CN120752067A

CN120752067A - Respiratory therapy system

Info

Publication number: CN120752067A
Application number: CN202380092839.XA
Authority: CN
Inventors: S·塔特科夫; S·J·R·凯利
Original assignee: Fisher and Paykel Healthcare Ltd
Current assignee: Fisher and Paykel Healthcare Ltd
Priority date: 2022-12-05
Filing date: 2023-12-04
Publication date: 2025-10-03
Also published as: AU2023391577A1; JP2025540206A; EP4630087A1; WO2024121700A1

Abstract

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

Description

Respiratory therapy system

Technical Field

The present disclosure relates generally to a respiratory therapy system for delivering a flow of gas to a patient. More particularly, the present disclosure relates to a respiratory therapy system that adjusts the average particle size of an aerosolized substance introduced into the system.

Background

Respiratory therapy devices or systems for delivering a flow of gas may be used to improve ventilation of a patient. Such devices or systems may be used to improve patient comfort and/or improve prognosis of respiratory disease in a patient.

In some systems, the respiratory therapy system may be configured to receive nebulized material, e.g., from a nebulizer. For example, a nebulizer may be used to deliver a pharmaceutical substance to the airway of a patient while delivering respiratory gases to the airway of the patient. In some cases, the respiratory therapy system receives an aerosolized substance that is then carried by the flow of gas through the respiratory conduit and output into the airway of the patient via the patient interface.

However, the efficiency of the delivery of the nebulized substance may not be as desired, for example when the nebulized substance sticks 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 airway of the patient, or a sufficient amount of substance does not advance as far into the airway of the patient as desired.

It is therefore an object of the present invention to provide a respiratory therapy apparatus or system which overcomes or at least partially ameliorates some of the above disadvantages or which at least provides the public with a useful choice.

Disclosure of Invention

In accordance with certain features, aspects, and advantages of at least one embodiment disclosed herein, a respiratory therapy system for delivering a flow of gas to a patient is disclosed, the respiratory therapy system for delivering a flow of gas to a patient comprising:

a flow generator configured to deliver the flow of gas to the patient;

A conduit configured for delivering the flow of gas from the flow generator to the patient, the conduit comprising a lumen and a heater wire configured for heating the flow of gas in the conduit;

a port configured in fluid communication with the conduit for receiving an atomized material and introducing the atomized material into a flow of gas to the patient, and

A controller configured to regulate at least the power delivered to the heater wire to regulate the average particle size of the atomized material to a target.

In some configurations, power is delivered to the heater wire to achieve a target relative humidity.

In some configurations, the controller continuously controls the power delivered to the heater wire to maintain the target relative humidity.

In some configurations, the target relative humidity is the relative humidity of the flowing gas in the conduit.

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

In some configurations, the target relative humidity is about 80%.

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

In some configurations, the target relative humidity is about 60%.

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

In some configurations, the target average particle size is based on a desired distance of travel into the patient's respiratory tract.

In some configurations, the desired travel distance is for dispersion in or around the upper respiratory tract of the patient.

In some configurations, the desired travel distance is for dispersion outside the upper respiratory tract of the patient.

In some configurations, the desired travel distance is for dispersion in or around the lower respiratory tract of the patient.

In some configurations, the target average particle size is relatively greater when the desired travel distance is dispersed in or around the upper respiratory tract of the patient than when the desired travel distance is dispersed in or around the lower respiratory tract of the patient.

In some configurations, the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) of <1.0 μm.

In some configurations, the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) between 0.5 μm and <1.0 μm.

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

In some configurations, the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) between 0.1 μm and 0.5 μm.

In some configurations, the respiratory therapy system further includes a humidifier including a heating element.

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 a target.

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

In some configurations, the controller controls the power delivered to the heater wire independently of the power delivered to the heating element to adjust the average particle size.

In some configurations, the heating element is a heating plate.

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

In some configurations, the port for the nebulizer is located at the humidifier.

In some configurations, the port for the nebulizer is located at or towards the inlet or outlet of the humidifier.

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 upstream of the device end of the conduit.

In some configurations, the port for the nebulizer is located at or towards the device end of the catheter.

In some configurations, the port is configured to indirectly receive the nebulizer.

In some configurations, the respiratory therapy system further includes a connector configured to connect to the port at one opening and to receive the nebulizer at the other opening.

In some configurations, the respiratory therapy system further includes a nebulizer configured to be connected at the port, the nebulizer introducing the nebulized substance into the flow of gas.

In some configurations, the system includes a standard treatment mode and an aerosolized treatment mode.

In some configurations, the nebulized treatment mode includes a target relative humidity that is lower than a target relative humidity in the standard treatment mode.

In some configurations, the power delivered to the heater wire in the nebulized treatment mode is higher than the power delivered in the standard treatment mode.

In some configurations, the standard treatment mode includes a target relative humidity of about 100%, and the nebulized treatment mode includes a target relative humidity of less than 100%.

In some configurations, the target relative humidity in the nebulized treatment mode is less than 80%.

In some configurations, the target relative humidity in the nebulized treatment mode is less than 60%.

In some configurations, the user may manually adjust between the standard treatment mode and the nebulized treatment mode.

In some configurations, after entering the aerosolized treatment mode, features for manually adjusting the target average particle size become available.

In some configurations, the system is configured to automatically control power to the heater wire to achieve a default target average particle size.

In some configurations, the system is configured to automatically control power to the heating element to achieve a default target average particle size.

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

In some configurations, the respiratory therapy system further comprises a user control interface.

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

In some configurations, the user control interface includes a user control interface element for adjusting a target travel distance into the patient's respiratory tract.

In some configurations, the user control interface includes a user control interface element for selecting a standard treatment mode and an aerosolized treatment mode.

In some configurations, the user control interface includes a touch screen interface.

In some configurations, the user control interface includes a mechanical interface having a physical element that is one of a slider, a dial, a button, or a combination thereof.

In some configurations, the catheter comprises a length greater than 0.5 meters.

In some configurations, the conduit comprises a length greater than 1 meter.

In some configurations, the conduit comprises a length greater than 1.5 meters.

In accordance with certain features, aspects, and advantages of at least one embodiment disclosed herein, a method for delivering a flow of gas to a patient is disclosed, the method for delivering a flow of gas to a patient comprising:

There is provided a respiratory therapy apparatus, the apparatus comprising:

-a flow generator configured to deliver the gas flow to the patient;

-a conduit configured for delivering the gas flow from the flow generator to the patient, the conduit comprising a lumen and a heating wire configured for heating the gas flow in the conduit;

introducing an atomized material into a gas stream of a patient, and

The power delivered to the heater wire is adjusted to adjust the average particle size of the atomized material to the target.

In some configurations, the method further comprises adjusting the power delivered to the heater wire to achieve a target relative humidity.

In some configurations, the method further comprises continuously controlling the power delivered to the heater wire to maintain the target relative humidity.

In some configurations, the target relative humidity is about 80%.

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

In some configurations, the target relative humidity is about 60%.

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

In some configurations, the target average particle size is relatively smaller when the desired travel distance is dispersed in or around the upper respiratory tract of the patient than when the desired travel distance is dispersed in or around the lower respiratory tract of the patient.

In some configurations, the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) between 0.5 μm and 1.0 μm.

In some configurations, the method further comprises providing a humidifier comprising a heating element.

In some configurations, the method further comprises adjusting the power delivered to the heating element to adjust the average particle size of the atomized material to a target.

In some configurations, the method further comprises controlling both the power delivered to the heater wire and the power delivered to the heating element to achieve the target average particle size.

In some configurations, the method further comprises controlling the power delivered to the heater wire independently of the power delivered to the heating element to adjust the average particle size.

In some configurations, the method further comprises connecting a nebulizer at the port, the nebulizer introducing the nebulized substance into the gas stream.

In some configurations, the method further comprises indirectly connecting the nebulizer to the port via a mount/connector.

In some configurations, the method further comprises adjusting the power of the heater wire such that the nebulized treatment mode reaches a target relative humidity that is lower than the target relative humidity in the standard treatment mode.

In some configurations, the method further comprises delivering higher power to the heater wire in the nebulized treatment mode than in the standard treatment mode.

In some configurations, the method further comprises adjusting the power to the heater wire to achieve a target relative humidity wherein the standard treatment mode comprises about 100% and the nebulized treatment mode comprises less than 100%.

In some configurations, the method further comprises manually adjusting between a standard treatment mode and an aerosolized treatment mode.

In some configurations, the method further comprises automatically controlling power to the heater wire to achieve a default target average particle size.

In some configurations, the method further comprises automatically controlling power to the heating element to achieve a default target average particle size.

In some configurations, the method further comprises adjusting the target average particle size.

In some configurations, the method further comprises adjusting a target travel distance of the nebulized material into the respiratory tract of the patient.

In some configurations, the method further comprises selecting a standard treatment mode and an aerosolized treatment mode on the user-control interface element.

a flow generator configured to deliver the flow of gas to the patient;

A humidifier including a heating element;

A controller configured to regulate at least the power delivered to the heating element to regulate the average particle size of the atomized material to a target.

In some configurations, the respiratory therapy system further includes a conduit configured to deliver the flow of gas from the flow generator to the patient, the conduit including a lumen and a heater wire configured to heat the flow of gas in the conduit.

In some configurations, the controller is configured to adjust the power delivered to the heater wire to adjust the average particle size of the atomized material to a target.

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

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

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

In some configurations, the target relative humidity is about 80%.

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

In some configurations, the target relative humidity is about 60%.

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

In some configurations, the heating element is a heating plate.

In some configurations, the respiratory therapy system further includes a mount/connector configured for connection to the port at one opening and for receiving the nebulizer at the other opening.

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

In some configurations, the conduit comprises a length greater than 1 meter.

In some configurations, the conduit comprises a length greater than 1.5 meters.

There is provided a respiratory therapy apparatus, the apparatus comprising:

-a flow generator configured to deliver the gas flow to the patient;

-a humidifier comprising a heating element;

introducing an atomized material into a gas stream of a patient, and

The power delivered to the heating element is adjusted to adjust the average particle size of the atomized material to the target.

a flow generator configured to deliver the flow of gas to the patient;

A controller for adjusting the power delivered to components in the system to adjust the average particle size of the atomized material to a target;

wherein the system comprises a standard treatment mode and an aerosolized treatment mode, and

Wherein the nebulized treatment mode comprises a target relative humidity that is lower than the target relative humidity in the standard treatment mode.

In some configurations, the respiratory therapy system further includes increasing the temperature of the gas flow relative to the dew point such that the relative humidity is reduced in the nebulized therapy mode.

In some configurations, the heating element is a heating plate.

a flow generator configured to deliver the flow of gas to the patient;

Wherein the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) of <1.0 μm.

In some configurations, the respiratory therapy system further includes increasing the temperature of the gas stream relative to the dew point such that the relative humidity is reduced to achieve the target average particle size.

In some configurations, the heating element is a heating plate.

a flow generator configured to deliver the flow of gas to the patient;

An atomizer in fluid communication with the conduit for introducing an atomized substance into a flow of gas to the patient, an

A controller configured to adjust the power delivered to components in the system to adjust the average particle size of the atomized material to a target.

In some configurations, the heating element is a heating plate.

In accordance with certain features, aspects, and advantages of at least one of the embodiments disclosed but not claimed herein, a method for delivering a flow of gas to a patient is disclosed, the method for delivering a flow of gas to a patient comprising:

There is provided a respiratory therapy apparatus, the apparatus comprising:

A flow generator configured to generate the gas flow;

introducing an atomized material into a gas stream flowing to a patient, and

In some configurations, the method further comprises adjusting the power delivered to the heater wire to achieve a target relative humidity of the gas stream.

In some configurations, the method further includes continuously controlling the power delivered to the heater wire to maintain a target relative humidity of the gas stream.

In accordance with certain features, aspects, and advantages of at least one of the embodiments disclosed but not claimed herein, a respiratory therapy system for delivering a flow of gas to a patient is disclosed, the respiratory therapy system for delivering a flow of gas to a patient comprising:

A flow generator configured to generate the gas flow;

A humidifier including a heating element;

a port configured to be in fluid communication with the conduit and configured to receive the nebulized material and introduce the nebulized material into a flow of gas to the patient, and

A controller configured to regulate at least the power delivered to the heating element to regulate the average particle size of the atomized material to or towards a target.

There is provided a respiratory therapy apparatus comprising:

A flow generator configured to generate the gas flow;

A humidifier including a heating element;

introducing an atomized material into a gas stream flowing to a patient, and

The power delivered to the heating element is adjusted to adjust the average particle size of the atomized material to or towards the target.

A flow generator configured to generate the gas flow;

a port configured in fluid communication for receiving an atomized material and introducing the atomized material into a flow of gas to the patient, and

A controller for adjusting the power delivered to components in the system to adjust the average particle size of the atomized material to or towards a target;

Wherein the nebulized treatment mode comprises a lower relative humidity than in the standard treatment mode.

A flow generator configured to generate the gas flow;

A port configured to be in fluid communication or receive an atomized material and introduce the atomized material into a flow of gas to the patient, and

Wherein the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) of <1.0 microns.

According to certain features, aspects, and advantages of at least one of the embodiments disclosed but not claimed herein, a respiratory therapy system for delivering a flow of gas to a patient, the respiratory therapy system for delivering a flow of gas to a patient comprising:

A flow generator configured to generate the gas flow;

An atomizer in fluid communication with the conduit for introducing an atomized substance into a flow of gas flowing to the patient, an

According to certain features, aspects, and advantages of at least one of the embodiments disclosed but not claimed herein, a respiratory therapy apparatus for delivering a flow of gas to a patient, the respiratory therapy apparatus for delivering a flow of gas to a patient comprising:

A flow generator configured to generate the gas flow;

A humidifier including a heating element;

a port configured to be in fluid communication with a conduit, the port configured to receive an aerosolized substance and introduce the aerosolized substance into a flow of gas to the patient, and

In some configurations, the device is configured for fluid connection to a conduit configured for delivering the flow of gas from the flow generator to the patient, the conduit comprising an inner lumen and a heater wire configured for heating the flow of gas in the conduit.

In some configurations, the respiratory therapy device further includes a mount/connector configured for connection to the port at one opening and for receiving the nebulizer at the other opening.

In some configurations, the port is configured to connect to a nebulizer that introduces the nebulized substance into the stream of gas.

In some configurations, the device includes a standard treatment mode and an aerosolized treatment mode.

In some configurations, the apparatus is configured to automatically control power to the heater wire to achieve a default target average particle size.

In some configurations, the apparatus is configured to automatically control power to the heating element to achieve a default target average particle size.

In some configurations, the respiratory therapy apparatus further comprises a user control interface.

The term "comprising" as used in this specification means "including, at least in part. When interpreting each expression of the term "comprising" in this specification, there may also be features other than those prefaced by that term. Related terms such as "comprise" and "include" will be interpreted in the same manner.

The application may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or features, and where specific integers are mentioned herein which have known equivalents in the art to which the application relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

The present invention includes the foregoing, and also contemplates configurations that are given below only as examples.

It should be understood that alternative embodiments may include any or all combinations of two or more of the parts, elements or features or configurations shown, described or referred to in this specification.

Drawings

Specific embodiments of the invention and modifications thereof will become apparent to those skilled in the art by reference to the following detailed description, taken in conjunction with the accompanying drawings, in which:

Fig. 1 shows a schematic diagram of a respiratory therapy system.

Fig. 2 shows another schematic diagram of a respiratory therapy system.

Fig. 3 illustrates a circuit sense plate that may be used in a respiratory therapy system.

Fig. 4 shows a schematic diagram of a respiratory therapy system that receives nebulized material from a nebulizer.

Fig. 5 illustrates a perspective view of a respiratory therapy apparatus for use in a respiratory therapy system configured in accordance with certain features, aspects, and advantages of some of the configurations described.

Fig. 6 shows a perspective view of a respiratory apparatus of a respiratory therapy system.

Fig. 7 shows a flow chart of a method of use and control of a respiratory therapy system.

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

Fig. 8B shows a graph of test results showing the correlation between relative humidity, air temperature and MMAD of nebulized material in respiratory therapy system at a flow rate of 40L/min.

Detailed Description

Although certain examples are described below, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed examples and/or uses and obvious modifications and equivalents thereof. Accordingly, it is intended that the scope of the disclosure herein disclosed should not be limited by any of the particular examples described below.

1. General description of respiratory therapy System

Referring to fig. 1, an exemplary configuration of a respiratory therapy system 100 is shown. Respiratory therapy system 100 delivers a flow of gas to a patient.

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

In some configurations, the flow generator 101 may also include a blower 106. The blower 106 may draw 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 vessel may include a valve that can be adjusted to control the flow of gas exiting the vessel. In some configurations, flow generator 101 may use such a compressed gas source and/or another gas source in place of blower 106. In some configurations, the blower 106 may be used in combination with another gas source. In some configurations, blower 106 may comprise a motorized blower, or may comprise a bellows arrangement or some other structure capable of generating a flow of gas. The blower 106 may operate at a motor speed greater than about 1,000rpm and less than about 8,000RPM, greater than about 2,000rpm and less than about 10,000rpm, or between any of the foregoing values. The blower 106 may mix gases entering the blower 106 through an inlet port (e.g., the ambient air inlet port 102 and/or the oxygen inlet port). The use of blower 106 as a mixer may reduce the pressure drop relative to a system having a separate mixer (e.g., a static mixer that includes baffles).

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

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 that is controlled to provide high flow and/or CPAP therapy. In some configurations, the flow generator 101 is controlled to provide one or more of bi-level pressure therapy, CPAP therapy, or high flow therapy.

In some configurations, the respiratory therapy system 100 measures and controls the oxygen content of the gas delivered to the patient, and thus the oxygen content of the gas inhaled by the patient. Oxygen may 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. The measurement may be made within respiratory therapy device 100, catheter 122, patient interface 124, or at any other suitable location.

The oxygen concentration measured in the device may be equal to the fraction of oxygen delivered (FdO 2) and may be substantially the same as the oxygen concentration of the patient's breath, the fraction of inhaled oxygen (FiO 2), and thus these terms may be considered equivalent.

The flow rates of the at least two gases may also be determined by measuring the oxygen concentration using flow rate sensors on at least two of the ambient air inlet conduit, the oxygen inlet conduit, and the patient breathing conduit. By determining the flow rates of the two inlet gases or one inlet gas and one total flow rate, and assuming or measuring the oxygen concentration of the inlet gas (about 20.9% for ambient air and about 100% for oxygen), the oxygen concentration of the final gas composition can be calculated. Alternatively, flow rate sensors may be placed at all three of the ambient air inlet, oxygen inlet and respiratory conduits to allow redundancy and to test each sensor to function properly by checking the consistency of the readings. Other methods of measuring the oxygen concentration delivered by respiratory therapy system 100 may also be used.

Respiratory therapy system 100 may provide high flow therapy in which the high flow rate of delivered gas meets or exceeds the peak inhalation demand of the patient.

High flow therapy as discussed herein is intended to be given its typical ordinary meaning as understood by those skilled in the art, and generally refers to a respiratory assistance device that delivers a target flow of humidified breathing gas via an intentionally unsealed patient interface at a flow rate generally intended to meet or exceed the flow of the patient's inspiration. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults are generally in the range of about 15 liters/minute to about 60 liters/minute or more, but are not limited thereto. Typical flow rates for pediatric patients (e.g., newborns, infants, and children) generally range from, but are not limited to, about 1 liter/minute/kilogram of patient body weight to about 3 liters/minute/kilogram of patient body weight or more. High flow therapy may also optionally include a gas mixture composition that includes supplemental oxygen and/or administration of a therapeutic agent. High flow therapy is commonly referred to as Nasal High Flow (NHF), humidified High Flow Nasal Cannula (HHFNC), high Flow Nasal Oxygen (HFNO), high Flow Therapy (HFT) or Tracheal High Flow (THF), among other common names.

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

High flow therapy may be effective to achieve or exceed the patient's inspiratory flow, increase the oxygenation of the patient, and/or decrease work of breathing.

High flow therapy may be administered to the nostrils and/or the mouth of the patient, or through a tracheostomy interface.

High flow therapy can create a flushing effect in the nasopharynx such that the anatomical dead space of the upper airway is flushed by the high flow of inlet gas. This may create a reservoir of fresh gas available for each and every breath, while reducing rebreathing of nitrogen and carbon dioxide. It is also important to meet inhalation needs and to flush the airway when attempting to control FdO of the patient. High flow therapy may be delivered, for example, through a non-sealing patient interface (e.g., nasal cannula). High flow therapy may slow the patient's respiratory rate. High flow therapy may provide expiratory resistance to the patient.

High flow therapy may be used to treat patients suffering from obstructive pulmonary disease (e.g., COPD), bronchiectasis, dyspnea, cystic fibrosis, emphysema, and/or patients suffering from respiratory distress or hypercapnia.

The term "unsealed patient interface" (i.e., an unsealed patient interface) as used herein may refer to an interface that provides a pneumatic link between the airway of a patient and an air flow source (e.g., from flow generator 101) that does not completely occlude the airway of the patient. The unsealed pneumatic link may include an occlusion of less than about 95% of the patient's airway. The unsealed pneumatic link may include an occlusion of less than about 90% of the patient's airway. The unsealed pneumatic link may include an obstruction of between about 40% and about 80% of the patient's airway. The airway may include one or both nostrils and/or their mouth of the patient. For nasal cannulae, the airway is through the nostril.

In some configurations, respiratory therapy system 100 further includes a conduit 122. The conduit 122 is configured to deliver a flow of gas from the flow generator 101 to a patient. In a preferred configuration, the conduit 122 is a patient breathing tube.

The conduit 122 includes an inner lumen and may include one or more heater wires 123 configured to heat the gas flow in the conduit. A conduit 122 including a heater wire 123 may be used to add heat to the gas passing through the conduit. The heat may reduce or eliminate the likelihood of water condensation entrained in the gas stream along the walls of conduit 122. The catheter heater may include one or more resistive wires located in, on, around, or near the wall of the catheter 122. In one or more configurations, such one or more resistance wires may be located outside of any gas channel. In one or more configurations, such one or more resistance wires are not in direct contact with the gas passing through conduit 122. In one or more configurations, a wall or surface of the conduit 122 is interposed between the one or more resistance wires and the gas passing through the conduit 122. In a preferred construction, the conduit 122 is a heated breathing tube.

Referring to fig. 6, an exemplary respiratory therapy system 100 is shown that may include an elbow 325 configured for connection to conduit 122 (and, for example, providing a gas outlet 103). The elbow 325 may include one or more sensors.

To deliver a flow of gas from the conduit 122 to a patient, gas passing through the conduit may be delivered to the patient interface 124. The patient interface 124 may pneumatically connect the respiratory therapy system 100 to the respiratory tract/airway of the patient.

In the illustrated configuration, the gas travels from the humidifier outlet 118 to the conduit 122.

Patient interface 124 may include a sealed or unsealed interface, and may include a nasal mask, oral-nasal mask, full face mask, nasal pillow mask, nasal cannula, endotracheal tube, combinations of the above, or some other gas delivery system.

In some configurations, a short length of tubing connects the interface 124 to the conduit 122. In some configurations, the short length of tubing may have smooth holes, as described elsewhere herein. For example, a short flexible length of tubing may connect a nasal cannula or the like to the catheter 122. The short length of tubing connecting the interface to the conduit 122 may be breathable so that it allows vapor to be transported through the tube wall. In some configurations, a short length of tubing may incorporate one or more heater wires, as described elsewhere herein. Smooth pores, whether heated or not, may increase the efficiency of delivering the atomized material, as described elsewhere herein. Any other suitable patient interface 124 may be used.

In some configurations, respiratory therapy system 100 includes humidifier 112. Humidifier 112 is used to humidify the flow of gas to the patient. Humidifier 112 is a gas humidifier that entrains moisture in the gas to provide a humidified gas stream. The illustrated gas humidifier 112 includes a humidifier inlet 116 and a humidifier outlet 118. The gas humidifier 112 may include, be configured to contain or contain water or another humidification or wetting agent (hereinafter referred to as water).

In some configurations, the gas humidifier 112 includes a heating element. The heating element may be used to heat water in the gas humidifier 112 to promote evaporation and/or entrainment of water in the gas stream and/or to increase the temperature of the gas passing through the gas humidifier 112. In some configurations, the heating element may, 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 contemplated. For example, the heating element may comprise a plastic electrically conductive heating plate or a chemical heating system with a controllable heat output.

In some configurations, the flow generator 101 and the gas humidifier 112 may share a 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.

The flow generator 101 directs the gas out through a gas outlet 104. In some configurations, flow generator 101 directs gas out through connecting conduit 110. In the illustrated configuration, the connection conduit 110 directs the gas to a gas humidifier 112.

In the configuration shown in fig. 5, respiratory therapy apparatus 200 includes a humidifier with an integrated flow generator. In other words, in the illustrated configuration, the housing 202 contains a flow generator (not shown) and at least a portion of the gas humidifier 204. In the illustrated construction, the flow generator and the gas humidifier 204 together form an integrated unit 206. In some configurations, respiratory therapy system 100 may be a device or system sold by Fisher & PAYKEL HEALTHCARE under the name AIRVO ^TM. Such a device or system is shown and described, for example, in U.S. patent No. 7,111,624, which is incorporated herein by reference in its entirety. In some configurations, respiratory therapy system 100 may be a device or system sold by Fisher & PAYKEL HEALTHCARE under the name AIRVO ^TM. Such a device or system is shown and described, for example, in PCT application No. PCT/IB2016/053761, which is incorporated herein by reference in its entirety. Any other suitable configuration described in these applications may be configured with any of the components or configurations described in this specification.

The gas humidifier 204 in the illustrated integrated unit 206 employs a chamber 210. The chamber 210 may have any suitable configuration, including any of the configurations shown and/or described in U.S. patent No. 7,146,979 and/or U.S. patent No. 6,349,722, each of which is incorporated by reference in its entirety. The chamber may 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 stream or gas stream.

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

In some configurations, respiratory therapy system 100 may include one or more sensors for detecting various characteristics of the gases in 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 characteristics of the patient or patient's health, including heart rate, respiration rate, EEG signals, EKG/ECG signals, blood oxygen concentration, blood CO2 concentration, and blood glucose, and/or one or more sensors for detecting various characteristics of gases or other objects external to respiratory therapy system 100, including ambient temperature and/or ambient humidity. One or more of these sensors may be used to help control components of respiratory therapy system 100 (including gas humidifier 112) through the use of a closed loop or open loop control system (which may be accomplished through the use of the aforementioned controller).

Referring to fig. 2, the operational sensors 3a, 3b, 3c (e.g., flow, temperature, humidity, and/or pressure sensors) may be placed at different locations in the respiratory therapy system 100. Additional sensors (e.g., sensors 20, 25) may be placed in different locations on the catheter 122 and/or patient interface 124 (e.g., there may be a temperature sensor 29 at or near the end of the inhalation tube).

Referring additionally to fig. 3, a sensing circuit board 2200 that may be implemented in respiratory therapy system 100 is shown. The sensing circuit board 2200 may be positioned in the sensor chamber such that the sensing circuit board 2200 is at least partially submerged in the gas flow. The gas flow may exit the flow generator through a conduit and enter a flow path in the sensor chamber. At least some of the sensors on the sensing circuit board 2200 may be positioned within the gas flow (as indicated by the direction of arrow 2203) to measure a characteristic of the gas within the flow. After passing through the flow path in the sensor chamber, the gas may exit to the humidifier 112 described above.

The sensing circuit board 2200 may be a printed sensing circuit board (PCB). Alternatively, the circuitry on board 2200 may be built with wires that connect the electronic components, rather than being printed on a circuit board. At least a portion of the sensing circuit board 2200 may be mounted outside of 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 thermistor 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 separate temperature sensors 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 can 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 can be configured to measure the flow rate of the gas by being supplied with constant power, or by being maintained at a constant temperature or constant temperature difference between the sensor and the gas flow.

Positioning one or more of the thermistor 2205 and/or thermistor flow rate sensor 2206 downstream of the combined flow generator and mixer means that the sensor reading 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 may increase the accuracy of the measurement. A sensor immersed in a flow is more likely to experience the same conditions as the gas flow, such as temperature and pressure, than an unsubmerged sensor. Thus, these submerged sensors may provide a better representation of the gas flow characteristics.

The sensing circuit board 2200 may include an ultrasonic transducer, transceiver, or other sensor to measure a characteristic of the gas flow, such as a gas composition or concentration of one or more gases within the gas flow. It will be appreciated that any suitable transducer, transceiver, or sensor may be mounted to the sensing circuit board 2200. In this structure, the gas composition sensor is an ultrasonic transducer that uses ultrasonic waves or acoustic waves to determine the concentration of the gas.

Some examples of Flow therapy devices are disclosed in international application No. pct/NZ2016/050193, entitled "Flow path sensing for Flow therapy device (Flow PATH SENSING for Flow Therapy Apparatus)" filed on month 12, and international application No. pct/IB2016/053761, entitled "breathing assistance device (Breathing Assistance Apparatus)" filed on month 6, 24, which are incorporated herein by reference in their entirety.

2. Atomized material

In a preferred configuration, respiratory therapy system 100 is configured to receive nebulized material and introduce it into a flow of gas of a patient. In some configurations, respiratory therapy system 100 includes a port configured to be in fluid communication with a conduit for receiving an aerosolized substance and introducing it into a gas stream.

The nebulized material is typically in the form of small aerosol/spray particles, which can be carried by the gas stream to be delivered to the patient. The nebulized material is mixed, combined, or otherwise carried with the flow of gas delivered to the patient. The atomized material may be "particles" or "droplets", i.e. a solid or a liquid, respectively, which are atomized, and both the terms particles and droplets are used interchangeably as atomized material introduced into the system.

In the illustrated configuration, and as indicated above, respiratory therapy system 100 may operate as follows. As the motor rotates the impeller of the blower 106, gas may be drawn into the flow generator 101 through the gas inlet 102. The gas is pushed out of the gas outlet 104 and through the connecting conduit 110. Gas enters the gas humidifier 112 through a 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 the heating element, which aids in humidifying and/or heating the gas passing through the gas humidifier 112. The gas exits the gas humidifier 112 through the humidifier outlet 118 and enters the conduit 122. The gas stream receives (and entrains) one or more substances from the atomizer 128 prior to entering the conduit 122. The flow of gas is directed from conduit 122 to patient interface 124, where the flow of gas is brought into the airway of the patient to help treat the respiratory disorder.

In some configurations, a sufficient amount of nebulized material delivered to the patient via the gas stream travels to a desired target location in the respiratory tract or airway of the patient. The particle size of the aerosolized substance can affect the travel, dispersion, and/or deposition behavior of the substance in the respiratory tract or airway of the patient. "particle size" may refer to the average size of particles of a substance, as quantified by various measurements or parameters, such as Mass Median Aerodynamic Diameter (MMAD).

In general, a gas stream carrying an aerosolized substance having a smaller average particle size may be able to travel a greater distance into a patient's respiratory tract or airway before being dispersed or deposited on the surface of the respiratory tract or airway. The particle size of the aerosolized material may 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, some proportion of the delivered substance may not deposit (or remain deposited) in the airway of the patient, but rather be exhaled by the patient's breath. Depending on various factors, including the composition of the aerosolized substance and the condition of the patient being treated, it may be desirable for a) as much of the substance to be deposited or dispersed into the patient's respiratory tract, or b) for some substance to exhale or partially exhale from the patient's respiratory tract. Thus, it is desirable for a clinician to be able to control the average size of particles of nebulized material provided in respiratory therapy systems.

In some configurations, respiratory therapy system 100 controls at least one component to adjust the particle size of the aerosolized substance. The respiratory therapy system 100 controls parameters of the system by controlling specific components internal to the system, such as by adjusting the power supplied to the heater wire in the breathing tube conduit and/or blower fan speed (more examples are provided below). Controlling the internal or built-in components of these systems may provide a more direct effect on the particle size of the atomized material in the gas flow path, closer to being received by the patient. The adjustment of the particle size in these structures does not take place outside the system, for example by the atomizer itself. Controlling, for example, the humidity inside the system to adjust the particle size of the nebulized substance is different from and may be in addition to any adjustment of the particle size that may occur upstream of the respiratory therapy system, for example, before the chamber 210. An advantage of controlling the humidity of the nebulized material in the system, and thus the size of the particles, is that the material is controlled more directly, predictably and/or more measurably in the vicinity of delivery to the patient (i.e. the control/adjustment of the particles takes place downstream of the chamber and near the end of the flow path of the system/near the patient end of the system).

In one or more configurations, the controller 113 is configured to adjust the power provided 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 components in the system in turn affects the amount of heat imparted to the gas flow in the system at different points in the flow path, e.g., the amount of heat applied to the water in the chamber of the humidifier or the amount of heat applied to the gas flow in the conduit.

In some configurations, adjustment of the mean particle size of the aerosolized material may also be achieved by a controller method that varies one or more built-in functions that will affect the relative humidity of the gas stream provided to the patient. The controller means may include controlling any number of dynamically controllable features, such as impeller or pump speed, to vary the air/gas flow rate, controlling the opening degree of the valve, orifice or other restriction, controlling the air-water contact area and residence time in the humidifier chamber or other region of the system (by, for example, baffles and/or other means of creating a tortuous flow path), controlling additional heating or cooling elements in the system, and/or the length of conduits within the system.

When the aerosolized substance is introduced into respiratory therapy system 100, the particles are suspended and/or entrained in the gas stream. The average size of the particles can affect how far the substance is carried into the patient's airway by the gas flow, thereby affecting the distance traveled. The relatively larger particle size of these nebulized materials (e.g., average particle size ≡1 μm MMAD) tends to deposit in the upper respiratory tract (e.g., oronasal passage), while the smaller droplet size in the humid gas stream (e.g., average particle size <1 μm MMAD) can travel further into the airway. In a preferred configuration, the average particle size may be adjusted within the system 100, as the particle size is affected by factors within the system.

In some configurations, controlling the particle size of the aerosolized substance can be achieved at least in part by adjusting the relative humidity of the humidified gas delivered to the patient. In some respiratory therapy systems with humidification of respiratory gases, it may be desirable for the control system to aim to maintain the relative humidity at 100% (i.e., to fully saturate the gas flow, thereby mimicking the natural humidification performed by the patient's airway). However, at least at some flow rates, and for some nebulized material, at 100% relative humidity, the particle size will be higher than desired (e.g., >1.0 μm) to disperse or deposit the material at a particular depth in the patient's airway. Thus, in a preferred configuration, respiratory therapy system 100 controls components of the system to affect humidity to achieve a target relative humidity of less than 100%.

It is contemplated that controlling the components of respiratory therapy system 100 to affect the relative humidity of the gas flow (i.e., affect the average particle size of the nebulized material) in the manner described helps to increase the likelihood that a sufficient amount of nebulized material will reach a desired location for dispersion or deposition in the airway of the patient. Control of the components in respiratory therapy system 100 in order to achieve a target relative humidity will be described in more detail later.

In some configurations, the controller 113 is configured to adjust at least the power provided to the heater wire 123 to adjust the average particle size of the atomized material to or toward 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 distance traveled into the patient's airway. If the desired location of dispersion or deposition of the aerosolized substance further or deeper into the airway, the desired distance traveled by the particles of the aerosolized substance is greater than if the desired location was not entered into the airway of the patient.

In some configurations, the desired travel distance may be for the dispersion or deposition to occur primarily in or around the upper respiratory tract of the patient. In these configurations, the travel distance of the atomized material particles is shorter than would be the case if the travel distance were desired such that dispersion or deposition occurred primarily in the lower respiratory tract.

In other configurations, the desired travel distance is used to disperse or deposit primarily outside of the upper respiratory tract of the patient. In these configurations, the distance traveled by the atomized material particles is greater than if the desired distance traveled reached a region in the upper respiratory tract. To achieve this (i.e., to cause a sufficient amount of the aerosolized matter particles to travel a greater distance to reach deeper regions of the airway of the patient), the average particle size of the aerosolized matter particles is in some configurations less than if the desired travel distance is to a region in or around the upper airway of the patient. In summary, in some configurations, the target average particle size when the desired travel distance is for dispersion or deposition in or around the upper respiratory tract of the patient is relatively larger than when the desired travel distance is for dispersion or deposition in or around the lower respiratory tract of the patient.

In some configurations, the desired travel distance is for dispersion or deposition in or around the lower respiratory tract of the patient.

In some configurations, the target average particle size (of the nebulized substance delivered to the patient via the gas stream) is a Mass Median Aerodynamic Diameter (MMAD) of <1.0 μm (micrometers).

In other configurations, the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) of <0.5 μm.

In other configurations, the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) between 0.1 μm and 0.5 μm.

It is contemplated that different target average particle sizes may depend on the particular aerosolized substance being delivered. Thus, the specific control of the system delivering the nebulized material to the desired location in the respiratory tract of the patient will vary. The hygroscopic properties of a substance, such as its hygroscopicity-how easily it will agglomerate with water vapour suspended in the gas stream-can also influence how large the particle size becomes. Highly hygroscopic substances may tend to absorb more water vapor from the humidified gas stream, resulting in a larger particle size, while weakly hygroscopic or even non-hygroscopic substances may have an opposite tendency, the particles not absorbing any or as much water vapor. Thus, the weakly hygroscopic or non-hygroscopic substance maintains the same size as the highly hygroscopic substance or smaller. That is, the weakly hygroscopic or non-hygroscopic substance may remain approximately the same size when dispensed from the nebulizer. As another example, particular substances having different dew points, heat capacities, and evaporation characteristics may require their own particular settings or patterns. Factors that may affect the desired control settings include, but are not limited to, different concentrations of oxygen in the air stream, different nebulizer substances (e.g., drugs or other medicaments), and mixtures of concentrations (e.g., osmotic concentration or osmotic pressure of a particular solution of the substances being nebulized).

The nebulized material introduced into the gas stream may be a pharmaceutical material. Other examples of nebulized materials that may be introduced into the gas stream may be mannitol, ringer's lactate, 5.0% dextrose in water, hartmann's solution, sodium lactate solution, and compound sodium lactate. The substance is introduced into the system 100 and may be carried by the gas flow and then delivered to the airway or respiratory tract of the patient along with the respiratory gas.

In some configurations, introducing the nebulized material into the stream of gas delivered to the patient may improve treatment of the respiratory disease or disorder.

With continued reference to fig. 1, in some configurations, the nebulizer 128 may be used with the respiratory therapy system 100. The nebulizer 128 may be separate from the respiratory therapy system 100 or form part of the respiratory therapy system 100.

The atomizer 128 produces a fine spray of liquid, i.e., an aerosol of particles. The atomized material is introduced into the conditioned gas stream or the preconditioned gas stream. Any suitable atomizer 128 may be used.

In some configurations, the port for the atomizer for dispensing the atomized material into the gas flow path is located downstream of the flow generator 101. In these arrangements, the atomized material will be carried by the gas stream from flow generator 101.

In some configurations, the port for the nebulizer is located at the humidifier 112. The nebulized material in these configurations is added to the flow of humidified gas 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 of the nebulizer is located downstream of the humidifier.

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 treatment apparatus. In other arrangements, the port for the atomizer is located at or towards the device end of the conduit. In these configurations, the atomized material introduced into the gas stream forms part of the gas mixture stream as it enters the conduit, so that adjustment of the power of the heater wire 123 in the conduit can have an effect on the particle size of the atomized material. In some configurations, the port for the atomizer is located on or in the conduit. In other configurations, the port for the atomizer is located at any position along the conduit or at a different position. For example, the port for the atomizer may be located on or in the conduit approximately one third of the distance from the device end, or half of the distance from the device end, or two thirds of the distance from the device end. In other arrangements, the port for the atomizer is located at or towards the device end of the conduit.

In some configurations, the conduit 122 includes a length greater than 0.5 meters. In some configurations, the conduit comprises a length greater than 1 meter. In some configurations, the conduit comprises a length greater than 1.5 meters. In some configurations, the length of the conduit 122 is such that the residence time of the gas stream and the atomized material is sufficient to adjust the power of the heater wire 123 to affect the relative humidity within the conduit and thereby adjust the average particle size of the atomized material to or towards the target particle size. In some configurations, the aforementioned control is sufficient to affect the relative humidity in the system to adjust the average particle size of the atomized material to the target particle size.

In some configurations, multiple components of the respiratory therapy system may be housed together. For example, two or more of the flow generator 101, the gas humidifier 112, and the atomizer 128 may share the housing 126.

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

In some configurations, the nebulizer 128 is not positioned in-line in any position between the humidifier outlet 118 and the patient interface 124. Rather, the atomizer 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 an inlet into the humidifier. In some configurations, the nebulizer 128 may be positioned between the airflow source and the chamber of the humidifier.

In some configurations, the position or orientation of the atomizer port defines a flow path for the atomized material. The flow path may include all or some portion of the device outlet, elbow, humidification chamber, conduit, and/or patient interface.

In the configuration shown in fig. 5, the outlet 129 of the atomizer 128 is positioned in connection with the chamber 210 for introducing the atomized material. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into the flow of conditioned gas downstream of the chamber 210 and upstream of the conduit 122 connecting the patient interface 124 to the integrated unit 206. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into the stream of conditioned gas downstream of the chamber 210 and upstream of the connection location of the detachable conduit 122 to the integrated unit 206. In some configurations, the nebulizer 128 is configured and positioned to inject the nebulized substance into the stream of gas prior to entering the chamber 210. In some configurations, the nebulizer 128 is configured and positioned to inject nebulized material into the stream of gas during entry into the chamber 210. In some configurations, the nebulizer 128 is configured and positioned to inject the nebulized substance into the stream of gas after entering the chamber 210. In some configurations, the atomizer 128 is configured and positioned to inject an atomized substance into the gas stream prior to being discharged from the chamber 210. In some configurations, the atomizer 128 is configured and positioned to inject an atomized substance into the gas stream during discharge from the chamber 210. In some configurations, the nebulizer 128 is configured and positioned to inject the nebulized substance into the stream of gas after exiting from the chamber 210.

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

The atomizer 128 may be connected to the portion of the gas passage by a connector or transmitter 130, which connector or transmitter 130 may include a conduit or adapter. Or the atomizer 128 may be directly connected to the gas passage, which may make the conveyor 130 unnecessary.

3. Controller for controlling a power supply

In some configurations, operation of flow generator 101, gas humidifier 112, or other components or aspects of respiratory therapy system 100 may be controlled by controller 113. The controller may comprise a microprocessor, a dedicated circuit such as an ASIC or FPGA, or other suitable device. The controller may be located in or on the flow generator 101, the gas humidifier 112, or other components of the respiratory therapy system 100, or on a remote computing device in remote communication with the respiratory therapy system 100. In some configurations, multiple controllers may be used.

Referring to fig. 2, in such a configuration, respiratory therapy system 100 may control the operation of components of the system, including, but not limited to, regulating the power delivered to the heated breathing conduit's heating wire 123 (to regulate the temperature in the heated breathing conduit), and the power delivered to the humidifier's heating element 25 (to regulate the heating of the humidifier's water).

In some configurations, the controller 113 adjusts the power provided to the heater wire 123 of the conduit 122 to adjust the average particle size of the atomized material toward the target. For example, in some configurations, the temperature within conduit 122 downstream of nebulizer 128 (when connected to respiratory therapy system 100) may be controlled to or towards a target to adjust the relative humidity of the gas flow within the conduit towards the target.

The relative humidity of the humidified gas delivered to the patient may be dynamically controlled by the respiratory therapy system 100 by increasing or decreasing the temperature of the heating conduit 122 relative to the temperature at the heating element 25 of the humidifier (e.g., by adjusting the power delivered to the heater wire). For example, increasing the temperature of the heating conduit 122 and/or decreasing the power provided to the heating element 25 will decrease the relative humidity of the humidified gas delivered to the patient. When there is a sufficient temperature difference between the temperature at the outlet of the humidifier and the temperature at the patient (e.g., as measured by a patient-side temperature sensor positioned in the conduit), a reduction in the relative humidity of the gas delivered to the patient may be achieved. A sufficient temperature difference may be about 5 degrees celsius. Smaller or larger temperature differences are also suitable. It should be appreciated that adjusting the power delivered to the heater wire of the heating conduit 122 allows for faster changes in relative humidity and, thus, 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, the power delivered to the heater wire may be adjusted faster than the water in the heating chamber. One or both controls of the power delivered to the heater wire or heating element 25 humidifier may be used to achieve the desired humidity.

When controlling respiratory therapy systems with humidification, it is generally preferred to control the power delivered to the heater wire and heating element in series in order to maintain 100% relative humidity and a certain absolute humidity (e.g., 44 mg/L). In contrast, in a preferred configuration of the present respiratory therapy system 100, the controller 113 may increase the power to the heater wire of the heating conduit 122 relative to the heating element 25 of the humidifier (i.e., not in series), resulting in a decrease in relative humidity and a decrease in the average particle size of the aerosolized substance.

In some configurations, after installing the atomizer 128 and dispensing the atomized substance, the power delivered to the heater wire 123 of the heating conduit 122 may be controlled to achieve the relative humidity target. In some configurations, the power to the heater wire 123 in the conduit 122 may be controlled to achieve a relative humidity target before atomization of the substance into the gas stream by the atomizer 128 begins.

In some configurations, the 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 the target. It will be appreciated 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 body of water stored in the humidification chamber), and thus the relative humidity will change more gradually in response to the adjustment of the power. As noted, this is because the thermal inertia of the heater plate and the water in the humidification chamber-cooling or heating a relatively large body of water can take a relatively long period of time.

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

In some configurations, the temperature of the heating element 25 and/or conduit 122 (or a parameter related to temperature, e.g., a duty cycle of a heating/control signal) may be maintained for a predetermined period of time (or a period of time as a function of flow rate, for example). Such a configuration may help address thermal inertia in the system while protecting the atomized material from excessive heating and/or possible thermal damage that may compromise the efficacy of the material.

In some configurations, the controller 113 may control the power supplied to the heater wire 123 of the conduit 122 independently of the control of the power supplied to the heating element 25 of the humidifier in order to adjust the average particle size. For example, there may be two separate control loops for each component. In some configurations, the heater wire 123 may not be controlled in close cooperation or synchronization with the heating element, which itself may be controlled to achieve an absolute humidity target or set point. In some configurations, the heater wire 123 is controlled to heat the gas flow in the conduit 122 to achieve a relative humidity target or set point. That is, the control loop for the heater wire 123 may be independent of the control loop for the heating element of the humidifier. The heater wire 123 in these configurations may be controlled independently of the heating element of the humidifier to achieve a certain relative humidity to achieve a desired average particle size of the substance atomized into or added to the gas stream delivered to the patient.

The particle size of the atomized material may also be affected by other parameters of the gas flow in the system-for example, when the flow is turbulent (as may occur, for example, once the flow reaches the patient, for example, to the nose), the particles may be more likely to coalesce or agglomerate, thereby increasing their size.

In some configurations, the system includes a standard treatment mode and an aerosolized treatment mode. The standard treatment mode may be a mode in which the system is operating when nebulized material is not added to the stream of humidified gas or has not been introduced.

In some configurations, in the nebulized therapy mode, the controller 113 targets a lower relative humidity of the gas stream than in the standard therapy mode. In the nebulization therapy mode, depending on the desired average particle size, the power delivered to the component can be increased, resulting in a lower relative humidity. In some of these configurations, the standard treatment mode may be targeted at a relative humidity of about 100%, while the nebulized treatment mode may be targeted at a relative humidity of less than 100%.

In some configurations, the target relative humidity in the nebulized treatment mode is less than 80%. In some configurations, the target relative humidity in the nebulized treatment mode is less than 60%.

In some configurations, the power supplied to the heater wire in the nebulized treatment mode is higher than the power supplied in the standard treatment mode.

In some configurations, the user may manually adjust between the standard treatment mode and the nebulized treatment mode. These modes may be adjusted through a user interface on the device.

In some configurations, in the nebulized treatment mode, the target relative humidity can be configured by a user (e.g., a clinician). This may be direct (e.g., the user selects a desired dew point temperature) or indirect, where the user selects a desired particle size and/or material composition (e.g., brine solution concentration)). In some configurations, a user interface feature (e.g., a touch screen element) for manually adjusting the target average particle size becomes capable of interacting with the aerosolized therapy mode after entering it.

In some configurations, the system is configured to automatically control the power delivered to the heater wire to achieve a default target average particle size (e.g., when in an aerosolized therapy mode).

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, the default target average particle size is <1.0 μm.

In some configurations, in the nebulized treatment mode, the flow rate range of the gas stream can be within a set flow rate range. The set flow rate range may be between about 30L/min and about 50L/min, but other flow rates may be suitable. In some configurations, the controller is configured to adjust the speed of the blower. In some configurations, the speed of the blower is adjusted to provide a range of flow rates of the gas stream within a set range of flow rates. The speed of the blower is adjusted so that the flow rate of the gas stream is within a set flow rate range.

In some configurations, the flow rate of the gas stream may be above or below a set flow rate range. When the nebulization therapy mode is activated, the speed of the blower can be adjusted to provide a flow rate range of the gas stream within the set flow rate range.

In some configurations, the flow rate range of the gas stream may be higher than the set flow rate range. When the nebulization therapy mode is activated, the controller is configured to reduce the speed of the blower to provide a flow rate range of the gas stream within the set flow rate range. Optionally, the controller is configured to reduce the speed of the blower to provide a range of flow rates of the gas stream in an upper region of the set range of flow rates. For example, if the flow rate of the gas stream is 60L/min and the set flow rate range is between about 30L/min and about 50L/min, the flow rate of the gas stream may be reduced to about 50L/min when the nebulization therapy mode is activated.

In some configurations, the flow rate range of the gas stream may be lower than the set flow rate range. When the nebulization therapy mode is activated, the controller is configured to increase the speed of the blower to provide a flow rate range of the gas stream within the set flow rate range. Optionally, the controller is configured to increase the speed of the blower to provide a range of flow rates of the gas stream in an upper region of the set range of flow rates. For example, if the flow rate of the gas stream is 20L/min and the set flow rate range is between about 30L/min and 50L/min, the flow rate of the gas stream may be increased to about 30L/min when the nebulization therapy mode is activated.

The flow rate of the gas stream is limited to a set flow rate range to reduce the likelihood of and/or the volume of atomized material being deposited in the flow path. For example, at higher flow rates, a higher volume of nebulized material may be deposited in the flow path and less nebulized material may reach the patient. In the nebulization therapy mode, it may be desirable to reduce the flow rate of the gas stream to a relatively low flow rate. Reducing the flow rate of the gas stream to a relatively low flow rate may facilitate delivery of the nebulized material to the airway of the patient/user. For example, the relatively low flow rate may be between about 10L/min and about 30L/min, although other flow rates may be suitable.

In some configurations, the humidification device is configured to raise or generate an alarm when the nebulization therapy mode is activated and the gas flow is above or below a set flow rate range. In some configurations, the nebulization therapy mode is active for a set period of time. In some configurations, the humidification device is configured to raise or generate an alarm when the nebulizer treatment mode is active for a period of time longer than a set period of time.

4. Relative humidity of

It should be appreciated that the particle size of the aerosolized substance is affected by many factors within respiratory treatment system 100.

For example, the relative humidity in the conduit 122 may affect the particle size (e.g., MMAD) of the aerosolized substance. In this system, relative humidity can be considered as the percentage of the amount of water vapor in the gas mixture to the maximum amount that it can hold at a particular temperature. Whereas absolute humidity is the actual or absolute amount (i.e., amount) 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/liter of gas).

Adjusting the relative humidity in respiratory therapy system 100 may affect the particle size of the aerosolized matter because the aerosolized particles tend to absorb (if the particles are relatively dry) water, and then absorb (if the particles are relatively wet) water, becoming larger in the process.

In humidified respiratory therapy, the desired relative humidity is typically controlled to be as close to 100% as possible in order to simulate natural humidification by the upper respiratory tract. However, it has been found that water vapor particles may coalesce with particles of the atomized material to form larger particles, resulting in increased MMAD (as described above), and thus the material may not travel into the respiratory tract as desired and/or in sufficient amounts. Accordingly, it may be desirable to reduce the saturation (i.e., relative humidity) of the humidified gas stream to a lower target in order to affect the particle size of the nebulized material and thereby the distance traveled by the nebulized material into the respiratory tract of the patient. Indeed, decreasing the relative humidity may cause an increase in the evaporation effect, leading to desorption of water from the atomized material particles and thus to a decrease in MMAD.

In some configurations, the target relative humidity is about 80%. In other configurations, the target relative humidity is less than 80%. For some atomized materials, a relative humidity of about 80% or less will maintain an average particle size of the atomized material of 1.0 μm or less than 1.0 μm. In some configurations, such parameters will be sufficient to cause the aerosolized substance to travel to at least the upper respiratory tract.

In some configurations, the target relative humidity is about 60%. In other configurations, the target relative humidity is less than 60%. For some atomized materials, a relative humidity of about 60% or less will maintain an average particle size of the atomized material of 0.5 μm or less than 0.5 μm. In some configurations, such parameters will be sufficient to cause the nebulized material to travel to the lower respiratory tract.

It is contemplated that different relative humidity targets may be necessary for different aerosolized substances to be delivered. Thus, the particular control parameters of the system selected for delivering the nebulized material to the desired location in the respiratory tract of the patient will vary. For example, a clinician or other suitable person may specify the type and/or concentration of active material to be introduced as an aerosolized material into the solution in system 100. The controller 113 may adjust the relative humidity of the gas stream carrying the atomized substance by maintaining or adjusting settings for one or more components accordingly. Higher concentrations of active substance typically require more relative humidity reduction in order to adjust the particle size to the desired target, e.g., MMAD <1.0 μm, in order to pass through the upper and proximal airway passages, while lower concentrations may require only a smaller reduction in relative humidity.

In some configurations, in which the nebulized material introduced into respiratory therapy system 100 comprises different solution components, adjustments to the relative humidity may be used to maintain a desired average particle size. If the composition of matter changes during respiratory therapy-e.g., due to a clinician increasing or decreasing the dosage of a drug-the system can adjust the target relative humidity so as to maintain the desired average particle size. If the change in the composition of the substance is such that the current relative humidity will result in an undesirably large average particle size (at the current setting), the system may, for example, achieve a decrease in relative humidity after the clinician interacts with the control of the system (e.g., via a user interface), and vice versa.

It will be appreciated that in some of these configurations, the user need not wait for the absolute humidity of the gas stream to decrease or increase (by cooling or heating the water in the humidifier) after adjustment of the nebulized material. A clinician or other user may specify to the system that the particle size needs to be reduced or increased, and the system may control components such as heater wires accordingly to rapidly adjust relative humidity. Thus, in these configurations, the workflow of the clinician or other user may be substantially more direct and/or rapid.

Referring to fig. 8A and 8B, the test results confirm the correlation between the relative humidity of the aerosolized substance in the system, the air temperature, and the MMAD. It can be seen that when the air temperature deviates from the dew point (and hence the relative humidity decreases), the MMAD of the atomized particles suspended in the gas stream decreases. Figures 8A and 8B show MMAD of atomized particles under a range of carrier gas conditions at gas flow rates of 20L/min and 40L/min, respectively. The average size of the particles is largely unaffected by these differences in flow rates. However, at much lower flow rates (e.g., 2-3L/min), the atomized particles will take a significantly longer time in the humidified gas stream, which may promote and allow for a greater increase in particle size, i.e., by adsorbing water vapor and other mechanisms. The figure also shows that the concentration of the brine solution in the nebulized solution (in this case representative of other nebulized formulation) can have a significant effect on the MMAD of the nebulized particles suspended in the gas stream. As described above, relative humidity is affected by increasing or decreasing the temperature of the gas stream. Or Absolute Humidity (AH) may be reduced, for example, by increasing the flow rate to reduce the residence time of the gas flowing through the chamber and/or reducing the power supplied to the heater plate to reduce the extent to which the water is heated. The opposite operation may be performed to increase the absolute humidity and thus the relative humidity. A higher flow rate will reduce the residence time of the gas in the heated breathing tube, which may reduce 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 the substance in the nebulized solution (e.g. NaCl or how much of the agent is relative to water) will have an effect on the MMAD of the particles, but is chosen outside the system and generally depends on what the patient is considered to need. In summary, the key physical variables that may affect the MMAD of the particles are temperature, absolute humidity and aerosolized pharmaceutical formulation.

As those graphs show, when the substance is a saline solution of 0.9% sodium chloride (NaCl), a higher relative humidity may be appropriate for a particular desired MMAD, whereas at a higher NaCl concentration (7.0%), the MMAD is much higher at the same relative humidity. As described above, higher concentrations of atomized material solutions generally require more relative humidity to adjust the particle size to the desired target than lower concentrations, at which the relative humidity may only need to be reduced by a smaller amount to achieve the desired target particle size.

In a preferred configuration, the controller 113 in the system adjusts settings, such as the power supplied to the heater wire 123 of the catheter, or the power of the heating element 25, based on the desired average particle size (e.g., MMAD). Adjusting these settings can adjust and in some configurations reduce the relative humidity of the humidified air in the conduit 122, which will reduce the size of the particles in the gas stream to a desired average size, allowing the aerosolized matter particles to travel a desired distance into the respiratory tract of the patient.

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

In some configurations, the controller 113 controls the power supplied to the heater wire to achieve a target relative humidity. In some configurations, the controller continuously controls the power supplied to the heater wire to maintain the target relative humidity. The power supplied to the heater wire may be adjusted by varying the duty cycle of a Pulse Width Modulation (PWM) signal supplied to the heater wire, and/or varying the voltage magnitude of the DC voltage supplied to the heater wire.

5. User control interface

In some configurations, 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, touch screens, speakers, displays, and/or other input or output modules that a user may use to input commands to the flow generator 101, view data, and/or control operation of the flow generator 101, and/or control operation of other aspects of the respiratory therapy system 100. In some configurations, the system may have multiple user control interfaces 108, 120 at different locations in the system 100, as shown in fig. 1.

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

6. Application method

In some configurations, respiratory therapy system 100 may be set as follows. The steps may be performed in any suitable order, and thus the following is merely an example of an order that may be used.

In some configurations, respiratory therapy system 100 may be used with nebulizer 128 and catheter 122 to provide any desired therapy that can be performed with a combination of components. In some configurations, a nasal cannula (which is the patient interface 124) is connected to the catheter and provides nasal high flow treatment while dispensing a substance (e.g., saline solution or a drug) into the gas stream via the nebulizer. The advantage of using high flow therapy while dispensing the substance is that the high flow rate of gas pushes the aerosolized particles within the gas into the airway of the patient. High flow rates may increase the likelihood and/or volume of nebulized material being deposited in the airway of a patient and/or further into the airway. Other configurations and methods are also possible.

Referring to fig. 7, a flow chart of the steps of a method of use is shown. Different configurations may include one or more of these steps.

In some configurations, a user selects a desired particle size of the aerosolized substance on a user-control interface. The particle size is selected, for example, by actuating a physical element (e.g., slider, button, etc.) or a digital interface element (i.e., touch screen). The particle size selected may be a particle size having a particular desired MMAD, or in other configurations selected by selecting a particular particle size mode (e.g., small, regular, large particle size mode). Or the user may be able to select a desired deposition or dispensing area. In some configurations, other modes may be detected or selected, such as the type of patient interface connected. The mode detected by the system or selected by the user may initiate a predetermined control (e.g., power delivered to a component of the system) to adjust the relative humidity that adjusts the average particle size of the aerosolized substance being delivered, which then affects delivery of the aerosolized substance to the patient.

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

7. General description of respiratory therapy apparatus

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

In some configurations, the device is configured to be fluidly connected to the conduit 122. The conduit 122 may be configured to deliver a flow of gas from the flow generator 101 to a patient. The conduit 122 may include an inner lumen and a heater wire 123 configured to heat the gas flow in the conduit 122.

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

In some configurations, the target relative humidity is the relative humidity of the flowing gas in conduit 122. The target relative humidity may be the relative humidity of the flowing gas at the patient end of the conduit 122. In some configurations, the target relative humidity may be about 80%. In other configurations, the target relative humidity may be less than 80%. In other configurations, the target relative humidity may be about 60%. In other configurations, the target relative humidity is less than 60%. It should be appreciated that in some of these configurations, the percentage of target relative humidity is an example, and other target relative humidities may be suitable.

In some configurations, the target average particle size may be based on a desired distance traveled into the patient's respiratory tract. In some configurations, the desired travel distance may be for dispersion in or around the upper respiratory tract of the patient. In other configurations, the desired travel distance may be for dispersion out of the upper respiratory tract of the patient. In other configurations, the desired travel distance may be used to disperse in or around the lower respiratory tract of the patient.

In some configurations, the target average particle size when the desired travel distance is dispersed in or around the upper respiratory tract of the patient is relatively smaller than the target average particle size when the desired travel distance is dispersed in or around the lower respiratory tract of the patient. In some configurations, the target average particle size may be a Mass Median Aerodynamic Diameter (MMAD) of <1.0 microns. In other configurations, the target average particle size is a Mass Median Aerodynamic Diameter (MMAD) between 0.5 microns and 1.0 microns. In other configurations, the target average particle size is a median aerodynamic diameter (MMAD) of <0.5 microns. In some configurations, the target average particle size may be a Mass Median Aerodynamic Diameter (MMAD) between 0.1 microns and 0.5 microns. It should be appreciated that in some of these configurations, the Mass Median Aerodynamic Diameter (MMAD) of the target average particle size is an example, and other diameters may be suitable.

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

In some configurations, the port for the nebulizer 128 is located downstream of the flow generator 101. In other configurations, the port for the nebulizer 128 is located at the humidifier 112. In other configurations, the port for the nebulizer 128 is located at or toward the inlet or outlet of the humidifier 112. In other configurations, the port for the nebulizer 128 is located at or toward the outlet of the humidifier 112. In other configurations, the port for the atomizer 128 is located upstream of the device end of the conduit 122. In other configurations, the port for the atomizer 128 is located at or toward the device end of the conduit 122. It should be appreciated that in some of these configurations, the location of the port of the atomizer 128 is an example, and that other locations for the port of the atomizer 128 are also suitable.

In some configurations, the port is configured to indirectly receive the nebulizer 128. In other configurations, respiratory therapy apparatus 200 further includes a mount or connector configured to connect to a port at one opening. A mount or connector may be used to receive the atomizer 128 at another opening. It should be appreciated that in some of these configurations, the target relative humidity is an example, and other target relative humidities may be suitable. In other configurations, the ports may be configured to connect to the atomizer 128, the atomizer 128 introducing atomized material into the gas stream.

In some configurations, respiratory therapy apparatus 200 includes a standard therapy mode and an aerosolized therapy mode. The nebulized 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 heater wire 123 in the nebulized treatment mode may be higher than the power delivered in the standard treatment mode.

In some configurations, the standard treatment mode may include a target relative humidity of about 100%, and the nebulized treatment mode includes a target relative humidity of less than 100%. In other configurations, the target relative humidity in the nebulized treatment mode is less than 80%. In other configurations, the target relative humidity in the nebulized treatment mode is less than 60%. It should be appreciated that in some of these configurations, the target relative humidity is an example, and other target relative humidities may be suitable.

In some configurations, the user may manually adjust between the standard treatment mode and the nebulized treatment mode. After entering the nebulization therapy mode, features for manually adjusting the target average particle size become available.

In some configurations, the device is configured to automatically control the power to the heater wire 123 to achieve a default target average particle size.

In some configurations, the apparatus is configured to automatically control the power to the heating element 25 to achieve a default target average particle size. The default target average particle size may be <1.0 microns.

In some configurations, respiratory therapy apparatus 200 further includes a user control interface. The user control interface includes a user control interface element for adjusting the target average particle size. The user control interface may include a user control interface element for adjusting a target travel distance into the patient's respiratory tract. In other configurations, the user control interface may include user control interface elements for selecting a standard treatment mode and an aerosolized treatment mode. In other configurations, the user control interface includes a touch screen interface. In other configurations, the user control interface includes a mechanical interface having a physical element that is one of a slider, a dial, a button, or a combination thereof.

In some configurations, a respiratory therapy system 100 for delivering a flow of gas to a patient is provided that includes a blower 106, a humidifier 112 including a heating element 25, and a conduit 122 in fluid communication with the humidifier 112. Humidifier 112 is in fluid communication with blower 106 and is configured to humidify the gas. Conduit 122 is configured to direct the flow of gases from humidifier 112 to the patient/user. The conduit 122 includes a heater wire 123 in the conduit 122. Respiratory therapy system 100 also includes ports fluidly coupled to humidifier 112 and conduit 122. The port is adapted to introduce an atomized material into the gas stream. Respiratory therapy system 100 further includes a controller 113, which controller 113 is operably coupled to heating element 25, heating wire 123, and blower 106. The controller 113 is configured to adjust the speed of the blower 106 to provide a target flow rate of gas flow, adjust the power of the heating element 25 and/or the heater wire 123, and control the particle size of the atomized material within a target size range.

In some configurations, a respiratory therapy system 100 for delivering a flow of gas to a patient is provided that includes a blower 106, a humidification device in fluid communication with the blower 106. The humidification device is configured to regulate the humidity of the flow of gas. Respiratory therapy system 100 also includes a gas path defined between blower 106 and the patient. The gas path includes a humidification device and a port adapted to receive an aerosolized substance. Respiratory therapy system 100 also includes a controller 113 that is operatively coupled to blower 106 and the humidification apparatus. The controller 113 is configured to adjust the speed of the blower 106 to provide a set flow rate of the gas flow and to adjust the humidity output of the humidification device to control the particle size of the atomized substance.

In some configurations, the humidification apparatus includes a humidifier 112 having a heater plate.

In some configurations, the humidification apparatus includes a conduit 122 having a heater wire 123.

In some configurations, the system includes an aerosolized treatment mode. In the nebulization therapy mode, the humidity of the gas stream from the humidifier 112 can be reduced for a set period of time or when the system is in the nebulization therapy mode. In some configurations, in the nebulization therapy mode, the power supplied to the heater plate and/or the temperature set point of the heater plate is reduced to reduce absolute humidity. In other configurations, the power supplied to the conduit 122 heater wire 123 is increased to reduce relative humidity.

In some configurations, in the nebulization therapy mode, the humidification device is configured to generate an alarm when the humidity of the gas stream is greater than an allowable absolute or allowable relative humidity.

In some configurations, in the nebulized treatment mode, the flow rate range of the gas stream is within a set flow rate range. In some configurations, the set flow rate range may be between about 30L/min and 50L/min.

In some configurations, when the nebulization therapy mode is activated, the controller 113 is configured to adjust the speed of the blower 106 to provide a flow rate range of the gas stream within the set flow rate range. In other configurations, when the nebulization therapy mode is activated and the flow rate of the gas stream is above the set flow rate range, the controller 113 is configured to reduce the speed of the blower 106 to provide a flow rate range of the gas stream within the set flow rate range. Optionally, the speed of the blower 106 will be reduced to provide a range of flow rates of the gas stream into an upper region of the set range of flow rates. In other configurations, when the nebulization therapy mode is activated and the flow rate of the gas stream is below the set flow rate range, the controller 113 is configured to increase the speed of the blower 106 to provide a flow rate range of the gas stream within the set flow rate range. Optionally, the speed of the blower 106 will be increased to provide a range of flow rates of the gas stream in a lower region of the set range of flow rates.

In some configurations, the humidification device is configured to cause an alarm when the nebulization therapy mode is activated and the gas flow is above or below a set flow rate range. The nebulization therapy mode may be activated for a set period of time. In other configurations, the humidification device is configured to cause an alarm when the nebulizer treatment mode is active for a period of time longer than a set period of time. When the nebulizer treatment mode is activated, the patient or user defines a particle size range.

In some configurations, the breathing apparatus is configured to vary relative humidity and/or absolute humidity to a particular range to control the particle size of the aerosolized substance. By adjusting the relative humidity and/or absolute humidity, the particle size of the atomized material can be controlled to or towards a specific size range.

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

Respiratory therapy apparatus 200 may have any one or more of the features and/or functions described herein.

The respiratory therapy apparatus 200 may be provided as a stand-alone device. Alternatively, the respiratory therapy apparatus 200 may be provided as part of the respiratory therapy system 100 or used in the respiratory therapy system 100, the respiratory therapy system 100 having the respiratory therapy apparatus 200 and one or more of the conduit 122, the patient interface 124, the nebulizer 128, or one or more other components described herein.

Throughout the specification and claims, unless the context clearly requires otherwise, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense, i.e. a sense of "including but not limited to".

Where in the foregoing description reference has been made to integers or components having known equivalents thereof, then such integers or components are herein incorporated as if individually set forth.

The disclosed methods, devices, and systems may also be broadly interpreted as including portions, elements, and features that are referred to or indicated in the disclosure, individually or collectively, in any or all combinations of two or more of the portions, elements, or features.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that prior art forms part of the common general knowledge in the field of endeavour in any country of the world.

Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the present disclosure as if it were individually recited herein. In addition, each sub-range of values within the range of values is incorporated into the present disclosure as if it were individually recited herein.

While the disclosure has been described in terms of certain embodiments, other embodiments apparent to those of ordinary skill in the art are also within the scope of this disclosure. Accordingly, various changes and modifications may be made without departing from the spirit and scope of the disclosure. For example, the various components may be repositioned as desired. Furthermore, not all features, aspects, and advantages are necessary to practice the present disclosure. Accordingly, it is intended that the scope of the disclosure be limited only by the claims appended hereto.

Claims

1. A respiratory therapy system for delivering a flow of gas to a patient, comprising:

a flow generator configured to generate the gas flow;

a catheter configured to deliver the flow of gas from the flow generator to the patient, the catheter comprising a lumen and a heater wire configured to heat the flow of gas in the catheter;

a port configured to be in fluid communication with the conduit and for receiving aerosolized substance and introducing the aerosolized substance into the patient's gas flow; and

A controller is configured to adjust power delivered to at least the heater wire to adjust the average particle size of the aerosolized substance to or towards a target.

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

3. The respiratory therapy system of any one of the preceding claims, wherein the controller continuously controls the power delivered to the heater wire to maintain a target relative humidity of the gas flow.

4. The respiratory therapy system of 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 any one of claims 2 to 4, wherein the target relative humidity is the relative humidity of the gas flow at the patient end of the conduit.

6. The respiratory therapy system of any one of claims 2 to 5, wherein the target relative humidity is approximately 80%.

7. The respiratory therapy system of any one of claims 2 to 5, wherein the target relative humidity is less than 80%.

8. The respiratory therapy system of claim 7, 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 any one of the preceding claims, wherein a target average particle size is based on an expected travel distance into the patient's airway.

11. The respiratory therapy system of claim 10, wherein the desired travel distance is for dispersion in or around the patient's upper airway.

12. The respiratory therapy system of claim 10 or 11, wherein the desired travel distance is for dispersion out of the patient's upper airway.

13. The respiratory therapy system of claim 10 or 11, wherein the desired travel distance is for dispersion in or around the patient's lower airway.

14. The respiratory therapy system of any of the preceding claims, wherein a target average particle size is relatively larger when the desired travel distance is dispersed in or around the patient's upper airway than when the desired travel distance is dispersed in or around the patient's lower airway.

15. The respiratory therapy system of any one of the preceding claims, wherein the target average particle size is a mass median aerodynamic diameter (MMAD) of <1.0 micron.

16. The respiratory therapy system of claim 15, wherein the target average particle size is a mass median aerodynamic diameter (MMAD) between 0.5 microns and 1.0 microns.

17. The respiratory therapy system of claim 15, wherein the target average particle size is a median aerodynamic diameter (MMAD) of <0.5 microns.

18. The respiratory therapy system of claim 17, wherein the target average particle size is a mass median aerodynamic diameter (MMAD) between 0.1 microns and 0.5 microns.

19. The respiratory therapy system of any preceding claim, further comprising a humidifier including a heating element.

20. The respiratory therapy system of claim 19, wherein the controller is configured to adjust the power delivered to the heating element to adjust the average particle size of the aerosolized substance to or towards a target.

21. The respiratory therapy system of claim 19 or 20, wherein the controller controls both the power delivered to the heater wire and the power delivered to the heating element to achieve a target average particle size.

22. The respiratory therapy system of claim 21, wherein the controller controls the power delivered to the heater wire independently of the power delivered to the heating element to adjust the average particle size.

23. The respiratory therapy system of any one of claims 19 to 22, wherein the heating element is configured to heat a heating plate.

24. The respiratory therapy system of any one of the preceding claims, wherein the port for the nebulizer is located downstream of the flow generator.

25. The respiratory therapy system of any preceding claim, wherein the port for the nebulizer is located at the humidifier.

26. The respiratory therapy system of claim 25, wherein the port for the nebulizer is located at or toward an inlet or outlet of the humidifier.

27. The respiratory therapy system of claim 26, wherein the port for the nebulizer is located at or toward an outlet of the humidifier.

28. The respiratory therapy system of any preceding claim, wherein the port for the nebulizer is located upstream of the device end of the conduit.

29. The respiratory therapy system of any one of claims 1 to 27, wherein the port for the nebulizer is located at or towards a device end of the conduit.

30. The respiratory therapy system of any preceding claim, wherein the port is configured to indirectly receive the nebulizer.

31. The respiratory therapy system of any one of the preceding claims, further comprising a connector configured to connect to the port at one opening and to receive the nebulizer at another opening.

32. The respiratory therapy system of any preceding claim, further comprising a nebulizer configured to connect at the port, the nebulizer introducing the aerosolized substance into the gas flow.

33. The respiratory therapy system of any preceding claim, wherein the respiratory therapy system comprises a standard therapy mode and a nebulized therapy mode.

34. The respiratory therapy system of claim 33, wherein the nebulized therapy mode includes a target relative humidity that is lower than a target relative humidity in the standard therapy mode.

35. The respiratory therapy system of claim 33 or 34, wherein the power delivered to the heater wire in the nebulization therapy mode is higher than the power delivered in the standard therapy mode.

36. The respiratory therapy system of any one of claims 33 to 35, wherein the standard therapy mode includes a target relative humidity of approximately 100% and the nebulized therapy mode includes a target relative humidity of less than 100%.

37. The respiratory therapy system of claim 36, wherein the target relative humidity in the nebulization therapy mode is less than 80%.

38. The respiratory therapy system of claim 37, wherein the target relative humidity in the nebulization therapy mode is less than 60%.

39. The respiratory therapy system of any one of claims 33 to 38, wherein a user can manually adjust between the standard therapy mode and the nebulized therapy mode.

40. The respiratory therapy system of any one of claims 33 to 39, wherein after entering a nebulization therapy mode, a feature for manually adjusting the target mean particle size becomes available.

41. The respiratory therapy system of any of the preceding claims, wherein the respiratory therapy system is configured to automatically control power delivered to the heater wire to achieve a default target average particle size of aerosolized substance delivered to the patient via the gas flow.

42. The respiratory therapy system of any one of claims 19 to 41, wherein the respiratory therapy system is configured to automatically control power delivered to the heating element to achieve a default target average particle size.

43. The respiratory therapy system of claim 41 or 42, wherein the default target average particle size is <1.0 micron.

44. The respiratory therapy system of any preceding claim, further comprising a user control interface.

45. The respiratory therapy system of claim 44, wherein the user control interface includes a user control interface element for adjusting a target average particle size.

46. The respiratory therapy system of Claim 44 or Claim 45, wherein the user control interface comprises a user control interface element for adjusting a target travel distance into the patient's airway.

47. The respiratory therapy system of any one of claims 44 to 46, wherein the user control interface includes user control interface elements for selecting a standard therapy mode and a nebulized therapy mode.

48. The respiratory therapy system of any one of claims 44 to 47, wherein the user control interface comprises a touch screen interface.

49. The respiratory therapy system of any one of claims 44 to 48, wherein the user control interface comprises a mechanical interface having a physical element that is one of a slider, a dial, a button, or a combination thereof.

50. The respiratory therapy system of any one of the preceding claims, wherein the conduit comprises a length greater than 0.5 meters.

51. The respiratory therapy system of claim 50, wherein the conduit comprises a length greater than 1 meter.

52. The respiratory therapy system of claim 51, wherein the conduit comprises a length greater than 1.5 meters.