CN117222444A

CN117222444A - Full face patient interface

Info

Publication number: CN117222444A
Application number: CN202280030467.3A
Authority: CN
Inventors: M·S·哈托诺; K·T·貌; L·T·希特; J·陈; B·H·谭; H·C·林; C·F·李; X·Y·吴; S·K·尚穆加·桑达拉; H·F·S·托马斯; S·杜贝尔; C·K·吴; A·J·贝特; M·R·威尔斯; P·D·沃森; S·W·普利尔
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2021-03-09
Filing date: 2022-03-09
Publication date: 2023-12-12

Abstract

A patient interface includes a plenum chamber, a first seal-forming structure for forming a seal around a patient's mouth, and a second seal-forming structure for forming a seal around a patient's nostril. The patient interface further includes at least one stop rib disposed in the cavity of the plenum chamber, spaced apart from the first seal forming structure in the rest position. The first seal forming structure is configured to contact the at least one stop rib in the operative position. The at least one stop rib is configured to resist compression of the first seal forming structure in a forward direction. The second seal forming structure is not configured to contact the at least one stop rib.

Description

Full face patient interface

Cross Reference to Related Applications

The present application claims the benefit of s.g. provisional patent application No. 10202105065S filed on day 5, month 14 of 2021 and s.g. provisional patent application No. 10202102386Q filed on day 3, month 9 of 2021, each of which is incorporated herein by reference in its entirety.

International application PCT/AU2020/050953, filed on 9/2020, claims priority from U.S. provisional patent application No. 63/058,001 filed on 29/2020, each of which is incorporated herein by reference in its entirety.

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.

Background

Human respiratory system and disorders thereof

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

The airways include a series of branches that become narrower, shorter and more numerous as the branch airways penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into venous blood, while carbon dioxide moves in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into end bronchioles. The bronchi constitute the conducting airways 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 where gas exchange occurs, known as the respiratory region. See John b.west, respiratory physiology (Respiratory Physiology), risperidone williams publishing company (Lippincott Williams & Wilkins), release 9 in 2012.

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

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

Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) characterized by events that include upper airway occlusion or obstruction during sleep. It is caused by the normal loss of abnormally small upper airway and muscle tone in the tongue, soft palate, and posterior oropharyngeal wall areas during sleep. Such conditions may cause 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 may lead to cardiovascular disease and brain damage. This syndrome is a common disorder, especially in middle-aged overweight men, although 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 control system of a patient in which rhythmic alternating periods of increasing and decreasing ventilation exist, called CSR periods. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. CSR may be detrimental due to repeated hypoxia. In some patients, CSR is associated with repeated arousal from sleep, which can lead to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Respiratory failure is a generic term for respiratory disorders 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 develop abnormal shortness of breath during exercise.

Obesity Hypoventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia without other known causes 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 certain common characteristics. These include increased resistance to air movement, prolonged expiration of the breath, 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 expectoration during exertion.

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, wheelchair seating, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as fast-progressive and slow-progressive: (i) fast progressive disorder: characterized by deterioration of muscle injury over months and leading to death within years (e.g., amyotrophic Lateral Sclerosis (ALS) and Du's Muscular Dystrophy (DMD) in teenagers; ii) variable or slow progression disorders characterized by deterioration of muscle injury over years and only slight shortening of life expectancy (e.g., limb banding, facial shoulder humerus and tonic muscular dystrophy).

Chest wall disorders are a group of chest 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, peripheral edema, sitting and breathing, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

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

Therapy method

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.

Respiratory pressure therapy

Respiratory pressure therapy is the application of air supplied to the entrance of the airway at a controlled target pressure nominally positive with respect to the atmosphere throughout the respiratory cycle of a patient (as opposed to negative pressure therapy such as a canister or chest-shell ventilator).

Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and thus, if the patient finds that the means for providing such therapy is present in one or more of the following conditions, they may choose a non-compliant therapy: uncomfortable, difficult to use, expensive, and aesthetically undesirable.

Non-invasive ventilation (NIV) provides ventilation support to a patient through the upper airway to assist the patient in breathing and/or to maintain adequate oxygen levels in the body by performing some or all of the respiratory work. 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 therapies may be improved.

Invasive Ventilation (IV) provides ventilation support for patients that are no longer able to breathe spontaneously effectively, and may be provided using an aero-cut tube. In some forms, the comfort and effectiveness of these therapies may be improved.

Flow therapy

Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim at delivering an inspiratory flow rate profile (possibly superimposed) over a target durationAt positive baseline pressure) to deliver a prescribed amount of respiration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy may supplement the regulated or enriched gas flow only to the patient's own spontaneous breathing. In one example, high Flow Therapy (HFT) is the provision of a continuous, heated, humidified air flow to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains substantially constant throughout the respiratory cycle. The therapeutic 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 disorders. One mechanism of action is the high flow rate of air at the entrance to the airway by flushing or flushing out exhaled CO from the anatomical dead space of the patient ₂ To improve ventilation efficiency. Thus, HFT is sometimes referred to as dead zone therapy (deadspace therapy, DST). Other benefits may include increased warmth and wettability (which may be beneficial for secretion management) and the possibility of moderately increasing airway pressure. As an alternative to 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 (21% to 100% of the oxygen fraction in ambient air), at a specified flow rate (e.g., 1 Liter Per Minute (LPM), 2LPM, 3LPM, etc.).

Oxygen supplementation

For some patients, oxygen therapy may be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized flow of gas. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to the HFT, the resulting therapy is referred to as HFT with supplemental oxygen.

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 conditions without treatment thereof.

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

Another form of therapy system is a mandibular reduction device.

Patient interface

The patient interface may be used to connect 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 to the patient's nose and/or mouth via a mask, to the mouth via a tube, or to the patient's airway via an aerocut tube. Depending on the therapy applied, the patient interface may form a seal with, for example, an area of the patient's face to facilitate delivery of gas at a pressure sufficiently different from ambient pressure to effect the therapy, for example, at about 10cmH relative to ambient pressure ₂ Positive pressure of O. For other forms of therapy, such as oxygen delivery, the patient interface may not include a sufficient amount to deliver about 10cmH ₂ The positive pressure of O gas is delivered to the airway seal. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nostrils, but specifically avoids a complete seal. An 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 at higher pressure from the outside, but not to maintain the internal air at a pressure above ambient pressure.

Certain masks may be clinically disadvantageous to the present technique, for example, where they block airflow through the nose and only allow airflow through the mouth.

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

Some masks may not be suitable for use while sleeping, for example, while sleeping on the head and on the side in a bed.

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

Because of these challenges, some masks present one or more problems, namely being obtrusive, unsightly, expensive, non-conforming, difficult to use, and uncomfortable, especially when worn for extended periods of time or when the patient is unfamiliar with a system. Wrong-sized masks may result in reduced compliance, reduced comfort, and poor patient prognosis. Masks designed only for pilots, 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 may be uncomfortable to wear for extended periods of time (e.g., hours). Such discomfort may lead to reduced patient compliance with the therapy. This is especially the case if the mask is worn during sleep.

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

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 named by their manufacturers under various names, including nasal masks, full face masks, nasal pillows, nasal puffs, and oral nasal masks.

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

Some seal-forming structures may be designed for mass production so that one design can conform to a variety of different facial shapes and sizes and be comfortable and effective. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be accommodated to form the 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, with the seal-forming structure in facing engagement with the patient's face. The seal-forming structure may comprise an air or fluid filled gasket, or a molded or formed surface of a resilient sealing element made of an elastomer, such as rubber. For this type of seal-forming structure, if the fit is inadequate, 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 the seal.

Another type of seal-forming structure includes a sheet-like seal of thin material located near 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 effect the seal, otherwise 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, for example, for insertion into nostrils, however some patients find these elements 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 often on their face.

A series of patient interface seal formation construction techniques are disclosed in the following patent applications assigned to rismel 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 Tascow corporation (Puritan Bennett). Another nasal pillow or nose puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al) assigned to Tascoot corporation (Puritan-Bennett Corporation).

The product of the combination nasal pillows manufactured by rismel limited is as follows: 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 rismel limited describe examples of nasal pillow masks: international patent application WO2004/073,778 (especially describing SWIFT from Russian Mich., ltd.) ^TM Various aspects of nasal pillows), U.S. patent application 2009/0044808 (particularly describingSWIFT from ruisimei inc ^TM Various aspects of LT nasal pillows); international patent applications WO 2005/063,328 and WO 2006/130,903 (in particular describing MIRAGE LIBERTY, of Ruisha Mich., ltd.) ^TM Various aspects of the full face mask); international patent application WO 2009/052,560 (in particular describes SWIFT from Ruisimai Co., ltd.) ^TM Various aspects of FX nasal pillows).

Positioning and stabilization

The seal-forming structure of a patient interface for positive air pressure therapy may be subjected to a corresponding air pressure force, thereby breaking the seal. Thus, 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 straps. Many such harnesses present one or more of the problems of discomfort, bulkiness, discomfort, and awkwardness.

Respiratory Pressure Therapy (RPT) device

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

Air circuit

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

Humidifier

Delivering a non-humidified air flow may result in airway dryness. A humidifier with an RPT device and patient interface is used to generate humidified gas to minimize dryness of the nasal mucosa and increase patient airway comfort. In addition, in colder climates, warm air, which is typically applied to the facial area within and around the patient interface, is more comfortable than cold air. Therefore, the humidifier generally has a function of heating the air flow and humidifying the air flow.

Oxygen source

Experts in the field have recognized that exercising by respiratory failure patients can provide long-term benefits that slow disease progression, improve quality of life, and extend patient life. However, most stationary forms of exercise, such as treadmills and stationary bicycles, are too laborious for these patients. Thus, the necessity of mobility has long been recognized. Until recently, this mobility was not achieved by using small compressed oxygen tanks or cylinders mounted on a cart with push wheels. A disadvantage of these oxygen tanks is that they contain limited amounts of oxygen and are heavy, weighing about 50 pounds when installed.

Oxygen concentrators have been in use for about 50 years to provide oxygen for respiratory therapy. Conventional oxygen concentrators are bulky and heavy, making their use for ordinary ambulatory activities difficult and impractical. Recently, companies that manufacture large stationary oxygen concentrators have begun to develop Portable Oxygen Concentrators (POCs). POC has the advantage that they can produce a theoretically unlimited supply of oxygen. In order to make these devices small and mobile, the various systems required to produce the oxygen-enriched gas are compressed. POC seeks to use the oxygen it produces as efficiently as possible to minimize weight, size and power consumption. This may be achieved by delivering oxygen in a series of pulses or "boluses," each bolus being timed to coincide with the start of inspiration. This mode of therapy is known as pulsed or on demand (oxygen) delivery (POD), as opposed to conventional continuous flow delivery, which is more suitable for stationary oxygen concentrators.

Data management

There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy is "compliant," e.g., the patient has used their RPT device according to one or more "compliance rules. An example of a compliance rule for CPAP therapy is that the patient needs to use the RPT device for at least four hours per night for at least 21 of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the therapy of a patient using the RPT device, calculate usage over a predetermined period of time, and compare to compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to compliance rules, the healthcare provider may notify third parties that the patient is compliant.

The transfer of therapy data to a third party or external system may be advantageous for other aspects of patient therapy.

Existing processes for communicating and managing such data may be costly, time consuming, error prone, and the like.

Mandible reduction

Mandibular Reduction Device (MRD) or Mandibular Advancement Device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (mandible) in a forward position during sleep. An MRD is a removable device that a patient inserts into his/her mouth before falling asleep and withdraws after falling asleep. Thus, MRDs are not designed to be worn all the time. The MRD may be custom made or produced in standard form and include an bite impression portion designed to allow fitting of the patient's teeth. This mechanical protrusion of the chin expands the posterior lingual space, exerting tension on the pharyngeal wall to reduce collapse of the airway and reduce palate vibration.

In some examples, the mandibular advancement device may include an upper splint for engaging or conforming to teeth on the upper jaw or the maxilla and a lower splint for engaging or conforming to teeth on the upper jaw or the mandible. The upper and lower clamp plates are laterally connected together via a pair of links. The pair of links are symmetrically fixed to the upper and lower clamping plates.

In this design, the length of the link is selected so that the mandible remains in the advanced position when the MRD is placed in the patient's mouth. The length of the link can be adjusted to vary the degree of protrusion of the mandible. The dentist can determine the extent of protrusion of the mandible, which will determine the length of the link.

Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs (such as Ruisimex Narval CC ^TM MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes side effects of the teeth and temporomandibular joint (TMJ). Thus, it is configured to minimize or prevent any movement of one or more teeth.

Ventilation technique

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

The vent may include an orifice and gas may flow through the orifice in use of the mask. Many such vents are very 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 concentrated airflow.

A number of improved mask ventilation techniques have been developed by rismate limited. See International patent application publication No. WO 1998/034,665; international patent application publication No. WO 2000/078,381; U.S. Pat. nos. 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, 10cmH at 1 m) ₂ O pressure

Sample only, at 10cmH in CPAP mode using the test method specified in ISO 3744 ₂ Measurement under O)。

The sound pressure values of the various objects are listed below

Screening, diagnostic and monitoring system

Polysomnography (PSG) is a conventional system for diagnosing and monitoring heart-lung disorders and typically involves a clinical specialist to apply the system. PSG typically involves placing 15 to 20 contact sensors on a patient in order to record various body signals, such as electroencephalograms (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing involves two-night observation of the patient at the clinic, with a pure diagnosis at one night and titration of the treatment parameters by the clinician at the second night. Thus, PSG is both expensive and inconvenient. In particular, it is not suitable for home screening/diagnosis/monitoring of sleep disordered breathing.

Screening and diagnosis generally describes identifying a disorder from its signs and symptoms. Screening will typically give true/false results indicating whether the patient's SDB is so severe that further examination is required, and diagnosis may yield clinically actionable information. Screening and diagnosis are often disposable procedures, and monitoring of the progression of a condition can continue indefinitely. Some screening/diagnostic systems are only suitable for screening/diagnosis, while some may also be used for monitoring.

Clinical professionals may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or where the clinical expert may not be affordable. Different clinical professionals may have different opinion on the condition of a patient. Furthermore, a given clinical expert may apply different criteria at different times.

Disclosure of Invention

The present technology aims to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, which devices have 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 devices that improve patient compliance with respiratory therapy.

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

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

a first seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an oral cavity entrance of the patient such that an air flow at said therapeutic pressure is delivered to the oral cavity, the first seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;

a second 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 nose such that an air flow at said therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

A ventilation structure allowing gas exhaled by the patient to be continuously vented from the interior of the plenum to the ambient environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the plenum in use;

the patient interface further includes:

a pair of support portions disposed on opposite sides of an interface between the second seal forming structure and a front wall of the plenum, wherein the support portions are configured to resist compression in a front-to-rear direction.

In an embodiment:

a) The support portion being connected to a portion of the second seal-forming structure which in use seals against the patient's upper lip;

b) The support portion being connected to a portion of the second seal-forming structure which, in use, seals with the patient's upper lip directly under the patient's lower corner of the nose;

c) The support portion is curved when viewed in a cross section parallel to the sagittal plane;

d) The support portion is curved when viewed in a cross section parallel to the anterior sagittal plane;

e) The plenum chamber includes an oral portion and a nasal portion;

f) Each support portion is connected to the oral portion of the plenum chamber at a boundary adjacent the lateral sidewall portion of the oral portion and the lateral sidewall portion of the nasal portion;

g) Each support portion is connected to the oral portion of the shell at a boundary adjacent the front wall portion of the oral portion and the front wall portion of the nasal portion;

h) The lateral sidewall portions of the plenum chamber being inwardly curved at a boundary adjacent the nasal cavity portions, wherein each support portion is substantially contiguous with an adjacent lateral sidewall portion;

i) The second seal-forming structure comprising at least one naris configured to deliver an air flow at the therapeutic pressure to an inlet of the patient's naris, wherein, in use, no part of any support portion is directly below the or each naris;

j) The interface also includes a positioning and stabilizing structure configured to generate a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head;

k) The plenum chamber is at least partially formed by the shell, and the vent structure is disposed on the shell; and/or

l) the support portion is connected to the second seal-forming structure and to the front wall of the plenum.

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

A first seal-forming structure connected to an oral portion of the plenum chamber, the first seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding an oral entrance of the patient such that an air flow at said therapeutic pressure is delivered to the oral cavity, the first seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout a respiratory cycle of the patient in use;

a second seal-forming structure connected to the nasal portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding the entrance to the patient's nose such that an air flow at said therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

wherein the method comprises the steps of

The first front wall portion of the nasal cavity portion of the plenum chamber is adjacent to the boundary of the oral cavity portion of the plenum chamber and is more flexible than the immediately adjacent region of the oral cavity portion of the plenum chamber, and the second front wall portion of the nasal cavity portion of the plenum chamber is immediately adjacent to the first front wall portion and on a side of the first front wall portion opposite the boundary of the oral cavity portion of the plenum chamber and is less flexible than the immediately adjacent portion of the front wall.

In the examples:

a) The first front wall portion being thinner than the immediately adjacent portion of the plenum wall;

b) The second front wall portion being thicker than the immediately adjacent portion of the plenum wall;

c) The first front wall portion and the second front wall portion are made of the same material;

d) The first front wall portion extends substantially across the entire width of the nasal cavity portion of the plenum chamber;

e) The second front wall portion extends across at least a majority of a width of the nasal cavity portion of the plenum;

f) The first front wall portion extends in an upward direction around at least one lateral edge of the second front wall portion;

g) The second front wall portion extends substantially across the entire width of the nasal cavity portion of the plenum chamber;

h) The central portion of the first front wall portion extends further in an upward direction than the lateral portion of the first front wall portion;

i) The upper boundary of the first front wall portion is curved;

i) The lower boundary of the first front wall portion is curved;

k) The plenum chamber is at least partially formed by the shell, and the vent structure is disposed on the shell;

l) the second anterior wall portion includes a strap extending through the first anterior wall portion and configured to extend through the plenum toward the patient;

m) the transition between the first front wall portion and the second front wall portion within the plenum is a substantially stepped surface;

m) the transition between the first front wall portion and the second front wall portion outside the plenum is a substantially smooth surface; and/or

o) in use, the first front wall portion extends further up than at least a portion of the strap.

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

a second seal-forming structure connected to the nasal portion of the plenum chamber, the second seal-forming structure being constructed and arranged to form a seal with an area of the patient's face surrounding the entrance to the patient's nose such that an air flow at said therapeutic pressure is delivered to the nose, the second seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;

wherein the method comprises the steps of

The rear surface of the lateral portion of the second seal-forming structure is inclined in an upward forward direction from the boundary of the first seal-forming structure and the second seal-forming structure.

In the examples:

a) The inclined surface of each transverse portion forms an angle of between 20 degrees and 90 degrees with the intermediate contact plane of the mask;

b) In use, no portion of the patient interface would contact the patient's alar vertex;

c) The interface is configured to prevent occlusion of the nostrils of the patient, or at least to reduce occlusion relative to prior art interfaces; and/or

d) The plenum is at least partially formed by the shell and the vent structure is disposed on the shell.

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

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

wherein the method comprises the steps of

The boundary between the first seal-forming structure and the second seal-forming structure includes a ridge.

In the examples:

a) The curvature radius of the ridge is less than 2mm;

b) The ridge extends substantially across the entire boundary between the first seal-forming structure and the second seal-forming structure;

c) In use, the ridge engages the patient's face proximate the nostril entrance where the nasal wings meet the face above the upper lip;

d) The ridge prevents the formation of folds in the first seal-forming structure and/or the second seal-forming structure adjacent the ridge; and/or

e) In use, the plenum is at least partially formed by the shell and the vent structure is provided on the shell.

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

wherein,

at least a portion of the oral portion of the plenum chamber comprises a flexible shell, wherein the flexible shell is formed of a material having a Young's modulus of less than 0.4 GPa.

In the examples:

a) The flexible shell is formed of a material having a Young's modulus of less than 0.1GPa, preferably between 0.3 and 0.7 MPa.

b) At least one component is connected to the flexible shell, wherein the at least one component is stiffer than a portion of the flexible shell adjacent the component;

c) The at least one component includes one or more of: a ventilation module; a headgear connector; a headgear connector connected to the rigid arm; a rigid member; a less flexible shell portion;

d) At least one component is releasably connected to the flexible shell;

e) At least one component is permanently connected to the flexible shell;

f) At least one component is overmolded to the flexible shell;

g) The flexible shell includes a reinforcing portion having a thickness greater than an immediately adjacent portion of the flexible shell;

h) At least one component is configured as a stiffener or a reinforcing strip;

i) The central portion of the oral portion of the plenum chamber has a greater stiffness than the remainder of the plenum chamber; and/or

j) The plenum is at least partially formed by the shell and the vent structure is disposed on the shell.

Another form of the present technology includes a frame configured to be coupled to a plenum, the frame including a central portion coupled to the plenum outside of a cavity and a plurality of connectors including a pair of upper connectors and a pair of lower connectors, the pair of lower connectors being flush with the central portion and the pair of upper connectors extending away from the central portion in a rearward direction configured to pass through the plenum.

In the examples:

a) Each upper connector of the pair of upper connectors includes a slot configured to receive a headgear strap;

b) Each slot includes a raised portion proximate the respective arm;

c) Each of the convex portions has a curved shape;

d) Each upper connector includes a rib near the central portion;

e) The combined width of the rib and the arm near the central portion is substantially equal to the width of the arm near the slot;

f) Each lower connector of the pair of lower connectors includes a magnet;

g) Each lower connector of the pair of lower connectors includes a recess configured to act as a hinge and allow each lower connector to flex relative to the central portion.

Another form of the present technology includes a frame configured to be coupled to a plenum, the frame including a central portion coupled to the plenum outside of a cavity and a pair of arms extending away from the central portion in a rearward direction configured to pass through the plenum, the pair of arms being more flexible than the central portion.

In the examples:

a) Each arm of the pair of arms is more flexible than the frame;

b) The central portion is thicker than each of the pair of arms;

c) The central portion and each arm of the pair of arms are constructed of the same material;

d) Each arm of the pair of arms includes a first connection point to which a headgear strap is coupled;

e) The first connection points are loops and the headgear strap is coupled to the loops such that the strap is perpendicular to an edge of each loop and applies a force vector perpendicular to the edge;

f) The first connection point is a loop and includes a region of reduced thickness that the headgear strap can contact;

g) The first magnet being overmolded onto the central portion of the frame, the headgear strap including a second magnet removably coupled to the first magnet;

h) The first magnet includes a housing at least partially enclosing a magnetic material, the housing including a planar surface and a lip extending from the planar surface;

i) The overhang is spaced apart from the second magnet and configured to engage the lip when the second magnet is coupled to the magnetic material;

j) The central portion is configured to be positioned within a recess of the plenum;

k) The central portion is removably positioned within the recess;

l) the groove comprises a protrusion, the central portion comprising a complementary slot configured to receive the protrusion;

m) the slot is tapered and includes a wider opening and a narrower opening, the protrusion being configured to be received through the wider opening before the narrower opening;

n) a sleeve covering at least a portion of one of the pair of arms;

o) the slot having a raised portion having a curvature configured to conform to a curvature of the sleeve; and/or

p) each arm of the pair of arms includes a rib near the central portion, the rib configured to secure the sleeve.

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

a plenum comprising a cavity capable of being pressurized to a therapeutic pressure of at least 6cmH2O above ambient air pressure, the plenum comprising a plenum inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration;

a second 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 nose such that an air flow at said therapeutic pressure is delivered to the nose, the second seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;

a ventilation structure allowing gas exhaled by the patient to be continuously vented from the interior of the plenum to the ambient environment, the ventilation structure being sized and shaped to maintain a therapeutic pressure in the plenum in use; and

A positioning and stabilizing structure configured to maintain a first seal-forming structure and a second seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

a frame coupled to the plenum, the frame comprising:

a central portion coupled to the plenum chamber outside the cavity, an

A pair of arms extending in a rearward direction away from the central portion past the second seal-forming structure, the pair of arms being more flexible than the central portion; and

a headgear strap coupled to the frame configured to provide tension into the patient's face to the first seal-forming structure and to the second seal-forming structure via the frame.

In the examples:

a) Each arm of the pair of arms is more flexible than the frame;

b) The central portion is thicker than each of the pair of arms;

j) The plenum chamber including a recess with a central portion positioned within the recess;

k) The central portion is removably positioned within the recess;

n) the protrusion includes a overhang configured to extend over the slot and retain the frame relative to the plenum;

o) the plenum includes a protrusion disposed adjacent the recess, the protrusion configured to retain the central portion within the recess;

p) the outer surface of the central portion being flush with the outer surface of the plenum, the outer surface of the central portion and the outer surface of the plenum being configured to face away from the patient in use;

q) the central portion comprising an annular shape, the plenum inlet port being disposed radially within the central portion with the frame coupled to the plenum;

r) the plenum inlet port is configured to receive an elbow configured to be spaced apart from the central portion when received within the plenum inlet port;

s) each arm is formed as a cantilever structure with respect to the central portion;

t) the thickness of each arm decreases from the fixed end to the free end;

u) the arm comprises a scalloped area on the inner surface configured to face the skin of the patient;

v) each arm is pivotable about a pivot point relative to the central portion; and/or

w) the pivot point is a living hinge.

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

a seal-forming structure constructed and arranged to form a seal with a region of a patient's face such that an air flow at the therapeutic pressure is delivered to the airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout a respiratory cycle of the patient in use; and

A positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position.

Another aspect of one form of the present technique is an oral-nasal patient interface that is more compact and less obtrusive to the patient.

Another aspect of one form of the present technique is an oral-nasal patient interface having a nose pad portion that provides improved fit to the lower corners of the nose.

Another aspect of one form of the present technique is an oronasal patient interface that reduces occlusion contact on the nose.

Another aspect of one form of the present technique is an oronasal patient interface that can self-adjust to accommodate patients with various nose wing angles.

Another aspect of one form of the present technique is an oral-nasal patient interface having a relatively flexible shell.

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.

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

a plenum comprising a chamber capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure cavity 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 headgear strap configured to provide tension into the patient's face to the first seal-forming structure and to the second seal-forming structure via the frame, wherein the headgear strap includes a first width and a second width that is greater than the first width; and

Wherein the headgear strap selectively passes through the opening to adjust the tension, the first width configured to fit through the opening, and the second width configured to be blocked from passing through the opening.

Another form of the present technology includes a positioning and stabilizing structure configured to maintain a seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

a headgear strap configured to provide tension into the patient's face to the seal-forming structure via the frame, wherein the headgear strap includes a first width and a second width that is greater than the first width; and

Another form of the present technology includes a plenum comprising:

a plenum chamber including a chamber capable of being pressurized to a high pressureAt ambient air pressure of at least 6cmH ₂ A therapeutic pressure cavity 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 frame coupled to the plenum, the frame comprising:

a pair of upper arms, and

a pair of lower arms, and

a headgear strap coupled to the pair of upper arms and the pair of lower arms, and configured to provide tension into the patient's face to the first seal forming structure and to the second seal forming structure via the frame.

Another form of the present technology includes a frame comprising:

a central portion;

a pair of upper arms extending away from the central portion in a rearward direction, the pair of arms being more flexible than the central portion;

a pair of first connectors coupled to the pair of upper arms, the pair of first connectors configured to selectively connect to a pair of upper straps;

A pair of lower arms extending away from the central portion;

a pair of second connectors coupled to the pair of lower arms, the pair of second connectors configured to selectively connect to the pair of lower straps.

In the examples:

a) The pair of first connectors is different from the pair of second connectors;

b) The pair of first connectors is selected from the group consisting of slots, ladder locks, and stops;

c) The pair of first connectors are slots;

d) The pair of first connectors each include a first ring segment and a second ring segment;

e) The pair of second connectors are magnets; and/or

f) The pair of first connectors is longer than the pair of second connectors.

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

a frame including a central portion coupled to the plenum;

wherein the plenum includes a recess configured to removably receive a central portion of the frame.

In the examples:

a) In the engaged position, at least a portion of the central portion of the frame is spaced apart from the recess;

b) The upper bar of the central portion is spaced from the recess when the central portion is coupled to the frame; and/or

c) The second seal-forming structure is spaced apart from the upper stem prior to use and is configured to contact the upper stem in use.

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

a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration;

the patient interface further includes:

at least one region disposed in the plenum that is spaced apart from the first seal-forming structure, the at least one region configured to resist compression of the first seal-forming structure in a forward direction.

In the examples:

a) At least one region is at least one stop rib;

b) The at least one stop rib includes a plurality of stop ribs spaced apart from one another;

c) The plurality of stop ribs are arranged in a c-shape;

d) A plurality of stop ribs extending around substantially the entire periphery of the first seal forming structure;

e) The at least one stop rib is an elongate member;

f) The at least one stop rib includes a beveled edge;

g) The beveled edge is the trailing edge;

h) The beveled edge being configured to contact the first seal-forming structure in use so as to limit forward movement of the first seal-forming structure;

i) The at least one stop rib includes a length measured substantially perpendicular to the first seal forming structure and a width measured substantially perpendicular to the length;

j) The length is greater than the width;

k) The first seal forming structure is configured to contact the at least one stop rib along the width in use;

l) at least one region is at least one reinforcing region;

m) at least one reinforcing region comprises a plurality of reinforcing regions;

n) at least one reinforcing region comprises a first thickness proximate to the inlet port and a second thickness distal from the inlet port, the second thickness being less than the first thickness;

o) at least one stiffening region is provided on the front surface of the plenum; and/or

p) at least one region is integrally formed with the plenum.

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

a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to an airway of the patient such that an air flow at said therapeutic pressure is delivered to the airway, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout a respiratory cycle of the patient in use;

a positioning and stabilizing structure configured to maintain a seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

a frame coupled to the plenum, the frame comprising:

a central portion removably positioned within a recess on the plenum chamber outside the cavity, and

a pair of upper arms extending away from the central portion; and

A pair of lower arms extending away from the central portion;

In the examples:

a) The pair of upper arms being longer than the pair of lower arms;

b) The pair of upper arms each include a first connector and the pair of lower arms each include a second connector different from the first connector;

c) The first connector is selected from the group consisting of a ring, a ladder lock, and a rope stopper;

d) The first connector is a ring comprising a first ring portion and a second ring portion adjacent the first ring portion;

e) The ring includes a dividing wall at least partially separating the first ring portion from the second ring portion;

f) The strap in the headgear strap is configured to be selectively inserted into the first loop portion and contact the dividing wall at an optimal tension in use, and wherein the strap is configured to move into the second loop portion at a tension greater than the optimal tension;

g) The second connector is a magnetic member;

h) The magnetic member includes a substantially elliptical shape;

i) The second connector is a magnetic member;

j) The housing is removably and magnetically connected to the magnetic member;

k) The housing includes a strap connector for connecting to a strap of the headgear strap, the strap connector selected from the group consisting of a loop, a ladder lock, and a cord stop;

l) the housing is configured to engage a lip of the housing;

m) at least one of the headgear straps includes a first width and a second width that is greater than the first width;

n) the first width is selectively receivable by the first connector, and wherein the second width is substantially prevented from passing through the first connector; and/or

o) the pair of first arms and the pair of second arms are integrally formed with the central portion.

Another form of the present technology includes a plenum comprising:

A positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position;

wherein the plenum chamber includes a lip extending around at least a portion of the inlet port and into the cavity.

Another form of the present technology includes a plenum comprising:

another form of the present technique includes a system for providing pressurized air to a patient, the system comprising:

a plenum comprising a cavity capable of being pressurized to a therapeutic pressure of at least 6cmH2O above ambient air pressure, the plenum comprising a plenum inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration, wherein the plenum comprises a lip extending at least partially around the plenum inlet port;

a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position; and

An air circuit removably connected to the plenum and configured to provide an air flow at a therapeutic pressure from the airflow generator to the cavity, the air circuit comprising a vent ring configured to be at least partially inserted through the plenum inlet port, the vent ring comprising:

a rear surface having a first diameter and,

a front surface having a second diameter smaller than the first diameter, and

a ring extending between the anterior surface and the posterior surface;

wherein the rear surface is configured to be positioned within the cavity and the front surface is configured to remain outside the cavity when connected to the plenum;

wherein the lip is configured to contact the vent ring along the ring body between the back surface and the front surface; and is also provided with

Wherein the first diameter is greater than the diameter of the lip.

In the examples:

a) The vent body is sloped between the rear surface and the front surface;

b) The rear surface being configured to contact, in use, the lip and a front wall of a plenum within the cavity;

c) The ring body comprises an inner wall, an outer wall and a groove arranged between the inner wall and the outer wall;

d) The annular seal is positioned within the groove;

e) The outer diameter of the annular sealing piece is smaller than the outer diameter of the groove;

f) The ring body includes a central opening configured to receive the elbow connector;

g) The system includes a quick release connector;

h) The quick release connector is a rotatable connector or a latching connector;

i) The quick release connector is configured to connect to a complementary connector; and/or

j) The seal-forming structure is spaced apart from the vent ring, and wherein the patient's face is not configured to contact the vent ring.

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

a plenum having a cavity capable of being pressurized to a therapeutic pressure of at least 6cmH2O above ambient air pressure;

a first seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an oral entrance of the patient, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure in the cavity of the plenum chamber throughout a respiratory cycle of the patient in use;

a second 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 nostrils, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure in the cavity of the plenum chamber throughout the patient's respiratory cycle in use; and

The patient interface further includes:

at least one stop rib disposed in the cavity plenum, spaced apart from the first seal-forming structure in the at-rest position, the first seal-forming structure configured to contact the at least one stop rib in the operational position, the at least one stop rib configured to resist compression of the first seal-forming structure in a forward direction; and

wherein the second seal forming structure is not configured to contact the at least one stop rib.

In the examples:

a) An upper lip portion disposed below the second seal forming structure and configured to contact the upper lip;

b) The lip upper portion is not configured to contact the at least one stop rib;

c) The plurality of stop ribs are arranged in a c-shape;

d) A plurality of stop ribs are unequally spaced apart from one another within the cavity;

e) A plurality of stop ribs extending around a majority of the periphery of the seal-forming structure;

f) The at least one stop rib is an elongate member;

g) The at least one stop rib includes a beveled edge;

h) The beveled edge is the trailing edge;

i) The beveled edge being configured to contact the seal-forming structure in use so as to limit forward movement of the seal-forming structure in the operative position;

j) The beveled edge being disposed away from the seal-forming structure toward the center of the plenum in the rest position;

k) The at least one stop rib comprises a length measured substantially perpendicular to the seal-forming structure and a width measured substantially perpendicular to the length, and wherein the length is greater than the width;

l) the first seal forming structure is configured to contact the at least one stop rib along the width in the operative position;

m) the width is substantially uniform along the length of the at least one stop rib;

n) the width varies along the length of the at least one stop rib; and/or

o) at least one stop rib is integrally formed with the plenum.

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

a plenum comprising a cavity capable of being pressurized to a therapeutic pressure of at least 6cmH2O above ambient air pressure and a groove formed on a surface of the plenum outside the cavity and exposed to ambient pressure, the plenum being formed entirely of a flexible material;

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, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the cavity of the plenum chamber throughout the patient's respiratory cycle in use;

A frame coupled to the plenum, the frame comprising:

a central portion including a plurality of grooves removably positioned within the grooves,

a pair of upper arms extending away from the central portion, an

A pair of lower arms extending away from the central portion; and

a headgear strap coupled to the pair of upper arms and the pair of lower arms of the frame and configured to provide tension into the patient's face to the seal-forming structure via the frame.

In the examples:

a) The pair of upper arms being longer than the pair of lower arms;

b) The pair of upper arms each include a first type of connector and the pair of lower arms each include a second type of connector different from the first type of connector;

c) The first type of connector is selected from the group consisting of a ring, a ladder lock, and a rope stopper;

d) The first type of connector is a ring comprising a first ring portion and a second ring portion adjacent the first ring portion;

f) The straps in the headgear strap being configured to be selectively inserted into the first loop portion and contact the dividing wall under optimal tension in use;

g) The belt is configured to move into the second loop portion under a tension greater than the optimal tension;

h) The second type of connector is a magnetic member;

i) The magnetic member includes a substantially elliptical shape;

j) The housing is removably and magnetically connected to the magnetic member;

l) the housing is configured to engage a lip of the housing;

n) the first width is selectively receivable by the first connector, and wherein the second width is substantially prevented from passing through the first connector;

o) the pair of upper arms and the pair of lower arms are integrally formed with the central portion.

p) the plenum includes at least one protrusion extending from the recess;

q) the central portion of the frame includes at least one slot configured to selectively receive at least one protrusion;

r) the pair of lower arms are substantially flush with the central portion;

s) the seal-forming structure further comprises a first seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding the patient's oral access opening;

t) the seal-forming structure further includes a second seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding the entrance to the patient's nostrils;

u) the groove is disposed on a plenum below the second seal-forming structure and opposite the first seal-forming structure;

v) a system for providing pressurized air to a patient, the system comprising: the patient interface of any one of the preceding examples; a respiratory therapy system (RPT) device configured to provide an air flow at a therapeutic pressure; and a conduit connecting the RPT device to the patient interface, the conduit configured to communicate a flow of air to the patient interface;

w) the conduit is connected to an inlet port of the plenum chamber, the inlet port being spaced from the inner periphery of the central portion of the frame;

x) the central portion includes an inner periphery and an outer periphery removably positioned within the recess;

y) a groove is formed radially outward of the inlet port, and the groove forms a closed perimeter; and/or

z) the inner perimeter is configured to be spaced apart from the inlet port when positioned within the groove.

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

a plenum comprising a cavity capable of being pressurized to a therapeutic pressure of at least 6cmH2O above ambient air pressure, the plenum comprising a plenum inlet port sized and configured to receive an air flow at the therapeutic pressure for patient respiration, wherein the plenum comprises a lip extending at least partially around the plenum inlet port and into the cavity;

a rear surface having a first diameter and,

a front surface having a second diameter smaller than the first diameter, and

a ring extending between the front surface and the rear surface, the ring including an inner wall, an outer wall, and a groove disposed between the inner wall and the outer wall;

wherein:

the rear surface is configured to be positioned within the cavity and the front surface is configured to remain outside the cavity when connected to the plenum;

the rear surface includes at least one vent opening configured to provide communication between the cavity and an ambient environment through the recess;

The lip is configured to contact the vent ring along the ring body between the posterior surface and the anterior surface; and is also provided with

The first diameter is greater than the diameter of the lip.

In the examples:

a) The ring body is inclined between the rear surface and the front surface;

c) The annular seal is positioned within the groove;

d) The outer diameter of the annular sealing piece is smaller than the outer diameter of the groove;

e) The ring body includes a central opening, and the system further includes an elbow connector, the central opening configured to receive the elbow connector;

f) The elbow connector is rotatably connected to the ring, and wherein the ring is rotatably connected to the plenum;

g) The at least one vent opening is a plurality of vent openings spaced around the perimeter of the recess;

h) The system includes a quick release connector;

i) The quick release connector is a rotatable connector or a latching connector;

j) Wherein the quick release connector is configured to connect to a complementary connector;

k) The quick release connector includes at least one planar surface;

l) at least one planar surface is a pair of planar surfaces spaced about 180 ° apart;

m) at least one planar surface configured to redistribute leakage of air flow from the system;

n) the seal-forming structure is spaced apart from the vent ring, and wherein the patient's face is not configured to contact the vent ring;

o) the quick release connector comprises a vent opening configured to vent a portion of the air flow into the surrounding environment;

p) the ring body includes an extension;

q) the ring body includes a disk configured to be positioned within the cavity and limit the discharge of exhaled air into the surrounding environment; and/or

r) the disc extends radially beyond a portion of the rear surface including at least one vent opening.

In the examples:

a) The elbow connector includes at least one button configured to be selectively actuated to disengage the connection between the elbow connector and the central opening;

b) At least one button is formed in a cantilever structure;

c) The at least one button includes a button lip configured to selectively engage the ring body and move relative to the rest of the elbow when the at least one button is actuated;

d) The button lip is configured to selectively engage an inner periphery of an inner wall of the ring body;

e) The at least one button includes a finger configured to selectively engage the ring body and move relative to the rest of the elbow when the at least one button is actuated;

f) The fingers are configured to selectively engage the ring body radially outward of the inner wall; and/or

g) The plenum inlet port includes an extension and the ring body is connected to the extension and spaced apart from a surface of the plenum.

Another form of the present technology includes an elbow configured to be removably connected to a plenum, the elbow including a button that is selectively engageable by a patient.

Another form of the present technology includes an elbow configured to be removably connected to a plenum, the elbow comprising:

a body including a first end configured to be at least partially inserted into a cavity of a plenum and a second end configured to be connected to an air circuit, the body further comprising:

a button having a fixed end proximate the first end and a free end extending away from the free end;

an outer lip extending substantially around at least a portion of the periphery of the body; and is also provided with

Wherein the button is selectively engageable by the patient to selectively disengage the body from the plenum.

In the examples:

a) The button forms a portion of the perimeter of the body;

b) The inner lip is spaced from the outer lip and is disposed closer to the first end than the outer lip,

c) The width of the inner lip is approximately the same as the width of the button;

d) The inner lip extending along a portion of the perimeter of the body;

e) The channel extends around a portion of the button forming a free end;

f) The button is a first button and the body further includes a second button;

g) The second button is spaced approximately 180 from the first button;

h) The first button and the second button are configured to move toward each other due to selective engagement by the patient;

i) The outer lip is configured to abut the vent ring and limit translational movement of the elbow;

j) The button is selectively engageable by the patient to selectively move the inner lip relative to the outer lip;

k) The inner lip is configured to be in a pressurized volume when connected to the plenum and supplied with pressurized air;

l) the inner lip is configured to selectively engage the groove and is configured to disengage the groove upon application of the button; and/or

m) the outer lip extends substantially around the periphery of the body.

In the examples:

a) The button includes a finger extending from the fixed end;

b) The finger extends toward the first end of the body;

c) The fingers are formed as cantilever structures relative to the buttons;

d) The button is a first button and the body further includes a second button;

e) The second button is spaced approximately 180 from the first button;

f) The first button and the second button are configured to move toward each other due to selective engagement by the patient;

g) The outer lip is disposed between the first button and the second button;

h) The distance between one end of the finger and the first end of the body is less than the distance between the outer lip and the first end of the body;

j) The fingers are configured to selectively connect to a vent ring outside of the pressurized volume; and/or

k) The selective engagement of the button is configured to space the finger further from the surface of the body.

a button spaced apart from a surface of the body; and

a finger coupled to the button;

wherein the button is selectively engageable by the patient to move the button relative to the surface of the body; and is also provided with

Wherein the finger is movable with the button.

In the examples:

a) The button is configured to move toward the surface of the body and the finger is configured to move away from the surface of the body when the button is engaged;

b) The button is a first button and the body further includes a second button;

c) The second button is spaced approximately 180 from the first button;

d) The first button and the second button are configured to move toward each other due to selective engagement by the patient; and/or

e) The fingers are configured to be selectively connected to an air ring outside of the pressurized volume.

a button forming a portion of a surface of the body, the button being configured to move to an inside of the body due to an external force; and

a finger coupled to the button and spaced apart from a surface of the body, the finger configured to move due to an external force applied to the button.

In the examples:

a) The fingers are configured to engage an outer surface of the vent ring;

b) The button is biased toward a relaxed position in which the button is substantially flush with the peripheral surface of the body;

c) The finger is spaced apart from the surface of the body by a first distance in the relaxed position and a second distance when an external force is applied, the second distance being greater than the first distance;

d) The button is a first button and the body further includes a second button;

e) The second button is spaced approximately 180 from the first button;

f) The fingers are substantially hook-shaped; and/or

g) The fulcrum is located between the button and the finger, the button is formed in a cantilever structure relative to the fulcrum, and the finger is formed in a cantilever structure relative to the fulcrum.

Another form of the present technology includes a vent ring configured to connect to a plenum and increase humidity within the plenum, the vent ring comprising:

a rear surface configured to be positioned within a pressurized environment, the rear surface comprising at least one vent opening configured to vent air from a plenum; and

a front surface spaced apart from the rear surface and configured to be positioned outside of the pressurized environment.

In the examples:

a) The disc is coupled to the rear surface and configured to be positioned within a pressurized environment;

b) The width of the disc is substantially the same as the width of the rear surface;

c) The disk extends radially outside the location of the at least one vent opening on the rear surface;

d) The tray is configured to deflect exhaled air back to the plenum;

e) An extension is connectable to the vent ring proximate the rear surface, the extension configured to space the at least one vent opening from a surface of the plenum;

f) The at least one vent opening is a plurality of vent openings spaced around the perimeter of the rear surface;

g) A plurality of vent openings equally spaced around the perimeter of the rear surface; and/or

h) A plurality of vent openings extend around less than half of the perimeter of the rear surface.

Another form of the present technique is a connector member having a first side and a second side opposite the first side. The first side and the second side each comprise connector material. The connector material is configured to be removably connected to a positioning and stabilizing structure of the patient interface.

In the examples:

a) The first side comprising the same connector material as the second side;

b) Wherein the connector material is a hook material or a loop material; and/or

c) The connector may be connected to an infinite number of locations.

Another form of the present technique includes a positioning and stabilizing structure including at least one lateral band having an inner surface configured to cover temporal bone of a patient and an outer surface opposite the inner surface; and a connecting member removably connected to the outer surface, the connecting member having a first side and a second side each comprising a connecting material; wherein the connecting member is connectable to a plurality of locations along the length of the at least one side strip.

In the examples:

a) The first and second sides of the connecting member include hook material;

b) The outer surface comprises a loop material;

c) The connecting member is connectable to an infinite number of locations along the length of the at least one side strap;

d) The patient interface includes a frame and positioning and stabilizing structure; wherein the frame comprises a loop configured to removably receive at least one side strap; and wherein the at least one strap is folded after passing through the loop such that the other side of the connecting member is removably connected to the at least one strap;

e) In use, the first side and the second side are removably connected to at least one strap;

f) The positioning and stabilizing structure further includes a posterior band configured to cover the patient's occiput, and wherein the at least one lateral band includes a pair of inferior bands configured to be removably connected to the frame and a pair of superior bands configured to be removably connected to the frame. The pair of upper side straps and the pair of lower side straps each include a connecting member; and/or

g) The connecting members on each of the upper and lower straps are removably connected to an infinite number of locations along the length of the respective strap.

Another form of the present technology includes a positioning and stabilizing structure including at least one side strap, at least one strap including an elastic portion stretchable between a first length and a second length, at least one strap including a portion that is substantially hidden in a first position and visible when the strap is extended in a second position.

In the examples:

a) The hidden portion has a different color than the remainder of the at least one strip;

b) The hidden portion is luminescent;

c) The hidden portion includes an electro-luminescent element (e.g., an LED);

d) At least one strap includes a haptic response element on either side of the hidden portion, the haptic response elements configured to be coupled together in a first position and decoupled in a second position;

e) The haptic response element is a magnet; and/or

f) The haptic response element is a mechanical connector.

Another form of the present technique includes a positioning and stabilizing structure having a posterior band configured to cover the occiput of a patient, a pair of inferior bands configured to be removably connected to the frame, and a pair of superior bands configured to be removably connected to the frame. The pair of upper side straps and the pair of lower side straps each include a connecting member.

In the examples:

a) The connecting members are removably connected to the respective bands;

b) The attachment members each include hook material on each side to facilitate removable attachment;

c) The at least one strap includes a first portion having a first width, a second portion having a second width, and a transition between the first portion and the second portion;

d) The second width is greater than the first width and is configured to be greater than a loop on the frame that receives the strap;

e) At least one of the strips includes a plurality of raised portions;

f) The plurality of raised portions are uniformly spaced apart along at least a portion of the at least one strip;

g) At least one band comprising raised portions of a first density and raised portions of a second density;

h) At least one of the strips includes a cutting edge;

i) The cutting edge is a square edge, a triangular edge or a circular edge;

j) The cutting edges are uniformly spaced apart along at least a portion of the at least one strip;

k) At least one strip includes a first density of cutting edges and a second density of cutting edges;

l) at least one belt comprises an elastic portion stretchable between a first length and a second length;

m) at least one band comprising a portion that is substantially hidden in the first position and visible when the band is extended in the second position;

n) the hidden portion has a different color and/or texture than the rest of the tape;

o) at least one strap comprising a haptic response element on either side of the hidden portion, the haptic response elements being configured to be coupled together in a first position and separated in a second position;

p) a top band configured to cover temporal and/or frontal bones of the patient, the top band having a first section and a second section and being selectively connected by a buckle; and/or

q) the patient interface is removably connected to the positioning and stabilizing structure.

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

One aspect of certain forms of the present technology is an easy-to-use medical device that is easy to use by persons who are not medically trained, by persons with limited dexterity and vision, or by persons with limited experience in using this type of medical device.

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

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

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

Of course, portions of these aspects may form sub-aspects of the present technique. 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 consideration of the following detailed description, abstract, drawings, and claims.

Drawings

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

respiratory therapy system

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

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

Respiratory system and facial anatomy

Fig. 2A shows a schematic diagram of the human respiratory system, including nasal and oral cavity, throat, vocal cords, esophagus, trachea, bronchi, lung, alveolar sacs, heart and diaphragm.

Fig. 2B shows a view of the upper respiratory tract of a human including the nasal cavity, nasal bone, lateral nasal cartilage, alar cartilage, nostril, upper lip, lower lip, throat, 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 lip corners. 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 direction and the front-back direction 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 mid-sagittal plane.

Fig. 2G shows a side view of the nose surface 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 mid sagittal plane, particularly showing the medial foot of the septal cartilage and the alar cartilage.

Fig. 2J shows a front view of the skull including frontal, nasal and zygomatic bones. The turbinates, maxilla and mandible are labeled.

Fig. 2K shows a side view of a skull with a head surface contour 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 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.

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 cross-section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a positive sign and has a relatively large magnitude when compared to the magnitude of curvature shown in fig. 3C.

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

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

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

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

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

Fig. 3H shows a cushion for a mask. The outer surface of the pad is indicated. The edges of the surface are marked. 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 illustrated surface 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 illustrates a left hand rule.

Fig. 3P illustrates a 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 twisting sign 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 rear view of the plenum of fig. 3U. The direction of this view is perpendicular to the intermediate contact surface. The radial plane in fig. 3V divides the plenum into left and right sides.

Fig. 3W shows a cross-section through the plenum of fig. 3V, the cross-section being taken at the sagittal plane shown in fig. 3V. Showing the "middle contact" face. The medial contact surface is perpendicular to the sagittal plane. The direction of the medial contact surface corresponds to the direction of the chord 3210, the chord 3210 being located in the sagittal plane and contacting the cushion of the plenum at only two points in the sagittal plane: an upper point 3220 and a lower point 3230. Depending on the geometry of the pad in this area, the intermediate contact surface may be tangential at the upper and lower points. For an oral-nasal interface configured with a plenum chamber having separate oral and nasal portions, such as an Ultra Compact Full Face (UCFF) mask, the upper and lower points are on a seal-forming structure of the oral portion of the mask.

Fig. 3X shows the location of the plenum chamber 3200 of fig. 3U in use on a face. The sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the in-use position. 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.

RPT device

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

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

Humidifier

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

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

Respiration waveform

Figure 6 shows a model representative breathing waveform of a person while sleeping.

Patient interface examples of the present technology

FIG. 7 is a rear perspective view of a plenum chamber in one form, with the inlet and outlet ports not shown, in accordance with the present technique.

Fig. 8 is a rear view of the plenum of fig. 7.

Fig. 9 is a front view of the plenum of fig. 7.

Fig. 10 is a side view of the plenum of fig. 7.

Fig. 11 is a top view of the plenum of fig. 7.

Fig. 12 is a cross-section of the plenum through plane 12-12.

Fig. 13 is a bottom view of the plenum of fig. 7.

Fig. 14 is a cross-section of the plenum through plane 14-14.

Fig. 15 is a cross-section of the plenum through plane 15-15.

Fig. 16 is a cross-section of the plenum through plane 16-16.

FIG. 16-1 is a cross-section of the plenum through plane 16-1-16-1.

FIG. 16-2 is a cross-section of the plenum of FIG. 16-1, illustrating the plenum in a deformed position.

Fig. 16-3 is a cross-section of another view of the plenum of fig. 16, illustrating a liner of a first size.

Fig. 16-4 are cross-sections of another view of the plenum of fig. 16, illustrating a second size of the cushion.

Fig. 16-5 are cross-sections of another view of the plenum of fig. 16, illustrating a third size of the cushion.

Figure 17 is a cross-section of the plenum through plane 17-17.

Fig. 18 is a cross-section of the plenum through plane 18-18.

FIG. 18-1 is a cross-section of the plenum through plane 18-1-18-1.

Fig. 18-2 is a cross-section of the plenum through plane 18-2-18-2.

Fig. 19 shows a side view of the plenum chamber in a use position with the patient's face, the plenum chamber being shown in outline for clarity.

Fig. 20 shows the patient's face, with specific areas of seal-forming structural engagement indicated.

Fig. 21 is a front perspective view of another form of patient interface in accordance with the present technique.

Fig. 21-1 is a front perspective view of another form of patient interface in accordance with the present technique.

Fig. 22 is a front perspective view of a patient interface according to yet another form of the present technology with the vent removed.

Fig. 23 is a front perspective view of a patient interface with a frame for connecting headgear straps to the plenum chamber.

Fig. 23-1 is a front perspective view of a patient wearing the patient interface of fig. 23.

Fig. 23-2 is a front perspective view of another version of a patient interface having a frame for connecting headgear straps to a plenum chamber.

Fig. 24 is an exploded view of the patient interface of fig. 23.

Fig. 24-1 is an exploded view of the patient interface of fig. 23-2.

Fig. 25 is a front view of a frame and plenum in accordance with one form of the present technique.

Fig. 26 is a front view of a frame and plenum in accordance with another form of the present technique.

Fig. 26-1 is a side perspective view of the frame and plenum of fig. 26.

FIG. 26-2 is a cross-sectional view of the frame and plenum of FIG. 26-1, as viewed along section 26-26.

Fig. 26-2a is a cross-sectional view of another example of the frame and plenum of fig. 26-1, as viewed along section 26-26.

Fig. 26-3 is a top view of the frame and plenum of fig. 26.

Fig. 26-4 are perspective views of the frame and plenum of fig. 26, illustrating the arms of the frame movable between a first position and a second position.

Fig. 26-5 is a rear perspective view of the frame and plenum of fig. 26-4, illustrating the curvature of the plenum in a second position.

Fig. 27 is a rear view of the frame of fig. 26, illustrating the tapered opening.

Fig. 27-1 is a top perspective view of the frame of fig. 26, illustrating the decreasing thickness of the arms of the frame.

Fig. 27-2 is a perspective view of the frame of fig. 26, illustrating loops on the free ends of the frame.

Fig. 27-3 is a perspective view of the frame of fig. 26, illustrating a cross-section of the arms of the frame.

Fig. 28 is a front view of a frame and plenum in accordance with yet another form of the technology.

Fig. 28-1 is a perspective view of a secondary connection point that may be used with a frame in one form of the present technology.

Fig. 28-2 is a cross-sectional view of the frame and plenum of fig. 28, illustrating the connection between the magnets and the secondary connection points of fig. 28-1.

FIG. 29 is a detailed view of a plenum, in accordance with yet another form of the present technology, illustrating a clamp support configured to selectively contact a frame.

FIG. 30 is a bottom view of the plenum of FIG. 29 connected to a frame, the plenum being in contact with a clamp support.

FIG. 31 is a front view of a plenum connected to a frame, the plenum including a clamp support, in accordance with yet another form of the present technique.

Fig. 32 is a front view of a frame illustrating ribs for restricting movement of a connecting member in accordance with yet another form of the present technique.

Fig. 33 is a front view of a frame illustrating a pair of ribs for restricting movement of a connecting member in accordance with yet another form of the present technique.

Fig. 34 is a front view of a frame illustrating an arm having a connection point in accordance with yet another form of the present technique.

Fig. 35 is a perspective view of a frame in accordance with yet another form of the present technique, illustrating raised portions adjacent an eyelet.

Fig. 35-1 is a side perspective view of a frame according to another example.

Fig. 35-2 is a detailed view of the eyelet of fig. 35.

FIG. 36 is a front view of a frame in accordance with yet another form of the present technique, illustrating an upper rod connected to the frame closer to the plenum of the elbow.

FIG. 37 is a front view of a frame illustrating an upper bar of the frame spaced from a plenum in accordance with yet another form of the present technique.

Fig. 38 is a perspective view of the frame of fig. 37.

Fig. 39 is a top view of the frame of fig. 37.

FIG. 40 is a side perspective view of a cushion in accordance with yet another form of the present technique, illustrating protrusions extending from a front surface of a plenum.

Fig. 41 is a detailed view of a strap of a positioning and stabilizing structure that may be used with the patient interface of fig. 23, the strap having a first width and a second width.

Fig. 41-1 is a detailed view of another example of a strap of a positioning and stabilizing structure that may be used with the patient interface of fig. 23, the strap having a raised portion.

Fig. 41-1-1 is a detailed view of another example of a strap having a positioning and stabilizing structure of the patient interface of fig. 23 with a raised portion of another configuration different from the raised portion of fig. 41-1.

Fig. 41-2 is a detailed view of another example of a band of positioning and stabilizing structure that may be used with the patient interface of fig. 23, the band having a cutting edge.

Fig. 41-3 are detailed views of another example of a strap of a positioning and stabilizing structure that may be used with the patient interface of fig. 23, the strap being positioned in a first position.

Fig. 41-4 is a detailed view of the band of fig. 41-3, illustrating the band in a second extended position in which the indicator becomes visible.

Fig. 41-5 are detailed views of another example of a strap of a positioning and stabilizing structure that may be used with the patient interface of fig. 23, the strap positioned in a second extended position in which the indicator becomes visible.

Fig. 41-6 are perspective views of a double sided connecting member having hook or loop material.

Fig. 41-7 is a rear view of the double-sided connecting member of fig. 41-6 connected to a headgear in a first position.

Fig. 41-8 is a rear view of the double-sided connecting member of fig. 41-6 connected to a headgear in a second position.

Fig. 42 is a front perspective view of the patient interface of fig. 23 using the strap of fig. 41.

Fig. 42-1 is a front perspective view illustrating another version of fig. 42, showing a patient interface with a sleeve on an arm of a frame.

Fig. 42-2 is a front perspective view of the patient interface of fig. 23 using another version of the strap.

Fig. 43 is a rear view of another form of liner, illustrating the stop rib in phantom.

Fig. 44 is a cross-sectional view of the gasket of fig. 43, as viewed along line 44-44, illustrating the shape of the stop rib.

Fig. 45 is a side view of the cross-sectional view of fig. 44.

Fig. 45-1 is a cross-sectional view of the gasket of fig. 43, as viewed along line 45-1-45-1, illustrating the shape of the stop rib.

FIG. 46 is a front view of the plenum of FIG. 26, illustrating a recess for receiving a frame.

Fig. 47 is a rear view of a liner in yet another form in accordance with the present technique, with the reinforced areas illustrated in phantom.

Fig. 47-1 is a cross-section of the liner from fig. 47, illustrating the reinforced areas.

Fig. 48 is a cross-section of a liner in accordance with yet another form of the present technique, illustrating another form of reinforcing area.

Fig. 49 is a cross-sectional view of the cushion of fig. 48.

FIG. 50 is a cross-sectional view of a gasket in yet another form in accordance with the present technique, illustrating the spacing between the seal-forming structure and the front surface of the plenum.

FIG. 50-1 is a cross-sectional view of a gasket in accordance with yet another form of the present technique, illustrating an air vent ring having an offset to create a space between a seal forming structure and an elbow.

Fig. 51 is a cross-sectional view illustrating the cushion of fig. 50 being worn by a patient.

Fig. 52 is a perspective view of an arm of a frame including a first ring portion and a second ring portion according to another example.

Fig. 53 is a perspective view of the arm of fig. 52 illustrating the headgear strap attached to the first loop portion at an optimal tension value.

Fig. 54 is a perspective view of 52 illustrating a headgear strap attached to the second loop portion at a tension value that exceeds the optimal tension value.

Fig. 55 is a perspective view of a patient interface according to another example, illustrating a frame with ladder locks attached to headgear straps.

Fig. 55-1 is a perspective view of a patient interface according to yet another example, illustrating a frame with ladder locks attached to headgear straps.

Fig. 56 is a perspective view of a patient interface according to another example, illustrating a frame with a cord stop attached to a headgear strap.

Fig. 56-1 is a perspective view of a patient interface according to yet another example, illustrating a frame with a cord stop attached to a headgear strap.

Fig. 57 is a cross-sectional view of a patient interface according to another example, illustrating an air ring connected to a lip of a plenum chamber inlet port.

Fig. 58 is an exploded view of an air circuit for connection to the patient interface of fig. 57.

Fig. 58-1 is a perspective view of a quick release connector for use in the air circuit of fig. 58.

Fig. 59 is a perspective view of the vent ring of fig. 57.

Fig. 60 is a bottom view of the vent ring of fig. 59 illustrating a plurality of vent holes.

Fig. 61 is a bottom view of another version of a housing for a magnet that is removably connected to the connection point of the frame in any of the previous examples.

Fig. 62 is a perspective view of a decoupling structure according to another form, including a connector for engagement inside an venting ring.

Fig. 63 is a perspective view of an venting ring for engagement with the decoupling structure of fig. 62, according to another example.

Fig. 63-1 is a cross-sectional view of the uncoupled structure of fig. 62 coupled to the vent ring of fig. 63.

Fig. 64 is a perspective view of a decoupling structure according to another form, including a connector for engagement on the exterior of a vent ring.

Fig. 65 is a perspective view of a decoupling structure according to yet another form, including a connector for engagement inside an air ring.

Fig. 66 is a perspective view of an venting ring for engagement with the uncoupled structure of fig. 64 or 65, in accordance with another example.

FIG. 66-1 is a perspective view of the uncoupled structure of FIG. 64 coupled to the vent ring of FIG. 66.

Fig. 66-2 is a perspective view of the uncoupled structure of fig. 65 coupled to the vent ring of fig. 66.

FIG. 66-3 is a cross-sectional view of the decoupling structure and vent ring of FIG. 66-2 coupled to a plenum.

Fig. 67 is a perspective view of a decoupling structure according to yet another form including a connector for engagement on the exterior of the vent ring.

Fig. 68 is a perspective view of an venting ring for engagement with the uncoupled structure of fig. 67 in accordance with yet another example.

Fig. 69 is a perspective view of the uncoupled structure of fig. 67 coupled to the vent ring of fig. 68, illustrating the arms of the uncoupled structure engaged to the vent ring.

FIG. 69-1 is a perspective view of the uncoupled structure of FIG. 67 coupled to the vent ring of FIG. 68, illustrating the arms of the uncoupled structure uncoupled from the vent ring.

FIG. 70 is a cross-sectional view of the decoupling structure and vent ring of FIG. 69 coupled to a plenum.

FIG. 71 is a perspective view of another form of elbow connector connected to a plenum and spaced apart from a surface of the plenum when fully connected.

Fig. 71-1 is a cross-sectional view of the elbow connector and plenum of fig. 71.

Fig. 72 is a side perspective view of yet another form of elbow connector including a zigzag floriation.

Fig. 73 is a front perspective view of the elbow connector of fig. 72.

FIG. 73-1 is a cross-sectional view of the elbow connector of FIG. 73 connected to a plenum.

Fig. 74 is a perspective view of yet another form of elbow connector with fewer vent holes.

Fig. 75 is a perspective view of a swivel used with the elbow connector of fig. 74, illustrating a vent.

Detailed Description

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

The following description is provided for 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, any single feature or combination of features in any example may constitute another example.

When anatomical directional terms are used to describe aspects and examples of the present technology, such as "anterior," "posterior," "superior," and the like, the direction should be understood in the context of the present technology during use by a patient. For example, the front side of the patient interface refers to the side of the patient interface that is in front relative to the patient when the patient wears the interface in the intended manner.

If a surface or portion is described as facing in a certain direction, e.g. "upper facing", "front facing", etc., such surface or portion is to be understood as at least partially facing in a particular direction unless the context clearly requires otherwise. A portion may be "upwardly facing" if it is generally upwardly facing, even though it is also partially facing in another direction.

Therapy method

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

In certain examples of the present technology, oral breathing is limited, restricted, or prevented.

Respiratory therapy system

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

Patient interface

A non-invasive patient interface 3000 according to 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. Thus, the sealed patient interface 3000 is adapted to deliver positive pressure therapy.

In some examples of the present technology, the plenum is at least partially formed by a shell 3250. In an example, the shell 3250 or a portion of the shell 3250 can have some flexibility, as discussed further below.

In some examples of the present technology, the patient interface is an oronasal patient interface, that is, the patient interface is configured to seal around both the nasal and oral airways of the patient. In some examples, the patient interface includes a separate seal around each of the nasal and oral airways.

In the example shown in fig. 7-22, the seal-forming structure of the nasal cavity portion is not located over the nasal bridge or ridge region of the patient's face, but rather seals against the lower surface of the patient's nose.

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 in accordance with one form of the present technique is constructed and arranged to be capable of at least 6cmH relative to the surrounding 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 at least 10cmH relative to the surrounding 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 at least 20cmH relative to the surrounding environment ₂ The positive pressure of O supplies air.

Seal forming 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 over time and from patient to patient within a given treatment session, depending on a number of factors including, for example, the location of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

As described in more detail below, in certain forms of the invention, the seal-forming structure 3100 includes a first seal-forming structure 3101 connected to an oral portion 3201 of the plenum chamber and constructed and arranged to form a seal with an area of the patient's face surrounding the patient's oral entrance, and a second seal-forming structure 3102 connected to the nasal portion 3202 of the plenum chamber 3200 and constructed and arranged to form a seal with an area of the patient's face surrounding the patient's nasal entrance. The phrase "connected to" is used herein to refer to portions or components that are formed as a single piece as well as portions or components that are separately formed and subsequently joined together. In some cases, the components may be connected by intermediate components.

In some forms, the first seal forming structure 3101 independently seals the patient's face as compared to the second seal forming structure 3102.

In some forms, the first seal-forming structure 3101 and the second seal-forming structure 3102 cooperate to form a single common seal against 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 (e.g., silicone rubber).

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

In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each configured to correspond to a different 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 for small-sized heads, and another form of seal-forming structure 3100 that is suitable for small-sized heads but not for large-sized heads.

Sealing mechanism

In one form, the seal forming structure 3100 includes a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to the positive system pressure acting on its underside inside the plenum chamber 3200 to urge 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 at least partially around the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange against buckling in use. Limiting the occurrence of buckling may limit the formation of wrinkles in the seal forming structure 3100, which may result in leakage and loss of therapeutic pressure.

In one form, the seal forming structure 3100 may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged to be in a compressed state, for example as a result of elastic tension in a positioning and stabilizing structure.

In one form, the seal forming structure 3100 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 3100 includes a region having an adhesive or cohesive surface.

In some forms of the present technology, the seal forming structure 3100 may include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tensioning portion, and a portion having an adhesive or bonding surface.

Nasal cavity region

Referring next to fig. 7-18, in some forms of the present technology, the second seal forming structure 3102 includes a central portion 3110 configured to seal with a surface of a patient's nose in use. The central portion may seal with the lower perimeter of the patient's nose (e.g., around the patient's nostrils) and the patient's upper lip. In an example, a portion of the seal-forming structure may engage a septum of a patient. The second seal forming structure 3102 may further include a lateral portion 3111 on a lateral side of the central portion 3110. In an example, the seal-forming structure 3102 may be configured to contact the patient's face below the bridge of the nose or below the point of the nose.

As best seen in fig. 10 and 16-19, the rear surface 3112 of the lateral portion 3111 is sloped forward in an upward/forward direction from the boundary 3103 of the first and second seal-forming structures 3101, 3102 such that the rear side of the mask nose is sloped forward in profile.

In embodiments where the ridge 3120 is provided (as described further below), the rear surface 3112 of the lateral portion 3111 may be inclined forwardly from the ridge 3120.

In some forms of the present technique, the rear surface 3112 of the lateral portion 3111 forms an angle with the intermediate interface of the mask between 20 ° and 90 °. The medial contact surface may be perpendicular to the sagittal plane and may extend substantially along the length of the spine 3120 and chord 3210. The angle may be measured in a clockwise direction in fig. 16, although the angle may also be measured in a counter-clockwise direction such that the measured angle is the complement of the above-described angle (i.e., between 90 ° and 160 °).

As shown in fig. 16-3 through 16-5, the second seal forming structure 3102 may be formed at different angles relative to the intermediate contact surface so that patients with different sized noses may each comfortably wear the patient interface 3000. As shown, two different angles of the second seal forming structure 3102 may be modified on different sized patient interfaces 3000 to provide a better fit for a wide range of patients.

The first angle 6056 may be measured from the intermediate contact surface to a first seal axis 6060 extending along the upper boundary 3247 of the second anterior wall portion 3242 and intersecting the nostril 3135. In some forms, the first angle 6056 may be between about 50 ° and about 150 °. In some forms, the first angle 6056 may be between about 75 ° and about 125 °. In some forms, the first angle 6056 may be between about 100 ° and about 110 °. For example, fig. 16-3 may include a first angle 6056-1 of approximately 108 °, fig. 16-4 may include a first angle 6056-2 of approximately 105 °, and fig. 16-5 may include a first angle 6056-3 of approximately 109 °. As shown, the first angle 6056 is measured in a counterclockwise direction as shown in fig. 16-3 through 16-5. However, the first angle 6056 may be measured in a clockwise direction such that the measured angle is the complement of the above-described angle.

The second angle 6064 may be measured from the intermediate contact surface to a second seal axis 6068 extending along a surface of the second seal-forming structure 3102 configured to contact the patient and intersecting the nostrils 3135. In some forms, the second angle 6064 may be between about 50 ° and about 160 °. In some forms, the second angle 6064 may be between about 100 ° and about 145 °. In some forms, the second angle 6064 may be between about 110 ° and about 130 °. For example, fig. 16-3 may include a second angle 6064-1 of about 127.5 °, fig. 16-4 may include a second angle 6064-2 of about 116.5 °, and fig. 16-5 may include a second angle 6064-3 of about 122 °. As shown, the second angle 6064 is measured in a counterclockwise direction as shown in fig. 16-3 through 16-5. However, the second angle 6064 may be measured in a clockwise direction such that the measured angle is the complement of the above-described angle.

The difference between the first angle 6056 and the second angle 6064 may form the inclination of the second seal-forming structure 3102. As noted above, in some forms, the difference may be between about 1 ° and about 110 °. In some forms, the difference may be between about 5 ° and about 50 °. In some forms, the difference may be between about 10 ° and about 20 °. For example, fig. 16-3 may include a difference of approximately 19.5 °, fig. 16-4 may include a difference of approximately 11.5 °, and fig. 16-5 may include a difference of approximately 13 °. In some forms, the difference may be similar to the angle measured between the back surface 3112 and the intermediate contact surface described above, although the two angles are different.

The different angles shown in fig. 16-3 through 16-5 may correspond to patients with different nasolabial angles (see, e.g., fig. 2E). The patient interface 3000 shown in each of the three figures may represent a different sized interface (e.g., small, medium, or large) each of which may fit comfortably to a patient over a range of nasal labial angles.

As shown in fig. 50 and 51, the first angle 6056 and the second angle 6064 of fig. 16-3-16-5 may provide relief for patients with long nasal prongs (e.g., greater distance between the nasal prongs and the alar apices). For example, the second front wall portion 3242 may be sufficiently spaced apart from the second seal-forming structure 3102 such that contact between the patient's nostrils and the second seal-forming structure 3102 maintains a sufficient distance from the second front wall 3242 to allow airflow. The distance 6072 may extend between the second front wall portion 3242 and the nostril 3135. The distance 6072 may be a shortest distance sufficiently spaced apart between the second front wall portion 3242 and the second seal forming structure 3102, and may not extend along the first axis 6060. Although in other examples, the first distance 6072 may extend substantially along the first seal shaft 6060. This may enable the second seal forming structure 3102 to stretch in a forward direction (e.g., when the patient's tip is longer) without contacting the second anterior wall portion 3242.

As shown in fig. 19, in some embodiments, lateral portion 3111 is configured such that no portion of patient interface 3000 contacts patient's alar vertex 1020 when in use.

Configuring the lateral portion 3111 to be angled in this manner results in a smaller portion of the nose of the interface 3000 extending on the sides of the nose wings than some similar interfaces of the prior art. In some forms of the present technology, this results in a reduction in the portion of the nasal wings that contact the seal-forming structure 3100 relative to the interface with the lateral portion that is sloped back toward the patient's face, thereby reducing the proportion of the nasal wings that can be deformed and occluded by the seal-forming structure 3100, for example, when the patient is sleeping on his side and the interface is in contact with a pillow.

Boundary of oral and nasal cavity regions

Referring specifically to fig. 7, 8, and 16-18, in one form of the present technology, the boundary between the first seal-forming structure 3101 and the second seal-forming structure 3102 forms or includes a corner or ridge 3120. In use, the corners or ridges 3120 may engage the patient's face above the upper lip and directly below the nose.

In an embodiment, the corners or ridges 3120 form a sharper angle than equivalent portions or areas of some oral nasal masks of the prior art, such as those described in PCT application PCT/AU 2019/050278.

The sharper angle reduces the likelihood of wrinkles forming in the first seal forming structure 3101 and/or the second seal forming structure 3102 on or adjacent the corners or ridges 3120 when the mask is donned and treated. Some oral-nasal patient interfaces that do not use such a structure may require a very thin rounded structure to be formed in this area, which may be less resistant to wrinkling. In contrast, the corners or ridges 3120 may be harder than such interfaces and may better retain their shape, and thus may better seal the depressions and folds present around the patient's nose. In embodiments where a support portion (such as support portion 3260 described herein) is provided, this effect may be enhanced because the support portion may resist or prevent compression of the region.

In some forms of the present technique, the radius of the corners or ridges 3120 may be less than 2mm, such as about 1.75mm. In one form of the present technique, the radius may vary from about 1.75mm in the center of the ridge to about 0.75mm in the lateral portion.

The angle formed by the first seal arrangement and the second seal arrangement may be between 20 degrees and 90 degrees, for example 36 degrees.

In some forms of the present technology, the corners or ridges 3120 may extend across substantially the entire boundary 3103 between the first seal-forming structure 3101 and the second seal-forming structure 3102. In embodiments, the corners or ridges 3120 may engage the patient's face at least near the nostril entrance, such as where the wings of the nose intersect the face above the upper lip, as shown by region 1010 in fig. 20.

Oral cavity region

As described above, in one form, the non-invasive patient interface 3000 includes a first seal-forming structure 3101 that forms a seal around the patient's mouth in use. The first seal forming structure 3101 may form a seal over the chin area of the patient's face.

In one form, the seal-forming structure includes a saddle region configured to form a seal over a chin region of a patient's face in use.

The seal forming structure 3100 includes a lower lip portion 3130 that forms a seal against the chin area of the patient and/or the patient's lower lip and/or chin. The under-lip portion 3130 may be connected to (e.g., adjoined to) the over-lip portion 3131 via the oral cavity peripheral portion 3132, as shown in fig. 16.

The seal forming structure 3100 includes a relatively low wall thickness (compared to the rest of the interface) at the mouth aperture peripheral portion 3132, the under-lip portion 3130 of the seal forming structure against the chin area, and at least the center of the under-lip portion 3130, for example less than 0.7 mm. The low wall thickness of these locations helps to achieve an effective, comfortable seal. The seal-forming structures in these areas can easily conform to any complex geometry.

In some forms of the present technique, the oral aperture 3133 is substantially trapezoidal, rather than oval or elliptical, to more accurately correspond to the shape of the patient's nose. This shape of the oral aperture may allow the interface 3000 to be particularly compact and not substantially wider than the width of the patient's nostrils.

As shown in fig. 51, the patient's mouth may be spaced apart from the inlet port 3604 (and thus from the elbow 3500 and/or the breather ring 3504, as shown in fig. 50). The distance 6076 may be measured in a direction substantially parallel to the distance 6072. This distance 6076 provides sufficient clearance for the patient's lips to extend into the cavity 3272 and further forward than the second seal forming structure 3102. The patient may slightly compress the second seal-forming structure 3102 in the forward direction and the distance 6076 may be large enough to prevent contact with the elbow 3500 and/or the breather ring 3504. However, the distance 6076 cannot be too large so that the patient interface 3000 maintains a compact profile.

Also or in addition, as shown in fig. 50-1, a breather ring 3504 (described in more detail below) can include an offset to create additional spacing between the elbow 3500 and the first seal-forming structure 3101 (and thus the patient's lips). The breather ring 3504 can include an offset 3506 (described below) that can space the elbow 3500 from the cavity 3272 of the plenum chamber 3200. For example, as shown in fig. 57, elbow 3500 contacts front surface 3512 of vent ring 3504 and extends beyond rear surface 3508 of plenum chamber 3200. This allows for a more compact design (e.g., because it minimizes extension in a forward direction away from the patient's face), but the elbow 3500 extends into the distance 6076. In other words, distance 6076 (as measured in fig. 51) is no longer the maximum separation between the patient's lips and the front of patient interface 3000. Applying offset 3506 may increase the distance patient interface 3000 extends in front of the patient's face, but also space elbow 3500 from the patient's lips such that distance 6076 remains at the maximum separation distance between the patient's lips and patient interface 3000 in the forward direction.

Nose pillow

In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs 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, at least a portion of which forms a seal on the underside of the patient's nose; a rod; located on the underside of the truncated cone and connecting the truncated cone to the flexible region of the stem. In addition, the structure to which the nasal pillows of the present technology are attached includes a flexible region adjacent the base of the stem. These flexible regions may cooperate to facilitate a gimbal structure that accommodates relative movement of both displacement and angle of the frustoconical and nasal pillow connected structure. For example, the frustoconical body may be axially displaced toward the structure to which the stem is connected.

Plenum chamber

In some forms, the plenum chamber 3200 (or at least a portion of the plenum chamber 3200) and the seal-forming structure 3100 are formed from a single sheet of homogeneous material (e.g., molded silicone). The combination of the seal-forming structure 3100 and the plenum chamber 3200 may be considered a gasket.

The angle of the nasal cavity part being adjustable

Referring specifically to fig. 9, 10 and 16-18-2, in one form of the present technology, the first front wall portion 3240 of the nasal cavity portion 3202 of the plenum chamber 3200 is more flexible than the immediate area of the oral cavity portion 3201. The first front wall portion 3240 may be disposed adjacent to a boundary 3241 of the nasal and oral portions of the plenum chamber 3200. In embodiments, the first anterior wall portion 3240 may be symmetrical about a mid-sagittal plane and may extend at least 50%, such as at least 80%, of the width of the nasal cavity portion 3202 through the plenum. In some embodiments, the first front wall portion 3240 may extend substantially across the entire width of the nasal cavity portion 3202 of the plenum.

In some forms of the present technique, second front wall portion 3242 is less flexible than the immediately adjacent portion of the front wall. In some embodiments, second front wall portion 3242 is immediately adjacent to first front wall portion 3240 on an opposite side of a boundary 3241 of the nasal and oral portions of the plenum. In embodiments, the second anterior wall portion 3242 may be symmetrical about a mid-sagittal plane and may extend at least 50%, such as at least 80%, of the width of the nasal cavity portion 3202 through the plenum. In some embodiments, second front wall portion 3242 may extend substantially across the entire width of nasal cavity portion 3202 of the plenum.

The flexible first front wall portion 3240 may allow the patient contact portion 3110 of the second seal forming structure 3102 to pivot or hinge about an area on the rear side of the interface 3000. This may help allow the interface to accommodate patients having various angles between the bottom of the nose and the upper lip (i.e., the nasolabial angle).

In embodiments featuring a corner or ridge 3120 between the first seal forming structure 3101 and the second seal forming structure 3102, as described above, the patient contacting portion 3110 may pivot or articulate about a region at or adjacent to the corner or ridge 3120. In embodiments where one or more support portions 3260 are provided (described further below), the articulation or pivot region may be located directly above the support portions 3260.

As shown in fig. 9, the first front wall portion 3240 can have an upper boundary 3243 and a lower boundary 3244. One or both of the upper and lower boundaries 3243, 3244 may be curved, e.g., such that a central portion of the boundary is below the lateral portion, as shown. The first front wall portion 3240 may have substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary across its width, e.g., such that the height of a central portion of the first front wall portion 3240 is greater than the height of a lateral portion, as shown in the embodiment of fig. 9. Changing the curvature of one or both of the boundaries 3243, 3244 and/or the height of the first front wall portion 3240 can change the stiffness of the first front wall portion 3240, that is, the resistance to collapsing or folding in response to forces on the patient contacting portion 3110 of the second seal forming structure 3102.

Similarly, second front wall portion 3242 may have an upper boundary 3247 and a lower boundary 3248. In some forms of the present technique, the lower boundary 3248 of the second front wall portion 3242 is the same as the upper boundary 3243 of the first front wall portion 3240. Both the upper and lower boundaries 3247, 3248 of the second front wall portion 3242 may be curved, e.g., such that a central portion of the boundary is located below the lateral portion. The second front wall portion 3242 may have substantially the same height across its width (i.e., the upper and lower boundaries may be substantially parallel), or the height may vary across its width, e.g., such that the height of a central portion of the second front wall portion 3242 is less than the height of a lateral portion.

In some forms of the present technology, other ways of configuring first front wall portion 3240 to have a desired stiffness may be used in addition to or in lieu of a curved boundary. For example, the thickness of first front wall portion 3240 can be selected to provide a desired stiffness. In an example, the first front wall portion 3240 can be thinner than an immediately adjacent portion of the plenum wall. Additionally and/or alternatively, the first front wall portion 3240 can extend in an upward direction about a lateral edge of the second front wall portion 3242, as shown in fig. 21, to provide reduced stiffness/compression or collapse resistance as compared to embodiments in which the first front wall portion 3240 is not shaped in this manner.

Second anterior wall portion 3242 (e.g., strap 3270) may help prevent collapse of nasal cavity portion 3202 and may provide support for patient contact portion 3110 of second seal-forming structure 3102, which is typically relatively thin. The insufficiently supported patient contacting portions may suffer from bursting of the sealing engagement with the patient's face. In one form, the second front wall portion 3242 is thicker than the immediately adjacent portion of the plenum wall. In some forms, the second front wall portion 3242 is provided as a thickened strip of material 3270, as shown in fig. 16-19. First front wall portion 3240 and second front wall portion 3242 may be made from the same material, for example, as part of an integrally molded shell 3250.

In some forms, first front wall portion 3240 and second front wall portion 3242 may include different thicknesses. For example, the thickness of second front wall portion 3242 may be greater than the thickness of first front wall portion 3240, which may provide increased stiffness in second front wall portion 3242 (e.g., as compared to first front wall portion 3240). In particular, second front wall portion 3242 may be a strip 3270 extending into cavity 3272 of plenum chamber 3200. For example, strap 3270 may extend through first front wall portion 3240 and toward a patient wearing patient interface 3000. The outer surface of nasal cavity portion 3202 may be substantially smooth, while the inner surface of the nasal cavity portion (e.g., within cavity 3272) may be stepped (or otherwise include discontinuities).

As shown in fig. 16-1 and 16-2, first front wall portion 3240 can act as a hinge and allow nasal cavity portion 3202 to flex. First anterior wall portion 3240 may be the thinnest area of nasal cavity portion 3202 and, thus, may be most susceptible to bending moments. The increased thickness of the strap 3270 directs bending moments away from the second front wall portion 3242 and toward the thinner first front wall portion 3240. The greater height of strap 3270 (i.e., greater distance between upper boundary 3247 and lower boundary 3248) may also make nasal cavity portion 3202 stiffer and less able to bend around first anterior wall portion 3240. When bending occurs, the first and second front wall portions 3240, 3242 may move in a forward direction (e.g., away from the patient).

As shown in fig. 18-1 and 18-2, the upper boundary 3243 of the first front wall portion 3240 is different from the lower boundary 3248 of the second front wall portion 3242. Conversely, the upper boundary 3243 is at least partially higher than the lower boundary 3248, and may be at least partially aligned with the upper boundary 3247 of the second front wall portion 3242. This allows the first front wall portion 3240 to be at least partially disposed alongside the strap 3270 (e.g., and around the strap 3270 on two or more sides). In other words, the first front wall portion 3240 may be disposed on at least one end of the strap 3270. This may provide greater flexibility to first anterior wall portion 3240, enabling nasal cavity portion 3202 to flex further (e.g., in a forward direction).

As shown in fig. 21-1, nasal cavity portion 3202 may also be formed without a hinge. In other words, the strips may not be formed on the second front wall portion 3242 such that the first front wall portion 3240 and the second front wall portion 3242 have a substantially uniform thickness. Nasal cavity portion 3202 is still able to flex even without straps because it may be constructed of silicone, which allows nasal cavity portion 3202 some compliance to accommodate different nasal lip angles.

Flexible shell

In some forms of the present technology, the housing 3250 can be made from a rigid material such as polycarbonate. However, in other forms of the present technology, the housing 3250 or a portion of the housing 3250 may be somewhat flexible. For example, in an example, the shell 3250 can be formed from a material having a young's modulus of 0.4GPa or less, such as a foam. In some forms of the present technology, the shell 3250 may be made of a material having a Young's modulus of 0.1GPa or less, such as rubber. In other forms of the present technique, the shell 3250 can be made from a material having a Young's modulus of 0.7MPa or less (e.g., between 0.7MPa and 0.3 MPa). One example of such a material is silicone.

In an example, the shell 3250 and one or both of the first and second seal forming structures 3101, 3102 may be formed from the same material (e.g., silicone, fabric, etc.).

In some forms of the present technology (see, e.g., fig. 23-28-2), the shell 3250 may be constructed substantially entirely of a flexible material, which may provide the shell 3250 with the greatest freedom of movement (i.e., substantially without rigidity and/or thickening that limits bending). The shell 3250 can be sufficiently flexible such that one or more components are added to provide a desired stiffness in one or more areas or regions of the shell 3250 (e.g., the region contacting the region 1010). For example, a ventilation module; a connection port; a headgear connector; one or more of the headgear connectors connected to the rigid arms and rigid members may be connected to the shell 3250 in such a way as to increase the rigidity of the plenum chamber 3200 in the area adjacent the component, for example, as described further below. In some forms of the present technology, these components may be releasably connected to the flexible housing 3250. Additionally or alternatively, one or more components may be permanently connected to the housing 3250, for example, by bonding and/or overmolding. The rigid member may also be used to increase the rigidity of the seal forming structure 3100 and/or support the shape of the seal forming structure.

In some forms of the present technology, the shell 3250 may generally be flexible, but may include a reinforcing portion having a greater thickness than an immediately adjacent portion of the shell 3250. Such reinforcing portions may be configured as ribs or strips, for example extending transversely across the shell and/or in an up-down direction, although many other configurations are possible. In some forms, the shell may include a substantially rigid portion, such as a portion made of polycarbonate, and a slightly flexible portion.

In some forms of the present technology, it may be preferable that the center portion 3251 of the front side of the oral portion 3201 of the plenum chamber has a greater stiffness than the remainder of the plenum chamber 3200. In some forms of the present technology, the region of increased stiffness may be located directly below nasal cavity portion 3202, as shown in fig. 21 and described further below, and/or directly above oral cavity portion 3201. In one form of the present technique, a portion or all of the first front wall portion 3240 may be an area of increased stiffness, rather than an area of increased flexibility. Providing increased stiffness in one or more of these areas may provide shape stability and may limit the extent to which the shell 3250 may deform due to headgear forces. Excessive deformation may cause the second seal-forming structure 3102 to block the nostrils. Avoiding such deformation may be particularly advantageous for patients with relatively wide noses, while it may be less important or in some cases undesirable for patients with narrower noses. In addition, the areas of increased stiffness described may help reduce torsional deformation of the interface that may otherwise cause one side of the second seal forming structure 3102 to lose contact with the patient's nose, creating a leakage path.

As shown in fig. 21 and 21-1, in one form of the present technology, the housing 3250 can be provided with a rigid portion 3263, or at least one portion that is more rigid than the remainder of the housing, with one or more connection ports 3600 provided thereon, e.g., molded thereon. In one form of the present technique, rigid portion 3263 may be made from polycarbonate. This may provide greater rigidity than a shell made of silicone alone. In one form of the present technique, the aperture forming the vent 3400 is molded into the rigid portion 3263. In some forms of the present technique, the connector 3310 for positioning and stabilizing the structure is mounted on the arm 3320 to provide some rigidity to the housing.

In one form of the present technique, the rigid portion 3263 extends laterally across the front of the plenum chamber near the upper boundary of the first front wall portion 3240, e.g., directly below the second front wall portion 3242. The rigid portion 3263 may extend continuously between the connection ports 3600 and may provide an airflow path for a pressurized airflow entering the plenum chamber 3200 through the connection ports 3600.

In some forms of the present technology, the cross-section of the connection port 3600 may be generally elliptical. The connection ports 3600 may be oriented such that a centerline of each port is substantially parallel to an outer surface of the plenum adjacent the port.

In some forms of the present technique, the rigid portion 3263 may protrude in a forward direction relative to an adjacent face of the first front wall portion 3240, and may be shaped to increase resistance to bending.

In some forms of the present technology (see, e.g., fig. 21), the connector 3310 and arm 3320 are provided below the connection port 3600 toward the lateral edge of the plenum chamber 3200. The connector 3310 may be provided at a lateral end of the arm 3320. The connector 3310 may provide additional rigidity to the plenum chamber 3200 and/or the seal-forming structure 3100.

In some forms of the present technology (see, e.g., fig. 21-1), the connector 3310 does not include an arm 3320, but is directly connected to the plenum chamber 3200. This may make the plenum chamber 3200 more flexible than the plenum chamber 3200 of fig. 21.

Fig. 22 shows a plenum chamber 3200 having vent mounting holes 3410 into which appropriate vent portions or modules may be inserted. The vent portion may be made of a relatively stiff material to increase the rigidity of the plenum. In some forms of the present technology, the vent mounting holes 3410 may be generally elliptical in shape with the minor axis of the ellipse being substantially parallel to the sagittal plane.

In the embodiment shown in fig. 22, the vent mounting holes are disposed toward the upper edge of the oral portion 3201 of the plenum chamber 3200.

The embodiment shown in fig. 22 is provided with a connector 3310 for use in positioning and stabilizing the structure. The connector 3310 may be mounted in a relatively thick region of the housing 3250. In the illustrated embodiment, the connector 3310 is located below the vent mounting holes 3410 and toward the lateral side of the plenum chamber 3200. In some forms of the present technology, the connector 3310 is a substantially circular magnetic headset connector.

Although no inlet or connection ports are shown in the diagrams of the plenums shown in fig. 7-19, one skilled in the art will appreciate that in practice one or more inlet ports, such as inlet port 3600 shown in fig. 21-22, will be provided. The inlet port 3600 allows an interface to connect to an air circuit 4170, as further described herein. In some forms of the present technology, one or more components of the air circuit 4170 may also be used as components of the positioning and stabilizing structure.

As shown in fig. 24, some forms of patient interface 3000 may include a single inlet port 3604. The inlet port 3604 may be generally circular and may be centered about an oral portion 3201 of the plenum chamber 3200.

As shown in fig. 57, the inlet port 3604 may include a lip 3608 (see, e.g., fig. 49) that extends around at least a portion of the perimeter of the inlet port 3604. For example, the lip 3608 may extend around the entire circumference of the circular inlet port 3604. The lip 3608 may extend into the cavity 3272 (see, e.g., fig. 18-1). The lip 3608 may slope toward the periphery of the circumference of the inlet port 3604.

In some forms, the lip 3608 is substantially perpendicular to the periphery of the circumference of the inlet port such that the diameter of the inlet port 3604 is substantially equal to the diameter of the opening formed by the lip 3608 within the cavity 3272. In other words, the lip 3608 may extend substantially parallel to the port axis 3612 extending through the inlet port 3604.

In other forms, the lip 3608 is inclined between about 1 ° and about 60 ° relative to the port axis 3612. In some forms, the lip 3608 is inclined between about 2 ° and about 50 ° relative to the port axis 3612. In some forms, the lip 3608 is inclined between about 5 ° and about 30 ° relative to the port axis 3612. In some forms, the lip 3608 is inclined between about 10 ° and about 15 ° relative to the port axis 3612.

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

In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material (e.g., translucent silicone). The use of translucent materials may reduce the obtrusive feel of the patient interface and help to improve compliance with therapy.

In some forms of the present technology, dedicated stiffening members or rigid members (e.g., without other functions) may be included on the plenum chamber 3200. These components may be formed of a more rigid material than the plenum chamber 3200 (e.g., than silicone). Dedicated stiffening members may be overmolded to the plenum chamber 3200 to provide greater rigidity than the rigid portions 3263 of the housing 3250 or arm 3320.

Support part

As best shown in fig. 12 and 14-18, in one form of the present technique, the support portion 3260 is provided on an opposite side of the interface 3000 between the second seal forming structure 3102 and the front wall of the plenum chamber 3200. As shown in fig. 12, in one example, each support portion 3260 extends to a lateral edge of the interface.

The support portion 3260 does not act as a base pad, but is configured to resist or hinder compression in the front-rear direction. The support portion 3260 thereby supports and/or reinforces the portion of the second seal-forming structure 3102 that engages the upper lip of the patient. In particular, the support portion 3260 may support and/or strengthen an area of the second seal-forming structure 3102 that may contact an area 1010 of the patient's face proximate to the nostril entrance where the wings of the nose intersect with an area above the upper lip, as shown in fig. 20. In other words, the region 1010 may be located directly below each lower corner of the patient's nose.

The support portion 3260 helps ensure that wrinkles are not formed in the seal forming structure 3100. Because the very flexible seal-forming structure has a large radius of curvature, conforming to the patient's face, wrinkles can form in the seal-forming structure. The seal-forming structure may fold or buckle upon itself due to being too flexible and cause leakage in the seal-forming structure. Wrinkles may be of particular concern when the seal-forming structure seals against the region 1010 of the patient's face. The support portion 3260 may be particularly advantageous when the seal forming structure is configured to form corners and/or ridges 3120 as described herein. The corners and/or ridges 3120 may be sharper curves (e.g., curves having a lower radius of curvature) than seal-forming structures without the support portion 3260. The increased support and/or rigidity by the support portion 3260 reduces the ability of the second seal-forming structure 3102 to conform to the patient's face. To maintain patient comfort, the corners and/or ridges 3120 are selected and/or sized to substantially match the geometry (e.g., contour) of the patient's face. For example, the seal-forming structure 3100 for a particular patient may be selected from a variety of sizes so as to substantially conform to the alar region of the nose (i.e., proximate region 1010). The sharper curvature allows the second seal-forming structure 3102 to seal various gaps around the patient's nose, thereby reducing the likelihood of wrinkling.

As particularly shown in fig. 14-16, in one form of the present technology, a support portion 3260 is connected to the front side of the oral portion 3201 of the plenum chamber adjacent to the boundary 3241 of the oral portion 3201 and the nasal portion 3202. In some embodiments, the support portion 3260 can be curved when viewed in a cross-section parallel to the sagittal plane (as shown in fig. 16-18) and/or when viewed in a cross-section parallel to the anterior sagittal plane (as shown in fig. 14 and 15). The curvature may be positive or negative. In the illustrated example, the curvature may be negative (e.g., relative to the patient's nose). In some examples, lateral sidewall portions 3245 of plenum chamber 3200 may curve inwardly adjacent boundary 3241 of nasal cavity portion 3202, and support portions 3260 may substantially abut adjacent lateral sidewall portions 3245. As shown in fig. 18, at least a portion of the support portion 3260 may be reduced in thickness between a first end 3261 adjacent the anterior wall of the plenum chamber 3200 and a second end 3262 adjacent the seal forming structure 3100 when viewed in a cross-section parallel to the sagittal plane. For example, the support portion 3260 may be thicker proximate the first end 3261, which may help provide increased support and/or rigidity to the second seal forming structure 3102. In some examples, the support portion 3260 can vary between a thickness of 0.1mm (e.g., near the second end 3262) and a thickness of 3.5mm (e.g., near the first end 3261). In some examples, the support portion 3260 can vary between a thickness of 0.3mm (e.g., near the second end 3262) and a thickness of 3mm (e.g., near the first end 3261). In some examples, the support portion 3260 can vary between a thickness of 1.3mm (e.g., near the second end 3262) and a thickness of 2.5mm (e.g., near the first end 3261).

The support portion 3260 having different geometries can be used for different patients. For example, a patient requiring more support and/or rigidity in the second seal-forming structure 3102 may use a seal-forming structure 3100 having a thicker (e.g., near the first end 3261 and/or at any location along the length) and/or more curved (e.g., with a lower radius of curvature) support portion 3260. For example, a patient desiring a more flexible second seal-forming structure 3102 may use a seal-forming structure 3100 having a support portion 3260 that is thinner (e.g., closer to the first end 3261 and/or anywhere along the length) and/or less curved (e.g., greater radius of curvature).

As particularly shown in fig. 14 and 15, in one form of the present technology, the support portion 3260 is connected to the oral portion 3201 of the plenum chamber adjacent the boundary of the lateral side wall portion 3245 of the oral portion 3201 and the lateral side wall portion 3246 of the nasal portion 3202.

In some forms of the present technique, the support portion 3260 is shaped to provide a substantially unobstructed flow path from the oral portion 3201 of the plenum to the nostrils 3135 during inhalation. In some forms of the present technique, no portion of any of the support portions 3260 is located directly below the nostrils 3135.

Overstretch support

As shown in fig. 43-45, patient interface 3000 may include stop ribs 6040 within cavity 3272 of plenum chamber 3200. The stop rib 6040 may be disposed within the oral portion 3201 of the plenum chamber 3200 and provide support around the patient's mouth. The stop rib 6040 may be integrally formed with the plenum chamber 3200 (e.g., in the same molding process) such that the stop rib 6040 is integral with the remainder of the plenum chamber 3200.

As shown in fig. 43, the patient interface 3000 may include a plurality of stop ribs 6040 that extend at least partially around the perimeter of the oral portion 3201 of the plenum chamber 3200 and the first seal forming structure 3101. As shown in fig. 43, the stop rib 6040 may extend only partially around the patient interface 3000 (e.g., in a C-shape or U-shape), and the stop rib 6040 may not be disposed adjacent to (e.g., directly forward of) the lip upper portion 3131. In other forms, the stop rib 6040 may extend around the entire perimeter of the oral portion 3201 and the first seal-forming structure 3101, or may extend around a different portion of the oral portion 3201 and the first seal-forming structure 3101 than shown in fig. 43.

With continued reference to fig. 43, the stop ribs 6040 are spaced apart from one another such that no stop rib 6040 is in contact with any other stop rib 6040. In some forms, the stop ribs 6040 may be equally spaced such that there is an equal distance between each pair of adjacent stop ribs 6040. In other forms, the stop ribs 6040 may not be equally spaced such that at least some of the stop rib pairs 6040 are closer together than others of the stop ribs. For example, the stop ribs 6040 may be closer together at locations that contact areas of the patient's face that are more suitable for receiving force (e.g., near the nasolabial folds).

As shown in fig. 44-45-1, the stop rib 6040 may be an elongated member extending from an inner surface of the plenum chamber 3200 toward the seal forming structure 3100. The stop rib 6040 may be connected to the oral portion 3201 of the plenum chamber 3200 and at least partially spaced from the first seal forming structure 3101 in a rest or non-use position. For example, the edge 6042 (e.g., rear edge) of each stop rib 6040 may be sloped (e.g., not perpendicular to the front-to-rear direction). This may provide additional spacing between the stop rib 6040 and the first seal forming structure 3101 in the unused position.

In use, the patient's face contacts the seal-forming structure 3100 and pushes the first seal-forming structure 3101 in a forward direction. Because each patient may individually tighten headgear straps 3354 (described in more detail below), the patient may over tighten headgear straps 3354 and cause seal forming structure 3100 to press too firmly against the patient's face. If the over-tensioned seal-forming structure 3100 folds or wrinkles and allows pressurized air to escape the plenum chamber 3200, this may cause patient discomfort and/or may reduce the quality of the seal. To limit the occurrence of the over-tightening, the stopper rib 6040 is spaced apart from the first seal forming structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the first seal forming structure 3101 contacts each stop rib 6040 at the edge 6042 along its width (e.g., a narrow width measured substantially parallel to the first seal forming structure 3101). Since the stopper ribs 6040 have a length greater than their width, the stopper ribs 6040 act as reinforcing members and limit the total distance that the first seal forming structure 3101 can move. The stopper rib 6040 may also be thicker than the first seal forming structure 3101 in any direction. This may allow the stop rib 6040 to be sized so that the patient may tighten the headgear strap 3354 to a predetermined point to form the desired seal, but not beyond the predetermined point to minimize discomfort and/or reduced tightness. The inclination of the rim 6042 may allow sufficient space for the patient's face to fit comfortably within the plenum chamber 3200 while also limiting excess space (which may result in excessive tightening, for example) and providing support for the patient's face. The stop rib 6040 can also include a curvature along the width surface (see, e.g., fig. 45-1).

Further, each stop rib 6040 may extend more than half way along the length of the first seal forming structure 3101 (e.g., two-thirds, four-thirds, etc.). This may help ensure that movement is restricted across substantially the entire first seal forming structure 3101.

As shown in fig. 47-49, patient interface 3000 may include a reinforced region 6044 within cavity 3272 of plenum chamber 3200. The reinforced region 6044 may be disposed within the oral portion 3201 of the plenum chamber 3200 and provide support around the patient's mouth. The reinforced region 6044 may be integrally formed with the plenum chamber 3200 (e.g., in the same molding process) such that the reinforced region 6044 is integral with the remainder of the plenum chamber 3200.

The reinforced region 6044 may be formed on the front surface 6046 of the plenum chamber 3200 within the cavity 3272 and proximate to the lateral sides of the oral portion 3201. The stiffening region 6044 may be located directly opposite the patient when the patient interface 3000 is worn. The reinforced regions 6044 may be substantially symmetrical on either side of the oral portion 3201 and may extend around the side regions 6048 of the plenum chamber 3200.

As shown in fig. 47, the height of the reinforced region 6044 may be substantially the same as the height of the inlet port 3604. In other words, the reinforced region 6044 may extend substantially along the length of the oral portion 3201 of the plenum chamber 3200. In some forms, the thickness may vary along the reinforced region 6044. For example, the reinforced region 6044 may be thicker near the inlet port 3604 and may be reduced in thickness away from the inlet port 3604 (although this may be reversed). In other examples, the reinforced region 6044 may be thicker near a lower portion of the oral portion 3201 and thinner near an upper portion of the oral portion 3201 (e.g., near the nasal portion 3202), although the two may be reversed.

As shown in fig. 47-1, some forms of reinforced regions 6044 may be about 0.01mm to about 10mm thicker than surrounding unreinforced regions. In some forms, the reinforced region 6044 may be about 0.1mm to about 5mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be about 1mm to about 2mm thicker than the surrounding unreinforced region. In some forms, the reinforced region 6044 may be about 1.8mm thicker than the surrounding unreinforced region. In some forms, this may be a constant thickness throughout the reinforced region 6044, while in other examples, this may be a maximum of variable thickness throughout the reinforced region 6044.

As shown in fig. 48 and 49, another version of the reinforced region 6044 may be smaller than the reinforced region described in fig. 47. In another version, the stiffening region may be disposed in a lower portion of the oral portion 3201 proximate the plenum chamber 3200. The reinforcing region 6044 may also extend in an oblique direction. For example, each reinforcing region 6044 may be inclined in an up-down direction such that the reinforcing region 6044 is closer to the inlet port 3604 than is further from the inlet port 3604.

Some forms of stiffening regions 6044 of fig. 48 and 49 may extend only along the front surface 6046 of the cavity 3272 and may not extend along the side regions 6048 of the plenum chamber 3200. During use, the stiffening region 6044 may be disposed directly in front of the patient's face. As shown in fig. 49, the reinforcement region 6044 may extend to the side region 6048 (e.g., adjacent to or in contact with the side region 6048), but may not extend around the side region 6048.

As shown in fig. 48, the thickness of the reinforced region 6044 may vary over its surface. For example, the reinforced region 6044 may be thicker near the center and thinner near the sides. Although in other instances this may be the opposite. In some forms, the reinforced region 6044 may be stepped such that there is no gradual transition between the thicker and thinner portions. In other examples, the transition may be gradual.

When the patient interface 3000 in fig. 47-49 is used, the patient's face contacts the seal forming structure 3100 and pushes the first seal forming structure 3101 in a forward direction. Because each patient may individually tighten headgear straps 3354 (described in more detail below), the patient may over tighten headgear straps 3354 and cause seal forming structure 3100 to press too firmly against the patient's face. If the over-tensioned seal-forming structure 3100 folds or wrinkles and allows pressurized air to escape the plenum chamber 3200, this may cause patient discomfort and/or may reduce the quality of the seal. To limit the occurrence of over-tightening, the reinforcing region 6044 is spaced apart from the first seal-forming structure 3101 to allow only a predetermined amount of movement in the forward direction. For example, the reinforcing region 6044 restricts compression of the first seal forming structure 3101 in the forward direction. The stiffening region 6044 may act like the stop rib 6040 and limit the total distance the first seal forming structure 3101 can move. However, the reinforced region 6044 may not provide a stop, but may limit compression because thicker regions require more force to compress. The reinforced region 6044 may be sized such that the patient may tighten the headgear strap 3354 to a predetermined point to form a desired seal, but not beyond the predetermined point to minimize discomfort and/or reduced tightness.

Positioning and stabilizing structure

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

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

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

In one form, the positioning and stabilizing structure 3300 provides retention force as a safety margin to overcome potential impact of interfering 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 the manner in which the patient is worn while sleeping. In one example, the positioning and stabilizing structure 3300 has a small profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap 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 not to be too large and cumbersome to prevent a patient from lying in a supine sleeping position with a rear region of the patient's head on the pillow.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured not to be too large 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 uncoupled section is not resistant to compression and may be, for example, a flexible band or a soft band. The uncoupling portion is constructed and arranged such that when a patient lays their head on the pillow, the presence of the uncoupling portion prevents forces acting on the rear from transmitting along the positioning and stabilizing structure 3300 and breaking the seal.

In one form of the present technique, the positioning and stabilizing structure 3300 includes a belt 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 includes an extensible strap, such as an elastically extensible strap. For example, the strap may be configured to be in tension when in use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strap may be configured as a lace.

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

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

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

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

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

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

Fig. 21 and 22 illustrate an embodiment provided with a connector 3310, such as a magnetic connector, for connection to a positioning and stabilizing structure 3300.

In some forms, the straps of the positioning and stabilizing structure 3300 may be constructed of stretchable (e.g., elastic) material. The positioning and stabilizing structure 3300 may be stretched to accommodate patients with different head sizes.

In some forms, the straps of the positioning and stabilizing structure 3300 may be constructed of an at least partially inextensible material. This may limit the stretching ability of the belt. Different sized straps may be used for different sized patients to accommodate different sized heads. The straps of the positioning and stabilizing structure 3300 may also be adjustable in length.

As shown in fig. 23-2, 24-1, 42-2, 55-1, and 56-1, some forms of the positioning and stabilizing structure 3300 may include an upper band 3357 that in use covers the patient's parietal and/or frontal bones. The upper band 3357 may be adjustable in length to accommodate different sized heads (e.g., using buckles 3369). Each patient may tighten or loosen the upper strap 3357 to fit their respective head. Tightening or loosening the straps adjusts the tension in the upper straps 3357 to provide comfort to the patient wearing the positioning and stabilizing structure 3300.

Frame

As shown in fig. 23-28-2, the frame 3350 is coupled to the plenum chamber 3200 and helps maintain a therapeutically effective position of the seal-forming structure 3100. The plenum chamber 3200 shown in fig. 23-28-2 specifically illustrates the elbow 3500 connected in front of the patient's face, although the frame may be used with other types of plenum chamber 3200 (e.g., the plenum chamber 3200 of fig. 21-22 is used with a catheter headgear).

In some forms, the frame 3350 is constructed of a rigid or semi-rigid material and provides support for the seal-forming structure 3100 and/or the plenum chamber 3200. For example, the frame 3350 may help maintain the shape of the seal-forming structure 3100 and/or the plenum chamber 3200 to reduce pressurized air leakage due to folds and/or wrinkles when the seal-forming structure 3100 engages the patient's face.

In some forms, the frame 3350 provides at least one connection point 3352 that may facilitate the indirect connection of the headgear straps 3354 to the plenum chamber 3200 and/or the seal forming structure 3100. The attachment point 3352 may be a ring (e.g., fully contoured around) for receiving a portion of the headgear strap 3354. For example, a length of upper left headgear strap 3356 may be threaded through the first loop 3352a and pulled away from the plenum chamber 3200 to apply tension through the upper left headgear strap 3356. The left upper headgear strap 3356 may be folded over on itself and maintained at a selected length (e.g., using velcro, magnets, adhesive, etc.) to maintain the applied tension. A similar procedure may be performed with respect to adjusting the tension in the upper right headgear strap 3358 in the second loop 3352b. In other forms, the connection point 3352 may include an open perimeter (e.g., a U-shape or a C-shape).

In some forms, each loop 3352a, 3352b may be oriented such that the force vector applied by the respective upper headgear strap 3356, 3358 is substantially perpendicular to the inner loop surface 3351 contacted by the upper headgear strap 3356, 3358. As shown in fig. 23, the right upper headgear strap 3358 engages the ring 3352b at the approximate center of the ring inner surface 3351. When the right upper headgear strap 3358 is tensioned, the force vector is applied in a substantially straight direction rather than being inclined relative to the inner ring surface 3351. This may improve the seal of the seal-forming structure 3100 because the force is directed along the arm 3362 rather than being oblique to the arm 3362, which may require further tightening of the upper headgear straps 3356, 3358 to receive the same sealing effect (e.g., compromising patient comfort) and/or may prevent the seal-forming structure 3100 from properly engaging the patient's face (e.g., causing leakage).

As shown in fig. 41 and 42, the upper headgear straps 3356, 3358 may include different widths along their lengths. For example, a first portion of each strip 3356, 3358 may be formed with a first width 3359 and a second portion of each strip 3356, 3358 may be formed with a second width 3361 that is greater than the first width. In some forms, a majority of the upper headgear straps 3356, 3358 may be formed with a second width 3361.

Although not shown, the lower headgear straps 3366, 3368 may also include different widths (e.g., and include a tapered shape), similar to the description of the upper headgear straps 3356, 3358. Accordingly, any description relating to upper headgear straps 3356, 3358 may be applicable to lower headgear straps 3366, 3368.

In the illustrated example, each upper headgear strap 3356, 3358 may taper between a first width 3359 and a second width 3361. The upper headgear straps 3356, 3358 may include substantially linear sides 3363 between the first width 3359 and the second width 3361. In other examples, the upper headgear straps 3356, 3358 may bend between the first width 3359 and the second width 3361. In still other examples, the upper headgear straps 3356, 3358 may not include a transition between the first width 3359 and the second width 3361, but may be stepped between the first width 3359 and the second width 3361.

As shown in fig. 41-1 and 41-2, additional feedback features may be used to alert the patient that the upper headgear straps 3356, 3358 are over-tensioned. The illustrated example shows that these features are independently incorporated into the upper headgear straps 3356, 3358 (e.g., in a strap having a substantially uniform width). However, the feedback features of FIGS. 41-1 and 41-2 may be incorporated into the tapered structure (or stepped band) of FIG. 41.

As shown in fig. 41-1, the upper bands 3356, 3358 may include dots 6128 (e.g., dots of silicone). The points 6128 may provide increased resistance as the strap passes through the respective loops 3352a, 3352b of the frame 3350. In other words, the points 6128 may rub against the respective loops 3352a, 3352b and provide a tactile response to the patient, which may alert the patient that the straps 3356, 3358 are too tight.

In some forms, the points 6128 may protrude from the surface of the bands 3356, 3358 to contact the rings 3352a, 3352b and provide a tactile response to the patient.

In the illustrated form, the points 6128 are used with a substantially uniform width belt. The width may be about the width of each ring 3352a, 3352b (e.g., at least a portion of the width of the band may be slightly greater than the width of the rings 3352a and 3352 b). If the patient attempts to pull either upper strap 3356, 3358 through the respective loop 3352a, 3352b, point 6128 will provide further resistance to movement through loops 3352a and 3352 b. For example, the patient may feel vibrations of the points 6128 of contact with the rings 3352a, 3352 b.

In another form, points 6128 are used in addition to the tapered shape of the upper bands 3356, 3358. Thus, point 6128 may serve as an additional signal to the patient indicating that upper straps 3356, 3358 are over-tensioned. In other words, the points 6128 may be positioned on portions of each of the upper bands 3356, 3358 having the second width 3361. If the patient attempts to pull the second width 3361 of either upper band 3356, 3358 through the respective loop 3352a, 3352b, the point 6128 will provide further resistance to movement through the loops 3352a and 3352 b.

In some forms, the points 6128 may be evenly distributed across the upper bands 3356, 3358. In other forms, the points 6128 may be unevenly distributed. For example, the concentration of points 6128 may increase in a direction away from the free ends of the respective bands 3356, 3358. This may provide the patient with an initial warning of possible over-tightening, and may transition to a greater number of points 6128 to alert the patient that over-tightening has occurred.

In other examples (see, e.g., fig. 41-1-1), point 6128 may be used to help guide the patient to the correct position. For example, the points 6128 may be arranged in a uniformly spaced linear pattern. As the patient passes the bands 3356, 3358 through the respective loops 3352a, 3352b, the points 6128 may provide feedback at each interval to communicate the distance the band has passed (e.g., similar to a hole on a belt). In other words, the patient may adjust the band to a particular location based on the number of discrete feedback signals they receive.

In some forms, this may help provide more targeted adjustment of the patient's head. The point 6128 may alert the patient to the particular strap length that is beneficial to his head, rather than simply alerting to over-tightening.

In some forms, the shape, size, and/or density of the dots 6128 can vary along the length of the bands 3356, 3358. For example, the points 6128 may be evenly (or substantially evenly) spaced apart prior to over-stretching to assist the patient in selecting the appropriate length, as described above. The configuration of points 6128 may change (e.g., become denser) at locations of the strap that would cause the patient to overstretch the straps 3356, 3358. The change in the configuration of point 6128 may produce a different haptic response, which may alert the patient to over-tightening.

In some forms, the points 6128 may extend substantially the entire length of the respective bands 3356, 3358. This may provide tactile cues for patients with a wide range of head sizes. In this example, points 6128 may be substantially evenly spaced (although there may be variations in configuration as described above). The point 6128 may allow the patient to continue to select the desired position rather than alert to a particular overtension position.

Although the above description refers to "dots," any suitable shape may be used. For example, the silicone (or other similar material) may comprise a triangle, rectangle, or any other similar shape.

As shown in fig. 41-2, the upper straps 3356, 3358 may include a cutting edge 6132 (e.g., square cut, triangular cut, circular cut, etc.). The cutting edge 6132 may provide a tactile response to the patient, which may alert the patient that the straps 3356, 3358 are too tight.

In the illustrated form, the cutting edge 6132 is used with a substantially uniform width tape. The width may be about the width of each ring 3352a, 3352b (e.g., at least a portion of the width of the band may be slightly greater than the width of the rings 3352a and 3352 b). If the patient attempts to pull either upper strap 3356, 3358 through the respective loop 3352a, 3352b, the change between the full width of the cutting edge 6132 and the discontinuity will provide further indication to the patient to stop tightening the upper straps 3356, 3358 through the loops 3352a, 3352 b.

In other forms, a cutting edge 6132 is used in addition to the tapered shape of the upper bands 3356, 3358. Thus, the cutting edge 6132 may serve as an additional signal to the patient indicating that the upper straps 3356, 3358 are over-tensioned. In other words, the cutting edge 6132 may be positioned on a portion of each of the upper bands 3356, 3358 having the second width 3361. If the patient attempts to pull the second width 3361 of either upper strap 3356, 3358 through the respective loop 3352a, 3352b, the change between the entire second width 3361 of the cutting edge 6132 and the discontinuity will provide a further indication to the patient to stop tightening of the upper straps 3356, 3358 by the loops 3352a, 3352 b.

In some forms, the cutting edges 6132 may be evenly distributed along a portion of the upper bands 3356, 3358. In other words, the distance between each adjacent kerf on the respective cutting edge 6132 may be equal. In other forms, the cutting edges 6132 may be unevenly distributed. For example, the distance between each cut on the cutting edge 6132 and/or the size of the cut may decrease in a direction away from the free end of each upper band 3356, 3358.

In other examples, the cutting edge 6132 may be used to help guide the patient to the correct position. For example, the cutting edges 6132 may be arranged in a uniformly spaced linear pattern. As the patient passes the bands 3356, 3358 through the respective loops 3352a, 3352b, the cutting edge 6132 may provide feedback at each interval to communicate the distance the band has passed (e.g., similar to a hole on a belt). In other words, the patient may adjust the band to a particular location based on the number of discrete feedback signals they receive.

In some forms, this may help provide more targeted adjustment of the patient's head. The cutting edge 6132 may alert the patient to the particular strap length that is beneficial to their head, rather than simply alerting to over-tightening.

In some forms, the shape, size, and/or density of the cutting edge 6132 can vary along the length of the bands 3356, 3358. For example, the cutting edges 6132 may be evenly (or substantially evenly) spaced apart prior to over-stretching to assist the patient in selecting the appropriate length, as described above. The configuration of the cutting edge 6132 may change (e.g., become smaller and/or closer together) at locations of the strap that would cause the patient to overstretch the straps 3356, 3358. The change in configuration of the cutting edge 6132 can produce a different tactile response that can alert the patient to over-tightening.

In some forms, the cutting edge 6132 may extend substantially the entire length of the respective bands 3356, 3358. This may provide tactile cues for patients with a wide range of head sizes. In this example, the cutting edges 6132 may be substantially evenly spaced (although there may be variations in configuration as described above). The cutting edge 6132 may allow the patient to continue to select the desired position rather than alerting to a particular over-tightening position.

In use, as described above, each upper headgear strap 3356, 3358 passes through a respective loop 3352a, 3352b. Since the first width is less than the width of the rings 3352a, 3352b, the first width 3359 may be selectively inserted through the openings of the respective rings 3352a, 3352b. The width of at least some of the transitions may also be less than the width of the rings 3352a, 3352b so that the transitions may also be received through the openings. However, the second width 3361 may be greater than the width of the rings 3352a, 3352b and may not be able to slide through either opening. The larger second width 3361 may provide a stop and limit the overall length that may pass through the respective ring 3352a, 3352b. This may reduce the patient from over-tightening due to the second width 3361. In some forms, the length of the upper headgear straps 3356, 3358 having the first width 3359 (or the length of the first width 3359 plus the transition portion 3363) may be designed for patients having larger heads. Thus, the upper headgear straps 3356, 3358 may be adjusted to achieve a desired degree of tightness before the second width reaches the respective loops 3352a, 3352b or at the same time. For smaller head patients, if the upper headgear straps 3356, 3358 are adjusted to the second width 3361, they can withstand greater tension. However, the second width 3361 may still prevent the patient from overstraining the upper headgear straps 3356, 3358 and limit deformation and leakage of the seal forming structure 3100. Alternatively, differently sized positioning and stabilizing structures 3300 may be configured for patients with differently sized heads (i.e., such that second width 3361 acts as a stop to limit over-tightening for patients with various head sizes).

In other examples, a strap extender may be connected to the upper headgear straps 3356, 3358 to provide a greater length of the first width 3359. This may allow a single positioning and stabilizing structure 3300 designed for a smaller patient's head to be used with a larger patient's head.

In some forms, the strap extender may have a double sided connector. The illustrated example shows the same type of connector on either side, although the connectors on each side may be different. For example, the strap extender may comprise hook and loop material. In some forms, loop material is formed on both sides, while in other forms hook material is formed on both sides. In yet other forms, the hook material is formed on one side and the loop material is formed on the other side.

In some forms, the strap extender may be used to provide additional length so that the patient does not overstretch the strap (e.g., upper straps 3356, 3358 and/or lower straps 3366, 3368).

In some forms, the strap extender may include similar features to the strap shown in fig. 41-5. For example, the belt extender may comprise a tapered shape as shown in fig. 41, or may comprise a stepped shape. This may limit the distance the strap extender may pass through the loops 3352a, 3352b to prevent over-tightening. The strap extender may also include points 6128 (see, e.g., fig. 41-1) and/or cutting edges (see, e.g., fig. 41-2) as described above to provide an indication of overstretching (e.g., haptic response). The strap extender may also include a hidden portion 3365 similar to that of fig. 41-3 through 41-5 that may provide a visual and/or tactile indication of over-tightening. Alternatively, the hidden portion 3365 may be referred to as a reminder portion.

Any of the features described in fig. 41-5 and included in the strap extender may alert the patient to adjust the strap extender relative to the headgear 3354. In some forms, this may involve adjusting the connection position of the strap extender relative to the corresponding strap (e.g., upper straps 3356, 3358 and/or lower straps 3366, 3368) on the headgear. For example, the patient may connect the band extender closer to the portion having the second width 3361 to shorten the effective length of the band, or may connect the band extender closer to the portion having the first width to increase the effective length of the band.

In some forms, the straps (e.g., upper straps 3356, 3358 and/or lower straps 3366, 3368) of the headgear 3354 may include an extension length connector configured to interface with a connector on the strap extender. For example, the upper straps 3356, 3358 may include hook or loop material along at least a portion of the first width 3359 and/or a portion of the second width 3361.

The patient may adjust the position of the strap extender along the length of each strap to select a suitable usable length for the patient (e.g., so that there is sufficient sealing force without excessively extending the strap).

In some forms, there may be different sizes of strap extenders (e.g., small, medium, large) so that the patient can make more targeted adjustments to their particular head and reduce variations in over-stretching of the strap extender.

Also, or in addition, the upper headgear straps 3356, 3358 may be constructed of an elastic material. The elastic material may change in visual appearance (e.g., may change in color) as a result of stretching under tension. The expansion of the headgear straps 3356, 3358 may also provide the patient with a tactile response that the straps 3356, 3358 are overstretched. This change in visual appearance may alert the patient (or a third party such as a bed partner) to overstretching headgear straps 3356, 3358. This may be beneficial when the patient has fully tightened the upper headgear straps 3356, 3358 before the second width reaches the respective loops 3352a, 3352 b.

For example, fig. 41-3 through 41-5 illustrate examples of straps (e.g., upper headgear straps 3356, 3358) that may include features that alert the patient that the straps have been over stretched, which may alert the patient that the straps should be loosened and/or that a different size (e.g., larger) headgear strap 3354 is required.

In fig. 41-3, an example belt is illustrated in a first position. This may be where the strap is not stretched prior to use by the patient. Fig. 41-3 may also illustrate a belt being tensioned to the correct length. For example, the patient may use the strap and adjust it to an appropriate length so that it does not overstretch.

In fig. 41-4, the example belt is illustrated in a second position, stretched and/or extended from an initial position. As described above, the strap may include a portion 3365 that is generally hidden but exposed in the second position. For example, the hidden portion 3365 may be elastic and stretch to an extended length when a pulling force applied to the strap exceeds a threshold value. The hidden portion 3365 may be a different color and/or texture to alert the patient that the tension in the belt has exceeded a predetermined limit. Such a change in appearance and/or feel may alert the patient that the belt is over stretched.

In some forms, the hidden portion 3365 may be luminescent and may be luminescent when exposed. In the darkroom, the dim light emitted from the hidden portion 3365 can be observed, thereby alerting the patient to the overstretching condition of the headgear straps 3354.

In some forms, the hidden portion 3365 may include a noise output device (e.g., a speaker) that outputs sound when the hidden portion 3365 is exposed to alert the patient.

In some forms, the hidden portion 3365 may include an electrical component (e.g., a light emitting element) that outputs light when the hidden portion 3365 is exposed. The output of light may alert the patient that headgear straps 3354 are over stretched. In some forms, headgear straps 3354 may include a battery (not shown) and/or electrical wires for providing power to the electrical components.

In some forms, the patient may not see that the strap has exceeded the threshold tension and the hidden portion 3365 is exposed (e.g., the strap may no longer be visible to the patient when the patient wears the strap). As shown in fig. 41-5, the band may include a haptic response element 3367 that may provide a haptic response to the patient to provide an indication that the tension in the band has exceeded a particular threshold.

In some forms, the haptic response element 3367 is a pair of magnets. When the strap is in the first position, the magnets 3367 are connected to each other. When the tension in the strap exceeds the magnetic force, the magnet 3367 separates and the hidden portion 3365 is exposed. Thus, the belt may be under tension and may stretch (e.g., if elastic) before the magnets 3367 separate.

When the magnet 3367 is disengaged, the patient may receive a disable response. This may be in the form of vibrations along the belt when disconnected from the magnet 3367 and/or in the form of an audible signal. Either or both of these conditions may alert the patient that the belt is too tight. Removing excess tension in the strap allows the magnets 3367 to reconnect to each other.

In other forms, the haptic response element 3367 may be an alternative connector (e.g., a mechanical connector). For example, the haptic response element 3367 may be constructed of plastic and/or silicone. Instead of magnetic force, the tactile response element 3367 may be connected with a mechanical connection (e.g., snap fit) or similar connection (e.g., a hook and loop connector). These alternative haptic response elements 3367 may have a retention force that allows for some extension below the separation threshold before the haptic response elements 3367. As with the magnet 3367, separation of the tactile response element 3367 may generate vibrations that the patient may detect and determine that the belt is over stretched.

In some forms, haptic response element 3367 may be wider than the bandwidth. This may provide an additional visual cue to the patient to determine that the belt tension has exceeded the threshold.

Although not shown, the overstretching features shown and described in fig. 41-3 through 41-5 may also be incorporated into other straps on headgear straps 3354. For example, the lower headgear straps 3366, 3368 may be fastened to the magnets in a similar manner so that over-tightening may occur. Additionally or alternatively, the adjustable upper strap 3357 (see, e.g., fig. 23-2, 24-1, 42-2, 55-1, and 56-1) may include a hidden portion 3365 to alert the patient to over-tightening. The adjustable upper strap 3357 may also include a tapered strap to limit over-stretching. The tapered straps may be used with strap extenders to allow a single headgear strap 3354 to be used on heads of various sizes.

As shown in fig. 41-6 through 41-8, headgear straps 3354 may utilize double-sided connection members 6136 to allow the patient to adjust the available length. As shown in fig. 41-6, the double-sided connecting member 6136 may include hook material (or loop material) on both sides (e.g., the first side 6136-1 and the second side 6136-2 may be functionally identical). The patient may attach the hook material to the loop material (or hook material) of headgear strap 3354 at a desired location. For example, the entire length of the headgear strap 3354 may include hook material such that there are an infinite number of positions to position the double-sided connecting member 6136. The patient can adjust the position as desired. For example, the patient may repeatedly connect and disconnect the double-sided connection member 6136 with the headgear strap 3354. Once attached, the patient may use the headgear straps 3354 like the other headgear straps 3354 and fold the free ends of the straps back upon themselves to attach the exposed sides of the double-sided attachment members 6136 to the headgear straps 3354 (e.g., in use, both sides are attached to the respective headgear straps 3354).

Because the double-sided connecting member 6136 may include the same connecting material on either side, the patient may connect either side to the headgear strap 3354.

In some forms, the double-sided connecting member 6136 may be used with the headgear strap 3354, otherwise the headgear strap 3354 would lack a secure connector.

As shown in fig. 41-7, the double-sided connecting member 6136 may be positioned in a first position (e.g., near the free ends of the various bands). This may result in a longer usable length of headgear strap 3354. For example, a patient with a larger head may attach double-sided connecting member 6136 in a first position in order to achieve a proper fit.

In the first position, a smaller head person may over tighten headgear straps 3354 to achieve a proper fit. Thus, the patient may move the double-sided connecting member 6136 to the second position (i.e., away from the free ends of the various bands, as shown in fig. 41-8). This may result in a smaller usable length so that a smaller head patient may achieve a snug fit using the same headgear strap 3354 without over tightening.

In some forms, the patient may sever the free end of the strap beyond where the double-sided connecting member 6136 is located. In other forms, the excess free end may remain so that a different patient (e.g., having a different sized head) may readjust the double-sided connecting member 6136 to fit their head.

In some forms, the double-sided connecting member may have hook material on one side and loop material on the other side such that the two sides are functionally different.

As shown in fig. 27-2, some forms of rings 3352a, 3352b may include eyelet cuts 3353 that may be formed on the patient side (e.g., the side that is adjacent to the patient's skin in use) of each ring 3352a, 3352 b. The eyelet cut 3353 may form a region of reduced thickness along the perimeter of each ring 3352a, 3352 b. The eyelet cut 3353 may extend around a portion (e.g., less than 360 °) of the perimeter of each ring 3352a, 3352 b. In the illustrated example, the respective headgear straps 3354 may contact the eyelet cutouts 3353 when received by the rings 3352a, 3352 b. The reduced thickness of the eyelet cut 3353 may result in reduced material used to manufacture the rings 3352a, 3352b, which may result in reduced manufacturing time and/or reduced manufacturing costs. The eyelet cut 3353 may also (or instead) result in reduced skin marks and increased patient comfort.

In one form, at least one of the rings 3352a, 3352b may not be formed entirely around the outer perimeter. In other words, the rings 3352a, 3352b may be C-shaped and/or U-shaped. The upper left and/or right headgear straps 3356, 3358 may be folded over on themselves individually and then inserted into the respective loops 3352a, 3352 b. This may allow the patient to maintain the same length adjustment in each of the upper headgear straps 3356, 3358 when the seal forming structure 3100 is removed from the therapeutically effective position.

As shown in fig. 35-2, some forms of frames 3350 include a ring 3352 having a raised profile. For example, the illustrated ring 3352b includes a raised portion 3390 adjacent to the arms 3362 b. The sleeve 6124 may bend due to the connection to the arm 3362 b. The raised portion 3390 may reflect the curvature of the sleeve to provide a more constant interface between the ring 3352b and the sleeve 6124.

The raised portion 3390 may include a circular shape (e.g., a semi-circular shape). In some forms, the raised portion 3390 may protrude from about 0.01mm to about 1cm. In some forms, the raised portion 3390 may protrude from about 0.05mm to about 5mm. In some forms, the raised portion 3390 may protrude from about 0.1mm to about 3mm. In some forms, the raised portion 3390 may protrude from about 0.5mm to about 1.5mm. In some forms, the raised portion 3390 may protrude about 1.2mm.

As shown in fig. 52-54, some forms of frames 3350 include another example of a ring 6080. In the illustrated example, the ring 6080 can include a dual eyelet shape. For example, each ring 6080 may include the shape of two adjacent rings 3352a, 3352b with a dividing wall 6084 formed therebetween. The divider wall 6084 may divide the ring 6080 into a first ring segment 6080-1 and a second ring segment 6080-2. The first ring segment 6080-1 may be adjacent to the respective arm 3362 and the second ring segment 6080-2 may form a free end of the frame 3350. The divider walls 6084 may not extend completely across the width of the rings 6080 such that each ring 6080 includes a single opening (e.g., two openings if the divider walls 6084 extend completely across, the opposite). In other words, the first ring segment 6080-1 and the second ring segment 6080-2 are not completely separated and the belt may move between the two segments. The partition wall 6084 may be formed in two sections with a central space 6088 formed therebetween.

As shown in fig. 53, the upper headgear straps 3356, 3358 may be connected to respective loops 6080 in a similar manner as described above with respect to loops 3352a, 3352 b. For example, the upper headgear straps 3356, 3358 may pass through the respective loops 6080 and apply a substantially perpendicular force against the divider wall 6084 to hold the seal forming structure 3100 in place.

With continued reference to fig. 53, the divider wall 6084 may help the patient limit over-tightening of the upper headgear straps 3356, 3358. The width of each upper headgear strap 3356, 3358 may be greater than the space between the dividing walls 6084. Each upper headgear strap 3356, 3358 may rest on a respective divider wall 6084 and provide a rearwardly directed force when the strap is tensioned. When the upper headgear straps 3356, 3358 remain relaxed or within a desired tension, the upper headgear straps 3356, 3358 contact the dividing wall 6084 and remain within the respective first ring segments 6080-1.

As shown in fig. 54, if the user applies excessive tension (e.g., tightens each upper headgear strap 3356, 3358 at the upper end of the desired tension range), the upper headgear straps 3356, 3358 may move into the second ring segment 6080-2. The upper headgear straps 3356, 3358 may bend or fold due to excessive tension. In other words, excessive force pulls each upper headgear strap 3356, 3358 through the central space 6088 and into the second ring segment 6080-2. The stiffness in the upper headgear straps 3356, 3358 may resist such bending movement (e.g., being pulled through the central space 6088) while the applied force remains within or below the desired tension range. Once the tension exceeds this range, the applied tension exceeds the stiffness of the upper headgear straps 3356, 3358 and causes the center of each upper headgear strap 3356, 3358 to bend (i.e., because the center is not supported by the dividing wall 6084). Once the upper headgear straps 3356, 3358 move through the central space 6088, the upper headgear straps 3356, 3358 contact the second ring segment 6080-2 and apply a vertical force. Movement of the upper headgear straps 3356, 3358 may alert the patient or a third party (e.g., via visual and/or tactile stimulus) that the upper headgear straps 3356, 3358 are pulled too tight. The patient can loosen the upper headgear straps 3356, 3358 and reposition the upper headgear straps 3356, 3358 against the respective divider wall 6084.

Because the upper headgear straps 3356, 3358 do not need to be stretched as much in the second ring segment 6080-2, the upper headgear straps 3356, 3358 may also reduce tension as they move from the first ring segment 6080-1 to the second ring segment 6080-2. This may temporarily reduce the tension in each upper headgear strap 3356, 3358. However, further increases in tension may not be prevented.

As shown in fig. 55, some forms of the frame 3350 may include ladder locks 6092 instead of rings (either ring 3352a, 3352b or ring 6080). The upper headgear straps 3356, 3358 may pass through the respective ladder locks 6092 to tighten the seal forming structure 3100 against the patient's face. In some forms, the ladder lock 6092 may be molded to the arm 3362 of the frame 3350. In other examples, the ladder lock 6092 may be a separate element (e.g., if two straps are connected together, such as in an upper region of the patient's head). For example, the housing 3371 may include ladder locks 6092.

As shown in fig. 56, some forms of frames 3350 may include stops 6096 that may help adjust the length of the upper headgear straps 3356, 3358. Stop 6096 may be coupled to either arm 3362 and used in place of a ring (e.g., rings 3352a, 3352b or ring 6080). Each upper headgear strap 3356, 3358 may pass through a respective stop 6096. Stop 6096 may include a spring loaded button 6100 that secures the respective upper headgear straps 3356, 3358 in place. The patient can actuate the button 6100 and move the corresponding upper headgear straps 3356, 3358 (e.g., tighten or loosen) to establish the proper fit. For example, housing 3371 may include stop 6096.

As shown in fig. 24-28, some forms of frames 3350 include a central portion 3360 coupled to a plenum chamber 3200. The central portion 3360 may have an annular shape and may have a contour (e.g., approximately a right dome curvature) corresponding to the shape of the plenum chamber 3200.

In one form, a single size central portion 3360 may be used with various sizes of plenums 3200 and/or seal-forming structures 3100. For example, the seal-forming structure 3100 can have a variety of sizes (e.g., small, medium, large, etc.) and/or shapes (e.g., narrow, wide, etc.) in order to better seal patients having a variety of facial shapes. The engagement area of the central portion 3360 may remain substantially the same regardless of the size of the plenum chamber 3200 and/or the seal-forming structure 3100. Thus, the central portion 3360 may be coupled to gaskets of various shapes and/or sizes and provide substantially the same support.

In one form, the central portion 3360 may be removably coupled to the plenum chamber 3200. The patient may use the same frame 3350 with multiple plenums 3200. This may be useful when the patient begins treatment for the first time and is trying to have a different size of the plenum chamber 3200 in order to find a proper fit. Removal of the frame 3350 may also be helpful when cleaning the patient interface 3000, as the different elements of the patient interface 3000 may be cleaned separately to help ensure a more thorough cleaning.

In other forms, different frames having differently sized and/or shaped central portions may be used with differently sized plenums 3200 and/or differently sized patients to provide a comfortable fit for various patients. As shown in fig. 36-39, the central portions 13360, 23360 of frames 13350, 23350 may include shapes to allow for a comfortable seal when used with patients having a large nose length (e.g., a distance measured in the anterior-posterior direction between the apex of the patient's nasal wings and the nasal protrusions).

As shown in fig. 36, the frame 13350 may include a central portion 13360 that is smaller than the central portion 3360 of fig. 25. For example, when each frame 3350, 13350 is connected to a plenum chamber 3200, an upper bar 16036 on the frame 13350 may be disposed below a similar upper bar 6036. This may allow the upper portion of the plenum chamber 3200 (e.g., nasal cavity portion 3202) and/or seal forming structure 3100 (e.g., second seal forming structure 3102) to move or flex when worn by a patient. This may be helpful for patients with larger noses. While the upper stem 6036 (e.g., as shown in fig. 25) may provide more rigid support, the plenum chamber 3200 and/or seal forming structure 3100 may not move a sufficient amount to receive a larger nose. Lowering the height of the upper bar 16036 (e.g., in fig. 36) provides flexion and better fit for patients with larger noses.

As shown in fig. 37-39, the frame 23350 can include a central portion 23360 having an upper stem 26036, the upper stem 26036 not being planar with the remainder of the central portion 23360. For example, the upper stem 26036 may extend in a forward direction from the remainder of the central portion 23360 (e.g., when connected to the plenum chamber 3200). Accordingly, the upper stem 26036 may be spaced apart from the nasal cavity portion 3202 of the plenum chamber 3200. The central portion 23360 can include a footprint substantially similar to the central portion 3360 such that it can be used with the same plenum chamber 3200. However, the spacing between the plenum chamber 3200 and the upper stem 26036 may allow the plenum chamber 3200 and/or seal forming structure 3100 to further deform and comfortably receive a larger nose.

In some forms, the upper stem 26036 may still provide support for the patient during use. For example, as a result of wearing patient interface 3000, the patient may deform nasal cavity portion 3202 of plenum chamber 3200 such that nasal cavity portion 3202 contacts upper stem 26036. The upper stem 26036 may be far enough in the neutral (i.e., unworn) position to allow the nasal cavity portion 3202 to expand comfortably while the patient is wearing, but contact the upper stem 26036, which provides support and limits excessive bending of the nasal cavity portion 3202. This may mimic the frame 3350, but is sized to facilitate patients with larger noses.

In some forms, the frame 3350 includes arms 3362 that extend away from the central portion 3360. Rings 3352a, 3352b are formed at the ends of arms 3362. In use, the arms 3362 may extend at least partially in a rearward direction, which may position the rings 3352a, 3352b further rearward than the plenum chamber 3200 and/or the seal forming structure 3100. The arm 3362 may also extend in a lateral direction (e.g., left or right, respectively) so as to generally follow the contours of the patient's face.

In some forms, arm 3362 engages a portion of the patient's face when patient interface 3000 is worn by the patient. For example, arm 3362 may contact the cheek of the patient. The shape of the arm 3362 may correspond to the curvature of the patient's face (e.g., extending in a posterior and lateral direction).

In some forms, the arms 3362 may not stretch significantly due to the tension applied by the respective headgear straps 3356, 3358 via the respective loops 3352a, 3352b (e.g., the arms 3362 may be rigid and/or may be inextensible). Tension may be transferred along the arms 3362 to the plenum chamber 3200 and/or the seal forming structure 3100 in order to maintain a therapeutically effective pressure and limit the occurrence of leaks.

In one form, the arms 3362 are constructed of a material that is more flexible than the material used to construct the central portion 3360. The two materials may be molded together such that the frame 3350 is constructed as a unitary, one-piece structure. The arms 3362 may have some rigidity to help maintain their shape. However, the arms 3362 may be bendable so that the patient may adjust the shape to correspond to their facial structure. Allowing the patient to adjust the shape of the arm 3362 may increase the comfort of the patient experience, which may increase patient compliance with the therapy. In this way, the arm 3362 may bend or flex (e.g., due to the cantilever configuration) relative to the central portion 3360, but may not be able to stretch further in the rearward direction (e.g., due to its inextensibility). In addition, the relatively flexible material used to construct each arm 3362 may help reduce facial tracking and increase patient comfort.

In one form, the arms 3362 and the central portion 3360 are constructed of the same material. Such materials provide sufficient flexibility to allow shape adjustment, and also provide sufficient rigidity to maintain the adjusted shape. The central portion 3360 may be more rigid than the arms 3362 due to coupling to the plenum chamber 3200. Additionally or alternatively, the central portion 3360 may be thicker than the arms 3362, which may also result in an increase in rigidity of the central portion 3360. Each arm 3362 is formed in a cantilever shape such that the end adjacent to the respective ring 3352a, 3352b is unsupported. Further, the thickness of the frame 3350 may decrease along the length of each arm 3362 in the direction of the respective loops 3352a, 3352b (see, e.g., fig. 27-1). This may provide each arm 3362 with the flexibility required for bending and/or shaping to substantially correspond to the shape of the patient's face (e.g., cheek). Reducing the width of each arm 3362 may also reduce cheek contact between the respective arm 3362 and the patient's cheek, which may improve patient comfort. Decreasing the width along the length of each arm 3362 may also allow for greater flexibility proximate each respective loop 3352a, 3352 b.

In one form, the sleeve 6124 may be used in conjunction with the arm 3362 to provide additional comfort to the patient. As shown in fig. 42-1, the sleeve 6124 may extend substantially along the length of the two arms 3362. For example, each sleeve 6124 may extend from the fixed end of each arm 3362 to near the central portion 3360 of the frame 3350. Each sleeve 6124 may extend toward the free end of each arm 3362 to near the ring 3352 (or 6080) of the frame 3350.

In the illustrated example, the sleeve 6124 may not cover the central portion 3360 or the ring 3352 (or 6080) of the frame 3350. In this manner, the sleeve 6124 may not block the strap from being connected to the ring 3352 and/or may not block the central portion 3360 from being connected to the plenum chamber 3200. In other examples, the sleeve may be used in conjunction with the central portion 3360 (e.g., to give the patient interface 3000 the appearance of a bedding article).

In some forms, the sleeve 6124 may be constructed from a comfortable material, which may be flexible and/or soft to the touch. As described above, the arm 3362 may be curved and/or shaped to conform to the shape of a patient's face (e.g., a patient's cheek). As a result, at least a portion of the arm 3362 is in intimate contact with the patient's skin. By including the sleeve 6124, the patient's skin can be contacted with a material that is comfortable to wear for extended periods of time. The material may be a fabric and/or foam, or any similar material.

In some forms, the sleeve 6124 may be constructed of an elastomeric material. This may allow the sleeve to stretch over the ring 3352 so that the sleeve 6124 may be removed from the arm 3362 (e.g., cleaned). In other examples, the sleeve 6124 may be wrapped around the arm 3362 by a hook-and-loop, magnetic, or mechanical connection. The connection may be broken to remove the sleeve 6124 from the arm 3362.

In one form, each ring 3352 may include a raised portion 3390 having a circular shape. The raised portion 3390 may include a smooth surface in a direction from the ring 3352 toward the arms 3362, which may allow the sleeve 6124 to slide past the ring 3352 without being hooked. The end 3392 of the raised portion 3390 adjacent to the arm 3362 may be formed as a protrusion or overhang. This may limit the sleeve from sliding in the opposite direction (i.e., disconnecting from the ring frame 3350 by sliding over the ring 3352).

In other forms (not shown), the arm 3362 may include comfort material only on an inner surface of the arm 3362, such as a surface including the scallops 3373 (see, e.g., fig. 27). This may be a piece of material that is attached to the surface that contacts the patient's skin during use, rather than a sleeve. Such material may be attached to the arm 3362 by an adhesive and may be removed and/or replaced with a new sheet of material (e.g., a clean sheet of material).

In some forms, the fixed end of each arm 3362 may have a thickness of between about 2mm and about 7 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between about 2.5mm and about 6 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between about 3mm and about 5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of about 4 mm.

In some forms, the free end of each arm 3362 may have a thickness of between about 0mm and about 4 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between about 0.5mm and about 3 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between about 1mm and about 2.5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of about 2 mm.

As shown in fig. 27-3, some forms of cross-section of each arm 3362 may be substantially rectangular. The corners of the generally rectangular shape (e.g., one corner, two corners, four corners, etc.) may be rounded. This may help to improve patient comfort by reducing sharp surfaces that contact the patient's skin. Each arm 3362 may also have a height greater than its thickness. The height may be designed to comfortably distribute pressure over the patient's skin (e.g., by increasing the height) without impeding the patient's peripheral vision or otherwise causing discomfort to the patient.

In some forms, the height of each arm 3362 may be between about 5mm and about 15 mm. In some forms, the height of each arm 3362 may be between about 6.5mm and about 13.5 mm. In some forms, the height of each arm 3362 may be between about 8mm and about 12 mm. In some forms, the height of each arm 3362 may be between about 9.5mm and about 10.5 mm. In some forms, the height of each arm 3362 may be about 10mm.

As shown in fig. 35, some forms of arms 3362 of the frame 3350 may include ribs 3394, and the ribs 3394 may extend from a lower surface of each arm 3362. Each arm 3362 may include at least one rib 3394. For example, the illustrated frame 3350 includes one rib 3394 on each arm 3362, wherein the rib 3394 is disposed proximate to the central portion 3360 of the frame 3350. In other examples, there may be more than one rib 3394 per arm 3362, and/or the ribs 3394 may be disposed at different locations along the length of the arm 3362 (e.g., near the respective ring 3352 and/or on different surfaces of the arm 3362).

In some forms, each rib 3394 may include a circular profile (e.g., have a semi-circular shape). The rounded profile may reduce or limit discomfort caused by sharp or angled shapes.

As described above, the sleeve 6124 may be positioned around each arm 3362 to provide additional comfort to the patient. The dimensions (e.g., thickness, height, and cross-section described above) of the arms 3362 provide the sleeve 6124 with a surface about which it can extend. However, in some examples, the sleeve 6124 may be larger than the arms 3362 (e.g., due to passing through the ring 3352) and may depend from the respective arms 3362. For example, the height of the arms 3362 may be greater proximate to the ring 3352. This may look and/or feel uncomfortable to the patient wearing patient interface 3000. The ribs 3394 on each arm 3362 may provide additional height (and/or thickness depending on the positioning of the ribs 3394) to the corresponding arm 3362 to extend out of the sleeve 6124 and minimize slack (e.g., to match the height of the arms 3362 near the ring 3352).

The smooth profile of the rib 3394 may limit the sleeve 6124 from catching and/or tearing on the rib 3394. It may also allow the sleeve 6124 to be connected to the arm 3362 or removed from the arm 3362 without damaging the sleeve 6124.

As shown in fig. 26-4 and 26-5, some forms of the frame 3350 may allow pivotal movement between each arm 3362 and the central portion 3360. The pivoting motion may be different from the bending motion described above in that the pivot point 6012 may connect each arm 3362 to the central portion 3360 and allow the entire arm 3362 to move at substantially the same angular distance. As described above, each arm 3362 is also capable of bending in addition to pivoting.

In one form, pivot points 6012 are disposed at substantially the same location on either side of frame 3350. In other words, each arm 3362 may be connected to the central portion 3360 at substantially the same height, and each arm 3362 may extend about the same length past the pivot point 6012. This may allow the patient to mirror the arm 3362. The patient may then individually flex or bend each arm to adjust for one side.

In one form, each pivot point 6012 is a living hinge. In other words, the frame 3350 may be constructed of a substantially uniform material (or the transition between each arm 3362 and the central portion 3360 may be constructed of a substantially uniform material). The thickness at each hinge 6012 may be substantially less than the thickness of the arm 3362 and the central portion 3360 immediately adjacent to the hinge 6012. For example, hinge 6012 may be formed as a recess in the surface of frame 3350 that faces away from the patient when in use. Constructing hinge 6012 uniformly and integrally from substantially the same material as arms 3362 and central portion 3360 may help reduce manufacturing costs (e.g., as compared to including hinges constructed from different materials).

Each arm 3362 may pivot about a respective hinge 6012 between a first position and a second position. The rings 3352a, 3352b may be spaced closer together in the second position than in the first position.

In one form, the first position may be a relaxed position and the second position may be a biased position. The arm 3362 may move to the second position when an external force is applied and may return to the first position when the external force is removed.

In one form, the arm 3362 may also be positioned in the first or second position without the need to continuously apply an external force. The arms 3362 may be moved to the second position such that the arms 3362 overlap each other (e.g., like eyeglasses). This may help provide a smaller footprint for packaging and/or storage.

In other forms (not shown), each arm 3362 may be separate from the central portion 3360 and may be coupled to the central portion 3360 by a swivel hinge (e.g., a pin joint). In still other forms, each arm 3362 may be coupled to the central portion 3360 by an overmolded flexible therebetween, which may allow some pivotal movement.

In some forms, the frame 3350 also includes at least one secondary connection point 3364 spaced apart from the rings 3352a, 3352 b. The secondary connection points 3364 provide additional connection locations that may further facilitate the indirect connection of the headgear straps 3354 to the plenum chamber 3200 and/or the seal forming structure 3100.

In some forms, the frame 3350 includes two secondary connection points 3364 (e.g., a left secondary connection point 3364a and a right secondary connection point 3364 b). The secondary connection points 3364a, 3364b may be located below the rings 3352a, 3352b when the patient interface 3000 is worn by a patient. Headgear straps 3354 may also include a left lower headgear strap 3366 and a right lower headgear strap 3368, each configured to be coupled to a respective secondary connection point 3364a, 3364b. The head cover 3354 as a whole can provide force to the seal forming structure 3100 and/or the upper and lower regions of the plenum chamber 3200.

In some forms, the secondary connection points 3364a, 3364b are formed directly on the central portion 3360. The secondary connection points 3364a, 3364b may be more forward than the rings 3352a, 3352b when the patient interface 3000 is worn by a patient.

In some forms, the secondary connection points 3364a, 3364b may be constructed from a single piece, which may help reduce tooling and/or manufacturing costs.

In some forms, left and/or right lower headgear straps 3366, 3368 are removably coupled to respective secondary connection points 3364a, 3364b. The secondary connection points 3364a, 3364b may be magnetic and the left and/or right lower headgear straps 3366, 3368 may pass through a housing 3371, the housing 3371 including a magnet 3370 having an opposite polarity to the secondary connection points 3364a, 3364b. The housing 3371 may be flexible or semi-rigid to aid in coupling and better retain the magnets in the connected position. The length of the left and/or right lower headgear straps 3366, 3368 may be adjusted by folding the respective straps 3366, 3368 on themselves about the cross bar 3386 (e.g., as is done with the left and/or right upper headgear straps 3356, 3358). In addition, the lower headgear straps 3366, 3368 may include a first width 3359 and a second width 3361. The straps shown in fig. 41 may similarly be used as part of the lower headgear straps 3366, 3368. Accordingly, the lower headgear straps 3366, 3368 may include stops having a second width 3361 to prevent or limit over-tightening. In some forms (not shown), the housing 3371 may include a pair of rings and the cross bar 3386 may not extend entirely between the two rings. Accordingly, the housing 3371 may include the shape described in fig. 52-54 and may similarly alert the patient when the lower headgear straps 3366, 3368 are over-tensioned. This may be used in conjunction with or instead of the lower headgear straps 3366, 3368 having a first width 3359 and a second width 3361.

Alternatively or additionally, the left and/or right lower headgear straps 3366, 3368 may include points 6128 and/or cutting edges 6132 as shown on the upper headgear straps 3356, 3358 (see, e.g., fig. 41-1 and 41-2). The description of the point 6128 and/or cutting edge 6132 on the upper headgear strap may also apply to the lower headgear straps 3366, 3368 to alert the patient that the strap is too tight.

In other examples, ladder locks 6092 and/or stops 6096 may be connected to the frame 3350 to provide adjustment for the lower headgear straps 3366, 3368.

Each magnet 3370 may be removed from the respective secondary connection point 3364a, 3364b without changing the length adjustment of the left and/or right lower headgear straps 3366, 3368. The patient may put on and/or take off the patient interface 3000 while removing the magnet 3370 from the respective secondary connection point 3364a, 3364b only (e.g., without having to remove the left and/or right upper headgear straps 3356, 3358 from the respective loops 3352a, 3352 b).

As shown in fig. 28-1 and 28-2, each secondary connection point 3364a, 3364b may be configured to improve retention with a corresponding magnet 3370. The housing 3376 of each secondary connection point 3364a, 3364b may include a substantially planar (e.g., flat) surface 3378 and a lip 3380 extending from the planar surface 3378.

In the illustrated example, the housing 3376 can have a generally oval shape and the lip 3380 can extend to near the apex of the planar surface 3378. The lip 3380 may also extend around only a portion (e.g., less than 360 °) of the planar surface 3378. In some examples, the lip 3380 may extend less than 180 ° around the planar surface 3378 (e.g., the lip 3380 may not extend to any common point of the generally elliptical planar surface 3378).

As shown in fig. 28-2, each secondary connection point 3364a, 3364b may be coupled to the frame 3350 such that the lip 3380 is disposed near the center of the frame 3350. In other words, each secondary connection point 3364a, 3364b may be oriented such that when the frame 3350 is coupled to the plenum chamber 3200, the lip 3380 is disposed proximate to the elbow 3500.

The magnet 3370 includes a substantially planar surface that may engage a substantially planar surface 3378 of the housing 3376. While engaging the planar surface 3378, the magnet 3370 may be magnetically coupled to the magnetic element 3382 of the secondary connection points 3364a, 3364 b. The overhang 3384 may be spaced apart from the magnet 3370. As shown, the overhang 3384 can be positioned on one side (e.g., the inner side) of the lip 3380 and the magnet 3370 can be positioned on the other side (e.g., the outer side) of the lip 3380. In use, the patient can adjust the length of each lower headgear strap 3366, 3368. Tightening one of the lower headgear straps 3366, 3368 may apply a force away from the center of the frame 3350 (e.g., in a laterally outward direction). This force may be greater than the magnetic force between the magnet 3370 and the magnetic element 3382 and may cause the magnet 3370 to move relative to the planar surface 3378.

The overhang 3384 prevents the magnet 3370 from disengaging from the magnetic material 3382 by tightening each of the lower headgear straps 3366, 3368. When the magnet 3370 begins to move, the overhang 3384 may contact the lip 3380, thereby limiting further movement away from the center of the frame 3350. The engagement between the lip 3380 and the overhang 3384 thus helps to reduce inadvertent disconnection of the magnet 3370 from the respective secondary connection points 3364a, 3364b when the respective lower headgear straps 3366, 3368 are tensioned, but does not limit the ability of the patient to move the magnet 3370 substantially perpendicular to the frame 3350 (e.g., to disengage the positioning and stabilizing structure 3300).

As shown in fig. 29-35, other configurations may be used to increase the retention of the connection points 3364a, 3364b with the corresponding magnets 3370. The forms described in fig. 29 to 35 may be used alone or in any combination with each other. Any of the forms described in fig. 29-35 may also be used with the lip 3380 shown in fig. 28-1 and 28-2.

As shown in fig. 29 and 30, the oral portion 3201 of the plenum chamber 3200 may include at least one clip support 6016. As shown in fig. 29, clip support 6016 may be disposed radially outward of groove 3280, proximate an edge of oral portion 3201. In some forms, a second clamp support 6016 may be provided on the other side of the plenum chamber 3200 in a mirror image position with the clamp support 6016 shown in fig. 29. When the frame 3350 is connected to the plenum chamber 3200, the clamp support 6016 may be spaced apart from the frame 3350 (and thus from the connection points 3364a, 3364 b).

As shown in fig. 29, some forms of clamp support 6016 may be spaced apart from the groove 3280 such that the distance between each connection point 3364a, 3364b and the clamp support 6016 is approximately the length of the housing or connection member 3371. In other words, the length between the overhang 3384 (see, e.g., fig. 28-2) and the cross bar 3386 (see, e.g., fig. 28) is approximately the length between the respective connection points 3364a, 3364b and the clamp support 6016.

With continued reference to fig. 29, some forms of clip support 6016 may protrude from the surface of oral portion 3201. The clip support 6016 may be integrally formed with the oral portion 3201 as a unitary structure (e.g., using an injection molding process). Accordingly, clip support 6016 may be formed of the same material as oral portion 3201. For example, clamp support 6016 may be constructed of a silicone material and may be flexible, bendable, and/or compressible. The increased thickness of clip support 6016 (e.g., as compared to the rest of oral portion 3201) may limit the flexibility, bendability, and/or compressibility of clip support 6016. The increased thickness may also enable clip support 6016 to act as a further rigid member (e.g., in addition to frame 3350) to further increase the rigidity of oral portion 3201.

In some forms, clamp support 6016 may also be curved or extend along an arcuate path. As shown in fig. 29, the clamp support 6016 may include a constant curvature (although a varying curvature may be used). The center of curvature may be the location of each connection point 3364a, 3364b.

As shown in fig. 46, some forms of clamp support 6016 may be connected to the groove rib 6052 and may be formed as a single molded piece. The shape may be varied along the length to form clamp support 6016 and groove rib 6052, respectively. In other forms, clamp support 6016 may be spaced apart from groove rib 6052.

As shown in fig. 30, the frame 3350 may be connected to the oral portion 3201 and the magnets 3370 may be connected to respective connection points 3364a, 3364b. The end of the connecting member 3371 proximate to the cross bar 3386 may extend upward to and/or slightly beyond the corresponding clamp support 6016. In some forms in which the connection member 3371 is rotatable relative to the frame 3350, rotation of the connection member 3371 may substantially follow the curvature of the clamp support 6016 such that the connection member 3371 extends the same distance relative to the clamp support 6016 throughout its angular movement.

In some forms, the height of the clip support 6016 from the oral portion 3201 may be less than the distance between the cross bar 3386 and the oral portion 3201. Thus, the cross bar 3386 and clamp support 6016 may be slightly spaced apart in the neutral position. The spacing may provide a gap for each lower strap 3366, 3368 to extend around the cross bar 3386. Once the respective lower straps 3366, 3368 are connected to the respective connecting members 3371, the connecting members 3371 may be substantially adjacent to or in contact with the clamp support 6016. This may limit or prevent the connecting member 3371 from rocking and/or pivoting toward the surface of the oral portion 3201. Rocking or pivoting may occur if the lip 3380 and overhang 3384 (see, e.g., fig. 28-2) are not fully engaged when the lower straps 3366, 3368 are pulled tight, and/or if the patient presses the connecting member 3371 closer to the crossbar 3386 (e.g., while the patient sleeps). In the case of clamp support 6016, cross bar 3386 contacts clamp support 6016 prior to the substantial rocking or pivoting motion. Thus, if the patient inadvertently touches the connection member 3371 during sleep, the magnet 3370 may remain connected to the respective connection points 3364a, 3364b, helping to ensure that the seal-forming structure 3100 remains in place. During use, clamp support 6016 may be at least partially covered such that patient interface 3000 may maintain its compact appearance.

As shown in fig. 31, another form may include the clamp support 6020 on the frame 3350 rather than on the plenum chamber 3200. The clamp support 6020 may be integrally formed with the frame 3350. The clamp support 6020 and the frame 3350 may be constructed of the same material, or each may be constructed using different materials (e.g., separate materials may be introduced into the mold to form the clamp support 6020). The clamp support 6020 may be substantially similar in shape to the clamp support 6016. For example, the clamp support 6020 may extend beyond the respective connection points 3364a, 3364b by about the length of the connection member 3371. The clamp support 6020 may also extend in a curved or arcuate path that may include a constant curvature about the respective connection points 3364a, 3364 b.

In some forms, the clamp support 6020 may be at least partially flush with the central portion 3360 of the frame 3350. For example, the interface between the proximal end of the clamp support 6020 and the central portion 3360 may be substantially flush such that the central portion 3360 and the clamp support 6020 each have the same thickness. In other forms, the clamp support 6020 may have a thickness that is less than the central portion 3360. In this case, the clamp support 6020 may be flush with only a portion of the central portion 3360 (e.g., the clamp support 6020 may be flush with an upper or lower edge of the central portion 3360).

In some forms, a distal end 6021 of the clip support 6020 opposite the proximal end may be curved or deflected and extend away from a surface of the oral portion 3201. Bending or flexing at distal end 6021 may form similarly shaped protrusions in clip support 6016 of fig. 29 and 30. In other words, the distal portion 6021 may extend the same distance from the surface of the oral portion 3201. Thus, the engaged connection member 3371 may be restricted or prevented from rocking or pivoting in substantially the same manner as the clamp support 6016.

As shown in fig. 32 and 33, the frame 3350 may include at least one rib 6024 proximate each connection point 3364a, 3364 b. The ribs 6024 can limit rotational movement of the connecting member 3371, which can maintain a desired orientation of the lower straps 3366, 3368 (e.g., to maintain an appropriate force vector).

As shown in fig. 32, the central portion 3360 of the frame 3350 may include a pair of ribs 6024 adjacent each connection point 3364a, 3364 b. In the illustrated example, one rib 6024 may be disposed above each connection point 3364a, 3364b and one rib 6024 may be disposed below each connection point 3364a, 3364 b. In some forms, the ribs 6024 may be evenly spaced about the respective connection points 3364a, 3364 b.

In the illustrated example, the shape of the ribs 6024 can be substantially rectangular, although any similar shape (e.g., oval, circular, triangular, etc.) can be used. The ribs 6024 may protrude from the surface of the central portion 3360. In some forms, the rib 6024 may extend to a height substantially equal to the height of the connecting member 3371, although the rib 6024 may extend to a position below the upper surface of the connecting member 3371.

When connected, each connecting member 3371 fits between a respective pair of ribs 6024. Each rib 6024 may contact a respective connecting member 3371 or may be substantially adjacent to a respective connecting component 3371. This limits or prevents rotation of the connection member 3371 about a vertical axis passing through each respective connection point 3364a, 3364 b. This may help maintain a desired orientation of the force vector of each lower band 3366, 3368 and also help minimize unintended disengagement of the magnet 3370 from the respective connection point 3364a, 3364 b.

As shown in fig. 33, another form of the frame 3350 may include ribs 6024 disposed adjacent each of the connection points 3364a, 3364 b. This form may include only a single rib 6024 associated with each connection point 3364a, 3364b, although it is also possible to include a pair of ribs 6024 from fig. 32. The single rib 6024 may be disposed such that it is generally aligned with the center of each connection point 3364a, 3364b (e.g., neither above nor below the center of the connection point 3364a, 3364 b).

The connecting member 3371 may include a cutout 6028 between the overhang 3384 and the cross bar 3386. The shape of the cutout 6028 may substantially correspond to the shape of the rib 6024. The cutouts 6028 receive the ribs 6024 when the connection members 3371 engage the respective connection points 3364a, 3364b. The ribs 6024 may contact the cutouts 6028 or be substantially adjacent to the cutouts 6028 to prevent or limit rotational movement of the respective connecting members 3371. Thus, a single rib 6024 may achieve substantially the same benefits as multiple ribs 6024.

As shown in fig. 34 and 35, the connection points 3364a, 3364b may not be formed directly on the central portion 3360 of the frame 3350. Rather, the frame 3350 may include arms 6032 that extend radially outward from either side of the central portion 3360. Each arm 6032 may be attached to the frame 3350 at approximately the same location as the attachment points 3364a, 3364b in the previous example (e.g., fig. 28). Each connection point 3364a, 3364b may alternatively be connected to the distal end of a respective arm 6032.

Positioning the connection points 3364a, 3364b at the ends of the arms 6032 may move the connection points 3364a, 3364b in a lateral and/or rearward direction. In some forms, the connection points 3364a, 3364b on either arm 6032 may be spaced from the central portion 3360 (e.g., measured along the surface of the arm 6032) by about 5mm to about 50mm. In some forms, the connection points 3364a, 3364b on either arm 6032 may be spaced from the central portion 3360 by about 10mm to about 40mm. In some forms, the connection points 3364a, 3364b on either arm 6032 may be spaced from the central portion 3360 by about 20mm to about 30mm. In some forms, the connection points 3364a, 3364b on either arm 6032 may be spaced about 29mm from the central portion 3360. In some forms, the connection points 3364a, 3364b on either arm 6032 may be spaced about 21mm from the central portion 3360.

In some forms, the arm 6032 may be integrally formed with the central portion 3360 as a unitary structure. In this example, the central portion 3360 and the arms 6032 may be constructed of substantially the same material. In other examples, the arms 6032 may be constructed of different materials, but integrally formed with the central portion 3360 (e.g., incorporating multiple materials in an injection molding process). In other examples, the arms 6032 may be formed using a different process than the central portion 3360 and may be connected to the frame 3350 using attachment means (e.g., adhesive, magnets, mechanical fasteners). In this example, the arm 6032 may be permanently attached or may be removable.

As shown in fig. 35 and 35-1, the arm 6032 may be substantially flush with the upper surface of the central portion 3360. This may help promote a compact aesthetic because the arms 6032 do not protrude beyond the frame 3350 in a forward direction. This may also help to promote patient compliance, as the compact design does not substantially interfere with the patient's vision.

The arms 6032 in fig. 34-35-1 are arranged in a cantilever configuration such that the distal ends, including the connection points 3364a, 3364b, are unsupported. In some examples, the arm 6032 may be flexible or semi-rigid and may be capable of bending or buckling. For example, the arm 6032 may flex in a rearward direction as the patient tightens the attached lower straps 3366, 3368. Although the arm 6032 may be capable of buckling, the total distance the arm 6032 is capable of buckling may be minimal. In this way, the arm 6032 can maintain the force vectors of the lower straps 3366, 3368. If the arm 6032 flexes, the arm 6032 returns to its original position when the force is removed (e.g., when the magnet 3370 is removed from each connection point 3364a, 3364 b).

As shown in fig. 35-1, some forms of arms 6032 may include grooves 6033 that may be positioned on the front and/or rear surfaces. The grooves 6033 may act as hinges to assist in bending the respective arms 6032. The frame 3350 of fig. 35-1 may be a separate frame or the recess 6033 may be incorporated into the frame of fig. 34 and/or 35 (or any other frame described herein).

In use, a patient may connect the connection members 3371 to the respective connection points 3364a, 3364b in a similar manner as when the connection points 3364a, 3364b are directly connected to the central portion 3360. Thus, there may be no impact on the ability of the patient to connect the magnet 3370 and the connection points 3364a, 3364b. In addition, creating wider connection points 3364a, 3364b (i.e., further spaced from the central portion 3360 of the frame 3350) may limit the occurrence of accidental disengagement of the magnets 3370 from the respective connection points 3364a, 3364b. For example, at least a portion of the flexible nature of the arm 6032 may allow bending in a rearward direction, which may limit rocking of the connection member 3371 at the respective connection points 3364a, 3364b. Thus, the magnet 3370 is less likely to accidentally disengage and may better maintain the seal between the patient's face and the seal-forming structure 3100.

In some forms, the arm 6032 may bend or flex relative to the central portion 3360. For example, arms 6032 may curve inwardly toward plenum chamber 3200 (and toward the patient's face when patient interface 3000 is worn). Bending or buckling may be the result of the force of the positioning and stabilizing structure 3300 (e.g., tightening straps 3366, 3368 may cause bending motion in arm 6032). As a result of the bending, the arm 6032 may be disposed very close to or in contact with the plenum chamber 3200 and/or the patient's face. This may help reduce the occurrence of rocking or accidental disengagement of the magnet 3370.

In some forms, the connection points 3364a, 3364b on the arm 6032 may not include a lip 3380. Instead, the connection points 3364a, 3364b may be substantially planar. The displacement of the connection points 3364a, 3364b away from the central portion 3360, in combination with the flexibility of the arms 6032, may reduce the likelihood of the magnet accidentally disengaging during use. In particular, the rearward positioning of the connection points 3364a, 3364b may reduce torque on the housing 3371 and the magnet 3370, possibly resulting in decoupling.

As shown in fig. 61, some forms of patient interface 3000 may include a flexible housing 6104 that may removably connect a strap to the frame 3350. The flexible housing 6104 may be substantially similar to the housing 3371. For example, the flexible housing 6104 may include a magnet 6108 (or similar type of connector) to removably engage the connection points 3364a, 3364 b. In addition, the flexible housing 6104 includes a cross bar 6112 to receive a strap (e.g., any of the straps 3356, 3358, 3366, 3368). The bendable segment 6116 may be disposed between the magnet 6108 and the cross bar 6112. The bendable segment 6116 may be a thin segment of the bendable housing 6104 and may be capable of elastic buckling without breaking. For example, the bendable segment 6116 may be bent about a bending axis 6120 such that the crossbar 6112 pivots relative to the magnet 6108. When the magnet 6108 is connected to the respective connection points 3364a, 3364b, bending about the bending axis 6120 may occur due to tension applied in the respective strips around the crossbar 6112. Movement about the bending axis 6120 may be more preferable than movement of the magnet 6108 so that the housing 6104 does not accidentally disengage from the respective connection points 3364a, 3364 b. In some forms, a flexible housing 6104 may be used in place of the arm 6032 (e.g., using a flexible housing 6104 when the connection points 3364a, 3364b are on the central portion 3360). In some forms, the flexible housing 6104 can be used with the arm 6032.

The length of the bendable segment 6116 may determine the amount of bending allowed in the bendable housing 6104. The longer bendable sections 6116 may allow more bending than the shorter bendable sections 6116. In some forms, the bendable segment 6116 is between about 0.1mm and about 20 mm. In some forms, the bendable segment 6116 is between about 1mm and about 10 mm. In some forms, the bendable segment 6116 is about 5mm.

As shown in fig. 24, the junction area of the plenum chamber 3200 may include a groove 3280. In the illustrated example, the groove 3280 can be included on the oral portion 3201 of the plenum chamber 3200 and can be located radially outward of the central portion 3251. The central portion 3360 of the frame 3350 may be positioned within the groove 3280. The shape of the central portion 3360 may substantially correspond to the shape of the recess 3280, which may help the patient properly orient the frame 3350 relative to the plenum chamber 3200 (e.g., in instances where the frame 3350 is removably coupled to the plenum chamber 3200).

As shown in fig. 37-39, the upper stem 6036 of the central portion 3360 may extend in a forward direction from the remainder of the central portion 3360 and may be spaced apart from the groove 3280. In other words, the upper stem 6036 may not contact the recess 3280 or any other portion of the plenum chamber 3200 prior to use.

In some forms, groove 3280 can have a fully formed perimeter having a substantially annular shape. In any size of pad, the perimeter may have substantially the same length.

In some forms, the groove 3280 is recessed relative to the remainder of the outer surface of the plenum chamber 3200. The recessed groove 3280 may not extend substantially into the plenum chamber 3200 and may not obscure the patient's face. The groove 3280 may have a substantially uniform depth throughout its circumference.

In some forms, the width of the groove 3280 can be less than the width of the central portion 3360 of the frame 3350. The compliance of the cushion may allow the wider central portion 3360 to be received within the groove 3280. This may allow the central portion 3360 to be coupled to the groove 3280 via a press fit, friction fit, and/or snap fit. The engagement between the groove 3280 and the central portion 3360 may help provide rigidity to the plenum chamber 3200 and/or the seal forming structure 3100, as the rigidity of the frame 3350 (e.g., as compared to the plenum chamber 3200) may limit some flexibility of the plenum chamber 3200 itself.

In some forms, the cushion may be molded to the frame 3350 such that the groove 3280 may be formed during the molding process. The material (e.g., silicone) of the plenum chamber 3200 may be molded at least partially around the central portion 3360 of the frame 3350 and may limit removal of the central portion 3360 from the recess 3280.

As shown in fig. 25, the frame 3350 may be constructed from multiple pieces of material (e.g., each piece of material is constructed from a different material). For example, the central portion may be constructed of a first material (e.g., hard plastic). The arms 3362 may be coupled to the central portion 3360 (e.g., via glue, molding, etc.) and may be constructed of a second material (e.g., flexible plastic, foam, etc.) that is more flexible than the first material. The third material may be a magnetic material and may be coupled to the central portion 3360 (e.g., via an adhesive). Once coupled together, the arms 3362 can similarly move in an integral, unitary structure as described above.

As shown in fig. 26 and 27, the frame 3350 may be constructed from a single piece of material. For example, the frame 3350 may be constructed of a TPE material, such as Hytrel. As described above, the materials used to construct the frame 3350 may provide rigidity and flexibility to the frame 3350. The magnet 3370 may be overmolded (or otherwise coupled) to the central portion 3360.

In some forms, the central portion 3360 includes a slot 3372 that may be formed on either lateral side of the central portion 3360. The slot 3372 may have a generally elongated shape (e.g., rectangular, oval, etc.) and may be formed entirely within the boundaries of the central portion 3360.

As shown in fig. 27, some forms of the central portion 3360 may include a tapered slot 3372. In particular, the opening to slot 3372 may be wider near the rear surface of central portion 3360 (e.g., the surface in contact with plenum chamber 3200). The opening to slot 3372 may decrease uniformly toward the front surface of central portion 3360.

Fig. 27 also illustrates that some forms of arms 3362a (or arms 3362 b) may include indentations or scallops 3373. The scallops 3373 may be formed on the inner surface of the arm 3362a and may be positioned proximate to the skin of the patient when the positioning and stabilizing structure 3300 is worn by the patient. The scallops 3373 reduce the thickness along a portion of the arm 3362a and may reduce the likelihood of sink marks forming in the arm 3362a during manufacturing (e.g., injection molding). The scallops 3373 may also result in reduced material used to manufacture the arm 3362a, which may result in reduced manufacturing time and/or reduced manufacturing costs.

Returning to fig. 26-2a, the plenum chamber 3200 may include protrusions 3284 on the oral portion 3201. The protrusion may be elongated and may have a shape (e.g., tapered) similar to slot 3372. The protrusions 3284 may be disposed within the grooves 3280 such that they mate with the frame 3350 during assembly.

As shown in fig. 40, the protrusions 3284 may extend substantially obliquely to the front surface of the plenum chamber 3200. The front surface of the plenum chamber 3200 may be partially curved or angled, and the protrusions 3284 may extend in a non-perpendicular direction relative to the surface such that the protrusions 3284 are aligned along the insertion direction of the frame 3350. In other words, when patient interface 3000 is worn, protrusions 3284 may extend in a front-to-back direction.

As shown in fig. 26-2 and 26-2a, some forms of protrusions 3284 may include overhanging portions 6000 that extend at least partially over grooves 3280. The overhang 6000 can be formed asymmetrically around the perimeter of the projection 3284. In other words, overhang 6000 may extend farther on one side than on the other side over recess 3280. As shown in fig. 26-2a, the opposite side 6002 may extend outwardly and form a slight overhang. For example, the opposite side 6002 may extend from about 1 ° to about 20 ° (e.g., 10 °) as compared to the example shown in fig. 26-2, which may increase the length of the opposite side 6002 by about 0.1mm to about 5mm (e.g., about 1 mm). This may provide additional retention force for retaining frame 3350 in groove 3280.

As shown in fig. 40, the top surface of the protrusion 3284 may be slightly sloped so that the overhang 6000 may extend substantially parallel to the surface of the recess 3280. This may allow a larger portion of the protrusion 3284 to extend over the groove 3280. As described in more detail below, this may help to better retain the frame 3350 within the groove 3280 and limit unintended disengagement.

In some forms, groove 3280 can also be asymmetric. Groove 3280 may include an undercut 6004 and an inclined surface 6008 on one side of protrusion 3284. Overhang 6000 may extend farther on undercut 6004 than on inclined surface 6008. The length of overhang 6000 extending over undercut 6004 may limit the ability of frame 3350 to be removed from plenum chamber 3200 in a vertical direction. The angle of the inclined surface 6008 may be directed toward the overhang 6000 and limit the ability of the frame 3350 to be removed in an oblique direction.

When frame 3350 is assembled to plenum chamber 3200 (e.g., via a press fit, friction fit, snap fit, etc.), the patient may align protrusions 3284 with slots 3372 such that protrusions 3284 are received within slots 3372 in use. The wider opening of the slot 3372 near the rear surface may help the patient align each protrusion 3284 in the corresponding slot 3372. The protrusion 3284 may be slightly wider than the front opening of each slot 3372, but can be received within the slot 3372 due to the flexible nature of the plenum chamber 3200 (e.g., constructed from an elastic material such as silicone). The protrusions 3284 may slightly deform (e.g., due to narrowing of the slots 3372) as they enter the corresponding slots 3372.

Once the protrusions 3284 pass through the slots 3372, the protrusions 3284 may substantially return to their original shape. For example, when slot 3372 receives projection 3284, overhang 6000 may deform (e.g., elastically deform) and once central portion 3360 is received within recess 3280, overhang 6000 may return to its original position. The patient may experience this deformation as a tactile response to more easily observe the proper connection between the frame 3350 and the plenum chamber 3200. The overhanging portion 6000 of the projection 3284 can be wider than the front opening of the corresponding slot 3372 in the relaxed or initial position.

In addition, the width of the undercut 6004 may be substantially the same as the central portion 3360 such that the frame 3350 is tightly received within the groove 3280. The flexible material of the plenum chamber 3200 may allow the undercut 6004 to be slightly smaller than the central portion 3360, such that the undercut 6004 may flex and receive the frame 3350 via a press fit, friction fit, snap fit, or the like.

Thus, the frame 3350 may not be easily removable from the plenum chamber 3200. The patient may have to apply force to the frame 3350 in order to remove it from the recess 3280. Such a force applied by the user may allow the frame 3350 to move in a vertical or oblique direction and overcome the retention provided by the overhang 6000. For example, the patient may lift the frame 3350 from the region of the central portion 3360 that contacts the inclined surface 6008 to provide a force for disengaging the frame 3350 from the plenum chamber 3200.

This force may exceed the force generated by normal movement of the plenum chamber 3200 and/or seal forming structure 3100. In other words, the seal-forming structure 3100 and/or the plenum chamber 3200 can move relative to the frame 3350 while the protrusions 3284 are received within the respective slots 3372. This may allow the seal-forming structure 3100 and/or the plenum chamber 3200 to flex and conform to the patient's face without loosening from the frame 3350 and without inadvertently causing the slot 3372 to disengage from the protrusion 3284.

In other forms, the plenum chamber 3200 may be molded to the frame 3350, and the protrusions 3284 may be created by a molding process to permanently maintain the position of the frame 3350 relative to the plenum chamber 3200.

As shown in fig. 26-3, some forms of frame 3350 may be oriented to reduce cheek contact when the patient wears the connected frame 3350 and plenum chamber 3200. For example, the arms 3362a, 3362b may be oriented (e.g., curved) so as to substantially conform to at least a portion of the patient's face (e.g., their cheeks). However, in some examples, the entire length of each arm 3362 may not contact the patient's skin, as the patient may feel uncomfortable with foreign objects contacting their face. Instead, a portion of each arm 3362 may be spaced apart from the patient's face such that a smaller surface area of the arm 3362 contacts the patient's face. Moving the point of contact between each arm 3362 and the plenum chamber 3200 (e.g., by a manufacturing process) may change the overall length of each arm 3362 contacting the patient's face while maintaining substantially the same curvature in each arm 3362. For example, if each arm 3362 contacts the plenum chamber 3200 at a location closer to the elbow 3500, the maximum gap between each arm 3362 and the patient's face may be greater. This means that a larger portion of each arm 3362 will be spaced apart from the patient's face (e.g., as opposed to if each arm 3362 contacted the plenum chamber 3200 at the distal end of the elbow 3500). Less contact between each arm 3362 and the patient's face may improve patient comfort.

Further, each arm 3362 contacting the plenum chamber 3200 at a location proximate to the elbow and thus distal to the rear surface 3112 may create less support at the lateral portion 3111 of the plenum chamber 3200 (e.g., because the rigid or semi-rigid arm less engages the lateral portion 3111). Thus, the lateral portion 3111 may have a greater degree of flexibility and may be able to better conform to the shape of the patient's nose and create an effective seal.

As shown in fig. 26-4 and 26-5, some forms of frames 3350 may include a hinge 6012 between each arm 3362 and the central portion 3360. Hinge 6012 may allow movement (e.g., pivotable movement) of arm 3362 without affecting the connection between frame 3350 and plenum chamber 3200. In other words, pivoting either arm 3362 about the respective hinge 6012 may not cause the protrusion 3284 to disengage from the slot 3372.

In some forms, the patient may move the arm 3362 to the second position to provide a better fit. For example, the distance between the rings 3352a, 3352b in the first position may be greater than the size of a normal patient's head. Thus, the patient may move the arm 3362 toward the second position to provide an appropriate fit (e.g., contact between the arm 3362 and the patient's head). By adjusting the upper headgear straps 3356, 3358, the arm 3362 may be maintained in the second position (i.e., the upper headgear straps 3356, 3358 may provide an external force).

Similar to the arms 3362, the plenum chamber 3200 and/or seal forming structure 3100 may be larger than the size of a typical patient's face. For example, the seal forming structure 3100 may not snugly engage the patient's mouth and/or nose. The plenum chamber 3200 and/or seal forming structure 3100 may also be moved toward a more compact position to better engage the face of the individual patient.

As shown in fig. 26-5, movement of the arm 3362 to the second position may directly result in movement of the seal-forming structure 3100 and/or the plenum chamber 3200 to a more compact position. The arm 3362 may contact the plenum chamber 3200 along the second front wall portion 3242. The arm 3362 may also contact the second front wall portion 3242, near the center of the plenum chamber 3200 and away from the lateral portion 3111.

The pivotal movement of each arm 3362 about hinge 6012 may provide an inwardly directed force to the plenum chamber 3200. This may reduce the distance between the lateral portions 3111 of the second seal-forming structure 3102 and position the second seal-forming structure 3102 against the nose of the patient. The compression seal forming structure 3100 and/or the plenum chamber 3200 may provide a better seal against the patient's face (e.g., by limiting the occurrence of leaks). Additionally, the application of an inwardly directed force near the center of the plenum chamber 3200 (e.g., as described with respect to fig. 26-3) may limit the formation of wrinkles in the seal forming structure 3100 by limiting the overall compression of the plenum chamber 3200.

As shown in fig. 46, the plenum chamber 3200 may include a recessed rib 6052 that may be disposed in front of the recess 3280 when the patient interface 3000 is worn by a patient. The recessed rib 6052 may be integrally formed with the plenum chamber 3200 and may be formed together during the molding process. The groove rib 6052 may protrude in a forward direction from the surface of the plenum chamber 3200 and may form a lower boundary of the groove 3280. The recessed rib 6052 may be thicker than a surrounding portion of the plenum chamber 3200 and may act as a reinforcing member. The groove rib 6052 may limit bending or buckling of the lower portion of the oral portion 3201. This may help maintain the shape of the groove 3280, thereby helping to retain the frame 3350 within the groove 3280.

As shown in fig. 28, the frame 3350 may have a shape similar to that of the frames of fig. 26 and 27. In other words, the frame 3350 may be constructed of a single material (e.g., having semi-rigid properties). The frame 3350 may be thicker near the central portion 3360 and thinner toward each respective ring 3352a, 3352 b.

In some forms, the central portion 3360 of the frame 3350 may be substantially entirely solid and may not include slots 3372, and the plenum chamber 3200 may not include protrusions 3284 within the grooves 3280. In contrast, the plenum chamber 3200 may include a protrusion 3288 disposed radially inside the groove 3280. The tab 3288 may protrude from the remainder of the front surface of the plenum chamber 3200. The tab 3288 may also extend at least partially in a radially outward direction. In other words, the protrusion 3288 may extend at least partially over the groove 3280 (e.g., the protrusion 3288 is spaced apart from the groove 3280).

While assembling the removable frame 3350 to the plenum chamber 3200, it may be desirable to position the frame 3350 such that it extends into the recess 3280 and under the tab 3288. Once the central portion 3260 is positioned, the tabs 3288 can help hold the central portion 3360 in place. To separate the frame 3350 from the plenum chamber 3200, the patient may push at least one of the protrusions 3288 (e.g., in a lateral direction toward the other protrusion 3288) such that the protrusion no longer extends over the groove 3280. In other forms, the plenum chamber 3200 may be molded to the frame 3350 and the protrusions 3288 may prevent the central portion 3360 from being removed.

In some forms, the frame 3350 of any of the examples described above may be substantially flush with the outer surface of the plenum chamber 3200 when positioned within the recess 3280. The depth of the groove 3280 corresponds substantially to the thickness of the central portion 3360. Similarly, the shape of the central portion may substantially approximate the shape of the pad as described above. The resulting assembly may have a substantially uniform surface. This helps maintain a low profile appearance of patient interface 3000 because frame 3350 does not protrude in front of the cushion, which might otherwise obstruct the patient's view.

Vent opening

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

In some forms, the vent 3400 is configured to allow a continuous flow of vent gas from the interior of the plenum chamber 3200 to the 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 rate is sufficient to reduce patient-to-exhale CO ₂ While maintaining the magnitude of the therapeutic pressure in the plenum 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 uncoupled structure, such as a rotator.

Although the venting structure is not shown in fig. 7-18, embodiments of the techniques shown in fig. 7-18 may provide suitable venting structures, such as in a plenum (one example of which is shown in fig. 21).

Uncoupling structure

In one form, patient interface 3000 includes at least one decoupling structure 3500, such as a swivel or a ball and socket. In some examples, the uncoupled structure may be an elbow 3500 that is connected (e.g., removably connected, permanently connected, etc.) to a plenum chamber 3200 (e.g., a plenum inlet port).

As shown in fig. 23-28, the central portion 3360 of the frame 3350 has an annular shape such that the central region of the oral portion 3201 of the plenum chamber 3200 is not covered by the frame 3350. In some examples, oral portion 3201 includes an opening for receiving elbow 3500. The opening may be much wider than the opening for receiving elbow 3500 such that frame 3350 is fully spaced from the opening. In other words, there is a length between the inner edge of the central portion 3360 and the opening for receiving the elbow 3500. Arms 3362a, 3362b and secondary connection portions 3342a, 3342b are each spaced apart from opening and elbow 3500 such that headgear straps 3358 do not interfere with movement (e.g., rotation) of the elbow.

Although not explicitly shown in the drawings of the plenum shown in fig. 7-19, those skilled in the art will appreciate that in practice an elbow 3500 (e.g., as shown in fig. 23) may be provided and allow for connection of the interface to an air circuit 4170.

As shown in fig. 57, an elbow 3500 may be connected to a plenum chamber 3200 to provide airflow through an inlet port 3604. In the illustrated example, the elbow 3500 is connected indirectly to the plenum chamber 3200, although in other examples the elbow 3500 may be connected directly to the plenum chamber 3200.

As shown in fig. 57 and 58, elbow 3500 is connected to vent ring 3504. The breather ring 3504 may be directly connected to the plenum chamber 3200 and the elbow 3500 to establish an indirect connection and airflow path between the air circuit 4170 (via the elbow) and the patient (via the plenum chamber 3200).

As shown in fig. 59, the breather ring 3504 includes a rear surface 3508, a front surface 3512, and a ring body 3516 extending therebetween. In the illustrated example, the breather ring 3504 includes a generally cylindrical shape, with the rear surface 3508 and the front surface 3512 being circular (although other shapes, such as oval, triangular, rectangular, etc., may be used). In some forms, the posterior surface 3508 and/or the anterior surface 3512 can extend beyond the ring body 3516 (i.e., have a larger diameter than the ring body 3516). Thus, the ring body 3516 can be formed as a concave groove.

In some forms, rear surface 3508 has a larger diameter than front surface 3512 (although these may be reversed). In some forms, the diameter of the rear surface 3508 may be between about 1mm and about 100 mm. In some forms, the diameter of the rear surface 3508 may be between about 10mm and about 75 mm. In some forms, the diameter of the rear surface 3508 may be between about 20mm and about 50 mm. In some forms, the diameter of the rear surface 3508 may be between about 30mm and about 40 mm. In some forms, the diameter of the rear surface 3508 may be about 39mm.

In some forms, the ring body 3516 may extend between the rear surface 3508 and the front surface 3512 in an oblique manner. For example, the diameter of ring body 3516 near anterior surface 3512 may be greater than the diameter near posterior surface 3508 (and vice versa). In some forms, the angle between the rear surface 3508 and the ring body 3516 can be substantially the same as the inclination of the lip 3608. This may allow the breather ring 3504 to engage the lip 3608 in a sealed configuration.

Returning to fig. 57, the breather ring 3504 can be connected to the plenum chamber 3200 by an engagement lip 3608. In the illustrated example, the length of the lip 3608 can be approximately the same as the length of the ring 3516. A substantially similar angle in both the ring 3516 and the lip 3608 allows the lip 3608 to be placed adjacent and parallel to the surface of the ring 3516. Because the lip 3608 is substantially the same length as the ring body 3516, the lip 3608 may contact the rear surface 3508 and the front surface 3512 when the breather ring 3504 is engaged with the plenum chamber 3200. The length of the lip 3608 may limit or prevent movement of the breather ring 3504 (e.g., along the port axis 3612) during use of the patient interface 3000. Such contact may create a sealing engagement such that air flow cannot escape between the breather ring 3504 and the inlet port 3604.

With continued reference to fig. 57, the breather ring 3504 may be connected to the plenum chamber 3200 such that the rear surface 3508 is positioned within the cavity 3272 (e.g., within the pressurized environment in use) and the front surface remains outside of the cavity 3272 (e.g., exposed to the ambient environment in use). The flexible material of the plenum chamber 3200 may allow the breather ring 3504 to be partially inserted through the inlet port 3604 and into an operating position. Once properly positioned, the rear surface 3508 can extend beyond the lip 3608. In other words, the diameter of the rear surface 3508 is greater than the diameter of the lip within the cavity 3272 of the plenum chamber 3200. This may help to secure or lock the breather ring 3504 in place and limit or prevent accidental disengagement between the breather ring 3504 and the inlet port 3604.

In some examples, the diameter of the rear surface 3508 may extend within the cavity 3272 near or adjacent to the inner surface of the plenum chamber 3200. For example, the diameter of the back surface 3508 may substantially match the contour of the plenum chamber 3200. The close proximity between the back surface 3508 and the wall of the plenum chamber 3200, or may create two areas of simultaneous contact (i.e., the lip 3608 and the wall of the plenum chamber 3200). The multiple contact areas may increase the overall retention of the breather ring 3504, thereby making accidental removal more difficult.

In some forms, the combination of the breather ring 3504 and the lip 3608 can create a retention force of between about 1N and about 50N. In some forms, the combination of the breather ring 3504 and the lip 3608 can create a retention force between about 20N and about 45N. In some forms, the combination of the breather ring 3504 and the lip 3608 can create a retention force of between about 25N and about 40N. In some forms, the combination of the breather ring 3504 and the lip 3608 can create a retention force of between about 30N and about 35N. In some forms, the combination of the breather ring 3504 and the lip 3608 can produce a retention force of about 33N. In some forms, the combination of the breather ring 3504 and the lip 3608 can produce a retention force of greater than about 20N. The greater holding force may limit accidental disengagement of the ventilation ring 3504 (and maintain pressurized flow of breathable gas to the patient) during use.

In some forms, the breather ring 3504 may include openings or vents 3520 that may allow air (e.g., exhaled carbon dioxide) to exit the cavity 3272 of the plenum chamber 3200. In some forms, there may be at least two vent holes 3520. In other forms, there may be four or five vent holes 3520. As shown in fig. 60, some forms of ventilation holes 3520 may extend around substantially the entire perimeter of the ventilation ring 3504. In some forms, the ventilation holes 3520 may be equally spaced around the perimeter of the ventilation ring 3504.

As shown in fig. 57 and 58, the ring body 3516 can include an inner wall 3524 and an outer wall 3528. The outer wall 3528 may be sloped while the inner wall 3524 may be substantially perpendicular to the rear portion 3508 and the front portion 3512. The inner wall 3524 and the outer wall 3528 can be spaced apart from each other to form a groove 3532. Vent holes 3520 may extend through rear surface 3508 and into recess 3532 to vent to the surrounding environment.

In some forms, an annular seal 3536 can be positioned within the groove 3532. An annular seal 3536 may extend around the outer surface of the inner wall 3524 of the ring body 3516. In some forms, the annular seal 3536 may not completely fill the groove 3532 and may leave room for air to escape the plenum chamber 3200 and vent to the ambient environment through the vent holes 3520.

In some forms, a gasket 3540 can be positioned in the groove 3532 and can contact the annular seal 3536. The gasket 3540 may include an outer diameter that is greater than or equal to an outer diameter of the annular seal 3536 in order to shield the annular seal 3536 from view (e.g., from a bed partner's view). The washers 3540 can be visually similar (e.g., color, texture, etc.) to provide a substantially continuous appearance of the front surface 3512 between the inner and outer walls 3524, 3528.

As shown in fig. 57, elbow 3500 may be inserted into breather ring 3504. For example, when elbow 3500 is inserted within the inner diameter of inner wall 3524, elbow 3500 may be connected to vent ring 3504 by a snap fit, friction fit, and/or press fit. Elbow 3500 may also include flange 3544 having an outer diameter that is greater than the outer diameter of inner wall 3524 but less than the inner diameter of outer wall 3528. In other words, the flange 3544 can extend partially, but not completely, across the width of the groove 3532. Thus, the flange 3544 may contact the gasket 3540 (or annular seal 3536), but not completely block the flow path through the vent 3520. Contact between flange 3544 and gasket 3540 can help retain annular seal 3536 and gasket 3540 within groove 3532.

As described above, in some forms, the elbow 3500 can extend beyond the rear surface 3508 when fully connected to the vent ring 3504 (e.g., the elbow 3500 contacts the rear surface 3508 to form a snap fit). In this position, the elbow may extend (slightly) to a distance 6076 (fig. 51) such that the front of the patient interface 3000 is closer to the patient's lips than the distance 6076. As shown in fig. 57, the distance that elbow 3500 extends beyond rear surface 3508 may be small and substantially insignificant to the patient (e.g., the patient's lips may not be able to stretch and contact elbow 3500).

In some forms, the force required to remove the elbow 3500 from the breather ring 3504 may be less than the force required to remove the breather ring 3504 from the inlet port 3604. In other words, the elbow 3500 may be easier to remove than the breather ring 3504. However, the force required to break the elbow 3500 may be large enough to limit unintended disengagement.

As shown in fig. 50-1, another form of the breather ring 3504 can include an offset 3506 extending beyond the front surface 3512 of the breather ring 3504. In some forms, offset 3506 may be about 0.1mm to about 50mm. In some forms, offset 3506 may be about 1mm to about 25mm. In some forms, the offset 3506 may be about 2mm to about 10mm. In some forms, the offset 3506 may be about 5mm.

The offset 3506 may be such that the elbow 3500 extends further from the rear surface 3508 when connected to the vent ring 3504. In the illustrated example, the extension 3507 can further extend from the front surface 3512 and further space the elbow from the rear surface 3508. With or without extension 3507, offset 3506 can limit extension of the elbow closer to the patient's lips than rear surface 3508. This may maintain distance 6076 at a maximum distance in front of the patient's lips and limit discomfort when wearing patient interface 3000.

With continued reference to fig. 57, elbow 3500 may deliver a pressurized gas stream 1500 into plenum chamber 3200 through inlet port 3604 (see, e.g., fig. 49). After passing through the elbow 3500, the pressurized gas 1500 may fill and pressurize the plenum chamber 3200. The patient may inhale the pressurized gas 1500 and exhale into the plenum chamber 3200. Exhaled gases 1600 (e.g., CO ₂ And water vapor) may exit the plenum through vent 3520 to vent into the ambient environment and limit rebreathing (e.g., rebreathing exhaled CO) ₂ ). To escape, the exhaled gas 1600 must travel in a direction opposite to the pressurized gas 1500, which at least partially obstructs the exhaled gas 1600.

Internal connection

As shown in fig. 62-63-1, another form of elbow 3550 may be connected to the plenum chamber 3200 to provide airflow through the inlet port 3604. In the illustrated example, the elbow 3550 is indirectly connected to the plenum chamber 3200, although in other examples the elbow 3550 may be directly connected to the plenum chamber 3200.

In some forms, elbow 3550 can include an outer lip 3552 and an inner lip 3554. In the illustrated example, the outer lip 3552 extends substantially around the perimeter of the elbow 3550. Inner lip 3554 may be spaced apart from outer lip 3552 and may extend around only a portion of the perimeter of elbow 3550.

In some forms, the elbow 3550 can include at least one button 3556 that can be selectively engaged by a patient. The illustrated example includes a pair of buttons 3556 spaced approximately 180 apart that may be simultaneously engaged by the patient (e.g., using their thumb and index finger).

In some forms, the button 3556 may be formed as a cantilever structure. For example, the button 3556 may be secured proximate to the first end 3558 of the elbow (e.g., proximate to the end of the plenum chamber 3200). The elbow 3550 may also include a channel 3560 extending substantially around the perimeter of each respective button 3556. Each channel 3560 may form a free end of each button 3556 opposite the fixed end.

In some forms, an outer lip 3552 can intersect each button 3556 along the perimeter of the elbow 3550. The channel 3560 can create a discontinuity such that the outer lip 3552 discontinuously extends around the perimeter of the elbow 3550.

In some forms, the inner lip 3554 may be provided only on the button 3556. For example, the inner lip 3554 may include two sections, each section being spaced approximately 180 ° apart. Further, the length of each section of the inner lip 3554 can be approximately the width of each button 3556 (e.g., the distance between channels 3560 through the buttons 3556).

In some forms, the cantilever structure of each button 3556 may allow each button to flex or bend when a force is applied by a patient. For example, each channel 3560 may allow the free end of button 3556 to move relative to the remainder of elbow 3550. The free end of each button 3556 may be able to move toward the center of the elbow 3550 (i.e., toward the opposite button 3556) due to the force exerted by the patient. The buttons 3556 (or generally the elbows 3550) may be constructed of an elastic material such that the buttons 3556 return to their original positions after the force is applied.

As shown in fig. 63, the breather ring 3562 can be substantially similar to the breather ring 3504 described above. Only some of the similarities and differences may be described below.

As shown in fig. 63, vent ring 3562 may include a center post 3564 protruding from inner wall 3524. In other words, the center post 3564 may have a smaller circumference than the inner wall 3524 and may include openings to still allow fluid to flow through the vent ring 3562. In some forms, the center post 3564 can protrude beyond the front surface 3512. In other words, one end of the center post 3564 may protrude away from the plenum chamber 3200 and may be the foremost portion of the vent ring 3562.

In some forms, the center post 3564 can include a groove 3566 that can extend at least partially around an inner periphery of the center post 3564. In the illustrated example, the groove 3566 can extend completely around the center post 3564. In other examples, the groove 3566 can extend around only a portion of the center post 3564, or a protrusion can replace the groove 3566. The protrusion may similarly extend around at least a portion (e.g., the entire inner periphery) of the inner periphery of the center post 3564.

As shown in fig. 63-1, the patient may insert elbow 3550 into vent ring 3562 to engage the two components (e.g., via a snap fit). The first end 3558 of the elbow 3550 can have a smaller diameter than the center post 3564 and can be inserted into the center post 3564. In the illustrated example, the inner lip 3554 can be beveled to facilitate insertion. Once inserted, the inner lip 3554 can be received within the groove 3566, and the outer lip 3552 can remain external to the center post 3564 (e.g., and act as a stop limiting additional insertion). Once received within recess 3566, inner lip 3554 can allow elbow 3550 to rotate 360 °. However, the elbow 3550 may not be disconnected from the vent ring 3562 because the inner lip 3554 locks the elbow 3550 in place. To remove the elbow 3550, the patient may engage the button 3556, with a portion of the button 3556 not within the center post 3564. Actuation of the button 3556 (e.g., simultaneously) may move the inner lip 3554 out of the groove 3566 such that the elbow 3550 may translate and disconnect relative to the vent ring 3562.

With continued reference to fig. 63-1, the elbow 3550 may not extend past the rear surface 3508 of the vent ring 3562 (e.g., more toward the cavity 3272 than the vent ring 3562). The recess 3566 may be positioned in a forward direction (e.g., away from the patient's face) so as to space the elbow 3550 from the cavity 3272 in use. This may be further aided by offset 3506. By spacing the elbow 3550 from the cavity 3272, the elbow 3550 may not encroach upon the distance 6076 (shown in fig. 51).

External connection

As shown in fig. 64-66-3, another form of elbow may be connected to the plenum chamber 3200 to provide airflow through the inlet port 3604. The elbow may be indirectly connected to the plenum chamber 3200, although in other examples the elbow may be directly connected to the plenum chamber 3200.

As shown in fig. 64, one form of elbow 3568 may include a lip 3570 extending from the body of elbow 3568. In the illustrated form, the lip 3570 can extend only partially around the perimeter of the elbow 3568, although in other examples the lip 3570 can extend completely around the elbow 3568.

With continued reference to fig. 64, the elbow 3568 may include a button 3572. The shape of button 3572 can be similar to button 3556 (e.g., a cantilever structure having a fixed end and a free end). Thus, the button 3572 can move relative to the rest of the elbow 3568.

In the illustrated example, the button 3572 can form a portion of an outer surface of the elbow 3568. For example, the shape of the button may substantially match the surrounding shape of the elbow 3568. This means that the button 3572 can be curved to substantially match the shape of the elbow 3568. When the button 3572 is in the relaxed position, the curvature of the button 3572 can be substantially aligned with the curvature of the elbow 3568. However, when the patient applies an external force to the button 3572, the button 3572 moves inward and the curvature of the button 3572 moves out of alignment with the curvature of the elbow 3568.

Unlike button 3556, button 3572 may not include a lip. Instead, button 3572 can include fingers 3574. The finger 3574 may be hook-shaped and may be attached near the fixed end of the button 3572. In the illustrated example, the finger 3574 can extend past the fixed end of the button 3572 and away from the free end. For example, the button 3572 can be cantilevered relative to the first end 3558, and the finger 3574 can be cantilevered relative to the button 3572. The first end 3558 can thus be a fulcrum disposed between the button 3572 and the finger 3574.

In some forms, each button 3572 can include fingers 3574 spaced apart (e.g., about 180 ° apart) on opposite sides of the elbow 3568. The fingers 3574 may be wider than the remainder of the button 3572 and may be spaced apart a first distance. In other words, the fingers 3574 may not form a portion of the perimeter of the surface of the elbow 3568. When the button 3572 is actuated, the patient pushes the free ends of the button 3572 toward each other. When this occurs, the fingers 3574 move farther from each other (i.e., are spaced apart by a second distance).

As shown in fig. 65, another example of an elbow 3576 may be similar to elbow 3568 described above. Only some similarities and differences between the elbows 3568, 3576 may be described below.

With continued reference to fig. 65, the elbow 3576 can include at least one button 3578 and at least one finger 3580 (e.g., one pair each). Both the button 3578 and the finger 3580 may protrude from the surface of the elbow 3576 and may not be included as forming part of the perimeter of the elbow 3576. Button 3578 may operate similarly to button 3572. For example, the patient may engage the buttons 3578 to move them closer together. In doing so, the finger 3580 may move from a first spacing distance to a second spacing distance, the second distance being greater than the first distance.

In some forms, arms 3581 may extend (e.g., vertically) from a surface of elbow 3576 to connect buttons 3578 and fingers 3580 to the surface of elbow 3576. An arm 3581 is disposed between (e.g., intermediate) the finger 3580 and the button 3578 and forms a pivot point or fulcrum. Engaging button 3578 to move finger 3580 causes a pivoting motion about arm 3581.

As shown in fig. 66, the vent ring 3582 may be substantially similar to the vent ring 3562 described above. Only some of the similarities and differences may be described below.

As shown in fig. 66, the vent ring 3582 may include a center post 3584 protruding from the inner wall 3524. In other words, the center post 3584 may have a smaller circumference than the inner wall 3524 and may include openings to still allow fluid to flow through the vent ring 3582. In some forms, the center post 3584 can protrude beyond the front surface 3512. In other words, one end of the center post 3584 may protrude away from the plenum chamber 3200 and may be the foremost portion of the vent ring 3582.

In some forms, the center post 3584 can include a lip 3586 that can extend at least partially around the outer periphery of the center post 3584. In the illustrated example, the lip 3586 can extend completely around the center post 3584. In other examples, the lip 3586 may extend around only a portion of the center post 3584, or a groove may replace the lip 3586. The groove may similarly extend around at least a portion (e.g., the entire outer perimeter) of the outer perimeter of the center post 3584.

As shown in fig. 66-1 through 66-3, the patient may insert either elbow 3568, 3576 into the vent ring 3582 to engage the two components (e.g., via a snap fit). The first ends 3558 of the elbows 3568, 3576 can have a smaller diameter than the center post 3584 and can be inserted into the center post 3584. Once inserted, the fingers 3574, 3580 can remain outside of the center post 3584. In addition, the lip 3570 can act as a stop to limit additional insertion in the elbow 3568. The shape of either finger 3574, 3580 can allow either finger to pass through lip 3586 when either elbow 3568, 3576 is inserted. However, the patient may also actuate the buttons 3572, 3578 to allow the fingers to pass the lip 3586. Fingers 3574, 3580 can grasp lip 3586 and can limit disconnection of the respective elbows 3568, 3576. The fingers 3574, 3580 may also allow the respective elbows 3568, 3576 to rotate 360 °. To remove the elbows 3568, 3576, the patient can engage buttons 3572, 3578. Actuation of the buttons 3572, 3578 (e.g., simultaneously) may space the fingers 3574, 3580 from the lip 3586 (e.g., wider than the outer periphery of the lip 3586) such that the elbows 3568, 3576 may be disconnected.

In some forms, either instance of the elbows 3568, 3576 may not translate when connected to the vent ring 3582. For example, the washer 3540 can be spaced apart from the lip 3586 such that the respective fingers 3574, 3580 can fit therebetween. This space may be just large enough for each finger 3574, 3580 such that the finger 3574, 3580 cannot move between the lip 3586 and the washer 3540. Limiting the transition of the elbows 3568, 3576 can limit flow disturbance or irritation to the patient that may be caused by translational movement of the elbows 3568, 3576 during use.

In some forms, the washer 3540 can be formed as an integral piece of the center post 3584, rather than a separate piece that can be removed. In this example, the gasket 3540 (or support surface) will still limit translation of the elbows 3568, 3576 when connected to the vent ring 3582.

As shown in fig. 66-3, the elbow 3576 may not extend farther toward the cavity 3272 than the bracket 5324. The lip 3586 may extend in a forward direction to space the elbow 3576 from the cavity 3272. This may be further aided by offset 3506. By spacing the elbow 3576 from the cavity 3272, the elbow may not encroach upon the distance 6076. Although this is shown and described with respect to elbow 3576, the description applies to similar elbows (e.g., elbow 3568).

As shown in fig. 67, another example of an elbow 3588 may be similar to elbows 3568 and 3576 described above. Only some of the similarities and differences between the elbows 3568, 3576, and 3588 may be described below.

With continued reference to fig. 67, the elbow 3588 can include at least one button 3590 and at least one finger 3592 (e.g., a pair of each). Both the button 3590 and the finger 3592 may protrude from the surface of the elbow 3588 and may not be included as part of the perimeter that forms the elbow 3588. Button 3590 may operate similar to button 3572 or button 3580. For example, the patient may engage the buttons 3590 to move them closer together. In doing so, the finger 3592 may move from a first spacing distance to a second spacing distance, the second distance being greater than the first distance.

In some forms, arms 3591 may extend (e.g., vertically) from a surface of elbow 3588 to connect buttons 3590 and fingers 3592 to the surface of elbow 3588. The arm 3591 is disposed between (e.g., intermediate) the finger 3592 and the button 3590 and forms a pivot point or fulcrum. Engaging button 3590 to move finger 3592 causes a pivoting motion about arm 3591.

In some forms, the arm 3591 can include a curved shape, which can be an S-shape. The curved shape of the arms 3591 may reduce stress points caused when engaging the button 3590.

As shown in fig. 68, vent ring 3594 may be substantially similar to vent rings 3562 and 3582 described above. Only some of the similarities and differences may be described below.

As shown in fig. 68, the vent ring 3594 may include a center post 3596 protruding from the inner wall 3524. In other words, the center post 3596 may have a smaller circumference than the inner wall 3524 and may include openings to still allow fluid to flow through the vent ring 3594. In some forms, the center post 3596 can protrude beyond the front surface 3512. In other words, one end of the center post 3596 may protrude away from the plenum chamber 3200 and may be the foremost portion of the vent ring 3594.

In some forms, the center post 3596 can include a lip 3598 that can extend at least partially around the outer periphery of the center post 3596. In the illustrated example, the lip 3598 can extend completely around the center post 3596. In other examples, the lip 3598 may extend around only a portion of the center post 3596, or a groove may replace the lip 3598. The groove may similarly extend around at least a portion (e.g., the entire outer perimeter) of the outer perimeter of the center post 3596.

As shown in fig. 69-70, the patient may insert elbow 3588 into vent ring 3594 to engage the two components (e.g., via a snap fit). The first end 3558 of the elbow 3588 can have a smaller diameter than the center post 3596 and can be inserted into the center post 3596. Once inserted, the fingers 3592 may remain external to the center post 3596. In addition, the lip 3598 can act as a stop to limit additional insertion in the elbow 3588. The shape of the fingers 3592 can allow either finger to pass through the lip 3596 when inserting the elbow 3588. However, the patient may also actuate the button 3590 to allow the finger 3592 to pass the lip 3598. Fingers 3592 can grasp lip 3596 and can limit disconnection of elbow 3588. Fingers 3592 may also allow elbow 3588 to rotate 360 °. To remove the elbow 3588, the patient can engage the button 3590. Actuation of the buttons 3590 (e.g., simultaneously) may space the fingers 3592 from the lip 3598 (e.g., wider than the outer periphery of the lip 3598) such that the elbow 3588 may be disconnected (e.g., see fig. 69-1, which illustrates a single button 3590 actuated to move the fingers 3592).

In some forms, the elbow 3588 may not translate when connected to the vent ring 3594. For example, the washer 3540 can be spaced apart from the lip 3598 such that the finger 3592 can fit therebetween. This space may be just large enough for the finger 3592 such that the finger 3592 cannot move between the lip 3598 and the washer 3540. Limiting the transition of the elbow 3588 may limit flow disturbances or irritation to the patient that may be caused by translational movement of the elbow 3588 during use.

In some forms, the washer 3540 can be formed as an integral piece of the center post 3596, rather than a separate piece that can be removed. In this example, the washer 3540 (or support surface) will still limit translation of the elbow 3588 when connected to the vent ring 3594.

In some forms, an elbow 3588 may be connected to the vent ring 3582 of fig. 66. Additionally, the elbows 3568, 3576 can be used with a vent ring 3594. The above description can be similarly applied to these combinations.

As shown in fig. 70, the elbow 3588 may not extend farther toward the cavity 3272 than the bracket 5324. The lip 3598 may extend in a forward direction to space the elbow 3588 from the cavity 3272. This may be further aided by offset 3506. By spacing the elbow 3588 from the cavity 3272, the elbow may not encroach upon the distance 6076.

Connection port

Connection port 3600 allows connection (e.g., via a snap-fit removable connection, a permanent connection, etc.) to air circuit 4170. Patient interface 3000 may include two connection ports 3600, one on either side of plenum chamber 3200. A conduit may be connected to connection port 3600 for delivering pressurized breathable gas to a patient. In some forms, the catheter may be a catheter hub and may contact the patient's head. The catheter may extend toward the top of the patient's head with the decoupling structure 3500 located at the top of the head.

As described above, the inlet port 3604 of the plenum chamber 3200 may include a lip 3608 that extends into the cavity 3272 and that helps secure the breather ring 3504 and/or elbow 3500 to the plenum chamber 3200. In the illustrated example, the breather ring 3504 can engage the lip 3608 via a snap fit or any other similar engagement technique.

Forehead support

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

Anti-asphyxia valve

In one form, the patient interface 3000 includes an anti-asphyxia valve. For example, elbow 3550 may include an anti-asphyxia valve 3800 that may be selectively closed due to the flow of pressurized air. When the pressurized air ceases to flow, the patient may be able to breathe through the anti-asphyxia valve 3800.

Port (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.

RPT device

An RPT device 4000 in accordance with one aspect of the present technology includes mechanical, pneumatic, and/or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an air stream 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, the 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 at least 6cmH ₂ O, or at least 10cmH ₂ O, or at least 20cmH ₂ Positive pressure of O.

The RPT device may have an outer housing 4010 formed in two parts: an upper portion 4012 and a lower portion 4014. Further, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

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

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

RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical component 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In another form, the RPT device 4000 may include more than one PCBA 4202.

Mechanical and pneumatic components of RPT devices

The RPT device may comprise one or more of the following components in an integral unit. In another form, one or more of the following components may be located as respective independent units.

Air filter

An RPT device in accordance with one form of the present technique may include an air filter 4110 or a plurality of air filters 4110.

In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

In one form, an outlet air filter 4114, such as an antimicrobial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

Muffler

An RPT device in accordance with one form of the present technique may include a muffler 4120 or a plurality of mufflers 4120.

In one form of the present technique, the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

In one form of the present technique, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

Pressure generator

In one form of the present technique, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. In delivering respiratory pressure therapy, the blower can deliver the air supply at a rate of, for example, up to about 120 liters/minute, at a positive pressure ranging from about 4cmH2O to about 20cmH2O, or in other forms up to about 30cmH 2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. patent No. 7,866,944; U.S. patent No. 8,638,014; U.S. patent No. 8,636,479; PCT patent application publication No. WO 2013/020167.

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

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

Anti-overflow return valve

In one form of the present technique, an anti-spill back valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The spill-resistant valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, such as toward the motor 4144.

RPT device algorithm

As noted above, in some forms of the present technology, the central controller may be configured to implement one or more algorithms, represented as computer programs stored in a non-transitory computer readable storage medium (e.g., memory). Algorithms are typically grouped into groups called modules.

In other forms of the present technology, some or all of the algorithms may be implemented by a controller of an external device, such as a local external device or a remote external device. In this form, the data representing the input signals required for the algorithm portion to be executed at the external device and/or the intermediate algorithm output may be transmitted to the external device via a local external communication network or a remote external communication network. In this form, the portion of the algorithm to be executed at the external device may be represented as a computer program stored in a non-transitory computer readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute part of the algorithm.

In this form, the therapy parameters generated by the external device via the therapy engine module (if so forming part of the algorithm executed by the external device) may be communicated to the central controller for communication to the therapy control module.

Air circuit

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

Specifically, the air circuit 4170 may be fluidly connected with an outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate 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 heating 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 heating wire circuit is described in U.S. patent 8,733,349, which is incorporated by reference herein in its entirety.

As shown in fig. 58, the air circuit 4170 is formed as a flexible conduit that is connected to the elbow 3500 at the first end 4172. The second end 4174, opposite the first end 4172, may include a quick release connector 4176. The quick release connector 4176 may assist the patient in disconnecting the air circuit 4170 from the RPT device 4000.

In some forms, the quick release connector 4176 may be a swivel sleeve. For example, the quick release connector 4176 of the air circuit 4170 may be attached to a complementary connector 4178 (e.g., either the RPT device 4000 or an intermediate catheter). The quick release connector 4176 and the complementary connector 4178 may each rotate relative to one another. This may allow for increased movement between the RPT device 4000 and the patient interface 3000, and may allow the patient to move while sleeping without interfering with the connection between the air circuit 4170 and the RPT device 4000.

In some forms, the connection between the quick release connector 4176 and the complementary connector 4178 may be formed by a swivel snap. For example, the complementary connector 4178 may receive the quick release connector 4176 (and vice versa) and a locking mechanism (not shown) may be rotated to lock the two components together. The locking mechanism may be rotated (e.g., in a clockwise direction) one-quarter turn (or half turn, full turn, etc.) to form a locking connection and may be rotated one-quarter turn in an opposite rotational direction (e.g., counter-clockwise) to release. Rotating the locking mechanism to facilitate the connection between the quick release connector 4176 and the complementary connector 4178 may not affect the relative rotation between the two connectors 4176, 4178. Rotation in a disengagement direction (e.g., counter-clockwise) may push the complementary connector 4178 off of the quick release connector 4176 to facilitate quick disengagement.

In some forms, the connection between the quick release connector 4176 and the complementary connector 4178 may be formed by a snap (not shown). In other examples, this may be the opposite. For example, the quick release connector 4176 may include a movable latch receivable within a complementary connector 4178. The movable latch may be biased toward the locked position to secure the two connectors 4176, 4178 together. Once secured, the movable latch is able to move (e.g., slide) around the perimeter of the complementary connector 4178 such that the connectors 4176, 4178 are still able to rotate relative to each other. To disconnect the air circuit 4170 from the RPT device 4000, the patient may engage a button 4179 on the quick release connector 4176, which may move the latch to the unlocked position and allow the air circuit 4170 to freely translate and disengage from the complementary connector 4178. In some forms, the quick release connector 4176 may be detachable from the complementary connector 4178 with one hand. For example, the patient may be able to disconnect the quick release connector 4176 and the complementary connector 4178 using only his thumb and forefinger. This may allow the patient to more easily disconnect the quick release connector 4176 and the complementary connector 4178.

As shown in fig. 58-1, some forms of quick release connectors 4176 may include a flat surface 4181. In other words, the quick release connector 4176 may not be entirely circular. This may help better distribute leakage from the system such that less leakage occurs through the vent 3520 and more humidity remains within the plenum chamber 3200.

Supplemental gas delivery

In one form of the present technique, supplemental gas (e.g., oxygen) 4180 is delivered to one or more points in the pneumatic path, such as upstream of pneumatic block 4020, to air circuit 4170, and/or to patient interface 3000.

Humidifier

Overview of humidifier

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

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

Humidifier component

Water reservoir

According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid (e.g., water) to be evaporated to humidify the air stream. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., one night sleep). Typically, the reservoir 5110 is configured to hold hundreds of milliliters of water, such as 300 milliliters (ml), 325ml, 350ml, or 400ml. In other forms, the humidifier 5000 may be configured to receive a supply of water from an external water source, such as a building water supply.

According to one aspect, the water reservoir 5110 is configured to add humidity to the air flow from the RPT device 4000 as the air flow travels therethrough. In one form, the water reservoir 5110 can be configured to cause an air stream to travel in a tortuous path through the reservoir 5110 upon contact with a volume of water therein.

According to one form, the reservoir 5110 can be removed from the humidifier 5000, for example, in a lateral direction as shown in fig. 5A and 5B.

The reservoir 5110 can also be configured to prevent liquid from flowing therefrom, such as through any orifice and/or intermediate its subcomponents, such as when the reservoir 5110 is displaced and/or rotated from its normal operating orientation. Since the air flow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure through leakage and/or flow impedance.

Conductive portion

According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient transfer of heat from the heating element 5240 to the liquid volume in the reservoir 5110. In one form, the conductive portion 5120 can be arranged as a plate, although other shapes can be suitable. All or a portion of the conductive portion 5120 can be made of a thermally conductive material such as aluminum (e.g., about 2mm thick, e.g., 1mm, 1.5mm, 2.5mm, or 3 mm), another thermally conductive metal, or some plastic. In some cases, a material having a lower thermal conductivity with a suitable geometry may be used to achieve a suitable thermal conductivity.

Humidifier reservoir base

In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (shown in fig. 5B) configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking member, such as a locking rod 5135, configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

Water level indicator

The humidifier reservoir 5110 may include a water level indicator 5150 as shown in fig. 5A to 5B. In some forms, the water level indicator 5150 can provide one or more indications to a user, such as the patient 1000 or a caregiver, regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined volume of water, any portion thereof (such as 25%, 50%, 75%), or a volume such as 200ml, 300ml, or 400 ml.

Passive humidification

As shown in fig. 71-75, the coupling may be connected to a plenum chamber 3200 to provide a moist environment within the plenum chamber during use. These couplings may be used in conjunction with humidifier 5000 and may help to increase the efficiency of the humidifier by maintaining a greater percentage of the supply humidity within plenum chamber 3200 during use. These couplings may also be used without humidifier 5000. Rather, the coupling may help retain moisture naturally exhaled by the patient within the plenum chamber 3200.

In some forms, passive humidification may occur solely through the shape and/or geometry of the plenum, vent ring, conduit, and/or elbow. In other words, only the shape and/or size of the structure may affect the airflow such that the humidity within the cavity of the plenum may be greater than the surrounding environment. A heat and humidity exchanger (HME) may not be required to achieve passive humidification.

In some forms, the HME and/or humidifier 5000 may be used in conjunction with passive humidification, described below, to allow for a more humid environment within the cavity.

Increasing spacing

As shown in fig. 71 and 71-1, a coupler or elbow 5300 may be connected to the plenum chamber 3200. The elbow 5300 may be connected to the venting ring 5304 in a similar manner (e.g., internally or externally connected) as any of the elbows described above. The vent ring 5304 may be similar to the vent ring previously described and may include a vent 5308. In the illustrated example, the vent 5308 can be spaced apart from the connection port 3600 by a distance 5312. The vent ring 5304 can include an extension 5316 that extends a distance 5312. For example, extension 5316 may extend from a rear surface (e.g., rear surface 3508 in fig. 57). Extension 5316 may be directly connected to connection port 3600 (e.g., in a similar manner to breather ring 3504 shown in fig. 57).

In other forms, the extension 5316 may be connected to the plenum chamber 3200 as part of the connection port 3600 (e.g., the extension 5316 may be permanently connected to the plenum chamber 3200). The breather ring 5304 can be removably connected to the extension 5316 (e.g., in the same manner as the breather ring 3504 is connected to the connection port 3600 described above).

In some forms, the distance 5312 may be between about 1mm and about 50 mm. In some forms, the distance 5312 may be between about 5mm and about 30 mm. In some forms, the distance 5312 may be between about 15mm and about 25 mm. In some forms, the distance 5312 may be about 20mm. The distance may be optimized to balance the increase in humidity (i.e., maximize) with the increase in carbon dioxide (e.g., minimize).

In use, the pressurized flow of breathable gas is delivered to the patient via elbow 5300 and extension 5316. Such air may be actively humidified (e.g., using humidifier 5000) or may have the humidity of ambient air. The patient inhales this breathable air and exhales a mixture of gas (e.g., carbon dioxide) and water vapor. As described above, this air is allowed to escape through the vent 5308, enabling the plenum chamber 3200 to replenish the pressurized breathable gas and to prevent the patient from inhaling the exhaled gas. However, the escaping gas brings water vapor into the surrounding environment. Especially when the patient is not using the humidifier, loss of water vapor during use (e.g., one night) may cause the patient to wake up with dry mouth and feel uncomfortable (e.g., which may prevent future use). By further spacing the vent 5308 from the connection port 3600 (and thus from the nose or mouth of the patient), the exhaled air must travel further to be expelled into the surrounding environment. Such impedance may make it more difficult for air and water vapor to escape, which may retain more moisture in the plenum chamber 3200 (e.g., from exhaled water vapor). Thus, during use, the patient's mouth may be less likely to dry. By spacing the vent holes 5308 apart by a distance 5312, a sufficient amount of exhaled gas can still escape the plenum chamber 3200 (e.g., such that the patient does not breathe recirculated air), but sufficient water vapor can be retained to help passively humidify the pressurized flow of breathable gas.

In some forms, the vent 5308 is not blocked or otherwise obstructed by a physical barrier that redirects or prevents fluid flow through the vent 5308. Conversely, the impedance may be generated by distance 5312, which causes exhaled air to travel farther while flowing against the opposite direction of the pressurized air flow.

In some forms, HME may be placed within extension 5316 to further increase the humidity that may be maintained within plenum chamber 3200. The HME may further increase the impedance of the exhaled air from the patient interface and be designed to capture at least some of the exhaled water vapor such that the pressurized air stream absorbs water and allows the patient to re-inhale the water. The material of the HME may be designed such that the CO within the plenum chamber 3200 ₂ Accumulation does not increase significantly.

As shown in fig. 71-1, the breather ring 5304 can be connected to a plenum chamber 3200 in a similar manner as the breather ring 3504 (see, e.g., fig. 57). For example, the lip 3608 may engage the ring body 3516 (e.g., a generally flush orientation between the anterior and posterior surfaces 3512). In use, the flow of pressurized gas 1500 passes through the elbow 5300 and toward the plenum chamber 3200 to pressurize the plenum chamber 3200 and allow the patient to inhale the pressurized air. When the patient exhales, the exhaled air 1600 must not only travel further to the vent 5308 in order to be expelled into the surrounding environment (e.g., as compared to fig. 57), but the distance 5312 of the extension 5316 also means that the exhaled air 1600 travels a greater distance (e.g., creates impedance) against the pressurized air 1500. This allows less exhaled air 1600 to be expelled while allowing the pressurized air 1500 to absorb exhaled water vapor from the exhaled air 1600 so that it may be inhaled again.

Barrier

As shown in fig. 72-73-1, the elbow 5300 may be connected to another example of the vent ring 5320, and the vent ring 5320 may have a similar structure to the vent ring 5304. The vent ring 5320 can include a bracket 5324 connected to a rear surface 5328 of the vent ring 5320.

In some forms, the support 5324 may be connected to the rear surface 5328 radially inward of the vent opening 5332 and may not substantially block the pores of the vent opening 5332.

As shown in fig. 72, some forms of the bracket 5324 may include an arm 5336 extending away from the rear surface 5328. In the illustrated example, the arms 5336 are spaced apart (e.g., equally spaced) from each other around the perimeter of the support 5324. A space 5340 may be formed between the arms 5336 (e.g., within the cradle 5324) through which air flow may pass.

In some forms, the perimeter of the opening of the inner wall 3524 can be larger than the bracket 5324. For example, there may be space radially outward of the support 5324. This may allow fluid to flow between the perimeter of the inner wall 3524 and the support 5324.

In some forms, the rear surface 5328 may abut the support 5324. For example, there may be substantially no space for fluid flow between the rear surface 5328 and the support 5324. Instead, space 5340 may include an opening 5342 which may be in communication with an opening of inner wall 3524. For example, there may be an air path through the vent ring 5304 through the space 5340.

In some forms, the rear surface 5328 may be annular, and the inner periphery of the rear surface 5328 may be spaced apart from the support 5324. For example, there may be space radially outward of the shelf 5324 and inward of the inner perimeter of the rear surface 5328. This may allow fluid to flow between the perimeter of the rear surface 5328 and the support 5324. In some forms, the support 5324 may not include the opening 5342.

As shown in fig. 73, some forms of the support 5324 may include a disk 5344 connected to an arm 5336. The disk 5344 may include a dome shape (e.g., a right dome shape that faces the patient in use). The tray 5344 may form one side of the space 5340 (e.g., a rear wall of the space 5340). The outer perimeter of the disk 5344 may also be substantially the same as the outer diameter of the rear surface 5328. The tray 5344 may cover the ventilation opening 5332 from the perspective of the patient. However, since the arms 5336 space the disc 5344 from the vent openings 5332, the disc 5344 may not block the vent openings 5332.

In some forms, different shaped trays 5344 may be used in order to retain different amounts of moisture within the plenum chamber 3200. For example, a disc 5344 having a smaller radius of curvature may extend closer to the nose and/or mouth of a patient than a disc 5344 having a larger radius of curvature. In other words, if the smaller curvature disc 5344 and the larger curvature disc 5344 both include the same end-to-end distance (e.g., equal to or exceeding the diameter between the vent openings 5332), the edges of the smaller curvature disc 5344 will extend closer to the patient's face. This may result in more exhaled air being redirected (i.e., increasing the impedance) such that more water vapor is retained within the plenum chamber 3200.

In some forms, a smaller radius of curvature may facilitate the flow of pressurized breathable gas around disk 5344 because the smaller radius of curvature directs more gas flow around disk 5344 rather than back toward elbow 5300.

In some forms, a larger radius of curvature may be more comfortable for the patient because the disc 5344 is spaced farther from the patient's face. For example, the patient may wish to maximize the second distance 6076 between his mouth and the plenum chamber 3200 (see, e.g., fig. 51). A larger distance 6076 may be achieved using a disc 5344 with a larger radius of curvature than may be achieved with a disc 5344 with a smaller radius of curvature.

In other forms, the disc 5344 may be substantially free of curvature and may be substantially planar with respect to the patient. For example, the disk 5344 may be substantially parallel to the rear surface 5328.

In some forms, the disk 5344 may be constructed of a gas impermeable material and may act as a barrier to increase the impedance of the exhalation to the ventilation opening 5332. The disk 5344 may obstruct or block a direct (e.g., straight) flow path between the airway (e.g., nose or mouth) of the patient and the ventilation opening 5332.

In some forms, the disc 5344 may be constructed of a semi-permeable material that may allow some airflow therethrough. For example, the tray 5344 may include HME (or may be constructed of HME material) such that some exhaled air may pass through the tray 5344, but water vapor may be captured. Alternatively, the tray 5344 may be constructed of another semipermeable material that does not retain moisture but still increases the resistance to air flow out of the plenum chamber 3200. Because the disc 5344 may be semi-permeable, some exhaled air may still be directed back to the patient (rather than being exhausted through the ventilation openings 5332).

As described above, the patient may lose moisture during exhalation and may experience uncomfortable dry mouth due to the loss of too much moisture (particularly if the patient interface 3000 is used without the humidifier 5000). As with the vent ring 5304, the vent ring 5320 serves to retain moisture exhaled by the patient within the plenum chamber to reduce the occurrence of dry mouth.

As shown in fig. 73-1, the support 5324 may face the patient during use such that the disc 5344 has a right dome shape relative to the patient's mouth or nose. Because the tray 5344 has substantially the same width as the rear surface 5328, the tray 5344 may block the exhaled airflow 1600 from exiting through the vent openings 5332 and may direct air back into the plenum chamber 3200. However, the negative dome shape of the disk 5344 relative to the flow direction of the pressurized air 1500 may allow airflow around the disk 5344 to flow to the patient without substantial obstruction. For example, the pressurized gas flow 1500 may flow between the inner periphery of the rear surface 5328 and the support 5324, or through the openings 5342 of the support 5324 and through the space 5340. As described above, the radius of curvature of the disk 5344 may affect the impedance of the pressurized air 1500 entering the plenum chamber 3200 (e.g., a smaller radius of curvature results in a smaller impedance).

Exhaled air can still bypass the disc 5344 to be exhausted through the vent opening 5332. However, the tray 5344 may make this condition more difficult (i.e., increase resistance) and may result in more expelled air remaining in the plenum chamber 3200 than if the tray 5344 were not present. As described above, the radius of curvature of the disk 5344 may affect the impedance of the exhaust air 1600 exiting the plenum chamber 3200 (e.g., a smaller radius of curvature creates a larger impedance). The tray 5344 functions similarly to the distance 5312 described above in that the tray 5344 prevents some water vapor from exiting the plenum chamber 3200 by directing exhaled air back into the plenum chamber 3200. Exhaled air 1600 that is not redirected to the patient's mouth has a greater distance of travel to reach the ventilation opening 5332 (e.g., as compared to fig. 57). This increased distance (e.g., similar to distance 5316 of fig. 71-1) in combination with the reverse flow of pressurized gas 1500 may allow more water vapor to be retained and re-inhaled by the patient. The increased impedance created by the disc 5344 relative to the exhaled air 1600 may not be aided by HME (although HME may be used), and may be merely a result of the shape and/or size of the disc 5344. This may help to alleviate dry mouth in the patient.

Multiple venting locations

As shown in fig. 74-75, the elbow 5300 may be used with a breather ring 5352 that is substantially similar to the breather ring 3504, and only some similarities and differences may be described. For example, as shown in fig. 74, the vent ring 5352 may include fewer vent openings 5356 than the vent ring 3504. In the illustrated example, the vent openings 5356 may be collected at specific areas of the vent ring 5352. In other examples, the vent openings 5356 may be evenly spaced around the perimeter of the vent ring 5352.

As shown in fig. 75, additional vent openings 5360 may be provided on a complementary connector 5364 that may be removably connected to quick release connector 4176. The vent openings 5360 may be collected at specific areas of the connector 5364. In other examples, the vent openings 5360 may be evenly spaced around the perimeter of the connector 5364.

In use, the vent opening 5356 may operate like the previously described vent openings and allow exhaled air to escape the plenum chamber 3200. In this example, fewer vent openings 5356 are created to reduce the flow rate of exhaust exiting the plenum chamber 3200. Because less gas as a whole may be vented through vent opening 5356, more exhaust gas and thus more water vapor remains in plenum chamber 3200, which may help to limit oral dryness in the patient.

Because less ventilation occurs in the plenum chamber 3200, ventilation may need to occur elsewhere so that the system does not become over pressurized. The vent opening 5360 of the connector 5364 may allow pressurized gas to vent to the ambient environment before reaching the patient. Although the pressure to the patient may be somewhat less, more air remains in the plenum chamber 3200 and thus the net pressure is substantially the same (e.g., as with the breather ring 3504).

Combination of two or more kinds of materials

In some forms, any combination of the above examples may be used in combination with one another. For example, the vent ring may include a smaller number of vent openings, and may also include a disk or be spaced a distance from the connection port. Including any two (or all three) of these features together may increase the amount of water vapor that remains in the plenum chamber 3200, which the patient may inhale on the next breath to help limit their xerostomia.

Respiration waveform

Figure 6 shows a model representative breathing waveform of a person while sleeping. The horizontal axis is time and the vertical axis is respiratory flow rate. While parameter values may vary, a typical breath may have the following approximations: tidal volume vt0.5L, inspiration time ti1.6s, peak inspiration flow rate qpeak 0.4L/s, expiration time te2.4s, peak expiration flow rate qpeak-0.5L/s. The total duration Ttot of respiration is about 4s. The person typically breathes at a rate of about 15 Breaths Per Minute (BPM), with a ventilation Vent of about 7.5L/min. A typical duty cycle Ti to Ttot ratio is about 40%.

Respiratory therapy mode

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

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.

General rule

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) outside of the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

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

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

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

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and maximum level, e.g., between each breath, depending on the presence or absence of an indication of an SDB event.

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

Flow rate: air volume (or mass) delivered per unit time. The flow rate may refer to an instantaneous quantity. In some cases, the reference to the flow rate 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., an amount having a magnitude and a direction. The flow rate may be represented by the symbol Q. "flow rate" is sometimes abbreviated simply as "flow" or "gas flow".

In the example of patient breathing, the flow rate 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 rate Qd is the flow rate of air leaving the RPT device. The total flow rate Qt is the flow rate of air and any supplemental gas to the patient interface via the air circuit. The ventilation flow rate Qv is the flow rate of air exiting the vent to allow the exhalation gases to escape. The leak flow rate Ql is the leak flow rate from the patient interface system or elsewhere. The respiratory flow rate Qr is the flow rate of air inhaled into the respiratory system of the patient.

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 generally positive throughout the respiratory cycle of the patient.

A humidifier: the term humidifier will be considered to refer to a humidification device constructed and arranged or configured with physical structures capable of providing a therapeutically beneficial amount of water (H) to an air stream ₂ O) vapor to ameliorate a medical respiratory condition of the patient.

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

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

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

Ventilation noise (acoustic): ventilation noise in this document 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 may be expressed in a series of units, including cmH ₂ O、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/m) ² =1 mbar to 0.001 atm. In the present specification, unless otherwise indicated, pressure is used tocmH ₂ O is the unit.

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 generally 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.

Material

Silicone or silicone elastomer: a synthetic rubber. In the present specification, reference to silicone resin is a reference 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 otherwise specified to the contrary, an exemplary form of LSR has a shore a (or type a) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: a thermoplastic polymer of bisphenol A carbonate.

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 in terms of Young's modulus or indentation hardness scale measured on a standardized sample size).

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

"hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

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

Flexible structures or components: when allowed to support its own weight for a relatively short period of time, such as within 1 second, a structure or component that changes shape (e.g., bends) will change.

Rigid structures or components: structures or components that do not significantly change shape when subjected to the loads typically encountered in use. An example of such use may be to place and maintain a patient interface in sealing relationship with the entrance to the patient's airway, such as at about 20 to 30cmH ₂ Under load of O pressure.

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

Respiratory cycle

Apnea: according to some definitions, an apnea is considered to occur when the flow drops below a predetermined threshold, for example for a duration of 10 seconds. Obstructive apneas are considered to occur when some obstruction of the airway does not allow air flow despite patient effort. Central apneas are considered to occur when an apnea is detected that is due to a reduction in respiratory effort or a lack of respiratory effort, although the airway is patent. Mixed apneas are considered to occur when a reduction in respiratory effort or the absence of an airway obstruction occurs simultaneously.

Respiratory rate: the frequency of spontaneous breathing of a patient is typically measured in breaths per minute.

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

Effort (respiration): spontaneously breathing people try 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 an operational state in the patient's breath in which an increase in the patient's effort does not cause a corresponding increase in flow. In the event that flow restriction occurs during the inspiratory portion of the respiratory cycle, it may be described as an 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: ascending, followed by a relatively flat portion, and then descending.

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

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

(iv) Inverted chair shape: with a relatively flat portion followed by a single local peak at the trailing edge.

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

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

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

Hyperrespiration: the flow increases above normal.

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

Patency (airway): the degree of airway opening, or the extent of airway opening. The open airway is open. Airway patency may be quantified, for example, a value of one (1) indicates patency and a value of zero (0) indicates closure (occlusion).

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

Peak flow rate (Q peak): respiratory flow waveform the maximum of the inspiratory portion flow rate.

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

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

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

(expiration) time (Te): the duration of the expiratory portion of the respiratory flow rate 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: on some predetermined time scale, recent values of ventilation Vent tend to concentrate on ventilation values, i.e., measurements of recent trend of ventilation.

Upper Airway Obstruction (UAO): including partial and complete upper airway obstruction. This may be associated with a flow restriction condition in which the flow rate increases only slightly, or even decreases, as the upper airway pressure differential increases (Starling damping behavior).

Ventilation (Vent): a measure of the rate 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.

Ventilation volume

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

Standby rate: ventilator parameters that determine the minimum rate of breathing (typically in breaths per minute) that the ventilator delivers 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, the ventilator is considered to cease delivering breath during the inspiratory portion of the respiratory cycle.

Positive expiratory airway pressure (EPAP): a base pressure to which a pressure that varies within the breath is added to produce a desired interface pressure that the ventilator attempts to reach at a given time.

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

Positive inspiratory airway pressure (IPAP): the ventilator attempts to reach the maximum desired interface pressure during the inspiratory portion of the breath.

Pressure support: the number representing the pressure increase during inspiration of the ventilator over the pressure increase during expiration of the ventilator generally refers to the pressure difference between the maximum value during inspiration and the base pressure (e.g., ps=ipap-EPAP). In some cases, pressure support refers to differences that the ventilator is intended to achieve, rather than differences that are actually achieved.

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

Spontaneous/timing (S/T): an attempt is made to detect the pattern of ventilators or other devices that spontaneously breathe the beginning of a patient's breath. 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 a breath of air to a spontaneously breathing patient, it is considered to be triggered by the patient's effort at the beginning of the respiratory part of the respiratory cycle.

Anatomical structure

Facial anatomy

Nose wing (Ala): the outer wall or "wing" of each naris

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

Winged curvature (or winged ridge) point: the last point in the curved baseline of each alar is located in the crease formed by the alar-cheek junction.

Auricle: the entire outer visible portion of the ear.

(nasal) skeletal frame: the skeletal frame of the nose includes the nasal bones, the frontal processes of the maxilla, and the nose of the frontal bone.

(nasal) cartilage scaffold: nasal cartilage frames include nasal septum cartilage, lateral cartilage, large cartilage and small cartilage.

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

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

Frankfurt level: a line extending from the lowest point of the orbital rim to the left cochlea. The tragus is the deepest point in the recess above the tragus of the pinna.

Intereyebrow: is positioned on the soft tissue and is the most prominent point of the mid-forehead sagittal plane.

Extranasal cartilage: a substantially triangular cartilage plate. The upper edge is attached to the nasal bone and the frontal process of the maxilla, and the lower edge is connected with the large cartilage of the nasal wing.

Lip, lower (lower lip midpoint): a point on the face between the mouth and the point on the chin lies in the median sagittal plane.

Lip, upper (upper lip midpoint): a point on the face between the mouth and nose lies in the median sagittal plane.

Nasal alar cartilage: a cartilage plate located under the extranasal cartilage. It curves around the anterior portion of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough layer of fibrous membrane containing three or four small cartilages of the winged bone.

Nostrils (Nostrils): forming an approximately oval aperture of the nasal cavity entrance. The singular form of nostrils (nares) is nostrils (naris). The nostrils are separated by the nasal septum.

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

Nose lip angle: the angle between the columella and the upper lip at the time of the junction of the subnasal points.

Sub-aural base point: the lowest point of the connection of the pinna with the facial skin.

Base point on ear: the highest point of the connection of the pinna with the facial skin.

Nose point: the most prominent point or tip of the nose, which can be identified in the 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 on the soft tissue, the foremost midpoint of the chin.

Ridge (nose): the nasal ridge is the midline bulge of the nose, extending from the nasal bridge point to the nasal bulge 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 is the most concave point covering the forehead suture.

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

The lower edge of the nose wing: at the point of the lower edge of the wing bottom, where the wing bottom is connected to the skin of the upper (upper) lip.

Subnasal point: is positioned on the soft tissue, and the point where the columella nasi meets the upper lip in the median sagittal plane.

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

Skull anatomy

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

Mandible: 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 parts of the face and form the "beam" of the nose through 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 recessed area above the bridge of the nose.

Occipital bone: occiput is located at the back and lower part of the skull. It includes oval hole, i.e. occipital macropore, through which cranial cavity is connected with vertebral canal. The curved plate behind the occipital macropores is occipital scale.

Orbit of eye: a bone cavity in the skull that accommodates the eyeball.

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.

Anatomy of 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 voice box accommodates 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 rear is fused with the nasopharynx through the posterior nasal orifice.

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 segments: nasopharynx (upper pharynx) (nose of pharynx), oropharynx (middle pharynx) (mouth of pharynx), laryngopharynx (lower pharynx).

Patient interface

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

Bending pipe: an elbow is an example of a structure that directs the axis of air flow therethrough through an angle to change direction. 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 rotated, for example about 360 degrees, relative to the mating component. In some forms, the elbow may be removed from the mating component, for example, via a snap-fit connection. In some forms, the elbow may be assembled to the mating component via a disposable snap during manufacture, but not removable by the patient.

A frame: the frame will be considered to refer to a mask structure that is subjected to a tension load between two or more attachment points to the headgear. The mask frame may be a non-airtight carrying structure in the mask. However, some forms of mask frames may also be airtight.

Headgear: headgear will be considered to mean a form of positioning and stabilising structure designed for use on the head. For example, the headgear may include a set of one or more struts, ties, and stiffeners configured to position and hold the patient interface in place on the patient's face for delivering respiratory therapy. Some laces are formed from a soft, flexible, elastic material, such as a laminated composite of 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: mask inflation chamber will be considered to refer to a portion of the patient interface having a wall that at least partially encloses a volume of space in which air is pressurized above atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

And (3) sealing: may be in the form of a noun representing a structure ("seal"), or in the form of a verb representing an effect ("seal"). The two elements may be constructed and/or arranged to "seal" or to achieve a "seal" therebetween without the need for a separate "sealing" element itself.

And (3) a shell: the shell refers to a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, the curved structural wall of the mask may be a shell. In some forms, the shell or a portion of the shell may not be rigid. 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 posts: a strut will be considered a structural component designed to increase the resistance to compression of another component in at least one direction.

Rotator (noun): a subassembly of components configured to rotate about a common axis, preferably independently, preferably at low torque. In one form, the rotating body may be configured to rotate through an angle of at least 360 degrees. In another form, the rotating body may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a pair of mating cylindrical conduits. Little or no air flow may leak from the rotator during use.

Lacing (noun): a structure for resisting tension.

Vent port: (noun): a structure that allows air to flow from the interior of a mask or conduit to ambient air for clinically effective flushing of exhaled air. For example, depending on mask design and therapeutic pressure, clinically effective irrigation may include a flow rate of about 10 liters per minute to about 100 liters per minute.

Structural shape

The product according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or impeller. The three-dimensional structure may be defined by a two-dimensional surface. 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., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

To facilitate the description of the three-dimensional structure and the shape of the surface, we first consider a cross-section through the surface of the structure at point p. Referring to fig. 3B-3F, examples of cross-sections at point p on the surface are shown, along with the resulting planar curves. Fig. 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, we describe the surface from the perspective of an imaginary small person standing upright on the surface.

One-dimensional curvature

The curvature of a planar curve at p may be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1/radius of a circle just touching the curve at p).

Positive curvature: if the curve at p turns to the outward normal, the curvature at that point will be positive (if the imagined small person leaves the point p, they must walk upward). 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 taken 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 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-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 cross-sections in the main direction. The principal curvature at p is the principal direction curvature.

Area of the surface: 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 area: 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 person turns).

Dome area: at each point the principal curvatures have regions of the same sign, for example both positive ("concave dome") or both 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, for example, zero within manufacturing tolerances).

Edge of surface: boundary or demarcation of a surface or area.

Path: in some forms of the present technology, a "path" will be used to represent 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. (imagined paths of people are where they walk on a surface and are similar to garden paths).

Path length: in some forms of the present technology, a "path length" will be considered to refer to 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 they 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 imaginary person, the straight distance will correspond to a distance of "straight")

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 twist at a point on the spatial curve can be characterized with reference to a tangent vector, a normal vector, and a sub-normal vector 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 from her vehicle at a certain point, the direction of the tangential vector is the direction in which 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.

Sub-normal unit vector: the secondary normal unit vector is perpendicular to both the tangent vector and the primary 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 unit vector of the sub-normal at that 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 amplitude of the twist near the top coil of the spiral of fig. 3S is greater than the amplitude of the twist of the bottom coil of the spiral of fig. 3S.

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

Equivalently, and with reference to the left hand rule (see fig. 3O), a space curve that turns toward the left hand sub-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.

Hole(s)

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, a pneumatic tire has 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 example cross-sections through the liner in fig. 3M and 3N, where the interior surface defining a 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. Also seen is a two-dimensional aperture through the structure shown in fig. 3K, which is defined by the surface shown.

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 files or records, but has the full scope of copyright protection.

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 the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

Furthermore, where a value or values described herein are implemented as part of the technology, it is to be understood that such value or values may be approximate unless otherwise stated, and that such value or values may be applicable to any suitable significant digit to the extent that practical technical implementations are 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 application belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

Obvious substitute materials with similar properties may be used as substitutes when a particular material is identified for use in constructing a component. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and 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 their plural equivalents unless the context clearly dictates otherwise.

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

The terms "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 should not be used to limit 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.

List of reference numerals

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Claims

1. A patient interface, comprising:

a plenum having a pressure capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure cavity for O;

a first seal-forming structure constructed and arranged to form a seal with an area of a patient's face surrounding the patient's oral inlet, the first seal-forming structure constructed and arranged to maintain the therapeutic pressure in the cavity of the plenum chamber throughout a respiratory cycle of the patient in use;

a second seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding the nostril entrance of the patient, the second seal-forming structure constructed and arranged to maintain the therapeutic pressure in the cavity of the plenum chamber throughout a respiratory cycle of the patient in use; and

a ventilation structure allowing the exhaled gas of the patient to be continuously exhausted from the interior of the plenum to the ambient environment, the ventilation structure being sized and shaped to maintain the therapeutic pressure in the plenum in use;

The patient interface further comprises:

at least one stop rib disposed in the cavity of the plenum, spaced apart from the first seal-forming structure in a rest position, the first seal-forming structure configured to contact the at least one stop rib in an operative position, the at least one stop rib configured to resist compression of the first seal-forming structure in a forward direction; and is also provided with

2. The patient interface of claim 1, further comprising an upper lip portion disposed below the second seal-forming structure and configured to contact an upper lip of the patient, the upper lip portion not configured to contact the at least one stop rib.

3. A patient interface according to any one of claims 1 or 2, wherein the at least one stop rib comprises a plurality of stop ribs spaced apart from one another within the cavity.

4. A patient interface according to claim 3, wherein the plurality of stop ribs are arranged in a c-shape.

5. A patient interface according to any one of claims 3-4, wherein the plurality of stop ribs are non-equally spaced from one another within the cavity.

6. A patient interface according to any one of claims 3 or 5, when dependent on claim 3, wherein the plurality of stop ribs extend around a majority of a periphery of the first seal-forming structure.

7. A patient interface according to any one of claims 1-6, wherein the at least one stop rib is an elongate member.

8. A patient interface according to any one of claims 1-7, wherein the at least one stop rib comprises a beveled edge.

9. A patient interface according to claim 8, wherein the inclined edge is a rear edge and the inclined edge is configured to contact the first seal-forming structure in use so as to limit forward movement of the first seal-forming structure in the operative position.

10. The patient interface according to any one of claims 8 to 9, wherein the beveled edge is disposed away from the first seal-forming structure toward a center of the plenum chamber in the rest position.

11. A patient interface according to any one of claims 1-10, wherein the at least one stop rib comprises a length measured substantially perpendicular to the first seal-forming structure and a width measured substantially perpendicular to the length, and wherein the length is greater than the width.

12. A patient interface according to claim 11, wherein the first seal-forming structure is configured to contact the at least one stop rib along the width in the operative position.

13. A patient interface according to any one of claims 11-12, wherein the width is substantially uniform along the length of the at least one stop rib.

14. A patient interface according to any one of claims 11-12, wherein the width varies along the length of the at least one stop rib.

15. The patient interface according to any one of claims 1 to 14, wherein the at least one stop rib is integrally formed with the plenum chamber.

16. A patient interface, comprising:

a plenum formed entirely of a flexible material, the plenum comprising:

a cavity capable of being pressurized to at least 6cmH above ambient air pressure ₂ The therapeutic pressure of O is set to,

an inlet port configured to provide fluid communication between the cavity and an ambient environment, an

A groove formed on a surface of the plenum chamber outside the cavity and exposed to ambient pressure, the groove formed radially outward of the inlet port, and the groove forming a closed perimeter;

A seal-forming structure constructed and arranged to form a seal with an area of a patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the cavity of the plenum chamber throughout a respiratory cycle of the patient in use;

a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising:

a frame coupled to the plenum, the frame comprising:

a central portion including an inner periphery and an outer periphery, the inner periphery and the outer periphery being removably positioned within the recess, the inner periphery being configured to be spaced apart from the inlet port when positioned within the recess,

a pair of upper arms extending away from the central portion, an

A pair of lower arms extending away from the central portion; and

a headgear strap coupled to the pair of upper arms and the pair of lower arms of the frame and configured to provide tension to the seal-forming structure into the patient's face via the frame.

17. A patient interface according to claim 16, wherein the pair of upper arms are longer than the pair of lower arms.

18. A patient interface according to any one of claims 16-17, wherein the pair of upper arms each comprise a first type of connector and the pair of lower arms each comprise a second type of connector different from the first type of connector.

19. A patient interface according to claim 18, wherein the first type of connector is selected from the group consisting of a ring, a ladder lock, and a cord stop.

20. A patient interface according to any one of claims 18-19, wherein the first type of connector is the ring, the ring comprising a first ring portion and a second ring portion adjacent the first ring portion.

21. A patient interface according to claim 20, wherein the ring includes a dividing wall that at least partially separates the first ring portion from the second ring portion.

22. A patient interface according to claim 21, wherein the straps in the headgear straps are configured to be selectively inserted into the first loop portion and contact the dividing wall at an optimal tension in use, and wherein the straps are configured to be moved into the second loop portion at a tension greater than the optimal tension.

23. A patient interface according to any one of claims 18-22, wherein the second type of connector is a magnetic member.

24. A patient interface according to claim 23, wherein the magnetic member comprises a substantially elliptical shape.

25. A patient interface according to any one of claims 23-24, wherein a housing is removably and magnetically connected to the magnetic member.

26. A patient interface according to claim 25, wherein the housing comprises a strap connector for connecting to a strap of the headgear strap, the strap connector selected from the group consisting of a loop, a ladder lock, and a cord stop.

27. A patient interface according to any one of claims 25-26, wherein the housing is configured to engage a lip of a shell.

28. The patient interface according to any one of claims 18 to 27, wherein at least one of the headgear straps comprises an elastic portion stretchable between a first position and a second position, and wherein the at least one strap comprises a reminder portion configured to be visible in the second position and to be substantially hidden in the first position.

29. A patient interface according to claim 28, wherein the at least one strap further comprises a haptic response element comprising a first portion and a second portion disposed on either side of the reminder portion, and wherein the first portion and the second portion of the haptic response element are connected in the first position and are configured to be separated in the second position so as to remind the patient.

30. A patient interface according to claim 29, wherein the haptic response element is a magnet.

31. The patient interface according to any one of claims 18 to 28, wherein at least one of the headgear straps comprises a first width and a second width that is greater than the first width.

32. A patient interface according to claim 31, wherein the first width is selectively receivable by the first type of connector, and wherein the second width is substantially blocked from passing through the first type of connector.

33. The patient interface according to any one of claims 18 to 28, wherein at least one of the headgear straps comprises a plurality of raised portions configured to provide a tactile response when passing through the first type of connector.

34. A patient interface according to claim 33, wherein the plurality of raised portions are glue sites.

35. The patient interface according to any one of claims 18 to 28, wherein at least one of the headgear straps includes a cutting edge configured to provide a tactile response when passing through the first type of connector.

36. A patient interface according to claim 35, wherein the cutting edge comprises a triangle, rectangle and/or circle.

37. A patient interface according to any one of claims 16-32, wherein the pair of upper arms and the pair of lower arms are integrally formed with the central portion.

38. The patient interface according to any one of claims 16 to 37, wherein the plenum chamber comprises at least one protrusion extending from the recess, and wherein the central portion of the frame comprises at least one slot configured to selectively receive the at least one protrusion.

39. A patient interface according to any one of claims 16-38, wherein the pair of lower arms are substantially flush with the central portion.

40. A patient interface according to any one of claims 16-39, wherein the seal-forming structure further comprises:

a first seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the patient's oral access opening;

a second seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding the patient's nostril entrance;

wherein the groove is disposed on the plenum below the second seal-forming structure and opposite the first seal-forming structure.

41. A patient interface according to any one of claims 16-40, wherein a fabric sleeve is connected to each upper arm of the pair of upper arms.

42. A system for providing pressurized air to a patient, the system comprising:

a patient interface according to any one of claims 16-41;

a respiratory therapy system (RPT) device configured to provide an air flow at the therapeutic pressure; and

a conduit connecting the RPT device to the patient interface, the conduit configured to communicate the air flow to the patient interface;

wherein the conduit is connected to the inlet port of the plenum.

43. A system for providing pressurized air to a patient, the system comprising:

A seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet such that the flow of air at the therapeutic pressure is delivered to the airway, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;

an air circuit removably connected to the plenum and configured to provide the air flow at the therapeutic pressure from an air flow generator to the cavity, the air circuit comprising a vent ring configured to be at least partially inserted through the plenum inlet port, the vent ring comprising:

a rear surface having a first diameter and,

a front surface having a second diameter smaller than the first diameter, and

wherein:

The first diameter is greater than a diameter of the lip.

44. The system of claim 43, wherein the ring body is sloped between the posterior surface and the anterior surface.

45. The system of any of claims 43-44, wherein the rear surface is configured to contact the lip and a front wall of the plenum within the cavity in use.

46. The system of claim 43, further comprising an annular seal positioned within the groove.

47. The system of claim 46, wherein an outer diameter of the annular seal is less than an outer diameter of the groove.

48. The system of any one of claims 43-47, wherein the ring body comprises a central opening, and the system further comprises an elbow connector, the central opening configured to receive the elbow connector.

49. The system of claim 48, wherein the elbow connector is rotatably connected to the ring, and wherein the ring is rotatably connected to the plenum.

50. The system of any of claims 48 to 49, wherein the elbow connector comprises at least one button configured to be selectively actuated to disengage the elbow connector from the plenum inlet port.

51. The system of claim 50, wherein the at least one button is formed as a cantilever structure.

52. The system of claim 51, wherein an arm connects the at least one button to the body of the elbow connector, the arm having an S-shape.

53. The system of any one of claims 50-52, wherein the at least one button includes a button lip configured to selectively engage the ring body and move relative to a remainder of the elbow connector when the at least one button is actuated.

54. The system of claim 53, wherein the button lip is configured to selectively engage an inner periphery of the inner wall of the ring body.

55. The system of any one of claims 50 to 51, wherein the at least one button comprises a finger configured to selectively engage the ring body and move relative to the rest of the elbow connector when the at least one button is actuated.

56. The system of claim 55, wherein the fingers are configured to selectively engage the ring body radially outward of the inner wall.

57. The system of any one of claims 43-56, wherein the at least one vent opening is a plurality of vent openings spaced around a perimeter of the groove.

58. The system of any of claims 43-57, wherein the plenum inlet port comprises an extension and the ring body is connected to the extension and spaced apart from a surface of the plenum.

59. The system of any one of claims 43 to 58, further comprising a quick release connector.

60. The system of claim 59, wherein the quick release connector is a rotatable connector or a latching connector.

61. The system of any one of claims 59-60, wherein the quick-release connector is configured to connect to a complementary connector.

62. The system of any one of claims 59-61, wherein the quick-release connector comprises at least one flat surface.

63. The system of claim 62, wherein the at least one planar surface is a pair of planar surfaces spaced approximately 180 ° apart.

64. A system according to any one of claims 54 to 55 when dependent on claim 57, wherein the at least one planar surface is configured to redistribute leakage of the air flow from the system.

65. The system of any of claims 59-64, wherein the quick-release connector includes a vent opening configured to vent a portion of the air flow into an ambient environment.

66. The system of any one of claims 43-65, wherein the seal-forming structure is spaced apart from the vent ring, and wherein the patient's face is not configured to contact the vent ring.

67. The system of any one of claims 43 to 66, wherein the ring body comprises an extension.

68. The system of any one of claims 43 to 67, wherein the ring body comprises a disc configured to be positioned within the cavity and limit the discharge of exhaled air into the surrounding environment.

69. The system of claim 68, wherein the disk extends radially beyond a portion of the rear surface that includes the at least one vent opening.