CN121752228A

CN121752228A - Forehead cooling system

Info

Publication number: CN121752228A
Application number: CN202480044645.7A
Authority: CN
Inventors: 利亚姆·霍利; 赛义达·玛丽亚姆·卡什夫
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2023-07-21
Filing date: 2024-07-18
Publication date: 2026-03-27
Also published as: WO2025019888A1

Abstract

This technology relates to a forehead cooling system configured for use with a patient interface to aid in the treatment of sleep and breathing disorders. Examples of this technology include fluid cooling systems, such as air cooling and water cooling. Other examples utilize phase change materials and thermoelectric coolers. In some examples, the forehead cooling system may be attached to a positioning and stabilizing structure.

Description

Forehead cooling system

Cross Reference to Related Applications

The present application claims the benefit of australian provisional patent application number 2023902322 filed on 7/21 2023, the contents of which are incorporated herein by reference in their entirety.

Background

2.1 Technical field

The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

2.2 Description of related Art

2.2.1 Human respiratory system and disorders thereof

The respiratory system of the human body promotes gas exchange. The nose and mouth form the entrance to the airway of the patient.

The airways include a series of branches that become narrower, shorter and more numerous as the branch airways penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from inhaled air into venous blood and carbon dioxide to move in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lung is the region where gas exchange occurs and is referred to as the respiratory region. See 9 th edition of respiratory physiology (Respiratory Physiology) by John b.west published by the liberty, williams and Wilkins groups (Lippincott Williams & Wilkins) 2012.

There are a range of respiratory disorders. Certain disorders may be characterized by specific events such as apneas, hypopneas, and hyperbreaths.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), tidal breathing (CSR), respiratory insufficiency, obese Hyperventilation Syndrome (OHS), chronic Obstructive Pulmonary Disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) characterized by events that include occlusion or blockage of the upper airway during sleep. It is caused by the combination of abnormally small upper airways and normal loss of muscular tension in the tongue, soft palate and posterior oropharyngeal wall areas during sleep. The condition causes the affected patient to stop breathing, typically for a period of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This often results in excessive daytime sleepiness, and can lead to cardiovascular disease and brain damage. Syndrome is a common disorder, especially in overweight men in middle age, but the affected person may not be aware of this problem, see for example U.S. Pat. No. 4,944,310 (Sullivan).

Tidal breathing (CSR) is another form of sleep disordered breathing. CSR is an obstacle to the respiratory controller of a patient in which there is a rhythmic alternating period of active and inactive ventilation called the CSR cycle. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR may be detrimental due to repeated hypoxia. In some patients, CSR is associated with repeated arousals from sleep, which results in severe sleep disruption, increased sympathetic activity, and increased afterload, see, for example, U.S. patent No. 6,532,959 (Berthon-Jones).

Respiratory failure is a covered term for respiratory disorders in which the lungs cannot inhale enough oxygen or exhale enough CO2 to meet the needs of the patient. Respiratory failure may encompass some or all of the following disorders.

Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath while exercising.

Obesity Hyperventilation Syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia upon waking, with no other known cause of hypoventilation. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any one of a group of lower airway diseases that share some common features. These include increased resistance to air movement, prolonged expiratory phases of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (major risk factor), occupational exposure, air pollution and genetic factors. Symptoms include effort dyspnea, chronic cough, and sputum production.

Neuromuscular disease (NMD) is a broad term that encompasses many diseases and afflictions that impair muscle function either directly by intrinsic muscle pathology or indirectly by neuropathology. Some NMD patients are characterized by progressive muscle damage that results in loss of walking ability, wheelchairs, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as fast-progressive and slow-progressive (i) fast-progressive disorders characterized by muscle damage worsening over months and leading to death within years (e.g., amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD) in teenagers), and (ii) variable or slow-progressive disorders characterized by muscle damage worsening over years and only slightly shortening the life expectancy (e.g., limb banding, facial shoulder humeral, and tonic muscular dystrophy). Symptoms of respiratory failure in NMD include increasing general weakness, dysphagia, dyspnea during exercise and rest, fatigue, somnolence, morning headaches, and difficulty concentrating and mood changes.

Chest wall disorders are a group of thoracic deformities that result in an inefficient coupling between the respiratory muscles and the thorax. These disorders are often characterized by restrictive defects and have the potential for long-term hypercarbonated respiratory failure. Scoliosis and/or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include dyspnea during exercise, peripheral edema, sitting breathing, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

A range of therapies have been used to treat or ameliorate such disorders. In addition, other healthy individuals can utilize such therapies to prevent the occurrence of respiratory disorders. However, these have a number of disadvantages.

2.2.2 Therapy

Various respiratory therapies, such as Positive Airway Pressure (PAP) therapy including 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 respiratory disorders described above.

2.2.2.1 Respiratory pressure therapy

Respiratory pressure therapy is the application of air supplied to the entrance of the airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a canister ventilator or chest armor).

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 thus patients may choose non-compliance therapy if they find the means for providing such therapy to be one or more of uncomfortable, difficult to use, expensive, and unsightly.

Non-invasive ventilation (NIV) provides ventilation support to a patient through the upper airway to assist the patient in breathing and/or to maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilation support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, such as OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.

Non-Invasive Ventilation (IV) provides ventilation support for patients who are unable to breathe effectively themselves, and may be provided using an tracheostomy tube or an endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved.

2.2.2.2 Flow therapy

Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by delivering an inspiratory flow curve (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy may supplement the regulated or enriched gas flow only to the patient's own spontaneous breathing. In one example, high Flow Therapy (HFT) is the provision of a continuous, heated, humidified air flow to the inlet of the airway through an unsealed or open patient interface to maintain a substantially constant "therapeutic flow" throughout the respiratory cycle. The therapeutic flow is nominally set to exceed the peak inspiratory flow of the patient. HFT has been used to treat OSA, CSR, respiratory failure, COPD and other respiratory disorders. One mechanism of action is that the high flow of air at the entrance of the airway increases ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Thus, HFT is sometimes referred to as Dead Space Therapy (DST). Other benefits may include increased warmth and humidification (which may be beneficial in secretion management) and the possibility of properly increasing airway pressure. As an alternative to a constant flow, the therapeutic flow may follow a curve that varies over the respiratory cycle.

Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. The physician may prescribe that a continuous flow of oxygen enriched air be delivered to the airway of the patient at a particular oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air), at a particular flow rate (e.g., 1 Liter Per Minute (LPM), 2 LPM, 3 LPM, etc.).

2.2.3 Respiratory therapy System

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

The respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

2.2.3.1 Patient interface

The patient interface may be used to couple the respiratory apparatus to its wearer, for example by providing an air flow to the inlet of the airway. The air flow may be provided to the patient's nose and/or mouth via a mask, to the patient's mouth via a tube, or to the patient's airway via an aero-cut tube. Depending on the therapy to be applied, the patient interface may form a seal with an area, such as the face of the patient, to facilitate delivering gas at a pressure that is sufficiently different from ambient pressure (e.g., a positive pressure of about 10cmH2O relative to ambient pressure) to effect the therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10cmH 2O. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nostrils, but specifically avoids a complete seal. One example of such a patient interface is a nasal cannula.

Some mask systems may not be functionally suitable for use in the art. For example, a purely decorative mask may not be able to maintain proper pressure. Mask systems for underwater swimming or diving may be configured to prevent ingress of water at higher pressure from the outside, but not to maintain the internal air at a pressure above ambient pressure.

Certain masks may be clinically disadvantageous to the present technique, for example if they block the flow of air through the nose and only allow it to pass through the mouth.

If a patient is required to insert a portion of the mask structure in their mouth to create and maintain a seal with their lips, some masks may be uncomfortable or impractical for the present technique.

Some masks may be impractical to use while sleeping, such as when lying on the side in a bed and the head sleeping on a pillow.

Some masks may make some patients feel claustrophobia, uncomfortable and/or may feel excessively annoying.

The design of patient interfaces presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from individual to individual. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jawbone or mandible may be moved relative to the other bones of the skull. The entire head may be moved during respiratory therapy.

Thus, some masks have raised, aesthetically undesirable, expensive, poorly fitting, difficult to use, and/or uncomfortable drawbacks, especially when worn for extended periods of time or when the patient is unfamiliar with the system. Wrong sized masks may lead to reduced compliance, reduced comfort, and poor patient outcome. Masks designed only for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks for administration of anesthetics are tolerable for their original application, but nonetheless such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may lead to reduced patient compliance with therapy, particularly if the mask is worn during sleep.

CPAP therapy is highly effective for treating certain respiratory disorders provided that the patient is compliant with the therapy. If the mask is uncomfortable or difficult to use, the patient may not follow the therapy. Because patients are often advised to regularly clean their masks, if the masks are difficult to clean (e.g., difficult to assemble or disassemble), the patients may not be able to clean their masks, and this may affect patient compliance.

While masks for other applications (e.g., navigator) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

For these reasons, patient interfaces for delivering CPAP during sleep form a different area.

2.2.3.1.1 Seal forming structure

The patient interface may include a seal-forming structure. Because the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

The patient interface may be characterized in part by the design intent of the seal-forming structure to engage the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left naris and a second sub-portion that forms a seal around the right naris. In one form of patient interface, the seal-forming structure may comprise a single element that in use surrounds both nostrils. Such a single element may be designed to cover, for example, the upper lip region and the nasal region of the face. In one form of patient interface, the seal-forming structure may comprise an element that in use surrounds the mouth region, for example by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure may comprise a single element that in use surrounds both nostrils and the mouth region. These different types of patient interfaces are known by their manufacturers under various names, including nasal masks, full face masks, nasal pillows, nasal sprays, and oral nasal masks.

Effective seal-forming structures in one region of a patient's face may be inadequate in another region, for example due to different shapes, structures, variability and sensitivity regions of the patient's face. For example, a seal on swimming goggles covering the forehead of a patient may not be suitable for use on the nose of a patient.

Certain seal-forming structures may be designed for mass production so that one design can fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be modified to form the seal.

One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface with the seal-forming structure in facing engagement with the patient's face. The seal-forming structure may comprise an air or fluid filled pad, or a molded or formed surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if there is insufficient fit, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to effect a seal.

Another type of seal-forming structure incorporates a flap seal of thin material around the perimeter of the mask to provide self-sealing against the patient's face when positive pressure is applied within the mask. Similar to the previous types of seal forming portions, if the fit between the face and mask is not good, additional force may be required to achieve the seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may buckle or flex during use, thereby causing leakage.

Another type of seal-forming structure may include friction-fit elements, such as for insertion into nostrils, however some patients find these uncomfortable.

Another form of seal-forming structure may use an adhesive to effect the seal. Some patients may find it inconvenient to apply and remove adhesive from their face often.

A series of patient interface seal forming structural techniques are disclosed in WO 1998/004310, WO 2006/074513, and WO 2010/135785.

One form of nasal pillows is found in Adam circuits manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Pat. No. 4,782,832 (Trimble et al) assigned to Puritan-Bennett Corporation.

The company ruisimi (ResMed inc.) has manufactured products that incorporate nasal pillows, SWIFTTM nasal pillow masks, SWIFTTM II nasal pillow masks, SWIFTTM LT nasal pillow masks, SWIFTTM FX nasal pillow masks, and MIRAGE LIBERTYTM full face masks. Examples of nasal pillows are described in International patent application WO 2004/073778 (which describes in particular aspects of SWIFTTM nasal pillows), U.S. patent application 2009/0044808 (which describes in particular aspects of SWIFTTM LT nasal pillows), international patent applications WO 2005/063228 and WO 2006/130903 (which describes in particular aspects of MIRAGE LIBERTYTM full face masks), and International patent application WO 2009/052560 (which describes in particular aspects of SWIFTTM FX nasal pillows).

2.2.3.1.2 Positioning and stabilizing structure

The seal-forming structure of the patient interface for positive barometric therapy is subjected to a corresponding force of the barometric pressure to break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain it in sealing relation with the appropriate portion of the face. Several factors may be considered when comparing different positioning and stabilization techniques. These include how effectively the technique holds the seal-forming structure in the desired position and in sealing engagement with the face during use of the patient interface, how comfortable the interface is for the patient, whether the patient feels invasive and/or claustrophobic when wearing the patient interface, and aesthetic appeal.

One technique is to use an adhesive, see for example U.S. patent application publication No. US 2010/0000534. However, the use of adhesives may be uncomfortable for some people.

Another technique is to use one or more straps and/or stabilizing straps. Many such belts suffer from one or more of poor fit, bulkiness, discomfort, and inconvenience in use.

2.2.3.1.3 Pressurized air conduit

In one type of therapy system, a flow of pressurized air is provided to a patient interface through a conduit in an air circuit that is fluidly connected to the patient interface at a location forward of the patient's face when the patient interface is positioned on the patient's face during use. The conduit may extend forward from the patient interface away from the patient's face.

2.2.3.1.4 Pressurized air conduit for locating/stabilizing seal forming structure

Another type of therapy system includes a patient interface in which a tube that delivers pressurized air to the patient's airway is also used as part of a headgear to position and stabilize a seal-forming portion of the patient interface over an appropriate portion of the patient's face. This type of patient interface may be referred to as having a "catheter headgear" or "head sleeve. Such a patient interface allows a conduit in an air circuit providing a flow of pressurized air from a Respiratory Pressure Therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. patent publication No. 2007/0246043, the contents of which are incorporated herein by reference, wherein a catheter is connected to a tube in a patient interface through a port that is positioned on top of the patient's head in use.

Ideally, a patient interface incorporating a head cannula is comfortable for the patient to wear for an extended duration while the patient is asleep, forming an airtight and stable seal with the patient's face, while also being able to accommodate a range of patient head shapes and sizes.

2.2.3.2 Respiratory Pressure Therapy (RPT) device

Respiratory Pressure Therapy (RPT) devices may be used alone or as part of a system to deliver one or more of the therapies described above, such as by operating the device to generate an air stream for delivery to an interface of an airway. The air flow may be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, the RPT device may also act as a flow therapy device. Examples of RPT devices include PAP devices and ventilators.

Barometric pressure generators are known in a range of applications (e.g., industrial scale ventilation systems). However, air pressure generators for medical applications have specific requirements that are not met by more common air pressure generators, such as reliability, size and weight requirements of medical devices. In addition, even devices designed for medical treatment may have drawbacks with respect to one or more of comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

An example of a particular requirement for some RPT devices is acoustic noise.

Noise output level table for existing RPT devices (only one sample, measured in CPAP mode at 10 cmh2o using the test method specified in ISO 3744).

One known RPT device for treating sleep disordered breathing is the S9 sleep therapy system manufactured by rismate company (ResMed inc.). Another example of an RPT device is a ventilator. The risman STELLARTM series of ventilators, such as adult and pediatric ventilators, can provide invasive and non-invasive, non-dependent ventilatory support for a range of patients for the treatment of a variety of conditions, such as, but not limited to, NMD, OHS, and COPD.

RESMED ELIS the 150 and RESMED VS IIITM ventilators can provide support for invasive and non-invasive dependent ventilation suitable for adult and pediatric patients to treat a variety of conditions. These ventilators provide a volumetric ventilation mode and a pneumatic ventilation mode through a single or double branch circuit. RPT devices typically include a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air may be supplied to the airway of the patient at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

The designer of the device may be faced with an unlimited number of choices. Design criteria often conflict, meaning that some design choices are far from routine or unavoidable. Furthermore, certain aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.

2.2.3.3 Air Loop

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

2.2.3.4 Humidifier

Delivering an air flow without humidification may result in airway dryness. A humidifier with an RPT device and patient interface is used to generate humidified gases that minimize nasal mucosa dryness and increase patient airway comfort. In addition, in colder climates, warm air, which is typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

2.2.3.5 Vent technique

Some forms of treatment systems may include vents to allow for flushing of expired carbon dioxide. The vent may allow gas to flow from an interior space (e.g., plenum) of the patient interface to an exterior (e.g., into the environment) of the patient interface.

The vent may include an orifice and the gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become clogged in use and thus provide insufficient flushing. Some vents may interfere with sleep of the bed partner 1100 of the patient 1000, for example, by noise or concentrated airflow.

A number of improved mask ventilation techniques have been developed by the company rismai, see for example international patent application publication No. WO 1998/034665, international patent application publication No. WO 2000/078381, U.S. Pat. No. 6,581,594, U.S. patent application publication No. US 2009/0050156, and U.S. patent application publication No. 2009/0044808.

Noise meter of existing mask (ISO 17510-2:2007, pressure of 10 cm H2O at 1 m)

Only one sample, measured in CPAP mode at 10cmH2O using the test method specified in ISO 3744.

The sound pressure values of the respective objects are listed below

Disclosure of Invention

The present technology aims to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to an apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating, or preventing a respiratory disorder.

One aspect of certain forms of the present technology is a method and/or apparatus for providing improved patient compliance with respiratory therapy.

One form of the present technique includes a positioning and stabilizing structure configured to provide a force that maintains the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one strap.

One form of the present technology includes a patient interface including a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure.

One form of the present technology includes a patient interface including a plenum chamber pressurizable to a therapeutic pressure of at least 4cmH2O above ambient air pressure. The plenum includes at least one plenum inlet port sized and configured to receive an air flow at a therapeutic pressure for patient respiration. The patient interface also includes a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding the patient airway inlet. The seal-forming structure has apertures therein such that an air flow at the therapeutic pressure is delivered to at least an inlet of a nostril of the patient. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the plenum throughout a patient breathing cycle in use. The patient interface also includes a positioning and stabilizing structure to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

Another aspect of one form of the present technique is a series of modular elements that may be interconnected to form different types of patient interfaces.

In one form, each modular element has at least two versions or types. These versions or types may be used interchangeably with each other to form different modular assemblies.

One form of the present technique includes a patient interface configured to deliver a flow of breathable gas to a patient for treating a respiratory disorder, the patient interface including a plenum chamber that is capable of being pressurized to a treatment pressure of at least 4cmH2O above ambient air pressure throughout a patient breathing cycle in use, the plenum chamber including a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding at least one entrance to the patient's airway, a positioning and stabilizing structure configured to maintain the seal-forming structure in position on the patient's face in use, and a forehead cooling system configured to cool the patient's forehead in use.

In an example of the present technology, the patient interface may be configured to connect to an air circuit to receive the flow of breathable gas from a flow generator.

In examples of the present technology, the forehead cooling system may be configured to direct a portion of the flow of breathable gas to the patient's forehead when in use.

In an example of the present technology, the forehead cooling system may be a conduit configured to direct a flow of breathable gas to the patient's forehead in use.

In examples of the present technology, the conduit may be fluidly connected to the plenum chamber and may be configured to direct breathable gas from the plenum chamber out toward the patient's forehead.

In an example of the present technology, the conduit may be connected to an air circuit configured to connect to a connection port on the patient interface.

In examples of the present technology, the catheter may be disposed in the positioning and stabilizing structure.

In an example of the present technology, a first conduit may be fluidly connected to a first side of the positioning and stabilizing structure in an area above the patient's eye.

In an example of the present technology, a second catheter may be positioned on a second, opposite side in the region above the patient's eye of the positioning and stabilizing structure.

In examples of the present technology, the first conduit may be fluidly connected to the second conduit by a semipermeable material configured to expel a flow of breathable gas to the forehead of the patient.

In examples of the present technology, the forehead cooling system may be positioned to contact the patient's forehead when in use.

In an example of the present technology, the forehead cooling system may include a fluid reservoir.

In examples of the present technology, the fluid reservoir may include any one or more of water, oil, gel, or sodium polyacrylate.

In examples of the present technology, the patient interface may further include a pump configured to flow fluid within the fluid reservoir.

In an example of the present technology, the forehead cooling system may include a thermoelectric cooler.

In an example of the present technology, the forehead cooling system may include a thermal interface material positioned to contact the patient's forehead in use.

In an example of the present technology, the forehead cooling system may include a heat sink.

Another aspect of one form of the present technique is a method of controlling a forehead cooling system, the method comprising the steps of a) monitoring a temperature of a patient's forehead, B) activating a forehead cooler if the forehead temperature is above a first predetermined threshold, C) deactivating the forehead cooler if the forehead temperature is below a second predetermined threshold.

In an example of the present technology, the first predetermined threshold may be between 20 degrees celsius and 30 degrees celsius.

In an example of the present technology, the first predetermined threshold may be substantially equal to 25 degrees celsius.

In an example of the present technology, the second predetermined threshold may be between 15 degrees celsius and 20 degrees celsius.

In an example of the present technology, the second predetermined threshold may be substantially equal to 18 degrees celsius.

In examples of the present technology, the forehead cooler may include a first active mode and a second active mode, wherein the first active mode provides a first cooling rate and the second active mode provides a second cooling rate that is less than the first active mode.

In an example of the present technology, the forehead cooling system may be configured to switch from the first active mode to the second active mode when the forehead temperature is below a third predetermined threshold, and switch from the second active mode to the first active mode when the forehead temperature is above the third predetermined threshold.

In an example of the present technology, the third predetermined threshold may be between 20 degrees and 22 degrees.

In examples of the present technology, the forehead cooling system may be active only during the sleep-on period and inactive when the patient is detected to be asleep.

In examples of the present technology, the forehead cooling system may be configured to increase the temperature of the patient's forehead as part of a wake process.

Another aspect of one form of the present technique is a patient interface configured to deliver a flow of breathable gas to a patient for treatment of a respiratory disorder, the patient interface comprising a plenum chamber capable of being pressurized to a treatment pressure of at least 4cmH2O above ambient air pressure throughout a patient breathing cycle in use, the plenum chamber comprising a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding at least one entrance to the patient's airway, a positioning and stabilizing structure configured to maintain the seal-forming structure in position on the patient's face in use, and a vent configured to vent gas from the plenum chamber into the environment,

Wherein the vent is fluidly connected to a conduit such that, in use, vented gases are directed through the conduit toward the forehead region of the patient.

In an example, the conduit may be adjustably connected to the vent to allow control of the amount and/or direction of the vented gases directed toward the forehead region of the patient.

In an example, the patient interface may include a housing constructed of a material that is more rigid than the seal-forming structure, and wherein the conduit is fluidly connected to the housing.

In an example, the conduit may be molded into the housing. In other examples, the conduit may be attached (such as detachably attached) to the housing.

In an example, the conduit may be connected to the seal-forming structure.

In an example, the vent may include a central member and an outer housing, wherein the central member may be rotated relative to the outer housing to regulate flow directed toward the patient's forehead.

In another aspect of one form of the present technique, there is provided an air circuit configured to deliver a flow of breathable gas to a patient interface for treating a respiratory disorder, the air circuit comprising:

an airway configured to receive the flow of breathable gas, the airway including a first end configured to be connected to a flow generator and a second end configured to be connected to the patient interface;

At least one vent configured to, in use, vent at least a portion of the flow of breathable gas and/or gas exhaled by the patient into the ambient environment, and

At least one conduit configured to direct the vented gases toward the patient's forehead in use.

In an example, the first end of the airway tube may include a connector or nipple configured to facilitate connection of the air circuit to the flow generator.

In an example, the second end of the airway tube may include a connector or nipple for facilitating connection of the air circuit to the flow generator.

In an example, the second end of the airway tube may include a decoupling structure. For example, the decoupling structure may have a patient interface side and an airway side.

In an example, the conduit may be connected to the patient interface side of the decoupling structure.

In an example, the air circuit may include one or more heating elements configured to heat air in the airway.

In an example, the heating element may be a heating wire loop and may include one or more transducers, such as temperature sensors.

In an example, the heating wire loop may be helically wound around a longitudinal axis of the air loop.

In accordance with another aspect of one form of the present technique, a ventilation port is provided for a respiratory pressure therapy system configured to deliver, in use, a flow of pressurized breathable gas to an airway of a patient, wherein the ventilation port is configured to transfer at least a portion of the pressurized breathable gas out of the respiratory pressure therapy system, and wherein the ventilation port is fluidly coupled to a conduit such that the portion of the pressurized breathable gas passing through the ventilation port is directed toward the forehead of the patient.

In an example, the vent may be configured to transfer the at least a portion of the pressurized breathable gas from the plenum chamber of the patient interface into the ambient environment.

In an example, the vent may be configured to transfer at least a portion of the gas exhaled by the patient from the plenum chamber into the ambient environment.

In an example, the vent may be adjustable to control the amount of pressurized breathable gas directed toward the patient's forehead.

In an example, the conduit may be attached to the vent.

In accordance with another aspect of one form of the present technique, a forehead cooling system is provided that includes a positioning and stabilizing structure configured to maintain a forehead cooler in contact with a user's forehead.

In an example, the forehead cooler may be a thermoelectric cooler.

In an example, the forehead cooler may be a fluid cooler.

In an example, the forehead cooling system may further include a pump to circulate fluid through the forehead cooler. For example, the fluid may be a liquid or a gas.

In an example, the forehead cooler may be configured to direct an air flow to the user's forehead.

In an example, the forehead cooling system may include one or more sensors configured to measure humidity, temperature, heart rate, or provide electroencephalogram (EEG) information about the user.

In an example, the forehead cooling system may be configured to actively cool the user's forehead to a pre-configured temperature.

In an example, the forehead cooling system may be configured to detect when the user falls asleep.

In an example, the forehead cooling system may be configured to attenuate forehead cooling when sleep is detected.

In an example, the forehead cooling system may be configured to alert the user when it is time to wake. For example, the forehead cooling system may increase the temperature of the user's forehead when it is time to wake up.

According to another aspect of one form of the present technology, there is provided a method of controlling a forehead cooling system, the method comprising the steps of:

A) Obtaining patient information from one or more sensors;

B) Comparing the acquired information with one or more predefined rules;

c) If the rule condition is satisfied, an action is performed.

In an example, the method may further include the step of determining whether the patient is awake or asleep.

In an example, the predefined rule may include whether the patient is awake, and whether the forehead temperature is above, within a predefined range, or below a predefined threshold. In other examples, the predefined rules may include whether the patient falls asleep, and whether the forehead cooling system should be deactivated, activated in a low-power state, or configured to achieve a predefined sleep temperature range.

In an example, the performed actions include one or more of controlling a temperature of the patient's forehead, generating auditory stimuli, changing a fluid flow rate within the cooling system, activating or deactivating the cooling system.

Another form of the present technique includes a patient interface configured to deliver a flow of breathable gas to a patient for treating a respiratory disorder, the patient interface including a plenum chamber that is capable of being pressurized to a treatment pressure of at least 4cmH2O above ambient air pressure throughout a patient breathing cycle in use, the plenum chamber including a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding at least one entrance to the patient's airway, a positioning and stabilizing structure configured to maintain the seal-forming structure in position on the patient's face in use, and a forehead cooling system configured to cool the patient's forehead in use, and a processor configured to detect a sleep state of the patient, wherein the forehead cooling system is controlled in accordance with the detected sleep state of the patient.

Another aspect of one form of the present technique is a patient interface that is molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

One aspect of one form of the present technology is a method of manufacturing an apparatus.

Another aspect of one form of the present technology is a method of assembling a modular system comprising selecting a positioning and stabilizing structure and connecting the positioning and stabilizing structure to a first pad or a second pad.

One aspect of certain forms of the present technology is an easy-to-use medical device, for example, for use by persons without medical training, by persons with limited dexterity, vision, or by persons with limited experience in using this type of medical device.

One aspect of one form of the present technology is a portable RPT device that may be carried by a person, for example, at a person's home.

One aspect of one form of the present technique is a patient interface that can be cleaned in a patient's home, such as in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier tub that may be cleaned in a patient's home, such as in soapy water, without the need for specialized cleaning equipment.

The described methods, systems, apparatuses, and devices may be implemented to improve the functionality of a processor, such as a processor of a special purpose computer, a respiratory monitor, and/or a respiratory therapy device. Furthermore, the described methods, systems, apparatuses, and devices may provide improvements in the art including automatic management, monitoring, and/or treatment of respiratory conditions, such as sleep disordered breathing.

Of course, some of these aspects may form sub-aspects of the present technology. Furthermore, various aspects of the sub-aspects and/or aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

Other features of the present technology will become apparent from the following detailed description, abstract, drawings, and claims.

Drawings

The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

4.1 respiratory therapy System

Fig. 1A shows a system comprising a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow that receives a supply of positive pressure air from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and passed 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.

Fig. 1B shows a system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives a supply of positive pressure air from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000.

Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. The patient is sleeping in a side-lying sleeping position.

4.2 Respiratory System and facial anatomy

Figure 2A shows a schematic diagram of the human respiratory system including nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveoli, heart and diaphragm.

Fig. 2B shows a view of the upper airway of a human including the nasal cavity, nasal bone, extra-nasal cartilage, alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea.

Fig. 2C is a front view of a face with several surface anatomical features identified, including the superior labia, inferior labia, mouth width, inner canthus, nasal wings, nasolabial folds, and oral corners. Also indicated are up, down, radially inward and radially outward directions.

Fig. 2D is a side view of a head with several surface anatomical features identified, including an inter-eyebrow, a nasal bridge point, a nasal protrusion point, a subnasal septum point, an upper lip, a lower lip, an upper chin point, a nasal ridge, a nasal wing apex, an upper ear point, and a lower ear point. Also indicated are up and down and front and back directions.

Fig. 2E is another side view of the head. The approximate location of frankfurt level and nose lip angle is indicated. Coronal plane is also indicated.

4.3 Patient interface

Fig. 3A illustrates a patient interface in the form of a nasal mask in accordance with one form of the present technique.

Fig. 3A-1 illustrates forces acting on the patient interface of fig. 3A in use.

Fig. 3Z illustrates a patient interface with a catheter hub in accordance with one form of the present technique.

Fig. 3Z-1 illustrates forces acting on the patient interface of fig. 3Z in use.

4.4RPT device

Fig. 4A illustrates an RPT device in one form in accordance with the present technique.

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

4.5 Humidifier

Figure 5A illustrates an isometric view of a humidifier in one form in accordance with the present technique.

Fig. 5B illustrates an isometric view of a humidifier in one form in accordance with the present technique, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

4.6 Respiratory waveform

Fig. 6A shows a typical breathing waveform model of a person while sleeping.

4.7 Modularization

Fig. 7A shows a perspective view of a cushion of a patient interface configured to be worn by a patient and to deliver pressurized air to a patient's nose and mouth.

Fig. 7B shows a perspective view of a cushion of a patient interface configured to be worn by a patient and to deliver pressurized air to a patient's nose.

Fig. 7C shows a perspective view of a tube that may be used with the liner of fig. 7A or the liner of fig. 7B.

Fig. 7D shows a perspective view of a rigidizer arm that may be used with the pad of fig. 7A or the pad of fig. 7B.

Fig. 7E shows a perspective view of a headgear strap that may be used with the cushion of fig. 7A.

Fig. 7F shows a perspective view of a headgear strap that may be used with the cushion of fig. 7B.

Fig. 7G shows a front view of a pair of sleeves removably fitted to the tube of fig. 7C or the rigidizer arm of fig. 7D.

Fig. 7H shows a front view of a complete sleeve removably fitted onto the rigidizer arm of fig. 7D.

Fig. 7I shows a front perspective view of a complete sleeve of yet another alternative form removably fitted to the rigidizer arm of fig. 7D.

Fig. 7J is a front view of a patient interface with nasal and mouth pads and in a tube up configuration worn by a patient.

Fig. 7K is a front view of a patient interface with nasal and mouth pads and in a tube down configuration worn by a patient.

Fig. 7L is a front view of a patient interface with a nasal cushion worn by a patient and in a tube up configuration.

Fig. 7M is a front view of a patient interface with a nasal cushion worn by a patient and in a tube down configuration.

Fig. 7N is an isolated perspective view of the vent of fig. 7L.

Fig. 7O is an isolated perspective view of a portion of the air circuit of fig. 7M.

4.8 Forehead Cooling

Fig. 8A illustrates an example of a patient interface 3000 including a forehead cooling system 2000 and a positioning and stabilizing structure 3300.

Fig. 8B illustrates a perspective view of an air circuit in accordance with one example of the present technology.

Fig. 8C shows a perspective view of an air circuit in accordance with another example of the present technology.

Fig. 9 shows a schematic of a fluid-based forehead cooling system.

Fig. 10 shows an example of a respiratory therapy system including a forehead cooling system.

Fig. 11 shows an example of an active cooling system in the form of a thermoelectric cooler and an interface for extracting heat from a fluid.

Fig. 12A shows a block diagram of an air-assisted thermoelectric cooling system.

Fig. 12B shows an example of a combined PAP therapy system in which the exhaust air is directed toward the forehead cooling system.

FIG. 13 illustrates a cooling control state machine in accordance with one example of the present technique.

Fig. 14 illustrates a simultaneous heating and cooling system configured to heat or humidify a supply of breathable gas for patient respiration and cool the forehead of a patient.

Fig. 15A shows an example of an air circuit configured to direct an air flow to a patient's forehead.

Fig. 15B illustrates another example of an air circuit configured to direct an air flow to a forehead of a patient.

Fig. 15C shows an example of a patient interface in use, wherein the air circuit is configured to direct an air flow to the forehead of a patient.

Fig. 16A shows an example of a cushion module/patient interface including a conduit configured to direct an air flow to a patient's forehead.

Fig. 16B illustrates an example of a cushion module/patient interface including an adjustable conduit configured to direct an air flow to a patient's forehead.

Fig. 16C shows a rear view of the cushion module/patient interface according to fig. 16A.

Fig. 17A illustrates a front view of a patient interface for use with a forehead cooling system in accordance with one example of the present technology.

Fig. 17B illustrates a front view of a patient interface for use with a forehead cooling system, according to another example of the present technology.

Fig. 17C illustrates a front view of a patient interface for use with a forehead cooling system, according to another example of the present technology.

Fig. 18A shows a front view of a patient interface for use with a vent configured to direct an air flow toward a forehead of a patient.

Fig. 18B shows a perspective view of the vent of fig. 18A.

Fig. 18C shows a perspective view of the central component of the vent of fig. 18A.

Fig. 19A illustrates a side view of a patient interface in accordance with another example of the present technology.

Fig. 19B illustrates a side view of another patient interface in accordance with another example of the present technology.

Fig. 20A illustrates a perspective view of a patient interface in accordance with one example of the present technology.

Fig. 20B illustrates a perspective view of a forehead cooling system according to another example of the present technology.

Fig. 20C illustrates a top view of a forehead cooling system according to another example of the present technology.

Fig. 21A shows a side view of a VR device including a patient interface.

Fig. 21B shows a cross-sectional view of the VR device of fig. 21A taken along the sagittal plane of the patient.

FIG. 22A is an illustration of an example system for monitoring sleep and providing insight and/or advice that includes a computing device.

FIG. 22B is a diagram of components of an example computing device according to FIG. 22A.

Fig. 23 is a flowchart showing a control method for automatic sleep-in detection and cooling control.

FIG. 24 is an example of a user interface for receiving feedback regarding sleep performance and/or controlling operation of one or more forehead cooling systems.

Detailed Description

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

The following description is provided with respect to various examples that may share one or more common features and/or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any of the examples, any single feature or combination of features may constitute further examples.

5.1 Therapy

In one form, the present technique includes a method for treating a respiratory disorder that includes applying positive pressure to an entrance to an airway of a patient 1000.

In some examples of the present technology, a positive pressure air supply is provided to the nasal passages of the patient via one or both nostrils.

In some examples of the present technology, mouth breathing is restricted, greatly constrained, or prevented.

5.2 Respiratory therapy System

In one form, the present technique includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air flow to the patient 1000 via the air circuit 4170 and the patient interface 3000 or 3800.

5.3 Patient interface

In accordance with one aspect of the present technique, a non-invasive patient interface 3000, such as shown in fig. 3A, includes functional aspects of a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects 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 airway of the patient so as to maintain a positive pressure at the entrance to the airway of the patient 1000. Thus, the sealed patient interface 3000 is adapted to deliver positive pressure therapy.

As shown in fig. 3Z, a non-invasive patient interface 3000 in accordance with another aspect of the present technique includes functional aspects of a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a form of connection port 3600 for connection to an air circuit, such as the air circuit 4170 shown in fig. 1A-1C. The plenum chamber 3200 may be formed from one or more modular components (e.g., the gasket module 3150 along with the seal forming structure 3100) in the sense that the one or more modular components may be replaced with different components (e.g., components of different sizes).

If the patient interface is unable to comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of providing a supply of air at a positive pressure above ambient, for example at least 2, 4, 6, 10 or 20 cmh2o relative to ambient.

5.3.1 Seal formation Structure

In one form of the present technique, the seal forming structure 3100 provides a target seal forming area, and may additionally provide a cushioning function. The target seal forming area is the area on the seal forming structure 3100 where a seal may occur. The area where the seal actually occurs-the actual sealing surface-may vary from day to day and from patient to patient within a given treatment session, depending on a number of factors including, for example, the location of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

In one form, the target seal-forming area is located on an outside surface of the seal-forming structure 3100.

In some forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material (e.g., silicone rubber).

The seal forming structure 3100 according to the present technology may be constructed of a soft, flexible, resilient material, such as silicone.

In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each configured to correspond to a different range of sizes and/or shapes. For example, the system may include one form of seal forming structure 3100 adapted for a large-sized head but not for a small-sized head, and another such seal forming structure adapted for a small-sized head but not for a large-sized head.

5.3.1.1 Sealing mechanism

In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to a systematic positive pressure within the plenum chamber 3200 acting against its bottom surface to bring it into tight sealing engagement with the face. The pressure assist mechanism may act in conjunction with elastic tension in the positioning and stabilizing structure.

In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1mm (e.g., about 0.25mm to about 0.45 mm) that extends around the perimeter of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and an edge of the plenum chamber 3200 and extends at least a portion of the way around the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange against buckling during use.

In one form, the seal-forming structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged to be in a compressed state, for example as a result of elastic tension in a positioning and stabilising structure.

In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is held in tension, for example by adjacent regions of the sealing flange.

In one form, the seal-forming structure includes a region having an adhesive or cohesive surface.

In some forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tensioning portion, and a portion having an adhesive or cohesive surface.

5.3.1.2 Nasal bridge or nasal ridge regions

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over a mid-nasal or ridge region of the patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal when used on a mid-nasal or ridge region of a patient's face.

5.3.1.3 Upper lip region

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over an upper lip region (i.e., an upper lip portion) of the patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal on an upper lip region of a patient's face in use.

5.3.1.4 Chin region

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over a chin area of the patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal when used on a chin region of a patient's face.

5.3.1.5 Forehead area

In one form, the seal-forming structure forms a seal over a forehead region of a patient's face in use. In this form, the plenum chamber may cover the eye in use.

5.3.1.6 Nasal pillows

In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

A nasal pillow in accordance with one aspect of the present technique includes a frustoconical body at least a portion of which forms a seal on a floor of a patient's nose, a handle, and a flexible region on the floor of the frustoconical body and connecting the frustoconical body to the handle. In addition, the nasal pillow attachment structure of the present technology includes a flexible region adjacent the base of the handle. The flexible regions may cooperate to facilitate a universal joint structure that is adaptable with relative movement of both displacement and angle between the frustoconical and nasal pillow connected structures. For example, the frustoconical position may be axially moved toward the stem-connecting structure.

5.3.1.7 Nose mask only

In one form, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airway, rather than around the patient's mouth. The seal forming structure 3100 can be configured to seal against the upper lip of the patient. Patient interface 3000 may leave the mouth of the patient uncovered. The patient interface 3000 may deliver a supply of air or breathable gas to both nostrils of the patient 1000 without delivering to the mouth. This type of patient interface may be identified as a nasal mask only.

One form of nasal mask alone according to the present technology is that conventionally identified as a nasal mask having a seal-forming structure 3100 configured to seal around the nose and over the bridge of the nose on the patient's face. The shape of the mask is generally triangular. In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that forms, in use, a seal to an upper lip region (e.g., an upper lip), to at least a portion of the bridge of the nose in the patient's nose or above the nasal prominence, and to the patient's face on each side of the patient's nose, e.g., near the patient's nasolabial sulcus. The patient interface 3000 shown in fig. 1B has a seal-forming structure 3100 of this type. This patient interface 3000 may deliver a supply of air or breathable gas to both nostrils of the patient 1000 through a single orifice.

Another form of nasal-only mask may seal around the lower perimeter of the patient's nose without engaging the patient's nasal ridge. For example, this type of patient interface 3000 may be identified as a "nose pad" mask, and the seal forming structure 3100 may be identified as a "nose pad". In one form, as shown for example in fig. 3Z, the seal-forming structure 3100 is configured to form a seal with the under-nasal surface around the nostrils in use. The seal-forming structure 3100 may be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including to the lower and/or anterior surfaces of the nasal punctum regions of the patient's nose and to the patient's wings. The seal forming structure 3100 may seal the upper lip of the patient. The seal forming structure 3100 may be shaped to match or closely follow the underside of the patient's nose and may not contact the mid-nasal region of the patient's nose or any portion of the patient's nose beyond the point of the nose. In one form of nasal cushion, the seal forming structure 3100 includes a bridge portion that divides the opening into two apertures, each of which, in use, supplies air or breathable gas to a respective one of the patient's nostrils. The bridge portion may be configured to contact or seal the patient's columella in use. Alternatively, the seal-forming structure 3100 may comprise a single opening, with both patient nostrils providing a flow of gas or air or breathable gas.

In some forms, only the nasal mask may include a nasal pillow as described above.

5.3.1.8 Nose and mouth mask

In one form, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around an entrance to the patient's nasal airway and around the patient's mouth. The seal-forming structure 3100 may be configured to seal to the patient's face proximate the chin area. The patient interface 3000 may deliver a supply of air or breathable gas to both nostrils and mouth of the patient 1000. This type of patient interface may be identified as a nasal and mouth mask.

One form of nasal mask in accordance with the present technique is that conventionally identified as a full face mask, having a seal forming structure 3100 configured to seal around the nose, under the mouth, and over the nose on the patient's face. The nose cup is generally triangular in shape. In one form, the patient interface 3000 includes a seal-forming structure 3100 that forms, in use, a seal against at least a portion of the patient's chin region (which may include the patient's lower lip and/or the region directly below the lower lip), the patient's nasal middle or bridge above the nasal projection, and the cheek region of the patient's face. The patient interface 3000 shown in fig. 1C is of this type. The patient interface 3000 may deliver a supply of air or breathable gas to both nostrils and mouth of the patient 1000 through a single orifice. This type of seal forming structure 3100 may be referred to as a nose pad.

In another form, the patient interface 3000 includes a seal-forming structure 3100 that forms, in use, a seal over the chin area of the patient (which may include the lower lip of the patient and/or the area directly below the lower lip), over the lower and/or anterior surfaces of the nasolabial portion of the patient's nose, over each side of the patient's nose, e.g., near the nasolabial folds, over the wings of the patient's nose and the patient's face. The seal forming structure 3100 may also form a seal against the upper portion of the patient's lips. A patient interface 3000 with this type of seal-forming structure may have a single opening configured to deliver an air flow or breathable gas to both nostrils and mouth of a patient, may have a mouth aperture configured to provide air or breathable gas to the mouth and a nose aperture configured to provide air or breathable gas to the nostrils, or may have a mouth aperture for delivering air to the mouth of a patient and two nose apertures for delivering air to the respective nostrils. This type of patient interface 3000 may have a nose and mouth that seals to the patient's face at a location similar to a nose cup.

In another form of nasal and mouth mask, the patient interface 3000 may include a seal-forming structure 3100 having a nose including a nasal pillow and a mouth configured to form a seal against the patient's face around the patient's mouth.

In some forms, the seal forming structure 3100 can have a nose that is separate and distinct from the mouth. In other forms, the seal-forming structure 3100 may form a continuous seal around the nose and mouth of the patient.

It should be appreciated that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, patient interface 3000 may include a combination of different features of the examples of just nasal masks and nasal and mouth masks described above.

5.3.2 Plenum

The plenum chamber 3200 has a perimeter shaped to complement the surface profile in the area where a typical human face will form a seal in use. In use, the boundary edge of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. The actual contact with the face is provided by the seal forming structure 3100. The seal forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and seal forming structure 3100 are formed from a single sheet of homogeneous material.

In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes in use. In other words, the eye is outside the pressurized volume defined by the plenum chamber. Such forms tend to be less noticeable and/or more comfortable to the wearer, which may improve compliance with the therapy.

In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material, such as a transparent polycarbonate. The use of transparent materials may reduce the prominence of the patient interface and help to improve compliance with therapy. The use of transparent materials may help a clinician to see how the patient interface is positioned and functioning.

In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of translucent materials may reduce the prominence of the patient interface and help to improve compliance with the therapy.

In some forms, the plenum chamber 3200 is constructed of a rigid material such as polycarbonate. The rigid material may provide support for the seal-forming structure.

In some forms, the plenum chamber 3200 is constructed of a flexible material (e.g., from a soft, flexible, resilient material such as silicone, textile, foam, etc.). For example, in an example, it may be formed of a material having a Young's modulus of 0.4GPa or less, such as foam. In some forms of the technology, the plenum chamber 3200 may be made of a material, such as rubber, having a young's modulus of 0.1GPa or less. In other forms of the technology, the plenum chamber 3200 may be made of a material having a Young's modulus of 0.7Mpa or less, for example between 0.7MPa and 0.3 MPa. An example of such a material is silica gel.

5.3.2.1.1 Nose and mouth mask

As shown in fig. 7A, the plenum chamber 3200-1 includes a pair of plenum inlet ports 3254-1 that may be used to transfer gases into the plenum chamber 3200-1 and/or out of the plenum chamber 3200-1. The plenum inlet ports 3254-1 may be arranged on opposite sides (e.g., left and right) of the plenum chamber 3200-1.

In some forms, the plenum chamber 3200-1 may also include at least one vent opening 3402-1 (see, e.g., fig. 7A). The vent opening 3402-1 is disposed in the center of the plenum chamber 3200-1. For example, the vent opening 3402-1 may be disposed between the plenum inlet ports 3254-1.

In some forms, the plenum chamber 3200-1 may include a pair of grooves 3266-1. Each groove 3266-1 may be disposed adjacent one of the plenum inlet ports 3254-1. Each groove 3266-1 may form a partially concave surface.

5.3.2.1.2 Nose mask only

The plenum chamber 3200-2 of the nasal cushion 3050-2 alone may be similar to the plenum chamber 3200-1 of the oral nasal cushion 3050-1. Only some similarities and differences between the plenums 3200-1, 3200-2 are described below.

As shown in fig. 7B, the plenum chamber 3200-2 includes a pair of plenum inlet ports 3254-2 that may be used to communicate gases into the plenum chamber 3200-2 and/or out of the plenum chamber 3200-2. The plenum inlet ports 3254-2 may be arranged on opposite sides (e.g., left and right) of the plenum chamber 3200-2.

In some forms, the plenum chamber 3200-2 may also include at least one vent opening 3402-2 (see, e.g., fig. 7B). The vent opening 3402-2 is disposed in the center of the plenum chamber 3200-2. For example, the vent opening 3402-2 may be disposed between the plenum inlet ports 3254-2.

In some forms, the plenum chamber 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be disposed adjacent one of the plenum inlet ports 3254-2. Each groove 3266-2 may form a partially concave surface.

5.3.3 Positioning and stabilization Structure

The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed position by a positioning and stabilizing structure 3300 when in use. Because the positioning and stabilizing structure 3300 engages the patient's head to hold the patient interface 3000 in the sealed position, the positioning and stabilizing structure 3300 may include and function as a "headgear". Examples of positioning and stabilizing structures are shown in fig. 3A and 3A-1.

In one form, the positioning and stabilizing structure 3300 provides a retention force (i.e., fiuff) that is at least sufficient to overcome the positive pressure effect in the plenum chamber 3200 to lift off the face.

In one form, the positioning and stabilizing structure 3300 provides a retention force to overcome the force of gravity on the patient interface 3000.

With continued reference to fig. 3A-1, the positioning and stabilizing structure 3300 provides a force FPSS that helps maintain the plenum chamber 3200 in a sealed position on the patient's face. The positioning and stabilizing force FPSS may be the resultant of various forces from different elements of the positioning and stabilizing structure 3300. For example, the headgear straps may provide strap force F alone to retain the seal forming structure 3100 on the patient's face. The force F strap may also be guided at least partially in an upward direction so as to overcome the gravitational force Fg. Gravity Fg may be specifically shown for seal forming structure 3100 and plenum chamber 3200, but gravity will act on the entire patient interface 3000 (i.e., in the same direction as gravity Fg illustrated).

The gravitational force Fg may be opposite to the frictional force Ff, which may act in a direction directly opposite to the gravitational force Fg. When gravity pulls the seal forming structure 3100 and the plenum chamber 3200 in a downward direction (as shown in fig. 3A-1), the frictional force Ff will act in an upward direction (e.g., against the patient's face). For example, the patient may experience a friction force Ff on their upper lip (and/or other surfaces of the patient's face that contact the seal-forming structure 3100) to oppose movement in the downward direction (which may help stabilize the cushion in place). Although the frictional force Ff is specifically shown as being opposite the gravitational force Fg of the seal-forming structure 3100 and the plenum chamber 3200, a component of the total frictional force (not shown) will also be opposite the gravitational force Fg associated with the positioning and stabilizing structure 3300 and any other portions of the patient interface 3000. Frictional forces may act anywhere along the patient interface 3000 that contacts the patient's skin (or hair). The friction force Ff extends in the opposite direction of the gravitational force Fg and along the patient's skin (or hair). In some forms, the gravitational force Fg may also counteract a vertical component of the reaction force from the patient's face acting on the seal-forming structure 3100, such as at the nose bridge and chin region of the patient's face.

In some forms, the sum of the various forces may be equal to zero such that patient interface 3000 is in equilibrium (e.g., does not move along the patient's face in use). Specifically, gravity Fg and blowout force fsteak tend to move the seal forming structure 3100 away from the desired sealing position. The positioning and stabilizing force FPSS is applied so as to counteract the gravitational force Fg and the blowing force fsteak (and any frictional forces Ff) and to keep the seal forming structure 3100 properly positioned. While the positioning and stabilizing force FPSS may exceed the sum of the gravitational force Fg and the blowout force fsteak (where any additional positioning and stabilizing force FPSS is balanced by reaction forces from the patient's head acting on portions of the patient interface 3000) and still maintain the seal-forming structure 3100 in the proper sealing position, patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on patient interface 3000 is zero and the positioning and stabilizing force FPSS is just strong enough to achieve this. In some examples, the positioning and stabilizing structure 3300 may be adjustable such that, when assembled, the positioning and stabilizing force FPSS is greater than the force required to precisely balance the gravity Fg and blowout force fsteak to keep the patient interface 3000 tight enough against the patient's head that damaging forces that may be experienced during use (such as tube resistance or lateral flow splitting of the plenum chamber 3200 during lateral recumbence) do not break the seal. As described below, when patient interface 3000 is used, various positions of the patient's head may determine the positioning and stabilizing forces FPSS necessary to achieve balance.

In one form, the positioning and stabilizing structure 3300 provides retention as a safety margin to overcome potential effects of damaging forces on the patient interface 3000, such as accidental interference from tube drag or with the patient interface.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with the manner in which the patient is wearing the device while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent the patient from lying down in a supine sleep position, with the back area of the patient's head on a pillow.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent a patient from lying on the pillow in a side sleep position with a lateral region of the patient's head.

In one form of the present technique, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The uncoupled section does not resist compression and may be, for example, a flexible or floppy belt. The decoupling portion is constructed and arranged such that the presence of the decoupling portion prevents forces acting on the posterior portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal when the patient lays their head on the pillow.

In one form of the present technique, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the belt. In one form, the outer layer of fabric includes loop material for partial engagement with the hook material.

In certain forms of the present technology, the positioning and stabilizing structure 3300 comprises an extensible (e.g., elastically extensible) strap. For example, the strap may be configured to be under tension in use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strap may be configured as a lace.

In one form of the present technique, the positioning and stabilizing structure includes a first strap constructed and arranged such that, in use, at least a portion of a lower edge of the first strap passes over an above-the-ear point of the patient's head and covers a portion of the top bone and not the occipital bone.

In one form of the present technology applicable to nasal only masks or to full face masks, the positioning and stabilizing structure includes a second strap constructed and arranged such that, in use, at least a portion of the upper edge of the second strap passes under the sub-aural point of the patient's head and covers or is located under the occiput of the patient's head.

In one form of the present technology applicable to nasal masks alone or to full face masks, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

In some forms of the present technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. This aspect has the advantage that the belt is more comfortable for the patient when sleeping.

In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable to allow moisture to be transported through the strap.

In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a retention force to correspond to a different size and/or shape range. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads, but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads, but not for large-sized heads.

5.3.3.1 Catheter headgear

5.3.3.1.1 Catheter head sleeve

In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more headgear tubes 3350, the headgear tubes 3350 delivering pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient airway, such as through the plenum chamber 3200 and seal forming structure 3100. In the form of the present technique shown in fig. 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350 that convey air from the air circuit 4170 to the plenum chamber 3200. The tube 3350 is configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 over an appropriate portion of the patient's face (e.g., nose and/or mouth) in use. This allows the conduit of the air circuit 4170 providing the pressurized air flow to be connected to the connection port 3600 of the patient interface, the connection port 3600 being located differently than the front of the patient's face, for example at the top of the patient's head.

In the form of the present technique shown in fig. 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being located on a different side of the patient's head in use and extending over a respective ear (over an above-the-ear point above the patient's head) through a respective cheek region to an elbow 3610 at the top of the patient's 1000 head. This form of technique may be advantageous because if a patient sleeps with their head on their side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of the present technology, patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

In one example where the patient interface has one tube 3350, a single tube 3350 is positioned on one side of the patient's head in use (e.g., across one cheek region), and the strap forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head in use (e.g., across another region) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the band may each be under tension in use to help maintain the seal forming structure 3100 in the sealed position.

In one form, the tube 3350 may be at least partially extendable such that the tube 3350 and strap may be adjusted to be of substantially equal length when worn by a patient. This may allow for substantially symmetrical adjustment between the tube 3350 and the band such that the seal-forming structure remains substantially in the middle.

In the technical form shown in fig. 3Z, two tubes 3350 are fluidly connected to each other at an upper end and to connection port 3600. In some examples, the two tubes 3350 are integrally formed, while in other examples, the tubes 3350 are formed separately, but are connected in use and may be disconnected, for example, for cleaning or storage. Where separate tubes are used, they may be indirectly connected together, for example, each tube may be connected to a T-connector. The T-connector may have two arms/branches, each of which may be fluidly connected to a respective one of the tubes 3350. In addition, the T-connector may have a third arm or opening that provides a connection port 3600 for fluid connection with the air circuit 4170 in use. The opening may be an inlet 3332 for receiving a flow of pressurized air (see, e.g., 7C).

In some forms, the third arm of the T-connector may be substantially perpendicular to each of the first two arms.

In some forms, the third arm of the T-connector may be formed obliquely with respect to each of the first two arms.

In some forms, a Y-connector may be used instead of a T-connector. The first two arms may be inclined relative to each other and the third arm may be inclined relative to the first two arms. The angled formation of the first two arms may resemble the shape of the patient's head so as to conform to that shape.

In some forms, at least one arm of the T-connector (or Y-connector) may be flexible. This may allow the connector to flex based on the shape of the patient's head and/or the forces in the positioning and stabilizing structure 3300.

In some forms, at least one arm of the T-connector (or Y-connector) may be at least partially rigidized. This may help to maintain the shape of the connector so that bending of the connector does not close the airflow path.

The tube 3350 may be formed of a flexible material, such as an elastomer, e.g., silicone or TPE, and/or one or more fabrics and/or foams. The tube 3350 may have a preformed shape and be able to bend or move to another shape when a force is applied, but may return to the original preformed shape in the absence of the force. The tube 3350 may be generally arcuate or curved in shape to approximate the head profile between the top of the patient's head and the nasal or oral area.

In some examples, the one or more tubes 3350 are pressure resistant to becoming blocked if collapsed during use, such as if squeezed between the patient's head and the pillow, especially if there is only one tube 3350. Tube 3350 may be formed with sufficient structural rigidity to resist collapsing, or may be as described in U.S. patent 6,044,844, the contents of which are incorporated herein by reference.

Each tube 3350 may be configured to receive an air flow from a connection port 3600 on top of the patient's head and deliver the air flow to the seal-forming structure 3100 at the entrance to the patient's airway. In the example shown in fig. 3Z, each tube 3350 is located in use on a path extending from the plenum chamber 3200 through the cheek region of the patient and over the patient's ear to the elbow 3610. For example, a portion of each tube 3350 proximate to the plenum chamber 3200 may cover a maxillary region of a patient's head in use. Another portion of each tube 3350 may cover an area of the patient's head above the on-ear base of the patient's head. Each tube 3350 may also be located on one or both of the patient's sphenoid and/or temporal bones and the patient's frontal and parietal bones. Elbow 3610 may be located in use on the patient's parietal bone, frontal bone, and/or at junctions therebetween (e.g., coronal sutures).

In some forms of the present technology, patient interface 3000 is configured such that connection port 3600 may be positioned in a range of positions across the top of a patient's head, such that patient interface 3000 may be positioned to suit the comfort or fit of an individual patient. In some examples, headgear tube 3350 is configured to allow an upper portion of patient interface 3000 (e.g., connection port 3600) to move relative to a lower portion of patient interface 3000 (e.g., plenum chamber 3200). That is, the connection port 3600 may be at least partially separated from the plenum chamber 3200. As such, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

As described above, in some examples of the present technology, patient interface 3000 includes seal-forming structure 3100 in the form of a cushion that is generally located under the nose and sealed to the lower perimeter of the nose (e.g., an under-the-nose cushion). The positioning and stabilizing structure 3300, including tube 3350, may be constructed and arranged to draw the seal-forming structure 3100 under the nose into the patient's face with a sealing force in a posterior and superior direction (e.g., posterior superior direction). Having a sealing force in the posterior-superior direction may cause the seal forming structure 3100 to form a good seal against the lower perimeter of the patient's nose and the anterior-facing surface of the patient's face, such as on either side of the patient's nose and the upper lip of the patient.

A conduit, such as a headgear strap, forming part of the positioning and stabilizing structure 3300 may provide a force that contributes to the positioning and stabilizing force FPSS. As shown in fig. 3Z-1, the positioning and stabilizing force FPSS may be the resultant of various forces from different elements of the positioning and stabilizing structure 3300. For example, each conduit may provide a force fsubject directed in a posterior and respective lateral direction so as to hold the seal-forming structure 3100 against the patient's face (into the upper lip and sealed under the nose) and oppose the effect of positive pressure in the plenum chamber 3200 lifting off the face (i.e., fiuff). The force Fg may also be directed at least partially in an upward direction to overcome the gravitational force Fg.

In some forms, the catheter may provide a force directed toward the patient's head when the catheter is filled with pressurized air. This force may help to grasp the patient's head. This force may be caused by inflation of the catheter during normal use. In some forms, the force may provide a cushioning effect for the patient's head. The catheter may be designed to limit expansion to prevent over-clamping of the patient's head.

The position of the patient's head may also change the clamping force of the catheter. For example, if the patient is lying on his side, the weight of the patient's head may compress one conduit, while the other conduit (e.g., the side not between the patient's head and the sleeping surface, such as a pillow) may additionally expand to maintain substantially the same pressurized air flow rate.

The gravitational force Fg may be opposite to the frictional force Ff, which may act in a direction directly opposite to the gravitational force Fg. When gravity pulls the seal forming structure 3100 and the plenum chamber 3200 in a downward direction (as shown in fig. 3A-1), the frictional force Ff will act in an upward direction (e.g., against the patient's face). For example, the patient may experience a friction force Ff on their upper lip (and/or other surfaces of the patient's face that contact the seal-forming structure 3100) to oppose movement in the downward direction (which may help stabilize the cushion in place). Although the frictional force Ff is specifically shown as being opposite the gravitational force Fg of the seal-forming structure 3100 and the plenum chamber 3200, a component of the total frictional force (not shown) will also be opposite the gravitational force Fg associated with the positioning and stabilizing structure 3300 and any other portions of the patient interface 3000. Frictional forces may act anywhere along the patient interface 3000 that contacts the patient's skin (or hair). The friction force Ff extends in the opposite direction of the gravitational force Fg and along the patient's skin (or hair).

In some forms, the sum of the various forces may be equal to zero such that patient interface 3000 is in equilibrium (e.g., does not move along the patient's face in use). Specifically, gravity Fg and blowout force fsteak tend to move the seal forming structure 3100 away from the desired sealing position. The positioning and stabilizing force FPSS is applied so as to counteract the gravitational force Fg and the blowing force fsteak (and any frictional forces Ff) and to keep the seal forming structure 3100 properly positioned. While the positioning and stabilizing force FPSS may exceed the sum of the gravitational force Fg and the blowout force fsteak (where any additional positioning and stabilizing force FPSS is balanced by reaction forces from the patient's head acting on portions of the patient interface 3000) and still maintain the seal-forming structure 3100 in the proper sealing position, patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on patient interface 3000 is zero and the positioning and stabilizing force FPSS is just strong enough to achieve this. In some examples, the positioning and stabilizing structure 3300 may be adjustable such that, when assembled, the positioning and stabilizing force FPSS is greater than the force required to precisely balance the gravity Fg and blowout force fsteak to inflate to hold the patient interface 3000 tightly enough against the patient's head that damaging forces that may be experienced in use (such as tube resistance or lateral shunting of the plenum chamber 3200 during lateral recumbence) do not break the seal. As described below, when patient interface 3000 is in use, various positions of the patient's head may determine the positioning and stabilizing forces FPSS required to achieve balance.

5.3.3.1.2 Extendable and inextensible tube portions

In some examples of the present technology, one or both of the tubes 3350 are inextensible in length. However, in some forms, the tube 3350 may include one or more extendable tube segments, such as tube segments formed from extendable accordion structures. In some forms, patient interface 3000 may include a positioning and stabilizing structure 3300, the positioning and stabilizing structure 3300 including at least one gas delivery tube that includes a tube wall having an extendable accordion structure. The patient interface 3000 shown in fig. 3Z includes a tube 3350, with an upper portion of the tube 3350 including extendable tube segments, each tube segment in the form of an extendable accordion 3362.

In some forms, the extendable accordion 3328 may be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion 3328 may be biased toward the retracted position and may be moved to the extended position when the patient is prone to position and stabilize the structure 3300. Because portions of tube 3350 may be substantially inextensible (e.g., inextensible tube sections 3363), accordion-like structure 3328 allows positioning and stabilizing structure 3300 to stretch to fit different sized heads. This may allow a single size tube 3350 to be used with multiple sizes of heads. For example, the locating and stabilizing structure 3300 may be "single-size fit" as a result of the accordion structure 3328. Alternatively, the tube 3350 may be manufactured in a variety of sizes (e.g., small, medium, large). The patient may choose to most closely conform to the length of his head and the accordion 3328 may make small adjustments to fit the individual patient.

In some forms, the inlet 3332 may be disposed in the middle of the conduit 6320. For example, the tube 3350 may be symmetrical about the inlet 3332 by at least one axis.

The cross-sectional shape of the non-extendable tube section 3363 of the tube 3350 may be circular, elliptical, oval, D-shaped, or rounded rectangular, such as described in U.S. patent No. 6,044,844. The cross-sectional shape of the flat surface of the tube on the side facing and contacting the patient's face or other part of the head may be more comfortable to wear than, for example, a tube having a circular cross-section.

In some examples of the present technology, non-extendable pipe section 3363 connects to plenum chamber 3200 from a low angle. Headgear tubes 3350 may extend down to the sides of the patient's head and then curve forward and toward the middle to connect to the plenum chamber 3200 in front of the patient's face. Prior to connection to the plenum chamber 3200, the tube 3350 may extend to a position that is in the same vertical position (or, in some examples, below) as the connection to the plenum chamber 3200. That is, the tube 3350 may protrude in an at least partially upward direction prior to connection with the plenum chamber 3200. A portion of the tube 3350 may be located below the plenum chamber 3200 and/or the seal forming structure 3100. The tube 3350 may contact the patient's face below the patient's cheekbones, which is more comfortable than contact on the patient's cheekbones, and may avoid overly obscuring the patient's peripheral vision.

5.3.3.1.3 Catheter headgear connection port

In some forms of the present technique, patient interface 3000 may include a connection port 3600 located near an upper, side, or rear portion of a patient's head. For example, in the form of the present technique shown in fig. 3Z, the connection port 3600 is located on top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, patient interface 3000 includes an elbow 3610 that forms connection port 3600. The elbow 3610 may be configured to fluidly connect with a conduit of the air circuit 4170. Elbow 3610 may be configured to rotate relative to positioning and stabilizing structure 3300 to at least partially separate the catheter from positioning and stabilizing structure 3300. In some examples, elbow 3610 may be configured to rotate by rotating about a substantially vertical axis, and in some specific examples, by rotating about two or more axes. In some examples, the elbow may include a tube 3350 or be connected to the tube 3350 by a ball joint. The connecting portion 3600 may lie in the sagittal plane of the patient's head in use.

A patient interface having a connection port that is not located in front of the patient's face may be advantageous because some patients may find the catheter connected to the patient interface in front of the patient's face unsightly and/or unobtrusive. For example, a conduit connected to a patient interface in front of a patient's face may be prone to interference with bedding or sheets, particularly if the conduit extends downwardly from the patient interface in use. The form of the present technology including a patient interface having a connection port positioned above the patient's head in use may make it easier or more comfortable for the patient to lie or sleep in one or more of a side sleep position, a supine position (e.g., on the back thereof, generally upward), or a prone position (e.g., on the front thereof, generally downward). Furthermore, connecting the catheter to the front of the patient interface exacerbates a problem known as tube resistance, wherein the catheter exerts undesirable forces on the patient interface during patient head or catheter movement, resulting in displacement away from the face. Tube drag may be less of a problem when forces are received near the seal-forming structure (where tube drag forces are more likely to break the seal) at an upper location on the patient's head than at the front of the patient's face.

5.3.3.1.4 Headgear fluid connection

Two tubes 3350 are fluidly connected at their lower ends to a plenum chamber 3200. In some forms of the technology, the connection between the tube 3350 and the plenum chamber 3200 is achieved by a connection of two rigid connectors. The tube 3350 and the plenum chamber 3200 may be configured so that the patient can easily connect the two components together in a reliable manner. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and/or audible feedback in the form of a "clicking sound" or similar sound so that the patient may easily know that each tube 3350 has been properly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed of silicone or a textile material, and the lower end of each silicone tube 3350 is overmolded onto a rigid connector made of, for example, polypropylene, polycarbonate, nylon, or the like. The rigid connector on each tube 3350 may include a female mating feature configured to connect with a male mating feature on the plenum chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. In other examples, the tubes 3350 may each include a male connector or a female connector formed of a flexible material (e.g., silicone or TPE), such as the same material as the tube 3350 is formed of.

In other examples, a compression seal is used to connect each tube 3350 to the plenum chamber 3200. For example, a resiliently flexible (e.g., silicone) tube 3350 without a rigid connector may be configured to be extruded to reduce its diameter so that it may be compressed into a port in the plenum chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward, sealing the tube 3350 in the port in an airtight manner. Alternatively, in a hard-to-hard type engagement between the tubes 3350 and the plenum chamber 3200, each tube 3350 and/or plenum chamber 3200 may include a pressure activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange may be urged against the junction between the tube and the circumferential surface of the port or connector surrounding the plenum chamber 3200 to form or enhance a seal between the tube 3350 and the plenum chamber 3200.

5.3.3.2 Headgear straps

In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 having at least one strap that may be worn by the patient to assist in properly orienting the seal-forming structure 3100 relative to the patient's face (e.g., to limit or prevent leakage).

As described above, some forms of headgear 3302 may be constructed of a textile material that may be comfortably placed against the skin of a patient. The fabric may be flexible so as to conform to various facial contours. Although the fabric may include rigidizers along a selected length, it may limit bending, flexing, and/or stretching of the headgear 3302.

In some forms, headgear 3302 may be at least partially extendable. For example, the headgear 3302 may include an elastic or similar extensible material. For example, the entire headgear 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than surrounding portions). This may allow the headgear 3302 to stretch under tension, which may help provide a sealing force to the seal forming structure 3100.

Two forms of headgear, four-point headgear 3302-1 and two-point headgear 3302-2, are discussed in more detail below as illustrative examples.

5.3.3.2.1 Four point connection

As shown in fig. 7E, some forms of headgear 3302-1 may be a four-point connection headgear. This means that the headgear 3302-1 may be attached to four separate locations on the plenum chamber 3200, to the frame of the plenum chamber 3200, and/or to the arms of the plenum chamber 3200. The headset 3302-1 may include four different straps that provide tension to help maintain the seal forming structure 3100 in the sealed position. The positioning and stabilizing structure 3300 of fig. 3A may also be considered a four-point connection headset.

In some forms, the headgear 3302-1 may include a lower strap 3304-1, and the lower strap 3304-1 may be connected to a lower portion of the pad 3050-1. Lower strap 3304-1 may extend along the patient's cheek toward a rear region of the patient's head. For example, lower strap 3304-1 may cover the bite muscles on either side of the patient's face. Thus, the lower strap 3304-1 may contact the patient's head below the patient's ear. Lower strap 3304-1 may meet at the back of the patient's head and may cover the occiput and/or trapezius muscles.

Headgear 3302-1 may also include upper strap 3305-1, which may cover temporal, parietal and/or occipital bones. Upper strap 3305-1 may also be connected to tube 3350 (e.g., by engaging tabs 3320).

The back strap 3307-1 may extend between the upper strap 3305-1 and the lower strap 3304-1. The lower strap 3304-1 and the upper strap 3305-1 on a given side (e.g., left or right) may also be connected to the rear strap 3307-1 adjacent to each other. Thus, the height of the back strap 3307-1 may be approximately the combined height of the lower strap 3304-1 and the upper strap 3305-1. In use, the posterior band 3307-1 may cover the occiput and/or parietal bone. This may allow the posterior strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

In the example shown, the headgear 3302-1 may be formed in a generally X-shape. The lower strap 3304-1 and the upper strap 3305-1 may be connected to the rear strap 3307-1 using stitching, ultrasonic welding, or any similar process.

In some forms, lower strap 3304-1 is connected to magnetic member 3306-1. For example, each lower strap 3304-1 may pass through magnetic member 3306-1, such that the length of each lower strap 3304-1 may be adjusted. The magnetic member 3306-1 may be removably connected to a magnet 3370-1 (described below) such that the lower strap 3304-1 may be disconnected from the plenum chamber 3200, but the length of the lower strap 3304-1 may not be affected.

In some forms, the upper strap 3305-1 may be directly connected to the tab 3320 of the tube 3350. The upper straps 3305-1 may be threaded through the tabs 3320 to adjust the length and control the tension of each upper strap 3305-1.

In some forms, headgear 3302-1 may be used with only nose and mouth pad 3050-1 (e.g., because only nose pad 3050-1 does not have four connection points). However, headgear 3302-1 may be used interchangeably with tube 3350 and rigidizer arm 3340.

5.3.3.2.2 Two-point connection

As shown in fig. 7F, some forms of headgear 3302-2 may be a two-point connector set. This means that the headset 3302-2 can be connected to two separate locations.

In some forms, the headgear 3302-2 may be formed from a continuous sheet of material. In other words, the headgear 3302-2 may not be formed from multiple straps that are connected (e.g., stitched) together. This may be comfortable for the patient because they do not come into contact with any seams or joints connecting the different bands. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two upper straps, a rear strap, etc.) that are connected together (e.g., by stitching, ultrasonic welding, etc.).

In some forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap that is used in addition to the tube 3350 to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. As shown in fig. 3Z, patient interface 3000 includes straps 3307-2 that form part of a positioning and stabilizing structure 3300. For example, strap 3307-2 may be referred to as a back strap or a rear headgear strap. Posterior band 3307-2 may cover temporal, parietal and/or occipital bones. In other examples of the present technology, one or more additional bands may be provided. For example, a patient interface 3000 with a nasal cushion in accordance with examples of the present technology may have a second lower strap configured to rest against the patient's head near the patient's neck and/or against the back surface of the patient's neck.

In the example shown in fig. 3Z, the strap 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350 that are located on each side of the patient's head and pass around the back of the patient's head, such as to overlie or lie under the occiput of the patient's head in use. A strap 3310 is connected to each tube over the patient's ear. Referring to fig. 3Z, the positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, the strap 3310 may be connected between the tabs 3320. The strap 3310 may be flexible enough to pass around the back of the patient's head and rest comfortably on the patient's head, even under tension during use.

As shown in fig. 7F, some forms of headgear 3302-2 may be at least partially bifurcated. For example, the back strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the back of the patient's head) may be wider than the surrounding portion of the headgear 3302-2. The intermediate section 3308-2 of the back strap 3307-2 may include a slit 3309-2. Thus, the upper section of the rear strap 3307-2 may move relative to the lower section due to the slit 3309-2. This may allow the patient to have greater strap coverage over the rear region of their head, which may help anchor headgear 3302-2 to the patient's head better because of the absence of straps (e.g., 3304-1).

In some forms, headgear 3302-2 may be used with only nose pad 3050-2 (e.g., because nose and mouth pad 3050-1 does not have four connection points). However, headgear 3302-2 may be used interchangeably with tube 3350 and rigidizer arm 3340.

5.3.3.3 Rigidizer arm

As shown in fig. 7D, rigidizer arm 3340 may be an elongated rigid member that helps to hold a pad (e.g., nose and mouth pad 3050-1 or nose pad 3050-2) in an operative position. The rigidizer arm 3340 may contact one side of the patient's head and provide a force to limit sliding of the seal forming structure 3100 from the patient's nose and/or mouth.

In some forms, rigidizer arm 3340 is constructed of a rigid material (e.g., plastic). The rigid material may not allow the rigidizer arm 3340 to stretch. Additionally, rigidizer arm 3340 may be inflexible and may not be bendable. The rigidizer arm 3340 may be pre-molded to a desired shape to fit the patient's head. For example, rigidizer arm 3340 may be molded in a curved shape to substantially correspond to the shape of the sides of the patient's head (e.g., to cover the bite muscles and/or temporal bones).

In some forms, the rigidizer arm 3340 may be molded to conform to a particular patient's head (e.g., custom rigidizer arm 3340).

In some forms, rigidizer arm 3340 may be flexible in at least one direction. For example, rigidizer arm 3340 may be flexible across its width and inflexible across its length. In other words, the rigidizer arm 3340 may bend about an axis along the width of the rigidizer arm 3340, but not about an axis perpendicular to the rigidizer arm 3340. This may allow individual patients to adjust the rigidizer arm 3340 to better fit their individual heads.

In some forms, rigidizer arm 3340 may remain in a new position after bending. This may allow the patient to adjust the shape of the rigidizer arm 3340 for their particular head, and then the rigidizer arm 3340 will maintain the desired shape in use in order to improve patient comfort.

In some forms, the first end 3342 of the rigidizer arm 3340 may be a free end, while the second end 3344 of the rigidizer arm 3340 (e.g., opposite the first end 3342) may be stationary. The first end 3342 may be curved to minimize sharp edges that may cause discomfort to the patient. In use, the first end 3342 may also cover the head of a patient adjacent to the temporal bone. The second end 3344 may be fixed to the arm connection 3504.

In some forms, arm connection structure 3504 may be similar to catheter connection structure 3500. For example, arm connection structure 3504 and catheter connection structure 3500 may have substantially the same shape. This may allow conduit connection 3500 or arm connection 3504 to fit into a groove (e.g., 3266-1 or 3266-2) and connect to plenum inlet port 3254. The arm connection structure 3504 may be connected to the nose and mouth pad 3050-1 or the nose pad 3050-2 alone in substantially the same manner as the catheter connection structure 3500 (e.g., via a snap fit, press fit, friction fit, etc.).

In some forms, the arm connection structure 3504 can function as a plug for the plenum inlet port 3254 (e.g., 3254-1 and/or 3254-2). Unlike tube 3350, rigidizer arm 3340 does not communicate pressurized air to plenum chamber 3200. The rigidifying arm 3340 may be used with a "tube down" configuration in which a hose is connected to the vent opening 3402 (e.g., 3402-1 and/or 3402-2) and air is delivered into the plenum chamber 3200 through the vent opening 3402. In this example, air need not travel into the plenum inlet opening 3254 or in and out of the plenum inlet opening 3254. Thus, the arm connection structure 3504 may form a seal with the plenum inlet opening 3254 to restrict airflow into or out of the plenum 3200.

5.3.4 Vents

In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for flushing of exhaled gases (e.g., carbon dioxide).

In some forms, the vent 3400 is configured to allow a continuous flow of vent gas from the interior of the plenum chamber 3200 to the environment while the pressure within the plenum chamber is positive relative to the environment. The vent 3400 is configured such that the size of the vent flow is sufficient to reduce re-breathing of exhaled CO2 by the patient while maintaining therapeutic pressure in the plenum in use.

One form of vent 3400 in accordance with the present technique includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

The vent 3400 may be located in the plenum chamber 3200. Optionally, the vent 3400 is located in a decoupling structure (e.g., rotating).

As shown in fig. 7N, a vent 3450 may be used with the patient interface 3000. The vent 3450 can have a substantially similar shape (e.g., a substantially circular shape) as the vent opening 3402-1.

The vent 3450 may be used with a mouth and nose plenum chamber 3200-1 (e.g., shown in fig. 7A) or a nose plenum chamber 3200-2 alone (e.g., shown in fig. 7B).

With continued reference to fig. 7A, the vent 3450 may include a vent housing 3404, which vent housing 3404 may be configured to engage with the vent opening 3402. The vent housing 3404 may be constructed of a rigid or semi-rigid material. For example, the vent housing 3404 may be constructed of plastic, metal, or any similar material. The vent housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit unwanted bending that may affect the position of the seal-forming structure 3100 on the patient's face).

The vent housing 3404 may include a front surface 3408, a rear surface 3412, and side walls/grooves 3416. The front surface 3408 faces away from the patient's face when in use and may be positioned outside the pressurized volume of the plenum chamber 3200. Rear surface 3412 is disposed opposite front surface 3408. In use, the rear surface 3412 may face the patient and may be disposed within the pressurized volume of the plenum chamber 3200. Grooves or sidewalls 3416 may be formed between front surface 3408 and rear surface 3412. A portion of the plenum chamber 3200 may be received within the recess/sidewall 3416 to hold the vent 3400 in place.

In some forms, a diffuser 3448 may be used with the vent housing 3404. The diffuser 3448 may help limit decibel output from any patient interface 3000 (or any other patient interface). In particular, the diffuser 3448 may help limit the decibel level associated with the air output (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 may limit the decibel level at any point in the patient interface.

In some forms, the diffuser 3448 may diffuse out of the plenum chamber 3200 and through the vents of the vent housing 3404 and thus slow it. The diffuser 3448 can help avoid jetting and associated discomfort to the patient and/or bed partner (e.g., noise caused by jetting onto pillows, sheets, bedding, etc.).

In some forms, the diffuser may include a central member 3456 having an outer surface that faces away from the patient in use. The outer diameter of the center component 3456 may be smaller than the inner diameter of the vent housing 3404 proximate the front surface 3408. This may form a gap 3464 through which air may travel.

5.3.5 Decoupling structure

In one form, the patient interface 3000 includes at least one decoupling structure to move at least one portion of the patient interface relative to another portion of the patient interface. For example, the decoupling structure may be configured to separate the connection port from the seal-forming structure. In some examples, the decoupling structure may be a swivel or a ball and socket.

5.3.6 Connection port

Connection port 3600 allows connection to air circuit 4170.

5.3.7 Forehead support

In one form, patient interface 3000 includes forehead support 3700.

5.3.8 Anti-asphyxia valve

In one form, the patient interface 3000 includes an anti-asphyxia valve.

5.3.9 Ports

In one form of the present technique, patient interface 3000 includes one or more ports that allow access to the volume within plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows for direct measurement of a property of the gas within the plenum chamber 3200, such as pressure.

5.3.10 Modularization

As described above, the cushion, headgear, and sleeve may be of different types, which may correspond to different uses (e.g., oral breathing, nasal breathing, etc.). The patient or clinician may select certain combinations of pads, headgear, and sleeves to optimize the effectiveness of the therapy and/or the comfort of the individual patient. Examples of such modular designs are described in PCT/SG2022/050777, filed at 28, 10, 2022, which is incorporated herein by reference in its entirety.

In some forms, different types of cushions, headgear, and sleeves may be used interchangeably with one another to form different combinations of patient interfaces. This may be beneficial from a manufacturing perspective, as fewer parts may be used to create a wider variety of patient interfaces. Additionally or alternatively, various combinations may allow the patient to change the type of patient interface without changing each component. The modular design is described in more detail below and in singapore patent application number 10202112048R, which is incorporated by reference in its entirety.

Air may be delivered to the patient in one of two primary ways. In one example, the patient may receive a flow of pressurized air through headgear tube 3350 (see, e.g., fig. 3Z). This may be referred to as a "tube up" configuration, and the connection port may be positioned on top of the patient's head. In another example, the patient may receive a flow of pressurized air through a conduit connected to the plenum chamber 3200, such as through the connection port 3600 (see, e.g., fig. 3A). This may be referred to as a "tube down" configuration, in which the airflow conduit is positioned in front of the patient's face. Different patients may be more comfortable with one type of air delivery over another (e.g., due to the type of sleep of the patient). Thus, it may be beneficial to allow a single type of patient interface to be used in either a "tube up" or "tube down" configuration.

The patient interface may be part of a modular assembly having various interchangeable components that the patient and/or clinician may swap out for use with one or more components of a different type. The following description describes various combinations that may be produced by assembling different components together.

5.3.10.1 Sleeve

In some forms, to achieve modularity, a sleeve may be used with the tube 3350 and/or rigidizer arm 3340. The sleeve may at least partially surround the tube 3350 and/or rigidizer arm 3340. As shown in fig. 7G-7I, differently shaped sleeves may be used, which may correspond to different types of positioning and stabilizing structures 3300. In some forms, the configuration of the sleeve may be customized to fit a particular patient's face. For example, the sleeve may be configured in a relatively more posterior region of the patient's head.

In some forms, the sleeve may be constructed of a comfort material. For example, the sleeve may be constructed of a textile material, a foam material, or a combination of both. The comfort material may contact the patient in use and may feel soft against the patient's skin in order to improve patient compliance.

The material may also be flexible to facilitate the donning and doffing of the sleeve from the tube 3350 or rigidizer arm 3340. For example, the material may allow the sleeve to flex to conform to the shape of the tube or catheter head cover 3350 or rigidizer arm 3340, which may vary depending on the shape of the individual patient's head.

In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastomeric material may assist in stretching the sleeve to fit around the tube 3350 or rigidizer arm 3340. The resilient material may then return to an initial position against the tube 3350 or rigidizer arm 3340 to limit sleeve slippage in use.

As described in more detail below, some forms of the sleeve may be dedicated to the stiffening element (e.g., tube 3350 and/or stiffening arm 3340). However, the sleeves may help the stiffening elements interchangeably connect with versions or types of pads (e.g., mouth and nose pad 3050-1, nose pad 3050-2 only, etc.).

5.3.10.1.1 Catheter hub

As shown in fig. 7G, one example of a sleeve is a catheter sleeve 3351, which may be used with the tube 3350 described above.

As shown in fig. 7G, the catheter sleeve 3351 may include a curved shape similar to the shape of the tube 3350 shown in fig. 7C. The flexible material used to construct the catheter hub 3351 may allow the catheter hub 3351 to flex further to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

In some forms, the conduit sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be disposed at one end of the catheter sleeve 3351. The upper opening 3352 may be an opening of a channel extending along at least a portion of the catheter sleeve 3351.

As shown in fig. 7G, some forms of catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned on an end of the conduit sleeve 3351 opposite the upper opening 3352. The catheter hub 3351 may be customized to fit a particular user's face. For example, the lower extension 3354 of the catheter sleeve 3351 may be disposed in a relatively more posterior or anterior region of the patient's head.

Some forms of lower extension 3354 may include a rigid or semi-rigid member (e.g., within sleeve 3351). The rigid or semi-rigid member may be constructed of a plastic material or the like. Or lower extension 3354 may be hardened using a manufacturing process (e.g., stitch-hardening lines, flat knitting, using thicker materials).

As shown in fig. 7G, some forms of lower extension 3354 may include a connecting member 3356. In the example shown, the connection member 3356 may be a magnet, although in other examples, the connection member 3356 may be a different type of connector (e.g., mechanical fasteners, adhesives, hook and loop material, etc.). The connection member 3356 may also be positioned at one end of the lower extension 3354, although the connection member 3356 may also be positioned anywhere along the lower extension 3354.

In some forms, a connection member 3356 (e.g., a magnet) may be removably connected to the magnet 3370-1 of the holster 3302-1. For example, when the catheter sleeve 3351 is connected to the tube 3350 (see, e.g., fig. 7J), the magnet 3370-1 connected to the lower strap 3304-1 may be removably connected to the connection member 3356 so as to provide tension.

5.3.10.1.2 Four-point arm sleeve

As shown in fig. 7H, another example of a sleeve is a four-point arm sleeve 3380 that may be used with the rigidizer arm 3340 described above.

As shown in fig. 7H, the four-point arm sleeve 3380 may include a curved shape similar to the rigidizer arm 3340 shown in fig. 7D. The flexible material used to construct the four-point arm sleeve 3380 may allow the four-point arm sleeve 3380 to further flex to correspond to the shape of the rigidizer arm 3340 (e.g., when worn by a patient and/or flexed by a patient).

As shown in fig. 7H, some forms of four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be located at one end of the four-point arm sleeve 3380.

In the illustrated example, the shape and/or configuration of the lower extension 3384 is substantially the same as the shape of the lower extension 3354. For example, the lower extension 3384 may be more rigid (e.g., due to rigidifying threads or rigid materials) than the rest of the four-point arm sleeve 3380.

As shown in fig. 7H, some forms of lower extension 3384 may include a connecting member 3386. In the example shown, the connection member 3386 may be a magnet, although in other examples, the connection member 3386 may be a different type of connector (e.g., mechanical fasteners, adhesives, hook and loop material, etc.). The connection member 3386 may also be positioned at one end of the lower extension 3384, although the connection member 3386 may also be positioned anywhere along the lower extension 3384.

In some forms, a connection member 3386 (e.g., a magnet) may be removably connected to the magnet 3370-1 of the holster 3302-1. For example, when the four-point arm sleeve 3380 is connected to the rigidizer arm 3340 (see, e.g., fig. 7K), the magnet 3370-1 connected to the lower strap 3304-1 may be removably connected to the connection member 3386 so as to provide tension.

As shown in fig. 7H, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tabs 3320 on the tube 3350. When the four-point arm sleeve 3380 is worn by a patient, the tabs 3394 may be positioned on the patient's head in substantially the same location as the tabs 3320 are positioned when the tube 3350 is worn by the patient.

5.3.10.1.3 Two-point arm sleeve

As shown in FIG. 7I, another example of a sleeve is a two-point arm sleeve 3380-1 that may be used with the rigidizer arm 3340 described above.

In some forms, the two-point arm sleeve 3380-1 may be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences are described below.

As shown in fig. 7I, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 at an end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening through the passage of the two-point arm sleeve 3380-1. In the example shown, the lower opening 3388-1 may open onto the surface of the catheter sleeve 3380-1.

As shown in fig. 7I, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may be similar to the tabs 3320 on the tube 3350. When the two-point arm sleeve 3380-1 is worn by a patient, the tab 3394-1 may be positioned on the patient's head in substantially the same location as the tab 3320 is positioned when the tube 3350 is worn by the patient.

5.3.10.2 Assembled patient interface

As shown in fig. 7J-7M, the various elements described above may be combined into four different patient interfaces. Different patient interfaces may allow patients to use different types based on their respective comfort levels. The modularity of the different elements (e.g., the ability to be used with multiple types of patient interfaces) may simplify manufacturing and/or may allow a patient to more easily switch between multiple types of patient interfaces.

5.3.10.2.1 Nasal and mouth mask tube up configuration

As shown in fig. 7J, the patient may wear the cushion 3050-1 in a tube-up configuration with the tube 3350 and four-point headgear 3302-1. The assembly may form a tubular up nose and mouth patient interface 3000-1.

In some forms, a catheter hub may be used with the tube 3350 to enable the patient to experience a "tube-up" air delivery type with a mouth and nose pad 3050-1. The catheter hub provides additional connection locations for connecting the four-point headset 3302-1, as described below. However, other forms of connectors other than or in addition to catheter hubs may be used.

In the example shown, the catheter hub may be connected to a tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 may be used (via the conduit connection 3500) to connect the tube 3350 to the pad 3050-1. The catheter sleeve provides a magnet for attachment to the magnet 3370-1 of the four-point headset 3302-1 (see, e.g., fig. 7E). Alternatively, a different form of connection may be used.

As shown in FIG. 7J, the four-point headgear 3302-1 may be attached at four separate locations to provide tension to maintain the cushion-1 in a sealed position on the patient's head.

For example, lower strap 3304-1 (e.g., via magnetic member 3306-1) may be removably connected to the magnets of the catheter hub. In use, each lower strap 3304-1 may contact a patient's cheek (e.g., cover the bite muscle). Lower strap 3304-1 may also extend under the patient's ear.

5.3.10.2.2 Nasal and mouth mask tube down configuration

As shown in fig. 7K, the patient may wear the cushion 3050-1 in a tube down configuration with the rigidizer arm 3340 and the four-point headgear 3302-1. The assembly may form a tube-down nasal and mouth patient interface 3000-2.

In some forms, a catheter sleeve may be used with rigidizer arm 3340 to enable a patient to experience a "tube-down" air delivery with mouth and nose pad 3050-1. The catheter hub provides additional connection locations for connecting the four-point headset 3302-1, as described below. However, other forms of connectors other than or in addition to catheter hubs may be used.

In the example shown, the catheter hub may be connected to a rigidizer arm 3340 of the positioning and stabilizing structure 3300. The rigidizer arm 3340 may be used (via a conduit connection 3504) to connect the rigidizer arm 3340 to the pad 3050-1. The catheter sleeve provides a magnet for attachment to the magnet 3370-1 of the four-point headset 3302-1 (see, e.g., fig. 7E). Alternatively, a different form of connection may be used.

As shown in FIG. 7K, the four-point holster 3302-1 may be attached at four separate locations to provide tension to hold the cushion 3050-1 in a sealed position on the patient's head.

5.3.10.2.3 Nasal mask tube up-set

As shown in fig. 7L, the patient may wear the cushion 3050-2 in a tube-up configuration with the tube 3350 and two-point headgear 3302-2. The assembly may form a tube-up nasal-only patient interface 3000-3

The catheter hub may be used with the tube 3350 and may provide additional comfort to the patient. The sleeve may not add additional points of attachment to attach the locating and stabilizing structure 3300 to the pad 3050-2. In the example shown, the tube 3350 of the positioning and stabilizing structure 3300 may be directly connected to the pad 3050-2.

As shown in fig. 7L, the two-point holster 3302-2 may be connected to tabs 3320 on the tube 3350 to provide tension to hold the cushion 3050-2 in a sealed position on the patient's head.

5.3.10.2.4 Nasal mask tube down configuration

As shown in FIG. 7M, the patient may wear a liner 3050-2 with a stiffening arm 3340 and tube up configuration of the two-point headgear 3302-2. The assembly may form a tube down nasal only patient interface 3000-4.

The catheter sleeve may be used with rigidizer arm 3340 and may provide additional comfort to the patient. The sleeve may not add additional points of attachment to attach the locating and stabilizing structure 3300 to the pad 3050-2. In the example shown, the rigidizer arm 3340 of the positioning and stabilizing structure 3300 may be directly connected to the pad 3050-2.

As shown in FIG. 7M, the two-point headgear 3302-2 may be attached to tabs 3320 on the sleeve to provide tension that holds the cushion 3050-2 in a sealed position on the patient's head.

5.3.10.2.5 Component modularity

Fig. 7P shows how the different elements are combined to form the four different patient interfaces described above. As shown, different components may be reused for different types of patient interfaces. This may allow for easier manufacturing and assembly, as a large number of identical components may be produced and used in a variety of types. The only component that is not used for the various types may be a sleeve. However, the sleeve may be easier to manufacture. Fig. 7O shows a portion of an air circuit 4170 that is connectable with a patient interface, while fig. 7N shows a vent 3404 that interchangeably replaces the air circuit shown in fig. 7O depending on the type of patient interface.

5.4RPT device

An RPT device 4000 in accordance with one aspect of the present technology includes mechanical, pneumatic, and/or electrical components and is configured to perform one or more algorithms 4300, such as any of all or part of the methods described herein. The RPT device 4000 may be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more of the respiratory disorders described elsewhere in this document.

In one form, RPT device 4000 is constructed and arranged to be capable of delivering an air flow in the range of-20L/min to +150L/min while maintaining a positive pressure of at least 4cmH2O, or at least 10cmH2O, or at least 20cmH 2O.

5.5 Air Circuit

The air circuit 4170 in accordance with an aspect of the present technique is a tube or tube (described herein as an airway tube) constructed and arranged to allow air flow to travel between two components (such as the RPT device 4000 and the patient interface 3000 or 3800) in use.

In particular, the air circuit 4170 may be fluidly connected with the outlet of the pneumatic block 4020 and the patient interface, for example, through a connection port 3600 connected to the patient interface. In some examples, the air circuit may include a connection sleeve or connector for facilitating connection of the air circuit to the RPT device 4000 or the flow generator and patient interface. For example, the first end of the catheter/airway tube may include a connector or nipple configured to facilitate connection of the air circuit to the flow generator, and the second end of the catheter/airway tube may include a connector or nipple for facilitating connection of the air circuit to the flow generator.

In some examples, the air circuit may include a decoupling structure, such as a swivel or ball joint, to allow one portion of the air circuit to swivel or rotate in a universal direction relative to another portion of the air circuit.

This air circuit may be referred to as an air delivery tube. In some cases, there may be separate branches of the circuit for inhalation and exhalation. In other cases, a single branch is used.

In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as temperature sensors. In one form, the heater wire loop may be helically wound about the axis of the air loop 4170. The heating element may be in communication with a controller for control thereof. One example of an air circuit 4170 that includes a heater wire circuit is described in U.S. patent 8,733,349, which is incorporated by reference herein in its entirety.

5.6 Humidifier

5.6.1 Humidifier overview

In one form of the present technique, a humidifier 5000 (e.g., as shown in fig. 5A) is provided to vary the absolute humidity of the air or gas for delivery to the patient relative to ambient air. Generally, humidifier 5000 is used to increase the absolute humidity of the air stream (relative to ambient air) and to increase the temperature of the air stream prior to delivery to the patient's airway.

The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air stream, and a humidifier outlet 5004 for delivering a humidified air stream. In some forms, as shown in fig. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which may be adapted to house the humidifier reservoir 5110 and include a heating element 5240.

5.7 Respiratory waveform

Fig. 6A shows a typical breathing waveform model of a person while sleeping. The horizontal axis is time and the vertical axis is respiratory flow. Although the parameter values may vary, a typical breath may have an approximation of tidal volume Vt 0.5L, inspiration time Ti1.6s, peak inspiration flow Qpeak0.4L/s, expiration time Te 2.4s, peak expiration flow Qpeak-0.5L/s. The total duration Ttot of respiration is about 4 s. The person typically breathes at a rate of about 15 Breaths Per Minute (BPM), with ventilation Vent being about 7.5L/min. A typical duty cycle (ratio of Ti to Ttot) is about 40%.

5.8 Forehead Cooling

Patients with OSA are more prone to co-morbid insomnia than average persons. Forehead cooling has been shown to shorten the fall-to-sleep time of insomnia patients. Accordingly, it is an aspect of the present technology to provide a forehead cooling system 2000 that is configured to reduce the temperature of a patient's forehead when in use.

In some examples, forehead cooling system 2000 may be incorporated into a system for treating sleep disordered breathing and/or insomnia. For example, the forehead cooling system may be incorporated into or configured to attach to the patient interface 3000, the positioning and stabilizing structure 3300 of the patient interface 3000, and/or the air circuit 4170 configured to deliver a flow of breathable gas to the patient interface 3000.

In some examples of the present technology discussed herein, these forehead cooling systems may use, for example, air flow from RPT device 4000 or exhaled air from the patient's airway as a means for cooling the patient's forehead. For example, the air flow may be directed to or through a surface of the patient's forehead to remove heat from the patient's forehead, such as by using convection.

In examples where humidifier 5000 is used in the present technology, the air flow may be humidified to further help reduce the temperature of the patient's forehead.

In other examples of the present technology, a liquid forehead cooling system 2000 may be provided. These systems are configured to facilitate heat transfer to the forehead of a patient, for example, through the use of conductive cooling.

In yet further examples of the present technology, the active forehead cooling system 2000 may be provided, for example, by using a peltier cooler.

In one example of the present technology, the system may include components such as a heat exchanger, an evaporative cooler, or an active component (such as a peltier cooler). Some examples of heat exchangers and/or humidity exchangers that may be used with the present technology are described in PCT publication No. WO/2013/067592, which is incorporated herein by reference in its entirety.

It should be appreciated that in the examples described herein, any one or more of these techniques may be used, alone or in combination, to provide forehead cooling functionality.

Although the present technology is described primarily in connection with the adjuvant treatment of insomnia, it is believed that the technology may also be beneficial in the adjuvant treatment of other disorders, such as the treatment of dyspnea, climacteric symptoms, hypertension, anxiety, hyperthyroidism, anhidrosis, diabetes, migraine and chronic pain. In other examples, the present technology may provide benefits in terms of sleep comfort, such as during pregnancy and luteal phase of the menstrual cycle.

5.8.1 Forehead cooling technique

5.8.1.1 Air cooling

Referring to fig. 8A, a patient interface 3000 is provided with a forehead cooling system 2000. Forehead cooling system 2000 is connected to and supported by positioning and stabilizing structure 3300. For example, the forehead cooling system may include a first end 2002 that is connected to and supported by a first side 4171 of the positioning and stabilizing structure 3300 and a second end 2004 that is connected to and supported by a second side 4172 of the positioning and stabilizing structure 3300.

In the illustrated example, the forehead cooling system 2000 is connected to the positioning and stabilizing structure 3300 at a location above the patient's eyes in order to minimize any potential obstruction of the patient's view. The forehead cooling system 2000 is also positioned such that there is a gap 2006 between the connection port 3600 on top of the patient's head and the forehead cooling system 2000 that may advantageously allow patient hair to extend through the gap, potentially improving comfort and reducing irritation.

Forehead cooling system 2000 may be positioned and attached to a positioning and stabilizing structure using any suitable method, such as being mounted to one or more straps as described herein.

Forehead cooling system 2000 may be configured to attach (such as removably attach) to positioning and stabilizing structure 3300 using one or more fasteners, such as snaps, buckles, or hook-and-loop fasteners, in some examples, forehead cooling system 2000 may be removably attached to one side of positioning and stabilizing structure 3300, in other examples of the present technology, the forehead cooling system may be non-removably engaged to the positioning and stabilizing structure 3300.

In some examples, forehead cooling system 2000 may be attached to positioning and stabilizing structure 3300 with an adjustment mechanism, such as a hook and loop fastener or buckle (not shown), to allow the patient to adjust the force applied to the patient's forehead when in use. Furthermore, the forehead cooling system may include an extensible material, such as an elastic material or a spandex material, to allow the forehead cooling system 2000 to remain in contact with the patient's forehead in a series of sleep postures.

In some examples, forehead cooling system 2000 may be configured to fluidly connect to patient interface 3000 or air circuit 4170. For example, the airflow through the patient interface 3000 and/or the air circuit 4170 may be used to cool the patient's forehead when in use as described herein. In the example of fig. 8A, the forehead cooling system 2000 may be fluidly connected to the first side 4171 of the positioning and stabilizing structure 3300 and/or the second side 4172 of the positioning and stabilizing structure such that the airflow received through the connection port 3600 passes through the forehead cooling system 2000 or otherwise (e.g., by using a venturi effect) generates an airflow within the forehead cooling system 2000 to remove heat from a forehead region of a patient.

For example, forehead cooling system 2000 may be fluidly connected to first side 4171 of positioning and stabilizing structure 3000 at first end 2002 such that airflow from connection port 3600 to the patient interface is fluidly coupled to forehead cooling system 2000. The second end 2004 may be configured to draw air from the ambient environment (e.g., using a venturi effect). This may advantageously draw in cooler and/or drier air than may be provided by the RPT device 4000, particularly if a heated/humidified air supply or air circuit 4170 is used. To prevent air from exiting the second end 2004, a one-way valve may be used that allows air to be drawn in but not air to be expelled. Examples of suitable valves should be well known to those skilled in the art.

For example, fig. 8B shows a cross-sectional view of a forehead cooling system 2000 in the form of a fluid conduit 8005, which may be fluidly coupled to patient interface 3000 and/or RPT device 4000. For example, as described herein, the positioning and stabilizing structure 3300 may include a conduit enclosure through which the pressurized flow of breathable gas is provided in use. For example, the pressurized flow of breathable gas generated by RPT device 4000 may be directed through a fluid conduit of forehead cooling system 2000 to cool the patient's forehead during use.

In one example, the fluid conduit 8005 may comprise or consist entirely of a fabric. Examples of fabric catheters are described in more detail in PCT publication No. WO2012167327A1 published 12/13 2012, the entire contents of which are incorporated herein by reference.

The use of a fabric may advantageously enhance patient comfort and, in turn, respiratory therapy compliance.

In one example of the present technique, the flow of breathable gas through forehead cooling system 2000 may be sufficient to cool the forehead region of the patient, for example, by convective cooling. In some examples of the present technology, the material used in fluid conduit 8005 may be selected to include at least one material having a relatively high thermal conductivity (such as greater than 0.5W/mK). For example, the fluid conduit may comprise a thermally conductive silicone (such as carbon impregnated silicone) or one or more metals (such as thin flexible wires or metal layers).

In some examples of the present technology, fluid conduit 8005 may include a semipermeable material configured to exhaust the air flow received from connection port 3600 to the patient's forehead in order to cool the forehead. For example, the fluid conduit 8005 material may be configured to allow a quantity of breathable gas to flow through the conduit and to the forehead region of the patient. For example, the fluid conduit 8005 may be configured to allow airflow therethrough. For example, fluid conduit 8005 may include one or more apertures 8007 configured to allow a flow of breathable gas therethrough. By using holes 8007, the airflow may be directed to specific areas of the forehead for better control of the location of cooling and the cooling rate (e.g., by controlling the number of holes and the size of the holes). For example, the fluid conduit 8005 may have between 3 and 100 holes 8007 disposed along the length of the fluid conduit 8005, such as between about 10 and 50 holes 8007.

In other examples, fluid conduit 8005 may be constructed of a gas permeable material that allows some gas flow therethrough. For example, the fluid conduit 8005 may be constructed of a fabric and may provide air flow between the interstices between the fibers or yarns of the fabric and/or the fibers or yarns may allow some air flow therethrough.

In other examples of the present technology, forehead cooling system 2000 may be configured to remain in contact with the patient's forehead and remove forehead heat by transferring the forehead heat into an air stream, followed by transferring the heated air to the patient's airway for breathing. As should be well known to those skilled in the art, heating the flow of breathable gas/air prior to inhalation by the patient may promote comfort and compliance with the respiratory pressure therapy system.

In one example shown in fig. 8C, a forehead cooling system 2000 is provided that includes a conduit 8005 having a patient contact layer 8009 configured to contact the patient's forehead when in use and to draw heat away from the patient's forehead when in use. For example, this patient contact layer 8009 may be constructed of a thermally conductive material as described herein.

In some examples of the present technology described herein, patient contact layer 8009 may be thermoelectric cooler 5005.

Attached to the patient contact layer is a fluid conduit 8005 configured to receive a fluid flow, such as a flow of breathable gas. In some examples, the fluid flow is a liquid, such as water, and in other examples, the fluid flow may be a breathable gas, such as air/oxygen. This fluid flow may advantageously be used to draw heat away from the patient contact layer and thus cool the patient's forehead.

In some examples, patient contact layer 8009 may form one of the walls of fluid conduit 8005, in other examples, such as shown in fig. 8C, patient contact layer 8009 may be attached to interface layer 8011 between patient contact layer 8009 and fluid flow 'F' through fluid conduit 8005. For example, it may be preferable to manufacture the fluid conduit 8005 separately from the patient contact layer 8009, and attach the fluid conduit 8005 to the patient contact layer using one or more fasteners (such as adhesive). In this example, the interface layer 8011 acts as one of the walls of the fluid conduit 8005. The interface layer 8011 may be further configured to be more porous (i.e., have more holes or larger pore sizes 8007) or have a higher thermal conductivity than other materials used in the fluid conduit 8005, such as a fabric material, in some examples described herein, this interface layer 8011 may be a thermal interface material 6002 as described in more detail in connection with fig. 12A.

In some examples of the present technology, it may be advantageous to monitor and/or control the temperature of the forehead cooling system 2000 and/or the patient's forehead. Thus, in some examples of the present technology, forehead cooling system 2000 may include one or more sensors 8013, such as a temperature sensor, a humidity sensor, a heart rate sensor, or an EEG sensor. These sensors 8013 may be used to provide information about the efficacy of the forehead cooling system 2000 or otherwise provide feedback as to whether forehead cooling is required. It should be appreciated that these sensors 8013 may be communicatively coupled to the processor, such as via a wired or wireless connection. For example, the processor may be provided in an RPT 4000 or a personal computing device (such as a smartphone or computer). Additional examples of monitoring systems are described herein.

5.8.1.2 Fluid cooling

In one example of the present technique shown in fig. 9, a forehead cooling system 2000 is provided that includes a fluid transfer system 3001 configured to transfer heat away from the forehead of the patient 1000, for example, using thermal conduction. While the system is schematically shown to simplify the illustration, it should be understood that the system may be attached or otherwise mounted to the patient interface 3000, such as to the positioning and stabilizing structure 3300 as described herein.

The fluid delivery system 3001 may include a reservoir 3002, such as a bladder, configured to receive a volume of fluid, such as water, oil, or air, in use. The reservoir 3002 may include an inlet 3004 configured to receive a fluid flow and an outlet 3006 configured to transfer fluid from the reservoir via a pump 3008, for example, for cooling or recirculation.

In some examples of the present technology, the pump 3008 may be a peristaltic pump or any other suitable fluid pump, for example, where the fluid is air, the pump 3008 may be a blower. In some examples of the present technology, the blower may be a blower included in an RPT device 4000 configured to generate a flow of breathable air to the patient's airway for use in treating sleep apnea.

In some examples of the present technology, the reservoir 3002 may be flexible to allow the reservoir 3002 to conform to the forehead of a patient, i.e., a flexible fluid bladder, such as a plastic bladder made of a flexible material such as polyvinyl chloride or thermoplastic polyurethane. In other examples, the reservoir may be configured to be thermally connected to the patient's forehead via a thermal interface material 6002 as discussed later in connection with fig. 12A.

In some examples of the present technology, the reservoir 3002 may contain a gel 3010 material, such as one or more gel beads. For example, the gel may comprise sodium polyacrylate or any other suitable gel. The use of a gel may advantageously improve the heat transfer characteristics of the forehead cooling system 2000, such as by providing a higher thermal conductivity than the use of a fluid such as oil or water alone or by increasing the heat capacity of the heat transfer medium (relative to the use of oil or water alone).

In some examples of the present technology (such as examples where the forehead cooling system is removable), the reservoir 3002 may be cooled in a refrigerator prior to use in order to quickly reduce the temperature, thereby helping to fall asleep. Accordingly, it is an aspect of the present technology to provide a forehead cooling system 2000 that is removable from the positioning and stabilizing structure 3300 and that cools prior to use to assist in falling asleep.

In some examples of the present technology, the reservoir 3002 may contain a Phase Change Material (PCM), such as sodium acetate trihydrate. In use, the phase change material may be heated to a liquid and in use, a bending process may be used or triggered by pressing a metal sheet inside the reservoir to change the PCM from its liquid state to a solid state, thereby creating a cooling effect. The PCM material may then be prepared for the next sleep period by reheating the liquid to change the PCM from a solid state to a liquid state. It should be appreciated that in examples where PCM material is used in the present technique, the pump 3008 is not required and the forehead cooling system 2000 may include only a reservoir of PCM material that is held in place on the patient's forehead.

Fig. 10 illustrates an example of the forehead cooling technique of fig. 9 engaged with the forehead of a patient 1000. In this example, the reservoir 3002 is supported to engage the forehead of the patient 1000 using a positioning and stabilizing structure 3300. For example, the reservoir may be attached to one or more straps or catheters on each side of the patient's head.

Thus, by combining forehead cooling system 2000 with a patient interface, positioning and stabilizing structure 3300 may be utilized to position and stabilize the patient interface for engagement with the patient's face. Similarly, patients with co-morbid insomnia and sleep apnea can be treated simultaneously in one system.

5.8.1.3 Thermoelectric cooling

Fig. 11 illustrates an example of the present technology, wherein a heat sink 5000 is provided to transfer heat between fluid within the forehead cooling system 2000 and ambient air. In one example, a heat sink 5006 is mounted to the fluid conduit 5002 for transferring or dissipating heat from the fluid conduit to the surrounding environment. As in the previous example, the fluid conduit may also include an inlet 3004 and an outlet 3006, which may be connected to a pump 3008 or a blower for circulation of fluid.

In some examples of the present technology, a thermoelectric cooler 5005, such as a peltier cooler, may be provided. The thermoelectric cooler 5005 allows for both heating and cooling. When a voltage is applied to the cooler 5005, the temperature of the first side 5005A drops and the temperature of the second side 5005B rises. The heating side and the cooling side of the thermoelectric cooler may be switched by applying voltages of opposite polarity.

In one example of the present technology, the thermoelectric cooler 5005 can have a first side 5005A configured to engage the fluid conduit 5002 to cool the fluid conduit 5002 in use and a second side 5005B configured to contact ambient air or in some cases be attached to a heat sink 5006 in fluid communication with ambient air in order to dissipate heat from the thermoelectric cooler.

In some examples, a fan or another blower may also be provided to improve air circulation of any one or more of the fluid conduit 5002, thermoelectric cooler 5005, and/or heat sink 5006. For example, the fan or blower may be an axial fan, a radial fan, or a piezo blower. In some examples, the blower may be provided by the RPT device 4000, e.g., air circulation may be provided by an air flow drawn into the RPT device 4000, e.g., from an air inlet, while in other examples, air flow may be provided by air vented through a vent 3450 or other similar structure (such as an anti-asphyxia valve).

In the illustrated example of fig. 11, the fluid conduit 5002 can be configured to expand from the inlet 3004 or the outlet 3006 as described herein to provide increased surface area for heat transfer. For example, the fluid conduit 5002 can have a substantially rectangular central portion 5008 that is sized to accommodate the thermoelectric cooler 5005. Between the substantially rectangular central portion 5008 and the inlet 3004 or the outlet 3006, the fluid conduit may include a smoothly tapered segment 5010 to minimize or reduce fluid turbulence within the fluid conduit 5002.

In other examples of the present technology, the heat sink 5006 and/or thermoelectric cooler 5005 can be configured to mount directly to a reservoir or to a patient's forehead when in use, such as shown in fig. 8.

In the example of fig. 12A, thermoelectric cooler 5005 is configured to be thermally connected to the patient's forehead via thermal interface material 6002 in some examples. For example, the thermal interface material 6002 may be a gel or an elastomer, such as biocompatible silicone. The use of a gel or elastomer may advantageously increase the rate of heat transfer from the patient's forehead to the reservoir or thermoelectric cooler 5005. In some examples, the thermal interface material may further act as a cushioning element that may at least partially conform to the shape of the patient's head, thereby enhancing patient comfort.

On the opposite side of thermoelectric cooler 5005 is a heat sink, optionally connected to thermoelectric cooler 5005 by another thermal interface material 6002. It should be appreciated that the thermal interface material 6002 for a heat sink need not have the same comfort and biocompatibility requirements as if the patient were in contact with the thermal interface material. For example, the thermal interface material may include a metal oxide.

5.8.1.4 Air-assisted heat dissipation

In some embodiments, the airflow may be directed toward the forehead of the patient. For example, the air flow may be provided by air expelled from the patient interface, air supplied from the RPT device 4000, or air that has been inhaled into the RPT device, e.g., via an air inlet. In other examples, the thermal interface material 6002 may be positioned on the forehead of a patient, and the flow of gas (or a portion of the flow of gas) of the vent 3400 may be directed toward the outward (non-patient contacting) surface of the thermal interface material 6002.

Thermal interface material 6002 may conduct heat from the forehead to the exhaust gas flow and to the atmosphere. In some embodiments, the ambient side of thermal interface material 6002 may include design features for increasing the surface area exposed to the flow path, for example, the design features may take the form of ribs or fins in the material. Thus, this thermal interface material 6002 can act as a heat sink.

In some embodiments, the thermally conductive material may be composed of a composite of different materials, e.g., the thermally conductive material may be designed as a layered structure such that the layer in contact with the forehead may have different properties than the layer exposed to the atmosphere. In this way, the contact layer material may in particular be chosen to be biocompatible with the forehead and the properties of the material may be designed to be more comfortable, e.g. the hardness of the material of the layer in contact with the forehead may be significantly lower than the other layers of the conductive material.

In some forms of the present technology, it may be advantageous to have a fluid flow across the heat sink surface to further remove heat from the system. For example, the fluid may be from a reservoir as described herein, or alternatively, when the forehead cooling technique is used in combination with a PAP system, the airflow from the PAP system may be used to transfer heat away from the radiator.

For example, the flow of pressurized air from the RPT device 4000 may be configured to flow over the heat sink to draw heat away from the heat sink and, thus, from the patient's forehead. In other examples, air expelled from the patient interface may be configured to draw heat away from the heat sink, and thus the forehead of the patient. For example, referring to fig. 12B, patient interface 3000 may be configured to expel air 'a' from patient interface 3000 toward the forehead, such as by directing an expelled air flow from patient interface 3000 upward toward the forehead of the patient. As described herein, this exhausted air may be used to cool a forehead cooler 2000, such as a thermoelectric cooler 5005.

Similarly, referring to fig. 8A, forehead cooling system 2000 may be configured to draw air from any one or more of air circuits 4170 for cooling the forehead and/or the heat sink described herein.

Accordingly, one aspect of the present technique is to utilize airflow from a vent in the patient interface 3000 to drive or assist the system to provide forehead cooling to the patient.

The invention described in any of the previously described embodiments may also be adapted for use without the need for PAP therapy by replacing the PAP ventilation flow with any alternative source (such as an alternative fan blower) or flow from a compressed air source. In some embodiments, the flow rate may be controlled to control the amount of heat exchange. As with the previous embodiments, this may be used as a way to achieve a particular temperature profile over time, or as part of a control loop to achieve a particular physiological effect.

5.8.1.5 Evaporative cooling

In some embodiments, improved cooling performance may be achieved by employing the principles of evaporative cooling. In some embodiments, the conductive medium layer exposed to the air flow may be made of a porous material or a water absorbing material so that it may be soaked with water (or other fluid) before sleep and when exposed to the air flow, water may begin to evaporate in such a way that heat may be removed from the layer at a faster rate due to the absorption of energy by the liquid molecules in the process of changing from liquid phase to solid phase. In some embodiments, the system may be equipped with a reservoir to replenish the liquid as it evaporates. In some embodiments, a wicking material may be present that connects the reservoir to the layer exposed to the atmospheric path, which may transport liquid out of the reservoir.

5.8.2 Cooling control

Fig. 13 shows one example of a state machine for controlling the forehead temperature of a patient. In the illustrated example, the state machine is associated with the thermoelectric cooler 5005, however this should not be considered limiting, and the logic of activation and deactivation of the thermoelectric cooler may instead be applied to control the flow of fluid or the evacuation of air toward the patient's forehead.

Referring to fig. 13, when RPT device 4000 is on, thermoelectric cooler 5005 may be configured to transition from an off state in which it is in an inactive state to an operating state in which it is actively cooling the forehead of patient 1000.

If the ambient temperature or the forehead temperature of the patient falls below a predetermined set temperature (such as between 18 degrees celsius and 25 degrees celsius, such as about 20 degrees celsius), the thermoelectric cooler 5005 may be configured to shut down or otherwise become inactive until the ambient temperature or the forehead temperature again rises above the predetermined set temperature. For example, the system may include a temperature sensor 8013 configured to provide a measurement of the temperature of the patient's forehead or a region adjacent to the patient's forehead.

In some examples, the thermoelectric cooler 5005 can be configured to have a second predetermined set temperature at which operation of the thermoelectric cooler is reduced to provide a reduced cooling rate, for example, the second predetermined set temperature can be between approximately 20 degrees celsius and 22 degrees celsius such that the thermoelectric cooler 5005 operates at a reduced rate between the first predetermined set temperature and the second predetermined set temperature. When above the second predetermined set temperature, the thermoelectric cooler 5005 may be configured to operate in a normal, full power mode.

The patient's forehead may typically be between 33 degrees celsius and 37 degrees celsius, and the present technique may be configured to reduce the forehead temperature to tens of degrees celsius, such as 14 degrees celsius to 18 degrees celsius, or more preferably about 14 degrees celsius or 15 degrees celsius.

In some examples of the present technology, it may not be practical to reduce the forehead temperature to 14 degrees celsius to 18 degrees celsius. For example, due to thermodynamic constraints on the cooling method used, or by power, noise, size or cost constraints. Thus, it may be advantageous to lower the forehead temperature below body temperature (including, for example, temperatures of about 20 degrees celsius to 30 degrees celsius).

In one example, the present technique is configured to reduce forehead temperature only for a period of time prior to falling asleep. In yet other examples, the present techniques may be used for periods of patient sleep or portions thereof.

In some examples of the present technology, such as in cold environments, heat transfer techniques may be used to transfer heat to the forehead or any other body part.

In some examples of the present technology, the cooling techniques described herein may be used to transfer heat away from, or otherwise cool, other parts of a patient's body. For example, for the treatment of injuries or pain such as muscle pain caused by overuse.

In some embodiments, a temperature sensor or sensor array (such as a thermocouple) may be embedded in or in contact with one of the layers of conductive material, or in contact with the forehead to sense forehead temperature. In some embodiments, a control loop may be established to achieve a particular temperature or a particular temperature profile. For example, the ventilation flow may be automatically increased or decreased to achieve a target temperature or temperature profile.

In some embodiments, the device may include sensors 8013 including EEG, ECG, and/or EMG sensing, and parameters of these signals may be used as control targets, e.g., forehead cooling may be applied to reduce frontal cortex brain activity or heart rate. In some embodiments, cooling may be enhanced or reduced in the presence of rapid eye movement.

In other examples, the systems designed herein may be configured to determine to fall asleep by analyzing the patient's respiratory waveform and to control the forehead cooling system when falling asleep is detected, such as disabling the cooling function or lowering the cooling target temperature.

In some embodiments, the system may be used as part of a broader relaxation program, for example, the patient may use the system in meditation or in performing deep breathing exercises (or other relaxation techniques) before attempting to sleep, or the system may be synchronized with a guided relaxation program (such as guided deep breathing) or medication.

5.8.3 Humidification and cooling

In another example of the present technology, thermoelectric cooler 5005 can be used to both raise the temperature of the fluid supply for humidification purposes and simultaneously lower the temperature of the fluid supply for forehead cooling purposes. For example, referring to fig. 14, a thermoelectric cooler 5005 can have a first side 5005A thermally engaged with a first fluid 8002 and a second side 5005B thermally engaged with a second fluid 8004. For example, the first fluid may be configured to be in thermal contact with the forehead of the patient, and the second fluid may be intended for breathing by the patient when in use.

In an example, the first fluid may be disposed in a first chamber or conduit and the second fluid may be disposed in a second chamber or conduit.

In one example, the first fluid supply 8002 may be air flowing to or from the patient's forehead. For example, the first fluid supply may be configured to cool the patient's forehead directly or indirectly (such as by cooling a heat sink attached to the patient's forehead). In other examples, the first fluid supply may be water or oil configured to cool the patient's forehead via a fluid delivery system as described herein.

In one example, the second fluid supply 8004 may be a breathable gas that passes through one or more air circuits 4170. In another example, the second fluid supply may include water for humidifying an air stream intended for patient breathing, and in another example, the second fluid supply may include humidifying a breathable gas.

5.8.4 Example of discharged air flow

In some examples of the present technology, the air circuit 4170 may include a vent 3400 or vent opening 3402 configured to vent exhaled air from the PAP system. Fig. 7O shows one example of an air circuit including a vent. Fig. 15A shows a modified version of this air circuit 4170 in which the vent is provided with a conduit 15000 configured to direct an air flow (generally indicated by arrow a) in an upward direction toward the forehead of the patient. In other words, the air circuit 4170 includes a conduit 15000 configured to direct a portion of the airflow through the conduit 15000 toward the forehead of the patient in use.

In the illustrated example, the conduit 15000 is made of a rigid plastic and includes a curved outlet 15002 that is disposed at an angle relative to the longitudinal axis 'L' of the conduit 15000. This curved outlet 15002 provides directional control to the exiting air flow, allowing the air flow to be directed back toward the patient's face and forehead. In some examples, the air circuit 4170 may include an anti-asphyxia valve (AAV) configured to selectively control the venting of air through the conduit 15000. Examples of AAV can be found in U.S. patent publication No. 2006/0074107 A1 published 13 at 4/2006 and U.S. patent publication No. 2009/0065729A1 published 13 at 3/2009, the disclosures of which are incorporated herein by reference in their entirety.

For example, the AAV may be configured to exhaust air through the conduit 15000 only during patient exhalation. In other examples, the air circuit 4170 may be configured to continuously exhaust air through the conduit 15000 when in use.

Fig. 15B shows another version of an air circuit 4170 configured to direct an air flow toward the forehead of a patient. In this example, the conduit is disposed on the patient interface side of the decoupling structure 15004 such that the positioning of the conduit relative to the patient interface remains substantially fixed while the decoupling structure 15004 allows the air circuit to pivot or rotate about the decoupling structure 15004. Other forms of decoupling structures, such as a swivel or ball joint, should be well known to those skilled in the art.

Fig. 15C shows an example of an air circuit of fig. 15A or 15B for use with a patient interface 3000 that includes a nasal seal forming structure 3100. It should be appreciated that the same air circuit 4170 may similarly be used with a patient interface 3000 having a seal-forming structure 3100 configured to deliver a flow of breathable gas to both the oral airway and the nasal airway of a patient in use.

As shown, the conduit 15000 extends from the air circuit 4170 in a downward, upward direction toward the forehead of the patient. In a preferred example, the end of the conduit 15000 is located above the nasal bump of the patient's face to ensure that the air flow does not interfere with or irritate sensitive areas of the patient's nose and/or limit the amount of air flow passing over the patient's eyes.

In the example shown, the catheter 15000 is positioned substantially centered with respect to the sagittal plane of the patient, which may advantageously prevent or limit drying or irritation of the patient's eyes when in use, i.e., the discharged air flow is directed between the patient's eyes and (in the direction generally indicated by arrow a) to the forehead region.

Fig. 16A and 16B illustrate an alternative example of the present technique, wherein a conduit 15000 is provided in the patient interface 3000 to direct air expelled from the patient interface toward the forehead of the patient. As with the previous example, the conduit 15000 may include a curved outlet 15002 configured to provide directional control to the discharged air flow, allowing the air flow (in the direction generally indicated by arrow a) to be directed back toward the patient's face and forehead. It should be appreciated that in each example, air flow through the conduit 15000 may be controlled through the vent 3400 as described herein.

Fig. 16B shows an alternative design of a patient interface 3000 that includes a conduit 15000 configured to direct an air flow to a forehead region of a patient. In this example, the conduit 15000 is adjustably connected to the patient interface, for example, via a support structure 15006 that includes a pivot 15008. This configuration may advantageously allow for adjusting the airflow direction to accommodate the human morphological differences between patients.

In fig. 16B, the conduits are also disposed in a spaced relationship relative to the patient interface 3000. This may allow for easy adjustment of the flow through the directional conduit, thereby adjusting the amount of airflow drawn from the vent 3450 (not shown in this example). This spatial relationship may also promote entrainment of air in the surrounding atmosphere such that the air flow delivered to the forehead of the patient is a mixture of the expelled air and ambient air. Since the expelled air may be heated by the patient's breathing and/or the RPT device 4000, the act of mixing ambient air may advantageously create a cooler air flow, thereby further assisting in cooling the patient's forehead.

Fig. 16C shows a rear view of the patient interface of fig. 16A or 16B, in each of which the patient interface 3000 includes a housing 3210, which may be constructed of a plastic such as polycarbonate. Attached to the housing 3210 is a seal-forming structure 3100 configured to deliver a flow of breathable gas to the nasal and oral airways of a patient.

In this example, the seal forming structure 3100 includes a nose portion 3230 configured to engage a surface on the underside of the patient's nose in use, e.g., against the nose point, against the nosewings on both sides, and against the upper lip in a forward direction, and a mouth portion 3260 configured to seal around the patient's oral airway in use.

Further examples of patient interfaces of this type are described in PCT publication No. WO2019183680A1 published 10/3/2019, the disclosure of which is incorporated herein by reference in its entirety.

In the illustrated example, the conduit 15000 extends from the housing 3210 of the patient interface 3000, either via a direct connection to the housing 3210 (including attachment to, removable connection to, or molded as part of the housing) or by being in a spaced relationship relative to the housing 3210. In these examples, the housing 3210 may similarly be constructed of a rigid plastic (such as polycarbonate) or other suitable plastic material. This may advantageously provide an airflow path between the plenum chamber 3200 and the forehead of the patient.

Fig. 17A illustrates another example of an 'up-tube' system that is substantially the same as the system described in connection with fig. 7L. However, in this example, airflow director 17000 is attached to connection port 3600 so as to direct an airflow in a front-down direction (in a direction generally indicated by arrow a) to the forehead of the patient. The airflow director includes a conduit 15000 that is curved to follow the contours of the patient's head and direct the airflow in a forward-downward direction to the patient's forehead in use.

In some examples, this airflow director 17000 may be a removable component that is removably attached to the connection port 3600. For example, an airflow director 17000 may be positioned between the connection port 3600 and the air circuit 4170 (not shown in fig. 17A) to receive an airflow from the RPT device 4000 and direct the airflow to the patient's forehead.

In other examples, airflow director 17000 may be provided as part of connection port 3600. In other words, the connection port 3600 may include a conduit 15000 configured to direct an air flow toward the forehead of the patient.

Fig. 17B shows another example of an airflow director 17000 that may be connected to a connection port 3600. In this example, the catheter 15000 is a flexible tube that can be repositioned as needed to direct the air flow to a desired region of the patient's forehead. In some examples, it may be advantageous for the catheter 15000 to retain its shape after being bent into a desired configuration, in other words, the material of the catheter may be selected to provide shape retention characteristics. For example, this may be achieved by a flexible metal tube (such as a bendable copper or aluminium tube), or the conduit may comprise an accordion or gooseneck section, as is common in plastic pipettes, in other examples the conduit may be provided with one or more swivel connectors allowing manipulation of one or more sections of the conduit relative to other sections.

In this example, the positioning and stabilizing structure 3300 may include one or more mounts 17002 for holding the catheter 15000. For example, the mount 17002 may be a clasp having a receiving cavity configured to receive the catheter 15000, or any other suitable form of fastening may be provided, such as using hook and loop fasteners, snaps, and buckles.

Fig. 17C shows another example of a tube-up configuration having an overall structure similar to fig. 17 and 7L. However, in this example, the positioning and stabilizing structure 3300 includes a pair of opposing tubes 15000 configured to direct air flows (in the direction generally indicated by arrow a) from opposing sides 4171, 4172 of the positioning and stabilizing structure 3300 inwardly toward the patient's forehead. It should be appreciated that in some examples, only a single conduit may be used, e.g., the positioning and stabilizing structure 3300 may be configured to direct an air flow from one side of the positioning and stabilizing structure.

5.8.4.1 Compact vent design

Fig. 18A-18C illustrate examples of a flow adjustable compact vent 3450 configured to direct air flow from the patient interface 3000 toward the patient's forehead.

In this example, the vent 3450 includes a central member 3456 and an outer housing 3466. The primary vent path is disposed between the central member 3456 and the gap 3464 between the outer housing 3466. The flow through the gap is configured by appropriately sizing the gap.

The aperture 18002 is disposed in a side wall or recess 3416 of the outer member such that when connected to the patient interface, this aperture 18002 faces towards the patient's forehead and acts as a conduit to direct a portion of the discharged airflow through the side wall 3416 towards the patient's forehead in use.

In some examples, the center member 3456 may be rotatably connected to the outer housing 3466 and may include one or more flow control apertures 18000, e.g., there are different sizes of flow control apertures such as illustrated in fig. 18C. In use, rotating this central member 3456 adjusts which flow control aperture 18000 is aligned with aperture 18002 in outer housing 3466, where a larger aperture results in increased airflow and a smaller aperture (or rotating the central member to a position where no apertures are aligned) results in decreased or restricted airflow. Thus, by rotating the central member relative to the outer housing 3466, the airflow directed toward the patient's forehead as illustrated in fig. 18A may be adjusted.

5.8.5 Other examples

Fig. 19A illustrates an example of a system 19000 that includes a patient interface 3000 and positioning and stabilizing structure 3300 that are configured to operate as a stand-alone unit for delivering a flow of breathable gas to the patient airway. The system includes a power source 6030 (such as a battery) and a flow generator 6400 configured to generate a flow of breathable gas to the patient airway via the seal-forming structure 3100. Additional details regarding these types of systems can be found in PCT application No. PCT/AU2024/050419 filed on day 2, 5, 2024, which is incorporated herein by reference in its entirety.

In this example, the system 19000 includes a conduit 15000 fluidly connected to the flow generator 6400 and configured to direct an air flow from the flow generator 6400 in an up-back direction (in a direction generally indicated by arrow a) toward the forehead of the patient.

In another example, the conduit 15000 may be configured to act as an air inlet and draw ambient air into the flow generator 6400. By angling the conduit towards the user's forehead, the air inlet may draw in incoming air from the forehead region of the patient in a downward forward direction, thereby cooling the patient's forehead in use.

In other examples, any of the methods described herein may be used (including, for example, using one or more catheters mounted to a positioning and stabilizing structure 3300 as illustrated in fig. 19B) to direct the airflow toward or withdraw the airflow from the forehead region of the patient. For example, the conduit may be fluidly connected to the flow generator 6400 via one or more air circuits (such as fabric air circuits) located within or attached to the positioning and stabilizing structure.

Fig. 20A illustrates another example of the present technology, which may incorporate a flow generator 6400 configured to generate a flow of breathable gas, a seal-forming structure 3100 for delivering the flow of breathable gas to the airway of a patient, and a positioning and stabilizing structure 3300 configured to support these components on the patient's head in use. In this example, the power source 6020 is provided via a cable, such as from an external battery or power source (such as a USB interface or power adapter).

In this example of the present technology, the positioning and stabilizing structure 3300 includes a headband, ring 8378, or ring configured to extend around the patient's head from the frontal bone of the patient to the occipital bone of the patient. In the illustrated example, the ring 8378 can be a continuous piece of material, although in other examples, the ring 8378 can include multiple pieces that allow the length of the ring 8378 to be adjusted.

In use, the ring structure is configured to be placed over a patient's forehead, and thus may be provided with any of the forehead cooling systems 2000 described herein, including but not limited to air or fluid cooling systems, PCM materials, and thermoelectric cooling systems.

In some examples, this ring 8378 may be provided with one or more sensors 8013 configured to measure one or more characteristics of the patient. For example, the sensor may comprise a temperature sensor, a humidity sensor, a heart rate sensor, or an EEG sensor. These sensors 8013 may be configured to communicate patient information to the controller to control any one or more of the operating parameters of the system, such as active cooling or flow characteristics of the forehead region.

Although not an essential part of the invention, in this example the device also includes an audio system 6800 that includes a pair of output devices 6804. Each output device 6804 may output sound to one of the patient's ears. In the illustrated example, the output device 6804 is formed as an earmuff and may rest against and/or enclose each ear of the patient. In other examples (not shown), the output device 6804 may be an earplug that fits within the ear of the patient. These audio systems may be integrated with the control systems described herein to provide auditory stimuli such as white noise to assist in falling asleep, and auditory stimuli such as alarm clocks or natural sounds to assist in waking up the patient at the appropriate times or at the appropriate stages of the patient's sleep cycle (such as during light sleep).

Additional details regarding these types of systems and devices can be found in PCT application No. PCT/AU2024/050419, filed on 5/2 of 2024, the entire contents of which are incorporated herein by reference.

Fig. 20B illustrates another form of the present technology, wherein the forehead cooling system 2000 described herein may be provided in the absence of respiratory therapy techniques. For example, any one or more of the forehead cooling systems 2000 may be provided in a positioning and stabilizing structure 3300 (such as a headband or ring 8378).

Fig. 20C shows a top view of a forehead cooling system 2000 configured to engage the forehead of a patient 1000. In this example, the forehead cooling system includes a housing 20002 that is attached to a positioning and stabilizing structure 3300. The housing includes a blower 20004 configured to circulate an air flow through the housing for cooling the forehead of a user in use. Blower 20004 may be an axial flow blower, a piezo blower, or any other form of blower known to those skilled in the art.

The housing is provided with an inlet 20006 and one or more outlets 20008A, 20008B through which in use the air flows. The air flow may be bi-directional, i.e., drawing air flow from over the patient's forehead and exhausting outwardly, such as in an upward or forward direction relative to the patient's head, or drawing air flow from in front of the patient's forehead, flowing over the forehead and exhausting in a transverse direction relative to the forehead.

In some examples, the forehead cooling system may also include one or more sensors 8013 configured to measure humidity, temperature, heart rate, or provide electroencephalogram (EEG) information about the user. For example, the sensor may include a thermocouple, an EEG electrode, and/or an Electrooculogram (EOG) electrode.

Control of the forehead cooling system 2000 may be performed using any of the methods described herein. For example, in one embodiment, forehead cooling system 2000 may adjust the flow of blower 20004 to maintain a target forehead temperature.

In some examples, it may be beneficial to determine the sleep state of the patient and then set the target temperature control accordingly. For example, it may be advantageous to provide a lower target temperature (such as about 15 degrees celsius) and an appropriate blower 20004 rotational speed to reach that temperature before falling asleep. For example, blower 20004 rotational speed may be determined based on ambient temperature and user's forehead temperature, such that a faster blower 20004 rotational speed is used when the difference between the target temperature and the measured temperature is maximum, and a slower rotational speed is used when the temperature difference is small (such as within 0 degrees to 3 degrees of the target temperature).

Once sleep is detected, it may be beneficial to set a second temperature, different from the first target temperature, as the target. For example, the second temperature may be higher than the temperature used prior to falling asleep. For example, the second temperature may be about 20 degrees celsius. Furthermore, it may be beneficial to limit blower 20004 rotational speed in order to reduce noise and vibration generation.

In some examples of the present technology, it may be beneficial to set the target temperature and/or blower 20004 rotational speed based on the user's sleep depth. For example, a lower set temperature may be used when forehead fever is detected or, for example, a higher level of brain activity is detected. Further, it may be beneficial to set the target temperature and fan speed based on detecting a sleep state (such as any one or more of awake, N1, N2, N3, or REM sleep states). For example, a first target temperature in an awake sleep state, a second target temperature in an N1 sleep state, a third target temperature in an N2 sleep state, a fourth target temperature in an N3 sleep state, and a fifth target temperature in a REM sleep state.

In some examples of the present technology, it may be beneficial to control blower speed based on the ambient temperature in the environment or control cooling power if a thermoelectric cooler is employed.

In some examples, it may be more beneficial to estimate the heat transfer rate based on the measured or estimated forehead temperature and its changes in response to achieving a target temperature change and/or blower speed change. The estimated heat transfer rate may then be used to adjust the blower speed, or in the case of a thermoelectric cooler, the cooling power based on the estimated heat transfer rate/efficacy of the forehead cooling system 2000.

In some examples, blower speed may be adjusted by adjusting the power or control (such as PWM control) of blower 20004. In other examples, the flow path may be modified using an airflow director. In other words, the inlet 20006 and or the outlets 20008A, 20008B may be modified to control effective cooling of the forehead in use.

Fig. 21A and 21B illustrate another form of the present technology, wherein the forehead cooling system 2000 described herein may be applied to other applications, such as Virtual Reality (VR) systems, augmented Reality (AR) systems, and mixed reality (XR) systems (referred to herein as VR devices for brevity). In this example, VR device 12000 includes a flow generator 6400 configured to generate a flow of breathable gas to the patient's airway via seal-forming structure 3100, and typical features of VR devices (such as a display 12070) configured to present an image or video stream for viewing by the patient during therapy.

Since VR device 12000 includes forehead support 12100, the forehead support may be adapted to include one or more sensors 8013 or forehead cooling system 2000 as described herein. For example, a thermoelectric cooler may be positioned in contact with the forehead, and or one or more sensors may be used to monitor forehead condition/temperature while in use. Because the VR device 12000 has been positioned in an area adjacent to the patient's forehead, the forehead cooling system 2000 described herein may be incorporated while cooling the patient's forehead.

In another example, a portion of the airflow generated by or drawn into the flow generator 6400 may be directed toward/extracted from the forehead region of the patient using the conduit 15000 as described herein. In other examples, the cushion 12100 adjacent to the patient's forehead may be provided with PCM material or a thermoelectric cooler as described herein.

In fig. 21A and 21B, VR device 12000 includes a patient interface 3000, however, this patient interface is not necessary to the present technology. For example, the VR device 12000 may be provided with a forehead cooling system 2000 without a patient interface.

It should be appreciated that a plurality of forehead cooling systems 2000 have been described herein, and that any one or more of these systems 2000 may be combined with any of the other systems 2000 described herein. For example, the contact forehead cooling system described in connection with any one of fig. 8A-14, 20A, or 20B may be combined with any of the non-contact forehead cooling systems of fig. 15A-19B. In other examples, multiple contact coolers, such as thermoelectric cooler 5005 and fluid coolers such as described in connection with fig. 8A-10, may be combined. In yet further examples, multiple non-contact forehead cooling systems may be combined, such as the ventilation flow of any of fig. 15A-16C or 18A-19B, in combination with airflow from the air circuit 4170 or connection port 3600 as described in connection with fig. 17A-17C.

Accordingly, one aspect of the present technology relates to an RPT system that combines two or more forehead cooling systems 2000 as described herein.

5.8.6 Control system

FIG. 22A depicts an example system 9000 that may be implemented to monitor sleep providing insight and/or advice and or to control operation of a forehead cooling system as described herein. The system 9000 can generally comprise one or more servers 9010, one or more communication networks 9030, and one or more computing devices 9040. The server 9010 and computing device 9040 may also communicate with one or more respiratory therapy devices (e.g., without limitation, the RPT device 4000, sensor 8013, and forehead cooling system 2000 described herein) via one or more communication networks 9030.

The one or more communication networks 9030 may include, for example, the internet, a local area network, a wide area network, and/or a personal area network implemented by a wired communication network 9032, a wireless communication network 9034, or a combination thereof (e.g., a wired network having a wireless link). In one form, the local communication network may utilize one or more communication standards, such as bluetooth, near Field Communication (NFC), or consumer infrared protocol.

The server 9010 may include processing facilities represented by one or more processors 9012, memory 9014, and other components typically found in such computing environments. The processing capabilities of processor 9012 may be provided, for example, by one or more general purpose processors, one or more special purpose processors, or a cloud computing service providing access to a shared pool of computing resources configured according to desired characteristics, service models, and deployment models. In the illustrated example, the memory 9014 stores information accessible by the processor 9012, including instructions 9016 executable by the processor 9012 and data 9018 retrievable, manipulable, or storable by the processor 9012. Memory 9014 may be any suitable device known in the art capable of storing information in a manner accessible to processor 9012, including a computer readable medium or other medium storing data that may be read by means of an electronic device. Although the processor 9012 and memory 9014 are illustrated as being within a single unit, it should be understood that this is not intended to be limiting, and that the functions of each as described herein may be performed by multiple processors and memories, which may or may not be remote from each other and the rest of the system 9000.

The instructions 9016 may comprise any set of instructions suitable for execution by the processor 9012. For example, instructions 9016 may be stored as computer code on a computer readable medium. The instructions may be stored in any suitable computer language or format. The data 9018 may be retrieved, stored, or modified by the processor 9012 in accordance with the instructions 9016. The data 9018 may also be formatted in any suitable computer-readable format. Furthermore, while the data is illustrated as being contained at a single location, it should be understood that this is not intended to be limiting—the data may be stored in multiple memories or locations. The data 9018 may include one or more databases 9020.

In some examples, the server 9010 may communicate unidirectionally with the computing device 9040 by providing information to one or more of the computing devices 9040, and vice versa. In other embodiments, the server 9010 and the computing device 9040 may communicate bi-directionally with each other, and may share information and/or processing tasks.

5.8.6.1 Computing device

The computing device 9040 may be any suitable processing device, such as, but not limited to, a personal computer, such as a desktop or laptop computer 9042, or a mobile computing device, such as a smart phone 9044 or tablet 9046. Fig. 22B depicts an exemplary general architecture 9100 of computing device 9040. The foregoing discussion describes components of a computing device that may be identical or otherwise identical to components of the server described in connection with fig. 22A, however, for clarity, components of a computing device have been identified with different reference numerals.

The computing device 9040 may include one or more processors 9110. The computing device 9040 may also include a memory/data storage device 9120, an input/output (I/O) device 9130, and a communication interface 9150.

The one or more processors 9110 may include functional components used in the execution of instructions, such as functional components that fetch control instructions from a location, such as memory/data storage 9120, decode program instructions, execute the program instructions, and write the results of the executed instructions.

The memory/data storage 9120 can be internal memory of a computing device, such as RAM, flash memory, or ROM. In some examples, the memory/data storage 9120 can also be external memory linked to the computing device 9040, such as, for example, an SD card, a USB flash drive, an optical disk, or remote memory (e.g., accessed via a server such as server 9010). In other examples, memory/data storage 9120 can be a combination of external memory and internal memory.

As described herein, the memory/data storage 9120 includes processor control instructions 9122 and stored data 9124 that instruct the processor 9110 to perform certain tasks. As described above, in an example, the instructions may be executed by a resource associated with the server 9010 in communication with the computing device 9040, and may be data stored in the resource associated with the server 9010 in communication with the computing device 9040 and/or accessed from the resource associated with the server 9010 in communication with the computing device 9040.

In an example, input/output (I/O) devices 9130 can include one or more displays 9132. In an example, the display 9132 can be a touch-sensitive screen that allows user input in addition to outputting visual information to a user of the computing device 9040. In an example, the I/O devices can include other output devices, including one or more speakers 9134 and haptic feedback devices 9136. In an example, the input/output (I/O) devices 9130 can include input devices such as physical input devices 9138 (e.g., buttons or switches), sensors 8013 including, for example, optical sensors 9140 (e.g., one or more imaging devices such as cameras), sound sensors or audio input devices (such as microphones that allow a patient to use their voice or sound control devices), and inertial sensors 9142 (particularly in examples where computing device 9040 is a mobile computing device). It is to be appreciated that other I/O devices 9130 can be included or otherwise accessed through I/O interface 9150 (e.g., interfacing with peripheral devices connected to computing device 9040). The communication interface 9160 enables the computing device 9040 to communicate via one or more networks 9030.

5.8.6.2 Computer-implementable method

Computer readable instructions may implement the exemplary methods described herein. In an example, the computer-readable instructions include one or more algorithms for execution by one or more of the processors 9012 described herein. The instructions for performing these functions are optionally included in a non-transitory computer-readable storage medium (e.g., memory 9014) or other computer program product configured for execution by the one or more processors 9012. The computer readable storage medium may be a tangible device that can hold and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. As used herein, a computer-readable storage medium cannot be construed as a transitory signal (such as a radio wave or other freely propagating electromagnetic wave, an electromagnetic wave propagating through a waveguide or other transmission medium, or an electrical signal transmitted through a wire) itself.

However, those of ordinary skill in the art will readily appreciate that the entire algorithm and/or portions thereof could alternatively be executed by a device other than a processor and/or embodied in firmware or dedicated hardware in a well-known manner, e.g., the entire algorithm and/or portions thereof could be implemented by an Application Specific Integrated Circuit (ASIC), a Programmable Logic Device (PLD), a Field Programmable Logic Device (FPLD), a Field Programmable Gate Array (FPGA), discrete logic, etc. For example, any or all of the components may be implemented by software, hardware, and/or firmware. Further, some or all of the instructions represented by the flowcharts may be implemented manually. Further, although the example algorithm is described with reference to the flow diagrams illustrated, persons of ordinary skill in the art will readily appreciate that many other methods of implementing the example processor-readable instructions may alternatively be used. For example, the order of execution of the blocks may be changed, and/or some of the blocks described may be changed, eliminated, or combined.

As used herein, the terms "component," "module," "system," and the like are generally intended to refer to a computer-related entity, either hardware (e.g., a circuit), a combination of hardware and software, or an entity related to an operating machine having one or more particular functions. For example, a component may be, but is not limited to being, a process running on a processor, an object, an executable, a thread of execution, a program, and/or a computer. By way of illustration, an application running on a controller and the controller may each be a component. One or more components may reside within a process and/or thread of execution and a component may be localized on one computer and/or distributed between two or more computers. Furthermore, the "means" may take the form of specially designed hardware, general-purpose hardware specialized for the hardware to be capable of performing the specified functions, software stored on a processor-readable medium, or a combination thereof.

5.8.6.3 Circadian rhythm support

In examples of the present technology, the forehead cooling system 2000 described herein may be controlled to support a healthy sleep cycle of an individual. For example, the forehead may be actively cooled during the first phase of the sleep cycle to assist in falling asleep. Then, once sleep is detected, cooling may be suspended (or cooling power reduced).

There are a variety of ways in which sleep may be detected, including but not limited to monitoring a patient's biometric signal (i.e., using one or more sensors 8013, such as a heart rate sensor or an EEG sensor) or by monitoring the patient's respiratory waveform.

In some examples, the system may be configured to detect a condition in which the patient wakes up at night, in which examples the system may detect the event and again cool the forehead to assist in falling asleep.

In the morning, the forehead cooling system may be used to assist the patient in waking up, for example, according to an alarm clock set on the mobile device or during the natural wake phase of the patient's sleep cycle. For example, in the case of a thermoelectric cooling system, the voltage polarity may be reversed and the patient's head heated to assist in patient wakefulness.

FIG. 23 illustrates one example of a control system configured to control the forehead cooling systems described herein. As shown, the system is turned on or activated by the patient. This may be done when the device is first turned on, or when pressurized delivery of breathable gas is initiated in the case of an RPT device.

Once activated, the system is configured to begin collecting patient information from the one or more sensors 8013. For example, the patient information may include forehead temperature readings, heart rate readings, respiratory waveforms, and the like.

This information is then compared to a set of predefined control rules. For example, this may include detecting:

whether the patient is awake, and whether the forehead temperature is above, within a predefined range, or below a predefined threshold.

Whether the patient falls asleep, and whether the forehead cooling system should be deactivated, activated in a low-power state, or configured to achieve a predefined sleep temperature range.

If any of the predefined rule criteria are met, the control system is configured to perform the action accordingly. For example, the forehead cooling system is controlled according to predefined rules.

The predefined rules may be selected by the user from a list of pre-configured settings, for example, settings may be provided to maintain cooling enabled during the night, and alternative settings may be provided to disable cooling once sleep is detected.

In other examples, the predefined rules may automatically adjust over time. For example, if sleep quality is detected better under certain conditions (e.g., by monitoring respiration, heart rate, temperature, and/or EEG data), these conditions may be automatically learned and repeatedly applied at subsequent nights. Conversely, if poor sleep is detected, the forehead cooling system may be configured to activate, such as by cooling the forehead to better regulate the patient's sleep.

In some examples, the predefined rules may be automatically adjusted for environmental changes (such as ambient temperature or noise level in the environment). For example, at night when the ambient temperature is measured at 27 degrees celsius, the system may be configured to set the cooling temperature to 15 degrees and the sleep temperature to between 20 degrees and 25 degrees. At night when the ambient temperature is measured to be 22 degrees, the system may be configured to set the cooling temperature to 15 degrees and the sleep temperature to between 18 and 22 degrees.

In another example, the target temperature profile may change during the night, for example, to match detected patient sleep stages. This may result in any suitable target temperature and slope setting as desired.

5.8.6.4 User control and feedback

Fig. 24 illustrates one example of a personal computing device 9040, such as a smart phone. The computing device 9040 may be configured to allow a patient to monitor and or control their preferred sleep mode, for example, by adjusting predefined rules described herein. In some examples, the control function may alternatively be provided by a user interface on the RPT device 4000.

In the illustrated example, the computing device 9040 is configured to present a patient/user with a list of configurable settings that can be adjusted as needed to adjust predefined rules considered by the cooling system described herein. For example, a user may be able to set a target sleep duration, sleep temperature, configure to automatically detect falling asleep, enable a wake-up alarm (including audible prompts and forehead heating options), configure whether cooling is required during sleep, whether white noise should be provided to aid sleep, and set whether settings should be automatically adapted during use. The foregoing is intended to be a non-exhaustive list and in some examples, advanced settings menus may be provided to allow a user to configure advanced parameters such as target temperature ranges, heating and cooling slope settings, and the like.

In some examples, the computing device 9040 may also provide detailed information to the patient/user regarding the quality, duration, and efficacy of the forehead cooling system 2000 described herein. For example, the system described herein may be advantageous to gather sleep information of a user in a series of situations (such as with and without forehead cooling, with and without auditory stimulation, or with and without respiratory pressure therapy, etc.) in order to determine the efficacy of any one or more of the provided settings.

Examples of the present technology provide a forehead cooling system 2000 that can be manually adjusted/controlled by the patient 1000. For example, relative to fig. 18A-18C, manual adjustment may be performed by rotating the center member 3456 relative to the outer housing 3466. However, in other examples of the present technology, cooling control may be performed using any one or more of controlling the size of conduit 15000, such as by closing or restricting a portion of the conduit or diverting a portion of the flow through conduit 15000, directing the flow through conduit 15000, i.e., by redirecting the flow of air, by adjusting the cooling or heating power (in the case of thermoelectric cooler 5005), controlling the flow rate or flow volume, such as using RPT device 4000 or flow generator, or a personal computing device in communication with RPT device 4000 or flow generator.

In other examples, the systems described herein may be provided with controls, such as sliders, knobs, dials, proximity or touch sensitive interfaces, by which the patient 1000 may control devices, such as raising or lowering temperature set points or regulating flow.

In some examples of the present technology, forehead cooling system 2000 may be controlled using one or more voice commands (such as "decrease temperature", "stop cooling", "increase flow", etc.). For example, as described herein, the forehead cooling system or any associated processor 9012 (such as the RPT device 4000, a flow generator, or a processor in a personal computer) may be connected to a sensor 8013 in the form of a microphone configured to collect audio. The processor 9012 may then process the audio to effect a control action, such as controlling operation of the forehead cooling system 2000 in response to the instructions.

By allowing the patient to directly control the forehead cooling system 2000, the present techniques may make the patient 1000 more comfortable and increase patient compliance with any therapy provided by the forehead cooling system 2000. Where manual control is provided, this may advantageously allow the patient to easily adjust, for example while lying in a bed, without having to navigate complex menus, thereby further improving the ease of use of the system described herein.

In some examples of the present technology, manual control may act to override any preconfigured therapy settings. For example, these manual settings may replace any existing settings, or alternatively, the system may be configured to return to preconfigured settings once a sleep state change is detected. For example, the system may be configured to return to a pre-configured setting once sleep onset occurs or once the patient enters an N1, N2, N3, or REM sleep state.

In some examples, the override settings may only affect settings that are active while the patient is awake.

Where the settings may be adjusted by the user, it may be advantageous for the settings to remain persistent so that they are maintained between different periods of time.

Each of these controls may be used with any one or more of the forehead cooling systems described herein. For example, where thermoelectric cooler 5005 is used, these settings may be used to adjust a cooling set point, temperature slope, etc., in examples where a fluid flow (such as water or air flow) is used, the control may be configured to adjust the flow rate, temperature, directionality, or timing of the flow.

5.9 Glossary of terms

For purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions may be applied.

5.9.1 General

Air in some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as oxygen enriched air.

Environment in certain forms of the present technology, the term environment will be considered to mean external to (i) the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

For example, the ambient humidity relative to the humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity in a room in which the patient sleeps. Such ambient humidity may be different from the humidity outside the room in which the patient is sleeping.

In another example, the ambient pressure may be pressure immediately adjacent to the body or outside the body.

In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room in which the patient is located, rather than noise generated by, for example, the RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

Automatic Positive Airway Pressure (APAP) therapy-CPAP therapy in which the treatment pressure is automatically adjustable (e.g., different per breath) between a minimum and maximum limit, depending on whether an indication of an SDB event is present.

Continuous Positive Airway Pressure (CPAP) therapy, which is respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the inlet of the airway is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, e.g., increase in response to detecting an indication of partial upper airway obstruction, and decrease in the absence of an indication of partial upper airway obstruction.

Flow rate: volume (or mass) of air delivered per unit time. Flow may refer to an immediate quantity. In some cases, reference to flow will be a reference to scalar, i.e., an amount having only a size. In other cases, reference to flow will be to a vector, i.e., an amount having a magnitude and direction. The traffic may be given by the symbol Q. "flow" is sometimes abbreviated simply as "flow" or "gas flow".

In an example of patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle and thus negative for the expiratory portion of the patient's breathing cycle. The device flow Qd is the flow of air leaving the RPT device. The total flow Qt is the flow of air and any supplemental gas to the patient interface via the air circuit. The ventilation flow Qv is the flow of air exiting the vent to allow flushing of the exhaled air. Leakage flow rate Ql is the flow rate that leaks from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the respiratory system of the patient.

Flow therapy-respiratory therapy that involves delivering an air flow to the entrance of an airway at a controlled flow rate called the therapeutic flow rate, which is generally positive throughout the respiratory cycle of the patient.

Humidifier the term humidifier will be taken to mean a humidification device constructed and arranged or configured with physical structure to be able to provide a therapeutically beneficial amount of water (H ₂ O) vapor to an air stream to alleviate a patient's medical respiratory condition.

Leakage the term leakage will be considered as unintended air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow that leads to the environment.

Conducted noise (acoustic) conducted noise in this document refers to noise transmitted to the patient through pneumatic paths such as the air circuit and patient interface and air therein. In one form, the conducted noise may be quantified by measuring the sound pressure level at the end of the air circuit.

Radiated noise (acoustic) the radiated noise in this document refers to noise transmitted by ambient air to a patient. In one form, the radiated noise may be quantified by measuring the acoustic power/sound pressure level of the subject in question in accordance with ISO 3744.

Vent noise (acoustic) vent noise in this document refers to noise generated by air flow through any vent, such as a vent hole of a patient interface.

Oxygen enriched air is air having an oxygen concentration greater than the oxygen concentration of atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "oxygen-enriched air" is sometimes shortened to "oxygen".

Medical oxygen is defined as oxygen-enriched air having an oxygen concentration of 80% or more.

Patients, humans, whether or not they have respiratory disorders.

Pressure, force per unit area. The pressure may be expressed in unit ranges including cmH ₂O、g-f/cm² and hPa. 1cmH ₂ O is equal to 1g-f/cm ² and is approximately 0.98 hPa (1 hPa=100 Pa=100N/m ² =1 mbar to 0.001 atm). In this specification, unless otherwise indicated, pressures are given in cmH ₂ O.

The pressure in the patient interface is given by the symbol Pm and the therapeutic pressure, which represents the target value obtained by the interface pressure Pm at the current moment, is given by the symbol Pt.

Respiratory pressure therapy, the application of an air supply to the inlet of the airway at a therapeutic pressure that is generally positive relative to the atmosphere.

Ventilator-a mechanical device that provides pressure support to a patient to perform some or all of the respiratory effort.

5.9.1.1 Materials and their properties

Hardness refers to a durometer or indentation hardness, which is a material property measured by indentation of an indenter (e.g., as measured according to ASTM D2240).

"Soft" materials may include silicone or thermoplastic elastomer (TPE) and may be easily deformed, for example, under finger pressure.

"Hard" materials may include polycarbonate, polypropylene, and may be, for example, not easily deformed under finger pressure.

Silicone or silicone elastomer, a synthetic rubber. In the present specification, reference to silicone is to Liquid Silicone Rubber (LSR) or Compression Molded Silicone Rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning corporation (Dow Corning). Another manufacturer of LSR is the Wacker group (Wacker). Unless specified to the contrary, exemplary forms of LSR have a shore a (or type a) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.

Polycarbonate-thermoplastic polymers of bisphenol A carbonate.

5.9.1.2 Mechanics

And (3) a shaft:

a. Neutral axis-an axis in which there is no longitudinal stress or strain in the cross section of the beam or plate.

B. longitudinal axis-an axis extending along the length of the shape. The axis typically passes through the center of the shape.

C. Circumferential axis-an axis oriented perpendicularly with respect to the longitudinal axis. The shaft may in particular be present in a pipe, tube, cylinder or the like having a circular and/or elliptical cross-section.

Deformation-the process by which the original geometry of the component changes when subjected to a force (e.g., a force in a direction relative to the axis). The process may include stretching or compressing, bending and twisting.

Elasticity, the ability of a material to recover its original geometry after deformation.

A flexible structure or member that will change shape (e.g., bend) when allowed to support its own weight for a relatively short period of time, such as1 second.

Rebound resilience is the ability of a material to absorb energy when elastically deformed and release energy when unloaded.

Elasticity-essentially all energy will be released upon unloading. Including, for example, certain silicones and thermoplastic elastomers.

Rigid structure or component-a structure or component that will not substantially change shape when subjected to the loads typically encountered in use. An example of such use may be to place and maintain a patient interface in sealing relationship with an entrance to a patient airway, for example, at a pressure of about 20cmH2O to 30cmH 2O.

As an example, the I-beam may include a different bending stiffness (resistance to bending loads) in the first direction than in the second orthogonal direction. In another example, the structure or component may be flexible in a first direction and rigid in a second direction.

Stiffness (or rigidity) of a structure or component, the ability of the structure or component to resist deformation in response to an applied load. The load may be a force or moment, such as compression, tension, bending or torsion. The structure or component may provide different resistances in different directions. The anti-sense of stiffness is compliance.

Viscosity, the ability of a material to resist flow.

Viscoelasticity, the ability of a material to exhibit elastic and viscous behavior in deformation.

Yield, the condition when the material no longer returns to its original geometry after deformation.

5.9.1.3 Structural component

Compression member a structural element that resists compressive forces.

An elbow is an example of a structure that directs the axis of an air flow traveling therethrough to change direction through an angle. In one form, the angle may be about 90 degrees. In another form, the angle may be greater or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotated relative to the mating component, for example, about 360 degrees. In some forms, the elbow may be removable from the mating component, for example, via a snap-fit connection. In some forms, the elbow may be assembled to the mating component via a disposable snap during manufacture, but cannot be removed by the patient.

Frame-the frame will be considered to mean a mask structure that carries the tension load between two or more connection points with the headgear. The mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frames may also be airtight.

Film-film will be considered to mean a typically thin element, which preferably has substantially no resistance to bending but resistance to stretching.

The laces (nouns) are designed to resist tension.

Thin structure:

a. The beam is provided with a plurality of grooves,

I. The beam may be relatively long in one dimension compared to the other two dimensions, such that the smaller dimension is relatively thin compared to the long dimension.

B. The film is formed by a film-type coating,

I. Relatively long in two dimensions and relatively thin in one dimension. Is easily deformed in response to bending force. Stretch-proof (and possibly also compression-proof).

C. Board and housing

I. they may be relatively long in both directions and relatively thin in one dimension. They may have bending, tensile and/or compressive stiffness.

Thick structure of solid

Sealing may refer to a noun form of the structure ("seal") or to a verb form of the effect ("seal"). The two elements may be constructed and/or arranged to "seal" or to achieve a "seal" therebetween without the need for a separate "seal" element itself.

Shell the shell will be understood to mean a curved, relatively thin structure with bending, stretching and compression stiffness. For example, the curved structural wall of the mask may be the shell. In some forms, the housing may be multi-faceted. In some forms, the housing may be airtight. In some forms, the shell may not be airtight.

Reinforcing member a reinforcing member will be considered to mean a structural member designed to increase the bending resistance of another member in at least one direction.

Struts, struts will be considered structural components designed to increase the resistance to compression of another component in at least one direction.

The spin-shaft (term) is a subassembly of components configured to rotate, preferably independently, about a common axis, preferably at low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a pair of mating cylindrical conduits. In use, little or no air flow leaks from the swivel.

5.9.2 Anatomy of

5.9.2.1 Facial anatomy

The alar wings (Ala) are the outer walls or "wings" of each nostril (plural: alar wings (alar))

Nose wing angle is the angle formed between the nose wings of each nostril.

Nose wing end, the outermost point on the nose wing.

The point of curvature (or nasal alar crest) of the nasal alar, the last point in the curved baseline of each nasal alar, is found in the fold formed by the connection of the nasal alar to the cheek.

Auricle-the entire externally visible portion of the ear.

(Nasal) skeletal frame-nasal skeletal frame includes nasal bone, frontal process of maxilla, and nasal portion of frontal bone.

Cartilage scaffold (nose) cartilage scaffold includes septum, lateral, large and small cartilage.

The nasal post, the skin strip that separates the nostrils and extends from the nasal projection to the upper lip.

Angle of the columella nose-the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the frankfurt horizontal plane and intersecting the point under the nose.

Frankfurt horizontal plane-a line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch in the upper part of the tragus of the pinna.

The point between the eyebrows is the most prominent point on the mid-forehead sagittal plane.

Extranasal cartilage-a plate of cartilage that is substantially triangular. The upper edge of which is attached to the nasal bone and the frontal process of the maxilla, and the lower edge of which is connected to the alar cartilage of the nose.

Under the lips (mid-lower lip), the lips extending between the under-nose point and the mouth.

Lip (upper lip midpoint) is the lip extending between the mouth and the chin point.

The great cartilage of nasal wing is the cartilage plate below the lateral nasal cartilage. It curves around the anterior portion of the nostril. The posterior end of which is connected to the frontal process of the maxilla by a tough fibrous membrane comprising three or four small cartilages of the nasal wings.

Nostrils-generally oval-shaped holes that form the nasal entrances. The singular form of a nostril (nares) is nostril (naris) (nostril (nostril)). The nostrils are separated by the nasal septum.

Nasolabial folds or nasolabial folds, skin folds or furrows extending from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

Angle of nasolabial horn-the angle between the columella and the upper lip (which simultaneously intersects the subseptal point of the nose).

Subtotal point-the lowest point at which the pinna attaches to the facial skin.

The point on the ear-the highest point where the pinna attaches to the facial skin.

Nose point-the most protruding point or tip of the nose, which can be identified in a side view of the rest of the head.

In humans, a midline groove extends from the lower boundary of the nasal septum to the top of the lip in the upper lip region.

The anterior chin point is the most anterior midpoint of the chin, which is located on the soft tissue.

Ridge (nose) the nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protrusion point.

Sagittal plane-a vertical plane from anterior (anterior) to posterior (posterior). The central sagittal plane is the sagittal plane that divides the body into right and left halves.

Nose bridge point is the most concave point on soft tissue and overlying frontal nasal suture area.

Septal cartilage (nose) the septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

The superior rear side panel, the point at the lower edge of the base of the nose, where the base of the nose engages the skin of the upper (superior) lip.

Subnasal point-the point where the columella nasi meets the upper lip in the central sagittal plane, located on the soft tissue.

The suprachin point is the point of maximum concavity located between the midpoint of the lower lip and the anterior chin point of the soft tissue in the midline of the lower lip

Skull dissection

Frontal bone comprises a larger vertical portion (frontal scale), which corresponds to an area called the forehead.

Mandible-mandible forms the mandible. The geniog is the bone bulge of the mandible forming the chin.

Maxillary bone-the maxilla forms the upper jaw and is located above the mandible and below the orbit. The maxillary frontal process protrudes upward from the lateral side of the nose and forms part of the lateral border.

Nasal bone-nasal bone is two small oval bones that vary in size and form among individuals, are positioned side by side in the middle and upper portions of the face, and form a "bridge" of the nose through their junction.

The nasal root is the intersection of frontal bone and two nasal bones, and is directly positioned between eyes and is positioned in a concave area at the upper part of nose bridge.

Occiput, occiput is located in the dorsal and lower parts of the cranium. It includes oval hole, i.e. occipital macropore, through which cranial cavity is connected with vertebral canal. The curved plate behind the occipital macropores is occipital scale.

Orbit-a bone cavity in the skull that accommodates the eyeball.

Parietal bone-parietal bone is a bone that when coupled together forms the top cap and both sides of the skull.

Temporal bone is located at the bottom and sides of the skull and supports the portion of the face called the temple.

Cheekbones-the face includes two cheekbones that are located in the upper lateral portion of the face and form the protrusion of the cheek.

5.9.2.2 Respiratory anatomy

Diaphragm, muscle pieces extending across the bottom of the rib cage. The diaphragm separates the chest cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the chest cavity increases and air is drawn into the lungs.

The larynx, the larynx or larynx, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

Lung, respiratory organ of human. The conducting areas of the lung contain the trachea, bronchi, bronchioles and terminal bronchioles. The respiratory region contains respiratory bronchioles, alveolar ducts, and alveoli.

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 into two parts by vertical fins called nasal septum. There are three horizontal branches on the sides of the nasal cavity, which are called turbinates (nasal conchae) (the singular is "turbinates") or turbinates. The front of the nasal cavity is the nose, while the back is incorporated into the nasopharynx via the inner nostril.

Pharynx is a portion of the throat immediately below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections, nasopharynx (upper pharynx) (nasal part of pharynx), oropharynx (middle pharynx) (oral part of pharynx), and hypopharynx (hypopharynx).

5.9.3 Patient interface

Anti-asphyxia valve (AAV) components or sub-components of the mask system that reduce the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

Headgear-headgear refers to a form of positioning and stabilizing structure designed to retain a device (e.g., mask) on the head.

Plenum chamber the mask plenum chamber will be considered to mean that portion of the patient interface having a wall at least partially surrounding a volume of space that, in use, has air pressurized therein to above atmospheric pressure. The shell may form part of the wall of the mask plenum chamber.

Sealing may refer to a noun form of the structure ("seal") or to a verb form of the effect ("seal"). The two elements may be constructed and/or arranged to "seal" or to achieve a "seal" therebetween without the need for a separate "sealing" element itself.

Vents (noun) allow air flow from the mask interior or conduit to ambient air to flow through structures that serve to clinically effectively flush exhaled air. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on mask design and treatment pressure.

5.10 Other comments

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 the patent office patent document or records, but otherwise reserves all copyright rights whatsoever.

Unless the context clearly indicates 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 intermediate ranges, which may independently be included in the intermediate 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 these limitations, ranges excluding either or both of those included limitations are also included in the technology.

Moreover, where one or more values are stated herein as being implemented as part of a technology, it is to be understood that such values can be approximate unless otherwise stated, and that such values can be used for any suitable significant number to the extent that an actual technology implementation can permit or require.

Furthermore, as used herein, "substantially," "about," or any similar term means +/-5-10% of the value.

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 exemplary methods and materials are described herein.

Obvious substitute materials with similar properties may be used as substitutes when a particular material is identified for use in constructing a component. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and, therefore, may be manufactured together or separately.

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.

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 matter 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 disclosure by virtue of prior application. Furthermore, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

The terms "comprises" and "comprising" are to 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 referenced.

The topic headings used in the detailed description are included for ease of reference to the reader only and are not to be construed as limiting the topic found throughout the disclosure or claims. The subject matter headings are not to be used to interpret the claims or the scope of the claims.

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, 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, they are not intended to represent any order, unless otherwise indicated, but rather may be used to distinguish between different elements. Furthermore, while process steps in a method may be described or illustrated in a sequential order, such order is not required. Those skilled in the art will recognize that such sequences may be modified and/or aspects thereof may be performed simultaneously or even synchronously.

Accordingly, it should 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 present technology.

Claims

1. A patient interface configured to deliver a breathable gas stream to a patient for the treatment of respiratory distress, the patient interface comprising:

An inflation chamber, which, when in use, can be pressurized to a therapeutic pressure at least 4 cmH2O higher than ambient pressure throughout the patient's respiratory cycle, the inflation chamber comprising: a sealing formation structure configured and arranged to form a seal with a region of the patient's face surrounding at least one inlet of the patient's airway;

A positioning and stabilizing structure configured to maintain the sealing structure in proper position on the patient's face during use; and

A forehead cooling system configured to cool the patient's forehead during use.

2. The patient interface of claim 1, wherein the forehead cooling system includes a conduit configured to direct an airflow to the patient's forehead during use.

3. The patient interface of claim 3, wherein the airflow includes at least a portion of the breathable gas flow.

4. The patient interface according to claim 2 or 3, wherein the catheter is connected to the inflation chamber and configured to guide the airflow from the inflation chamber toward the patient's forehead.

5. The patient interface according to claim 2 or 3, wherein the catheter is connected to an air circuit, the air circuit being configured to connect to a connection port on the patient interface.

6. The patient interface according to claim 2 or 3, wherein the catheter is disposed in the positioning and stabilizing structure.

7. The patient interface of claim 6, wherein the first conduit is fluidly connected to a first side of the positioning and stabilizing structure in the region above the patient's eye.

8. The patient interface according to claim 6 or 7, the patient interface further comprising a second catheter positioned on a second opposite side in the region above the patient's eye of the positioning and stabilizing structure.

9. The patient interface of claim 8, wherein the first catheter is fluidly connected to the second catheter via a semi-permeable material configured to allow airflow to the patient's forehead.

10. The patient interface of claim 1, wherein the forehead cooling system is positioned to contact the patient's forehead during use.

11. The patient interface of claim 10, wherein the forehead cooling system includes a fluid reservoir.

12. The patient interface of claim 11, wherein the fluid reservoir comprises any one or more of the following: water, oil, gel, or sodium polyacrylate.

13. The patient interface of claim 11 or 12, further comprising a pump configured to cause fluid to flow within the fluid reservoir.

14. The patient interface of claim 10, wherein the forehead cooling system comprises a thermoelectric cooler.

15. The patient interface according to any one of the preceding claims, wherein the forehead cooling system includes a thermal interface material positioned to contact the patient's forehead during use.

16. The patient interface according to any one of the preceding claims, wherein the forehead cooling system includes a radiator.

17. A method for controlling a forehead cooling system, the method comprising the following steps:

A) Monitor the patient's forehead temperature;

B) If the forehead temperature is higher than a first predetermined threshold, then activate the forehead cooler;

C) If the forehead temperature is below a second predetermined threshold, then the forehead cooler is deactivated.

18. The method of claim 17, wherein the forehead cooler comprises a thermoelectric cooler.

19. The method according to claims 17 to 18, wherein the first predetermined threshold is between 20 degrees Celsius and 30 degrees Celsius.

20. The method according to any one of claims 17 to 19, wherein the first predetermined threshold is substantially equal to 25 degrees Celsius.

21. The method according to claims 17 to 20, wherein the second predetermined threshold is between 15 degrees Celsius and 20 degrees Celsius.

22. The method according to any one of claims 17 to 21, wherein the second predetermined threshold is substantially equal to 18 degrees Celsius.

23. The method according to any one of claims 17 to 22, wherein the forehead cooler is capable of including a first active mode and a second active mode, wherein the first active mode provides a first cooling rate and the second active mode provides a second cooling rate less than that of the first active mode.

24. The method of claim 23, wherein the forehead cooling system is configured to switch from the first active mode to the second active mode when the forehead temperature is below a third predetermined threshold, and to switch from the second active mode to the first active mode when the forehead temperature is above the third predetermined threshold.

25. The method of claim 24, wherein the third predetermined threshold is between 20 degrees and 22 degrees.

26. The method according to any one of claims 17 to 25, wherein the forehead cooling system is active only during the sleep-in period and inactive when the patient is detected to be asleep.

27. The method of any one of claims 17 to 26, wherein the forehead cooling system is configured to increase the temperature of the patient's forehead as part of the wake-up process.