pair of male and female members (such as corresponding protrusions and holes) that are adapted to connect to corresponding male and female members of a similar connector 230. A rest on the protrusion can connect to a depression in the female member to provide a snap fit engagement between the members. It should be understood that in alternative configurations, any other suitable connector configuration may be used to releasably connect the secondary end portions of the strap to each other, as well as to releasably connect to the end portions of additional strap segments.

[0463] The cannula connector 240 is disposed at the main end portions 201 and 202 of the main strap 210. These connectors 240 have similar strap connection mechanisms to the strap connectors 230 of the secondary end portions 203 and 204, but include a clamp member, such as a push-fit clamp 241, at the end of the connector 240 opposite the strap end. The clamp 241 is configured to releasably couple a corresponding structure 101, 102 on one side of the nasal interface 100. The clamp member 241 can be a bendable portion, such as a plastic portion, which forms a hinged portion relative to the strap. The clamp 241 can be preformed to have a curved shape along its length, such as a curved shape having an angle between 0 degrees (flat) and 20 degrees. In some configurations, the clamp 241 can be preformed to have a bend. The clamp 241 includes at least two portions that are angled relative to each other. The at least two portions can be positioned at an angle greater than between 0 degrees and 20 degrees. That is, the two portions may be about 180 degrees relative to each other, or may differ from 180 degrees by up to 20 degrees. This bend or angle allows the clamp 241 to adapt to the contours of the patient's face in the area of ​​the clamp 241.

[0464] The nasal interface may include sleeves 270. Each sleeve 270 may be preformed to have a curved shape along its length, such as a curved shape having an angle between 0 degrees (flat) and 20 degrees. The curvature allows the sleeve to fit the contour of the patient's face or cheek in the sleeve area during use. Alternatively, the sleeve 270 may take the shape of a curved sleeve when engaged with the main end portion 201, 202 of the headband 200 or the connector 240.

[0465] Sleeve 270 provides a surface area with a relatively high friction surface material for frictionally engaging with the user's face or facial skin. This surface area will be positioned for frictional engagement with the user's facial cheek skin. The surface area is at least localized to the strap or the segment of the strap that will be positioned on the user's cheek. The surface area provided with a relatively high friction surface material can have a material that is smooth and comfortable on the patient's skin. Therefore, sleeve 270 or at least surface area 271 is formed of a relatively softer material than connector 240.

[0466] In one configuration, the surface region 271 or sleeve 270 is formed from a soft thermoplastic elastomer (TPE), but may alternatively be formed from another plastic material, such as silicone, or any other biocompatible material.

[0467] Surface area 271 can be a surface having a wider surface area closer to the patient interface than a surface area further away from the patient interface. In one configuration, sleeve 270 tapers from a relatively wider surface area 273 to a relatively smaller surface area 274 in a direction extending away from the connection point between connector 240 and nasal interface 100. The width of one end 273 of the sleeve can be the same or similar to the width of the tapered distal end of the corresponding wing portions 113, 114 of the facial mount 110. This provides a smooth transition between the nasal interface 100 and the headgear to improve aesthetics and achieve a visually appealing effect.

[0468] The sleeve 270 can be colored to provide identification of the nasal interface 100. As described herein, the nasal interface can be provided in different sizes, such as small, medium, and large. The sleeves 270 having each of these sizes can include different colors to represent the different sizes. Alternatively or in addition, these sleeves can be colored in a particular manner to represent that the nasal interface has an asymmetrical nasal delivery element rather than a symmetrical one.

[0469] Headgear for other forms of interfaces besides nasal cannulae may also include a plurality of cheek supports 270 as described or similar at or near either side end of the headgear strap of the interface, connected to the nasal interface for frictional engagement with the user's face to stabilize the mask at the cheeks on the face. Such headgear may likewise include a single head strap adapted to extend along the patient's cheeks, over the ears and around the back of the head, in use, with the ends including clamps in any suitable form that couple to the nasal interface on either side (or are permanently attached to the nasal interface).

[0470] refer to Figures 1A to 1CIn the illustrated configuration, the patient interface 1 includes a tube retaining clamp 280. The tube retaining clamp 280 can support the patient conduit 300 or other gas supply tube from a portion of the patient interface 1. By supporting the patient conduit 300 or other gas supply tube from or near the nasal interface 100, the tube retaining clamp 280 will resist bending movement applied to the patient conduit 300 or other gas supply tube 300 due to asymmetric flow through the first prong 111 and the second prong 112, and / or movement of the patient's head, thereby enhancing patient comfort.

[0471] In the illustrated configuration, the tube retaining fixture 280 includes a tubular body 281 for receiving and containing a portion of a patient conduit 300 or other gas supply tube therein.

[0472] In the illustrated configuration, the tube retaining clamp 280 supports the patient conduit 300 or other gas supply tube from the headgear of the patient interface. In alternative configurations, the tube retaining clamp 280 can support the patient conduit 300 or other gas supply tube from a portion of the nasal interface 100 of the patient interface. For example, the tube retaining clamp 280 can support the patient conduit 300 or other gas supply tube from another portion of the cannula body 118, or the facial mount 110. In some configurations, the tube retaining clamp 280 can support the patient interface from one or either of the wing portions 114, 115 of the nasal interface 100.

[0473] The hook 282 protrudes from the body 281 to couple to a strap or other component of the headgear. In this way, the catheter 300 can be coupled or tied to the head strap 210 or headgear during use. If the catheter 300 is pulled, the force will be applied to the head strap 210 instead of directly to the cannula 100. This relocation of force will reduce the likelihood that the prongs 111 and 112 of the nasal interface 100 will protrude out of the patient's nostrils.

[0474] A protrusion or bump is provided at or near the free end of the hook 282. The protrusion extends inwardly towards the body 281. The protrusion or bump reduces the gap at the entrance of the hook, which helps to hold the clamp on the strap when the hook is engaged, i.e. the strap does not slip out of the hook channel. This also provides the advantage that the hook is held on the strap when hooked in a top-down direction, the protrusion or bump holds the hook on the strap against gravity.

[0475] One or more tie points for connecting the tube retaining clamp 280 may be available on the headgear, with at least two symmetrical tie points on either side of the headgear being preferred to improve usability.

[0476] It should also be appreciated that the tube retaining clamp 280 may be removable from the patient conduit 300 or other gas supply tube, or may be a permanent fitment thereon.

[0477] The tube retaining clamp 280 can have any suitable form. In an alternative configuration, the tube retaining clamp 280 can include or be formed from a band or a ring. The ring can include a fabric, an elastomeric, or a textile band or ring.

[0478] The retaining clamp 280 may be connected or retained to a portion of the patient interface 1, such as a portion of the interface that provides a relatively more rigid area (e.g., to facilitate support of the patient conduit 300). The retaining clamp may also be positioned or attached at a specific location on the patient conduit 300, for example, a predetermined position may be provided to retain the retaining clamp in place.

[0479] The patient interface 1 may have any one or more of the features and functions described in PCT Publication No. WO 2014 / 182179 or US Pat. No. 10,406,311. The contents of these specifications are incorporated herein by reference in their entirety.

[0480] As an alternative to headgear, the patient interface may include a securing system of the type described in PCT Publication No. WO 2012 / 053910 or U.S. Pat. No. 10,238,828. The contents of these specifications are incorporated herein by reference in their entirety.

[0481] refer to Figure 1C and Figures 2 to 3 In some configurations, the nasal interface 100 of the present disclosure includes a first fork 111 and a second fork 112 that are asymmetric to each other, and a gas manifold 120 having a gas inlet 121. The first fork 111 and the second fork 112 are in fluid communication with the gas inlet 121. The nasal interface is configured such that at least about 60% of the total volume flow of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111.

[0482] The gas inlet 121 may be at a side of the gas manifold 120. In alternative configurations, the gas inlet 121 may be at a different location on the gas manifold 120. For example, the gas inlet 121 may enter the front of the gas manifold 120 at or near the center of the gas manifold 120 or at or near a side of the gas manifold 120.

[0483] This may vary based on the patient's breathing cycle and internal nasal geometry.The figures and scales herein are when the nasal interface is not being worn and before any influence of the patient's breathing and / or nasal geometry.

[0484] By way of example, if the blower of a respiratory therapy device is producing a flow of 100 liters per minute (lpm) and that flow is delivered into gas inlet 121 , at least about 60 lpm passes through first prong 111 and is delivered out of nasal interface 100 .

[0485] The remainder of the total gas flow is delivered through the second prong 112. In the above example, about 40 lpm or less passes through the second prong 112 and is delivered out of the nasal interface 100 through the second prong 112. Alternatively, some of the remainder of the total gas flow may be exhausted to the atmosphere rather than being delivered through the first prong 111 or the second prong 112.

[0486] The first prong 111 and the second prong can be considered as asymmetric nasal delivery elements.

[0487] The first prong 111 and the second prong 112 are not symmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.

[0488] The nasal interface 100 is configured to achieve asymmetric gas flow at, within, and / or outside of the patient's nares.

[0489] In some configurations, the nasal interface 100 includes a cannula body 118 having a first prong 111 and a second prong 112 .

[0490] In some configurations, the gas manifold 120 is integral with the cannula body 118 or is separate from the cannula body 118 and can be coupled thereto.

[0491] In some configurations, the first prong 111 and the second prong 112 are configured to engage with the nasal passage in an unsealed (non-sealing) manner. In some configurations, at least the second prong 112 is configured to engage with the nasal passage in a non-sealing manner.

[0492] In some configurations, the first prong 111 and the second prong 112 allow exhaled gas to escape around the first prong and the second prong.

[0493] In some configurations, the first prong 111 and the second prong 112 are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0494] The first tine 111 has a first tine outlet 111a defined by an opening at a tip or terminal end 111b thereof to deliver gas from the first tine 111. The gas delivered through the first tine 111 exits the first tine via the first tine outlet 111a.

[0495] The second prong 112 has a second prong outlet 112a defined by an opening at a tip or terminal end 112b thereof to deliver gas from the second prong 112. The gas delivered through the second prong 112 exits the second prong via the second prong outlet 112a.

[0496] refer to Figure 3 and Figure 4AIn some configurations of the nasal interface 100, the inner diameter ID1 and / or the inner cross-sectional area A1 of the first fork 111 in a direction GFD1 transverse to the gas flow passing through the first fork 111 are larger than the inner diameter ID2 and / or the inner cross-sectional area A2 of the second fork 112 in a direction GFD2 transverse to the gas flow passing through the second fork 112.

[0497] ID1, ID2, A1, and A2 can be measured at substantially the same location along the first fork 111 and the second fork 112 (e.g., from the base of each fork or from the outlet of each fork at the same distance along the length of the fork). This can be a useful reference for curved and / or angled forks. In some embodiments, ID1, ID2, A1, and A2 can be measured along the same plane. This can be a useful reference for straight forks.

[0498] In some configurations, the direction transverse to the gas flow is substantially perpendicular or orthogonal to the gas flow through the respective forks 111, 112. Alternatively, the direction transverse to the gas flow may be at an acute or obtuse angle relative to the gas flow through the respective forks 111, 112.

[0499] The nasal interface 100 is configured to achieve asymmetric gas flow at the patient's nares.

[0500] The inner diameter ID1, ID2 and / or the inner cross-sectional area A1, A2 may be substantially constant along the length of the forks 111, 112. Alternatively, the inner diameter ID1, ID2 and / or the inner cross-sectional area A1, A2 may vary along at least a portion of the length of the forks 111, 112. For example, the forks 111, 112 may taper from a wider dimension at their base near the cannula body 118 than at their tip or terminal end 111b, 112b. The relevant inner diameter ID1, ID2 and inner cross-sectional area A1, A2 may be at the outlet 111a, 112a of the forks and / or at the distal portion of the forks 111, 112 adjacent to the outlet 111a, 112a.

[0501] The inner surface at the base of each prong 111, 112 may be rounded or chamfered to reduce the pressure of the gas and reduce the velocity drop as the gas changes flow direction within the manifold. This may help reduce noise and improve the delivery of therapy.

[0502] The nasal interface 100 may be configured such that about 60% to about 90% of the total volumetric flow of gas flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first prongs 111. The nasal interface may be configured such that about 60% to about 80% of the total volumetric flow of gas flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first prongs 111. The nasal interface may be configured such that about 65% to about 80% of the total volumetric flow of gas flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first prongs 111. The nasal interface may be configured such that about 70% to about 80% of the total volumetric flow of gas flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first prongs 111. The nasal interface may be configured such that about 70% to about 75% of the total volumetric flow of gas flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first prongs 111. The nasal interface can be configured such that approximately 70% of the total volumetric flow of gas flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first prong 111 .

[0503] It has been found that a flow ratio of at least about 60:40 between the forks 111, 112 is sufficient to begin to see the benefits of the asymmetric flow described below. A ratio of between about 70:30 and about 75:25 is considered optimal.

[0504] The proportion of the total volume flow delivered through each prong 111, 112 can be determined by delivering a gas having a known volume flow rate to the gas inlet 121 of the nasal interface 100 when the nasal interface is not applied to the patient's nostrils. The volume flow rate exiting each outlet 111a, 112a can be measured by a suitable flow meter or sensor to determine the proportion of the total volume flow rate of gas flowing into the gas inlet 121 that exits from the outlet 111a, 112a of each prong 111, 112.

[0505] The inner diameter ID1 of the first fork 111 can be between about 4 mm and about 10 mm, optionally between about 5 mm and about 9 mm, optionally between about 6 mm and about 8 mm, optionally about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or any diameter between any two of these diameters.

[0506] The inner diameter ID2 of the second fork 112 can be between about 2 mm and about 8 mm, optionally between about 3 mm and about 7 mm, optionally between about 4 mm and about 6 mm, optionally about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, or any diameter between any two of these diameters.

[0507] In some configurations, the wall thickness of the first prong 111 and / or the second prong 112 is between about 0.1 mm and about 0.5 mm. Thus, 2 x wall thickness can be added to the inner diameter value to obtain the associated outer diameter value.

[0508] The nasal interface 100 can be configured such that approximately 75% to approximately 80% of the total gas flow is delivered through the first prong 111 .

[0509] The nasal interface 100 can be configured such that approximately 75% of the total gas flow is delivered through the first prong 111.

[0510] The nasal interface 100 can be configured such that approximately 80% of the total gas flow is delivered through the first prong 111.

[0511] The inner cross-sectional area A1 of the first fork 111 may be about 15 mm 2 To about 80mm 2 between, optionally between about 20 mm 2 To about 75mm 2 between, optionally between about 25 mm 2 To about 70mm 2 between, optionally between about 30 mm 2 To about 65mm 2 between, optionally between about 35 mm 2 To about 60mm 2 between, optionally between about 40 mm 2 To about 55mm 2 between, optionally between about 45 mm 2 To about 50mm 2 between, optionally about 15 mm 2 , about 16mm 2 、Approx. 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 、Approx. 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 , about 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2 、About 50mm 2 、Approx. 51mm 2 、Approx. 52mm 2 、Approx. 53mm 2 、Approx. 54mm 2 、Approx. 55mm 2 、Approx. 56mm 2 、Approx. 57mm 2 、Approx. 58mm 2 、Approx. 59mm 2 、Approx. 60mm 2 、Approx. 61mm 2 、Approx. 62mm 2 、Approx. 63mm 2 、Approx. 64mm 2 、Approx. 65mm 2 、Approx. 66mm 2 、Approx. 67mm 2 、Approx. 68mm 2 、Approx. 69mm 2 、Approx. 70mm 2 、Approx. 71mm 2 、Approx. 72mm 2 、Approx. 73mm 2 、Approx. 74mm 2 、Approx. 75mm 2 、Approx. 76mm 2 、Approx. 77mm 2 、Approx. 78mm 2 、Approx. 79mm 2 、Approx. 80mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0512] The inner cross-sectional area A2 of the second fork 112 may be about 5 mm 2 To about 50mm 2 between, optionally between about 10 mm 2 To about 45mm2 between, optionally between about 15 mm 2 To about 40mm 2 between, optionally between about 20 mm 2 To about 35mm 2 between, optionally between about 25 mm 2 To about 30mm 2 between, optionally about 5 mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 、About 9mm 2 , about 10mm 2 , about 11mm 2 , about 12mm 2 , about 13mm 2 , about 14mm 2 , about 15mm 2 , about 16mm 2 、Approx. 17mm 2 , about 18mm 2 、Approx. 19mm 2 , about 20mm 2 , about 21mm 2 、Approx. 22mm 2 、Approx. 23mm 2 、Approx. 24mm 2 , about 25mm 2 、Approx. 26mm 2 、Approx. 27mm 2 、Approx. 28mm 2 、Approx. 29mm 2 , about 30mm 2 、Approx. 31mm 2 、Approx. 32mm 2 、Approx. 33mm 2 、Approx. 34mm 2 、Approx. 35mm 2 、Approx. 36mm 2 、Approx. 37mm 2 、Approx. 38mm 2 、Approx. 39mm 2 、Approx. 40mm 2 、Approx. 41mm 2 、Approx. 42mm 2 、Approx. 43mm 2 、Approx. 44mm 2 、Approx. 45mm 2 、Approx. 46mm 2 、Approx. 47mm 2 、Approx. 48mm 2 、Approx. 49mm 2, about 50mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0513] Having a certain difference between the inner diameters ID1 , ID2 and / or the inner cross-sectional areas A1 , A2 may contribute to a desired level of asymmetry.

[0514] The combined inner cross-sectional area (A1+A2) of the first fork 111 and the second fork 112 can be about 20 mm 2 To about 130mm 2 between, optionally between about 30 mm 2 About 120mm 2 between, optionally between about 40 mm 2 To about 110mm 2 between, optionally between about 50 mm 2 To about 100mm 2 between, optionally between about 60 mm 2 To about 90mm 2 between, optionally between about 70 mm 2 To about 80mm 2 between, optionally about 20 mm 2 , about 25mm 2 、About 30mm 2 、Approx. 35mm 2 、Approx. 40mm 2 、Approx. 45mm 2 , about 50mm 2 、Approx. 55mm 2 、Approx. 60mm 2 、Approx. 65mm 2 、Approx. 70mm 2 、Approx. 75mm 2 、Approx. 80mm 2 、Approx. 85mm 2 、Approx. 90mm 2 、Approx. 95mm 2 , about 100mm 2 、Approx. 105mm 2 、Approx. 110mm 2 、Approx. 115mm 2 , about 120mm 2 , about 125mm 2 、Approx. 130mm 2 , or any cross-sectional area between any two of these cross-sectional areas.

[0515] The ratio of the inner cross-sectional area A1 of the first fork 111 to the inner cross-sectional area A2 of the second fork 112 can be between about 60:40 and about 80:20, optionally between about 65:35 and about 80:20, optionally between about 70:30 and about 80:20, optionally between about 70:30 and about 75:25, optionally about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, optionally between about 75:25 and 80:20, optionally about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20.

[0516] refer to Figure 1C , Figure 2 and Figure 3 In some configurations, the nasal interface 100 of the present disclosure includes a first fork 111 and a second fork 112 that are asymmetric to each other, and a gas manifold 120 having a gas inlet 121. The first fork 111 and the second fork 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to achieve an asymmetric gas flow at the patient's nostrils. The nasal interface 100 is configured so that when the total volume flow of the gas flow flowing into the gas inlet 121 is between about 5 liters / minute (lpm) and about 70 lpm, about 60% to about 80% of the total volume flow of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first fork 111. In some configurations, the total volume flow of the gas flow flowing into the gas inlet 121 is at least about 5 lpm. In some configurations, the total volume flow of the gas flow flowing into the gas inlet 121 is greater than about 5 lpm. In some configurations, the total volumetric flow rate of gas flow into the gas inlet 121 is between about 5 lpm and about 120 lpm. In some configurations, the total volumetric flow rate of gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm.

[0517] The nasal interface 100 can be configured such that when the total flow rate of gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 70% to about 80% of the total volume flow rate of gas flow into the gas inlet is delivered out of the nasal interface 100 through the first fork 111.

[0518] The nasal interface 100 can be configured such that when the total flow rate of gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 70% to about 75% of the total volume flow rate of gas flow into the gas inlet 121 is delivered out of the nasal interface 100 through the first fork 111.

[0519] The nasal interface 100 can be configured such that when the total flow rate of gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 75% to about 80% of the total volume flow rate of gas flow into the gas inlet 121 is delivered out of the nasal interface 100 through the first fork 111.

[0520] The nasal interface 100 can be configured such that when the total volumetric flow of gas flowing into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 75% of the total flow of gas flowing into the gas inlet 121 is delivered out of the nasal interface 100 through the first prong 111.

[0521] The nasal interface can be configured such that the amount of asymmetry in the flow from the first prong 111 and the second prong 112 varies with the total flow of gas flow into the gas inlet 121. A higher total volumetric flow of gas flow into the gas inlet 121 can generally achieve a greater portion of the total volumetric flow of gas flow being delivered out of the nasal interface 100 through the first prong 111, and a lower total flow of gas flow into the gas inlet 121 can achieve a smaller portion of the total volumetric flow of gas flow being delivered out of the nasal interface 100 through the first prong 111.

[0522] Table 1 shows the volume flow rates for bench testing of exemplary nasal cannulas.

[0523]

[0524] Table 1

[0525] Testing and modeling indicate that by using asymmetric prongs 111, 112 in the nasal interface 100 of the present disclosure, a reduction in dead space (i.e., the amount of air that needs to be rebreathed at the beginning of inspiration) can be achieved. This is most significant at higher flow rates, higher respiratory rates, and higher levels of asymmetry. It should be understood that within the patient's upper airway, a certain proportion of gas moves in a unidirectional manner, flowing into one nostril and out of the other nostril, thereby reducing the upper airway dead space. Increasing the expiratory pressure has the effect of slowing the respiratory rate. Slowing the respiratory rate also makes the exhalation phase longer than the inhalation phase. The reduced respiratory rate increases the time to flush the upper airway at the end of exhalation.

[0526] It has been found that dead space clearance increases with increasing asymmetry. For example, at a total volume flow of 30 lpm and a respiratory rate of 45 breaths per minute, a nasal interface with symmetrical prongs produces about 87 ml of anatomical dead space, a nasal interface 100 of the present disclosure having a ratio of the inner cross-sectional area of ​​the first prong 111: the second prong 112 of 60:40 produces about 80 ml of anatomical dead space, and a nasal interface 100 of the present disclosure having a ratio of the cross-sectional area of ​​the first prong 111: the second prong 112 of 70:30 produces about 78 ml of anatomical dead space. The corresponding values ​​change to about 66 ml, about 62 ml, and about 36 ml at 50 lpm, and to about 49 ml, 41 ml, and 21 ml at 70 lpm.

[0527] Figure 6 (a) to Figure 6 (e) shows the dependence of dead space clearance on upper airway volume, respiratory rate, and flow. Figure 6 (a) to Figure 6 (c) shows the result of a larger upper airway, and Figure 6 (d) and Figure 6 (e) shows the results for a smaller upper airway. These results are for the Opitflow from Fisher & Paykel Healthcare Ltd. TM +OPT944 (Medium) cannula, Optiflow from Fisher & Paykel Healthcare TM +946 (large) cannula, a medium nasal interface 100' according to the present disclosure, and a large nasal interface 100" according to the present disclosure.

[0528] Figure 7 The effect of the degree of nasal obstruction is shown. For a given gas flow rate, increasing the obstruction of the nostrils increases the pressure delivered to the patient. For an asymmetric nasal interface of the present disclosure, the reduced cross-sectional area of ​​the small second prong 112 helps prevent simultaneous obstruction of both nostrils. A significantly smaller nasal interface may be uncomfortable and noisy due to the jets and high velocity gases in the patient's nose. The pressure drop or flow resistance of a significantly smaller nasal interface may limit the range of flows that a flow generator can provide. A significantly larger nasal interface may be less likely to fit comfortably with the patient because the prongs may contact the septum or wings of the nose. For larger prongs according to the present disclosure, low gas velocities may achieve quieter gas delivery.

[0529] refer to FIG. 4A to FIG. 4C The nasal interface 100 can be, for example, a small nasal interface 100 ( Figure 4A ), medium nose interface 100'( Figure 4B ), and large nose interface 100" ( Figure 4CThe wings 113, 113', 113", 114, 114', 114" generally have the same spacing and size in each size of the nasal interface so that all nasal interfaces can be used with the same headgear. In each of the small nasal interface 100, the medium nasal interface 100', and the large nasal interface 100", the size and spacing of the nasal prongs may be different.

[0530] The nasal interfaces 100', 100" can have any one or more of the features and / or functions described and illustrated herein for the nasal interface 100. Like reference numerals indicate like parts, with a prime (') added to the medium nasal interface 100' and double primes (" added to the large nasal interface 100". It should be understood that any reference to the nasal interface 100 herein may instead be a reference to the nasal interface 100' or the nasal interface 100".

[0531] The nasal interface 100 ′, 100 ″ may be used in any combination, system, or application described herein for the nasal interface 100 .

[0532] Exemplary dimensions are summarized below in Table 2. As summarized in Table 2, each size of nasal interface 100, 100', 100" may have several different sizes of first prongs 111, 111', 111" and / or second prongs 112, 112', 112" available.

[0533] Table 2 shows exemplary dimensions and ratios for small, medium, and large nasal interfaces according to the present disclosure. It should be understood that these are merely exemplary dimensions and may vary.

[0534]

[0535]

[0536] Table 2

[0537] refer to FIG. 4A to FIG. 4C , with respect to the vertical dimension, for each size of nasal interface 100, 100', 100", the flow center C1 of the first prong and the flow center C2 of the second prong are at the same height above the central axis CA of the gas manifold 120 and the cannula body 118, 118', 118". This is Figure 4A , Figure 4B , Figure 4C This is indicated by the constant distance between the upper and lower dashed lines. This is believed to provide benefits in terms of easily clearing exhaled gas around the second prong 112, centering the inspiratory flow from the two outlets 111a, 112a at the same height, and enhancing comfort and usability.

[0538] In an alternative configuration, the lower edge of the outlet 111a, 111a', 111a" of the first fork 111, 111', 111" can be aligned with the lower edge of the outlet 112a, 112a', 112a" of the second fork 112, 112', 112", or the upper edge of the outlet 111a, 111a', 111a" of the first fork 111, 111', 111" can be aligned with the upper edge of the outlet 112a, 112a', 112a" of the second fork 112, 112', 112".

[0539] Figure 8 Exemplary septum spacings and prong heights are shown for a small nasal interface 100, a medium nasal interface 100', and a large nasal interface 100".

[0540] At least the large first forks 111, 111', 111", and optionally also the small second forks 112, 112', 112", are made of a soft material and have thin walls to allow them to deform and adapt to different nose geometries. The septum distance can be optimized. This is because the septum contacts the forks closer to the base than the nasal skin (alas). The farther this contact is from the base, the more flexible the nasal interface appears. In the nasal vestibule, the septum walls are more sensitive to and less tolerant of pressure from the nasal interface than the compliant ala. Therefore, the septum distance D1 can be selected to minimize the contact between the forks and the diaphragm.

[0541] The gap or diaphragm spacing D1 between the adjacent outer surfaces of the first fork 111, 111', 111" and the base of the second fork 112, 112', 112" adjacent to the first fork 111, 111', 111" and the second fork 112, 112', 112" can be between about 5 mm and about 15 mm, optionally between about 6 mm and about 14 mm, optionally between about 7 mm and about 13 mm, optionally between about 8 mm and about 12 mm, optionally between about 9 mm and about 11 mm, optionally about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, or any value between any two of these values.

[0542] Exemplary dimensions are listed in Table 3. It should be appreciated that other dimensions may be used.

[0543]

[0544] Table 3

[0545] In some configurations, the nasal interface 100, 100', 100" includes a cannula body 118, 118', 118" having a first prong 111, 111', 111" and a second prong 112, 112', 112". The outer surface of the cannula body between the first prong and the second prong includes a recess 118e (eg, Figure 3 ), to accommodate a portion of the patient's nose and reduce pressure on the bottom side of the accommodated portion.

[0546] In the illustrated configuration, the recess 118e includes a hollow outer portion and / or a recessed outer profile in the upper surface of the cannula body 118, 118', 118" between the bases of the forks 111 and 112 to relieve pressure at the septum / columella, thereby improving patient comfort and reducing pressure damage to the columella and philtrum.

[0547] The hollowness should be as much as possible without significantly impairing the flow delivered to the patient. The concave portion may be aligned with the periphery 123a, 123a' (eg, Fig. 9 and Fig.10 As shown) to maintain an effective seal between the cannula body 118, 118', 118" and the gas manifold 120, 120'. The concave portion can be received in the outlet 123 of the gas manifold.

[0548] The combination of the recess 118e in the outer surface of the cannula body 118 and the lower flow rate required for a given amount of irrigation using the asymmetric tines 111, 112 enhances patient comfort.

[0549] refer to Figure 1C , Figures 2 to 3 ,and FIG. 4A to FIG. 4C In some configurations, the nasal interface 100 of the present disclosure includes a first fork 111 and a second fork 112 that are asymmetric to each other, and a gas manifold 120 having a gas inlet 121. The first fork 111 and the second fork 112 are in fluid communication with the gas inlet 121. The inner cross-sectional area A1 of the first fork 111 in the direction GFD1 transverse to the gas flow passing through the first fork 111 is greater than the inner cross-sectional area A2 of the second fork 112 in the direction GFD2 transverse to the gas flow passing through the second fork 112. The second fork 112 has a distinct oval or elliptical cross-sectional shape in the direction GFD2 transverse to the gas flow passing through the second fork, the distinct oval or distinct oval cross-sectional shape having a first ratio of the widest dimension to the narrowest dimension, and the first fork 111 has a non-distinct oval or non-distinct oval cross-sectional shape in the direction GFD1 transverse to the gas flow passing through the first fork 111. The non-distinct oval or non-distinct oval cross-sectional shape of the first fork may have a second ratio of the widest dimension to the narrowest dimension that is less than the first ratio, or have a substantially circular cross-sectional shape.

[0550] In alternative configurations, the two forks 111, 112 may have substantially the same cross-sectional shape in a direction transverse to the gas flow through the respective forks. For example, the two forks 111, 112 may both have a generally circular cross-sectional shape, or may both have different shapes.

[0551] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow through the respective forks. Alternatively, the direction transverse to the gas flow may be at an acute or obtuse angle relative to the gas flow through the respective forks 111 , 112 .

[0552] The inner cross-sectional area A1, A2 and / or the inner cross-sectional shape may be substantially constant along the length of the forks 111, 112. Alternatively, the inner cross-sectional area A1, A2 and / or the inner cross-sectional shape may vary along at least a portion of the length of the forks 111, 112. The inner cross-sectional area and / or the inner cross-sectional shape of the first and second forks may be at the outlets 111a, 112a of the first and second forks 111, 112 and / or at the distal portions of the first and second forks 111, 112 adjacent to the outlets 111a, 112a.

[0553] The first prong 111 is more flexible than the second prong 112. This may be due to the first prong 111 having a reduced wall thickness relative to the overall thickness of the first prong compared to the second prong.

[0554] The larger first prong 111 may be more comfortable when having a less distinct oval, less distinct elliptical, or more circular cross-sectional shape so that it can most easily conform to the shape of the patient's nasal cavity.

[0555] The smaller second prong 112 is less flexible. By having a substantially oval or substantially elliptical cross-sectional shape, the second prong 112 can match the shape of the patient's nasal cavity at rest.

[0556] In some exemplary configurations, the first ratio is greater than 1.0. In some configurations, the first ratio is at least about 1.05, optionally at least about 1.1, optionally at least about 1.2, optionally at least about 1.3, optionally at least about 1.4, optionally at least about 1.5, optionally at least about 1.6, optionally at least about 1.7, optionally at least about 1.8, optionally at least about 1.9, optionally at least about 2.0, optionally greater than about 2.

[0557] In some exemplary configurations, the second ratio is approximately 1.

[0558] refer to Fig.13 and Fig.14The first fork 111 has a first terminal end 111b adjacent to the first opening 111a, and the second fork 112 has a second terminal end 112b adjacent to the second opening 112a.

[0559] refer to Fig.14 (a), the first terminal end 111b includes a substantially fan-shaped surface. Fig.14 (a) and Fig.14 In (c), the sector surface is represented by the dot-dash line A.

[0560] In the configuration shown, the lower portion of the scalloped surface is concave when viewed from the outside of the first prong 111 in a direction toward the opening 111a. The upper portion of the scalloped surface may be convex when viewed from the outside of the first prong in a direction toward the opening 111a. The combination of the concave lower portion and the convex upper portion together provide the overall zigzag shape.

[0561] refer to Fig.14 (b) and Fig.14 (c), the second terminal end 112b has an inconspicuous fan-shaped surface. Fig.14 (b) and Fig.14 The face is indicated by a dashed line B in (c) of FIG. Although the face of the second terminal end is concave when viewed from the outside of the second prong 112 in a direction toward the opening 112a, the degree of concavity or scalloping is less than that of the first prong 111. In some configurations, the face of the second prong can be substantially planar.

[0562] The scalloped surface of the first nasal prong 111 can provide many advantages. Compared with a plane surface, the first nasal prong 111 can be deformed or distorted more easily because it has a lower structural rigidity. This makes the larger prong more comfortable in the patient's nasal passage. Since the smaller second nasal prong 112 has more clearance in the patient's nasal cavity, the nasal prong 112 does not need to be deformed. Due to the scalloped surface, the gas does not leave the nasal prong through the small hole as a jet. The fan provides a larger area of ​​the outlet opening at the outlet of the prong, so that the speed of the gas or the air speed is reduced at the point where the gas leaves the nasal prong. That is, the size of the outlet hole (defined by the edge or perimeter of the cutout section) is greater than the size or cross-sectional area of ​​the inlet hole of the nasal prong, and the size or cross-sectional area of ​​the inlet hole is defined by the base of the nasal prong connected to the facial mounting portion 110. The air velocity of the gas decreases as the area increases. That is, the prong is shaped so that the speed of the gas leaving the nasal prong is reduced compared to the gas speed at or near the gas inlet point entering the nasal prong. This allows a proportionally larger amount of gas to be delivered to the patient (compared to a nasal prong that does not include a scalloped surface) without causing discomfort. The air jet effect is reduced by the scalloped surface. The jet of airflow is reduced by the continuity equation based on the conservation of energy or mass, which states that an increase in cross-sectional area is equivalent to a decrease in airflow velocity. The jet of gas delivered to the user's nasal passages may irritate or potentially damage tissue within the nasal passages. The reduction in the velocity of the gas stream delivered by the nasal prongs reduces irritation within the user's nostrils, thereby reducing the jet effect. It can also be seen from the continuity equation that the larger the hole through which the gas flows, the greater the amount of diffusion. The gas stream is directed in a generally backward direction (relative to the patient's head) relative to the patient's nasal passages. These effects may be more beneficial to the larger first nasal prong 111 than to the smaller second nasal prong 112 (which has more clearance in the nostrils during use).

[0563] In some configurations, the nasal interface 100 can be configured such that the gas velocities exiting the first prong 111 and the second prong 112 are substantially similar. The benefits of having substantially similar exit velocities are patient comfort and low noise levels. Patient comfort may be due to reducing or avoiding the jetting of gas flow into the sensitive interior of the nostrils. In some configurations or applications, the nasal interface 100 disclosed herein may have a lower average exit velocity than a symmetrical nasal interface at the same flow rate, but may be considered more comfortable due to the reduction in the work of breathing. The reduction in the work of breathing may be due to the nasal interface 100 having greater dead space clearance relative to a symmetrical nasal interface at the same flow rate.

[0564] For example, refer to Figure 3 , Figure 4A, FIG. 12( a ), and FIG. 12( b ), in some configurations, the nasal interface 100 of the present disclosure includes: a gas inlet 121, a first fork 111 and a second fork 112 that are asymmetric to each other, and a gas flow path 122 from the gas inlet 121 to the first fork 111 and the second fork 112, and wherein the first fork 111 has a first fork outlet 111a and the second fork 112 has a second fork outlet 112a. The inner cross-sectional area A1 of the first fork 111 in a direction GFD1 transverse to the gas flow through the first fork 111 is greater than the corresponding inner cross-sectional area A2 of the second fork 112. For a given gas flow rate at the gas inlet 121 in use, different gas flow rates are provided through the first fork 111 and the second fork 112, and the speeds at which the gas leaves the first fork outlet 111a and the second fork outlet 112a are substantially similar.

[0565] The velocities referred to in this section may be average velocities of gas leaving the respective first and second forked outlets 111a, 112a, rather than velocity profiles or peak velocities. In some configurations, these velocities may be peak velocities.

[0566] In some configurations, the nasal interface is a non-sealing nasal interface.

[0567] Although different gas flow rates are provided through the first and second prongs 111, 112, the larger first prong 111 has a larger flow rate, and the smaller second prong 112 has a smaller flow rate, such that the exit velocities from each prong are substantially similar.

[0568] In some configurations, the velocity of the gas exiting the first prong outlet 111a is within about 20% of the velocity of the gas exiting the second prong outlet 112a.

[0569] In some configurations, the velocity of the gas exiting the first prong outlet 111a is within about 16% of the velocity of the gas exiting the second prong outlet 112a.

[0570] In some configurations, at flow rates above about 42 lpm, the velocity of gas exiting the gas outlet 111a is within about 10% of the velocity of gas exiting the second prong outlet 112a.

[0571] The inventors have discovered a substantially linear trend between the total volumetric flow rate of the gas flow into the gas inlet 121 and the speed at which the gas leaves the first and second forked outlets 111a, 112a. That is, for a given increase in the total volumetric flow rate of the gas flow into the gas inlet, there is a corresponding increase in the average gas flow out of the two outlets 111a, 112a.

[0572] In some configurations, for a total volumetric flow rate of gas flow into gas inlet 121 greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of first and second forked outlets 111a, 112a is greater than 0 m / s and less than about 32 m / s.

[0573] In some configurations, for a total volumetric flow rate of gas flow into gas inlet 121 greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of first and second forked outlets 111a, 112a is greater than 0 m / s and less than 32 m / s.

[0574] In some configurations, for a total volumetric flow rate of gas flow greater than 9 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first fork outlet 111a and the second fork outlet 112a is greater than about 2 m / s and less than about 32 m / s, optionally greater than about 2 m / s and less than 32 m / s, optionally greater than about 2 m / s and up to about 25 m / s, and optionally greater than about 2.5 m / s and up to about 20 m / s.

[0575] The exit velocity values ​​and relationships are related to the first prong 111 being farther from the gas inlet 121 and the second prong being closer to the gas inlet 121. If the configuration is reversed, depending on how balanced the gas manifold 120 is, the velocities may have a small change (e.g., less than about 20%) with the first prong 111 being closer to the gas inlet 121 and the second prong 112 being farther from the gas inlet 121. The first prong 111 may have a higher flow rate and a higher average exit velocity when it is farther from the gas inlet 121 than when it is closer to the gas inlet 121. The second prong 112 may have a higher flow rate and a higher average exit velocity when it is farther from the gas inlet 121 than when it is closer to the gas inlet 121.

[0576] The speeds described above are for a medium nasal interface 100'. The speeds for a small nasal interface 100 or a large nasal interface 100" may be proportionally reduced or increased from those values ​​as the inner cross-sectional area of ​​the fork varies.

[0577] In some configurations, the nasal interface 100 is configured such that the total volumetric flow rate of gas flow into the gas inlet 121 is at least about 5 liters per minute (lpm).

[0578] In some configurations, the nasal interface 100 is configured such that the total volumetric flow rate of gas flowing into the gas inlet 121 is between about 5 lpm and about 120 lpm.

[0579] In some configurations, the nasal interface 100 is configured such that the total volumetric flow rate of gas flowing into the gas inlet 121 is between about 5 lpm and about 70 lpm.

[0580] In some configurations, the nasal interface 100 is configured such that approximately 7 lpm is delivered out of the nasal interface 100 through the first prong 111 at a volumetric flow rate of approximately 9.5 lpm at the gas inlet 121, and / or such that approximately 13.5 lpm is delivered out of the nasal interface 100 through the first prong 111 at a volumetric flow rate of approximately 19 lpm at the gas inlet 121, and / or such that approximately 21 lpm is delivered out of the nasal interface 100 through the first prong 111 at a volumetric flow rate of approximately 29 lpm at the gas inlet 121, and / or such that approximately 38 lpm is delivered out of the nasal interface 100 through the first prong 111 at a volumetric flow rate of approximately 38 lpm at the gas inlet 121. .5lpm is delivered out of the nasal interface 100 through the first prong 111, and / or approximately 35lpm is delivered out of the nasal interface 100 through the first prong 111 at a volume flow rate of approximately 47.5lpm at the gas inlet 121, and / or approximately 44lpm is delivered out of the nasal interface 100 through the first prong 111 at a volume flow rate of approximately 58lpm at the gas inlet 121, and / or approximately 48.5lpm is delivered out of the nasal interface 100 through the first prong 111 at a volume flow rate of approximately 64lpm at the gas inlet 121.

[0581] The remainder of the gas flow volumetric rate will typically be delivered out of the nasal interface through the second prong 112. Table 4 shows exemplary approximate flow rates.

[0582]

[0583]

[0584] Table 4

[0585] The nasal interface 100 can have any of the features or functionality described herein.

[0586] For example, refer to Figure 3 , Figure 4A , FIG. 12( a ), and FIG. 12( b ), in some configurations, the nasal interface 100 of the present disclosure includes: a gas inlet 121, a first fork 111 and a second fork 112 that are asymmetric to each other, and a gas flow path 122 from the gas inlet 121 to the first fork and the second fork. The inner cross-sectional area A1 of the first fork 111 in a direction GFD1 transverse to the gas flow passing through the first fork 111 is greater than the inner cross-sectional area A2 of the second fork 112 in a direction GFD2 transverse to the gas flow passing through the second fork 112. The first fork 111 is downstream of the gas flow path 122 of the second fork 112.

[0587] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow through the respective forks. Alternatively, the direction transverse to the gas flow may be at an acute or obtuse angle relative to the gas flow through the respective forks 111 , 112 .

[0588] The gas flow path 122 is defined by a flow channel or lumen 124 in the gas manifold 120. The gas flow direction GFD3 of the gas flow path 122 is substantially perpendicular to the gas flow directions GFD1, GFD2 of the gas flow paths through the first fork 111 and the second fork 112. The first fork is farther from the gas inlet 121, while the second fork is closer to the gas inlet 121.

[0589] exist Figure 3 In the configuration shown, a first section 124a of a flow channel or lumen in the gas manifold 120 has a large first vertical dimension V1. The opposite end of the flow channel or lumen forms a flow cavity 124b in the cannula body 118 that delivers gas to the first prong 111 and the second prong 112. When the gas manifold 120 is in place in the cannula body 118, the flow cavity 124b is in fluid communication with the flow passageway through the first prong 111 and the second prong 112. At least a portion of the flow cavity 124b has a vertical dimension V2 that is less than the first vertical dimension V1.

[0590] The gas manifold 120 includes one or more internal angled walls to provide size reduction and direct the gas flow into the first prong 111 and / or the second prong 112 .

[0591] The gas manifold 120 is configured to not obstruct any portion of the interior cross-section of either fork 111, 112. In alternative configurations, the manifold may be configured to partially obstruct the interior cross-section of one or both of the forks 111, 112.

[0592] Bench tests have shown that the anatomical dead space is reduced when the larger first prong 111 is further away from the gas inlet 121 and the smaller second prong 112 is closer to the gas inlet 121, as shown in FIG. Fig.11 This is a result of having opposing angled walls in the manifold that help direct the gas into the larger first prong 111.

[0593] exist Fig.11 In the test, references to M, L, XL, and XXL relate to the size of the prongs used in the nasal interface in the test. For example, L+M refers to a nasal interface with a large prong and a medium prong, XL+M refers to a nasal interface with an extra-large prong and a medium prong. XXL+M refers to a nasal interface with an extra-extra-large prong and a medium prong.

[0594] As outlined above, the nasal interface can be configured such that at least about 60% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 60% to about 90% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 60% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 65% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 70% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, The fork 111 is delivered out of the nasal interface, optionally so that about 70% to about 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 70% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 75% to about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally so that about 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111.

[0595] In some configurations, the nasal interface 100 disclosed herein includes a cannula body 118 including a first prong 111 and a second prong 112 that are asymmetric to each other and a gas manifold 120 having a gas inlet 121. The first prong 111 and the second prong 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to achieve an asymmetric gas flow at the patient's nostrils.

[0596] The cannula body 118 includes a first fork 111 and a second fork 112. The gas manifold 120 can be reconfigured relative to the cannula body 118 to be in a first configuration as shown in Figures 12(a) and 12(b), and in a second configuration as shown in Figures 12(c) and 12(d). The first configuration corresponds to the gas manifold 120 being inserted into the cannula body 118 from a first side of the cannula body 118, so that the second fork 112 is closer to the gas inlet 121 and the first fork 111 is farther away from the gas inlet 121. The second configuration corresponds to the gas manifold 120 being inserted into the cannula body from a second side of the cannula body 118, so that the first fork 111 is closer to the gas inlet 121 and the second fork 112 is farther away from the gas inlet 121.

[0597] The gas manifold may include a flow channel or lumen having a gas flow direction GFD3 that is substantially perpendicular to the gas flow directions GFD1 , GFD2 through the first and second prongs 111 , 112 .

[0598] The cannula body 118 and / or the gas manifold 120 may include retaining feature(s) to removably retain the gas manifold 120 in engagement with the cannula body 118 in the first and second configurations.

[0599] In the illustrated configuration, these retaining features include a resilient annular portion 118c of the cannula body that is received in a complementary recess 120a of the gas manifold to removably retain the gas manifold 120 in engagement with the cannula body 118. The resilient annular portion 118c may flex to enable the gas manifold 120 to be removed from the cannula body 118. The annular portion may be circular or non-circular in shape.

[0600] Additionally or alternatively, such as Figure 3 As shown, the gas manifold 120 may include a retaining flange 120b around its face that is removably received in a complementary resilient rim 118d of the cannula body 118. The engagement of the retaining flange 120b with the complementary resilient rim 118d of the cannula body 118 helps to form a seal between the gas manifold 120 and the cannula body 118.

[0601] For example, any other suitable type of retaining feature(s) may be used, such as clips or fasteners.

[0602] The side swap of the gas manifold 120 relative to the cannula body 118 enables the user to adjust which side the gas conduit 300 is on based on comfort and the location of the respiratory therapy device. In addition, the side swap enables the selection of an asymmetric amount of gas flow from the forks 111, 112, which can be beneficial depending on the desired application or patient requirements.

[0603] In some configurations, the nasal interface 100 disclosed herein includes a first prong 111 and a second prong 112, and a gas manifold 120 having a gas inlet 121. The first prong 111 and the second prong 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to achieve an asymmetric gas flow at the patient's nostrils. The gas inlet 121 is in fluid communication with the ventilating tube.

[0604] For example, the conduit 300 may include a permeable tube. A permeable tube is a tube whose wall is permeable to water vapor, but liquid water and a large amount of gas cannot pass through the wall of the tube. For example, water vapor may be able to pass through the material and / or sealing skin of the wall of the tube, but liquid water and a large amount of gas cannot flow through the material and / or sealing skin of the wall of the tube.

[0605] The catheter 300 may be made, for example, of an open-cell foam material having a sealed skin.

[0606] In an alternative configuration, catheter 300 may include a membrane. Fig.22A An exemplary method for manufacturing a single-walled breathable tube is schematically shown. This method may be particularly suitable for thin-walled catheters. A film 306 is arranged in a spiral or helix shape so that the edge portions of adjacent layers overlap and form the wall of the breathing gas conduit 300. A reinforcing element is inserted into the overlapping edges of adjacent windings of the film 306, the reinforcing element comprising a bead 303 of a polymer material that is bonded to the overlapping portion of the film 306 to seal the joint between the windings and form a continuous breathing gas conduit 300. A seam is formed between the edge 305 of the first film layer 306 and the edge 307 of the second adjacent film layer 306, and when the polymer bead 303 melts, the second film layer covers the top of the bead. The overlapping layers of the film, being so thin, follow the contour of the bead 303 very closely and produce a smooth inner wall of the conduit. In Fig. 22B In another alternative schematically shown, the bead 303 is not interposed between the overlapping edges of adjacent windings of the film 306, but is disposed on two layers on the outer surface of the film 306. More specifically, the film 306 is first arranged in a spiral or spiral shape so that the edges of adjacent layers partially overlap. Next, a bead 303 of polymer material is disposed on the overlapping edges of the film 306 to form the breathing gas conduit 300. In some configurations, the bead 303 can be disposed on the inner surface of the film 306, whereby the bead 303 is exposed to the lumen of the gas conduit 300. In such a configuration, the elongated film is wrapped around the outside of the bead 303 so that the bead 303 interacts with the lumen of the gas conduit 300, and the film 306 forms the outer surface of the gas conduit 300.

[0607] The conduit 300 may have any one or more features outlined in U.S. Patent Application Publication No. 2019 / 0224439, entitled “Breathing Circuit Components for Respiratory Apparatus” and U.S. Patent Application Publication No. 2017 / 0304578, entitled “Tube for Medical System”. The contents of these specifications are incorporated herein by reference in their entirety.

[0608] In an alternative configuration, the tube between the patient conduit 300 and the gas inlet 121 may include a gas permeable tube. The gas permeable tube fluidly connects the patient conduit 300 with the gas inlet 121.

[0609] The gas manifold 120 may be formed integrally with the gas permeable tube or may be coupled with the gas permeable tube.

[0610] When the patient interface is used with humidified gases, it is beneficial that the gas inlet 121 is in fluid communication with the vent tube. The vent tube allows high levels of humidity to be achieved while reducing the risk of rainwash forming condensation in the flow path.

[0611] For the nasal interfaces 100, 100', 100" of the present disclosure, if the fork inner diameter ID1 is greater than the manifold 120 width, a portion of the interior of the forks 111, 112 is restricted and there may be increased noise levels. The gas manifold 120 is advantageously configured such that the manifold width is equal to or greater than the fork inner diameter ID1.

[0612] Fig. 9 (a) and Fig. 9 (b) shows an exemplary gas manifold 120 that can be used with a small nasal interface 100. The width W of the gas flow path 122 adjacent to the first fork 111 and the second fork 112 is equal to or greater than the inner diameter ID1 of the first fork 111. For example, the width W of the gas flow path 122 can be at least about 1.2x the inner diameter ID1 of the first fork 111. Exemplary dimensions are ID1 = 5.6 mm and W = 6.8 mm, but it should be understood that these dimensions can vary.

[0613] Fig.10 (a) and Fig.10 (b) shows an exemplary gas manifold 120' that can be used with the medium nasal interface 100' or the large nasal interface 100". The same reference numerals indicate the same parts of the gas manifold 120, but with the addition of an apostrophe ('). The width W' of the gas flow path 122', adjacent to the first fork 111' and the second fork 112' during use, is equal to or greater than the inner diameter ID1 of the first fork 111' of the medium nasal interface 100'. For example, the width W' of the gas flow path 122' can be at least about 1.04x the inner diameter ID1 of the first fork 111'. Exemplary dimensions are ID1=7.5mm and W'=7.8mm, but it should be understood that these dimensions can vary.

[0614] The gas manifold 120' may also be used with a large nasal interface 100" while still reducing noise, even though the inner diameter of the first prong 111" of the large nasal interface 100" may be larger than the width W", such as 9.4 mm.

[0615] It should be appreciated that these are merely exemplary dimensions and that the dimensions of the prongs of the nasal interface 100, 100', 100" and the gas manifold 120, 120' may vary.

[0616] The nasal interfaces 100, 100', 100" described herein may have any one or more of the features and / or functionality described in PCT Publication No. WO 2015 / 020540 or US Pat. No. 10,569,043. The contents of these specifications are incorporated herein by reference in their entirety.

[0617] In the configuration shown, the larger first nasal prongs 111, 111', 111" are on one side of the cannula body 118, and the smaller second nasal prongs 112, 112', 112" are on the other side of the cannula body 118. It should be understood that these prongs can be interchanged so that they are on the opposite side from that shown. Alternatively, the nasal interface 100, 100', 100" can be designed in a manner so that the left nasal prong and the right nasal prong can be interchanged.

[0618] When using the nasal interface 100, 100', 100", the pressure and flow in the nostrils can be measured and controlled simultaneously or separately. The flow in one nostril can be continuous, while the flow in the other nostril varies according to the breathing cycle. Different interfaces (each interface delivering an asymmetric flow in the nose) can be used to continuously deliver supplemental oxygen and to deliver continuous or variable nasal high flow. One nasal prong element can be used to deliver oxygen, gas, aerosol, etc. to the patient, while another nasal delivery prong can be used to deliver a higher air flow, or a different flow of oxygen, gas, aerosol, etc. to the patient. Each nasal delivery element can supply a different flow to the patient and can be connected to a different flow generating element.

[0619] The respiratory therapy system disclosed herein having a nasal interface 100, 100', 100" can improve the performance of NHF therapy, particularly in therapy delivered to infants and children. The nasal interface of the present disclosure can reduce resistance compared to existing nasal interfaces and can expand and improve the functionality of respiratory devices without modifying hardware or software.

[0620] Asymmetric flows useful herein can be provided by a nasal interface using any form of pressure support, such as continuous positive airway pressure (CPAP) or non-invasive therapy (NIV). During therapy with increased airway pressure, anatomical dead space can be cleared by unidirectional flow through the nose, where one nostril can be sealed or used to inhale from the device without entraining room air, while the other nostril can be used for exhalation.

[0621] One prong, and therefore one nostril, can be connected to the inspiratory limb of a double-limb ventilator circuit or a single-limb circuit, such as the breathing tube in a CPAP blower. The other prong, and therefore the other nostril, can be connected to a conventional ventilation hole in the interface to achieve bias flow, or to the expiratory limb in a double-limb circuit ventilator. The expiratory limb connected to the ventilator can allow the use of flow changes to control breathing in periodic breathing or central sleep apnea due to carbon dioxide clearance in the upper airway or rebreathing of the expiratory limb.

[0622] Opening the mouth can reduce the pressure delivered to the patient and can improve the clearance of anatomical dead space. A suction nozzle can be inserted to maintain the leak, and the nozzle can be further connected to a negative pressure line or expiratory limb to increase or control the clearance of dead space. The amount of leak can be configurable to control the amount of pressure.

[0623] To achieve a comfortable asymmetric flow, high levels of humidity (such as that provided by a so-called AIRVO TM or ICON TM (AIRVO TM is a humidifier with an integrated flow generator device, and the ICON TM The CPAP device manufactured by Fisher & Paykel Healthcare Inc. delivers a CPAP device to prevent drying of the nasal epithelium. A comfortable temperature and dew point level may be determined based on the ratio and may be, but is not limited to, within the range of 27°C-37°C, optionally 31°C-37°C, optionally 33°C-37°C, and may depend on the flow rate.

[0624] In some configurations, the system is configured to deliver gas through the nasal interface at a relative humidity of up to 100%.

[0625] In some configurations, the system is configured to deliver gas through the nasal interface at an absolute humidity greater than about 33 mg / l. In some configurations, the system is configured to deliver gas through the nasal interface at an absolute humidity up to about 44 mg / l.

[0626] One or both nasal prongs may be provided with fittings, such as but not limited to sleeves and inserts, to optimize NHF therapy. A sleeve as described herein refers to any structure added to the exterior of a nasal delivery element of a nasal interface. An insert as described herein refers to any structure added to the interior of a nasal delivery element of a nasal interface.

[0627] NHF therapy can be improved or optimized to deliver a desired pressure curve and effectively clear anatomical dead space. A nasal delivery element with a smaller diameter of a nasal interface can produce a jet with a higher velocity, which can clear the patient's dead space more effectively than a nasal delivery element with a larger diameter. Effectively clearing the dead space reduces the amount of carbon dioxide rebreathing that occurs. However, a larger diameter can reduce leakage that occurs around the nasal delivery element of the nasal interface and can produce higher delivery pressures during inspiration and exhalation. In acute situations, especially when the patient is suffering from respiratory distress, a larger diameter may be more preferred because higher expiratory pressures may reduce respiratory rate and improve ventilation.

[0628] By adding a fitting to the nasal delivery element of the nasal interface, it is possible to have a nasal delivery element that combines a smaller inner diameter with a larger outer diameter to improve or optimize dead space clearance while maintaining high pressure at the same flow rate. A nasal delivery element with a combination of a large outer diameter and a smaller inner diameter can have a similar pressure effect to a nasal delivery element with a large diameter and no insert, while the smaller inner diameter can provide a lower pressure. If the outer diameter is too large for the patient, the inspiratory pressure may become negative because the flow from the interface may be lower than the peak inspiratory flow.

[0629] It is generally undesirable to increase the wall thickness of the nasal delivery element because it may be hard in the patient's nose, which may damage the inner surface of the nostril and cause patient discomfort. However, by attaching different fittings to the interface, it is possible to benefit from a combination of inner and outer diameters while still providing the patient with a soft nasal delivery element to fit into the nostril, thereby maintaining patient comfort.

[0630] For example, by adding a sleeve to the nasal delivery element of a nasal interface, the inner diameter of the nasal delivery element remains the same and can allow a jet effect to be obtained to effectively clear anatomical dead space, while the outer diameter has been increased to reduce leakage around the nasal delivery element and can produce higher pressure fluctuations during breathing. Once the desired therapy has been delivered, or higher pressure is no longer needed, the added sleeve can be removed. The sleeve can also be used as a one-way valve, which can expand during exhalation and increase the expiratory pressure. In order to inhibit or prevent condensate accumulation, semi-permeable materials can be used, leaks can be introduced, or a combination of these can be used. A sleeve can also be added to the interface to reduce the outer diameter and thereby also reduce the inner diameter, which can increase the jet effect, deviate or split the flow from the center of the nasal delivery element to the periphery, or these can be combined.

[0631] A second example is to add an insert within the nasal delivery element. This can reduce the inner diameter to reduce pressure and increase dead space clearance while keeping the outer diameter the same. The smaller inner diameter increases the jet effect, deviates or splits the flow from the center of the nasal delivery element to the periphery, or can combine the flow jet effect with deviating or splitting the flow from the center of the nasal delivery element to the periphery.

[0632] Other configurations may include using a fitting that can block the nasal delivery element, allowing the NHF to be delivered to the patient through an unblocked nasal delivery element, using a fitting that can allow an asymmetric flow to occur, or fittings that can make an asymmetric interface symmetric. Adding a sleeve that is already separately fitted to the patient can reduce the operating flow, which can achieve reduced noise, reduced use of supplemental oxygen, improved patient comfort, etc. Reduced operating flow can also allow for less heating, water usage, etc. Only one interface is required per patient, and it can be specially fitted to the patient to change pressure or dead space clearance.

[0633] Fig. 20 Test results of the nasal interface of the present disclosure are shown.

[0634] Fig. 20 (a) shows how the nasal interface 100, 100', 100" of the present disclosure can be used to achieve an increased obstruction area while still maintaining a safe gap in one nostril. In the event of a device or system failure, the patient can still breathe through the nostril and maintain a safe gap.

[0635] Fig. 20 (b) shows test data showing increased positive end-expiratory pressure (PEEP) and reduced rebreathing using a nasal interface with asymmetric prongs of the present disclosure compared to a nasal interface with symmetric prongs when a nasal high flow of 30 liters / minute (lpm) is applied. The data shows a rebreathing pattern with a respiratory rate of 15 breaths per minute and 35 breaths per minute and an I:E ratio of 0.69, where I:E is the ratio of inspiratory time to expiratory time. The dotted line represents rebreathing that occurs when no nasal high flow is applied.

[0636] Fig. 20 (c) shows a similar Fig. 20 (b) but for a nasal high flow of 60 lpm. The data shows a rebreathing pattern with a respiratory rate of 15 breaths per minute and 35 breaths per minute and an I:E ratio of 0.69, where I:E is the ratio of the inspiratory time to the expiratory time. The dotted line represents the rebreathing that occurs when no nasal high flow is applied.

[0637] The data indicate that nasal high flows delivered via a nasal interface of the present disclosure with increased obstruction can produce greater positive airway pressure and dead space clearance and reduced rebreathing compared to a nasal interface with symmetrical prongs.

[0638] Fig.21 Shown are the maximum airway pressures that can be achieved with each size of nasal interface of the present disclosure when the larger prong completely blocks one of the patient's nostrils.

[0639] More specifically, Fig.21 The airway pressure that can be achieved under static conditions for each size of nasal interface 100, 100', 100" is shown when the larger prong completely blocks one of the patient's nostrils. This represents the maximum possible obstruction of each nasal interface 100, 100', 100", and thus represents the maximum pressure that can be achieved under static conditions.

[0640] The data shows that even at maximum flow, with possible user error resulting in the use of an incorrectly sized nasal interface 100, 100', 100", the maximum pressure under static conditions is still within a safe range.

[0641] In the nasal interface 100, 100', 100" of the present disclosure, the first fork 111 has a shape, and the second fork 112 has a shape. The inner diameter ID1 and / or the inner cross-sectional area A1 of the first fork 111 in a direction GFD1 transverse to the gas flow passing through the first fork 111 are greater than the inner diameter ID2 and / or the inner cross-sectional area A2 of the second fork 112 in a direction GFD2 transverse to the gas flow passing through the second fork 112. At least the first fork 111 can be made of an elastomeric material so that the first fork can deform and set its shape in response to temperature and contact with the patient's nostrils during use. That is, the first fork 111 is configured to deform and set its shape in response to temperature and contact with the patient's nostrils when the nasal interface 100, 100', 100" is in use.

[0642] In some configurations, the temperature can be between about 20° C. and about 41° C., optionally above 20° C. and up to about 41° C., optionally between about 31° C. and about 41° C., optionally between about 36° C. and about 39° C., optionally about 37° C., or any other suitable temperature experienced during therapy. The temperature is typically above ambient temperature.

[0643] In some configurations, the first prong 111 can be configured to deform and set its shape to substantially match the interior shape of the patient's nostril during use. In alternative configurations, the first prong 111 can be configured to bend or deform to set its shape in response to temperature and contact with the patient's nostril, but may not substantially match the interior shape of the patient's nostril after shape setting. For example, one or more discrete portions of the outer surface of the first prong 111 can contact one or more discrete areas of the patient's nostril during use, causing the one or more discrete portions of the outer surface to deform and set its shape.

[0644] The deformation and shape setting may be permanent deformation. Alternatively, the deformation and shape setting may be reversible after applying a suitable combination of temperature and time.

[0645] The elastomeric material may exhibit time and temperature dependent properties at or below the desired therapy temperature to enable in-use shape setting of at least the first prong 111 to more appropriately fit the patient's nostril. For example, the elastomeric material may exhibit compression set properties to enable shape setting. The elastomeric material may also exhibit tensile deformation and / or stress relaxation properties that are typically associated with compression set properties. Elastomeric materials that exhibit compression set, tensile deformation, and / or stress relaxation properties at or below the therapy temperature may reduce discomfort that a user may experience due to the nasal prongs impacting the inner surface of the nostrils during therapy delivery.

[0646] The first fork 111 and the second fork 112 can both be made of an elastomeric material. In this configuration, the first fork 111 and the second fork 112 can both be deformed and set in shape during use. The cannula body 118, the first fork 111 and the second fork 112 can be made of an elastomeric material. Alternatively, the second fork 112 can be made of a different material.

[0647] The elastomeric material allows at least the larger first prong 111, and optionally the second prong 112, to deform and set its shape in relation to contact between the outer side of the prong(s) and the interior of the patient's nostril in use.

[0648] Since the larger first prong 111 can be sized to have a smaller gap than the symmetrical prongs, deforming and shaping the first prong 111 during use to at least partially fit into the patient's nostril can improve comfort.

[0649] To achieve this performance, at least the first prong 111 of the patient interface, and optionally both prongs 111, 112 of the patient interface, are made of an elastomeric material such that the prong(s) are able to deform and set their shape at a temperature equal to or lower than the temperature of the gas flow passing through the prong(s) 111, 112 of the nasal interface. The material can be selected to be incapable of shape setting at ambient temperature such that the prong(s) do not set their shape when the nasal interface 100, 100', 100" is not in use.

[0650] In some configurations, the elastomeric material enables the first prong to deform and set its shape to substantially match the internal shape of the patient's nostril at a therapy temperature between about 31°C and about 41°C, optionally between about 36°C and about 39°C, and optionally about 37°C.

[0651] In some configurations, the first prong 111 is not made of, and does not include, silicone because it cannot be shape-set at therapy temperatures.

[0652] In some configurations, at least the first prong 111 is made of a thermoplastic elastomer.

[0653] In some configurations, the elastomeric material exhibits a compression set of between about 10% and about 50% after 72 hours at a temperature of between about 20°C and about 40°C when tested according to Method A of ISO 815-1:2014.

[0654] In some configurations, the elastomeric material exhibits a compression set of between about 10% and about 45%, optionally between about 10% and about 40%, optionally between about 10% and about 35%, optionally between about 10% and about 30%, optionally between about 10% and about 25%, optionally between about 10% and about 20%, optionally between about 11% and about 19%, optionally between about 12% and about 18%, optionally between about 13% and about 17%, optionally between about 14% and about 16%, optionally about 15% at a temperature between about 20°C and about 40°C after 72 hours when tested in accordance with Method A of ISO 815-1:2014.

[0655] In some configurations, the elastomeric material is 815-1:2014, method A, exhibits a compression set of between about 10% to about 45%, optionally between about 10% to about 40%, optionally between about 10% to about 35%, optionally between about 10% to about 30%, optionally between about 10% to about 25%, optionally between about 10% to about 20%, optionally between about 11% to about 19%, optionally between about 12% to about 18%, optionally between about 13% to about 17%, optionally between about 14% to about 16%, optionally about 15% after 72 hours at a temperature above about 20°C up to about 35°C, optionally at a temperature of about 21°C or about 22°C or about 23°C or about 24°C or about 25°C or more.

[0656] The elastomeric material may be selected so that shape setting occurs at about 23°C or higher (generally above ambient temperature but below use temperature).

[0657] The elastomeric material may include any elastomer that exhibits shape-setting properties at the therapeutic temperature. In some configurations, the elastomeric material is from Kraiburg TPE GmbH & Co. KG. K TF3STE-TPE.

[0658] In addition to the elastomeric material, the nasal interface 100, 100', 100" may additionally have any one or more of the features described herein.

[0659] A patient interface 1 having a nasal interface 100, 100', 100" configured according to the present invention can be used in a respiratory therapy method. The respiratory therapy method includes: delivering gas to the airway of a patient in need, improving ventilation of a patient in need, reducing the volume of anatomical dead space within the airway volume of a patient in need, and / or treating a respiratory condition in a patient in need, as described above.

[0660] A patient interface 1 including a nasal interface 100 , 100 ′, 100 ″ of the type disclosed herein may be used in a respiratory therapy system to deliver gases to a patient.

[0661] In some configurations, the respiratory therapy system 1000 includes a respiratory therapy device 1100 and a patient interface 1 having a nasal interface 100 , 100 ′, 100 ″.

[0662] Fig.15 An exemplary respiratory therapy device 1100 is shown.

[0663] The respiratory therapy device 1100 includes a main housing 1101 that houses a flow generator 1011 (e.g., a blower) in the form of a motor / impeller arrangement, an optional humidifier 1012 for humidifying gases, a controller 1013, and a user interface 1014 (including, for example, a display and (multiple) input devices, such as (multiple) buttons, a touch screen, etc.).

[0664] The controller 1013 may be configured or programmed to control the operation of the device. For example, the controller may control components of the device, including, but not limited to: operating the flow generator 1011 to generate a gas flow (flows of gases) for delivery to the patient; operating the humidifier 1012 (if present) to humidify and / or heat the generated gas flow; controlling the flow of oxygen into the flow generator blower; receiving user input from the user interface 1014 to reconfigure and / or user-defined operations of the device 1000; and outputting information to the user (e.g., on a display).

[0665] The user may be a patient, a healthcare professional, or any other person interested in using the device. As used herein, "gas flow" may refer to any gas flow that may be used in a respiratory assistance or breathing apparatus, such as an ambient air flow, a flow containing substantially 100% oxygen, a flow containing some combination of ambient air and oxygen, and the like.

[0666] One end of the patient breathing conduit 300 is coupled to a gas outflow port 1021 in a housing 1100 of a respiratory therapy device 1100. The other end of the patient breathing conduit 300 is coupled to a nasal interface 100 having a gas manifold 120 and nasal prongs 111,112.

[0667] The gas flow generated by the respiratory therapy device 1100 can be humidified and delivered to the patient through the nasal interface 100 via the patient conduit 300. The patient conduit 300 can have a heater to heat the gas flow flowing to the patient. For example, the patient conduit 300 can have a heating wire 300a to heat the gas flow flowing to the patient. The heating wire 300a can be controlled by the controller 1013. The patient conduit 300 and / or the nasal interface 100 can be considered as part of the respiratory therapy device 1100, or alternatively on its periphery. The respiratory therapy device 1100, the respiratory conduit 300, and the patient interface 1 including the nasal interface 100 can form a respiratory therapy system 1000.

[0668] Controller 1013 can control flow generator 1011 to generate gas flow with desired flow rate. Controller 1013 can also control supplementary oxygen inlet to allow delivery of supplementary oxygen, humidifier 1012 (if present) can humidify gas flow and / or heat gas flow to appropriate level, etc. Gas flow is guided to the patient through patient conduit 300 and nasal interface 100. Controller 1013 can also control the heating element in humidifier 1012 and / or the heating element 300a in patient conduit 300 to heat gas to desired temperature to achieve patient's desired treatment level and / or comfort level. Controller 1013 can be programmed with suitable target temperature of gas flow or can determine suitable target temperature of gas flow. In some configurations, administration of gas mixture composition and / or therapeutic drug including supplementary oxygen can be provided through supplementary oxygen inlet. The gas mixture composition may include oxygen, heliox, nitrogen, nitric oxide, carbon dioxide, argon, helium, methane, sulfur hexafluoride, and combinations thereof, and / or the supplemental gas may include aerosolized medication.

[0669] The oxygen inlet port 1028 may include a valve 1028a through which the pressurized gas can pass into the flow generator or blower. The valve can control the flow of oxygen into the flow generator blower. The valve can be any type of valve, including a proportional valve or a two-position valve. The oxygen source can be an oxygen tank or a hospital oxygen supply. The purity of medical grade oxygen is generally between 95% and 100%. A lower purity oxygen source can also be used. Examples of valve modules and filters are disclosed in PCT Publication No. WO 2018 / 074935 and U.S. Patent Application Publication No. 2019 / 0255276 (both of which are entitled "Valve Modules and Filters"). The contents of these specifications are incorporated herein by reference in their entirety.

[0670] Respiratory therapy device 1100 can measure and control the oxygen content of the gas delivered to the patient, and therefore measure and control the oxygen content of the gas inhaled by the patient. During high flow therapy, the high flow of the gas delivered meets or exceeds the peak inspiratory demand of the patient. This means that the volume of gas delivered to the patient by the device during inhalation meets or exceeds the volume of gas inhaled by the patient during inhalation. Therefore, high flow therapy helps to prevent the inclusion of ambient air when the patient exhales, and washes out the exhaled gas in the patient's airway. As long as the flow of the gas delivered meets or exceeds the peak inspiratory demand of the patient, the possibility of entraining ambient air is reduced, and the gas delivered by the device is typically substantially the same as the gas inhaled by the patient. Thus, the oxygen concentration measured in the device (delivered oxygen fraction (FdO2)) will be substantially the same as the oxygen concentration (inhaled oxygen fraction (FiO2)) breathed by the user, and thus such terms can be regarded as equivalent.

[0671] Operational sensors 1003a, 1003b, 1003c (such as flow sensors, temperature sensors, humidity sensors, and / or pressure sensors) can be placed in various locations in the respiratory therapy device 1100. Additional sensors (e.g., sensors 1020, 1025) can be placed in various locations on the patient conduit 300 and / or nasal interface 100 (e.g., there can be a temperature sensor 1029 at or near one end of the inspiratory tube). The outputs from the sensors can be received by the controller 1013 to assist the controller in operating the respiratory therapy device 1100 in a manner that provides appropriate therapy. In some configurations, providing appropriate therapy includes meeting the patient's respiratory demand, optionally the patient's peak inspiratory demand. The device 1100 may have a transmitter and / or receiver 1015 to enable the controller 1013 to receive signals 1008 from the sensor and / or control various components of the respiratory therapy device 1100, including but not limited to the flow generator 1011, the humidifier 1012, and the heating wire 300a or accessories or peripherals associated with the respiratory therapy device 1100. Additionally or alternatively, the transmitter and / or receiver 1015 may deliver data to a remote server or enable remote control of the device 1100.

[0672] After the oxygen and ambient air have been mixed, the oxygen can be measured by placing one or more gas composition sensors (such as an ultrasonic transducer system, also referred to as an ultrasonic sensor system). The measurement can be made within the device, delivery catheter, patient interface, or at any other suitable location.

[0673] The respiratory therapy device 1100 may include a patient sensor 1026 (such as a pulse oximeter or patient monitoring system) to measure one or more physiological parameters of the patient (such as the patient's blood oxygen saturation (SpO2), heart rate, respiratory rate, perfusion index) and provide a measure of signal quality.

[0674] The sensor 1026 may communicate with the controller 1013 through a wired connection or through communication via a wireless transmitter on the sensor 1026 .

[0675] Sensor 1026 may be a disposable adhesive sensor designed to be attached to a patient's finger.Sensor 1026 may be a non-disposable sensor.

[0676] Sensors designed for different age groups and to be attached to different locations on the patient are available and can be used with respiratory therapy device 1100 .

[0677] The pulse oximeter will be attached to the user (typically at their finger), but other locations (such as the earlobe) are also an option. The pulse oximeter will be connected to a processor in the device and will continuously provide a signal indicative of the patient's blood oxygen saturation. Patient sensor 1026 may be a hot-swappable device that can be attached or interchanged during operation of respiratory therapy device 1100. For example, patient sensor 1026 may be connected using a USB interface or using a wireless communication protocol (e.g., such as near field communication, WiFi, or ) is connected to the respiratory therapy device 1100. When the patient sensor 1026 is disconnected during operation, the respiratory therapy device 1100 can continue to operate in its previous operating state for a defined period of time. After the defined period of time, the respiratory therapy device 1100 can trigger an alarm, transition from an automatic mode to a manual mode, and / or completely exit a control mode (e.g., an automatic mode or a manual mode). The patient sensor 1026 can be a bedside monitoring system or other patient monitoring system that communicates with the respiratory therapy device 1100 through a physical or wireless interface.

[0678] Respiratory therapy device 1100 may include high flow therapy device. High flow therapy discussed herein is intended to be given its typical common meaning understood by those skilled in the art, which generally refers to the following respiratory assistance system, which delivers humidified respiratory gas of target flow via an intentionally unsealed (non-sealed) patient interface with a flow rate that is generally intended to meet or exceed the patient's inspiratory flow rate. Typical patient interfaces include but are not limited to nasal or tracheal patient interfaces. The range of typical flow rates for adults is generally (but not limited to) about 15 liters / minute (lpm) to about 70 liters / minute or more. The range of typical flow rates for pediatric patients (such as newborns, infants and children) is generally (but not limited to) about one liter / minute / kilogram of patient weight to about three liters / minute / kilogram of patient weight or more. High flow therapy can also optionally include a gas mixture composition, which includes supplemental oxygen and / or administration of therapeutic drugs. High flow therapy is commonly referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT) or tracheal high flow (THF) and other common names. The flow rate used to achieve "high flow" can be any of the flow rates listed below. For example, in some configurations, for adult patients, 'high flow therapy' can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 lpm), such as between about 10 lpm and about 100 lpm, or between about 15 lpm and about 95 lpm, or between about 20 lpm and about 90 lpm, between about 25 lpm and about 75 lpm, or between about 25 lpm and about 85 lpm, or between about 30 lpm and about 80 lpm, or between about 35 lpm and about 75 lpm, or between about 40 lpm and about 70 lpm, or between about 45 lpm and about 65 lpm, or between about 50 lpm and about 60 lpm. In some configurations, for neonates, infants, or children, "high flow therapy" can refer to delivering gas to the patient at a flow rate greater than 1 lpm, such as between about 1 lpm and about 25 lpm, or between about 2 lpm and about 25 lpm, or between about 2 lpm and about 5 lpm, or between about 5 lpm and about 25 lpm, or between about 5 lpm and about 10 lpm, or between about 10 lpm and about 25 lpm, or between about 10 lpm and about 20 lpm, or between about 10 lpm and 15 lpm, or between about 20 lpm and 25 lpm. A high flow therapy device for an adult patient, neonate, infant, or child patient can deliver gas to the patient at a flow rate between about 1 lpm and about 100 lpm or at a flow rate in any of the sub-ranges listed above. The flow therapy device 1000 can deliver any concentration of oxygen (e.g., FdO2) up to 100% at any flow rate between about 1 lpm and about 100 lpm.In some configurations, any of these flow rates can be combined with an oxygen concentration (FdO2) of about 20% to 30%, 21% to 30%, 21% to 40%, 30% to 40%, 40% to 50%, 50% to 60%, 60% to 70%, 70% to 80%, 80% to 90%, and 90% to 100%. In some combinations, the flow rate can be between about 25 lpm and 75 lpm and combined with an oxygen concentration (FdO2) of about 20% to 30%, 21% to 30%, 21% to 40%, 30% to 40%, 40% to 50%, 50% to 60%, 60% to 70%, 70% to 80%, 80% to 90%, and 90% to 100%. In some configurations, the respiratory therapy device 1100 can include safety thresholds when operating in manual mode that prevent the user from delivering too much oxygen to the patient.

[0679] In some configurations, the respiratory therapy device 1100 includes a controller 1013; a blood oxygen saturation sensor 1026; an ambient air inlet 1027; an oxygen inlet 1028; a valve 1028a, which is fluidly connected to the oxygen inlet 1028 to control the flow of oxygen through the oxygen inlet 1028; and a gas outlet 1021; wherein the controller 1013 is configured to control the valve 1028a based on at least one oxygen saturation measurement from the blood oxygen saturation sensor 1026.

[0680] The patient interface 1 used with the respiratory therapy device 1100 in the respiratory therapy system 1000 includes a nasal interface 100, which includes: a first prong 111 and a second prong 112 that are asymmetric to each other; and a gas manifold 120, which includes a gas inlet 121, wherein the first prong 111 and the second prong 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to achieve an asymmetric gas flow at the patient's nostrils.

[0681] The first prong 111 and the second prong 112 are not symmetrical to each other, or are not symmetrical to each other, or are different in shape and configuration from each other, or are asymmetrical when compared to each other.

[0682] In some configurations, the nasal interface 100 includes a cannula body 118 having a first prong 111 and a second prong 112 .

[0683] In some configurations, the gas manifold 120 is integral with the cannula body 118 or is separate from the cannula body 118 and can be coupled thereto.

[0684] In some configurations, the first prong 111 and the second prong 112 are configured to engage the nasal passage in an unsealed (non-sealing) manner.

[0685] In some configurations, the first prong 111 and the second prong 112 allow exhaled gas to escape around the first prong and the second prong.

[0686] In some configurations, the first prong 111 and the second prong 112 are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0687] The nasal interface 100 may have any one or more of the features and / or functionalities described herein for the nasal interfaces 100, 100', 100".

[0688] In some configurations, the respiratory therapy device 1000 includes a flow generator 1011 and a humidifier 1012 .

[0689] In some configurations, the respiratory therapy system includes a patient conduit 300 having a heater 300a.

[0690] In some configurations, the patient interface includes a vent tube in fluid communication with the gas inlet 121, and the patient interface further includes a headgear to hold the nasal interface on the patient's face.

[0691] Patients with various health conditions and diseases can benefit from oxygen therapy. For example, patients with chronic obstructive pulmonary disease (COPD), pneumonia, asthma, bronchopulmonary dysplasia, heart failure, cystic fibrosis, sleep apnea, lung disease, respiratory trauma, acute respiratory distress, receiving preoperative and postoperative oxygen delivery and other conditions or diseases can benefit from oxygen therapy. A common way to solve such problems is to prevent their blood oxygen saturation (SpO2) from dropping too low (e.g., below about 90%) by supplying supplemental oxygen to the patient. However, supplying too much oxygen to the patient will overoxygenate his blood and is also considered dangerous. In general, the patient's SpO2 is maintained in the range of about 80% to about 99% and preferably about 92% to about 96%, but these ranges may vary due to the patient's condition. Due to various factors, such as respiratory rate, lung tidal volume, heart rate, activity level, height, weight, age, gender and other factors, there is no prescribed level of supplemental oxygen that can consistently achieve a targeted range of SpO2 responses for each patient. Individual patients will periodically need to monitor and adjust the fraction of oxygen (FdO2) delivered to the patient to ensure they are receiving the correct FdO2 to achieve a target SpO2. Achieving a correct and consistent SpO2 is an important factor in treating patients with a variety of health conditions or diseases. Additionally, patients with these health problems can benefit from a system that automatically controls oxygen saturation. The present disclosure is applicable to a wide variety of patients who require fast and accurate oxygen saturation control.

[0692] refer to Fig.15, the controller 1013 may be programmed with or configured to implement a closed-loop control system for controlling the operation of the respiratory therapy device 1100. The closed-loop control system may be configured to ensure that the patient's SpO2 reaches a target level and remains at or near that level.

[0693] The controller 1013 may receive (multiple) inputs from the user that may be used by the controller 1013 to execute a closed-loop control system. The target SpO2 value may be a single value or a range of values. The (multiple) values ​​may be preset, selected by a clinician, or determined based on a patient type, where the patient type may refer to a current ailment and / or information about the patient (such as age, weight, height, gender, and other patient characteristics). Similarly, the target SpO2 may be two values, each selected in any manner described above. These two values ​​will represent a range of acceptable values ​​for the patient's SpO2. The controller may use a value within the range as a target. The target value may be the middle value of the range or any other value within the range, which may be preset or selected by the user. Alternatively, the range may be automatically set based on the target value of SpO2. The controller may be configured to have one or more set responses when the patient's SpO2 value moves outside the range. The response may include issuing an alarm, changing to manual control of FdO2, changing FdO2 to a specific value, and / or other responses. A controller may have one or more ranges, wherein when the controller is moved outside of each range, one or more different responses occur.

[0694] In general, SpO2 will be controlled between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99%, or between about 92% and about 96%. SpO2 can be controlled between any two suitable values ​​from any two ranges in the above ranges. The target SpO2 can be between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99%, or between about 92% and about 96%, or about 94%, or 94%, or about 90%, or 90%, or about 85%, or 85%. The SpO2 target can be any value between any two suitable values ​​from any two ranges in the above ranges. For a defined range, the SpO2 target can correspond to the middle of the SpO2.

[0695] FdO2 can be configured to be controlled within a certain range. As long as the flow rate meets or exceeds the patient's peak inspiratory demand, the oxygen concentration (FdO2) measured in the device will be substantially the same as the oxygen concentration (FiO2) breathed by the patient, and such terms can be considered equivalent. Each range limit can be preset, selected by the user, or determined based on a patient type, where the patient type can refer to a current ailment and / or information about the patient (such as age, weight, height, gender, and / or other patient characteristics). Alternatively, a single value of FdO2 can be selected, and the range can be determined at least in part based on the value. For example, the range can be above and below a certain set amount of the selected FdO2. The selected FdO2 can be used as a starting point for the controller. If the controller attempts to move FdO2 out of the range, the system can have one or more responses. These responses can include sounding an alarm, preventing FdO2 from moving out of the range, switching to manual control of FdO2, and / or switching to a specific FdO2. The device can have one or more ranges, where one or more different responses occur when the device reaches the limit of each range.

[0696] refer to Fig.16 , shows a schematic diagram of a closed-loop control system 1500. The closed-loop control system can utilize two control loops. The first control loop can be implemented by an SpO2 controller. The SpO2 controller can determine a target FdO2 based in part on the target SpO2 and / or the measured SpO2. As discussed above, the target SpO2 value can be a single value or a range of acceptable values. The (multiple) values ​​can be preset, selected by a clinician, or automatically determined based on customer characteristics. In general, the target SpO2 value is received or determined before or at the beginning of a therapy session, but the target SpO2 value can be received at any time during the therapy session. During the therapy session, the SpO2 controller can also receive the following items as input: measured (multiple) FdO2 readings from a gas composition sensor, and measured (multiple) SpO2 readings and (multiple) signal quality readings from a patient sensor. In some configurations, the SpO2 controller can receive a target FdO2 as an input, in which case the output of the SpO2 controller can be provided directly back to the SpO2 controller as an input. Based at least in part on these inputs, the SpO2 controller may output a target FdO2 to the second control loop.

[0697] During a therapy session, the SpO2 controller and the FdO2 controller may continue to automatically control the operation of respiratory therapy device 1100 until the therapy session ends or an event triggers a change from automatic mode to manual mode.

[0698] The increased flushing effect caused by the asymmetry of the prongs 111, 112 in the nasal interface 100, 100', 100" can improve the effectiveness of supplemental oxygen. Compared to a symmetrical nasal high flow, closed-loop SpO2 control of the asymmetric nasal interface 100, 100', 100" can allow the patient's SpO2 to be maintained at or near a target value while using a reduced amount of oxygen. This can achieve oxygen conservation.

[0699] The respiratory therapy system may have any one or more of the features and functions described in PCT Publication No. WO 2021 / 049954 and U.S. Provisional Application No. 62 / 898,464. The contents of these specifications are incorporated herein by reference in their entirety.

[0700] Fig.17 An alternative exemplary respiratory therapy system 2000 is shown that may utilize a patient interface 1 including a nasal interface 100, 100', 100".

[0701] In the illustrated configuration, the respiratory therapy system 2000 includes a respiratory therapy device 2100. The respiratory therapy device may include a flow generator 2101.

[0702] The flow generator 2101 shown includes a gas inlet 2102 and a gas outlet 2104. The flow generator 2101 may include a blower 2106. The blower 2106 may draw gas from the gas inlet 2102. In some configurations, the flow generator 2101 may include a compressed gas (e.g., air, oxygen, etc.) source or container. The container may include a valve that may be adjusted to control the flow of gas leaving the container. In some configurations, the flow generator 2101 may use this compressed gas source and / or other gas sources to replace the blower 2106. In some configurations, the blower 2106 may be used in combination with another gas source. In some configurations, the blower 2106 may include a motorized blower or may include a bellows arrangement or some other structure capable of generating a gas flow. In some configurations, the flow generator 2101 draws atmospheric gas through the gas inlet 2102. In some configurations, the flow generator 2101 is adapted to draw in atmospheric gas through the gas inlet 2102 and is adapted to receive other gases (eg, oxygen, nitric oxide, or carbon dioxide, etc.) through the same gas inlet 2102 or a different gas inlet. Other configurations are also possible.

[0703] The illustrated flow generator 2101 includes a user control interface 2108. The user control interface 2108 may include one or more buttons, knobs, dials, switches, levers, touch screens, speakers, displays, and / or other input or output modules that a user may use to input commands into the flow generator 2101, to view data, and / or to control the operation of the flow generator 2101, and / or to control the operation of other aspects of the respiratory therapy system 2000.

[0704] The flow generator 2101 can direct gas through the gas outlet 2104 to the first conduit 2110. In the illustrated configuration, the first conduit 2110 directs the gas to a gas humidifier 2112. The gas humidifier is optional.

[0705] The gas humidifier 2112 is used to entrain moisture in the gas so as to provide a humidified gas flow. The gas humidifier 2112 shown includes a humidifier inlet 2116 and a humidifier outlet 2118. The gas humidifier 2112 may include, may be configured to hold, or may hold water or other humidification or hydration agents (hereinafter referred to as water).

[0706] In some configurations, the gas humidifier 2112 includes a heating element (not shown). The heating element can be used to heat the water in the gas humidifier 2112, thereby promoting water evaporation and / or entraining water in the gas flow and / or increasing the temperature of the gas passing through the gas humidifier 2112. The heating element can include, for example, a resistive metal heating plate. However, other heating elements can be envisioned. For example, the heating element can include a plastic conductive heating plate or a chemical heating system with a controllable heat output.

[0707] In the illustrated configuration, the gas humidifier 2112 includes a user control interface 2120. The user control interface 2120 includes one or more buttons, knobs, dials, switches, levers, touch screens, speakers, displays, and / or other input or output modules that a user can use to input commands into the gas humidifier 2112, to view data, and / or control the operation of the gas humidifier 2112, and / or to control the operation of other aspects of the respiratory therapy system 2000.

[0708] In some configurations, the flow generator 2101 and the gas humidifier 2112 can share a housing 2126. In some configurations, the gas humidifier 2112 can share only a portion of the housing 2126 with the flow generator 2101. Other configurations are also possible. For example, the flow generator 2101 and the gas humidifier 2112 can include separate housings.

[0709] In the illustrated configuration, gas travels from the humidifier outlet 2118 to the second conduit 300. The second conduit 300 may include Fig.15 The conduit heater described herein can be used to add heat to the gas passing through the second conduit 300. The heat can reduce or eliminate the possibility of water entrained in the gas flow condensing along the wall of the second conduit 300. The conduit heater can include one or more resistive wires located in, on, or around the wall of the second conduit 300. In one or more configurations, such one or more resistive wires can be located outside any gas passage. In one or more configurations, such one or more resistive wires are not in direct contact with the gas passing through the second conduit 300. In one or more configurations, the wall or surface of the second conduit 300 is between the one or more resistive wires and the gas passing through the second conduit 300.

[0710] Gas passing through the second conduit 300 can be delivered to the nasal interface 100. The nasal interface 100 can link the respiratory therapy system 100 to the patient's airway. In some configurations, the respiratory therapy system 2000 utilizes a two-limb system that includes separate inspiratory gas channels and expiratory gas channels that interface with one or more airways of the patient.

[0711] In some configurations, a short length of tubing connects the nasal interface 100 to the second conduit 300. In some configurations, the short length of tubing can have a smooth bore. For example, a short length of flexible tubing can connect the nasal interface to the second conduit 300. The short length of tubing connecting the nasal interface to the second conduit 300 can be breathable, so it allows steam to be transmitted through the tube wall. In some configurations, the short length of tubing can be combined with one or more heating wires, as described elsewhere herein. Smooth bores can improve the efficiency of delivering aerosolized substances whether heated or not, as described elsewhere herein.

[0712] The respiratory therapy device 2100 includes a nebulizer 2128. In some configurations, if a nebulizer 2128 is used, the flow generator 2101, the gas humidifier 2112, and the nebulizer 2128 can share a housing 2126. In some configurations, the nebulizer 2128 is separate from the housing 2126.

[0713] The nebulizer 2128 can be linked to a portion of the gas passage extending between the flow generator 2101 (which can include the gas inlet 2102) and the nasal interface 100, although other arrangements can be utilized for the nebulizer 2128 or another nebulizer. In some configurations, the nebulizer 2128 is not positioned in series in any position between the humidifier outlet 2118 and the patient interface 100. Instead, the nebulizer 2128 is positioned upstream of the humidifier outlet 2118 or upstream of the entrance to the second conduit 2122. In some configurations, the nebulizer 2128 can be positioned upstream of the entrance to the humidifier. In some configurations, the nebulizer 2128 can be positioned between the gas flow source and the chamber.

[0714] The nebulizer 2128 may include a substance (e.g., a medicinal substance, a tracer gas, etc.) that may be introduced into the gas stream. The substance may be entrained in the gas stream and may be delivered to the patient's airway along with the respiratory gas. The nebulizer 2128 may be linked to a portion of the gas passageway via a transmitter 2130, which may include a conduit or an adapter. Alternatively, the nebulizer 2128 may be directly interfaced with the gas passageway, which may obviate the need for the transmitter 2130.

[0715] The respiratory therapy device 2100 may include a controller 2113. The controller 2113 may be configured or programmed to control the operation of the device. For example, the controller 2113 may control components of the device, including, but not limited to: operating the flow generator 2101 to generate a gas flow (flows of gases) for delivery to the patient; operating the humidifier 2112 (if present) to humidify and / or heat the generated gas flow; controlling the flow of oxygen into the flow generator blower; receiving user input from the user interface 2108 and / or 2120 to reconfigure and / or user-defined operations of the device 2100; and outputting information to the user (e.g., on a display).

[0716] Controller 2113 can control flow generator 2101 to generate gas flow with desired flow rate. Controller 2113 can also control supplementary oxygen inlet to allow delivery of supplementary oxygen, humidifier 2112 (if present) can humidify gas flow and / or heat gas flow to appropriate level, etc. Controller 2113 can also control operation nebulizer 2128. Gas flow is guided to the patient through patient conduit 300 and nasal interface 100. Controller 2113 can also control the heating element in humidifier 2112 and / or the heating element in patient conduit 300 to heat gas to desired temperature to achieve patient's desired therapy level and / or comfort level. Controller 2113 can be programmed with suitable target temperature of gas flow or can determine suitable target temperature of gas flow. In some configurations, administration of gas mixture composition and / or therapeutic drug including supplementary oxygen can be provided through supplementary oxygen inlet. The gas mixture composition can include oxygen, heliox, nitrogen, nitric oxide, carbon dioxide, argon, helium, methane, sulfur hexafluoride, and combinations thereof, and / or the supplemental gas can include aerosolized medication from the nebulizer 2128.

[0717] In some configurations, the respiratory therapy device 2100 includes a gas inlet 2102, a gas outlet 2118, and a nebulizer 2128 to deliver one or more substances into the gas flow. The nasal interface 100 used with the respiratory therapy device 2100 in the respiratory therapy system 2000 includes: a gas inlet 121, which is fluidly connected to the gas outlet 2118 to receive gas and one or more substances from the respiratory therapy device; a first prong 111 and a second prong 112 that are asymmetric to each other; and a gas manifold 120, which includes the gas inlet 121. The first prong 111 and the second prong 112 are fluidly connected to the gas inlet 121. The nasal interface 100 is configured to achieve an asymmetric gas flow at the patient's nostrils.

[0718] The respiratory therapy system 2000 may include conduits 300 , 320 (examples of which are described below) to receive gas and one or more substances from the respiratory therapy device 2100 and deliver the gas and one or more substances to the gas inlet 121 of the nasal interface 100 .

[0719] In the configuration shown, the respiratory therapy system 2000 can operate as follows. Due to the rotation of the impeller of the motor of the blower 2106, gas can be drawn into the flow generator 2101 through the gas inlet 2102. The gas can be pushed out of the gas outlet 2104 and pushed along the first conduit 2110. The gas enters the gas humidifier 2112 through the humidifier inlet 2116. Once in the gas humidifier 2112, the gas is entrained with moisture when passing through the water in the gas humidifier 2112 or near the water. The water is heated by the heating element, which helps to humidify and / or heat the gas passing through the gas humidifier 2112. The gas leaves the gas humidifier 2112 through the humidifier outlet 2118 and enters the second conduit 300. Before entering the second conduit 300, the gas receives one or more substances from the nebulizer 128. The gas is transferred from the second conduit 300 to the nasal interface 100, where the gas enters the patient's airway to help treat respiratory diseases.

[0720] For example, refer to Figure 2 , Figure 3 ,and Fig.15 In some configurations, the respiratory therapy system 1000 of the present disclosure includes:

[0721] Respiratory therapy device 1100, the respiratory therapy device comprising:

[0722] at least one gas inlet 1027, 1028;

[0723] a humidifier 1012 for humidifying the gas; and

[0724] Gas outlet 1021;

[0725] and a patient interface 1, the patient interface comprising a nasal interface 100, wherein the nasal interface comprises:

[0726] A first fork 111 and a second fork 112 that are asymmetric to each other, and wherein the first fork 111 has a first fork outlet 111a and the second fork 112 has a second fork outlet 112a;

[0727] and a gas manifold 120 comprising a gas inlet 121, wherein the first prong 111 and the second prong 112 are in fluid communication with the gas inlet 121;

[0728] Wherein, the nasal interface 100 is configured to achieve asymmetric gas flow at the patient's nostrils;

[0729] Wherein, the respiratory therapy system 1000 is configured to deliver gas through the first fork outlet 111a and the second fork outlet 112a at a temperature range between about 27°C-37°C, at a relative humidity greater than about 33 mg / l, and / or at a velocity greater than 0 m / s and less than about 32 m / s for a total volume flow rate of gas flow greater than 0 lpm and up to about 70 lpm into the gas inlet.

[0730] In some configurations, the respiratory therapy system 1000 is configured to deliver gas through the first prong outlet 111a and the second prong outlet 112a at a temperature range between approximately 31°C-37°C.

[0731] In some configurations, the respiratory therapy system 1000 is configured to deliver gas through the first prong outlet 111a and the second prong outlet 112a at a relative humidity of up to about 44 mg / l.

[0732] In some configurations, the respiratory therapy system 1000 is configured to provide a total volumetric flow rate of gas flow to the gas inlet 121 of at least about 5 liters per minute (lpm), optionally between about 5 plm to about 120 lpm, and optionally between about 5 lpm to about 70 lpm.

[0733] In some configurations, the respiratory therapy system 1000 is configured to deliver at least about 60% of the total volumetric flow of gas flowing into the gas inlet 121 through the first prong 111 out of the nasal interface, optionally about 60% to about 90% of the total volumetric flow of gas flowing into the gas inlet 121 through the first prong 111 out of the nasal interface, optionally about 60% to about 80% of the total volumetric flow of gas flowing into the gas inlet 121 through the first prong 111 out of the nasal interface, optionally about 65% to about 80% of the total volumetric flow of gas flowing into the gas inlet 121 through the first prong 111 out of the nasal interface, optionally about 70% to about 80% of the total volumetric flow of gas flowing into the gas inlet 121 through the first prong 111 out of the nasal interface Delivering the nasal interface through the first fork 111, optionally delivering about 70% to about 75% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first fork 111, optionally delivering about 70% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first fork 111, optionally delivering about 75% to about 80% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first fork 111, optionally delivering about 75% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first fork 111, optionally delivering about 80% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first fork 111.

[0734] In some configurations, the respiratory therapy system 1000 is configured to provide different gas flow rates through the first prong 111 and the second prong 112, and to deliver substantially similar velocities of gas through the first prong outlet 111a and the second prong outlet 112a.

[0735] In some configurations, the velocity of gas exiting the first fork outlet 111a is within about 20% of the velocity of gas exiting the second fork outlet 112a, optionally within about 16% of the velocity of gas exiting the second fork outlet 112a, and optionally within about 10% of the velocity of gas exiting the second fork outlet 112a at flow rates greater than about 42 lpm.

[0736] In some configurations, for a total volumetric flow rate of gas flow into gas inlet 121 greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of first and second forked outlets 111a, 112a is greater than 0 m / s and less than 32 m / s.

[0737] In some configurations, for a total volumetric flow rate of gas flow greater than 9 lpm and up to about 70 lpm flowing into the gas inlet 121, the velocity of the gas leaving each of the first fork outlet 111a and the second fork outlet 112a is greater than about 2 m / s and less than about 32 m / s, optionally greater than about 2 m / s and less than 32 m / s, optionally greater than about 2 m / s and up to about 25 m / s, and optionally greater than about 2.5 m / s and up to about 20 m / s.

[0738] In some configurations, the nasal interface 100 includes a cannula body 118 having a first prong 111 and a second prong 112 .

[0739] In some configurations, the gas manifold 120 is integral with the cannula body 118 or is separate from the cannula body 118 and can be coupled thereto.

[0740] In some configurations, the first prong 111 and the second prong 112 are configured to engage the nasal passage in an unsealed (non-sealing) manner.

[0741] In some configurations, first prong 111 and second prong 112 allow exhaled gas to escape around first prong 111 and second prong 112 .

[0742] In some configurations, the first prong 111 and the second prong 112 are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0743] In some configurations, the first and second prongs are configured to provide gas to the patient independent of the patient's breathing.

[0744] In some configurations, the respiratory therapy system includes a conduit 300 for receiving gas from the respiratory therapy device and delivering the gas to the gas inlet 121 of the nasal interface.

[0745] The respiratory therapy system 1000, patient interface 1, and nasal interface 100 may have any of the features and functionality described herein.

[0746] A method for providing respiratory support to a patient is disclosed, the method comprising:

[0747] A respiratory therapy system 1000 is provided, the respiratory therapy system comprising:

[0748] Respiratory therapy device 1100, the respiratory therapy device comprising:

[0749] at least one gas inlet 1027, 1028;

[0750] Traffic generator 1011;

[0751] Gas outlet 1021;

[0752] and a patient interface 1, the patient interface comprising a nasal interface 100, wherein the nasal interface 100 comprises:

[0753] A first fork 111 and a second fork 112 that are asymmetric to each other, and wherein the first fork 111 has a first fork outlet 111a and the second fork 112 has a second fork outlet 112a;

[0754] and a gas manifold 120 comprising a gas inlet 121, wherein the first prong 111 and the second prong 112 are in fluid communication with the gas inlet 121;

[0755] operating the respiratory therapy device 1100 to provide a flow of gas to the nasal interface 100; and

[0756] An asymmetric flow of gas from respiratory therapy device 1100 is delivered at the patient's nares through first and second prong outlets 111a, 112a.

[0757] In some configurations, the method includes delivering an asymmetric gas flow through a first fork outlet and a second fork outlet at a temperature range of between about 27°C-37°C, at a relative humidity greater than about 33 mg / l, and / or at a velocity greater than 0 m / s and less than about 32 m / s for a total volumetric flow rate of gas flow greater than 0 lpm and up to about 70 lpm flowing into the gas inlet 121.

[0758] In some configurations, the method includes delivering an asymmetric gas flow at a temperature range between about 31°C-37°C.

[0759] In some configurations, the method includes providing a total volume flow rate of gas flow of at least about 5 liters per minute (lpm) to the gas inlet 121, optionally providing a total volume flow rate of gas flow between about 5 lpm and about 120 lpm to the gas inlet, and optionally providing a total volume flow rate of gas flow between about 5 lpm and about 70 lpm to the gas inlet.

[0760] In some configurations, the method includes delivering at least about 60% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first prong 111 to the nasal interface, optionally delivering about 60% to about 90% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first prong 111 to the nasal interface, optionally delivering about 60% to about 80% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first prong 111 to the nasal interface, optionally delivering about 65% to about 80% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first prong 111 to the nasal interface, optionally delivering about 70% to about 80% of the total volumetric flow of the gas flow flowing into the gas inlet 121 through the first prong 111 to the nasal interface, 111 delivers the gas out of the nasal interface, optionally about 70% to about 75% of the total volume flow of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally about 70% of the total volume flow of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally about 75% to about 80% of the total volume flow of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally about 75% of the total volume flow of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111, optionally about 80% of the total volume flow of the gas flow flowing into the gas inlet 121 is delivered out of the nasal interface through the first fork 111.

[0761] In some configurations, the method includes delivering the gas through the first prong outlet 111a and the second prong outlet 112a at a relative humidity of up to about 44 mg / l.

[0762] In some configurations, the method includes providing different gas flow rates through the first prong 111 and the second prong 112, and delivering substantially similar velocities of gas through the first prong outlet 111a and the second prong outlet 112a.

[0763] In some configurations, the velocity of gas exiting the first fork outlet 111a is within about 20% of the velocity of gas exiting the second fork outlet 112a, optionally within about 16% of the velocity of gas exiting the second fork outlet 112a, and optionally within about 10% of the velocity of gas exiting the second fork outlet 112a at flow rates greater than about 42 lpm.

[0764] In some configurations, for a total volumetric flow rate of gas flow into gas inlet 121 greater than 0 lpm and up to about 70 lpm, the velocity of gas exiting each of first and second forked outlets 111a, 112a is greater than 0 m / s and less than 32 m / s.

[0765] In some configurations, for a total volumetric flow rate of gas flow greater than 9 lpm and up to about 70 lpm flowing into the gas inlet 121, the velocity of the gas leaving each of the first fork outlet 111a and the second fork outlet 112a is greater than about 2 m / s and less than about 32 m / s, optionally greater than about 2 m / s and less than 32 m / s, optionally greater than about 2 m / s and up to about 25 m / s, and optionally greater than about 2.5 m / s and up to about 20 m / s.

[0766] In some configurations, the nasal interface 100 includes a cannula body 118 having a first prong 111 and a second prong 112 .

[0767] In some configurations, the gas manifold 120 is integral with the cannula body 118 or is separate from the cannula body 118 and can be coupled thereto.

[0768] In some configurations, the method includes engaging the first prong 111 and the second prong 112 with the nasal passage in an unsealed (non-sealing) manner.

[0769] In some configurations, the method includes allowing exhaled gas to escape around the first prong 111 and the second prong 112 .

[0770] In some configurations, the method includes providing gas to the patient without interfering with the patient's spontaneous breathing.

[0771] In some configurations, the method includes providing gas to the patient independent of the patient's breathing.

[0772] In some configurations, the nasal interface 100 is as described above or generally herein.

[0773] In some configurations, the respiratory therapy device 1100 includes a humidifier 1012 , and the method includes using the humidifier 1012 to humidify the flow of gas.

[0774] In some configurations, the respiratory therapy system 1000 includes a patient conduit 300 having a heater 300a, and the method includes operating the heater 300a.

[0775] In some configurations, the patient interface includes a gas permeable tube in fluid communication with the gas inlet, and the method includes allowing water vapor to pass through a wall of the tube, but preventing liquid water and bulk gas from flowing through the wall of the tube.

[0776] The respiratory therapy system 1000, patient interface 1, and nasal interface 100 used in the method may have any of the features and functionality described herein.

[0777] Fig.18 An exemplary type of conduit or catheter 300 that can be used to deliver gas to a nasal interface 100 is shown. A conduit or catheter 300 featuring a smooth hole 302 or a non-corrugated hole is shown. This type of conduit is best described and shown in U.S. Patent Application Publication No. 2014 / 0202462 (also published as PCT Publication No. WO 2012 / 164407A1) and PCT Publication No. WO 2014 / 088430 and U.S. Patent No. 11,058,844. The contents of these specifications are incorporated herein by reference in their entirety. As described therein, the conduit is formed by a bead 304 and a small tube or bubble 306. In general, the peak-to-valley surface roughness of such a conduit is on the order of 0.15 mm to 0.25 mm. In one configuration, the conduit or conduit has an internal hole diameter of 13 mm to 14 mm. The two components 304, 306 combine to define a conduit or tube having a lumen with minimal surface area deviation. In some configurations, the bead 304 contains multiple wires 308. One or more of these wires can be used to heat the wall of the conduit without being positioned within the flow conveyed by the conduit or pipe 300. In the illustrated configuration, the bead 304 contains four wires 308. In some configurations, the bead 304 can contain two wires 308. Other numbers of wires can also be used.

[0778] Fig.19 An alternative exemplary type of conduit or tube 320 that may be used to deliver gas to the nasal interface 100 is shown. Fig. 20 , the catheter or tube 320 shown is a corrugated tube. In one configuration, the catheter or tube 320 has an internal bore diameter of 20 mm to 21 mm. The corrugated tube 320 includes deep grooves 322 along the wall 324 of the tube 320. In many cases, the grooves 322 result in one or more spiral obstacles extending along the length of the lumen defined by the wall 324. As such, the inner surface of the catheter or tube is Fig.18 In general, corrugated conduits or pipes have a peak to valley surface roughness on the order of 1.5 mm to 2.5 mm. Fig.19 In the illustrated configuration, one or more heating wires 326 may also be wound and positioned in direct contact with the gas flowing through the lumen. When these wires are positioned within the gas flow path, the heating wires add an added "surface roughness" of 2 mm to 3 mm, although this is only an estimate of the effect of heating wires positioned within the gas flow path.

[0779] With the use of e.g. Fig.19 Compared to the more conventional heated breathing tube 320 shown in Fig.18 The smooth bore heating tube 300 shown in FIG. 1 is used to transport medication from the above-described nebulizer 2128 to achieve a significant increase in medication delivery efficiency. The efficiency improvement is believed to be due to a significant reduction in the amount of aerosolized medication that is captured within the grooves 322 and exposed heating wires 326 of the more conventional heated breathing tube 320. For example, it has been estimated that the amount of aerosolized medication captured by these surfaces is less than that retained by, for example, Fig.18 300% more aerosolized drug is present in the smooth bore heated breathing tube 300 shown in FIG. 300, for example and without limitation. It is believed that because there are fewer eddies in the flow and fewer obstacles representing effective roughness, deposition processes such as impingement are reduced.

[0780] In some configurations, when the flow rate exceeds the optimal flow rate, it is found that the transport efficiency is reduced. In other words, at certain high flow rates above 30 lpm, the flow rate is somewhat inversely proportional to the atomization efficiency (i.e., high flow rates result in more drug being trapped in the circuit rather than being delivered to the patient).

[0781] With a nasal cannula 100 having asymmetric nasal prongs 111, 112, a reduction in flow for the same dead space clearance may be possible, which may improve the provision of respiratory therapy using aerosolized medications. Aerosolized medications may be less likely to "spray," where a portion of the medication is deposited on the inner surface of the flow path instead of being delivered to the patient, or suffer other losses due to smoother flow transitions impinging on the surface. With the partially unidirectional flow provided by the nasal interface 100, when the patient exhales against the flow, less medication is wasted than would otherwise be the case. Other aspects of the nasal cannula 100 having asymmetric nasal prongs 111, 112, including the cross-sectional area of ​​the prongs and the relationship of those cross-sectional areas, may improve the provision of respiratory therapy using aerosolized medications.

[0782] The patient interface 1 and nasal interface 100 used in the respiratory therapy system 2000 may have any one or more of the features and / or functions described herein for the nasal interfaces 100 , 100 ′, 100 ″.

[0783] The respiratory therapy system 2000 may have any one or more features and / or functions of the systems described in PCT Publication No. WO 2016 / 085354 or U.S. Patent Application Publication No. 2017 / 0312472. The contents of these specifications are incorporated herein by reference in their entirety.

[0784] Additionally or alternatively, respiratory therapy system 2000 may have any one or more of the features and / or functionality of the systems described with respect to respiratory therapy system 1000 .

[0785] The nasal interfaces 100, 100', 100" described herein may be used in a healthcare facility, a home setting, an emergency vehicle, or any other suitable setting. Thus, references herein to a "patient" should be interpreted as any suitable subject for use of a nasal interface.

[0786] Although the present disclosure has been described with respect to certain embodiments, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of the present disclosure. Therefore, various changes and modifications may be made without departing from the spirit and scope of the present disclosure. For example, the various components may be repositioned as needed. Features from any of the described embodiments may be combined with one another, and / or the device may include one, more than one, or all of the features of the above-described embodiments. In addition, not all of these features, aspects, and advantages are essential to practicing the present disclosure. Therefore, the scope of the present disclosure is intended to be limited only by the appended claims.

Claims

1. A nasal interface, comprising: A first fork and a second fork that are asymmetrical to each other; and a gas manifold comprising a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, wherein the nasal interface is configured to achieve an asymmetric gas flow at the patient's nostrils, And wherein, the nasal interface is configured so that at least about 60% of the total volume flow of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork (Note: For the convenience of review, please refer to the parent case specification [0008]-[0012], [0498] for the modification basis, and this note will be deleted during the subsequent review process).

2. The nasal interface of claim 1, wherein: The nasal interface is configured such that when the total volume flow rate of the gas flow flowing into the gas inlet is between about 5 liters / minute (lpm) and about 70 lpm, about 60% to about 80% of the total volume flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork (see the parent case specification [0047] for the modification basis).

3. The nasal interface according to claim 1 or 2, comprising: a gas flow path from the gas inlet to the first fork and the second fork, Among them, the inner cross-sectional area of ​​the first fork in the direction transverse to the gas flow passing through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork in the direction transverse to the gas flow passing through the second fork (for the modification basis, please see the parent case specification [0112], [0019]).

4. The nasal interface of claim 3, wherein: The direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork (for modification basis, please refer to the parent case specification [0116]).

5. The nasal interface according to claim 3 or 4, wherein: The inner cross-sectional area is the area at the exit of the first fork and the second fork (please refer to the parent case specification [0117] for the modification basis).

6. The nasal interface according to any one of claims 1 to 5, wherein: The nasal interface includes a cannula body, which includes a first fork and a second fork (please see the parent case specification [0118] for the modification basis).

7. The nasal interface of claim 6, comprising a gas manifold, wherein: The gas manifold is integrated with the cannula body, or is separate from the cannula body and can be connected thereto (for modification, please see the parent case specification [0119]).

8. The nasal interface of claim 7, wherein: The nasal interface includes a facial mounting portion, and the first fork and the second fork include a pair of asymmetric tubular nasal forks molded integrally with the facial mounting portion or removably attached thereto (for modification basis, please see the parent case specification [0428]).

9. The nasal interface of claim 8, wherein: The facial mounting portion includes at least one substantially horizontal side access passage leading to the interior of the base portion of the facial mounting portion or the cannula body to releasably receive the outlet of the gas manifold therethrough (for modification basis, please see the parent case specification [0429]).

10. The nasal interface of claim 9, wherein: The facial mounting portion includes a pair of opposite side entry passages leading to the interior of the base portion or the cannula body, each side entry passage being adapted to releasably receive the outlet of the gas manifold therethrough (for modification basis, please see the parent case specification [0431]).

11. The nasal interface according to any one of claims 8 to 10, wherein: The gas manifold can be inserted into the facial mounting portion; alternatively, the gas manifold can be inserted into the facial mounting portion from one of two opposite horizontal directions (for modification basis, please see the parent case specification [0429], [0430]).

12. The nasal interface according to any one of claims 8 to 11, wherein: The gas manifold is formed of a relatively hard material, and the facial mounting portion provides a soft docking component for the patient. The gas manifold fluidly connects the catheter to the nasal prong of the facial mounting portion (please see the parent case specification [0432] for the modification basis).

13. The nasal interface according to any one of claims 1-12, wherein: The first fork and the second fork are configured to engage with the patient's nasal passages in a non-sealed manner; and / or wherein the first fork and the second fork allow exhaled gas to escape around the first fork and the second fork (see the parent case specification [0120], [0121] for the modification basis).

14. The nasal interface according to any one of claims 1-13, wherein: The first fork and the second fork are configured to provide gas to the patient without interfering with the patient's spontaneous breathing (see the parent case specification [0122] for the modification basis).

15. The nasal interface of any one of claims 1-14, wherein: The first and second prongs are curved and extend into the patient's nostrils during use and provide a smooth flow path for gas to flow through; and / or, the inner surfaces of the first and second prongs are contoured to reduce noise; and / or, the bases of the first and second prongs include curved surfaces to provide smoother gas flow; and / or, the first and second prongs are substantially hollow and substantially tubular in shape; and / or, the diameters of the first and second prongs are consistent along their lengths, or alternatively the first and second prongs are shaped to fit the contour of the patient's nostrils; and / or, the facial mounting portion is shaped to generally follow the contour of the patient's face around the upper lip area; and / or, the facial mounting portion is molded or preformed so as to be able to conform to the contour of the patient's face in the facial area where the nasal interface is to be positioned and / or is flexible so as to adapt, accommodate and / or correspond to the contour of the patient's face in the facial area where the nasal interface is to be positioned (for modification basis, please see the parent case specification [0434]-[0437]).

16. The nasal interface of claim 3, wherein: The ratio of the inner cross-sectional area of ​​the first fork to the inner cross-sectional area of ​​the second fork is between about 60:40 and about 80:20, or between about 65:35 and about 80:20, or between about 70:30 and about 80:20, or between about 70:30 and about 75:25, or about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, or between about 75:25 and 80:20, or about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20 (please see the parent case specification [0514] for the modification basis).

17. The nasal interface of any one of claims 3-5 or 16, wherein: The gas flow path is defined by a flow channel, the gas flow direction of the flow channel is substantially perpendicular to the gas flow path passing through the first fork and the second fork, and wherein the first fork is farther away from the gas inlet and the second fork is closer to the gas inlet (see the parent case specification [0123] for the basis for the modification).

18. The nasal interface of claim 17, wherein: The nasal interface includes a cannula body, which includes a first fork and a second fork; wherein the nasal interface includes a gas manifold, which is integral with the cannula body or separate from the cannula body and can be connected thereto; wherein a first section of a flow channel in the gas manifold has a large first vertical dimension, and opposite ends of the flow channel form a flow cavity in the cannula body, the flow cavity delivers gas to the first fork and the second fork, and when the gas manifold is in place in the cannula body, the flow cavity is connected to the flow path fluid passing through the first fork and the second fork; wherein at least a portion of the flow cavity has a vertical dimension that is smaller than the first vertical dimension (for modification basis, please see the parent case specification [0118]; [0119]; [0587]).

19. The nasal interface of claim 18, wherein: The gas manifold includes one or more internal angled walls to provide a size reduction from a first vertical dimension to a vertical dimension smaller than the first vertical dimension and to direct the gas flow into the first fork and / or the second fork (see the parent case specification [0588] for the modification basis).

20. The nasal interface of any one of claims 1-19, wherein: The gas manifold of the nasal interface is configured not to obstruct any portion of the internal cross-section of either the first fork or the second fork; or wherein the gas manifold is configured to partially obstruct the internal cross-section of one or both of the first fork and the second fork (see the parent case specification [0589] for the modification basis).

21. The nasal interface of any one of claims 1-20, wherein: The nasal interface is configured so that approximately 65% ​​to approximately 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork, or approximately 70% to approximately 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork, or approximately 70% to approximately 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork, or approximately 70% to approximately 70% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork, or approximately 75% to approximately 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork, or approximately 75% to approximately 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork, or approximately 75% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork, or approximately 80% of the total volumetric flow rate of the gas flow flowing into the gas inlet is delivered out of the nasal interface through the first fork (for modification basis, please see the parent case specification [0124]).

22. The nasal interface of any one of claims 1-21, wherein: The gas inlet is connected to the vent tube fluid (for modification basis, please see the parent case specification [0125]).

23. The nasal interface of claim 22, wherein: Water vapor can pass through the wall of the ventilation tube, but liquid water and a large amount of gas cannot pass through the wall of the ventilation tube (please see the parent case specification [0126] for the basis for the modification).

24. The nasal interface of any one of claims 1-23, wherein: The nasal interface includes a cannula body, the cannula body includes a first fork and a second fork, and the nasal interface includes a gas manifold; wherein the gas manifold is capable of being reconfigured between a first configuration and a second configuration relative to the cannula body; wherein the first configuration corresponds to the gas manifold being inserted into the cannula body from a first side of the cannula body so that the second fork is closer to the gas inlet and the first fork is farther away from the gas inlet, and the second configuration corresponds to the gas manifold being inserted into the cannula body from a second side of the cannula body so that the first fork is closer to the gas inlet and the second fork is farther away from the gas inlet (for the modification basis, please see the parent case specification [0127]).

25. The nasal interface of any one of claims 1-24, wherein: The first fork and the second fork are asymmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration, and / or are asymmetrical when compared to each other (for the basis for the modification, please see the parent case specification [0115]).

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