Patient Interface

Abstract

The nasal interface has a first nasal delivery element and a second nasal delivery element each configured to seal with a respective nasal cavity of the patient. The gas manifold includes a gas inlet for delivering respiratory gas to the gas manifold. The first nasal delivery element and the second nasal delivery element are in fluid communication with the gas inlet through the gas manifold. The first nasal delivery element is proximal to the gas inlet and the second nasal delivery element is distal from the gas inlet. The nasal interface includes a bypass restriction for providing a pressure drop through the nasal interface between the first nasal delivery element and the second nasal delivery element such that when gas is delivered from the gas inlet to the first nasal delivery element and the second nasal delivery element, the pressure at the first nasal delivery element is higher than the pressure at the second nasal delivery element.

Description

[Technical field]

[0001] The present disclosure relates generally to patient interfaces for delivering respiratory gas to the airway of a patient. [Background technology]

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

[0003] A patient interface including a nasal interface can be used to deliver the gas flow to the patient. The nasal delivery element is inserted into the patient's nose to deliver the required therapy. The nasal delivery element may need to create a seal or semi-seal with the nose to deliver the therapy, or may not need to create a seal with the nose. Summary of the Invention [Means for solving the problem]

[0004] A respiratory interface and respiratory therapy system is disclosed that may use nasal flow, for example through a nasal delivery element, of a nasal interface to deliver respiratory gas to a patient via asymmetric flow. Asymmetric flow may increase dead space clearance in the patient's upper airway. Noise may be reduced due to a reduced maximum expiratory pressure.

[0005] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: a first nasal delivery element and a second nasal delivery element, the first nasal delivery element and the second nasal delivery element, respectively, configured to seal with respective nasal passages of the patient; a gas manifold including a gas inlet for delivering a breathing gas to the gas manifold; the first nasal delivery element and the second nasal delivery element are in fluid communication with the gas inlet via a gas manifold, the first nasal delivery element being proximal to the gas inlet and the second nasal delivery element being distal to the gas inlet; the nasal interface includes a gas manifold including a bypass restriction for providing a pressure drop across the nasal interface between the first nasal delivery element and the second nasal delivery element such that when gas is delivered from the gas inlet to the first nasal delivery element and the second nasal delivery element, the pressure at the first nasal delivery element is higher than the pressure at the second nasal delivery element; a bias flow restriction for gas flow exiting the nasal interface; Includes.

[0006] In some configurations, the pressure drop through the gas manifold is such that when there is gas flow from the gas inlet to the first nasal delivery element and the second nasal delivery element, the gas flow from the gas inlet to the first nasal delivery element is greater than the gas flow from the gas inlet to the second nasal delivery element.

[0007] In some configurations, the nasal interface includes a gas flow channel within the gas manifold, and the bypass restriction provides a reduced cross-sectional area of ​​a portion of the gas flow channel.

[0008] In some configurations, a portion of the gas flow channel is between the first and second nasal delivery elements and / or adjacent to the second nasal delivery element.

[0009] In some configurations, the bypass restriction includes at least one protrusion that extends into the gas flow channel, and optionally, the bypass restriction includes multiple protrusions that extend into the gas flow channel.

[0010] In some configurations, the gas manifold includes a proximal bypass projection proximal to the nasal delivery elements and / or a distal bypass projection distal to the nasal delivery elements.

[0011] In some configurations, the gas manifold includes both a proximal bypass protrusion and a distal bypass protrusion that, in combination, define a predetermined bypass dimension between the first nasal delivery element and the second nasal delivery element for restricted gas flow through the gas manifold.

[0012] In some configurations, the bypass restriction includes an angled leading edge and an angled trailing edge that define converging and diverging bypass restrictions in the direction of gas flow through the gas manifold from the first nasal delivery element to the second nasal delivery element.

[0013] In some configurations, the biased flow restriction includes at least one aperture for gas flow from the nasal interface to the surrounding environment, and optionally, the biased flow restriction includes multiple apertures for gas flow from the nasal interface to the surrounding environment.

[0014] In some configurations, the bias flow restriction includes a filter or diffuser to filter or diffuse the gas flowing through the aperture.

[0015] In some configurations, the nasal interface includes a filter unit between the gas manifold and the bias flow restriction.

[0016] In some configurations, the bias flow restriction is in fluid communication with a gas manifold, and optionally the gas manifold includes or is coupled to the bias flow restriction, and optionally the bias flow restriction is in fluid communication with the gas manifold but located remotely from the gas manifold.

[0017] In some configurations, the gas inlet is in fluid communication with the breathing conduit.

[0018] In some configurations, the breathing conduit is between about 12 mm and about 23 mm, optionally greater than about 12 mm and up to about 23 mm, optionally greater than about 12 mm and up to about 22 mm, optionally greater than about 12 mm and up to about 21 mm, optionally greater than about 12 mm and up to about 20 mm, optionally greater than about 12 mm and up to about 19 mm, optionally greater than about 12 mm and up to about 18 mm, optionally between about 13 mm and about 17 mm, optionally It has an inner diameter of about 14 mm to about 16 mm, optionally about 12 mm, optionally about 13 mm, optionally about 14 mm, optionally about 15 mm, optionally about 16 mm, optionally about 17 mm, optionally about 18 mm, optionally about 19 mm, optionally about 20 mm, optionally about 21 mm, optionally about 22 mm, optionally about 23 mm, or optionally any value between any two of these values.

[0019] In some configurations, the gas manifold includes a sealing flange or collar for engaging the first and second nasal delivery elements.

[0020] In some configurations, the bypass restriction includes an insert for mounting to the gas manifold.

[0021] In some configurations, the first and second nasal delivery elements are attached to or integral with the base portion of the interface body.

[0022] In some configurations, the base is positioned such that, in use, it is located between the patient's face and the gas manifold.

[0023] In some configurations, the interface body includes two side arms extending laterally from opposite sides of the base portion.

[0024] In some configurations, the nasal interface includes headgear having ends that connect to side arms of the interface body.

[0025] In some configurations, the bypass restriction provides a cross-sectional area of ​​a portion of the gas flow channel that is greater than 0 to about 1.5 times the total cross-sectional area of ​​the nasal delivery element.

[0026] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: a first nasal delivery element and a second nasal delivery element, the first nasal delivery element and the second nasal delivery element, respectively, configured to seal with respective nasal passages of the patient; a gas manifold including a gas inlet for delivering a breathing gas to the gas manifold; Including, the first nasal delivery element and the second nasal delivery element are in fluid communication with the gas inlet via a gas manifold, the first nasal delivery element being proximal to the gas inlet and the second nasal delivery element being distal to the gas inlet; The nasal interface is configured to create a pressure differential between the first and second nasal delivery elements such that when gas is delivered from the gas inlet to both the first and second nasal delivery elements, the pressure in the first nasal delivery element is higher than the pressure in the second nasal delivery element.

[0027] In some configurations, the pressure differential is such that when there is gas flow from the gas inlet to the first nasal delivery element and the second nasal delivery element, the gas flow from the gas inlet to the first nasal delivery element is greater than the gas flow from the gas inlet to the second nasal delivery element.

[0028] In some configurations, the gas inlet is in fluid communication with the breathing conduit.

[0029] In some configurations, the respiratory conduit has an inner diameter of about 12 mm to about 23 mm, optionally about 12 mm to about 22 mm, optionally about 12 mm to about 21 mm, optionally about 12 mm to about 20 mm, optionally about 12 mm to about 19 mm, optionally about 12 mm to about 18 mm, optionally about 13 mm to about 17 mm, optionally about 14 mm to about 16 mm, optionally about 12 mm, optionally about 13 mm, optionally about 14 mm, optionally about 15 mm, optionally about 16 mm, optionally about 17 mm, optionally about 18 mm, optionally about 19 mm, optionally about 20 mm, optionally about 21 mm, optionally about 22 mm, optionally about 23 mm, or optionally any value between any two of these values.

[0030] In some configurations, when gas is delivered from the gas inlet to both the first nasal delivery element and the second nasal delivery element, the pressure of the gas flow in the second nasal delivery element is up to about 1 cmH2O less than the pressure of the gas flow in the first nasal delivery element.

[0031] In some configurations, the nasal interface is configured such that the pressure differential of the gas flow between the first nasal delivery element and the second nasal delivery element is higher during the inhalation phase than during the exhalation phase.

[0032] In some configurations, the nasal interface is configured such that the pressure at the first nasal delivery element is higher than the pressure at the second nasal delivery element during both the inhalation and exhalation phases.

[0033] In some configurations, the nasal interface is configured to achieve a patient pressure at the first and second nasal delivery elements of from about 2 cmH2O to about 30 cmH2O in use, optionally from about 2 cmH2O to about 25 cmH2O in use, optionally from about 2 cmH2O to about 20 cmH2O in use, optionally from about 2 cmH2O to about 15 cmH2O in use, optionally from about 2 cmH2O to about 14 cmH2O in use, optionally from about 2 cmH2O to about 13 cmH2O in use, optionally from about 2 cmH2O to about 12 cmH2O in use, optionally from about 2 cmH2O to about 11 cmH2O in use, optionally from about 2 cmH2O to about 10 cmH2O in use.

[0034] In some configurations, the pressure differential between the first nasal delivery element and the second nasal delivery element is configured to provide an asymmetric flow through the patient's upper airway of at least about 1 liter per minute (lpm), optionally between about 1 lpm and about 5 lpm.

[0035] In some configurations, the asymmetric flow allows for the transfer of CO from the patient's anatomical dead space. 2 Promotes the removal of

[0036] In some configurations, the nasal interface includes a bypass restriction that provides a cross-sectional area of ​​a portion of the gas flow channel that is greater than 0 to about 1.5 times the total cross-sectional area of ​​the nasal delivery element.

[0037] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body part including a first nasal delivery element and a second nasal delivery element, the first nasal delivery element and the second nasal delivery element each configured to seal with a respective nasal cavity of the patient; a gas manifold component including a gas inlet for delivering a breathing gas to the gas manifold component; Including, the interface body part is engagable with the gas manifold part to fluidly connect the first nasal delivery element and the second nasal delivery element to the gas inlet, such that the first nasal delivery element is proximal to the gas inlet and the second nasal delivery element is distal to the gas inlet; The nasal interface includes at least one gas flow restriction to gas flow through the nasal interface such that when gas is delivered from the gas inlet to the first nasal delivery element and the second nasal delivery element, the pressure in the first nasal delivery element is higher than the pressure in the second nasal delivery element.

[0038] In some configurations, the at least one gas flow restriction includes a bypass restriction for providing a pressure drop through the gas manifold component between the first nasal delivery element and the second nasal delivery element such that when gas is delivered from the gas inlet to the first nasal delivery element and the second nasal delivery element, the pressure at the first nasal delivery element is higher than the pressure at the second nasal delivery element.

[0039] In some configurations, the bypass restriction provides a cross-sectional area of ​​a portion of the gas flow channel that is greater than 0 to about 1.5 times the total cross-sectional area of ​​the nasal delivery element.

[0040] In some configurations, the nasal interface includes a gas flow channel within a gas manifold component, and the bypass restriction provides a reduced cross-sectional area of ​​a portion of the gas flow channel.

[0041] In some configurations, a portion of the gas flow channel is between the first and second nasal delivery elements and / or adjacent to the second nasal delivery element.

[0042] In some configurations, the bypass restriction includes at least one protrusion that extends into the gas flow channel, and optionally, the bypass restriction includes multiple protrusions that extend into the gas flow channel.

[0043] In some configurations, the gas manifold component includes a proximal bypass projection proximal to the nasal delivery elements and / or a distal bypass projection distal to the nasal delivery elements.

[0044] In some configurations, the gas manifold component includes both a proximal bypass protrusion and a distal bypass protrusion that, in combination, define a predetermined bypass dimension between the first nasal delivery element and the second nasal delivery element for restricted gas flow through the gas manifold.

[0045] In some configurations, the bypass restriction includes an angled leading edge and an angled trailing edge that define converging and diverging bypass restrictions in the direction of gas flow through the gas manifold from the first nasal delivery element to the second nasal delivery element.

[0046] In some configurations, the bypass restriction includes an insert for mounting to the gas manifold component.

[0047] In some configurations, the nasal interface further includes a biased flow restriction for gas flow out of the nasal interface.

[0048] In some configurations, the biased flow restriction includes at least one aperture for gas flow from the nasal interface to the surrounding environment, and optionally, the biased flow restriction includes multiple apertures for gas flow from the nasal interface to the surrounding environment.

[0049] In some configurations, the bias flow restriction includes a filter or diffuser to filter or diffuse the gas flowing through the aperture.

[0050] In some configurations, the nasal interface includes a filter unit between the gas manifold component and the bias flow restriction.

[0051] In some configurations, the bias flow restriction is in fluid communication with a gas manifold component, and optionally the gas manifold includes or is coupled to the bias flow restriction, and optionally the bias flow restriction is in fluid communication with but located remote from the gas manifold component.

[0052] In some configurations, the gas inlet is in fluid communication with the breathing conduit.

[0053] In some configurations, the respiratory conduit has an inner diameter of about 12 mm to about 23 mm, optionally about 12 mm to about 22 mm, optionally about 12 mm to about 21 mm, optionally about 12 mm to about 20 mm, optionally about 12 mm to about 19 mm, optionally about 12 mm to about 18 mm, optionally about 13 mm to about 17 mm, optionally about 14 mm to about 16 mm, optionally about 12 mm, optionally about 13 mm, optionally about 14 mm, optionally about 15 mm, optionally about 16 mm, optionally about 17 mm, optionally about 18 mm, optionally about 19 mm, optionally about 20 mm, optionally about 21 mm, optionally about 22 mm, optionally about 23 mm, or optionally any value between any two of these values.

[0054] In some configurations, the gas manifold component includes a sealing flange or collar for engaging the first and second nasal delivery elements when the interface body component is engaged with the gas manifold component.

[0055] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: a first nasal delivery element and a second nasal delivery element, the first nasal delivery element and the second nasal delivery element, respectively, configured to seal with respective nasal passages of the patient; a gas manifold including a gas inlet and a gas flow channel for delivering a breathing gas to the gas manifold; Including, the first nasal delivery element and the second nasal delivery element are in fluid communication with the gas inlet via the gas flow channel, the first nasal delivery element being proximal to the gas inlet and the second nasal delivery element being distal to the gas inlet; the nasal interface includes a bypass restriction providing a cross-sectional area of ​​a portion of the gas flow channel; Each of the first nasal delivery element and the second nasal delivery element includes an inner cross-sectional area that, together, provides a total cross-sectional area of ​​the nasal delivery element, and a cross-sectional area of ​​a portion of the gas flow channel is greater than 0 to about 1.5 times the total cross-sectional area of ​​the nasal delivery element.

[0056] In some configurations, the cross-sectional area of ​​a portion of the gas flow channel is at most about 1.3 times the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 time the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 2 / 3 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 / 2 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 2 / 5 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 / 3 the total cross-sectional area of ​​the nasal delivery elements.

[0057] In some configurations, the inner cross-sectional area of ​​each of the first and second nasal delivery elements is at the smallest transverse dimension of the respective nasal delivery element.

[0058] In some configurations, the smallest transverse dimension is transverse to the direction of gas flow through the nasal delivery element.

[0059] In some configurations, the inner cross-sectional area of ​​each of the first and second nasal delivery elements is at the exit of the respective nasal delivery element.

[0060] In some configurations, a portion of the gas flow channel is between the first and second nasal delivery elements and / or adjacent to the second nasal delivery element.

[0061] In some configurations, the bypass restriction includes at least one protrusion that extends into the gas flow channel, and optionally, the bypass restriction includes multiple protrusions that extend into the gas flow channel.

[0062] In some configurations, the gas manifold includes a proximal bypass projection proximal to the nasal delivery elements and / or a distal bypass projection distal to the nasal delivery elements.

[0063] In some configurations, the gas manifold includes both a proximal bypass protrusion and a distal bypass protrusion that, in combination, define a predetermined bypass dimension between the first nasal delivery element and the second nasal delivery element for restricted gas flow through the gas manifold.

[0064] In some configurations, the bypass restriction includes an angled leading edge and an angled trailing edge that define converging and diverging bypass restrictions in the direction of gas flow through the gas manifold from the first nasal delivery element to the second nasal delivery element.

[0065] In some configurations, the nasal interface includes an interface body and a gas manifold component, the interface body and the gas manifold component together forming a gas manifold.

[0066] In some configurations, the gas inlet is at the side of the gas manifold.

[0067] In some configurations, the open area for gas flow through the bias flow restriction is about 10 mm 2 ~about 30mm 2 , optionally about 25 mm 2 ~about 30mm 2 and optionally about 27.5 mm 2 It is.

[0068] In some configurations, the open area for gas flow through the bias flow restriction is 0 mm 2 Super ~ approx. 40mm2 , optionally about 2 mm 2 ~ approx. 40mm 2 , optionally about 2 mm 2 ~about 5mm 2 , optionally about 12 mm 2 ~ approx. 40mm 2 , optionally about 20 mm 2 ~about 30mm 2 It is.

[0069] In some configurations, the biased flow restriction is configured such that when in use a pressure of greater than 0 cmH2O and up to about 30 cmH2O is provided to the gas inlet and the nasal delivery element is occluded, the flow rate of gas flow out of the nasal interface through the biased flow restriction is greater than 0 lpm to about 80 lpm.

[0070] In some configurations, the biased flow restriction is configured such that, in use, when a pressure of between about 3 cmH2O and about 10 cmH2O is provided to the gas inlet and the nasal delivery element is occluded, the flow rate of gas flow out of the nasal interface through the biased flow restriction is between about 4 lpm and about 15 lpm.

[0071] In some configurations, the biased flow restriction is configured such that, in use, when a pressure of between about 4 cmH2O and about 30 cmH2O is provided to the gas inlet and the nasal delivery element is occluded, the flow rate of gas flow out of the nasal interface through the biased flow restriction is between about 15 lpm and about 80 lpm.

[0072] In some configurations, the biased flow restriction includes at least one aperture for gas flow from the nasal interface to the surrounding environment, and optionally, the biased flow restriction includes multiple apertures for gas flow from the nasal interface to the surrounding environment.

[0073] In some configurations, the bias flow restriction includes a filter or diffuser to filter or diffuse the gas flowing through the aperture.

[0074] In some configurations, the nasal interface includes a filter unit between the gas manifold and the bias flow restriction.

[0075] In some configurations, the bias flow restriction is in fluid communication with a gas manifold, and optionally the gas manifold includes or is coupled to the bias flow restriction, and optionally the bias flow restriction is in fluid communication with the gas manifold but located remotely from the gas manifold.

[0076] In some configurations, the cross-sectional area of ​​a portion of the gas flow channel is from about 10% up to about 100% of the first cross-sectional area of ​​an adjacent portion of the gas flow channel, optionally greater than or equal to about 10% and less than 100% of the first cross-sectional area, optionally up to about 90% of the first cross-sectional area, optionally up to about 80% of the first cross-sectional area, optionally up to about 70% of the first cross-sectional area, optionally up to about 60% of the first cross-sectional area, optionally up to about 55% of the first cross-sectional area, optionally up to about 40% of the first cross-sectional area, optionally up to about 30% of the first cross-sectional area, and optionally up to about 25% of the first cross-sectional area.

[0077] In some configurations, the cross-sectional area of ​​a portion of the gas flow channel is at most about 200 mm 2 , optionally up to about 160 mm 2 , optionally up to about 110 mm 2 , optionally up to about 80 mm 2 , optionally up to about 60 mm 2 and optionally up to about 50 mm 2 It is.

[0078] In some configurations, the total cross-sectional area of ​​the nasal delivery element is less than 0 mm 2 Ultra-large and up to approx. 250mm 2 , optionally about 1 mm 2 ~about 250mm 2 , optionally about 1.6 mm 2 ~about 250mm 2 , optionally about 50 mm2 ~about 250mm 2 , optionally about 50 mm 2 ~about 200mm 2 , optionally about 30 mm 2 ~about 200mm 2 , optionally about 30 mm 2 ~approx. 155mm 2 , optionally about 50 mm 2 ~approx. 155mm 2 and optionally about 70 mm 2 ~approx. 155mm 2 It is.

[0079] In some configurations, the cross-sectional area of ​​the portion of the gas flow channel is greater than 0 to about 1.5 times the total cross-sectional area of ​​the nasal delivery elements, and the total cross-sectional area of ​​the nasal delivery elements is greater than about 1 mm 2 ~about 250mm 2 It is.

[0080] In some configurations, the cross-sectional area of ​​a portion of the gas flow channel is at most about 1.3 times the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 time the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 2 / 3 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 / 2 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 2 / 5 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 / 3 the total cross-sectional area of ​​the nasal delivery elements.

[0081] In some configurations, the total cross-sectional area of ​​the nasal delivery element is about 1.6 mm 2 ~about 250mm 2 , optionally about 50 mm 2 ~about 250mm 2 , optionally about 50 mm 2 ~about 200mm 2 , optionally about 30 mm 2 ~about 200mm 2 , optionally about 30 mm 2 ~approx. 155mm 2 , optionally about 50 mm 2 ~approx. 155mm 2 and optionally about 70 mm 2 ~approx. 155mm 2 It is.

[0082] In some configurations, the bypass restriction provides a pressure drop across the nasal interface between the first and second nasal delivery elements such that when gas is delivered from the gas inlet to the first and second nasal delivery elements, the pressure in the first nasal delivery element is higher than the pressure in the second nasal delivery element.

[0083] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: a first nasal delivery element and a second nasal delivery element, the first nasal delivery element and the second nasal delivery element, respectively, configured to seal with respective nasal passages of the patient; a gas manifold including a gas inlet and a gas flow channel for delivering a breathing gas to the gas manifold; Including, the first nasal delivery element and the second nasal delivery element are in fluid communication with the gas inlet via the gas flow channel, the first nasal delivery element being proximal to the gas inlet and the second nasal delivery element being distal to the gas inlet; the nasal interface includes a bypass restriction providing a cross-sectional area of ​​a portion of the gas flow channel; each of the first nasal delivery element and the second nasal delivery element comprises an inner cross-sectional area; The inner cross-sectional area of ​​the nasal delivery elements and the cross-sectional area of ​​a portion of the gas flow channels are related to produce an asymmetric gas flow from the nasal delivery elements in use.

[0084] In some configurations, the inner cross-sectional areas together provide a total cross-sectional area of ​​the nasal delivery element, and the cross-sectional area of ​​the portion of the gas flow channel is greater than 0 to about 1.5 times the total cross-sectional area of ​​the nasal delivery element.

[0085] In some configurations, the cross-sectional area of ​​a portion of the gas flow channel is at most about 1.3 times the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 time the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 2 / 3 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 / 2 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 2 / 5 the total cross-sectional area of ​​the nasal delivery elements, optionally at most about 1 / 3 the total cross-sectional area of ​​the nasal delivery elements.

[0086] In some configurations, the inner cross-sectional area of ​​each of the first and second nasal delivery elements is at the smallest transverse dimension of the respective nasal delivery element.

[0087] In some configurations, the smallest transverse dimension is transverse to the direction of gas flow through the nasal delivery element.

[0088] In some configurations, the inner cross-sectional area of ​​each of the first and second nasal delivery elements is at the exit of the respective nasal delivery element.

[0089] In some configurations, the cross-sectional area of ​​the portion of the gas flow channel is at most about 1 times, optionally at most about 2 / 3 times, the total cross-sectional area of ​​the nasal delivery element, and the nasal interface is configured to provide a bias flow of 20 lpm through the bias flow restriction when a pressure of 4 cmH2O is provided to the gas inlet and the nasal delivery element is occluded.

[0090] In some configurations, the cross-sectional area of ​​the portion of the gas flow channel is at most about 1 times, optionally at most about 2 / 3 times, the total cross-sectional area of ​​the nasal delivery element, and the nasal interface is configured to provide a bias flow of 32 lpm through the bias flow restriction when a pressure of 8 cmH2O is provided to the gas inlet and the nasal delivery element is occluded.

[0091] In some configurations, the cross-sectional area of ​​the portion of the gas flow channel is up to about 2 / 3 times the total cross-sectional area of ​​the nasal delivery element, and the nasal interface is configured to provide a bias flow of 20 lpm through the bias flow restriction when a pressure of 4 cmH2O is provided to the gas inlet and the nasal delivery element is occluded, or to provide a bias flow of 32 lpm through the bias flow restriction when a pressure of 8 cmH2O is provided to the gas inlet and the nasal delivery element is occluded, or to provide a bias flow of 41 lpm through the bias flow restriction when a pressure of 12 cmH2O is applied to the gas inlet and the nasal delivery element is occluded, or to provide a bias flow of 48 lpm through the bias flow restriction when a pressure of 16 cmH2O is applied to the gas inlet and the nasal delivery element is occluded, or to provide a bias flow of 53 lpm through the bias flow restriction when a pressure of 20 cmH2O is applied to the gas inlet and the nasal delivery element is occluded.

[0092] In some configurations, the cross-sectional area of ​​the portion of the gas flow channel is up to about 2 / 3 times the total cross-sectional area of ​​the nasal delivery element, and the nasal interface is configured to provide a bias flow of 32 lpm or more through the bias flow restriction when a pressure of 8 cmH2O is provided to the gas inlet and the nasal delivery element is occluded.

[0093] In some configurations, the cross-sectional area of ​​the portion of the gas flow channel is up to about 1 / 3 times the total cross-sectional area of ​​the nasal delivery element and the nasal interface is configured to provide a bias flow of 32 lpm or more through the bias flow restriction when a pressure of 8 cmH2O is provided to the gas inlet and the nasal delivery element is occluded, or the cross-sectional area of ​​the portion of the gas flow channel is up to about 2 / 5 times the total cross-sectional area of ​​the nasal delivery element and the nasal interface is configured to provide a bias flow of 41 lpm or more through the bias flow restriction when a pressure of 12 cmH2O is provided to the gas inlet and the nasal delivery element is occluded, or the cross-sectional area of ​​the portion of the gas flow channel is up to about 2 / 3 times the total cross-sectional area of ​​the nasal delivery element and the nasal interface is configured to provide a bias flow of 48 lpm or more through the bias flow restriction when a pressure of 16 cmH2O is provided to the gas inlet and the nasal delivery element is occluded.

[0094] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body configured to substantially form a seal with a nasal airway of the patient, the interface body configured to deliver gas to a first nasal cavity of the patient and to a second nasal cavity of the patient; a gas inlet for delivering respiratory gas to the nasal interface, the gas inlet being in fluid communication with the interface body to deliver respiratory gas from the gas inlet through the interface body in use to the first and second nasal cavities of the patient; the nasal interface is configured to receive inlet gas from the gas inlet and to provide from the inlet gas a first gas flow stream configured to be provided substantially to a first nasal cavity of the patient in use and a second gas flow stream configured to be provided substantially to a second nasal cavity of the patient in use, and configured to direct more of the inlet gas into the first gas flow stream than the second gas flow stream to create an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0095] In some configurations, the interface body includes a first outlet or first outlet portion configured to deliver gas substantially to a first nasal cavity of the patient, and includes a second outlet or second outlet portion configured to deliver gas substantially to a second nasal cavity of the patient.

[0096] In some configurations, the gas inlet is at least partially aligned with the first outlet or first outlet portion and less aligned or unaligned with the second outlet or second outlet portion.

[0097] In some configurations, the gas inlet is substantially axially aligned with the first outlet or the first outlet portion.

[0098] In some configurations, at least half of the cross-sectional area of ​​the gas inlet is axially aligned with at least half of the cross-sectional area of ​​the first outlet or first outlet portion.

[0099] In some configurations, the gas inlet includes an outer portion for connecting a breathing conduit for providing a gas flow of a gas source to the interface body, and further includes an inner portion in fluid communication with the interface body.

[0100] In some configurations, the inner portion of the gas inlet is at least partially aligned with the first outlet or the first outlet portion.

[0101] In some configurations, the gas inlet is angled towards the first outlet or the first outlet portion.

[0102] In some configurations, the first gas flow stream has at least one dimension that is greater than a corresponding dimension of the second gas flow stream.

[0103] In some configurations, the at least one dimension includes a lateral dimension of a first gas flow stream and the corresponding dimension includes a lateral dimension of a second gas flow stream.

[0104] In some configurations, the first gas flow stream has a diameter, cross-sectional area and / or volume that is larger than a corresponding diameter, cross-sectional area and / or volume of the second gas flow stream.

[0105] In some configurations, the ratio of the cross-sectional area of ​​the first gas flow stream to the corresponding cross-sectional area of ​​the second gas flow stream is from about 2:1 to about 5:1, optionally from about 2:1 to about 4:1, optionally about 2.5:1 and about 3.5:1, optionally about 3:1.

[0106] In some configurations, the first outlet or first outlet portion and the second outlet or second outlet portion include substantially the same cross-sectional area.

[0107] In some configurations, the nasal interface is configured to deliver a gas flow through the first outlet or first outlet portion at a rate that is lower than a rate of gas flow through the second outlet or second outlet portion during the inhalation phase of the respiratory cycle.

[0108] In some configurations, the nasal interface is configured to deliver a gas flow through the first outlet or first outlet portion at a higher pressure than the pressure of the gas flow through the second outlet or second outlet portion during the inhalation phase of the respiratory cycle.

[0109] In some configurations, the nasal interface includes a single outlet for delivering gas to a first nasal cavity and a second nasal cavity of the patient, the single outlet including a first outlet portion and a second outlet portion, and the nasal interface is configured such that the first gas flow stream is substantially delivered to the first outlet portion and the second gas flow stream is substantially delivered to the second outlet portion.

[0110] In some configurations, the interface body includes a first nasal delivery element including a first outlet and a second nasal delivery element including a second outlet, and the nasal interface is configured such that the first gas flow stream is delivered substantially to the first nasal delivery element and the second gas flow stream is delivered substantially to the second nasal delivery element, the first nasal delivery element and the second nasal delivery element are each configured to seal with a respective nasal cavity of the patient.

[0111] In some configurations, the nasal interface includes a flow director configured to direct more incoming gas from the gas inlet into the first gas flow stream than into the second gas flow stream.

[0112] In some configurations, the nasal interface includes a connector or elbow for connecting the respiratory conduit to the patient interface.

[0113] In some configurations, the connector or elbow includes or is the flow director.

[0114] In some configurations, the flow director includes a nozzle configured to accelerate the flow towards the first outlet or the first outlet portion.

[0115] In some configurations, the nasal interface is configured to direct more incoming gas into the first gas flow stream than into the second gas flow stream during an inhalation phase of a breathing cycle.

[0116] In some configurations, the interface body is a nasal cushion.

[0117] In some configurations, the nasal interface is configured to deliver respiratory gas simultaneously, in use, from the gas inlet through the interface body to both the first and second nasal cavities of the patient.

[0118] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body configured to substantially form a seal with a nasal airway of the patient, the interface body configured to deliver gas to a first nasal cavity of the patient and to a second nasal cavity of the patient; a gas inlet for delivering respiratory gas to the nasal interface, the gas inlet being in fluid communication with the interface body to deliver respiratory gas from the gas inlet through the interface body in use to the first and second nasal cavities of the patient; the nasal interface is configured to provide a greater dynamic pressure in use at a first nasal passage of the patient and a lesser dynamic pressure in use at a second nasal passage of the patient to create asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0119] In some configurations, the interface body includes a first outlet or first outlet portion configured to deliver gas to a first nasal cavity of the patient, and includes a second outlet or second outlet portion configured to deliver gas to a second nasal cavity of the patient.

[0120] In some configurations, the nasal interface includes a flow director configured to direct more incoming gas from the gas inlet to the first outlet or first outlet portion than to the second outlet or second outlet portion.

[0121] In some configurations, the flow director includes a nozzle configured to accelerate the flow towards the first outlet or the first outlet portion.

[0122] In some configurations, the nasal interface is configured to receive inflow gas from the gas inlet and provide from the inflow gas a first gas flow stream configured to be provided substantially to a first nasal cavity of the patient in use and a second gas flow stream configured to be provided substantially to a second nasal cavity of the patient in use, and configured to direct more of the inflow gas into the first gas flow stream than into the second gas flow stream.

[0123] In some configurations, the nasal interface includes a flow splitter configured to unequally split a flow from the gas inlet into a first gas flow stream and a second gas flow stream.

[0124] In some configurations, the nasal interface is configured to deliver respiratory gas simultaneously, in use, from the gas inlet through the interface body to both the first and second nasal passages of the patient.

[0125] The nasal interface of this embodiment may have one or more of the features outlined in relation to any of the other embodiments.

[0126] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body configured to substantially form a seal with a nasal airway of the patient, the interface body configured to deliver gas to a first nasal cavity of the patient and to a second nasal cavity of the patient; a gas inlet for delivering respiratory gas to the nasal interface, the gas inlet being in fluid communication with the interface body to deliver respiratory gas from the gas inlet through the interface body to the first and second nasal cavities of the patient in use; a flow splitter configured to split a flow from the gas inlet unequally into a first gas flow stream configured to be provided substantially to a first nasal cavity of the patient in use and a second gas flow stream configured to be provided substantially to a second nasal cavity of the patient in use, the first gas flow stream configured to deliver more gas flow along the first gas flow stream than along the second gas flow stream to create an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle; Includes.

[0127] In some configurations, the interface body includes a first outlet or first outlet portion configured to deliver gas to a first nasal cavity of the patient, and includes a second outlet or second outlet portion configured to deliver gas to a second nasal cavity of the patient.

[0128] In some configurations, the gas inlet is at least partially aligned with the first outlet or first outlet portion and less aligned or unaligned with the second outlet or second outlet portion.

[0129] In some configurations, the gas inlet is substantially axially aligned with the first outlet or the first outlet portion.

[0130] In some configurations, at least half of the cross-sectional area of ​​the gas inlet is axially aligned with at least half of the cross-sectional area of ​​the first outlet or first outlet portion.

[0131] In some configurations, the gas inlet includes an outer portion for connecting a breathing conduit for providing a gas flow of a gas source to the interface body, and further includes an inner portion in fluid communication with the interface body.

[0132] In some configurations, the inner portion of the gas inlet is at least partially aligned with the first outlet or the first outlet portion.

[0133] In some configurations, the gas inlet is angled towards the first outlet or the first outlet portion.

[0134] In some configurations, the first gas flow stream has at least one dimension that is greater than a corresponding dimension of the second gas flow stream.

[0135] In some configurations, the at least one dimension includes a lateral dimension of a first gas flow stream and the corresponding dimension includes a lateral dimension of a second gas flow stream.

[0136] In some configurations, the first gas flow stream has a diameter, cross-sectional area and / or volume that is larger than a corresponding diameter, cross-sectional area and / or volume of the second gas flow stream.

[0137] In some configurations, the ratio of the cross-sectional area of ​​the first gas flow stream to the corresponding cross-sectional area of ​​the second gas flow stream is from about 2:1 to about 5:1, optionally from about 2:1 to about 4:1, optionally from about 2.5:1 to about 3.5:1, optionally about 3:1.

[0138] In some configurations, the first outlet or first outlet portion and the second outlet or second outlet portion include substantially the same cross-sectional area.

[0139] In some configurations, the nasal interface is configured to deliver a gas flow through the first outlet or first outlet portion at a rate that is lower than a rate of gas flow through the second outlet or second outlet portion during the inhalation phase of the respiratory cycle.

[0140] In some configurations, the nasal interface is configured to deliver a gas flow through the first outlet or first outlet portion at a higher pressure than the pressure of the gas flow through the second outlet or second outlet portion during the inhalation phase of the respiratory cycle.

[0141] In some configurations, the nasal interface includes a gas manifold, and the interface body, the gas manifold, and / or the gas inlet include a flow divider.

[0142] In some configurations, the flow divider includes a wall extending toward or into the gas inlet, with a first gas flow stream located on one side of the wall and a second gas flow stream located on an opposite side of the wall.

[0143] In some configurations, the flow divider extends into the gas inlet and divides the gas inlet into a first gas flow stream portion on said one side of the flow divider and a second gas flow stream portion on an opposite side of the flow divider.

[0144] In some configurations, the flow divider is substantially rigid.

[0145] In some configurations, the interface body is a nasal cushion.

[0146] In some configurations, the nasal cushion includes a flow divider that is configured to move and / or deform upon compression of the nasal cushion.

[0147] In some configurations, the flow divider includes a first wall and a second wall.

[0148] In some configurations, the first wall and the second wall are hinged to one another and the relative angle of the walls is configured to change upon compression of the nasal cushion.

[0149] In some configurations, the first wall and the second wall overlap one another in a relaxed state of the nasal cushion, and the degree of overlap of the walls increases upon compression of the nasal cushion.

[0150] In some configurations, the nasal interface includes a single outlet for delivering gas to a first nasal cavity and a second nasal cavity of the patient, the single outlet including a first outlet portion and a second outlet portion, and the nasal interface is configured such that the first gas flow stream is substantially delivered to the first outlet portion and the second gas flow stream is substantially delivered to the second outlet portion.

[0151] In some configurations, the interface body includes a first nasal delivery element including a first outlet and a second nasal delivery element including a second outlet, and the nasal interface is configured such that the first gas flow stream is delivered substantially to the first nasal delivery element and the second gas flow stream is delivered substantially to the second nasal delivery element, the first nasal delivery element and the second nasal delivery element are each configured to seal with a respective nasal cavity of the patient.

[0152] In accordance with at least one particular feature, aspect, and advantage of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body including a first nasal delivery element including a first outlet configured to deliver gas to a first nasal cavity of the patient and a second nasal delivery element including a second outlet configured to deliver gas to a second nasal cavity of the patient, the first nasal delivery element and the second nasal delivery element each configured to seal with a respective nasal cavity of the patient; a gas inlet for delivering respiratory gas to the nasal interface, the gas inlet in fluid communication with the interface body to deliver respiratory gas from the gas inlet through the first nasal delivery element and through the second nasal delivery element; a flow splitter for unequally splitting a flow from the gas inlet into a first gas flow stream configured to be provided substantially to a first nasal delivery element and a second gas flow stream configured to be provided substantially to a second nasal delivery element, the first gas flow stream configured to deliver more gas flow along the first gas flow stream than along the second gas flow stream to produce an asymmetric gas flow in the patient's nasal airways throughout the patient's respiratory cycle; Includes.

[0153] In some configurations, the nasal interface includes a flow director configured to direct more incoming gas from the gas inlet into the first gas flow stream than into the second gas flow stream.

[0154] In some configurations, the flow director includes a nozzle configured to accelerate the flow towards the first outlet or the first outlet portion.

[0155] In some configurations, the nasal interface is configured to direct more incoming gas into the first gas flow stream than into the second gas flow stream during an inhalation phase of a breathing cycle.

[0156] In some configurations, the interface body is a nasal cushion.

[0157] In some configurations, the nasal interface is configured to deliver respiratory gas simultaneously, in use, from the gas inlet through the interface body to both the first and second nasal cavities of the patient.

[0158] In some configurations, the nasal interface includes a biased flow restriction that includes at least one aperture for gas flow from the nasal interface to the surrounding environment.

[0159] In some configurations, the bias flow restriction includes a filter or diffuser to filter or diffuse the gas flowing through the aperture.

[0160] In some configurations, the nasal interface is configured such that the pressure differential of gas flow through the first outlet or first outlet portion and the second outlet or second outlet portion is higher during an exhalation phase than during an inhalation phase.

[0161] In some configurations, the nasal interface is configured to achieve a patient pressure at the first outlet or first outlet portion and the second outlet or second outlet portion of about 2 cmH2O to about 30 cmH2O in use, optionally about 2 cmH2O to about 25 cmH2O in use, optionally about 2 cmH2O to about 20 cmH2O in use, optionally about 2 cmH2O to about 15 cmH2O in use, optionally about 2 cmH2O to about 14 cmH2O in use, optionally about 2 cmH2O to about 13 cmH2O in use, optionally about 2 cmH2O to about 12 cmH2O in use, optionally about 2 cmH2O to about 11 cmH2O in use, optionally about 2 cmH2O to about 10 cmH2O in use.

[0162] In some configurations, the pressure differential between the first outlet or first outlet portion and the second outlet or second outlet portion is configured to provide an asymmetric flow through the patient's upper airway of at least about 1 liter per minute (lpm), optionally between about 1 lpm and about 5 lpm.

[0163] In some configurations, the asymmetric flow allows for the transfer of CO from the patient's anatomical dead space. 2 Promotes the removal of

[0164] In accordance with at least one particular feature, aspect, and advantage of an embodiment disclosed herein, a respiratory therapy system is disclosed, the respiratory therapy system comprising: a gas source for breathing gas, the gas source configured to provide a pressure-controlled breathing gas; a breathing tube for receiving a pressure-controlled breathing gas; a nasal interface as described above or generally herein in fluid communication with a respiratory tube for delivering respiratory gas to the patient; Includes.

[0165] In some configurations, the interface body includes a first outlet or first outlet portion configured to deliver gas to a first nasal cavity of the patient and a second outlet or second outlet portion configured to deliver gas to a second nasal cavity of the patient, and the nasal interface is configured to create a pressure differential between the first outlet or first outlet portion and the second outlet or second outlet portion such that when gas is delivered from the gas inlet to both the first outlet or first outlet portion and the second outlet or second outlet portion, the pressure at the first outlet or first outlet portion is higher than the pressure at the second outlet or second outlet portion.

[0166] In accordance with at least one particular feature, aspect, and advantage of an embodiment disclosed herein, a respiratory therapy system is disclosed, the respiratory therapy system comprising: a gas source for breathing gas, the gas source configured to provide a pressure-controlled breathing gas; a breathing tube for receiving a pressure-controlled breathing gas; a nasal interface having a gas inlet in fluid communication with a respiratory tube for delivering respiratory gas to a patient, the nasal interface comprising a first nasal delivery element and a second nasal delivery element, the first nasal delivery element and the second nasal delivery element each configured to seal with a respective nasal cavity of the patient, the nasal interface being configured to create a pressure differential between the first nasal delivery element and the second nasal delivery element such that when gas is delivered from the gas inlet to both the first nasal delivery element and the second nasal delivery element, the pressure at the first nasal delivery element is higher than the pressure at the second nasal delivery element; Includes.

[0167] In some configurations, the respiratory therapy system includes a respiratory conduit for receiving pressure-controlled respiratory gas from the respiratory tube, the respiratory conduit being in fluid communication with the respiratory tube and a gas inlet of the nasal interface.

[0168] In some configurations, the respiratory therapy system further includes a respiratory gas filter.

[0169] In some configurations, the respiratory gas filter is located between the respiratory tube and the respiratory conduit.

[0170] In some configurations, the breathing gas filter is located between the gas manifold and the bias flow restriction.

[0171] In some configurations, the respiratory therapy system further includes a humidifier configured to humidify the pressure-controlled breathing gas prior to delivering it to the nasal interface.

[0172] In some configurations, the breathing tube is a heated breathing tube and is configured to receive pressure-controlled breathing gas from the humidifier.

[0173] In some configurations, the temperature of the gas flow exiting the first and second nasal delivery elements is from about 31°C to about 41°C, optionally greater than 31°C and up to about 41°C, optionally from about 36°C to about 39°C, optionally about 37°C.

[0174] In accordance with at least one particular feature, aspect, or advantage of an embodiment disclosed herein, there is provided a method of providing respiratory assistance to a patient, the method comprising: A respiratory therapy system is provided, the respiratory therapy system comprising: a gas source for breathing gas, the gas source configured to provide a pressure-controlled breathing gas; a breathing tube for receiving a pressure-controlled breathing gas; a nasal interface having a gas inlet in fluid communication with a respiratory tube for delivering respiratory gas to a patient, the nasal interface including a first nasal delivery element and a second nasal delivery element; providing, sealing a first nasal delivery element and a second nasal delivery element against respective nostrils of the patient; operating the respiratory therapy device to provide a gas flow to the nasal interface; Delivering an asymmetric gas flow from a respiratory therapy device through a first nasal delivery element and a second nasal delivery element to the patient's nasal passages; Includes.

[0175] In some configurations, the nasal delivery elements are in fluid communication with the gas inlets via gas flow channels, a first nasal delivery element is proximal to the gas inlet and a second nasal delivery element is distal to the gas inlet, the nasal interface includes a bypass restriction that provides a cross-sectional area of ​​a portion of the gas flow channel, each of the first nasal delivery element and the second nasal delivery element include an inner cross-sectional area that together provide a total cross-sectional area of ​​the nasal delivery elements, and the cross-sectional area of ​​the portion of the gas flow channel is greater than 0 to about 1.5 times the total cross-sectional area of ​​the nasal delivery elements.

[0176] In some configurations, a cross-sectional area of ​​a portion of the gas flow channel is at most about 1 times, optionally at most about 2 / 3 times, the total cross-sectional area of ​​the nasal delivery element, and the method includes providing a pressure of 4 cmH2O to the gas inlet such that there is a bias flow of 20 lpm through the bias flow restriction.

[0177] In some configurations, a cross-sectional area of ​​a portion of the gas flow channel is at most about 1 times, optionally at most about 2 / 3 times, the total cross-sectional area of ​​the nasal delivery element, and the method includes providing a pressure of 8 cmH2O to the gas inlet such that there is a bias flow of 32 lpm through the bias flow restriction.

[0178] In some configurations, a cross-sectional area of ​​the portion of the gas flow channel is up to about 2 / 3 times the total cross-sectional area of ​​the nasal delivery element, and the method includes providing a pressure of 4 cmH2O to the gas inlet such that there is a bias flow of 20 lpm through the bias flow restriction, or the method includes providing a pressure of 8 cmH2O to the gas inlet such that there is a bias flow of 32 lpm through the bias flow restriction, or the method includes providing a pressure of 12 cmH2O to the gas inlet such that there is a bias flow of 41 lpm through the bias flow restriction, or the method includes providing a pressure of 16 cmH2O to the gas inlet such that there is a bias flow of 48 lpm through the bias flow restriction, or the method includes providing a pressure of 20 cmH2O to the gas inlet such that there is a bias flow of 53 lpm through the bias flow restriction.

[0179] In some configurations, a cross-sectional area of ​​a portion of the gas flow channel is up to about 2 / 3 times the total cross-sectional area of ​​the nasal delivery element, and the method includes providing a pressure of 8 cmH2O to the gas inlet such that there is a bias flow of at least 32 lpm through the bias flow restriction.

[0180] In some configurations, the cross-sectional area of ​​the portion of the gas flow channel is up to about 1 / 3 times the total cross-sectional area of ​​the nasal delivery element and the method includes providing a pressure of 8 cmH2O to the gas inlet such that there is a bias flow of 32 lpm or more through the bias flow restriction; or the cross-sectional area of ​​the portion of the gas flow channel is up to about 2 / 5 times the total cross-sectional area of ​​the nasal delivery element and the method includes providing a pressure of 12 cmH2O to the gas inlet such that there is a bias flow of 41 lpm or more through the bias flow restriction; or the cross-sectional area of ​​the portion of the gas flow channel is up to about 2 / 3 times the total cross-sectional area of ​​the nasal delivery element and the method includes providing a pressure of 16 cmH2O to the gas inlet such that there is a bias flow of 48 lpm or more through the bias flow restriction.

[0181] In some configurations, the temperature of the gas flow exiting the first and second nasal delivery elements is from about 31°C to about 41°C, optionally greater than 31°C and up to about 41°C, optionally from about 36°C to about 39°C, optionally about 37°C.

[0182] In some configurations, the nasal interface is as described above or as outlined herein.

[0183] In some configurations, the respiratory therapy system is as described above or generally herein.

[0184] In accordance with at least one particular feature, aspect, or advantage of an embodiment disclosed herein, there is provided a method of providing respiratory assistance to a patient, the method comprising: A respiratory therapy system is provided, the respiratory therapy system comprising: a gas source for breathing gas, the gas source configured to provide a pressure-controlled breathing gas; a breathing tube for receiving a pressure-controlled breathing gas; a nasal interface in fluid communication with the respiratory tube 16 for delivering respiratory gas to the patient; providing, sealing the patient's nasal airway with a nasal interface; operating the respiratory therapy device to provide a gas flow to the nasal interface; receiving an inlet gas at a gas inlet of the nasal interface and generating an asymmetric gas flow in the patient's nasal airway; Includes.

[0185] In some configurations, the method includes producing an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0186] In some configurations, the nasal interface is as described above or as outlined herein.

[0187] In some configurations, the respiratory therapy system is as described above or generally herein.

[0188] The features of one or more embodiments or configurations may be combined with the features of one or more other embodiments or configurations. Two or more embodiments or configurations may also be used together in a respiratory assistance system in the process of providing respiratory assistance to a patient.

[0189] As used herein, the term "(s)" following a noun refers to the plural and / or the singular form of that noun.

[0190] As used herein, the term "and / or" means "and" or "or" or both, where the context permits.

[0191] As used herein, the term "comprises" means "consisting at least in part of." In interpreting each statement herein containing the term "comprises," there may be other features present than the feature preceding the term. Likewise, related terms such as "comprise" and "comprises" are to be interpreted in the same manner.

[0192] Reference to a numerical range disclosed herein (e.g., 1-10) is intended to include reference to every rational number within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and any rational number range within that range (e.g., 2-8, 1.5-5.5, and 3.1-4.7), and therefore, all subranges of every range explicitly disclosed herein are intended to be hereby expressly disclosed. These are merely specifically intended examples, and all possible combinations of numerical values ​​between the minimum and maximum values ​​recited are to be considered as being expressly set forth in this application as well.

[0193] The present disclosure may also be broadly described as consisting of the parts, elements and features referred to or shown in the specification of this application, either individually or collectively, and any combination of two or more of said parts, elements and features, and where specific integers having known equivalents in the art to which this disclosure pertains are referred to herein, such known equivalents are intended to be incorporated herein as if individually set forth.

[0194] This disclosure contemplates the following merely exemplary structures, with the foregoing being considered.

[0195] Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein which proceeds with reference to the figures. [Brief description of the drawings]

[0196] [Figure 1] FIG. 1 is a front perspective view of a patent interface of an exemplary configuration of the present disclosure including a nasal interface. [Diagram 2] FIG. 2 is an enlarged perspective view of a nasal interface. [Diagram 3] FIG. 2 is a rear perspective view of the patient interface. [Figure 4] FIG. 2 is an enlarged perspective view of a nasal interface. [Diagram 5] FIG. 13 is a front perspective view of a patient interface showing a gas manifold component separated from an interface body component including a nasal delivery element, a bias flow restriction component separated from the gas manifold component, and a respiratory conduit separated from the gas manifold component. [Figure 6a] FIG. 13 is a front perspective view of a bias flow restrictor component. [Figure 6b] FIG. 13 is an exploded front perspective view of the components of the bias flow restrictor assembly. [Figure 7a] FIG. 13 is a perspective cross-sectional view of a bias flow restrictor component. [Figure 7b] FIG. 13 is an orthogonal cross-sectional view of a bias flow restrictor component. [Figure 8] FIG. 13 is an orthogonal view toward the front of the bias flow restrictor component. [Figure 9] FIG. 13 is a front partial cross-sectional view of the nasal interface showing a gas flow restriction in the gas manifold. [Figure 10a] FIG. 13 is a front perspective cross-sectional view of a nasal interface, illustrating generally the direction of gas flow through the nasal interface. [Figure 10b] 1A-1C are orthogonal front cross-sectional views of a nasal interface, illustrating generally the direction of gas flow through the nasal interface. [Figure 11] 11A and 11B show views of a gas manifold, where FIG. 11(a) is a front perspective view, FIG. 11(b) is a front perspective view cut in a horizontal plane, and FIG. 11(c) is a front perspective view cut in a vertical plane. [Figure 12] 12(a) shows a diagram of a gas manifold, where FIG. 12(a) is a top view, FIG. 12(b) is a cross-sectional view along line bb in FIG. 12(d), FIG. 12(c) is a front view, FIG. 12(d) is an end view, and FIG. 12(e) is a cross-sectional view along line ee in FIG. 12(d). [Figure 13] 13A and 13B show views of the face attachment part or interface body part of the nasal interface, where FIG. 13(a) is a rear view, FIG. 13(b) is a front view, and FIG. 13(c) is a cross-sectional view taken along line cc in FIG. 13(b). [Figure 14] FIG. 2 is a cross-sectional view through the gas manifold and one of the nasal delivery elements. [Figure 15] FIG. 1 is a schematic diagram of the functions and effects for use of the patient interface. [Figure 16] Shown is a left / right swap function; in FIG. 16(a), the breathing conduit is coupled to the right side of the gas manifold, and in FIG. 16(b), the breathing conduit is coupled to the left side of the gas manifold. [Figure 17a] 13 shows the remote placement of the bias flow restrictor components. [Figure 17b] 13 illustrates a remote placement of the bias flow restriction component with a filter between the gas manifold and the bias flow restriction component. [Figure 18] FIG. 13 is an exploded view of the headgear components of the patient interface. [Figure 19] 19A and 19B show schematic configurations of the nasal interfaces of FIGS. 1 to 18. [Figure 20] 13A-13C are schematic diagrams illustrating alternative configurations of nasal interfaces; [Figure 21] 13A-B show schematic diagrams of another alternative configuration of a nasal interface; [Figure 22] 1 illustrates a respiratory therapy system incorporating a patient interface and a nasal interface of the present disclosure. [Diagram 23] Figure 1 shows the results of testing different ratios of bypass restriction to total nasal delivery element area for a breathing pattern of 10i:20e 500Vt (tidal volume) at a respiratory rate of 15 breaths / min at pressures of 4cmH2O to 8cmH2O. [Figure 24] Figure 2 shows the results of testing different ratios of bypass restriction to total nasal delivery element area for ARDS (acute respiratory distress syndrome) breathing pattern at a respiratory rate of 25 breaths / min at pressures of 4cmH2O, 8cmH2O, 12cmH2O, 16cmH2O and 20cmH2O. [Diagram 25] 1 shows the results of testing different ratios of bypass restriction to total nasal delivery element area for a sinusoidal breathing pattern with a respiratory rate of 45 breaths / min and 350 Vt (tidal volume) at pressures of 4 cmH2O, 8 cmH2O, 12 cmH2O, 16 cmH2O and 20 cmH2O. [Figure 26] 1 shows the modeled effects of different nasal delivery element sizes, different bypass restriction cross-sectional areas, different set pressures and different bias flow restriction opening states on rebreathing through a nasal interface at a respiratory rate of 15 breaths / min. [Figure 27] 1 shows the modeled effect of different nasal delivery element sizes, different bypass restriction cross-sectional areas, different set pressures and different bias flow restriction opening states on rebreathing through a nasal interface at a respiratory rate of 25 breaths / min. [Figure 28] 1 shows the modeled effects of different nasal delivery element sizes, different bypass restriction cross-sectional areas, different set pressures and different bias flow restriction opening states on rebreathing through a nasal interface at a respiratory rate of 45 breaths / min. [Figure 29]13A-13C illustrate schematic diagrams of alternative configurations of nasal interfaces for use in the patient interface; [Diagram 30] 1 illustrates a front perspective view of an exemplary configuration of a nasal interface. [Diagram 31] FIG. 1 shows a front cross-sectional view of a nasal interface showing the gas flow paths. [Diagram 32] FIG. 13 shows a front cross-sectional view of a nasal interface showing the exhaust gas flow paths. [Diagram 33] 1 shows an upper partial cross-sectional view of a nasal interface. [Diagram 34] 13 shows another upper partial cross-sectional view of the nasal interface. [Diagram 35] FIG. 2 shows a top front perspective view of the interface body / nasal cushion of the nasal interface. [Diagram 36] FIG. 2 shows a lower front perspective view of the interface body / nasal cushion of the nasal interface. [Figure 37] 13 illustrates a front cross-sectional view of a nasal interface in another exemplary configuration. [Figure 38] 13 illustrates a front perspective cross-sectional view of a nasal interface of another alternative exemplary configuration. [Figure 39] 13 illustrates a front perspective view of a nasal interface in another alternative exemplary configuration. [Diagram 40] 1 shows a partial cross-sectional view of a nasal interface. [Diagram 41] 13A shows a front perspective cross-sectional view of a nasal interface in another exemplary configuration. [Diagram 42] 13A shows a front perspective cross-sectional view of a nasal interface in another exemplary configuration. [Diagram 43] 13 illustrates a top view of a nasal interface in another exemplary configuration. [Diagram 44] 44(a) and 44(b) show front cross-sectional views of a nasal interface of another exemplary configuration, with FIG. 44(a) showing the nasal cushion in a resting state and FIG. 44(b) showing the nasal cushion in a compressed state. [Diagram 45] 14A-14C show front perspective views of nasal cushions of another exemplary configuration for use in a nasal interface. [Figure 46]FIG. 2 shows a rear perspective view of the nasal cushion. [Figure 47] 13 illustrates the deformation or movement of the flow director or flow divider of the nasal cushion. [Figure 48] 13 illustrates alternative deformations or movements of the flow directors or flow dividers of the nasal cushion. [Figure 49] 49(a) and 49(b) show a first front perspective view and a second front perspective view, respectively, of an alternative exemplary configuration of nasal cushions for use in a nasal interface. [Fig. 50a-50c] 1 illustrates three alternative exemplary configurations of nasal cushions for use in the nasal interface. [Figure 51] 51(a) and 51(b) show a top perspective view and a front view, respectively, of nasal cushions of another exemplary configuration for use in a nasal interface. [Figure 52] 52(a) and 52(b) show a nasal cushion of another exemplary configuration for use in a nasal interface, with FIG. 52(a) being a rear view and FIG. 52(b) being a top perspective view. [Figure 53] FIG. 13 is a front perspective view of a nasal interface in another exemplary configuration. [Figure 54] FIG. 2 is an exploded front perspective view of a nasal interface. [Figure 55] FIG. 13 is an exploded rear perspective view of the nasal interface. [Figure 56] FIG. 2 is a top cross-sectional view of a nasal interface. [Figure 57] FIG. 13 is a front perspective view of a patient interface including a nasal interface of another exemplary configuration. [Figure 58] FIG. 2 is a top cross-sectional view of a nasal interface. [Figure 59] FIG. 13 is a front perspective view of the nasal cushions of the nasal interface. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0197] A patient interface can be used to deliver respiratory gas to the patient's airway. The patient interface can include a nasal interface that can be used to deliver the gas flow to the patient. In some configurations, a nasal delivery element, such as nasal prongs or pillows, is inserted into the patient's nose to deliver the required therapy. It may be desirable for the nasal delivery element to seal against the nose to deliver the therapy. One or more of the nasal delivery elements can include nasal pillows to seal against the nose.

[0198] Disclosed is a system for delivering gas to a patient via a nasal interface.

[0199] The system provides a pressure difference between the first and second nasal delivery elements of the nasal interface, resulting in different gas flows in the first and second nasal delivery elements. This allows asymmetric flow to be delivered to both nasal cavities through the nasal interface. Asymmetric flow as described herein refers to different flows in the nasal interface or nose. In this way, different flows can be delivered by each nasal delivery element. Asymmetric flow can also include partial unidirectional flow.

[0200] Asymmetric flow delivery can improve clearance of dead space in the upper airway, and the nasal interfaces described are configured to generate such asymmetric flow through the nasal delivery elements.

[0201] The flow generated by respiratory therapy depends on the flow through the nasal interface, which in turn depends on the pressure at each nasal delivery element. If the pressures at each nasal delivery element are different, asymmetric gas flow will occur.

[0202] If the flow, leakage, or a combination of flow and leakage is asymmetric through the nasal interface, the flow through the nose during breathing may become asymmetric. Partial unidirectional flow may be a type of asymmetric flow. Partial unidirectional flow may result in improved clearance of anatomical dead space as air is washed out of the upper airway. Partial unidirectional flow may be more comfortable than total unidirectional flow. Total unidirectional flow herein includes all flows that enter one nasal cavity by the nasal delivery element, exit through the other nasal cavity via the nasal delivery element, or are exhausted to the atmosphere due to the absence of the nasal delivery element. Partial unidirectional flow described herein includes flows that can enter the nose through both nasal cavities and exit the nose through one nasal cavity, flows that can enter the nose through one nasal cavity and exit the nose through both nasal cavities, or different proportions of flows that can enter the nose through both nasal cavities and / or different proportions of flows that can exit the nose through both nasal cavities, and may be flows that enter the nose through both nasal cavities and exit the nose from one or both nasal cavities and optionally through the mouth. When there is a pressure difference between the first nasal delivery element and the second nasal delivery element, during inhalation, the first nasal delivery element receives a greater gas flow from the gas inlet than the second nasal delivery element. During exhalation, the second nostril associated with the second nasal delivery element expels a greater gas flow than the first nostril associated with the first nasal delivery element. The pressure difference between the first nasal delivery element and the second nasal delivery element can be varied depending on whether the patient's respiratory cycle is in the inhalation or exhalation phase.

[0203] The asymmetric flow assessment may be applied over any suitable period of time, for example, the asymmetric flow assessment may be applied over one respiratory cycle of the patient or alternatively over a number of different respiratory cycles of the patient.

[0204] The partial unidirectional flow may reduce turbulence in the patient's nasal passages and improve comfort.

[0205] 1-5 show an exemplary patient interface 1 including a nasal interface 100 having nasal delivery elements including a first nasal delivery element 111 and a second nasal delivery element 112.

[0206] The nasal interface 100 provides the patient with a patient interface suitable for the delivery of pressure-controlled, optionally humidified, gas flow to the patient's nasal cavity / sinus. In some configurations, the nasal interface 100 is adapted to deliver a high flow rate of gas over a wide flow rate range (e.g., about 8 lpm or perhaps 10-50 lpm, 20-40 lpm or more, etc., depending on other therapeutic applications). The flow rate may be a bias flow averaged over time. In some configurations, the nasal interface 100 is adapted to deliver a low flow rate of gas. The flow is pressure dependent and therefore may vary with different breathing pressures and set pressures. The set pressure relates to the therapeutic and / or patient pressure maintained by the assisted respiratory therapy device when used with the nasal interface of the present disclosure.

[0207] The nasal interface 100 includes a face attachment or interface body 110 component that includes a pair of hollow nasal delivery elements 111 and 112 that are either integrally molded with or removably attached to the interface body 110. The nasal interface 100 includes a gas manifold 120 component that includes a gas inlet 121. The gas manifold 120 may be either integrally molded or removably attached to the respiratory conduit 300.

[0208] The interface body 110 components may be connectable or engagable with the gas manifold 120 components, or may be integrally formed or permanently engaged with the gas manifold 120 components. When the interface body 110 components are engagable with the gas manifold components 120, the engagement places the first nasal delivery element 111 and the second nasal delivery element 112 in fluid communication with the gas inlet 121, such that the first nasal delivery element 111 is more proximal to the gas inlet 121 and the second nasal delivery element 112 is more distal to the gas inlet 121.

[0209] The interface body 110 may be formed from a soft, flexible material such as silicone, a thermoplastic elastomer, or other polymers known in the art. The nasal delivery elements 111 and 112 may be flexible and may be formed from a sufficiently thin layer of silicone or other suitable material to achieve this characteristic. The interface body 110 and nasal delivery elements 111, 112 may be formed from an elastomeric material that can conform to the geometry of the patient's nostrils and / or cheeks and provide an effective pneumatic seal, for example.

[0210] The gas manifold 120 may be formed from a relatively rigid material such as polycarbonate, high density polyethylene (HDPE), or any other suitable plastic material known in the art. The interface body 110 provides a soft interfacing component to the patient for comfortable delivery of gas flow through the nasal delivery elements 111, 112, and the gas manifold 120 fluidly couples the respiratory conduit 300 to the nasal delivery elements 111, 112 of the interface body 110.

[0211] Nasal delivery element 111 and nasal delivery element 112 are substantially hollow.

[0212] The first nasal delivery element 111 and the second nasal delivery element 112 may have the same shape and configuration as one another, i.e., may be symmetrical. In other configurations, the first nasal delivery element and the second nasal delivery element may have different shapes and / or configurations from one another, i.e., may be asymmetrical.

[0213] The interface body 110 is shaped to generally follow the contour of the patient's face around the upper lip area. The interface body 110 is molded or preformed so that it can conform to and / or is flexible to accommodate, accommodate and / or correspond to the contours of the user's face in the area of ​​the face where the nasal interface will be placed.

[0214] 13(a)-13(c), interface body 110 includes a base portion 118 from which nasal delivery element 111 and nasal delivery element 112 extend.

[0215] The base portion 118 is disposed so as to be located, during use, between the patient's face and the gas manifold 120. The base portion 118 may function as a cushion to prevent the gas manifold 120 from touching the patient's face.

[0216] In the illustrated configuration, the interface body 110 includes two side arms extending laterally from opposite sides of the base portion 118 .

[0217] In the illustrated configuration, the side arms include wings 113 and 114 that extend laterally from opposite sides of a base portion 118. Wings 113 and 114 are integrally formed with base portion 118, but may alternatively be separate pieces.

[0218] In some configurations, the nasal delivery elements 111 , 112 extend generally upwardly and rearwardly from the base portion 118 of the interface body 110 .

[0219] An adhesive pad (not shown) may be provided on each wing 113, 114 to facilitate attachment of the nasal interface 100 to the patient.

[0220] The gas manifold 120 is generally tubular in shape with gas ports 121, 122 on at least one side thereof and optionally both sides thereof (FIGS. 5, 11 and 12). At least one of the gas ports 121, 122 may be removably attachable to the respiratory conduit 300, for example by a threaded engagement, but alternatively by a snap fit or any other type of connection known in the art, thereby allowing at least one of the gas ports 121, 122 to function as a gas inlet for the gas manifold 120 and thus for the nasal interface 100. Alternatively, the ports 121, 122 may be fixedly coupled to or integrally formed with the respiratory conduit 300.

[0221] By having the respiratory conduit 300 extending from the side of the gas manifold 120 and therefore the side of the nasal interface 100, the patient's mouth may be easily accessible, for example for nutrition / feeding, drinking or verbal communication, while wearing the nasal interface.

[0222] The flow enters the nasal interface 100 through the gas inlet and travels through the gas manifold 120 in a direction substantially transverse to the direction that the flow will travel to the first nasal delivery element 111 and the second nasal delivery element 112.

[0223] The gas inlet is in fluid communication with the breathing conduit 300 .

[0224] In some configurations, the respiratory conduit 300 is between about 12 mm and about 23 mm, optionally greater than about 12 mm and up to about 23 mm, optionally greater than about 12 mm and up to about 22 mm, optionally greater than about 12 mm and up to about 21 mm, optionally greater than about 12 mm and up to about 20 mm, optionally greater than about 12 mm and up to about 19 mm, optionally greater than about 12 mm and up to about 18 mm, optionally between about 13 mm and about 17 mm, optionally In one embodiment, the inner diameter is about 14 mm to about 16 mm, optionally about 12 mm, optionally about 13 mm, optionally about 14 mm, optionally about 15 mm, optionally about 16 mm, optionally about 17 mm, optionally about 18 mm, optionally about 19 mm, optionally about 20 mm, optionally about 21 mm, optionally about 22 mm, optionally about 23 mm, or optionally any value between any two of these values.

[0225] With reference to FIGS. 11 and 12, the gas flow path is defined by a lumen or flow channel 125 within the gas manifold 120 .

[0226] A flow channel 125 extends from gas port 121 on one side of gas manifold 120 through the gas manifold to gas port 122 on the other side of gas manifold 120 .

[0227] The flow channel 125 is in fluid communication with the first gas outlet 123 and the second gas outlet 124. The first gas outlet 123 is configured to deliver gas to the first nasal delivery element 111 and the second gas outlet 124 is configured to deliver gas to the second nasal delivery element 112.

[0228] The shape of the gas outlets 123, 124 correspond to and mate with the interface body 110, for example by a friction fit or snap fit engagement, such that significant force, or at least deliberate force, applied by a user or caregiver is required to separate the manifold 120 from the interface body 110.

[0229] Upon engagement of the gas manifold 120 and the interface body 110 , an effective seal is formed between the gas outlets 123 , 124 and the interface body 110 .

[0230] In the illustrated configuration, each of the gas outlets is provided in a respective outlet portion 123 a , 124 a of the gas manifold 120 .

[0231] Each outlet portion 123a, 124a includes a sealing flange 123b, 124b for engaging with the first nasal delivery element 111 and the second nasal delivery element 112.

[0232] A sealing flange 123b, 124b extends transversely outwardly from adjacent sections of each outlet portion 123a, 123b. The sealing flanges 123b, 124b are received in respective portions 111x, 112x of the nasal delivery elements 111, 112.

[0233] In the illustrated configuration, the sealing flanges 123b, 124b are generally annular in shape and each portion 111x, 112x of the nasal delivery element includes an annular channel on the inner surface of the nasal delivery element 111,112.

[0234] In alternative configurations, the sealing flanges 123b, 124b and each portion 111x, 112x may have different shapes, for example they may comprise one or more separate members that do not extend around the entire circumference of the outlet portions 123a, 123b and nasal delivery elements 111, 112, respectively.

[0235] In the illustrated configuration, the outlet portions 123a, 124a and sealing flanges 123b, 124b are received within the nasal delivery elements 111, 112. In an alternative configuration, this may be reversed such that the bases of the nasal delivery elements 111, 112 are received within the body portions 123a, 124a. In that configuration, the outlet portions 123a, 124a may include sealing collars for engaging the first and second nasal delivery elements. The sealing collars may engage the exterior of the nasal delivery elements to provide a seal therebetween.

[0236] The nasal delivery elements 111, 112 may include protrusions that are received in respective recesses in the sealing collars. The protrusions and recesses may be generally annular in shape or may have different configurations as described above with respect to the sealing flanges 123b, 124b and complementary portions 111x, 112x.

[0237] In some configurations, the sealing flange or collar and the complementary portion of the nasal delivery element further function as a retention feature to maintain the interface body 110 and the gas manifold 120 in engagement with one another. In alternative configurations, the interface body 110 and the gas manifold 120 may include one or more other retention features, such as, for example, clips or fasteners, to maintain the interface body 110 and the gas manifold 120 in engagement with one another.

[0238] The gas manifold 120 may consist of a single piece or may include multiple components that are combined. For example, the gas manifold 120 may have a first body portion that provides the gas flow channel 125 and optionally the gas ports 121, 122. The gas manifold 120 may have a second body portion that provides the gas outlets 123, 124. Alternatively, the gas manifold 120 may be a single component. In an alternative configuration, the gas manifold 120 may include a single outlet and the interface body 110 may include a single complementary gas inlet that mates with the single outlet of the gas manifold 120 and is in fluid communication with the first nasal delivery element 111 and the second nasal delivery element 112 to deliver gas to the first nasal delivery element 111 and the second nasal delivery element 112.

[0239] 1-14 and 18, in some configurations, a nasal interface 100 of the present disclosure includes a first nasal delivery element 111 and a second nasal delivery element 112. The first nasal delivery element 111 and the second nasal delivery element 112 are each configured to seal with a respective nasal cavity of a patient. The first nasal delivery element is configured to seal with a first nasal cavity of the patient and the second nasal delivery element is configured to seal with a second nasal cavity of the patient.

[0240] In some configurations, the first nasal delivery element 111 and the second nasal delivery element 112 are configured to seal the entrance of the patient's nasal cavity. In some configurations, the first nasal delivery element 111 and the second nasal delivery element 112 are configured to seal the inside of the patient's nasal cavity. In some configurations, the first nasal delivery element 111 and the second nasal delivery element 112 are configured to seal both the entrance of the nasal cavity and the inside of the patient's nasal cavity.

[0241] The nasal interface includes a gas manifold 120 including a gas inlet 121 for delivering respiratory gas to the gas manifold. The first nasal delivery element 111 and the second nasal delivery element 112 are in fluid communication with the gas inlet 121 via the gas manifold 120.

[0242] The gas inlet 121 communicates with a single gas entry portion of the gas manifold's gas flow channel 125. With this configuration, breathing gas enters the gas manifold 125 from a single region, for example from a single side of the gas manifold, and is delivered to the first nasal delivery element 111 and the second nasal delivery element 112 from that single region.

[0243] In addition to passing through the first nasal delivery element 111 and the second nasal delivery element 112, the gas flows generally unidirectionally from one side of the gas manifold to the opposite side of the gas manifold.

[0244] The gas manifold 120 may include a single gas inlet 121 .

[0245] Referring to Figures 9, 10 and 11, the nasal interface includes a bypass restriction 130 between the first nasal delivery element 111 and the second nasal delivery element 112 to provide a pressure drop through the nasal interface 100 so that the pressure in the first nasal delivery element 111 is higher than the pressure in the second nasal delivery element 112 when gas is delivered from the gas inlet 121 to the first nasal delivery element 111 and the second nasal delivery element 112.

[0246] As used herein, the bypass restriction 130 may be any feature or geometry that provides a pressure drop across the nasal interface 100 between the first nasal delivery element 111 and the second nasal delivery element 112 such that when gas is delivered from the gas inlet 121 to the first nasal delivery element 111 and the second nasal delivery element 112, the pressure at the first nasal delivery element 111 is higher than the pressure at the second nasal delivery element 112. In some configurations, the bypass restriction 130 is a cross-sectional area (A) of the first nasal delivery element 111 and the second nasal delivery element 112 relative to the gas inlet 121 relative to the adjacent portion of the gas flow channel 125. 3 +A 4 It may be a physical restriction against the nasal interface 100 and / or against any other part of the nasal interface 100.

[0247] In some configurations, the bypass restriction 130 may be a flow divider or flow director.

[0248] The pressure drop is such that the gas pressure upstream of the bypass restriction is higher than the gas pressure downstream of the bypass restriction.

[0249] The pressure on the first nasal delivery element 111 can be at the outlet of the first nasal delivery element and / or along and / or adjacent to the first nasal delivery element. The pressure on the second nasal delivery element 112 can be at the outlet of the second nasal delivery element and / or along and / or adjacent to the second nasal delivery element.

[0250] The pressure drop through the gas manifold 120 can be such that when there is gas flow from the gas inlet 121 to the first nasal delivery element 111 and the second nasal delivery element 112, the gas flow from the gas inlet 121 to the first nasal delivery element 111 is greater than the gas flow from the gas inlet 121 to the second nasal delivery element 112.

[0251] The bypass restriction 130 may restrict gas flow through the gas manifold 120 between the first nasal delivery element 111 and the second nasal delivery element 112.

[0252] In some configurations, when gas is delivered from the gas inlet 121 to both the first nasal delivery element 111 and the second nasal delivery element 112, the pressure of the gas flow in the second nasal delivery element 112 is up to about 1 cmH2O less than the pressure of the gas flow in the first nasal delivery element.

[0253] The pressure drop caused by the bypass restriction 130, and therefore the pressure difference of the gas flow between the first nasal delivery element 111 and the second nasal delivery element 112, is typically higher during the inhalation phase than during the exhalation phase. This is because when the patient exhales gas, more exhaled gas passes through the second nasal delivery element 112 than through the first nasal delivery element 111. For example, during the inhalation phase, the pressure of the gas flow in the second nasal delivery element 112 may be about 0.6 cmH2O less than the pressure of the gas flow in the first nasal delivery element 111, and during the exhalation phase, the pressure of the gas flow in the second nasal delivery element 112 may be about 0.3 cmH2O less than the pressure of the gas flow in the first nasal delivery element 111. The magnitude of the difference between the pressure of the gas flow at the first nasal delivery element 111 and the pressure of the gas flow at the second nasal delivery element 112 for a given bypass restriction 130 depends on the set pressure as well as the phase of the respiratory cycle.

[0254] In some configurations, the nasal interface 100 is configured to achieve a patient pressure at the first nasal delivery element 111 and the second nasal delivery element 112 of about 2 cmH2O to about 30 cmH2O in use, optionally about 2 cmH2O to about 25 cmH2O in use, optionally about 2 cmH2O to about 20 cmH2O in use, optionally about 2 cmH2O to about 15 cmH2O in use, optionally about 2 cmH2O to about 14 cmH2O in use, optionally about 2 cmH2O to about 13 cmH2O in use, optionally about 2 cmH2O to about 12 cmH2O in use, optionally about 2 cmH2O to about 11 cmH2O in use, optionally about 2 cmH2O to about 10 cmH2O in use.

[0255] The nasal interface 100 may be configured such that the pressure at the first nasal delivery element 111 is higher than the pressure at the second nasal delivery element 112 during both the inhalation and exhalation phases.

[0256] A set pressure may be delivered to the second nasal delivery element 112 and a higher pressure may be delivered to the first nasal delivery element 111.

[0257] As the set pressure increases, the pressure difference between the first and second nasal delivery elements increases, which increases results in increased dead space clearance or washout.

[0258] In some configurations, the pressure differential between the first nasal delivery element 111 and the second nasal delivery element 112 is configured to provide an asymmetric flow through the patient's upper airway of at least about 1 liter per minute (lpm), optionally between about 1 lpm and about 2 lpm, optionally between about 1 lpm and about 5 lpm. In some configurations, the asymmetric flow may be less than 1 lpm.

[0259] The nasal interface 100 is configured to create an asymmetric gas flow through the first nasal delivery element 111 and the second nasal delivery element 112 to the patient's nasal passages due to the pressure drop through the gas manifold and the resulting pressure difference between the first nasal delivery element 111 and the second nasal delivery element 112. The resulting asymmetric gas flow can result in improved dead space clearance.

[0260] In some configurations, the gas manifold 120 includes a gas flow channel 125 within the gas manifold 120 , and the bypass restriction 130 provides a reduced cross-sectional area of ​​a portion of the gas flow channel 125 .

[0261] This is shown, for example, in FIG. 10, where it can be seen that the spacing within the gas flow channels 125 in the region of the bypass restriction 130 is significantly reduced compared to the spacing within the gas flow channels 125 on either side of the bypass restriction 130.

[0262] The portion of the restricted gas flow channel 125 may be between the first nasal delivery element 111 and the second nasal delivery element 112 and / or adjacent to the second nasal delivery element 112. In particular, the portion of the restricted gas flow channel may be between the first gas outlet 123 and the second gas outlet 124 of the gas manifold.

[0263] FIG. 19 shows a schematic representation of the nasal interface configuration of FIGS. 1 to 18, but additionally shows a bypass restriction area (area A 2 ) and the adjacent or main portion of the gas flow channel 125 (area A 1 ) shows the relative cross-sectional areas of the first nasal delivery element 111 and the second nasal delivery element 112 in this configuration.

[0264] In some configurations, the plenum volumes at the base of the first nasal delivery element 111 and the second nasal delivery element 112 are substantially the same. The bypass restriction 130 can be a localized restriction.

[0265] 20 illustrates generally an alternative configuration of a nasal interface in which a bypass restriction 130 is adjacent to the second nasal delivery element 112. The bypass restriction 130 is disposed opposite the base of the second nasal delivery element 112.

[0266] 21 illustrates generally an alternative configuration of a nasal interface in which the bypass restriction 130 is both between the first and second nasal delivery elements 111 and the second nasal delivery element 112, but also adjacent to the second nasal delivery element. The bypass restriction 130 is partially opposite the base of the second nasal delivery element.

[0267] The volume of the gas flow channel 125 at the base of the second nasal delivery element 112 is smaller than the volume of the gas flow channel at the base of the first nasal delivery element 111.

[0268] The bypass restriction 130 may extend into the gas flow channel in one or more directions (i.e., from one or more walls of the gas flow channel 125). In some configurations, the bypass restriction 130 may extend into the gas flow channel in one direction, such as upward, downward, forward, or rearward. In some configurations, the bypass restriction 130 may extend into the gas flow channel in two or more directions, such as two or more of upward, downward, forward, or rearward.

[0269] The bypass restriction 130 may include at least one protrusion 130a, 130b that extends into the gas flow channel 135. In some configurations, the bypass restriction 130 may include multiple protrusions that extend into the gas flow channel 125.

[0270] For example, the bypass restriction 130 may include diametrically opposed protrusions that extend into the flow channel.

[0271] In some configurations, the gas manifold 120 includes a proximal bypass protrusion 130a proximal to the first nasal delivery element 111 and the second nasal delivery element 112 and / or a distal bypass protrusion 130b distal to the first nasal delivery element 111 and the second nasal delivery element 112.

[0272] In the illustrated configuration, the gas manifold 120 includes both a proximal bypass protrusion 130a and a distal bypass protrusion 130b, which in combination define a predetermined bypass dimension BD between the first nasal delivery element 111 and the second nasal delivery element 112 for restricted gas flow through the gas manifold 120.

[0273] The predetermined bypass dimension BD is generally substantially smaller than the dimensions of the adjacent or main portions of the gas flow channel 125 .

[0274] The given bypass dimension BD is the cross-sectional area A outlined below. 2 may be related to.

[0275] When multiple protrusions are provided, they may be separate protrusions, semi-continuous, or continuous. Figures 11(a) and 11(b), for example, show that a portion of the bypass restriction extends around substantially the entire circumference of the gas flow channel 125 to form an upper bypass protrusion 130a and a lower bypass protrusion 130b.

[0276] Referring to FIG. 11(c), the bypass restriction 130 includes angled leading edges 130a', 130b' and angled trailing edges 130a", 130b" that define converging and diverging bypass restrictions in the direction of gas flow through the gas manifold from the first nasal delivery element 111 to the second nasal delivery element 112.

[0277] The angled leading edge 130a', 130b' and / or the angled trailing edge 130a", 130b" may be substantially straight or flat, or alternatively may be curved. If curved, the curved surface may be convex so as to curve in a direction toward the center of the gas flow channel 125, or concave so as to curve in a direction away from the center of the gas flow channel 125.

[0278] Any suitable combination of shapes may be provided. For example, at least one of the leading edges 130a', 130b' may be one of straight, concave, or convex, and at least one of the trailing edges 130a", 130b" may be another one of straight, concave, or convex.

[0279] The leading edges 130a', 130b' and trailing edges 130a", 130b" may have the same configuration as one another or may have different configurations. For example, the slope and / or curvature on the upstream side may be different from the slope and / or curvature on the downstream side.

[0280] When multiple protrusions are provided for the bypass restriction 130, the protrusions may be of the same shape and configuration as one another, or may have different shapes and configurations as one another.

[0281] In the illustrated configuration, the upper protrusions 130a have a smaller width in a direction along the gas flow channel than the lower protrusions 130b. In alternative configurations, the upper protrusions 130a may be the same width as the lower protrusions 130b or may have a smaller width than the lower protrusions.

[0282] In the illustrated configuration, the upper protrusions 130a extend substantially the same distance into the gas flow channels 125 as the lower protrusions 130b. In alternative configurations, the upper protrusions 130a may extend further into the gas flow channels 125 than the lower protrusions 130b, or the lower protrusions 130b may extend further into the gas flow channels 125 than the upper protrusions 130a.

[0283] The bypass restriction 130 may be integrally formed with the gas manifold 120. Alternatively, the bypass restriction 130 may include an insert for attachment to the gas manifold 120. For example, the bypass restriction may be formed as a sleeve or plug. The sleeve or plug may be attached to the gas manifold in any suitable manner. For example, the sleeve or plug may be press-fit, threaded, fastened, etc., into the gas flow channel 125 of the gas manifold.

[0284] The bypass restriction 130 may be provided by the gas manifold 120, the base portion 118 of the interface body, or both the gas manifold 120 and the base portion 118 of the interface body.

[0285] The bypass restriction 130 is a first cross-sectional area A of the adjacent or main portion of the gas flow channel 125. 1 The reduced second cross-sectional area A of the gas flow channel 125 compared to 2 is configured to provide.

[0286] In some configurations, the second cross-sectional area A 2 is the first cross-sectional area A 1 In some configurations, the second cross-sectional area A 2 is the first cross-sectional area A 1 about 10% to about 35% of the first cross-sectional area A 1 about 10% to about 30% of the first cross-sectional area A 1 and optionally a first cross-sectional area A 1 In some configurations, the second cross-sectional area A 2 is the first cross-sectional area A1 about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31%, about 32%, about 33%, about 34%, about 35%, about 36%, about 37%, about 38%, about 39% or about 40% of the total, or any percentage between any two of these percentages.

[0287] In one exemplary configuration, the first cross-sectional area is about 200 mm 2 (corresponding to a radius of about 8 mm), and the second cross-sectional area may be about 20 mm 2 ~about 80mm 2 , optionally about 20 mm 2 ~about 70mm 2 , optionally about 20 mm 2 ~about 60mm 2 , optionally about 20 mm 2 ~ approx. 50mm 2 , optionally about 30 mm 2 ~ approx. 40mm 2 and optionally about 35 mm 2 It could be.

[0288] The predetermined bypass dimension BD is, for example, from about 5 mm to about 10 mm, optionally from about 5 mm to about 9.5 mm, optionally from about 5 mm to about 8.75 mm, optionally from about 5 mm to about 8 mm. 2 , optionally from about 6 mm to about 7 mm, optionally from about 6.5 mm to about 7 mm, and optionally about 6.7 mm.

[0289] In some configurations, the nasal interface 100 includes an interface body 110 that includes a first nasal delivery element 111 and a second nasal delivery element 112 .

[0290] In some configurations, the gas manifold 120 is integral with the interface body 110 or is separate from and connectable to the interface body 110 .

[0291] The first nasal delivery element 111 has a first outlet 111a defined by an opening at its tip or end 111b for delivering gas from the first nasal delivery element 111. Gas delivered through the first nasal delivery element 111 exits the first nasal delivery element 111 through the first outlet 111a.

[0292] The second nasal delivery element 112 has a second outlet 112a defined by an opening at its tip or end 112b for delivering gas from the second nasal delivery element 112. Gas delivered through the second nasal delivery element 112 exits the second nasal delivery element through the second outlet 112a.

[0293] The first nasal delivery element 111 and the second nasal delivery element 112 may have any suitable shape to seal the patient's nasal passages. For example, in one configuration, the first nasal delivery element 111 and the second nasal delivery element 112 may be substantially tubular and sized larger than the patient's nasal passages, but may be soft or flexible so as to deform and seal the passages when inserted into the passages. In some configurations, the nasal delivery elements 111, 112 are more soft or flexible than the body portion 118.

[0294] As another example and as shown, the first nasal delivery element 111 and the second nasal delivery element 112 may include nostril positioners or pillows for sealing against the patient's nasal passages.

[0295] In the illustrated configuration, for example as shown in Figures 13 and 14, each pillow may generally taper narrowing toward its respective outlet 111a, 112a at its tip or end 111b, 112b. Thus, the proximal opening 111a, 112a may have a smaller diameter or transverse dimension than the distal opening 111c, 112c at the base of the pillow. In general, the pillows may taper in the proximal direction toward their tip or end 111b, 112b.

[0296] In the illustrated configuration, the tips or ends 111b, 112b of the pillows are configured to be received in the patient's nasal passages and the enlarged regions 111d, 112d of the pillows adjacent the tips or ends 111b, 112b are configured to seal the entrance to the nasal passages. In other configurations, the tips or ends 111b, 112b and portions of the enlarged regions 111d, 112d may be configured to be received in and seal against the nasal passages.

[0297] The pillows may be soft or flexible so that they deform when inserted into or in contact with the nasal passages to seal against the nasal passages. In some configurations, the pillows are soft or flexible relative to the body portion 118.

[0298] The pillow is also desirably sufficiently rigid to reduce the likelihood of bulging or being insufficiently self-supporting to provide the user with an indication of the correct position and orientation of the nasal interface 100 relative to the face. The pillow may have sufficient rigidity to inhibit or prevent significant collapse in response to positioning of the pillow relative to the patient's nasal passages. In some configurations, the pillow may have a thickness of approximately 0.7 mm, with some variation slightly higher and lower than this possible, keeping in mind that it is desirable to reduce discomfort to the user while still assisting in positioning the nasal interface.

[0299] The pillow may include one or more reinforcing elements or features to inhibit collapse of the pillow.

[0300] The first nasal delivery element 111 and the second nasal delivery element 112 may be movable relative to the body portion 118 to allow the angle and position of the nasal delivery elements 111, 112 to be adjusted in response to contact with the patient's nasal passages.

[0301] The pillow and nasal interface may have any one or more of the features described in connection with the nostril positioner in U.S. Patent No. 10,918,818, the contents of which are incorporated herein by reference in their entirety.

[0302] If leakage occurs between the nasal delivery elements 111, 112 and the patient's nasal passages, it is minimal and can be compensated for or controlled by adjusting the flow rate of the therapeutic gas.

[0303] The nasal interface 100 is configured to create an asymmetric gas flow in the patient's nasal passages due to a pressure drop across the gas flow channels 125 of the nasal interface 100.

[0304] The nasal interface 100 may be configured to deliver between about 10 lpm and about 50 lpm from the nasal interface 100 through the nasal delivery elements 111, 112. The rate delivered through each nasal delivery element will vary depending on the patient, the pressure differential and the stage of the respiratory cycle.

[0305] Having a difference in flow rates between nasal delivery elements 111 and 112 can provide the benefits of asymmetric flow, as described below.

[0306] In some configurations, there is a relatively constant pressure differential between the nasal delivery elements 111 and 112, and a resulting relatively constant asymmetric flow through the nasal delivery elements 111, 112. In some configurations, the pressure differential and resulting asymmetric flow can vary. As long as there is a pressure drop through the gas manifold 120 during at least some portion of the breathing cycle, asymmetric flow will occur.

[0307] The percentage of the total volumetric flow rate delivered through each prong 111, 112 can be determined by delivering a known volumetric flow rate of gas to the gas inlet 121 of the nasal interface 100 when the nasal interface is not applied to the patient's nasal cavities. The volumetric flow rate exiting each outlet 111a, 112a can be measured by a suitable flow meter or sensor to determine the percentage of the total volumetric flow rate of gas flow entering the gas inlet 121 that exits the outlet 111a, 112a of each nasal delivery element 111, 112.

[0308] The nasal interface 100 includes a bias flow restriction 140 for gas flow exiting the nasal interface 100 and optionally for gas flow exiting the gas manifold 120 .

[0309] 1-5, 16 and 18, the bias flow restriction 140 is in fluid communication with the gas manifold 120, and more specifically, with the gas ports 122 of the gas manifold 120.

[0310] The bias flow restriction 140 is positioned within the patient interface 100 downstream from the first nasal delivery element 111 and the second nasal delivery element 112 and opposite the gas port 121 so that gas can be routed from the first nasal delivery element 111 and the second nasal delivery element 112 and exit the nasal interface via the bias flow restriction 140. A portion of the gas entering the gas inlet port 121 can travel out of the bias flow restriction 140 without passing through the first nasal delivery element 111 and the second nasal delivery element 112. The gas traveling out of the nasal interface via the bias flow restriction may include exhaled gas and may further include some inlet gas that has not passed through the first nasal delivery element 111 and the second nasal delivery element 112.

[0311] The bias flow restriction 140 allows for the delivery of pressure therapy to the patient's nasal passages. The bias flow restriction 140 allows for restricted gas flow out of the nasal interface 100 through the bias flow restriction. If the bias flow restriction 140 was not present and the gas port 122 was closed, all exhaled gas would be rebreathed. If the bias flow restriction was not present and the gas port 122 was open, the respiratory therapy device would not be able to apply pressure through the nasal interface.

[0312] The opening area for gas flow through the bias flow restriction may be selected to provide sufficient area for the bias flow while minimizing noise due to the bias flow. In one exemplary configuration, when a patient pressure of approximately 10 cmH2O is provided, the gas flow through the nasal interface 100 may be approximately 25-45 lpm, and the opening area for gas flow through the bias flow restriction may be approximately 10 mm. 2 ~about 15mm 2 However, this is merely an example and these values ​​may vary depending on system parameters and patient requirements. In another example, the opening area for gas flow through the bias flow restriction may be about 10 mm 2 ~about 30mm 2 , optionally about 25 mm 2 ~about 30mm 2 and optionally about 27.5 mm 2 It could be.

[0313] The gas manifold 120 may include or be coupled to the bias flow restriction 140. In an alternative configuration shown in FIG. 18, the bias flow restriction 140 may be in fluid communication with the gas manifold 120, but located remotely from the gas manifold 120. In this alternative configuration, the expiratory gas conduit 160 is coupled to the gas port 122 of the gas manifold 120 and to the bias flow restriction 140. The expiratory gas conduit 160 may have any suitable length. This configuration allows the expiratory gas and any inlet gases that bypass the first nasal delivery element 111 and the second nasal delivery element 112 to be exhausted through the bias flow restriction 140, which is located remotely from the patient.

[0314] 6-9, the biased flow restriction 140 includes one or more gas outlets for gas flow from the nasal interface 100 and optionally the gas manifold 120 to the surrounding environment.

[0315] The one or more gas outlets may include one or more apertures. In the illustrated configuration, the one or more gas outlets include a plurality of apertures 142 for gas flow from the nasal interface 100 and optionally the gas manifold 120 to the surrounding environment.

[0316] The plurality of apertures 142 may be provided in any suitable arrangement or arrangement. For example, in the illustrated configuration, the plurality of apertures 142 are provided in an arrangement of four long rows and two outer short rows. However, any other suitable arrangement may be provided, such as more or fewer rows of apertures, more or fewer apertures within each row, or irregular arrangements of apertures.

[0317] The bias flow restriction 140 may include 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50 or more apertures.

[0318] Additionally or alternatively, the one or more gas outlets may include one or more slots, which may be straight, curved, wavy, serpentine, or any other suitable shape.

[0319] The one or more gas outlets typically have exit dimensions substantially smaller than the size of the gas inlet to the bias flow restriction 140 to create a pressure drop or resistance to flow out of the one or more gas outlets. The pressure drop is such that the gas pressure upstream of the one or more gas outlets is higher than the gas pressure downstream of the one or more gas outlets.

[0320] However, if multiple outlets are provided, the sum of the outlet dimensions may approach the size of the gas inlet.

[0321] In some configurations, a gas inlet 148 and one or more gas outlets are located in the bias flow restriction 140 such that the gas flow F must change direction between entering and exiting the bias flow restriction, as shown, for example, by arrow F in FIG.

[0322] In some configurations, one or more gas outlets are provided in the restriction component body 144. The restriction component body 144 defines a body gas flow passage 146 that is in fluid communication with a body gas inlet 148. The one or more gas outlets are in fluid communication with the body gas flow passage 146 such that gas enters the body gas flow passage 146 from gas ports 122 of the gas manifold and exits through one or more gas outlets (e.g., apertures 142).

[0323] 7(b), the restriction piece body 144 may have a tapered configuration in which the body gas flow passage 146 is smaller distal from the body gas inlet 148 than proximal to the body gas inlet 148. The body ceiling, end wall 144b and / or the wall 144c containing the one or more gas outlets may be angled non-parallel and non-perpendicular to one another to encourage flow from the body gas inlet 148 to pass through the one or more gas outlets.

[0324] In some configurations, the bias flow restriction 140 is configured to direct gas flow exiting the bias flow restriction away from the patient's face. In the illustrated configuration, the bias flow restriction 140 is configured to direct gas flow at least partially in an anterior direction, away from the patient's face, and in some configurations, completely in an anterior direction.

[0325] The bias flow restriction 140 is configured to allow for the use of one or more gas outlets to allow for the flow of carbon dioxide (CO 2 ) to vent. In the illustrated embodiment, the nasal interface 100 has apertures 142 for venting gases from the interior of the nasal interface 100 to the environment. The apertures 142 or other openings may help vent carbon dioxide gas from the user to reduce rebreathing of carbon dioxide gas.

[0326] The one or more gas outlets provide a controlled or known leak to allow for the exhaust of the user's exhaled carbon dioxide gas. There may be a performance trade-off between the location (relative to the patient's nose) of the one or more openings and the amount of bias flow required. As used herein, bias flow refers to the gas flow through the bias flow restriction 140 to the environment. The bias flow rate and the design of the one or more openings may affect the noise level and the amount of draft the bias flow creates as well as the amount of entrainment the exiting gas flow may cause.

[0327] The one or more gas outlets may include multiple through holes 142 that exhaust gases from the nasal interface. In other configurations, the gas outlets may be slits or large openings instead of or in addition to small through holes. In some configurations, the gas outlets may be located in other parts of the interface. In general, a relatively smaller hole size will generate less airflow noise compared to a larger hole size, given the same flow rate through both hole sizes. Multiple holes help reduce airflow noise when exhausting a given amount of gas, compared to having one or several holes with the same exhaust area.

[0328] The one or more gas outlets may have any one or more of the features or functions described with respect to vents in U.S. Patent No. 10,898,866, the contents of which are incorporated herein by reference in their entirety.

[0329] The bias flow restriction 140 may include one or more gas outlets, such as any filter or diffuser for filtering or diffusing gas flowing through the aperture.

[0330] The filter may reduce respiratory contaminants that are released through the bias flow restriction.

[0331] The diffuser can diffuse the gas exiting the bias flow restriction to reduce noise.

[0332] 6 shows a filter or diffuser member 150 configured to cover at least one or more gas outlets and filter or diffuse gas as it exits the one or more gas outlets. The filter or diffuser member 150 may comprise any suitable material, such as one or more of a non-woven fibrous material (including polymeric fibers), an open cell foam, or a sintered polymer.

[0333] In some configurations, the restrictor body 144 includes a filter or diffuser recess 145 for receiving a filter or diffuser member 150 .

[0334] The bias flow restriction 140 may include a shroud 152 attached to the restriction body 144 and configured to maintain a filter or diffuser member 150 in place over one or more gas outlets.

[0335] The shroud 152 includes an aperture 153 that is at least the size of at least one opening in the restrictor body 144 .

[0336] The shroud 152 may hold the filter or diffuser member 150 within the aperture 153 , or the filter or diffuser member 150 may be sandwiched between the shroud 152 and the recess 145 .

[0337] The shroud 152 may be removably attachable to the restrictor body 144 to allow for cleaning or replacement of the filter or diffuser member 150 .

[0338] The shroud 152 may be attached to the restrictor body 144 by any suitable arrangement, such as clips, fasteners, etc. In the illustrated configuration, the shroud 152 includes two inwardly facing engagement pieces 154 that snap into complementary engagement recesses 147 in the restrictor body 144.

[0339] The shroud may include one or more gripping portions 156 to allow the engagement parts 154 to be released from the recesses 147 to remove the shroud 152 from the limiting part body 144. In the illustrated configuration, the gripping parts 156 include outward protrusions to allow a user to apply an outward and downward force to forcibly disengage the engagement parts from the limiting part body 152, although any other suitable configuration may be used.

[0340] 17(b), a filter unit 500′ may be provided between the gas manifold 120 and the bias flow restriction 140. The filter unit 500′ may have any one or more of the features described herein with respect to the filter unit 500.

[0341] In some configurations, the nasal interface 100 of the present disclosure includes a first nasal delivery element 111 and a second nasal delivery element 112, each configured to seal with a respective nasal cavity of a patient, and a gas manifold 120, the gas manifold 120 including a gas inlet 121 for delivering respiratory gas to the gas manifold, the first nasal delivery element 111 and the second nasal delivery element 112 being configured to seal with a respective nasal cavity of a patient. The nasal interface 100 is fluidly connected to a gas inlet 121 via a nifold 120, with the first nasal delivery element 111 proximal to the gas inlet 121 and the second nasal delivery element 112 distal to the gas inlet 121, and is configured to create a pressure differential between the first nasal delivery element 111 and the second nasal delivery element 112 such that when gas is delivered from the gas inlet 121 to both the first nasal delivery element 111 and the second nasal delivery element 112, the pressure in the first nasal delivery element 111 is higher than the pressure in the second nasal delivery element 112.

[0342] In some configurations, the pressure difference is such that when there is gas flow from the gas inlet 121 to the first nasal delivery element 111 and the second nasal delivery element 112, the gas flow from the gas inlet 121 to the first nasal delivery element 111 is greater than the gas flow from the gas inlet 121 to the second nasal delivery element 112.

[0343] In some configurations, the gas inlet 121 is in fluid communication with the breathing conduit 300 .

[0344] In some configurations, when gas is delivered from the gas inlet to both the first nasal delivery element and the second nasal delivery element, the pressure of the gas flow in the second nasal delivery element 112 is up to about 1 cmH2O less than the pressure of the gas flow in the first nasal delivery element 111.

[0345] For example, the pressure of the gas flow at the second nasal delivery element 112 may be about 0.1 cmH2O, about 0.2 cmH2O, about 0.3 cmH2O, about 0.4 cmH2O, about 0.5 cmH2O, about 0.6 cmH2O, about 0.7 cmH2O, about 0.8 cmH2O, about 0.9 cmH2O or about 1 cmH2O less than the pressure of the gas flow at the first nasal delivery element 111, or the difference may be any value between any two of these values.

[0346] The pressure difference of the gas flow between the first and second nasal delivery elements may be higher during the inhalation phase than during the exhalation phase.

[0347] The nasal interface may be configured to achieve a patient pressure at the first and second nasal delivery elements of about 2 cmH2O to about 30 cmH2O in use, optionally about 2 cmH2O to about 25 cmH2O in use, optionally about 2 cmH2O to about 20 cmH2O in use, optionally about 2 cmH2O to about 15 cmH2O in use, optionally about 2 cmH2O to about 14 cmH2O in use, optionally about 2 cmH2O to about 13 cmH2O in use, optionally about 2 cmH2O to about 12 cmH2O in use, optionally about 2 cmH2O to about 11 cmH2O in use, optionally about 2 cmH2O to about 10 cmH2O in use.

[0348] In some configurations, the pressure differential between the first nasal delivery element 111 and the second nasal delivery element 112 is configured to provide an asymmetric flow through the patient's upper airway of about 1 liter per minute (lpm) to about 5 lpm.

[0349] For example, the asymmetric flow through the patient's upper airway can be about 1 lpm, about 1.25 lpm, about 1.5 lpm, about 1.75 lpm, about 2 lpm, about 2.25 lpm, about 2.5 lpm, about 2.75 lpm, about 3 lpm, about 3.25 lpm, about 3.5 lpm, about 3.75 lpm, about 4 lpm, about 4.25 lpm, about 4.5 lpm, about 4.75 lpm, about 5 lpm, or any value between any two of these values.

[0350] Asymmetric flow is the mechanism by which CO is drawn from the patient's anatomical dead space. 2 Promotes the removal of

[0351] As outlined above, the interface body 110 may be engagable with the gas manifold 120. Thus, in some configurations, the nasal interface 100 of the present disclosure includes an interface body 110 component including a first nasal delivery element 111 and a second nasal delivery element 112, each configured to seal with a respective nasal cavity of a patient. The nasal interface 100 of the present disclosure further includes a gas manifold 120 component including a gas inlet 121 for delivering respiratory gas to the gas manifold component. The interface body 110 component is engagable with the gas manifold 120 component to place the first nasal delivery element 111 and the second nasal delivery element 112 in fluid communication with the gas inlet 121, such that the first nasal delivery element 111 is more proximal to the gas inlet 121 and the second nasal delivery element 112 is more distal to the gas inlet 121. The nasal interface 100 includes at least one gas flow restriction 130 for gas flow through the nasal interface such that when gas is delivered from the gas inlet 121 to the first nasal delivery element 111 and the second nasal delivery element 112, the pressure in the first nasal delivery element is higher than the pressure in the second nasal delivery element.

[0352] The at least one flow restriction may include a bypass restriction, which may have any one or more of the features and functions described herein with respect to bypass restriction 130.

[0353] In some configurations, the nasal interface further includes a bias flow restriction. The bias flow restriction may have any one or more of the features and functions described herein with respect to the bias flow restriction 140.

[0354] Thus, the nasal interfaces described herein may include a bypass restriction, a bias flow restriction, or may include both a bypass restriction and a bias flow restriction.

[0355] By providing asymmetric flow, use of the nasal interface 100 of the present disclosure may result in a reduction in dead space (i.e., the volume of air not participating in gas exchange within the lungs) compared to traditional continuous positive airway pressure (CPAP) therapy. It is understood that within a patient's upper airway, a percentage of gas moves unidirectionally, flowing in one nostril and out the other, reducing upper airway dead space. This may be most noticeable at higher set pressures, which leads to increased asymmetric flow and therefore increased dead space clearance.

[0356] The bypass restriction 130 promotes asymmetric flow. The biased restriction 140 in combination with the sealing nasal elements 111, 112 allows for the delivery of CPAP-style therapy. The nasal interface 100 allows for CPAP with increased dead space clearance. The bypass restriction 130 allows for dead space clearance. The sealing nasal delivery elements 111, 112 allow for CPAP therapy.

[0357] Inhalation and exhalation flow exists in both nostrils, however this flow is partially unidirectional with a greater proportion of the inhalation flow through the nostril closer to the gas inlet 121 and therefore the flow source.

[0358] The nasal interface 100 may be used in pressure controlled therapy, but with increased humidity compared to traditional CPAP therapy, which is believed to be advantageous along with increased dead space clearance.

[0359] In some configurations, the nasal interface 100 may be suitable for or may be used in pressure controlled therapy using treatment pressures of about 2 cmH2O to about 10 cmH2O, depending on the patient and treatment requirements.

[0360] For example, the nasal interface may be suitable for use in or may be used in pressure controlled therapy using treatment pressures of about 2 cmH2O, 2.5 cmH2O, 3 cmH2O, 3.5 cmH2O, 4 cmH2O, about 4.5 cmH2O, about 5 cmH2O, about 5.5 cmH2O, about 6 cmH2O, about 6.5 cmH2O, about 7 cmH2O, about 7.5 cmH2O, about 8 cmH2O, about 8.5 cmH2O, about 9 cmH2O, about 9.5 cmH2O or about 10 cmH2O.

[0361] The pressure may be set or controlled by a respiratory therapy system, an example of which is described below.

[0362] A gas flow is provided to maintain the desired pressure, with the rate of flow depending on the phase of the breathing cycle and the geometry of the bias flow restriction 130, among other factors.

[0363] 10(a) and 10(b) show gas flow through the nasal interface 100. When gas flow F enters the flow channel 125 of the gas manifold 120, a portion of the flow F1 passes through the upstream first nasal delivery element 111 and through the patient's upper airway. A portion of the flow F2 passes across the bypass restriction 130. The portion of the flow F2 that passes across the bypass restriction 130 allows flow F3 through the downstream second nasal delivery element 111, so that inspiration can occur through both nasal delivery elements 111, 112 (assuming neither naris is blocked).

[0364] During inhalation, flow F has a preference to enter the upstream nostril, with slightly more flow entering the upstream nostril than the downstream nostril. During exhalation, flow has a preference to exit the downstream nostril (flow F5), with more flow exiting that nostril than the upstream nostril (flow F4), since flow F3 is less than flow F1.

[0365] During breath holding, flow F1 entering the upstream nostril is greater than flow F3 entering the downstream nostril, so some of the flow shifts to the upstream nostril and exits through the downstream nostril.

[0366] The geometry of the bias flow restriction 140 defines the amount of positive flow through the nasal interface 100. The larger the bias flow area, the greater the flow rate required for the gas source to reach the desired therapeutic pressure.

[0367] The bypass restriction 130 creates a pressure drop between the gas F1 delivered to the upstream nostril and the gas F3 delivered to the downstream nostril, resulting in a pressure difference between the first nasal delivery element 111 and the second nasal delivery element 112.

[0368] The pressure drop creates an asymmetric flow that leads to the "flushing" or "clearance" of the dead space. Dead space is the volume of gas not participating in gas exchange within the alveoli, primarily CO 2 It consists of:

[0369] In some configurations, the asymmetric flow rate can be from about 1 to about 5 lpm.

[0370] In some configurations, the pressure at the downstream nostril may be about 1 cmH2O less than the pressure delivered to the upstream nostril, for example about 6 cmH2O at the upstream nostril and about 5 cmH2O at the downstream nostril.

[0371] The bias flow restriction 140 can be configured to avoid negative flow during the delivery of respiratory therapy.

[0372] It is recognized that negative flow contributes to dead space or rebreathing, therefore, the bias flow restriction 140 should be large enough to allow a high enough bias flow so that the occurrence of negative flow and the amount of rebreathing is reduced or eliminated.

[0373] Asymmetric flow reduces the amount of gas rebreathed throughout the respiratory cycle as the upper airway volume is ventilated.

[0374] This may alternatively be expressed as reducing the dead space or reducing the amount of gas that does not participate in gas exchange during the respiratory cycle.

[0375] The effect of reducing dead space is also seen in high-flow therapy, for example.

[0376] This reduces CO 2 rebreathing of oxygen is reduced and the amount of oxygen available for gas exchange is increased.

[0377] The delivered gas may require more humidity than is typically used for non-invasive ventilation (NIV) or continuous positive airway pressure (CPAP) therapy to prevent drying of the upper airway as gas in the dead space is replaced with gas provided by the therapy.

[0378] The anatomical dead space volume of a patient may typically be between 100ml and 150ml.

[0379] The bypass flow created by the bypass restriction 130 is such that there is a pressure differential between the two nares in response to the device delivering flow in conjunction with breathing or during apnea. While several possible configurations of the bypass restriction may be as described, in alternative configurations of the bypass restriction this may be achieved by a combination of one or more of the following: restricting the bypass flow by having a reduced cross section or some element for creating this restriction, for example one or more protrusions or nozzles or other reduced cross section, The geometry of the bypass restriction may be designed to favor movement in one direction over another, for example by using geometries that provide a higher pressure drop in one direction than the other, such as a horn-shaped nozzle or restriction, a low pressure ejector or a check valve. A flexible element or valve that creates preferential (but not exclusive) flow from upstream to downstream. A valve that is user adjustable by a screw or other mechanism to change the cross-sectional area through which the bypass flow can pass. The flow enters the first nasal delivery element either axially, radially, angled tangentially or some combination of these flows, directing the gas flow preferentially in the first nasal delivery element rather than the second nasal delivery element. The bypass restriction comprises a loose network of material to create a pressure drop, such as a filter, nonwoven polypropylene, foamed plastic, sintered material or any other material that creates a pressure drop across the material when flow is present.

[0380] The bypass restriction may include any one or more of the features described in U.S. Patent Application Publication No. 2016 / 0228665, the contents of which are incorporated herein by reference in their entirety.

[0381] The overall bias flow is controlled in large part by the choice of geometry of the bias flow restriction 140. Several possible configurations of the bias flow restriction can be as described, but in alternative configurations, the pressure drop across the bias flow restriction can be achieved by one or a combination of two or more of the following: The bias flow is restricted, for example by having one or more members or a nozzle or other having a reduced cross section or some element for creating this restriction. A flexible element or valve that creates preferential and possibly exclusive flow out of the nasal interface to reduce or prevent entrainment of ambient air. Check valves may be used to reduce / prevent entrainment of ambient air. Flexible elements may be used to create the pressure drop, which are less likely to clog in the presence of water or phlegm than rigid holes / nozzles. There may be a loose network of material that creates a pressure drop, such as a filter, nonwoven polypropylene, foamed plastic, sintered material or any other material that creates a pressure drop across the material when flow is present. A valve that is user adjustable by a screw or other mechanism to change the cross-sectional area of ​​flow. -Change flow direction multiple times.

[0382] The pressure drop across the nasal interface 100 may be relatively constant over the patient's respiratory cycle, or may instead vary over the patient's respiratory cycle.

[0383] Table 1, with reference to FIG. 15, summarizes the various gas flows that may occur during use of the nasal interface 100.

[0384] [Table 1]

[0385] In Figure 15, positive flow is in the direction of the arrow and negative flow is opposite to the direction of the arrow. Either means that the flow can move in either direction based on several factors. Zero means that there is no net flow in this situation.

[0386] If the upstream nostril is completely blocked, the patient will receive flow into the downstream nostril.

[0387] If the downstream nostril is completely blocked, the patient will receive flow through the upstream nostril.

[0388] In both of these cases, the patient will not tolerate any asymmetric flow, but treatment delivery will continue without this component.

[0389] When either nostril is substantially, but not completely, blocked, there is a reduced amount of asymmetric flow.

[0390] The device may be used in similar patient populations suitable for non-invasive ventilation (NIV).

[0391] Nasal cycling can introduce variations in the asymmetric flow provided by the nasal interface 100.

[0392] As shown diagrammatically in Fig. 15, the nasal interface 100 forms a circuit with the patient's upper airway and lungs. A first portion of the circuit includes a first nasal delivery element 111, the patient's upstream nostril associated with the first nasal delivery element 111, the patient's upper airway and lungs, a second nasal delivery element 112, and the patient's downstream nostril associated with the second nasal delivery element 112. A second portion of the circuit includes the first nasal delivery element 111, a bypass restriction 130, and the second nasal delivery element 112. The bypass restriction provides a pressure drop through the gas manifold between the first nasal delivery element 111 and the second nasal delivery element 112, resulting in asymmetric flow through the first nasal delivery element 111 and the second nasal delivery element 112.

[0393] The nasal interface 100 creates a pressure differential between the two nostrils such that, during at least some portion of the respiratory cycle, the upstream nostril has a higher pressure than the downstream nostril.

[0394] This pressure difference creates flow in the upper airway such that after a complete respiratory cycle, more flow enters the upstream nostril than the downstream nostril and more flow exits the downstream nostril than the upstream nostril. This additional flow entering the upstream nostril and exiting the downstream nostril is asymmetric flow.

[0395] Asymmetric flow dilutes the gas within the patient's airways, which is referred to in the art as washout or dead space clearance.

[0396] There are several ways to achieve this pressure difference between the entrances to the two nostrils, including having a bypass flow between the nostrils regulated to provide some pressure drop.

[0397] In some configurations of the nasal interface 100, the gas manifold 120 may be configured to allow the respiratory conduit 300 to be connected to either the right side of the gas manifold (FIG. 16(a)) or the left side of the gas manifold (FIG. 16(b)). That is, the respiratory conduit 300 and optionally the bias flow restriction 140 may be left-right interchangeable with respect to the gas manifold 120. This allows the respiratory conduit 300 to be positioned on the right or left side of the patient in use.

[0398] In some configurations, the gas ports 121, 122 may have the same configuration as each other such that the respiratory conduit 300 can selectively couple to either of the gas ports 121, 122. The gas port to which the patient respiratory conduit is connected forms the gas inlet of the gas manifold 120, and the opposite gas port forms the gas outlet of the gas manifold. For example, in the configuration of FIG. 16(a), the gas port 121 forms the gas inlet and the first nasal delivery element 111 forms the upstream nasal delivery element that is more proximal to the gas inlet. In the configuration of FIG. 16(b), the gas port 122 forms the gas inlet and the second nasal delivery element 112 forms the upstream nasal delivery element that is more proximal to the gas inlet.

[0399] The internal features of the gas manifold 120 may be symmetrical so that the performance of the nasal interface 100 does not change depending on which side of the gas manifold the respiratory conduit 300 is connected to.

[0400] If a bias flow restriction 140 is provided, it may be selectively coupled to either of the gas ports 121, 122 opposite the breathing conduit 300. The breathing conduit 300 and the bias flow restriction 140 may have the same coupling characteristics as each other.

[0401] The breathing conduit 300 may be selectively connected to either side of the gas manifold 120, however, at any stage during use of the nasal interface, one of the ports 121, 122 functions as a single gas inlet to the gas manifold 120. The other of the ports 121, 122 typically functions as a gas outlet from the gas manifold for delivering gas to the bias flow restriction 140.

[0402] The nasal interface 100 may include one or more pressure ports to allow for pressure measurement for respiratory therapy device control or reporting purposes. The pressure ports may be provided upstream and / or downstream of the nasal interface 100 and / or within the nasal interface 100.

[0403] Gases entering and / or exiting the nasal interface 100 may be filtered. To this end, upstream and / or downstream filters may be provided.

[0404] In the illustrated configuration, the patient interface 1 includes a filter 500 in fluid communication with the respiratory conduit 300 for filtering gases entering the respiratory conduit 300 .

[0405] The filter may have any one or more of the features and functions of the filters of U.S. Patent No. 6,619,287, the contents of which are incorporated herein by reference in their entirety.

[0406] To enhance patient comfort, it may be desirable to configure the cross-sectional area of ​​the bypass restriction 130 to be as large as possible. However, increasing the cross-sectional area of ​​the bypass restriction 130 comes at the risk of reducing the amount of asymmetric flow. That is, increasing the cross-sectional area of ​​the bypass restriction 130 reduces the degree of restriction, and therefore reduces the pressure difference between the upstream nasal delivery element 111 and the downstream nasal delivery element 112, which promotes asymmetric flow and washout.

[0407] As outlined above, the bypass restriction 130 can be any feature or geometry that provides a pressure drop across the nasal interface 100 between the first nasal delivery element 111 and the second nasal delivery element 112 such that when gas is delivered from the gas inlet 121 to the first nasal delivery element 111 and the second nasal delivery element 112, the pressure at the first nasal delivery element 111 is higher than the pressure at the second nasal delivery element 112. In some configurations, the bypass restriction 130 is configured to reduce the total cross-sectional area A of the first nasal delivery element 111 and the second nasal delivery element 112 relative to the gas inlet 121 relative to the adjacent portion of the gas flow channel 125. 3 +A 4 It may be a physical restriction against the nasal interface 100 and / or against any other part of the nasal interface 100.

[0408] The inventors have discovered that effective asymmetric flow can be maintained over a wide range of ratios of bypass restriction cross-sectional area to total nasal delivery element cross-sectional area, which may allow for optimizing patient comfort while preserving therapeutically effective asymmetric flow.

[0409] Therapeutically effective asymmetric flow may be provided by having sufficient washout from the patient's upper airway dead space. The washout level may be at least about 10% of the volume of the patient's upper airway, optionally at least about 20% of that volume, optionally at least about 30% of that volume, optionally at least about 40% of that volume, optionally at least about 50% of that volume, optionally at least about 60% of that volume, optionally at least about 70% of that volume, optionally at least about 80% of that volume, optionally at least about 90% of that volume, optionally about 100% of that volume. In some configurations, the washout level may be determined over a single respiratory cycle.

[0410] Cross-sectional area A of bypass restriction portion 130 2 and the total nasal delivery element 111, 112 cross-sectional area A 3 +A 4The ratio of the cross-sectional area A of the bypass restriction 130 contributes to achieving asymmetric flow and therefore effective washout. 2 and the total nasal delivery element 111, 112 cross-sectional area A 3 +A 4 is the cross-sectional area or inner cross-sectional area for gas flow. 3 +A 4 may be at the smallest transverse dimension of each nasal delivery element 111, 112.

[0411] The bypass restriction 130 promotes asymmetric flow by restricting gas flow to the downstream nasal delivery element 112 relative to the upstream nasal delivery element 111. Thus, the cross-sectional area A 2 is the total nasal delivery element 111, 112 cross-sectional area A such that the restriction, and therefore the pressure difference, is achieved. 3 +A 4 It should be sufficiently narrow (or in other words, sufficiently restrictive) for

[0412] However, to enhance patient comfort and treatment versatility, the cross-sectional area A of the bypass restriction 130 is 2 It is also desirable that the cross-sectional area A of the bypass restriction portion 130 be as large as possible. 2 The cross-sectional area A of the bypass restriction 130 is preferably wide enough so that if the upstream nasal delivery element 111 or nasal passages become blocked during treatment, the patient can still receive CPAP therapy through the downstream nasal delivery element 112. Increased inspiratory effort may cause the patient to feel as though they are short of air. 2 Increasing the cross-sectional area A of the bypass restriction 130 means that a greater proportion of the inhaled flow goes through the downstream nasal delivery element 112 to the downstream nasal cavity. This reduces the pressure drop experienced by the patient, reducing this discomfort. However, 2Increasing the flow rate transitions the treatment to conventional CPAP therapy without the therapeutically effective asymmetric flow. Patients on conventional CPAP therapy may feel more comfortable because there is less restriction, the device can control the flow more easily, the flow rate is reduced, and noise and the sensation of spraying in the nostrils is reduced.

[0413] In some configurations, the nasal interface 100 of the present disclosure includes a first nasal delivery element 111 and a second nasal delivery element 112, the first nasal delivery element 111 and the second nasal delivery element 112 each configured to seal with a respective nasal cavity of a patient, and a gas manifold 120 including a gas inlet 121 and a gas flow channel 125 for delivering respiratory gas to the gas manifold 120, the first nasal delivery element 111 and the second nasal delivery element 112 in fluid communication with the gas inlet 121 via the gas flow channel 125, the first nasal delivery element 111 being proximal to the gas inlet 121 and the second nasal delivery element 112 being distal to the gas inlet 121, and the nasal interface includes a cross-sectional area A of a portion of the gas flow channel 125. 2 Each of the first nasal delivery element 111 and the second nasal delivery element 112 includes a bypass restriction 130 that provides an inner cross-sectional area A 3 , A 4 Including the inner cross-sectional area A 3 , A 4 is the total cross-sectional area A of the nasal delivery elements 111, 112 together. 3 +A 4 and a cross-sectional area A of a portion of the gas flow channel 125. 2 is the total cross-sectional area A of the nasal delivery element 3 +A 4 It is more than 0 to approximately 1.5 times.

[0414] Such configurations having the recited relative cross-sectional areas may be used in any of the nasal interfaces 100 disclosed herein.

[0415] In some configurations, the cross-sectional area A of a portion of the gas flow channel 2is the total cross-sectional area A of the nasal delivery element 3 +A 4 It is 0.25 to about 1.5 times.

[0416] In some configurations, the cross-sectional area A of a portion of the gas flow channel 2 is the total cross-sectional area A of the nasal delivery element 3 +A 4 up to about 1.3 times the total cross-sectional area A of the nasal delivery element, optionally 3 +A 4 , optionally up to about 1 times the total cross-sectional area A of the nasal delivery element. 3 +A 4 up to about 2 / 3 of the total cross-sectional area A of the nasal delivery element, optionally 3 +A 4 , optionally up to about ½ of the total cross-sectional area A of the nasal delivery element 3 +A 4 , optionally up to about 2 / 5 of the total cross-sectional area A of the nasal delivery element 3 +A 4 The maximum is about one-third of that.

[0417] In some configurations, the cross-sectional area A of a portion of the gas flow channel 2 is 0 mm 2 Ultra and maximum of approx. 375mm 2 , optionally about 1 mm 2 ~Approx. 375mm 2 , optionally about 1 mm 2 ~about 250mm 2 , optionally about 1 mm 2 ~about 200mm 2 , optionally about 1 mm 2 ~Approx. 167mm 2 , optionally about 50 mm 2 ~Approx. 167mm 2 , optionally about 50 mm 2 ~ approx. 103mm 2 , optionally about 35 mm 2 ~ approx. 100mm 2 The cross-sectional area A of the bypass restriction portion 130 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 listed herein 3 +A 4may be any other value or range of values ​​related to

[0418] In some configurations, the inner cross-sectional area A of each of the first nasal delivery element 111 and the second nasal delivery element 112 3 , A 4 is at the smallest transverse dimension of each nasal delivery element.

[0419] In some configurations, the inner cross-sectional area of ​​each of the first nasal delivery element 111 and the second nasal delivery element 112 is at the exit 111a, 112a of the respective nasal delivery element 111, 112. Alternatively, the inner cross-sectional area can be elsewhere, such as midway along the nasal delivery element 111, 112 or at the entrance or base of the nasal delivery element.

[0420] The inner cross-sectional area A of each of the nasal delivery elements 111, 112 3 , A 4 may be transverse to the direction of gas flow through the nasal delivery elements 111, 112.

[0421] In some configurations, the bypass restriction 130 includes at least one protrusion 130a, 130b that extends into the gas flow channel 125. In some configurations, the bypass restriction 130 includes multiple protrusions that extend into the gas flow channel 125.

[0422] In some configurations, the gas manifold 120 includes a proximal bypass protrusion 130a proximal to the nasal delivery elements 111, 112 and / or a distal bypass protrusion 130b distal from the nasal delivery elements 111, 112.

[0423] In some configurations, the gas manifold 120 includes both a proximal bypass protrusion 130a and a distal bypass protrusion 130b that in combination define a predetermined bypass dimension BD between the first nasal delivery element 111 and the second nasal delivery element 112 for restricted gas flow through the gas manifold 120. In some configurations, the predetermined bypass dimension BD may be limited relative to adjacent portions of the gas flow channel 125, relative to the gas inlet 121, relative to the total cross-sectional area A3+A4 of the first nasal delivery element 111 and the second nasal delivery element 112, and / or relative to any other portion of the nasal interface 100.

[0424] The predetermined bypass dimension BD is generally substantially smaller than the dimensions of the adjacent or main portions of the gas flow channel 125 .

[0425] In some configurations, the bypass restriction 130 includes angled leading edges 130a', 130b' and angled trailing edges 130a", 130b" that define converging and diverging bypass restrictions in the direction of gas flow through the gas manifold from the first nasal delivery element 111 to the second nasal delivery element 112.

[0426] In some configurations, the gas manifold 120 includes a single inlet and a single outlet.

[0427] In some configurations, the nasal interface 100 includes an interface body 110 and a gas manifold component that together form a gas manifold 120 .

[0428] In some configurations, the cross-sectional area A 2 A portion of the gas flow channels providing this is provided by the interface body 110 and the gas manifold components.

[0429] As generally discussed above, the interface body 110 may be formed from a soft, flexible material.

[0430] In some configurations, the cross-sectional area A of a portion of the gas flow channel 2 For example, when a patient wears the nasal interface 100, a portion of the patient's face may contact the nasal delivery elements 111, 112 or the base of the interface body 110, narrowing the bypass restriction 130, thereby reducing the cross-sectional area A of a portion of the gas flow channel. 2 This may be affected by the distance of the base of the nasal delivery elements 111, 112 from the patient's septum. In some configurations, the interface body 110, or a portion thereof, may narrow the cross-sectional area A of a portion of the gas flow channel when the patient is wearing the nasal interface 100. 2 For example, a portion of the interface body 110 may be reinforced with another, more rigid material, may be reinforced using a more rigid material, and / or may be designed with a particular geometric shape.

[0431] In some configurations, the gas manifold 120 or gas manifold components are separable from the interface body 110 .

[0432] In some configurations, the gas inlet 121 is in the side of the gas manifold 120 .

[0433] In some configurations, the nasal interface 100 includes a bias flow restriction 140 for gas flow to exit the nasal interface 100 through the bias flow restriction 140 .

[0434] In some configurations, the bias flow restriction 140 includes at least one aperture 142 for gas flow from the nasal interface 100 to the surrounding environment. In some configurations, the bias flow restriction 140 includes multiple apertures 142 for gas flow from the nasal interface 100 to the surrounding environment.

[0435] In some configurations, the bias flow restriction 140 includes a filter or diffuser to filter or diffuse the gas flowing through the aperture 142 .

[0436] In some configurations, the nasal interface includes a filter unit 500 ′ between the gas manifold 120 and the bias flow restriction 140 .

[0437] In some configurations, the bias flow restriction 140 is in fluid communication with the gas manifold 120. In some configurations, the gas manifold 120 includes or is coupled to the bias flow restriction 140. In some configurations, the bias flow restriction 140 is in fluid communication with the gas manifold 120 but is located remotely from the gas manifold.

[0438] In some configurations, the bias flow restriction 140 includes an opening area for gas flow out of the nasal interface 100 through the bias flow restriction 140. In some configurations, the opening area is less than 0 mm 2 Super ~ approx. 40mm 2 , optionally about 2 mm 2 ~ approx. 40mm 2 , optionally about 2 mm 2 ~about 5mm 2 , optionally about 12 mm 2 ~ approx. 40mm 2 , optionally about 20 mm 2 ~about 30mm 2 It is.

[0439] In some configurations, the opening area for gas flow exiting the nasal interface 100 through the bias flow restriction is approximately 1 mm 2 , about 2 mm 2 , about 3mm 2 , about 4mm 2 , about 5mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 , approx. 9mm 2 , about 10mm2 , about 11mm 2 , approx. 12 mm 2 , about 13mm 2 , approx. 14mm 2 , about 15mm 2 , about 16mm 2 , approx. 17mm 2 , approx. 18mm 2 , about 19mm 2 , about 20mm 2 , about 21mm 2 , about 22mm 2 , about 23mm 2 , about 24mm 2 , about 25mm 2 , about 26mm 2 , about 27mm 2 , about 28mm 2 , about 29mm 2 , about 30mm 2 , about 31mm 2 , about 32mm 2 , about 33mm 2 , about 34mm 2 , about 35mm 2 , about 36mm 2 , about 37mm 2 , about 38mm 2 , about 39mm 2 Or about 40 mm 2 Or any value between any two of these values.

[0440] For a given pressure differential between the body gas flow passage 146 and the outside of the bias flow restriction 140, the flow through the bias flow restriction 140 is determined primarily by the cross-sectional area of ​​the apertures 142 and their geometry. The geometric factor may be known as the discharge coefficient. For example, a cylindrical outlet aperture 142 with sharp edges will allow less flow than a smooth aperture shaped like a Venturi nozzle or aperture with substantial radii, chamfers, or other expansion and contraction features on either the inlet or outlet side. Viscous effects, such as in a long, thin channel, may also reduce the overall flow rate through the aperture, depending on its geometry.

[0441] The size of the aperture 140 can be increased, while the design of the filter or diffuser can be adjusted to additionally or alternatively add resistance.

[0442] Thus, the upper limit of the range of the size of the opening area for gas flow exiting the nasal interface 100 through the bias flow restriction 140 may be up to 25% (e.g., 40 mm 2 ) when a properly configured filter or diffuser is used. 2 rather than 50mm 2 ) can be increased.

[0443] Similarly, if an aperture 142 having a high discharge coefficient is used, the lower limit of the range of the size of the open area for gas flow is a maximum of 50% (e.g., 12 mm 2 rather than 6mm 2 ) can be reduced.

[0444] In some configurations, the bias flow restriction 140 is configured such that when a pressure of greater than 0 cmH2O and up to about 30 cmH2O is provided to the gas inlet 121 in use, the flow rate of gas flow exiting the nasal interface 100 through the bias flow restriction 140 is greater than 0 lpm to about 80 lpm.

[0445] In some configurations, the bias flow restriction 140 is configured such that when a pressure of about 5 cmH2O, about 10 cmH2O, about 15 cmH2O, about 20 cmH2O, about 25 cmH2O, about 30 cmH2O, or any value between any two of these values ​​is provided to the gas inlet 121 in use, the flow rate of gas flow out of the nasal interface 100 through the bias flow restriction 140 is about 5 lpm, about 10 lpm, about 15 lpm, about 20 lpm, about 25 lpm, about 30 lpm, about 35 lpm, about 40 lpm, about 45 lpm, about 50 lpm, about 55 lpm, about 60 lpm, about 65 lpm, about 70 lpm, about 75 lpm, about 80 lpm, or any value between any two of these values.

[0446] In some configurations, the biased flow restriction 140 is configured such that when in use a pressure of about 5 cmH2O to about 10 cmH2O is applied to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, the flow rate of gas flow exiting the nasal interface 100 through the biased flow restriction 140 is about 35 lpm to about 55 lpm.

[0447] In some configurations, the bias flow restriction 140 is configured such that when in use a pressure of about 3 cmH2O to about 10 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, the flow rate of gas flow exiting the nasal interface 100 through the bias flow restriction 140 is about 4 lpm to about 15 lpm.

[0448] In some configurations, the biased flow restriction 140 is configured such that, in use, when a pressure of about 3 cmH2O, about 4 cmH2O, about 5 cmH2O, about 6 cmH2O, about 7 cmH2O, about 8 cmH2O, about 9 cmH2O, about 10 cmH2O, or any value between any two of these values ​​is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, the flow rate of gas flow out of the nasal interface 100 through the biased flow restriction 140 is about 5 lpm, about 6 lpm, about 7 lpm, about 8 lpm, about 10 lpm, about 11 lpm, about 12 lpm, about 13 lpm, about 14 lpm, about 15 lpm, or any value between any two of these values.

[0449] In some configurations, the bias flow restriction 140 is configured such that when in use a pressure of between about 4 cmH2O and about 30 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, the flow rate of gas flow exiting the nasal interface 100 through the bias flow restriction 140 is between about 15 lpm and about 80 lpm.

[0450] In some configurations, the biased flow restriction 140 is configured such that, in use, when a pressure of about 5 cmH2O, about 10 cmH2O, about 15 cmH2O, about 20 cmH2O, about 25 cmH2O, about 30 cmH2O, or any value between any two of these values ​​is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, the flow rate of gas flow out of the nasal interface 100 through the biased flow restriction 140 is about 15 lpm, about 20 lpm, about 25 lpm, about 30 lpm, about 35 lpm, about 40 lpm, about 45 lpm, about 50 lpm, about 55 lpm, about 60 lpm, about 65 lpm, about 70 lpm, about 75 lpm, about 80 lpm, or any value between any two of these values.

[0451] In some configurations, in addition to or instead of having a bias flow restriction, the nasal interface 100 may be connected to the expiratory limb of a ventilator or may have a positive end-expiratory pressure (PEEP) valve to control the amount of bias flow out of the nasal interface 100, which affects the pressure and washout at the nasal interface 100.

[0452] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is transverse to the direction of gas flow through a portion of the gas flow channel 125.

[0453] The inner cross-sectional area A of each nasal delivery element 111, 112 3 +A 4 may be the cross-sectional area defined by the inner wall of the nasal delivery elements 111, 112. For non-circular cross-sections, references to diameter herein may be interpreted as the transverse dimension. In some configurations, references to diameter herein include, but are not limited to, hydraulic diameter.

[0454] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the cross-sectional area A of the adjacent portion of the gas flow channel 125 1 is decreased compared to

[0455] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the first cross-sectional area A of the adjacent portion of the gas flow channel 1 about 10% to about 100% of the first cross-sectional area, optionally about 10% or more and less than 100% of the first cross-sectional area A 1 at most about 90% of a first cross-sectional area A 1 at most about 80% of the first cross-sectional area A 1 at most about 70% of the first cross-sectional area A 1 at most about 60% of the first cross-sectional area A 1 at most about 55% of the first cross-sectional area A 1 at most about 40% of the first cross-sectional area A 1 and optionally a first cross-sectional area A 1 The maximum is about 25%.

[0456] In some configurations, the cross-sectional area A of a portion of the gas flow channel 2 The maximum is about 200 mm 2 , optionally up to about 160 mm 2 , optionally up to about 110 mm 2 , optionally up to about 80 mm 2 , optionally up to about 60 mm 2 and optionally up to about 50 mm 2 It is.

[0457] In some configurations, the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 is 0 mm 2 Ultra-large and up to approx. 250mm 2 , optionally about 1 mm 2 ~about 250mm 2 , optionally about 1.6 mm 2 ~about 250mm 2 , optionally about 50 mm 2 ~about 250mm 2 , optionally about 50 mm 2 ~about 200mm 2, optionally about 30 mm 2 ~about 200mm 2 , optionally about 30 mm 2 ~Maximum approx. 155mm 2 and optionally about 50 mm 2 ~Maximum approx. 155mm 2 It is.

[0458] In some configurations, the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 is about 1 mm 2 , about 1.6mm 2 , about 5mm 2 , about 10mm 2 , about 15mm 2 , about 20mm 2 , about 25mm 2 , about 30mm 2 , about 35mm 2 , approx. 40mm 2 , about 45mm 2 , about 50 mm 2 , about 55mm 2 , about 60mm 2 , about 65mm 2 , about 70mm 2 , about 75mm 2 , about 80mm 2 , about 85mm 2 , about 90mm 2 , about 95mm 2 , about 100 mm 2 , about 105mm 2 , about 110mm 2 , about 115mm 2 , about 120mm 2 , about 125mm 2 , about 130mm 2 , approx. 135mm 2 , about 140mm 2 , about 145mm 2 , about 150mm 2 , about 155mm 2 , about 160mm 2 , about 165mm 2 , about 170mm 2 , about 175mm 2 , about 180mm 2 , about 185mm 2, about 190mm 2 , about 195mm 2 , about 200mm 2 , about 205mm 2 , about 210mm 2 , about 215mm 2 , about 220mm 2 , about 225mm 2 , about 230mm 2 , about 235mm 2 , about 240mm 2 , about 245mm 2 Or about 250mm 2 Or any value between any two of these values.

[0459] In some configurations, the bypass restriction 130 provides a pressure drop between the first nasal delivery element 111 and the second nasal delivery element 112 through the nasal interface 100 such that the pressure in the first nasal delivery element 111 is higher than the pressure in the second nasal delivery element 112 when gas is delivered from the gas inlet 121 to the first nasal delivery element 111 and the second nasal delivery element 112.

[0460] In some configurations, the nasal interface 100 of the present disclosure includes a first nasal delivery element 111 and a second nasal delivery element 112, the first nasal delivery element 111 and the second nasal delivery element 112 each configured to seal with a respective nasal cavity of a patient, and a gas manifold 120 including a gas inlet 121 and a gas flow channel for delivering respiratory gas to the gas manifold 120, the first nasal delivery element 111 and the second nasal delivery element 112 in fluid communication with the gas inlet 121 via the gas flow channel 125, the first nasal delivery element 111 being proximal to the gas inlet 121 and the second nasal delivery element 112 being distal to the gas inlet 121, and the nasal interface includes a cross-sectional area A of a portion of the gas flow channel. 2 Each of the first nasal delivery element 111 and the second nasal delivery element 112 includes a bypass restriction 130 that provides an inner cross-sectional area A 3 , A 4 and an inner cross-sectional area A of the nasal delivery element.3 , A 4 and the cross-sectional area A of a portion of the gas flow channel 2 are associated to produce an asymmetric gas flow from the nasal delivery elements 111, 112 in use.

[0461] In some configurations, the inner cross-sectional area A 3 , A 4 is the total cross-sectional area A of the nasal delivery elements 111, 112 together. 3 +A 4 and a cross-sectional area A of a portion of the gas flow channel 125. 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 It is more than 0 to approximately 1.5 times.

[0462] In some configurations, the cross-sectional area A of a portion of the gas flow channel 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 up to about 1.3 times the total cross-sectional area A of the nasal delivery elements 111, 112, optionally 3 +A 4 at most about 1 times the total cross-sectional area A of the nasal delivery elements 111, 112, 3 +A 4 up to about 2 / 3 of the total cross-sectional area A of the nasal delivery elements 111, 112, optionally 3 +A 4 up to about ½ of the total cross-sectional area A of the nasal delivery elements 111, 112, optionally 3 +A 4 up to about 2 / 5 of the total cross-sectional area A of the nasal delivery elements 111, 112, optionally 3 +A 4 The maximum is about one-third of that.

[0463] In some configurations, the inner cross-sectional area A of each of the first nasal delivery element 111 and the second nasal delivery element 112 3 , A 4 is at the smallest transverse dimension of each nasal delivery element 111, 112.

[0464] In some configurations, the inner cross-sectional area A of each of the first nasal delivery element 111 and the second nasal delivery element 112 3 , A 4 is at the exit 111a, 112a of each nasal delivery element 111, 112. Alternatively, the inner cross-sectional area can be elsewhere, for example, midway along the nasal delivery element or at the entrance or base of the nasal delivery element 111, 112.

[0465] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the nasal interface is configured to provide a bias flow of 20 lpm through the bias flow restriction 140 when a pressure of 4 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded. This may be, for example, in a patient with an adult breathing pattern of 15 breaths per minute (BPM), 10i:20e, 500Vt.

[0466] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 , and the nasal interface is configured to provide a bias flow of 32 lpm through the bias flow restriction 140 when a pressure of 8 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded. This may be, for example, in a patient with an adult breathing pattern of 15 BPM, 10i:20e, 500Vt.

[0467] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4, and the nasal interface is configured to provide a bias flow of 20 lpm through the bias flow restriction 140 when a pressure of 4 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded (this could be, for example, in a patient with an adult breathing pattern of 15 BPM, 10i:20e, 500Vt or a patient with ARDS and an adult breathing pattern of 25 BPM) or to provide a bias flow of 32 lpm through the bias flow restriction 140 when a pressure of 8 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded. or configured to provide a bias flow of 41 lpm through the bias flow restriction 140 when a pressure of 12 cmH2O is applied to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, or configured to provide a bias flow of 48 lpm through the bias flow restriction 140 when a pressure of 16 cmH2O is applied to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, or configured to provide a bias flow of 53 lpm through the bias flow restriction 140 when a pressure of 20 cmH2O is applied to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded. This may be, for example, in a patent with ARDS and an adult breathing pattern of 25 BPM.

[0468] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the nasal interface is configured to provide a bias flow of 32 lpm or more through the bias flow restriction 140 when a pressure of 8 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded. This could be, for example, in a patent with an adult breathing pattern of 15 BPM, 10i:20e, 500Vt or a patent with ARDS and an adult breathing pattern of 25 BPM or a patent with a sinusoidal breathing pattern with a tidal volume of 350 mL and an adult breathing pattern of 25 BPM.

[0469] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the nasal interface is configured to provide a bias flow of 32 lpm or more through the bias flow restriction 140 when a pressure of 8 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, or a cross-sectional area A of a portion of the gas flow channel is 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the nasal interface is configured to provide a bias flow of 41 lpm or more through the bias flow restriction 140 when a pressure of 12 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded, or a cross-sectional area A of a portion of the gas flow channel 125 is less than or equal to 100 cmH2O. 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the nasal interface is configured to provide a bias flow of 48 lpm or more through the bias flow restriction 140 when a pressure of 16 cmH2O is provided to the gas inlet 121 and the nasal delivery elements 111, 112 are occluded.

[0470] The effectiveness of the asymmetric flow (and resulting washout) of the nasal interface 100 was evaluated in three different tests for six different ratios.

[0471] Each test included a set breathing pattern based on which the CPAP settings were varied. Tables 2 and 3 show the constant and varied settings of the tests, respectively. The results of the tests are shown in Figures 23-25.

[0472] [Table 2]

[0473] [Table 3]

[0474] In the above table, xi:ye is the ratio of inhalation time x to exhalation time y, and Vt is the tidal volume, a measure (in ml) of the amount of air that moves in and out of the lungs in each respiratory cycle.

[0475] In each test, asymmetric flow and washout were measured by rebreathing (the less rebreathing, the greater the washout). A typical level of rebreathing in CPAP without asymmetric flow is about 60ml. Therefore, for the purposes of these tests, washout can be understood to be equal to "60ml-x", where x=volume of rebreathing (ml). 60ml is an exemplary figure for the upper airway model excluding the interface itself, and assumes that there is no dead space within the interface.

[0476] As shown in Figures 23-25, effective washout was generally achieved at ratios of 102:154 (approximately 2 / 3) or less (bypass restriction cross-sectional area (BRA):total nasal delivery element cross-sectional area (CNDEA)).

[0477] Studies at ratios of 1:1 (BRA:CNDEA) and above have shown inconsistent and / or minimal washout. However, at ratios as high as 1.5:1 (BRA:CNEDA), some washout is shown / expected. In practice, the ratio selected may be less than 1:1 (BRA:CNDEA).

[0478] Study 1 (15 bpm, 4, 8 cmH2O) showed significant washout at ratios below 102:154 (approximately 2 / 3) (BRA:CNEDA), inconsistent washout at 1:1 (BRA:CNDEA) and minimal washout at 200:154 (approximately 1.5) (BRA:CNDEA).

[0479] Study 2 (25 bpm, 4, 8, 12, 16, 20 cmH2O) showed significant washout at ratios below 102:154 (approximately 2 / 3) (BRA:CNDEA), but minimal washout at ratios above 1:1 (BRA:CNDEA).

[0480] Study 3 (45 bpm, 4, 8, 12, 16, 20 cmH2O) showed washout at ratios below 102:154 (approximately 2 / 3) (BRA:CNDEA) at higher cmH2O levels, but no significant washout was otherwise observed.

[0481] More specifically, referring to Figure 23, in Study 1, significant washout was achieved at ratios of 102:154 (approximately 2 / 3) (BRA:CNDEA) and below. A ratio of 1:1 (BRA:CNEDA) showed effective washout at 8 cmH2O, but minimal washout at 4 cmH2O. Minimal washout was achieved at 200:154 (approximately 1.5) (BRA:CNDEA).

[0482] Referring to Figure 24, in Study 2, significant washout was achieved at ratios of 102:154 (approximately 2 / 3) (BRA:CNDEA) or less (except for 102:154 BRA:CNDEA at 4 cmH2O). Minimal washout was demonstrated at the 4, 8 and 12 cmH2O levels for ratios of 1:1 (BRA:CNDEA) or greater. These ratios were not tested at the 16 cmH2O and 20 cmH2O levels.

[0483] At low pressures and high respiratory rates, rebreathing can occur due to insufficient bias flow, which can affect outcomes especially at low pressures, since bias flow increases at high pressures.

[0484] Referring to Figure 25, in Study 3, significant washout was achieved at ratios below 102:154 (approximately 2 / 3) (BRA:CNDEA) at high cmH2O levels, but not at low cmH2O levels. Better washout than baseline was achieved at 50:154 (approximately 1 / 3) (BRA:CNDEA) at 8cmH2O or higher, 60:154 (approximately 2 / 5) (BRA:CNDEA) at 12cmH2O or higher, and 75:154 (approximately 1 / 2) and 102:154 (approximately 2 / 3) (BRA:CNDEA) at 16cmH2O or higher. In this study, washout was not achieved at ratios above 1:1 (BRA:CNDEA).

[0485] Figures 26-28 show modeled effects of different nasal delivery element 111, 112 sizes, different bypass restriction cross-sectional areas, different set pressures and different bias flow restriction opening states on rebreathing using a nasal interface at respiratory rates of 15 breaths / min, 25 breaths / min and 45 breaths / min, respectively.

[0486] The Y-axis (dependent axis) of the chart indicates rebreathing, with smaller volumes being better and indicating more washout.

[0487] The "nasal delivery element size" in each chart is the total cross-sectional area A of the nasal delivery elements 111, 112. 3 +A 4 Shows.

[0488] A is smaller than B. AB is the total cross-sectional area A 3 +A 4 This provides a possible range of

[0489] As outlined herein, in some configurations, the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 is 0 mm 2 Ultra (A) and up to about 250 mm 2 (B), optionally about 1 mm 2 ~about 250mm 2 , optionally about 1.6 mm 2~about 250mm 2 , optionally about 50 mm 2 ~about 250mm 2 , optionally about 50 mm 2 ~about 200mm 2 , optionally about 30 mm 2 ~about 200mm 2 , optionally about 30 mm 2 ~approx. 155mm 2 , optionally about 50 mm 2 ~approx. 155mm 2 and optionally about 70 mm 2 ~approx. 155mm 2 It is.

[0490] The “Bypass Restriction Size” portion of each chart is the cross-sectional area A of the bypass restriction 130. 2 , i.e., the cross-sectional area A of a portion of the gas flow channel 2 Shows.

[0491] C is smaller than D. CD is the cross-sectional area of ​​the bypass restriction A 2 This provides a possible range of

[0492] As outlined herein, in some configurations, the cross-sectional area A of the bypass restriction 130 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 0 to about 1.5 times the total cross-sectional area A of the nasal delivery elements 111, 112, optionally 3 +A 4 about 0.25 to about 1.5 times the total cross-sectional area A of the nasal delivery elements 111, 112, optionally 3 +A 4 about 1 times or less of the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 This is approximately 2 / 3 or less of the original amount.

[0493] As outlined herein, in some configurations, the cross-sectional area A of the bypass restriction 130 2 is 0 mm 2 Ultra (C) and up to approx. 375mm 2 (D), optionally about 1 mm2 ~Approx. 375mm 2 , optionally about 1 mm 2 ~about 250mm 2 , optionally about 1 mm 2 ~about 200mm 2 , optionally about 1 mm 2 ~Approx. 167mm 2 , optionally about 50 mm 2 ~Approx. 167mm 2 , optionally about 50 mm 2 ~ approx. 103mm 2 , optionally about 35 mm 2 ~ approx. 100mm 2 The cross-sectional area A of the bypass restriction portion 130 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 listed herein 3 +A 4 may be any other value or range of values ​​related to

[0494] In some configurations, the cross-sectional area A of a portion of the gas flow channel 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the total cross-sectional area A of the nasal delivery elements 111, 112 is greater than 0 to about 1.5 times 3 +A 4 is about 1 mm 2 ~about 250mm 2 It is.

[0495] The “Set Pressure” portion of each chart indicates the pressure applied to the gas inlet 121 of the nasal interface 100 .

[0496] E is less than F. EF provides the possible range of pressures applied to the gas inlet 121.

[0497] As outlined herein, in some configurations, a pressure of greater than 0 cmH2O (E) and up to about 30 cmH2O (F) is provided to the gas inlet 121 in use.

[0498] In some configurations, a pressure of about 3 cmH2O to about 10 cmH2O is provided to the gas inlet 121 during use.

[0499] In some configurations, a pressure of about 4 cmH2O to about 30 cmH2O is applied to the gas inlet 121 during use.

[0500] The "Bias" portion of each chart shows the effect on rebreathing and washout of the open area for gas flow out of the nasal interface 100 through the bias flow restriction 140. "No Filter" indicates a more open bypass restriction with no filter or diffuser placed in the bypass restriction. "With Filter" indicates a more closed bypass restriction with a filter or diffuser placed in the bypass restriction.

[0501] As outlined above, in some configurations, the bias flow restriction 140 includes an opening area for gas flow out of the nasal interface 100 through the bias flow restriction 140. In some configurations, the opening area is less than 0 mm 2 Super ~ approx. 40mm 2 , optionally about 2 mm 2 ~ approx. 40mm 2 , optionally about 2 mm 2 ~about 5mm 2 , optionally about 12 mm 2 ~ approx. 40mm 2 , optionally about 20 mm 2 ~about 30mm 2 It is.

[0502] In some configurations, the bias flow restriction 140 is configured such that when a pressure of greater than 0 cmH2O and up to about 30 cmH2O is provided to the gas inlet 121 in use, the flow rate of gas flow out of the nasal interface through the bias flow restriction is greater than 0 lpm to about 80 lpm.

[0503] In some configurations, the bias flow restriction 140 is configured such that when a pressure of about 3 cmH2O to about 10 cmH2O is provided to the gas inlet 121 in use, the flow rate of gas flow out of the nasal interface through the bias flow restriction is between about 4 lpm and about 15 lpm.

[0504] In some configurations, the bias flow restriction 140 is configured such that when a pressure of between about 4 cmH2O and about 30 cmH2O is provided to the gas inlet 121 in use, the flow rate of gas flow out of the nasal interface through the bias flow restriction is between about 15 lpm and about 80 lpm.

[0505] The plots show that at low breathing rates, such as 15 BPM and 25 BPM, increasing the total cross-sectional area of ​​the nasal delivery element, decreasing the cross-sectional area of ​​the bypass restriction, increasing the pressure applied to the gas inlet and / or increasing the opening area for gas flow through the bias flow restriction 140 reduces the amount of rebreathing and increases the amount of washout.

[0506] Total cross-sectional area A of nasal delivery elements 111, 112 3 +A 4 may be maximized to a size that fits comfortably within the patient's nasal cavity to increase washout.

[0507] Cross-sectional area A of bypass restriction portion 130 2 Although increasing this cross-sectional area may increase patient comfort, it may be minimized to increase washout.

[0508] The plot shows that at high breathing rates, such as 45 BPM, varying the cross-sectional area of ​​the nasal delivery element or the bypass restriction may have only a negligible effect due to rebreathing in the gas conduit (hence the two left boxes in the 45 BPM plot are shaded grey as the results are not statistically significant). Increasing the pressure applied to the gas inlet 121 and / or increasing the open area for gas flow through the bias flow restriction 140 reduces the amount of rebreathing and increases the amount of washout.

[0509] Headgear may be used to hold the nasal interface 100 against the patient's face. The headgear includes a head strap 200. The head strap 200 may be a single continuous length and, in use, may be adapted to extend along the patient's cheeks, over the ears and around the back of the head, may be adjustable, and / or may extend around other portions of the patient's head.

[0510] The headgear has ends that connect to the side arms of the interface body 110 .

[0511] In the illustrated exemplary configuration (FIG. 18), main end portion 201 and main end portion 202 of strap 200 are adapted to releasably connect to respective formations 101 and 102 on either side of nasal interface 100 to hold nasal interface 100 in place during use.

[0512] In one configuration, each end portion 201, 202 is provided with a clip component that can be received and retained within a corresponding formation 101, 102. The clip components can be coupled to the straps at each main end portion. Additionally, the head strap 200 is adjustable in length to help customize the strap to the wearer's head. The strap 200 can be formed from a soft, stretchy / elastic material, such as an elastic woven material / fabric, that is comfortable for the wearer. Alternatively, the strap 200 can be formed from a substantially stiffer or less flexible material, such as a hard plastic material.

[0513] The headgear may further include additional straps or other headgear components that couple to strap 200 so as to extend over the top of the patient's head in use. A top strap or component may have the advantage of pulling strap 200 up and over the patient's ears in use, improving fit and comfort.

[0514] A rear portion of the strap 200 may extend through a receiver 204. The receiver 204 may allow the rear portion of the strap 200 to be adjusted to adjust the size of the headgear to fit the patient's head.

[0515] Fixed length strap segments can be removably connected to the main strap to extend its length.

[0516] To provide alternative adjustment lengths, several strap segments of different predetermined lengths may be provided. For example, one or more strap segments may be provided having a length in the range of about 1 cm to about 10 cm, or in the range of about 2 cm to about 6 cm. Strap segment 220 may have a length of, for example, about 2 cm, about 4 cm, or about 6 cm. These examples are not intended to be limiting, and it will be understood that the length of each strap segment can be of any size depending on the user and / or application.

[0517] Additionally, each end of each strap segment may be connectable to each end of another strap segment and / or each minor end portion of the main strap 210, thereby allowing a user to combine one or more strap segments of the same or different lengths to customize the overall length of the extension as needed.

[0518] The additional strap segments may be formed from a soft, stretchy / elastic material, such as an elastic woven material / fabric, that is comfortable for the wearer. For example, a tubular knit type head strap or section of head strap 210 may be used for comfort specifically over the user's ears.

[0519] It will be appreciated that particular comfort may be achieved by a head strap that can provide for proper positioning of the nasal interface 100 in a relatively stable position on the user's face, while at the same time providing a relatively loose fit or low tension fit around the user's head.

[0520] Alternatively, the additional strap segments may be formed from a substantially rigid material, such as a hard plastic material.

[0521] The main strap 210 is provided with interface connectors 240 at the main end portions 201, 202. These connectors 240 have a strap connection mechanism for connecting the main end portions 201, 202, but include a clip member, such as a push-fit clip 241, at the end of the connector 240 opposite the strap end. The clip 241 is configured to releasably couple to each formation 101, 102 on the side of the nasal interface 100. The clip member 241 may be a bendable part, such as a plastic part, that forms a hinge portion for the strap. The clip 241 may be preformed to have a curved shape along its length, for example a shape having an angle between flat and 20 degrees. This curvature allows the clip 241 to fit the contours of the patient's face in the region of the clip 241.

[0522] The nasal interface may include sleeves 270. Each sleeve 270 may be preformed to have a curved shape along its length, such as a shape having an angle between flat and 20 degrees. The curvature allows the sleeve to fit the contours of the patient's face or cheek in the region of the sleeve in use. Alternatively, the sleeve 270 may assume the shape of a curved sleeve upon engagement with the main end portions 201, 202 or connector 240 of the head strap 200.

[0523] The sleeve 270 provides a surface area of ​​a relatively high friction surface material for frictionally engaging the face or facial skin of a user. The surface area is positioned to frictionally engage the cheek skin of the user's face. The surface area is at least locally positioned on the strap or on the section of the strap that is positioned over the user's cheek. The surface area with the relatively high friction surface material may be of a material that is smooth and comfortable against the patient's skin. The sleeve 270, or at least the surface area 271, is thus formed from a relatively softer material than the connector 240.

[0524] In one configuration, the surface region 271 or sleeve 270 is formed from a soft thermoplastic elastomer (TPE), but may alternatively be formed from another plastic material such as silicone or any other biocompatible material.

[0525] The surface area 271 may be a surface having a greater surface area closer to the patient interface than the surface area further from the patient interface. In one configuration, the sleeve 270 tapers from a relatively greater surface area 273 to a relatively smaller surface area 274 in a direction extending away from the connection point between the connector 240 and the nasal interface 100. The width of the sleeve at the end 273 may be the same or similar to the width of the tapered distal ends of the corresponding wings 113, 114 of the face attachment component 110. This provides a smooth transition between the nasal interface 100 and the headgear for improved aesthetics and visual appeal.

[0526] The sleeve 270 may be colored to provide identification of the nasal interface 100. As described herein, the nasal interfaces may be provided in different sizes, such as small, medium, and large. Each of these sizes of sleeve 270 may include a different color to represent the different sizes. Alternatively, or in addition, the sleeve may be colored in a particular manner to represent that the nasal interface has asymmetrical rather than symmetrical nasal delivery elements.

[0527] The headgear may include cheek supports 270 as described or similar at or adjacent to either end of the headgear straps of the interface, which connect to the nasal interface and frictionally engage the user's face to stabilize the mask on the face at the cheeks. Such headgear may again include a single head strap adapted to extend along the patient's cheeks, over the ears and around the back of the head in use, and having ends including any suitable form of clip that couples to (or is permanently attached to) the nasal interface on both sides.

[0528] The patient interface 1 may include a tube retention clip (not shown). The tube retention clip may support the respiratory conduit 300 or other gas delivery tube 16 from a portion of the patient interface 1. By supporting the respiratory conduit 300 or other gas delivery tube from or near the nasal interface 100, bending moments applied to the respiratory conduit 300 or other gas delivery tube 16 as a result of asymmetric flow through the first nasal delivery element 111 and the second nasal delivery element 112 and / or movement of the patient's head are resisted by the tube retention clip, thereby improving patient comfort.

[0529] The patient interface 1 may have any one or more of the features and functions described in PCT Publication No. WO 2014 / 182179 or U.S. Patent No. 10,406,311, the contents of which are incorporated herein by reference in their entireties.

[0530] As an alternative to headgear, the patient interface may include a fastening system of the type described in PCT Publication No. WO 2012 / 053910 or U.S. Patent No. 10,238,828, the contents of which are incorporated herein by reference in their entireties.

[0531] Figure 29 illustrates generally an alternative configuration of a nasal interface 1100 for use in the patient interface 1. Unless otherwise described below, the features, functions, alternatives and uses of the nasal interface 1100 are as described with respect to the nasal interface 100. Like reference numbers refer to like parts increased by 1000. Exemplary configurations of nasal interfaces are described in further detail below with reference to Figures 30-59.

[0532] The nasal interface 1100 includes an interface body 1110 configured to substantially form a seal with the patient's nasal airway. The interface body 1110 is configured to deliver gas to a first nasal cavity of the patient and to a second nasal cavity of the patient.

[0533] The nasal interface 1100 includes a gas inlet 1121 for delivering respiratory gas to the nasal interface 1100. The gas inlet 1121 is in fluid communication with the interface body 1110 to deliver respiratory gas from the gas inlet 1121 through the interface body 1110 to the first and second nasal cavities of the patient in use.

[0534] The nasal interface 1100 is configured to receive an inflow gas F0 from the gas inlet 1121 and to provide from the inflow gas F0 a first gas flow stream F1 configured to be provided substantially to a first nasal cavity of a patient in use, and a second gas flow stream F2 configured to be provided substantially to a second nasal cavity of the patient in use.

[0535] The nasal interface 1100 is configured to direct more incoming gas into the first gas flow stream F1 than into the second gas flow stream F2 to produce an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0536] The flow generated by respiratory therapy depends on the flow through the nasal interface 1100. The flow through the nasal interface 1100 is related to the pressure at each of the outlets 1111a, 1112a of the nasal interface. If the pressures at each of the outlets 1111a, 1112a are different, asymmetric gas flow will occur.

[0537] The nasal interface may include separate outlets 1111a, 1112a for delivering respiratory gas to each of the patient's nasal cavities. Alternatively, the nasal interface may include a single outlet defining first and second outlet portions for delivering respiratory gas to each of the patient's nasal cavities. Thus, references herein to a "first outlet" and a "second outlet" may instead be considered as references to a "first outlet portion" and a "second outlet portion," respectively. Some of the possible exemplary configurations are described in further detail below.

[0538] Asymmetric flow is provided by the nasal interface 1100 by directing more flow to the first nasal cavity / first outlet 1111a than to the second nasal cavity / second outlet 1112a. This may be considered flow directionality.

[0539] The nasal interface 1100 may be structured and configured to provide flow directionality in different ways. For example, the nasal interface 1100 may include flow directors and / or flow dividers and / or at least partial alignment of the gas inlet with the first outlet 1111a to provide flow directionality. Some of the possible exemplary configurations are described in more detail below.

[0540] In some configurations, the nasal interface 1100 may include an interface body 1110 and a gas manifold 1120 .

[0541] The interface body 1110 and the gas manifold 1120 may cooperate to define a gas plenum 1115 therein. In some alternative configurations, the gas plenum 1115 may be defined substantially or only by the interface body 1110. Instead of having a gas manifold 1120, the nasal interface 1100 may include a frame component for supporting the interface body and / or one or more other components (such as the gas inlet 1121, the headgear 200, and / or the interface body 1110). Thus, any reference herein to a "gas manifold" may instead be considered a reference to a "frame."

[0542] The interface body 1110 may be configured to contact and seal with the interior of the patient's nasal cavity, may be configured to contact and seal at the entrance to the patient's nasal cavity, and / or may be configured to seal around the exterior surface of the nose, for example around the alar and nasal tip.

[0543] In some configurations, the interface body 1110 includes a first outlet 1111a configured to deliver gas substantially to a first nasal cavity of the patient and includes a second outlet 1111b configured to deliver gas substantially to a second nasal cavity of the patient.

[0544] In some configurations, the interface body 1110 includes a first nasal delivery element 1111 and a second nasal delivery element 1112 configured to engage each nostril of the patient.

[0545] In some configurations, the interface body 1110 is a nasal cushion. The nasal cushion may include a single outlet that provides a first outlet portion and a second outlet portion. Alternatively, the nasal cushion may include a first nasal delivery element 1111 and a second nasal delivery element 1112 configured to respectively engage each nostril of the patient.

[0546] The nasal interface 1110 is structured and arranged to create an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0547] In the configuration shown in FIG. 29, the gas inlet 1121 is at least partially aligned with the first outlet 1111a and less aligned or unaligned with the second outlet 1112a.

[0548] This configuration provides a substantially direct gas flow from the gas inlet 1121 to the first outlet 1111a. The alignment of the gas inlet 1121 and the first outlet 1111a may act as a flow director.

[0549] The gas flow path from the gas inlet 1121 to the second outlet 1112a is more tortuous than the gas flow path from the gas inlet 1121 to the first outlet 1111a. Additionally or alternatively, the gas flow path from the gas inlet 1121 to the second outlet 1112a may be longer than the gas flow path from the gas inlet 1121 to the first outlet 1111a.

[0550] The gas inlet 1121 is offset from a central axis CA of the nasal interface 1100 .

[0551] In some configurations, the gas inlet 1121 is substantially axially aligned with the first outlet 1111a.

[0552] In some configurations, at least half of the cross-sectional area A0 of the gas inlet 1121 is axially aligned with at least half of the cross-sectional area A1 of the first outlet 1111a.

[0553] The gas inlet includes an outer portion 1121 a for connecting to a breathing conduit 300 or other gas supply tube 16 and providing a gas flow from a gas source to the interface body 1110 , and further includes an inner portion 1121 b in fluid communication with the interface body 1110 .

[0554] The inner portion 1121b of the gas inlet 1121 is at least partially aligned with the first outlet 1111a or the first outlet portion.

[0555] The inner portion 1121b and the outer portion 1121a may be aligned with one another or may be at an angle relative to one another.

[0556] In some configurations, the first outlet 1111a and the second outlet 1112a include substantially the same cross-sectional area, i.e., the flow asymmetry is caused by other features of the nasal interface 1100 rather than by different outlet sizes.

[0557] In some configurations, the first outlet 1111a and the second outlet 1112a may be symmetrically and structurally identical.

[0558] In some configurations, the nasal interface 1100 is configured to deliver a lower rate of gas flow through the first outlet 1111a than the rate of gas flow through the second outlet 1112a during the inhalation phase of the breathing cycle.

[0559] Due to its less restricted flow path to the first outlet 1111a, the first gas flow stream F1 has a lower velocity and higher pressure than the second gas flow stream F2 along its more restricted flow path to the second outlet 1112a.

[0560] The nasal interface 1100 may include a restriction to restrict flow to the second outlet 1112a. The restriction may be provided by one or more of a flow director, a flow divider, or any other suitable feature. The restriction may include a bypass restriction.

[0561] In some configurations, the nasal interface 1100 is configured to deliver a gas flow through the first outlet 1111a at a higher pressure than the pressure of the gas flow through the second outlet 1112a during the inhalation phase of the breathing cycle.

[0562] In the configuration shown in FIG. 29, the interface body 1110 includes a first nasal delivery element 1111 including a first outlet 1111a and a second nasal delivery element 1112 including a second outlet 1112a, and the nasal interface 1100 is configured such that a first gas flow stream F1 is substantially delivered to the first nasal delivery element 1111 and a second gas flow stream F2 is substantially delivered to the second nasal delivery element 1112, and the first nasal delivery element and the second nasal delivery element are each configured to seal with the patient's respective nasal cavities.

[0563] In some configurations, the nasal interface includes a flow director configured to direct more of the incoming gas F0 from the gas inlet 1121 into the first gas flow stream F1 than into the second gas flow stream F2.

[0564] 29 shows a first exemplary configuration of the flow director. In this configuration, the flow director includes an inner portion 1121a of the gas inlet 1121. Because the gas inlet is more aligned with the first outlet 1111a than with the second outlet 1112a, the flow director directs more of the incoming gas F0 to the first gas flow stream F1 than to the second gas flow stream F2.

[0565] In some configurations, and as described below, the nasal interface includes a connector or elbow for connecting the respiratory conduit 300 to the patient interface.

[0566] The connector or elbow may include or be a flow director, i.e., the connector or elbow may be a component that directs more flow toward the first outlet 1111a than the second outlet 1112a.

[0567] In some configurations, the nasal interface 1100 is configured to direct more incoming gas into the first gas flow stream F1 than into the second gas flow stream F2 during the inhalation phase of a respiratory cycle. This may also occur during the exhalation phase of a respiratory cycle. The inhalation and exhalation phases may define a respiratory cycle.

[0568] In some configurations, the flow path F1 to the first nasal cavity includes a converging flow path. Additionally or alternatively, the flow path F2 to the second nasal cavity includes a diverging flow path.

[0569] In some configurations, the flow director includes a nozzle configured to accelerate the flow towards the first outlet 1111a.

[0570] In such a configuration, a first portion of the nozzle proximal to the gas inlet 1121 or proximal to the entry 1121a to the gas inlet may have a relatively large cross-sectional dimension, and a second portion of the nozzle distal to the gas inlet 1121 or proximal to the entry 1121a to the gas inlet (and proximal to the gas plenum in the interface body 1110 and / or gas manifold 1120) may have a relatively small cross-sectional dimension. Due to the reduced cross-sectional area, the nozzle accelerates the gas through the nozzle towards the first exit 1111a.

[0571] In some configurations, the reduction in the cross-sectional area of ​​the nozzle can be a gradual reduction in cross-sectional area between the first and second portions of the nozzle, such as a tapering, hi another configuration, the reduction in the cross-sectional area of ​​the nozzle can be one or more substantially abrupt reductions in cross-sectional area provided between the first and second portions of the nozzle, such as one or more step changes.

[0572] The nozzle may include a portion of the gas inlet 1121 or may be coupled or in fluid communication with the gas inlet 1121 .

[0573] In some configurations, the nozzle may be provided in combination with an additional flow director. Alternatively, the nozzle may function as the flow director.

[0574] The nasal interface 1100 is configured, in use, to deliver respiratory gases simultaneously from the gas inlet 1121 through the interface body 1110 to both the first and second nasal cavities of a patient.

[0575] The nasal interface 1100 includes a biased flow restriction 1140 that includes at least one aperture 1140a, optionally multiple apertures 1140a, for gas flow from the nasal interface 1100 to the surrounding environment.

[0576] The bias flow restrictor 1140 may provide the functionality described above with respect to the bias flow restrictor 140 .

[0577] During respiratory therapy, there is typically a positive gas flow out of the patient interface 1100 through the bias flow restriction 1140.

[0578] The bias flow restriction 1140 may include a filter and / or diffuser to filter or diffuse the gas flowing through the aperture 1140a. If a filter is used, in some configurations the filter may additionally function as a diffuser.

[0579] In the illustrated configuration, the bias flow restriction 1140 is provided in the gas manifold 1120 .

[0580] In some configurations, the biased flow restriction is positioned closer to the second nasal delivery element 1112 and the second outlet 1112a than to the first nasal delivery element 1111 and the first outlet 1111a, thereby encouraging exhaled gas to pass through the second nasal delivery element 1112 and exit the nasal interface through the biased flow restriction 1140.

[0581] The bias flow restriction 1140 may be located elsewhere than in the gas manifold 1120 .

[0582] When inlet gas is delivered to the nasal interface 1100 and the nasal interface is not attached to a patient and there is no restriction in the outlets, there is an asymmetric gas flow through the first outlet 1111a and the second outlet 1112a. The pressure at the outlets 1111a, 1111b can be checked to determine that there is asymmetric flow.

[0583] The nasal interface 1100 is configured to provide a greater dynamic pressure in a first nasal passage of the patient, in use, and a lesser dynamic pressure in a second nasal passage of the patient, in use.

[0584] Thus, the nasal interface 1100 may be considered to include an interface body 1110 configured to substantially form a seal with the patient's nasal airway, and the interface body 1110 is configured to deliver gas to the patient's first nasal cavity and the patient's second nasal cavity.

[0585] The nasal interface 1100 includes a gas inlet 1121 for delivering respiratory gas to the nasal interface, the gas inlet 1121 being fluidly connected to the interface body 1110 to deliver respiratory gas from the gas inlet 1121 through the interface body 1110 to the patient's first and second nasal cavities during use.

[0586] The nasal interface 1100 is configured to provide a greater dynamic pressure in a first nasal cavity of the patient in use, and a lesser dynamic pressure in a second nasal cavity of the patient in use. The greater dynamic pressure in the first nasal cavity compared to the lesser dynamic pressure in the second nasal cavity of the patient causes an asymmetric gas flow in the patient's nasal airway in use. The asymmetric gas flow in the patient's nasal airway may be created during an inspiration phase of a respiratory cycle. This may also occur during an expiration phase of a respiratory cycle. The inspiration phase and the expiration phase may define a respiratory cycle. Thus, an asymmetric flow may be provided to the patient's nasal airway by the nasal interface 1100 throughout the patient's respiratory cycle.

[0587] The nasal interface 1100 provides asymmetric flow: when in use of the nasal interface, when flow or pressure therapy, such as CPAP or BiPAP, is delivered to a patient, there is a net flow from the patient's first nasal cavity to the patient's second nasal cavity throughout the respiratory or breath cycle.

[0588] In some configurations, the patient may be spontaneously breathing.

[0589] The respiratory cycle may be described as having an inhalation phase, a diversion phase during which the patient is neither inhaling nor exhaling (this phase may also be known as a breath-holding phase), and an exhalation phase. The diversion phase may take place over a significantly shorter period of time than the inhalation and / or exhalation phases.

[0590] Flow enters the nasal interface 1100 from the gas inlet 1121 at some total pressure delivered by the respiratory assistance device. The flow has a static component of pressure and a dynamic component of pressure, the dynamic component of pressure referring to the flow component.

[0591] The gas flow from the gas inlet is split within the nasal interface, with a resulting first gas flow stream F1, which may have a larger cross-sectional area (herein referred to as A-1), being directed toward the first nasal cavity and a second gas flow stream F2, which may have a smaller cross-sectional area (herein referred to as A-2), being directed toward the second nasal cavity and the bias flow restriction 1140.

[0592] This flow division can create a bias towards the first nostril.

[0593] In some configurations, area A-1 is larger than area A-2, and the pressure drop or flow restriction of gas flow through area A-2 is greater than through area A-1.

[0594] In some configurations, area A-1 is greater than area A-2, and a majority of the gas flow is directed toward the first nostril.

[0595] In some configurations, area A-1 may not be greater than area A-2, but the incoming gas flow may be directed more toward the first nasal cavity than the second nasal cavity and / or the flow path of the second gas flow stream F2 to the second nasal cavity may be more tortuous than the flow path of the first gas flow stream F1 to the first nasal cavity.

[0596] In such a configuration, at least a portion of area A-2 may include a filter or diffuser to filter or diffuse gas flowing to the second nasal cavity via second gas flow stream F2. The filter or diffuser provided in at least a portion of area A-2 may function to create a bias toward the first nasal cavity.

[0597] Due to the bias of flow towards the first nasal cavity, the dynamic pressure in the first nasal cavity will be greater than the dynamic pressure in the second nasal cavity. Because the flow is coming in with its energy directed towards the first nasal cavity, the dynamic pressure is the flow component of the total pressure.

[0598] During the inhalation phase of breathing, the flow from the gas inlet 1121 enters both nasal passages in different proportions, with more flow entering the first nasal passage than the second nasal passage due to the bias created as described above. Flow that does not enter the first and / or second nasal passage may exit the patient interface to atmosphere through the bias flow restriction 1140. In some configurations, flow may exit the second nasal passage rather than entering the second nasal passage during some or all of inspiration. Such flow may be a portion of the flow from the gas inlet 1121 or flow exiting the patient's airway through the second nasal passage, or a combination thereof.

[0599] During the breath-holding phase, the flow from the gas inlet 1121 is split within the nasal interface with a portion of the split flow entering the first nasal cavity and exiting the second nasal cavity through the patient's airway. Flow (or a portion thereof) from the split flow and / or flow exiting the patient's airway through the first and / or second nasal cavity exits to atmosphere through the bias flow restriction 1140.

[0600] During the expiratory phase of breathing, flow can either exit both nasal passages or flow can enter the first nasal passage and exit the second nasal passage through the bias flow restriction 1140, depending on the configuration. Some flow can backflow through the nasal interface to the gas inlet 1121. If flow exits the first nasal passage, the incoming gas stagnates and travels, along with the flow from the first nasal passage, through the gas plenum 1115 towards the second nasal passage and exits through the bias flow restriction 1140 to the atmosphere. Because the total pressure in the second nasal passage is lower than in the first nasal passage, flow will exit the second nasal passage if there is a net flow from the lungs.

[0601] The nasal interface provides a pressure differential between the flow path of the first gas flow stream F1 and the flow path of the second gas flow stream F2.

[0602] In at least some configurations, breathing gases from the gas inlet 1121 are more likely to enter the first nasal cavity because they are directed towards that nasal cavity and there is resistance (e.g., in the form of a tortuous and / or reduced flow path) to travel towards the second nasal cavity. The second gas flow stream F2 may have to retrace its steps or pass through a restriction to enter the second nasal cavity, whereas the first gas flow stream F1 does not, resulting in more gas flowing into the first nasal cavity. Similarly, in the second nasal cavity, gases exhaled by the patient are more likely to exit through the second nasal cavity because the exhaled gases are directed towards the bias flow restriction 1140 and there is resistance (again, due to a tortuous and / or reduced flow path) to travel back towards the first nasal cavity. Thus, there is a dynamic pressure difference in both directions (into the first nasal cavity and out of the second nasal cavity).

[0603] The nasal interface 1100 has a single gas inlet 1121. Thus, the first and second outlets 1111a, 1112a or outlet portions receive gas flow from their breathing gases from the inlet.

[0604] The nasal interface 1100 may be used with a single gas source, such as, for example, a single flow generator.

[0605] Exemplary configurations of nasal interfaces providing the functionality described with respect to the nasal interface of Fig. 29 are described below with reference to Figs. 30-59. Unless described differently below, the features, functions, alternatives and uses of the nasal interfaces are as described with respect to nasal interface 1100 or any of the other described nasal interfaces. With respect to each exemplary configuration, like reference numbers indicate like parts increased by 100.

[0606] 30-36 show exemplary configurations of a nasal interface 1200. FIG.

[0607] The nasal interface 1200 includes an interface body 1210 and a gas manifold 1220 .

[0608] The gas manifold 1220 and the interface body 1210 are coupled to one another and define therein a gas plenum 1215. The gas plenum 1215 provides fluid communication between a gas inlet 1221 and the first and second outlets 1211a and 1212a.

[0609] The nasal interface 1200 includes a biased flow restriction 1240 that includes at least one aperture for gas flow from the nasal interface 1100 to the surrounding environment.

[0610] The bias flow restriction 1240 is at least partially aligned with the second outlet 1212a and less aligned or not aligned with the first outlet 1211a.

[0611] In the illustrated configuration, the bias flow restriction is substantially axially aligned with the second outlet 1212a.

[0612] The gas inlet 1221 is provided as part of or coupled to a connector or elbow 1222 for connecting the respiratory conduit 300 to the patient interface 1200 .

[0613] The connector or elbow 1222 enters the gas manifold 1220 from the front of the gas manifold. Alternatively, the connector or elbow 1222 can enter the gas manifold 1220 at a different location, such as the side of the gas manifold 1220 or underneath the gas manifold.

[0614] The nasal interface 1200 includes connector portions 1213 , 1214 for connecting the headgear 200 to the gas manifold 1220 and / or the interface body 1210 .

[0615] As shown in FIG. 31, the input stream F0 is split into two gas flow streams F1, F2 along respective flow paths leading to each of the outlets 1211a, 1212a and each of the nasal cavities.

[0616] 31, the first gas flow stream F1 has at least one dimension D1 that is greater than a corresponding dimension D2 of the second gas flow stream F2. The same may be true for other configurations of the nasal interfaces described herein.

[0617] At least one dimension D1 may comprise a lateral dimension of the first gas flow stream F1 and a corresponding dimension D2 may comprise a lateral dimension of the second gas flow stream F2.

[0618] For example, the first gas flow stream F1 may have a diameter, cross-sectional area and / or volume that is larger than a corresponding diameter, cross-sectional area and / or volume of the second gas flow stream F2.

[0619] In some configurations, the ratio of a cross-sectional area (along dimension D1) of the first gas flow stream F1 to a corresponding cross-sectional area (along dimension D2) of the second gas flow stream F2 is from about 2:1 to about 5:1, optionally from about 2:1 to about 4:1, optionally from about 2.5:1 to about 3.5:1, optionally about 3:1.

[0620] In some configurations, the ratio of the cross-sectional area of ​​the first gas flow stream F1 to the corresponding cross-sectional area of ​​the second gas flow stream F2 is about 2:1, 2.25:1, 2.5:1, 2.75:1, 3:1, 3.25:1, 3.5:1, 3.75:1, 4:1, 4.25:1, 4.5:1, 4.75:1, 5:1, or any value between any two of these values.

[0621] By way of example only, the total cross-sectional area of ​​the first gas flow stream F1 and the second gas flow stream F2 at or near the gas inlet 1221 may be approximately 200 mm 2 and the cross-sectional area of ​​the first gas flow stream F1 may be about 150 mm 2 and the cross-sectional area of ​​the second gas flow stream F2 may be about 50 mm 2 It could be.

[0622] Although the above relationship between at least one dimension D1 of the first gas flow stream F1 and a corresponding dimension D2 of the second gas flow stream F2 has been described in relation to the configurations of Figures 30-36, the same relationship may be used in any of the configurations of Figures 29-59.

[0623] The flow rate relationships may be slightly different between inhalation and exhalation and / or when different pressures / flows are delivered by the flow generator.

[0624] In some configurations, the nasal interface 1200 is configured to provide less asymmetry during the inhalation phase of the respiratory cycle and more asymmetry during the exhalation phase of the respiratory cycle, but is configured to provide asymmetric flow throughout the respiratory cycle, i.e., the pressure difference between the gas flow through the first outlet 1121a and the second outlet 1221b is higher during the exhalation phase than during the inhalation phase.

[0625] The flow direction provides more flow to the first outlet 1211a and less flow to the second outlet 1212a.

[0626] Thus, a higher pressure is provided to the first nasal delivery element 1211 and the first outlet 1211a than to the second nasal delivery element 1212 and the second outlet 1212a.

[0627] This creates a pressure differential between the nasal cavities providing asymmetric gas flow to the patient's airways.

[0628] Because more flow enters one nasal cavity (the first nasal cavity associated with the first outlet 1211a) than the other nasal cavity (the second nasal cavity associated with the second outlet 1212a), this means that the other nasal cavity can be used to exhale. This is illustrated in FIG. 32, which shows the main exhalation flow EF. The nasal cavity associated with the first outlet 1212a can also exhale, but the exhalation flow from that nasal cavity takes a longer and more tortuous path towards the bias flow restriction 1240.

[0629] This causes flow to enter primarily the first nostril and wash out the dead space as it exits the other nostril.

[0630] As described elsewhere herein, the nasal interface may be used in pressure controlled therapy (i.e. CPAP, BiPAP). Asymmetric flow within the nasal interface is the result of a pressure differential.

[0631] In the use of a nasal interface, if one nasal cavity is completely blocked, pressure controlled therapy (i.e. CPAP, BiPAP) is provided in the unblocked nasal cavity without asymmetry. The work of rebreathing can be increased. The nasal interface provides this functionality by default by not directing 100% of the incoming gas flow to one nasal cavity.

[0632] In the configuration shown, the nasal interface 1200 has two flow director features. Different configurations of the nasal interface 1200 may have one or both flow director features.

[0633] The first flow director feature is the location of the gas inlet 1221 closer to the first outlet 1211a than to the second outlet 1212b, as described above in connection with FIG.

[0634] The second flow director feature includes a flow splitter 1230 configured to split the flow F0 from the gas inlet 1221 unequally into a first gas flow stream F1 configured to be provided substantially to a first nasal cavity of the patient in use and a second gas flow stream F2 configured to be provided substantially to a second nasal cavity of the patient in use. The first gas flow stream F1 is configured to deliver more gas flow along the first gas flow stream F1 than along the second gas flow stream F2 to create an asymmetric gas flow in the patient's airway in use.

[0635] In some configurations, the nasal interface 1200 includes an interface body 1210 configured to substantially form a seal with a patient's nasal airway, the interface body 1210 configured to deliver gas to a first nasal cavity of the patient and a second nasal cavity of the patient; and a gas inlet 1221 for delivering respiratory gas to the nasal interface, the gas inlet 1221 in fluid communication with the interface body 1210 to deliver respiratory gas from the gas inlet 1221 through the interface body 1210 to the first nasal cavity and the second nasal cavity of the patient in use. The gas inlet 1221 includes an inlet 1221 and a flow divider 1230 configured to divide flow from the gas inlet 1221 unequally into a first gas flow stream F1 configured to be provided substantially to a first nasal cavity of the patient in use and a second gas flow stream F2 configured to be provided substantially to a second nasal cavity of the patient in use, the first gas flow stream F1 configured to deliver more gas flow along the first gas flow stream F1 than along the second gas flow stream F2 to create an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0636] In some configurations, the nasal interface 1200 includes an interface body 1210 including a first nasal delivery element 1211 including a first outlet 1211a configured to deliver gas to a first nasal cavity of a patient, and a second nasal delivery element 1212 including a second outlet 1212a configured to deliver gas to a second nasal cavity of the patient, the first nasal delivery element 1211 and the second nasal delivery element 1212 each configured to seal with a respective nasal cavity of the patient; and a gas inlet 1221 for delivering respiratory gas to the nasal interface 1200, the gas inlet 1221 being in fluid communication with the interface body 1210 to allow air to pass through the gas inlet 1221. The nasal delivery system includes a gas inlet 1221 that delivers respiratory gas through a first nasal delivery element 1211 and a second nasal delivery element 1212, and a flow divider 1230 that unequally divides flow from the gas inlet 1221 into a first gas flow stream F1 configured to be substantially provided to the first nasal delivery element 1211 and a second gas flow stream F2 configured to be substantially provided to the second nasal delivery element 1212, wherein the first gas flow stream F1 is configured to deliver more gas flow along the first gas flow stream F1 than along the second gas flow stream F2 to create an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0637] The flow divider 1230 may be located in the interface body 1210, the gas manifold 1220, and / or the gas inlet 1221. The gas inlet 1221 may be part of the elbow / connector 1222 or a separate component.

[0638] The flow divider 1230 may be integrally formed with one or more of these components or may be formed separately and connected to one or more of these components.

[0639] The flow divider 1230 may be a removable insert that is positioned to connect to one or more of these components. The removable insert may be used to convert an existing nasal interface to an asymmetric nasal interface.

[0640] In the illustrated configuration, the flow division section 1230 includes a wall extending towards or into the gas inlet 1221, with a first gas flow stream F1 located on one side of the wall and a second gas flow stream F2 located on the opposite side of the wall.

[0641] In some configurations, the flow divider 1230 extends into the gas inlet and divides the gas inlet 1221 into a first gas flow flow portion on a first side of the flow divider 1230 and a second gas flow flow portion on the opposite side of the flow divider 1230.

[0642] 31-34 and 35-36, for example, the flow divider 1230 may include a cylindrical wall that is aligned with the first outlet 1211a and extends in a direction away from the first outlet 1211a (and toward or into the gas inlet 1221). Alternatively, the flow divider 1230 may have a different configuration. For example, the flow divider 1230 may include a wall (flat or another shape) disposed between the first nasal delivery element 1211 and the second nasal delivery element 1212.

[0643] The flow divider 1230 may be a substantially rigid section such that a substantially constant relationship is provided between the first gas flow stream F1 and the second gas flow stream F2.

[0644] In some configurations, the nasal interface may include a flow director configured to direct more incoming gas from the gas inlet 1221 to the first flow stream F1 than to the second flow stream F2. The flow director may be provided in addition to the flow divider 1230.

[0645] In some configurations, the flow director may include a nozzle configured to accelerate the flow towards the first outlet 1221.

[0646] As shown in FIG. 32, body portion 1210 includes mating features 1210 a for engaging complementary mating features 1220 a on gas manifold 1220 .

[0647] In the illustrated configuration, the mating feature 1210a includes an inwardly opening recess and the complementary mating feature 1220a includes a radially outwardly extending flange that is received in the recess. Alternatively, the mating feature 1210a could include a radially inwardly opening flange and the complementary mating feature could include an outwardly opening recess.

[0648] In the illustrated configuration, the interface body 1210 is a nasal cushion.

[0649] The nasal cushions are made of one or more flexible materials, such as, for example, a thermoplastic elastomer, latex, vinyl, silicone, or polyurethane.

[0650] 32, in some configurations, an inner portion 1210b of the nasal cushion configured to contact the user's face is more flexible than an outer portion 1210c of the nasal cushion not configured to contact the user's face. The outer portion 1210c is stiffer or harder than the more flexible or softer inner portion 1210b. The inner portion 1210b includes first and second nasal delivery elements 1211 and 1212 and / or first and second outlets 1211 and 1212.

[0651] The stiffer outer portion 1210c supports the overall shape of the nasal cushion, while the more flexible inner portion 1210b improves the seal against the patient's face and also improves patient comfort.

[0652] In the illustrated configuration, at least a portion of the stiffer outer portion 1210c has thicker walls than the more flexible inner portion 1210b. Additionally or alternatively, the stiffer outer portion 1210c may include one or more features to increase its stiffness, such as, for example, one or more ribs.

[0653] The nasal cushions and nasal interface may have any one or more features outlined in U.S. Patent No. 10,792,451 or U.S. Patent Application Publication No. 2020 / 0046928, the contents of which are incorporated herein by reference in their entireties.

[0654] FIG. 37 illustrates another exemplary configuration of a nasal interface 1300.

[0655] In this configuration, a flow divider 1330 is provided within the interface body 1310 and the gas manifold 1320 .

[0656] The flow split includes a first split portion 1330 a within the interface body 1310 and a second split portion 1330 b within the gas manifold 1320 .

[0657] The first split portion 1330a includes a wall that extends towards or into the gas inlet 1321. The second split portion 1330b includes a wall within the gas inlet 1321.

[0658] The second split portion 1330b splits the gas inlet 1321 into a first gas flow stream portion on one side of the second split portion 1330b and a second gas flow stream portion on the opposite side of the second split portion 1330b.

[0659] The first and second divider portions 1330a, 1330b are configured to be adjacent to one another and may contact one another or at least partially overlap.

[0660] A first gas flow stream F1 is located on one side of the first and second split portions 1330a, 1330b, and a second gas flow stream F2 is located on the opposite side of the first and second split portions 1330a, 1330b.

[0661] The second split portion 1330b splits the gas inlet 1321 into a first gas flow stream portion on one side of the second split portion 1330b and a second gas flow stream portion on the opposite side of the second split portion 1330b.

[0662] FIG. 38 illustrates another exemplary configuration of a nasal interface 1400.

[0663] This configuration uses gas inlet alignment and a tortuous flow path to create asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0664] In this configuration, the gas inlet 1421 is substantially aligned with the first outlet 1411a or the first outlet portion, thereby providing a substantially direct flow path of the first gas flow stream F1 to the first outlet 1411a.

[0665] The flow splitter 1430 provides a restricted, tortuous flow path for the second gas flow stream F2 to the second outlet 1412a (indicated by the arrow near reference numeral 1415 in FIG. 38).

[0666] The serpentine flow path increases the flow velocity and therefore reduces the pressure at the second outlet 1412a.

[0667] 39 and 40 show another exemplary configuration of a nasal interface 1500.

[0668] This configuration uses gas inlet alignment and a tortuous path to create asymmetric gas flow in the patient's nasal airway. Asymmetric gas flow in the patient's nasal airway may be created during the inhalation phase of the respiratory cycle. This may also occur during the exhalation phase of the respiratory cycle. The inhalation and exhalation phases may define a respiratory cycle. Thus, asymmetric flow may be provided to the patient's nasal airway by the nasal interface 1100 throughout the patient's respiratory cycle.

[0669] In this configuration, the gas inlet 1521 is substantially aligned with the first outlet 1511a or the first outlet portion, thereby providing a substantially direct flow path of the first gas flow stream F1 to the first outlet 1511a.

[0670] A restriction 1530 is provided in the gas plenum 1515 formed between the gas manifold 1520 and the interface body 1510 .

[0671] The restriction provides a restricted, tortuous path for the second gas flow stream F2 to the second outlet 1512a.

[0672] The serpentine flow path increases the flow velocity and therefore reduces the pressure at the second outlet 1512a.

[0673] FIG. 41 illustrates another exemplary configuration of a nasal interface 1600.

[0674] In this configuration, the gas inlet 1621 enters the gas manifold 1620 from the side rather than the front.

[0675] The gas inlet 1621 includes an outer portion 1621a for connection to the breathing conduit 300 to supply gas flow from a gas source to the interface body 1610, and further includes an inner portion 1621b in fluid communication with the interface body.

[0676] The inner portion 1621b of the gas inlet 1621 is at least partially aligned with the first outlet 1611 or the first outlet portion.

[0677] The gas inlet 1621 includes a change in direction between an outer portion 1621a and an inner portion 1621b.

[0678] The change in direction can be any suitable angle, in some configurations, the change in direction can be from about 30 degrees to about 100 degrees, optionally from about 45 degrees to about 100 degrees, optionally from about 60 degrees to about 100 degrees, and optionally about 90 degrees.

[0679] Again, the nasal interface 1600 provides a restricted, tortuous flow path for the second gas flow stream F2.

[0680] FIG. 42 illustrates another exemplary configuration of a nasal interface 1700.

[0681] The flow divider 1730 in this configuration is similar to that in FIG.

[0682] This configuration differs in that the gas inlet 1721 is not aligned with the first outlet 1711a, but enters more centrally with the nasal interface, i.e., the axis along the center of the gas inlet is relatively centered between the axes extending through the outlets 1711a, 1712a.

[0683] In some configurations, the gas inlet 1721 is located in the center of the nasal interface.

[0684] In the configuration of FIG. 42, flow divider 1730 alone may provide flow directionality.

[0685] FIG. 43 illustrates another exemplary configuration of a nasal interface 1800.

[0686] In this configuration, the gas inlet 1821 is offset from but angled towards the first outlet 1811a or first outlet portion, thereby directing more gas flow towards the first outlet 1811a or first outlet portion than towards the second outlet 1812a or second outlet portion.

[0687] Due to the inclination of the gases inlet 1821 , an axis AA extending through the gases inlet 1821 is at a non-parallel angle to a central axis CA through the nasal interface 1800 .

[0688] This angle depends on the amount of offset between the gas inlet 1821 into the gas manifold 1820 and the first outlet 1811a.

[0689] In some configurations, the angle is greater than 0 degrees and up to about 30 degrees, optionally up to about 20 degrees, optionally up to about 15 degrees, and optionally up to about 10 degrees.

[0690] The angled gas inlet 1821 configuration may be used in nasal interfaces having a centrally located gas inlet or a nasal interface having a gas inlet offset towards the first outlet 1811a or first outlet portion.

[0691] This angled gas inlet 1821 configuration may be the only feature of the nasal interface 1800 that directs flow toward the first outlet 1811a or first outlet portion. Alternatively, the nasal interface 1800 may have one or more of the other flow directing features described herein, such as, for example, a flow divider.

[0692] FIG. 44 illustrates another exemplary configuration of a nasal interface 1800.

[0693] In this configuration, the interface body 1910 is a nasal cushion.

[0694] To properly seal with the patient's face and provide a comfortable experience for the patient, the nasal cushions are flexible and designed to compress / deform against the patient's face. The cushions can compress / deform in multiple directions when placed on and in contact with the face.

[0695] The nasal cushion includes a flow divider 1930. The flow divider 1930 in this configuration is configured to move and / or deform upon compression of the nasal cushion.

[0696] Compression / deformation of the nasal cushions can result in a patient-to-patient variation in the ratio or percentage of directing or splitting flow depending on the level of compression / bending of the nasal cushions.

[0697] The geometry of the flow split may be altered by moving and / or deforming the flow splitter 1930 to change the ratio between the first gas flow stream F1 and the second gas flow stream F2.

[0698] The flow divider 1930 may be flexible and configured to deform upon compression / deformation of the nasal cushion. Alternatively, the flow divider 1930 may be more rigid.

[0699] In the illustrated configuration, the flow splitter 1930 is configured to move more towards or into the gas inlet 1921 upon compression / deformation of the nasal cushion, as shown in FIG. 44(b). This may direct more flow along the first gas flow stream F1 than the second gas flow stream F2, as compared to a rest position of the nasal cushion (as shown in FIG. 44(a)).

[0700] 45 and 46 show another example configuration of a nasal cushion 2010 that may be used as the interface body in any of the nasal interfaces disclosed herein.

[0701] In this configuration, the nasal cushion 2010 includes a single outlet for delivering gas to the first and second nasal cavities of the patient. The single outlet includes a first outlet portion 2011a' and a second outlet portion 2012a'. The nasal cushion 2010, and thus the nasal interface, is configured such that the first gas flow stream F1 is configured to be delivered substantially to the first outlet portion 2011a' and the second gas flow stream F2 is configured to be delivered substantially to the second outlet portion 2012a'.

[0702] In the illustrated configuration, the nasal cushion 2010 includes a flow divider 2030 having a first wall portion 2030a and a second wall portion 2030b. The first wall portion 2030a and the second wall portion 2030b are hinged to one another. The relative angle of the first wall portion 2030a and the second wall portion 2030b is configured to change upon deformation / compression of the nasal cushion 2010.

[0703] The deformation of the flow divider 2030 may be configured to maintain a substantially constant ratio between the first gas flow stream F1 and the second gas flow stream F2 as the nasal cushion 2010 is deformed or compressed. Alternatively, the deformation of the flow divider 2030 may be configured to change the ratio between the first gas flow stream F1 and the second gas flow stream F2 as the nasal cushion 2010 is deformed or compressed.

[0704] 47 and 48 show an exemplary deformation of the flow divider 2030 as the nasal cushion 2010 is compressed.

[0705] As shown in these figures, in some configurations, the perimeter wall 2030c opposing the first wall portion 2030a and the second wall portion 2030b may also deform upon deformation / compression of the nasal cushion 2010.

[0706] FIG. 49 shows another example configuration of a nasal cushion 2110 that may be used as the interface body in any of the nasal interfaces disclosed herein.

[0707] In this configuration, the flow splitter 2130 also includes a first wall portion 2130a and a second wall portion 2130b.

[0708] The first wall 2130a and the second wall 2130b overlap one another in the relaxed state of the nasal cushion 2110. The degree of overlap of the walls 2130a, 2130b increases when the nasal cushion 2110 is compressed.

[0709] The configurations of Figures 47-49 may be used in nasal cushions or interface bodies having first and second nasal delivery elements with their own outlets, rather than having a single outlet with first and second outlet portions.

[0710] As outlined above, any of the nasal interfaces disclosed herein may use a nasal cushion with a single outlet for delivering gas to a first and second nasal cavity of a patient. The single outlet includes a first outlet portion and a second outlet portion. The single outlet may not have a distinct septum division between the nostrils and may be more comfortable for the patient by not having a septum contact portion.

[0711] In such configurations, the flow directing / flow splitting occurs before the outlet portion. Figure 50 shows three exemplary configurations of such nasal cushions 2210, 2310, 2410 where the flow directing features or flow splitting portions 2330, 2430 are provided by the gas manifold portions 2220, 2320, 2420.

[0712] Alternatively, the flow directing features may be provided by nasal cushions, for example as described with respect to the configurations of Figures 45-48.

[0713] In an alternative configuration, the nasal cushion may have a septum contacting portion. An exemplary configuration of such a nasal cushion 2510 is shown in FIG.

[0714] The septum contacting portion 2513 forms a first outlet 2511a and a second outlet 2512a for delivering gas to each nostril of the patient.

[0715] The septum contact portion 2513 may provide greater flow separation between the first gas flow stream F1 and the second gas flow stream F2 and reduce mixing of the flow streams before they are delivered through the first and second outlets 2511a, 2512a.

[0716] FIG. 52 illustrates another exemplary nasal cushion 2610.

[0717] This configuration includes shorter first and second nasal delivery elements 2611, 2612. The nasal delivery elements are shorter than those shown in the embodiment of FIG.

[0718] By having a shorter nasal delivery element, the first and second openings 2611a, 2612a may be larger than those with a longer nasal delivery element.

[0719] The nasal delivery elements 2611a, 2612a may form positioning features to aid in positioning the nasal delivery elements 2611a, 2612a within the nasal cavity and help keep the cavity open.

[0720] 53-56 show another exemplary configuration of a nasal interface 2700. FIG.

[0721] In this configuration, the flow director includes a gas inlet 2721 that is angled toward the first outlet 2711a, thereby directing more gas flow toward the first outlet 2711a than the second outlet 2712a.

[0722] The gas inlet 2721 includes a nozzle configured to accelerate a flow towards the first outlet 2711a or a first outlet portion.

[0723] In the illustrated configuration, a first portion of the nozzle proximal to the approach 2721a to the gas inlet has a relatively large cross-sectional dimension D3, and a second portion of the nozzle distal from the approach 2721a to the gas inlet (and proximal to the gas plenum 2715 in the interface body 2710 and / or gas manifold 2720) has a relatively smaller cross-sectional dimension. The nozzle accelerates gas through the nozzle toward the first outlet 2711a or outlet portion.

[0724] In some configurations, the outlet of the second portion of the nozzle is about 15 mm 2 ~about 150mm 2 has a cross-sectional area of

[0725] The nozzle may include a portion of the gas inlet 2721 or may be coupled or in fluid communication with the gas inlet.

[0726] In the illustrated configuration, the gas inlet 2721 is part of a connector or elbow 2722. The connector or elbow 2722 is therefore configured to direct more gas flow towards the first outlet 2711a than the second outlet 2712a.

[0727] The gas inlet 2721 and the connector or elbow 2722 may be integrally formed or may be coupled to one another.

[0728] In the illustrated configuration, the nozzle acts as a flow director. In alternative configurations, the nozzle may be provided in combination with additional flow directors. For example, the nozzle may be shorter than shown, and additional flow directors in the interface body 2710 and / or gas manifold 2720 may direct more flow from the nozzle toward the first outlet 2711 a or first outlet portion than the second outlet 2712 a or second outlet portion.

[0729] The second gas flow stream F2 has a more restricted tortuous path compared to the first gas flow stream F1.

[0730] The bias flow restriction may be provided in any suitable location on the nasal interface 2700.

[0731] In one configuration, the bias flow restriction 2740' is located in the interface body 2710 / nasal cushions. In another alternative, the bias flow restriction 2740'' can be located in the gas manifold 2720.

[0732] 57-59 show another exemplary configuration of a patient interface 2800. FIG.

[0733] In this configuration, a flow divider 2830 is provided within the interface body 2810 and the gas manifold 2820 .

[0734] The flow split includes a first split portion 2830 a within the interface body 2810 and a second split portion 2830 b within the gas manifold 2820 .

[0735] The first split portion 2830a includes a wall that extends towards or into the gas inlet 2821. The second split portion 2830b includes a wall of the gas inlet 2821.

[0736] The first split portion 2830 a is received within the second split portion 2830 b of the gas inlet 2821 .

[0737] The first split portion 2830a splits the gas flow F0 from the gas inlet into a first gas flow flow portion on one side of the first split portion 2830a and a second gas flow flow portion on the opposite side of the first split portion 2830a.

[0738] The first split portion 2830a and the second split portion 2830b are configured to be adjacent to each other and to partially overlap.

[0739] A gap is provided between the exterior of the first split portion 2830a and the interior of the second split portion, the gap providing a flow path for the second gas flow stream F2 to travel in a restricted tortuous path and be delivered to the second outlet 2812a or to the second outlet portion.

[0740] In the illustrated configuration, the bias flow restriction 2840 includes a series of apertures 2840 a at the front of the gas manifold 2820 .

[0741] In some configurations, the straps 210' of the headgear 200' may be integrally formed with the gas manifold 2820. For example, the straps 210' may be overmolded with the gas manifold 2820.

[0742] As outlined above with respect to nasal interface 100, in some configurations of nasal interfaces 1100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800, the nasal interface may provide a nasal flow rate of between about 2 cmH2O and about 30 cmH2O when in use, optionally between about 2 cmH2O and about 25 cmH2O when in use, optionally between about 2 cmH2O and about 20 cmH2O when in use, optionally The device is configured to achieve a patient pressure at the first outlet or first outlet portion and the second outlet or second outlet portion of from about 2 cmH2O to about 15 cmH2O when in use, optionally from about 2 cmH2O to about 14 cmH2O when in use, optionally from about 2 cmH2O to about 13 cmH2O when in use, optionally from about 2 cmH2O to about 12 cmH2O when in use, optionally from about 2 cmH2O to about 11 cmH2O when in use, optionally from about 2 cmH2O to about 10 cmH2O when in use.

[0743] As outlined above with respect to nasal interface 100, in some configurations of nasal interfaces 1100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800, the pressure differential between the first outlet 1111a or first outlet portion and the second outlet 1112a or second outlet portion is configured to provide an asymmetric flow through the patient's upper airway of at least about 1 liter per minute (lpm), optionally between about 1 lpm and about 5 lpm.

[0744] The asymmetric flow provided by the nasal interface 100, 1100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800 allows for the removal of CO from the patient's anatomical dead space. 2 Promotes the removal of

[0745] The nasal interfaces 100, 1100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800 disclosed herein are configured to deliver respiratory gases simultaneously from the gas inlet through the interface body to both the first and second nasal cavities of a patient in use.

[0746] In some configurations, during the exhalation phase, as the patient exhales, flow may exit one or both of the first and / or second nasal cavity. A portion of the gas exhaled from the first and / or second nasal cavity may then enter the first and / or second nasal cavity as the patient subsequently inhales.

[0747] A patient interface 1 having a nasal interface 100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800 in accordance with the configurations described herein may be used in a method to deliver gas to a patient's airway as required, to improve ventilation of the patient as required, to reduce the volume of anatomical dead space within the volume of the patient's airway as required, and / or to treat a respiratory condition of the patient as required, as described above.

[0748] Patient interfaces 1, including nasal interfaces 100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800 of the type disclosed herein, may be used in respiratory therapy systems for delivering gas to a patient.

[0749] The patient interface 1 may include any of the types of nasal interfaces disclosed herein (or nasal interface components such as interface bodies 2110, 2210, 2310, 2410, 2610), and therefore any references herein and below to nasal interface 100 may instead be taken as references to any of the other nasal interfaces 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800.

[0750] In some configurations, the respiratory therapy system 1000 includes a respiratory therapy device 1100 and a patient interface 1 that includes a nasal interface 100 .

[0751] An exemplary respiratory therapy device 1100 is shown in FIG.

[0752] The respiratory therapy device 1100 includes a main housing 1101 that houses a flow generator 1011 in the form of a motor / impeller arrangement (e.g., a blower), an optional humidifier 1012, a controller 1013, and a user interface 1014 (e.g., including a display and input devices such as buttons, touch screen, etc.).

[0753] The controller 1013 may be configured or programmed to control the operation of the device. For example, the controller may control the components of the device, including, but not limited to, operating the flow generator 1011 to generate a gas flow for delivery to the patient, operating the humidifier 1012 (if present) to humidify and / or heat the generated gas flow, controlling the flow of oxygen to the blower of the flow generator, receiving user input from the user interface 1014 for reconfiguration and / or user-defined operation of the device 1000 and outputting information to the user (e.g., on a display).

[0754] A user may be a patient, a medical professional, or anyone else interested in using the device. As used herein, "gas flow" may refer to any gas flow that may be used in a respiratory assistance or breathing device, such as a flow of ambient air, a flow containing substantially 100% oxygen, a flow containing some combination of ambient air and oxygen, etc.

[0755] The controller 1013 may be implemented as a pure hardware controller, a software regime running on the controller hardware, or software running on other non-dedicated controller hardware of the device. Alternatively, the controller 1013 may be implemented as a combination of any number of the foregoing implementations.

[0756] In various forms, the controller 1013 may include a processor and a memory.

[0757] It will be understood that the various detecting, operating, sensing, comparing, enabling or disabling, triggering, pulsing, monitoring, receiving, determining, and such like steps by the controller 1013 or as part of the method of operation of the device may be performed autonomously, automatically, or dynamically. For example, the steps or various steps may be performed by the controller, whether as hardware and software or internal or external system implementations, independently of any other input or control signal. As a further example, they may be performed automatically in response to one or more precursor steps or preconditions.

[0758] When a method or control step or structural element is described as being associated with another method or control step or structural element, this is generally understood to indicate a relationship between the two features. In particular, in the context of a method or control step, this may indicate a relationship of precedence, dependency, successor or general connection to the method or control step. In the context of structural elements, this may indicate a functional association between the structural elements, such as an operational relationship or connection or synergy to provide a particular result. Alternatively, in the context of structural elements, this may indicate a direct physical relationship between the two structural elements. Where appropriate, further meaning of the term "associated with" in relation to such elements or steps should be understood from the surrounding context.

[0759] The respiratory tube 16 is coupled at one end to a gas flow outlet 1021 of the housing 1100 of the respiratory therapy device 1100. At the other end, the respiratory tube 16 is coupled to a nasal interface 100 having a gas manifold 120 and nasal prongs 111, 112. The connection to the nasal interface 100 may be a direct connection to the nasal interface or may be via a respiratory conduit 300 and optionally a filter 500.

[0760] The gas flow generated by the respiratory therapy device 1100 may be humidified and delivered to the patient via the respiratory tube 16 through the nasal interface 100. The respiratory tube 16 may have a heater for heating the gas flow passing through to the patient. For example, the respiratory tube 16 may have a heater wire 16a for heating the gas flow passing through to the patient. The heater wire 16a may be under the control of the controller 1013. The respiratory tube 16a, the respiratory conduit 300 (if provided) and / or the nasal interface 100 may be considered part of the respiratory therapy device 1100 or may instead be considered peripheral thereto. The patient interface 1 including the respiratory therapy device 1100, the respiratory tube 16, the respiratory conduit 300 (if provided) and the nasal interface 100 may together form a respiratory therapy system 1000.

[0761] The controller 1013 can control the flow generator 1011 to generate a gas flow at a desired rate. The controller 1013 can also control the supplemental oxygen inlet to enable delivery of supplemental oxygen, the humidifier 1012 (if present) can humidify and / or heat the gas flow to an appropriate level, etc. The gas flow is directed to the patient through the respiratory tube 16, the respiratory conduit 300, and the nasal interface 100. The controller 1013 can also control the heating element of the humidifier 1012 and / or the heating element 16a of the patient conduit 16 to heat the gas to a desired temperature for a desired level of therapy and / or level of patient comfort. The controller 1013 can be programmed with or can determine an appropriate target temperature for the gas flow. In some configurations, a mixed gas composition including supplemental oxygen and / or a dose of a therapeutic agent can be provided through the supplemental oxygen inlet. The mixed gas composition may include oxygen, heliox, nitrogen, nitric oxide, carbon dioxide, argon, helium, methane, sulfur hexafluoride, and combinations thereof, and / or the auxiliary gas may include an aerosolized medicament.

[0762] Operational sensors 1003a, 1003b, 1003c, such as flow, temperature, humidity and / or pressure sensors, may be located at various locations within the respiratory therapy device 1100. Additional sensors (e.g., sensors 1020, 1025) may be located at various locations on the respiratory tube 16, respiratory conduit 300 and / or nasal interface 100 (e.g., there may be a temperature sensor 1029 at or near the end of the inspiratory tube). Output from the sensors may be received by the controller 1013 and assist the controller in operating the respiratory therapy device 1100 to provide an appropriate therapy. In some configurations, providing an appropriate therapy includes meeting the patient's maximum inspiratory demand. The device 1100 may have a transmitter and / or receiver 1015 to enable the controller 1013 to receive signals 1008 from the sensors and / or control various components of the respiratory therapy device 1100, including but not limited to the flow generator 1011, the humidifier 1012 and the heater wire 16 or accessories or peripherals associated with the respiratory therapy device 1100. Additionally or alternatively, the transmitter and / or receiver 1015 may deliver data to a remote server or enable remote control of the device 1100.

[0763] In some configurations, the respiratory therapy system 1000 includes a gas source 1011 for respiratory gas configured to provide pressure-controlled respiratory gas, a respiratory tube 16 for receiving the pressure-controlled respiratory gas, and a nasal interface.

[0764] In some configurations of the respiratory therapy system 1000, the nasal interface 100 includes any one or more of the features outlined herein in fluid communication with the respiratory tube 16 to deliver pressure-controlled respiratory gas to the patient.

[0765] In some configurations of the respiratory therapy system 1000, the nasal interface 100 has a gas inlet 121 in fluid communication with the respiratory tube 16 to deliver respiratory gas to the patient, the nasal interface includes a first nasal delivery element 111 and a second nasal delivery element 112, each configured to seal with a respective nasal cavity of the patient, and the nasal interface 100 is configured to create a pressure differential between the first nasal delivery element 111 and the second nasal delivery element 112 such that when gas is delivered from the gas inlet 121 to both the first nasal delivery element 111 and the second nasal delivery element 112, the pressure in the first nasal delivery element 111 is higher than the pressure in the second nasal delivery element 112.

[0766] In some configurations of the respiratory therapy system, a nasal interface 1100 used in the respiratory therapy system includes an interface body 1110 configured to substantially form a seal with a patient's nasal airway. The interface body 1110 is configured to deliver gas to a first nasal cavity of the patient and a second nasal cavity of the patient. The nasal interface 1100 includes a gas inlet 1121 for delivering respiratory gas to the nasal interface 1100. The gas inlet 1121 is in fluid communication with the interface body 1110 to deliver respiratory gas from the gas inlet 1121 through the interface body 1110 in use to the first nasal cavity and the second nasal cavity of the patient. The nasal interface 1100 is configured to receive an inflow gas F0 from the gas inlet 1121 and provide from the inflow gas F0 a first gas flow stream F1 configured to be substantially provided to the first nasal cavity of the patient in use and a second gas flow stream F2 configured to be substantially provided to the second nasal cavity of the patient in use. The nasal interface 1100 is configured to direct more incoming gas into the first gas flow stream F1 than into the second gas flow stream F2 to produce an asymmetric gas flow in the patient's nasal airway throughout the patient's respiratory cycle.

[0767] In some configurations of the respiratory therapy system, a nasal interface 1100 used in the respiratory therapy system includes an interface body 1110 configured to substantially form a seal with a patient's nasal airway, the interface body 1110 configured to deliver gas to a first nasal cavity of the patient and a second nasal cavity of the patient. The nasal interface 1100 includes a gas inlet 1121 for delivering respiratory gas to the nasal interface, the gas inlet 1121 in fluid communication with the interface body 1110 to deliver respiratory gas from the gas inlet 1121 through the interface body 1110 to the first nasal cavity and the second nasal cavity of the patient in use. The nasal interface 1100 is configured to provide a greater dynamic pressure in the patient's first nasal cavity in use and a lesser dynamic pressure in the patient's second nasal cavity in use to create an asymmetric gas flow in the patient's nasal airway.

[0768] Asymmetric gas flow in the patient's nasal airway may be created during the inhalation phase of the respiratory cycle. This may also occur during the exhalation phase of the respiratory cycle. The inhalation and exhalation phases may define a respiratory cycle. Thus, asymmetric flow may be provided to the patient's nasal airway by nasal interface 1100 throughout the patient's respiratory cycle.

[0769] In some configurations, the interface body 1100 includes a first outlet 1111a or first outlet portion configured to deliver gas to a first nasal cavity of the patient and a second outlet 1112a or second outlet portion configured to deliver gas to a second nasal cavity of the patient, and the nasal interface 1100 is configured to create a pressure differential between the first outlet 1111a or first outlet portion and the second outlet 1112a or second outlet portion such that when gas is delivered from the gas inlet 1221 to both the first outlet 1111a or first outlet portion and the second outlet 1112a or second outlet portion, the pressure at the first outlet 1111a or first outlet portion is higher than the pressure at the second outlet 1112a or outlet portion.

[0770] In some configurations, the respiratory therapy system 1000 includes a respiratory conduit 300 for receiving pressure-controlled respiratory gas from the respiratory tube 16, which is in fluid communication with the respiratory tube 16 and the gas inlet 121 of the nasal interface 100, 1100.

[0771] In some configurations, the respiratory therapy system 1000 includes a respiratory gas filter 500 .

[0772] In some configurations, the respiratory gas filter 500 is located between the heated breathing tube 16 and the breathing conduit 300. In an additional or alternative configuration, and as shown, for example, in FIG. 17(b), the respiratory gas filter 500' may be located between the gas manifold 120 and the bias flow restriction 140. For example, in the configuration of FIG. 18, the respiratory gas filter 500' may be located between the expiratory gas conduit 160 and the bias flow restriction 140.

[0773] In some configurations, the respiratory therapy system includes a humidifier 1012 configured to humidify the pressure-controlled respiratory gas prior to delivery to the nasal interface 100,1100.

[0774] In some configurations, the breathing tube 16 is a heated breathing tube and is configured to receive pressure-controlled breathing gas from the humidifier 1012.

[0775] In some configurations, the temperature of the gas flow exiting the first and second nasal delivery elements 111 and 112 or exiting the nasal interface 1100 for delivery to the patient's nasal airways may be from about 31° C. to about 41° C., optionally greater than about 31° C. and up to about 41° C., optionally from about 36° C. to about 39° C., optionally about 37° C. For example, the temperature may be about 31° C., about 32° C., about 33° C., about 34° C., about 35° C., about 36° C., about 37° C., about 38° C., about 39° C., about 40° C., or about 41° C., or any value between any two of these values.

[0776] The respiratory therapy system may have any one or more of the features and functionality described in PCT Publication No. WO 2021 / 048744 and U.S. Provisional Patent Application Nos. 62 / 897,899 and 63 / 025,151, and / or PCT Publication No. WO 2021 / 049954 and U.S. Provisional Patent Application No. 62 / 898,464, the contents of which are incorporated herein by reference in their entireties.

[0777] The patient interface 1 and nasal interface 100 used in the respiratory therapy system 1000 may have any one or more of the features and / or functions described herein with respect to the nasal interface 100 or any of the other nasal interfaces disclosed herein.

[0778] In some configurations, the nasal interface 100, patient interface 1 and / or respiratory therapy system 1000 may be used in a method of providing respiratory assistance to a patient.

[0779] In some configurations, a method of providing respiratory assistance to a patient includes: A respiratory therapy system 1000 is provided, the respiratory therapy system 1000 comprising: a gas source 1011 for breathing gas, the gas source 1011 being configured to provide a pressure-controlled breathing gas; a breathing tube 16 for receiving pressure-controlled breathing gas; A nasal interface 100 having a gas inlet 121 in fluid communication with a respiratory tube 16 for delivering respiratory gas to a patient, the nasal interface 100 including a first nasal delivery element 111 and a second nasal delivery element 112. providing, sealing each of the patient's nasal passages with a first nasal delivery element 111 and a second nasal delivery element 112; operating the respiratory therapy device 1000 to provide a gas flow to the nasal interface 100; Delivering asymmetric gas flows from the respiratory therapy device 1000 to the patient's nasal passages through the first nasal delivery element 111 and the second nasal delivery element 112; Includes.

[0780] In some configurations, the nasal delivery elements 111, 112 are in fluid communication with the gas inlet 121 via a gas flow channel 125, with the first nasal delivery element 111 being proximal to the gas inlet 121 and the second nasal delivery element 112 being distal to the gas inlet 121, and the nasal interface having a cross-sectional area A 2 Each of the first nasal delivery element 111 and the second nasal delivery element 112 includes a bypass restriction 130 that provides an inner cross-sectional area A 3 , A 4 and the inner cross-sectional area is, taken together, the total cross-sectional area A 3 +A 4 and a cross-sectional area A of a portion of the gas flow channel 125. 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 It is more than 0 to approximately 1.5 times.

[0781] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 at most about 1x, optionally at most about 2 / 3x, and the method includes providing a pressure of 4 cmH2O to the gas inlet 121 such that there is a bias flow of 20 lpm through the bias flow restriction 140.

[0782] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 at most about 1x, optionally at most about 2 / 3x, and the method includes providing a pressure of 8 cmH2O to the gas inlet 121 such that there is a bias flow of 32 lpm through the bias flow restriction 140.

[0783] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 or the method includes providing a pressure of 4 cmH2O to the gas inlet 121 such that there is a bias flow of 20 lpm through the bias flow restriction 140, or the method includes providing a pressure of 8 cmH2O to the gas inlet 121 such that there is a bias flow of 32 lpm through the bias flow restriction 140, or the method includes providing a pressure of 12 cmH2O to the gas inlet 121 such that there is a bias flow of 41 lpm through the bias flow restriction 140, or the method includes providing a pressure of 16 cmH2O to the gas inlet 121 such that there is a bias flow of 48 lpm through the bias flow restriction 140, or the method includes providing a pressure of 20 cmH2O to the gas inlet 121 such that there is a bias flow of 53 lpm through the bias flow restriction 140.

[0784] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the method includes providing a pressure of 8 cmH2O to the gas inlet 121 such that there is a bias flow of at least 32 lpm through the bias flow restriction 140.

[0785] In some configurations, the cross-sectional area A of a portion of the gas flow channel 125 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the method includes providing a pressure of 8 cmH2O to the gas inlet 121 such that there is a bias flow of 32 lpm or more through the bias flow restriction 140, or a cross-sectional area A of a portion of the gas flow channel 125. 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4and the method includes providing a pressure of 12 cmH2O to the gas inlet 121 such that there is a bias flow of 41 lpm or more through the bias flow restriction 140, or a cross-sectional area A of a portion of the gas flow channel 125. 2 is the total cross-sectional area A of the nasal delivery elements 111, 112 3 +A 4 and the method includes providing a pressure of 16 cmH2O to the gas inlet 121 such that there is a bias flow of at least 48 lpm through the bias flow restriction 140.

[0786] In some configurations, the temperature of the gas flow exiting the first nasal delivery element 111 and the second nasal delivery element 112 is from about 31°C to about 41°C, optionally greater than 31°C and up to about 41°C, optionally from about 36°C to about 39°C, optionally about 37°C.

[0787] In some configurations, a method of providing respiratory assistance to a patient includes: A respiratory therapy system 1000 is provided, the respiratory therapy system 1000 comprising: a gas source 1011 for breathing gas, the gas source 1011 being configured to provide a pressure-controlled breathing gas; a breathing tube 16 for receiving pressure-controlled breathing gas; a nasal interface 1100 in fluid communication with the respiratory tube 16 for delivering respiratory gas to the patient; providing, sealing the patient's nasal airway with a nasal interface 1100; operating the respiratory therapy device 1000 to provide a gas flow to the nasal interface 1100; receiving an inlet gas at a gas inlet 1221 of the nasal interface and creating an asymmetric gas flow in the patient's nasal airway; Includes.

[0788] Asymmetric gas flow in the patient's nasal airway may be created during the inhalation phase of the respiratory cycle. This may also occur during the exhalation phase of the respiratory cycle. The inhalation and exhalation phases may define a respiratory cycle. Thus, asymmetric flow may be provided to the patient's nasal airway by nasal interface 1100 throughout the patient's respiratory cycle.

[0789] The nasal interface can be any one of the nasal interfaces 1100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800 disclosed herein.

[0790] In some configurations, the system is configured to deliver gas through the nasal interface 100, 1100 at up to 100% relative humidity.

[0791] In some configurations, the system is configured to deliver gas through the nasal interface 100, 1100 at a relative humidity of about 14 mg / l to about 34 mg / l.

[0792] In some configurations, the temperature of the gas flow exiting the first nasal delivery element 111 and the second nasal delivery element 112 and / or exiting the nasal interface 1100 for delivery to the patient's nasal cavities is between about 16°C and about 32°C.

[0793] In some configurations, the system is configured to deliver gas through the nasal interface 100, 1100 at greater than about 33 mg / L absolute humidity. In some configurations, the system is configured to deliver gas through the nasal interface 100 at up to about 44 mg / L absolute humidity.

[0794] In some configurations, the system is configured to deliver gas through the nasal interface 100, 1100 at a maximum absolute humidity of about 54 mg / l.

[0795] In some configurations, the temperature of the gas flow exiting the first nasal delivery element 111 and the second nasal delivery element 112 and / or exiting the nasal interface 1100 for delivery to the patient's nasal cavities is up to about 41°C.

[0796] The patient interface 1 and nasal interfaces 100, 1100 used in the method may have any one or more of the features and / or functions described herein with respect to nasal interfaces 100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800.

[0797] The respiratory therapy system 1000 used in the method may have any one or more of the features and / or functionality described herein with respect to the respiratory therapy system 1000.

[0798] When using the patient interface 1 and nasal interfaces 100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800 of the present disclosure for CPAP-style therapy, CPAP-style therapy may provide one or more of quieter treatment, increased treatment pressure, respiratory rate, removal of the nasal interface, and / or easier detection of leaks (by controlling pressure) compared to high-flow therapy.

[0799] The nasal interfaces 100, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 2700, 2800 disclosed herein may be used in a medical facility, a home environment, an emergency vehicle, or any other suitable environment, and thus references herein to a "patient" should be interpreted as any suitable subject for which the nasal interface is used.

[0800] Although the present disclosure has been described in terms of specific embodiments, other embodiments apparent to those skilled in the art are also within the scope of the present disclosure. Thus, various changes and modifications may be made without departing from the spirit and scope of the present disclosure. For example, various components may be repositioned as necessary. Features of any of the described embodiments may be combined with each other, and / or a device may include one, more than one, or all of the features of the above-described embodiments. Moreover, not all features, aspects, and advantages are necessarily required to practice the present disclosure. Thus, it is intended that the scope of the present disclosure be defined solely by the following claims.

Claims

1. 1. A nasal interface, comprising: an interface body configured to substantially form a seal with a patient's nasal airway, the interface body configured to deliver gas to a first nostril of the patient and a second nostril of the patient; a gas inlet for delivering respiratory gas to the nasal interface, the gas inlet being in fluid communication with the interface body such that, in use, the respiratory gas is delivered from the gas inlet through the interface body to the first and second nasal cavities of the patient; the nasal interface is configured to receive inlet gas from the gas inlet and to provide from the inlet gas a first gas flow stream configured to be provided substantially to the first nasal cavity of the patient in use and a second gas flow stream configured to be provided substantially to the second nasal cavity of the patient in use; and to direct more of the inlet gas into the first gas flow stream than into the second gas flow stream to create asymmetric gas flows in the patient's nasal airways throughout the patient's respiratory cycle.

2. 10. The nasal interface of claim 1, wherein the interface body includes a first outlet or first outlet portion configured to deliver gas substantially to the first nasal cavity of the patient, and a second outlet or second outlet portion configured to deliver gas substantially to the second nasal cavity of the patient.

3. 3. The nasal interface of claim 2, wherein the gas inlet is at least partially aligned with the first outlet or first outlet portion and less aligned or not aligned with the second outlet or second outlet portion.

4. 4. The nasal interface of claim 3, wherein the gas inlet is substantially axially aligned with the first outlet or first outlet portion.

5. 5. The nasal interface of claim 4, wherein at least half of the cross-sectional area of ​​the gas inlet is axially aligned with at least half of the cross-sectional area of ​​the first outlet or first outlet portion.

6. 3. A nasal interface according to claim 2, wherein the gas inlet is angled towards the first outlet or first outlet portion.

7. A nasal interface according to any one of claims 2 to 6, wherein the first gas flow stream has at least one dimension that is greater than a corresponding dimension of the second gas flow stream.

8. The nasal interface of claim 7 , wherein the at least one dimension comprises a lateral dimension of the first gas flow stream and the corresponding dimension comprises a lateral dimension of the second gas flow stream.

9. 8. The nasal interface of claim 7, wherein the first gas flow stream has a diameter, cross-sectional area and / or volume that is larger than a corresponding diameter, cross-sectional area and / or volume of the second gas flow stream.

10. 7. A nasal interface according to any one of claims 2 to 6, configured to deliver a gas flow through the first outlet or first outlet portion at a rate that is lower than a rate of gas flow through the second outlet or second outlet portion during an inhalation phase of a breathing cycle.

11. 7. A nasal interface according to any one of claims 2 to 6, configured to deliver a gas flow through the first outlet or first outlet portion at a pressure higher than the pressure of the gas flow through the second outlet or second outlet portion during the inhalation phase of a breathing cycle.

12. 7. A nasal interface according to claim 2, comprising a single outlet for delivering gas to the first and second nasal cavities of the patient, the single outlet comprising the first outlet portion and the second outlet portion, the nasal interface configured such that the first gas flow stream is delivered substantially to the first outlet portion and the second gas flow stream is delivered substantially to the second outlet portion.

13. 7. The nasal interface of claim 2, wherein the interface body comprises a first nasal delivery element including the first outlet and a second nasal delivery element including the second outlet, the nasal interface configured such that the first gas flow stream is delivered substantially to the first nasal delivery element and the second gas flow stream is delivered substantially to the second nasal delivery element, the first nasal delivery element and the second nasal delivery element each configured to seal with a respective nasal cavity of a patient.

14. 7. A nasal interface according to claim 2, comprising a flow director configured to direct more of the incoming gas from the gas inlet into the first gas flow stream than into the second gas flow stream.

15. 15. A nasal interface according to claim 14, comprising a connector or elbow for connecting a respiratory conduit to the patient interface.

16. A nasal interface as described in any one of claims 1 to 6, wherein the nasal interface is configured to direct more of the incoming gas into the first gas flow stream than into the second gas flow stream during the inspiratory phase of the breathing cycle, and / or the interface body is a nasal cushion, and / or the nasal interface is configured to deliver the respiratory gas simultaneously from the gas inlet through the interface body to both the first and second nasal cavities of the patient in use.

Images