Nasal interface and respiratory therapy system

Abstract

A nasal interface 100 has a cannula body 118 having a first fork 111 and a second fork 112. The first fork 111 and the second fork 112 are asymmetrical. A 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 the gas manifold 120 being inserted into the cannula body 118 from a first side. The second configuration corresponds to the gas manifold 120 being inserted into the cannula body 118 from a second side.

Description

[Technical Field]

[0001] This disclosure generally relates to a patient interface for delivering respiratory gases to a patient's airway. [Previous Technology]

[0002] A humidifier is used to provide humidified breathing gas to the patient. The gas is delivered to the patient via a patient interface. Examples of patient interfaces include masks, nasal masks, nasal cannulas, combinations of masks and nasal masks, etc.

[0003] Patient interfaces including nasal interfaces can be used to deliver high-flow-rate gas 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 partially sealed at the nose, or may not need to be sealed at the nose, to deliver the therapy. Nasal high-flow typically refers to the delivery of a relatively high volumetric flow rate of unsealed therapy to a patient via a nasal interface, which may be sufficient to meet or exceed the patient's inspiratory flow rate. [Summary of the Invention]

[0004] While forks for nasal interfaces exist in the art, one aspect of at least one configuration disclosed herein includes recognizing problems with inserting some prior art forks into a patient's nose. Forks in the art require high motor speeds of flow generating devices to deliver the desired flow to the patient. Flow generating devices are means of delivering a gas flow to a patient.

[0005] If the interface is suddenly blocked, the static pressure may increase to equal the back pressure in the system, which could potentially reach undesirable levels. Undesirable high static pressure can be exacerbated in children and infants because the reduced fork diameter required to fit a child's or infant's nostrils may increase resistance to flow through the interface to the patient.

[0006] Currently, it is difficult to obtain nasal delivery elements of different sizes to better fit patients, and it may be difficult to optimize dead space clearance and the pressure delivered to the patient. Some options may require supplemental oxygen, more heating, more water, and may not provide a high level of patient comfort. The desired pressure effect is achieved by delivering an undesirable or excessively high flow rate to the patient using existing interfaces. Nasal delivery elements with smaller diameter nasal interfaces may have high leakage and therefore deliver lower pressure to the patient. Larger diameters may not effectively clear anatomical dead space in the patient's airway.

[0007] A nasal interface and respiratory therapy system are disclosed, which can combine a high-flow nasal interface with an asymmetric nasal delivery element for delivering breathing gases to a patient via an asymmetric flow rate. The asymmetric nasal delivery element can provide increased dead space clearance for the patient's upper airway. Noise can be reduced due to the lower peak expiratory pressure, and the asymmetric nasal delivery element can provide more desirable therapy for infants due to the reduced risk of complete airway obstruction. The asymmetry of the nasal delivery element can reduce resistance to flow through the nasal interface, which can achieve the desired flow rate by using lower back pressure and / or a lower motor speed of the flow generator. Nasal interfaces with asymmetric nasal delivery element interfaces can reduce the risk of complete obstruction of both nostrils due to an improperly sized nasal interface.

[0008] In one aspect of this disclosure, based on certain features, aspects and advantages of at least one embodiment disclosed herein, a nose interface is disclosed, the nose interface comprising: a first fork and a second fork that are asymmetrical to each other; and a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, and wherein the nose interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0009] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0010] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0011] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0012] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0013] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0014] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0015] In some configurations, the inner diameter and / or inner cross-sectional area of ​​the first fork in the direction transverse to the gas flow passing through the first fork is greater than the corresponding inner diameter and / or inner cross-sectional area of ​​the second fork in the direction transverse to the gas flow passing through the second fork.

[0016] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork.

[0017] In some configurations, the inner diameter and / or inner cross-sectional area are at the exits of the first and second forks.

[0018] In some configurations, the nose interface is configured such that about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0019] In some configurations, the nose interface is configured such that about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0020] In some configurations, the nose interface is configured such that about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0021] In some configurations, the nose interface is configured such that about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0022] In some configurations, the nose interface is configured such that about 70% to about 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0023] In some configurations, the nose interface is configured such that approximately 70% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0024] In some configurations, the nose interface is configured such that about 75% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0025] In some configurations, the nose interface is configured such that approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0026] In some configurations, the nose interface is configured such that approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0027] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, between about 5 mm and about 9 mm as needed, between about 6 mm and about 8 mm as needed, or between about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm as needed, or any diameter between any two of these diameters.

[0028] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, between about 3 mm and about 7 mm as needed, between about 4 mm and about 6 mm as needed, or between about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm as needed, or any diameter between any two of these diameters.

[0029] In some configurations, the wall thickness of the first fork and / or the second fork is between about 0.1 mm and about 0.5 mm.

[0030] In some configurations, the inner cross-sectional area of ​​the first fork is between about 15 mm² and about 80 mm², depending on the need, between about 20 mm² and about 75 mm², depending on the need, between about 25 mm² and about 70 mm², depending on the need, between about 30 mm² and about 65 mm², depending on the need, between about 35 mm² and about 60 mm², depending on the need, between about 40 mm² and about 55 mm², depending on the need, between about 45 mm² and about 50 mm², depending on the need, or depending on the need, about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², about 31 mm², about 32 mm², about 33 mm², etc. mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², approximately 51 mm², approximately 52 mm², approximately 53 mm², approximately 54 mm², approximately 55 mm², approximately 56 mm², approximately 57 mm², approximately 58 mm², approximately 59 mm², approximately 60 mm², approximately 61 mm², approximately 62 mm², approximately 63 mm², approximately 64 mm², approximately 65 mm², approximately 66 mm², approximately 67 mm², approximately 68 mm², approximately 69 mm², approximately 70 mm², approximately 71 mm², approximately 72 mm², approximately 73 mm², approximately 74 mm² mm2, about 75 mm2, about 76 mm2, about 77 mm2, about 78 mm2, about 79 mm2, about 80 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0031] In some configurations, the inner cross-sectional area of ​​the second fork is between about 5 mm² and about 50 mm², depending on the requirements, between about 10 mm² and about 45 mm², depending on the requirements, between about 15 mm² and about 40 mm², depending on the requirements, between about 20 mm² and about 35 mm², depending on the requirements, between about 25 mm² and about 30 mm², depending on the requirements, and is approximately 5 mm², about 6 mm², about 7 mm², about 8 mm², about 9 mm², about 10 mm², about 11 mm², about 12 mm², about 13 mm², about 14 mm², about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², etc. mm², approximately 31 mm², approximately 32 mm², approximately 33 mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², or any cross-sectional area between any two of these cross-sectional areas.

[0032] In some configurations, the combined cross-sectional area of ​​the first and second forks is between about 20 mm² and about 130 mm², depending on the requirements, between about 30 mm² and about 120 mm², depending on the requirements, between about 40 mm² and about 110 mm², depending on the requirements, between about 50 mm² and about 100 mm², depending on the requirements, between about 60 mm² and about 90 mm², depending on the requirements, between about 70 mm² and about 80 mm², depending on the requirements, and depending on the requirements, approximately 20 mm², approximately 25 mm², approximately 30 mm², approximately 35 mm², approximately 40 mm², approximately 45 mm², approximately 50 mm², approximately 55 mm², approximately 60 mm², approximately 65 mm², approximately 70 mm², approximately 75 mm², approximately 80 mm², approximately 85 mm², approximately 90 mm², approximately 95 mm², approximately 100 mm², approximately 105 mm², approximately 110 mm², approximately 115 mm², etc. mm2, approximately 120 mm2, approximately 125 mm2, approximately 130 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0033] 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, depending on the need, between about 65:35 and about 80:20, depending on the need, between about 70:30 and about 80:20, depending on the need, between about 70:30 and about 75:25, depending on the need, about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, depending on the need, between about 75:25 and 80:20, depending on the need, about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20. : 20.

[0034] In some configurations, the gap between adjacent outer surfaces of the first fork and the second fork, adjacent to the base of the first fork and the second fork, is between about 5 mm and about 15 mm, or as needed, between about 6 mm and about 14 mm, or as needed, between about 7 mm and about 13 mm, or as needed, between about 8 mm and about 12 mm, or as needed, between about 9 mm and about 11 mm, or as needed, between 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.

[0035] In some configurations, the gas inlet is in fluid communication with the vent pipe.

[0036] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0037] In some configurations, the nasal interface includes a cannula body, the cannula body including a first fork and a second fork, 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 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.

[0038] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, comprising: a first fork and a second fork asymmetrical to each other; and a gas manifold including 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 asymmetrical gas flow at a patient's nostrils, and wherein the nasal interface is configured such that when the total volumetric flow rate of the 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 the gas flow into the gas inlet is delivered out of the nasal interface through the first fork.

[0039] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0040] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0041] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0042] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0043] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0044] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0045] In some configurations, the nose interface is configured such that when the total flow rate of the 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 the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0046] In some configurations, the nose interface is configured such that when the total flow rate of the 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 the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0047] In some configurations, the nose interface is configured such that when the total flow rate of the gas flow into the gas inlet is between about 5 lpm and about 70 lpm, about 75% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0048] In some configurations, the nose interface is configured such that when the total flow rate of the gas flow into the gas inlet is between about 5 lpm and about 70 lpm, about 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0049] In some configurations, the nose interface is configured such that the asymmetry of the flow from the first fork and the second fork varies with the total flow of gas into the gas inlet.

[0050] In some configurations, the nose interface is configured such that a higher total volume flow rate of the gas flow into the gas inlet achieves a larger portion of the total volume flow rate of the gas flow being delivered out of the nose interface through the first fork, and wherein a lower total flow rate of the gas flow into the gas inlet achieves a smaller portion of the total volume flow rate of the gas flow being delivered out of the nose interface through the first fork.

[0051] In some configurations, the gas inlet is in fluid communication with the vent pipe.

[0052] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0053] In some configurations, the nasal interface includes a cannula body, the cannula body including a first fork and a second fork, 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 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.

[0054] In another aspect of this disclosure, based on certain features, aspects and advantages of at least one embodiment disclosed herein, a nose interface is disclosed, the nose interface comprising: a gas inlet; a first fork and a second fork that are asymmetrical to each other; and a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, wherein the inner diameter and / or inner cross-sectional area of ​​the first fork in the direction transverse to the gas flow through the first fork is greater than the corresponding inner diameter and / or inner cross-sectional area of ​​the second fork in the direction transverse to the gas flow through the second fork.

[0055] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0056] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork.

[0057] In some configurations, the inner diameter and / or inner cross-sectional area is at the exit of the first fork and the second fork.

[0058] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0059] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0060] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0061] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0062] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, between about 5 mm and about 9 mm as needed, between about 6 mm and about 8 mm as needed, or between about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm as needed, or any diameter between any two of these values.

[0063] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, between about 3 mm and about 7 mm as needed, between about 4 mm and about 6 mm as needed, or between about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm as needed, or any diameter between any two of these values.

[0064] In some configurations, the inner cross-sectional area of ​​the first fork is between about 15 mm² and about 80 mm², depending on the requirements, between about 20 mm² and about 75 mm², depending on the requirements, between about 25 mm² and about 70 mm², depending on the requirements, between about 30 mm² and about 65 mm², depending on the requirements, between about 35 mm² and about 60 mm², depending on the requirements, between about 40 mm² and about 55 mm², depending on the requirements, between about 45 mm² and about 50 mm², depending on the requirements, or depending on the requirements, about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², about 31 mm², about 32 mm², about 3 ... mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², approximately 51 mm², approximately 52 mm², approximately 53 mm², approximately 54 mm², approximately 55 mm², approximately 56 mm², approximately 57 mm², approximately 58 mm², approximately 59 mm², approximately 60 mm², approximately 61 mm², approximately 62 mm², approximately 63 mm², approximately 64 mm², approximately 65 mm², approximately 66 mm², approximately 67 mm², approximately 68 mm², approximately 69 mm², approximately 70 mm², approximately 71 mm², approximately 72 mm², approximately 73 mm², approximately 74 mm² mm2, about 75 mm2, about 76 mm2, about 77 mm2, about 78 mm2, about 79 mm2, about 80 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0065] In some configurations, the inner cross-sectional area of ​​the second fork is between about 5 mm² and about 50 mm², depending on the requirements, between about 10 mm² and about 45 mm², depending on the requirements, between about 15 mm² and about 40 mm², depending on the requirements, between about 20 mm² and about 35 mm², depending on the requirements, between about 25 mm² and about 30 mm², depending on the requirements, and is approximately 5 mm², about 6 mm², about 7 mm², about 8 mm², about 9 mm², about 10 mm², about 11 mm², about 12 mm², about 13 mm², about 14 mm², about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², etc. mm², approximately 31 mm², approximately 32 mm², approximately 33 mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², or any cross-sectional area between any two of these cross-sectional areas.

[0066] In some configurations, the combined cross-sectional area of ​​the first and second forks is between about 20 mm² and about 130 mm², depending on the requirements, between about 30 mm² and about 120 mm², depending on the requirements, between about 40 mm² and about 110 mm², depending on the requirements, between about 50 mm² and about 100 mm², depending on the requirements, between about 60 mm² and about 90 mm², depending on the requirements, between about 70 mm² and about 80 mm², depending on the requirements, and depending on the requirements, approximately 20 mm², approximately 25 mm², approximately 30 mm², approximately 35 mm², approximately 40 mm², approximately 45 mm², approximately 50 mm², approximately 55 mm², approximately 60 mm², approximately 65 mm², approximately 70 mm², approximately 75 mm², approximately 80 mm², approximately 85 mm², approximately 90 mm², approximately 95 mm², approximately 100 mm², approximately 105 mm², approximately 110 mm², approximately 115 mm², etc. mm2, approximately 120 mm2, approximately 125 mm2, approximately 130 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0067] 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, depending on the need, between about 65:35 and about 80:20, depending on the need, between about 70:30 and about 80:20, depending on the need, between about 70:30 and about 75:25, depending on the need, about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, depending on the need, between about 75:25 and 80:20, depending on the need, about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20. : 20.

[0068] In some configurations, the gap between adjacent outer surfaces of the first fork and the second fork, adjacent to the base of the first fork and the second fork, is between about 5 mm and about 15 mm, or as needed, between about 6 mm and about 14 mm, or as needed, between about 7 mm and about 13 mm, or as needed, between about 8 mm and about 12 mm, or as needed, between about 9 mm and about 11 mm, or as needed, between 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.

[0069] In some configurations, the nose interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork, and, if desired, about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork, and, if desired, about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork, and, if desired, about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork, and, if desired, about 70% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork. 80% is delivered through the first fork to the nose interface, and as needed, about 70% to about 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork to the nose interface.

[0070] In some configurations, the gas inlet is in fluid communication with the vent pipe.

[0071] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0072] In some configurations, the nasal interface includes a cannula body, the cannula body including a first fork and a second fork, 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 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.

[0073] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a nose interface is disclosed, comprising: a first fork and a second fork that are asymmetrical to each other; and a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, wherein the first fork has an inner cross-sectional area in the direction transverse to the gas flow through the first fork that is larger than the corresponding inner cross-sectional area of ​​the second fork in the direction transverse to the gas flow through the second fork, wherein the second fork has a distinctly oval or distinctly elliptical cross-sectional shape in the direction transverse to the gas flow through the second fork, the distinctly oval or distinctly elliptical cross-sectional shape having a first ratio of the widest dimension to the narrowest dimension, and wherein the first fork has a non-distinctly oval or non-distinctly elliptical cross-sectional shape in the direction transverse to the gas flow through the first fork, the non-distinctly oval or non-distinctly elliptical cross-section forming a second ratio of the widest dimension to the narrowest dimension that is less than the first ratio, or having a generally circular cross-sectional shape.

[0074] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0075] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0076] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0077] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0078] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0079] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0080] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork.

[0081] In some configurations, the inner cross-sectional area and inner cross-sectional shape of the first fork and the second fork are at the outlet of the first fork and the second fork.

[0082] In some configurations, the first fork is more flexible than the second fork.

[0083] In some configurations, the first fork has a generally circular shape.

[0084] In some configurations, the first fork has a first terminating end, and the second fork has a second terminating end, wherein the first terminating end includes a generally fan-shaped surface.

[0085] In some configurations, the second termination end has a generally planar surface.

[0086] In some configurations, the gas inlet is in fluid communication with the vent pipe.

[0087] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0088] In some configurations, the nasal interface includes a cannula body, the cannula body including a first fork and a second fork, 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 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.

[0089] In another aspect of this disclosure, based on certain features, aspects and advantages of at least one embodiment disclosed herein, a nose interface is disclosed, the nose interface comprising: a gas inlet; a first fork and a second fork that are asymmetrical to each other; and a gas flow path from the gas inlet to the first fork and the second fork, wherein the inner cross-sectional area of ​​the first fork in the direction transverse to the gas flow through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork, and wherein the first fork is downstream of the gas flow path of the second fork.

[0090] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0091] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork.

[0092] In some configurations, the inner cross-sectional area is at the exit of the first fork and the second fork.

[0093] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0094] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0095] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0096] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0097] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0098] In some configurations, the gas flow path is defined by a flow channel whose gas flow direction is substantially perpendicular to the gas flow path passing through the first fork and the second fork, wherein the first fork is further away from the gas inlet and the second fork is closer to the gas inlet.

[0099] In some configurations, the nose interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork. The gas flow rate is delivered through the first fork to the nose interface, and as needed, about 70% to about 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork to the nose interface, and as needed, about 75% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork to the nose interface, and as needed, about 75% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork to the nose interface, and as needed, about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork to the nose interface.

[0100] In some configurations, the gas inlet is in fluid communication with the vent pipe.

[0101] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0102] In some configurations, the nasal interface includes a cannula body, the cannula body including a first fork and a second fork, 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 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.

[0103] In another aspect of this disclosure, based on certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, comprising: a first fork and a second fork; and a gas manifold including 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 asymmetrical gas flow at the nostrils of a patient, and wherein the gas inlet is in fluid communication with a ventilator.

[0104] In some configurations, the first fork and the second fork are asymmetrical to each other, or not symmetrical to each other, and / or different in shape and configuration, or asymmetrical when compared to each other.

[0105] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0106] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0107] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0108] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0109] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0110] In some configurations, the gas manifold is integrally formed with or connected to the vent pipe.

[0111] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0112] In some configurations, the nasal interface includes a cannula body including the first fork and the second fork, 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 such that the first fork is closer to the gas inlet and the second fork is further away from the gas inlet.

[0113] In some configurations, the nasal interface includes a cannula body, the cannula body including the first fork and the second fork, and wherein the outer surface of the cannula body between the first fork and the second fork includes a recess to receive a portion of the patient's nose and reduce pressure on the underside of the received portion.

[0114] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, comprising: a cannula body including a first fork and a second fork, wherein the first fork and the second fork are asymmetrical with respect to each other; and a gas manifold including 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 asymmetrical gas flow at a patient's nostrils; 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 such that the second fork is closer to the gas inlet and the first fork is further 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 further away from the gas inlet.

[0115] In some configurations, the first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0116] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0117] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0118] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0119] In some configurations, the gas manifold includes a flow channel in which the gas flow direction is substantially perpendicular to the gas flow path passing through the first fork and the second fork.

[0120] In some configurations, the gas inlet is in fluid communication with the vent pipe.

[0121] In some configurations, the gas manifold is integrally formed with or connected to the vent pipe.

[0122] In another aspect of this disclosure, based on certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, comprising: a cannula body; a first fork and a second fork that are asymmetrical to each other; and a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, and wherein the outer surface of the cannula body between the first fork and the second fork includes a recess.

[0123] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0124] In some configurations, the recess is arranged to accommodate a portion of the patient’s nose and reduce pressure on the underside of the accommodated portion.

[0125] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0126] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0127] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0128] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0129] In some configurations, a portion of the gas manifold is complementary to the recess.

[0130] In some configurations, the portion of the gas manifold that is complementary to the recess is the outlet of the gas manifold, and, if necessary, the periphery of the outlet of the gas manifold.

[0131] In some configurations, the cannula body and / or the gas manifold includes (a plurality of) retaining features to removably retain the gas manifold in engagement with the cannula body.

[0132] In some configurations, such retaining features include an elastic annular portion of the cannula body that is received in a complementary recess of the gas manifold.

[0133] In another aspect of this disclosure, based on certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, comprising: a cannula body; a first fork and a second fork asymmetrical to each other; and a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, the nasal interface further comprising two side arms including wing portions extending laterally from one side of the cannula body, the nasal interface comprising or provided in conjunction with a tube holding clamp.

[0134] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0135] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0136] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0137] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0138] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0139] In some configurations, the tube retainer is configured to support the patient catheter or other gas supply tube.

[0140] In another aspect of this disclosure, based on certain features, aspects and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, comprising: a first fork having a shape and a second fork having a shape; and a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, wherein the inner cross-sectional area of ​​the first fork in the direction transverse to the gas flow through the first fork is greater than the corresponding inner cross-sectional area of ​​the second fork in the direction transverse to the gas flow through the second fork, and wherein at least the first fork is made of an elastomeric material such that the first fork can deform and set its shape in response to temperature and contact with the patient's nostril during use.

[0141] In some configurations, the temperature may be between about 20°C and about 41°C, or more than 20°C and up to about 41°C as needed, or between about 31°C and about 41°C as needed, or between about 36°C and about 39°C as needed, or about 37°C as needed.

[0142] In some configurations, the first fork is configured to deform in use and set its shape to substantially match the internal shape of the patient's nostrils.

[0143] In some configurations, the elastomeric material enables the first fork to deform and shape at a therapeutic temperature between about 31°C and about 41°C, or as needed between about 36°C and about 39°C, or as needed about 37°C, to substantially match the internal shape of the patient’s nostrils.

[0144] In some configurations, the first fork is not made of silicone resin.

[0145] In some configurations, at least the first fork is made of a thermoplastic elastomer.

[0146] In some configurations, the material exhibits compressive deformation of about 10% to about 50% after 72 hours at a temperature between about 20°C and about 40°C when tested according to Method A of ISO 815-1:2014.

[0147] In some configurations, the elastomer material, when tested according to Method A of ISO 815-1:2014, exhibits, after 72 hours, a compressive deformation of about 10% to about 45%, as desired, between about 10% and about 40%, as desired, between about 10% and about 35%, as desired, between about 10% and about 30%, as desired, between about 10% and about 25%, as desired, between about 10% and about 20%, as desired, between about 11% and about 19%, as desired, between about 12% and about 18%, as desired, between about 13% and about 17%, as desired, between about 14% and about 16%, as desired, or about 15%.

[0148] In some configurations, the elastomer material, when tested according to Method A of ISO 815-1:2014, exhibits between about 10% and about 45% after 72 hours at temperatures above about 20°C to up to about 35°C, as needed at temperatures above about 20°C to up to about 30°C, as needed at temperatures above about 20°C to up to about 25°C, as needed at temperatures of about 21°C, about 22°C, about 23°C, about 24°C, or about 25°C or higher, as needed. Compression deformation of approximately 10% to 40%, or as required, between approximately 10% and 35%, or as required, between approximately 10% and 30%, or as required, between approximately 10% and 25%, or as required, between approximately 10% and 20%, or as required, between approximately 11% and 19%, or as required, between approximately 12% and 18%, or as required, between approximately 13% and 17%, or as required, between approximately 14% and 16%, or as required, between approximately 15%.

[0149] In some configurations, both the first fork and the second fork are made of an elastomeric material.

[0150] In some configurations, the second fork has a distinctly oval or elliptical cross-sectional shape in the direction transverse to the gas flow passing through the second fork, the distinctly oval or elliptical cross-sectional shape having a first ratio of the widest dimension to the narrowest dimension, and wherein the first fork has a non-distinctly oval or elliptical cross-sectional shape in the direction transverse to the gas flow passing through the first fork, the non-distinctly oval or elliptical cross-sectional shape having a second ratio of the widest dimension to the narrowest dimension less than the first ratio, or having a generally circular cross-sectional shape.

[0151] In some configurations, the first fork has a generally circular shape.

[0152] In some configurations, the first fork has a first terminating end, and the second fork has a second terminating end, wherein the first terminating end includes a generally fan-shaped surface.

[0153] In some configurations, the second termination end has a generally planar surface.

[0154] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, between about 5 mm and about 9 mm as needed, between about 6 mm and about 8 mm as needed, or between about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm as needed, or any diameter between any two of these values.

[0155] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, between about 3 mm and about 7 mm as needed, between about 4 mm and about 6 mm as needed, or between about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm as needed, or any diameter between any two of these values.

[0156] In some configurations, the wall thickness of the first fork and / or the second fork is between about 0.1 mm and about 0.5 mm.

[0157] In some configurations, the inner cross-sectional area of ​​the first fork is between about 15 mm² and about 80 mm², depending on the requirements, between about 20 mm² and about 75 mm², depending on the requirements, between about 25 mm² and about 70 mm², depending on the requirements, between about 30 mm² and about 65 mm², depending on the requirements, between about 35 mm² and about 60 mm², depending on the requirements, between about 40 mm² and about 55 mm², depending on the requirements, between about 45 mm² and about 50 mm², depending on the requirements, or depending on the requirements, about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², about 31 mm², about 32 mm², about 3 ... mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², approximately 51 mm², approximately 52 mm², approximately 53 mm², approximately 54 mm², approximately 55 mm², approximately 56 mm², approximately 57 mm², approximately 58 mm², approximately 59 mm², approximately 60 mm², approximately 61 mm², approximately 62 mm², approximately 63 mm², approximately 64 mm², approximately 65 mm², approximately 66 mm², approximately 67 mm², approximately 68 mm², approximately 69 mm², approximately 70 mm², approximately 71 mm², approximately 72 mm², approximately 73 mm², approximately 74 mm² mm2, about 75 mm2, about 76 mm2, about 77 mm2, about 78 mm2, about 79 mm2, about 80 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0158] In some configurations, the inner cross-sectional area of ​​the second fork is between about 5 mm² and about 50 mm², depending on the requirements, between about 10 mm² and about 45 mm², depending on the requirements, between about 15 mm² and about 40 mm², depending on the requirements, between about 20 mm² and about 35 mm², depending on the requirements, between about 25 mm² and about 30 mm², depending on the requirements, and is approximately 5 mm², about 6 mm², about 7 mm², about 8 mm², about 9 mm², about 10 mm², about 11 mm², about 12 mm², about 13 mm², about 14 mm², about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², etc. mm², approximately 31 mm², approximately 32 mm², approximately 33 mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², or any cross-sectional area between any two of these cross-sectional areas.

[0159] In some configurations, the combined cross-sectional area of ​​the first and second forks is between about 20 mm² and about 130 mm², depending on the requirements, between about 30 mm² and about 120 mm², depending on the requirements, between about 40 mm² and about 110 mm², depending on the requirements, between about 50 mm² and about 100 mm², depending on the requirements, between about 60 mm² and about 90 mm², depending on the requirements, between about 70 mm² and about 80 mm², depending on the requirements, and depending on the requirements, approximately 20 mm², approximately 25 mm², approximately 30 mm², approximately 35 mm², approximately 40 mm², approximately 45 mm², approximately 50 mm², approximately 55 mm², approximately 60 mm², approximately 65 mm², approximately 70 mm², approximately 75 mm², approximately 80 mm², approximately 85 mm², approximately 90 mm², approximately 95 mm², approximately 100 mm², approximately 105 mm², approximately 110 mm², approximately 115 ... mm2, approximately 120 mm2, approximately 125 mm2, approximately 130 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0160] 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 approximately 60:40 and approximately 80:20, depending on the requirements, between approximately 65:35 and approximately 80:20, depending on the requirements, between approximately 70:30 and approximately 80:20, depending on the requirements, between approximately 70:30 and approximately 75:25, depending on the requirements, approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26, or approximately 75:25, depending on the requirements, between approximately 75:25 and 80:20, depending on the requirements, approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79:21, or approximately 80:20. : 20.

[0161] In some configurations, the gas inlet is in fluid communication with the vent pipe.

[0162] In some configurations, the nasal interface includes a cannula body, the cannula body including a first fork and a second fork, 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 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.

[0163] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a nasal interface is disclosed, comprising: a first fork and a second fork asymmetrical to each other; and a gas manifold including 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 asymmetrical gas flow at a patient's nostrils, wherein the inner cross-sectional area of ​​the first fork is between about 15 mm² and about 80 mm², wherein the inner cross-sectional area of ​​the second fork is between about 5 mm² and about 50 mm², wherein the combined inner cross-sectional area of ​​the first fork and the second fork is between about 20 mm² and about 130 mm², and 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.

[0164] In some configurations, the inner cross-sectional area of ​​the first fork is between about 20 mm² and about 75 mm², depending on the need, between about 25 mm² and about 70 mm², depending on the need, between about 30 mm² and about 65 mm², depending on the need, between about 35 mm² and about 60 mm², depending on the need, between about 40 mm² and about 55 mm², depending on the need, between about 45 mm² and about 50 mm², depending on the need, about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², about 31 mm², about 32 mm², about 33 mm², about 34 mm², about 35 mm², about 36 mm², depending on the need. mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², approximately 51 mm², approximately 52 mm², approximately 53 mm², approximately 54 mm², approximately 55 mm², approximately 56 mm², approximately 57 mm², approximately 58 mm², approximately 59 mm², approximately 60 mm², approximately 61 mm², approximately 62 mm², approximately 63 mm², approximately 64 mm², approximately 65 mm², approximately 66 mm², approximately 67 mm², approximately 68 mm², approximately 69 mm², approximately 70 mm², approximately 71 mm², approximately 72 mm², approximately 73 mm², approximately 74 mm², approximately 75 mm², approximately 76 mm², approximately 77 mm2, approximately 78 mm2, approximately 79 mm2, approximately 80 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0165] In some configurations, the inner cross-sectional area of ​​the second fork is between about 10 mm² and about 45 mm², depending on the need, between about 15 mm² and about 40 mm², depending on the need, between about 20 mm² and about 35 mm², depending on the need, between about 25 mm² and about 30 mm², depending on the need, or depending on the need, about 5 mm², about 6 mm², about 7 mm², about 8 mm², about 9 mm², about 10 mm², about 11 mm², about 12 mm², about 13 mm², about 14 mm², about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², about 31 mm², about 32 mm², etc. mm², approximately 33 mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², or any cross-sectional area between any two of these cross-sectional areas.

[0166] In some configurations, the combined internal cross-sectional area of ​​the first and second forks is between about 30 mm² and about 120 mm², depending on the requirements, between about 40 mm² and about 110 mm², depending on the requirements, between about 50 mm² and about 100 mm², depending on the requirements, between about 60 mm² and about 90 mm², depending on the requirements, between about 70 mm² and about 80 mm², depending on the requirements, and depending on the requirements, about 20 mm², about 25 mm², about 30 mm², about 35 mm², about 40 mm², about 45 mm², about 50 mm², about 55 mm², about 60 mm², about 65 mm², about 70 mm², about 75 mm², about 80 mm², about 85 mm², about 90 mm², about 95 mm², about 100 mm², about 105 mm², about 110 mm², about 115 mm², about 120 mm², about 125 mm², about 130 mm², etc. mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0167] 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, or as needed between about 70:30 and about 80:20, or as needed between about 70:30 and about 75:25, or as needed about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, or as needed between about 75:25 and 80:20, or as needed about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20.

[0168] In some configurations, the inner cross-sectional area of ​​the first fork is between about 24 mm2 and 25 mm2, and the inner cross-sectional area of ​​the second fork is between about 6 mm2 and about 17 mm2.

[0169] In some configurations, the inner cross-sectional area of ​​the first fork is between about 44 mm2 and about 45 mm2, and the inner cross-sectional area of ​​the second fork is between about 11 mm2 and about 30 mm2.

[0170] In some configurations, the inner cross-sectional area of ​​the first fork is between about 69 mm2 and about 70 mm2, and the inner cross-sectional area of ​​the second fork is between about 17 mm2 and about 47 mm2.

[0171] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a nose interface is disclosed, the nose interface comprising: a gas inlet; a first fork and a second fork that are asymmetrical to each other, wherein the first fork has a first fork outlet and the second fork has a second fork outlet; and a gas flow path from the gas inlet to the first fork and the second fork, wherein the inner cross-sectional area of ​​the first fork in the direction transverse to the gas flow through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork, wherein for a given gas flow rate at the gas inlet in use, different gas flow rates are provided through the first fork and the second fork, and the gas exits the first fork outlet and the second fork outlet at substantially similar velocities.

[0172] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0173] In some configurations, the velocity of the gas leaving the first fork outlet is within about 20% of the velocity of the gas leaving the second fork outlet.

[0174] In some configurations, the velocity of the gas leaving the first fork outlet is within about 16% of the velocity of the gas leaving the second fork outlet.

[0175] In some configurations, at flow rates above about 40 lpm, the gas exits the first fork outlet at a velocity of about 10% of the gas exits the second fork outlet.

[0176] In some configurations, at flow rates above about 42 lpm, the gas exits the first fork outlet at a velocity of about 10% of the gas exits the second fork outlet.

[0177] In some configurations, for a total volumetric flow rate of gas greater than 0 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first and second branch outlets is greater than 0 m / s and less than about 32 m / s.

[0178] In some configurations, for a total volumetric flow rate of gas greater than 0 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first and second branch outlets is greater than 0 m / s and less than 32 m / s.

[0179] In some configurations, for a total volumetric flow rate of gas 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 and second branch outlets is greater than about 2 m / s and less than about 32 m / s, as needed, greater than about 2 m / s and less than 32 m / s, as needed, greater than about 2 m / s and up to about 25 m / s, and as needed, greater than about 2.5 m / s and up to about 20 m / s.

[0180] In some configurations, the nose interface is configured such that the total volumetric flow rate of the gas flowing into the gas inlet is at least about 5 liters per minute (lpm).

[0181] In some configurations, the nose interface is configured such that the total volumetric flow rate of the gas flowing into the gas inlet is between about 5 lpm and about 120 lpm.

[0182] In some configurations, the nose interface is configured such that the total volumetric flow rate of the gas flow into the gas inlet is between about 5 lpm and about 70 lpm.

[0183] In some configurations, the nose interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0184] In some configurations, the nose interface is configured such that about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0185] In some configurations, the nose interface is configured such that about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0186] In some configurations, the nose interface is configured such that about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0187] In some configurations, the nose interface is configured such that about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0188] In some configurations, the nose interface is configured such that about 70% to about 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0189] In some configurations, the nose interface is configured such that approximately 70% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0190] In some configurations, the nose interface is configured such that about 75% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0191] In some configurations, the nose interface is configured such that approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0192] In some configurations, the nose interface is configured such that approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

[0193] In some configurations, the inner diameter of the first fork is between about 4 mm and about 10 mm, between about 5 mm and about 9 mm as needed, between about 6 mm and about 8 mm as needed, or between about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm as needed, or any diameter between any two of these diameters.

[0194] In some configurations, the inner diameter of the second fork is between about 2 mm and about 8 mm, between about 3 mm and about 7 mm as needed, between about 4 mm and about 6 mm as needed, or between about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm as needed, or any diameter between any two of these diameters.

[0195] In some configurations, the inner cross-sectional area of ​​the first fork is between about 15 mm² and about 80 mm², depending on the requirements, between about 20 mm² and about 75 mm², depending on the requirements, between about 25 mm² and about 70 mm², depending on the requirements, between about 30 mm² and about 65 mm², depending on the requirements, between about 35 mm² and about 60 mm², depending on the requirements, between about 40 mm² and about 55 mm², depending on the requirements, between about 45 mm² and about 50 mm², depending on the requirements, or depending on the requirements, about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², about 31 mm², about 32 mm², about 3 ... mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², approximately 51 mm², approximately 52 mm², approximately 53 mm², approximately 54 mm², approximately 55 mm², approximately 56 mm², approximately 57 mm², approximately 58 mm², approximately 59 mm², approximately 60 mm², approximately 61 mm², approximately 62 mm², approximately 63 mm², approximately 64 mm², approximately 65 mm², approximately 66 mm², approximately 67 mm², approximately 68 mm², approximately 69 mm², approximately 70 mm², approximately 71 mm², approximately 72 mm², approximately 73 mm², approximately 74 mm² mm2, about 75 mm2, about 76 mm2, about 77 mm2, about 78 mm2, about 79 mm2, about 80 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0196] In some configurations, the inner cross-sectional area of ​​the second fork is between about 5 mm² and about 50 mm², depending on the requirements, between about 10 mm² and about 45 mm², depending on the requirements, between about 15 mm² and about 40 mm², depending on the requirements, between about 20 mm² and about 35 mm², depending on the requirements, between about 25 mm² and about 30 mm², depending on the requirements, and is approximately 5 mm², about 6 mm², about 7 mm², about 8 mm², about 9 mm², about 10 mm², about 11 mm², about 12 mm², about 13 mm², about 14 mm², about 15 mm², about 16 mm², about 17 mm², about 18 mm², about 19 mm², about 20 mm², about 21 mm², about 22 mm², about 23 mm², about 24 mm², about 25 mm², about 26 mm², about 27 mm², about 28 mm², about 29 mm², about 30 mm², etc. mm², approximately 31 mm², approximately 32 mm², approximately 33 mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², or any cross-sectional area between any two of these cross-sectional areas.

[0197] In some configurations, the combined cross-sectional area of ​​the first and second forks is between about 20 mm² and about 130 mm², depending on the requirements, between about 30 mm² and about 120 mm², depending on the requirements, between about 40 mm² and about 110 mm², depending on the requirements, between about 50 mm² and about 100 mm², depending on the requirements, between about 60 mm² and about 90 mm², depending on the requirements, between about 70 mm² and about 80 mm², depending on the requirements, and depending on the requirements, approximately 20 mm², approximately 25 mm², approximately 30 mm², approximately 35 mm², approximately 40 mm², approximately 45 mm², approximately 50 mm², approximately 55 mm², approximately 60 mm², approximately 65 mm², approximately 70 mm², approximately 75 mm², approximately 80 mm², approximately 85 mm², approximately 90 mm², approximately 95 mm², approximately 100 mm², approximately 105 mm², approximately 110 mm², approximately 115 ... mm2, approximately 120 mm2, approximately 125 mm2, approximately 130 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0198] 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, depending on the need, between about 65:35 and about 80:20, depending on the need, between about 70:30 and about 80:20, depending on the need, between about 70:30 and about 75:25, depending on the need, about 70:30, about 71:29, about 72:28, about 73:27, about 74:26, or about 75:25, depending on the need, between about 75:25 and 80:20, depending on the need, about 75:25, about 76:24, about 77:23, about 78:22, about 79:21, or about 80:20. : 20.

[0199] In some configurations, the inner diameter and / or inner cross-sectional area of ​​the first and second forks are measured along the same plane (i.e., common plane).

[0200] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork.

[0201] In some configurations, the inner diameter and / or inner cross-sectional area are at the first fork outlet and the second fork outlet.

[0202] In some configurations, the nose interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; optionally, about 70% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork. 80% is delivered through the first fork to the nose interface, and as needed, about 70% to about 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork to the nose interface.

[0203] In some configurations, the nose interface is configured such that approximately 7 lpm is delivered through the first fork at a volumetric flow rate of approximately 9.5 lpm at the gas inlet, and / or approximately 13.5 lpm is delivered through the first fork at a volumetric flow rate of approximately 19 lpm at the gas inlet, and / or approximately 21 lpm is delivered through the first fork at a volumetric flow rate of approximately 29 lpm at the gas inlet, and / or approximately 28 lpm is delivered through the first fork at a volumetric flow rate of approximately 38.5 lpm at the gas inlet, and / or approximately 35 lpm is delivered through the first fork at a volumetric flow rate of approximately 47.5 lpm at the gas inlet, and / or approximately 44 lpm is delivered through the first fork at a volumetric flow rate of approximately 58 lpm at the gas inlet, and / or approximately 48.5 lpm is delivered through the first fork at a volumetric flow rate of approximately 64 lpm at the gas inlet. The lpm is delivered out of the nose interface through the first fork.

[0204] In some configurations, the nose interface includes a gas manifold, which includes a gas inlet.

[0205] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0206] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0207] In some configurations, the gas inlet is located on one side of the gas manifold 120.

[0208] In some configurations, the gas manifold includes one or more internal angled walls to guide the gas flow into the first branch and / or the second branch.

[0209] In some configurations, the nose interface is a non-sealed nose interface.

[0210] Based on certain features, aspects, and advantages disclosed herein, a patient interface is disclosed, which includes a nasal interface as described above or outlined herein.

[0211] In some configurations, the patient interface further includes a headgear to hold the nasal interface to the patient’s face.

[0212] In some configurations, the patient interface further includes a tube in fluid communication with the gas inlet.

[0213] In some configurations, the piping system is a vent pipe.

[0214] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0215] In some configurations, the gas manifold is integrally formed with or connected to the vent pipe.

[0216] In some configurations, the patient interface further includes a tube holding clamp.

[0217] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one of the above-disclosed contents, a respiratory therapy system is disclosed, comprising: a respiratory therapy device, the respiratory therapy device comprising: a controller; a blood oxygen saturation sensor; an ambient air inlet; an oxygen inlet; a valve in fluid communication with the oxygen inlet to control the oxygen flow rate through the oxygen inlet; and a gas outlet; wherein the controller is configured to control the valve based on at least one oxygen saturation measurement from the blood oxygen saturation sensor; and a patient interface including a nasal interface, wherein the nasal interface includes: a first branch and a second branch that are asymmetrical with each other; and a gas manifold including a gas inlet, wherein the first branch and the second branch are in fluid communication with the gas inlet, wherein the nasal interface is configured to achieve asymmetrical gas flow at the patient's nostrils.

[0218] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0219] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0220] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0221] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0222] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0223] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0224] In some configurations, the nose interface is as described above or in this article.

[0225] In some configurations, the respiratory therapy device includes a flow generator and a humidifier.

[0226] In some configurations, the respiratory therapy system includes a patient catheter with a heater.

[0227] In some configurations, the patient interface includes a ventilator 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.

[0228] In some configurations, water vapor can pass through the wall of the tube, but liquid water and large amounts of gas cannot pass through the wall of the tube.

[0229] In some configurations, the gas manifold is integrally formed with or connected to the vent pipe.

[0230] In some configurations, the patient interface further includes a tube holding clamp.

[0231] In some configurations, the patient interface is as described above or in this article.

[0232] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one of the above-disclosed contents, a respiratory therapy system is disclosed, comprising: a respiratory therapy device including: a gas inlet; a gas outlet; a nebulizer for delivering one or more substances into the gas stream; and a patient interface including a nasal interface, wherein the nasal interface includes: a first branch and a second branch that are asymmetrical to each other; a gas manifold including a gas inlet, wherein the first branch and the second branch 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; wherein the nasal interface is configured to achieve an asymmetrical gas stream at the patient's nostrils.

[0233] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0234] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0235] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0236] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in a non-sealing manner.

[0237] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0238] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0239] 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 one or more substances to the gas inlet of the nasal interface.

[0240] In some configurations, the conduit includes a smooth-hole heating tube.

[0241] In some configurations, the nose interface is as described above or in this article.

[0242] In some configurations, the patient interface is as described above or in this article.

[0243] In another aspect of this disclosure, based on certain features, aspects, and advantages of at least one of the above-disclosed contents, a respiratory therapy system is disclosed, comprising: a respiratory therapy device including: at least one gas inlet; a humidifier for humidifying the gas; and a gas outlet; and a patient interface including a nasal interface, wherein the nasal interface includes: a first branch and a second branch that are asymmetrical to each other, and wherein the first branch has a first branch outlet and the second branch has a second branch outlet; and a gas manifold including a gas inlet, wherein the first branch and the second branch are in fluid communication with the gas inlet, wherein the nasal interface is configured to achieve asymmetrical gas flow at the patient's nostrils; wherein the respiratory therapy system is configured to, for a total volumetric flow rate of gas flow greater than 0 lpm and up to about 70 lpm flowing into the gas inlet, deliver the gas at a temperature range between about 27°C and 37°C, at a relative humidity greater than about 33 mg / L, and / or at a relative humidity greater than 0 lpm. The gas is delivered through the first fork outlet and the second fork outlet at a speed of m / s and less than about 32 m / s.

[0244] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0245] In some configurations, the respiratory therapy system is configured to deliver gas at a temperature range of about 31°C to 37°C through the first fork outlet and the second fork outlet.

[0246] In some configurations, the respiratory therapy system is configured to deliver gas at a relative humidity of up to about 44 mg / l through the first fork outlet and the second fork outlet.

[0247] In some configurations, the respiratory therapy system is configured to provide a total volumetric flow rate of gas to the gas inlet of at least about 5 liters per minute (lpm), between about 5 lpm and about 120 lpm as needed, and between about 5 lpm and about 70 lpm as needed.

[0248] In some configurations, the respiratory therapy system is configured to deliver at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork to the nasal interface, and, as needed, deliver about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork to the nasal interface, and, as needed, deliver about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork to the nasal interface, and, as needed, deliver about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork to the nasal interface, and, as needed, deliver about 70% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork to the nasal interface. Approximately 80% of the total volumetric flow rate of the gas flowing into the gas inlet is delivered through the first fork to the nose interface. Approximately 70% to 75% of the total volumetric flow rate of the gas flowing into the gas inlet is delivered through the first fork to the nose interface as needed. Approximately 70% to 80% of the total volumetric flow rate of the gas flowing into the gas inlet is delivered through the first fork to the nose interface as needed. Approximately 75% of the total volumetric flow rate of the gas flowing into the gas inlet is delivered through the first fork to the nose interface as needed. Approximately 80% of the total volumetric flow rate of the gas flowing into the gas inlet is delivered through the first fork to the nose interface as needed.

[0249] In some configurations, the respiratory therapy system is configured to provide different gas flow rates through the first fork and the second fork, and to deliver gas at substantially similar velocities through the outlets of the first fork and the second fork.

[0250] In some configurations, the gas exit velocity from the first fork outlet is within about 20% of the gas exit velocity from the second fork outlet, or as needed, within about 16% of the gas exit velocity from the second fork outlet, or as needed, within about 10% of the gas exit velocity from the second fork outlet at flow rates above about 40 lpm, or as needed, within about 10% of the gas exit velocity from the second fork outlet at flow rates above about 42 lpm.

[0251] In some configurations, for a total volumetric flow rate of gas greater than 0 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first and second branch outlets is greater than 0 m / s and less than 32 m / s.

[0252] In some configurations, for a total volumetric flow rate of gas 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 and second branch outlets is greater than about 2 m / s and less than about 32 m / s, as needed, greater than about 2 m / s and less than 32 m / s, as needed, greater than about 2 m / s and up to about 25 m / s, and as needed, greater than about 2.5 m / s and up to about 20 m / s.

[0253] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0254] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0255] In some configurations, the first fork and the second fork are configured to engage with the nasal passage in an unsealed (non-sealed) manner.

[0256] In some configurations, the first fork and the second fork allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0257] In some configurations, the first and second forks are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0258] In some configurations, the first and second forks are configured to deliver gas to the patient independently of the patient’s breathing.

[0259] 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.

[0260] In some configurations, the conduit includes a smooth-hole heating tube.

[0261] In some configurations, the nose interface is as described above or in this article.

[0262] In another aspect of this disclosure, according to certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein, a method for providing respiratory support to a patient is provided, the method comprising: providing a respiratory therapy system comprising: a respiratory therapy device comprising: at least one gas inlet; a flow generator; and a gas outlet; and a patient interface including a nasal interface, wherein the nasal interface includes: an asymmetrical first fork and a second fork extending through a first fork outlet and a second fork outlet; and a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet; operating the respiratory therapy device to provide a gas flow to the nasal interface; and delivering the asymmetrical gas flow from the respiratory therapy device through the first fork outlet and the second fork outlet at the patient's nostrils.

[0263] The first fork and the second fork are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0264] In some configurations, the method includes delivering the asymmetric gas stream through the first fork outlet and the second fork outlet at a temperature range of about 27°C to 37°C, at a relative humidity of more than about 33 mg / l, and / or at a velocity of more than 0 m / s and less than about 32 m / s for a total volumetric flow rate of the gas stream flowing into the gas inlet from a gas stream greater than 0 lpm to about 70 lpm.

[0265] In some configurations, the method includes delivering an asymmetric gas stream in a temperature range of about 31°C to 37°C.

[0266] In some configurations, the method includes: providing a total volumetric flow rate of at least about 5 liters per minute (lpm) of gas to the gas inlet, providing a total volumetric flow rate of about 5 lpm to about 120 lpm of gas to the gas inlet as needed, and providing a total volumetric flow rate of about 5 lpm to about 70 lpm of gas to the gas inlet as needed.

[0267] In some configurations, the method includes delivering at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork and exiting the nose interface; delivering about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork and exiting the nose interface as needed; delivering about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork and exiting the nose interface as needed; delivering about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork and exiting the nose interface as needed; and delivering about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet through the first fork and exiting the nose interface as needed. The nose interface is delivered through the first fork, and approximately 70% to 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork to the nose interface as needed.

[0268] In some configurations, the method includes delivering gas through a first fork outlet and a second fork outlet at a relative humidity of up to about 44 mg / l.

[0269] In some configurations, the method includes providing different gas flow rates through the first fork and the second fork, and delivering gas at substantially similar velocities through the outlets of the first fork and the second fork.

[0270] In some configurations, the gas exit velocity from the first fork outlet is within about 20% of the gas exit velocity from the second fork outlet, or as needed, within about 16% of the gas exit velocity from the second fork outlet, and as needed, within about 10% of the gas exit velocity from the second fork outlet at flow rates above about 42 lpm.

[0271] In some configurations, for a total volumetric flow rate of gas greater than 0 lpm and up to about 70 lpm flowing into the gas inlet, the velocity of the gas leaving each of the first and second branch outlets is greater than 0 m / s and less than 32 m / s.

[0272] In some configurations, for a total volumetric flow rate of gas 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 and second branch outlets is greater than about 2 m / s and less than about 32 m / s, as needed, greater than about 2 m / s and less than 32 m / s, as needed, greater than about 2 m / s and up to about 25 m / s, and as needed, greater than about 2.5 m / s and up to about 20 m / s.

[0273] In some configurations, the nasal interface includes a cannula body, which includes a first fork and a second fork.

[0274] In some configurations, the gas manifold is integrated with the cannula body, or it is separate from the cannula body but can be connected to it.

[0275] In some configurations, the method includes engaging the first and second forks with the nasal passage in an unsealed (non-sealed) manner.

[0276] In some configurations, the method includes allowing exhaled gas to escape around the first and second forks.

[0277] In some configurations, the method involves supplying gas to the patient without interfering with the patient’s spontaneous breathing.

[0278] In some configurations, the method includes delivering gas to the patient independently of the patient’s breathing.

[0279] In some configurations, the nose interface is as described above or in this article.

[0280] In some configurations, the respiratory therapy device includes a humidifier, and the method includes using the humidifier to humidify the gas stream.

[0281] In some configurations, the respiratory therapy system includes a patient catheter with a heater, and the method includes operating the heater.

[0282] In some configurations, the patient interface includes a ventilator in fluid communication with a gas inlet, and the method includes allowing water vapor to pass through the wall of the ventilator, but preventing liquid water and large amounts of gas from flowing through the wall of the ventilator.

[0283] Features from one or more embodiments or configurations can be combined with features from one or more other embodiments or configurations. Additionally, more than one embodiment or configuration can be used together in the respiratory support system during the patient's respiratory support process.

[0284] As used herein, the word “(multiple)” following a noun refers to the plural and / or singular forms of that noun.

[0285] As used herein, the term "and / or" means "and" or "or" or both.

[0286] As used in this specification, the term "comprise" means "consisting of at least in part with". When interpreting each statement in this specification containing the term "comprise", there may also be features other than the features that follow that term. Related terms such as "comprise" and "comprises" will be interpreted in the same manner.

[0287] It is intended that references to the range of digits disclosed herein (e.g., 1 to 10) also include 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. These are merely examples of specific intentions, and all possible combinations of numerical values ​​between the enumerated minimum and maximum values ​​should be considered to be explicitly stated in a similar manner in this application.

[0288] This disclosure may also be broadly interpreted as any part, element, or feature individually or collectively mentioned or indicated in the specification of this application, and any or all combinations of any two or more of the said parts, elements, or features.

[0289] When a specific integer having a known equivalent in the field to which this disclosure pertains is mentioned herein, such known equivalent is considered to be incorporated herein as if described separately.

[0290] This disclosure includes the foregoing and also envisions various structures, of which only examples are given below.

Implementation Method

[0318] A patient interface can be used to deliver breathing gases into a patient's airway. The patient interface may include a nasal interface, which can be used to deliver high-flow-rate gases to a patient. A nasal delivery element (such as a nasal fork that may include a nasal pillow, if desired) is inserted into the patient's nose to deliver the desired therapy. The nasal delivery element may be intended to seal or partially block at the nose, or may not require a seal at the nose, to deliver the therapy. A nasal fork typically refers to a nasal delivery element that is designed to be unsealed or only partially blocked at the nose. When one or more nasal forks include a nasal pillow, the nasal delivery element is designed to seal at the nose. High-flow-rate (NHF) nasal therapy is typically an unsealed therapy that delivers a relatively high volume of gas to a patient via a patient interface, such as a nasal interface. The nasal interface described herein may refer to, but is not limited to, a nasal cannula.

[0319] A system for delivering gas to a patient via an asymmetric nasal cannula or nasal interface is disclosed. As described herein, an asymmetric interface or asymmetric nasal delivery element refers to an interface with different sizes of nasal delivery elements (e.g., internal and / or external lateral dimensions or diameters and / or internal and / or external cross-sectional areas). 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 diameter mentioned herein can be interpreted as a lateral dimension. In some configurations, the diameter mentioned herein includes, but is not limited to, the hydraulic diameter.

[0320] This system allows for the delivery of asymmetric flow rates through the interface to both nostrils or either nostril. As described herein, asymmetric flow rate refers to different flow rates within the interface, within the nose, or between the interface and the nose. In this way, each nasal delivery element can deliver different flow rates, or the flow rates between inhalation and exhalation can be different, or the delivered flow rates can be a combination of the above. Asymmetric flow rate may also include a portion of unidirectional flow rate.

[0321] Delivering asymmetric flow can improve the clearance of dead space in the upper airway, reduce peak expiratory pressure, particularly improve the safety of the therapy in 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 generate such asymmetric flow through the asymmetric nasal delivery element.

[0322] The pressure generated by NHF depends on the flow rate through the nasal interface, the size of the nasal delivery element and / or the patient's nostrils, and the respiratory cycle. The flow rate through the nose may be asymmetrical if the flow rate, leakage, or combination of flow rate and leakage through the nasal interface is asymmetrical during respiration. Partial unidirectional flow and total unidirectional flow can be types of asymmetrical flow. Partial unidirectional flow or total unidirectional flow can provide improved clearance 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 rates that enter one nostril via the nasal delivery element and exit through the other nostril via the nasal delivery element, flow rates that are discharged into the atmosphere due to the absence of a nasal delivery element, and so on. As described herein, some unidirectional flows include flows that can enter the nose through both nostrils and exit the nose through one nostril, flows that can enter the nose through one nostril and exit the nose through both nostrils, or different proportions of flows that can enter the nose through both nostrils and different proportions of flows that can exit the nose through both nostrils, and flows that can enter the nose through both nostrils and exit the nose through one or both nostrils and exit through the mouth as needed.

[0323] The NHF delivered through an asymmetric nose interface can be fabricated with respect to the following: its nose delivery element has 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 nose delivery element has a small inner diameter and therefore higher gas flow resistance. By using nose delivery elements of different lengths, each nose delivery element can have a different inner diameter (e.g., a minimum inner diameter or area). Longer nose delivery elements can have smaller inner diameters and higher gas flow resistance; shorter nose delivery elements can have larger inner diameters (e.g., a larger minimum inner diameter), thus reducing gas flow resistance at the interface. Reduced flow resistance allows for the use of lower back pressure, or lower motor speeds of the gas generating device, or a combination of both, to achieve the desired flow rate.

[0324] Asymmetric nasal delivery elements can reduce peak expiratory pressure due to different cross-sectional areas of the nasal delivery elements at the nose, which can provide a different inner diameter for each nasal delivery element.

[0325] The pressure during exhalation using an asymmetrical nasal interface can be higher than that using a symmetrical interface, which is beneficial because a higher positive end-expiratory pressure (PEEP) is part of COPD treatment (here, pressure refers to intrathoracic pressure). Expiratory pressure depends on the combined cross-sectional area of ​​the two forks. Increasing the cross-section of a symmetrical fork carries the risk of complete nasal obstruction. Using an asymmetrical fork allows for an increased total cross-sectional area without the risk of obstruction. Partial unidirectional flow can reduce turbulence in the patient's nasal cavity, which can improve comfort.

[0326] In the example, the asymmetric nasal interface used with a gas generating device, such as the AIRVO™ flow generator from Fisher & Paykel Healthcare, Inc. (e.g., via a catheter or breathing tube connection), reduces flow resistance. This allows the motor speed of the AIRVO™ to be reduced from the range of 18,000–22,000 RPM to the range of 14,000–18,000 RPM, while still achieving the appropriate flow rate of the desired therapy (e.g., NHF), such as approximately 8 liters per minute (lpm). For example, if an incorrectly sized fork forms a seal with the patient's nostril, the asymmetric nasal delivery element may reduce the back pressure generated in the system.

[0327] For smaller patients, such as infants or children, when the nostrils are too small relative to the two forks, using an asymmetric nasal delivery element can reduce the over-insertion of these forks into the nostrils, which could lead to undesirable partial or complete closure. Asymmetric flow can be delivered to the patient even when only one fork is tightly positioned in the nose. Because compressed gas can be used in systems without pressure control, the asymmetric interface improves the performance of treatments for infants.

[0328] Figures 1A to 1C and 2 illustrate an exemplary patient interface 1, which includes a nasal cannula or nasal interface 100 with asymmetrical nasal delivery elements 111, 112.

[0329] The nasal interface 100 provides a patient interface suitable for delivering a high-flow, high-humidity gas stream to a patient's nasal cavity / nostril. In some configurations, the nasal interface 100 is adapted to deliver high-flow-rate gas over a wide flow range (e.g., approximately 8 lpm 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.

[0330] The nasal interface 100 includes a face mount portion 110 and a gas manifold portion 120. The face mount portion includes a pair of asymmetrical tubular nose forks 111 and 112 integrally molded with or removably attached to the face mount portion 110. The gas manifold portion is removably attached to or integrally molded with the conduit 300.

[0331] The gas manifold 120 can be inserted into the face mount 110. The face mount 110 may include at least one substantially horizontal lateral 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 through it.

[0332] The gas manifold 120 can be inserted into the face mount 110 from one of two opposite horizontal directions, i.e., from the left or right side, as needed. In this way, the position or orientation of the gas manifold 120 can be reconfigured relative to the face mount 110. In other words, the user can choose to have the manifold 120 (and the tubing 300 extending therefrom) extend from the left or right side of the face mount 110 of the nasal interface 100, depending on what is most convenient, for example, depending on which side the gas source or ventilator is positioned on. In an alternative configuration, the gas manifold 120 cannot be reconfigured relative to the face mount 110.

[0333] The face mount 110 may include a pair of opposite side access passages 118a, 118b leading to the interior of the base portion or cannula body 118, each side access passage being adapted to releasably receive an outlet of the gas manifold 120 through it.

[0334] The facial mounting portion 100 is formed of a soft, flexible material, such as silicone or other cannulation materials known in the art. The nose forks 111 and 112 are preferably flexible and can be formed of a sufficiently thin silicone layer to achieve this characteristic.

[0335] 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 face mount 110 provides a soft docking component for the patient to comfortably deliver a flow of gas through the nose forks 111 and 112, while the gas manifold 120 fluidly connects the conduit 300 to the nose forks 111 and 112 of the face mount 110.

[0336] The nose forks 111 and 112 bend and extend into the patient's nostrils during use, providing a smooth flow path for gas to pass through. The inner surfaces of the forks 111 and 112 may have a noise-reducing profile. The bases of the forks 111 and 112 may include curved surfaces to provide a smoother gas flow. This can reduce the noise level during operation.

[0337] Nose forks 111 and 112 are basically hollow and are basically tubular in shape.

[0338] The diameters of the nasal forks 111 and 112 may be consistent along their length, or alternatively may be shaped to fit the contours of the nostrils.

[0339] The face mount 110 is shaped to generally follow the contour of the patient's face around the upper lip region. In the area of ​​the face where the cannula is located, the face mount 110 is molded or pre-formed to conform to the contour of the user's face and / or is flexible to adapt to, accommodate and / or correspond to the contour of the user's face.

[0340] The asymmetry of the nasal forks 111 and 112 can reduce the chance of accidental obstruction of both nostrils. Therefore, the size of at least one of the nasal forks 111 and 112 is determined to maintain a sufficient gap between the outer surfaces of the forks 111 and 112 and the patient's skin to avoid gas pathways between the nasal interface 100 and the patient. It should be understood that, in the context of this disclosure, the nasal forks 111 and 112 are asymmetrical, as described below.

[0341] The face mounting portion 110 includes a base portion or cannula body 118 extending therefrom the nose forks 111 and 112, 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.

[0342] Adhesive pads 113A, 114A (Fig. 4A) may be provided on each wing portion 112 and 114 to facilitate the attachment of the cannula 100 to the patient, especially for younger children (e.g., under 5 years old).

[0343] The gas manifold 120 is generally tubular in shape, having a generally annular gas inlet 121 at one end and a curved, elongated oval outlet 123 at the opposite end (Figures 9 and 10). The inlet 121 may be removably attached to the conduit 300, for example via a threaded engagement, but alternatively via a snap-fit ​​or any other type of connection known in the art. Alternatively, the inlet may be fixedly connected to or integrally formed with the conduit 300.

[0344] The shape of the outlet 123 corresponds to that of the cannula body 118 and is engaged in the cannula body, for example by friction or snap-fit, such that a significant force or at least a targeted force is required by the user or caregiver to separate the manifold 120 from the face mount 110.

[0345] When outlet 123 engages with cannula body 118, an effective seal is formed between the two parts 118 and 120. As discussed below, as shown in FIG3, gas manifold 120 may include a retaining flange 120b surrounding its surface, which is removably received in a complementary resilient edge 118d of cannula body 118. The engagement of retaining flange 120b with complementary resilient edge 118d of cannula body 118 facilitates the formation of a seal between gas manifold 120 and cannula body 118.

[0346] The nose forks 111 and 112 are aligned with corresponding holes extending through the upper surface of the cannula body 118 to fluidly connect them when the manifold outlet 123 is connected to the nose forks 111 and 112.

[0347] The headgear can be used to secure the nasal interface 100 to the patient's face. The headgear includes a head strap 200. The head strap 200 may be a single continuous length and is adapted to extend along the patient's cheeks, above the ears and around the back of the head in use, and may be adjustable and / or may extend around other parts of the patient's head.

[0348] In the exemplary configuration shown, the main end portions 201 and 202 of the head strap 200 are adapted to be releasably connected to corresponding configurations 101 and 102 on one side of the nose interface 100 to hold the nose interface 100 in place during use.

[0349] In one configuration, a clamping component is provided at each end portion 201, 202, which can be received and held within the corresponding construction 101, 102. The clamping component can be coupled to the corresponding main end portion of the headband. Furthermore, the length of the headband 200 is adjustable to facilitate customizing the headband for the wearer's head. The headband 200 can be formed of a soft and stretchable / elastic material (such as an elastic, textile / fabric material that is comfortable for the wearer). Alternatively, the headband 200 can be formed of a substantially stiffer or less flexible material (such as a hard plastic material).

[0350] The headgear may further include additional straps or connecting straps 200 to extend over other headgear components during use. The head straps or head components may have the benefit of pulling the straps 200 upwards and above the patient's ears during use to improve fit and comfort.

[0351] In general, but also referring 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.

[0352] A fixed-length strap segment 220 can be releasably connected to a 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, which are releasably connected to each other and also releasably connected to corresponding 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 initial length / size for the wearer. To extend the length of the strap 200 beyond this initial length, the main strap 210 can be broken at the secondary end portions 203 / 204 and one or more additional strap segments 220 can be connected therebetween.

[0353] Multiple strap segments 220 of varying predetermined lengths may be provided to provide multiple alternative adjustable lengths. For example, one or more strap segments 220 may be provided with lengths ranging from about 1 cm to about 10 cm, or from about 2 cm to about 6 cm. These strap segments 220 have lengths 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 strap segment can be of any size, depending on the user and / or application.

[0354] Furthermore, each end 221, 222 of each strap segment 220 may be connected 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 having the same or varying lengths to achieve the desired overall length of the customized extension.

[0355] 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, especially for comfort, multiple segments of a tubular knitted type headband or headband 210 can be used above the user's ears.

[0356] It should be understood that special comfort can be achieved by a head strap that provides a suitable positioning of the nose 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.

[0357] Alternatively, these additional strap segments may be formed of substantially rigid materials (such as hard plastic materials).

[0358] 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.

[0359] Each connector 230 has a strap connection mechanism at one end that is connected to the strap material, and a connection mechanism at the opposite end that can be releasably connected to the corresponding end of a similar connector 230.

[0360] In an alternative, the connector 230 may be a variety of adjustable buckles suitable for adjusting the length or tension of the head strap segment 210, which holds the patient interface in place around the user’s head.

[0361] It should also be understood that the connector 230 can be positioned off-center from the back of the user's head, or off-center to one side of the user's head. This may be advantageous to avoid impacting a part of the user's head, which could otherwise cause discomfort in certain positions (such as while sleeping).

[0362] In yet another configuration, these strap segments may have different lengths so as to be provided asymmetrically or to aid in operability in offset positions of the connector 230. Furthermore, it is also possible that one of the strap segments 210 has an adjustable length while the other is not. For example, one strap segment 210 may have a permanent length or be permanently attached to the connector 230.

[0363] In an exemplary configuration, the strap connection mechanism may include a series of internal teeth positioned within the connector body for establishing a frictional engagement with an opposite end of the strap. A hinged clamp of the body is provided and closes on the teeth to securely hold one end of the strap on the teeth. A releasable connection mechanism at the other end includes a pair of convex and concave members (such as corresponding protrusions and holes) adapted to connect to corresponding convex and concave members of a similar connector 230. Supports on the protrusions may engage recesses in the concave members 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 secondary end portions of the strap to each other, and releasably connect to end portions of other strap segments.

[0364] The cannula connector 240 is disposed at the main end portions 201 and 202 of the main strap 210. These connectors 240 have a similar strap connection mechanism to the strap connector 230 at the secondary end portions 203 and 204, but include a clamping 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 engage corresponding configurations 101, 102 on one side of the nose interface 100. The clamping member 241 may be a bendable portion, such as a plastic portion, which forms a hinged portion relative to the strap. The clamp 241 may be pre-formed to have a curved shape along its length, such as a curved shape with an angle between 0 degrees (flat) and 20 degrees. In some configurations, the clamp 241 may be pre-formed to have a bent portion. The clamp 241 includes at least two portions angled relative to each other. These at least two portions may be positioned at an angle greater than 0 degrees to 20 degrees. That is, the two parts can be approximately 180 degrees relative to each other, or can differ from 180 degrees by a maximum of 20 degrees. This curvature or angle allows the clamp 241 to conform to the contour of the patient's face within the area of ​​the clamp 241.

[0365] The nasal interface may include a sleeve 270. Each sleeve 270 may be pre-formed to have a curved shape along its length, such as a curved shape with an angle between 0 degrees (flat) and 20 degrees. This curvature allows the sleeve to adapt to the contours 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 portions 201, 202 or connector 240 of the head strap 200.

[0366] The sleeve 270 provides a surface area with a relatively high-friction surface material for frictional engagement with the user's face or facial skin. This surface area will be positioned for frictional engagement with the user's facial cheek skin. This surface area is at least localized to the band or the segment of the band to be positioned on the user's cheek. The surface area with the relatively high-friction surface material can have a material that is smooth and comfortable on the patient's skin. Therefore, the sleeve 270 or at least the surface area 271 is formed of a material that is relatively softer than the connector 240.

[0367] In one configuration, the surface region 271 or sleeve 270 is formed of a soft thermoplastic elastomer (TPE), but may alternatively be formed of another plastic material (such as silicone) or any other biocompatible material.

[0368] Surface region 271 may be a surface with a wider surface area closer to the patient interface compared to a surface area further away from the patient interface. In one configuration, sleeve 270 gradually decreases in size from a relatively wide surface area 273 to a relatively small surface area 274 in a direction extending away from the connection point between connector 240 and nose interface 100. The width of one end 273 of sleeve may be the same as or similar to the width of the tapered distal ends of the corresponding wing portions 113, 114 of face mount 110. This provides a smooth transition between nose interface 100 and headgear to improve aesthetics and achieve a visually appealing effect.

[0369] The sleeve 270 may be colored to provide identification of the nose interface 100. As described herein, the nose interface may be provided in different sizes, such as small, medium, and large. Sleeves 270 having each of these sizes may include different colors to indicate different sizes. Alternatively or additionally, these sleeves may be colored in a particular manner to indicate that the nose interface has asymmetrical nose delivery elements rather than symmetrical ones.

[0370] Headgear for interfaces other than nasal cannulas may also include, at or near either end of the headgear strap of the interface, a plurality of cheek supports 270 as described or similar, which are connected to the nasal interface for frictional engagement with the user’s face to stabilize the cheeks covering the face. Such headgear may also include a single head strap adapted to extend along the patient’s cheek above the ear and around the back of the head in use, wherein the ends include clips of any suitable form that are attached to (or permanently attached to) the nasal interface on either side.

[0371] Referring to Figures 1A to 1C, in the illustrated configuration, the patient interface 1 includes a tube holding clamp 280. The tube holding clamp 280 can support the patient catheter 300 or other gas supply tubing from a portion of the patient interface 1. By supporting the patient catheter 300 or other gas supply tubing from or near the nasal interface 100, the tube holding clamp 280 will resist flexural movement of the patient catheter 300 or other gas supply tubing 300 due to asymmetrical flow through the first fork 111 and the second fork 112, and / or movement of the patient's head, thereby enhancing patient comfort.

[0372] In the configuration shown, the tube holding clamp 280 includes a tubular body 281 for receiving and housing a portion of the patient catheter 300 or other gas supply tube therein.

[0373] In the illustrated configuration, the tube retention clamp 280 supports the patient catheter 300 or other gas supply tubing from the headgear of the patient interface. In an alternative configuration, the tube retention clamp 280 may support the patient catheter 300 or other gas supply tubing from a portion of the nasal interface 100 of the patient interface. For example, the tube retention clamp 280 may support the patient catheter 300 or other gas supply tubing from another portion of the cannula body 118 or the face mount 110. In some configurations, the tube retention clamp 280 may support the patient interface from one or both of the wing portions 114, 115 of the nasal interface 100.

[0374] Hook 282 protrudes from body 281 to connect to the head strap or other parts of the headgear. In this way, catheter 300 can be connected or attached to head strap 210 or headgear during use. If catheter 300 is pulled, the force will be applied to head strap 210 instead of directly to cannula 100. This repositioning of force will reduce the likelihood that forks 111 and 112 of nasal interface 100 will protrude outside the patient's nostrils.

[0375] A protrusion or bump is provided at or near the free end of the hook 282. The protrusion extends inward toward the body 281. The protrusion or bump reduces the gap at the hook inlet, which helps to hold the clamp on the strap when the hook is engaged, i.e., the strap will not slip out of the hook channel. This also provides the advantage that the hook is held on the strap when it is hooked in a top-down direction, and the protrusion or bump holds the hook on the strap against gravity.

[0376] One or more tethering points for connecting tube retaining clamp 280 may be obtained on the headgear, wherein preferably there are at least two symmetrical tethering points on either side of the headgear to improve usability.

[0377] It should also be understood that the tube retention clamp 280 may be removable from the patient catheter 300 or other gas supply tubing, or may be a permanent fitting thereon.

[0378] The tube retaining clamp 280 can have any suitable form. In alternative configurations, the tube retaining clamp 280 may include or be constituted by a belt or loop. The loop may include fabric, elastomer, or textile belt or loop.

[0379] The retaining clamp 280 may be attached to or secured to a portion of the patient interface 1, for example, to an interface portion that provides a relatively more rigid area (e.g., to facilitate support for the patient catheter 300). The retaining clamp may also be positioned or attached to a specific location on the patient catheter 300, for example, a predetermined position may be provided to hold the retaining clamp in place.

[0380] The patient interface 1 may have one or more features and functions described in PCT Publication No. WO 2014 / 182179 or U.S. Patent No. 10,406,311. The contents of these specifications are incorporated herein by reference in their entirety.

[0381] As an alternative to the headgear, the patient interface may include a fixation system of the type described in PCT Publication No. WO 2012 / 053910 or U.S. Patent No. 10,238,828. The contents of these specifications are incorporated herein by reference in their entirety.

[0382] Referring to FIG1C and FIGS2-3, in some configurations, the nose interface 100 of this disclosure includes a first fork 111 and a second fork 112 that are asymmetrical 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 nose interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface through the first fork 111.

[0383] Gas inlet 121 may be located on one side of gas manifold 120. In alternative configurations, gas inlet 121 may be located at different locations on gas manifold 120. For example, gas inlet 121 may enter the front of gas manifold 120 at or near the center of gas manifold 120 or at or near one side of gas manifold 120.

[0384] This can be modified based on the patient's respiratory circulation and the internal geometry of the nose. The figures and proportions in this article are based on the nasal interface not being worn and before being affected by the patient's breathing and / or nasal geometry.

[0385] By way of example, if the blower of the respiratory therapy device is generating a flow rate of 100 liters per minute (lpm) and that flow rate is delivered to the gas inlet 121, then at least about 60 lpm passes through the first fork 111 and is delivered out of the nasal interface 100 through the first fork 111.

[0386] The remainder of the total gas flow is delivered through the second fork 112. In the example above, approximately 40 lpm or less passes through the second fork 112 and is delivered out of the nose interface 100 through the second fork 112. Alternatively, some of the remainder of the total gas flow may be discharged into the atmosphere instead of being delivered through the first fork 111 or the second fork 112.

[0387] The first fork 111 and the second fork can be considered as asymmetrical nose delivery elements.

[0388] The first fork 111 and the second fork 112 are asymmetrical to each other, and / or not symmetrical to each other, and / or different in shape and configuration, and / or asymmetrical when compared to each other.

[0389] The nasal interface 100 is configured to achieve asymmetrical gas flow at, within and / or outside the patient's nostrils.

[0390] In some configurations, the nasal interface 100 includes a cannula body 118 having a first fork 111 and a second fork 112.

[0391] In some configurations, the gas manifold 120 is integrated with the cannula body 118, or it is separate from the cannula body 118 but can be connected to it.

[0392] In some configurations, the first fork 111 and the second fork 112 are configured to engage the nasal passage in an unsealed (non-sealed) manner. In some configurations, at least the second fork 112 is configured to engage the nasal passage in a non-sealed manner.

[0393] In some configurations, the first fork 111 and the second fork 112 allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0394] In some configurations, the first fork 111 and the second fork 112 are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0395] The first fork 111 has a first fork outlet 111a defined by an opening at its end or termination end 111b for delivering gas from the first fork 111. Gas delivered through the first fork 111 exits the first fork via the first fork outlet 111a.

[0396] The second fork 112 has a second fork outlet 112a defined by an opening at its end or termination end 112b for delivering gas from the second fork 112. Gas delivered through the second fork 112 exits the second fork via the second fork outlet 112a.

[0397] Referring to Figures 3 and 4A, in some configurations of the nose interface 100, the inner diameter ID1 and / or inner cross-sectional area A1 of the first fork 111 in the direction GFD1 transverse to the gas flow through the first fork 111 is greater than the inner diameter ID2 and / or inner cross-sectional area A2 of the second fork 112 in the direction GFD2 transverse to the gas flow through the second fork 112.

[0398] 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 exit of each fork along the same fork length). 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.

[0399] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding forks 111, 112. Alternatively, the direction transverse to the gas flow may be at an acute or obtuse angle relative to the gas flow passing through the corresponding forks 111, 112.

[0400] The nasal interface 100 is configured to achieve asymmetrical gas flow at the patient's nostrils.

[0401] The inner diameters ID1, ID2 and / or the inner cross-sectional areas A1, A2 may be substantially constant along the length of the forks 111, 112. Alternatively, the inner diameters ID1, ID2 and / or the inner cross-sectional areas 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 ends or termination ends 111b, 112b. The associated inner diameters ID1, ID2 and inner cross-sectional areas A1, A2 may be at the outlets 111a, 112a of the forks, and / or at the distal portions of the forks 111, 112 adjacent to the outlets 111a, 112a.

[0402] The inner surface at the base of each fork 111, 112 may be rounded or chamfered to reduce gas pressure and decrease velocity drop as the gas changes flow direction within the manifold. This can help reduce noise and improve the delivery of therapies.

[0403] The nose interface 100 can be configured such that approximately 60% to approximately 90% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111. The nose interface can be configured such that approximately 60% to approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111. The nose interface can be configured such that approximately 65% ​​to approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111. The nose interface can be configured such that approximately 70% to approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111. The nose interface can be configured such that approximately 70% to approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111. The nose interface can be configured such that approximately 70% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111.

[0404] It has been found that a flow ratio of at least approximately 60:40 between crosses 111 and 112 is sufficient to begin to see the benefits of the asymmetric flow described below. A ratio between approximately 70:30 and approximately 75:25 is considered optimal.

[0405] The proportion of the total volumetric flow rate delivered through each fork 111, 112 can be determined by delivering gas with a known volumetric 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 volumetric flow rate leaving each outlet 111a, 112a can be measured by a suitable flow meter or sensor to determine the proportion of the total volumetric flow rate of the gas flow into the gas inlet 121 that leaves the outlet 111a, 112a of each fork 111, 112.

[0406] The inner diameter ID1 of the first fork 111 may be between about 4 mm and about 10 mm, between about 5 mm and about 9 mm as needed, between about 6 mm and about 8 mm as needed, or between about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm as needed, or any diameter between any two of these diameters.

[0407] The inner diameter ID2 of the second fork 112 may be between about 2 mm and about 8 mm, between about 3 mm and about 7 mm as needed, between about 4 mm and about 6 mm as needed, or between about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm as needed, or any diameter between any two of these diameters.

[0408] In some configurations, the wall thickness of the first fork 111 and / or the second fork 112 is between about 0.1 mm and about 0.5 mm. Therefore, the inner diameter value can be increased by twice the wall thickness to obtain the associated outer diameter value.

[0409] The nose interface 100 can be configured such that about 75% to about 80% of the total gas flow is delivered through the first fork 111.

[0410] The nose interface 100 can be configured such that approximately 75% of the total gas flow is delivered through the first fork 111.

[0411] The nose interface 100 can be configured such that approximately 80% of the total gas flow is delivered through the first fork 111.

[0412] The inner cross-sectional area A1 of the first fork 111 can be between about 15 mm2 and about 80 mm2, depending on the need, between about 20 mm2 and about 75 mm2, depending on the need, between about 25 mm2 and about 70 mm2, depending on the need, between about 30 mm2 and about 65 mm2, depending on the need, between about 35 mm2 and about 60 mm2, depending on the need, between about 40 mm2 and about 55 mm2, depending on the need, between about 45 mm2 and about 50 mm2, depending on the need, or depending on the need, approximately 15 mm2, approximately 16 mm2, approximately 17 mm2, approximately 18 mm2, approximately 19 mm2, approximately 20 mm2, approximately 21 mm2, approximately 22 mm2, approximately 23 mm2, approximately 24 mm2, approximately 25 mm2, approximately 26 mm2, approximately 27 mm2, approximately 28 mm2, approximately 29 mm2, approximately 30 mm2, approximately 31 mm2, approximately 32 mm2, approximately 3 ... mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², approximately 51 mm², approximately 52 mm², approximately 53 mm², approximately 54 mm², approximately 55 mm², approximately 56 mm², approximately 57 mm², approximately 58 mm², approximately 59 mm², approximately 60 mm², approximately 61 mm², approximately 62 mm², approximately 63 mm², approximately 64 mm², approximately 65 mm², approximately 66 mm², approximately 67 mm², approximately 68 mm², approximately 69 mm², approximately 70 mm², approximately 71 mm², approximately 72 mm², approximately 73 mm², approximately 74 mm² mm2, about 75 mm2, about 76 mm2, about 77 mm2, about 78 mm2, about 79 mm2, about 80 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0413] The inner cross-sectional area A2 of the second fork 112 can be between about 5 mm2 and about 50 mm2, depending on the need, between about 10 mm2 and about 45 mm2, depending on the need, between about 15 mm2 and about 40 mm2, depending on the need, between about 20 mm2 and about 35 mm2, depending on the need, between about 25 mm2 and about 30 mm2, depending on the need, or depending on the need, about 5 mm2, about 6 mm2, about 7 mm2, about 8 mm2, about 9 mm2, about 10 mm2, about 11 mm2, about 12 mm2, about 13 mm2, about 14 mm2, about 15 mm2, about 16 mm2, about 17 mm2, about 18 mm2, about 19 mm2, about 20 mm2, about 21 mm2, about 22 mm2, about 23 mm2, about 24 mm2, about 25 mm2, about 26 mm2, about 27 mm2, about 28 mm2, about 29 mm2, about 30 mm2, etc. mm², approximately 31 mm², approximately 32 mm², approximately 33 mm², approximately 34 mm², approximately 35 mm², approximately 36 mm², approximately 37 mm², approximately 38 mm², approximately 39 mm², approximately 40 mm², approximately 41 mm², approximately 42 mm², approximately 43 mm², approximately 44 mm², approximately 45 mm², approximately 46 mm², approximately 47 mm², approximately 48 mm², approximately 49 mm², approximately 50 mm², or any cross-sectional area between any two of these cross-sectional areas.

[0414] Specific differences between inner diameters ID1, ID2 and / or inner cross-sectional areas A1, A2 can contribute to the desired level of asymmetry.

[0415] The combined internal cross-sectional area (A1 + A2) of the first fork 111 and the second fork 112 can be between approximately 20 mm² and approximately 130 mm², depending on the need, between approximately 30 mm² and approximately 120 mm², depending on the need, between approximately 40 mm² and approximately 110 mm², depending on the need, between approximately 50 mm² and approximately 100 mm², depending on the need, between approximately 60 mm² and approximately 90 mm², depending on the need, between approximately 70 mm² and approximately 80 mm², depending on the need, approximately 20 mm², approximately 25 mm², approximately 30 mm², approximately 35 mm², approximately 40 mm², approximately 45 mm², approximately 50 mm², approximately 55 mm², approximately 60 mm², approximately 65 mm², approximately 70 mm², approximately 75 mm², approximately 80 mm², approximately 85 mm², approximately 90 mm², approximately 95 mm², approximately 100 mm², approximately 105 mm², approximately 110 mm², etc. mm2, approximately 115 mm2, approximately 120 mm2, approximately 125 mm2, approximately 130 mm2, or any cross-sectional area between any two of these cross-sectional areas.

[0416] 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 may be between approximately 60:40 and approximately 80:20, depending on the need, between approximately 65:35 and approximately 80:20, depending on the need, between approximately 70:30 and approximately 80:20, depending on the need, between approximately 70:30 and approximately 75:25, depending on the need, approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26, or approximately 75:25, depending on the need, between approximately 75:25 and 80:20, depending on the need, approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79: 21, or approximately 80:20.

[0417] Referring to Figures 1C, 2, and 3, in some configurations, the nasal interface 100 of this disclosure includes a first fork 111 and a second fork 112 that are asymmetrical 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 asymmetrical gas flow at the patient's nostrils. The nasal interface 100 is configured such that when the total volumetric flow rate of the gas flow into the gas inlet 121 is between about 5 liters per minute (lpm) and about 70 lpm, about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nasal interface 100 through the first fork 111. In some configurations, the total volumetric flow rate of the gas flow into the gas inlet 121 is at least about 5 lpm. In some configurations, the total volumetric flow rate of the gas flow into the gas inlet 121 is greater than about 5 lpm. In some configurations, the total volumetric flow rate of the gas flowing into gas inlet 121 is between about 5 lpm and about 120 lpm. In some configurations, the total volumetric flow rate of the gas flowing into gas inlet 121 is between about 5 lpm and about 70 lpm.

[0418] The nose interface 100 can be configured such that when the total flow rate of the gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface 100 through the first fork 111.

[0419] The nose interface 100 can be configured such that when the total flow rate of the gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 70% to about 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111.

[0420] The nose interface 100 can be configured such that when the total flow rate of the gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 75% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111.

[0421] The nose interface 100 can be configured such that when the total volumetric flow rate of the gas flow into the gas inlet 121 is between about 5 lpm and about 70 lpm, about 75% of the total flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface 100 through the first fork 111.

[0422] The nose interface can be configured such that the asymmetry in the flow rates from the first fork 111 and the second fork 112 varies with the total flow rate of the gas flow into the gas inlet 121. A higher total volumetric flow rate of the gas flow into the gas inlet 121 typically results in a larger portion of the total volumetric flow rate of the gas flow being delivered out of the nose interface 100 through the first fork 111, and a lower total flow rate of the gas flow into the gas inlet 121 results in a smaller portion of the total volumetric flow rate of the gas flow being delivered out of the nose interface 100 through the first fork 111.

[0423] Table 1 shows the volumetric flow rate of an exemplary nasal cannula benchtop test. Total volumetric flow rate (lpm) into gas inlet 121 The flow rate (lpm) flowing out from the first branch 111 The flow rate (lpm) flowing out from the second branch 112 Second branch: Flow ratio of the first branch (lpm) 9.6 7.1 2.5 2.84 19 13.6 5.4 2.52 29.1 twenty one 8.1 2.59 38.6 28.1 10.5 2.68 47.7 35 12.7 2.76 57.8 44.2 13.6 3.25 64.2 48.6 15.6 3.12 [Table 1]

[0424] Testing and modeling indicate that by using asymmetric forks 111 and 112 in the nasal interface 100 of this disclosure, a reduction in dead space (i.e., the amount of air that needs to be re-breathed at the start of inspiration) can be achieved. This is most significant at higher flow rates, higher respiratory rates, and higher degrees of asymmetry. It should be understood that within the patient's upper airway, a certain proportion of gas moves unidirectionally, flowing in from one nostril and out from the other, thereby reducing upper airway dead space. Increasing expiratory pressure has the effect of slowing the respiratory rate. Slowing the respiratory rate also makes the expiratory phase longer than the inspiratory phase. The reduced respiratory rate increases the time for flushing the upper airway at the end of expiration.

[0425] It has been found that dead space clearance increases with increasing asymmetry. For example, at a total volumetric flow rate of 30 lpm and a respiratory rate of 45 breaths per minute, a nasal interface with symmetrical forks produces approximately 87 ml of anatomical dead space, a nasal interface 100 of the present disclosure with an inner cross-sectional area ratio of 60:40 fork 111 to fork 112 produces approximately 80 ml of anatomical dead space, and a nasal interface 100 of the present disclosure with an inner cross-sectional area ratio of 70:30 fork 111 to fork 112 produces approximately 78 ml of anatomical dead space. The corresponding values ​​change to approximately 66 ml, approximately 62 ml, and approximately 36 ml at 50 lpm, and to approximately 49 ml, 41 ml, and 21 ml at 70 lpm.

[0426] Figures 6(a) through 6(e) illustrate the dependence of dead space clearance on upper airway volume, respiratory rate, and flow rate. Figures 6(a) through 6(c) show results for a larger upper airway, and Figures 6(d) and 6(e) show results for a smaller upper airway. These results are for the Opitflow™+ OPT944 (medium) cannula from Fisher & Paykel Healthcare, Inc., the Optiflow™+ 946 (large) cannula from Fisher & Paykel Healthcare, Inc., the medium nasal interface 100' according to this disclosure, and the large nasal interface 100” according to this disclosure.

[0427] Figure 7 illustrates the effect of the degree of nasal obstruction. For a given gas flow rate, increasing nasal obstruction increases the pressure delivered to the patient. For the asymmetric nasal interface of this disclosure, the reduced cross-sectional area of ​​the smaller second fork 112 helps prevent simultaneous obstruction of both nostrils. A significantly smaller nasal interface can be uncomfortable and noisy due to the jetting and high-velocity gas in the patient's nose. The pressure drop or flow resistance of a significantly smaller nasal interface may limit the flow rate range that the flow generator can provide. A significantly larger nasal interface may be less comfortable for the patient because the fork may touch the septum or nasal ala. For the larger fork according to this disclosure, a lower gas velocity allows for quieter gas delivery.

[0428] Referring to Figures 4A to 4C, the nose interface 100 can be provided in various sizes, such as small nose interface 100 (Figure 4A), medium nose interface 100' (Figure 4B), and large nose interface 100" (Figure 4C). The wings 113, 113', 113", 114, 114', and 114" generally have the same spacing and dimensions in each size of nose interface so that all nose interfaces can be used with the same headgear. In each of the small nose interface 100, medium nose interface 100', and large nose interface 100", the size and spacing of the nose forks can be different.

[0429] Nose interfaces 100' and 100” may have any one or more features and / or functions described and illustrated herein with respect to nose interface 100. The same reference numerals indicate the same parts, wherein the medium nose interface 100' is marked with an apostrophe (') and the large nose interface 100” is marked with a double apostrophe ("). It should be understood that any reference herein to nose interface 100 may instead be a reference to nose interface 100' or nose interface 100”.

[0430] The nose interface 100', 100” can be used in any combination, system or application described herein with respect to the nose interface 100.

[0431] Exemplary dimensions are outlined in Table 1 below. As outlined in Table 1, each size of nose interface 100, 100', 100” may have several different sizes of first forks 111, 111', 111” and / or second forks 112, 112', 112” available.

[0432] Table 2 shows exemplary dimensions and ratios of small, medium, and large nose interfaces according to this disclosure. It should be understood that these are merely exemplary dimensions and may vary. Cannula size The inner diameter of the first fork 111 is ID1 (mm). The inner circumference of the first fork (mm) The cross-sectional area A1 (mm) of the first fork 111 2 ) The inner diameter of the second fork is 112 mm. The inner circumference of the second fork (112 mm) The cross-sectional area A2 (mm²) of the second fork 112 2 ) The ratio of the inner cross-sectional areas A1 / A2 Combined internal cross-sectional area A1 + A2 (mm) 2 ) small 5.58 17.54 24.48 4.56 14.32 16.32 60 / 40 40.80 5.58 17.54 24.48 3.65 11.48 10.49 70 / 30 34.97 5.58 17.54 24.48 3.22 10.13 8.16 75 / 25 32.64 5.58 17.54 24.48 2.79 8.77 6.12 80 / 20 30.60 Medium 7.50 23.56 44.16 6.12 19.23 29.44 60 / 40 73.60 7.50 23.56 44.16 4.91 15.42 18.93 70 / 30 63.09 7.50 23.56 44.16 4.33 13.59 14.70 75 / 25 58.86 7.50 23.56 44.16 3.75 11.78 11.04 80 / 20 55.20 large 9.43 29.64 69.90 7.70 24.20 46.60 60 / 40 116.50 9.43 29.64 69.90 6.18 19.40 29.96 70 / 30 99.86 9.43 29.64 69.90 5.42 17.03 23.08 75 / 25 92.98 9.43 29.64 69.90 4.72 14.82 17.48 80 / 20 87.38 [Table 2]

[0433] Referring to Figures 4A to 4C, regarding the vertical dimensions, for each size of the nasal interface 100, 100', 100”, the flow center C1 of the first fork and the flow center C2 of the second fork are at the same height above the central axis CA of the gas manifold 120 and the cannula body 118, 118', 118”. This is indicated in Figures 4A, 4B, and 4C by a constant distance between the upper and lower dashed lines. This is believed to provide benefits such as easy clearance of exhaled air around the second fork 112, keeping the inspiratory flow centers from the two outlets 111a, 112a at the same height, and enhanced comfort and usability.

[0434] In an alternative configuration, the lower edges of the outlets 111a, 111a', and 111" of the first forks 111, 111', and 111" may be aligned with the lower edges of the outlets 112a, 112a', and 112" of the second forks 112, 112', and 112"; or the upper edges of the outlets 111a, 111a', and 111" of the first forks 111, 111', and 111" may be aligned with the upper edges of the outlets 112a, 112a', and 112" of the second forks 112, 112', and 112".

[0435] Figure 8 shows exemplary diaphragm spacing and fork height for small nose interface 100, medium nose interface 100', and large nose interface 100".

[0436] At least the larger first prongs 111, 111', 111”, and, if necessary, the smaller second prongs 112, 112', 112”, are made of a soft material and have thin walls to allow them to deform and adapt to different nasal geometries. The septum spacing can be optimized. This is because the septum contacts the prongs closer to the base than the nasal skin (alae). The farther this contact is from the base, the more flexible the nasal interface becomes. Within the nasal vestibule, the septum walls are more sensitive to and less tolerant of pressure from the nasal interface than the compliant alar. Therefore, the septum spacing D1 can be selected to minimize the contact between the prongs and the septum.

[0437] The gap or diaphragm spacing D1 between the adjacent outer surfaces of the first fork 111, 111', 111” and the second fork 112, 112', 112” adjacent to the base of the first fork 111, 111', 111” and the second fork 112, 112', 112” may be between about 5 mm and about 15 mm, between about 6 mm and about 14 mm as needed, between about 7 mm and about 13 mm as needed, between about 8 mm and about 12 mm as needed, between about 9 mm and about 11 mm as needed, between 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 as needed, or any value between any two of these values.

[0438] Table 3 lists exemplary dimensions. It should be understood that other dimensions may be used. Nose interface Diaphragm spacing D1 (mm) The first fork has a height D2 (mm). The height difference D3 (mm) between the first fork 111 and the second fork 112 The second fork height is D2-D3 (mm). Small 100 10 + / - 1.0 12.2 + / - 1.5 1.2 11 + / - 1.5 Medium 100' 9.9 + / - 1.0 14.6 + / - 1.5 1.4 13.2 + / - 1.5 Large 100” 9.8 + / - 1.0 17.7 + / - 1.5 1.86 15.84 + / - 1.5 [Table 3]

[0439] In some configurations, the nasal interfaces 100, 100', 100” include cannula bodies 118, 118', 118” having first forks 111, 111', 111” and second forks 112, 112', 112”. The outer surface of the cannula body between the first and second forks includes a recess 118e (schematically shown by dashed lines in FIG3) to accommodate a portion of the patient’s nose and reduce pressure on the underside of the accommodated portion.

[0440] In the configuration shown, the recess 118e includes a hollow outer portion and / or a recessed outer contour in the upper surface of the cannula bodies 118, 118', 118" between the bases of the forks 111 and 112, to relieve pressure at the diaphragm / columella, thereby improving patient comfort and reducing pressure damage to the columella and philtrum.

[0441] The hollow portion should be as large as possible without significantly reducing the flow rate delivered to the patient. This recessed portion can complement the periphery 123a, 123a' of the outlets 123, 123' of the gas manifolds 120, 120' (e.g., shown in Figures 9 and 10) to maintain an effective seal between the cannula bodies 118, 118', 118" and the gas manifolds 120, 120'. This recessed portion can be received within the outlet 123 of the gas manifold.

[0442] The recess 118e in the outer surface of the cannula body 118, together with the lower flow rate required for a given amount of flushing using the asymmetric forks 111, 112, enhances patient comfort.

[0443] Referring to Figures 1C, 2-3, and 4A-4C, in some configurations, the nose interface 100 of this disclosure includes a first fork 111 and a second fork 112 that are asymmetrical 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 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 through the second fork 112. The second fork 112 has a distinctly oval or elliptical cross-sectional shape in the direction GFD2 transverse to the gas flow through the second fork, the distinctly oval or elliptical cross-sectional shape having a first ratio of the widest dimension to the narrowest dimension, and the first fork 111 has a less distinctly oval or elliptical cross-sectional shape in the direction GFD1 transverse to the gas flow through the first fork 111. The indistinct oval or elliptical cross-sectional shape of the first fork may have a second ratio of the widest to the narrowest dimension that is less than the first ratio, or it may have an approximately circular cross-sectional shape.

[0444] In an alternative configuration, the two forks 111 and 112 may have substantially the same cross-sectional shape in the direction transverse to the gas flow passing through the respective fork. For example, the two forks 111 and 112 may both have a generally circular cross-sectional shape, or they may both have different shapes.

[0445] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork. Alternatively, the direction transverse to the gas flow may be at an acute or obtuse angle relative to the gas flow passing through the corresponding forks 111, 112.

[0446] The inner cross-sectional areas 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 areas 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 areas and / or the inner cross-sectional shapes of the first and second forks may be at the outlets 111a, 112a of the first fork 111 and the second fork 112, and / or at the distal portions of the first fork 111 and the second fork 112 adjacent to the outlets 111a, 112a.

[0447] The first fork 111 is more flexible than the second fork 112. This may be due to the fact that the first fork 111 has a reduced wall thickness relative to the total thickness of the first fork compared to the second fork.

[0448] A larger first fork 111 can be more comfortable when it has a less obvious oval, less obvious elliptical, or more circular cross-sectional shape, so it can most easily conform to the shape of the patient's nasal cavity.

[0449] The smaller second fork 112 is less flexible. By having a distinctly oval or elliptical cross-sectional shape, the second fork 112 can match the shape of the patient's nasal cavity at rest.

[0450] In some exemplary configurations, the first ratio is greater than 1.0. In some configurations, the first ratio is at least about 1.05, at least about 1.1 as needed, at least about 1.2 as needed, at least about 1.3 as needed, at least about 1.4 as needed, at least about 1.5 as needed, at least about 1.6 as needed, at least about 1.7 as needed, at least about 1.8 as needed, at least about 1.9 as needed, at least about 2.0 as needed, or greater than about 2 as needed.

[0451] In some exemplary configurations, the second ratio is approximately 1.

[0452] Referring to Figures 13 and 14, the first fork 111 has a first termination end 111b adjacent to the first opening 111a. The second fork 112 has a second termination end 112b adjacent to the second opening 112a.

[0453] Referring to FIG14(a), the first termination end 111b includes a generally fan-shaped surface. The fan-shaped surface is indicated by a dashed line A in FIG14(a) and FIG14(c).

[0454] In the configuration shown, the lower portion of the fan-shaped surface is concave when viewed from the outside of the first fork 111 in the direction toward the opening 111a. The upper portion of the fan-shaped surface can be convex when viewed from the outside of the first fork in the direction toward the opening 111a. The combination of the concave lower portion and the convex upper portion together provides an overall tortuous shape.

[0455] Referring to Figures 14(b) and 14(c), the second termination end 112b has a less distinct fan-shaped surface. This surface is indicated by a dashed line B in Figures 14(b) and 14(c). Although the surface of the second termination end is concave when viewed from the outside of the second fork 112 in the direction toward the opening 112a, the degree of concavity or fan-shapedness is less than that of the first fork 111. In some configurations, the surface of the second fork may be substantially planar.

[0456] The fan-shaped surface of the first nose fork 111 offers several advantages. Compared to a planar surface, the first nose fork 111 can be more easily deformed or distorted due to its lower structural stiffness. This makes the larger fork more comfortable in the patient's nasal passage. Since the smaller second nose fork 112 has more space within the patient's nasal cavity, the nose fork 112 does not need to be deformed. Due to the fan-shaped surface, gas does not exit the nose fork as a jet through a small orifice. The fan shape provides a larger area of ​​outlet opening at the exit of the fork, causing the gas velocity, or air velocity, to decrease at the point where the gas exits the nose fork. That is, the size of the outlet orifice (defined by the edge or perimeter of the cut section) is larger than the size or cross-sectional area of ​​the inlet orifice of the nose fork, which is defined by the base of the nose fork connected to the face mounting portion 110. The air velocity of the gas decreases with increasing area. That is, the fork is shaped such that the velocity of the gas exiting the nose fork is reduced compared to the gas velocity at or near the gas inlet point entering the nose fork. This allows for a proportionally larger volume of gas to be delivered to the patient without causing discomfort (compared to a nose fork without a fan-shaped surface). The fan-shaped surface reduces the air jet effect. A continuity equation based on the conservation of energy or mass reduces the jetting of the airflow, stating that increasing the cross-sectional area is equivalent to a decrease in airflow velocity. A gas jet delivered into the user's nasal passages can irritate or potentially damage the tissue within the nasal passages. The reduced velocity of the gas flow delivered by the nose fork reduces irritation within the user's nostrils, thus reducing the jetting effect. It can also be seen from the continuity equation that the larger the orifice through which the gas flows, the greater the diffusion. The gas flow is directed in a generally posterior direction relative to the patient's head within the nasal passages. These effects may be more beneficial for the larger first nose fork 111 than for the smaller second nose fork 112 (which has more space in the nostrils during use).

[0457] In some configurations, the nasal interface 100 can be configured such that the gas velocities exiting the first fork 111 and the second fork 112 are substantially similar. The benefits of having substantially similar exit velocities include patient comfort and low noise levels. Patient comfort may be due to reduced or avoided gas flow being ejected 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 at the same flow rate than a symmetrical nasal interface, but may be considered more comfortable due to the reduced work of breathing. The reduced work of breathing may be due to the greater dead space clearance of the nasal interface 100 relative to a symmetrical nasal interface at the same flow rate.

[0458] For example, referring to Figures 3, 4A, 12(a), and 12(b), in some configurations, the nose interface 100 of this disclosure includes: a gas inlet 121, a first fork 111 and a second fork 112 that are asymmetrical to each other, and a gas flow path 122 from the gas inlet 121 to the first fork 111 and the second fork 112, 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 the 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 gas exits the first fork outlet 111a and the second fork outlet 112a at substantially similar velocities.

[0459] The velocities mentioned in this section may be the average velocities of the gas leaving the corresponding first fork outlet 111a and second fork outlet 112a, rather than velocities as a curve or peak velocities. In some configurations, such velocities may be peak velocities.

[0460] In some configurations, the nose interface is a non-sealed nose interface.

[0461] Although different gas flow rates are provided through the first fork 111 and the second fork 112, the larger first fork 111 has a larger flow rate and the smaller second fork 112 has a smaller flow rate, such that the exit velocity from each fork is substantially similar.

[0462] In some configurations, the velocity of the gas leaving the first fork outlet 111a is within about 20% of the velocity of the gas leaving the second fork outlet 112a.

[0463] In some configurations, the velocity of the gas leaving the first fork outlet 111a is within about 16% of the velocity of the gas leaving the second fork outlet 112a.

[0464] In some configurations, at flow rates above about 42 lpm, the velocity of gas leaving gas outlet 111a is within about 10% of the velocity of gas leaving second branch outlet 112a.

[0465] The inventors have discovered a substantially linear relationship between the total volumetric flow rate of the gas flow into the gas inlet 121 and the velocity of the gas leaving the first branch outlet 111a and the second branch outlet 112a. That is, for a given increase in the total volumetric flow rate of the gas flow into the gas inlet, the average gas flow rate exiting from the two outlets 111a, 112a also increases accordingly.

[0466] In some configurations, for a total volumetric flow rate of gas flowing into gas inlet 121 that is greater than 0 lpm and up to about 70 lpm, the velocity of gas leaving each of the first branch outlet 111a and the second branch outlet 112a is greater than 0 m / s and less than about 32 m / s.

[0467] In some configurations, for a total volumetric flow rate of gas flowing into gas inlet 121 that is greater than 0 lpm and up to about 70 lpm, the velocity of gas leaving each of the first branch outlet 111a and the second branch outlet 112a is greater than 0 m / s and less than 32 m / s.

[0468] In some configurations, for a total volumetric flow rate of gas 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 branch outlet 111a and the second branch outlet 112a is greater than about 2 m / s and less than about 32 m / s, as needed, greater than about 2 m / s and less than 32 m / s, as needed, greater than about 2 m / s and up to about 25 m / s, and as needed, greater than about 2.5 m / s and up to about 20 m / s.

[0469] The exit velocity values ​​and relationships are related to the first fork 111 being farther away from the gas inlet 121 and the second fork being closer to the gas inlet 121. If the configuration is reversed, depending on the balance of the gas manifold 120, the velocity may have a small variation (e.g., less than about 20%) when the first fork 111 is closer to the gas inlet 121 and the second fork 112 is farther away from the gas inlet 121. The first fork 111 can have a higher flow rate and a higher average exit velocity when it is farther away from the gas inlet 121 than when it is closer to the gas inlet 121. The second fork 112 can have a higher flow rate and a higher average exit velocity when it is farther away from the gas inlet 121 than when it is closer to the gas inlet 121.

[0470] The speeds described above are for the medium-sized nose interface 100'. The speeds for the small-sized nose interface 100' or the large-sized nose interface 100' can be reduced or increased proportionally from those values ​​as the inner cross-sectional area of ​​the fork changes.

[0471] In some configurations, the nose interface 100 is configured such that the total volumetric flow rate of the gas flowing into the gas inlet 121 is at least about 5 liters per minute (lpm).

[0472] In some configurations, the nose interface 100 is configured such that the total volumetric flow rate of the gas flowing into the gas inlet 121 is between about 5 lpm and about 120 lpm.

[0473] In some configurations, the nose interface 100 is configured such that the total volumetric flow rate of the gas flowing into the gas inlet 121 is between about 5 lpm and about 70 lpm.

[0474] In some configurations, the nose interface 100 is configured such that approximately 7 lpm is delivered through the first fork 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 through the first fork 111 at a volumetric flow rate of approximately 19 lpm at the gas inlet 121, and / or such that approximately 21 lpm is delivered through the first fork 111 at a volumetric flow rate of approximately 29 lpm at the gas inlet 121, and / or such that approximately 28 lpm is delivered through the first fork 111 at a volumetric flow rate of approximately 38.5 lpm at the gas inlet 121, and / or such that approximately 35 lpm is delivered through the first fork 111 at a volumetric flow rate of approximately 47.5 lpm at the gas inlet 121, and / or approximately 58 lpm is delivered through the first fork 111 at the gas inlet 121. At a volumetric flow rate of lpm, approximately 44 lpm is delivered through the first fork 111 to the nose interface 100, and / or at a volumetric flow rate of approximately 64 lpm at the gas inlet 121, approximately 48.5 lpm is delivered through the first fork 111 to the nose interface 100.

[0475] The remaining gas flow volumetric flow rate will typically be delivered out of the nose interface through the second fork 112. Table 4 shows exemplary approximate flow rates. Total volumetric flow rate at the gas inlet (lpm) Flow through the first fork 111 Flow through the second fork 112 9.5 7 2.5 19 13.5 5.5 29 twenty one 8 38.5 28 10.5 47.5 35 12.5 58 44 14 64 48.5 15.5 [Table 4]

[0476] The nose interface 100 may have any of the features or functions described herein.

[0477] For example, referring to Figures 3, 4A, 12(a), and 12(b), in some configurations, the nose interface 100 of this disclosure includes: a gas inlet 121, a first fork 111 and a second fork 112 that are asymmetrical to each other, and a gas flow path 122 from the gas inlet 121 to the first and second forks. The inner cross-sectional area A1 of the first fork 111 in the direction GFD1 transverse to the gas flow 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 through the second fork 112. The first fork 111 is downstream of the gas flow path 122 of the second fork 112.

[0478] In some configurations, the direction transverse to the gas flow is substantially perpendicular to or orthogonal to the gas flow passing through the corresponding fork. Alternatively, the direction transverse to the gas flow may be at an acute or obtuse angle relative to the gas flow passing through the corresponding forks 111, 112.

[0479] 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 and GFD2 of the gas flow paths passing through the first branch 111 and the second branch 112. The first branch is further away from the gas inlet 121, while the second branch is closer to the gas inlet 121.

[0480] In the configuration shown in FIG3, a first section 124a of the flow passage or lumen in the gas manifold 120 has a large first vertical dimension V1. The opposite end of this flow passage or lumen forms a flow cavity 124b in the cannula body 118, which delivers gas to the first fork 111 and the second fork 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 path through the first fork 111 and the second fork 112. At least a portion of the flow cavity 124b has a vertical dimension V2 smaller than the first vertical dimension V1.

[0481] The gas manifold 120 includes one or more internal angled walls to provide a reduction in size and to direct gas flow into the first fork 111 and / or the second fork 112.

[0482] The gas manifold 120 is configured not to obstruct any portion of the internal cross-section of either fork 111 or 112. In an alternative configuration, the manifold may be configured to partially obstruct the internal cross-section of one or both of forks 111 or 112.

[0483] Benchtop testing showed that the anatomical dead space decreased when the larger first fork 111 was further away from the gas inlet 121 and the smaller second fork 112 was closer to the gas inlet 121, as indicated by the results shown in Figure 11. This is a result of having opposing angled walls in the manifold, which helps to guide gas into the larger first fork 111.

[0484] In Figure 11, the references to M, L, XL, and XXL relate to the size of the forks used in the nose interface during testing. For example, L + M refers to a nose interface with large and medium forks, XL + M refers to a nose interface with extra-large and medium forks, and XXL + M refers to a nose interface with extra-large and medium forks.

[0485] As summarized above, the nose interface can be configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface through the first fork 111, and, if necessary, about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface through the first fork 111, and, if necessary, about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface through the first fork 111, and, if necessary, about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface through the first fork 111, and, if necessary, about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered out of the nose interface through the first fork 111. The gas flow into the gas inlet 121 is delivered through the first fork 111 and exits the nose interface. Approximately 70% to 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 and exits the nose interface. Approximately 70% to 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 and exits the nose interface. Approximately 75% to 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 and exits the nose interface. Approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 and exits the nose interface.

[0486] In some configurations, the nasal interface 100 disclosed herein includes a cannula body 118 and a gas manifold 120 having a gas inlet 121, the cannula body including a first fork 111 and a second fork 112 that are asymmetrical with each other. 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 asymmetrical gas flow at the patient's nostrils.

[0487] 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 in the forms shown in Figures 12(a) and 12(b), and in the forms 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, such that the second fork 112 is closer to the gas inlet 121 and the first fork 111 is further away from the gas inlet 121. The second configuration corresponds to the gas manifold 120 being inserted into the cannula body 118 from a second side, such that the first fork 111 is closer to the gas inlet 121 and the second fork 112 is further away from the gas inlet 121.

[0488] The gas manifold may include a flow channel or lumen, wherein the gas flow direction GFD3 is substantially perpendicular to the gas flow directions GFD1 and GFD2 passing through the first fork 111 and the second fork 112.

[0489] The cannula body 118 and / or the gas manifold 120 may include (a plurality of) retaining features to removably retain the gas manifold 120 in engagement with the cannula body 118 in first and second configurations.

[0490] In the illustrated configuration, these retaining features include a resilient annular portion 118c of the cannula body, which 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 can be flexed to allow the gas manifold 120 to be removed from the cannula body 118. The annular portion can be circular or non-circular in shape.

[0491] Alternatively or as shown in FIG3, the gas manifold 120 may include a retaining flange 120b surrounding its surface, which is removably received in a complementary resilient edge 118d of the cannula body 118. The engagement of the retaining flange 120b with the complementary resilient edge 118d of the cannula body 118 facilitates the formation of a seal between the gas manifold 120 and the cannula body 118.

[0492] For example, any other suitable type of holding feature (multiple) can be used, such as a clamp or fastener.

[0493] The side interchangeability of the gas manifold 120 relative to the cannula body 118 allows the user to adjust the gas tubing 300 to one side based on comfort and the position of the respiratory therapy device. Furthermore, the side interchangeability allows for selection of asymmetrical amounts of gas flow from the forks 111 and 112, which can be beneficial depending on the desired application or patient requirements.

[0494] In some configurations, the nasal interface 100 disclosed herein includes a first fork 111 and a second fork 112, 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 asymmetrical gas flow at the patient's nostrils. The gas inlet 121 is in fluid communication with a ventilator.

[0495] For example, conduit 300 may include a vent tube. A vent tube is a tube in which water vapor can pass through the tube wall, but liquid water and large quantities of gas cannot pass through the tube wall. For example, water vapor may be able to pass through the tube wall material and / or sealing surface, but liquid water and large quantities of gas cannot flow through the tube wall material and / or sealing surface.

[0496] The conduit 300 may be made, for example, of an open-cell foam material with a sealed outer skin.

[0497] In an alternative configuration, the conduit 300 may include a membrane. Figure 22A schematically illustrates an exemplary method for manufacturing a single-walled ventilator. This method can be particularly suitable for thin-walled conduits. The membrane 306 is arranged in a spiral or helix shape such that the edge portions of adjacent layers overlap and form the wall of the breathing gas conduit 300. A reinforcing element comprising a bead edge 303 of polymer material is inserted at the overlapping edge of adjacent windings of the membrane 306, the bead edge being bonded to the overlapping portion of the membrane 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 membrane layer 306 and the edge 307 of the second adjacent membrane layer 306, the second membrane layer covering the top of the bead when the polymer bead edge 303 melts. The overlapping layers of the membrane follow the contour of the bead edge 303 very closely due to their thinness, resulting in a smooth inner wall of the conduit. In another alternative schematically shown in Figure 22B, the beaded edge 303 is not inserted between the overlapping edges of adjacent coils of the membrane 306, but is instead disposed on two layers on the outer surface of the membrane 306. More specifically, the membrane 306 is first arranged in a spiral or coiled shape such that the edge portions of adjacent layers overlap. Next, polymeric material beads 303 are disposed on the overlapping edges of the membrane 306 to form a breathing gas conduit 300. In some configurations, the beaded edge 303 may be disposed on the inner surface of the membrane 306, thereby exposing the beaded edge 303 to the lumen of the gas conduit 300. In such a configuration, an elongated membrane wraps around the outer side of the beaded edge 303 such that the beaded edge 303 interacts with the lumen of the gas conduit 300, and the membrane 306 forms the outer surface of the gas conduit 300.

[0498] The catheter 300 may have one or more features outlined in U.S. Patent Application Publication No. 2019 / 0224439 entitled "Breathing Circuit Component for a Respiratory Device" and U.S. Patent Application Publication No. 2017 / 0304578 entitled "Tube for a Medical System". The contents of these specifications are incorporated herein by reference in their entirety.

[0499] In an alternative configuration, the tube between the patient catheter 300 and the gas inlet 121 may include a ventilator. The ventilator fluidly connects the patient catheter 300 to the gas inlet 121.

[0500] The gas manifold 120 may be integrally formed with the vent pipe or may be connected to the vent pipe.

[0501] When the patient interface is used with humidified gas, fluid communication between the gas inlet 121 and the vent tube is beneficial. The vent tube allows for a high level of humidity while reducing the risk of rain washing and condensation formation in the flow path.

[0502] For the nose interfaces 100, 100', 100" of this disclosure, if the inner diameter ID1 of the fork is greater than the width of the manifold 120, a portion of the interior of the forks 111, 112 is confined, and there may be an increased noise level. The gas manifold 120 is advantageously configured such that the manifold width is equal to or greater than the inner diameter ID1 of the fork.

[0503] Figures 9(a) and 9(b) illustrate an exemplary gas manifold 120 that can be used with the small nose 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.

[0504] Figures 10(c) and 10(b) show an exemplary gas manifold 120' that can be used with a medium nose interface 100' or a large nose interface 100'. The same reference numerals indicate the same portions of the gas manifold 120, but with the addition of an apostrophe ('). The width W' of the gas flow path 122', which is adjacent to the first fork 111' and the second fork 112' in use, is equal to or greater than the inner diameter ID1 of the first fork 111', 112' of the medium nose 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 = 7.5 mm and W' = 7.8 mm, but it should be understood that these dimensions can vary.

[0505] The gas manifold 120' can also be used with the large nose interface 100” while still reducing noise, even though the inner diameter of the first fork 111” of the large nose interface 100” can be greater than the width W”, for example, 9.4 mm.

[0506] It should be understood that these are merely exemplary dimensions, and the dimensions of the forks of the nose interfaces 100, 100', 100” and the gas manifolds 120, 120' may vary.

[0507] The nose interfaces 100, 100', 100” described herein may have any one or more features and / or functions described in PCT Publication No. WO 2015 / 020540 or U.S. Patent No. 10,569,043. The contents of those specifications are incorporated herein by reference in their entirety.

[0508] In the configuration shown, the larger first nose forks 111, 111, 111” are on one side of the cannula body 118, while the smaller second nose forks 112, 112', 112” are on the other side of the cannula body 118. It should be understood that these forks can be interchanged so that they are on the opposite side as shown. Alternatively, the nose interfaces 100, 100', 100” can be designed in a way that the left and right nose forks are interchangeable.

[0509] When using nasal interfaces 100, 100', and 100”, pressure and flow rate in the nostrils can be measured and controlled simultaneously or separately. Flow rate in one nostril can be continuous, while flow rate in the other nostril varies according to the respiratory cycle. Different interfaces (each delivering asymmetrical flow rates in the nose) can be used to continuously deliver supplemental oxygen and deliver continuous or variable nasal high flow rates. One nasal fork element can be used to deliver oxygen, gas, aerosol, etc., to the patient, while another nasal delivery fork can be used to deliver a higher airflow rate, or different flow rates of oxygen, gas, aerosol, etc., to the patient. Each nasal delivery element can supply a different flow rate to the patient and can be connected to different flow generation elements.

[0510] The respiratory therapy system with 100, 100', 100” nasal interface disclosed herein can improve the performance of NHF treatment, especially in the delivery of therapies to infants and children. The nasal interface disclosed herein can reduce resistance compared to existing nasal interfaces and can expand and improve the functionality of the respiratory device without modifying the hardware or software.

[0511] The asymmetric flow useful in this article can be provided by a nasal interface using any form of pressure support, such as continuous positive airway pressure (CPAP) or noninvasive therapy (NIV). During therapy with increased airway pressure, anatomical dead space can be cleared by unidirectional nasal flow, 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.

[0512] One fork, and therefore one nostril, can connect to the inspiratory branch of a two-branch ventilator circuit or a single-branch circuit, such as the breathing tube in a CPAP blower. The other fork, and therefore the other nostril, can connect to a regular ventilation port in the interface for deflection, or connect to the expiratory branch of a two-branch circuit ventilator. Due to carbon dioxide clearance in the upper airway or rebreathing in the expiratory branch, the expiratory branch connected to the ventilator can allow for flow rate variations to control periodic breathing or breathing in central sleep apnea.

[0513] Opening the mouth reduces the pressure transmitted to the patient and improves the clearance of anatomical dead space. A suction nozzle can be inserted to maintain the leak, and this nozzle can be further connected to a negative pressure line or expiratory branch to increase or control the clearance of dead space. The leak rate can be configurable to control the pressure.

[0514] To achieve comfortable asymmetric flow, a high level of humidity (e.g. delivered by a device known as AIRVOTM or ICONTM (AIRVOTM is a humidifier with an integrated flow generator device and ICONTM is a CPAP device manufactured by Fisher & Paykel Healthcare Limited) may be required to prevent nasal epithelial cells from drying out. Comfortable temperature and dew point levels can be determined based on ratios and can be, but not limited to, in the range of 27°C - 37°C, 31°C - 37°C as necessary, 33°C - 37°C as needed, and may depend on flow.

[0515] In some configurations, the system is configured to deliver a gas through the nasal interface at a relative humidity of up to 100%.

[0516] In some configurations, the system is configured to deliver a gas through the nasal interface at an absolute humidity greater than about 33 mg / l. In some configurations, the system is configured to deliver a gas through the nasal interface at an absolute humidity of up to about 44 mg / l.

[0517] One or both nose forks may be provided with fittings, such as, but not limited to, sleeves and inserts to optimize NHF therapy. Sleeves as described herein refer to any structure external to the nasal delivery element added to the nasal interface. The inserts described herein refer to any structure inside the nasal delivery element added to the nasal interface.

[0518] NHF therapy can be improved or optimized to deliver the desired pressure curve and efficiently clear anatomical dead space. A nasal delivery element with a smaller diameter at the nasal interface can produce a jet with a higher velocity, which can clear the patient dead space more efficiently than a nasal delivery element with a larger diameter. Effective clearing of dead space reduces the amount of carbon dioxide rebreathing that occurs. However, a larger diameter reduces leakage occurring around the nasal delivery elements at the nasal interface and can create higher delivery pressures during inspiration and expiration. In acute situations, especially when patients suffer from respiratory distress, larger diameters can be preferable, as higher expiratory pressure may decrease respiratory frequency and improve ventilation.

[0519] By adding fittings to the nasal delivery element of the nasal interface, it is possible to have a nasal delivery element combining a smaller inner diameter and 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 as a nasal delivery element with a large diameter and without an insert, whereas a smaller inner diameter can provide a smaller 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.

[0520] 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 could 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 be fitted into the nostril, thereby maintaining patient comfort.

[0521] For example, by adding a sleeve to the nasal delivery element at the nasal interface, the inner diameter of the nasal delivery element remains the same and allows for a jetting effect to effectively clear anatomical dead space, while the outer diameter has been increased to reduce leakage around the nasal delivery element and to generate higher pressure fluctuations during respiration. The added sleeve can be removed once the desired therapy has been delivered, or when higher pressure is no longer needed. The sleeve can also function as a one-way valve, which expands during exhalation and increases expiratory pressure. To inhibit or prevent condensation buildup, semi-permeable materials can be used, which may introduce leakage, or a combination thereof can be used. A sleeve can also be added to the interface to reduce the outer diameter and thus also reduce the inner diameter, which can increase the jetting effect, deflect or split the flow from the center of the nasal delivery element to the periphery, or a combination thereof can be used.

[0522] The second example involves adding an insert within the nasal delivery element. This reduces the inner diameter to decrease pressure and increase dead space clearance while maintaining the same outer diameter. The smaller inner diameter increases the jetting effect, deflects or splits the flow from the center of the nasal delivery element to the periphery, or can combine the jetting effect with deflecting or splitting the flow from the center of the nasal delivery element to the periphery.

[0523] Other configurations may include: using fittings that can block the nasal delivery element, allowing NHF to be delivered to the patient through an unblocked nasal delivery element, using fittings that enable asymmetric flow rates, or fittings that enable symmetric interfaces. Adding a sleeve already individually fitted to the patient can reduce operating flow rates, which can result in reduced noise, reduced supplemental oxygen usage, and improved patient comfort. Reduced operating flow rates can also allow for less heating and water usage. Only one interface is required per patient, and it can be specifically fitted to the patient to modify pressure or clear dead space.

[0524] Figure 20 shows the test results of the nose interface of this disclosure.

[0525] Figure 20(a) illustrates how the nasal interfaces 100, 100', 100” of this disclosure can be used to achieve an enlarged obstruction area while still maintaining a safe gap in one nostril. In the event of device or system failure, the patient can still breathe through the nostril and maintain a safe gap.

[0526] Figure 20(b) shows test data illustrating the increased positive end-expiratory pressure (PEEP) and reduced rebreathing when using the asymmetric fork nasal interface of this disclosure compared to the symmetric fork nasal interface when a high nasal flow rate of 30 liters per minute (lpm) is applied. The data shows rebreathing patterns with respiratory rates 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. Dashed lines represent rebreathing that occurs without a high nasal flow rate.

[0527] Figure 20(c) shows test data similar to Figure 20(b), but for a nasal high-flow rate of 60 lpm. This data shows rebreathing patterns with respiratory rates 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 dashed line represents rebreathing that occurred without a nasal high-flow rate.

[0528] This data indicates that, compared to nasal interfaces with symmetrical forks, nasal high flow delivered via the nasal interface with increased obstruction as disclosed herein can produce greater positive airway pressure and dead space clearance as well as reduced rebreathing.

[0529] Figure 21 shows the maximum airway pressure achievable for each size of nasal interface in this disclosure when a larger fork completely obstructs one of the patient's nostrils.

[0530] More specifically, Figure 21 shows the airway pressures achievable under static conditions for each size of nasal interface 100, 100', 100” when a patient’s nostril is completely blocked by a larger fork. This represents the maximum possible blockage for each nasal interface 100, 100', 100”, and consequently the maximum pressure achievable under static conditions.

[0531] This data shows that even at maximum flow, the maximum pressure under static conditions is still within safe limits due to possible user errors leading to the use of incorrectly sized nose interfaces 100, 100', 100”.

[0532] In the nasal interfaces 100, 100', 100” of this disclosure, a first fork 111 has a shape, and a second fork 112 has a shape. The inner diameter ID1 and / or inner cross-sectional area A1 of the first fork 111 in the direction GFD1 transverse to the gas flow through the first fork 111 is greater than the inner diameter ID2 and / or inner cross-sectional area A2 of the second fork 112 in the direction GFD2 transverse to the gas flow through the second fork 112. At least the first fork 111 may be made of an elastomeric material such 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 using the nasal interfaces 100, 100', 100”.

[0533] In some configurations, the temperature may be between about 20°C and about 41°C, or, as needed, more than 20°C and up to about 41°C, or, as needed, between about 31°C and about 41°C, or, as needed, between about 36°C and about 39°C, or, as needed, about 37°C, or may be any other suitable temperature experienced during the therapy. This temperature is generally higher than the ambient temperature.

[0534] In some configurations, the first fork 111 may be configured to deform in use and shape itself to substantially match the internal shape of the patient's nostril. In alternative configurations, the first fork 111 may be configured to bend or deform in response to temperature and contact with the patient's nostril to shape itself, but may not substantially match the internal shape of the patient's nostril after the shape is set. For example, one or more discrete portions of the outer surface of the first fork 111 may contact one or more discrete regions of the patient's nostril in use, causing the one or more discrete portions of the outer surface to deform and shape itself.

[0535] The deformation and shape setting can be permanent. Alternatively, the deformation and shape setting can be reversible after a suitable combination of applied temperature and time.

[0536] The elastomeric material can exhibit time- and temperature-dependent properties at or below the desired therapeutic temperature, so that the shape setting of at least the first fork 111 in use can more appropriately conform to the patient's nostrils. For example, the elastomeric material can exhibit compressive deformation properties to achieve the shape setting. The elastomeric material can also exhibit tensile deformation and / or stress relaxation properties typically associated with compressive deformation properties. Elastomeric materials exhibiting compressive deformation, tensile deformation, and / or stress relaxation properties at or below the therapeutic temperature can reduce discomfort that the user may experience during therapy delivery due to the nose fork impacting the inner surface of the nostrils.

[0537] Both the first fork 111 and the second fork 112 can be made of an elastomeric material. In this configuration, both the first fork 111 and the second fork 112 can be deformed and shaped 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.

[0538] The elastomeric material allows at least the larger first fork 111, and, if necessary, the second fork 112, to deform and shape in relation to the contact between the outer side of the fork(multiple) and the inside of the patient's nostril during use.

[0539] Since the size of the larger first fork 111 can be determined to have a smaller gap compared to the symmetrical fork, deforming the first fork 111 in use and setting its shape to at least partially fit the patient's nostrils can improve comfort.

[0540] To achieve this performance, at least the first fork 111 of the patient interface, and optionally the two forks 111, 112 of the patient interface, are made of an elastomeric material, such that the forks(s) can deform and shape at a temperature equal to or lower than the temperature of the gas flow passing through the forks(s) 111, 112 of the nasal interface. The material may be selected to be non-shape-setting at ambient temperature, such that the forks(s) do not shape when the nasal interfaces 100, 100', 100" are not in use.

[0541] In some configurations, the elastomeric material enables the first fork to deform and set its shape at a therapeutic temperature between about 31°C and about 41°C, or as needed between about 36°C and about 39°C, or as needed about 37°C to substantially match the internal shape of the patient’s nostrils.

[0542] In some configurations, the first fork 111 is not made of silicone and does not contain silicone because it cannot be shaped at therapeutic temperatures.

[0543] In some configurations, at least the first fork 111 is made of a thermoplastic elastomer.

[0544] In some configurations, the elastomer material exhibits compressive deformation of about 10% to about 50% after 72 hours at a temperature between about 20°C and about 40°C when tested according to Method A of ISO 815-1:2014.

[0545] In some configurations, the elastomer material, when tested according to Method A of ISO 815-1:2014, exhibits, after 72 hours, a compressive deformation of about 10% to about 45%, as desired, between about 10% and about 40%, as desired, between about 10% and about 35%, as desired, between about 10% and about 30%, as desired, between about 10% and about 25%, as desired, between about 10% and about 20%, as desired, between about 11% and about 19%, as desired, between about 12% and about 18%, as desired, between about 13% and about 17%, as desired, between about 14% and about 16%, as desired, or about 15%.

[0546] In some configurations, the elastomer material, when tested according to Method A of ISO 815-1:2014, exhibits between about 10% and about 45% after 72 hours at temperatures above about 20°C to up to about 35°C, as needed at temperatures above about 20°C to up to about 30°C, as needed at temperatures above about 20°C to up to about 25°C, as needed at temperatures of about 21°C, about 22°C, about 23°C, about 24°C, or about 25°C or higher, as needed. Compression deformation of approximately 10% to 40%, or as required, between approximately 10% and 35%, or as required, between approximately 10% and 30%, or as required, between approximately 10% and 25%, or as required, between approximately 10% and 20%, or as required, between approximately 11% and 19%, or as required, between approximately 12% and 18%, or as required, between approximately 13% and 17%, or as required, between approximately 14% and 16%, or as required, between approximately 15%.

[0547] The elastomer material can be selected such that shape setting occurs at a temperature of about 23°C or higher (typically above ambient temperature but below operating temperature).

[0548] The elastomeric material may include any elastomeric material that exhibits shape-setting properties at therapeutic temperatures. In some configurations, the elastomeric material is THERMOLAST® K TF3STE - TPE from Kraiburg TPE GmbH & Co. KG.

[0549] In addition to the elastomer material, the nose interfaces 100, 100', 100” may have any one or more features described herein.

[0550] A patient interface 1 having a nasal interface 100, 100', 100" configured according to the present invention can be used in respiratory therapy methods. The respiratory therapy methods include: delivering gas to the airway of a patient in need, improving ventilation in a patient in need, reducing the volume of anatomical dead space within the airway volume of a patient in need, and / or treating respiratory conditions in a patient in need, as described above.

[0551] Patient interfaces 1, including the types of nasal interfaces 100, 100', 100" disclosed herein, can be used in respiratory therapy systems to deliver gas to patients.

[0552] In some configurations, the respiratory therapy system 1000 includes a respiratory therapy device 1100 and a patient interface 1 having nasal interfaces 100, 100', 100"

[0553] Figure 15 illustrates an exemplary respiratory therapy device 1100.

[0554] The respiratory therapy device 1100 includes a main housing 1101 that houses a flow generator 1011 (e.g., a blower) arranged in a motor / impeller configuration, a humidifier 1012 for humidifying the gas as needed, a controller 1013, and a user interface 1014 (including, for example, a display and input devices such as buttons, a touch screen, etc.).

[0555] The controller 1013 can be configured or programmed to control the operation of the device. For example, the controller can control components of the device, including but not limited to: operating the flow generator 1011 to generate gas flows (flows of individual gases) for delivery to the patient; operating the humidifier 1012 (if present) to humidify and / or heat the generated gas flows; controlling the oxygen flow into the flow generator blower; receiving user input from the user interface 1014 to reconfigure and / or perform user-defined operations on the device 1000; and outputting information to the user (e.g., on a display).

[0556] The user can be a patient, a healthcare professional, or any other person interested in using the device. As used herein, “gas flow” can refer to any gas flow that can be used in a respiratory aid or breathing device, such as an ambient air flow, a flow containing essentially 100% oxygen, a flow containing some combination of ambient air and oxygen, etc.

[0557] One end of the patient breathing tube 300 is connected to the gas outlet 1021 in the housing 1100 of the respiratory therapy device 1100. The other end of the patient breathing tube 300 is connected to the nasal interface 100 having a gas manifold 120 and nasal forks 111, 112.

[0558] The gas flow generated by the respiratory therapy device 1100 can be humidified and delivered to the patient via the patient conduit 300 through the nasal interface 100. The patient conduit 300 may have a heater to heat the gas flow to the patient. For example, the patient conduit 300 may have a heating wire 300a to heat the gas flow to the patient. The heating wire 300a may be controlled by a controller 1013. The patient conduit 300 and / or the nasal interface 100 may be considered as part of the respiratory therapy device 1100, or alternatively as part of its periphery. The respiratory therapy device 1100, the breathing conduit 300, and the patient interface 1 including the nasal interface 100 together can form a respiratory therapy system 1000.

[0559] Controller 1013 can control flow generator 1011 to generate a gas flow with a desired flow rate. Controller 1013 can also control supplemental oxygen inlet to allow delivery of supplemental oxygen, and humidifier 1012 (if present) can humidify and / or heat the gas flow to an appropriate level, etc. The gas flow is directed to the patient through patient catheter 300 and nasal interface 100. Controller 1013 can also control heating elements in humidifier 1012 and / or heating elements 300a in patient catheter 300 to heat the gas to a desired temperature to achieve the patient's desired level of treatment and / or comfort. Controller 1013 can be programmed with a suitable target temperature for the gas flow or can determine a suitable target temperature for the gas flow. In some configurations, administration of a gas mixture comprising supplemental oxygen and / or therapeutic drugs can be provided through supplemental oxygen inlet. The gas mixture may include oxygen, helium-oxygen mixture, nitrogen, nitric oxide, carbon dioxide, argon, helium, methane, sulfur hexafluoride, and combinations thereof, and / or supplementary gas may include nebulized medication.

[0560] The oxygen inlet port 1028 may include a valve 1028a through which pressurized gas can enter a flow generator or blower. The valve controls the oxygen flow into the flow generator or blower. The valve can be any type of valve, including proportional valves or two-position valves. The oxygen source can be an oxygen cylinder or a hospital oxygen supply source. Medical-grade oxygen typically has a purity between 95% and 100%. Lower purity oxygen sources may 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 entitled "Valve Modules and Filters"). The contents of these specifications are incorporated herein by reference in their entirety.

[0561] The respiratory therapy device 1100 can measure and control the oxygen content of the gas delivered to the patient, and thus measure and control the oxygen content of the gas inhaled by the patient. During high-flow therapy, the high flow rate of the delivered gas meets or exceeds the patient's peak inspiratory requirement. This means that the volume of gas delivered to the patient by the device during inspiration meets or exceeds the volume of gas inhaled by the patient during inspiration. Therefore, high-flow therapy helps prevent entrainment of ambient air during the patient's inhalation and flushes out exhaled air from the patient's airway. As long as the flow rate of the delivered gas meets or exceeds the patient's peak inspiratory requirement, the possibility of entrainment of ambient air is reduced, and the gas delivered by the device is typically substantially the same as the gas inhaled by the patient. Therefore, the oxygen concentration measured in the device (delivered oxygen fraction (FdO2)) will be substantially the same as the oxygen concentration inhaled by the user (inhaled oxygen fraction (FiO2)), and thus such terms can be considered equivalent.

[0562] Operating sensors 1003a, 1003b, 1003c (e.g., flow sensors, temperature sensors, humidity sensors, and / or pressure sensors) may be placed in various locations within the respiratory therapy device 1100. Additional sensors (e.g., sensors 1020, 1025) may be placed in various locations on the patient catheter 300 and / or nasal interface 100 (e.g., temperature sensor 1029 may be present at or near one end of the inspiratory tube). Outputs from the sensors may be received by 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 breathing needs and, as needed, the patient's peak inspiratory needs. Device 1100 may have a transmitter and / or receiver 1015 to enable controller 1013 to receive signals 1008 from sensors and / or control various components of the respiratory therapy device 1100, including but not limited to flow generator 1011, humidifier 1012, and heating wire 300a, or accessories or peripheral devices associated with the respiratory therapy device 1100. Additionally or alternatively, transmitter and / or receiver 1015 may deliver data to a remote server or enable remote control of device 1100.

[0563] After oxygen and ambient air have been mixed, oxygen can be measured by placing one or more gas composition sensors (such as an ultrasonic transducer system, also known as an ultrasonic sensor system). This measurement can be performed within the device, delivery catheter, patient interface, or any other suitable location.

[0564] The respiratory therapy device 1100 may include a patient sensor 1026 (such as a pulse oximeter or a 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.

[0565] The sensor 1026 can communicate with the controller 1013 via a wired connection or via a wireless transmitter on the sensor 1026.

[0566] Sensor 1026 may be a disposable adhesive sensor designed to be attached to a patient's finger. Sensor 1026 may also be a non-disposable sensor.

[0567] Sensors designed for different age groups and to be attached to different locations on the patient are available, and these sensors can be used with the respiratory therapy device 1100.

[0568] The pulse oximeter will be attached to the user (typically on their finger), but other locations (such as the earlobe) are also an option. The pulse oximeter will connect to the processor in the device and will continuously provide signals indicating the patient's blood oxygen saturation. The patient sensor 1026 may be a hot-swappable device that can be attached to or interchanged during operation of the respiratory therapy device 1100. For example, the patient sensor 1026 may connect to the respiratory therapy device 1100 using a USB interface or using a wireless communication protocol (e.g., near field communication, WiFi, or Bluetooth®). When the patient sensor 1026 is disconnected during operation, the respiratory therapy device 1100 may 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 may trigger an alarm, switch from automatic mode to manual mode, and / or exit control mode completely (e.g., automatic or manual mode). The patient sensor 1026 may be a bedside monitoring system or other patient monitoring systems that communicate with the respiratory therapy device 1100 via a physical or wireless interface.

[0569] The respiratory therapy device 1100 may include a high-flow therapy device. The high-flow therapy discussed herein is intended to be given its typical, general meaning as understood by those skilled in the art, and generally refers to a respiratory support system that delivers a target flow rate of humidified respiratory gas via an intentionally unsealed (non-sealed) patient interface at a flow rate generally designed to meet or exceed the patient's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults typically range from, but are not limited to, about 15 liters per minute (lpm) to about 70 liters per minute or greater. Typical flow rates for pediatric patients (such as newborns, infants, and children) typically range from, but are not limited to, about 1 liter per minute per kilogram of patient weight to about 3 liters per minute per kilogram of patient weight or greater. High-flow therapy may also, as needed, include a gas mixture composition comprising 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), among 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" may 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 neonatal, infant, or pediatric patients, "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 about 15 lpm, or between about 20 lpm and 25 lpm. High-flow therapy devices for adult, neonatal, infant, or pediatric patients can deliver gas to the patient at a flow rate between about 1 lpm and about 100 lpm or at any of the subranges listed above.The flow therapy device 1000 can deliver oxygen (e.g., FdO2) at any flow rate between about 1 lpm and about 100 lpm, up to 100% of any concentration. In some configurations, any of these flow rates can be combined with oxygen concentrations (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 oxygen concentrations (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 may include safety thresholds when operating in manual mode, which prevent the user from delivering too much oxygen to the patient.

[0570] 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 in fluid communication with the oxygen inlet 1028 to control the flow rate 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 measurement of oxygen saturation from the blood oxygen saturation sensor 1026.

[0571] The patient interface 1 used in the respiratory therapy system 1000 having the respiratory therapy device 1100 includes a nasal interface 100, which includes: a first fork 111 and a second fork 112 that are asymmetrical to each other, and a gas manifold 120 including a gas inlet 121, wherein 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 asymmetrical gas flow at the patient's nostrils.

[0572] The first fork 111 and the second fork 112 are asymmetrical to each other, or not symmetrical to each other, or different in shape and configuration, or asymmetrical when compared with each other.

[0573] In some configurations, the nasal interface 100 includes a cannula body 118 having a first fork 111 and a second fork 112.

[0574] In some configurations, the gas manifold 120 is integrated with the cannula body 118, or it is separate from the cannula body 118 but can be connected to it.

[0575] In some configurations, the first fork 111 and the second fork 112 are configured to engage with the nasal passage in an unsealed (non-sealed) manner.

[0576] In some configurations, the first fork 111 and the second fork 112 allow exhaled gas to escape into the vicinity of the first fork and the second fork.

[0577] In some configurations, the first fork 111 and the second fork 112 are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0578] The nose interface 100 may have any one or more features and / or functions described herein with respect to nose interfaces 100, 100', 100”.

[0579] In some configurations, the respiratory therapy device 1000 includes a flow generator 1011 and a humidifier 1012.

[0580] In some configurations, the respiratory therapy system includes a patient catheter 300 having a heater 300a.

[0581] In some configurations, the patient interface includes a ventilator 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.

[0582] Patients with a variety of 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, those receiving pre- and post-operative oxygen delivery, and other conditions or diseases can benefit from oxygen therapy. A common approach to addressing these issues is to supply supplemental oxygen to the patient to prevent their blood oxygen saturation (SpO2) from dropping too low (e.g., below about 90%). However, supplying too much oxygen to a patient can lead to over-oxygenation of their blood and is also considered dangerous. Generally, a patient's SpO2 is maintained within the range of about 80% to about 99%, and preferably about 92% to about 96%, but these ranges may vary depending on the patient's condition. Due to various factors such as respiratory rate, lung tidal volume, heart rate, activity level, height, weight, age, sex, and other factors, there is no single prescribed level of supplemental oxygen that can consistently achieve a targeted range of SpO2 responses for each patient. Individual patients will require regular monitoring and adjustment of their fractional oxygen (FdO2) to ensure they receive the correct amount to achieve their target SpO2. Achieving correct and consistent SpO2 is a crucial factor in the treatment of patients with various health conditions or diseases. Furthermore, patients with such health problems can benefit from systems that automatically control oxygen saturation. This disclosure is applicable to a wide range of patients requiring rapid and accurate oxygen saturation control.

[0583] Referring to Figure 15, the controller 1013 may be programmed or configured to execute 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.

[0584] The controller 1013 may receive input(s) from a user that can 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(s) values ​​may be preset, selected by a clinician, or determined based on patient type, where patient type may refer to current ailment and / or information about the patient (e.g., age, weight, height, gender, and other patient characteristics). Similarly, the target SpO2 may be two values, each selected in any of the ways described above. These two values ​​will represent a range of acceptable SpO2 values ​​for the patient. The controller may target values ​​within the range. The target value may be the middle 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 preset responses when the patient's SpO2 value moves out of the range. Responses may include issuing an alarm, changing to manual control of FdO2, changing FdO2 to a specific value, and / or other responses. A controller can have one or more ranges, where one or more different responses occur when the controller moves outside each range.

[0585] Overall, SpO2 will be controlled between approximately 80% and approximately 100%, or between approximately 80% and approximately 90%, or between approximately 88% and approximately 92%, or between approximately 90% and approximately 99%, or between approximately 92% and approximately 96%. SpO2 can be controlled between any two suitable values ​​from any two of the above ranges. The target SpO2 can be between approximately 80% and approximately 100%, or between approximately 80% and approximately 90%, or between approximately 88% and approximately 92%, or between approximately 90% and approximately 99%, or between approximately 92% and approximately 96%, or approximately 94%, or 94%, or approximately 90%, or 90%, or approximately 85%, or 85%. The SpO2 target can be any value between any two suitable values ​​from any two of the above ranges. For the defined range, the SpO2 target can correspond to the middle of SpO2.

[0586] FdO2 can be configured to be controlled within a 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) in the patient's breath, and thus such terms can be considered equivalent. Each range boundary can be preset, user-selected, or determined based on patient type, where patient type can refer to current ailment and / or information about the patient (e.g., age, weight, height, sex, 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 that 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 the starting point for the controller. If the controller attempts to move FdO2 out of range, the system can have one or more responses. Such responses can include issuing an alarm, preventing FdO2 from moving out of range, switching to manual control of FdO2, and / or switching to a specific FdO2. The device may have one or more ranges, wherein one or more different responses occur when the device reaches the boundary of each range.

[0587] Referring to Figure 16, a schematic diagram of the closed-loop control system 1500 is shown. 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 the target FdO2 in part based 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 the clinician, or automatically determined based on client characteristics. Generally, the target SpO2 value is received or determined before or at the start of the treatment period, but it can be received at any time during the treatment period. During the treatment period, the SpO2 controller can also receive the following inputs: measured FdO2 readings from the gas composition sensor, and measured SpO2 readings and (multiple) signal quality readings from the patient sensor. In some configurations, the SpO2 controller can receive the target FdO2 as input. In such cases, the output of the SpO2 controller can be directly provided back to the SpO2 controller as input. Based at least in part on these inputs, the SpO2 controller can output the target FdO2 to a second control loop.

[0588] During the treatment period, the SpO2 controller and FdO2 controller can continue to automatically control the operation of the respiratory therapy device 1100 until the end of the treatment period or an event triggers a change from automatic mode to manual mode.

[0589] The increased flushing effect caused by the asymmetry of the crosses 111 and 112 in the nasal interfaces 100, 100', and 100” can improve the effectiveness of supplemental oxygen. Compared with symmetrical high nasal flow, closed-loop SpO2 control of the asymmetric nasal interfaces 100, 100', and 100” allows the patient's SpO2 to be maintained at or near the target value while reducing the amount of oxygen used. This achieves oxygen conservation.

[0590] The respiratory therapy system may have one or more 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.

[0591] Figure 17 illustrates an alternative exemplary respiratory therapy system 2000, which can utilize a patient interface 1 including nasal interfaces 100, 100', 100"

[0592] 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.

[0593] 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 source or container of compressed gas (e.g., air, oxygen, etc.). The container may include a valve that can be adjusted to control the flow of gas leaving the container. In some configurations, the flow generator 2101 may use such a compressed gas source and / or other gas source instead of the blower 2106. In some configurations, the blower 2106 may be used in conjunction 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 in 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 to receive other gases (e.g., oxygen, nitrogen oxides, or carbon dioxide) through the same gas inlet 2102 or different gas inlets. Other configurations are also possible.

[0594] The flow generator 2101 shown 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 the user can use to input commands into the flow generator 2101 to view data, and / or control the operation of the flow generator 2101, and / or control other aspects of the operation of the respiratory therapy system 2000.

[0595] The flow generator 2101 can guide gas through the gas outlet 2104 to the first conduit 2110. In the illustrated configuration, the first conduit 2110 guides the gas to the gas humidifier 2112. The gas humidifier is optional.

[0596] A gas humidifier 2112 is used to encapsulate moisture in a gas to provide a humidified gas flow. The illustrated gas humidifier 2112 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 humidifying or moisturizing agents (hereinafter referred to as water).

[0597] 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 stream and / or increasing the temperature of the gas passing through the gas humidifier 2112. The heating element may, for example, include a resistive metal heating plate. However, other heating elements are conceivable. For example, the heating element may include a plastic conductive heating plate or a chemical heating system with controllable heat output.

[0598] In the shown 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 the 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 control other aspects of the operation of the respiratory therapy system 2000.

[0599] In some configurations, the flow generator 2101 and the gas humidifier 2112 may share the housing 2126. In some configurations, the gas humidifier 2112 may 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 may include separate housings.

[0600] In the illustrated configuration, gas travels from humidifier outlet 2118 to second conduit 300. Second conduit 300 may include a conduit heater as described with respect to FIG. 15. The conduit heater can be used to increase the heat of the gas passing through second conduit 300. The heat can reduce or eliminate the possibility of water entrained in the gas flow condensing along the wall of second conduit 300. The conduit heater may include one or more resistance wires located in, on, or around the wall of second conduit 300. In one or more configurations, such one or more resistance wires may be located outside any gas passage. In one or more configurations, such one or more resistance wires are not in direct contact with the gas passing through second conduit 300. In one or more configurations, the wall or surface of second conduit 300 lies between the one or more resistance wires and the gas passing through second conduit 300.

[0601] Gas passing through the second conduit 300 can be delivered to the nasal interface 100. The nasal interface 100 can inflate the respiratory therapy system 2000 to the patient's airway. In some configurations, the respiratory therapy system 2000 utilizes a two-way system comprising separate inspiratory and expiratory gas channels that connect to one or more of the patient's airways.

[0602] In some configurations, a short conduit connects the nose interface 100 to the second conduit 300. In some configurations, the short conduit may have smooth orifices. For example, a short, flexible conduit may connect the nose interface to the second conduit 300. The short conduit connecting the nose interface to the second conduit 300 may be permeable, thus allowing vapor to pass through the conduit wall. In some configurations, the short conduit may incorporate one or more heating wires, as described elsewhere herein. Smooth orifices, whether heated or not, can improve the efficiency of delivering atomized material, as described elsewhere herein.

[0603] The respiratory therapy device 2100 includes a nebulizer 2128. In some configurations, if the nebulizer 2128 is used, the flow generator 2101, the gas humidifier 2112, and the nebulizer 2128 may share a housing 2126. In some configurations, the nebulizer 2128 is separate from the housing 2126.

[0604] The nebulizer 2128 may be connected to a portion of a gas passage extending between the flow generator 2101 (which may include the gas inlet 2102) and the nasal interface 100, although other arrangements may be utilized for the nebulizer 2128 or another nebulizer. In some configurations, the nebulizer 2128 is not located in series at any location between the humidifier outlet 2118 and the patient interface 100. Instead, the nebulizer 2128 is located upstream of the humidifier outlet 2118 or upstream of the inlet leading to the second conduit 2122. In some configurations, the nebulizer 2128 may be located upstream of the inlet leading to the humidifier. In some configurations, the nebulizer 2128 may be located between the gas flow source and the chamber.

[0605] The nebulizer 2128 may include a substance (e.g., a medical substance, a tracer gas, etc.) that can be introduced into the gas stream. The substance can be entrained in the gas stream and delivered to the patient's airway along with the breathing gas. The nebulizer 2128 may be connected to a portion of the gas channel via a transmitter 2130, which may include a tubing or adapter. Alternatively, the nebulizer 2128 may be directly interfaced with the gas channel, which would eliminate the need for the transmitter 2130.

[0606] 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 gas flows (flows of individual gases) for delivery to the patient; operating the humidifier 2112 (if present) to humidify and / or heat the generated gas flows; controlling the oxygen flow into the flow generator blower; receiving user input from the user interface 2108 and / or 2120 to reconfigure and / or perform user-defined operations on the device 2100; and outputting information to the user (e.g., on a display).

[0607] Controller 2113 can control flow generator 2101 to generate a gas flow with a desired flow rate. Controller 2113 can also control supplemental oxygen inlet to allow delivery of supplemental oxygen, and humidifier 2112 (if present) can humidify and / or heat the gas flow to an appropriate level, etc. Controller 2113 can also operate nebulizer 2128. The gas flow is directed to the patient through patient catheter 300 and nasal interface 100. Controller 2113 can also control heating elements in humidifier 2112 and / or patient catheter 300 to heat the gas to a desired temperature to achieve the patient's desired therapeutic level and / or comfort level. Controller 2113 can be programmed with a suitable target temperature for the gas flow or can determine a suitable target temperature for the gas flow. In some configurations, administration of a gas mixture comprising supplemental oxygen and / or therapeutic drugs can be provided through supplemental oxygen inlet. The gas mixture may include oxygen, helium-oxygen mixture, nitrogen, nitric oxide, carbon dioxide, argon, helium, methane, sulfur hexafluoride, and combinations thereof, and / or supplementary gas may include nebulized medication from nebulizer 2128.

[0608] In some configurations, the respiratory therapy device 2100 includes a gas inlet 2102, a gas outlet 2118, and a nebulizer 2128 for delivering one or more substances into the gas stream. A patient interface 100 used in a respiratory therapy system 2000 having the respiratory therapy device 2100 includes a gas inlet 121, a first fork 111 and a second fork 112 that are asymmetrically positioned, and a gas manifold 120 including the gas inlet 121, which is in fluid communication with the gas outlet 2118 to receive gas and one or more substances from the respiratory therapy device. 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 asymmetrical gas stream at the patient's nostrils.

[0609] 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 to deliver the gas and one or more substances to the gas inlet 121 of the nasal interface 100.

[0610] In the illustrated configuration, 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 through the gas inlet 2102 into the flow generator 2101. The gas can be pushed out of the gas outlet 2104 and propelled 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 carries moisture as it passes through or near the water in the gas humidifier 2112. The water is heated by a heating element that helps to humidify and / or heat the gas passing through the gas humidifier 2112. The gas exits 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. Gas is delivered from the second conduit 300 to the nasal interface 100, where it enters the patient's airway to help treat respiratory illnesses.

[0611] For example, referring to Figures 2, 3, and 15, in some configurations, the respiratory therapy system 1000 of this disclosure includes: a respiratory therapy device 1100, which includes: at least one gas inlet 1027, 1028; a humidifier 1012 for humidifying the gas; and a gas outlet 1021; and a patient interface 1 including a nasal interface 100, wherein the nasal interface includes: a first fork 111 and a second fork 112 that are asymmetrical 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; and a gas manifold 120 including a gas inlet 121, wherein the first fork 111 and the second fork 112 are in fluid communication with the gas inlet 121; wherein the nasal interface 100 is configured to achieve asymmetrical gas flow at the patient's nostrils; The respiratory therapy system 1000 is configured to deliver gas through the first fork outlet 111a and the second fork outlet 112a for a total volumetric flow rate of gas flowing into the gas inlet greater than 0 lpm and up to about 70 lpm, at a temperature range of about 27°C to 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.

[0612] In some configurations, the respiratory therapy system 1000 is configured to deliver gas through a first fork outlet 111a and a second fork outlet 112a in a temperature range of about 31°C to 37°C.

[0613] In some configurations, the respiratory therapy system 1000 is configured to deliver gas at a relative humidity of up to about 44 mg / l through a first fork outlet 111a and a second fork outlet 112a.

[0614] In some configurations, the respiratory therapy system 1000 is configured to provide a total volumetric flow rate of gas to the gas inlet 121, which is at least about 5 liters per minute (lpm), between about 5 lpm and about 120 lpm as needed, and between about 5 lpm and about 70 lpm as needed.

[0615] In some configurations, the respiratory therapy system 1000 is configured to deliver at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 to the nasal interface, and, if necessary, deliver about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 to the nasal interface, and, if necessary, deliver about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 to the nasal interface, and, if necessary, deliver about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 to the nasal interface, and, if necessary, deliver about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 to the nasal interface. 0% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 to the nose interface; approximately 70% to approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 to the nose interface as needed; approximately 75% to approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 to the nose interface as needed; approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 to the nose interface as needed; approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 is delivered through the first fork 111 to the nose interface as needed.

[0616] In some configurations, the respiratory therapy system 1000 is configured to provide different gas flow rates through the first fork 111 and the second fork 112, and to deliver gas at substantially similar velocities through the first fork outlet 111a and the second fork outlet 112a.

[0617] In some configurations, the velocity of the gas leaving the first fork outlet 111a is within about 20% of the velocity of the gas leaving the second fork outlet 112a, or as needed, within about 16% of the velocity of the gas leaving the second fork outlet 112a, and or as needed, within about 10% of the velocity of the gas leaving the second fork outlet 112a at a flow rate above about 42 lpm.

[0618] In some configurations, for a total volumetric flow rate of gas flowing into gas inlet 121 that is greater than 0 lpm and up to about 70 lpm, the velocity of gas leaving each of the first branch outlet 111a and the second branch outlet 112a is greater than 0 m / s and less than 32 m / s.

[0619] In some configurations, for a total volumetric flow rate of gas flowing into gas inlet 121 greater than 9 lpm and up to about 70 lpm, the velocity of gas leaving each of the first branch outlet 111a and the second branch outlet 112a is greater than about 2 m / s and less than about 32 m / s, as needed greater than about 2 m / s and less than 32 m / s, as needed greater than about 2 m / s and up to about 25 m / s, and as needed greater than about 2.5 m / s and up to about 20 m / s.

[0620] In some configurations, the nasal interface 100 includes a cannula body 118 having a first fork 111 and a second fork 112.

[0621] In some configurations, the gas manifold 120 is integrated with the cannula body 118, or it is separate from the cannula body 118 but can be connected to it.

[0622] In some configurations, the first fork 111 and the second fork 112 are configured to engage with the nasal passage in an unsealed (non-sealed) manner.

[0623] In some configurations, the first fork 111 and the second fork 112 allow exhaled gas to escape into the vicinity of the first fork 111 and the second fork 112.

[0624] In some configurations, the first fork 111 and the second fork 112 are configured to deliver gas to the patient without interfering with the patient’s spontaneous breathing.

[0625] In some configurations, the first and second forks are configured to deliver gas to the patient independently of the patient’s breathing.

[0626] 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.

[0627] The respiratory therapy system 1000, the patient interface 1, and the nasal interface 100 may have any of the features and functions described herein.

[0628] A method for providing respiratory support to a patient is disclosed, the method comprising: providing a respiratory therapy system 1000, the respiratory therapy system comprising: a respiratory therapy device 1100, the respiratory therapy device comprising: at least one gas inlet 1027, 1028; a flow generator 1011; a gas outlet 1021; and a patient interface 1, the patient interface comprising a nasal interface 100, wherein the nasal interface 100 comprises: a first fork 111 and a second fork 112 that are asymmetrical 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; and a gas manifold 120, the gas manifold comprising a gas inlet 121, wherein the first fork 111 and the second fork 112 are in fluid communication with the gas inlet 121; Operate the respiratory therapy device 1100 to provide a gas flow to the nasal interface 100; and deliver an asymmetric gas flow from the respiratory therapy device 1100 through the patient's nostrils via a first fork outlet 111a and a second fork outlet 112a.

[0629] In some configurations, the method includes delivering the asymmetric gas stream through the first fork outlet and the second fork outlet at a temperature range of about 27°C to 37°C, at a relative humidity of more than about 33 mg / l, and / or at a velocity of more than 0 m / s and less than about 32 m / s for a total volumetric flow rate of the gas stream flowing into the gas inlet 121.

[0630] In some configurations, the method includes delivering an asymmetric gas stream in a temperature range of about 31°C to 37°C.

[0631] In some configurations, the method includes: providing a total volumetric flow rate of at least about 5 liters per minute (lpm) of gas to gas inlet 121, providing a total volumetric flow rate of gas between about 5 lpm and about 120 lpm as needed, and providing a total volumetric flow rate of gas between about 5 lpm and about 70 lpm as needed.

[0632] In some configurations, the method includes delivering at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and out of the nose interface; delivering about 60% to about 90% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and out of the nose interface as needed; delivering about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and out of the nose interface as needed; delivering about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and out of the nose interface as needed; and delivering about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and out of the nose interface as needed. A fork 111 delivers the nose interface, and as needed, delivers approximately 70% to approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and delivers it out of the nose interface; as needed, delivers approximately 70% to approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and delivers it out of the nose interface; as needed, delivers approximately 75% to approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and delivers it out of the nose interface; as needed, delivers approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and delivers it out of the nose interface; as needed, delivers approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet 121 through the first fork 111 and delivers it out of the nose interface.

[0633] In some configurations, the method includes delivering gas through a first fork outlet 111a and a second fork outlet 112a at a relative humidity of up to about 44 mg / l.

[0634] In some configurations, the method includes providing different gas flow rates through the first fork 111 and the second fork 112, and delivering gas at substantially similar velocities through the first fork outlet 111a and the second fork outlet 112a.

[0635] In some configurations, the velocity of the gas leaving the first fork outlet 111a is within about 20% of the velocity of the gas leaving the second fork outlet 112a, or as needed, within about 16% of the velocity of the gas leaving the second fork outlet 112a, and or as needed, within about 10% of the velocity of the gas leaving the second fork outlet 112a at a flow rate above about 42 lpm.

[0636] In some configurations, for a total volumetric flow rate of gas flowing into gas inlet 121 that is greater than 0 lpm and up to about 70 lpm, the velocity of gas leaving each of the first branch outlet 111a and the second branch outlet 112a is greater than 0 m / s and less than 32 m / s.

[0637] In some configurations, for a total volumetric flow rate of gas flowing into gas inlet 121 greater than 9 lpm and up to about 70 lpm, the velocity of gas leaving each of the first branch outlet 111a and the second branch outlet 112a is greater than about 2 m / s and less than about 32 m / s, as needed greater than about 2 m / s and less than 32 m / s, as needed greater than about 2 m / s and up to about 25 m / s, and as needed greater than about 2.5 m / s and up to about 20 m / s.

[0638] In some configurations, the nasal interface 100 includes a cannula body 118 having a first fork 111 and a second fork 112.

[0639] In some configurations, the gas manifold 120 is integrated with the cannula body 118, or it is separate from the cannula body 118 but can be connected to it.

[0640] In some configurations, the method includes engaging the first fork 111 and the second fork 112 with the nasal passage in an unsealed (non-sealed) manner.

[0641] In some configurations, the method includes allowing exhaled gas to escape around the first fork 111 and the second fork 112.

[0642] In some configurations, the method involves supplying gas to the patient without interfering with the patient’s spontaneous breathing.

[0643] In some configurations, the method includes delivering gas to the patient independently of the patient’s breathing.

[0644] In some configurations, the nose interface 100 is as described above or in this article.

[0645] In some configurations, the respiratory therapy device 1100 includes a humidifier 1012, and the method includes using the humidifier 1012 to humidify the gas stream.

[0646] In some configurations, the respiratory therapy system 1000 includes a patient catheter 300 having a heater 300a, and the method includes operating the heater 300a.

[0647] In some configurations, the patient interface includes a ventilator in fluid communication with a gas inlet, and the method includes allowing water vapor to pass through the wall of the ventilator, but preventing liquid water and large amounts of gas from flowing through the wall of the ventilator.

[0648] The respiratory therapy system 1000, patient interface 1, and nasal interface 100 used in this method may have any of the features and functions described herein.

[0649] Figure 18 illustrates an exemplary type of conduit or tubing 300 that can be used to deliver gas to a nasal interface 100. A conduit or tubing 300 characterized by a smooth orifice 302 or a non-corrugated orifice is shown. This type of conduit is best described and illustrated in U.S. Patent Application Publication No. 2014 / 0202462 (also published as PCT Publication No. WO2012 / 164407A1) and PCT Publication No. WO2014 / 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 from a beaded rim 304 and small tubes or bubbles 306. Typically, the surface roughness of such a conduit has peak and valley values ​​on the order of 0.15-0.25 mm. In one configuration, the conduit or tubing has an inner bore diameter of 13-14 mm. These two components 304 and 306 combine to define a conduit or tube with a lumen having minimal surface deviation. In some configurations, the beaded rim 304 contains multiple wires 308. One or more of these wires may be used to heat the walls of the conduit without needing to be positioned within the flow carried by the conduit or tube 300. In the configuration shown, the beaded rim 304 contains four wires 308. In some configurations, the beaded rim 304 may contain two wires 308. Other numbers of wires may also be used.

[0650] Figure 19 illustrates an alternative exemplary type of conduit or tubing 320 that can be used to deliver gas to the nasal interface 100. Referring to Figure 20, the conduit or tubing 320 shown is a corrugated conduit. In one configuration, the conduit or tubing 320 has an inner bore diameter of 20-21 mm. The corrugated conduit 320 includes deep grooves 322 along the wall 324 of the conduit 320. In many cases, the grooves 322 result in one or more helical barriers extending along the length of the lumen defined by the wall 324. Thus, the inner surface of the conduit or tubing is significantly rougher than the smooth-hole conduit 300 shown in Figure 18. Typically, the surface roughness peaks and valleys of the corrugated conduit or tubing are on the order of 1.5-2.5 mm. In the configuration shown in Figure 19, one or more heating wires 326 may also be coiled and positioned to directly contact the gas flow through the lumen. When the heating wire is positioned within the gas flow path, the heating wire gains an additional 2 to 3 mm of "surface roughness," although this is only an estimate of the effect of the heating wire positioned within the gas flow path.

[0651] Compared to using a more conventional heated breathing tube 320, as shown in Figure 19, the use of a smooth-hole heated tube 300, as shown in Figure 18, for transporting medicine from the aforementioned nebulizer 2128 yields a significant increase in medicine transport efficiency. This efficiency improvement is attributed to a substantial reduction in the amount of atomized medicine trapped 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 atomized medicine trapped by these surfaces is 300% greater than that retained within, for example, the smooth-hole heated breathing tube 300 shown in Figure 18, for example, but not in a limiting sense. It is believed that the deposition process (e.g., impaction) is reduced due to fewer vortices in the flow and fewer obstacles representing effective roughness.

[0652] In some configurations, a decrease in delivery efficiency was observed when the flow rate exceeded the optimal flow rate. In other words, at some high flow rates above 30 lpm, the flow rate was somewhat inversely proportional to the nebulization efficiency (i.e., higher flow rates resulted in more drug being trapped in the circuit rather than being delivered to the patient).

[0653] By using a nasal cannula 100 with asymmetrical nose forks 111, 112, it is possible to reduce the flow rate required for the same dead space clearance, which can improve the delivery of respiratory therapy using nebulized medications. Nebulized medications may be less likely to "eject," with some of the medication deposited on the inner surface of the flow path instead of being delivered to the patient, or suffer other losses due to the smoother flow transition impacting the surface. With the partially unidirectional flow provided by the nasal interface 100, less medication is wasted when the patient exhales retrogradely compared to other cases. Other aspects of the nasal cannula 100 with asymmetrical nose forks 111, 112 (including the cross-sectional area of ​​the forks and the relationship between those cross-sectional areas) can improve the delivery of respiratory therapy using nebulized medications.

[0654] The patient interface 1 and nasal interface 100 used in the respiratory therapy system 2000 may have any one or more features and / or functions described herein with respect to nasal interfaces 100, 100', 100"

[0655] The respiratory therapy system 2000 may have one or more features and / or functions of the system described in PCT Publication No. WO 2016 / 085354 or U.S. Patent Application Publication No. 2017 / 0312472. The contents of those specifications are incorporated herein by reference in their entirety.

[0656] Alternatively or additionally, the respiratory therapy system 2000 may have any one or more features and / or functions of the system described with respect to the respiratory therapy system 1000.

[0657] The nasal interfaces 100, 100', 100” described herein can be used in healthcare facilities, home environments, emergency vehicles, or any other suitable environment. Therefore, the reference to “patient” herein should be interpreted as any suitable object using the nasal interface.

[0658] Although this disclosure has been described with respect to certain embodiments, other embodiments that are apparent to those skilled in the art are also within the scope of this disclosure. Therefore, various changes and modifications can be made without departing from the spirit and scope of this disclosure. For example, the components may be repositioned as needed. Features from any of the described embodiments may be combined with each other, and / or the device may include one, more, or all of the features of the described embodiments. Furthermore, not all such features, aspects, and advantages are essential to practicing this disclosure. Therefore, the scope of this disclosure is intended to be defined only by the appended claims. [Simplified Explanation of the Diagram]

[0291] Specific embodiments and modifications thereof will become clear to those skilled in the art by referring to the following figures, in accordance with the detailed description herein, in which:

[0292] [Figure 1A] is a left front perspective view of an exemplary configuration of a patient interface of the present disclosure, the patient interface including a nasal interface with an asymmetric nasal delivery element.

[0293] [Figure 1B] is a right anterior stereoscopic view of the patient interface.

[0294] [Figure 1C] is a left anterior exploded stereoscopic view of the patient interface.

[0295] [Figure 2] shows the nose interface, wherein Figure 2(a) is a top view, Figure 2(b) is a front view, and Figure 2(c) is a bottom view.

[0296] [Figure 3] is a schematic diagram of the nose interface before the content of this disclosure is inserted into the user's nostril.

[0297] [Fig. 4A] is a rear view of the small nose interface of the disclosed content.

[0298] [Fig. 4B] is a rear view of the medium-sized nose interface of the disclosed content.

[0299] [Fig. 4C] is a rear view of the large nose interface of the disclosed content.

[0300] [Figure 5] is a rear view of the small, medium, and large nose interfaces superimposed on each other.

[0301] [Figure 6] shows the results of the desktop test of the nasal interface, wherein Figures 6(a), 6(b) and 6(c) show the dead space clearance of the larger upper airway at 25, 35 and 45 breaths per minute, respectively, and Figures 6(d) and 6(e) show the dead space clearance of the smaller upper airway at 15 and 25 breaths per minute, respectively, where I:E is the ratio of inspiratory time to expiratory time.

[0302] [Figure 7] shows the test results of the nasal interface, wherein Figure 7(a) shows the results of the Optiflow™+ OPT944+ nasal interface from Fisher & Paykel Healthcare Limited, Figure 7(b) shows the results of the nasal interface of this disclosure, and Figure 7(c) shows the comparison results.

[0303] [Figure 8] illustrates exemplary septum spacing and nose fork height for (a) small nose interface, (b) medium nose interface, and (c) large nose interface of this disclosure.

[0304] [Figure 9] shows an exemplary gas manifold for use in a small nose interface, wherein Figure 9(a) shows a top view and Figure 9(b) shows a front cross-sectional view obtained along line bb of Figure 9(a).

[0305] [Figure 10] shows an exemplary gas manifold for use in a medium or large nose interface, wherein Figure 10(a) shows a top view and Figure 10(b) shows a front cross-sectional view obtained along line bb of Figure 10(a).

[0306] [Figure 11] shows the effect of the orientation of the fork relative to the gas inlet on the nose interface of this disclosure.

[0307] [Fig. 12] shows possible configurations of the gas manifold relative to the cannula body, wherein Fig. 12(a) shows a first insertion direction of the gas manifold into the cannula body, and Fig. 12(b) shows the gas manifold connected to the cannula body in a first configuration, wherein Fig. 12(c) shows a second insertion direction of the gas manifold into the cannula body, and Fig. 12(d) shows the gas manifold connected to the cannula body in a second configuration.

[0308] [Figure 13] shows details of the fork geometry of the exit of the nose fork of the nose interface of this disclosure.

[0309] [Fig. 14] shows details of the termination end of the nose interface of the present disclosure, wherein Fig. 14(a) shows a left cross-sectional view of the nose interface showing an exemplary geometry of the outlet of the large nose fork, Fig. 14(b) shows a right cross-sectional view of the nose interface showing an exemplary geometry of the outlet of the small nose fork, and Fig. 14(c) shows a comparison of the outlet geometry.

[0310] [Figure 15] shows a respiratory therapy system that combines a patient interface and a nasal interface with the contents of this disclosure.

[0311] [Figure 16] shows the control loop of the respiratory therapy system for closed-loop control of blood oxygen saturation (SpO2).

[0312] [Figure 17] illustrates an alternative breathing therapy system that combines a patient interface and a nasal interface with the contents of this disclosure.

[0313] [Figure 18] shows a cross-sectional view of a patient catheter that can be used in a respiratory therapy system and / or used with the nasal interface of this disclosure.

[0314] [Figure 19] shows a cross-sectional view of an alternative patient catheter that can be used in a respiratory therapy system and / or used in conjunction with the nasal interface of this disclosure.

[0315] [Figure 20] shows the test results of the nasal interface, wherein Figure 20(a) shows how the nasal interface of the present disclosure can be used to achieve an increased obstruction area while still maintaining safe clearance in one nostril, Figure 20(b) shows test data showing increased positive end-expiratory pressure (PEEP) and reduced rebreathing when using the nasal interface of the present disclosure with an asymmetric fork at a nasal high flow rate of 30 liters / minute compared to a nasal interface with a symmetric fork, and Figure 20(c) shows test data similar to Figure 20(b) but for a nasal high flow rate of 60 liters / minute.

[0316] [Figure 21] shows the maximum airway pressure achievable for each size of nasal interface in this disclosure when one nostril of a patient is completely blocked by a larger fork.

[0317] [Figures 22A and 22B] are schematic cross-sectional views of an exemplary configuration of a single-walled, breathable patient catheter.

Claims

1. A nasal interface, comprising: The first and second forks are asymmetrical; And a gas manifold including 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 asymmetrical gas flow at the patient's nostrils, and wherein the nasal interface is configured such that at least about 60% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nasal interface through the first fork.

2. The nose interface as described in claim 1, wherein, The nose interface is configured such that when the total volumetric flow rate of the gas flow into the gas inlet is between about 5 liters per minute (lpm) and about 70 liters per minute (lpm), about 60% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork.

3. The nose interface as described in claim 1 or 2, comprising: The gas flow path from the gas inlet to the first fork and the second fork, wherein the cross-sectional area of ​​the first fork in the direction transverse to the gas flow through the first fork is larger than the corresponding cross-sectional area of ​​the second fork, and wherein the first fork is downstream of the gas flow path of the second fork.

4. The nose interface as described in 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.

5. The nose interface as described in claim 3, wherein the inner cross-sectional area is at the exit of the first fork and the second fork.

6. The nasal interface as described in claim 1, wherein the nasal interface includes a cannula body, the cannula body including the first fork and the second fork.

7. The nasal interface as described in claim 6, wherein the gas manifold is integral with the cannula body or separate from and connectable to the cannula body.

8. The nose interface as claimed in claim 7, wherein the nose interface includes a face mount, and wherein the first fork and the second fork include a pair of asymmetrical tubular nose forks integrally molded with or removably attached to the face mount.

9. The nasal interface as claimed in claim 8, wherein the face mount includes at least one substantially horizontal lateral access passage leading to the interior of the base portion of the face mount or the cannula body to releasably receive the outlet of the gas manifold through it.

10. The nasal interface as claimed in claim 9, wherein the face mount includes a pair of opposing side access passages leading to the interior of the base portion or cannula body, each side access passage being adapted to releasably receive the outlet of the gas manifold through it.

11. The nose interface as claimed in claim 8, wherein the gas manifold can be inserted into the face mount, or wherein the gas manifold can be inserted into the face mount from one of two opposite horizontal directions.

12. The nasal interface as claimed in claim 8, wherein the gas manifold is formed of a material that is harder than the face mount, and the face mount provides a flexible docking component for the patient, wherein the gas manifold fluidly connects the conduit to the nose forks of the face mount.

13. The nasal interface as described in claim 1 or 2, wherein the first fork and the second fork are configured to engage with the patient's nasal passage in a non-sealing manner, and / or wherein the first fork and the second fork allow exhaled air to escape into the vicinity of the first fork and the second fork; and / or wherein the first fork and the second fork are configured to deliver air to the patient without interfering with the patient's spontaneous breathing.

14. The nasal interface as claimed in claim 1 or 2, wherein the first fork and the second fork bend 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 fork and the second fork have a noise-reducing profile; and / or the bases of the first fork and the second fork include curved surfaces to provide smoother gas flow; and / or the first fork and the second fork are substantially hollow and substantially tubular in shape; and / or the diameters of the first fork and the second fork are consistent along their length, or alternatively shaped to conform to the profile of the patient's nostrils; and / or a face mount or the face mount is shaped to generally follow the profile of the patient's face around the upper lip region; and / or a face mount or the face mount is molded or pre-formed to conform to the profile of the patient's face in the area of ​​the face in which the nasal interface is positioned and / or is flexible to adapt to, accommodate and / or correspond to the profile of the patient's face in that area.

15. The nose interface as described in 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.

16. The nose interface as described in claim 3, wherein the gas flow path is defined by a flow channel, the gas flow direction of which is substantially perpendicular to the gas flow path passing through the first fork and the second fork, and wherein, The first fork is further away from the gas inlet, while the second fork is closer to the gas inlet.

17. The nasal interface as claimed in claim 16, wherein the nasal interface includes a cannula body including the first fork and the second fork, wherein the gas manifold is integral with or separate from and connectable to the cannula body, wherein a first section of the flow passage in the gas manifold has a large first vertical dimension, the opposite end of the flow passage forms a flow cavity in the cannula body, the flow cavity delivering gas to the first fork and the second fork, wherein when the gas manifold is in place in the cannula body, the flow cavity is in fluid communication with a flow passage through the first fork and the second fork, and wherein at least a portion of the flow cavity has a vertical dimension smaller than the first vertical dimension.

18. The nose interface as claimed in claim 17, wherein the gas manifold includes one or more internal angled walls to provide a size reduction from the first vertical dimension to a vertical dimension smaller than the first vertical dimension, and to guide gas flow into the first fork and / or the second fork.

19. The nose interface as claimed in claim 16, wherein the gas manifold of the nose 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 and second forks.

20. A nose interface as claimed in claim 1 or 2, wherein the nose interface is configured such that about 65% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; or such that about 70% to about 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; or such that about 70% to about 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered out of the nose interface through the first fork; or such that... Approximately 70% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork and exits the nose interface; or approximately 75% to approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork and exits the nose interface; or approximately 75% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork and exits the nose interface; or approximately 80% of the total volumetric flow rate of the gas flow into the gas inlet is delivered through the first fork and exits the nose interface.

21. A nasal interface, comprising: First fork and second fork; And a gas manifold including a gas inlet, wherein the first branch and the second branch are in fluid communication with the gas inlet, wherein the nasal interface is configured to achieve asymmetrical gas flow at the patient's nostrils, wherein the gas inlet is in fluid communication with a ventilator, and wherein the ventilator is configured to allow water vapor to pass through one wall of the ventilator, but prevent liquid water and a large amount of gas from flowing through the wall of the ventilator.

22. A nasal interface, comprising: Gas inlet; The first and second forks are asymmetrical; And a gas flow path from the gas inlet to the first fork and the second fork, wherein the inner cross-sectional area of ​​the first fork in the direction transverse to the gas flow through the first fork is larger than the corresponding inner cross-sectional area of ​​the second fork, and wherein the first fork is downstream of the gas flow path of the second fork.

23. A nasal interface, comprising: The cannula body includes a first fork and a second fork that are asymmetrical to each other; The nasal interface further includes a gas manifold including a gas inlet, wherein the first fork and the second fork are in fluid communication with the gas inlet, and the nasal interface further includes two side arms, each side arm including a wing portion extending laterally from both sides of the cannula body, and the nasal interface includes or is provided in conjunction with a tube holding clamp configured to support the patient catheter from a portion of the cannula body, side arms, or wing portions of the nasal interface.

24. A nasal interface, comprising: The first and second forks are asymmetrical; The gas manifold includes 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 asymmetrical gas flow at the patient's nostrils, wherein the inner cross-sectional area of ​​the first fork is between about 15 mm² and about 80 mm², wherein the inner cross-sectional area of ​​the second fork is between about 5 mm² and about 50 mm², wherein the combined inner cross-sectional area of ​​the first fork and the second fork is between about 20 mm² and about 130 mm², and 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.

25. A respiratory therapy system, comprising: A respiratory therapy device comprising: a controller; a blood oxygen saturation sensor; an ambient air inlet; an oxygen inlet; a valve in fluid communication with the oxygen inlet to control the flow rate of oxygen through the oxygen inlet; and a gas outlet; wherein the controller is configured to control the valve based on at least one oxygen saturation measurement from the blood oxygen saturation sensor; and a patient interface including a nasal interface as described in claim 1, wherein the gas outlet is in fluid communication with the gas inlet of the gas manifold, and wherein the nasal interface is configured to achieve asymmetrical gas flow at the patient's nostrils.

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