This application is the U.S. national phase of International Application No. PCT/AU2017/050912 filed Aug. 28, 2017 which designated the U.S. and claims priority to AU Patent Application No. 2016903417 filed Aug. 26, 2016, the entire contents of each of which are hereby incorporated by reference.

1 BACKGROUND OF THE TECHNOLOGY

1.1 Field of the Technology

The present technology relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use.

1.2 Description of the Related Art

1.2.1 Human Respiratory System and its Disorders

The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings.

1.2.2 Therapy

Various therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-Invasive Ventilation (NIV) and Invasive Ventilation (IV) have been used to treat one or more of the above respiratory disorders.

1.2.3 Treatment Systems

These therapies may be provided by a treatment system or device. A treatment system may comprise a Respiratory Pressure Therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

1.2.3.1 Patient Interface

A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and/or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmH2O.

1.2.3.2 Respiratory Pressure Therapy (RPT) Device

A respiratory pressure therapy (RPT) device may be used to deliver one or more of a number of therapies described above, such as by generating a flow of air for delivery to an entrance to the airways. The flow of air may be pressurised. Examples of RPT devices include a CPAP device and a ventilator.

1.2.3.3 Vent Technologies

Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide. The vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.

The vent may comprise an orifice and gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become blocked in use and thus provide insufficient washout. Some vents may be disruptive of the sleep of a bed partner1100of the patient1000, e.g. through noise or focussed airflow.

ResMed Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998/034,665; International Patent Application Publication No. WO 2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application Publication No. US 2009/0050156; US Patent Application Publication No. 2009/0044808.

1.2.3.4 Humidifier

Delivery of a flow of air without humidification may cause drying of airways. The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. In addition in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.

A range of artificial humidification devices and systems are known, however they may not fulfil the specialised requirements of a humidifier for medical use, e.g. a medical humidifier.

Medical humidifiers are used to increase humidity and/or temperature of the flow of air in relation to ambient air when required, typically where the patient may be asleep or resting (e.g. at a hospital). A medical humidifier for bedside placement may be small. A medical humidifier may be configured to only humidify and/or heat the flow of air delivered to the patient without humidifying and/or heating the patient's surroundings. Room-based systems (e.g. a sauna, an air conditioner, or an evaporative cooler), for example, may also humidify air that is breathed in by the patient, however those systems would also humidify and/or heat the entire room, which may cause discomfort to the occupants. Furthermore medical humidifiers may have more stringent safety constraints than industrial humidifiers

While a number of medical humidifiers are known, they can suffer from one or more shortcomings. Some medical humidifiers may provide inadequate humidification, some are difficult or inconvenient to use by patients.

In certain prior art medical humidifiers, condensation in the air circuit can be a problem for patients. If water condenses in the air circuit while a patient is wearing the system, some water may enter the patient's airways. In some cases, water may flow back towards a respiratory therapy device, and/or the humidifier, which may potentially then create a risk of damaging or interfering with an operation of the device and/or the humidifier. For example, water may interfere with internal electronics, occlude a flow path, occlude a sensing port, leak and create a hazard, and/or create ‘gurgling’ noise as it is splashed about by the flow of air.

To mitigate this risk, the air circuit may be heated in some instances of the prior art. However, this may increase a cost and complexity of the air circuit, as well as decreasing an overall efficiency of the RPT system, as heat from the air circuit is lost to the ambient due to the temperature difference between the heated air circuit and the ambient. This may lead to an increase in cost/bulk of the therapy system, including from an increased power requirements to power the heated air circuit.

Furthermore, some prior art humidifiers may suffer from a slow response time, for example at start-up, or during operation.

It is an object of the invention to address one or more of the foregoing problems or at least provide the public with a useful choice.

2 BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devices used in the diagnosis, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used in the diagnosis, amelioration, treatment or prevention of a respiratory disorder.

Another aspect of the present technology relates to methods used in the diagnosis, amelioration, treatment or prevention of a respiratory disorder.

An aspect of the present technology is a medical humidification system.

An aspect of certain forms of the present technology is to provide a respiratory pressure treatment system comprising a medical humidification system which provides increased comfort to a patient. An aspect of certain forms of the present technology is to provide methods and/or apparatus that improve the compliance of patients with respiratory therapy.

One form of the present technology provides an energy efficient humidification system for medical use.

One aspect of the present technology is a humidification system for medical use which is less likely to give rise to condensation in an air circuit.

One aspect of the present technology is a humidification system for medical use for a patient which provides a supply of air with water droplets to travel along an air circuit, and which vaporises the water droplets at an end of the air circuit close to the patient.

One aspect of the present technology is a humidification system for medical use comprising a nebuliser, an air circuit and a vaporiser.

An aspect of certain forms of the present technology is a medical device that is easy to use, e.g. by a person who does not have medical training, by a person who has limited dexterity, vision or by a person with limited experience in using this type of medical device.

An aspect of one form of the present technology is a portable RPT device that may be carried by a person, e.g., around the home of the person.

An aspect of one form of the present technology is a patient interface that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment. An aspect of one form of the present technology is a humidifier tank that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment.

According to one aspect of the present technology, there is provided an apparatus or system for treating a respiratory disorder in a patient. The apparatus may comprise a respiratory pressure therapy device. The respiratory pressure therapy device may be configured to generate a flow of air for treating the respiratory disorder. The flow of air may be at a positive pressure with respect to ambient pressure.

The apparatus may further comprise an air circuit adapted to transport the flow of air generated by the respiratory pressure therapy device to a patient interface. The air circuit may have a proximal end connectable to the respiratory pressure therapy device and a distal end connectable to the patient interface.

The apparatus may further comprise a nebuliser module located at or adjacent to the proximal end of the air circuit. The nebuliser module may be adapted to nebulise a liquid to form a nebula of the liquid. The nebuliser may be further adapted to admit the nebula into the flow of air generated by the respiratory pressure therapy device.

The apparatus may further comprise a vaporiser located at the distal end of the air circuit. The vaporiser may be adapted to receive the nebula. The vaporiser may be further adapted to vaporise the nebula to form a humidified flow of air.

The apparatus may further comprise a patient interface adapted for receiving the humidified flow of air and providing the humidified flow of air to the patient for treating the respiratory disorder.

The apparatus may further comprise a reservoir adapted to retain the liquid.

One form of the present technology provides a treatment system for treating a respiratory disorder in a patient. The system may comprise a respiratory pressure therapy device configured to generate a flow of air at a positive pressure with respect to ambient pressure, an air circuit adapted to transport the flow of air to a patient interface, a water reservoir configured to retain a volume of water for humidification of the flow of air, a nebuliser module adapted to receive water from the water reservoir and to generate a nebula, and to admit the nebula into the flow of air for delivery to a vaporiser module, and the vaporiser module adapted to receive the nebula and comprising a heating element configured to generate heat to vaporise the received nebula to humidify the flow of air.

The vaporiser module may be directly connectable to the patient interface.

The heating element may be formed of a thermally conductive material comprising one or more of a metal, a polymer, or a ceramic.

The vaporiser module may comprise a labyrinthine path therethrough for the nebula and the flow of air.

The nebuliser module may be configured to admit the nebula into the flow of air parallel to the flow of air.

The nebuliser module may comprise the water reservoir.

The nebuliser module may comprise a nebuliser configured to float in the water reservoir.

The nebuliser module may be located proximal to the respiratory pressure therapy device.

The air circuit may be located between the nebuliser module and the vaporiser module.

The treatment system may further comprise a liquid filter located downstream of the vaporiser module and configured to block passage of liquid water therethrough.

The air circuit may comprise a wire circuit to provide power and signalling to the vaporiser module.

The air circuit may further comprise a hydrophobic coating on an inner surface thereof.

Another form of the present technology provides a nebuliser apparatus for a respiratory treatment system, the respiratory treatment system for treating a respiratory disorder in a patient. The nebuliser apparatus may comprise an air inlet for receiving a flow of air at a positive pressure with respect to ambient pressure, a nebuliser configured to receive a supply of water, generate a nebula from the supply of water, and admit the nebula into the flow of air. The nebuliser apparatus may further comprise an outlet for the flow of air comprising the nebula, wherein the nebuliser module is configured to admit the nebula into the flow of air parallel to the flow of air.

The nebuliser apparatus may further comprise a water reservoir configured to retain a volume of water, the nebuliser being configured to receive the supply of water from the water reservoir.

The nebuliser may be configured to float in the water reservoir.

Another form of the present technology provides a vaporiser apparatus for a respiratory treatment system, the respiratory treatment system for treating a respiratory disorder in a patient. The vaporiser apparatus may comprise a vaporiser inlet for receiving a nebula in a flow of air at a positive pressure with respect to ambient pressure, a heating element configured to generate heat to vaporise the received nebula to humify the flow of air, and a vaporiser outlet for the humidified flow of air. The vaporiser inlet and the vaporiser outlet may each be configured to be directly connectable to respective parts of an air circuit.

Another form of the present technology provides a vaporiser apparatus for a respiratory treatment system, the respiratory treatment system for treating a respiratory disorder in a patient. The vaporiser apparatus may comprise a vaporiser inlet for receiving a nebula in a flow of air at a positive pressure with respect to ambient pressure, a heating element configured to generate heat to vaporise the received nebula to humidify the flow of air, and a vaporiser outlet for the humidified flow of air. The vaporiser apparatus may be configured to be directly connectable to a patient interface.

The heating element may be formed of a thermally conductive material comprising one or more of a metal, a polymer, or a ceramic.

The vaporiser apparatus may comprise a labyrinthine path therethrough for the nebula and the flow of air.

The vaporiser apparatus may comprise one or more sensors adapted for sensing one or more parameters of the flow of air in the vaporiser outlet, wherein the one or more parameters comprise one or more of: temperature; flow rate; pressure; and humidity of the flow of air in the vaporiser outlet.

The vaporiser apparatus may comprise a vent for venting a flow of exhaled gases from a patient.

The vent may be positioned such that any water vapour in the flow of exhaled gas from the patient is available for vaporising by the heating element for humidifying the flow of air before venting through the vent.

The vaporiser apparatus may comprise a vaporiser housing structured to mate, in use, with a supporting structure of the patient interface.

The vaporiser housing may comprise one or more connecting surfaces surrounding the vaporiser outlet, the one or more connecting surfaces being structured to mate, in use, with a supporting structure of the patient interface.

Another form of the present technology provides a respiratory apparatus for use in treating a respiratory disorder in a patient. The system may comprise a vaporiser apparatus comprising a vaporiser inlet for receiving a nebula in a flow of air at a positive pressure with respect to ambient pressure, a heating element configured to generate heat to vaporise the received nebula to humidify the flow of air, and a vaporiser outlet for the humidified flow of air, and a patient interface directly connected to the vaporiser apparatus.

The vaporiser apparatus may comprise a vaporiser housing and the patient interface comprises a plenum chamber, wherein the vaporiser housing is connected to the plenum chamber.

The vaporiser housing may comprise one or more connecting surfaces surrounding the vaporiser outlet, the one or more connecting surfaces being connected to a supporting structure of the plenum chamber.

The respiratory apparatus may comprise a vent for venting a flow of exhaled gases from a patient.

The vent may be provided in the vaporiser housing.

An aspect of one form of the present technology is a method of manufacturing apparatus in any of the previous aspects.

The methods, systems, devices and apparatus described herein can provide improved functioning in a processor, such as of a processor of a specific purpose computer, respiratory monitor and/or a respiratory therapy apparatus. Moreover, the described methods, systems, devices and apparatus can provide improvements in the technological field of automated management, monitoring and/or treatment of respiratory conditions, including, for example, sleep disordered breathing.

Of course, portions of the aspects may form sub-aspects of the present technology. Various ones of the sub-aspects and/or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.

Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.

