Respiratory therapy system

Abstract

A respiratory therapy system (100) for delivering a gas stream to a patient. The respiratory therapy system (100) has a flow generator (101) configured to generate a gas stream and a conduit (122) configured to deliver the gas stream from the flow generator (104) to the patient. The conduit (122) has an inner lumen and a heating wire configured to heat the gas stream in the conduit. The respiratory therapy system (100) has a port configured to be in fluid communication with the conduit (122) and for receiving and introducing the atomized material into the gas stream flowing toward the patient. The respiratory therapy system (100) has a controller configured to adjust the power delivered to at least the heating wire to adjust the average particle size of the atomized material toward a target or orientation.

Description

[0001] This application is a divisional application of the invention patent application filed on December 4, 2023, with application number 202380092839.X (international application number PCT / IB2023 / 062167) and entitled "Respiratory Therapy System". Technical Field

[0002] This disclosure generally relates to a respiratory therapy system for delivering a gas stream to a patient. More specifically, this disclosure relates to a respiratory therapy system that adjusts the average particle size of the atomized material introduced into the system. Background Technology

[0003] Respiratory therapy devices or systems that deliver gas flow can be used to improve patient ventilation. Such devices or systems can be used to improve patient comfort and / or improve the prognosis of patients with respiratory diseases.

[0004] In some systems, the respiratory therapy system can be configured to receive nebulized material, for example, from a nebulizer. For instance, a nebulizer can be used to deliver a medicinal substance to a patient's airway while simultaneously delivering breathing gases to the patient's airway. In some cases, the respiratory therapy system receives nebulized material, which is then carried by a gas flow through a breathing tube and output to the patient's airway via a patient interface.

[0005] However, the delivery efficiency of nebulized material may not be as expected, for example, when the nebulized material adheres to the inner wall of the catheter, settles along the inner wall of the catheter, or becomes stuck on the inner wall of the catheter and does not advance into the patient's airway, or when a sufficient amount of material does not advance as far into the patient's airway as expected.

[0006] Therefore, the object of the present invention is to provide a respiratory therapy device or system that overcomes or at least partially improves some of the above-mentioned disadvantages, or at least provides the public with a useful alternative. Summary of the Invention

[0007] According to certain features, aspects, and advantages of at least one embodiment disclosed herein, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0008] A flow generator configured to deliver the gas flow to the patient;

[0009] A catheter configured to deliver the gas flow from the flow generator to the patient, the catheter including an inner lumen and a heating wire configured to heat the gas flow in the catheter;

[0010] A port configured to be in fluid communication with the catheter for receiving nebulized material and introducing the nebulized material into a gas stream flowing toward the patient; and

[0011] A controller is configured to at least adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to a target.

[0012] In some configurations, power is delivered to the heating wires to achieve the target relative humidity.

[0013] In some configurations, the controller continuously controls the power delivered to the heating wire to maintain the target relative humidity.

[0014] In some configurations, the target relative humidity is the relative humidity of the gas flowing in the duct.

[0015] In some configurations, the target relative humidity is the relative humidity of the flowing gas at the patient end of the catheter.

[0016] In some configurations, the target relative humidity is approximately 80%.

[0017] In some configurations, the target relative humidity is less than 80%.

[0018] In some configurations, the target relative humidity is approximately 60%.

[0019] In some configurations, the target relative humidity is less than 60%.

[0020] In some configurations, the target average particle size is based on the expected travel distance into the patient's airway.

[0021] In some configurations, the desired travel distance is for dispersion in or around the patient's upper respiratory tract.

[0022] In some configurations, the desired travel distance is intended to be distributed outside the patient's upper respiratory tract.

[0023] In some configurations, the desired travel distance is to disperse the patient's lower respiratory tract or around it.

[0024] In some configurations, the target mean particle size is relatively larger when the expected travel distance is dispersed in or around the patient's upper respiratory tract than when the expected travel distance is dispersed in or around the patient's lower respiratory tract.

[0025] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) of <1.0 μm.

[0026] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.5 μm and <1.0 μm.

[0027] In some configurations, the target average particle size is the median aerodynamic diameter (MMAD) of <0.5 μm.

[0028] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.1 μm and 0.5 μm.

[0029] In some configurations, the respiratory therapy system also includes a humidifier that incorporates a heating element.

[0030] In some configurations, the controller is configured to adjust the power delivered to the heating element to adjust the average particle size of the atomized material to the target.

[0031] In some configurations, the controller controls the power delivered to the heating wire and the power delivered to the heating element to achieve the target average particle size.

[0032] In some configurations, the controller controls the power delivered to the heating wire independently of the power delivered to the heating element in order to adjust the average particle size.

[0033] In some configurations, the heating element is a heating plate.

[0034] In some configurations, the port for the atomizer is located downstream of the flow generator.

[0035] In some configurations, the port for the atomizer is located at the humidifier.

[0036] In some configurations, the port for the atomizer is located at or toward the inlet or outlet of the humidifier.

[0037] In some configurations, the port for the atomizer is located at or toward the outlet of the humidifier.

[0038] In some configurations, the port for the atomizer is located upstream of the device end of the conduit.

[0039] In some configurations, the port for the atomizer is located at or towards the device end of the duct.

[0040] In some configurations, this port is set up to receive the atomizer indirectly.

[0041] In some configurations, the respiratory therapy system also includes a connector configured to connect to the port at one opening and to receive the nebulizer at another opening.

[0042] In some configurations, the respiratory therapy system also includes a nebulizer configured to connect at the port, which introduces the atomized substance into the gas stream.

[0043] In some configurations, the system includes both a standard treatment mode and a nebulizer treatment mode.

[0044] In some configurations, the nebulizer treatment mode includes a target relative humidity that is lower than the target relative humidity in the standard treatment mode.

[0045] In some configurations, the power delivered to the heating wire in nebulizer mode is higher than that delivered in standard treatment mode.

[0046] In some configurations, the standard treatment mode includes a target relative humidity of approximately 100%, while the nebulizer treatment mode includes a target relative humidity of less than 100%.

[0047] In some configurations, the target relative humidity in the nebulizer treatment mode is less than 80%.

[0048] In some configurations, the target relative humidity in the nebulizer treatment mode is less than 60%.

[0049] In some configurations, users can manually switch between standard treatment mode and nebulizer treatment mode.

[0050] In some configurations, a feature for manually adjusting the target average particle size becomes available after entering nebulizer therapy mode.

[0051] In some configurations, the system is set to automatically control the power to the heating wire to achieve the default target average particle size.

[0052] In some configurations, the system is set to automatically control the power to the heating element to achieve the default target average particle size.

[0053] In some configurations, the default target average particle size is <1.0 μm.

[0054] In some configurations, the respiratory therapy system also includes a user control interface.

[0055] In some configurations, the user control interface includes a user control interface element for adjusting the target average particle size.

[0056] In some configurations, the user control interface includes user control interface elements for adjusting the target travel distance into the patient's airway.

[0057] In some configurations, the user control interface includes user control interface elements for selecting standard treatment modes and nebulizer treatment modes.

[0058] In some configurations, the user control interface includes a touchscreen interface.

[0059] In some configurations, the user control interface includes a mechanical interface with physical elements, which are one or a combination of sliders, dials, and buttons.

[0060] In some configurations, the conduit includes a length greater than 0.5 meters.

[0061] In some configurations, the conduit includes a length greater than 1 meter.

[0062] In some configurations, the conduit includes a length greater than 1.5 meters.

[0063] Based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a method for delivering a gas stream to a patient is disclosed, the method comprising:

[0064] A respiratory therapy device is provided, the device comprising:

[0065] - A flow generator configured to deliver the gas flow to the patient;

[0066] - A catheter configured to deliver the gas flow from the flow generator to the patient, the catheter including an inner lumen and a heating wire configured to heat the gas flow in the catheter;

[0067] Introducing atomized substances into the patient's gas stream; and

[0068] Adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to the target.

[0069] In some configurations, the method also includes adjusting the power delivered to the heating wire to achieve the target relative humidity.

[0070] In some configurations, the method also includes continuously controlling the power delivered to the heating wire to maintain the target relative humidity.

[0071] In some configurations, the target relative humidity is the relative humidity of the gas flowing in the duct.

[0072] In some configurations, the target relative humidity is the relative humidity of the flowing gas at the patient end of the catheter.

[0073] In some configurations, the target relative humidity is approximately 80%.

[0074] In some configurations, the target relative humidity is less than 80%.

[0075] In some configurations, the target relative humidity is approximately 60%.

[0076] In some configurations, the target relative humidity is less than 60%.

[0077] In some configurations, the target average particle size is based on the expected travel distance into the patient's airway.

[0078] In some configurations, the desired travel distance is for dispersion in or around the patient's upper respiratory tract.

[0079] In some configurations, the desired travel distance is intended to be distributed outside the patient's upper respiratory tract.

[0080] In some configurations, the desired travel distance is to disperse the patient's lower respiratory tract or around it.

[0081] In some configurations, the target mean particle size is relatively smaller when the expected travel distance is dispersed in or around the patient's upper respiratory tract than when the expected travel distance is dispersed in or around the patient's lower respiratory tract.

[0082] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) of <1.0 μm.

[0083] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.5 μm and 1.0 μm.

[0084] In some configurations, the target average particle size is the median aerodynamic diameter (MMAD) of <0.5 μm.

[0085] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.1 μm and 0.5 μm.

[0086] In some configurations, the method also includes providing a humidifier that includes a heating element.

[0087] In some configurations, the method also includes adjusting the power delivered to the heating element to adjust the average particle size of the atomized material to a target.

[0088] In some configurations, the method also includes controlling both the power delivered to the heating wire and the power delivered to the heating element to achieve a target average particle size.

[0089] In some configurations, the method also includes controlling the power delivered to the heating wire independently of the power delivered to the heating element to adjust the average particle size.

[0090] In some configurations, the method also includes connecting an atomizer at the port, which introduces the atomized material into the gas stream.

[0091] In some configurations, the method also includes indirectly connecting the atomizer to the port via a mounting bracket / connector.

[0092] In some configurations, the system includes both a standard treatment mode and a nebulizer treatment mode.

[0093] In some configurations, the method also includes adjusting the power of the heating wire so that the nebulization treatment mode achieves a target relative humidity that is lower than the target relative humidity in the standard treatment mode.

[0094] In some configurations, the method also includes delivering higher power to the heating wire in the nebulizer treatment mode than in the standard treatment mode.

[0095] In some configurations, the method also includes adjusting the power to the heating wire to achieve a target relative humidity of approximately 100% for the standard treatment mode and less than 100% for the nebulized treatment mode.

[0096] In some configurations, the method also includes manual adjustment between standard treatment mode and nebulizer treatment mode.

[0097] In some configurations, the method also includes automatic control of the power to the heating wire to achieve a default target average particle size.

[0098] In some configurations, the method also includes automatic control of the power to the heating element to achieve a default target average particle size.

[0099] In some configurations, the method also includes adjusting the target average particle size.

[0100] In some configurations, the method also includes adjusting the target travel distance of the nebulized material into the patient's airway.

[0101] In some configurations, the method also includes selecting a standard treatment mode and a nebulization treatment mode on the user control interface element.

[0102] According to certain features, aspects, and advantages of at least one embodiment disclosed herein, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0103] A flow generator configured to deliver the gas flow to the patient;

[0104] A humidifier, which includes a heating element;

[0105] A port configured to be in fluid communication with the catheter for receiving nebulized material and introducing the nebulized material into a gas stream flowing toward the patient; and

[0106] A controller is configured to at least adjust the power delivered to the heating element to adjust the average particle size of the atomized material to a target.

[0107] In some configurations, the respiratory therapy system also includes a catheter configured to deliver the gas flow from the flow generator to the patient. The catheter includes an inner lumen and a heating wire configured to heat the gas flow within the catheter.

[0108] In some configurations, the controller is configured to adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to the target.

[0109] In some configurations, the controller controls both the power delivered to the heating wire and the power delivered to the heating element to achieve the target average particle size.

[0110] In some configurations, the controller controls the power delivered to the heating wire independently of the power delivered to the heating element in order to adjust the average particle size.

[0111] In some configurations, the controller controls the power delivered to the heating element and / or heating wire to achieve the target relative humidity.

[0112] In some configurations, the controller continuously controls the power delivered to the heating element and / or heating wire to maintain the target relative humidity.

[0113] In some configurations, the target relative humidity is the relative humidity of the gas flowing in the duct.

[0114] In some configurations, the target relative humidity is the relative humidity of the flowing gas at the patient end of the catheter.

[0115] In some configurations, the target relative humidity is approximately 80%.

[0116] In some configurations, the target relative humidity is less than 80%.

[0117] In some configurations, the target relative humidity is approximately 60%.

[0118] In some configurations, the target relative humidity is less than 60%.

[0119] In some configurations, the target average particle size is based on the expected travel distance into the patient's airway.

[0120] In some configurations, the desired travel distance is for dispersion in or around the patient's upper respiratory tract.

[0121] In some configurations, the desired travel distance is intended to be distributed outside the patient's upper respiratory tract.

[0122] In some configurations, the desired travel distance is to disperse the patient's lower respiratory tract or around it.

[0123] In some configurations, the target mean particle size is relatively smaller when the expected travel distance is dispersed in or around the patient's upper respiratory tract than when the expected travel distance is dispersed in or around the patient's lower respiratory tract.

[0124] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) of <1.0 μm.

[0125] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.5 μm and 1.0 μm.

[0126] In some configurations, the target average particle size is the median aerodynamic diameter (MMAD) of <0.5 μm.

[0127] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.1 μm and 0.5 μm.

[0128] In some configurations, the heating element is a heating plate.

[0129] In some configurations, the port for the atomizer is located downstream of the flow generator.

[0130] In some configurations, the port for the atomizer is located at the humidifier.

[0131] In some configurations, the port for the atomizer is located at or toward the inlet or outlet of the humidifier.

[0132] In some configurations, the port for the atomizer is located at or toward the outlet of the humidifier.

[0133] In some configurations, the port for the atomizer is located upstream of the device end of the conduit.

[0134] In some configurations, the port for the atomizer is located at or towards the device end of the duct.

[0135] In some configurations, this port is set up to receive the atomizer indirectly.

[0136] In some configurations, the respiratory therapy system also includes a mount / connector configured to connect to the port at one opening and to receive the nebulizer at another opening.

[0137] In some configurations, the respiratory therapy system also includes a nebulizer configured to connect at the port, which introduces the atomized substance into the gas stream.

[0138] In some configurations, the system includes both a standard treatment mode and a nebulizer treatment mode.

[0139] In some configurations, the nebulizer treatment mode includes a target relative humidity that is lower than the target relative humidity in the standard treatment mode.

[0140] In some configurations, the power delivered to the heating wire in nebulizer mode is higher than that delivered in standard treatment mode.

[0141] In some configurations, the standard treatment mode includes a target relative humidity of approximately 100%, while the nebulizer treatment mode includes a target relative humidity of less than 100%.

[0142] In some configurations, the target relative humidity in the nebulizer treatment mode is less than 80%.

[0143] In some configurations, the target relative humidity in the nebulizer treatment mode is less than 60%.

[0144] In some configurations, users can manually switch between standard treatment mode and nebulizer treatment mode.

[0145] In some configurations, a feature for manually adjusting the target average particle size becomes available after entering nebulizer therapy mode.

[0146] In some configurations, the system is set to automatically control the power to the heating wire to achieve the default target average particle size.

[0147] In some configurations, the system is set to automatically control the power to the heating element to achieve the default target average particle size.

[0148] In some configurations, the default target average particle size is <1.0 μm.

[0149] In some configurations, the respiratory therapy system also includes a user control interface.

[0150] In some configurations, the user control interface includes a user control interface element for adjusting the target average particle size.

[0151] In some configurations, the user control interface includes user control interface elements for adjusting the target travel distance into the patient's airway.

[0152] In some configurations, the user control interface includes user control interface elements for selecting standard treatment modes and nebulizer treatment modes.

[0153] In some configurations, the user control interface includes a touchscreen interface.

[0154] In some configurations, the user control interface includes a mechanical interface with physical elements, which are one or a combination of sliders, dials, and buttons.

[0155] In some configurations, the conduit includes a length greater than 0.5 meters.

[0156] In some configurations, the conduit includes a length greater than 1 meter.

[0157] In some configurations, the conduit includes a length greater than 1.5 meters.

[0158] Based on certain features, aspects, and advantages of at least one embodiment disclosed herein, a method for delivering a gas stream to a patient is disclosed, the method comprising:

[0159] A respiratory therapy device is provided, the device comprising:

[0160] - A flow generator configured to deliver the gas flow to the patient;

[0161] - A humidifier that includes a heating element;

[0162] Introducing atomized substances into the patient's gas stream; and

[0163] Adjust the power delivered to the heating element to adjust the average particle size of the atomized material to the target.

[0164] According to certain features, aspects, and advantages of at least one embodiment disclosed herein, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0165] A flow generator configured to deliver the gas flow to the patient;

[0166] A port configured to be in fluid communication with the catheter for receiving nebulized material and introducing the nebulized material into a gas stream flowing toward the patient; and

[0167] A controller, which adjusts the power delivered to components in the system to adjust the average particle size of the atomized material to the target.

[0168] The system includes a standard treatment mode and a nebulizer treatment mode; and

[0169] The nebulization treatment mode includes a target relative humidity that is lower than that in the standard treatment mode.

[0170] In some configurations, the respiratory therapy system also includes a temperature rise relative to the dew point of the gas stream, which reduces the relative humidity in nebulized therapy mode.

[0171] In some configurations, the respiratory therapy system also includes a catheter configured to deliver the gas flow from the flow generator to the patient. The catheter includes an inner lumen and a heating wire configured to heat the gas flow within the catheter.

[0172] In some configurations, the controller is configured to adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to the target.

[0173] In some configurations, the respiratory therapy system also includes a humidifier that incorporates a heating element.

[0174] In some configurations, the controller is configured to adjust the power delivered to the heating element to adjust the average particle size of the atomized material to the target.

[0175] In some configurations, the controller controls both the power delivered to the heating wire and the power delivered to the heating element to achieve the target average particle size.

[0176] In some configurations, the heating element is a heating plate.

[0177] According to certain features, aspects, and advantages of at least one embodiment disclosed herein, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0178] A flow generator configured to deliver the gas flow to the patient;

[0179] A port configured to be in fluid communication with the catheter for receiving nebulized material and introducing the nebulized material into a gas stream flowing toward the patient; and

[0180] A controller, which adjusts the power delivered to components in the system to adjust the average particle size of the atomized material to the target.

[0181] The target average particle size is the mass median aerodynamic diameter (MMAD) of <1.0 μm.

[0182] In some configurations, the target average particle size is based on the expected travel distance into the patient's airway.

[0183] In some configurations, the travel distance is intended to be used to disperse the patient outside the upper respiratory tract.

[0184] In some configurations, the desired travel distance is to disperse the patient's lower respiratory tract or around it.

[0185] In some configurations, the respiratory therapy system also includes raising the temperature of the gas stream relative to the dew point, thereby reducing the relative humidity to achieve the target average particle size.

[0186] In some configurations, the respiratory therapy system also includes a catheter configured to deliver the gas flow from the flow generator to the patient. The catheter includes an inner lumen and a heating wire configured to heat the gas flow within the catheter.

[0187] In some configurations, the controller is configured to adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to the target.

[0188] In some configurations, the respiratory therapy system also includes a humidifier that incorporates a heating element.

[0189] In some configurations, the controller is configured to adjust the power delivered to the heating element to adjust the average particle size of the atomized material to the target.

[0190] In some configurations, the controller controls the power delivered to the heating wire and the power delivered to the heating element to achieve the target average particle size.

[0191] In some configurations, the heating element is a heating plate.

[0192] According to certain features, aspects, and advantages of at least one embodiment disclosed herein, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0193] A flow generator configured to deliver the gas flow to the patient;

[0194] A catheter configured to deliver the gas flow from the flow generator to the patient, the catheter including an inner lumen and a heating wire configured to heat the gas flow in the catheter;

[0195] A nebulizer, in fluid communication with the catheter, for introducing atomized material into a gas stream flowing toward the patient; and

[0196] A controller is configured to adjust the power of components delivered to the system to adjust the average particle size of the atomized material to a target.

[0197] In some configurations, the target average particle size is based on the expected travel distance into the patient's airway.

[0198] In some configurations, the travel distance is intended to be used to disperse the patient outside the upper respiratory tract.

[0199] In some configurations, the desired travel distance is to disperse the patient's lower respiratory tract or around it.

[0200] In some configurations, the respiratory therapy system also includes raising the temperature of the gas stream relative to the dew point, thereby reducing the relative humidity to achieve the target average particle size.

[0201] In some configurations, the respiratory therapy system also includes a catheter configured to deliver the gas flow from the flow generator to the patient. The catheter includes an inner lumen and a heating wire configured to heat the gas flow within the catheter.

[0202] In some configurations, the controller is configured to adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to the target.

[0203] In some configurations, the respiratory therapy system also includes a humidifier that incorporates a heating element.

[0204] In some configurations, the controller is configured to adjust the power delivered to the heating element to adjust the average particle size of the atomized material to the target.

[0205] In some configurations, the controller controls both the power delivered to the heating wire and the power delivered to the heating element to achieve the target average particle size.

[0206] In some configurations, the heating element is a heating plate.

[0207] Based on certain features, aspects, and advantages of at least one of the embodiments disclosed herein but not claimed, a method for delivering a gas stream to a patient is disclosed, the method comprising:

[0208] A respiratory therapy device is provided, the device comprising:

[0209] A flow generator configured to generate the gas flow;

[0210] A catheter configured to deliver the gas flow from the flow generator to the patient, the catheter including an inner lumen and a heating wire configured to heat the gas flow in the catheter;

[0211] Introducing atomized material into the gas stream flowing toward the patient; and

[0212] Adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to the target.

[0213] In some configurations, the method also includes adjusting the power delivered to the heating wire to achieve a target relative humidity for the gas flow.

[0214] In some configurations, the method also includes continuously controlling the power delivered to the heating line to maintain the target relative humidity of the gas flow.

[0215] Based on certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein but not claimed, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0216] A flow generator configured to generate the gas flow;

[0217] A humidifier, which includes a heating element;

[0218] A port configured to be in fluid communication with a catheter, and the port configured to receive nebulized material and introduce the nebulized material into a gas stream flowing toward the patient; and

[0219] The controller is configured to regulate at least the power delivered to the heating element to adjust the average particle size of the atomized material toward or towards the target.

[0220] Based on certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein but not claimed, a method for delivering a gas stream to a patient is disclosed, the method comprising:

[0221] A respiratory therapy device is provided, the respiratory therapy device comprising:

[0222] A flow generator configured to generate the gas flow;

[0223] A humidifier, which includes a heating element;

[0224] Introducing atomized material into the gas stream flowing toward the patient; and

[0225] Adjust the power delivered to the heating element to adjust the average particle size of the atomized material to the target or towards the target.

[0226] Based on certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein but not claimed, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0227] A flow generator configured to generate the gas flow;

[0228] A port configured in fluid communication for receiving atomized material and introducing it into a gas stream flowing toward the patient; and

[0229] A controller, used to adjust the power delivered to components in the system to adjust the average particle size of the atomized material toward or towards the target;

[0230] The system includes a standard treatment mode and a nebulizer treatment mode; and

[0231] The nebulization therapy mode includes a lower relative humidity than that in the standard therapy mode.

[0232] Based on certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein but not claimed, a respiratory therapy system for delivering a gas stream to a patient is disclosed, the respiratory therapy system for delivering a gas stream to a patient comprising:

[0233] A flow generator configured to generate the gas flow;

[0234] The port is configured to be in fluid communication or to receive atomized material and introduce the atomized material into the gas flow toward the patient; and

[0235] A controller, used to adjust the power delivered to components in the system to adjust the average particle size of the atomized material toward or towards the target;

[0236] The target average particle size is the mass median aerodynamic diameter (MMAD) of <1.0 micrometers.

[0237] According to certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein but not claimed, a respiratory therapy system for delivering a gas stream to a patient includes:

[0238] A flow generator configured to generate the gas flow;

[0239] A catheter configured to deliver the gas flow from the flow generator to the patient, the catheter including an inner lumen and a heating wire configured to heat the gas flow in the catheter;

[0240] A nebulizer, in fluid communication with the catheter, is used to introduce atomized material into a gas stream flowing toward the patient; and

[0241] A controller is configured to adjust the power of components delivered to the system to adjust the average particle size of the atomized material to a target.

[0242] According to certain features, aspects, and advantages of at least one embodiment of the embodiments disclosed herein but not claimed, a respiratory therapy device for delivering a gas stream to a patient includes:

[0243] A flow generator configured to generate the gas flow;

[0244] A humidifier, which includes a heating element;

[0245] A port configured to be in fluid communication with a catheter, the port being configured to receive nebulized material and introduce the nebulized material into a gas stream flowing toward the patient; and

[0246] The controller is configured to regulate at least the power delivered to the heating element to adjust the average particle size of the atomized material toward or towards the target.

[0247] In some configurations, the device is configured to be fluidly connected to a catheter configured to deliver the gas flow from the flow generator to the patient. The catheter includes an inner lumen and a heating wire configured to heat the gas flow within the catheter.

[0248] In some configurations, the controller is configured to adjust the power delivered to the heating wire to adjust the average particle size of the atomized material to the target.

[0249] In some configurations, the port for the atomizer is located upstream of the device end of the conduit.

[0250] In some configurations, the port for the atomizer is located at or towards the device end of the duct.

[0251] In some configurations, the respiratory therapy device also includes a mount / connector configured to connect to the port at one opening and to receive the nebulizer at another opening.

[0252] In some configurations, the port is set to connect to an atomizer that introduces the atomized material into the gas stream.

[0253] In some configurations, the device includes both a standard treatment mode and a nebulizer treatment mode.

[0254] In some configurations, the device is set to automatically control the power to the heating wires to achieve the default target average particle size.

[0255] In some configurations, the device is set to automatically control the power to the heating element to achieve a default target average particle size.

[0256] In some configurations, the respiratory therapy device also includes a user control interface.

[0257] As used in this specification, the term "comprising" means "at least partially comprising". When interpreting each expression containing the term "comprising" in this specification, there may be features other than those beginning with that term. Related terms such as "comprise" and "comprises" will be interpreted in the same manner.

[0258] The invention can also be broadly described as including parts, elements, and features individually or collectively mentioned or indicated in the specification of this application, and any or all combinations of any two or more of said parts, elements, or features, and wherein specific integers are referred to herein, having known equivalents in the field to which the invention relates, which are considered to be included herein as if they were set forth separately.

[0259] The present invention includes the foregoing, and also contemplates the following constructions, which are given as examples only.

[0260] It should be understood that alternative embodiments may include any or all combinations of two or more of the components, elements, features, or configurations shown, described, or mentioned in this specification. Attached Figure Description

[0261] For those skilled in the art, specific embodiments and modifications thereof will become apparent from the following detailed description of the accompanying drawings, in which:

[0262] Figure 1 A schematic diagram of a respiratory therapy system is shown.

[0263] Figure 2 Another schematic diagram of a respiratory therapy system is shown.

[0264] Figure 3 A circuit sensing board that can be used in a respiratory therapy system is shown.

[0265] Figure 4 A schematic diagram of a respiratory therapy system that receives atomized substances from a nebulizer is shown.

[0266] Figure 5 A perspective view of a respiratory therapy device for use in a respiratory therapy system is shown, which is configured according to certain features, aspects and advantages of some of the described configurations.

[0267] Figure 6 A perspective view of the respiratory equipment of a respiratory therapy system is shown.

[0268] Figure 7 A flowchart illustrating the use and control methods of the respiratory therapy system is shown.

[0269] Figure 8A The graph showing the test results illustrates the correlation between relative humidity, air temperature, and MMAD of the nebulized material in the respiratory therapy system at a flow rate of 20 L / min.

[0270] Figure 8B The graph showing the test results illustrates the correlation between relative humidity, air temperature, and MMAD of the nebulized material in the respiratory therapy system at a flow rate of 40 L / min. Detailed Implementation

[0271] Although certain examples are described below, those skilled in the art will understand that this disclosure extends beyond the specific examples disclosed and / or their uses and obvious modifications and equivalents. Therefore, the scope of the disclosure herein is not intended to be limited to any specific examples described below.

[0272] 1. General description of respiratory therapy systems

[0273] refer to Figure 1 An exemplary configuration of a respiratory therapy system 100 is shown. The respiratory therapy system 100 delivers a gas stream to a patient.

[0274] In a preferred configuration, the respiratory therapy system 100 includes a flow generator 101 for generating a gas flow to be delivered to the patient. The flow generator 101 shown includes a gas inlet 102 and a gas outlet 104.

[0275] In some configurations, the flow generator 101 may also include a blower 106. The blower 106 may draw in gas from the gas inlet 102. In some configurations, the flow generator 101 may include a source or container of compressed gas (e.g., air, oxygen, etc.). The container may include a valve that can be adjusted to control the flow of gas leaving the container. In some configurations, the flow generator 101 may use this compressed gas source and / or another gas source instead of the blower 106. In some configurations, the blower 106 may be used in conjunction with another gas source. In some configurations, the blower 106 may include a motorized blower, or may include a bellows arrangement or some other structure capable of generating a gas flow. The blower 106 may operate at motor speeds greater than about 1,000 RPM and less than about 8,000 RPM, greater than about 2,000 RPM and less than about 10,000 RPM, or any of the foregoing values. Blower 106 can mix gases entering blower 106 through inlet ports (e.g., ambient air inlet port 102 and / or oxygen inlet port). Using blower 106 as a mixer can reduce the pressure drop relative to a system with a separate mixer (e.g., a static mixer including baffles).

[0276] In some configurations, the flow generator 101 draws in atmospheric gases through gas inlet 102. In other configurations, the flow generator 101 is adapted to draw in atmospheric gases through gas inlet 102 and receive other gases (e.g., oxygen, nitric oxide, carbon dioxide, etc.) through the same gas inlet 102 or different gas inlets. For example, gas inlet 102 may be a supplemental oxygen inlet. The supplemental oxygen inlet may include a valve (e.g., a proportional valve, a binary valve, or other suitable valve type) capable of controlling the oxygen flow into the flow generator 101. This valve may be electrically connected to the controller 113 of the respiratory therapy system 100. Other configurations are also possible.

[0277] In some configurations, the flow generator 101 is controlled to provide high-flow therapy. In some configurations, the flow generator 101 is controlled to provide continuous positive airway pressure (CPAP) therapy. In some configurations, the flow generator 101 is a dual-therapy device controlled to provide high-flow and / or CPAP therapy. In some configurations, the flow generator 101 is controlled to provide one or more of the following: bilevel pressure therapy, CPAP therapy, or high-flow therapy.

[0278] In some configurations, the respiratory therapy system 100 measures and controls the oxygen content of the gas delivered to the patient, and thus measures and controls the oxygen content of the gas inhaled by the patient. Oxygen can be measured by placing one or more gas composition sensors (e.g., an ultrasonic transducer system) after the oxygen and ambient air have been mixed. This measurement can be performed within the respiratory therapy device 100, catheter 122, patient interface 124, or at any other suitable location.

[0279] The oxygen concentration measured in the device can be equal to the fraction of delivered oxygen (FdO2) and can be substantially the same as the oxygen concentration of the patient’s breath, the fraction of inhaled oxygen (FiO2), and therefore these terms can be considered equivalent.

[0280] Oxygen concentration can also be determined by using flow rate sensors on at least two of the ambient air inlet tubing, oxygen inlet tubing, and patient breathing tubing to determine the flow rates of at least two gases. By determining the flow rates of the two inlet gases or one inlet gas and a total flow rate, along with the assumed or measured oxygen concentration of the inlet gases (approximately 20.9% for ambient air and approximately 100% for oxygen), the oxygen concentration of the final gas composition can be calculated. Alternatively, flow rate sensors can be placed at all three locations in the ambient air inlet tubing, oxygen inlet tubing, and breathing tubing to allow for redundancy and to test the correct operation of each sensor by checking the consistency of the readings. Other methods for measuring the oxygen concentration delivered by the respiratory therapy system 100 can also be used.

[0281] The respiratory therapy system 100 can provide high-flow therapy, wherein the high flow rate of the delivered gas meets or exceeds the patient’s peak inspiratory needs.

[0282] As discussed herein, high-flow therapy is intended to be given its typical, general meaning as understood by those skilled in the art; it generally refers to a respiratory assist device that delivers a target flow rate of humidified breathing gas via an intentionally unsealed patient interface at a flow rate generally designed to meet or exceed the patient's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults are typically in the range of about 15 liters / minute to about 60 liters / minute or higher, but are not limited to this. Typical flow rates for pediatric patients (e.g., newborns, infants, and children) are typically in the range of about 1 liter / minute / kg of patient weight to about 3 liters / minute / kg of patient weight or higher. High-flow therapy may also optionally include a gas mixture composition comprising supplemental oxygen and / or the administration of therapeutic drugs. High-flow therapy is commonly referred to as nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or tracheal high-flow (THF), and other generic names.

[0283] For example, in some configurations, for adult patients, "high-flow therapy" can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for neonates, infants, or pediatric patients, "high-flow therapy" can refer to delivering gas to the patient at a flow rate greater than 1 LPM, for example, between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. In some configurations, high-flow therapy devices for adult patients, neonates, infants, or pediatric patients can deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or at any of the above subranges. The delivered gas may include a percentage of oxygen. In some configurations, the oxygen percentage in the delivered gas can be between about 20% and about 100%, or between about 30% and about 100%, or between about 40% and about 100%, or between about 50% and about 100%, or between about 60% and about 100%, or between about 70% and about 100%, or between about 80% and about 100%, or between about 90% and about 100%, or about 100%, or 100%.

[0284] High-flow therapy can effectively reach or exceed the patient's inspiratory flow rate, increase the patient's oxygenation, and / or reduce the work of breathing.

[0285] High-flow therapy can be administered through the patient's nostrils and / or mouth, or via a tracheostomy port.

[0286] High-flow-rate therapy creates a flushing effect in the nasopharynx, flushing the anatomical dead space of the upper airway with a high inlet gas flow. This creates a reservoir of fresh gas available for each breath and rebreath, while reducing nitrogen and carbon dioxide rebreathing. Meeting inspiratory needs and flushing the airway are equally important when attempting to control a patient's FdO2. High-flow-rate therapy can be delivered, for example, through a non-sealed patient interface (e.g., a nasal cannula). High-flow-rate therapy may slow the patient's respiratory rate. High-flow-rate therapy may provide expiratory resistance to the patient.

[0287] High-flow therapy can be used to treat patients with obstructive pulmonary disease (e.g., COPD), bronchiectasis, dyspnea, cystic fibrosis, emphysema, and / or patients with respiratory distress or hypercapnia.

[0288] As used herein, the term "unsealed patient interface" (i.e., an unsealed patient interface) can refer to an interface that provides a pneumatic link between a patient's airway and a flow source (e.g., from flow generator 101) that does not completely obstruct the patient's airway. An unsealed pneumatic link may include obstruction of less than approximately 95% of the patient's airway. An unsealed pneumatic link may include obstruction of less than approximately 90% of the patient's airway. An unsealed pneumatic link may include obstruction between approximately 40% and approximately 80% of the patient's airway. The airway may include one or both of the patient's nostrils and / or their mouth. For nasal intubation, the airway is through the nostrils.

[0289] In some configurations, the respiratory therapy system 100 also includes a catheter 122. The catheter 122 is configured to deliver a gas flow from the flow generator 101 to the patient. In a preferred configuration, the catheter 122 is a patient breathing tube.

[0290] The conduit 122 includes an inner lumen and may include one or more heating wires 123 configured to heat a gas flow within the conduit. The conduit 122, including the heating wires 123, can be used to apply heat to the gas flowing through the conduit. The heat can reduce or eliminate the possibility of water condensation entrained in the gas flow along the wall of the conduit 122. The conduit heater may include one or more resistance wires located in, on, around, or near the wall of the conduit 122. In one or more configurations, such one or more resistance wires may be located outside any gas passage. In one or more configurations, such one or more resistance wires are not in direct contact with the gas flowing through the conduit 122. In one or more configurations, the wall or surface of the conduit 122 lies between the one or more resistance wires and the gas flowing through the conduit 122. In a preferred configuration, the conduit 122 is a heated breathing tube.

[0291] See Figure 6An exemplary respiratory therapy system 100 is shown, which may include a bend 325 configured for connection to a conduit 122 (and, for example, to provide a gas outlet 103). The bend 325 may include one or more sensors.

[0292] To deliver a gas flow from catheter 122 to the patient, the gas through the catheter can be delivered to patient interface 124. Patient interface 124 allows the respiratory therapy system 100 to be pneumatically connected to the patient's airway / airway.

[0293] In the configuration shown, gas travels from humidifier outlet 118 to duct 122.

[0294] The patient interface 124 may include a sealed or unsealed interface and may include a nasal mask, oral mask, oronasal mask, full face mask, nasal pillow mask, nasal tube, endotracheal tube, combination of the above or some other gas delivery system.

[0295] In some configurations, a short-length conduit connects the interface 124 to the catheter 122. In some configurations, the short-length conduit may have smooth orifices, as described elsewhere. For example, a short, flexible-length conduit may connect a nasal cannula or the like to the catheter 122. The short-length conduit connecting the interface to the catheter 122 may be ventilated, allowing steam to pass through the conduit wall. In some configurations, the short-length conduit may be combined with one or more heating wires, as described elsewhere. Smooth orifices, whether heated or not, can improve the efficiency of nebulized material delivery, as described elsewhere herein. Any other suitable patient interface 124 may be used.

[0296] In some configurations, the respiratory therapy system 100 includes a humidifier 112. The humidifier 112 is used to humidify the gas flow directed to the patient. The humidifier 112 is a gas humidifier that encapsulates moisture in the gas to provide a humidified airflow. The illustrated gas humidifier 112 includes a humidifier inlet 116 and a humidifier outlet 118. The gas humidifier 112 may include, and is configured to contain, water or another humidifying or wetting agent (hereinafter referred to as water).

[0297] In some configurations, the gas humidifier 112 includes a heating element. The heating element can be used to heat water in the gas humidifier 112 to promote water evaporation in the gas stream and / or entrain and / or increase the temperature of the gas passing through the gas humidifier 112. In some configurations, the heating element can, for example, heat a resistive metal heating plate, i.e., the heating element is configured to heat the heating plate. However, other heating elements are also conceivable. For example, the heating element may include a plastic conductive heating plate or a chemical heating system with controllable heat output.

[0298] In some configurations, the flow generator 101 and the gas humidifier 112 may share the housing 126. In some configurations, the gas humidifier 112 may share only a portion of the housing 126 with the flow generator 101. Other configurations are also possible.

[0299] Flow generator 101 directs gas through gas outlet 104. In some configurations, flow generator 101 directs gas through connecting conduit 110. In the configuration shown, connecting conduit 110 directs the gas to gas humidifier 112.

[0300] exist Figure 5 In the illustrated configuration, the respiratory therapy device 200 includes a humidifier with an integrated flow generator. In other words, in the illustrated configuration, the housing 202 contains at least a portion of a flow generator (not shown) and a gas humidifier 204. In the illustrated structure, the flow generator and the gas humidifier 204 together form an integrated unit 206. In some configurations, the respiratory therapy system 100 may be a device or system sold by Fisher & Paykel Healthcare under the name AIRVO™ 2. For example, such a device or system is shown and described in U.S. Patent No. 7,111,624, which is incorporated herein by reference in its entirety. In some configurations, the respiratory therapy system 100 may be a device or system sold by Fisher & Paykel Healthcare under the name AIRVO™ 3. For example, such a device or system is shown and described in PCT Application No. PCT / IB2016 / 053761, which is incorporated herein by reference in its entirety. Any other suitable configurations described in these applications may be configured using any of the components or configurations described in this specification.

[0301] The gas humidifier 204 in the illustrated integrated unit 206 employs a chamber 210. The chamber 210 can have any suitable configuration, including any configuration shown and / or described in U.S. Patent Nos. 7,146,979 and / or 6,349,722, each of which is incorporated herein by reference in its entirety. The chamber can contain or hold a volume of liquid, such as water, which is used to humidify the gas as it passes through the chamber. In some configurations, the chamber simply defines a location in the system where liquid (e.g., water) is transferred into the gas flow or stream.

[0302] As described above, gas that has already been conditioned (e.g., heated and / or humidified) within system 100 can be delivered to the patient or other user. In some configurations, a tube or conduit 122 is used to deliver the gas to the patient or other user. Some examples of tubes or conduits that may be used with integrated unit 206 include, but are not limited to, those shown and described in U.S. Patent Publication Nos. 2014 / 0202462A1 (also disclosed as WO2012 / 164407A1) and WO2014 / 088430, each of which is incorporated herein by reference in its entirety. Any other suitable tubes or conduits may also be used.

[0303] In some configurations, the respiratory therapy system 100 may include one or more sensors for detecting various properties of gases within the respiratory therapy system 100 (including pressure, flow rate, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, and / or carbon dioxide concentration), one or more sensors for detecting various properties of the patient or the patient's health (including heart rate, respiratory rate, EEG signal, EKG / ECG signal, blood oxygen concentration, blood CO2 concentration, and blood glucose), and / or one or more sensors for detecting various properties of gases or other objects outside the respiratory therapy system 100 (including ambient temperature and / or ambient humidity). One or more of these sensors may be used to assist in controlling components of the respiratory therapy system 100 (including the gas humidifier 112) using a closed-loop or open-loop control system (this can be achieved by using the aforementioned controller).

[0304] refer to Figure 2 The operating sensors 3a, 3b, 3c (e.g., flow, temperature, humidity, and / or pressure sensors) can be placed in different locations within the respiratory therapy system 100. Additional sensors (e.g., sensors 20, 25) can be placed in different locations on the catheter 122 and / or patient interface 124 (e.g., temperature sensor 29 may be present at or near the end of the inspiratory tube).

[0305] For further reference Figure 3 The diagram illustrates a sensing circuit board 2200 that can be implemented in a respiratory therapy system 100. The sensing circuit board 2200 can be positioned within a sensor chamber such that it is at least partially immersed in a gas flow. The gas flow can exit the flow generator through a conduit and enter a flow path within the sensor chamber. At least some sensors on the sensing circuit board 2200 can be positioned within the gas flow (as indicated by arrow 2203) to measure the gas characteristics within the flow. After passing through the flow path in the sensor chamber, the gas can exit to the aforementioned humidifier 112.

[0306] The sensing circuit board 2200 may be a printed sensing circuit board (PCB). Alternatively, the circuitry on board 2200 may be constructed using wires connecting electronic components, rather than being printed on a circuit board. At least a portion of the sensing circuit board 2200 may be mounted external to the gas flow. The gas flow may be generated by the flow generator 101 described above. The sensing circuit board 2200 may include an ultrasonic transducer 2204. The sensing circuit board 2200 may include one or more thermistors 2205. The thermistors 2205 may be configured to measure the temperature of the gas flow. The sensing circuit board 2200 may include a thermistor flow rate sensor 2206. The sensing circuit board 2200 may include other types of sensors, such as humidity sensors (including humidity-only sensors used with a separate temperature sensor and combined humidity and temperature sensors), sensors for measuring atmospheric pressure, sensors for measuring differential pressure, and / or sensors for measuring gauge pressure. The thermistor flow rate sensor 2206 may include a hot-wire anemometer, such as a platinum wire, and / or a thermistor, such as a negative temperature coefficient (NTC) or positive temperature coefficient (PTC) thermistor. Other non-limiting examples of heated temperature sensing elements include glass- or epoxy-encapsulated or unencapsulated thermistors. The thermistor flow rate sensor 2206 may be configured to measure the gas flow rate by being supplied with a constant power, or by being maintained at a constant temperature or a constant temperature difference between the sensor and the gas flow.

[0307] Positioning one or more of the thermistor 2205 and / or thermistor flow sensor 2206 downstream of the combined flow generator and mixer means that the sensor readings will depend on the heat supplied to the gas flow by the flow generator. Furthermore, immersing at least a portion of the sensing circuit board and the sensor in the flow path can increase measurement accuracy. Sensors immersed in the flow are more likely to experience the same conditions, such as temperature and pressure, as the gas flow, compared to unimmersed sensors. Therefore, these immersed sensors can provide a better representation of the gas flow characteristics.

[0308] The sensing circuit board 2200 may include an ultrasonic transducer, transceiver, or other sensor to measure characteristics of a gas flow, such as the gas composition or concentration of one or more gases within the gas flow. It is understood that any suitable transducer, transceiver, or sensor can be mounted on the sensing circuit board 2200. In this configuration, the gas composition sensor is an ultrasonic transducer that uses ultrasound or sound waves to determine the gas concentration.

[0309] Examples of flow therapy devices are disclosed in international application No. PCT / NZ2016 / 050193, filed on December 2, 2016, entitled “Flow Path Sensing for Flow Therapy Apparatus,” and international application No. PCT / IB2016 / 053761, filed on June 24, 2016, entitled “Breathing Assistance Apparatus,” which are incorporated herein by reference in their entirety.

[0310] 2. Atomizing substances

[0311] In a preferred configuration, the respiratory therapy system 100 is configured to receive nebulized material and introduce it into the patient's gas flow. In some configurations, the respiratory therapy system 100 includes a port configured to be in fluid communication with a conduit for receiving the nebulized material and introducing it into the gas flow.

[0312] Nebulized material is typically in the form of small aerosol / spray particles that can be carried by a gas stream to be delivered to the patient. The nebulized material may be mixed, combined, or otherwise carried with the gas stream delivered to the patient. The nebulized material can be either “particles” or “droplets,” i.e., atomized solids or liquids, respectively, and the terms particles and droplets are used interchangeably as nebulized material introduced into the system.

[0313] In the illustrated configuration, and as shown above, the respiratory therapy system 100 can operate as follows: Gas is drawn into the flow generator 101 through the gas inlet 102 as the impeller of the blower 106 is rotated by the motor. The gas is expelled from the gas outlet 104 and passes through the connecting conduit 110. The gas enters the gas humidifier 112 through the humidifier inlet 116. Once in the gas humidifier 112, the gas entrains moisture as it passes over or near the water in the gas humidifier 112. The water is heated by a heating element, which helps to humidify and / or heat the gas passing through the gas humidifier 112. The gas leaves the gas humidifier 112 through the humidifier outlet 118 and enters the conduit 122. Before entering the conduit 122, the gas flow receives (and entrains) one or more substances from the nebulizer 128. The gas flow is directed from the conduit 122 to the patient interface 124, where the gas flow is introduced into the patient's airway to aid in the treatment of respiratory distress.

[0314] In some configurations, a sufficient amount of atomized material delivered to the patient via a gas stream travels to a desired target location in the patient's respiratory tract or airway. The particle size of the atomized material can affect the material's travel, dispersion, and / or deposition behavior in the patient's respiratory tract or airway. "Particle size" can refer to the average size of the material's particles, as quantified by various measurements or parameters, such as the mass median aerodynamic diameter (MMAD).

[0315] Typically, a gas stream carrying nebulized material with a small average particle size may travel a considerable distance into a patient's respiratory tract or airway before being dispersed or deposited on its surface. The particle size of the nebulized material can also affect the deposition and retention of the material in the respiratory tract (i.e., how effectively the particles of the material remain dispersed or deposited in the respiratory tract or airway). However, if the particle size is too small, a proportion of the delivered material may not deposit (or remain deposited) in the patient's airway and may instead be exhaled by the patient. Depending on various factors—including the composition of the nebulized material and the condition of the patient being treated—it may be desirable that: a) as much material as possible is deposited or dispersed in the patient's respiratory tract, or b) some material is exhaled or partially exhaled from the patient's respiratory tract. Therefore, it is expected that clinicians can control the average particle size of the nebulized material delivered in a respiratory therapy system.

[0316] In some configurations, the respiratory therapy system 100 controls at least one component to adjust the particle size of the nebulized material. The respiratory therapy system 100 controls system parameters, such as adjusting the power supplied to the heating wires in the breathing tubing and / or the blower fan speed (more examples are provided below), by controlling specific components within the system. Controlling these internal or built-in components can provide a more direct influence on the particle size of the nebulized material in the gas flow path, closer to patient reception. Particle size adjustment in these configurations does not occur outside the system, for example, through the nebulizer itself. Controlling, for example, the humidity within the system to adjust the particle size of the nebulized material differs from and can be added to any particle size adjustment that may occur upstream of the respiratory therapy system, for example, before chamber 210. The advantage of controlling the humidity of the nebulized material in the system and thus controlling the particle size is that the material can be controlled more directly, predictably, and / or more measurably closer to patient delivery (i.e., particle control / adjustment occurs downstream of the chamber and closer to the end of the system's flow path / closer to the patient end of the system).

[0317] In one or more configurations, controller 113 is configured to adjust the power supplied to components in the system to adjust the average particle size of the atomized material to a target. In some of these configurations, adjusting the power delivered to the components in the system, in turn, affects the heat supplied to the gas flow in the system at different points in the flow path, such as the heat applied to the water in the chamber of the humidifier or the heat applied to the gas flow in the duct.

[0318] In some configurations, the adjustment of the average particle size of the atomized material can also be achieved through a controller method that alters one or more built-in functions that affect the relative humidity of the gas flow provided to the patient. This controller method may include controlling any number of dynamically controllable features, such as impeller or pump speed, to alter the air / gas flow rate; controlling the degree of valve opening, orifice, or other restrictions; controlling the air-water contact area and residence time in the humidifier chamber or other areas of the system (via features such as baffles and / or other means of creating tortuous flow paths); controlling additional heating or cooling elements in the system; and / or the length of conduits within the system.

[0319] When nebulized material is introduced into the respiratory therapy system 100, particles are suspended and / or carried in the gas stream. The average particle size can affect how far the material is carried into the patient's airway by the gas stream, thus affecting the distance traveled. The relatively larger particle sizes of these nebulized materials (e.g., average particle size ≥1 µm MMAD) tend to deposit in the upper respiratory tract (e.g., the oronasal passage), while smaller droplet sizes in the moist gas stream (e.g., average particle size <1 µm MMAD) can travel further into the airway. In a preferred configuration, the average particle size can be adjusted within the system 100 because particle size is affected by factors within the system.

[0320] In some configurations, controlling the particle size of the atomized material can be achieved, at least in part, by adjusting the relative humidity of the humidifying gas delivered to the patient. In some respiratory therapy systems with humidified breathing gases, it may be desirable for the control system to maintain a relative humidity of 100% (i.e., to fully saturate the gas flow, thereby mimicking natural humidification performed by the patient's airway). However, at at least some flow rates, and for some atomized materials, at 100% relative humidity, the particle size will be larger than desired (e.g., >1.0 μm) to disperse or deposit the material at a specific depth in the patient's airway. Therefore, in a preferred configuration, the respiratory therapy system 100 controls components of the system to influence humidity, thereby achieving a target relative humidity below 100%.

[0321] It is anticipated that controlling the components of the respiratory therapy system 100 to influence the relative humidity of the gas flow (i.e., to influence the average particle size of the nebulized material) in the manner described will help increase the likelihood of a sufficient amount of nebulized material reaching the desired location for dispersion or deposition in the patient's airway. The control of the components in the respiratory therapy system 100 for achieving the target relative humidity will be described in more detail later.

[0322] In some configurations, the controller 113 is configured to at least regulate the power supplied to the heating wire 123 to adjust the average particle size of the atomized material to or towards a target, i.e., to adjust the power to achieve a target particle size. In some of these configurations, the target average particle size is based on the desired travel distance into the patient's airway. If the desired location of dispersion or deposition of the atomized material further or deeper into the airway, the desired travel distance of the atomized material particles is greater than if the desired location does not enter the patient's airway as far.

[0323] In some configurations, the desired travel distance can be designed to ensure that dispersion or deposition occurs primarily in or around the patient's upper respiratory tract. In these configurations, the travel distance of the nebulized material particles is shorter than if the desired travel distance were designed to ensure that dispersion or deposition occurs primarily in the lower respiratory tract.

[0324] In other configurations, the desired travel distance is used primarily for dispersion or deposition outside the patient's upper respiratory tract. In these configurations, the travel distance of the nebulized material particles is greater than the travel distance if the desired travel distance were to reach areas within the upper respiratory tract. To achieve this (i.e., to allow a sufficient amount of nebulized material particles to travel a greater distance to reach deeper areas of the patient's airway), the average particle size of the nebulized material particles is smaller in some configurations than if the desired travel distance were to reach areas within or around the patient's upper respiratory tract. In summary, in some configurations, the target average particle size is relatively larger when the desired travel distance is used for dispersion or deposition within or around the patient's upper respiratory tract than the target average particle size is when the desired travel distance is used for dispersion or deposition within or around the patient's lower respiratory tract.

[0325] In some configurations, the desired travel distance is for dispersion or deposition in or around the patient's lower respiratory tract.

[0326] In some configurations, the target average particle size (of the atomized material delivered to the patient via a gas stream) is a median mass aerodynamic diameter (MMAD) of <1.0 μm (micrometers).

[0327] In some configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.5 μm and 1.0 μm.

[0328] In other configurations, the target average particle size is the median mass aerodynamic diameter (MMAD) of <0.5 μm.

[0329] In other configurations, the target average particle size is the mass median aerodynamic diameter (MMAD) between 0.1 μm and 0.5 μm.

[0330] The expected target average particle size can vary depending on the specific nebulized material being delivered. Therefore, the specific controls of the system delivering the nebulized material to the desired location in the patient's airway will vary. The hygroscopic properties of the material, such as its hygroscopicity—how easily it will clump with water vapor suspended in the gas stream—can also affect how large the particle size becomes. Highly hygroscopic materials may tend to absorb more water vapor from the humidified gas stream, resulting in larger particle sizes, while weakly hygroscopic or even non-hygroscopic materials may have the opposite tendency, with particles absorbing no or just as much water vapor. Therefore, weakly hygroscopic or non-hygroscopic materials may maintain the same size or smaller than highly hygroscopic materials. That is, when dispensed from the nebulizer, weakly hygroscopic or non-hygroscopic materials may maintain approximately the same size. As another example, specific materials with different dew points, heat capacities, and evaporation properties may require their own specific settings or modes. Factors that may affect the required control settings include, but are not limited to, mixtures of different concentrations of oxygen in the airflow, different nebulizer substances (e.g., pharmaceuticals or other drugs), and concentrations (e.g., the osmotic concentration or osmotic pressure of a particular solution of the nebulized substance).

[0331] The nebulized substance introduced into the gas stream can be a pharmaceutical substance. Other examples of nebulized substances that can be introduced into the gas stream include: mannitol, lactated Ringer's solution, 5.0% glucose aqueous solution, Hartmann's solution, sodium lactate solution, and compound sodium lactate. The substance is introduced into system 100 and can be carried by the gas stream and then delivered to the patient's airway or respiratory tract along with the exhaled gas.

[0332] In some configurations, introducing nebulized material into the gas stream delivered to the patient can improve the treatment of respiratory diseases or conditions.

[0333] See also Figure 1 In some configurations, the nebulizer 128 can be used in conjunction with the respiratory therapy system 100. The nebulizer 128 can be independent of the respiratory therapy system 100 or form part of the respiratory therapy system 100.

[0334] Atomizer 128 produces a fine spray of liquid, i.e., an aerosol of particles. The atomized material is introduced into a regulated or pre-regulated gas stream. Any suitable atomizer 128 can be used.

[0335] In some configurations, the port for distributing the atomized material into the gas flow path for the atomizer is located downstream of the flow generator 101. In these configurations, the atomized material is carried by the gas flow from the flow generator 101.

[0336] In some configurations, the port for the nebulizer is located at the humidifier 112. In these configurations, the nebulizing material is added to the humidified gas stream to be delivered to the patient. In some configurations, the port for the nebulizer is located at or towards the inlet 116 or outlet 118 of the humidifier 112. In some configurations, the port for the nebulizer is located at or towards the outlet of the humidifier. In some configurations, the port for the nebulizer is located downstream of the humidifier.

[0337] In some configurations, the port for the nebulizer is located upstream of the device end of the conduit 122 (patient breathing tube) of the respiratory therapy device. In other configurations, the port for the nebulizer is located at or towards the device end of the conduit. In these configurations, the atomized material introduced into the gas flow forms part of the gas mixture flow upon its entry into the conduit, such that adjustment of the power of the heating wire 123 in the conduit can affect the particle size of the atomized material. In some configurations, the port for the nebulizer is located on or within the conduit. In other configurations, the port for the nebulizer is located at any or different locations along the conduit. For example, the port for the nebulizer may be located on or within the conduit, approximately one-third of the distance from the device end, or half the distance from the device end, or two-thirds of the distance from the device end. In other configurations, the port for the nebulizer is located at or towards the device end of the conduit.

[0338] In some configurations, the conduit 122 has a length greater than 0.5 meters. In some configurations, the conduit has a length greater than 1 meter. In some configurations, the conduit has a length greater than 1.5 meters. In some configurations, the length of the conduit 122 is sufficient to allow for adjustment of the power of the heating wire 123 to influence the relative humidity within the conduit, thereby adjusting the average particle size of the atomized material to or towards the target particle size. In some configurations, the aforementioned control is sufficient to influence the relative humidity in the system to adjust the average particle size of the atomized material to the target particle size.

[0339] In some configurations, multiple components of the respiratory therapy system can be housed together. For example, two or more of the flow generator 101, gas humidifier 112, and nebulizer 128 can share a housing 126.

[0340] In some configurations, the nebulizer 128 is separate from the housing 126. In these configurations, the nebulizer 128 may be connected to a portion of a gas passage extending between the flow generator 101 (which may include a gas inlet 102) and the patient interface 124, although other arrangements for the nebulizer 128 or another nebulizer may be used.

[0341] In some configurations, the nebulizer 128 is not positioned in-line between the humidifier outlet 118 and the patient interface 124. Instead, the nebulizer 128 may be located upstream of the humidifier outlet 118 or upstream of the inlet of the conduit 122. In some configurations, the nebulizer 128 may be positioned upstream of the inlet to the humidifier. In some configurations, the nebulizer 128 may be positioned between the airflow source and the humidifier chamber.

[0342] In some configurations, the location or orientation of the nebulizer port defines the flow path of the nebulized material. This flow path may include all or some of the device outlet, elbow, humidification chamber, catheter, and / or patient interface.

[0343] exist Figure 5 In the illustrated configuration, the outlet 129 of the nebulizer 128 is positioned to connect to the chamber 210 to introduce nebulized material. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into a regulated gas flow downstream of the chamber 210 and upstream of the catheter 122 connecting the patient interface 124 to the integration unit 206. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into a regulated gas flow downstream of the chamber 210 and upstream of the connection point of the detachable catheter 122 to the integration unit 206. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into the gas flow before entering the chamber 210. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into the gas flow during entry into the chamber 210. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into the gas flow after entering the chamber 210. In some configurations, the atomizer 128 is configured and positioned to inject atomized material into the gas stream before it exits from chamber 210. In some configurations, the atomizer 128 is configured and positioned to inject atomized material into the gas stream during exit from chamber 210. In some configurations, the atomizer 128 is configured and positioned to inject atomized material into the gas stream after it has exited chamber 210.

[0344] In some configurations, the port is set to receive the nebulizer indirectly. The respiratory therapy system may have a connector configured to connect to the port at one opening and to receive the nebulizer at another opening. In these configurations, the nebulizer is not directly connected to the port because a connector or transmitter for connection exists between the nebulizer and the port.

[0345] The atomizer 128 can be connected to this portion of the gas channel via a connector or transmitter 130, which may include a conduit or adapter. Alternatively, the atomizer 128 can be connected directly to the gas channel, which would eliminate the need for the transmitter 130.

[0346] 3. Controller

[0347] In some configurations, the operation of the flow generator 101, the gas humidifier 112, or other components or aspects of the respiratory therapy system 100 can be controlled by the controller 113. The controller may include a microprocessor, dedicated circuitry such as an ASIC or FPGA, or other suitable devices. The controller may be located within or on top of the flow generator 101, the gas humidifier 112, or other components of the respiratory therapy system 100, or on a remote computing device that communicates remotely with the respiratory therapy system 100. In some configurations, multiple controllers may be used.

[0348] See Figure 2 In such a configuration, the respiratory therapy system 100 can control the operation of the system's components, including but not limited to: adjusting the power of the heating wire 123 delivered to the heated breathing tube (to adjust the temperature in the heated breathing tube), and the power of the heating element 25 delivered to the humidifier (to adjust the heating of the water in the humidifier).

[0349] In some configurations, controller 113 regulates the power supplied to heating wire 123 of conduit 122 to adjust the average particle size of the nebulized material toward a target. For example, in some configurations, the temperature within conduit 122 downstream of nebulizer 128 (when connected to respiratory therapy system 100) can be controlled toward a target or toward a target to adjust the relative humidity of the gas flow within the conduit toward a target.

[0350] The relative humidity of the humidified gas delivered to the patient can be dynamically controlled by the respiratory therapy system 100 by raising or lowering the temperature of the heating conduit 122 relative to the heating element 25 of the humidifier (e.g., by adjusting the power delivered to the heating wire). For example, increasing the temperature of the heating conduit 122 and / or decreasing the power supplied to the heating element 25 will reduce the relative humidity of the humidified gas delivered to the patient. A reduction in the relative humidity of the gas delivered to the patient can be achieved when a sufficient temperature difference exists between the temperature at the humidifier outlet and the temperature at the patient (e.g., as measured by a patient-end temperature sensor located in the conduit). A sufficient temperature difference can be approximately 5 degrees Celsius. Smaller or larger temperature differences are also suitable. It should be understood that adjusting the power of the heating wire delivered to the heating conduit 122 allows for faster changes in relative humidity and therefore allows for faster changes in the average particle size of the atomized material in the conduit 122. By adjusting the power delivered to the heating element of the humidifier, adjusting the power delivered to the heating wire can be faster than heating water in the heating chamber. The desired humidity can be achieved by controlling one or both of the power delivered to the heating line or heating element 25 of the humidifier.

[0351] When controlling a respiratory therapy system with humidification, it is generally preferred to control the power delivered to the heating wires and heating elements in series in order to maintain 100% relative humidity and a certain absolute humidity (e.g., 44 mg / L). Conversely, in a preferred configuration of this respiratory therapy system 100, the controller 113 may increase the power delivered to the heating wires of the heating conduit 122 relative to the heating element 25 of the humidifier (i.e., not in series), thereby resulting in a decrease in relative humidity and a reduction in the average particle size of the atomized material.

[0352] In some configurations, after the atomizer 128 is installed and the atomized material is dispensed, the power of the heating wire 123 delivered to the heating conduit 122 can be controlled to achieve a relative humidity target. In some configurations, the power of the heating wire 123 in the conduit 122 can be controlled to achieve a relative humidity target before the atomizer 128 begins atomizing the material into the gas stream.

[0353] In some configurations, controller 113 adjusts the power supplied to the heating element 25 of the humidifier to adjust the average particle size of the atomized material toward a target. It should be understood that adjusting the power of the heating element 25 will have a slower effect on the temperature of the gas flow (due to the thermal inertia of the humidifier heater plate and the water stored in the humidification chamber), and therefore the relative humidity will change more gradually in response to the power adjustment. As noted, this is because of the thermal inertia of the heater plate and the water in the humidification chamber—cooling or heating a relatively large volume of water can take a relatively long time.

[0354] In some configurations, the controller controls the power supplied to the heating wire and the power delivered to the heating element to achieve the target average particle size.

[0355] In some configurations, the temperature of the heating element 25 and / or the conduit 122 (or a temperature-related parameter, such as the duty cycle of the heating / control signal) can be maintained for a predetermined period of time (or, for example, a period of time as a function of flow rate). Such a configuration can help address thermal inertia in the system while protecting the atomized material from overheating and / or potential thermal damage that could impair its efficacy.

[0356] In some configurations, controller 113 can control the power supplied to heating wire 123 to conduit 122 independently of controlling the power supplied to heating element 25 of the humidifier, in order to regulate the average particle size. For example, there may be two separate control loops for each component. In some configurations, heating wire 123 may not be strictly coordinated or synchronized with the heating element, which itself may be controlled to achieve an absolute humidity target or setpoint. In some configurations, heating wire 123 is controlled to heat the gas flow in conduit 122, thereby achieving a relative humidity target or setpoint. That is, the control loop for heating wire 123 may be independent of the control loop for the heating element of the humidifier. In these configurations, heating wire 123 can be controlled independently of the heating element of the humidifier to achieve a certain relative humidity, thereby achieving the desired average particle size of the substance atomized into or incorporated into the gas flow delivered to the patient.

[0357] The particle size of the atomized material can also be affected by other parameters of the gas flow in the system—for example, when the flow is turbulent (which may happen once the flow reaches the patient, for example, flowing towards the nose), the particles may be more likely to coalesce or agglomerate, thus increasing their size.

[0358] In some configurations, the system includes a standard treatment mode and a nebulizer treatment mode. The standard treatment mode is one in which the system operates when no nebulized material is added to or introduced into the humidifying gas stream.

[0359] In some configurations, in the nebulizer therapy mode, the controller 113 targets a lower relative humidity for the gas stream than the target relative humidity in the standard therapy mode. In the nebulizer therapy mode, the power delivered to the component can be increased based on the desired average particle size, resulting in lower relative humidity. In some of these configurations, the standard therapy mode may target approximately 100% relative humidity, while the nebulizer therapy mode may target less than 100% relative humidity.

[0360] In some configurations, the target relative humidity in the nebulizer mode is less than 80%. In other configurations, the target relative humidity in the nebulizer mode is less than 60%.

[0361] In some configurations, the power supplied to the heating wire in nebulizer mode is higher than that supplied in standard treatment mode.

[0362] In some configurations, users can manually switch between standard treatment mode and nebulizer treatment mode. These modes can be adjusted via the user interface on the device.

[0363] In some configurations, the target relative humidity can be configured by the user (e.g., a clinician) in nebulizer mode. This can be direct (e.g., the user selects a desired dew point temperature) or indirect, where the user selects a desired particle size and / or composition (e.g., saline solution concentration). In some configurations, user interface features (e.g., touchscreen elements) for manually adjusting the target average particle size become interactive after entering nebulizer mode.

[0364] In some configurations, the system is configured to automatically control the power delivered to the heating wire to achieve a default target average particle size (e.g., when in nebulizer therapy mode).

[0365] In some configurations, the system will automatically control the power delivered to the heating element to achieve a default target average particle size. In some configurations, this default target average particle size is <1.0 μm.

[0366] In some configurations, during nebulizer therapy, the gas flow rate can be within a set range. This set range can be between approximately 30 L / min and approximately 50 L / min, but other flow rates are also suitable. In some configurations, the controller is configured to adjust the blower speed. In some configurations, the blower speed is adjusted to provide a gas flow rate within the set range. The blower speed is adjusted so that the gas flow rate is within the set range.

[0367] In some configurations, the gas flow rate can be higher or lower than a set flow rate range. When the nebulizer therapy mode is activated, the blower speed can be adjusted to provide a gas flow rate within the set flow rate range.

[0368] In some configurations, the gas flow rate range can be higher than a set flow rate range. When the nebulizer mode is activated, the controller is configured to reduce the blower speed to provide a gas flow rate range within the set flow rate range. Optionally, the controller is configured to reduce the blower speed to provide the gas flow rate range in the upper region of the set flow rate range. For example, if the gas flow rate is 60 L / min and the set flow rate range is between approximately 30 L / min and approximately 50 L / min, then when the nebulizer mode is activated, the gas flow rate can be reduced to approximately 50 L / min.

[0369] In some configurations, the gas flow rate range can be lower than a set flow rate range. When the nebulizer mode is activated, the controller is configured to increase the blower speed to provide a gas flow rate range within the set flow rate range. Optionally, the controller is configured to increase the blower speed to provide the gas flow rate range in the upper region of the set flow rate range. For example, if the gas flow rate is 20 L / min and the set flow rate range is between approximately 30 L / min and 50 L / min, then when the nebulizer mode is activated, the gas flow rate can be increased to approximately 30 L / min.

[0370] The gas flow rate is limited to a set range to reduce the likelihood and / or volume of nebulized material deposited in the flow path. For example, at higher flow rates, a larger volume of nebulized material can be deposited in the flow path, and less material reaches the patient. In nebulization therapy modes, it may be desirable to reduce the gas flow rate to a relatively low level. Reducing the gas flow rate to a relatively low level can facilitate the delivery of nebulized material to the patient / user's airway. For example, a relatively low flow rate could be between approximately 10 L / min and approximately 30 L / min, but other flow rates may also be appropriate.

[0371] In some configurations, the humidifier is set to trigger or generate an alarm when the nebulizer therapy mode is activated and the gas flow rate is above or below a set flow rate range. In some configurations, the nebulizer therapy mode is activated for a set time period. In some configurations, the humidifier is set to trigger or generate an alarm when the nebulizer therapy mode is activated for a period longer than the set time period.

[0372] 4. Relative humidity

[0373] It should be understood that the particle size of the nebulized material is affected by many factors within the respiratory therapy system 100.

[0374] For example, the relative humidity in conduit 122 can affect the particle size of the atomized material (e.g., MMAD). In this system, relative humidity can be considered as the percentage of water vapor in the gas mixture relative to the maximum amount it can retain at a given temperature. Absolute humidity, on the other hand, is the actual or absolute amount (i.e., quantity) of water vapor carried in the gas stream in the system, regardless of the temperature of the gas stream (e.g., mg / L, in milligrams of water per liter of gas).

[0375] Adjusting the relative humidity in the respiratory therapy system 100 can affect the particle size of the atomized material because the atomized particles tend to absorb water (if the particles are relatively dry) and then absorb water (if the particles are relatively wet), becoming larger in the process.

[0376] In humidified respiratory therapy, the desired relative humidity is typically controlled as close to 100% as possible to mimic natural humidification from the upper respiratory tract. However, it has been found that water vapor particles can coalesce with particles of the nebulized material to form larger particles, leading to increased MMAD (as described above), and thus the material may not travel into the respiratory tract as desired and / or in sufficient quantity. Therefore, it may be desirable to lower the saturation (i.e., relative humidity) of the humidifying gas stream to a lower target to influence the particle size of the nebulized material and, consequently, the distance the nebulized material travels into the patient's respiratory tract. In fact, lowering the relative humidity can cause an increase in the evaporation effect, leading to the desorption of water from the nebulized material particles, and thus resulting in a decrease in MMAD.

[0377] In some configurations, the target relative humidity is approximately 80%. In other configurations, the target relative humidity is less than 80%. For some atomized substances, a relative humidity of approximately 80% or lower will maintain the average particle size of the atomized substance at or below 1.0 μm. In some configurations, such parameters will be sufficient to allow the atomized substance to travel to at least the upper respiratory tract.

[0378] In some configurations, the target relative humidity is approximately 60%. In other configurations, the target relative humidity is less than 60%. For some atomized substances, a relative humidity of approximately 60% or lower will maintain the average particle size of the atomized substance at or below 0.5 μm. In some configurations, such parameters will be sufficient to allow the atomized substance to travel into the lower respiratory tract.

[0379] Different relative humidity targets may be required for different nebulized substances being delivered. Therefore, specific control parameters of the system selected for delivering the nebulized substance to the desired location in the patient's airway will vary. For example, a clinician or other suitable person may specify the type and / or concentration of the active substance to be introduced as the nebulized substance into the solution of system 100. Controller 113 can regulate the relative humidity of the gas stream carrying the nebulized substance by correspondingly maintaining or adjusting settings for one or more components. Higher concentrations of active substances generally require a greater reduction in relative humidity to adjust the particle size to the desired target, such as MMAD < 1.0 μm, for passage through upper and proximal airway channels, while lower concentrations may require only a smaller reduction in relative humidity.

[0380] In some configurations, the nebulized material introduced into the respiratory therapy system 100 comprises different solution components, and the desired average particle size can be maintained by adjusting the relative humidity. If the composition of the material changes during respiratory therapy—for example, due to a clinician increasing or decreasing the dosage of the medication—the system can adjust the target relative humidity to maintain the desired average particle size. If a change in the composition of the material results in the current relative humidity leading to an undesirable large average particle size (at the current setting), the system can, for example, reduce the relative humidity after the clinician interacts with the system's controls (e.g., via a user interface), and vice versa.

[0381] It should be understood that in some of these configurations, the user does not need to wait for the absolute humidity of the gas stream to decrease or increase after the atomized material is regulated (by cooling or heating the water in the humidifier). Clinicians or other users can specify to the system that the particle size needs to be reduced or increased, and the system can accordingly control components such as heating wires to quickly regulate the relative humidity. Therefore, in these configurations, the workflow for clinicians or other users can be considerably more direct and / or faster.

[0382] refer to Figure 8A and Figure 8B The test results confirmed the correlation between the relative humidity of the atomized material, air temperature, and MMAD in the system. It can be seen that when the air temperature deviates from the dew point (and therefore the relative humidity decreases), the MMAD of the atomized particles suspended in the gas stream decreases. Figure 8A and Figure 8BThe figure shows the MMAD of atomized particles under a range of carrier gas conditions at gas flow rates of 20 L / min and 40 L / min. The average particle size is largely unaffected by these flow rate differences. However, at much lower flow rates (e.g., 2–3 L / min), the atomized particles spend a significantly longer time in the humidified gas stream, which can promote and allow for greater particle size growth, i.e., through adsorption of water vapor and other mechanisms. The figure also shows that the concentration of the brine solution in the atomizing solution (representative of other atomizing formulations in this case) can have a significant effect on the MMAD of atomized particles suspended in the gas stream. As mentioned above, relative humidity is affected by increasing or decreasing the gas stream temperature. Alternatively, absolute humidity (AH) can be reduced, for example, by increasing the flow rate to reduce the residence time of the gas through the chamber and / or reducing the power supplied to the heater plate to reduce the degree to which the water is heated. The opposite can be done to increase absolute humidity, thereby increasing relative humidity. Higher flow rates will reduce the residence time of the gas in the heated breathing tube, which may lower the temperature of the gas received by the patient (if the power to the heated breathing tube is not increased accordingly). Furthermore, the concentration of substances in the nebulized solution (e.g., how much NaCl or drug is relative to water) will affect the MMAD of the granules, but this is an external selection and generally depends on what the patient is deemed to need. In summary, the key physical variables that can affect the MMAD of the granules are temperature, absolute humidity, and the nebulized drug formulation.

[0383] As the graphs show, when the substance is a 0.9% sodium chloride (NaCl) aqueous solution, higher relative humidity may be suitable for a specific desired MMAD, while at higher NaCl concentrations (7.0%), the MMAD is much higher at the same relative humidity. As mentioned above, higher concentrations of atomized material solutions generally require a greater reduction in relative humidity to adjust the particle size to the desired target compared to lower concentrations, where only a smaller reduction in relative humidity may be needed to achieve the desired particle size.

[0384] In a preferred configuration, the controller 113 in the system adjusts settings based on a desired average particle size (e.g., MMAD), such as the power supplied to the heating wire 123 of the catheter or the power of the heating element 25. Adjusting these settings can regulate and, in some configurations, reduce the relative humidity of the humidified air in the catheter 122, which will reduce the size of the particles in the gas stream to the desired average size, thereby allowing the atomized material particles to travel the desired distance into the patient's airway.

[0385] In a preferred configuration, controller 113 controls the system components to achieve a target relative humidity (which regulates the particle size of the atomized material, as discussed). The target relative humidity can be specific to a region of the system. In some configurations, the target relative humidity is the relative humidity of the flowing gas in catheter 122. In some configurations, the target relative humidity is the relative humidity of the flowing gas at the patient end of the catheter. The target relative humidity at the patient end can be adjusted and achieved after the gas flow has been heated along the length of catheter 122 through the flow channel.

[0386] In some configurations, controller 113 controls the power supplied to the heating wire to achieve a target relative humidity. In some configurations, the controller continuously controls the power supplied to the heating wire to maintain the target relative humidity. The power supplied to the heating wire can be adjusted by changing the duty cycle of the pulse width modulation (PWM) signal supplied to the heating wire and / or changing the voltage amplitude of the DC voltage supplied to the heating wire.

[0387] 5. User control interface

[0388] In some configurations, the respiratory therapy system 100 may include a user control interface. The user control interface 108 may include one or more buttons, knobs, dials, switches, levers, touchscreens, speakers, displays, and / or other input or output modules that a user can use to input commands to the flow generator 101, view data, and / or control the operation of the flow generator 101, and / or control other aspects of the respiratory therapy system 100. In some configurations, the system may have multiple user control interfaces 108, 120 at different locations within the system 100, such as... Figure 1 As shown.

[0389] In some configurations, the user control interface includes a user control interface element for adjusting the target average particle size.

[0390] In some configurations, the user control interface includes user control interface elements for adjusting the target travel distance into the patient's airway.

[0391] In some configurations, the user control interface includes user control interface elements for selecting standard treatment modes and nebulizer treatment modes.

[0392] In some configurations, the operation of components of the respiratory therapy system 100 can be wirelessly controlled using a user control interface located on a remote computing device, which may be a tablet computer, mobile phone, personal digital assistant, or other computing device.

[0393] 6. How to use

[0394] In some configurations, the respiratory therapy system 100 can be set up as follows. The steps can be performed in any suitable order; therefore, the following are merely examples of possible sequences.

[0395] In some configurations, the respiratory therapy system 100 can be used with a nebulizer 128 and a catheter 122 to provide any desired treatment that can be performed using the combination of components. In some configurations, a nasal cannula (patient interface 124) is connected to the catheter and provides high-flow nasal therapy while dispensing a substance (e.g., saline solution or medication) into the gas stream via the nebulizer. The advantage of using high-flow therapy while dispensing a substance is that the high-flow-rate gas propels the atomized particles within the gas into the patient's airway. The high flow rate can increase the likelihood and / or volume of atomized material depositing in and / or further into the patient's airway. Other configurations and methods are also possible.

[0396] refer to Figure 7 The diagram illustrates the steps involved in using the method. Different configurations may include one or more of these steps.

[0397] In some configurations, the user selects the desired particle size of the atomized material on a user control interface. This selection can be made, for example, via actuated physical elements (e.g., sliders, buttons, etc.) or digital interface elements (i.e., a touchscreen). The selected particle size can be a particle size with a specific desired MMAD (Mean Momentum Optimization Ability), or in other configurations, by selecting a specific particle size mode (e.g., small, regular, large particle size mode). Alternatively, the user may be able to select the desired deposition or dispersion area. In some configurations, other modes can be detected or selected, such as the type of patient interface connected. Modes detected by the system or selected by the user can trigger predetermined controls (e.g., power delivery to components of the system) to regulate relative humidity, which in turn regulates the average particle size of the delivered atomized material, and this average particle size then affects the delivery of the atomized material to the patient.

[0398] In a preferred configuration, once input is provided, the power supplied to the heating wire of the catheter and the power delivered to the heating element of the humidifier and / or other components of system 100 are adjusted based on the desired particle size, the desired deposition or dispersion area in the patient, the type of patient interface, or other parameters. For example, clinicians may want different desired MMADs, desired dispersion, or deposition areas based on the type of patient interface used (e.g., nasal cannula, mask, oral interface, or tracheostomy interface). Reducing the relative humidity of the humidified air in catheter 122 reduces the size of the liquid particles to the desired MMAD, thereby allowing the atomized material particles or droplets to travel the desired distance into the patient's airway (a greater distance than if the relative humidity were higher). Alternatively, increasing the relative humidity of the humidified air in catheter 122 increases the size of the liquid particles to the desired MMAD, thereby allowing the atomized material particles or droplets to travel the desired distance into the patient's airway (a shorter distance than if the relative humidity were lower).

[0399] 7. General description of respiratory therapy equipment

[0400] In some configurations, a respiratory therapy device 200 is provided for delivering a gas stream to a patient. The respiratory therapy device 200 includes a flow generator 101 configured to generate a gas stream; a humidifier 112 including a heating element 25; a port configured to be in fluid communication with a conduit 122; and a controller 113. The port is configured to receive and introduce atomized material into the gas stream flowing toward the patient. The controller 113 is configured to regulate the power delivered to at least the heating element 25 to adjust the average particle size of the atomized material toward or towards a target.

[0401] In some configurations, the device is configured to be fluidly connected to catheter 122. Catheter 122 may be configured to deliver a gas flow from flow generator 101 to the patient. Catheter 122 may include an inner lumen and a heating wire 123 configured to heat the gas flow in catheter 122.

[0402] In some configurations, controller 113 is configured to regulate the power delivered to heating wire 123 to adjust the average particle size of the atomized material to a target. Controller 113 can control both the power delivered to heating wire 123 and the power delivered to heating element 25 to achieve the target average particle size. Controller 113 can control the power delivered to heating wire 123 independently of the power delivered to heating element 25 to regulate the average particle size. Controller 113 can control the power delivered to heating element 25 and / or heating wire 123 to achieve a target relative humidity. Controller 113 can continuously control the power delivered to heating element 25 and / or heating wire 123 to maintain the target relative humidity.

[0403] In some configurations, the target relative humidity is the relative humidity of the flowing gas in catheter 122. The target relative humidity may be the relative humidity of the flowing gas at the patient end of catheter 122. In some configurations, the target relative humidity may be approximately 80%. In other configurations, the target relative humidity may be less than 80%. In other configurations, the target relative humidity may be approximately 60%. In other configurations, the target relative humidity is less than 60%. It should be understood that in some of these configurations, the percentage of target relative humidity is illustrative, and other target relative humidityes may be appropriate.

[0404] In some configurations, the target average particle size may be based on the expected distance traveled into the patient's airway. In some configurations, the expected distance may be for dispersion within or around the patient's upper airway. In other configurations, the expected distance may be for dispersion outside the patient's upper airway. In still other configurations, the expected distance may be for dispersion within or around the patient's lower airway.

[0405] In some configurations, the target mean particle size is relatively smaller when the desired travel distance is dispersed in or around the patient's upper respiratory tract than when the desired travel distance is dispersed in or around the patient's lower respiratory tract. In some configurations, the target mean particle size can be a median mass aerodynamic diameter (MMAD) of <1.0 micrometer. In other configurations, the target mean particle size is a median mass aerodynamic diameter (MMAD) between 0.5 and 1.0 micrometers. In other configurations, the target mean particle size is a median aerodynamic diameter (MMAD) of <0.5 micrometers. In some configurations, the target mean particle size can be a median mass aerodynamic diameter (MMAD) between 0.1 and 0.5 micrometers. It should be understood that in some of these configurations, the median mass aerodynamic diameter (MMAD) of the target mean particle size is merely an example, and other diameters may be suitable.

[0406] In some configurations, the heating element 25 is a heating plate.

[0407] In some configurations, the port for atomizer 128 is located downstream of flow generator 101. In other configurations, the port for atomizer 128 is located at humidifier 112. In other configurations, the port for atomizer 128 is located at or towards the inlet or outlet of humidifier 112. In other configurations, the port for atomizer 128 is located at or towards the outlet of humidifier 112. In other configurations, the port for atomizer 128 is located upstream of the device end of conduit 122. In other configurations, the port for atomizer 128 is located at or towards the device end of conduit 122. It should be understood that the locations of the ports for atomizer 128 in some of these configurations are examples, and other locations for the ports for atomizer 128 are also suitable.

[0408] In some configurations, the port is configured to indirectly receive the nebulizer 128. In other configurations, the respiratory therapy device 200 also includes a mount or connector configured to connect to the port at one opening. The mount or connector can be used to receive the nebulizer 128 at another opening. It should be understood that in some of these configurations, the target relative humidity is merely an example, and other target relative humidityes may be suitable. In other configurations, the port may be configured to connect to the nebulizer 128, which introduces atomized material into the gas stream.

[0409] In some configurations, the respiratory therapy device 200 includes a standard treatment mode and a nebulization treatment mode. The nebulization treatment mode may include a target relative humidity that is lower than the target relative humidity in the standard treatment mode. The power delivered to the heating wire 123 in the nebulization treatment mode may be higher than the power delivered in the standard treatment mode.

[0410] In some configurations, the standard treatment mode may include a target relative humidity of approximately 100%, and the nebulizer treatment mode may include a target relative humidity of less than 100%. In other configurations, the target relative humidity in the nebulizer treatment mode is less than 80%. In still other configurations, the target relative humidity in the nebulizer treatment mode is less than 60%. It should be understood that the target relative humidity in some of these configurations is illustrative, and other target relative humidity levels may be appropriate.

[0411] In some configurations, users can manually switch between standard treatment mode and nebulizer treatment mode. Once in nebulizer treatment mode, features for manually adjusting the target average particle size become available.

[0412] In some configurations, the device is set to automatically control the power to the heating wire 123 to achieve the default target average particle size.

[0413] In some configurations, the device is set to automatically control the power to the heating element 25 to achieve a default target average particle size. The default target average particle size can be <1.0 micrometer.

[0414] In some configurations, the respiratory therapy device 200 also includes a user control interface. The user control interface includes user control interface elements for adjusting the target average particle size. The user control interface may include user control interface elements for adjusting the target travel distance into the patient's airway. In other configurations, the user control interface may include user control interface elements for selecting a standard treatment mode and a nebulization treatment mode. In other configurations, the user control interface includes a touchscreen interface. In other configurations, the user control interface includes a mechanical interface with physical elements, said physical elements being one or a combination of sliders, dials, and buttons.

[0415] In some configurations, a respiratory therapy system 100 for delivering a gas stream to a patient is provided. The respiratory therapy system includes a blower 106, a humidifier 112 including a heating element 25, and a conduit 122 in fluid communication with the humidifier 112. The humidifier 112 is in fluid communication with the blower 106 and configured to humidify the gas. The conduit 122 is configured to guide the flow of gas from the humidifier 112 to the patient / user. The conduit 122 includes a heating wire 123 within it. The respiratory therapy system 100 also includes a port fluidly coupled to the humidifier 112 and the conduit 122. The port is adapted to introduce atomized material into the gas stream. The respiratory therapy system 100 also includes a controller 113 operatively coupled to the heating element 25, the heating wire 123, and the blower 106. The controller 113 is configured to: adjust the speed of the blower 106 to provide a gas flow at a target velocity, adjust the power of the heating element 25 and / or the heating wire 123, and control the particle size of the atomized material within a target size range.

[0416] In some configurations, a respiratory therapy system 100 for delivering a gas stream to a patient is provided. The respiratory therapy system includes a blower 106 and a humidifier in fluid communication with the blower 106. The humidifier is configured to regulate the humidity of the gas stream. The respiratory therapy system 100 also includes a gas path defined between the blower 106 and the patient. The gas path includes the humidifier and a port adapted to receive atomized material. The respiratory therapy system 100 also includes a controller 113 operatively coupled to the blower 106 and the humidifier. The controller 113 is configured to regulate the speed of the blower 106 to provide a gas stream at a set flow rate and to regulate the humidity output of the humidifier to control the particle size of the atomized material.

[0417] In some configurations, the humidification device includes a humidifier 112 with a heater plate.

[0418] In some configurations, the humidifier includes a conduit 122 with a heating wire 123.

[0419] In some configurations, the system includes a nebulizer mode. In nebulizer mode, the humidity of the gas stream from humidifier 112 can be reduced for a set time period or while the system is in nebulizer mode. In some configurations, in nebulizer mode, the power supplied to the heater plate and / or the temperature setpoint of the heater plate is reduced to lower the absolute humidity. In other configurations, the power supplied to the heating wire 123 of conduit 122 is increased to lower the relative humidity.

[0420] In some configurations, during nebulizer therapy mode, the humidifier is configured to generate an alarm when the humidity of the gas stream exceeds the permissible absolute or relative humidity.

[0421] In some configurations, the gas flow rate in nebulizer mode is within a set range. In some configurations, the set flow rate range can be between approximately 30 L / min and 50 L / min.

[0422] In some configurations, when the nebulizer mode is activated, the controller 113 is configured to adjust the speed of the blower 106 to provide a gas flow rate range within a set flow rate range. In other configurations, when the nebulizer mode is activated and the gas flow rate is higher than the set flow rate range, the controller 113 is configured to reduce the speed of the blower 106 to provide a gas flow rate range within the set flow rate range. Optionally, the speed of the blower 106 will be reduced to provide a gas flow rate range in the upper region of the set flow rate range. In other configurations, when the nebulizer mode is activated and the gas flow rate is lower than the set flow rate range, the controller 113 is configured to increase the speed of the blower 106 to provide a gas flow rate range within the set flow rate range. Optionally, the speed of the blower 106 will be increased to provide a gas flow rate range in the lower region of the set flow rate range.

[0423] In some configurations, the humidifier is set to trigger an alarm when the nebulizer therapy mode is activated and the gas flow rate is above or below a set range. The nebulizer therapy mode can be activated for a set period of time. In other configurations, the humidifier is set to trigger an alarm when the nebulizer therapy mode is activated for a period longer than a set period. When the nebulizer therapy mode is activated, the patient or user limits the particle size range.

[0424] In some configurations, the breathing device is set to change relative and / or absolute humidity to a specific range to control the particle size of the atomized material. By adjusting the relative and / or absolute humidity, the particle size of the atomized material can be controlled to or towards a specific size range.

[0425] In some configurations, the respiratory therapy system 100 is configured to provide high-flow therapy. In other configurations, the respiratory therapy system 100 is configured to provide high-flow nasal therapy with nebulized material.

[0426] The respiratory therapy device 200 may have any one or more of the features and / or functions described herein.

[0427] The respiratory therapy device 200 may be provided as a stand-alone device. Alternatively, the respiratory therapy device 200 may be provided as part of or used in a respiratory therapy system 100, which has the respiratory therapy device 200 and one or more of the following components: catheter 122, patient interface 124, nebulizer 128, or one or more other components described herein.

[0428] Unless the context clearly requires otherwise, throughout the specification and claims, the terms “comprise”, “comprising”, etc., shall be interpreted as inclusive, meaning “including but not limited to”, contrary to the meaning of exclusion or exhaustive.

[0429] In the preceding description, reference has been made to the whole or parts having their known equivalents, which are incorporated herein as if described separately.

[0430] The disclosed methods, apparatus and systems may also be broadly described as including any or all combinations of the parts, elements or features mentioned or indicated individually or jointly in this disclosure as any or all combinations of two or more of the said parts, elements or features.

[0431] Any reference to prior art in this specification is not and should not be construed as an admission or suggestion of any kind that such prior art forms part of the common general knowledge in any country of the world.

[0432] Unless otherwise stated herein, the enumeration of numerical ranges herein is intended only as a shorthand method for individually referring to each individual value falling within that range, and each individual value is incorporated into this disclosure as if it were individually enumerated herein. Furthermore, each subrange of values ​​within a range is incorporated into this disclosure as if it were individually described herein.

[0433] While this disclosure has been described with reference to certain embodiments, other embodiments that will be apparent to those skilled in the art are also within the scope of this disclosure. Therefore, various changes and modifications can be made without departing from the spirit and scope of this disclosure. For example, various components may be repositioned as needed. Furthermore, not all features, aspects, and advantages are necessary for practicing this disclosure. Therefore, the scope of this disclosure is intended to be defined solely by the appended claims.

Claims

1. A respiratory therapy system for delivering a gas stream to a patient, comprising: A flow generator configured to generate the gas flow; A catheter configured to deliver the gas flow from the flow generator to the patient, the catheter including an inner lumen and a heating wire configured to heat the gas flow in the catheter; A port configured to be in fluid communication with the catheter and for receiving atomized material and introducing the atomized material into a gas stream delivered to the patient; as well as A controller is configured to adjust the power delivered to at least the heating wire to adjust the average particle size of the atomized material to a target or toward a target.

2. The respiratory therapy system of claim 1, wherein the controller controls the power delivered to the heating wire to achieve a target relative humidity of the gas flow.

3. The respiratory therapy system of claim 1, wherein the controller continuously controls the power delivered to the heating wire to maintain the target relative humidity of the gas flow.

4. The respiratory therapy system according to claim 2 or 3, wherein the target relative humidity is the relative humidity of the gas flow in the conduit.

5. The respiratory therapy system of claim 4, wherein the target relative humidity is the relative humidity of the gas flow at the patient end of the catheter.

6. The respiratory therapy system according to claim 2 or 3, wherein the target relative humidity is approximately 80%.

7. The respiratory therapy system according to claim 2 or 3, wherein the target relative humidity is less than 80%.

8. The respiratory therapy system according to claim 2 or 3, wherein the target relative humidity is approximately 60%.

9. The respiratory therapy system of claim 7, wherein the target relative humidity is less than 60%.

10. The respiratory therapy system of claim 1, wherein the target average particle size is based on a desired travel distance into the patient's airway, wherein the desired travel distance is intended to disperse the particles in or around the patient's upper airway, or outside the patient's upper airway; or in or around the patient's lower airway.

11. The respiratory therapy system of claim 1 or 10, wherein the target average particle size is relatively larger when the desired travel distance is dispersed in or around the patient's upper respiratory tract than when the desired travel distance is dispersed in or around the patient's lower respiratory tract.

12. The respiratory therapy system according to claim 1 or 10, wherein the target average particle size is <1.0 micrometer, or between 0.5 micrometer and 1.0 micrometer, or <0.5 micrometer, or between 0.1 micrometer and 0.5 micrometer.

13. The respiratory therapy system according to claim 1 or 10 further includes a humidifier, the humidifier including a heating element.

14. The respiratory therapy system of claim 1 or 10, wherein the controller is configured to adjust the power delivered to the heating element to adjust the average particle size of the atomized material to a target or toward a target.

15. The respiratory therapy system of claim 1 or 10, wherein the controller controls both the power delivered to the heating wire and the power delivered to the heating element to achieve a target average particle size.

16. The respiratory therapy system of claim 15, wherein the controller controls the power delivered to the heating wire independently of the power delivered to the heating element to adjust the average particle size.

17. The respiratory therapy system according to claim 1 or 10, wherein the port for the nebulizer is located downstream of the flow generator or at the humidifier.

18. The respiratory therapy system according to claim 1 or 10 further includes a user control interface.

19. The respiratory therapy system of claim 18, wherein the user control interface includes a user control interface element for adjusting a target average particle size or for adjusting a target travel distance into the patient's airway.

20. The respiratory therapy system according to claim 1 or 10, wherein the user control interface includes a touch screen interface or a mechanical interface, the mechanical interface having physical elements, the physical elements being one or a combination of a slider, a dial pad, and a button.

21. The respiratory therapy system according to claim 1 or 10, wherein the catheter has a length greater than 0.5 meters, greater than 1 meter, or greater than 1.5 meters.

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