CN116635099A - Combination and stabilization structure with textile sleeve - Google Patents

Abstract

The patient interface includes a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure. The positioning and stabilizing structure includes a gas delivery tube that delivers a flow of air to the inlet of the patient airway via the seal-forming structure, and an elongate textile sleeve that is disposed about the gas delivery tube and is arranged to contact the patient's face in use. The sleeve includes a wall having an opening allowing the patient to view a portion of the gas delivery tube. The strap engagement portion is configured to protrude through the opening of the fabric sleeve in use. A gap exists longitudinally between the edge of the opening and the strap engaging portion. The gap allows the gas delivery tube to stretch in use without the strap engagement portion contacting the edge of the opening.

Description

Combination and stabilization structure with textile sleeve

1 background Art

1.1 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.

1.2 description of related Art

1.2.1 human respiratory system and diseases 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 enter venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into end bronchioles. The bronchi form the air duct and 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 respiratory physiology (Respiratory Physiology), 9 th edition published by John b.west, lippincott Williams & Wilkins in 2012.

There are a range of respiratory diseases. Certain conditions 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) that includes the event of occlusion or blockage of the upper airway during sleep. It results from the combination of abnormally small upper airway and normal loss of muscle tone in the tongue, soft palate, and area of the posterior oropharyngeal wall 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. The complications are common disorders, especially in middle-aged overweight men, but the affected person may not be aware of the problem. See U.S. Pat. No. 4,944,310 (Sullivan).

Tidal breathing (CSR) is another form of sleep disordered breathing. CSR is a disorder of the respiratory controller of a patient in which there are alternating periods of rhythms of active and inactive ventilation called CSR cycles. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. CSR may be detrimental due to insufficient repetitive oxygen. In some patients, CSR is associated with repeated arousals from sleep, which results in severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Respiratory failure is a term for respiratory disease in which the lungs cannot inhale enough oxygen or exhale enough CO ₂ 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 hyper-ventilation 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 airflow resistance, prolonged expiratory phase 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: 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 categorized as fast-progressive and slow-progressive: (i) fast-progressive disease: muscle injuries characterized by deterioration over months and death over years (e.g., amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD) in young teenagers); (ii) a variable or slowly progressive disorder: (ii) a variable or chronic progressive disorder: characterized by deterioration of muscle injury over several years and only a slight reduction in life expectancy (e.g., limb banding, facial shoulder humerus, and tonic muscular dystrophy). Symptoms of respiratory failure of NMD include: progressive general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, sleepiness, morning headaches, and difficulty concentrating and mood changes.

The chest wall is 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 up and breathing, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

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

1.2.2 methods of treatment

Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive Ventilation (IV), and High Flow Therapy (HFT), have been used to treat one or more of the respiratory disorders described above.

1.2.2.1 respiratory pressure treatment

Respiratory pressure therapy is the supply of air to the airway inlet 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 tank ventilators or ducted ventilators).

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, so if the patient finds the means for providing such treatment to be: any one or more of uncomfortable, difficult to use, expensive, and unsightly, the patient may choose to not follow the treatment.

Non-invasive ventilation (NIV) provides ventilation support to a patient through the upper airway to assist the patient in breathing and/or to maintain proper oxygen levels within 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 in forms such as OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these treatments 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 aero-cut tube. In some forms, the comfort and effectiveness of these treatments may be improved.

1.2.2.2 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 rate profile (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 flow of regulated or enriched gas 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 airway inlet through an unsealed or open patient interface at a "therapeutic flow" that remains substantially constant throughout the respiratory cycle. The treatment flow rate is nominally set to exceed the peak inspiratory flow rate of the patient. HFT has been used to treat OSA, CSR, respiratory failure, COPD and other respiratory diseases. One mechanism of action is the high flow of air at the entrance of the airway through the flushing or washout of expired CO from the patient's anatomical dead space ₂ To improve ventilation efficiency. Thus, HFT is sometimes referred to as dead zone therapy (deadspace therapy) (DST surgery). Other benefits may include increased warmth and wettability (which may be beneficial in secretion management) and the possibility of properly increasing airway pressure. Instead of a constant flow rate, the therapeutic flow rate 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 gas be delivered to the airway of the patient at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%), at a specified flow rate (e.g., 1 Liter Per Minute (LPM), 2LPM, 3LPM, etc.).

1.2.3 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.

Respiratory therapy systems may include respiratory pressure therapy devices (RPT devices), air circuits, humidifiers, patient interfaces, oxygen sources, and data management.

Another form of treatment system is a mandibular reduction device.

1.2.3.1 patient interface

The patient interface may be used to couple the breathing apparatus to its wearer, for example by providing an air flow to the inlet of the airway. The air flow may be provided into the patient's nose and/or mouth via a mask, into the mouth via a tube, or into the patient's trachea via an autogenous cutting tube. Depending on the treatment to be applied, the patient interface may form a seal with an area, such as the patient's face, thereby facilitating the gas to be at a pressure that is sufficiently different from ambient pressure (e.g., at least 6cmH relative to ambient pressure ₂ O, e.g. about 10cmH ₂ Positive pressure of O) to effect treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include sufficient to facilitate about 10cm H ₂ The gas supply at positive pressure of O is delivered to the seal of the airway. 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 other 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 from the outside at higher pressures, but not to maintain the internal air at a pressure above ambient.

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

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

Some masks may not be practical for use while sleeping, such as when the head is lying on the side on a pillow and sleeping in a bed.

The design of patient interfaces presents several 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 mandible or mandible may be moved relative to the other bones of the skull. The entire head may be moved during the respiratory therapy session.

Because of these challenges, some masks face one or more of the following problems: abrupt, unsightly, expensive, incompatible, difficult to use, especially when worn for extended periods of time or uncomfortable for the patient when not familiar with the system. Wrong sized masks may result in reduced compliance, reduced comfort, and poor patient results. Masks designed for pilots only, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetic agents are acceptable for their original application, but such masks are not ideal as comfortable for wearing for long periods of time (e.g., several hours). Such discomfort may lead to reduced patient compliance with the treatment. This is especially true if the mask is worn during sleep.

Nasal CPAP therapy is very effective in treating certain respiratory disorders, provided that the patient is following the therapy. Patients may not be compliant with treatment if the mask is uncomfortable or difficult to use. 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, which may affect patient compliance.

While masks for other applications (e.g., pilots) 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 field.

1.2.3.1.1 seal forming structure

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

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 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 bridge 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 may be variously named by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oral-nasal masks.

Seal-forming structures that may be effective in one region of a patient's face may not be suitable in another region, for example, because of differences in shape, structure, variability, and sensitive areas of the patient's face. Seals, for example on swimming goggles covering the forehead of a patient, may not be suitable for use over the nose of a patient.

Some seal-forming structures may be designed for mass production such that one design is suitable, 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 a mass-produced patient interface, one or both must be accommodated to form a seal.

One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in face-to-face engagement with the patient's face. The seal-forming structure may comprise an air or fluid filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., rubber). For 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 sheet-like seal of thin material around the periphery 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 bend 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 formation architecture techniques are disclosed in the following patent applications assigned to rismate limited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in Adam Circuit (Adam Circuit) 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 following products containing nasal pillows were manufactured by rismai corporation: SWIFT ^TM Nasal pillow mask, SWIFT ^TM II nasal pillows mask, SWIFT ^TM LT nasal pillow mask, SWIFT ^TM FX nasal pillow mask and MIRAGE LIBERTY ^TM A full face mask. The following patent applications assigned to resmed limited describe examples of nasal pillow masks: international patent application WO2004/073,778 (wherein SWIFT of Ruisimei Co., ltd ^TM Aspects of nasal pillows), U.S. patent application 2009/0044808 (which describes aspects of a nasal pillow from rismel limited SWIFTTM LT); international patent applications WO 2005/063, 328 and WO 2006/130,903 (in which MIRAGE LIBERTY, a Raymet al, inc. is described ^TM Various aspects of the full face mask); international patent application WO 2009/052,560 (describing SWIFT from Ruisimai Co., ltd.) ^TM Various aspects of FX nasal pillows).

1.2.3.1.2 positioning and stabilization

The seal-forming structure of a patient interface for positive air pressure therapy is subjected to a corresponding force of air 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.

One technique is to use an adhesive. See, for example, U.S. patent application publication No. US2010/0000534. However, the use of adhesives may be uncomfortable for some people.

Another technique is to use one or more straps and/or stabilizing the harness. Many such harnesses suffer from one or more of inappropriateness, bulkiness, discomfort, and ease of use.

One form of positioning and stabilizing structure includes a pair of gas delivery tubes for receiving a flow of gas from a connection port on top of a patient's head and delivering the flow of gas to an inlet of the patient's airway through a seal-forming structure. In an example, the gas delivery tube may be made of silicone.

A fabric sleeve may be provided over the gas delivery tube to avoid contact between the tube surface and the patient's face. However, because such sleeves are generally opaque, the use of such sleeves may prevent a patient from visually confirming the cleanliness of the gas delivery tube. If the cleanliness of the device, particularly the cleanliness of the components in the airflow path, cannot be verified, the patient may be uncomfortable using the device.

If a textile sleeve is provided, it may be desirable to ensure that the sleeve is permanently connected to the gas delivery tube so as to ensure that the sleeve does not bunch up (e.g., bunch up or pucker) or roll up, or move away from its correct position on the tube. However, the presence of the sleeve should not affect the ability of the tube to elastically extend, and if provided, the sleeve should be comfortable against the skin of the patient.

1.2.3.2 Respiratory Pressure Treatment (RPT) devices

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

Barometric pressure generators are known in the field of applications such as industrial scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by the more common air pressure generators, such as reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may suffer from drawbacks related to one or more of comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

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

Noise output level table of existing RPT devices (sample only, test method specified in ISO 3744 at 10cmH in CPAP mode ₂ Measurement under O).

RPT device name	A-weighted sound pressure level dB (A)	Years (approximately)
			C series Tango TM	31.9	2007
C series Tango with humidifier TM	33.1	2007
			S8 Escape TM II	30.5	2005
With H4i TM S8 Escape of humidifier TM II	31.1	2005
			S9 AutoSet TM	26.5	2010
S9 AutoSet with H5i humidifier TM	28.6	2010

One known RPT device for treating sleep disordered breathing is the S9 sleep treatment system manufactured by rismate (ResMed). Another example of an RPT device is a ventilator. ResMed stiller for respirators, such as adult and pediatric respirators ^TM A range of invasive and non-invasive non-dependent ventilation support may be provided to a range of patients to treat a variety of conditions such as, but not limited to, NMD, OHS and COPD.

Ruisimai elise ^TM 150 ventilator and ruisimei VS III ^TM Breathing machineSupport for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of diseases. These ventilators provide a volumetric ventilation mode and a pneumatic ventilation mode with either a single-limb circuit or a dual-limb 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 provided to the airway of the patient at a 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 offer an unlimited number of choices that may be made. 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.

1.2.3.3 air Loop

The air circuit is a conduit or tube constructed and arranged to allow air flow to travel between two components of the respiratory therapy system, such as the RPT device and the 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 inhalation and exhalation.

1.2.3.4 humidifier

Delivering the air flow without humidification may result in airway dryness. The use of a humidifier with an RPT device and patient interface generates humidified gases, minimizing nasal mucosa desiccation and increasing patient airway comfort. Furthermore, 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. Thus, humidifiers typically have the ability to heat an air stream and humidify it.

Many manual humidification devices and systems are known, however they do not meet the specific requirements of medical humidifiers.

Medical humidifiers are used to increase the humidity and/or temperature of the air stream relative to ambient air when needed, typically at a point where the patient may be asleep or resting (e.g., at a hospital). Medical humidifiers placed at the bedside may be small. The medical humidifier may be configured to only humidify and/or heat the air stream delivered to the patient, without humidifying and/or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) may also humidify the air inhaled by the patient, however these systems may also humidify and/or heat the entire room, which may be uncomfortable for the occupants. Furthermore, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide inadequate humidification, and some patients may have difficulty or inconvenience in use.

1.2.3.5 exhaust techniques

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

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

A number of improved mask ventilation techniques have been developed by rismate limited. See International patent application publication No. WO 1998/034,665; and International patent application publication No. WO2000/078,381; U.S. Pat. No.6,581,594; U.S. patent application publication No. us2009/0050156; U.S. patent application publication No.2009/0044808.

Noise table of existing masks (ISO 17510-2:2007,1m out with 10cmH ₂ O pressure

Only one sample at 10cmH in CPAP mode using the test method specified in ISO 3744 ₂ O-under measurement

The sound pressure values of the various objects are listed below

2 summary of the 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 to provide methods and/or apparatus for improving patient compliance with respiratory therapy.

One form of the present technology includes: a patient interface including a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway for sealing the flow of delivery air at a therapeutic pressure; and a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

One form of the present technology includes a patient interface comprising:

a plenum chamber that is pressurizable to at least 6cmH above ambient air pressure ₂ A therapeutic pressure of O, the plenum comprising a plenum inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration;

a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airway for, in use At least 6cmH above ambient air pressure throughout the patient's respiratory cycle ₂ Sealing a flow of delivery air at a therapeutic pressure of O, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to an inlet of a nostril of a patient, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

a positioning and stabilizing structure for providing a force to maintain a seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airway for, in use, at least 6cmH above ambient air pressure throughout the patient's respiratory cycle ₂ The therapeutic pressure of O sealingly delivers an air flow to at least the nostrils of the patient.

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

One form of the present technique includes an elongate textile sleeve configured to be disposed about the gas delivery tube and arranged to contact the patient's face in use, the sleeve including a wall having an opening therein for allowing the patient to view a portion of the gas delivery tube when the positioning and stabilizing structure is not in use.

One form of the present technique includes a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airway for use in at least 6cmH above ambient air pressure throughout the patient's respiratory cycle ₂ The therapeutic pressure of O sealingly delivers an air flow to at least the nostrils of the patient, the positioning and stabilizing structure comprising:

a gas delivery tube receiving a flow of air from a connection port on top of the patient's head and delivering the flow of air via the seal-forming structure to an inlet of the patient's airway, the gas delivery tube being constructed and arranged to contact, in use, at least one region of the patient's head above an on-ear base point of the patient's head,

the positioning and stabilizing structure further comprises an elongate textile sleeve disposed about the gas delivery tube and arranged to contact the patient's face in use, the sleeve comprising a wall having an opening therein for allowing the patient to view a portion of the gas delivery tube when the positioning and stabilizing structure is not in use.

In the example

a) The fabric sleeve is elastically flexible in the axial direction; b) The textile sleeve is elastically flexible in the circumferential direction; c) The textile sleeve having greater flexibility in the axial direction than in the circumferential direction; d) The opening is generally oval, elliptical or stadium shaped; e) The gas delivery tube comprises a hexagonal portion and a non-hexagonal portion, wherein the non-hexagonal portion is on a side of the hexagonal portion opposite the connection port, wherein the fabric sleeve is arranged such that the entire edge of the opening is located over the non-hexagonal portion of the gas delivery tube; f) The sleeve extending to an end of the non-hexagonal portion of the gas delivery tube opposite the hexagonal portion; g) The gas delivery tube includes a strap engaging portion for engaging a strap, and the fabric sleeve is arranged such that the strap engaging portion protrudes through the opening; h) The strap engaging portion includes a tab; i) A gap exists between the edge of the opening and the strap engaging portion; j) The gap is in the longitudinal direction; k) The gap allowing the gas delivery tube to stretch in use without the strap engagement portion contacting the edge of the opening; l) said opening is approximately 65mm long; m) the opening is less than 65mm long; n) having a lateral gap of less than 5mm between the tab and each lateral edge of the opening; o) the width of the opening is less than 50% of the circumference of the gas delivery tube when the opening and the gas delivery tube are measured at the same longitudinal position; p) the locating and stabilizing structure comprises a second strap engaging portion and the textile sleeve comprises a second said opening, wherein the textile sleeve is arranged such that the second strap engaging portion protrudes through the second opening; q) the positioning and stabilizing structure comprises a second gas delivery tube, the fabric sleeve extending over both gas delivery tubes; r) the textile sleeve comprises a first material on a patient contacting side of the sleeve and a second material on a non-patient contacting side of the sleeve; s) the first material is connected to the second material by a seam, wherein the seam is configured to allow stretching in the circumferential direction; t) the first material comprises a moisture wicking needle material; u) the second material comprises a smooth surface; v) providing a seam tape to the edge of the opening to reduce or eliminate wear of the fabric; w) the textile sleeve comprises a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use; x) the fabric sleeve includes a seam tape disposed to an edge of the connection port opening; and/or y) said seam tape disposed to said edge of said connection port opening is disposed on an inner surface of said fabric sleeve.

Another form of the present technique includes a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to an airway of the patient for delivering, in use, an air flow seal to at least the nostrils of the patient at a therapeutic pressure of at least 6cmH2O above ambient air pressure throughout the respiratory cycle of the patient, the positioning and stabilizing structure comprising:

a gas delivery tube receiving a flow of air from a connection port on top of the patient's head and delivering the flow of air via the seal-forming structure to an inlet of the patient's airway, the gas delivery tube being constructed and arranged to contact, in use, at least one region of the patient's head above an on-ear base point of the patient's head,

the positioning and stabilizing structure further comprises an elongate textile sleeve disposed about the gas delivery tube and arranged to contact the patient's face in use, wherein the sleeve comprises a single piece knit and/or woven structure that is resiliently flexible both circumferentially and axially.

In the examples:

a) The textile sleeve comprises a main structure and one or more functional areas knitted and/or woven into the main structure, each of the functional areas having one or more textile properties different from the textile properties of the main structure; b) At least one of the functional zones is a transparent or semi-transparent zone through which at least a portion of the gas delivery tube is visible; c) The one or more fabric properties include one or more of the following: knitting density; weaving density; a plurality of stitches in the knit pattern; the knitted or woven pattern; yarn density; yarn type; a fiber cross section; d) Coating or impregnating at least a portion of the textile sleeve with at least one functional and/or aesthetic property imparting material; e) The at least one material is one or more of the following: phosphorescent materials, luminescent materials or antimicrobial compositions; f) The textile sleeve having greater flexibility in the axial direction than in the circumferential direction; g) The gas delivery tube includes a strap engaging portion and the fabric sleeve has a first opening through which at least a portion of the strap engaging portion is accessible to engage a strap; h) The strap engaging portion includes a tab; i) The positioning and stabilizing structure includes a second strap engaging portion and the fabric sleeve includes a second opening through which the second strap engaging portion is accessible to engage a strap; j) The positioning and stabilizing structure includes a second gas delivery tube and the fabric sleeve extends over both gas delivery tubes; k) The textile sleeve comprises a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use; l) said first opening is generally oval, elliptical or stadium-shaped; and/or, if present, the second opening is generally oval, elliptical, or stadium-shaped; m) at least one of the first opening, the second opening, and the connection port opening includes an edge reinforcement structure to reduce or eliminate wear of the fabric; and/or n) the edge reinforcing structure comprises one or more of: a joint adhesive tape; stitching; a thermal bonding section; a thickened region; and an end cap.

Another form of the present technique includes a textile sleeve for a positioning and stabilizing structure for providing a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including a gas delivery tube that receives a flow of air from a connection port on top of the patient's head and delivers the flow of air to an inlet of a patient's airway via the seal-forming structure, the textile sleeve being arranged to fit around the gas delivery tube and in contact with the patient's face in use, the textile sleeve including a single piece knit and/or woven structure that is resiliently flexible in both circumferential and axial directions.

In the examples:

a) The textile sleeve comprises a main structure and one or more functional areas knitted and/or woven into the main structure, each of the functional areas having one or more textile properties different from the textile properties of the main structure; b) At least one of the functional zones is a transparent or translucent zone through which at least a portion of the gas delivery tube is visible when the textile sleeve is assembled to the positioning and stabilizing structure; c) The one or more fabric properties include one or more of the following: knitting density; weaving density; a plurality of stitches in the knit pattern; the knitted or woven pattern; yarn density; yarn type; a fiber cross section; d) Coating or impregnating at least a portion of the textile sleeve with at least one functional and/or aesthetic property imparting material; e) The at least one material is one or more of the following: phosphorescent materials, luminescent materials or antimicrobial compositions; f) The textile sleeve having greater flexibility in the axial direction than in the circumferential direction; g) The textile sleeve having a first opening through which at least a portion of the strap engaging portion of the gas delivery tube is accessible for engagement of a strap when the textile sleeve is assembled onto the gas delivery tube; h) The strap engaging portion includes a tab; i) The textile sleeve includes a second opening through which a second belt engaging portion of the gas delivery tube is accessible to engage a strap when the textile sleeve is assembled to the gas delivery tube; j) The textile sleeve being adapted to extend over the gas delivery tube and a second gas delivery tube of the positioning and stabilizing structure; k) The textile sleeve comprises a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use; l) said first opening is generally oval, elliptical or stadium-shaped; and/or, if present, the second opening is generally oval, elliptical, or stadium-shaped; m) at least one of the first opening, the second opening, and the connection port opening includes an edge reinforcement structure to reduce or eliminate wear of the fabric; and/or n) the edge reinforcing structure comprises one or more of: a joint adhesive tape; stitching; a thermal bonding section; a thickened region; and an end cap.

Another form of the present technique includes a positioning and stabilizing structure to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to an airway of the patient for delivering, in use, an air flow seal to at least the nostrils of the patient at a therapeutic pressure of at least 6cmH2O above ambient air pressure throughout the respiratory cycle of the patient, the positioning and stabilizing structure comprising:

at least one gas delivery tube receiving a flow of air from a connection port on top of the patient's head and delivering the flow of air via the seal-forming structure to an inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head above an on-ear base point of the patient's head,

at least one elongate textile sleeve disposed about at least a portion of the at least one gas delivery tube and configured to contact the patient's face in use,

wherein the at least one textile sleeve is fixed relative to the at least one gas delivery tube at a location adjacent an end of the at least one gas delivery tube adjacent the seal-forming structure.

In the examples:

a) The textile sleeve is secured to the at least one gas delivery tube by an adhesive; b) Providing a seam tape layer on an end of the fabric sleeve adjacent the gas delivery tube; c) The seam tape is attached to the fabric sleeve by an adhesive; d) The at least one textile sleeve is secured relative to the at least one gas delivery tube by an end cap; e) The end cap extends from an outer surface of the at least one textile sleeve, over an end of the at least one textile sleeve, and over at least a portion of an edge of the at least one gas delivery tube; f) The end cap includes an annular sidewall and an end flange extending radially inwardly from the sidewall; g) The sidewall includes at least one adhesive recess; h) The at least one adhesive recess is annular; i) The at least one adhesive recess being offset from an end of the sidewall remote from the end flange; j) The at least one adhesive recess being offset from the end flange; k) The side wall includes at least one axial recess extending from an end of the side wall toward the end flange; l) receiving at least one seam of the textile sleeve in the at least one axial recess; m) at least one seam of the fabric sleeve comprises a first seam and a second seam, the at least one axial recess comprising a first axial recess in which the first seam is received and a second axial recess in which the second seam is received; n) the end cap comprises at least one visual indicator that indicates one or more of: alignment of the at least one gas delivery tube with the connection of the seal-forming structure, and the size of the positioning and stabilizing structure; o) the at least one textile sleeve is fixed relative to the at least one gas delivery tube by a local high friction interface; p) the localized high friction interface is provided by a polymer layer between the textile sleeve and the at least one gas delivery tube; q) the polymer layer is a polymer gel strip; r) the polymer gel strip is a thermoplastic polyurethane gel strip; s) the polymer adhesive tape is an organic silicon adhesive tape; t) the polymer layer is a silicone layer; u) the at least one textile sleeve is fixed relative to the at least one gas delivery tube by means of a double-sided adhesive tape between the at least one textile sleeve and the at least one gas delivery tube; v) the double-sided tape is coated with a silicone adhesive on a first side and a non-silicone adhesive on a second side; w) the non-silicone adhesive is an acrylic adhesive; x) the at least one textile sleeve is fixed relative to the at least one gas delivery tube by an overmolded end; y) the overmolded end portion extends from the outer surface of the at least one textile sleeve, extends over the end of the at least one textile sleeve, and extends over at least a portion of the edge of the at least one gas delivery tube; z) the overmolded end portion comprises at least one visual indicator indicating one or more of: alignment of the at least one gas delivery tube with the connection of the seal-forming structure, and the size of the positioning and stabilizing structure; aa) the at least one gas delivery tube is made of an elastomeric material; bb) the at least one gas delivery tube comprises a pair of gas delivery tubes and the textile sleeve extends over both gas delivery tubes; cc) the at least one textile sleeve is fixed relative to the two gas delivery tubes proximate the respective ends of the seal-forming structure; and/or dd) the at least one textile sleeve is further secured to the at least one gas delivery tube proximate the connection port.

Another form of the present technology includes a patient interface, the patient interface comprising:

a plenum chamber that is pressurizable to at least 6cmH above ambient air pressure ₂ O, said plenum including a plenum inlet port,the plenum inlet port is sized and configured to receive an air flow at the therapeutic pressure for patient respiration;

a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airway for use in at least 6cmH above ambient air pressure throughout the patient's respiratory cycle ₂ Sealing a flow of delivery air at a therapeutic pressure of O, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to an inlet of a nostril of a patient, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

a positioning and stabilizing structure according to one of the above technical forms.

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 a device.

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 patient interface that can be cleaned at the 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 at the patient's home, for example in soapy water, without the need for specialized cleaning equipment.

Of course, some of these aspects may form sub-aspects of the present technology. 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.

Description of the 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:

3.1 respiratory therapy System

Fig. 1A shows a system that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal pillow receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

Fig. 1B illustrates a system that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

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

3.2 respiratory System and facial anatomy

Fig. 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 upper lip, upper lip red, lower lip, mouth width, inner canthus, nose wings, nasolabial folds, and corners of the mouth. Upper, lower, radially inward and radially outward directions are also indicated.

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 base point, and a lower ear base point. The up-down and front-back directions are also indicated.

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

Figure 2F shows a bottom view of a nose with several features identified, including the nasolabial folds, lower lips, upper lip reds, nostrils, subseptal points, columella, nasal punctum, long axis of nostrils, and central sagittal plane.

Fig. 2G shows a side view of the nose skin feature.

Fig. 2H shows subcutaneous structures of the nose, including lateral cartilage, septal cartilage, alar cartilage, seedlike cartilage, nasal bone, epidermis, adipose tissue, frontal processes of the maxilla, and fibrous adipose tissue.

Fig. 2I shows a medial anatomic view of the nose, about a few millimeters from the central sagittal plane, showing, among other things, the medial foot of the septal cartilage and the alar cartilage.

Fig. 2J shows a front view of the skull, including the frontal, nasal and zygomatic bones. Turbinates, as well as maxilla and mandible, are also indicated.

Fig. 2K shows a side view of a skull with a head surface profile and several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone and occipital bone. The chin bulge is also indicated. The following muscles are shown: two abdominal muscles, a chewing muscle, a sternocleidomastoid muscle and a trapezius muscle.

Fig. 2L shows a front-to-outside view of the nose.

3.3 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. 3B shows a schematic view of a cross section through a structure at a point. The outward normal at the point is indicated. The curvature at this point has a positive sign and has a relatively large amplitude when compared to the amplitude of curvature shown in fig. 3C.

Fig. 3C shows a schematic view of a cross section through a structure at a point. The outward normal at the point is indicated. The curvature at this point has a positive sign and has a relatively small amplitude when compared to the amplitude of curvature shown in fig. 3B.

Fig. 3D shows a schematic view of a cross section through a structure at a point. The outward normal at the point is indicated. The curvature at the point has a zero value.

Fig. 3E shows a schematic view of a cross section through a structure at a point. The outward normal at the point is indicated. The curvature at this point has a negative sign and a relatively small amplitude when compared to the curvature amplitude shown in fig. 3F.

Fig. 3F shows a schematic view of a cross section through a structure at a point. The outward normal at the point is indicated. The curvature at this point has a negative sign and a relatively large amplitude when compared to the curvature amplitude shown in fig. 3E.

Fig. 3G shows a cushion for a mask comprising two pillows. The outer surface of the pad is indicated. Showing the edges of the surface. The dome and saddle regions are shown.

Fig. 3H shows a cushion for a mask. The outer surface of the pad is indicated. Showing the edges of the surface. The path on the surface between points a and B is indicated. The straight line distance between a and B is indicated. Two saddle regions and one dome region are indicated.

Fig. 3I shows a surface with a one-dimensional pore structure on the surface. The planar curve illustrated forms the boundary of a one-dimensional hole.

Fig. 3J shows a cross section through the structure of fig. 3I. The surface shown defines a two-dimensional aperture in the structure of fig. 3I.

Fig. 3K shows a perspective view of the structure of fig. 3I, including two-dimensional holes and one-dimensional holes. The surface defining the two-dimensional aperture in the structure of fig. 3I is also shown.

Fig. 3L shows a mask with an inflatable bladder as a cushion.

Fig. 3M shows a cross section through the mask of fig. 3L and illustrates the inner surface of the balloon. The inner surface defines a two-dimensional aperture in the mask.

Fig. 3N shows another cross-section through the mask of fig. 3L. The inner surface is also indicated.

Fig. 3O shows a left hand rule.

Fig. 3P shows the right hand rule.

Fig. 3Q shows the left ear, including the left ear spiral.

Fig. 3R shows the right ear, including the right ear spiral.

Fig. 3S shows a right-hand spiral.

Fig. 3T shows a view of the mask including a sign of torsion of the spatial curve defined by the edges of the sealing film in different regions of the mask.

Fig. 3U shows a view of the plenum chamber 3200, showing the sagittal and intermediate contact surfaces.

Fig. 3V shows a view of the rear of the plenum of fig. 3U. The direction of this view is perpendicular to the intermediate contact surface. The sagittal plane in fig. 3V bisects the plenum into left and right sides.

Fig. 3W shows a section through the plenum of fig. 3V, the section being taken at the sagittal plane shown in fig. 3V. The "middle contact" plane is shown. The intermediate contact surface is perpendicular to the sagittal plane. The orientation of the intermediate contact surface corresponds to the orientation of the chord 3210, which lies in the sagittal plane and just two points on the sagittal plane contact the cushion of the plenum: an upper point 3220 and a lower point 3230. The intermediate contact surface may be tangential at the upper and lower points, depending on the geometry of the pad in this region.

Fig. 3X shows the location of the plenum chamber 3200 of fig. 3U in use on a face. When the plenum chamber is in the in-use position, the sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face. The intermediate contact surface generally corresponds to a 'face plane' when the plenum is in the use position. In fig. 3X, the plenum chamber 3200 is the plenum chamber of the nasal mask, and the upper point 3220 is located approximately on the root of the nose, while the lower point 3230 is located on the upper lip.

Fig. 4 shows a perspective view of the patient interface in use.

3.4 patient interface of the present technology

Fig. 5 shows a perspective view of a patient interface including a fabric sleeve in one form in accordance with the present technique, the fabric sleeve being disposed in a use orientation.

Fig. 6 illustrates a top view of a positioning and stabilizing structure including a textile sleeve in accordance with one form of the present technique.

Fig. 7 illustrates a bottom view of a positioning and stabilizing structure including a fabric sleeve in accordance with one form of the present technique.

Fig. 8 shows an enlarged top view of the gas delivery tube of the positioning and stabilizing structure, wherein the edges of the openings of the textile sleeve according to one form of the invention are shown, but the rest of the textile sleeve is omitted for clarity.

Fig. 9 illustrates an enlarged view of a connection port opening of a fabric sleeve in accordance with one form of the present technique.

Fig. 10 illustrates a bottom view of a textile sleeve in accordance with one form of the present technique.

Fig. 11 is a perspective view of a patient interface including a pair of textile sleeves in accordance with one form of the present technique.

Fig. 12 is a perspective view of a fabric sleeve in accordance with one form of the present technique.

Fig. 13A is a schematic illustration of an example knit pattern for a fabric sleeve in accordance with the forms of the present technique.

Fig. 13B is a schematic illustration of an exemplary weave pattern of a fabric sleeve in accordance with forms of the present technique.

Fig. 13C is a schematic illustration of another example weave pattern of a fabric sleeve in accordance with forms of the present technique.

Fig. 14A illustrates a first rear perspective view of an end cap for a positioning and stabilizing structure in accordance with one form of the present technique.

Fig. 14B shows a second rear perspective view of the end cap of fig. 14A.

Fig. 14C shows a rear view of the end cap of fig. 14A.

Fig. 14D shows an elevation view of the end cap of fig. 14A.

Fig. 14E shows a front perspective view of the end cap of fig. 14A.

Fig. 14F shows a side view of the end cap of fig. 14A.

Fig. 14G shows an enlarged cross-sectional side view of the end cap of fig. 14A.

Fig. 15 shows a cross section of an end cap applied to a gas delivery tube and fabric sleeve in accordance with one form of positioning and stabilizing structure of the present technique.

Fig. 16A illustrates a top perspective view of an end cap for a positioning and stabilizing structure in accordance with one form of the present technique.

Fig. 16B shows a top view of the end cap of fig. 16A.

Fig. 17A illustrates a schematic cross-sectional view of a positioning and stabilizing structure having a high friction interface between a gas delivery tube and a fabric sleeve in accordance with one form of the present technique.

Fig. 17B illustrates a schematic cross-sectional view of another positioning and stabilizing structure having a high friction interface between a gas delivery tube and a fabric sleeve in accordance with one form of the present technique.

Fig. 18 shows a schematic cross-sectional view of one form of positioning and stabilizing structure with a double sided adhesive tape applied between the gas delivery tube and the fabric sleeve in accordance with the present technique.

Fig. 19 shows a schematic cross-sectional view of one form of positioning and stabilizing structure having molded ends applied to a gas delivery tube and fabric sleeve in accordance with the present technique.

Figure 20 illustrates a cross-section of another form of end cap applied to a positioning and stabilizing structure for a gas delivery tube and fabric sleeve in accordance with one form of the present technique, wherein the gas delivery tube is connected to a plenum chamber of a patient interface.

Figure 21 illustrates a schematic cross-sectional view of one form of positioning and stabilizing structure having a seam tape disposed on the end of a fabric sleeve in accordance with the present technique.

Description of the preferred embodiments

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 herein is for the purpose of describing particular examples discussed herein only and is not intended to be limiting.

The following description is provided in connection with 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.

4.1 methods of treatment

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

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

In certain examples of the present technology, mouth breathing is defined, restricted, or prevented.

4.2 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 an air circuit 4170 and a patient interface 3000.

4.3 patient interface

A non-invasive patient interface 3000 in accordance with one aspect of the present technique includes the following functional aspects: seal forming structure 3100, plenum chamber 3200, positioning and stabilizing structure 3300, vents 3400, one form of connection port 3600 for connection to air circuit 4170, and 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 patient's airway in order to maintain a positive pressure at the airway entrance of the patient 1000. The sealed patient interface 3000 is thus suitable for delivery of positive pressure therapy.

If the patient interface is not able 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 according to one form of the present technology is constructed and arranged to be capable of being at least 6cm H relative to the environment ₂ The positive pressure of O supplies air.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of being at least 10cm H relative to the environment ₂ The positive pressure of O supplies air.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of being at least 20cm H relative to the environment ₂ O (e.g. 30cm H ₂ O) positive pressure supply air.

4.3.1 seal formation Structure

In one form of the present technique, the seal forming structure 3100 provides a target seal forming region and may additionally provide a cushioning function. The target seal forming area is an area on the seal forming structure 3100 where sealing 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 where the patient interface is placed 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 outer 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, such as silicone rubber.

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

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 size and/or shape range. For example, the system may include one form of seal forming structure 3100 that is suitable for large sized heads but not small sized heads, and another suitable for small sized heads but not large sized heads.

4.3.1.1 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 comprises a relatively thin member having a thickness of less than about 1mm, such as about 0.25mm to about 0.45mm, which 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 around at least a portion of the path of the perimeter. The support flange is or comprises a spring-like element and acts to support the sealing flange against bending in 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 the 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 sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

4.3.1.2 nose pillow

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 according to one aspect of the present technology includes: a frustoconical body having at least a portion thereof forming a seal on a bottom surface of the patient's nose; a handle; on the frustoconical floor and connecting the frustoconical to the flexible region of the stem. 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 both in terms of displacement and angle between the frustoconical and nasal pillow connected structures. For example, the frustoconical position may be axially displaced toward the structure to which the stem is connected.

4.3.2 plenum

In the region where the seal is formed in use, the plenum chamber 3200 has a perimeter shaped to complement the surface contour of an average human face. 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 along 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 eyes are outside of 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 treatment.

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 a transparent material may reduce the prominence of the patient interface and help to improve compliance with the 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.

4.3.3 positioning and stabilization Structure

The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state by a positioning and stabilizing structure 3300 when in use.

In one form, the positioning and stabilizing structure 3300 provides a retention force that is at least sufficient to overcome the effect of positive pressure 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.

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 from tube drag or accidental interference 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 being worn by a patient while sleeping. In one example, the locating and stabilizing structure 3300 has a smaller side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilizing structure 3300 includes at least one strip that is rectangular in 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 small and cumbersome to prevent a patient from lying in a supine sleeping 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 in a side sleep position, with a side region of the patient's head on a pillow.

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 decoupling portion is not resistant to compression and may be, for example, a flexible strap or a floppy strap. The decoupling portion is constructed and arranged such that the presence of the decoupling portion prevents forces acting on the rear 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 a strap that is extendable, e.g., elastically extendable. For example, the strap may be configured to be under tension during 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 upper ear base of a patient's head and covers a portion of a parietal bone and not an 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 an upper edge of the second strap passes under a lower ear base of a patient's head and covers or is located under an occipital bone of the patient's head.

In one form of the present technology applicable to nasal only masks 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 certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is bendable and, for example, non-rigid. This aspect has the advantage that the strap makes the patient more comfortable to lie on while sleeping.

In some 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 range of sizes and/or shapes. 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.

In some forms of the present technique, the positioning and stabilizing structure 3300 includes one or more gas delivery tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the airway of the patient, for example as shown in fig. 4.

In an example, the positioning and stabilizing structure 3300 includes two tubes 3350 that convey air from the air circuit 4170 to the seal forming structure 3100. Tube 3350 is an integral part of positioning and stabilizing structure 3300 of patient interface 3000 to position and stabilize seal-forming structure 3100 of the patient interface to the appropriate portions of the patient's face (e.g., nose or nose and mouth). This allows the conduit of the air circuit 4170 that provides the pressurized air flow to connect to the connection port 3600 of the patient interface, which connection port 3600 is in a position other than in front of the patient's face, which may be aesthetically unattractive to some people. While there are some advantages to using a pair of tubes 3350, in some examples, the positioning and stabilizing structure 3300 includes only a single tube 3350 configured to cover the patient's head on one side. A strap or other stabilizing member may be provided on the other side of the patient's head between the top end of the single tube 3350 and the seal-forming structure 3100 to provide a balanced force on the seal-forming structure 3100. Any example of a positioning and stabilizing structure described below with reference to fig. 5-21 may include a single tube 3350 or two tubes 3350 unless specifically indicated otherwise.

In certain forms of the present technology, at least one of the gas delivery tubes 3350 is constructed and arranged to contact at least an area of the patient's head above an on-the-ear base point of the patient's head in use.

Patient interface 3000 may include a connection port 3600 located near the top, side, or back of the patient's head. For example, in the form of the present technique shown in fig. 4, the connection port 3600 is located on top of the patient's head, e.g., covering the parietal bone. In this example, patient interface 3000 includes an elbow 3610 with a connection port 3600 provided to elbow 3610. Elbow 3610 can be rotated relative to positioning and stabilizing structure 3300 in order to decouple movement of a catheter connected to connection port 3600 from positioning and stabilizing structure 3300. The elbow 3610 may be connected to a fluid connection opening 3360 in the headgear duct 3350 or to a fluid connection opening 3360 in a component to which the headgear duct 3350 is connected. Additionally or alternatively, the conduit connected to connection port 3600 may rotate relative to elbow 3610. In the illustrated example, the elbow 3610 includes a swivel tube connector including a connection port 3600 to which a tube of the air circuit 4170 is connectable such that the tube can swivel about its longitudinal axis relative to the elbow 3610. In some examples, the air circuit 4170 may be connected to the fluid connection opening 3360. Elbow 3610 may be rotatably connected to fluid connection opening 3360 or to a ring received in fluid connection opening 3360.

In the example shown in fig. 4, the two tubes 3350 are integrally formed and include a fluid connection opening 3360, and the swivel elbow is connected to the fluid connection opening 3360. In other examples, when separate tubes are used, they may be indirectly connected together, e.g., each may be connected to a T-shaped catheter having two catheter arms, each fluidly connected to tube 3350. The coronary connector may include a third catheter arm. Connection port 3600 may include an elbow 3610 received at the center of crown connector 3360. Elbow 3610 is configured to rotate.

In some examples of the present technology, the tube 3350 is configured to receive the strap 3310 (e.g., by providing a strap engaging portion such as the tab 3320) at a location above and near the patient's ear.

In an example, at least one of the gas delivery tubes 3350 includes a variable length portion 3352. The variable length portion 3352 may extend, compress, or both extend and compress from its "resting" or natural length. In an example, the variable length portion 3352 includes at least one corrugated or hexagonal portion 3354. In an example, the gas delivery tube includes a substantially constant length portion 3356 that extends between the variable length portion 3352 and an end portion 3358 of the gas delivery tube 3350, the gas delivery tube 3350 being connected to the plenum connectors 3204, one of the plenum connectors 3204 being disposed on each lateral side of the plenum 3200.

The example shown in fig. 4 is provided with a prior art sleeve 3363.

4.3.3.1 textile sleeve

Referring now to fig. 5 to 21, in one form of the technology, at least one elongate textile sleeve 3650 is provided over the or each gas delivery tube 3350. Sleeve 3650 is positioned over gas delivery tube 3350 such that at least a portion of sleeve 3650 is in contact with the patient's face, e.g., the patient's cheeks, in use. In some examples, the sleeve 3650 is configured to cover two gas delivery tubes of the positioning and stabilizing structure 3300, but in other forms of the technology (not shown), a separate sleeve 3650 may be provided for each gas delivery tube 3350.

In an example, the sleeve 3650 is positioned over the gas delivery tube 3350 such that a portion 3652 of the sleeve overlaps a substantially constant length portion 3356 of the gas delivery tube 3350 and a portion 3654 overlaps a variable length portion 3352 of the gas delivery tube. Thus, while portions 3356 and 3352 of gas delivery tube 3350 are visible in fig. 4, these portions are hidden by sleeve 3650 in fig. 5-21.

Referring now specifically to fig. 5, in an example, a wall 3666 of the sleeve 3650 is provided with an opening 3668. In an example, the opening 3668 is sized such that a patient can view a portion of the gas delivery tube 3350 through the opening.

In one form of the technology, the sleeve 3650 is configured for use with a gas delivery tube 3350, the gas delivery tube 3350 being provided with a strap engaging portion 3320 (typically integrally formed with the gas delivery tube) for engaging a strap (e.g., a harness), the strap engaging portion 3320 being in the form of, for example, a tab having a loop or hook for engaging the strap. The tab 3320 may have an aperture 3322 through which the strap may pass for engagement.

In one example, sleeve 3650 is resiliently flexible in the axial direction. The axial direction referred to herein refers to the direction of the centerline CL of the sleeve 3650, a portion of which is shown in fig. 6. In an example, sleeve 3650 is resiliently flexible in the circumferential direction C. In one form of the technique, sleeve 3650 is flexible in both the axial and circumferential directions and has greater flexibility in the axial direction than in the circumferential direction C.

Sleeve 3650 may include a first material 3670 and a second material 3672. The first material 3670 may form the patient-contacting side 3674 of the sleeve 3650 and the second material 3672 may form the non-patient-contacting side 3676 of the sleeve 3650. The first and second materials 3670, 3672 may be joined by a seam 3678. In an example, at least one of the seams 3678 is configured to allow stretching in the circumferential direction. Examples of suitable seams may include pull-out seams, hemmed seams, and/or zigzag seams.

The first material 3670 can be selected to provide good moisture absorption properties and/or a soft hand. In one example, the first material 3670 includes a woven structure. In an example, the first material 3670 is dark. One example of a suitable material is Weimei JC1937A. The first material 3670 may be, for example, 0.6mm thick.

The second material 3672 may be selected to be smooth so as to reduce friction when slid over bedding in use. One example of a suitable material is gemmakints IAP027AA. The second material 3672 may be, for example, 0.5mm thick. In an embodiment, the first and second materials both comprise nylon and spandex.

In some forms, the fabric sleeve 3650 covers the entire length of the gas delivery tube 3350. This is desirable to improve the aesthetic appearance of the positioning and stabilizing structure 3300, and thus improve patient compliance with respiratory therapy. In other forms, the fabric sleeve 3650 may cover only those portions of the gas delivery tube 3350 that are normally in contact with the patient's skin during use to enhance patient comfort (by avoiding direct contact with the material of the gas delivery tube 3350, which is typically formed of silicone or similar materials).

In some forms, textile sleeve 3650 is a generally tubular structure that includes a single piece knit and/or braid structure that is resiliently flexible in both the circumferential direction C and the axial direction a (these directions are shown in fig. 11). Textile sleeve 3650 may comprise a single layer or more than one layer. Textile sleeve 3650 may be produced in a single knitting process. Where the fabric sleeve comprises more than one layer, the layers may be interconnected in a single braiding process.

The circumferential elastic flexibility (across the width of the elongate textile sleeve 3650) enables the textile sleeve 3650 to form a sliding fit with the gas delivery tube 3350 even though the gas delivery tube 3350 varies in width along its length. For example, in some forms of the present technology, the gas delivery tube 3350 is narrower at an end proximal to the fluid connection opening 3360 than at an end distal to the fluid connection opening 3360 and proximal to the plenum connector 3204. In this case, when the fabric sleeve 3650 is assembled to the gas delivery tube 3350, the fabric sleeve 3650 tends to shrink to "catch" the tube 3350 at the proximal and distal portions 3654, 3652. In addition, the circumferential resilient flexibility enables the sleeve 3650 to stretch over the strap engaging portion of the gas delivery tube 3350, such as the hooked tabs 3320.

In some versions of the technology, the elasticity of sleeve 3650 may vary along its length. For example, the elasticity in the sleeve region (e.g., sleeve portion 3654 or joint 3320 overlapping the variable length portion) for receiving the wider portion of gas delivery tube 3350 may be greater than the elasticity in the region (e.g., sleeve portion 3652) for receiving the narrower portion of gas delivery tube 3350. The elasticity can be varied, for example, by varying the knitting density, the number of stitches in the knitted fabric, and/or the knitting pattern itself.

The axial elastic flexibility (along the length of the elongate textile sleeve 3650) tends to reduce or eliminate the likelihood of sleeve 3650 buckling when the positioning and stabilizing structure 3300 is worn by a patient and the gas delivery tube 3350 flexes as the patient moves.

By forming the textile sleeve 3650 with a one-piece knit and/or woven structure, a seamless and thus more comfortable structure may be provided without any sharp edges, and post-processing steps that would otherwise be required may be minimized or eliminated if the sleeve were manufactured, for example, by cutting and joining portions of the material used to form the sleeve.

Textile sleeve 3650, such as any of those shown in fig. 5-12, may be formed using a programmable knitting machine or loom, such as an electronic double needle bar warp knitting machine or needle loom. The use of such a machine can impart various aesthetic and functional properties to textile sleeve 3650 in a single manufacturing process.

For example, in the case of a loom, the fabric may be programmed so that various pattern structures, such as rearrangements of warp and weft twill fabrics, may be imparted to provide comfort for skin contact and a more aesthetically pleasing finish.

In the case of a knitting machine, different knitting patterns may be programmed to alter the elasticity, softness, and other physical properties of fabric sleeve 3650. This may be done for single and multi-layer sleeves 3650. For multi-layer sleeve 3650, different layers can be configured differently for robustness, feel, or stretch by programming the knitting machine to use different yarn parameters (e.g., different yarn types, yarn densities, yarn compositions, etc.). For example, for a single layer sleeve 3650, yarn parameters may be varied in different regions along the length of the fabric sleeve 3650.

In some forms, textile sleeve 3650 is formed at least in part from a first synthetic yarn, which may include fibers such as nylon 66, polyester, acrylic, and/or polyolefin.

Yarn specifications may be selected to achieve various advantages such as softness, surface smoothness and flatness, stretchability, and/or translucency. For example, relatively lower denier yarns may have increased translucency, allowing the patient to see through textile sleeve 3650. Furthermore, relatively low denier yarns may have increased softness, which achieves greater comfort for the patient. Alternatively, the use of relatively higher denier yarns may facilitate manufacturing. The first synthetic yarn may have a denier in the range of about 20D to 80D, or about 25D to 75D, or about 30D to 70D, or about 35D to 65D, or about 40D to 60D, or about 45D to 55D.

Textile sleeve 3650 may alternatively or additionally be at least partially formed from a second synthetic yarn, such as spandex, lycra ^TM 、Spandex ^TM Or ROICA ^TM Is formed from fibers of (a) and (b) is provided. The second synthetic yarn may be a high stretch elastic yarn having a denier in the range of about 50D to 140D, or about 55D to 135D, or about 60D to 130D, or about 65D to 125D, or about 70D to 120D, or about 75D to 115D, or about 80D to 110D, or about 85D to 105D, or about 90D to 100D. The high stretch yarns may contribute to the circumferential elastic flexibility and/or the axial elastic flexibility of fabric sleeve 3650.

The textile sleeve may alternatively or additionally be formed at least in part from a second synthetic yarn, such as spandex, lycra ^TM 、Spandex ^TM Or ROICA ^TM Is formed from fibers of (a) and (b) is provided. The second synthetic yarn may be a high stretch elastic yarn having a denier in the range of about 50D to 140D, or about 55D to 135D, or about 60D to 130D, or about 65D to 125D, or about 70D to 120D, or about 75D to 115D, or about 80D to 110D, or about 85D to 105D, or about 90D to 100D. The high stretch yarns may contribute to the circumferential elastic flexibility and/or the axial elastic flexibility of fabric sleeve 3650.

In some forms, textile sleeve 3650 may be formed at least in part from one or a combination of any two or more of a double knit (double knit) structure, as shown in fig. 13A; a plain weave 1 x 1 structure as shown in fig. 13B; and a plain weave 2 x 2 structure as shown in fig. 13C.

Textile sleeve 3650 may have a stretchability (or stretchability) that is greater than 100% (e.g., about 120% to 300%) of its resting length or resting width. In some forms, the stretching may be between about 130% and 190%; or between 140% and 180%; or between 150% and 170%. The stretch in one direction may be greater than the stretch in the other direction. For example, the stretch in the circumferential direction C may be greater than the stretch in the axial direction a.

In some forms, textile sleeve 3650 may be stretchable such that it shrinks to less than 100% of its resting length (e.g., about 80% of its resting length) or less than 100% of its resting width (e.g., 80% of its resting width). For example, when textile sleeve 3650 is stretched over 100% of its resting length, its resting width may contract due to the straightening caused by the tension of the stitches in the knit.

In some forms, textile sleeve 3650 includes a primary structure, and one or more functional regions knitted and/or woven into the primary structure. Each functional region may have one or more fabric properties that differ from the primary structure. For example, as shown in fig. 11, sleeve 3650 may include a functional zone 3660, the functional zone 3660 extending partially along a non-patient contacting side 3676 of the fabric sleeve 3650 and differing in fabric properties from the rest of the non-patient contacting side 3676 and patient contacting side 3674 of the sleeve 3650.

In some forms, the functional region 3660 can be a transparent or translucent region through which at least a portion of the gas delivery tube 3350 can be seen. This allows the patient to view portions of the gas delivery tube 3350 when the positioning and stabilizing structure is not in use, thereby enabling the patient to be prompted to clean the tube 3350 if dust or other particulate matter is observed within the tube 3350.

Transparent or translucent region 3660 may be formed during manufacture of sleeve 3650 by knitting or braiding a portion of sleeve 3650 with a low density yarn or combination of yarns, a low density knit or braid pattern, or yarns formed from specific fiber types (e.g., synthetic monofilament or multifilament yarns formed from fibers having a flattened cross-section). One suitable type of yarn is described in U.S. patent publication No. 20040168479, the entire contents of which are incorporated herein by reference.

Although only a single transparent or translucent region 3660 is shown in fig. 11, it should be understood that a plurality of such regions may be formed along the length of the fabric sleeve 3650. In some examples, the entirety of the non-patient contacting side 3676 of the fabric sleeve 3650 can be made transparent or translucent.

In some forms of the present technology, the one or more functional zones may be enhanced comfort zones that enhance patient comfort. For example, a majority of the textile sleeve 3650 (e.g., those portions of the sleeve 3650 that normally contact the patient in use) or the entirety of the patient contacting side 3674 may be formed as an enhanced comfort zone. To this end, the enhanced comfort zone may include one or more textured yarns that provide a soft feel, thermal comfort, and breathability. For example, the textured yarn may be a flat lay structure comprising a plurality of fibers having different cross-sections.

In some forms, at least one friction-enhancing region of the one or more functional regions may include diagonal lines for localized grasping at the at least one friction-enhancing region.

In some forms, one or more regions may be formed with a weave pattern that achieves a particular aesthetic effect, such as a weave belt with complete but offset blind stitches, or a V-shaped weave velour belt for a smooth appearance.

In some forms, the fabric sleeve 3650 may be formed as a low friction structure to facilitate mounting on the gas delivery tube 3350. For example, the yarn density and fiber cross-section may be selected to provide a low friction surface of sleeve 3650.

In some forms, the fabric sleeve 3650 may be provided to the patient as a separate component (e.g., as part of a kit, or as an alternative component) for the patient to fit to the gas delivery tube 3350. Textile sleeve 3650 may be provided with indicia to communicate to the patient the proper orientation to fit sleeve 3650 onto tube 3350. Such indicia may take the form of text or graphics, and/or colors and/or patterns that indicate that one side is patient-contacting side 3674 and the other side is non-patient-contacting side 3676.

In some examples, at least a portion of textile sleeve 3650 is coated or impregnated with at least one material that imparts functional and/or aesthetic properties. For example, textile sleeve 3650 may be coated or impregnated (e.g., by printing, or by impregnating fibers of yarn prior to knitting or braiding textile sleeve 3650) with a "glow-in-the-dark" material (e.g., a phosphorescent or luminescent material). In some examples, textile sleeve 3650 may be coated or impregnated with an antimicrobial composition to reduce or eliminate unpleasant odors or discoloration due to sweat or other contaminants being absorbed during use.

In one form of the technique, sleeve 3650 is configured to allow strap engaging portion 3320 to extend through opening 3668. The opening 3668 may expose the entirety of the strap engaging portion 3320, as shown in fig. 3, 6, 7, 8, and 11, or may expose only the aperture 3322 of the strap engaging portion 3320.

In some forms, for example if a single sleeve 3650 is arranged to extend over two gas delivery tubes 3350, sleeve 3650 may include more than one such opening. In this case, the sleeve 3650 may further include a connection port opening 3680, the connection port opening 3680 configured to allow the air circuit 4170 or the elbow 3600 to be connected to the connection port 3360, as shown in fig. 9.

Referring now specifically to fig. 8, in an example, the length L of the opening 3668 is greater than the length B of the base of the strap engagement portion 3320, measured parallel to the longitudinal or central axis of the gas delivery tube 3350. In an example, the width of the opening 3668 is greater than the width of the base of the strap engagement portion 3320, measured perpendicular to the longitudinal or central axis of the gas delivery tube 3350. In an example, the gap CB between the base of the strap engaging portion 3320 and the edge 3669 of the opening 3668 is at least sufficient to allow the patient to grasp the fabric material surrounding the opening 3668 (e.g., in a pinching action between a finger and thumb) and pull at least the material at the edge 3669 of the opening 3668 away from the gas delivery tube 3350. Allowing the patient to view a portion of tube 3350 that would otherwise be covered by sleeve 3650. This may allow the patient to visually confirm the cleanliness of the gas delivery tube 3350 without having to remove the fabric sleeve from the tube.

The opening 3668 may also have sufficient clearance CB from the base of the strap engaging portion 3320 to ensure that the gas delivery tube 3350 can move (e.g., stretch) within the sleeve 3650 (e.g., when the variable length portion is extended) without being constrained by the strap engaging portion 3320 adjacent the edge 3669 of the opening 3668.

In one form of the technique, such gaps CB are disposed at both ends of the opening 3668.

In one example, the opening 3668 is generally rectangular. In one example, the generally rectangular opening 3668 has arcuate corners. In other examples, opening 3668 is generally stadium-shaped, i.e., it has pairs of parallel sides joined at either end by arcs or semicircles.

In one form of the technique, the width of the opening 3668 is less than 50% of the circumference of the gas delivery tube 3350 when two measurements are taken at the same longitudinal location (e.g., the same location on the centerline CL). This ensures that the material at the edges of the openings 3668 remain in contact with the gas delivery tube 3350. The wider opening may cause the material at the edge 3669 of the opening 3668 to peel away from the gas delivery tube 3350.

In one example, the opening 3668 is configured to extend a distance D of approximately 7-8mm from an edge 3351 of the gas delivery tube 3350 from which the strap engaging portion 3320 extends as shown in fig. 8. When a locating and stabilizing structure is used, the edge 3351 may be the bottom edge of the tube 3350. In an example, the opening is substantially entirely on the non-patient contacting side of the fabric sleeve 3650 to avoid or prevent contact between the patient's skin and the surface of the gas delivery tube 3350.

In one example, the opening 3668 may have a length L of approximately 65mm. The axial gap distance CB may be approximately 5mm. The width of the opening may be selected such that the opening fits closely around the side of the base of the belt engaging portion, e.g. the gap distance D is less than 5mm, e.g. less than 2mm, e.g. close to zero. This narrower gap D may result in a more complete appearance and may help ensure that sleeve 3650 does not become wrinkled, wrinkled or crimped over time.

In other examples, the length L and the distance CB may be different from those provided above. For example, these values may be varied to accommodate belt engaging portions of different lengths and/or widths, or to provide increased or decreased clearance. In an example, the length L may be less than 65mm.

In one form of the technique, the sleeve 3650 extends substantially the entire length of the positioning and stabilizing structure, such as over two gas delivery tubes 3350 (as shown in fig. 5-7). In an example, the positioning and stabilizing structure includes two strap engaging portions 3320 and the sleeve 3650 includes two of the openings 3668 described above. In examples where the sleeve 3650 extends substantially the entire length of the positioning and stabilizing structure, the sleeve 3650 may also be provided with a connection port opening 3680, the connection port opening 3680 being configured to allow, in use, the air circuit 4170 or elbow 3600 to be connected to the fluid connection opening 3360 of the gas delivery tube 3350. The connection port opening 3680 may be a generally circular opening and may be sized to provide clearance around the fluid connection opening 3360, allowing the air circuit or elbow to be connected to the fluid connection opening 3360 without interfering with the sleeve 3650.

In an example, the end of the sleeve 3650 and/or the material surrounding the edges of each opening 3668, 3680 can be provided with a seam tape to reduce or eliminate wear of the material.

In some examples, the opening 3668 may be formed as part of a single knit and/or woven structure of the sleeve 3650 in a single manufacturing process such that no post-treatment is required for creating the opening 3668.

As shown in fig. 11, in some forms, the opening 3668 may include edge reinforcement structures 3902 to reduce or eliminate wear of the fabric sleeve 3650 in the area of the opening 3668 and the connection port opening 3680. Edge reinforcing structure 3902 may be formed by ultrasonic welding, laser cutting, applying a reinforcing seam tape, stitching, thermal bonding, or depositing additional materials such as thermoplastic materials.

In one example, the seam tape is attached to the outer surface of fabric sleeve 3650 by a suitable technique such as gluing. Openings 3668 can then be formed in both the seam tape and the fabric sleeve 3650.

Similar techniques may be used to apply the seam tape around the connection port opening 3680. In an example, a seam tape is applied to the inner surface of fabric sleeve 3650. However, in an alternative embodiment, a seam tape is applied to the outer surface of sleeve 3650.

4.3.3.2 fixing the textile sleeve relative to the gas delivery tube

As shown in fig. 11, in some examples, fabric sleeve 3650 may further include edge reinforcing structures 3800 at a first end proximate to plenum chamber 3200 and edge reinforcing structures 3900 at a second end opposite the first end remote from plenum chamber 3200. Edge reinforcing structures 3800 and/or edge reinforcing structures 3900 can be formed by ultrasonic welding, laser cutting, applying a reinforcing seam tape, stitching, thermal bonding, or depositing additional materials such as thermoplastic materials.

In an example, the fabric sleeve 3650 can also be secured to the gas delivery tube 3350 proximate to the connection port 3600, i.e., at the fluid connection opening 3360 or proximate to the fluid connection opening 3360. In such examples, the edge reinforcing structure 3800 may be an end cap, such as the end caps shown in fig. 14A-14G.

In some forms of the present technique, the fabric sleeve 3650 may be fixed relative to the gas delivery tube 3350 in a position near the end 3358.

Securing the sleeve in this manner may help provide stability to the relationship between the fabric sleeve 3650 and the gas delivery tube 3350, particularly during dynamic movements in which the patient may force the fabric sleeve 3650 unidirectional and the seal-forming structure 3100 or plenum chamber 3200 unidirectional. In such a case, it is desirable that the fabric sleeve 3650 remain in place and not disengage from the connection between the gas delivery tube 3350 and the plenum chamber 3200 (e.g., by rolling or rolling). While the relative sizes of the fabric sleeve 3650 and the gas delivery tube 3350 may be used to provide a tight fit to resist such movement, the introduction of a lubricant (e.g., a detergent) may disrupt such movement and, for at least this reason, it is desirable to provide a more secure connection.

In accordance with one aspect of the present technique, an end cap 3800 is provided at an end 3358 of the gas delivery tube 3350 that connects the fabric sleeve 3650 to the gas delivery tube 3350. One such example is shown in fig. 5.

Fig. 14A-14G illustrate an exemplary end cap 3800. The end cap 3800 includes an annular sidewall 3802. As used herein, the term "annular" is understood to mean generally annular, as opposed to having to follow strictly a circular form, i.e., the sidewall 3802 may be in the shape of an irregular ring. The end flange 3804 extends radially inward from the sidewall 3802, defining an end cap opening 3806 through which, in use, a plenum connector 3204 may be received.

In an example, the sidewall 3802 has an end 3808 distal from the end flange 3804, and an inner surface 3810 between the end 3808 and the end flange 3804. The sidewall 3802 may have at least one annular adhesive recess 3812 disposed in the inner surface 3810. The adhesive recess 3812 may be used to aid in dispensing adhesive around the end cap 3800 and to control the dispersion of the adhesive prior to application to the fabric sleeve 3650 and the gas delivery tube 3350. In the example of fig. 14A-14G, the adhesive recess 3812 is offset from both the end 3808 and the end flange 3804 of the sidewall 3802. In an alternative example, adhesive recess 3812 may extend to end 3808 of sidewall 3802. In another alternative example, the adhesive recess 3812 may extend to the end flange 3804.

In an example, the sidewall 3802 may have at least one axial recess 3814 extending from the end 3808 of the sidewall 3802 toward the end flange 3804. Axial recess 3814 may be configured to receive seam 3678 of fabric sleeve 3650. In the example of fig. 14A-14G, the end cap 3814 includes opposing axial recesses 3814 to receive two seams 3678 of the fabric sleeve 3650 shown in fig. 5.

In an example, end cap 3800 can be secured to fabric sleeve 3650 and gas delivery tube 3350 using an adhesive (e.g., silicone). As shown in fig. 15, a fabric sleeve 3650 may be disposed around the gas delivery tube 3350 near an end 3358 of the gas delivery tube 3350. An adhesive is applied to the adhesive recess 3812 and the end cap 3800 is fitted to the end 3358 of the gas delivery tube 3350. When assembled, the example end cap 3800 extends from the outer surface of the fabric sleeve 3650, over the end of the fabric sleeve 3650, and over a portion of the edge 3359 of the gas delivery tube 3350 (i.e., the end face of the gas delivery tube 3350). The overlapping portion of the end flange 3804 may help control the spread of the adhesive. The overlapping portion of the end flange 3804 may act as a stop to aid in alignment during assembly of the end cap 3800.

As shown, for example, in fig. 16A and 16B, the end cap 3800 can have at least one visual indicator 3816 for indicating, for example, a desired alignment of the gas delivery tube 3350 relative to the plenum connector 3204, or a size of the positioning and stabilizing structure 3300. In the example shown, visual indicators 3816 are formed in side walls 3802 of end cap 3800. The sidewall 3802 may have an extended tab 3818 to receive the visual indicator 3816.

In another example of this technique, an end cap without end flange 3804 is provided, as shown in fig. 20. In this example, textile sleeve 3650 extends only to adhesive recess 3812, but does not extend beyond adhesive recess 3812 in the direction of edge 3359 (i.e., the end of tube 3350).

The inner surface 3810 has a first inner surface portion 3810A and a second inner surface portion 3810B, the first inner surface portion 3810A extending between the adhesive recess 3812 and the end of the tube 3350 and the second inner surface portion 3810B extending between the end 3808 and the adhesive recess.

The first inner surface portion 3810A is sized to fit snugly onto the tube 3350, while the second inner surface portion 3810B is sized to receive the sleeve 3650 and is therefore wider.

The engagement of the inner surface portion 3810A with the tube 3350 ensures that adhesive does not leak out of the end cap 3800 during manufacture.

In this example, an adhesive provided to adhesive recess 3812 adheres sleeve 3650 to tube 3350 and end cap 3800 to tube 3350 and sleeve 3650.

In accordance with another aspect of the present technique, the fabric sleeve 3650 is fixed relative to the gas delivery tube 3350 by a localized high friction interface. At the localized high friction interface, the relative movement between the fabric sleeve 3650 and the gas delivery tube 3350 is limited by the high degree of friction therebetween. It is contemplated that this may be accomplished by providing localized areas of different material properties on textile sleeve 3650, although in alternative examples, the localized areas may be provided on gas delivery tube 3350. In the example of fig. 17A, a localized high friction interface is provided by a discrete polymer layer 3850 between a textile sleeve 3650 and a gas delivery tube 3350. In an example, the discrete polymer layer 3850 may be provided by a Thermoplastic Polyurethane (TPU) adhesive tape or silicone tape. In an example, a silicone gel strip may be applied to the inner and outer surfaces of textile sleeve 3650.

In an alternative embodiment, the discrete polymeric layer 3850 may be provided by applying (e.g., by screen printing) an uncured silicone layer to the textile sleeve 3650, and curing the silicone to obtain the desired properties. In the example shown in fig. 17B, a silicone layer 3852 may be printed on the inner and outer surfaces of textile sleeve 3650.

In accordance with another aspect of the present technique, as shown in fig. 18, a textile sleeve 3650 may be secured relative to a gas delivery tube 3350 by a double sided adhesive tape 3854 between the textile sleeve 3650 and the gas delivery tube 3350. In one example, double-sided tape 3854 can be coated with a silicone adhesive on a first side facing gas delivery tube 3350 and a non-silicone adhesive (e.g., an acrylic adhesive) on a second side facing textile sleeve 3650. One example of a suitable double-sided tape may be "double-sided coated tape for silicone rubber bonding No. 5303W" provided by Nitto Denko company. Another example of a suitable double-sided adhesive tape may be one described by VVB-Birzer"adt-x" strips provided by GmbH. It is contemplated that double-sided tape 3854 may be applied to gas delivery tube 3350 before textile sleeve 3650 is pulled or rolled into place.

In accordance with another aspect of the present technique, as shown in fig. 19, the fabric sleeve 3650 can be secured relative to the gas delivery tube 3350 by an overmolded end 3860. The overmolded end 3860 includes an annular sidewall 3862 extending along an outer surface of the fabric sleeve 3650, and an end flange 3864 extending radially inward from the sidewall 3862 over the end of the fabric sleeve 3650 and over a portion of the edge 3359 of the gas delivery tube 3350. In an alternative example, the overmolded end 3860 extends over the edge 3359 and into the interior of the gas delivery tube 3350. In an example, the overmolded end 3860 may be made of high durability silicone.

In another form of the technique, as shown in fig. 21, a fabric sleeve 3650 may be extended to the end of the tube 3350 and may be connected to the end of the tube 3350 by an adhesive layer 3813. A layer of seam tape 3920 may be provided on the end of the tube 3350 on the fabric sleeve 3650. Seam tape 3920 may be secured to fabric sleeve 3650 by a second layer of adhesive 3813.

In an example, the ends of fabric sleeve 3650 may be provided with notches (not shown). The notches may make it easier to roll the ends of sleeve 3650 back before depositing the adhesive layer on tube 3350. However, in alternative examples, the notch may not be necessary.

4.3.4 vent

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

In some forms, the vent 3400 is configured to allow continuous venting flow from the interior of the plenum chamber 3200 to the ambient environment while the pressure within the plenum chamber is positive relative to the ambient environment. The vent 3400 is configured such that the vent flow has sufficient CO to reduce patient-to-exhale ₂ While maintaining the therapeutic pressure in the inflatable chamber in use.

One form of vent 3400 in accordance with the present technology 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. Alternatively, the vent 3400 is located in a decoupling structure, such as a swivel.

4.3.5 decoupling structures

In one form, patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

4.3.6 connection port

Connection port 3600 allows connection to air circuit 4170.

4.3.7 forehead support

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

4.3.8 anti-asphyxia valve

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

4.3.9 Port

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.

4.4RPT 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, such as any of all or part of the methods described herein. RPT device 4000 may be configured to generate an air flow for delivery to an airway of a patient, for example, for treating one or more respiratory conditions 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 6cmH2O, or at least 10cmH2O, or at least 20cmH 2O.

4.5 air Circuit

The air circuit 4170 according to one aspect of the present technique is a tube or pipe that is constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000, when in use.

Specifically, the air circuit 4170 may be fluidly connected with an outlet of the pneumatic block and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate branches for the inspiration and expiration circuits. 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 around the axis of the air loop 4170. The heating element may be in communication with a controller such as the central controller 4230. 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.

4.6 humidifier

4.6.1 overview of humidifier

In one form of the present technique, a humidifier 5000 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 and to increase the temperature of the air stream (relative to ambient air) prior to delivery to the airway of the patient.

Humidifier 5000 may include a humidifier reservoir, a humidifier inlet for receiving an air stream, and a humidifier outlet for delivering a humidified air stream.

4.7 respiratory treatment modes

Various respiratory therapy modes may be implemented by the disclosed respiratory therapy system, including CPAP and bi-layer therapy.

4.8 glossary of terms

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

4.8.1 overview

Air: in certain 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 atmospheric air enriched with oxygen.

Environment: in certain forms of the present technology, the term environment may have the meaning of (i) external to 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 is sleeping. 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 directly around 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, in addition to noise generated by, for example, the RPT device or transmitted from the mask or patient interface. Ambient noise may be generated by sound sources outside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy, in which the treatment pressure is automatically adjustable between a minimum and maximum level, for example, varies with each breath, depending on whether an indication of an SDB event is present.

Continuous Positive Airway Pressure (CPAP) treatment: wherein the treatment pressure may be an approximately constant respiratory pressure treatment throughout the respiratory cycle of the patient. In some forms, the pressure at the entrance to the airway will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

Flow rate: air volume (or mass) delivered per unit time. The flow rate may refer to an instantaneous amount. In some cases, the reference to the flow will be a reference to a scalar, i.e., an amount having only a magnitude. In other cases, the reference to flow rate will be a reference to a vector, i.e., a quantity having both magnitude and direction. The flow rate may be given the symbol Q. Sometimes the "flow rate" is shortened to a simple "flow" or "air stream".

In the 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 air flow 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 air flow leaving the ventilation port to allow flushing of the exhaled air. Leakage flow rate Ql is leakage flow rate 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: flow therapy: respiratory therapy involves delivering a flow of air to the entrance of the airway at a controlled flow rate, known as the therapeutic flow rate, which is typically positive throughout the patient's respiratory cycle.

A humidifier: the term humidifier is considered to refer to a humidification device constructed and arranged or configured to have a water H capable of providing a therapeutically beneficial amount of water to an air stream ₂ O) steam to improve the physical structure of the medical respiratory condition of the patient.

Leakage: the word leakage will be considered an undesired 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 to the surrounding environment.

Conductive noise (acoustic): conductive noise refers to noise that is carried 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): radiation noise refers to noise carried to the patient by the surrounding air. In one form, the radiated noise may be quantified by measuring the acoustic power/pressure level of the object in question according to ISO 3744.

Ventilation noise (acoustic): ventilation noise refers to noise generated by air flow through any vent, such as a vent of a patient interface.

Patient: a person, whether or not they have a respiratory disorder.

Pressure: force per unit area. The pressure can be expressed as a unit range including cmH2O, g-f/cm ² And hundred pascals. 1cmH ₂ O is equal to 1g-f/cm ² And about 0.98 hPa (1 hPa=100 Pa=100N/m2=1 mbar to 0.001 atm). In the present specification, unless otherwise indicated, the pressure is in cm H ₂ O is given in units.

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 (RPT): the air supply is applied to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

Breathing machine: mechanical means for providing pressure support to the patient to perform some or all of the respiratory effort.

4.8.1.1 material

Silicone or silicone elastomer: a synthetic rubber. In the present specification, reference to silicone refers 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 LSRs have a shore a (or type a) dent hardness in the range of about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.

4.8.1.2 mechanical Properties

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

Elasticity: substantially all of the energy will be released upon unloading. Including, for example, certain silicones and thermoplastic elastomers.

Hardness: the ability of the material itself to resist deformation (e.g., described by Young's modulus or indentation hardness scale measured on a standardized sample size).

The 'soft' material may comprise silicone rubber or thermoplastic elastomer (TPE) and may be easily deformed, for example, under finger pressure.

The 'hard' material may comprise polycarbonate, polypropylene, steel or aluminium and may be less deformable, for example under finger pressure.

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 inverse of stiffness is the compliance.

Floppy disk structure or component: when allowed to support its own weight for a relatively short period of time, for example, within 1 second, the structure or component will change shape (e.g., bend).

Rigid structures or components: structures or components that do not substantially change shape when subjected to loads typically encountered in use. Examples of such use may be, for example, at about 20 to 30cmH ₂ The patient interface is disposed and maintained in sealing relationship with the entrance to the patient airway under load of the pressure of O.

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.

4.8.2 respiratory cycle

Apnea: according to some definitions, an apnea is considered to occur when the flow drops below a predetermined threshold for a period of time (e.g., 10 seconds). Obstructive apneas are considered to occur when some obstruction of the airway does not allow air flow, even if the patient is struggling. Central apneas are considered to occur when an apnea is detected due to a reduction in respiratory effort or the absence of respiratory effort, despite the airway being open. Mixed apneas are considered to occur when a reduction in respiratory effort or the absence of an airway obstruction occurs simultaneously.

Respiration rate: the rate of spontaneous breathing of a patient, which is typically measured in breaths per minute.

Duty cycle: ratio of inspiration time Ti to total breath time Ttot.

Effort (respiration): spontaneous respirators attempt to breathe the work done.

The expiratory portion of the respiratory cycle: a time period from the start of the expiratory flow to the start of the inspiratory flow.

Flow restriction: flow restriction will be considered a condition in the patient's breath in which an increase in the patient's effort does not result in a corresponding increase in flow. In the case where flow restriction occurs during the inspiratory portion of the respiratory cycle, it may be described as inspiratory flow restriction. In the event that flow restriction occurs during the expiratory portion of the respiratory cycle, it may be described as an expiratory flow restriction.

Type of flow-limited inspiratory waveform:

(i) Flattening: with an ascending, followed by a relatively flat portion, followed by a descending.

(ii) M shape: (ii) form M: there are two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

(iii) Chair shape: (iii) chair shape: with a single local peak at the leading edge followed by a relatively flat portion.

(iv) Reverse-seat shape: (iv) reverse chair shape: with a relatively flat portion followed by a single local peak, the peak being located at the trailing edge.

Hypopnea: by some definitions, hypopnea will be considered a decrease in flow, rather than a cessation of flow. In one form, a hypopnea may be considered to occur when flow falls below a threshold rate for a period of time. Central hypopneas are considered to occur when hypopneas are detected due to a reduction in respiratory effort. In one form of adult, any of the following may be considered to be hypopneas:

(i) Patient respiration decreases by 30% for at least 10 seconds plus the associated 4% desaturation; or alternatively

(ii) The patient's respiration decreases (but less than 50%) for at least 10 seconds with associated at least 3% desaturation or arousal.

Hyperrespiration: the flow increases to a level above normal.

Inhalation portion of the respiratory cycle: the period from the beginning of the inspiration flow to the beginning of the expiration flow is considered the inspiration portion of the respiratory cycle.

Patency (airway): the degree to which the airway is open or the degree to which the airway is open. The open airway is open. Airway patency may be quantified, for example, with a value of (1) being open and a value of zero (0) being closed (occluded).

Positive End Expiratory Pressure (PEEP): the pressure present in the lungs at the end of expiration is higher than atmospheric pressure.

Peak flow (Qpeak): maximum value of flow during the inspiratory portion of the respiratory flow waveform.

Respiratory flow, patient air flow, respiratory air flow (Qr): these terms may be understood to refer to an estimate of respiratory flow by the RPT device, as opposed to "true respiratory flow" or "true respiratory flow," which is the actual respiratory flow experienced by a patient, typically expressed in liters per minute.

Tidal volume (Vt): when no additional effort is applied, the volume of air inhaled or exhaled during normal breathing. In principle, the inspiratory volume Vi (volume of inhaled air) is equal to the expiratory volume Ve (volume of exhaled air), so a single tidal volume Vt can be defined as being equal to either volume. In practice, the tidal volume Vt is estimated as some combination, e.g., average, of the inhalation and exhalation amounts Vi, ve.

(inhalation) time (Ti): the duration of the inspiratory portion of the respiratory flow waveform.

(expiration) time (Te): the duration of the expiratory portion of the respiratory flow waveform.

(total) time (Ttot): the total duration between the beginning of the inspiratory portion of one respiratory flow waveform and the beginning of the inspiratory portion of a subsequent respiratory flow waveform.

Typical recent ventilation: the recent value of ventilation Vent is a measure of the central tendency of recent values of ventilation around its tendency to cluster over some predetermined timescales.

Upper Airway Obstruction (UAO): including partial and total upper airway obstruction. This may be associated with a state of flow restriction where the flow increases only slightly, or even decreases (Starling impedance behavior) as the pressure differential across the upper airway increases.

Aeration (Vent): a measure of the flow of gas exchanged by the respiratory system of the patient. The measure of ventilation may include one or both of inspiratory and expiratory flow (per unit time). When expressed as a volume per minute, this amount is commonly referred to as "ventilation per minute". Ventilation per minute is sometimes given simply as volume and is understood to be volume per minute.

4.8.3 aeration

Adaptive Servo Ventilator (ASV): a servo ventilator having a variable, rather than fixed, target ventilation. The variable target ventilation may be known from some characteristic of the patient, such as the respiratory characteristics of the patient.

Standby rate: the parameters of the ventilator that determine the minimum respiratory rate (typically in breaths per minute) that the ventilator will deliver to the patient, if not triggered by spontaneous respiratory effort.

And (3) circulation: the ventilator inhalation phase is terminated. When a ventilator delivers breath to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is considered to circulate to stop delivering breath.

Positive expiratory airway pressure (EPAP): the pressure that varies within the breath is added to it to create a base pressure of the desired interface pressure that the ventilator will attempt to achieve at a given time.

End-tidal pressure (EEP): the ventilator attempts to achieve the desired interface pressure at the end of the expiratory portion. If the pressure waveform template pi (Φ) is zero at the end of expiration, i.e., pi (Φ) =0, when Φ=1, then EEP is equal to EPAP.

Inspiratory Positive Airway Pressure (IPAP): the ventilator attempts to reach the maximum expected interface pressure during the inspiratory portion of the breath.

Pressure support: a number indicating that the pressure during inspiration of the ventilator increases over the pressure during expiration of the ventilator, and generally means the pressure difference between the maximum value during inspiration and the base pressure (e.g., ps=ipap-EPAP). In some cases, pressure support means the difference that the ventilator is intended to achieve, not the actual one.

Servo ventilator: a ventilator that measures ventilation of a patient, having a target ventilation and adjusts a level of pressure support to bring the ventilation of the patient to the target ventilation.

Spontaneous/timed (S/T): a mode of a ventilator or other device that attempts to detect the onset of breathing of a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device will automatically initiate delivery of the breath.

Swinging: equivalent to the term pressure support.

Triggering: when a ventilator delivers breathing air to a spontaneously breathing patient, effort by the patient is considered to be triggered at the beginning of the breathing portion of the breathing cycle.

4.8.4 anatomical structure

4.8.4.1 facial anatomy

ALA: the outer wall or "wing" of each naris (plural: winged)

Nose wing end: the outermost points on the nose wings.

Nose wing bending (or nose wing top) point: the rearmost point in the curved baseline of each alar is found in the folds formed by the combination of the alar and cheek.

Auricle: the entire outer visible portion of the ear.

(nasal) skeleton: the nasal bone frame comprises nasal bone, frontal process of upper jaw bone and nose of frontal bone.

(nasal) cartilage scaffold: the nasal cartilage frame includes septum, lateral side, large and small cartilage.

Nose post: skin strips separating the nostrils and extending from the nasal projection to the upper lip.

Nose columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort (Frankfort) plane (with both lines intersecting at the subnasal septum point).

Frankfurt level: 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 intereyebrows are located on the soft tissue, the most prominent point in the mid-sagittal plane of the forehead.

The nasal lateral cartilage is a generally triangular cartilage plate. 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.

Lip, lower (lower lip midpoint):

lip, upper (upper lip midpoint):

the large cartilage of the nasal wing is positioned 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 (Nostrils): forming an approximately oval aperture of the nasal cavity entrance. The singular form of a nostril (nare) is a nostril (nares) (nose-eye). The nostrils are separated by the nasal septum.

Nasolabial folds or folds: the nose extends from each side of the nose to the skin folds or furrows at the corners of the mouth, which separates the cheeks from the upper lip.

Nose lip angle: the angle between the post and the upper lip, while intersecting the subnasal space.

Sub-aural base point: the pinna is attached to the lowest point of the facial skin.

The base pinna on the ear is attached to the highest point of 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 extending from the lower boundary of the nasal septum to the top of the lip in the upper lip region.

Anterior chin point: is located at the anterior most midpoint of the chin above the soft tissue.

Ridge (nose): the nasal ridge is a midline projection of the nose that extends from the nasal bridge point to the nasal projection point.

Sagittal plane: a vertical plane from front (front) to back (rear). The mid-sagittal plane is the sagittal plane that divides the body into right and left halves.

Nose bridge point: is positioned on the soft tissue and covers the most concave point of the frontal nasal suture area.

Septal cartilage (nose): the septum cartilage forms a portion of the septum and separates the anterior portion of the nasal cavity.

Rear upper side sheet: at 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 nose pillar meets the upper lip in the median sagittal plane is located on the soft tissue.

Chin upper point: the point of maximum concavity in the midline of the lower lip between the midpoint of the lower lip and the anterior genitalia of the soft tissue

4.8.4.2 skull dissection

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

The lower jaw: the mandible forms the mandible. The geniog is the bone bulge of the mandible forming the chin.

Maxilla: the maxilla forms the upper jaw and is located above the lower jaw and below the orbit. The maxillary frontal process protrudes upward from the 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; they are located side by side in the middle and upper part of the face and form a nasal "beam" by their junction.

Root of nose: the intersection of the frontal bone and the two nasal bones is located directly between the eyes and in the concave region above the bridge of the nose.

Occipital bone: occiput is located at the back and lower part of the skull. It comprises oval holes (occipital macropores) through which the cranial cavities communicate with the vertebral canal. The curved plate behind the occipital macropores is occipital scale.

Orbit of eye: a bone cavity in the skull of the eye is received.

Parietal bone: the parietal bone is the bone that when joined together forms the top cap and both sides of the skull.

Temporal bone: the temporal bones are located at the bottom and sides of the skull and support the portion of the face called the temple.

Cheekbones: the face includes two cheekbones that are located on the upper and lateral portions of the face and form the protrusions of the cheeks.

4.8.4.3 anatomy of the respiratory system

A 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.

Throat: the larynx or larynx receives the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

Lung: the respiratory organs of humans. 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: the nasal cavity (or nasal fossa) is a larger 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 the nasal septum. There are three horizontal branches on the sides of the nasal cavity, called nasal concha (singular "nasal concha") or turbinates. The front of the nasal cavity is the nose, while the back is incorporated into the nasopharynx via the inner nostril.

Pharynx: located immediately below the nasal cavity and a portion of the throat above the esophagus and larynx. The pharynx is conventionally divided into three sections: nasopharynx (upper pharynx) (nose of pharynx), oropharynx (middle pharynx) (mouth of pharynx), laryngopharynx (lower pharynx).

4.8.5 patient interface

Anti-asphyxia valve (AAV): by opening to the atmosphere in a fail-safe manner, patient excess CO is reduced ₂ Components or sub-components of the mask system that are at risk of rebreathing.

Bending pipe: an elbow is an example of a structure that directs the axis of an air stream 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 than 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 rotatable 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 single snap during manufacture, but not removable by the patient.

A frame: a 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.

A headband: the headband will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a set of one or more support rods, straps, and reinforcements configured to position and maintain the patient interface in a position on the patient's face for delivering respiratory therapy. Some laces are formed from a laminate composite of a soft, flexible, resilient material, such as foam and fabric.

Film: a film will be considered to mean a typically thin element that is preferably substantially free of bending resistance, but stretch resistant.

A 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.

And (3) sealing: may refer to the noun form of the structure (seal) or the 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.

A shell: the housing will be considered to mean a curved and relatively thin structure having a bendable, stretchable and compressible stiffness. For example the curved structural wall of the mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

Reinforcement: a reinforcement will be considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

And (3) supporting: the support will be considered as a structural component designed to increase the resistance to compression of another component in at least one direction.

Swivel (noun): the sub-components of the component configured to rotate about the common axis are preferably independent, 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 sub-components of the component preferably comprise pairs of matching cylindrical conduits. There may be little or no air flow leaking from the swivel during use.

Lacing (noun): a structure designed to resist tension.

Vent (noun): allowing air flow from the mask interior or conduit to ambient air, such as for efficient flushing of 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.

4.8.6 structural shape

Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a propeller. The three-dimensional structures may be bonded by two-dimensional surfaces. These surfaces may be distinguished using indicia to describe the relative surface orientation, position, function, or some other feature. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contacting (e.g., exterior) surface and a separate non-face-contacting (e.g., underside or interior) surface. In another example, a structure may include a first surface and a second surface.

To assist in describing the three-dimensional structure and shape of the surface, consider first a cross-section through a point p of the structure surface, see fig. 3B-3F, which show an example of a cross-section at the point p on the surface and the resulting planar curve. On the surface, the resulting plane is curved. Fig. 3B to 3F also show the outward normal vector at p. An outward normal vector at a point p away from the surface. In some examples, a surface from an imagined small person's point of view standing on the surface is described.

4.8.6.1 one-dimensional curvature

The curvature of a planar curve at p may be described as having a sign (e.g., positive, negative) and a number (e.g., the inverse of the radius of a circle contacting only the curve at p).

Positive curvature: if the curve at p turns towards the outward normal, the curvature at that point will be positive (if the imagined small person leaves the point p, they have to walk up a slope). See fig. 3B (relatively large positive curvature compared to fig. 3C) and fig. 3C (relatively small positive curvature compared to fig. 3B). Such curves are often referred to as concave.

Zero curvature: if the curve at p is a straight line, the curvature will be taken to be zero (if an imagined small person leaves the point p, they can walk horizontally without going up or down). See fig. 3D.

Negative curvature: if the curve at p turns away from the outward normal, the curvature in that direction at that point will be negative (if an imagined small person leaves the point p, they must walk down a slope). See fig. 3E (relatively small negative curvature compared to fig. 3F) and fig. 3F (relatively large negative curvature compared to fig. 3E). Such curves are commonly referred to as convexities.

Curvature of 4.8.6.2 two-dimensional surface

The description of the shape at a given point on a two-dimensional surface according to the present technique may include a plurality of normal cross-sections. The plurality of cross-sections may cut the surface in a plane comprising an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at this point may have the same sign or different signs. Each curvature at this point has, for example, a relatively small amplitude. The planar curves in fig. 3B through 3F may be examples of such multiple cross-sections at specific points.

Principal curvature and principal direction: the direction of the normal plane in which the curvature of the curve takes its maximum and minimum values is called the principal direction. In the examples of fig. 3B to 3F, the maximum curvature occurs in fig. 3B and the minimum curvature occurs in fig. 3F, so fig. 3B and 3F are sections in the main direction. The principal curvature at p is the curvature in the principal direction.

Surface area: a set of connection points on the surface. The set of points in the region may have similar characteristics, such as curvature or sign.

Saddle region: where at each point the principal curvatures have opposite signs, i.e. one sign is positive and the other sign is negative (they can walk up or down depending on the direction in which the imagined individual is turning).

Dome area: where the principal curvature has the same sign at each point, for example two regions of positive ("concave dome") or two negative ("convex dome").

Cylindrical region: where one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

Planar area: a surface area where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

Surface edge: boundary or demarcation of a surface or area.

Path: in some forms of the present technology, 'path' will be considered to mean a path in a mathematical-topological sense, such as a continuous space curve from f (0) to f (1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course, including, for example, a set of points on a surface. (the imaginary path of a person is where they walk on the surface and is similar to a garden path).

Path length: in some forms of the present technology, the 'path length' will be considered as the distance along the surface from f (0) to f (1), i.e. the distance along the path on the surface. There may be more than one path between two points on the surface, and such paths may have different path lengths. (the path length of an imaginary person would be the distance that they must walk along the path on the surface.

Straight line distance: the straight line distance is the distance between two points on the surface, but the surface is not considered. On a planar area, there will be a path on the surface that has the same path length as the straight line distance between two points on the surface. On a non-planar surface, there may not be a path with the same path length as the straight line distance between the two points. (for an imagined person, a straight line distance will correspond to a distance that is "in line"

4.8.6.3 space curve

Space curve: unlike planar curves, the spatial curves do not have to lie in any particular plane. The space curve may be closed, i.e. without end points. The space curve may be considered as a one-dimensional segment of three-dimensional space. An imaginary person walking on one strand of the DNA helix walks along the space curve. A typical human left ear includes a helix, which is a left-handed helix, see fig. 3Q. A typical human right ear includes a spiral, which is a right-hand spiral, see fig. 3R. Fig. 3S shows a right-hand spiral. The edges of the structure, e.g. the edges of the membrane or impeller, may follow a space curve. In general, a spatial curve may be described by curvature and torsion at each point on the spatial curve. Torque is a measure of how a curve rotates out of plane. The torque is signed and sized. The torsion at a point on the spatial curve can be characterized with reference to tangential vectors, normal vectors, and double normal vectors at that point.

Tangent unit vector (or unit tangent vector): for each point on the curve, the vector at that point specifies the direction from that point and the magnitude. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person flies along a curve and falls off his aircraft at a certain point, the direction of the tangential vector is the direction she will travel.

Unit normal vector: this tangent vector itself changes as the hypothetical person moves along the curve. The unit vector pointing in the direction of change of the tangent vector is referred to as a unit principal normal vector. It is perpendicular to the tangential vector.

Double normal unit vector: the double normal unit vector is perpendicular to both the tangent vector and the main normal vector. Its direction may be determined by a right-hand rule (see, e.g., fig. 3P) or alternatively by a left-hand rule (fig. 3O).

Close plane: a plane containing the unit tangent vector and the unit principal normal vector. See fig. 3O and 3P.

Torsion of space curve: the twist at a point of the space curve is the magnitude of the rate of change of the double normal unit vector at the point. It measures how far the curve deviates from the plane of close. The space curve lying in the plane has zero torsion. A space curve that deviates from the plane of close proximity by a relatively small amount will have a relatively small amount of twist (e.g., a gently sloping helical path). A space curve that deviates from the plane of close proximity by a relatively large amount will have a relatively large amount of twist (e.g., a steeply inclined helical path). Referring to fig. 3S, since T2> T1, the amount of twist near the top coil of the spiral of fig. 3 is greater than the amount of twist of the bottom coil of the spiral of fig. 3S.

Referring to the right-hand rule of fig. 3P, a space curve directed toward the right-hand side double normal direction may be considered to have a right-hand positive twist (e.g., the right-hand spiral shown in fig. 3S). The space curve turning away from the right hand double normal direction may be considered to have a right hand negative twist (e.g., left hand spiral).

Likewise, referring to the left hand rule (see fig. 3O), a space curve directed toward the left hand double normal direction may be considered to have a left hand positive twist (e.g., a left hand spiral). The left hand is therefore positive and equivalent to the right hand negative. See fig. 3T.

4.8.6.4 hole

The surface may have one-dimensional holes, for example holes defined by planar curves or by space curves. A thin structure (e.g., a film) with holes can be described as having one-dimensional holes. See, for example, the one-dimensional holes in the planar curve-bordered surface of the structure shown in fig. 3I.

The structure may have two-dimensional apertures, such as apertures defined by surfaces. For example pneumatic tires have a two-dimensional aperture defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel may have a two-dimensional aperture. See, for example, the liner of fig. 3L and the exemplary cross-sections through fig. 3M and 3N, where the inner surface defining the two-dimensional hole is shown. In yet another example, the conduit may include a one-dimensional aperture (e.g., at its inlet or at its outlet) and a two-dimensional aperture defined by an inner surface of the conduit. See also the two-dimensional aperture bounded by the illustrated surfaces in the structure shown in fig. 3K.

4.9 other remarks

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 the records, but otherwise reserves all copyright rights whatsoever.

Unless the context clearly indicates and provides a range of values, it is understood that every intermediate value between the upper and lower limits of the range, to one tenth of the unit of the lower limit, and any other stated or intermediate value within the range, is broadly encompassed within the present technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges, and are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where a range includes one or both of the limits, the present technology also includes ranges excluding either or both of those included limits.

Furthermore, 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 actual technology implementation is permissible or required.

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 provided for the construction of the component. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus 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 plural equivalents thereof 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 "include" and "comprising" are to be interpreted as: to each element, component, or step in a non-exclusive manner, indicating that the referenced element, component, or step 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.

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

4.10 list of reference numerals

Claims (88)

1. A positioning and stabilising structure providing a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to an airway of the patient for use in at least 6cmH above ambient air pressure throughout the respiratory cycle of the patient ₂ The therapeutic pressure of O sealingly delivers an air flow to at least the nostrils of the patient, the positioning and stabilizing structure comprising:

a gas delivery tube receiving a flow of air from a connection port on top of the patient's head and delivering the flow of air via the seal-forming structure to an inlet of the patient's airway, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head above an on-ear base point of the patient's head,

the positioning and stabilizing structure further comprises an elongate textile sleeve disposed about the gas delivery tube and arranged to contact the patient's face in use, the sleeve comprising a wall having an opening therein for allowing the patient to view a portion of the gas delivery tube when the positioning and stabilizing structure is not in use.

2. The positioning and stabilizing structure of claim 1, wherein the fabric sleeve is resiliently flexible in an axial direction.

3. The positioning and stabilizing structure of claim 1 or 2, wherein the fabric sleeve is resiliently flexible in the circumferential direction.

4. A positioning and stabilising structure according to claim 1, 2 or 3, wherein the textile sleeve has greater flexibility in the axial direction than in the circumferential direction.

5. The positioning and stabilising structure according to any one of claims 1 to 4, wherein the opening is generally oval, elliptical or stadium shaped.

6. The positioning and stabilizing structure of any one of claims 1 to 5, wherein the gas delivery tube includes a hexagonal portion and a non-hexagonal portion, wherein the non-hexagonal portion is located on a side of the hexagonal portion opposite the connection port, wherein the fabric sleeve is arranged such that the entire edge of the opening is located on the non-hexagonal portion of the gas delivery tube.

7. The positioning and stabilizing structure of claim 6, wherein the sleeve extends to an end of the non-hexagonal portion of the gas delivery tube opposite the hexagonal portion.

8. The positioning and stabilising structure according to any one of claims 1 to 7, wherein the gas delivery tube includes a strap engaging portion for engaging a strap, and the fabric sleeve is arranged such that the strap engaging portion protrudes through the opening.

9. The positioning and stabilizing structure of claim 8, wherein the strap engaging portion includes a tab.

10. A positioning and stabilising structure according to claim 8 or 9, wherein there is a gap between the edge of the opening and the strap engaging portion.

11. The positioning and stabilizing structure of claim 10, wherein the gap is longitudinal.

12. The positioning and stabilizing structure of claim 11, wherein the gap allows the gas delivery tube to stretch in use without the strap engaging portion contacting the edge of the opening.

13. The positioning and stabilising structure according to any one of claims 1 to 12, wherein the opening is substantially 65mm long.

14. The positioning and stabilizing structure of any one of claims 1-12, wherein the opening is less than 65mm in length.

15. The positioning and stabilizing structure of any one of claims 10 to 14, wherein there is a lateral gap of less than 5mm between the tab and each lateral edge of the opening.

16. The positioning and stabilizing structure of any one of claims 1 to 15, wherein the width of the opening is less than 50% of the circumference of the gas delivery tube when the opening and the tube are measured at the same longitudinal position.

17. The positioning and stabilizing structure of any one of claims 8 to 16, wherein the positioning and stabilizing structure includes a second strap engaging portion and the fabric sleeve includes a second of the openings, wherein the fabric sleeve is arranged such that the second strap engaging portion protrudes through the second opening.

18. The positioning and stabilizing structure of any one of claims 1 to 17, wherein the positioning and stabilizing structure includes a second gas delivery tube, the fabric sleeve extending over both gas delivery tubes.

19. The positioning and stabilizing structure of any one of claims 1 to 18, wherein the fabric sleeve includes a first material on a patient contacting side of the sleeve and a second material on a non-patient contacting side of the sleeve.

20. The positioning and stabilizing structure of claim 19, wherein the first material is connected to the second material by a seam, wherein the seam is configured to allow stretching in the circumferential direction.

21. The positioning and stabilizing structure of any one of claims 19 or 20, wherein the first material comprises a hygroscopic knit material.

22. The positioning and stabilizing structure of any one of claims 19 to 21, wherein the second material includes a smooth surface.

23. The positioning and stabilizing structure of any one of claims 1 to 22, wherein a seam tape is provided at the edge of the opening to reduce or eliminate wear of the fabric.

24. The positioning and stabilising structure according to any one of claims 1 to 23, wherein the textile sleeve includes a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use.

25. The positioning and stabilizing structure of claim 24, wherein the fabric sleeve includes a seam tape disposed on the edge of the connection port opening.

26. The positioning and stabilizing structure of claim 25, wherein the seam tape provided to the edge of the connection port opening is provided on an inner surface of the fabric sleeve.

27. A positioning and stabilizing structure that provides a force that maintains a seal-forming structure at a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to a patient's airway for In use at least 6cmH above ambient air pressure throughout the patient's respiratory cycle ₂ The therapeutic pressure of O sealingly delivers an air flow to at least the nostrils of the patient, the positioning and stabilizing structure comprising:

a gas delivery tube receiving the flow of air from a connection port on top of the patient's head and delivering the flow of air to the inlet of the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head above an on-ear base point of the patient's head,

the positioning and stabilizing structure further comprises an elongate textile sleeve disposed about the gas delivery tube and arranged to contact the patient's face in use, wherein the sleeve comprises a single piece knit and/or woven structure that is resiliently flexible both circumferentially and axially.

28. The positioning and stabilizing structure of claim 27, wherein the textile sleeve includes a main structure and one or more functional areas knitted and/or woven into the main structure, each functional area having one or more textile properties different from the main structure.

29. The positioning and stabilizing structure of claim 28, wherein at least one of the functional zones is a transparent or semi-transparent zone through which at least a portion of the gas delivery tube is visible.

30. The positioning and stabilizing structure of claim 28 or 29, wherein the one or more fabric properties include one or more of: knitting density; weaving density; a plurality of stitches in the knit pattern; knitting or braiding patterns; yarn density; yarn type; a fiber cross section.

31. The positioning and stabilising structure according to any of claims 26-30, wherein at least a portion of the textile sleeve is coated or impregnated with at least one material that imparts functional and/or aesthetic properties.

32. The positioning and stabilizing structure of claim 31, wherein the at least one material is one or more of: phosphorescent materials, luminescent materials or antimicrobial compositions.

33. The positioning and stabilizing structure of any one of claims 26 to 32, wherein the fabric sleeve has greater flexibility in the axial direction than in the circumferential direction.

34. The positioning and stabilizing structure of any one of claims 26 to 33, wherein the gas delivery tube includes a strap engaging portion and the fabric sleeve has a first opening through which at least a portion of the strap engaging portion is accessible to engage a strap.

35. The positioning and stabilizing structure of claim 34, wherein the strap engaging portion includes a tab.

36. The positioning and stabilizing structure of claim 34 or 35, wherein the positioning and stabilizing structure includes a second strap engaging portion, the fabric sleeve including a second opening through which the second strap engaging portion is accessible to engage a strap.

37. The positioning and stabilizing structure of any one of claims 26 to 36, wherein the positioning and stabilizing structure includes a second gas delivery tube and the fabric sleeve extends over both gas delivery tubes.

38. A positioning and stabilising structure according to any one of claims 26 to 37, wherein the textile sleeve includes a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use.

39. The positioning and stabilizing structure of any one of claims 34-38, wherein the first opening is generally oval, elliptical, or stadium-shaped; and/or, if present, the second opening is generally oval, elliptical, or stadium-shaped.

40. The positioning and stabilizing structure of any one of claims 34 to 39, wherein at least one of the first opening, the second opening and the connection port opening includes an edge reinforcing structure to reduce or eliminate wear of the fabric.

41. The locating and stabilizing structure of claim 40, wherein the edge reinforcing structure includes one or more of: a joint adhesive tape; stitching; a thermal bonding section; a thickened region; and an end cap.

42. A textile sleeve for a positioning and stabilising structure for providing a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilising structure comprising a gas delivery tube receiving a flow of air from a connection port on top of the patient's head and delivering the flow of air to an inlet of the patient's airway via the seal-forming structure, the textile sleeve being arranged to fit around the gas delivery tube and in contact with the patient's face in use, the textile sleeve comprising a single piece knitted and/or woven structure, the knitted and/or woven structure being resiliently flexible in both circumferential and axial directions.

43. The textile sleeve of claim 42, comprising a main structure and one or more functional areas knitted and/or woven into said main structure, each said functional area having one or more textile properties different from said main structure.

44. The fabric sleeve of claim 43 wherein at least one of said functional areas is a transparent or translucent area through which at least a portion of said gas delivery tube is visible when said fabric sleeve is assembled to said positioning and stabilizing structure.

45. The fabric sleeve of claim 43 or claim 44 wherein said one or more fabric properties include one or more of the following: knitting density; weaving density; a plurality of stitches in the knit pattern; the knitted or woven pattern; yarn density; yarn type; a fiber cross section.

46. The textile sleeve according to any one of claims 42 to 45, wherein at least a portion of the textile sleeve is coated or impregnated with at least one material that imparts a functional and/or aesthetic property.

47. The fabric sleeve of claim 46 wherein said at least one material is one or more of the following: phosphorescent materials, luminescent materials or antimicrobial compositions.

48. The textile sleeve of any one of claims 42-47, wherein the textile sleeve has greater flexibility in an axial direction than in a circumferential direction.

49. The fabric sleeve of any one of claims 42 to 48 wherein the fabric sleeve has a first opening through which at least a portion of the strap engaging portion of the gas delivery tube is accessible to engage a strap when the fabric sleeve is assembled to the gas delivery tube.

50. The fabric sleeve of claim 49 wherein said strap engaging portion includes a tab.

51. The fabric sleeve of claim 49 or 50 wherein said fabric sleeve includes a second opening through which a second strap engaging portion of said gas delivery tube is accessible to engage a strap when said fabric sleeve is assembled to said gas delivery tube.

52. The fabric sleeve of any one of claims 42 to 51 wherein said fabric sleeve is adapted to extend over said gas delivery tube and a second gas delivery tube of said locating and stabilizing structure.

53. A textile sleeve according to any one of claims 42 to 52, wherein the textile sleeve comprises a connection port opening configured to allow, in use, an air circuit or elbow to be connected to the connection port.

54. The textile sleeve of any one of claims 49-53 wherein the first opening is generally oval, elliptical, or stadium-shaped; and/or, if present, the second opening is generally oval, elliptical, or stadium-shaped.

55. The fabric sleeve of any one of claims 49 to 54 wherein at least one of the first opening, the second opening and the connection port opening includes an edge reinforcement structure to reduce or eliminate wear of the fabric.

56. The fabric sleeve of claim 55 wherein said edge reinforcing structure includes one or more of the following: a joint adhesive tape; stitching; a thermal bonding section; a thickened region; and an end cap.

57. A positioning and stabilizing structure that provides a force that maintains a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to engage the patient's face around the patient's airwayThe region of the mouth forms a seal for use in at least 6cmH above ambient air pressure throughout the patient's respiratory cycle ₂ The therapeutic pressure of O sealingly delivers an air flow to at least the nostrils of the patient, the positioning and stabilizing structure comprising:

At least one gas delivery tube receiving a flow of air from a connection port on top of the patient's head and delivering the flow of air via the seal-forming structure to an inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head above an on-ear base point of the patient's head,

at least one elongate textile sleeve disposed about at least a portion of the at least one gas delivery tube and configured to contact the patient's face in use,

wherein the at least one textile sleeve is fixed relative to the at least one gas delivery tube at a location adjacent an end of the at least one gas delivery tube adjacent the seal-forming structure.

58. The positioning and stabilizing structure of claim 57, wherein the fabric sleeve is secured to the at least one gas delivery tube by an adhesive.

59. The positioning and stabilizing structure of claim 58, wherein a seam tape layer is provided on the end of the fabric sleeve adjacent the gas delivery tube.

60. The positioning and stabilizing structure of claim 59, wherein the seam tape is attached to the fabric sleeve by an adhesive.

61. The positioning and stabilizing structure of claim 57, wherein the at least one textile sleeve is secured relative to the at least one gas delivery tube by an end cap.

62. The positioning and stabilizing structure of claim 61, wherein the end cap extends from the outer surface of the at least one textile sleeve, over the end of the at least one textile sleeve, and over at least a portion of the edge of the at least one gas delivery tube.

63. The positioning and stabilizing structure of claims 61 to 62, wherein the end cap includes an annular side wall and an end flange extending radially inwardly from the side wall.

64. The positioning and stabilizing structure of claim 63, wherein the side wall includes at least one adhesive recess.

65. The positioning and stabilizing structure of claim 64, wherein the at least one adhesive recess is annular.

66. The positioning and stabilizing structure of claims 64 to 65, wherein the at least one adhesive recess is offset from an end of the side wall remote from the end flange.

67. The positioning and stabilizing structure of claims 64 to 66, wherein the at least one adhesive recess is offset from the end flange.

68. The positioning and stabilizing structure of claims 63 to 67, wherein the side wall includes at least one axial recess extending from an end of the side wall to the end flange.

69. The positioning and stabilizing structure of claim 68, wherein at least one seam of the fabric sleeve is received in the at least one axial recess.

70. The positioning and stabilizing structure of claim 69, wherein the at least one seam of the fabric sleeve includes a first seam and a second seam, and the at least one axial recess includes a first axial recess and a second axial recess, and the first seam is received in the first axial recess and the second seam is received in the second axial recess.

71. The positioning and stabilizing structure of claims 61 to 70, wherein the end cap includes at least one visual indicator that indicates one or more of the following: the alignment of the connection of the at least one gas delivery tube to the seal-forming structure, and the size of the positioning and stabilizing structure.

72. The positioning and stabilizing structure of claim 60, wherein the at least one textile sleeve is fixed relative to the at least one gas delivery tube by a localized high friction interface.

73. The positioning and stabilizing structure of claim 72, wherein the localized high friction interface is provided by a polymer layer between the textile sleeve and the at least one gas delivery tube.

74. The positioning and stabilizing structure of claim 73, wherein the polymer layer is a polymer gel strip.

75. The positioning and stabilizing structure of claim 74, wherein the polymer gel strip is a thermoplastic polyurethane gel strip.

76. The positioning and stabilizing structure of claim 74, wherein the polymer gel strip is a silicone gel strip.

77. The positioning and stabilizing structure of claim 73, wherein the polymer layer is a silicone layer.

78. The positioning and stabilizing structure of claim 57, wherein the at least one textile sleeve is fixed relative to the at least one gas delivery tube by a double sided adhesive tape between the at least one textile sleeve and the at least one gas delivery tube.

79. The positioning and stabilizing structure of claim 78, wherein the double-sided tape is coated with a silicone adhesive on a first side and a non-silicone adhesive on a second side.

80. The positioning and stabilizing structure of claim 79, wherein the non-silicone adhesive is an acrylic adhesive.

81. The positioning and stabilizing structure of claim 57, wherein the at least one textile sleeve is fixed relative to the at least one gas delivery tube by an overmolded end.

82. The positioning and stabilizing structure of claim 81, wherein the overmolded end extends from the outer surface of the at least one textile sleeve, extends past the end of the at least one textile sleeve, and extends past at least a portion of the edge of the at least one gas delivery tube.

83. The positioning and stabilizing structure of claims 81 to 82, wherein the overmolded end comprises at least one visual indicator indicating one or more of the following: the alignment of the connection of the at least one gas delivery tube to the seal-forming structure, and the size of the positioning and stabilizing structure.

84. The positioning and stabilizing structure of claims 57 to 83, wherein the at least one gas delivery tube is made of an elastic material.

85. The positioning and stabilizing structure of claims 57 to 84, wherein the at least one gas delivery tube comprises a pair of gas delivery tubes and the fabric sleeve extends over both gas delivery tubes.

86. The positioning and stabilizing structure of claim 85, wherein the at least one textile sleeve is fixed relative to two gas delivery tubes near respective ends near the seal-forming structure.

87. The positioning and stabilizing structure of claims 57-86, wherein the at least one fabric sleeve is further secured to at least one gas delivery tube proximate the connection port.

88. A patient interface, the patient interface comprising:

a plenum chamber capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure of O, the plenum comprising a plenum inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration;

a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding the patient airway inlet for, in use, at least 6cmH above ambient air pressure throughout the patient's respiratory cycle ₂ Sealing a flow of delivery air at a therapeutic pressure of O, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered at least to an inlet of a nostril of a patient, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

The positioning and stabilising structure according to any one of claims 1 to 41 or 57 to 87, or comprising the positioning and stabilising structure of a textile sleeve according to any one of claims 42 to 56.