Respiratory therapy device

Abstract

An acoustic respiratory therapy device comprises a transducer interface comprising at least two acoustic transducers, the transducer interface for positioning the at least two acoustic transducers proximate a neck of a user, and a controller configured to control the at least two acoustic transducers to output acoustic waveforms that constructively interfere with one another at one or more target location(s) within a patient corresponding to at least a partial occlusion of the patient's airway.

Description

RESPIRATORY THERAPY DEVICE1 BACKGROUND OF THE TECHNOLOGY1.1 FIELD OF THE TECHNOLOGY

[0001] The present technology relates to one or more of the screening, diagnosis, monitoring, 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 ART1.2.1 Human Respiratory System and its Disorders

[0002] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0003] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “ Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0004] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0005] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

[0006] Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem, e.g. see US Patent No. 4,944,310 (Sullivan).

[0007] 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 Therapies

[0008] Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.1.2.2.1 Respiratory pressure therapies

[0009] Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).

[0010] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.1.2.3 Respiratory Therapy Systems

[0011] These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

[0012] A respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.1.2.3.1 Patient Interface

[0013] 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 cmfhO 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 cmFFO. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0014] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.1.2.3.3 Air circuit

[0015] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.1.2.3.4 Humidifier

[0016] 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.1.2.3.5 Data Management

[0017] There may be clinical reasons to obtain data to determine whether the patient prescribed with respiratory therapy has been “compliant”, e.g. that the patient has used their RPT device according to one or more “compliance rules”. One example of a compliance rule for CPAP therapy is that a patient, in order to be deemed compliant, is required to use the RPT device for at least four hours a night for at least 21 of 30 consecutive days. In order to determine a patient's compliance, a provider of the RPT device, such as a health care provider, may manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period, and compare with the compliance rule. Once the health care provider has determined that the patient has used their RPT device according to the compliance rule, the health care provider may notify a third party that the patient is compliant.

[0018] There may be other aspects of a patient’s therapy that would benefit from communication of therapy data to a third party or external system.

[0019] Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.1.2.3.6 Vent technologies

[0020] 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.1.2.4 Screening, Diagnosis, and Monitoring Systems

[0021] Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular, it is unsuitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0022] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient’s SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.

[0023] Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient’s condition. In addition, a given clinical expert may apply a different standard at different times.2 BRIEF SUMMARY OF THE TECHNOLOGY

[0024] The present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0025] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0026] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0027] 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.

[0028] One form of the present technology comprises an acoustic respiratory therapy (“ART”) device for applying acoustic therapy to at least ameliorate at least a partial occlusion of the patient’s airway.

[0029] In one aspect, an acoustic respiratory therapy (“ART”) device comprises a transducer interface comprising at least two acoustic transducers, the transducer interface for positioning the at least two acoustic transducers proximate a neck of a user, and a controller configured to control the at least two acoustic transducers tooutput acoustic waveforms that constructively interfere with one another at one or more target location(s) within a patient corresponding to at least a partial occlusion of the patient’s airway.

[0030] In another aspect of one form of the present technology, the target location is a patient airway and the controller controls the at least two acoustic transducers to constructively interfere at one or more target location(s) proximate the at least a partial occlusion of the patient’s airway.

[0031] In another aspect of one form of the present technology, the one or more target location(s) are in or surrounding an anatomical structure proximate the patient’s airway.

[0032] In another aspect, the ART device further comprises one or more sensors, and the controller is configured to process an output of the one or more sensors to determine the one or more target locations.

[0033] In another aspect, wherein the controller processes an output of the at least two acoustic transducers to determine the one or more target locations.

[0034] In another aspect, the controller controls a phase of a waveform of at least one of the at least two acoustic transducers to constructively interfere with a waveform or at least another one of the at least two transducers.

[0035] In another aspect, the controller controls at least one of frequency and amplitude of a waveform of at least one of the at least two acoustic transducers.

[0036] In another aspect, the ART device has at least one detection sensor, and the controller processes an output of the at least one detection sensor to detect occurrence of at least one of and obstruction apnea and snoring

[0037] Another aspect of one form of the present technology is a method of acoustic respiratory therapy comprising positioning the at least two acoustic transducers proximate a neck of a user, and controlling the at least two acoustic transducers to output acoustic waveforms that constructively interfere with one another at one or more target location(s) within a patient corresponding to at least a partial occlusion of the patient’s airway.

[0038] In another aspect, the method of acoustic respiratory therapy further comprises providing a transducer interface comprising the at least two acoustic transducers for positioning the at least two acoustic transducers proximate the neck of a user.

[0039] In another aspect, the target location is a patient airway and the method comprises controlling the at least two acoustic transducers to constructively interfere at one or more target location(s) proximate the at least a partial occlusion of the patient’s airway.

[0040] In another aspect, one or more target location(s) are in or surrounding an anatomical structure proximate the patient’s airway.

[0041] In another aspect, the method further comprises processing an output of the at least two acoustic transducers to determine the one or more target locations.

[0042] In another aspect, the method of acoustic respiratory therapy further comprises processing an output of one or more sensors to determine the one or more target locations.

[0043] In another aspect, the method of acoustic respiratory therapy comprises controlling a phase of a waveform of at least one of the at least two acoustic transducers to constructively interfere with a waveform of at least another one of the at least two transducers.

[0044] In another aspect, the method of acoustic respiratory therapy comprises controlling at least one of frequency and amplitude of a waveform of at least one of the at least two acoustic transducers.

[0045] Another aspect of one form of the present technology is a transducer interface for acoustic respiratory therapy comprising at least two acoustic transducers, and a collar supporting the transducer interface for positioning the at least two acoustic transducers proximate a neck of a user.

[0046] In an aspect, the transducer interface further comprises a controller supported on the collar, the controller configured to control the at least two acoustic transducers to output acoustic waveforms that constructively interfere with one another at one or more target location(s) within a patient corresponding to at least a partial occlusion of the patient’s airway.

[0047] In an aspect, the controller processes an output of the at least two acoustic transducers to determine the one or more target locations.

[0048] In an aspect, the transducer interface further comprises one or more sensors supported on the collar, and wherein the controller is configured to process an output of the one or more sensors to determine the one or more target locations and / or an to detect occurrence of at least one of and obstruction apnea and snoring.

[0049] The methods, systems, devices and apparatus described may be implemented so as to improve the functionality of a processor, such as 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.

[0050] Of course, portions of the aspects may form sub-aspects of the present technology. Also, 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.

[0051] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.3 BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:3.1 RESPIRATORY THERAPY SYSTEMS

[0053] Fig. 1 A shows a system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0054] Fig. IB shows a system including a patient 1000 wearing a patient interface 3000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.

[0055] Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000, in the form of a full -face mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.3.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0056] Fig. 2A shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.

[0057] Fig. 2B shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.3.3 PATIENT INTERFACE

[0058] Fig. 3 A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.3.4 RPT DEVICE

[0059] Fig. 4A shows an RPT device in accordance with one form of the present technology.

[0060] Fig. 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. The directions of upstream and downstream are indicated with reference to the blower and the patient interface. The blower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0061] Fig. 4C is a schematic diagram of the electrical components of an RPT device in accordance with one form of the present technology.3.5 HUMIDIFIER

[0062] Fig. 5A shows an isometric view of a humidifier in accordance with one form of the present technology.

[0063] Fig. 5B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.3.6 ACOUSTIC RESPIRATORY THERAPY DEVICE

[0064] Fig. 6A is a schematic diagram of transducer interface 6100 of an acoustic respiratory therapy device (ART device) 6000 in accordance with one form of the present technology.

[0065] Fig. 6B shows a patient 1000 wearing transducer interface 6100 in accordance with one form of the present technology.

[0066] Fig. 6C illustrates an example target location for acoustic respiratory therapy in accordance with one form of the present technology.

[0067] Fig. 6D is a schematic diagram of an acoustic respiratory therapy device 6000 in accordance with one form of the present technology and connection of the acoustic respiratory therapy device to a patient 1000.

[0068] Fig. 6E is a schematic diagram of the electrical components an acoustic respiratory therapy device 6000 in accordance with one form of the present technology.

[0069] Fig. 6F is a flow chart of an acoustic respiratory therapy method in accordance with one form of the present technology.4 DETAILED DESCRIPTION OF EXAMPLES OF THETECHNOLOGY

[0070] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0071] The following description is provided in relation to various examples which may share one or more common characteristics and / or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.4.1 THERAPY

[0072] In one form, the present technology comprises a method for treating a respiratory disorder comprising applying constructive interference generated using acoustic transducers to at least one target location within a patient 1000. In one form of the technology, the at least one target location corresponds to at least a partial occlusion of the patient’s airway in order to at least ameliorate an apnea.

[0073] In one form, the present technology may be combined with a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0074] The treatment technologies may be combined by being conducted concurrently, or by one treatment being conducted as a primary treatment before activating the other treatment to supplement the primary treatment or to replace the primary treatment /

[0075] In certain examples of applying positive pressure to the entrance of the airways of a patient 1000, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0076] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.4.2 ACOUSTIC THERAPY SYSTEMS

[0077] In one form, the present technology comprises an acoustic respiratory therapy system for treating a respiratory disorder. The acoustic respiratory therapy system may comprise an ART device 6000 for generating constructive acoustic interference at a target location corresponding to an occlusion of a patient’s airway. In one form of the technology an ART device 6000 comprises acoustic transducers and a controller for controlling the acoustic transducers to output acoustic waveforms that constructively interfere with one another. In some forms of the technology, the ART device uses the acoustic transducers to sense a condition of the patient, such as an occlusion of a patient’s airway, and the controller controls the acoustic transducers at least partly on the basis of the sensed condition. In some forms of the technology, the ART device further comprises at least one sensor for sensing the condition of a patient.TRANSDUCER INTERFACE

[0078] In one form, the present technology comprises a transducer interface 6100, such as shown in Fig. 6A. In accordance with one aspect of the present technology, transducer interface comprises the following functional aspects: acoustic transducers 6110, sensors 6120 for monitoring a condition of a patient, a clasp 6150, and a control unit 6200. In an aspect, the control unit 6200 is connected to the acoustic transducers 6110 and sensors 6120 by cable 6130 that supplies power and communications to each sensor 6120 and acoustic transducer 6110. In an aspect,control unit 6200 comprises a power input port or an inductive charging circuit for connecting to an inductive charger in order to charge the control unit battery. In this aspect of the technology, the control unit 6200 forms part of the transducer interface and is rechargeable.

[0079] In an aspect, cable 6130 is incorporated within a collar 6160 for physically supporting the transducers 6110 and holding the transducers 6110 firmly against the patient’s neck. In another aspect, the cable 6130 may be in form of wires, flexible circuit or integrated into a rigid-flex board. In an aspect, the collar 6160 is connected by clasp 6150 which comprises first 6150A and second 6150B magnetic clasp members at each end of the collar to hold the transducer interface 6100 in place while allowing the transducer interface 6100 to become detached if it becomes snagged. In an aspect, the acoustic transducers 6110 and cable 6130 may be placed within the collar 6160 to be physically supported by the collar 6160. Fig. 6B illustrates how transducer interface 6100 may be worn by a patient 1000 with two transducers 6110 on either side of the patient’s neck.

[0080] Fig. 6 A shows an aspect using four acoustic transducers 6110A, 6110B, 6110C, 6110D. In aspect, at least two acoustic transducers are used to enable constructive interference to be generated from the acoustic waveforms output by the acoustic transducers 6110. In an aspect, larger numbers of acoustic transducers may enable more effective control of targeting of the constructive interference or enable the output of a wider range of waveforms (e.g. at different frequencies) in order to shape the waveforms and the constructive interference. In aspect, at least three acoustic transducers are used in order to enable three-dimensional focussing of the acoustic transducers. In some forms of the technology, the acoustic transducers are ultrasound transducers. Other acoustic transducers may be used instead of, or in addition to, ultrasound transducers depending on the desired waveforms.

[0081] FIG. 6 A shows the acoustic transducers 6110 separate from the sensors6120. In an aspect, the sensors 6120 may be integrated with the acoustic transducers 6110. In a form of the technology, where the acoustic transducers 6110 are ultrasound transducers, the ultrasound transducers may be used to monitor for obstruction of the patient’s airway.

[0082] In another form of the technology, the control unit 6200 is provided separately from the transducer interface 6100 and communicates wirelessly with the acoustic transducers 6110 and sensors 6120. In an aspect of this form of thetechnology, the transducers and sensors may be individually rechargeable, for example, using inductive charging. An advantage of this aspect of the technology is that fewer components on the transducer interface will tend to improve patient comfort. Another advantage of this aspect is to allow the control unit to be connected to a general purpose electrical outlet such that it does not need to be recharged.

[0083] In another form of the technology, the transducer interface may be formed by individually placing the transducers and / or the sensors on the patient’s neck, for example, using adhesive patches. In an aspect of this form of the technology, the transducers and sensors may be individually rechargeable, for example, using inductive charging. In this form of the technology, the transducers and / or the sensors communicate wirelessly with the control unit.

[0084] In an aspect, a conductive gel may be used between the acoustic transducers and the patient’s skin. In an aspect, a gel pad may be used. In an aspect, the collar 6160 may be formed from a strip of hook and loop material (e.g. Velcro). In this aspect, the collar 6160 may not require a clasp. In an aspect, the transducer interface may be in the form of a shaped pillow.CONTROL UNIT

[0085] As shown in Fig. 6D, in one form, the present technology the ART device 6000 comprises a control unit 6200 in integral form. In other forms, the components of the control unit may be distributed. In accordance with one aspect of the present technology, the control unit 6200 comprises the following functional aspects: primary sensors 6210 for sensing an apnea which may include a bone conduction microphone and / or an accelerometer and / or a vibration sensor and / or an electroencephalogram (EEG) sensor; additional sensors 6220, such as a gas sensor, standard microphone or flow sensor; rechargeable battery 6230; power management circuit 6240; a processor 6250, such as an MCU or MPU; a charging circuit 6260 which may be inductive or wired; a wireless communication circuit 6270 such as Bluetooth Low Energy or Wi-Fi which provides a data communication system; storage 6275 (formed from one or more memory components) for storing, for example, control logic; other circuits 6280; and an ultrasound control circuit 6285. The ultrasound circuit 6285 is connected to the ultrasound transducers 6110. It will be appreciated that in this aspect, the processor 6250 acts as a central controller for the ART device and is configured toimplement one or more methods for acoustic respiratory treatment, such as the algorithms described herein which may be implemented with processor-control instructions, expressed as computer programs stored in the storage 6275 which acts as a non-transitory computer readable storage medium.

[0086] As also illustrated schematically in Fig. 6D, ultrasound transducers 6110 are placed in proximity to the patient’s skin 6310 and transmit ultrasound waveforms through the skin 6310, and muscle and / or other tissue 6320 to the target location 6330 within the patient 1000.

[0087] Fig. 6C illustrates an example of the ultrasound control circuit 6285 controlling ultrasound transducers 6110 to cause acoustic waveforms to interfere at a target location. In this example, patient 1000 is breathing in air 6450. The patient is experiencing an apnea such that there is at least a partial occlusion 6430 of the patient’s airway. As shown, in Fig 6C, ultrasound control circuit 6285 is controlling first and second ultrasound transducers 6110A, 6110B to output first waveforms 6410 A, and third and fourth ultrasound transducers 6110C, 6110D to output second waveforms 6410B so that they will constructively interfere at a target location 6330, for example, in the muscle wall adjacent to the obstruction to cause the occlusion to open thereby treating the apnea. In aspect, the waveforms are alternating waveforms such that the constructive interference of the waveforms will periodically generate a region of high intensity that acts, for example, on the muscle wall adjacent the occlusion . In some example, manipulation may be achieved by electronically steering the beam by altering the phase of the wave emitted from each transducer and / or changing which transducers are used. Although the force applied depends on many factors, a region of low intensity surrounded by a region of high intensity defines an intensity well that can provide a method to act on the target region. In an aspect, vortex beams are used to create such an intensity well. The vortex is created by varying the phase of the wave emitted across a transducer surface so that it is generating a helical wavefront. In an example, the phase is increased linearly with the circumferential angle and the helicity has a pitch so that it is continuous around the circumference. The outcome is destructive interference of the wave on-axis, but constructive interference off-axis, resulting in an intensity ring in the plane transverse to the beam axis. If the ring is placed around a target region and shifted transversely, force from the higher-intensity ring will generally “push” toward the centre of the ring.4.2.1 ART device electrical circuit

[0088] As shown in Fig. 6E, an ART device 6000 may comprise an inductive coil or connector 6265 connected to a charging circuit 6260 which in turn is connected to battery 6230. In an example, ART device 6000 comprises a power management integrated circuit 6240 under control of processor 6250 (e.g. an MPU or MCU) and controlling the supply of power from the battery 6230 to the primary sensors 6210, processor 6250, storage 6275, wireless communication circuit 6270, and ultrasound circuit.

[0089] In one form of the technology, processor 6250 controls ultrasound transducers and / or primary sensors 6210 to conduct monitoring to gather data indicative of the target location. In one example, the primary sensors 6210 are at least two bone conduction microphones and are used to determine at least one target location by the processor 6250 processing the microphone output to extract signal components characteristic of an apnea using analysis algorithms in storage 6275 and using triangulation to determine a location of the apnea and determine one or more target locations based on the apnea location. In one aspect, at least one sensor is a detection sensor for detecting occurrence of at least one of an obstruction apnea and snoring.

[0090] Processor 204 then determines waveforms that will constructively interfere at the target location and controls the ultrasound circuit 6285 to drive the ultrasound transducer 6110 to output the determined waveforms.

[0091] In an aspect of the technology, the processor 6250 may determine more than one location (e.g. changing locations or a pattern of locations) and control the ultrasound circuit 6285 to drive ultrasound transducers 6110 to cause the waveforms to constructively interfere at each of these locations.4.2.2 ART device algorithms

[0092] As mentioned above, in some forms of the present technology, the control unit 6200 may be configured to implement one or more algorithms expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 6275.

[0093] An algorithm 6500 of one form of the technology for treating an apnea is shown in Fig. 6F. At step 6510 the ART device is started. In one form, the ART device 6000 may be started by the patient as they are preparing to go to sleep. In thisrespect, the ART device may include one or more input devices such as buttons, switches or the like for the patient to start / stop the device. The one or more input devices may also be provided by a local external device, software, e.g. an application running on an electronic device such as a personal computer, mobile phone, tablet or remote control.

[0094] In another form, the ART device 6000 may be started by a connected system such as an RPT device 4000 in response to control logic in the RPT device 4000 determining that therapy is to be commenced. In another form, the ART device 6000 may start monitoring for apneas when it is detected that the patient is asleep.

[0095] At step 6520, the processor 6250 reads data from the ultrasound transducers and / or the primary sensors 6210. In one example, the primary sensors 6210 are bone conducting microphones). At step 6530, the processor 6250 processes the data (e.g. to extract sensor data corresponding to breathing from background noise) and at step 6540, the processor 6250 applies an apnea detection algorithm 6540 to the processed data to determine a target location. In an aspect, the apnea detection algorithm processes the ultrasound transducer output to detect and locate an apnea. In an aspect, the apnea detection algorithm sensor additionally or instead processes the data from the primary sensors to detect and locate the apnea.

[0096] At step 6550 processor 6250 determines whether an apnea is detected and, upon making a positive determination, applies 6260 ultrasonic energy for apnea treatment via transducers 6110. In an aspect, the processor 6250 controls at least one of phase, frequency and amplitude of the waveforms in order to generate the desired constructive interference location and characteristics. In an aspect, the processor 6250 determines a desired overall waveform and then uses frequency decomposition to determine the frequency of waveforms for individual transducers. In an aspect, the processor 6250 controls which ultrasound transducers are used.

[0097] At step 6570, processor 6250 determines whether to end the therapy. In some examples, the therapy is ended when the patient has woken. If processor 6250 makes a decision to continue therapy at step 6570, processor 6250 iterates back to step 6520.

[0098] In other aspects, the detection technique may depend on the primary sensor, for example, EEG electrodes may be used as an EEG sensor to monitor for an apnea and another sensor may be used to determine a target location.

[0099] While in this form of the technology, the device 6000 continually monitors for apneas and only applies ultrasound when an apnea is detected, in other forms of the technology, the device may apply ultrasound energy continuously or for a defined time period after an apnea is detected without checking for an ongoing apnea.

[0100] In another form of the technology, the processor 6250 may control the transducer to output a waveform tuned to a particular flesh-type.RESPIRATORY THERAPY SYSTEMS

[0101] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder in combination with the ART device 6000 described herein. The respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0102] In one form the ART device 6000 and RPT device 4000 have independent physical components. In an aspect, this enables them to be supplied independently as separate modular components. In this aspect, control logic implemented by one or both of the ART device and RPT device coordinates operation to apply combined therapy. In another form, the ART device and RPT device may share some physical components such as by having some common electrical components such as a processor, memory, a power circuit. This aspect may reduce construction costs.4.3 PATIENT INTERFACE

[0103] A non-invasive patient interface 3000, such as that shown in Fig. 3A, in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal -forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.4.4 RPT DEVICE

[0104] An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0105] The RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015. The RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0106] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.

[0107] One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.

[0108] As shown in Fig. 4C, the RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducers 4270, data communication interface 4280 and one or more output devices 4290. Electrical components 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.4.4.1 RPT device mechanical & pneumatic components

[0109] An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.4.4.1.1 Air filter(s)

[0110] An RPT device in accordance with one form of the present technology may include an air filter 4110, or a plurality of air filters 4110.

[0111] In one form illustrated in Fig. 4B, an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.

[0112] In one form illustrated in Fig. 4B, an outlet air filter 4114, for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000 or 3800.4.4.1.2 Muffler(s)

[0113] An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0114] In one form of the present technology (see e.g., Fig. 4B), an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.

[0115] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000 or 3800.4.4.1.3 Pressure generator

[0116] In one form of the present technology, a pressure generator 4140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be located in a volute. The blower may be capable of delivering a supply of air, for example at a rate of up to about 120 litres / minute, at a positive pressure in a range from about 4 cmH20 to about 20 cmH20, or in other forms up to about 30 cmH20 when delivering respiratory pressure therapy. The blower may be as described in any one of the following patents or patent applications the contents of which are incorporated herein by reference in their entirety: U.S.Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0117] The pressure generator 4140 may be under the control of the therapy device controller 4240.

[0118] In other forms, a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows.4.4.1.4 Transducer(s)

[0119] Transducers may be internal of the RPT device, or external of the RPT device. External transducers may be located for example on or form part of the air circuit, e.g., the patient interface. External transducers may be in the form of noncontact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.

[0120] In one form of the present technology (see e.g., Fig. 4B), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate signals representing properties of the flow of air such as a flow rate, a pressure or a temperature at that point in the pneumatic path.

[0121] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800.

[0122] In one form, a signal from a transducer 4270 may be filtered, such as by low-pass, high-pass or band-pass filtering.4.4.1.4.1 Flow rate sensor

[0123] A flow rate sensor 4274 in accordance with the present technology may be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION.

[0124] In one form, a signal generated by the flow rate sensor 4274 and representing a flow rate is received by the central controller 4230.4.4.1.4.2 Pressure sensor

[0125] A pressure sensor 4272 in accordance with the present technology is located in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the NPA Series from GENERAL ELECTRIC.

[0126] In one form, a signal generated by the pressure sensor 4272 and representing a pressure is received by the central controller 4230.4.4.1.4.3 Motor speed transducer

[0127] In one form of the present technology a motor speed transducer 4276 is used to determine a rotational velocity of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to thetherapy device controller 4240. The motor speed transducer 4276 may, for example, be a speed sensor, such as a Hall effect sensor.4.4.1.5 Anti-spill back valve

[0128] As shown in Fig. 4B, one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144.4.4.2 RPT device electrical components4.4.2.1 Power supply

[0129] A power supply 4210 may be located internal or external of the external housing 4010 of the RPT device 4000.

[0130] In one form of the present technology, power supply 4210 provides electrical power to the RPT device 4000 only. In another form of the present technology, power supply 4210 provides electrical power to both RPT device 4000 and humidifier 5000.4.4.2.1 Input devices

[0131] In one form of the present technology, an RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a person to interact with the device. The buttons, switches or dials may be physical devices, or software devices accessible via a touch screen. The buttons, switches or dials may, in one form, be physically connected to the external housing 4010, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 4230.

[0132] In one form, the input device 4220 may be constructed and arranged to allow a person to select a value and / or a menu option.4.4.2.3 Central controller

[0133] In one form of the present technology, the central controller 4230 is one or a plurality of processors suitable to control an RPT device 4000. The central controller 4230 is show in Fig. 4C.

[0134] Suitable processors may include an x86 INTEL processor, a processor based on ARM® Cortex®-M processor from ARM Holdings such as an STM32 series microcontroller from ST MICROELECTRONIC. In certain alternative forms of the present technology, a 32-bit RISC CPU, such as an STR9 series microcontrollerfrom ST MICROELECTRONICS or a 16-bit RISC CPU such as a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS may also be suitable.

[0135] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0136] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 comprises discrete electronic components.

[0137] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and / or the humidifier 5000.

[0138] The central controller 4230 may be configured to provide output signal(s) to one or more of an output device 4290, a pressure generator 4140, a therapy device controller 4240, a data communication interface 4280, and / or the humidifier 5000.

[0139] In some forms of the present technology, the central controller 4230 is configured to implement the one or more methodologies described herein, such as the one or more algorithms 4300 which may be implemented with processor-control instructions, expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260. In some forms of the present technology, the central controller 4230 may be integrated with an RPT device 4000.4.4.1.4 Clock

[0140] The RPT device 4000 may include a clock 4232 that is connected to the central controller 4230.4.4.1.5 Therapy device controller

[0141] In one form of the present technology, therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form a MC33035 brushless DC motor controller, manufactured by ONSEMI is used.4.4.1.6 Protection circuits

[0142] The one or more protection circuits 4250 in accordance with the present technology may comprise an electrical protection circuit, a temperature and / or pressure safety circuit.4.4.1.7 Memory

[0143] In accordance with one form of the present technology the RPT device 4000 includes memory 4260, e.g., non-volatile memory. In some forms, memory4260 may include battery powered static RAM. In some forms, memory 4260 may include volatile RAM.

[0144] Memory 4260 may be located on the PCBA 4202. Memory 4260 may be in the form of EEPROM, or NAND flash.

[0145] Additionally, or alternatively, RPT device 4000 includes a removable form of memory 4260, for example a memory card made in accordance with the Secure Digital (SD) standard.

[0146] In one form of the present technology, the memory 4260 acts as a non- transitory computer readable storage medium on which is stored computer program instructions expressing the one or more methodologies described herein, such as the one or more algorithms 4300.4.4.1.8 Data communication systems

[0147] In one form of the present technology, a data communication interface 4280 is provided, and is connected to the central controller 4230 (see e.g., Fig. 4C). Data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0148] In one form, data communication interface 4280 is part of the central controller 4230. In another form, data communication interface 4280 is separate from the central controller 4230, and may comprise an integrated circuit or a processor.

[0149] In one form, remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g. via Ethernet, or optical fibre) or a wireless protocol (e.g. CDMA, GSM, LTE) to connect to the Internet.

[0150] In one form, local external communication network 4284 utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol.

[0151] In one form, remote external device 4286 is one or more computers, for example a cluster of networked computers. In one form, remote external device 4286 may be virtual computers, rather than physical computers. In either case, such a remote external device 4286 may be accessible to an appropriately authorised person such as a clinician.

[0152] The local external device 4288 may be4.4.1.9 Output devices including optional display, alarms

[0153] An output device 4290 in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display.4.4.2.9.1 Display driver

[0154] A display driver 4292 receives as an input the characters, symbols, or images intended for display on the display 4294, and converts them to commands that cause the display 4294 to display those characters, symbols, or images.4.4.2.9.2 Display

[0155] A display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol, such as the figure “0”, to eight logical signals indicating whether the eight respective segments are to be activated to display a particular character or symbol.4.5 AIR CIRCUIT

[0156] An air circuit 4170 in accordance with an aspect of the present technology is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components such as RPT device 4000 and the patient interface 3000 or 3800.

[0157] In particular, the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases there may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used.

[0158] In some forms, the air circuit 4170 may comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air. The heating element may be in a form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors. In one form, the heated wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller 4230. One example of an air circuit 4170 comprising a heated wire circuit is described in United States Patent 8,733,349, which is incorporated herewithin in its entirety by reference.4.6 HUMIDIFIER4.6.1 Humidifier overview

[0159] In one form of the present technology there is provided a humidifier 5000 (e.g. as shown in Fig. 5A) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delivery to the patient’s airways.

[0160] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air. In some forms, as shown in Fig. 5A and Fig. 5B, an inlet and an outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively. The humidifier 5000 may further comprise a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and comprise a heating element 5240.4.6.2 Humidifier components4.6.2.1 Water reservoir

[0161] According to one arrangement, the humidifier 5000 may comprise a water reservoir 5110 configured to hold, or retain, a volume of liquid (e.g. water) to be evaporated for humidification of the flow of air. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water in order to provide adequate humidification for at least the duration of a respiratory therapy session, such as one evening of sleep. Typically, the reservoir 5110 is configured to hold several hundred millilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400 ml. In other forms, the humidifier 5000 may be configured to receive a supply of water from an external water source such as a building’s water supply system.

[0162] According to one aspect, the water reservoir 5110 is configured to add humidity to a flow of air from the RPT device 4000 as the flow of air travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the flow of air to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0163] According to one form, the reservoir 5110 may be removable from the humidifier 5000, for example in a lateral direction as shown in Fig. 5 A and Fig. 5B.

[0164] The reservoir 5110 may also be configured to discourage egress of liquid therefrom, such as when the reservoir 5110 is displaced and / or rotated from its normal, working orientation, such as through any apertures and / or in between its subcomponents. As the flow of air to be humidified by the humidifier 5000 is typically pressurised, the reservoir 5110 may also be configured to prevent losses in pneumatic pressure through leak and / or flow impedance.4.6.2.1 Conductive portion

[0165] According to one arrangement, the reservoir 5110 comprises a conductive portion 5120 configured to allow efficient transfer of heat from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may also be suitable. All or a part of the conductive portion 5120 may be made of a thermally conductive material such as aluminium (e.g. approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm or 3 mm), another heat conducting metal or some plastics. In some cases, suitable heat conductivity may be achieved with less conductive materials of suitable geometry.4.6.1.3 Humidifier reservoir dock

[0166] In one form, the humidifier 5000 may comprise a humidifier reservoir dock 5130 (as shown in Fig. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may comprise a locking feature such as a locking lever 5135 configured to retain the reservoir 5110 in the humidifier reservoir dock 5130.4.6.1.4 Water level indicator

[0167] The humidifier reservoir 5110 may comprise a water level indicator 5150 as shown in Fig. 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user such as the patient 1000 or a care giver regarding a quantity of the volume of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum, predetermined volume of water, any portions thereof, such as 25%, 50% or 75% or volumes such as 200 ml, 300 ml or 400ml.4.7 RESPIRATORY THERAPY MODES

[0168] Various respiratory therapy modes may be implemented by the disclosed respiratory therapy system.4.8 GLOSSARY

[0169] For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.4.8.1 General

[0170] Air '. In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. oxygen enriched air.

[0171] Ambient'. In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0172] For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.

[0173] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0174] Continuous Positive Airway Pressure (CPAP) therapy. Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

[0175] Flow rate'. The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

[0176] Flow therapy. Respiratory therapy comprising the delivery of a flow of air to an entrance to the airways at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient’s breathing cycle.

[0177] Humidifier'. The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapour to a flow of air to ameliorate a medical respiratory condition of a patient.

[0178] Leak'.

[0179] Patient'. A person, whether or not they are suffering from a respiratory condition.

[0180] Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmFFO, g-f / cm2and hectopascal. 1 cmFLO is equal to 1 g-f / cm2and is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m2= 1 millibar ~ 0.001 atm). In this specification, unless otherwise stated, pressure is given in units of cmFLO.

[0181] The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the interface pressure Pm at the current instant of time, is given the symbol Pt.

[0182] Respiratory Pressure Therapy. The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.

[0183] Ventilator'. A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.4.8.1.1 Mechanics

[0184] Axes: a. Neutral axis: An axis in the cross-section of a beam or plate along which there are no longitudinal stresses or strains. b. Longitudinal axis: An axis extending along the length of a shape. The axis generally passes through a center of the shape. c. Circumferential axis: An axis oriented perpendicularly with respect to the longitudinal axis. The axis may be specifically present in pipes, tubes, cylinders, or similar shapes with a circular and / or elliptical cross section.

[0185] Rigid structure or component: A structure or component that will not substantially change shape when subject to the loads typically encountered in use. An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient's airways, e.g. at a load of approximately 20 to 30 cmH20 pressure.4.8.2 Respiratory cycle

[0186] Apnea: According to some definitions, an apnea is said to have occurred when flow falls below a predetermined threshold for a duration, e.g. 10 seconds. An obstructive apnea will be said to have occurred when, despite patient effort, some obstruction of the airway does not allow air to flow. A central apnea will be said to have occurred when an apnea is detected that is due to a reduction in breathing effort, or the absence of breathing effort, despite the airway being patent. A mixed apnea occurs when a reduction or absence of breathing effort coincides with an obstructed airway.

[0187] Flow limitation: Flow limitation will be taken to be the state of affairs in a patient's respiration where an increase in effort by the patient does not give rise to a corresponding increase in flow. Where flow limitation occurs during an inspiratory portion of the breathing cycle it may be described as inspiratory flow limitation. Where flow limitation occurs during an expiratory portion of the breathing cycle it may be described as expiratory flow limitation.

[0188] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the RPT device’s estimate of respiratory flow rate, as opposed to “true respiratory flow rate” or “true respiratory flow rate”, which is the actual respiratory flow rate experienced by the patient, usually expressed in litres per minute.

[0189] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, in which the flow rate increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behaviour).4.8.3 Anatomy4.8.3.1 Anatomy of the respiratory system

[0190] Diaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, containing the heart, lungs andribs, from the abdominal cavity. As the diaphragm contracts the volume of the thoracic cavity increases and air is drawn into the lungs.

[0191] Larynx: The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.

[0192] Lungs: The organs of respiration in humans. The conducting zone of the lungs contains the trachea, the bronchi, the bronchioles, and the terminal bronchioles. The respiratory zone contains the respiratory bronchioles, the alveolar ducts, and the alveoli.

[0193] Nasal cavity: The nasal cavity (or nasal fossa) is a large air filled space above and behind the nose in the middle of the face. The nasal cavity is divided in two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal outgrowths called nasal conchae (singular "concha") or turbinates. To the front of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.

[0194] Pharynx: The part of the throat situated immediately inferior to (below) the nasal cavity, and superior to the oesophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).4.9 OTHER REMARKS

[0195] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.

[0196] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0197] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0198] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means + / - 5-10% of the recited value.

[0199] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0200] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0201] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents, unless the context clearly dictates otherwise.

[0202] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0203] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0204] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0205] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and / or aspects thereof may be conducted concurrently or even synchronously.

[0206] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.

Claims

CLAIMS1. An acoustic respiratory therapy (“ART”) device comprising: a transducer interface comprising at least two acoustic transducers, the transducer interface for positioning the at least two acoustic transducers proximate a neck of a user; and a controller configured to control the at least two acoustic transducers to output acoustic waveforms that constructively interfere with one another at one or more target location(s) within a patient corresponding to at least a partial occlusion of the patient’s airway.

2. The ART device as claimed in claim 1, wherein the target location is a patient airway and the controller controls the at least two acoustic transducers to constructively interfere at one or more target location(s) proximate the at least a partial occlusion of the patient’s airway.

3. The ART device as claimed in claim 1 or claim 2, wherein the one or more target location(s) are in or surrounding an anatomical structure proximate the patient’s airway.

4. The ART device as claimed in any one of claims 1 to 3, wherein the controller processes an output of the at least two acoustic transducers to determine the one or more target locations.

5. The ART device as claimed in claim 4, further comprising one or more sensors, and wherein the controller is configured to process an output of the one or more sensors to determine the one or more target locations.

6. The ART device as claimed in any one of claims 1 to 5, wherein the controller controls a phase of a waveform of at least one of the at least two acoustic transducers to constructively interfere with a waveform or at least another one of the at least two transducers.

7. The ART device as claimed in any one of claims 1 to 6, wherein the controller controls at least one of frequency and amplitude of a waveform of at least one of the at least two acoustic transducers.

8. The ART device as claimed in any one of claims 1 to 7, further comprising at least one detection sensor, and wherein the controller processes an output of the at least one detection sensor to detect occurrence of at least one of an obstruction apnea and snoring.

9. A method of acoustic respiratory therapy comprising: positioning at least two acoustic transducers proximate a neck of a user; and controlling the at least two acoustic transducers to output acoustic waveforms that constructively interfere with one another at one or more target location(s) within a patient corresponding to at least a partial occlusion of the patient’s airway.

10. The method of acoustic respiratory therapy as claimed in claim 9, further comprising providing a transducer interface comprising the at least two acoustic transducers for positioning the at least two acoustic transducers proximate the neck of a user.

11. The method of acoustic respiratory therapy as claimed in claim 9 or claim 10, wherein the target location is a patient airway and the method comprises controlling the at least two acoustic transducers to constructively interfere at one or more target location(s) proximate the at least a partial occlusion of the patient’s airway.

12. The method of acoustic respiratory therapy as claimed in any one of claims 9 to 11, wherein the one or more target location(s) are in or surrounding an anatomical structure proximate the patient’s airway.

13. The method of acoustic respiratory therapy as claimed in any one of claims 9 to 13, further comprising processing an output of the at least two acoustic transducers to determine the one or more target locations.

14. The method of acoustic respiratory therapy as claimed in any one of claims 9 to 13, further comprising processing an output of one or more sensors to determine the one or more target locations.

15. The method of acoustic respiratory therapy as claimed in any one of claims 9 to 14, comprising controlling a phase of a waveform of at least one of the at least two acoustic transducers to constructively interfere with a waveform or at least another one of the at least two transducers.

16. The method of acoustic respiratory therapy as claimed in any one of claims 9 to 14, comprising controlling at least one of frequency and amplitude of a waveform of at least one of the at least two acoustic transducers.

17. A transducer interface for acoustic respiratory therapy comprising: at least two acoustic transducers; and a collar supporting the transducer interface for positioning the at least two acoustic transducers proximate a neck of a user.

18. The transducer interface as claimed in claim 17, further comprising a controller supported on the collar, the controller configured to control the at least two acoustic transducers to output acoustic waveforms that constructively interfere with one another at one or more target location(s) within a patient corresponding to at least a partial occlusion of the patient’s airway.

19. The transducer interface as claimed in claim 18, wherein the controller processes an output of the at least two acoustic transducers to determine the one or more target locations.

20. The transducer interface as claimed in claim 19, further comprising one or more sensors supported on the collar, and wherein the controller is configured toprocess an output of the one or more sensors to determine the one or more target locations and / or to detect occurrence of at least one of an obstruction apnea and snoring.

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