Patient interface

The nasal interface with asymmetrical nozzles addresses high flow resistance and static pressure issues in nasal delivery devices by optimizing gas distribution and reducing motor speed, enhancing comfort and efficiency in respiratory therapy.

DE202022003343U1Active Publication Date: 2026-04-09FISHER & PAYKEL HEALTHCARE LTD
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Patent Information

Authority / Receiving Office
DE · DE
Patent Type
Utility models
Current Assignee / Owner
Filing Date
2022-04-29
Publication Date
2026-04-09

AI Technical Summary

Technical Problem

Existing nasal delivery devices for respiratory therapy face challenges such as high flow resistance, excessive flow rates, and inadequate dead space clearance, particularly in children and infants, leading to undesirably high static pressures and discomfort.

Method used

A nasal interface with asymmetrical nasal delivery elements, featuring two nozzles of different sizes and configurations, allows for optimized gas distribution, reducing flow resistance and peak expiratory pressure, and enhancing dead space clearance.

Benefits of technology

The asymmetrical design reduces the risk of airway obstruction, lowers motor speed requirements, and improves patient comfort by achieving desired flow rates with lower back pressure and noise, while maintaining efficient gas delivery.

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Abstract

Nasal interface, comprehensive: a gas inlet; a first spigot and a second spigot, which are asymmetrical to each other; and a gas flow path from the gas inlet to the first nozzle and the second nozzle, wherein the first nozzle has a larger external cross-sectional area in a direction perpendicular to the gas flow through the first nozzle than a corresponding external cross-sectional area of ​​the second nozzle, wherein the nasal interface is configured to cause an asymmetrical gas flow at the nostrils of a patient, and where the first nozzle forms a smaller leakage area with one of the patient's nostrils than the second nozzle with another of the patient's nostrils.
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Description

TECHNICAL AREA

[0001] The present invention generally relates to a patient interface for delivering respiratory gases to the airways of a patient. BACKGROUND

[0002] Humidifiers are used to deliver humidified breathing gases to a patient. Gases are delivered to the patient via a patient interface. Examples of patient interfaces include an oropharyngeal mask, a nasal mask, a nasal cannula, a combination of an oropharyngeal mask and the like.

[0003] Patient interfaces, including nasal interfaces, can be used to deliver a high flow of gases to a patient. Nasal delivery devices are inserted into a patient's nose to deliver the required therapy. To deliver the therapy, the nasal delivery devices may need to seal, partially seal, or not seal the nose at all. High-flow therapy is typically non-sealing, delivering a relatively high-volume flow to the patient via a nasal interface, which may be sufficient to match or exceed the patient's inspiratory flow rate. SUMMARY

[0004] Although prior art exists for nasal incision nozzles, at least one aspect of the configurations disclosed here acknowledges that there are problems with inserting some prior art nozzles into a patient's nose. Prior art nozzles require high motor speeds of the flow-generating device to deliver the desired flow velocity to the patient. A flow-generating device is a device that delivers a gas flow to a patient.

[0005] If the interface is suddenly closed, the static pressure can increase against the back pressure in the system, potentially reaching undesirable levels. This undesirably high static pressure is exacerbated in mouthpieces for children and infants, as the reduced mouthpiece diameter required to fit a child's or infant's nostrils can increase flow resistance through the interface to the patient.

[0006] Currently, there are few nasal delivery elements of varying sizes that can be better fitted to a patient, and optimizing dead space clearance and delivered pressure can be challenging. Some options may require supplemental oxygen, more warming and water, and may not provide optimal patient comfort. Patients may experience undesirably high or excessively high flow rates to achieve the desired pressure effects with the available interfaces. A nasal delivery element with a smaller diameter nasal interface may exhibit high leakage and consequently deliver lower pressure to the patient. A larger diameter may not be as efficient at removing anatomical dead space from the patient's airway.

[0007] A nasal interface and respiratory therapy system is disclosed that utilizes nasal high-flow in combination with asymmetric nasal delivery elements to deliver respiratory gases to a patient via an asymmetric flow. Asymmetric nasal delivery elements can provide the patient with greater dead space clearance in the upper airways. Due to a reduction in peak expiratory pressure, noise can be reduced, and asymmetric nasal delivery elements may be a more desirable therapy for use in infants because they reduce the risk of complete airway obstruction. The asymmetry of the nasal delivery elements can reduce flow resistance through the nasal interface, thereby enabling the desired flow rates to be achieved with lower back pressure and / or lower motor speeds of the flow-generating device.A nasal incision with asymmetrical nasal delivery elements can reduce the risk of both of a patient's nostrils being completely closed due to a nasal incision of the wrong size.

[0008] In one aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein is disclosed as a nose interface, wherein the nose interface comprises the following: a first nozzle and a second nozzle, which are asymmetrical to each other, and a gas distributor which includes a gas inlet, wherein the first nozzle and the second nozzle are in fluid communication with the gas inlet, and wherein the nose interface is configured such that that at least approximately 60% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0009] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0010] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0011] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0012] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0013] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0014] In some configurations, the first and second ports are configured to provide gas to a patient without interfering with the patient's spontaneous breathing.

[0015] In some configurations, the first nozzle has a larger inner diameter and / or cross-sectional area in a direction perpendicular to the gas flow through the first nozzle than a corresponding inner diameter and / or cross-sectional area of ​​the second nozzle in a direction perpendicular to the gas flow through the second nozzle.

[0016] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle.

[0017] In some configurations, the inner diameters and / or inner cross-sectional areas are located at the outlets of the first and second nozzles.

[0018] In some configurations, the nose interface is configured such that between approximately 60% and approximately 90% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0019] In some configurations, the nose interface is configured such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0020] In some configurations, the nose interface is configured such that between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0021] In some configurations, the nose interface is configured such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0022] In some configurations, the nose interface is configured such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0023] In such configurations, the nose interface is configured so that approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0024] In some configurations, the nose interface is configured such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0025] In such configurations, the nose interface is configured so that approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0026] In such configurations, the nose interface is configured so that approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0027] In some configurations, the first nozzle has an inner diameter of between approximately 4 mm and approximately 10 mm, optionally between approximately 5 mm and approximately 9 mm, optionally between approximately 6 mm and approximately 8 mm, optionally approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm or any diameter between any two of these diameters.

[0028] In some configurations, the second nozzle has an inner diameter of between approximately 2 mm and approximately 8 mm, optionally between approximately 3 mm and approximately 7 mm, optionally between approximately 4 mm and approximately 6 mm, optionally approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm or any diameter between any two of these diameters.

[0029] In some configurations, the first nozzle and / or the second nozzle have a wall thickness between approximately 0.1 mm and approximately 0.5 mm.

[0030] In some configurations, the first nozzle has an internal cross-sectional area of ​​approximately 15 mm². 2 and about 80 mm 2 , optionally between approximately 20 mm 2 and about 75 mm 2 , optionally between approximately 25 mm 2 and about 70 mm 2 , optionally between approximately 30 mm 2 and about 65 mm 2 , optionally between approximately 35 mm 2 and about 60 mm 2 , optionally between approximately 40 mm 2 and about 55 mm 2 , optionally between approximately 45 mm 2 and about 50 mm 2 , optionally about 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 , approximately 51 mm 2 , approximately 52 mm 2 , approximately 53 mm 2 , approximately 54 mm 2 , approximately 55 mm 2 , approximately 56 mm 2 , approximately 57 mm 2 , approximately 58 mm 2 , approximately 59 mm 2 , approximately 60 mm 2 , approximately 61 mm 2 , approximately 62 mm 2 , approximately 63 mm 2 , approximately 64 mm 2 , approximately 65 mm 2 , approximately 66 mm 2 , approximately 67 mm 2 , approximately 68 mm 2 , approximately 69 mm 2 , approximately 70 mm 2 , approximately 71 mm2 , approximately 72 mm 2 , approximately 73 mm 2 , approximately 74 mm 2 , approximately 75 mm 2 , approximately 76 mm 2 , approximately 77 mm 2 , approximately 78 mm 2 , approximately 79 mm 2 , approximately 80 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0031] In some configurations, the second nozzle has an internal cross-sectional area of ​​approximately 5 mm². 2 and about 50 mm 2 , optionally between approximately 10 mm 2 and about 45 mm 2 , optionally between approximately 15 mm 2 and about 40 mm 2 , optionally between approximately 20 mm 2 and about 35 mm 2 , optionally between approximately 25 mm 2 and about 30 mm 2 , optionally about 5 mm 2 , approximately 6 mm 2 , approximately 7 mm 2 , approximately 8 mm 2 , approximately 9 mm 2 , approximately 10 mm 2 , approximately 11 mm 2 , approximately 12 mm 2, approximately 13 mm 2 , approximately 14 mm 2 , approximately 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2or any cross-sectional area between any two of these cross-sectional areas.

[0032] In some configurations, the combined internal cross-sectional area of ​​the first and second nozzles is approximately 20 mm². 2 and about 130 mm 2 , optionally between approximately 30 mm 2 and about 120 mm 2 , optionally between approximately 40 mm 2 and approximately 110 mm 2 , optionally between approximately 50 mm 2 and about 100 mm 2 , optionally between approximately 60 mm 2 and about 90 mm 2 , optionally between approximately 70 mm 2 and about 80 mm 2 , optionally about 20 mm 2 , approximately 25 mm 2 , approximately 30 mm 2 , approximately 35 mm 2 , approximately 40 mm 2 , approximately 45 mm 2 , approximately 50 mm 2 , approximately 55 mm 2 , approximately 60 mm 2 , approximately 65 mm 2 , approximately 70 mm 2 , approximately 75 mm 2 , approximately 80 mm 2, approximately 85 mm 2 , approximately 90 mm 2 , approximately 95 mm 2 , approximately 100 mm 2 , approximately 105 mm 2 , approximately 110 mm 2 , approximately 115 mm 2 , approximately 120 mm 2 , approximately 125 mm 2 , approximately 130 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0033] In some configurations, the ratio of the internal cross-sectional area of ​​the first nozzle to the internal cross-sectional area of ​​the second nozzle is between approximately 60:40 and approximately 80:20; optionally between approximately 65:35 and approximately 80:20; optionally between approximately 70:30 and approximately 80:20; optionally between approximately 70:30 and approximately 75:25; optionally approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26 or approximately 75:25; optionally between approximately 75:25 and 80:20; optionally approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79:21 or approximately 80:20.

[0034] In some configurations, the gap between adjacent outer surfaces of the first and second nozzles adjacent to a base of the first and second nozzles is between approximately 5 mm and approximately 15 mm, optionally between approximately 6 mm and approximately 14 mm, between approximately 7 mm and approximately 13 mm, optionally between approximately 8 mm and approximately 12 mm, optionally between approximately 9 mm and approximately 11 mm, optionally approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, approximately 11 mm, approximately 12 mm, approximately 13 mm, approximately 14 mm, approximately 15 mm, or any value between two of these values.

[0035] In some configurations, the gas inlet is in fluid communication with a breathing tube.

[0036] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0037] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, with the gas distributor being reconfigurable relative to the cannula body between a first configuration and a second configuration, where the first configuration refers to the gas distributor being inserted into the cannula body from a first side of the cannula body, so that the second nozzle is further proximal to the gas inlet and the first nozzle is further distal to the gas inlet, and the second configuration refers to the gas distributor being inserted into the cannula body from a second side of the cannula body, so that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0038] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a first spigot and a second spigot that are asymmetrical to each other, and a gas distributor comprising a gas inlet, wherein the first nozzle and the second nozzle are in fluid communication with the gas inlet, wherein the nasal interface is configured to cause an asymmetric gas flow at the nostrils of a patient, and wherein the nasal interface is configured such that that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet are discharged through the first nozzle from the nose interface when the total volumetric flow rate of the gases into the gas inlet is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0039] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0040] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0041] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0042] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0043] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0044] In some configurations, the first and second ports are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0045] In some configurations, the nose interface is configured such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged through the first nozzle from the nose interface when the total volumetric flow rate of the gases entering the gas inlet is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0046] In some configurations, the nose interface is configured such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases entering the gas inlet is discharged through the first nozzle from the nose interface when the total volumetric flow rate of the gases entering the gas inlet is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0047] In some configurations, the nose interface is configured such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged through the first nozzle from the nose interface when the total volumetric flow rate of the gases entering the gas inlet is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0048] In some configurations, the nose interface is configured such that approximately 70% of the total volumetric flow rate of the gases entering the gas inlet is discharged through the first nozzle from the nose interface when the total volumetric flow rate of the gases entering the gas inlet is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0049] In some configurations, the nose interface is configured such that the degree of flow asymmetry from the first and second nozzles is a function of the total flow rate of the gases flowing into the gas inlet.

[0050] In some configurations, the nose interface is configured such that a higher overall flow rate of the gases flowing into the gas inlet results in a larger proportion of the total volumetric flow rate of the gases being discharged through the first nozzle from the nose interface, and a lower overall flow rate of the gases flowing into the gas inlet results in a smaller proportion of the total volumetric flow rate of the gases being discharged through the first nozzle from the nose interface.

[0051] In some configurations, the gas inlet is in fluid communication with a breathing tube.

[0052] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0053] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, with the gas distributor being reconfigurable relative to the cannula body between a first configuration and a second configuration, where the first configuration refers to the gas distributor being inserted into the cannula body from a first side of the cannula body, so that the second nozzle is further proximal to the gas inlet and the first nozzle is further distal to the gas inlet, and the second configuration refers to the gas distributor being inserted into the cannula body from a second side of the cannula body, so that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0054] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a gas inlet, a first spigot and a second spigot that are asymmetrical to each other, and a gas distributor that includes a gas inlet, where the first nozzle and the second nozzle are in fluid contact with the gas inlet, wherein the first nozzle has a larger inner diameter and / or a larger inner cross-sectional area in a direction transverse to the gas flow through the first nozzle than a corresponding inner diameter and / or a corresponding inner cross-sectional area of ​​the second nozzle in a direction transverse to the gas flow through the second nozzle.

[0055] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0056] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle.

[0057] In some configurations, the inner diameters and / or inner cross-sectional areas are located at the outlets of the first and second nozzles.

[0058] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0059] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0060] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0061] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0062] In some configurations, the first nozzle has an inner diameter of between approximately 4 mm and approximately 10 mm, optionally between approximately 5 mm and approximately 9 mm, optionally between approximately 6 mm and approximately 8 mm, optionally approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm or any diameter between two of these values.

[0063] In some configurations, the second nozzle has an inner diameter of between approximately 2 mm and approximately 8 mm, optionally between approximately 3 mm and approximately 7 mm, optionally between approximately 4 mm and approximately 6 mm, optionally approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm or any diameter between two of these values.

[0064] In some configurations, the first nozzle has an internal cross-sectional area of ​​approximately 15 mm². 2 and about 80 mm 2 , optionally between approximately 20 mm 2 and about 75 mm 2 , optionally between approximately 25 mm 2 and about 70 mm 2 , optionally between approximately 30 mm 2 and about 65 mm 2 , optionally between approximately 35 mm 2 and about 60 mm 2 , optionally between approximately 40 mm 2 and about 55 mm 2 , optionally between approximately 45 mm 2 and about 50 mm 2 , optionally about 15 mm 2 , approximately 16 mm2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 , approximately 51 mm 2 , approximately 52 mm 2 , approximately 53 mm 2 , approximately 54 mm 2 , approximately 55 mm 2 , approximately 56 mm2 , approximately 57 mm 2 , approximately 58 mm 2 , approximately 59 mm 2 , approximately 60 mm 2 , approximately 61 mm 2 , approximately 62 mm 2 , approximately 63 mm 2 , approximately 64 mm 2 , approximately 65 mm 2 , approximately 66 mm 2 , approximately 67 mm 2 , approximately 68 mm 2 , approximately 69 mm 2 , approximately 70 mm 2 , approximately 71 mm 2 , approximately 72 mm 2 , approximately 73 mm 2 , approximately 74 mm 2 , approximately 75 mm 2 , approximately 76 mm 2 , approximately 77 mm 2 , approximately 78 mm 2 , approximately 79 mm 2 , approximately 80 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0065] In some configurations, the second nozzle has an internal cross-sectional area of ​​approximately 5 mm². 2 and about 50 mm 2 , optionally between approximately 10 mm 2 and about 45 mm 2 , optionally between approximately 15 mm 2and about 40 mm 2 , optionally between approximately 20 mm 2 and about 35 mm 2 , optionally between approximately 25 mm 2 and about 30 mm 2 , optionally about 5 mm 2 , approximately 6 mm 2 , approximately 7 mm 2 , approximately 8 mm 2 , approximately 9 mm 2 , approximately 10 mm 2 , approximately 11 mm 2 , approximately 12 mm 2 , approximately 13 mm 2 , approximately 14 mm 2 , approximately 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2, approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0066] In some configurations, the combined internal cross-sectional area of ​​the first and second nozzles is approximately 20 mm². 2 and about 130 mm 2 , optionally between approximately 30 mm 2 and about 120 mm 2 , optionally between approximately 40 mm 2 and approximately 110 mm 2 , optionally between approximately 50 mm 2 and about 100 mm 2 , optionally between approximately 60 mm 2 and about 90 mm 2 , optionally between approximately 70 mm 2 and about 80 mm 2, optionally about 20 mm 2 , approximately 25 mm 2 , approximately 30 mm 2 , approximately 35 mm 2 , approximately 40 mm 2 , approximately 45 mm 2 , approximately 50 mm 2 , approximately 55 mm 2 , approximately 60 mm 2 , approximately 65 mm 2 , approximately 70 mm 2 , approximately 75 mm 2 , approximately 80 mm 2 , approximately 85 mm 2 , approximately 90 mm 2 , approximately 95 mm 2 , approximately 100 mm 2 , approximately 105 mm 2 , approximately 110 mm 2 , approximately 115 mm 2 , approximately 120 mm 2 , approximately 125 mm 2 , approximately 130 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0067] In some configurations, the ratio of the internal cross-sectional area of ​​the first nozzle to the internal cross-sectional area of ​​the second nozzle is between approximately 60:40 and approximately 80:20; optionally between approximately 65:35 and approximately 80:20; optionally between approximately 70:30 and approximately 80:20; optionally between approximately 70:30 and approximately 75:25; optionally approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26 or approximately 75:25; optionally between approximately 75:25 and 80:20; optionally approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79:21 or approximately 80:20.

[0068] In some configurations, the gap between adjacent outer surfaces of the first and second nozzles adjacent to a base of the first and second nozzles is between approximately 5 mm and approximately 15 mm, optionally between approximately 6 mm and approximately 14 mm, between approximately 7 mm and approximately 13 mm, optionally between approximately 8 mm and approximately 12 mm, optionally between approximately 9 mm and approximately 11 mm, optionally approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, approximately 11 mm, approximately 12 mm, approximately 13 mm, approximately 14 mm, approximately 15 mm, or any value between two of these values.

[0069] In some configurations, the nose interface is configured such that at least approximately 60% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 60% and approximately 90% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases entering the gas inletfrom the nose interface through the first nozzle, optionally such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet,delivered from the nasal incision through the first nozzle.

[0070] In some configurations, the gas inlet is in fluid communication with a breathing tube.

[0071] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0072] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, with the gas distributor being reconfigurable relative to the cannula body between a first configuration and a second configuration, where the first configuration refers to the gas distributor being inserted into the cannula body from a first side of the cannula body, so that the second nozzle is further proximal to the gas inlet and the first nozzle is further distal to the gas inlet, and the second configuration refers to the gas distributor being inserted into the cannula body from a second side of the cannula body, so that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0073] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a first spigot and a second spigot that are asymmetrical to each other, and a gas distributor comprising a gas inlet, wherein the first nozzle and the second nozzle are in fluid communication with the gas inlet, wherein the first nozzle has a larger internal cross-sectional area in a direction transverse to the gas flow through the first nozzle than a corresponding internal cross-sectional area of ​​the second nozzle in a direction transverse to the gas flow through the second nozzle, wherein the second nozzle has a substantially oval or substantially elliptical cross-sectional shape in the direction transverse to the gas flow through the second nozzle, wherein the substantially oval or substantially elliptical cross-sectional shape has a first ratio of a widest dimension to a narrowest dimension, and wherein the first nozzle has a less oval or less elliptical cross-sectional shape in the direction transverse to the gas flow through the first nozzle, wherein the less oval or less elliptical cross-sectional shape either has a second ratio of a widest dimension to a narrowest dimension that is smaller than the first ratio, or has a substantially circular cross-sectional shape.

[0074] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0075] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0076] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0077] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0078] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0079] In some configurations, the first and second ports are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0080] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle.

[0081] In some configurations, the internal cross-sectional areas and internal cross-sectional shapes of the first and second nozzles are located at the outlets of the first and second nozzles.

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

[0083] In some configurations, the first nozzle has an essentially circular shape.

[0084] In some configurations, the first nozzle has a first connection end and the second nozzle has a second connection end, the first connection end comprising a substantially corrugated surface.

[0085] In some configurations, the second terminal end has an essentially flat surface.

[0086] In some configurations, the gas inlet is in fluid communication with a breathing tube.

[0087] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0088] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, with the gas distributor being reconfigurable relative to the cannula body between a first configuration and a second configuration, where the first configuration refers to the gas distributor being inserted into the cannula body from a first side of the cannula body, so that the second nozzle is further proximal to the gas inlet and the first nozzle is further distal to the gas inlet, and the second configuration refers to the gas distributor being inserted into the cannula body from a second side of the cannula body, so that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0089] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a gas inlet, a first spigot and a second spigot that are asymmetrical to each other, and a gas flow path from the gas inlet to the first and second nozzles, wherein the first nozzle has a larger internal cross-sectional area in a direction transverse to the gas flow through the first nozzle than a corresponding internal cross-sectional area of ​​the second nozzle, and wherein the first nozzle is located downstream of the second nozzle in the gas flow path.

[0090] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0091] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle.

[0092] In some configurations, the inner cross-sectional areas are located at the outlets of the first and second nozzles.

[0093] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0094] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0095] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0096] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0097] In some configurations, the first and second ports are configured to provide 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 that has a gas flow direction that is essentially perpendicular to the gas flow paths through the first nozzle and the second nozzle, with the first nozzle being located further distal to the gas inlet and the second nozzle being located further proximal to the gas inlet.

[0099] In some configurations, the nose interface is configured such that at least approximately 60% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 60% and approximately 90% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases entering the gas inletfrom the nose interface through the first nozzle, optionally such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet,delivered from the nasal incision through the first nozzle.

[0100] In some configurations, the gas inlet is in fluid communication with a breathing tube.

[0101] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0102] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, with the gas distributor being reconfigurable relative to the cannula body between a first configuration and a second configuration, where the first configuration refers to the gas distributor being inserted into the cannula body from a first side of the cannula body, so that the second nozzle is further proximal to the gas inlet and the first nozzle is further distal to the gas inlet, and the second configuration refers to the gas distributor being inserted into the cannula body from a second side of the cannula body, so that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0103] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a first nozzle and a second nozzle, and a gas distributor which includes a gas inlet, where the first nozzle and the second nozzle are in fluid contact with the gas inlet, where the nasal interface is configured to cause an asymmetrical gas flow at the patient's nostrils, and wherein the gas inlet is in fluid communication with a breathing tube.

[0104] In some configurations, the first nozzle and the second nozzle are asymmetrical to each other, or not symmetrical to each other, or differ in shape and configuration from each other, or are asymmetrical in comparison to each other.

[0105] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0106] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0107] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0108] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0109] In some configurations, the first and second ports are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0110] In some configurations, the gas distributor is formed as a single unit with the breathing tube or coupled to the breathing tube.

[0111] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0112] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, with the gas distributor being reconfigurable relative to the cannula body between a first configuration and a second configuration, the first configuration referring to the gas distributor being inserted into the cannula body from a first side of the cannula body, and the second configuration referring to the gas distributor being inserted into the cannula body from a second side of the cannula body, so that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0113] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, and wherein an outer surface of the cannula body between the first nozzle and the second nozzle includes a depression to accommodate a section of a patient's nose and reduce pressure on the underside of the accommodated section.

[0114] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a cannula body comprising a first nozzle and a second nozzle, wherein the first nozzle and the second nozzle are asymmetrical to each other, and a gas distributor comprising a gas inlet, wherein the first nozzle and the second nozzle are in fluid communication with the gas inlet, where the nasal interface is configured to cause an asymmetrical gas flow at the patient's nostrils, and wherein the gas distributor is reconfigurable relative to the cannula body between a first configuration and a second configuration, the first configuration relating to the gas distributor being inserted into the cannula body from a first side of the cannula body, such that the second nozzle is further proximal to the gas inlet and the first nozzle is further distal to the gas inlet, and the second configuration relating to the gas distributor being inserted into the cannula body from a second side of the cannula body, such that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0115] In some configurations, the first nozzle and the second nozzle are asymmetrical to each other and / or not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0116] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0117] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0118] In some configurations, the first and second ports are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0119] In some configurations, the gas distributor includes a flow channel that has a gas flow direction that is essentially perpendicular to the gas flow paths through the first nozzle and the second nozzle.

[0120] In some configurations, the gas inlet is in fluid communication with a breathing tube.

[0121] In some configurations, the gas distributor is formed as a single unit with the breathing tube or coupled to the breathing tube.

[0122] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a cannula body comprising a first nozzle and a second nozzle, which are asymmetrical to each other, and a gas distributor which includes a gas inlet, where the first nozzle and the second nozzle are in fluid contact with the gas inlet, and wherein an outer surface of the cannula body has a depression between the first nozzle and the second nozzle.

[0123] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0124] In some configurations, the depression is positioned to accommodate a section of a patient's nose and reduce pressure on the underside of the accommodated part.

[0125] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0126] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0127] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0128] In some configurations, the first and second ports are configured to provide gas to a patient without interfering with the patient's spontaneous breathing.

[0129] In some configurations, a section of the gas distributor is complementary to the deepening.

[0130] In some configurations, the section of the gas distributor that is complementary to the sink is an outlet of the gas distributor and optionally a periphery of the outlet of the gas distributor.

[0131] In some configurations, the cannula body and / or the gas distributor include retention features to keep the gas distributor detachably engaged with the cannula body.

[0132] In some configurations, the retention features include an elastic ring-shaped section of the cannula body that is received in a complementary recess of the gas distributor.

[0133] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a cannula body comprising a first nozzle and a second nozzle, which are asymmetrical to each other, and a gas distributor which includes a gas inlet, where the first nozzle and the second nozzle are in fluid contact with the gas inlet, wherein the nasal interface further comprises two lateral arms comprising wing sections extending laterally from both sides of the cannula body, the nasal interface includes or is provided in combination with a tube retaining clip.

[0134] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0135] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0136] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0137] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0138] In some configurations, the first and second ports are configured to provide gas to a patient without interfering with the patient's spontaneous breathing.

[0139] In some configurations, the hose retaining clip is configured to support a patient line or other gas supply hose.

[0140] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a first spout with a shape and a second spout with a shape, and a gas distributor that includes a gas inlet, where the first nozzle and the second nozzle are in fluid contact with the gas inlet, wherein the first nozzle has a larger internal cross-sectional area in a direction transverse to the gas flow through the first nozzle than a corresponding internal cross-sectional area of ​​the second nozzle in a direction transverse to the gas flow through the second nozzle, and wherein at least the first nozzle is made of an elastomeric material which enables the first nozzle to deform and establish its shape when used in response to temperature and contact with the patient's nostrils.

[0141] In some configurations, the temperature can range between approximately 20°C and approximately 41°C, optionally more than 20°C and up to approximately 41°C, optionally between approximately 31°C and approximately 41°C, optionally between approximately 36°C and approximately 39°C, optionally approximately 37°C.

[0142] In some configurations, the first nozzle is configured to deform during use and to fix its shape so that it essentially matches the internal shape of the patient's nostril.

[0143] In some configurations, the elastomer material allows the first nozzle to deform and fix its shape so that, at therapeutic temperatures between approximately 31 °C and approximately 41 °C, optionally between approximately 36 °C and approximately 39 °C, optionally approximately 37 °C, it essentially matches the internal shape of the patient's nostrils.

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

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

[0146] In some configurations, the material exhibits a compression set of between approximately 10% and approximately 50% at temperatures between approximately 20°C and approximately 40°C after 72 hours of testing according to Method A of ISO 815-1:2014.

[0147] In some configurations, the elastomer material exhibits a compression set of between approximately 10% and approximately 45%, optionally between approximately 10% and approximately 40%, optionally between approximately 10% and approximately 35%, optionally between approximately 10% and approximately 30%, optionally between approximately 10% and approximately 25%, optionally between approximately 10% and approximately 20%, optionally between approximately 11% and approximately 19%, optionally between approximately 12% and approximately 18%, optionally between approximately 13% and approximately 17%, optionally between approximately 14% and approximately 16%, optionally approximately 15% at temperatures between approximately 20°C and approximately 40°C after 72 hours when tested according to Method A of ISO 815-1:2014.

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

[0149] In some configurations, both the first nozzle and the second nozzle are made of the elastomer material.

[0150] In some configurations, the second nozzle has a substantially oval or substantially elliptical cross-sectional shape in the direction transverse to the gas flow through the second nozzle, wherein the substantially oval or substantially elliptical cross-sectional shape has a first ratio of a widest dimension to a narrowest dimension, and wherein the first nozzle has a less oval or less elliptical cross-sectional shape in the direction transverse to the gas flow through the first nozzle, wherein the less oval or less elliptical cross-sectional shape has either a second ratio of a widest dimension to a narrowest dimension that is smaller than the first ratio, or a substantially circular cross-sectional shape.

[0151] In some configurations, the first nozzle has an essentially circular shape.

[0152] In some configurations, the first nozzle has a first connection end and the second nozzle has a second connection end, the first connection end comprising a substantially corrugated surface.

[0153] In some configurations, the second terminal end has an essentially flat surface.

[0154] In some configurations, the first nozzle has an inner diameter of between approximately 4 mm and approximately 10 mm, optionally between approximately 5 mm and approximately 9 mm, optionally between approximately 6 mm and approximately 8 mm, optionally approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm or any diameter between two of these values.

[0155] In some configurations, the second nozzle has an inner diameter of between approximately 2 mm and approximately 8 mm, optionally between approximately 3 mm and approximately 7 mm, optionally between approximately 4 mm and approximately 6 mm, optionally approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm or any diameter between two of these values.

[0156] In some configurations, the first nozzle and / or the second nozzle have a wall thickness between approximately 0.1 mm and approximately 0.5 mm.

[0157] In some configurations, the first nozzle has an internal cross-sectional area of ​​approximately 15 mm². 2 and about 80 mm 2 , optionally between approximately 20 mm 2 and about 75 mm 2 , optionally between approximately 25 mm 2 and about 70 mm 2 , optionally between approximately 30 mm 2 and about 65 mm 2 , optionally between approximately 35 mm 2 and about 60 mm 2 , optionally between approximately 40 mm2 and about 55 mm 2 , optionally between approximately 45 mm 2 and about 50 mm 2 , optionally about 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2, approximately 50 mm 2 , approximately 51 mm 2 , approximately 52 mm 2 , approximately 53 mm 2 , approximately 54 mm 2 , approximately 55 mm 2 , approximately 56 mm 2 , approximately 57 mm 2 , approximately 58 mm 2 , approximately 59 mm 2 , approximately 60 mm 2 , approximately 61 mm 2 , approximately 62 mm 2 , approximately 63 mm 2 , approximately 64 mm 2 , approximately 65 mm 2 , approximately 66 mm 2 , approximately 67 mm 2 , approximately 68 mm 2 , approximately 69 mm 2 , approximately 70 mm 2 , approximately 71 mm 2 , approximately 72 mm 2 , approximately 73 mm 2 , approximately 74 mm 2 , approximately 75 mm 2 , approximately 76 mm 2 , approximately 77 mm 2 , approximately 78 mm 2 , approximately 79 mm 2 , approximately 80 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0158] In some configurations, the second nozzle has an internal cross-sectional area of ​​approximately 5 mm².2 and about 50 mm 2 , optionally between approximately 10 mm 2 and about 45 mm 2 , optionally between approximately 15 mm 2 and about 40 mm 2 , optionally between approximately 20 mm 2 and about 35 mm 2 , optionally between approximately 25 mm 2 and about 30 mm 2 , optionally about 5 mm 2 , approximately 6 mm 2 , approximately 7 mm 2 , approximately 8 mm 2 , approximately 9 mm 2 , approximately 10 mm 2 , approximately 11 mm 2 , approximately 12 mm 2 , approximately 13 mm 2 , approximately 14 mm 2 , approximately 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2, approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0159] In some configurations, the combined internal cross-sectional area of ​​the first and second nozzles is approximately 20 mm². 2 and about 130 mm 2 , optionally between approximately 30 mm 2 and about 120 mm 2 , optionally between approximately 40 mm 2 and approximately 110 mm 2 , optionally between approximately 50 mm 2 and about 100 mm 2, optionally between approximately 60 mm 2 and about 90 mm 2 , optionally between approximately 70 mm 2 and about 80 mm 2 , optionally about 20 mm 2 , approximately 25 mm 2 , approximately 30 mm 2 , approximately 35 mm 2 , approximately 40 mm 2 , approximately 45 mm 2 , approximately 50 mm 2 , approximately 55 mm 2 , approximately 60 mm 2 , approximately 65 mm 2 , approximately 70 mm 2 , approximately 75 mm 2 , approximately 80 mm 2 , approximately 85 mm 2 , approximately 90 mm 2 , approximately 95 mm 2 , approximately 100 mm 2 , approximately 105 mm 2 , approximately 110 mm 2 , approximately 115 mm 2 , approximately 120 mm 2 , approximately 125 mm 2 , approximately 130 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0160] In some configurations, the ratio of the internal cross-sectional area of ​​the first nozzle to the internal cross-sectional area of ​​the second nozzle is between approximately 60:40 and approximately 80:20; optionally between approximately 65:35 and approximately 80:20; optionally between approximately 70:30 and approximately 80:20; optionally between approximately 70:30 and approximately 75:25; optionally approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26 or approximately 75:25; optionally between approximately 75:25 and 80:20; optionally approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79:21 or approximately 80:20.

[0161] In some configurations, the gas inlet is in fluid communication with a breathing tube.

[0162] In some configurations, the nasal interface comprises a cannula body that includes the first nozzle and the second nozzle, with the gas distributor being reconfigurable relative to the cannula body between a first configuration and a second configuration, where the first configuration refers to the gas distributor being inserted into the cannula body from a first side of the cannula body, so that the second nozzle is further proximal to the gas inlet and the first nozzle is further distal to the gas inlet, and the second configuration refers to the gas distributor being inserted into the cannula body from a second side of the cannula body, so that the first nozzle is further proximal to the gas inlet and the second nozzle is further distal to the gas inlet.

[0163] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a first spigot and a second spigot that are asymmetrical to each other, and a gas distributor comprising a gas inlet, wherein the first nozzle and the second nozzle are in fluid communication with the gas inlet, where the nasal interface is configured to cause an asymmetrical gas flow at the patient's nostrils, the first nozzle has an inner cross-sectional area of ​​approximately 15 mm² 2 and about 80 mm 2 has the second nozzle having an inner cross-sectional area of ​​approximately 5 mm² 2 and approximately 50 mm 2exhibits a combined internal cross-sectional area of ​​the first nozzle and the second nozzle of approximately 20 mm² 2 and about 130 mm 2 lies, whereby the ratio of the internal cross-sectional area of ​​the first nozzle to the internal cross-sectional area of ​​the second nozzle is between approximately 60:40 and approximately 80:20.

[0164] In some configurations, the first nozzle has an internal cross-sectional area of ​​approximately 20 mm². 2 and about 75 mm 2 , optionally between approximately 25 mm 2 and about 70 mm 2 , optionally between approximately 30 mm 2 and about 65 mm 2 , optionally between approximately 35 mm 2 and about 60 mm 2 , optionally between approximately 40 mm 2 and about 55 mm 2 , optionally between approximately 45 mm 2 and about 50 mm 2 , optionally about 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 , approximately 51 mm 2 , approximately 52 mm 2 , approximately 53 mm 2 , approximately 54 mm 2 , approximately 55 mm 2 , approximately 56 mm 2 , approximately 57 mm 2 , approximately 58 mm 2 , approximately 59 mm 2 , approximately 60 mm2 , approximately 61 mm 2 , approximately 62 mm 2 , approximately 63 mm 2 , approximately 64 mm 2 , approximately 65 mm 2 , approximately 66 mm 2 , approximately 67 mm 2 , approximately 68 mm 2 , approximately 69 mm 2 , approximately 70 mm 2 , approximately 71 mm 2 , approximately 72 mm 2 , approximately 73 mm 2 , approximately 74 mm 2 , approximately 75 mm 2 , approximately 76 mm 2 , approximately 77 mm 2 , approximately 78 mm 2 , approximately 79 mm 2 , approximately 80 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0165] In some configurations, the second nozzle has an internal cross-sectional area of ​​approximately 10 mm². 2 and about 45 mm 2 , optionally between approximately 15 mm 2 and about 40 mm 2 , optionally between approximately 20 mm 2 and about 35 mm 2 , optionally between approximately 25 mm 2 and about 30 mm 2, optionally about 5 mm 2 , approximately 6 mm 2 , approximately 7 mm 2 , approximately 8 mm 2 , approximately 9 mm 2 , approximately 10 mm 2 , approximately 11 mm 2 , approximately 12 mm 2 , approximately 13 mm 2 , approximately 14 mm 2 , approximately 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 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 nozzles is approximately 30 mm². 2 and about 120 mm 2 , optionally between approximately 40 mm 2 and approximately 110 mm 2 , optionally between approximately 50 mm 2 and about 100 mm 2 , optionally between approximately 60 mm 2 and about 90 mm 2 , optionally between approximately 70 mm 2 and about 80 mm 2 , optionally about 20 mm 2 , approximately 25 mm 2 , approximately 30 mm 2 , approximately 35 mm 2 , approximately 40 mm 2 , approximately 45 mm 2 , approximately 50 mm 2 , approximately 55 mm 2 , approximately 60 mm 2 , approximately 65 mm 2, approximately 70 mm 2 , approximately 75 mm 2 , approximately 80 mm 2 , approximately 85 mm 2 , approximately 90 mm 2 , approximately 95 mm 2 , approximately 100 mm 2 , approximately 105 mm 2 , approximately 110 mm 2 , approximately 115 mm 2 , approximately 120 mm 2 , approximately 125 mm 2 , approximately 130 mm 2 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 nozzle to the inner cross-sectional area of ​​the second nozzle is between approximately 65:35 and approximately 80:20; optionally between approximately 70:30 and approximately 80:20; optionally between approximately 70:30 and approximately 75:25; optionally approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26 or approximately 75:25; optionally between approximately 75:25 and 80:20; optionally approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79:21 or approximately 80:20.

[0168] In some configurations, the first nozzle has an internal cross-sectional area of ​​approximately 24 mm². 2 and 25 mm 2 and the second nozzle has an inner cross-sectional area of ​​approximately 6 mm² 2 and about 17 mm 2 on.

[0169] In some configurations, the first nozzle has an internal cross-sectional area of ​​approximately 44 mm². 2 and about 45 mm 2 and the second nozzle has an inner cross-sectional area of ​​approximately 11 mm² 2 and about 30 mm 2 on.

[0170] In some configurations, the first nozzle has an internal cross-sectional area of ​​approximately 69 mm². 2 and about 70 mm 2 and the second nozzle has an internal cross-sectional area of ​​approximately 17 mm² 2 and about 47 mm 2 on.

[0171] In another aspect of the disclosure, according to certain features, aspects and advantages, at least one of the embodiments disclosed herein discloses a nose interface, wherein the nose interface comprises the following: a gas inlet, a first nozzle and a second nozzle that are asymmetrical to each other, wherein the first nozzle has a first nozzle outlet and the second nozzle has a second nozzle outlet, and a gas flow path from the gas inlet to the first and second nozzles, wherein the first nozzle has a larger internal cross-sectional area in a direction transverse to the gas flow through the first nozzle than a corresponding internal cross-sectional area of ​​the second nozzle, wherein for a given gas flow rate at the gas inlet used, different gas flow rates are provided through the first nozzle and the second nozzle, and the velocity of the gases leaving the first nozzle outlet and the second nozzle outlet is essentially similar.

[0172] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0173] In some configurations, the velocity of the gases leaving the first nozzle outlet is within approximately 20% of the velocity of the gases leaving the second nozzle outlet.

[0174] In some configurations, the velocity of the gases leaving the first nozzle outlet is within approximately 16% of the velocity of the gases leaving the second nozzle outlet.

[0175] In some configurations, at flow rates above approximately 40 l / min, the velocity of the gases leaving the first nozzle outlet is within approximately 10% of the velocity of the gases leaving the second nozzle outlet.

[0176] In some configurations, at flow rates above approximately 42 l / min, the velocity of the gases leaving the first nozzle outlet is within approximately 10% of the velocity of the gases leaving the second nozzle outlet.

[0177] In some configurations, the velocity of the gases exiting each of the first nozzle outlet and the second nozzle outlet is greater than 0 m / s and less than about 32 m / s for a total volumetric flow rate of gas flow into the gas inlet of greater than 0 l / min and up to about 70 l / min.

[0178] In some configurations, the velocity of the gases exiting each of the first nozzle outlet and the second nozzle outlet is greater than 0 m / s and less than 32 m / s for a total volumetric flow rate of a gas flow into the gas inlet of greater than 0 l / min and up to about 70 l / min.

[0179] In some configurations, the velocity of the gases exiting each of the first nozzle outlet and the second nozzle outlet is more than approximately 2 m / s and less than approximately 32 m / s, optionally more than approximately 2 m / s and less than 32 m / s, optionally more than approximately 2 m / s and up to approximately 25 m / s, and optionally more than approximately 2.5 m / s and up to approximately 20 m / s for a total volumetric flow rate of a gas flow into the gas inlet of more than 9 l / min and up to approximately 70 l / min.

[0180] In some configurations, the nose interface is configured so that the total volumetric flow rate of the gases flowing into the gas inlet is at least approximately 5 liters per minute (l / min).

[0181] In some configurations, the nose interface is configured so that the total volumetric flow rate of the gases flowing into the gas inlet is between approximately 5 l / min and approximately 120 l / min.

[0182] In some configurations, the nose interface is configured so that the total volumetric flow rate of the gases flowing into the gas inlet is between approximately 5 l / min and approximately 70 l / min.

[0183] In some configurations, the nose interface is configured such that at least approximately 60% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0184] In some configurations, the nose interface is configured such that between approximately 60% and approximately 90% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0185] In some configurations, the nose interface is configured such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0186] In some configurations, the nose interface is configured such that between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0187] In some configurations, the nose interface is configured such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0188] In some configurations, the nose interface is configured such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0189] In such configurations, the nose interface is configured so that approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0190] In some configurations, the nose interface is configured such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0191] In such configurations, the nose interface is configured so that approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0192] In such configurations, the nose interface is configured so that approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged through the first nozzle from the nose interface.

[0193] In some configurations, the first nozzle has an inner diameter of between approximately 4 mm and approximately 10 mm, optionally between approximately 5 mm and approximately 9 mm, optionally between approximately 6 mm and approximately 8 mm, optionally approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm or any diameter between any two of these diameters.

[0194] In some configurations, the second nozzle has an inner diameter of between approximately 2 mm and approximately 8 mm, optionally between approximately 3 mm and approximately 7 mm, optionally between approximately 4 mm and approximately 6 mm, optionally approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm or any diameter between any two of these diameters.

[0195] In some configurations, the internal cross-sectional area of ​​the first nozzle is approximately 15 mm². 2 and about 80 mm 2 , optionally between approximately 20 mm 2 and about 75 mm 2 , optionally between approximately 25 mm 2 and about 70 mm 2 , optionally between approximately 30 mm 2 and about 65 mm 2 , optionally between approximately 35 mm 2 and about 60 mm 2 , optionally between approximately 40 mm 2 and about 55 mm 2 , optionally between approximately 45 mm 2 and about 50 mm 2 , optionally about 15 mm 2 , approximately 16 mm 2, approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 , approximately 51 mm 2 , approximately 52 mm 2 , approximately 53 mm 2 , approximately 54 mm 2 , approximately 55 mm 2 , approximately 56 mm 2, approximately 57 mm 2 , approximately 58 mm 2 , approximately 59 mm 2 , approximately 60 mm 2 , approximately 61 mm 2 , approximately 62 mm 2 , approximately 63 mm 2 , approximately 64 mm 2 , approximately 65 mm 2 , approximately 66 mm 2 , approximately 67 mm 2 , approximately 68 mm 2 , approximately 69 mm 2 , approximately 70 mm 2 , approximately 71 mm 2 , approximately 72 mm 2 , approximately 73 mm 2 , approximately 74 mm 2 , approximately 75 mm 2 , approximately 76 mm 2 , approximately 77 mm 2 , approximately 78 mm 2 , approximately 79 mm 2 , approximately 80 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0196] In some configurations, the internal cross-sectional area of ​​the second nozzle is approximately 5 mm². 2 and about 50 mm 2 , optionally between approximately 10 mm 2 and about 45 mm 2 , optionally between approximately 15 mm 2 and about 40 mm 2, optionally between approximately 20 mm 2 and about 35 mm 2 , optionally between approximately 25 mm 2 and about 30 mm 2 , optionally about 5 mm 2 , approximately 6 mm 2 , approximately 7 mm 2 , approximately 8 mm 2 , approximately 9 mm 2 , approximately 10 mm 2 , approximately 11 mm 2 , approximately 12 mm 2 , approximately 13 mm 2 , approximately 14 mm 2 , approximately 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2, approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0197] In some configurations, the combined internal cross-sectional area of ​​the first and second nozzles is approximately 20 mm². 2 and about 130 mm 2 , optionally between approximately 30 mm 2 and about 120 mm 2 , optionally between approximately 40 mm 2 and approximately 110 mm 2 , optionally between approximately 50 mm 2 and about 100 mm 2 , optionally between approximately 60 mm 2 and about 90 mm 2 , optionally between approximately 70 mm 2 and about 80 mm 2 , optionally about 20 mm 2, approximately 25 mm 2 , approximately 30 mm 2 , approximately 35 mm 2 , approximately 40 mm 2 , approximately 45 mm 2 , approximately 50 mm 2 , approximately 55 mm 2 , approximately 60 mm 2 , approximately 65 mm 2 , approximately 70 mm 2 , approximately 75 mm 2 , approximately 80 mm 2 , approximately 85 mm 2 , approximately 90 mm 2 , approximately 95 mm 2 , approximately 100 mm 2 , approximately 105 mm 2 , approximately 110 mm 2 , approximately 115 mm 2 , approximately 120 mm 2 , approximately 125 mm 2 , approximately 130 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0198] In some configurations, the ratio of the internal cross-sectional area of ​​the first nozzle to the internal cross-sectional area of ​​the second nozzle is between approximately 60:40 and approximately 80:20; optionally between approximately 65:35 and approximately 80:20; optionally between approximately 70:30 and approximately 80:20; optionally between approximately 70:30 and approximately 75:25; optionally approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26 or approximately 75:25; optionally between approximately 75:25 and 80:20; optionally approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79:21 or approximately 80:20.

[0199] In some configurations, the inner diameters and / or internal cross-sectional areas of the first nozzle and the second nozzle are measured along the same plane (i.e., a common plane).

[0200] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle.

[0201] In some configurations, the inner diameters and / or inner cross-sectional areas are located at the first nozzle outlet and at the second nozzle outlet.

[0202] In some configurations, the nose interface is configured such that at least approximately 60% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 60% and approximately 90% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet is discharged from the nose interface through the first nozzle; optionally, such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases entering the gas inletfrom the nose interface through the first nozzle, optionally such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle, optionally such that approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet,delivered from the nasal incision through the first nozzle.

[0203] In some configurations, the nose interface is configured to deliver approximately 7 l / min from the nose interface through the first nozzle at a volumetric flow rate of approximately 9.5 l / min at the gas inlet, and / or to deliver approximately 13.5 l / min from the nose interface through the first nozzle at a volumetric flow rate of approximately 19 l / min at the gas inlet, and / or to deliver approximately 21 l / min from the nose interface through the first nozzle at a volumetric flow rate of approximately 29 l / min at the gas inlet, and / or to deliver approximately 28 l / min from the nose interface through the first nozzle at a volumetric flow rate of approximately 38.5 l / min at the gas inlet, and / or approximately 35 l / min from the nose interface through the first nozzle at a volumetric flow rate of 47.5 l / min at the gas inlet, and / or to deliver approximately 13.5 l / min from the nose interface through the first nozzle at a volumetric flow rate of approximately 19 l / min at the gas inlet.that approximately 44 l / min are delivered from the nose interface through the first nozzle at a volumetric flow rate of approximately 58 l / min at the gas inlet and / or approximately 48.5 l / min are delivered from the nose interface through the first nozzle at a volumetric flow rate of 64 l / min at the gas inlet.

[0204] In some configurations, the nose interface includes a gas distributor that encompasses the gas inlet.

[0205] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0206] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

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

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

[0209] In some configurations, the nasal interface is a non-sealing nasal interface.

[0210] According to certain features, aspects and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed, wherein the patient interface comprises the nasal interface as described above or herein.

[0211] In some configurations, the patient interface also includes a head restraint to hold the nasal interface against a patient's face.

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

[0213] In some configurations, the hose is a breathable hose.

[0214] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0215] In some configurations, the gas distributor is formed as a single unit with the breathing tube or coupled to the breathing tube.

[0216] In some configurations, the patient interface also includes a tube retaining clip.

[0217] In another aspect of the disclosure, a respiratory therapy system is disclosed according to certain features, aspects and advantages of at least one of the embodiments disclosed herein, wherein the respiratory therapy system comprises the following: a respiratory therapy facility, comprehensive: a control system; a blood oxygen saturation sensor; an ambient air inlet; an oxygen inlet; a valve in fluid connection with the oxygen inlet to control oxygen flow through the oxygen inlet; and a gas outlet; wherein the controller is configured to control the valve based on at least one measurement of oxygen saturation from the blood oxygen saturation sensor; and a patient interface comprising a nasal interface, wherein the nasal interface comprises: a first nozzle and a second nozzle that are asymmetrical to each other; and a gas distributor comprising a gas inlet, wherein the first nozzle and the second nozzle are in fluid communication with the gas inlet; the nasal interface is configured to cause an asymmetrical gas flow at the nostrils of a patient.

[0218] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0219] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0220] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0221] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0222] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0223] In some configurations, the first and second ports are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

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

[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 line with a heater.

[0227] In some configurations, the patient interface includes a breathing tube in fluid communication with the gas inlet, and the patient interface further includes a head support to hold the nasal interface to the face of a patient.

[0228] In some configurations, water vapor can flow through a wall of the hose, but liquid water and a mass flow of gases cannot flow through the wall of the hose.

[0229] In some configurations, the gas distributor is formed as a single unit with the breathing tube or coupled to the breathing tube.

[0230] In some configurations, the patient interface also includes a tube retaining clip.

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

[0232] In another aspect of the disclosure, a respiratory therapy system is disclosed according to certain features, aspects and advantages of at least one of the embodiments disclosed herein, wherein the respiratory therapy system comprises the following: a respiratory therapy facility, comprehensive: a gas inlet; a gas outlet; a nebulizer for releasing one or more substances into a gas stream; and a patient interface comprising a nasal interface, wherein the nasal interface comprises: a first nozzle and a second nozzle that are asymmetrical to each other; a gas distributor comprising a gas inlet, wherein the first nozzle and the second nozzle are in fluid communication with the gas inlet, wherein the gas inlet is in fluid communication with the gas outlet to receive gases and the one or more substances from the respiratory therapy device; the nasal interface is configured to cause an asymmetrical gas flow at the nostrils of a patient.

[0233] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0234] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0235] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0236] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed.

[0237] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0238] In some configurations, the first and second ports are configured to provide 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 the gases and one or more substances from the respiratory therapy device and for delivering the gases and one or more substances to the gas inlet of the nasal interface.

[0240] In some configurations, the duct includes a heating pipe with a smooth bore.

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

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

[0243] In another aspect of the disclosure, a respiratory therapy system is disclosed according to certain features, aspects and advantages of at least one of the embodiments disclosed herein, wherein the respiratory therapy system comprises the following: a respiratory therapy facility, comprehensive: at least one gas inlet; a humidifier for humidifying gases; and a gas outlet; and a patient interface comprising a nasal interface, wherein the nasal interface comprises the following: a first nozzle and a second nozzle which are asymmetrical to each other, wherein the first nozzle has a first nozzle outlet and the second nozzle has a second nozzle outlet; and a gas distributor that includes a gas inlet, wherein the first nozzle and the second nozzle are in fluid contact with the gas inlet; wherein the nasal interface is configured to cause an asymmetric gas flow at the nostrils of a patient; wherein the respiratory therapy system is configured to deliver gases through the first nozzle outlet and the second nozzle outlet in a temperature range between about 27 °C and 37 °C and 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 of gases entering the gas inlet of more than 0 l / min and up to about 70 l / min.

[0244] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0245] In some configurations, the respiratory therapy system is configured to deliver gases through the first nozzle outlet and the second nozzle outlet in a temperature range between approximately 31°C and 37°C.

[0246] In some configurations, the respiratory therapy system is configured to deliver gases with a relative humidity of up to approximately 44 mg / l through the first nozzle outlet and the second nozzle outlet.

[0247] In some configurations, the respiratory therapy system is configured to provide a total volumetric flow rate of gases flowing into the gas inlet of at least approximately 5 liters per minute (l / min), optionally between approximately 5 l / min and approximately 120 l / min, and optionally between approximately 5 l / min and approximately 70 l / min.

[0248] In some configurations, the respiratory therapy system is configured to deliver at least approximately 60% of the total volumetric flow rate of the gases entering the gas inlet from the nasal interface through the first nozzle; optionally between approximately 60% and approximately 90% of the total volumetric flow rate of the gases entering the gas inlet from the nasal interface through the first nozzle; optionally between approximately 60% and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet from the nasal interface through the first nozzle; optionally between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet from the nasal interface through the first nozzle; optionally between approximately 70% and approximately 80% of the total volumetric flow rate of the gases entering the gas inlet from the nasal interface through the first nozzle.optionally, between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle; optionally, approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle; optionally, between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle; optionally, approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle; optionally, approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet is discharged from the nose interface through the first nozzle.

[0249] In some configurations, the respiratory therapy system is configured to provide different flow rates of gases through the first port and the second port, and to deliver an essentially similar velocity of gases through the first port outlet and the second port outlet.

[0250] In some configurations, the velocity of gases exiting the first nozzle outlet is within approximately 20% of the velocity of gases exiting the second nozzle outlet, optionally within approximately 16% of the velocity of gases exiting the second nozzle outlet, and optionally within approximately 10% of the velocity of gases exiting the second nozzle outlet at flow rates above approximately 40 l / min, and optionally within approximately 10% of the velocity of gases exiting the second nozzle outlet at flow rates above approximately 42 l / min.

[0251] In some configurations, the velocity of the gases exiting each of the first nozzle outlet and the second nozzle outlet is greater than 0 m / s and less than 32 m / s for a total volumetric flow rate of a gas flow into the gas inlet of greater than 0 l / min and up to about 70 l / min.

[0252] In some configurations, the velocity of the gases exiting each of the first nozzle outlet and the second nozzle outlet is more than approximately 2 m / s and less than approximately 32 m / s, optionally more than approximately 2 m / s and less than 32 m / s, optionally more than approximately 2 m / s and up to approximately 25 m / s, and optionally more than approximately 2.5 m / s and up to approximately 20 m / s for a total volumetric flow rate of a gas flow into the gas inlet of more than 9 l / min and up to approximately 70 l / min.

[0253] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0254] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0255] In some configurations, the first and second nozzles are configured to enter the nasal passages unsealed (not sealing).

[0256] In some configurations, the first and second ports allow exhaled gases to escape around the first and second ports.

[0257] In some configurations, the first and second ports are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

[0258] In some configurations, the first and second ports are configured to provide gas to the patient regardless of the patient's breathing.

[0259] In some configurations, the respiratory therapy system includes a line for receiving gases from the respiratory therapy device and delivering the gases to the gas inlet of the nasal interface.

[0260] In some configurations, the duct includes a heating pipe with a smooth bore.

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

[0262] In another aspect of the disclosure, a method for providing respiratory support to a patient is provided according to certain features, aspects and advantages of at least one of the embodiments disclosed herein, the method comprising the following: Provision of a respiratory therapy system, including: a respiratory therapy facility, comprehensive: at least one gas inlet; a flow generator; and a gas outlet; and a patient interface comprising a nasal interface, wherein the nasal interface comprises the following: a first nozzle and a second nozzle, which are asymmetrical to each other, through the first nozzle outlet and the second nozzle outlet; and a gas distributor that includes a gas inlet, wherein the first nozzle and the second nozzle are in fluid contact with the gas inlet; Operating the respiratory therapy device to provide a gas flow to the nasal interface; and Delivery of an asymmetrical gas flow from the respiratory therapy device through the first nozzle outlet and the second nozzle outlet to the nostrils of a patient.

[0263] The first nozzle and the second nozzle are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0264] In some configurations, the procedure involves releasing the asymmetric gas flow in a temperature range between approximately 27 °C and 37 °C, at a relative humidity of more than approximately 33 mg / l and / or at a velocity of more than approximately 0 m / s and less than approximately 32 m / s for a total volumetric flow rate of the gases flowing into the gas inlet of more than 0 l / min and up to approximately 70 l / min.

[0265] In some configurations, the process involves releasing the asymmetric gas flow in a temperature range between approximately 31 °C and 37 °C.

[0266] In some configurations, the procedure includes providing a total volumetric flow rate of the gases flowing into the gas inlet of at least about 5 liters per minute (l / min), optionally providing a total volumetric flow rate of the gases flowing into the gas inlet between about 5 l / min and about 120 l / min, and optionally providing a total volumetric flow rate of the gases flowing into the gas inlet between about 5 l / min and about 70 l / min.

[0267] In some configurations, the procedure includes the release of at least approximately 60% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally between approximately 60% and approximately 90% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally between approximately 70% and approximately 80% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet.optionally between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally approximately 70% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally approximately 75% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet, optionally approximately 80% of the total volumetric flow rate of the gases flowing from the nasal interface through the first nozzle into the gas inlet.

[0268] In some configurations, the procedure involves the release of gases through the first nozzle outlet and the second nozzle outlet with a relative humidity of up to approximately 44 mg / l.

[0269] In some configurations, the procedure involves providing different flow rates of gases through the first nozzle and the second nozzle, and delivering gases of substantially similar velocity through the first nozzle outlet and the second nozzle outlet.

[0270] In some configurations, the velocity of the gases leaving the first nozzle outlet is within approximately 20% of the velocity of the gases leaving the second nozzle outlet, optionally within approximately 16% of the velocity of the gases leaving the second nozzle outlet, and optionally within approximately 10% of the velocity of the gases leaving the second nozzle outlet at flow rates above approximately 42 l / min.

[0271] In some configurations, the velocity of the gases exiting each of the first nozzle outlet and the second nozzle outlet is greater than 0 m / s and less than 32 m / s for a total volumetric flow rate of a gas flow into the gas inlet of greater than 0 l / min and up to about 70 l / min.

[0272] In some configurations, the velocity of the gases exiting each of the first nozzle outlet and the second nozzle outlet is more than approximately 2 m / s and less than approximately 32 m / s, optionally more than approximately 2 m / s and less than 32 m / s, optionally more than approximately 2 m / s and up to approximately 25 m / s, and optionally more than approximately 2.5 m / s and up to approximately 20 m / s for a total volumetric flow rate of a gas flow into the gas inlet of more than 9 l / min and up to approximately 70 l / min.

[0273] In some configurations, the nasal interface includes a cannula body that incorporates the first nozzle and the second nozzle.

[0274] In some configurations, the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it.

[0275] In some configurations, the procedure involves bringing the first and second nozzles into contact with the nasal passages in an unsealed (non-sealing) manner.

[0276] In some configurations, the procedure involves releasing exhaled gases around the first and second nozzles.

[0277] In some configurations, the procedure involves delivering gases to the patient without affecting the patient's spontaneous breathing.

[0278] In some configurations, the procedure involves delivering gases to the patient regardless of the patient's breathing.

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

[0280] In some configurations, the respiratory therapy device includes a humidifier, and the procedure involves humidifying the gas flow using the humidifier.

[0281] In some configurations, the respiratory therapy system includes a patient line with a heater, and the procedure involves operating the heater.

[0282] In some configurations, the patient interface includes a breathing tube in fluid communication with the gas inlet, and the procedure involves allowing water vapor to pass through one wall of the tube, but preventing the passage of liquid water and a mass flow of gases through the wall of the tube.

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

[0284] As used herein, “(e)”, “(en)”, “(s)” following a noun refer to a plural and / or singular form of that noun.

[0285] The term “and / or” used here means “and” or “or” or both, where the context allows.

[0286] The term "comprehensive" as used in this specification means "consisting at least partially of". When interpreting any statement in this specification that includes the term "comprehensive", features other than those preceded by the term may also be present. Related terms such as "comprise" and "includes" are to be interpreted in the same way.

[0287] It is intended that a reference to a range of numbers disclosed herein (e.g., 1 to 10) also includes a reference to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and also to 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 therefore all subranges of all ranges expressly disclosed herein are hereby expressly disclosed. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between the lowest and highest enumerated values ​​are deemed to be expressly disclosed in this application in a similar manner.

[0288] In the broadest sense, it can also be said that this disclosure consists of the parts, elements and features referred to or specified in the application specification, individually or collectively, as well as any or all combinations of two or more of these parts, elements or features.

[0289] Where specific integers are mentioned herein which have equivalents known in the prior art to which this disclosure relates, those known equivalents shall be deemed to be included herein as if they were presented individually.

[0290] The revelation consists of the foregoing and also provides for constructions, of which only examples are given below. BRIEF DESCRIPTION OF THE DRAWINGS

[0291] Specific embodiments and modifications thereof will be apparent to the person skilled in the art from the detailed description herein with reference to the following figures. These show: Fig. 1A a perspective view from the front left of an exemplary configuration of a patient interface of the present disclosure, comprising a nasal interface with asymmetrical nasal delivery elements; Fig. 1B a perspective front view of the patient interface from the right; Fig. 1C a perspective expanded view of the patient interface from the front left; Fig. 2 the nasal interface, whereby Fig. 2(a) a top view, Fig. 2(b) a front view and Fig. 2(c) is a subview; Fig. 3 a front sectional view of a nasal interface of the present disclosure, inserted into the nostrils of a user; Fig. 4A a rear view of a small nasal incision of the present disclosure; Fig. 4B a rear view of a medium-sized nasal interface of the present disclosure; Fig. 4C a rear view of a large nasal interface of the present disclosure; Fig. 5 a rear view of the superimposed small, medium and large nasal incisions; Fig. 6 the results of desktop tests of the nasal interfaces, wherein Fig. 6(a), Fig. 6(b) and Fig. 6(c) show the dead space clearance for larger upper airways at 25, 35 and 45 breaths per minute and Fig. 6(d) and Fig. 6(e) show the dead space clearance for smaller upper airways at 15 or 25 breaths per minute, where I:E is the ratio of inspiration time to expiratory time; Fig. 7 the test results of the nasal incisions, whereby Fig.7(a) the results for Optiflow™+ OPT944+ nasal interface from Fisher & Paykel Healthcare Limited show, Fig. 7(b) Results for the nasal interfaces of the present disclosure show and Fig. 7(c) shows comparison results; Fig. 8 exemplary septum spacings and nasal stub heights for the (a) small nasal incision, (b) medium nasal incision and (c) large nasal incision of the present disclosure; Fig. 9 an exemplary gas distributor for use in the small nasal incision, wherein Fig. 9(a) a top view and Fig. 9(b) a front view in section along line bb of Fig. 9(a) shows; Fig. 10 an exemplary gas distributor for use in the medium or large nasal interface, wherein Fig. 10(a) a top view and Fig. 10(b) a front view in section along line bb of Fig. 10(a) shows; Fig. 11 the effects of the nozzle orientation relative to the gas inlet for the nose interface of the present disclosure; Fig. 12 possible configurations of the gas distributor relative to the cannula body, wherein Fig. 12(a) shows a first insertion direction of the gas distributor into the cannula body and Fig. 12 (b) shows the gas distributor coupled to the cannula body in a first configuration, and wherein Fig. 12(c) shows a second insertion direction of the gas distributor into the cannula body and Fig. 12(d) shows the gas distributor coupled to the cannula body in a second configuration; Fig. 13 Details of the nozzle geometry of the outlets of the nasal nozzles of the nasal interface of the present disclosure are shown; Fig. 14 Details of the ends of the nose interface nozzles of the present disclosure, wherein Fig.14 (a) shows a left sectional view of the nasal incision, which shows an exemplary geometry of the outlet of the large nasal incision, Fig. 14(b) shows a right-hand sectional view of the nasal incision, which shows an exemplary geometry of the outlet of the small nasal stub, and Fig. 14 (c) shows a comparison of the outlet geometries; Fig. 15 a respiratory therapy system comprising the patient interface and nasal interface of the present disclosure; Fig. 16 a control loop of the respiratory therapy system for regulating blood oxygen saturation (SpO2) in a closed control loop; Fig. 17 an alternative respiratory therapy system comprising the patient interface and the nasal interface of the present disclosure; Fig.18 a sectional view of a patient line that can be used in the respiratory therapy systems and / or with the nasal interfaces of the present disclosure; Fig. 19 a sectional view of an alternative patient conduit that can be used in the respiratory therapy systems and / or with the nasal interfaces of the present disclosure; Fig. 20 the test results of the nasal interfaces, whereby Fig. 20(a) shows how a nasal interface of the present disclosure can be used to achieve a larger occlusion area while maintaining safe clearance in one nostril, Fig.20 (b) Test data showing an increased positive end-expiratory pressure (PEEP) and reduced rebreathing when a nasal interface of the present disclosure with asymmetrical nozzles is used compared to a nasal interface with symmetrical nozzles when a nasal high flow of 30 liters per minute is applied, and Fig. 20(c) similar test data as Fig. 20(b) shows, however, for a nasal high flow of 60 liters per minute; Fig. 21 the maximum airway pressure that can be achieved for each size of nasal interface of the present disclosure when the larger nozzle completely closes one of the patient's nostrils; Fig. 22A and Fig. 22B Schematic cross-sectional views of exemplary configurations for single-walled patient breathing lines. DETAILED DESCRIPTION

[0292] Patient interfaces can be used to deliver respiratory gases to a patient's airway. These interfaces may include nasal interfaces, which can be used to deliver a high flow of gas to a patient. Nasal delivery devices, such as nasal prongs, which may optionally include nasal cushions, are inserted into a patient's nose to deliver the required therapy. It may be desirable for the nasal delivery devices to seal or partially occlude the nose, or it may not be necessary for them to seal the nose to deliver the therapy. Nasal prongs are generally understood to be nasal delivery devices designed not to seal or only partially occlude the nose. If one or more of the nasal prongs include a nasal cushion, the nasal delivery devices are designed to seal the nose.Nasal high flow (NHF) is typically a non-occlusive therapy that delivers a relatively high-volume flow to the patient via a patient interface, such as a nasal incision. A nasal incision, as described herein, may refer to a nasal cannula, but is not limited to it.

[0293] A system for delivering gases to a patient through an asymmetric nasal cannula or nasal interface is disclosed. An asymmetric interface or asymmetric nasal delivery elements, as described herein, refers to an interface in which the nasal delivery elements differ in size, for example, their inner and / or outer transverse dimensions or diameters and / or their inner and / or outer cross-sectional areas. The outer cross-sectional area is the cross-sectional area bounded by the outer wall of the nasal delivery element. For non-circular cross-sections, references herein to a diameter may be interpreted as a transverse dimension. In some configurations, references herein to a diameter include, but are not limited to, a hydraulic diameter.

[0294] The system allows for the delivery of an asymmetric flow through the interface to both nostrils or to one of them. The asymmetric flow described here refers to a flow pattern that differs within the interface, within the nose, or between the interface and the nose. In this way, a different flow can be delivered from each nasal delivery element, the flow can differ between inspiration and expiration, or the delivered flow can be a combination of the above. An asymmetric flow can also include a partially unidirectional flow pattern.

[0295] Providing asymmetric flow can improve dead space clearance in the upper airways, reduce peak expiratory pressure, increase therapy safety, particularly in children and infants, and decrease interface resistance. An asymmetric nasal interface and / or nasal delivery elements, as described herein, include interfaces or systems configured to generate such asymmetric flow through asymmetric nasal delivery elements.

[0296] The pressure generated by nasal high-flow nasal (NHF) depends on the flow through the nasal interface, the size of the patient's nasal delivery elements and / or nostrils, and the respiratory cycle. If the flow, leakage, or a combination of flow and leakage through the nasal interface is asymmetrical, the nasal flow may become asymmetrical during breathing. Partially and completely unidirectional flow can represent asymmetrical flow patterns. Partially or completely unidirectional flow may result in improved anatomical dead space clearance because air is continuously flushed from the upper airways. Partially unidirectional flow may be more comfortable than completely unidirectional flow.The fully unidirectional flow described herein includes a flow that enters one nostril through a nasal discharge element and exits the other nostril through a nasal discharge element, or venting to the atmosphere due to the absence of a nasal discharge element, or the like. A partially unidirectional flow, as described herein, includes a flow that can enter the nose through both nostrils and exit the nose through one nostril, a flow that can enter the nose through one nostril and exit the nose through both nostrils, or different flow components that can enter the nose through both nostrils and different flow components that can exit the nose through both nostrils, and can be a flow that can enter the nose through both nostrils and exit the nose through one or both nostrils and optionally through the mouth.

[0297] The delivery of NHF via an asymmetrical nasal interface may involve creating an interface where the nasal delivery elements have different sizes, e.g., different lengths and / or inner diameters or cross-sectional areas and / or outer diameters or cross-sectional areas. Particularly in children or infants, nasal delivery elements have a small inner diameter and therefore greater resistance to gas flow. By using nasal delivery elements of different lengths, each nasal delivery element can have a different inner diameter (e.g., minimum inner diameter or area). A longer nasal delivery element may have a smaller inner diameter and greater resistance to gas flow; a shorter nasal delivery element may have a larger inner diameter (e.g.,a larger minimum inner diameter) and thus exhibit less resistance to the gas flow at the interface. Reduced flow resistance makes it possible to achieve the desired flow through lower back pressure or lower motor speed of the gas generation device, or a combination of both.

[0298] Asymmetrical nasal delivery elements can cause a decrease in peak expiratory pressure due to the different cross-sectional areas of the nasal delivery elements on the nose, which can lead to different internal diameters for each nasal delivery element.

[0299] The exhalation pressure against an asymmetric nasal port can be higher than with a symmetric one, which is beneficial because a higher positive end-expiratory pressure (PEEP) is part of COPD treatment (pressure here refers to intrathoracic pressure). The exhalation pressure depends on the combined cross-sectional area of ​​the two ports. Increasing the cross-sectional area of ​​symmetric ports carries the risk of complete nostril occlusion. Using asymmetric ports allows for an increase in the total cross-sectional area without the associated risk of occlusion. The partially unidirectional airflow can reduce turbulence in the patient's nasal cavity, potentially improving comfort.

[0300] In one example, an asymmetric nasal interface used with a gas-generating device such as a Fisher & Paykel Healthcare Limited AIRVO™ flow generator (e.g., coupled via tubing or a breathing tube) reduces flow resistance. This can cause the AIRVO™ motor speed to decrease from a range of 18,000–22,000 rpm to a range of 14,000–18,000 rpm while still achieving a suitable flow rate for the desired therapy (e.g., NHF), for example, approximately 8 liters per minute (l / min). The asymmetric nasal delivery elements can also reduce backpressure generated in the system if, for example, an incorrectly sized nozzle creates a seal with a patient's nasal cavity.

[0301] In smaller patients, such as infants or children, the use of asymmetric nasal delivery elements can reduce the risk of over-inserting both nozzles into the nostrils when the nostrils are too small compared to the nozzles, which could result in an undesirable partial or complete seal. The asymmetric flow can be delivered to the patient even if only one nozzle is firmly seated in the nose. The asymmetric interface improves therapy performance in infants because pressurized gas can be used in a system without pressure regulation.

[0302] Fig. 1A to 1C and Fig. Figure 2 shows an exemplary patient interface 1 comprising a nasal cannula or nasal interface 100 with asymmetrical nasal delivery elements 111, 112.

[0303] The Nasal Interface 100 provides a patient interface suitable for delivering a high-flow, high-humidity gas into the patient's nasal cavity / nostrils. In some configurations, the Nasal Interface 100 is designed to deliver a high flow of gases over a wide flow range (e.g., approximately 8 l / min or higher, depending on other therapeutic applications, perhaps 10-50 l / min or higher). In other configurations, the Nasal Interface 100 is designed to deliver gases at relatively low pressure.

[0304] The nasal interface 100 comprises a face attachment part 110 with a pair of asymmetric tubular nasal prongs 111 and 112, which are integrally formed with the face attachment part 110 or detachably attached to it, and a gas distributor part 120, which is detachably attached or integrally formed with the conduit 300.

[0305] The gas distributor 120 can be inserted into the face attachment part 110. The face attachment part 110 can include at least one substantially horizontal lateral inlet passage 118a, 118b to the interior of a base section or cannula body 118 of the face attachment part 110 in order to detachably receive the outlet of the gas distributor 120.

[0306] The gas distributor 120 can be inserted into the face attachment part 110 from either of two opposite horizontal directions, i.e., either from the left or the right side. In this way, the position or orientation of the gas distributor 120 relative to the face attachment part 110 is reconfigurable. In other words, a user can choose whether the distributor part 120 (and the line 300 leading from it) should exit from either the left or the right side of the face attachment part 110 of the nasal interface 100, depending on what is most practical. This depends, for example, on which side of the user the gas source or ventilator is located. In an alternative configuration, the gas distributor 120 is not reconfigurable relative to the face attachment part 110.

[0307] The face attachment part 110 can comprise a pair of opposing lateral entry passages 118a, 118b to the interior of the base section or cannula body 118, each designed to detachably receive the outlet of the gas distributor 120.

[0308] The facial attachment part 100 is made of a soft, flexible material such as silicone or another cannula material known in technical applications. The nasal prongs 111 and 112 are preferably pliable and can consist of a sufficiently thin layer of silicone to achieve this property.

[0309] The gas distributor 120 is made of a relatively harder material such as polycarbonate, high-density polyethylene (HDPE), or another suitable plastic material known in the art. The face attachment part 110 provides the patient with a soft connecting component for the comfortable delivery of the gas flow through the nasal ports 111 and 112, while the gas distributor 120 connects the liquid line 300 to the nasal ports 111 and 112 of the face attachment part 110.

[0310] The nasal prongs 111 and 112 are curved to extend into the patient's nostrils during use, providing a smooth flow path for gases. The inner surfaces of prongs 111 and 112 may be contoured to reduce noise. The bases of prongs 111 and 112 may have curved surfaces to ensure a more uniform gas flow, thereby reducing noise levels during operation.

[0311] The nosepieces 111 and 112 are essentially hollow and essentially tubular.

[0312] The nasal prongs 111 and 112 can have a uniform diameter along their length or alternatively be shaped to conform to the contours of the nostrils.

[0313] The facial attachment part 110 is shaped to generally follow the contours of a patient's face around the upper lip area. The facial attachment part 110 is shaped or pre-shaped to conform to the contours of the user's face in the area where the cannula is to be inserted, and / or is flexible to adapt to, accommodate, and / or conform to these contours.

[0314] The asymmetry of the nasal prongs 111 and 112 can reduce the likelihood of accidental closure of both nostrils. Therefore, at least one of the nasal prongs 111 and 112 is dimensioned such that a sufficient gap is maintained between the outer surface of the prongs 111 and 112 and the patient's skin to prevent a seal on the gas passage between the nasal interface 100 and the patient. It is understood that, in the context of this disclosure, the nasal prongs 111 and 112 are asymmetrical, as described below.

[0315] The facial attachment part 110 comprises the base part or cannula body 118, from which the nasal prongs 111 and 112 extend, and two side arms comprising wing sections 113 and 114, which extend laterally from both sides of the cannula body 118. The wing sections 113 and 114 are formed integrally with the cannula body 118, but can alternatively be separate parts.

[0316] Adhesive pads 113a, 114a can be attached to each wing section 113, 114 ( Fig. 4A) should be provided to facilitate the coupling of the 100 cannula to the patient - especially for younger children (e.g. under 5 years of age).

[0317] The gas distributor 120 is generally tubular and has at one end an essentially annular gas inlet 121, which curves at the opposite end into an elongated oval outlet 123 ( Fig. 9 and Fig.10) The inlet 121 can be detachably attached to a line 300, for example via a threaded connection, or alternatively via a snap connection or any other type of coupling known in engineering. Alternatively, the inlet is permanently connected to a line 300 or formed integrally with it.

[0318] The shape of the outlet 123 corresponds to the cannula body 118 and fits into it, e.g. with a friction fit or a snap connection, so that separating the distributor requires a considerable force or at least an intentional application of force by a user or caregiver to separate the distributor 120 from the face attachment part 110.

[0319] When the two parts 118 and 120 interlock, an effective seal is created between the outlet 123 and the cannula body 118. As explained further below and in Fig.As shown in Figure 3, the gas distributor 120 can encompass a retaining flange 120b around a surface thereof, which is removably received in a complementary elastic rim 118d of the cannula body 118. The engagement of the retaining flange 120b with the complementary elastic rim 118d of the cannula body 118 supports the formation of a seal between the gas distributor 120 and the cannula body 118.

[0320] The nasal nozzles 111, 112 are aligned with corresponding openings that extend through an upper surface of the cannula body 118 to fluidically connect the distributor outlet 123 to the nasal nozzles 111 and 112 in the coupled state.

[0321] To hold the nasal interface 100 against the patient's face, a head restraint can be used. The head restraint includes a headband 200. The headband 200 can be of a single continuous length and be adjusted to extend along the patient's cheeks, over the ears, and around the back of the head during use; it can be adjustable and / or extend around other parts of the patient's head.

[0322] In the exemplary configuration shown, the primary end sections 201 and 202 of the headband 200 are adapted so that they can be detachably connected to the respective formations 101 and 102 on both sides of the nose interface 100 in order to hold the nose interface 100 in position during use.

[0323] In one configuration, a clip component is provided at each end section 201, 202, which can be received and held in the corresponding formation 101, 102. The clip component can be coupled to the band at the respective primary end section. Furthermore, the headband 200 is length-adjustable to facilitate fitting the band to the wearer's head. The band 200 can be made of a soft and stretchable / elastic material, such as an elastic textile / fabric, which is comfortable for the wearer. Alternatively, the band 200 can be made of a significantly stiffer or less flexible material, such as a hard plastic material.

[0324] The head restraint may further include an additional strap or other head restraint component that couples the Band 200 so that it extends over the patient's crown during use. A crown strap or component can have the advantage of pulling the Band 200 upwards and over the patient's ears during use to improve fit and comfort.

[0325] In general, but also with reference to Fig. 1A to 1C, in an exemplary configuration of an adjustable band 200, the adjustment mechanism is provided in the form of one or more insertable / removable band segments or band extensions 220.

[0326] Fixed-length band segments 220 can be detachably connected to the main band 210 to extend its length. In this configuration, the main band 210 comprises a pair of intermediate or secondary end sections 203, 204, which can be detachably connected to each other and which can also be detachably connected to the respective ends 221 and 222 of the band segments 220. When the secondary end sections 203 and 204 are connected to each other, the main band 210 has a continuous initial length / size for the wearer. To extend the length of the band 210 beyond this initial length, the main band 210 can be cut at the secondary end sections 203 / 204, and one or more additional band segments 220 can be connected in between.

[0327] To provide alternative setting lengths, a number of band segments 220 of different predetermined lengths can be provided. For example, one or more band segments 220 with a length in the range of approximately 1 cm to approximately 10 cm or in the range of approximately 2 cm to approximately 6 cm can be provided. The band segments 220 have lengths of, for example, approximately 2 cm, approximately 4 cm, or approximately 6 cm. It is understood that these examples are not intended to be limiting and the length of each band segment can be arbitrarily large depending on the user and / or application.

[0328] Furthermore, each end 221, 222 of each band segment 220 can be connected to a corresponding end 221, 222 of another band segment 220 and / or to a corresponding secondary end section 203, 204 of the main band 210, thereby enabling a user to combine one or more band segments 220 of the same or different lengths to adjust the overall length of the extension as desired.

[0329] The additional band segments can be made of a soft and stretchy / elastic material, such as an elastic textile / fabric, that is comfortable for the wearer. For example, a tubular knitted headband or sections of headband 210 can be used, particularly for comfort over the user's ears.

[0330] It is understood that particular comfort can be achieved by a headband that is able to position the nose interface 100 in a relatively stable position on the face of a user, while at the same time ensuring a relatively loose fit or a fit with low tension around the user's head.

[0331] Alternatively, the additional belt segments can be made of an essentially rigid material such as a hard plastic material.

[0332] A band connector 230 is provided at each of the secondary end sections 203, 204 of the main band 210 and at the respective end sections 203, 204 of the band segments 220.

[0333] Each connector 230 is equipped at one end with a tape connection mechanism for connection to the tape material and a coupling mechanism at an opposite end for detachable connection of the respective end of a similar connector 230.

[0334] Alternatively, the connector 230 can be various forms of adjustable buckles suitable for adjusting the length or tension of the headband sections 210 that hold the patient interface in position around the head of a user.

[0335] It is also understood that the connector 230 can be positioned so that it is offset from the center of the back of a user's head, or that it can be offset to one side of the user's head. This can be advantageous in order to avoid contact with a part of the user's head that might otherwise be uncomfortable for the user in certain positions, for example, while sleeping.

[0336] In yet another configuration, the band segments can have different lengths to be provided asymmetrically or to facilitate operation with an offset position of the connector 230. Furthermore, one of the two band segments 210 may be length-adjustable, while the other is not. For example, one band segment 210 may have a fixed length or be permanently connected to the connector 230.

[0337] In an exemplary configuration, the band connection mechanism can include a series of internal teeth located in the body of the connector to create a force-fit engagement with the respective end of the band. A hinged jaw of the body is provided and closes over the teeth to securely hold the end of the band on the teeth. The releasable coupling mechanism at the other end includes a pair of male and female elements, such as a projection and an opening, respectively, both suitable for connection with corresponding male and female elements of a similar connector 230. A projection on the projection can couple with a recess in the female element to allow a snap-fit ​​engagement between the elements.It is understood that in alternative configurations any other suitable connector configuration can be used to detachably connect the secondary end sections of the belt to each other and to the end sections of the additional belt segments.

[0338] Cannula connectors 240 are provided at the primary end sections 201 and 202 of the main band 210. These connectors 240 have a similar band connection mechanism to the band connectors 230 of the secondary end sections 203 and 204, but include a clip element, such as a plug-in clip 241, at one end of the connector 240, opposite the band ends. The clip 241 is configured to be detachably coupled to the respective formation 101, 102 on the side of the nasal interface 100. The clip element 241 can be a flexible part, for example, a plastic part that forms a hinged section relative to the band. The clip 241 can be pre-shaped to have a curved form along its length, for example, with an angle between 0 (flat) and 20 degrees. In some configurations, the Clip 241 may be pre-shaped to have a bend.The Clip 241 comprises at least two sections that are angled relative to each other. These two sections can be positioned at an angle between more than 0 degrees and 20 degrees. That is, the two sections can be approximately 180 degrees to each other or differ by up to 20 degrees from 180 degrees. This curvature or angle allows the Clip 241 to conform to the patient's facial contour in the area where the Clip 241 is applied.

[0339] The nasal incision can include sleeves 270. Each sleeve 270 can be pre-shaped to have a curved form along its length, for example, with an angle between 0 degrees (flat) and 20 degrees. The curvature allows the sleeve to conform to the contour of the patient's face or cheek in the area of ​​use. Alternatively, the sleeve 270 can assume the shape of a curved sleeve during the procedure with the primary end section 201, 202, or the connector 240 of the headgear 200.

[0340] The sleeve 270 provides a surface area made of a relatively higher-friction material for frictional contact with the user's face or facial skin. This surface area is to be positioned so that it makes frictional contact with the user's cheek skin. The surface area is limited at least to the band or band section that is to be positioned on the user's cheek. The surface area provided with the relatively higher-friction material can be made of a material that is smooth and comfortable against the patient's skin. The sleeve 270, or at least the surface area 271, is therefore made of a relatively softer material than the connector 240.

[0341] In one configuration, the surface area 271 or the sleeve 270 is formed from a soft thermoplastic elastomer (TPE), but can alternatively be formed from another plastic material such as silicone or other biocompatible materials.

[0342] Surface area 271 can be a surface with a larger surface area closer to the patient interface than the surface area farther from the patient interface. In one configuration, the sleeve 270 tapers from a relatively wider surface area 273 to a relatively smaller surface area 274 in a direction extending away from a connection point between the connector 240 and the nasal interface 100. The width of the sleeve at the end 273 can be equal to or similar to the width of the tapered distal end of the corresponding wing section 113, 114 of the facial attachment part 110. This provides a smooth transition between the nasal interface 100 and the head attachment to improve aesthetics and create a visually appealing effect.

[0343] The sleeves 270 can be colored to allow identification of the nasal interface 100. As described here, the nasal interfaces can be provided in different sizes, for example, small, medium, and large. The sleeves 270 of each of these sizes can have different colors to represent the different sizes. Alternatively or additionally, the sleeves can be colored in a specific way to indicate that the nasal interfaces have asymmetrical rather than symmetrical nasal delivery elements.

[0344] Head restraints for other interface types, in addition to the nasal cannula, may include cheek rests 270 as described or similar, at or beside both lateral ends of the interface's head restraint straps that connect to the nasal interface, to engage frictionally with the user's face to stabilize the mask against the cheeks. Such a head restraint may, in turn, include a single head strap that, during use, extends along the patient's cheeks, over the ears, and around the back of the head, the ends of which include clips of any suitable shape that connect to (or are permanently attached to) the nasal interface on both sides.

[0345] With reference to Fig.In the configuration shown, patient interface 1 (1A-1C) includes a tube retaining clip 280. The tube retaining clip 280 can support the patient line 300 or another gas supply tube from a portion of the patient interface 1. By supporting the patient line 300 or other gas supply tube at or near the nasal interface 100, the tube retaining clip 280 resists a bending moment exerted on the patient line 300 or other gas supply tube 300 as a result of the asymmetrical flow through the first and second ports 111, 112 and / or movement of the patient's head, thereby increasing patient comfort.

[0346] In the configuration shown, the hose retaining clip 280 comprises a tubular body 281 for receiving and accommodating part of the patient line 300 or another gas supply hose therein.

[0347] In the configuration shown, the tube retaining clip 280 supports the patient line 300 or another gas supply tube from the head mount of the patient interface. In an alternative configuration, the tube retaining clip 280 could support the patient line 300 or another gas supply tube from a portion of the nasal interface 100 of the patient interface. For example, the tube retaining clip 280 could support the patient line 300 or another gas supply tube from the cannula body 118 or another portion of the face attachment part 110. In some configurations, the tube retaining clip 280 could support the patient interface at one or both of the wing sections 114, 115 of the nasal interface 100.

[0348] A hook 282 protrudes from the body 281 to couple the band or another component of the headgear. In this way, the line 300 can be coupled to or attached to the headgear 210 or the headgear during use. When the line 300 is pulled, the force is applied to the headgear 210 and not directly to the cannula 100. This force distribution reduces the likelihood of the prongs 111 and 112 of the nasal interface 100 being dislodged from the patient's nostrils.

[0349] A projection or ridge is provided at or near the free end of the hook 282. The projection extends inwards towards the body 281. The projection or ridge narrows the gap at the entrance of the hook, which helps to hold the clip on a webbing when the hook is engaged; that is, the webbing does not slip out of the hook channel. This also provides the advantage of holding the hook on the webbing when it is clipped in a bottom-up direction – the projection or ridge holds the hook against gravity on the webbing.

[0350] The head mount may have one or more attachment points for connecting the hose retaining clip 280, preferably at least two symmetrical attachment points on both sides of the head mount to increase ease of use.

[0351] It is also understood that the hose retaining clip 280 can be detachable from the patient line 300 or another gas supply hose, or can be permanently connected to it.

[0352] The hose retaining clip 280 could have any suitable shape. In an alternative configuration, the hose retaining clip 280 could include or consist of a band or loop. The loop could be a woven, elastomeric, or textile band or loop.

[0353] The retaining clip 280 can be connected to or held in place by a part of the patient interface 1, for example, a part of the interface that provides a relatively rigid area (such as to facilitate support of the patient line 300). The retaining clip can also be positioned or attached at a specific point on the patient line 300; for example, a predefined point may be provided that holds the retaining clip in place.

[0354] The patient interface 1 may incorporate one or more of the features and functions described in PCT Publication No. WO 2014 / 182179 or US Patent No. 10,406,311. The contents of these specifications are incorporated herein by reference.

[0355] As an alternative to a head restraint, 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.

[0356] With reference to Fig.In some configurations, a nose interface 100 of the present disclosure comprises a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other, and a gas distributor 120 with a gas inlet 121. The first nozzle 111 and the second nozzle 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 gases flowing into the gas inlet 121 is discharged from the nose interface through the first nozzle 111.

[0357] The gas inlet 121 can be located on one side of the gas distributor 120. In an alternative configuration, the gas inlet 121 can be located at a different location on the gas distributor 120. For example, the gas inlet 121 can enter at the front of the gas distributor 120, in or near the center of the gas distributor 120, or at or near one side of the gas distributor 120.

[0358] This can vary depending on the patient's breathing cycle and internal nasal geometry. The figures and proportions given here refer to the state in which the nasal interface is not worn and before any influence of the patient's breathing and / or nasal geometry.

[0359] For example, if a blower of a respiratory therapy device generates a flow of 100 liters per minute (l / min) and this is delivered into the gas inlet 121, at least about 60 l / min would flow through the first nozzle 111 and be delivered from the nasal interface 100 through the first nozzle 111.

[0360] The remainder of the total gas flow is discharged through the second port 112. In the example above, approximately 40 l / min or less would flow through the second port 112 and be discharged through the nose port 100. Alternatively, a portion of the remaining total gas flow can be vented into the atmosphere instead of being discharged through the first port 111 or the second port 112.

[0361] It can be assumed that the first nozzle 111 and the second nozzle are asymmetrical to each other.

[0362] The first nozzle 111 and the second nozzle 112 are asymmetrical to each other and / or are not symmetrical to each other and / or differ in shape and configuration from each other and / or are asymmetrical in comparison to each other.

[0363] The Nasal Interface 100 is configured to cause an asymmetric gas flow at, into and / or out of a patient's nostrils.

[0364] In some configurations, the nasal interface 100 includes a cannula body 118 which includes the first nozzle 111 and the second nozzle 112.

[0365] In some configurations, the gas distributor 120 is part of the cannula body 118 or separate from the cannula body 118 and can be coupled to it.

[0366] In some configurations, the first and second ports 111, 112 are configured to engage the nasal passages unsealed (non-sealing). In some configurations, at least the second port 112 is configured to engage a nasal passage in a non-sealing manner.

[0367] In some configurations, the first and second ports 111, 112 allow exhaled gases to escape around the first and second ports.

[0368] In some configurations, the first and second ports 111, 112 are configured to provide gases to the patient without interfering with the patient's spontaneous breathing.

[0369] The first nozzle 111 has a first nozzle outlet 111a, which is defined by an opening at its tip or connection end 111b for the release of gases from the first nozzle 111. Gases released through the first nozzle 111 leave the first nozzle via the first nozzle outlet 111a.

[0370] The second nozzle 112 has a second nozzle outlet 112a, which is defined by an opening at its tip or connection end 112b for the release of gases from the second nozzle 112. Gases released through the second nozzle 112 leave the second nozzle via the second nozzle outlet 112a.

[0371] With reference to Fig. 3 and Fig. 4A In some configurations of a nose interface 100, the first nozzle 111 has a larger inner diameter ID1 and / or a larger inner cross-sectional area A1 in a direction transverse to the gas flow GFD1 through the first nozzle 111 than a corresponding inner diameter ID2 and / or an inner cross-sectional area A2 of the second nozzle 112 in a direction transverse to the gas flow GFD2 through the second nozzle 112.

[0372] ID1, ID2, A1, and A2 can be measured at essentially the same location along the first nozzle 111 and the second nozzle 112 (e.g., at equal distances along the nozzle length from the base of each nozzle or from the outlet of each nozzle). This can be a useful reference for bent and / or angled nozzles. In some embodiments, ID1, ID2, A1, and A2 can be measured along the same plane. This can be a useful reference for straight nozzles.

[0373] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle 111, 112. Alternatively, the direction perpendicular to the gas flow could be at an acute or obtuse angle relative to the gas flow through the respective nozzle 111, 112.

[0374] The Nasal Interface 100 is configured to cause an asymmetrical gas flow at a patient's nostrils.

[0375] The inner diameter ID1, ID2 and / or the inner cross-sectional area A1, A2 could be essentially constant along the length of the nozzles 111, 112. Alternatively, the inner diameter ID1, ID2 and / or the inner cross-sectional area A1, A2 could vary along at least part of the length of the nozzles 111, 112. For example, the nozzles 111, 112 could taper from a wider degree at their bases near the cannula body 118 than at their tips or connecting ends 111b, 112b. The relevant inner diameter ID1, ID2 and the cross-sectional area A1, A2 could be located at the outlets 111a, 112a of the nozzles and / or at the distal sections of the nozzles 111, 112 adjacent to the outlets 111a, 112a.

[0376] The inner surface at the base of each nozzle 111, 112 may be rounded or chamfered to reduce the pressure and velocity drop of the gases when they change their flow direction within the manifold. This can help reduce noise and improve therapy delivery.

[0377] The nose interface 100 can be configured such that between approximately 60% and approximately 90% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100. The nose interface can be configured such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100. The nose interface can be configured such that between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100. The nose interface can be configured such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 are discharged through the first nozzle 111 from the nose interface 100.The nose interface can be configured such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100.

[0378] A flow rate ratio between nozzles 111 and 112 of at least approximately 60:40 has proven sufficient to realize the advantages of asymmetric flow described below. A ratio between approximately 70:30 and approximately 75:25 is considered optimal.

[0379] The fraction of the total volumetric flow rate delivered through each nozzle 111, 112 can be determined by delivering gases with a known volumetric flow rate to the gas inlet 121 of the nasal interface 100 while the nasal interface is not attached to a patient's nostrils. The volumetric flow rate exiting each outlet 111a, 112a can be measured with a suitable flow meter or sensor to determine the fraction of the total volumetric flow rate of the gases flowing into the gas inlet 121 that exits from the outlet 111a, 112a of each nozzle 111, 112.

[0380] The first nozzle 111 can have an inner diameter of between approximately 4 mm and approximately 10 mm, optionally between approximately 5 mm and approximately 9 mm, optionally between approximately 6 mm and approximately 8 mm, optionally approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm or any diameter between two of these diameters.

[0381] The second nozzle 112 can have an inner diameter of between approximately 2 mm and approximately 8 mm, optionally between approximately 3 mm and approximately 7 mm, optionally between approximately 4 mm and approximately 6 mm, optionally approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm or any diameter between two of these diameters.

[0382] In some configurations, the first nozzle 111 and / or the second nozzle 112 have a wall thickness between approximately 0.1 mm and approximately 0.5 mm. Therefore, twice the wall thickness can be added to the inner diameter values ​​to obtain the corresponding outer diameter values.

[0383] The nose interface 100 can be configured so that between approximately 75% and approximately 80% of the total gas flow is delivered through the first nozzle 111.

[0384] The nose interface 100 can be configured so that approximately 75% of the total gas flow is delivered through the first nozzle 111.

[0385] The nose interface 100 can be configured so that approximately 80% of the total gas flow is delivered through the first nozzle 111.

[0386] The first nozzle 111 can have an internal cross-sectional area A1 of approximately 15 mm² 2 and about 80 mm 2 , optionally between approximately 20 mm 2and about 75 mm 2 , optionally between approximately 25 mm 2 and about 70 mm 2 , optionally between approximately 30 mm 2 and about 65 mm 2 , optionally between approximately 35 mm 2 and about 60 mm 2 , optionally between approximately 40 mm 2 and about 55 mm 2 , optionally between approximately 45 mm 2 and about 50 mm 2 , optionally about 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2 , approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2, approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 , approximately 51 mm 2 , approximately 52 mm 2 , approximately 53 mm 2 , approximately 54 mm 2 , approximately 55 mm 2 , approximately 56 mm 2 , approximately 57 mm 2 , approximately 58 mm 2 , approximately 59 mm 2 , approximately 60 mm 2 , approximately 61 mm 2 , approximately 62 mm 2 , approximately 63 mm 2 , approximately 64 mm 2 , approximately 65 mm 2 , approximately 66 mm 2 , approximately 67 mm 2 , approximately 68 mm 2 , approximately 69 mm 2 , approximately 70 mm 2 , approximately 71 mm 2 , approximately 72 mm 2 , approximately 73 mm 2 , approximately 74 mm 2 , approximately 75 mm 2 , approximately 76 mm 2 , approximately 77 mm 2 , approximately 78 mm 2, approximately 79 mm 2 , approximately 80 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0387] The second nozzle 112 can have an internal cross-sectional area A2 of approximately 5 mm² 2 and about 50 mm 2 , optionally between approximately 10 mm 2 and about 45 mm 2 , optionally between approximately 15 mm 2 and about 40 mm 2 , optionally between approximately 20 mm 2 and about 35 mm 2 , optionally between approximately 25 mm 2 and about 30 mm 2 , optionally about 5 mm 2 , approximately 6 mm 2 , approximately 7 mm 2 , approximately 8 mm 2 , approximately 9 mm 2 , approximately 10 mm 2 , approximately 11 mm 2 , approximately 12 mm 2 , approximately 13 mm 2 , approximately 14 mm 2 , approximately 15 mm 2 , approximately 16 mm 2 , approximately 17 mm 2 , approximately 18 mm 2 , approximately 19 mm 2 , approximately 20 mm 2, approximately 21 mm 2 , approximately 22 mm 2 , approximately 23 mm 2 , approximately 24 mm 2 , approximately 25 mm 2 , approximately 26 mm 2 , approximately 27 mm 2 , approximately 28 mm 2 , approximately 29 mm 2 , approximately 30 mm 2 , approximately 31 mm 2 , approximately 32 mm 2 , approximately 33 mm 2 , approximately 34 mm 2 , approximately 35 mm 2 , approximately 36 mm 2 , approximately 37 mm 2 , approximately 38 mm 2 , approximately 39 mm 2 , approximately 40 mm 2 , approximately 41 mm 2 , approximately 42 mm 2 , approximately 43 mm 2 , approximately 44 mm 2 , approximately 45 mm 2 , approximately 46 mm 2 , approximately 47 mm 2 , approximately 48 mm 2 , approximately 49 mm 2 , approximately 50 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0388] Specific differences between the inner diameters ID1, ID2 and / or the inner cross-sectional areas A1, A2 can contribute to desired levels of asymmetry.

[0389] A combined internal cross-sectional area (A1 + A2) of the first nozzle 111 and the second nozzle 112 can be between approximately 20 mm 2 and about 130 mm 2 , optionally between approximately 30 mm 2 and about 120 mm 2 , optionally between approximately 40 mm 2 and approximately 110 mm 2 , optionally between approximately 50 mm 2 and about 100 mm 2 , optionally between approximately 60 mm 2 and about 90 mm 2 , optionally between approximately 70 mm 2 and about 80 mm 2 , optionally about 20 mm 2 , approximately 25 mm 2 , approximately 30 mm 2 , approximately 35 mm 2 , approximately 40 mm 2 , approximately 45 mm 2 , approximately 50 mm 2 , approximately 55 mm 2 , approximately 60 mm 2 , approximately 65 mm 2 , approximately 70 mm 2, approximately 75 mm 2 , approximately 80 mm 2 , approximately 85 mm 2 , approximately 90 mm 2 , approximately 95 mm 2 , approximately 100 mm 2 , approximately 105 mm 2 , approximately 110 mm 2 , approximately 115 mm 2 , approximately 120 mm 2 , approximately 125 mm 2 , approximately 130 mm 2 or any cross-sectional area between any two of these cross-sectional areas.

[0390] The ratio of the internal cross-sectional area A1 of the first nozzle 111 to the internal cross-sectional area A2 of the second nozzle 112 can be between approximately 60:40 and approximately 80:20; optionally between approximately 65:35 and approximately 80:20; optionally between approximately 70:30 and approximately 80:20; optionally between approximately 70:30 and approximately 75:25; optionally approximately 70:30, approximately 71:29, approximately 72:28, approximately 73:27, approximately 74:26 or approximately 75:25; optionally between approximately 75:25 and 80:20; optionally approximately 75:25, approximately 76:24, approximately 77:23, approximately 78:22, approximately 79:21 or approximately 80:20.

[0391] With reference to Fig. 1C, Fig. 2 and Fig.In some configurations, the nasal interface 100 of the present disclosure comprises a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other, and a gas distributor 120 with a gas inlet 121. The first nozzle 111 and the second nozzle 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to cause an asymmetrical gas flow at the nostrils of a patient. The nasal interface 100 is configured such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged from the nasal interface 100 through the first nozzle 111 when the total volumetric flow rate of the gases into the gas inlet 121 is between approximately 5 liters per minute (l / min) and approximately 70 l / min. In some configurations, the total volumetric flow rate of the gases flowing into gas inlet 121 is at least approximately 5 l / min.In some configurations, the total volumetric flow rate of the gases flowing into gas inlet 121 is more than approximately 5 l / min. In some configurations, the total volumetric flow rate of the gases flowing into gas inlet 121 is between approximately 5 l / min and approximately 120 l / min. In some configurations, the total volumetric flow rate of the gases flowing into gas inlet 121 is between approximately 5 l / min and approximately 70 l / min.

[0392] The nose interface 100 can be configured such that between approximately 70% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100, when the total volumetric flow rate of the gases into the gas inlet is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0393] The nose interface 100 can be configured such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100, when the total volumetric flow rate of the gases into the gas inlet 121 is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0394] The nose interface 100 can be configured such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100, when the total volumetric flow rate of the gases into the gas inlet 121 is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0395] The nose interface 100 can be configured such that approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface 100, if the total volumetric flow rate of the gases into the gas inlet 121 is between approximately 5 liters per minute (l / min) and approximately 70 l / min.

[0396] The nose interface can be configured such that the degree of flow asymmetry from the first nozzle 111 and the second nozzle 112 is a function of the total flow rate of the gases flowing into the gas inlet 121. A higher total flow rate of the gases flowing into the gas inlet 121 generally results in a larger proportion of the total volumetric flow rate of the gas flow through the first nozzle 111 being discharged from the nose interface 100, and a lower total flow rate of the gas flow into the gas inlet 121 results in a smaller proportion of the total volumetric flow rate of the gas flow from the nose interface 100 being discharged through the first nozzle 111.

[0397] Table 1 shows the volumetric flow rate for a test bench of an exemplary nasal cannula. Table 1 Total volumetric flow rate into the gas inlet: 121 l / min Flow rate from the first nozzle: 111 l / min Flow rate from the second nozzle: 112 l / min Flow ratio of second nozzle to first nozzle (l / min) 9, 6 7,1 2,5 2, 84 19 13,6 5,4 2,52 29,1 21 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

[0398] Tests and modeling show that the use of asymmetrical nozzles 111, 112 in the nasal interfaces 100 of the present disclosure can achieve a reduction in dead space (i.e., the volume of air that would have to be re-inhaled at the beginning of inspiration). This is most noticeable at higher flow rates, higher respiratory rates, and higher degrees of asymmetry. It is assumed that some of the gas in the patient's upper airways moves in one direction, flowing into one nostril and out of the other, thereby reducing dead space in the upper airways. Increased pressure during exhalation leads to a slowing of the respiratory rate. A slowing of the respiratory rate also results in a longer expiratory phase compared to the inspiratory phase. A reduced respiratory rate prolongs the time at the end of expiration during which the upper airways are ventilated.

[0399] It was found that dead space clearance improves with the degree of asymmetry. For example, at a total volumetric flow rate of 30 l / min and a respiratory rate of 45 breaths per minute, a nasal interface with symmetrical nozzles results in an anatomical dead space of approximately 87 ml; a nasal interface 100 of the present disclosure with a ratio of the internal cross-sectional area of ​​the first nozzle 111 to the second nozzle 112 of 60:40 results in an anatomical dead space of approximately 80 ml; and a nasal interface 100 of the present disclosure with a ratio of the cross-sectional area of ​​the first nozzle 111 to the second nozzle 112 of 70:30 results in an anatomical dead space of approximately 78 ml. The respective values ​​change to approximately 66 ml, approximately 62 ml, and approximately 36 ml at 50 l / min and to approximately 49 ml, 41 ml, and 21 ml at 70 l / min.

[0400] Fig.Figures 6(a)-6(e) show the dependence of dead space clearance on the volume of the upper airways, the respiratory rate and the flow rate. Fig. 6(a)-6(c) show results for larger upper airways and Fig. 6(d) and Fig. 6(e) show results for smaller upper airways. The results relate to the Fisher & Paykel Healthcare Limited Optiflow™+ OPT944 (medium) cannula, the Fisher & Paykel Healthcare Limited Optiflow™+ 946 (large) cannula, a medium 100' nasal incision as described in the present disclosure, and a large 100'' nasal incision as described in the present disclosure.

[0401] Fig.Figure 7 shows the effect of the degree of nostril closure. Increasing nostril closure increases the pressure exerted on the patient at a given gas flow rate. In the asymmetric nasal interface of this disclosure, the reduced cross-sectional area of ​​the small second nozzle 112 helps to prevent simultaneous closure of both nostrils. A significantly smaller nasal interface may be uncomfortable and noisy due to the expulsion and high velocity of the gas in the patient's nose. The pressure drop or flow resistance of a significantly smaller nasal interface may limit the flow range that can be provided by a flow generator. A significantly larger nasal interface may be less likely to fit the patient comfortably, as the nozzles may contact either the nasal septum or the alar lobes.With a larger nozzle according to the present disclosure, the lower gas velocity can lead to a quieter gas discharge.

[0402] With reference to Fig. 4A to 4C, the nose interfaces 100 can be provided in several sizes, such as the small nose interface 100 ( Fig. 4A), middle nose interface 100' ( Fig. 4B) and large nose interface 100'' ( Fig. 4C). The wings 113, 113', 113", 114, 114', 114" generally have the same spacing and dimensions for each nose interface size to allow the use of all nose interfaces with the same head harness. The size and spacing of the nose prongs may differ for the small nose interface 100, the medium nose interface 100', and the large nose interface 100" respectively.

[0403] The nasal interfaces 100' and 100'' may have one or more of the features and / or functions described and shown herein for nasal interface 100. Identical reference numerals denote identical parts with the addition of a single dash (') for the middle nasal interface 100' and a double dash (") for the large nasal interface 100". It is understood that any reference herein to nasal interface 100 could instead be a reference to nasal interface 100' or nasal interface 100''.

[0404] The 100' and 100'' nasal interfaces can be used in any of the combinations, systems, or applications described herein for the 100 nasal interface.

[0405] Exemplary dimensions are given below in Table 2. As shown in Table 2, for each nose interface size 100, 100', 100'', several different sizes of the first nozzle 111, 111', 111'' and / or the second nozzle 112, 112', 112'' may be available.

[0406] Table 2 shows exemplary dimensions and ratios for small, medium, and large nasal incision sites according to the present disclosure. It is understood that these are merely exemplary dimensions and may vary. Table 2 cannula size First nozzle 111 Inner diameter ID 1 (mm) First nozzle 111 Inner circumference (mm) First nozzle 111 Internal cross-sectional area A1 (mm²) 2 ) Second nozzle 112 inner diameter (mm) Second fitting 112 inner circumference (mm) Second nozzle 112 Internal cross-sectional area A2 (mm²) 2 ) Ratio of internal cross-sectional area A1 / A2 Combined internal cross-sectional area A1+A2 (mm²) 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

[0407] Referring to Fig.4A to 4C have, with respect to a vertical dimension, a flow center C1 for the first nozzle and a flow center C2 for the second nozzle at the same height above a central axis CA of the gas distributor 120 and the cannula body 118, 118', 118'' for each nasal interface size 100, 100', 100''. This is indicated by the constant distance between the upper and lower dashed lines in Fig. 4A, Fig. 4B, Fig. 4C is specified. It is assumed that this offers advantages in terms of the easy removal of expiratory gases around the second nozzle 112, with the center of the inspiratory flow from the two outlets 111a, 112a being at the same level, thus increasing comfort and ease of use.

[0408] In alternative configurations, a lower edge of the outlet 111a, 111a', 111a'' of the first nozzle 111, 111', 111'' can be aligned with the lower edge of the outlet 112a, 112a', 112a'' of the second nozzle 112, 112', 112'', or an upper edge of the outlet 111a, 111a', 111a'' of the first nozzle 111, 111', 111'' can be aligned with the upper edge of the outlet 112a, 112a', 112a'' of the second nozzle 112, 112', 112''.

[0409] Fig. Figure 8 shows exemplary septum spacings and stub heights for the 100 small nasal incision, the 100 medium nasal incision and the 100 large nasal incision.

[0410] At least the large first prong (111, 111', 111'') and optionally the small second prong (112, 112', 112'') are made of soft material and are thin-walled to allow them to deform and adapt to different nasal geometries. The septum distance can be optimized. This is because the septum comes into contact with the prongs closer to its base than to the outer nasal skin (ala). The further this contact is from the base, the more flexible the nasal incision becomes. In the nasal vestibule, the septum wall is more sensitive and less tolerant of the pressure of the nasal incision than the yielding nostrils. Therefore, the septum distance D1 can be selected to minimize the contact between the prongs and the septum.

[0411] The gap or septum distance D1 between adjacent outer surfaces of the first nozzle 111, 111', 111'' and the second nozzle 112, 112', 112'' adjacent to a base of the first nozzle 111, 111', 111'' and the second nozzle 112, 112', 112'' can be between about 5 mm and about 15 mm, optionally between about 6 mm and about 14 mm, optionally between about 7 mm and about 13 mm, optionally between about 8 mm and about 12 mm, optionally between about 9 mm and about 11 mm, optionally about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm or any value between any two of these values.

[0412] Table 3 lists example dimensions. It is understood that other dimensions could also be used. Table 3 Nose interface Septum distance D1 (mm) First nozzle 111 Height D2 (mm) Height difference D3 between first port 111 and second port 112 (mm) Second nozzle height D2-D3 (mm) Small size 100 10 + / - 1,0 12,2+ / -1,5 1,2 11 + / -1,5 Medium size 100' 9, 9 + / -1, 0 14, 6+ / -1,5 1, 4 13,2 + / -1,5 Large size 100' 9,8 + / -1,0 17,7+ / -1,5 1,86 15,84+ / - 1,5

[0413] In some configurations, the nasal interface 100, 100', 100'' comprises a cannula body 118, 118', 118'' which includes the first port 111, 111', 111'' and the second port 112, 112', 112''. An outer surface of the cannula body between the first and second ports has a recess 118e (as shown schematically in dashed lines in Figure 1). Fig. 3 shown), to capture part of a patient's nose and reduce the pressure on the underside of the captured part.

[0414] In the configuration shown, the recess 118e comprises a hollowed-out outer section and / or a submerged outer profile in an upper surface of the cannula body 118, 118', 118'' between the bases of the nozzles 111 and 112 to alleviate pressure on the septum / columella in order to increase patient comfort and reduce pressure damage to the columella and philtrum.

[0415] The recess should be as large as possible without significantly impairing the flow supplied to the patient. The recessed section can be complementary to the circumference 123a, 123a' of the outlet 123, 123' of the gas distributor 120, 120' (as, for example, in Fig. 9 and Fig. (10 shown), to maintain an effective seal between the cannula body 118, 118', 118'' and the gas distributor 120, 120'. The recessed section can be accommodated in the outlet 123 of the gas distributor.

[0416] The combination of the recess 118e in the outer surface of the cannula body 118 and the lower flow rate required for a specific flushing volume using the asymmetric nozzles 111, 112 together increases patient comfort.

[0417] With reference to Fig.In Figures 1C, 2 to 3, and 4A to 4C, a nose interface 100 of the present disclosure comprises, in some configurations, a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other, as well as a gas distributor 120 comprising a gas inlet 121. The first nozzle 111 and the second nozzle 112 are in fluid communication with the gas inlet 121. The first nozzle 111 has a larger internal cross-sectional area A1 in a direction transverse to the gas flow GFD1 through the first nozzle 111 than a corresponding internal cross-sectional area A2 of the second nozzle 112 in a direction transverse to the gas flow GFD2 through the second nozzle 112.The second nozzle 112 has a substantially oval or elliptical cross-sectional shape in the direction transverse to the gas flow GFD2 through the second nozzle, wherein the substantially oval or substantially elliptical cross-sectional shape has a first ratio of a widest dimension to a narrowest dimension, and the first nozzle 111 has a less oval or less elliptical cross-sectional shape in the direction transverse to the gas flow GFD1 through the first nozzle 111. The less oval or less elliptical cross-sectional shape of the first nozzle can either have a second ratio of a widest dimension to a narrowest dimension that is smaller than the first ratio, or a substantially circular cross-sectional shape.

[0418] In an alternative configuration, both nozzles 111, 112 can have essentially the same cross-sectional shapes in the direction perpendicular to the gas flow through the respective nozzles. For example, both nozzles 111, 112 can have an essentially circular cross-sectional shape, or they can have different shapes.

[0419] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle. Alternatively, the direction perpendicular to the gas flow could be at an acute or obtuse angle relative to the gas flow through the respective nozzle 111, 112.

[0420] The internal cross-sectional areas A1, A2 and / or the internal cross-sectional shapes could be essentially constant along the length of the nozzles 111, 112. Alternatively, the internal cross-sectional areas A1, A2 and / or the internal cross-sectional shapes could vary at least over part of the length of the nozzles 111, 112. The internal cross-sectional areas and internal cross-sectional shapes of the first and second nozzles could be located at the outlets 111a, 112a of the first and second nozzles 111, 112 and / or at the distal sections of the first and second nozzles 111, 112 adjacent to the outlets 111a, 112a.

[0421] The first fitting 111 is more flexible than the second fitting 112. This may be due to the fact that the first fitting 111 has a thinner wall compared to the overall width of the first fitting than the second fitting.

[0422] The larger first tube 111 may be more comfortable if it has a less oval, less elliptical or more circular cross-sectional shape, so that it can most easily adapt to the shape of the patient's nasal cavity.

[0423] The smaller second tube 112 is less flexible. Because the second tube 112 has an essentially oval or essentially elliptical cross-sectional shape, it can adapt to the shape of the patient's nasal cavity when at rest.

[0424] In some example configurations, the first ratio is greater than 1.0. In some configurations, the first ratio is at least approximately 1.05, optionally at least approximately 1.1, optionally at least approximately 1.2, optionally at least approximately 1.3, optionally at least approximately 1.4, optionally at least approximately 1.5, optionally at least approximately 1.6, at least approximately 1.7, optionally at least approximately 1.8, optionally at least approximately 1.9, optionally at least approximately 2.0, optionally more than approximately 2.

[0425] In some example configurations, the second ratio is approximately 1.

[0426] With reference to Fig. 13 and Fig. 14. The first nozzle 111 has a first connection end 111b next to the first opening 111a. The second nozzle 112 has a second connection end 112b next to the second opening 112a.

[0427] With reference to Fig.14(a) the first connecting end 111b comprises a substantially corrugated surface. The corrugated surface is defined by the dashed line A in Fig. 14(a) and Fig. 14(c) shown.

[0428] In the configuration shown, a lower section of the corrugated surface is concave when viewed from the outside of the first nozzle 111 towards the opening 111a. An upper part of the corrugated surface may be convex when viewed from the outside of the first nozzle towards the opening 111a. The combination of the concave lower part and the convex upper part results in an overall coiled shape.

[0429] With reference to Fig. 14(b) and Fig. 14(c) the second connecting end 112b has a less corrugated surface. The surface is defined by the dashed line B in Fig. 14(b) and Fig.Figure 14(c) shows that although the surface of the second terminal end is concave when viewed from the outside of the second nozzle 112 towards the opening 112a, the degree of concavity or corrugation is less than that of the first nozzle 111. In some configurations, the surface of the second nozzle may be essentially flat.

[0430] The corrugated surface of the first nasal cone 111 can offer several advantages. The first nasal cone 111 can deform or warp more easily than if it had a flat surface, due to its lower structural rigidity. This allows the larger cone to sit more comfortably in the patient's nasal passage. Since the smaller second nasal cone 112 has greater clearance within the patient's nasal cavity, deformation of the second nasal cone 112 is unnecessary. With a corrugated surface, gases do not exit the nasal cone as a jet through a small opening. The corrugation provides a larger exit surface area at the cone's outlet, thus reducing the velocity of the gases at the point of exit.This means that the size of the outlet opening (defined by the edge or circumference of the cut-out section) is larger than the size or cross-sectional area of ​​the nasal cannula's inlet opening, which is defined by the base of the cannula where it connects to the facial attachment part 110. The velocity of the gases decreases with increasing surface area. That is, the cannula is shaped such that the velocity of the gases exiting the cannula is reduced compared to the velocity of the gases at or near the gas inlet point. This allows a proportionally larger volume of gas to be delivered to a patient without causing discomfort (compared to a nasal cannula without a corrugated surface). The corrugated surface reduces air jet effects.The jet of airflow is reduced based on the continuity equation for conservation of energy or mass, which states that an increase in cross-sectional area corresponds to a decrease in the velocity of the airflow. A jet of gas delivered into a user's nasal passage can irritate or potentially damage the tissue in the nasal passage. Reducing the velocity of the gas flow as it is delivered through the nasal conduit decreases irritation in the user's nostril and thus the jet effects. It also follows from the continuity equation that the larger the opening through which a gas flows, the greater the diffusion. The gas flow is generally directed posteriorly relative to a patient's nasal passage (relative to the patient's head).These effects may be more advantageous for the larger first nasal cone 111 than for the smaller second nasal cone 112, which has more clearance in the nostril during use.

[0431] In some configurations, the nasal interface 100 can be configured such that the gas velocities exiting the first port 111 and the second port 112 are substantially similar. An advantage of substantially similar exit velocities is patient comfort and a lower noise level. Patient comfort may result from the fact that less gas flows into, or does not flow into, the sensitive inner surface of the nostrils. In some configurations or applications, the nasal interface 100 disclosed herein may have a lower average exit velocity than a symmetrical nasal interface at the same flow rate, but may be perceived as more comfortable due to the reduced work of breathing.The reduction in respiratory work may be due to a greater dead space clearance of the nasal interface 100 compared to a symmetrical nasal interface at the same flow rate.

[0432] With reference to Fig. 3, Fig. 4A, Fig. 12(a) and Fig.For example, in some configurations, a nose interface 100 of the present disclosure comprises a gas inlet 121, a first nozzle 111, and a second nozzle 112, which are asymmetrical to each other, and wherein the first nozzle 111 has a first nozzle outlet 111a, and the second nozzle 112 has a second nozzle outlet 112a, as well as a gas flow path 122 from the gas inlet 121 to the first nozzle 111 and to the second nozzle 112. The first nozzle 111 has a larger internal cross-sectional area A1 in a direction transverse to the gas flow GFD1 through the first nozzle 111 than a corresponding internal cross-sectional area A2 of the second nozzle 112.For a given gas flow rate at the gas inlet 121 used, different gas flow rates are provided through the first nozzle 111 and the second nozzle 112, and the velocity of the gases exiting the first nozzle outlet 111a and the second nozzle outlet 112a is essentially similar.

[0433] The velocities mentioned in this section may be the average velocities of gases exiting the respective first nozzle outlet 111a and the second nozzle outlet 112a, and not velocity profiles or peak velocities. In some configurations, the velocities may be peak velocities.

[0434] In some configurations, the nasal interface is a non-sealing nasal interface.

[0435] Although different gas flow velocities are provided by the first nozzle 111 and the second nozzle 112, the larger first nozzle 111 has a greater flow and the smaller second nozzle 112 has a lesser flow, so that the outlet velocities from each nozzle are essentially similar.

[0436] In some configurations, the velocity of the gases leaving the first nozzle outlet 111a is within approximately 20% of the velocity of the gases leaving the second nozzle outlet 112a.

[0437] In some configurations, the velocity of the gases leaving the first nozzle outlet 111a is within approximately 16% of the velocity of the gases leaving the second nozzle outlet 112a.

[0438] In some configurations, at flow rates above approximately 42 l / min, the velocity of the gases leaving gas outlet 111a is within approximately 10% of the velocity of the gases leaving the second nozzle outlet 112a.

[0439] The inventors discovered an essentially linear trend between the total volumetric flow rate of the gases entering gas inlet 121 and the velocity of the gases exiting the first nozzle outlet 111a and the second nozzle outlet 112a. That is, for a given increase in the total volumetric flow rate of the gas flow into the gas inlet, there is a corresponding increase in the average gas flow from the two outlets 111a and 112a.

[0440] In some configurations, the velocity of the gases exiting each of the first nozzle outlet 11a and the second nozzle outlet 112a is greater than 0 m / s and less than about 32 m / s for a total volumetric flow rate of a gas flow into the gas inlet 121 of greater than 0 l / min and up to about 70 l / min.

[0441] In some configurations, the velocity of the gases exiting each of the first nozzle outlet 111a and the second nozzle outlet 112a is greater than 0 m / s and less than 32 m / s for a total volumetric flow rate of a gas flow into the gas inlet 121 of greater than 0 l / min and up to about 70 l / min.

[0442] In some configurations, the velocity of the gases exiting each of the first nozzle outlet 111a and the second nozzle outlet 112a is more than about 2 m / s and less than about 32 m / s, optionally more than about 2 m / s and less than 32 m / s, optionally more than about 2 m / s and up to about 25 m / s, and optionally more than about 2.5 m / s and up to about 20 m / s for a total volumetric flow rate of a gas flow into the gas inlet of more than 9 l / min and up to about 70 l / min.

[0443] The outlet velocity values ​​and relationships are configured such that the first nozzle 111 is located further away from the gas inlet 121, and the second nozzle is located closer to the gas inlet 121. If the configuration were reversed, depending on the balance of the gas distributor 120, there could be a small change (e.g., less than approximately 20%) in the velocities, with the first nozzle 111 being closer to the gas inlet 121 and the second nozzle 112 being further away. The first nozzle 111 could have a higher flow rate and a higher average outlet velocity when it is located further away from the gas inlet 121 than when it is located closer to it. Similarly, the second nozzle 112 could have a higher flow rate and a higher average outlet velocity when it is located further away from the gas inlet 121 than when it is located closer to it.

[0444] The speeds described above apply to a medium-sized nose interface of 100'. The speeds for the small nose interface of 100 or the large nose interface of 100'' can decrease or increase proportionally from these values ​​with the change in the internal cross-sectional area of ​​the nozzles.

[0445] In some configurations, the nose interface 100 is configured such that the total volumetric flow rate of the gases flowing into the gas inlet 121 is at least about 5 liters per minute (l / min).

[0446] In some configurations, the nose interface 100 is configured such that the total volumetric flow rate of the gases flowing into the gas inlet 121 is between about 5 l / min and about 120 l / min.

[0447] In some configurations, the nose interface 100 is configured such that the total volumetric flow rate of the gases flowing into the gas inlet 121 is between about 5 l / min and about 70 l / min.

[0448] In some configurations, the nose interface 100 is configured such that approximately 7 l / min are discharged from the nose interface 100 through the first nozzle 111 at a volumetric flow rate of approximately 9.5 l / min at the gas inlet 121, and / or such that approximately 13.5 l / min are discharged from the nose interface 100 through the first nozzle 111 at a volumetric flow rate of approximately 19 l / min at the gas inlet 121, and / or such that approximately 21 l / min are discharged from the nose interface 100 through the first nozzle 111 at a volumetric flow rate of approximately 29 l / min at the gas inlet 121, and / or such that approximately 28 l / min are discharged from the nose interface 100 through the first nozzle 111 at a volumetric flow rate of approximately 38.5 l / min at the gas inlet 121, and / or approximately 35 l / min are discharged from the nose interface through the first nozzle at a volumetric flow rate of 47.5 l / min at the gas inlet, and / or so,that approximately 44 l / min are discharged from the nose interface 100 through the first nozzle 111 at a volumetric flow rate of approximately 58 l / min at the gas inlet 121 and / or approximately 48.5 l / min are discharged from the nose interface 100 through the first nozzle 111 at a volumetric flow rate of 64 l / min at the gas inlet 121.

[0449] The remainder of the volumetric flow rate of a gas flow is typically discharged through the second nozzle 112 from the nose interface. Table 4 shows exemplary approximate flow rates. Table 4 Total volumetric flow rate at the gas inlet (l / min) Flow rate through the first nozzle 111 Flow rate through second nozzle 112 9, 5 7 2,5 19 13,5 5,5 29 21 8 38,5 28 10,5 47,5 35 12,5 58 44 14 64 48,5 15,5

[0450] The nose interface 100 can have all the features or functions described herein.

[0451] With reference to Fig. 3, Fig. 4A, Fig. 12(a) and Fig.For example, in some configurations, a nose interface 100 of the present disclosure comprises a gas inlet 121, a first nozzle 111, and a second nozzle 112, which are asymmetrical to each other, and a gas flow path 122 from the gas inlet 121 to the first nozzle and second nozzle. The first nozzle 111 has a larger internal cross-sectional area A1 in a direction transverse to the gas flow GFD1 through the first nozzle 111 than a corresponding internal cross-sectional area A2 of the second nozzle 112 in a direction transverse to the gas flow GFD2 through the second nozzle 112. The first nozzle 111 is located downstream of the second nozzle 112 in the gas flow path 122.

[0452] In some configurations, the direction perpendicular to the gas flow is essentially perpendicular or normal to the gas flow through the respective nozzle. Alternatively, the direction perpendicular to the gas flow could be at an acute or obtuse angle relative to the gas flow through the respective nozzle 111, 112.

[0453] The gas flow path 122 is defined by a flow channel or lumen 124 in the gas distributor 120. One gas flow direction GFD3 of the gas flow path 122 runs essentially perpendicular to the gas flow directions GFD1 and GFD2 of the gas flow paths through the first nozzle 111 and the second nozzle 112. The first nozzle is located further distal to the gas inlet 121, and the second nozzle is located further proximal to the gas inlet 121.

[0454] In the Fig.In the configuration shown in Figure 3, a first section 124a of the flow channel or lumen in the gas distributor 120 has a first large vertical dimension V1. An opposite end of the flow channel or lumen forms a flow cavity 124b in the cannula body 118, which discharges gases to the first and second ports 111, 112. The flow cavity 124b is in fluid communication with the flow channels through the first and second ports 111, 112 when the gas distributor 120 is positioned in the cannula body 118. At least a portion of the flow cavity 124b has a vertical dimension V2 that is smaller than the first vertical dimension V1.

[0455] The gas distributor 120 includes one or more angled inner walls to reduce the dimensions and to direct the gas flow into the first nozzle 111 and / or the second nozzle 112.

[0456] The gas distributor 120 is configured so that it does not block any part of the inner cross-section of the nozzles 111 and 112. In an alternative configuration, the distributor can be configured so that it partially blocks the inner cross-section of one or both nozzles 111 and 112.

[0457] Test benches have shown a reduction in the anatomical dead space when the larger first nozzle 111 is located further distal to the gas inlet 121 and the smaller second nozzle 112 is located further proximal to the gas inlet 121, as shown in the Fig. This is evident from the results shown in Figure 11. This may be a consequence of the opposite angled wall in the distributor, which helps to direct gases into the larger first nozzle 111.

[0458] In Fig.11. References to M, L, XL, and XXL refer to the size of the nosebands used in the tests. For example, L+M refers to a noseband with one large noseband and one medium noseband, XL+M refers to a noseband with one extra-large noseband and one medium noseband, and XXL+M refers to a noseband with one extra-large noseband and one medium noseband.

[0459] As outlined above, the nose interface can be configured such that at least approximately 60% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface; optionally, such that between approximately 60% and approximately 90% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface; optionally, such that between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface; optionally, such that between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface; optionally, such that between approximately 70% % and approximately 80% of the total volumetric flow rate of the gases,the gases flowing into the gas inlet 121 are discharged through the first nozzle 111 from the nose interface, optionally such that between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface, optionally such that approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface, optionally such that between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface, optionally such that approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121 is discharged through the first nozzle 111 from the nose interface optionally, such that approximately 80% of the total volumetric flow rate of the gases,which flow into the gas inlet 121, are discharged through the first nozzle 111 from the nose interface.

[0460] In some configurations, a nasal interface 100 disclosed herein comprises a cannula body 118 with a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other, and a gas distributor 120 with a gas inlet 121. The first nozzle 111 and the second nozzle 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to cause an asymmetrical gas flow at the nostrils of a patient.

[0461] The cannula body 118 comprises a first port 111 and a second port 112. The gas distributor 120 is positioned relative to the cannula body 118 between a first configuration, e.g., as in Fig. 12(a) and Fig. 12(b) shown, and in a second configuration, e.g. as in Fig. 12(c) and Fig.Figure 12(d) shows a reconfigurable gas distributor 120 inserted into the cannula body 118 from a first side, such that the second nozzle 112 is located further proximal to the gas inlet 121 and the first nozzle 111 is located further distal to the gas inlet 121. The second configuration corresponds to the gas distributor 120 inserted into the cannula body 118 from a second side, such that the first nozzle 111 is located further proximal to the gas inlet 121 and the second nozzle 112 is located further distal to the gas inlet 121.

[0462] The gas distributor may include a flow channel or lumen having a gas flow direction GFD3 that is substantially perpendicular to the gas flow directions GFD1, GFD2 through the first nozzle 111 and the second nozzle 112.

[0463] The cannula body 118 and / or the gas distributor 120 may include retention feature(s) to detachably hold the gas distributor 120 engaged with the cannula body 118 in the first and second configurations.

[0464] In the configuration shown, the retention features comprise an elastic annular section 118c of the cannula body, which is received in a complementary recess 120a of the gas distributor to hold the gas distributor 120 removably engaged with the cannula body 118. The elastic annular section 118c can be bent to allow the gas distributor 120 to be removed from the cannula body 118. The annular section can be circular or non-circular.

[0465] Additionally or alternatively, the gas distributor can be 120, as in Fig.Figure 3 shows a retaining flange 120b encompassing a surface thereof, which is removably received in a complementary elastic rim 118d of the cannula body 118. The engagement of the retaining flange 120b with the complementary elastic rim 118d of the cannula body 118 supports the formation of a seal between the gas distributor 120 and the cannula body 118.

[0466] Any other suitable type of retaining feature(s) could be used, such as clips or fasteners.

[0467] By changing the position of the gas distributor 120 relative to the cannula body 118, a user can adjust the position of the gas line 300 according to comfort and the location of the respiratory therapy device. Furthermore, this change allows the user to select the degree of asymmetry in the gas flow from the ports 111 and 112, which can be advantageous depending on the desired application or patient requirements.

[0468] In some configurations, a nasal interface 100 disclosed herein comprises a first port 111 and a second port 112, as well as a gas distributor 120 with a gas inlet 121. The first port 111 and the second port 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to produce an asymmetric gas flow at the nostrils of a patient. The gas inlet 121 is in fluid communication with a breathing tube.

[0469] For example, conduit 300 may include a breathing tube. A breathing tube is a tube in which water vapor can pass through the tube wall, but liquid water and most gases cannot. For example, water vapor may be able to pass through the material and / or the sealing membrane of the tube wall, but liquid water and a mass flow of gases cannot.

[0470] The 300-meter pipe could, for example, be made of an open-cell foam with a sealing skin.

[0471] In an alternative configuration, line 300 could comprise a thin film. Fig.Figure 22A schematically shows an exemplary method for manufacturing a single-walled breathing tube. This method may be particularly suitable for thin-walled conduits. The thin film 306 is arranged in a spiral or helix such that the edge sections of adjacent layers overlap and form the wall of a breathing gas conduit 300. Between the overlapping edges of adjacent turns of the film 306 is a reinforcing element comprising a bead 303 of polymer material, which is connected to the overlapping sections of the film 306, thus sealing the connection between the turns and forming a continuous breathing gas conduit 300. The seam is formed between the edge 305 of a first film layer 306 and the edge 307 of a second, adjacent film layer 306, which is placed over the polymer bead 303 while the bead is melted.Because the overlapping film layer is so thin, it follows the contour of the bead 303 very precisely, resulting in a smooth inner conductor wall. Another alternative, shown schematically in . Fig.As shown in Figure 22B, the bead 303 is not arranged between overlapping edges of adjacent turns of the film 306, but rather on both layers on an outer surface of the film 306. More precisely, the thin film 306 is first arranged in a spiral or helix such that edge sections of adjacent layers overlap. Then, the polymer bead 303 is arranged on the overlapping edges of the thin film 306 to form the breathing gas conduit 300. In some configurations, the bead 303 can be arranged on an inner surface of the film 306, so that the bead 303 is exposed to the lumen of the gas conduit 300. In such configurations, the elongated film is wound around the outside of the bead 303, so that the bead 303 interacts with the lumen of the gas conduit 300 and the film 306 forms the outer surface of the gas conduit 300.

[0472] The 300 tube may have one or more features described in U.S. Patent Application No. 2019 / 0224439 entitled "Breathing circuit components for respiratory apparatus" or U.S. Patent Application No. 2017 / 0304578 entitled "Tubes for medical systems." The contents of these specifications are incorporated herein by reference.

[0473] In an alternative configuration, a tube between patient line 300 and gas inlet 121 can contain the breathing tube. The breathing tube connects patient line 300 fluidically to gas inlet 121.

[0474] The gas distributor 120 can be formed as a single piece with the breathing tube or connected to the breathing tube.

[0475] The fluid connection of the gas inlets 121 to a breathing tube is advantageous when the patient interfaces are used with humidified gases. The breathing tube allows for high humidity while simultaneously reducing the risk of condensation forming in the airflow path due to rainfall.

[0476] If, at the nose interfaces 100, 100', 100" of the present disclosure, the inner diameter ID1 of the nozzle is larger than the width of the distributor 120, part of the interior of the nozzle 111, 112 is restricted and increased noise levels could occur. The gas distributor 120 is advantageously configured such that the distributor width is equal to or larger than the nozzle inner diameter ID1.

[0477] Fig. 9(a) and Fig.Figure 9(b) shows an exemplary gas distributor 120 that can be used with the small nose interface 100. The width W of the gas flow path 122 adjacent to the first and second nozzles 111, 112 is equal to or greater than the inner diameter ID1 of the first nozzle 111. For example, the width W of the gas flow path 122 can be at least approximately 1.2 times the inner diameter ID1 of the first nozzle 111. Exemplary dimensions are ID1 = 5.6 mm and B = 6.8 mm, although it is clear that the dimensions can vary.

[0478] Fig. 10(a) and Fig.Figure 10(b) shows an exemplary gas distributor 120' which can be used with the medium nose port 100' or the large nose port 100". Identical reference numerals denote identical parts of the gas distributor 120 with the addition of a dash ('). The width W' of the gas flow path 122' adjacent to the first and second ports 111', 112' used is equal to or greater than the inner diameter ID1 of the first port 111' of the medium nose port 100'. For example, the width W' of the gas flow path 122' can be at least approximately 1.04 times the inner diameter ID1 of the first port 111'. Exemplary dimensions are ID1 = 7.5 mm and W' = 7.8 mm, although it is clear that the dimensions can vary.

[0479] The gas distributor 120' can also be used with the large nose interface 100'' and still reduce noise, even if the inner diameter of the first nozzle 111'' of the large nose interface 100'' may be larger than the width W'', for example at 9.4'' mm.

[0480] It is understood that these are only exemplary dimensions and the dimensions of the nose interface nozzles 100, 100', 100'' and the gas distributors 120, 120' may vary.

[0481] The nose interfaces 100, 100', 100'' described herein may have one or more of the features and / or functions described in PCT Publication No. WO 2015 / 020540 or U.S. Patent No. 10,569,043. The contents of these specifications are incorporated herein by reference.

[0482] In the configurations shown, the larger first nasal port 111, 111', 111'' is located on one side of the cannula body 118, and the smaller second nasal port 112, 112', 112'' is located on the other side of the cannula body 118. It is understood that these ports can be interchanged so that they are located on the opposite side of the figure. Alternatively, the nasal interface 100, 100', 100'' can be designed so that the left and right nasal ports can be interchanged.

[0483] When using the 100, 100', and 100'' nasal interfaces, pressure and flow in the nostrils can be measured and controlled simultaneously or separately. The flow can be continuous in one nostril while varying in the other depending on the breathing cycle. Different interfaces, each delivering an asymmetrical flow in the nose, can be used for the continuous delivery of supplemental oxygen and for providing a continuous or variable nasal high flow. One nasal nozzle element can be used to deliver oxygen, gases, aerosols, or the like to the patient, while another nasal nozzle can be used to deliver a higher airflow or a different flow of oxygen, gases, aerosols, or the like to the patient.Each nasal delivery element can deliver different flow rates to the patient and can be connected to different flow-generating elements.

[0484] The respiratory therapy systems disclosed herein, featuring nasal interfaces of 100, 100', and 100", can improve the performance of NHF therapy, particularly in the treatment of infants and children. They can reduce resistance compared to existing nasal interfaces and expand and enhance the functionality of ventilators without requiring any hardware or software modifications.

[0485] A useful asymmetrical airflow can be provided through a nasal incision using any form of pressure support, such as continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV). Anatomical dead space can be eliminated by transnasal, unidirectional airflow during increased airway pressure therapy, with one nostril sealed or used for inspiration from the device without trapping room air, and the other nostril used for expiration.

[0486] One port, and thus one nostril, can be connected to the inspiratory limb of a two-limb ventilator circuit or to a breathing tube in a single-limb ventilator circuit, such as a CPAP machine. The other port, and thus the other nostril, can be connected to conventional vent holes at the interface for pre-tensioned airflow or to the expiratory limb of a two-limb ventilator. Connection to the expiratory limb of a ventilator allows the use of flow fluctuations to control breathing in periodic breathing or central sleep apnea due to carbon dioxide clearance in the upper airways or rebreathing from the expiratory limb.

[0487] Opening the mouth can reduce the pressure exerted on the patient and improve the clearance of anatomical dead space. A mouthpiece can be inserted to maintain leakage and can also be connected to a negative pressure line or the expiratory limb to increase or control dead space clearance. The leakage rate can be configured to control the pressure.

[0488] To achieve a comfortable asymmetric airflow, high humidity may be necessary, such as that provided by devices known as AIRVO™ or ICON™ (AIRVO™ is a humidifier with an integrated flow generator, and ICON™ is a CPAP device manufactured by Fisher & Paykel Healthcare Limited), to prevent drying of the nasal epithelium. The comfort level of temperature and dew point can be determined from a ratio and can, but are not limited to, range from 27°C to 37°C, optionally 31°C to 37°C, or optionally 33°C to 37°C, and may depend on the airflow rate.

[0489] In some configurations, the system is configured to deliver gases with a relative humidity of up to 100% through the nasal interface.

[0490] In some configurations, the system is configured to deliver gases with an absolute humidity greater than approximately 33 mg / l through the nasal interface. In some configurations, the system is configured to deliver gases with an absolute humidity of up to approximately 44 mg / l through the nasal interface.

[0491] One or both nasal limbs may be fitted with fittings such as, but not limited to, sleeves and inserts to optimize NHF therapy. Sleeves described herein refer to any structure attached externally to a nasal delivery element of a nasal incision. Inserts, as described herein, refer to any structure inserted internally into a nasal delivery element of a nasal incision.

[0492] NHF therapy can be enhanced or optimized to provide a desired pressure profile and efficiently eliminate anatomical dead spaces. A smaller-diameter nasal delivery element of a nasal interface can generate a higher-velocity jet, which can clear the patient's dead space more effectively than a larger-diameter nasal delivery element. Efficient dead space clearance reduces the amount of carbon dioxide rebreathing that occurs. However, a larger diameter can reduce leakage around the nasal delivery element of the nasal interface and can result in a higher delivered pressure during both inhalation and exhalation. A larger diameter may be preferable in an acute situation, particularly if a patient is experiencing respiratory distress, as a higher expiratory pressure can lower the respiratory rate and improve ventilation.

[0493] By adding fittings to the nasal outlet elements of the nasal interface, it is possible to have nasal outlet elements that combine a smaller inner and a larger outer diameter to improve or optimize dead space clearance while maintaining high pressure at the same flow rate. A combination of a nasal outlet element with a large outer diameter and a smaller inner diameter can have similar pressure effects to a nasal outlet element with a large diameter and no insert, whereas a smaller inner diameter may generate less pressure. If the outer diameter is too large for a patient, the inspiratory pressure may become negative because the flow from the interface may be lower than the maximum inspiratory flow rate.

[0494] Generally, increasing the wall thickness of a nasal discharge device is not desirable, as it can become rigid inside the patient's nose, potentially damaging the inner surface of the nostrils and causing discomfort. However, by combining different shapes at the interface, it may be possible to leverage the combination of inner and outer diameters to provide the patient with soft nasal discharge devices that conform to the nostrils, thus maintaining patient comfort.

[0495] By attaching a sleeve to a nasal delivery element of a nasal interface, for example, the inner diameter of the nasal delivery element remains the same and can enable jet effects to efficiently eliminate the anatomical dead space, while the outer diameter is increased to reduce leakage around the nasal delivery element and can produce higher pressure fluctuations during breathing. The added sleeve can then be removed once the desired therapy has been delivered or the higher pressure is no longer required. A sleeve can also function as a one-way valve that inflates during exhalation, increasing the expiratory pressure. To prevent or avoid condensate buildup, a semipermeable material can be used, a vent can be introduced, or a combination of both can be employed.A sleeve can also be attached at the interface to reduce the outer diameter and thus also the inner diameter, which can enhance the jet effects, deflect or divide the flow from the center of the nose discharge element to the periphery, or combine both.

[0496] A second example is the addition of an insert within the nasal delivery element. This allows the inner diameter to be reduced to lower pressure and increase dead space clearance, while keeping the outer diameter the same. A smaller inner diameter enhances jet effects, diverts or splits the flow from the center of the nasal delivery element to the periphery, or can combine jet effects with a diversion or splitting of the flow from the center of the nasal delivery element to the periphery.

[0497] Other configurations may involve the use of a fitting that can block a nasal delivery element, thus allowing NHF delivery to the patient through the unblocked nasal delivery element; the use of fittings that can create asymmetrical flow; or the use of fittings that can make an asymmetrical interface symmetrical. Adding custom-fitted sleeves can reduce operating flow, which can result in less noise, a reduced need for supplemental oxygen, improved patient comfort, and the like. Reduced operating flow can also lead to reduced heating, water consumption, and other requirements. Only one interface is needed per patient, which can be customized to vary the pressure or dead space clearance.

[0498] Fig.Figure 20 shows the test results of the nasal interfaces of the present disclosure.

[0499] Fig. 20(a) shows how a nasal interface 100, 100', 100'' of the present disclosure can be used to achieve a larger occlusion area while maintaining safe clearance in one nostril. In the event of a device or system failure, the patient can continue to breathe through the nostrils with safe clearance.

[0500] Fig.Figure 20(b) shows test data demonstrating increased positive end-expiratory pressure (PEEP) and reduced rebreathing when using a nasal interface of the present disclosure with asymmetrical nozzles compared to a nasal interface with symmetrical nozzles when a nasal high flow of 30 liters per minute (l / min) is applied. The data are shown for 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 the rebreathing that occurs when no nasal high flow is applied.

[0501] Fig. 20(c) shows similar test data as Fig.20(b), however, for a nasal high flow of 60 l / min. The data are shown for 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 the rebreathing that occurs when no nasal high flow is applied.

[0502] The data suggest that the nasal high flow delivered via a nasal interface of the present disclosure with increased occlusion, compared to a nasal interface with symmetrical nozzles, may lead to greater positive airway pressure and dead space clearance, as well as reduced rebreathing.

[0503] Fig.Figure 21 shows the maximum airway pressure that can be achieved for each size of nasal interface of the present disclosure when the larger nozzle completely closes one of the patient's nostrils.

[0504] In particular, it shows Fig. 21. The airway pressure that can be achieved in a static state for each size of nasal port 100, 100', 100" when the larger port completely occludes one of the patient's nostrils. This represents the maximum possible occlusion for each nasal port 100, 100', 100" and, in turn, represents the maximum pressure that can be achieved in a static state.

[0505] The data show that even at maximum flow rate and with a possible user error resulting in the use of the wrong nose interface size (100, 100', 100"), the maximum pressure under static conditions is still within a safe range.

[0506] In the nasal interfaces 100, 100', 100'' of the present disclosure, the first nozzle 111 and the second nozzle 112 have a specific shape. The first nozzle 111 has a larger inner diameter ID1 and / or a larger inner cross-sectional area A1 in a direction transverse to the gas flow GFD1 through the first nozzle 111 than a corresponding inner diameter ID2 and / or inner cross-sectional area A2 of the second nozzle 112 in a direction transverse to the gas flow GFD2 through the second nozzle 112. At least the first nozzle 111 can be made of an elastomeric material that allows the first nozzle to deform and establish its shape when used in response to temperature and contact with the patient's nostrils.This means that the first nozzle 111 is configured so that, when using the nasal interface 100, 100', 100'', it deforms and establishes its shape in response to temperature and contact with the patient's nostrils.

[0507] In some configurations, the temperature can range from approximately 20°C to approximately 41°C, optionally from more than 20°C to approximately 41°C, optionally from approximately 31°C to approximately 41°C, optionally from approximately 36°C to approximately 39°C, optionally from approximately 37°C, or it can be any other suitable temperature that occurs during therapy. The temperature is generally above the ambient temperature.

[0508] In some configurations, the first nozzle 111 may be configured to deform during use, thereby fixing its shape to substantially match the internal shape of the patient's nostril. In alternative configurations, the first nozzle 111 may be configured to bend or deform in response to temperature and contact with the patient's nostrils to fix its shape, but may not substantially match the internal shape of the patient's nostrils once the shape is fixed. For example, one or more discrete sections of an outer surface of the first nozzle 111 may, during use, contact one or more discrete areas of the patient's nostril, causing the one or more discrete sections of the outer surface to deform and fix their shape.

[0509] The deformation and shaping process can be permanent. Alternatively, the deformation and shaping process can be reversible through the application of a suitable combination of temperature and time.

[0510] The elastomer material may exhibit time- and temperature-dependent properties at or below a desired therapy temperature to allow shape retention during use of at least the first nasal cone 111, thus better conforming to the patient's nostrils. For example, the elastomer material may exhibit compression deformation properties to facilitate shape retention. The elastomer material may also exhibit tensile deformation and / or stress relaxation properties, which are typically related to the compression deformation properties. Elastomer material exhibiting residual compression deformation, residual tensile deformation, and / or stress relaxation properties at or below the therapy temperature may reduce discomfort a user might experience during therapy due to the impact of a nasal cone on the inner surface of the nostril.

[0511] Both the first nozzle 111 and the second nozzle 112 can be made of the elastomer material. In this configuration, both the first nozzle 111 and the second nozzle 112 can deform during use and settle into their shapes. The cannula body 118, the first nozzle 111, and the second nozzle 112 can be made of the elastomer material. Alternatively, the second nozzle 112 can be made of a different material.

[0512] The elastomer material allows at least the larger first nozzle 111 and optionally the second nozzle 112 to deform and fix their shape during use in relation to the contact between the outside of the nozzle(s) and the inside of the patient's nostrils.

[0513] Since the larger first tube 111 may be dimensioned to have a smaller clearance than symmetrical tubes, it may increase comfort if the larger first tube 111 deforms during use and settles its shape to conform, at least partially, to the patient's nostrils.

[0514] To achieve this performance, at least the first port 111 of the patient interface, and optionally both ports 111 and 112 of the patient interface, are made of an elastomeric material that allows the port(s) to deform and lock into their shape at or below the temperature of the gases flowing through the ports 111 and 112 of the nasal interface. The material can be selected to prevent deformation at ambient temperatures, so that the ports do not lock into their shape when the nasal interface 100, 100', 100'' is not in use.

[0515] In some configurations, the elastomer material allows the first nozzle to deform and fix its shape so that, at therapeutic temperatures between approximately 31 °C and approximately 41 °C, optionally between approximately 36 °C and approximately 39 °C, optionally approximately 37 °C, it essentially matches the internal shape of the patient's nostrils.

[0516] In some configurations, the first nozzle 111 is not made of silicone and does not contain silicone, as it does not allow for shape retention at therapeutic temperatures.

[0517] In some configurations, at least the first nozzle 111 is made of a thermoplastic elastomer.

[0518] In some configurations, the elastomer material exhibits a compression set of between approximately 10% and approximately 50% at temperatures between approximately 20°C and approximately 40°C after 72 hours of testing according to Method A of ISO 815-1:2014.

[0519] In some configurations, the elastomer material exhibits a compression set of between approximately 10% and approximately 45%, optionally between approximately 10% and approximately 40%, optionally between approximately 10% and approximately 35%, optionally between approximately 10% and approximately 30%, optionally between approximately 10% and approximately 25%, optionally between approximately 10% and approximately 20%, optionally between approximately 11% and approximately 19%, optionally between approximately 12% and approximately 18%, optionally between approximately 13% and approximately 17%, optionally between approximately 14% and approximately 16%, optionally approximately 15% at temperatures between approximately 20°C and approximately 40°C after 72 hours when tested according to Method A of ISO 815-1:2014.

[0520] In some configurations, the elastomer material exhibits a compression set of between approximately 10% and approximately 45%, optionally between approximately 10% and approximately 40%, optionally between approximately 10% and approximately 35%, optionally between approximately 10% and approximately 30%, optionally between approximately 10% and approximately 25%, optionally between approximately 10% and approximately 20%, optionally between approximately 11% and approximately 19%, optionally between approximately 12% and approximately 18%, optionally between approximately 13% and approximately 17%, optionally between approximately 14% and approximately 16%, optionally approximately 15% at temperatures above approximately 20°C and up to approximately 35°C, optionally at temperatures above approximately 20°C and up to approximately 30°C, optionally at temperatures above approximately 20°C and up to approximately 25°C, optionally at a temperature of approximately 21°C, approximately 22°C, approximately 23°C, or approximately 24°C, or approximately 25 °C or higher after 72 hours when tested according to method A of ISO 815-1:2014.

[0521] The elastomer material can be selected so that the shape determination takes place at a temperature of approximately 23 °C or higher, which is generally above the ambient temperature but below the service temperature.

[0522] The elastomer material could include any elastomer that exhibits shape-retaining properties at therapeutic temperatures. In some configurations, the elastomer material THERMOLAST® K TF3STE - TPE - from Kraiburg TPE GmbH & Co. KG is used.

[0523] In addition to the elastomer material, the nose interfaces 100, 100', 100'' may also have one or more of the features described herein.

[0524] Patient interfaces 1 with nasal interfaces 100, 100', 100" according to the configurations described here can be used in a respiratory therapy procedure. The respiratory therapy procedure includes delivering gas to the airway of a patient who requires it, improving the ventilation of a patient who requires it, reducing the volume of anatomical dead space within the volume of the airway of a patient who requires it, and / or treating a respiratory disease in a patient who requires it, as described above.

[0525] Patient interfaces 1, comprising nasal interfaces 100, 100', 100'' of the type disclosed herein, can be used in a respiratory therapy system for the delivery of gases to a patient.

[0526] In some configurations, the respiratory therapy system 1000 includes a respiratory therapy unit 1100 and a patient interface 1, which includes a nasal interface 100, 100', 100''.

[0527] An exemplary respiratory therapy facility 1100 is located in Fig. 15 shown.

[0528] The respiratory therapy device 1100 comprises a main housing 1101, which contains a flow generator 1011 in the form of a motor / impeller assembly (e.g. a blower), an optional humidifier 1012 for humidifying gases, a control unit 1013 and a user interface 1014 (comprising, for example, a display and input device(s) such as button(s), a touchscreen or the like).

[0529] 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 a flow of gas (gas flow) for delivery to a patient; operating the humidifier 1012 (if present) to humidify and / or heat the generated gas flow; controlling an oxygen flow into the flow generator blower; receiving user input from the user interface 1014 for reconfiguration and / or user-defined operation of the device 1000; and outputting information (for example, on the display) to the user.

[0530] The user may be a patient, a healthcare professional, or anyone else interested in using the device. As used herein, a "gas flow" may refer to any gas flow that can be used with the respiratory support or ventilation device, such as an ambient air flow, a flow comprising essentially 100% oxygen, a flow comprising a combination of ambient air and oxygen, and / or the like.

[0531] A patient breathing line 300 is connected at one end to a gas outlet 1021 in the housing 1100 of the respiratory therapy device 1100. The patient breathing line 300 is connected at the other end to the nasal interface 100 via the gas distributor 120 and the nasal nozzles 111, 112.

[0532] The gas flow generated by the respiratory therapy device 1100 can be humidified and delivered to the patient via the patient line 300 through the nasal interface 100. The patient line 300 can be equipped with a heater to warm the gas flow to the patient. For example, the patient line 300 can have a heating wire 300a to warm the gas flow reaching the patient. The heating wire 300a can be controlled by the controller 1013. The patient line 300 and / or the nasal interface 100 can be considered part of the respiratory therapy device 1100 or, alternatively, peripheral to it. The respiratory therapy device 1100, the breathing channel 300, and the patient interface 1, which includes a nasal interface 100, can together form a respiratory therapy system 1000.

[0533] The controller 1013 can control the flow generator 1011 to generate a gas flow at the desired flow rate. The controller 1013 can also control an inlet for supplemental oxygen to enable the delivery of supplemental oxygen. The humidifier 1012 (if present) can humidify the gas flow and / or heat the gas flow to a suitable level, and / or perform similar functions. The gas flow is routed to the patient via the patient line 300 and the nasal interface 100. The controller 1013 can also control a heating element in the humidifier 1012 and / or the heating element 300a in the patient line 300 to heat the gas to a desired temperature for a desired therapeutic and / or comfort level for the patient. The controller 1013 can be programmed with or determine a suitable target temperature for the gas flow.In some configurations, gas mixture compositions including supplemental oxygen and / or the delivery of therapeutic drugs can be provided through the supplemental oxygen inlet. The gas mixture compositions may include oxygen, heliox, nitrogen, nitric oxide, carbon dioxide, argon, helium, methane, sulfur hexafluoride, and combinations thereof, and / or the supplemental gas may include an aerosolized drug.

[0534] The oxygen inlet port 1028 may include a valve 1028a through which pressurized gas may enter the flow generator or blower. The valve may control the flow of oxygen into the flow generator blower. The valve may be any type, including a proportional or binary valve. The oxygen source may be an oxygen tank or a hospital oxygen supply. Medical oxygen typically has a purity between 95% and 100%. Oxygen sources of lower purity may also be used. Examples of valve modules and filters are disclosed in PCT Publication No. WO 2018 / 074935 and U.S. Patent Application No. 2019 / 0255276, both entitled "Valve Module and Filter." The contents of these specifications are incorporated herein by reference.

[0535] The 1100 respiratory therapy device can measure and control the oxygen content of the gas delivered to the patient and, consequently, the oxygen content of the gas inhaled by the patient. In high-flow therapy, the high flow rate of the delivered gas meets or exceeds the patient's maximum inspiratory requirement. This means that the volume of gas delivered by the device to the patient during inhalation equals or exceeds the volume of gas inhaled by the patient. High-flow therapy therefore helps to prevent the inclusion of ambient air during the patient's inhalation and to clear the patient's airways of exhaled gas.As long as the flow rate of the delivered gas meets or exceeds the patient's peak inspiratory demand, the probability of ambient air being drawn in is lower, and the gas delivered by the device is typically essentially the same as the gas the patient inhales. Accordingly, the oxygen concentration measured in the device, i.e., the fraction of delivered oxygen (FdO2), would be essentially the same as the oxygen concentration the user breathes, i.e., the fraction of inhaled oxygen (FiO2), and as such, the terms can be considered equivalent.

[0536] Operating sensors 1003a, 1003b, 1003c, such as flow, temperature, humidity, and / or pressure sensors, can be placed at various locations within the respiratory therapy device 1100. Additional sensors (for example, sensors 1020, 1025) can be placed at various locations on the patient line 300 and / or the nasal interface 100 (for example, a temperature sensor 1029 can be located at or near the end of the inspiratory tube). The sensor output can be received by the controller 1013 to assist the controller in operating the respiratory therapy device 1100 to deliver appropriate therapy. In some configurations, delivering appropriate therapy includes meeting a patient's inspiratory needs, optionally their peak inspiratory needs.The device 1100 can be equipped with a transmitter and / or receiver 1015 to enable the controller 1013 to receive signals 1008 from the sensors and / or to control the various components of the respiratory therapy device 1100, including, but not limited to, the flow generator 1011, the humidifier 1012, the heating wire 300a, or accessories or peripheral devices connected to the respiratory therapy device 1100. Additionally or alternatively, the transmitter and / or receiver 1015 can transmit data to a remote server or enable remote control of the device 1100.

[0537] Oxygen can be measured by placing one or more gas composition sensors (e.g., an ultrasonic transducer system, also known as an ultrasonic sensor system) after the oxygen and ambient air have completely mixed. The measurement can be performed within the facility, the delivery line, the patient interface, or at any other suitable location.

[0538] The respiratory therapy device 1100 can include a patient sensor 1026, for example a pulse oximeter or a patient monitoring system, to measure one or more physiological parameters of the patient, for example blood oxygen saturation (SpO2), heart rate and respiratory rate of the patient, perfusion index, and provide a measure of signal quality.

[0539] The sensor 1026 can communicate with the controller 1013 via a cable connection or by communication via a wireless transmitter on the sensor 1026.

[0540] The 1026 sensor can be a disposable adhesive sensor designed for attachment to a patient's finger. The 1026 sensor can also be a non-disposable sensor.

[0541] Sensors are available that are designed for different age groups and can be connected to various parts of the patient, which can be used with the 1100 respiratory therapy device.

[0542] The pulse oximeter is attached to the user, usually on the finger, although other locations such as the earlobe are possible. The pulse oximeter would connect to a processor in the device and continuously provide signals indicating the patient's blood oxygen saturation. The Patient Sensor 1026 can be a hot-swappable device that can be attached or replaced while the Respiratory Therapy Device 1100 is in operation. For example, the Patient Sensor 1026 can connect to the Respiratory Therapy Device 1100 via a USB interface or wireless communication protocols (such as near-field communication, Wi-Fi, or Bluetooth®). If the Patient Sensor 1026 is disconnected during operation, the Respiratory Therapy Device 1100 can continue to operate in its previous state for a defined period.After a defined period, the respiratory therapy device 1100 can trigger an alarm, switch from automatic to manual mode, and / or completely exit the control mode (e.g., automatic or manual). The patient sensor 1026 can be a bedside monitoring system or another patient monitoring system that communicates with the respiratory therapy device 1100 via a physical or wireless interface.

[0543] The Respiratory Therapy Device 1100 may include a high-flow therapy device. The high-flow therapy described herein shall have its typical, ordinary meaning as understood by a person skilled in the art, generally referring to a respiratory support system that delivers a directed flow of humidified respiratory gases through an intentionally unsealed (non-sealing) patient interface at flow rates generally intended to equal or exceed a patient's inspiratory flow. Typical patient interfaces include, but are not limited to, a nasal or tracheal patient interface. Typical flow rates for adults are often between about fifteen liters per minute (L / min) and about seventy liters per minute or more. Typical flow rates for pediatric patients (e.g.,High-flow therapy (for newborns, infants, and children) typically ranges from approximately one liter per minute per kilogram of patient weight to approximately three liters per minute per kilogram of patient weight or more, but is not limited to these values. High-flow therapy may optionally include gas mixture compositions, including supplemental oxygen, and / or the administration of therapeutic drugs. High-flow therapy is commonly referred to by other names such as nasal high-flow (NHF), nasal cannula with humidified high-flow (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or tracheal high-flow (THF). The flow rates used to achieve a "high flow" may be one of those listed below.For example, in some configurations for an adult patient, “high-flow therapy” may refer to the delivery of gases to a patient at a flow rate of more than or equal to approximately 10 liters per minute (10 l / min), for example, between approximately 10 l / min and approximately 100 l / min, or between approximately 15 l / min and approximately 95 l / min, or between approximately 20 l / min and approximately 90 l / min, or between 25 l / min and approximately 75 l / min, or between approximately 25 l / min and approximately 85 l / min, or between approximately 30 l / min and approximately 80 l / min, or between approximately 35 l / min and approximately 75 l / min, or between approximately 40 l / min and approximately 70 l / min, or between approximately 45 l / min and approximately 65 l / min, or between approximately 50 l / min and approximately 60 l / min.In some configurations, “high-flow therapy” for a newborn, infant, or child patient may refer to the delivery of gases to a patient at a flow rate greater than 1 l / min, for example, between approximately 1 l / min and approximately 25 l / min, between approximately 2 l / min and approximately 25 l / min, or between approximately 2 l / min and approximately 5 l / min, or between approximately 5 l / min and approximately 25 l / min, or between approximately 5 l / min and approximately 10 l / min, or between approximately 10 l / min and approximately 25 l / min, or between approximately 10 l / min and approximately 20 l / min, or between approximately 10 l / min and 15 l / min, or between approximately 20 l / min and 25 l / min. A high-flow therapy device for an adult patient, a newborn, an infant or a child patient can deliver gases to the patient at a flow rate between approximately 1 l / min and approximately 100 l / min or at a flow rate in one of the sub-ranges listed above.The Flow Therapy Unit 1000 can deliver any oxygen concentration (e.g., FdO2) up to 100% at any flow rate between approximately 1 l / min and approximately 100 l / min. In some configurations, each of these flow rates can be combined with oxygen concentrations (FdO2s) of approximately 20%–30%, 21%–30%, 21%–40%, 30%–40%, 40%–50%, 50%–60%, 60%–70%, 70%–80%, 80%–90%, and 90%–100%. In some combinations, the flow rate can be combined with an oxygen concentration (FdO2) of approximately 20%–30%, 21%–30%, 21%–40%, 30%–40%, 40%–50%, 50%–60%, 60%–70%, 70%–80%, 80%–90%, and 90%–100%. In some configurations, the Respiratory Therapy Device 1100 may include safety thresholds when operating in manual mode to prevent a user from administering too much oxygen to the patient.

[0544] In some configurations, the respiratory therapy device 1100 comprises 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 an oxygen flow 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.

[0545] The patient interface 1 used in the respiratory therapy system 1000 with the respiratory therapy device 1100 comprises a nasal interface 100, including: a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other; and a gas distributor 120 with a gas inlet 121, wherein the first nozzle 111 and the second nozzle 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to cause an asymmetrical gas flow at the patient's nostrils.

[0546] The first nozzle 111 and the second nozzle 112 are asymmetrical to each other or not symmetrical to each other or differ in shape and configuration from each other or are asymmetrical in comparison to each other.

[0547] In some configurations, the nasal interface 100 includes a cannula body 118 which includes the first nozzle 111 and the second nozzle 112.

[0548] In some configurations, the gas distributor 120 is part of the cannula body 118 or separate from the cannula body 118 and can be coupled to it.

[0549] In some configurations, the first and second nozzles 111, 112 are configured to enter the nasal passages unsealed (not sealing).

[0550] In some configurations, the first and second ports 111, 112 allow exhaled gases to escape around the first and second ports.

[0551] In some configurations, the first and second ports 111, 112 are configured to provide gases to the patient without interfering with the patient's spontaneous breathing.

[0552] The nasal interface 100 may have one or more of the features and / or functions described herein for the nasal interfaces 100, 100', 100''.

[0553] In some configurations, the respiratory therapy device 1000 includes a flow generator 1011 and a humidifier 1012.

[0554] In some configurations, the respiratory therapy system includes a patient line 300 with a heater 300a.

[0555] In some configurations, the patient interface includes a breathing tube that is in fluid communication with the gas inlet 121, and the patient interface further includes a head support to hold the nasal interface against a patient's face.

[0556] Patients suffering from various health problems and illnesses 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 diseases, respiratory trauma, acute respiratory distress, those receiving pre- and post-operative oxygen therapy, and those suffering from other conditions or illnesses may benefit from oxygen therapy. A common procedure for treating such problems is to administer supplemental oxygen to the patient to prevent their blood oxygen saturation (SpO2) from dropping too low (e.g., below approximately 90%). However, administering too much oxygen can lead to hyperoxygenation of the patient's blood and is also considered dangerous.Generally, a patient's SpO2 is maintained within a range of approximately 80% to 99%, and preferably between 92% and 96%, although these ranges may vary depending on the patient's condition. Due to various factors such as respiratory rate, tidal volume, heart rate, activity level, height, weight, age, sex, and others, there is no prescribed amount of supplemental oxygen that will consistently achieve a target SpO2 response for every patient. For individual patients, the fraction of oxygen delivered to the patient (FdO2) must be regularly monitored and adjusted to ensure they receive the correct FdO2 to achieve the target SpO2. Maintaining a correct and consistent SpO2 is a critical factor in the management of patients with various health conditions or diseases.Furthermore, patients suffering from these health problems can benefit from a system that automatically controls oxygen saturation. The present disclosure is applicable to a wide range of patients who require rapid and accurate control of oxygen saturation.

[0557] With reference to Fig. 15. The controller 1013 can be programmed with a closed-loop control system to control the operation of the respiratory therapy device 1100, or configured to execute the same. The closed-loop system can be configured to ensure that the patient's SpO2 value reaches a target value and remains constant at or near that value.

[0558] The controller 1013 can receive input from a user, which it can use to operate the system in a closed-loop system. The target SpO2 value can be a single value or a range of values. The value(s) could be preset, selected by a physician, or determined based on the patient type, which may refer to the current condition and / or information about the patient such as age, weight, height, sex, and other patient characteristics. Similarly, the target SpO2 can consist of two values, each selected in the manner described above. These two values ​​represent a range of acceptable SpO2 values ​​for the patient. The controller can target a value within this range. The target value could be the midpoint of the range or any other value within the range, which can be preset or selected by a user.Alternatively, the range can be automatically set based on the SpO2 target value. The controller can be configured to trigger one or more responses when the patient's SpO2 value leaves the range. These responses can include an alarm, switching to manual FdO2 control, changing the FdO2 to a specific value, and / or other actions. The controller can have one or more zones, within which one or more different responses occur when the SpO2 value moves outside each zone.

[0559] Generally, SpO2 is controlled between approximately 80% and 100%, or approximately 80% and 90%, or approximately 88% and 92%, or approximately 90% and 99%, or approximately 92% and 96%. SpO2 could be controlled between any two suitable values ​​from the two ranges mentioned above. The target SpO2 could be between approximately 80% and 100%, or between approximately 80% and 90%, or between approximately 88% and 92%, or between approximately 90% and 99%, or between approximately 92% and 96%, or approximately 94%, or 94%, or approximately 90%, or 90%, or approximately 85%. The target SpO2 value could be any value between any two suitable values ​​from any two of the ranges mentioned above. The SpO2 target value can correspond to the midpoint of the SpO2 range for a defined area.

[0560] The FdO2 can be configured to be controlled within a specific range. The oxygen concentration measured in the device (FdO2) is essentially the same as the oxygen concentration the patient breathes (FiO2) as long as the flow rate meets or exceeds the patient's maximum inspiratory requirement, and accordingly, the terms can be considered equivalent. Each of the range limits can be preset, user-selected, or determined based on patient type, which may refer to current symptoms and / or patient information such as age, weight, height, sex, and / or other patient characteristics. Alternatively, a single FdO2 value can be selected, and the range can be determined, at least in part, based on that value.The range can, for example, be a defined value above and below the selected FdO2. The selected FdO2 can be used as the starting point for control. The system can have one or more responses when the controller attempts to move the FdO2 out of the range. These responses can include alarms, preventing the FdO2 from moving outside the range, switching to manual FdO2 control, and / or switching to a specific FdO2. The system can have one or more ranges, in each of which one or more different responses occur when the boundary of each range is reached.

[0561] With reference to Fig.Figure 16 shows a schematic diagram of the System 1500 with closed-loop control. The closed-loop system can use two control loops. The first control loop can be implemented using SpO2 control. SpO2 control can determine a target FdO2 based partly on the target SpO2 and / or the measured SpO2. As explained above, the SpO2 target value can be a single value or a range of acceptable values. The value(s) can be preset, selected by a physician, or automatically determined based on client characteristics. Generally, the SpO2 target values ​​are received or determined before or at the beginning of a therapy session, although they can be received at any time during the therapy session.During a therapy session, the SpO2 controller can also receive the following inputs: measured FdO2 value(s) from a gas composition sensor, as well as measured SpO2 value(s) and signal quality value(s) from the patient sensor. In some configurations, the SpO2 controller can receive the target FdO2 as input. In such a case, the output of the SpO2 controller can be directly fed back to the SpO2 controller as input. Based at least partially on the inputs, the SpO2 controller can output a target FdO2 to the second control loop.

[0562] During the therapy session, the SpO2 and FdO2 controls can continue to automatically control the operation of the respiratory therapy device 1100 until the therapy session ends or an event triggers a change from automatic mode to manual mode.

[0563] The increased irrigation caused by the asymmetry of the nozzles 111, 112 at the nasal interface 100, 100', 100'' can improve the effectiveness of supplemental oxygen. Closed-loop SpO2 control with an asymmetrical nasal interface 100, 100', 100'' can allow the patient's SpO2 level to be maintained at or near a target value, while consuming less oxygen compared to a symmetrical nasal high-flow system. This can lead to oxygen conservation.

[0564] The respiratory therapy system may incorporate one or more of the features and functions described in PCT Publication No. WO 2021 / 049954 and Preliminary US Application No. 62 / 898464. The contents of these specifications are incorporated herein by reference.

[0565] Fig.Figure 17 shows an alternative exemplary respiratory therapy system 2000 that can utilize the patient interface 1, which includes a nasal interface 100, 100', 100''.

[0566] In the configuration shown, the respiratory therapy system 2000 includes a respiratory therapy unit 2100. The respiratory therapy unit may include a flow generator 2101.

[0567] The flow generator 2101 shown comprises a gas inlet 2102 and a gas outlet 2104. The flow generator 2101 may include a blower 2106. The blower 2106 can draw gas from the gas inlet 2102. In some configurations, the flow generator 2101 may include a source or container for compressed gas (e.g., air, oxygen, etc.). The container may include a valve that can be adjusted to control the gas flow leaving the container. In some configurations, the flow generator 2101 may use such a compressed gas source and / or another 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 bellows assembly or other structure capable of generating a gas flow.In some configurations, the flow generator 2101 draws in atmospheric gases through the gas inlet 2102. In some configurations, the flow generator 2101 is capable of drawing in atmospheric gases through the gas inlet 2102 as well as other gases (e.g., oxygen, nitrogen oxides, carbon dioxide, etc.) through the same gas inlet 2102 or a different gas inlet. Other configurations are also possible.

[0568] The illustrated flow generator 2101 includes a user control interface 2108. The user control interface 2108 may include one or more buttons, knobs, dials, switches, levers, touchscreens, speakers, displays and / or other input or output modules that a user could use to input commands into the flow generator 2101, to display data and / or to control the operation of the respiratory therapy system 2101 and / or to control the operation of other aspects of the respiratory therapy system 2000.

[0569] The flow generator 2101 can direct gases through the gas outlet 2104 to a first line 2110. In the configuration shown, the first line 2110 directs the gases to a gas humidifier 2112. The gas humidifier is optional.

[0570] The gas humidifier 2112 serves to retain moisture in the gases to provide a humidified gas flow. The illustrated gas humidifier 2112 comprises a humidifier inlet 2116 and a humidifier outlet 2118. The gas humidifier 2112 may include, be configured to include, or contain water or another humidifying or humectant (hereinafter referred to as water).

[0571] In some configurations, the 2112 gas humidifier includes a heating element (not shown). The heating element can be used to heat the water in the 2112 gas humidifier to promote evaporation and / or the inclusion of water in the gas flow, and / or to increase the temperature of the gases flowing through the 2112 gas humidifier. The heating element may, for example, be a metal resistance heating plate. However, other heating elements are also conceivable. For example, the heating element could be an electrically conductive plastic heating plate or a chemical heating system with adjustable heating power.

[0572] In the configuration shown, the 2112 gas humidifier includes a 2120 user control interface. The 2120 user control interface includes one or more buttons, knobs, rotary controls, switches, levers, touchscreens, speakers, displays, and / or other input or output modules that a user could use to input commands into the 2112 gas humidifier and display data, and / or to control the operation of the 2112 gas humidifier and / or the operation of other aspects of the 2000 respiratory therapy system.

[0573] In some configurations, the flow generator 2101 and the gas humidifier 2112 can share a housing 2126. In other configurations, the gas humidifier 2112 may share only part of the housing 2126 with the flow generator 2101. Other configurations are also possible. For example, the flow generator 2101 and the gas humidifier 2112 can have separate housings.

[0574] In the configuration shown, gases flow from the humidifier outlet 2118 to a second line 300. The second line 300 may include a line heater, as described in relation to Fig.15. The line heater can be used to supply heat to gases flowing through the second line 300. The heat can reduce or eliminate the likelihood of condensation of water trapped in the gas flow along a wall of the second line 300. The line heater can comprise one or more resistance wires arranged in, on, around, or near a wall of the second line 300. In one or more configurations, one or more such resistance wires may be located outside a gas passage. In one or more configurations, this one or these multiple resistance wires are not in direct contact with the gases flowing through the second line 300. In one or more configurations, a wall or surface of the second line 300 lies between the one or more resistance wires and the gases flowing through the second line 300.

[0575] Gas flowing through the second line (300) can be delivered to a nasal interface (100). The nasal interface (100) can pneumatically connect the respiratory therapy system (100) to a patient's airway. In some configurations, the respiratory therapy system (2000) utilizes a two-part system with separate inspiratory and expiratory gas passages connected to one or more of the patient's airways.

[0576] In some configurations, a short length of tubing connects the nose interface 100 to the second line 300. In some configurations, the short length of tubing may have a smooth bore. For example, a short flexible length of tubing may connect the nose interface to the second line 300. The short length of tubing connecting the nose interface to the second line 300 may be permeable to air, allowing vapor to pass through the tubing wall. In some configurations, the short length of tubing may contain one or more heating wires, as described elsewhere herein. The smooth bore, whether heated or not, may improve the efficiency of nebulized substance delivery, as described elsewhere herein.

[0577] The respiratory therapy device 2100 includes a nebulizer 2128. In some configurations, when a nebulizer 2128 is used, the flow generator 2101, the gas humidifier 2112, and the nebulizer 2128 can share the housing 2126. In some configurations, the nebulizer 2128 is separate from the housing 2126.

[0578] The nebulizer 2128 can be connected to a portion of the gas passage extending between the flow generator 2101 (which may include the gas inlet 2102) and the nasal interface 100, although other arrangements for the nebulizer 2128 or a different nebulizer may also be used. In some configurations, the nebulizer 2128 is not positioned in a line between the humidifier outlet 2118 and the nasal interface 100. Rather, the nebulizer 2128 is positioned upstream of the humidifier outlet 2118 or upstream of the inlet to the second line 2122. In some configurations, the nebulizer 2128 may be positioned upstream of an inlet to the humidifier. In some configurations, the nebulizer 2128 may be positioned between the source of the gas flow and the chamber.

[0579] The nebulizer 2128 can contain a substance (e.g., a medicinal substance, trace gases, etc.) that can be introduced into the gas flow. The substance can be captured in the gas flow and delivered into the patient's airways along with the respiratory gases. The nebulizer 2128 can be connected to the gas passage via a conveyor 2130, which may include a tube or an adapter. Alternatively, the nebulizer 2128 can be connected directly to the gas passage, which may eliminate the need for the conveyor 2130.

[0580] The respiratory therapy device 2100 may include a controller 2113. The controller 2113 can be configured or programmed to control the operation of the device. For example, the controller 2113 can control components of the device, including but not limited to: operating the flow generator 2101 to generate a flow of gas (gas stream) for delivery to a patient; operating the humidifier 2112 (if present) to humidify and / or warm the generated gas stream; controlling an oxygen flow into the flow generator blower; receiving user input from the user interface 2108 and / or 2120 for reconfiguration and / or user-defined operation of the device 2100; and outputting information (for example, on a display) to the user.

[0581] The controller 2113 can control the flow generator 2101 to generate a gas flow at the desired flow rate. The controller 2113 can also control an inlet for supplemental oxygen to enable the delivery of additional oxygen. The humidifier 2112 (if present) can humidify the gas flow and / or heat the gas flow to a suitable level, and / or perform similar functions. The controller 2113 can also control the operation of the nebulizer 2128. The gas flow is routed to the patient via the patient line 300 and the nasal interface 100. The controller 2113 can also control a heating element in the humidifier 2112 and / or a heating element in the patient line 300 to heat the gas to a desired temperature for a desired therapeutic and / or comfort level for the patient. The controller 2113 can be programmed with or determine a suitable target temperature for the gas flow.In some configurations, gas mixture compositions including supplemental oxygen and / or the delivery of therapeutic drugs can be provided through the supplemental oxygen inlet. The gas mixture compositions may include oxygen, heliox, nitrogen, nitric oxide, carbon dioxide, argon, helium, methane, sulfur hexafluoride, and combinations thereof, and / or the supplemental gas may include an aerosolized drug from nebulizer 2128.

[0582] In some configurations, the respiratory therapy device 2100 includes a gas inlet 2102, a gas outlet 2118, and a nebulizer 2128 to deliver one or more substances into a gas stream. The nasal interface 100 used in the respiratory therapy system 2000 with the respiratory therapy device 2100 comprises: a gas inlet 121 in fluid communication with the gas outlet 2118 to receive gases and the one or more substances from the respiratory therapy device; a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other; and a gas distributor 120 with a gas inlet 121. The first nozzle 111 and the second nozzle 112 are in fluid communication with the gas inlet 121. The nasal interface 100 is configured to create an asymmetrical gas flow at the patient's nostrils.

[0583] The respiratory therapy system 2000 can include a line 300, 320 (examples of which are described below) to receive the gases and the one or more substances from the respiratory therapy device 2100 and to deliver the gases and the one or more substances to the gas inlet 121 of the nasal interface 100.

[0584] In the configuration shown, the respiratory therapy system 2000 can function as follows. By rotating an impeller of the blower motor 2106, gases are drawn through the gas inlet 2102 into the flow generator 2101. The gases are expelled from the gas outlet 2104 and through the first line 2110. The gases enter the gas humidifier 2112 through the humidifier inlet 2116. Once in the gas humidifier 2112, the gases trap moisture when they flow over or near water in the gas humidifier 2112. The water is heated by the heating element, which aids in the humidification and / or warming of the gases flowing through the gas humidifier 2112. The gases exit the gas humidifier 2112 through the humidifier outlet 2118 and enter the second line 300. Before entering the second line 300, the gases receive one or more substances from the nebulizer 128.The gases are routed from the second line 300 to the nasal interface 100, where the gases are introduced into the patient's airways to assist in the treatment of respiratory diseases.

[0585] With reference to Fig. 2, Fig. 3 and Fig. 15 includes, for example, in some configurations a respiratory therapy system 1000 of the present disclosure: a respiratory therapy facility comprising 1100: at least one gas inlet 1027, 1028; a humidifier 1012 for humidifying gases; and a gas outlet 1021; and a patient interface 1 comprising a nasal interface 100, wherein the nasal interface comprises the following: a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other, and wherein the first nozzle 111 has a first nozzle outlet 111a and the second nozzle 112 has a second nozzle outlet 112a; and a gas distributor 120 with a gas inlet 121, wherein the first nozzle 111 and the second nozzle 112 are in fluid communication with the gas inlet 121; wherein the nasal interface 100 is configured to cause an asymmetric gas flow at the nostrils of a patient; where the respiratory therapy system 1000 is configured as follows: that it discharges gases through the first nozzle outlet 111a and the second nozzle outlet 112a in a temperature range between about 27 °C and 37 °C and 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 gases flowing into the gas inlet of more than 0 l / min and up to about 70 l / min.

[0586] In some configurations, the respiratory therapy system 1000 is configured to deliver gases through the first nozzle outlet 111a and the second nozzle outlet 112a in a temperature range between approximately 31 °C and 37 °C.

[0587] In some configurations, the Respiratory Therapy System 1000 is configured to deliver gases with a relative humidity of up to approximately 44 mg / l through the first outlet 111a and the second outlet 112a.

[0588] In some configurations, the respiratory therapy system is configured to provide a total volumetric flow rate of gases flowing into gas inlet 121 of at least approximately 5 liters per minute (l / min), optionally between approximately 5 l / min and approximately 120 l / min, and optionally between approximately 5 l / min and approximately 70 l / min.

[0589] In some configurations, the respiratory therapy system 1000 is configured to deliver at least approximately 60% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nasal interface through the first nozzle 111; optionally between approximately 60% and approximately 90% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nasal interface through the first nozzle 111; optionally between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nasal interface through the first nozzle 111; optionally between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nasal interface through the first nozzle 111; optionally between approximately 70% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121,from the nasal interface through the first nozzle 111, optionally between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 flow, from the nasal incision through the first nozzle 111.

[0590] In some configurations, the respiratory therapy system 1000 is configured to provide different flow rates of gases through the first port 111 and the second port 112, and to deliver an essentially similar velocity of gases through the first port outlet 111a and the second port outlet 112a.

[0591] In some configurations, the velocity of the gases leaving the first nozzle outlet 111a is within approximately 20% of the velocity of the gases leaving the second nozzle outlet 112a, optionally within approximately 16% of the velocity of the gases leaving the second nozzle outlet 112a, and optionally within approximately 10% of the velocity of the gases leaving the second nozzle outlet 112a at flow rates above approximately 42 l / min.

[0592] In some configurations, the velocity of the gases exiting each of the first nozzle outlet 111a and the second nozzle outlet 112a is greater than 0 m / s and less than 32 m / s for a total volumetric flow rate of a gas flow into the gas inlet 121 of greater than 0 l / min and up to about 70 l / min.

[0593] In some configurations, the velocity of the gases exiting each of the first nozzle outlet 111a and the second nozzle outlet 112a is more than about 2 m / s and less than about 32 m / s, optionally more than about 2 m / s and less than 32 m / s, optionally more than about 2 m / s and up to about 25 m / s, and optionally more than about 2.5 m / s and up to about 20 m / s for a total volumetric flow rate of a gas flow into the gas inlet 121 of more than 9 l / min and up to about 70 l / min.

[0594] In some configurations, the nasal interface 100 includes a cannula body 118 which includes the first nozzle 111 and the second nozzle 112.

[0595] In some configurations, the gas distributor 120 is part of the cannula body 118 or separate from the cannula body 118 and can be coupled to it.

[0596] In some configurations, the first and second nozzles 111, 112 are configured to enter the nasal passages unsealed (not sealing).

[0597] In some configurations, the first and second ports 111, 112 allow exhaled gases to escape around the first and second ports 111, 112.

[0598] In some configurations, the first and second ports 111, 112 are configured to provide gases to the patient without interfering with the patient's spontaneous breathing.

[0599] In some configurations, the first and second ports are configured to provide gas to the patient regardless of the patient's breathing.

[0600] In some configurations, the respiratory therapy system includes a 300 line for receiving gases from the respiratory therapy device and delivering gases to the 121 gas inlet of the nasal interface.

[0601] The Respiratory Therapy System 1000, the Patient Interface 1 and the Nasal Interface 100 can all have the features and functions described herein.

[0602] A method for providing respiratory support to a patient is disclosed, the method comprising: Provision of a respiratory therapy system 1000, including: a respiratory therapy facility comprising 1100: at least one gas inlet 1027, 1028; a flow generator 1011; a gas outlet 1021; and a patient interface 1 comprising a nasal interface 100, wherein the nasal interface 100 comprises the following: a first nozzle 111 and a second nozzle 112, which are asymmetrical to each other, wherein the first nozzle 111 has a first nozzle outlet 111a and the second nozzle 112 has a second nozzle outlet 112a; and a gas distributor 120 with a gas inlet 121, wherein the first nozzle 111 and the second nozzle 112 are in fluid communication with the gas inlet 121; operating the respiratory therapy device 1100 to provide a gas flow to the nasal interface 100; and Delivery of an asymmetric gas flow from the respiratory therapy device 1100 through the first nozzle outlet 111a and the second nozzle outlet 112a to the nostrils of a patient.

[0603] In some configurations, the procedure involves releasing the asymmetric gas flow in a temperature range between about 27 °C - 37 °C, at a relative humidity of more than about 33 mg / l and / or at a velocity of more than about 0 m / s and less than about 32 m / s for a total volumetric flow rate of the gases flowing into the gas inlet 121 of more than 0 l / min and up to about 70 l / min.

[0604] In some configurations, the process involves releasing the asymmetric gas flow in a temperature range between approximately 31 °C and 37 °C.

[0605] In some configurations, the procedure includes providing a total volumetric flow rate of the gases flowing into the gas inlet of at least about 5 liters per minute (l / min), optionally providing a total volumetric flow rate of the gases flowing into the gas inlet 121 between about 5 l / min and about 120 l / min, and optionally providing a total volumetric flow rate of the gases flowing into the gas inlet between about 5 l / min and about 70 l / min.

[0606] In some configurations, the procedure includes the discharge of at least approximately 60% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nose interface through the first nozzle 111; optionally, the discharge of between approximately 60% and approximately 90% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nose interface through the first nozzle 111; optionally, the discharge of between approximately 60% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nose interface through the first nozzle 111; optionally, the discharge of between approximately 65% ​​and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121 from the nose interface through the first nozzle 111; optionally, the discharge of between approximately 70% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121,from the nasal interface through the first nozzle 111, optionally releasing between approximately 70% and approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally releasing approximately 70% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally releasing between approximately 75% and approximately 80% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally releasing approximately 75% of the total volumetric flow rate of the gases flowing into the gas inlet 121, from the nasal interface through the first nozzle 111, optionally releasing approximately 80% of the total volumetric flow rate the gases flowing into the gas inlet 121 from the nose interface through the first nozzle 111.

[0607] In some configurations, the procedure involves the release of gases through the first nozzle outlet 111a and the second nozzle outlet 112a with a relative humidity of up to approximately 44 mg / l.

[0608] In some configurations, the procedure involves providing different gas flow rates through the first nozzle 111 and the second nozzle 112 and delivering gases of substantially similar velocity through the first nozzle outlet 111a and the second nozzle outlet 112a.

[0609] In some configurations, the velocity of the gases leaving the first nozzle outlet 111a is within approximately 20% of the velocity of the gases leaving the second nozzle outlet 112a, optionally within approximately 16% of the velocity of the gases leaving the second nozzle outlet 112a, and optionally within approximately 10% of the velocity of the gases leaving the second nozzle outlet 112a at flow rates above approximately 42 l / min.

[0610] In some configurations, the velocity of the gases exiting each of the first nozzle outlet 111a and the second nozzle outlet 112a is greater than 0 m / s and less than 32 m / s for a total volumetric flow rate of a gas flow into the gas inlet 121 of greater than 0 l / min and up to about 70 l / min.

[0611] In some configurations, the velocity of the gases exiting each of the first nozzle outlet 111a and the second nozzle outlet 112a is more than about 2 m / s and less than about 32 m / s, optionally more than about 2 m / s and less than 32 m / s, optionally more than about 2 m / s and up to about 25 m / s, and optionally more than about 2.5 m / s and up to about 20 m / s for a total volumetric flow rate of a gas flow into the gas inlet 121 of more than 9 l / min and up to about 70 l / min.

[0612] In some configurations, the nasal interface 100 includes a cannula body 118 which includes the first nozzle 111 and the second nozzle 112.

[0613] In some configurations, the gas distributor 120 is part of the cannula body 118 or separate from the cannula body 118 and can be coupled to it.

[0614] In some configurations, the procedure involves interposing the first and second nozzles 111, 112 with the nasal passages in an unsealed (non-sealing) manner.

[0615] In some configurations, the procedure involves releasing exhaled gases around the first and second ports 111, 112.

[0616] In some configurations, the procedure involves delivering gases to the patient without affecting the patient's spontaneous breathing.

[0617] In some configurations, the procedure involves delivering gases to the patient regardless of the patient's breathing.

[0618] In some configurations, the nose interface is 100 as described above or here.

[0619] In some configurations, the respiratory therapy device 1100 includes a humidifier 1012 and the procedure includes humidifying the gas flow using the humidifier 1012.

[0620] In some configurations, the respiratory therapy system 1000 includes a patient line 300 with a heater 300a, and the procedure includes actuating the heater 300a.

[0621] In some configurations, the patient interface includes a breathing tube in fluid communication with the gas inlet, and the procedure involves allowing water vapor to pass through one wall of the tube, but preventing the passage of liquid water and a mass flow of gases through the wall of the tube.

[0622] The Respiratory Therapy System 1000, the Patient Interface 1 and the Nasal Interface 100 used in the procedure may all have features and functions described herein.

[0623] Fig.Figure 18 shows an exemplary hose or tube type 300 that can be used to deliver gases to the nose interface 100. The hose or tube 300 is shown with a smooth bore 302 or a non-corrugated bore. This type of hose is best described and illustrated, for example, in U.S. Patent Application 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 those specifications are incorporated herein by reference. As described therein, the hose is formed from a bead 304 and a small tube or bubble 306. In general, the tip-to-valley surface roughness of such hoses is on the order of 0.15–0.25 mm. In one configuration, the pipe or hose has an inner bore diameter of 13-14 mm.The two components 304 and 306 together form a conduit or tube with a lumen exhibiting minimal surface deviations. In some configurations, the bead 304 contains wires 308. One or more of the wires can be used to heat the wall of the conduit without needing to be positioned within the flow conveyed through the conduit or tube 300. In the configuration shown, the bead 304 contains four wires 308. In some configurations, the bead 304 may contain two wires 308. Other numbers of wires may also be used.

[0624] Fig. Figure 19 shows an alternative exemplary hose or tube type 320 that can be used to deliver the gases to the nasal interface 100. With reference to Fig.In Figure 20, the depicted conduit or hose 320 is a corrugated hose. In one configuration, the conduit or hose 320 has an inner bore diameter of 20-21 mm. The corrugated hose 320 has deep grooves 322 along one wall 324 of the hose 320. In many cases, the grooves 322 result in one or more spiral breaks extending along a length of the lumen defined by the wall 324. Therefore, the inner surface of the conduit or hose is significantly rougher than that of the smooth-bore hose 300 described in Figure 20. Fig. Figure 18 shows that, generally, the corrugated pipe or hose has a peak-to-valley surface roughness on the order of 1.5 to 2.5 mm. In the configuration shown, Fig.19. One or more heating wires 326 can also be wound and positioned in direct contact with the gas flow through the lumen. If the wires are positioned within the gas flow path, the heating wire adds 2-3 mm of additional "surface roughness", although this is only an estimate of the effect of positioning the heating wire within the gas flow path.

[0625] The use of the 300 mm heating hose with a smooth bore, such as the one in Fig. The device shown in Figure 18, for use in the drug delivery described above from the nebulizer 2128, has led to significant increases in the efficiency of drug delivery compared to the use of a more conventional heated breathing tube 320, such as the one shown in Figure 18. Fig.Figure 19 illustrates this. The efficiency improvement is assumed to be due to a significant reduction in the amount of nebulized drug trapped in the grooves 322 and exposed heating wires 326 of the more conventional heated breathing tube 320. For example, it has been estimated that 300% more of the nebulized drug is trapped by the surfaces than is retained in the smooth bore heated breathing tube 300, as illustrated, but without limitation, in Fig. Figure 18 shows that, due to the reduced turbulence in the flow and fewer obstacles that represent effective roughness, there is a reduction in deposition processes, such as impaction.

[0626] In some configurations, it has been found that transport efficiency decreases when the flow rate exceeds an optimal flow rate. In other words, at some high flow rates above 30 l / min, the flow rate is approximately inversely proportional to nebulization efficiency (i.e., high flow rates result in more medication being trapped in the circulation rather than being delivered to the patient).

[0627] With the 100 mm nasal cannula and asymmetrical nasal tips 111, 112, a reduction in flow rate with equivalent dead space clearance may be possible, which can improve the delivery of nebulized medications. There is potentially less chance of the nebulized medication "popping out," with some of it accumulating on the inner surface of the flow path instead of being delivered to the patient, or experiencing other losses due to impact on surfaces caused by the smoothing of flow transitions. The partially unidirectional flow provided by the 100 mm nasal interface results in less medication being wasted when a patient exhales against the flow than would otherwise be the case.Other aspects of the nasal cannula 100 with asymmetric nasal prongs 111, 112, including the cross-sectional areas of the prongs and the relationships of these cross-sectional areas, can improve the provision of respiratory therapy with nebulized drugs.

[0628] The patient interface 1 and the nasal interface 100 used in the respiratory therapy system 2000 may have one or more of the features and / or functions described herein for the nasal interfaces 100, 100', 100''.

[0629] The Respiratory Therapy System 2000 may incorporate one or more of the features and / or functions of the system described in PCT Publication No. WO 2016 / 085354 or US Patent Application No. 2017 / 0312472. The contents of these specifications are incorporated herein by reference.

[0630] Additionally or alternatively, the Respiratory Therapy System 2000 may have one or more of the features and / or functions of the system described in relation to the Respiratory Therapy System 1000.

[0631] The nasal interfaces 100, 100', 100'' disclosed herein could be used in a medical care facility, a domestic setting, an emergency vehicle, or any other suitable environment. Therefore, references to "patient" herein should be interpreted as referring to any suitable person for whom or by whom the nasal interfaces are used.

[0632] Although the present disclosure has been described with regard to certain embodiments, other embodiments that are obvious to the person skilled in the art in the field also fall within the scope of protection of this disclosure. Thus, various changes and modifications can be made without departing from the spirit and scope of the disclosure. For example, various components can be repositioned as desired. Features of each of the described embodiments can be combined with one another, and / or a device can include one, several, or all of the features of the embodiments described above. Furthermore, not all features, aspects, and advantages are necessarily required to put the present disclosure into practice. Accordingly, the scope of the present disclosure is to be defined only by the following claims. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2014 / 182179

[0354] US 10,406,311

[0354] WO 2012 / 053910

[0355] US 10,238,828

[0355] US 2019 / 0224439

[0472] WO 2015 / 020540

[0481] US 10,569,043

[0481] WO 2018 / 074935

[0534] US 2019 / 0255276

[0534] WO 2021 / 049954

[0564] US 62 / 898464

[0564] US 2014 / 0202462

[0623] WO 2012 / 164407A1

[0623] WO 2014 / 088430

[0623] US 11,058,844

[0623] Cited non-patent literature

[0000] ISO 815-1:2014 [0146, 0147, 0148, 0518, 0519]

Claims

[1] Nasal incision, encompassing: a gas inlet; a first spigot and a second spigot, which are asymmetrical to each other; and a gas flow path from the gas inlet to the first nozzle and the second nozzle, wherein the first nozzle has a larger external cross-sectional area in a direction perpendicular to the gas flow through the first nozzle than a corresponding external cross-sectional area of ​​the second nozzle, wherein the nasal interface is configured to cause an asymmetrical gas flow at the nostrils of a patient, and where the first nozzle forms a smaller leakage area with one of the patient's nostrils than the second nozzle with another of the patient's nostrils. [2] Nose interface according to claim 1, wherein the first nozzle is arranged downstream of the second nozzle in the gas flow path. [3] Nasal interface according to one of the preceding claims, wherein the ratio of the outer cross-sectional area of ​​the first nozzle to a respective nostril cross-sectional area is greater than the ratio of the outer cross-sectional area of ​​the second nozzle to a respective nostril cross-sectional area. [4] Nasal interface according to claim 3, wherein the ratio of the outer cross-sectional area of ​​the first nozzle to the respective nostril cross-sectional area is between 0.49 and 0.

82. [5] Nasal interface according to claim 3 or 4, wherein the ratio of the outer cross-sectional area of ​​the second nozzle to the respective nostril cross-sectional area is between 0.25 and 0.

42. [6] Nose interface according to one of the preceding claims, wherein the ratio of the outer cross-sectional area of ​​the first nozzle to the leakage area of ​​the first nozzle is greater than the ratio of the outer cross-sectional area of ​​the second nozzle to the leakage area of ​​the second nozzle. [7] Nose interface according to one of the preceding claims, wherein the direction transverse to the gas flow is substantially perpendicular or normal to the gas flow through the respective nozzle. [8] Nose interface according to one of the preceding claims, wherein the first and the second nozzle have internal cross-sectional surfaces located at the outlets of the first and the second nozzle. [9] Nose interface according to claim 8, wherein the ratio of an inner cross-sectional area of ​​the first nozzle to an inner cross-sectional area of ​​the second nozzle 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 is about 70:30, about 71:29, about 72:28, about 73:27, about 74:26 or about 75:25; or is between about 75:25 and 80:20; or is about 75:25, about 76:24, about 77:23, about 78:22, about 79:21 or about 80:

20. [10] Nasal interface according to one of the preceding claims, wherein the nasal interface comprises a cannula body comprising the first nozzle and the second nozzle. [11] Nasal interface according to claim 10, comprising a gas distributor, wherein the gas distributor is an integral part of the cannula body or separate from the cannula body and can be coupled to it. [12] Nose interface according to one of the preceding claims, wherein the nose interface comprises a face attachment part, and wherein the first nozzle and the second nozzle comprise a pair of asymmetric tubular nose nozzles which are integrally formed with the face attachment part or detachably attached thereto. [13] Nasal interface according to claim 12, wherein the facial attachment part comprises at least one substantially horizontal lateral entry passage to the interior of a base section or cannula body of the facial attachment part in order to detachably receive an outlet of the gas distributor. [14] Nasal interface according to one of the preceding claims, wherein the first nozzle and the second nozzle are configured to enter unsealed into the nasal passages of a patient. [15] Nose interface according to one of the preceding claims, wherein the first nozzle has a larger inner diameter than a corresponding inner diameter of the second nozzle. [16] Nose interface according to claim 15, wherein the first nozzle has an inner diameter of between about 4 mm and about 10 mm, optionally between about 5 mm and about 9 mm, optionally between about 6 mm and about 8 mm, optionally about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm or any diameter between two of these diameters. [17] Nose interface according to claim 15 or 16, wherein the second nozzle has an inner diameter of between about 2 mm and about 8 mm, optionally between about 3 mm and about 7 mm, optionally between about 4 mm and about 6 mm, optionally about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm or any diameter between two of these diameters. [18] Nose interface according to one of the preceding claims, wherein the first nozzle and / or the second nozzle has a wall thickness between about 0.1 mm and about 0.5 mm. [19] Nose interface according to one of the preceding claims, wherein a gap between adjacent outer surfaces of the first nozzle and the second nozzle adjacent to a base of the first nozzle and the second nozzle is between about 5 mm and about 15 mm, optionally between about 6 mm and about 14 mm, optionally between about 7 mm and about 13 mm, optionally between about 8 mm and about 12 mm, optionally between about 9 mm and about 11 mm, optionally is 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 two of these values. [20] Nasal interface according to one of the preceding claims, wherein the gas inlet is in fluid communication with a breathing tube. [21] Nose interface according to claim 20, wherein water vapor can flow through a wall of the tube, but liquid water and a mass flow of gases cannot flow through the wall of the tube.

Citation Information

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