Patient interface

Abstract

To provide a medical device having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.SOLUTION: A seal-forming structure for a patient interface may include: a patient-contacting surface configured to engage the facial skin of a patient to form a seal; a posterior opening formed in the patient-contacting surface, the posterior opening configured to provide the flow of air at the therapeutic pressure to the nares of the patient; and a support structure extending from the patient-contacting surface to an interior surface of the seal-forming structure, where the support structure and the interior surface form a continuous loop. The patient interface is configured to allow the patient to breath from the atmosphere through their mouth in the absence of a flow of pressurized air through a plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.SELECTED DRAWING: Figure 7A

Description

Technical Field

[0001] 1 Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 480,059, filed Mar. 31, 2017, and the entire disclosure of the above application is incorporated herein by reference for all purposes.

[0002] 2 Background of the Technology 2.1 Field of the Technology This technology relates to one or more of the detection, diagnosis, treatment, prevention, and amelioration of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

Background Art

[0003] 2.2 Description of Related Technologies 2.2.1 The Human Respiratory System and Its Diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airways.

[0004] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, and this region is called the respiratory zone. See, e.g., "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory diseases exist. Certain diseases can be characterized by specific manifestations (e.g., apnea, hypopnea, and hyperpnea).

[0006] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of closure or obstruction of the upper airway during sleep. This is due to an abnormally small upper airway during sleep and a normal lack of muscle tension in the tongue area, combined with the soft palate and posterior oropharyngeal wall. Due to such conditions, the breathing stops of affected patients typically last for 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular disease and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients have no awareness of the symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, in which alternating increases and decreases in ventilation, known as the CSR cycle, continue periodically. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by repeated sleep awakenings, which can cause severe insomnia, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory insufficiency is a general term for respiratory disorders, referring to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases.

[0010] Patients with respiratory insufficiency (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0011] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other clear causes of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include an increase in resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing a number of disorders and diseases that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Some NMD patients are characterized by progressive muscle impairment, which can result in inability to walk, confinement to a wheelchair, dysphagia, reduced respiratory muscle strength, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified into the following rapid - and slow - progressive types: (i) Rapid - progressive disorders: Characterized by muscle impairment that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slow - progressive disorders: Characterized by muscle impairment that worsens over years and only results in a slightly reduced life expectancy (e.g., limb - girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory failure symptoms in NMD include increased general weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, headache upon waking, and difficulty with concentration and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the connection between the respiratory muscles and the thorax. These disorders are mainly characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. Symptoms of respiratory failure are listed below: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, headache on waking, fatigue, poor sleep quality, and loss of appetite.

[0015] To treat or improve such conditions, a range of treatments are being used. Additionally, in other aspects, healthy individuals can also advantageously utilize preventive and therapeutic measures for respiratory diseases. However, there are several drawbacks in these.

[0016] 2.2.2 Treatment methods A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are used for the treatment of one or more of the above respiratory diseases.

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to move forward or backward against the posterior oropharyngeal wall, continuous positive pressure ventilation therapy functions as an air splint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following about the device used for treatment delivery, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0018] Non-invasive ventilation (NIV) provides ventilatory assistance to a patient through the upper airway and performs some or all of the respiratory functions to assist the patient's breathing and / or maintain an appropriate oxygen level in the body. The ventilatory assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0019] Invasive ventilation (IV) provides ventilatory assistance to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] 2.2.3 Treatment Systems These treatments can be provided by a treatment system or device. Such systems and devices can also be used for diagnosis without treating the disease.

[0021] A treatment system can include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another form of treatment system is a mandibular repositioning device.

[0023] 2.2.3.1 Patient Interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an airflow to an airway inlet. The airflow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure along with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0024] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a mask for purely decorative purposes, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the surroundings.

[0025] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks the airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a sealed state via the lips.

[0027] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0028] There are several challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0029] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in adaptability, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic mask can withstand their original uses, but in such cases of masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's commitment to treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0030] CPAP therapy is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's commitment.

[0031] Masks designed for the treatment of sleep apnea may be suitable for other uses in some cases, as masks for other uses (e.g., pilots) may be inappropriate for the treatment of sleep apnea.

[0032] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0033] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the patient interface makes direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0034] The patient interface can be partially characterized according to the design intent of where the seal-forming structure engages with the face during use. In one form of the patient interface, the seal-forming structure can include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure can include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0035] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] Certain seal-forming structures can be designed for mass production to fit one design for a wide range of different face shapes and sizes and be comfortable and effective. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of any mismatch between them.

[0037] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure can include an air or fluid-filled cushion or can include a shaped or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure uses a thin flap seal disposed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not match the patient's shape, creases or buckling can occur in the seal-forming portion during use, causing leakage.

[0039] Another type of seal-forming structure can include friction fit elements inserted into the nostrils, for example, but there are also patients who find these seal-forming portions uncomfortable.

[0040] Another form of seal-forming structure can use an adhesive portion to achieve a seal. Among patients, there are also patients who always feel it is inconvenient to attach or remove the adhesive portion to their own face.

[0041] Techniques for forming a patient interface seal structure within a certain range are disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0042] One form of nasal pillows can be found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0043] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGELIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (in particular, describes the appearance of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application No. 2009 / 0044808 (in particular, describes the appearance of ResMed Limited's SWIFT® LT nasal pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (in particular, describe the appearance of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); International Patent Application WO2009 / 052,560 (in particular, describes the appearance of ResMed Limited's SWIFT® FX nasal pillow).

[0044] 2.2.3.1.2 Positioning and Stabilization The seal-forming structure of the patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming structure and maintain the seal against the appropriate part of the face.

[0045] In one technique, an adhesive portion is used. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, when an adhesive portion is used, there may be discomfort.

[0046] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a number of such harnesses, one or more of the following apply: poor fit, bulky, uncomfortable, and difficult to handle.

[0047] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device The respiratory pressure therapy (RPT) device can be used for the delivery of one or more of the above-described therapies, for example, by generating an air delivery flow to the airway inlet. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0048] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0049] An example of a special requirement for a particular RPT device is acoustic noise.

[0050] [Table 1]

[0051] One known RPT device used for the treatment of sleep apnea is the S9 sleep therapy system (manufacturer: ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar® series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive independent breathing for patients for a certain range for the treatment of multiple conditions (non-limiting examples include NMD, OHS, and COPD).

[0052] The ResMed Elise′e® 150 ventilator and the ResMed VSIII® ventilator can provide assistance for invasive and non-invasive dependent breathing suitable for adult or pediatric patients for the treatment of multiple conditions. With these ventilators, volume ventilation mode and pressure ventilation mode using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (e.g., an electric blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0053] The device designers can be presented with countless options. Since design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect can also be greatly affected by minor changes in one or more parameters.

[0054] 2.2.3.3 Humidifier If the delivery of the air flow is carried out without humidification, it can lead to drying of the airway. When a humidifier is used together with the RPT device and the patient interface, humidified gas is generated, so the drying of the nasal mucosa is minimized and the comfort of the patient's airway is increased. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort more than in the case of cold air.

[0055] Artificial humidification devices and systems within a certain range are known, but they do not meet the special requirements of medical humidifiers.

[0056] Medical humidifiers are typically used to increase the humidity and / or temperature of the air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed near the patient's head may be small. A medical humidifier may be configured to humidify and / or heat only the air flow delivered to the patient, and not to humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since they also humidify and / or heat the entire room, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, there may be more stringent safety constraints than for industrial humidifiers.

[0057] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use.

[0058] 2.2.3.4 Data Management There may be a case where data is obtained to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following certain "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, the provider of the RPT device (e.g., a healthcare provider) may obtain data describing the patient's treatment with the RPT device manually, calculate the usage rate over a given period, and compare this to the compliance rule. If the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0059] In a patient's treatment, there may be other ways to benefit from communication of treatment data to a third party or an external system.

[0060] In the case of existing processes for communicating and managing such data, one or more of high cost, time consumption, and susceptibility to errors may occur.

[0061] 2.2.3.5 Mandibular Repositioning A mandibular repositioning 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 dentists or other providers that holds the mandible (lower jaw) in a forward position during sleep. The MRD is a removable device that is inserted into the mouth before the patient goes to sleep and removed after sleep. Therefore, the MRD is not designed for continuous wear applications. The MRD may be custom-made or manufactured in a standard form and includes an occlusal impression site designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension to the pharyngeal wall, reducing airway collapse and reducing palatal vibration.

[0062] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or fit over the teeth on the maxilla or maxilla bone and a lower splint intended to engage or fit over the teeth on the maxilla or mandible. The upper splint and the lower splint are laterally connected to each other via a pair of connecting rods. This set of connecting rods is symmetrically fixed on the upper splint and the lower splint.

[0063] In such a design, the length of the connecting rod is selected such that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to vary the level of protrusion of the mandible. The dentist can determine the level of protrusion according to the mandible, and as a result, the length of the connecting rod is determined.

[0064] There are also MRDs configured to push the mandible forward relative to the maxilla bone, and there are those designed to hold the mandible in a forward position, such as other MADs like the ResMed Narval CC (registered trademark) MRD. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ) between the temples and the mandible. Therefore, this device is configured to minimize or avoid any movement of one or more of the teeth.

[0065] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a ventilation section for expelling the exhaled carbon dioxide. This ventilation section may enable the flow from the internal space of the patient interface (for example, the plenum chamber) to the outside (for example, the surroundings) of the patient interface.

[0066] This ventilation section may include an orifice, and when using a mask, gas can flow through the orifice. In the case of a number of such ventilation sections, it is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation sections, for example, due to noise or airflow concentration, it may interfere with the sleep of the patient 1000 and the co - sleeper 1100.

[0067] ResMed Limited has developed a number of improved mask ventilation technologies. See the following: International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0068] [Table 2]

[0069] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0070] [Table 3]

[0071] 2.2.4 Diagnostic systems and monitoring systems A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases and typically requires expert clinical staff for system application. In a PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram recording (EOG), electromyography (EMG)). For PSG of sleep disordered breathing, patients had to be observed in a specialized hospital for two nights. That is, the first night was for pure diagnosis and the second night was necessary for titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. PSG is particularly unsuitable for sleep tests at home.

[0072] Clinical experts can appropriately diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert is not possible. Opinions of clinical experts may differ regarding the patient's condition. Furthermore, some clinical experts may apply different criteria depending on the time.

Summary of the Invention

Means for Solving the Problems

[0073] 3 Brief Description of the Technology The present technology relates to the provision of medical devices used in the diagnosis, improvement, treatment or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0074] The first aspect of the present technology relates to a device used in the diagnosis, improvement, treatment or prevention of respiratory diseases.

[0075] Another aspect of the present technology relates to a method used in the diagnosis, improvement, treatment or prevention of breathing disorders.

[0076] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respect to respiratory therapy.

[0077] Aspects of the present technology relate to a seal-forming structure for a patient interface configured to form a seal with a patient's nostrils. The seal-forming structure includes a support structure that forms a continuous loop with the inner surface of the seal-forming structure. The loop structure supports the upper portion of the patient contact surface of the seal-forming structure, and the upper portion of the patient contact surface has a single layer that is not supported by an under-cushion.

[0078] Aspects of the present technology relate to a patient interface: The patient interface is a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for breathing by the patient, a plenum chamber, a seal-forming structure constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, a positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a tie, the tie being constructed and arranged such that at least a portion thereof is disposed over a region of the patient's head above the auricular basal point of the patient's head during use, a ventilation structure for moving a continuous gas flow exhaled by the patient from the interior of the plenum chamber to the atmosphere, the ventilation structure being sized and shaped such that it can maintain the treatment pressure within the plenum chamber during use, and the patient interface being configured to allow the patient to breathe from the atmosphere through their own mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface being configured to leave the patient's mouth exposed, the seal-forming structure further including a patient contact surface configured to engage the patient's facial skin to form a seal and a rear opening formed within the patient contact surface, the rear opening being configured to provide an air flow at the treatment pressure to the patient's nostrils, and the seal-forming structure including a support structure extending from a first position of the patient contact surface to a second position on the inner surface of the seal-forming structure, the support structure and the inner surface forming a continuous loop.

[0079] In an example, (a) the seal-forming structure may include a front opening formed within the patient non-contact surface and a front tie encompassing the front opening, and a first end of the support structure may be connected to the front tie; (b) the seal-forming structure may include an edge bounding a rear opening within the patient contact surface, and a second end of the support structure may be connected to the patient contact surface in an upper region of the edge; (c) the seal-forming structure may include an under-cushion supporting the patient contact surface; (d) a lower portion of the seal-forming structure may include the under-cushion, and an upper portion of the seal-forming structure may not include the under-cushion; (e) the support structure may have a length in an un-deformed state that is longer than a straight-line distance from a first position to a second position; (f) the support structure may be configured to be positioned in contact with or adjacent to a patient's nasal column during use; (g) the support structure may be curved along a longitudinal axis of the support structure in an un-deformed state; (h) the support structure may have a thickness different from the patient contact surface; (i) the support structure may be thicker than the patient contact surface; (j) the support structure may not extend across the entire rear opening; (k) the seal-forming structure may at least partially form a gas chamber, and the support structure may extend into the gas chamber in an un-deformed state; (l) the support structure may have a variable thickness in a longitudinal direction; (n) the support structure may have an increased thickness adjacent to the first position and / or the second position; (n) a portion of the support structure may be curved away from the patient's nose along a longitudinal axis of the support structure in an un-deformed state, and / or (o) the under-cushion may be structured to support the patient contact surface only against the patient's upper lip.

[0080] Aspects of the present technology relate to a seal-forming structure for a patient interface. The seal-forming structure is constructed and arranged to form a seal with an area of the patient's face that surrounds the patient's airway inlet. The seal-forming structure is constructed and arranged to maintain a treatment pressure of at least 6 cmH2O in the plenum chamber that exceeds ambient air pressure throughout the patient's respiratory cycle during use. The seal-forming structure includes a patient contact surface configured to engage the patient's facial skin to form a seal, a rear opening formed within the patient contact surface, the rear opening being configured to provide an air flow to the patient's nostrils at the treatment pressure, and a support structure extending from a first position of the patient contact surface to a second position on the inner surface of the seal-forming structure, the support structure and the inner surface forming a continuous loop. The patient interface is configured to allow the patient to breathe from the atmosphere through their mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0081] In an example, (a) the seal-forming structure may include a front opening formed within the patient non-contact surface and a front tie encompassing the front opening, and a first end of the support structure may be connected to the front tie; (b) the seal-forming structure may include an edge bounding a rear opening within the patient contact surface, and a second end of the support structure may be connected to the patient contact surface in an upper region of the edge; (c) the seal-forming structure may include an under-cushion supporting the patient contact surface; (d) a lower portion of the seal-forming structure may include the under-cushion, and an upper portion of the seal-forming structure may not include the under-cushion; (e) the support structure may have a length in an un-deformed state that is longer than a straight-line distance from a first position to a second position; (f) the support structure may be configured to be positioned in contact with or adjacent to a patient's nasal column during use; (g) the support structure may be curved along a longitudinal axis of the support structure in an un-deformed state; (h) the support structure may have a thickness different from the patient contact surface; (i) the support structure may be thicker than the patient contact surface; (j) the support structure may not extend across the entire rear opening; (k) the seal-forming structure may at least partially form a gas chamber, and the support structure may extend into the gas chamber in an un-deformed state; (l) the support structure may have a variable thickness in a longitudinal direction; (n) the support structure may have an increased thickness adjacent to the first position and / or the second position; (n) a portion of the support structure may be curved away from the patient's nose along the longitudinal axis of the support structure in an un-deformed state, and / or (o) the under-cushion may be configured to support the patient contact surface only against the patient's upper lip.

[0082] Aspects of the present technology relate to a patient interface: The patient interface includes a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow at the treatment pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with the region of the patient's face that surrounds the entrance to the patient's airway, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a strap, the strap being constructed and arranged to be disposed at least in part over a region of the patient's head above the auricular basal point of the patient's head during use; a release structure; and a ventilation structure that moves a continuous gas flow exhaled by the patient from the interior of the plenum chamber to the atmosphere, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use. The patient interface is configured to allow the patient to breathe from the atmosphere through their mouth when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed, and the ventilation structure further includes an opening through the release structure and an opening through the plenum chamber.

[0083] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0084] One aspect of one form of the present technology is a method of manufacturing an apparatus.

[0085] One aspect of a particular form of this technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

[0086] One aspect of one form of this technology is a patient interface that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning equipment is required. One aspect of one form of this technology is a patient interface that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning equipment is required.

[0087] Of course, some of the above aspects can form sub-aspects of this technology. Also, various combinations of various ones of the sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of this technology.

[0088] Other features of this technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0089] 4 Brief Description of the Drawings This technology is illustrated by way of non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements:

[0090] 4.1 Treatment System

Figure 1A

Figure 1B

Figure 1C

[0091] 4.2 Respiratory System and Facial Anatomy

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 2F

Figure 2G

Figure 2H

Figure 2I

Figure 2J

Figure 2K

Figure 2L

[0092] 4.3 Patient Interface

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 3F

Figure 3G

Figure 3H

Figure 3I

Figure 3J

Figure 3K

Figure 3L

Figure 3M

Figure 3N

Figure 3O

Figure 3P

Figure 3Q

Figure 3R

Figure 3S

Figure 3T

Figure 3U

Figure 3V

Figure 3W

Figure 3X

[0093] 4.4 RPT Device

Figure 4A

Figure 4B

[0094] 4.5 Humidifier

Figure 5A

Figure 5B

[0095] 4.6 Respiratory Waveform

Figure 6

[0096] 4.7 Patient Interface According to the Present Technology

Figure 7A

Figure 7B

Figure 7C

Figure 7D

Figure 7E

Figure 7F

Figure 7G

Figure 7H

Figure 7I

Figure 7J

Figure 7K

Figure 7L

Figure 7M

Figure 8A

Figure 8B

Figure 9A

Figure 9B

Figure 10

Figure 11

Mode for Carrying Out the Invention

[0097] 5 Detailed Description of Embodiments of the Present Technology Before further describing the present technology in detail, it should be understood that the present technology is not limited to the specific embodiments that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0098] The following description is provided in connection with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. Additionally, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0099] 5.1 Treatment Method In one form, the present technology includes a method of treating a respiratory disease. The method includes the step of applying positive pressure to the entrance of the airway of patient 1000.

[0100] In a particular embodiment of the present technology, an air supply at positive pressure is provided to the nasal passage of the patient through one or both of the nostrils.

[0101] In a particular embodiment of the present technology, mouth breathing is restricted, limited, or impeded.

[0102] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0103] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional modalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of air at positive pressure to the airway.

[0104] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0105] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the ambient.

[0106] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the ambient.

[0107] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the ambient.

[0108] 5.3.1 Seal-Forming Structure In one aspect of the present technology, the seal formation structure 3100 may provide a target seal formation region and may further provide a cushioning function. The target seal formation region is a region in the seal formation structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0109] In one aspect, the target seal formation region is disposed on the outer surface of the seal formation structure 3100.

[0110] In a particular aspect of the present technology, the seal formation structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0111] The seal formation structure 3100 according to the present technology can be composed of a soft, flexible, and elastic material (e.g., silicone).

[0112] In a particular aspect of the present technology, a system is provided that includes more than one seal formation structure 3100. Each seal formation structure 3100 is configured to correspond to a different size and / or shape range. For example, the system can include one form of the seal formation structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0113] 5.3.1.1 Sealing mechanism In one aspect, the seal formation structure includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilization structure.

[0114] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length 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 the peripheral portion of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0115] In one form, the seal-forming structure may include a compression seal or a gasket seal. During use, the compression seal or gasket seal is constructed and arranged to be in a compressed state, for example, due to elastic tension in a positioning and stabilizing structure.

[0116] In one form, the seal-forming structure includes a tension portion. During use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0117] In one form, the seal-forming structure includes a region having an adhesive surface or an adherent surface.

[0118] In certain forms of the technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension portion, and a site having an adhesive surface or an adherent surface.

[0119] 5.3.1.2 Nasal bridge or nasal sill region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0120] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0121] 5.3.1.3 Upper Lip Region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0122] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face during use.

[0123] 5.3.1.4 Jaw Region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0124] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the jaw region of the patient's face during use.

[0125] 5.3.1.5 Forehead Region In one form, the seal-forming structure forms a seal over the forehead region of the patient's face during seal use. In such a form, the plenum chamber may cover the eyes during use.

[0126] 5.3.1.6 Nasal Pillows In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose.

[0127] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a part of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem portion, and a flexible region on the lower side of the frustum of the cone, and connects the frustum of the cone to the stem portion. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem portion. The flexible region may function to facilitate a self-aligning structure. The self-aligning structure corresponds to the mutual movement of both the displacement and the angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stem portion is connected.

[0128] 5.3.1.7 Seal formation structure using a support structure Figures 7A - 7M show a seal formation structure 3100 according to an example of the present technology. The seal formation structure 3100 may be characterized as a nasal cradle cushion. The seal formation structure 3100 may be configured to seal the patient's face around the patient's nostrils so as to send pressurized breathable air to the patient's nasal airway (without covering the patient's mouth).

[0129] The lower part of the seal formation structure 3100 may engage with the patient's upper lip to form a seal, and the seal formation structure 3100 may not extend beyond the upper lip to the patient's vermilion border of the upper lip. In one example, the upper part of the seal formation structure 3100 may be configured to engage with the patient's nose below the patient's nasal bone to form a seal. In another example, the upper part of the seal formation structure 3100 may be configured to engage with the patient's nose below the patient's nasal tip point to form a seal. The lateral part of the seal formation structure 3100 may be configured to engage with the patient's face between the patient's alae nasi and the patient's cheek to form a seal. The lateral part of the seal formation structure 3100 may be configured to engage with and form a seal with the patient's face beyond the alar apex point.

[0130] The seal formation structure 3100 according to the present technology may include the attributes of the nasal cradle cushions disclosed in International Application Publication Nos. WO2014 / 110626 (filing date: January 16, 2014) and WO2015 / 070289 (filing date: November 14, 2014). The entire contents of each of these documents are incorporated herein by reference for all purposes.

[0131] The seal formation structure 3100 according to the example shown in FIGS. 7A to 7M includes a connection region 3102 on its front side. The connection region 3102 is structured to connect the seal formation structure 3100 to the plenum chamber 3200. The connection region 3102 provides an interface that engages with the plenum chamber 3200. The connection region 3102 can be connected to the plenum chamber 3200 via a mechanical connection (e.g., friction fitting, snap fitting, or mechanical coupling of corresponding overhanging portions). The connection region 3102 can provide a removable connection to the plenum chamber 3200. This removable connection allows the seal formation structure 3100 to be removed for cleaning or replacement.

[0132] The connection region 3102 of this example surrounds a front opening 3104 or a hole. The front opening 3104 can be in fluid communication with the plenum chamber 3200 to receive a flow of pressurized breathable gas, and exhaled gas from the patient can move through the front opening 3104 to the plenum chamber 3200 and be exhausted from the ventilation portion 3400. The front opening 3104 of this example is also divided by a front band 3108 that vertically encompasses the front opening 3104 between the lower part and the upper part of the connection region 3102.

[0133] The seal formation structure 3100 of this example also includes a patient non-contact surface 3116 that surrounds the connection region 3102. The patient non-contact surface 3116 faces away from the patient's face and does not contact the patient's face during use. The patient non-contact surface 3116 can also be at least partially in contact with the plenum chamber 3200.

[0134] The seal formation structure 3100 of this example also includes a patient contact surface 3114. The patient contact surface 3114 faces the patient's face during use. The patient contact surface 3114 can at least partially seal the facial skin of the patient during use. The patient contact surface 3114 is arranged such that the facial skin of the patient contacts the patient contact surface 3114 during use. The facial skin of the patient may contact only a part of the patient contact surface 3114, or alternatively, the facial skin of the patient may contact the entire patient contact surface 3114 during use. The patient contact surface 3114 can be adjacent to the patient non-contact surface 3116. The patient contact surface 3114 can also be adjacent to the patient non-contact surface 3116.

[0135] The seal formation structure 3100 of this example also includes a gas chamber 3120 that is at least partially bounded by an inner surface 3112 of the seal formation structure 3100. The gas chamber 3120 can be pressurized up to 30 cmH2O by the pressurized breathable gas received from the plenum chamber 3200 during use.

[0136] As can be seen from the rear view of FIG. 7D, a rear opening 3106 or hole is formed in the patient contact surface 3114. The pressurized breathable gas in the gas chamber 3120 of the seal formation structure 3100 is communicated to the patient's nostrils through the rear opening 3106. The gas exhaled from the patient's nostrils is communicated to the gas chamber 3120 through the rear opening 3106 and exhausted through the ventilation portion 3400. The rear opening 3106 may be a single opening formed in the patient contact surface 3114, or alternatively, the rear opening 3106 may be divided into two separate openings, with each opening communicating with the corresponding nostril of the patient. The rear opening 3106 can be bounded by an edge 3118 of the patient contact surface 3114.

[0137] The seal forming structure 3100 of this example also includes a support structure 3110 as shown in FIGS. 7C, 7J, and 7M. The support structure 3110 is connected at one end to the front tie 3108, and the connection is made to the surface of the front tie 3108 facing the inside of the gas chamber 3120, or faces in the rearward direction relative to the seal forming structure 3100. The other end of the support structure 3110 is connected to the patient contact surface 3114 at the edge 3118. As can be seen from the cross-sectional views of FIGS. 7G - 7K and 7M, the upper part of the patient contact surface 3114 of the seal forming structure 3100 is not supported by an under-cushion. The patient contact surface 3114 of the seal forming structure 3100 can be a single layer that engages with the patient's nose proximal to the nasal tip point. The single layer of the seal forming structure 3100 in this region can be more flexible compared to a double-wall arrangement configuration (i.e., an arrangement configuration including an under-cushion), so that the seal for a wider range of nose shapes can be more comfortable and effective. However, in the case of such a single-layer arrangement configuration, there is a greater possibility of rupture (e.g., due to pressurized breathable gas, the patient contact surface 3114 of the seal forming structure 3100 is disengaged from the patient's nose). The support structure 3110 counteracts this effect by fastening the edge 3118 of the patient contact surface 3114 to another part of the seal forming structure 3100.

[0138] The support structure 3110 can also partially contact or be adjacent to the patient's nasal column so that the patient's nose does not protrude into the gas chamber 3120 of the seal forming structure 3100. Depending on the size and shape of the individual patient's nose, the support structure 3110 can be in the vicinity such that it does not directly contact the patient's nasal column. The support structure 3110 can also support the patient contact surface 3114 and bias the patient contact surface 3114 to engage with the patient's nose proximal to the nasal tip point to ensure an effective seal. FIG. 7J also shows, for example, that the support structure 3110 does not cover the rear opening 3106 and does not extend between the upper and lower parts of the edge 3118.

[0139] The support structure 3110 may have a thickness different from that of the patient contact surface 3114. The support structure 3110 may be thicker than the patient contact surface 3114. The support structure 3110 may have a variable thickness in the longitudinal direction. The support structure 3110 may have an increased thickness adjacent to one or both of the positions where the support structure 3110 joins the seal forming structure 3100.

[0140] As shown in FIG. 7G, the support structure 3110 forms a continuous loop with the inner surface 3112 of the seal forming structure 3100 and the front tie 3108. In another example, the support structure 3110 may be connected to the inner surface 3112 of the seal forming structure 3100 and may not be connected to the front tie 3108. In such another example, the front tie 3108 may be omitted. The support structure 3110 may have a length in the non-deformed state that is longer than the straight-line distance from two positions where the support structure 3110 connects to the seal forming structure 3110 to provide a certain degree of relaxation to the support structure.

[0141] FIG. 7G also shows that the support structure 3110 is slightly curved inwardly in the gas chamber 3120 in the non-deformed state. This curved shape may enable the support structure 3110 to better accommodate the patient's nose (including the nasal tip point). Alternatively, the support structure 3110 may be straight in the non-deformed state of another example. Thus, FIG. 7G shows the patient contact surface 3114 adjacent to the outer or rear surface of the support structure 3110. In another example, the support structure 3110 may be connected to the inner surface 3112 of the seal forming structure 3100 on the opposite side of the patient contact surface 3114 such that the patient contact surface 3114 and the support structure 3110 are separated by the edge 3118.

[0142] The seal forming structure 3100 (in particular, the support structure 3110) may include the attributes of the tie 3110 disclosed by International Application Publication No. WO2016 / 149769 (filing date: March 24, 2016). The entire content of this document is incorporated herein by reference for all purposes.

[0143] As shown in FIGS. 7G to 7M, the seal formation structure 3100 may also include an undercushion 3122 that supports a part of the patient contact surface 3114. The undercushion 3122 may support only the lower part of the undercushion 3122. The undercushion 3122 may be provided only to the lower half of the seal formation structure 3100. The undercushion 3122 in these examples may be configured to support the patient contact surface 3114 against the patient's upper lip so as to ensure an effective seal. A similar undercushion layer 3105 is disclosed in U.S. Provisional Application No. 62 / 328,988 filed on April 28, 2016. Each of the entire documents is incorporated herein by reference for all purposes.

[0144] The connection region 3102 of the seal formation structure 3100 may have a shape similar to an infinite loop (∞) or the shape of the number 8. It could also be described as having an hourglass shape. The connection region 3102 may have a shape such that its narrowest tip comes to the center line of the seal formation structure 3100. Then, the connection region 3102 may expand upward and downward on both sides away from the center line, as shown in FIG. 7B for example.

[0145] 5.3.2 Prenum Chamber The prenum chamber 3200 has an edge with a shape that is complementary to the surface contour of an average person's face in the region where a seal is formed during use. During use, the peripheral edge of the prenum chamber 3200 is positioned close to the adjacent surface of the face. The actual contact with the face is provided by the seal formation structure 3100. The seal formation structure 3100 may extend around the entire edge of the prenum chamber 3200 during use. In some forms, the prenum chamber 3200 and the seal formation structure 3100 are formed from a single homogeneous piece of material.

[0146] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye during use. In other words, the eye is outside the pressurized space defined by the plenum chamber. In such forms, treatment compliance can be improved because pressure is often reduced and / or wearer comfort is increased.

[0147] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). Utilization of a transparent material can reduce the harshness of the pressure of the patient interface and can assist in improving compliance with treatment. Utilization of a transparent material can assist a clinician in viewing the placement and function of the patient interface.

[0148] In certain forms of the present technology, the plenum chamber 3200 is composed of a translucent material. Use of a translucent material can reduce the harshness of the pressure of the patient interface and can assist in improving compliance with treatment.

[0149] 5.3.3 Positioning and Stabilization Structure The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by a positioning and stabilization structure 3300 during use.

[0150] In one form, the positioning and stabilization structure 3300 provides at least sufficient holding force to overcome the effect of the positive pressure in the plenum chamber 3200 that causes it to lift off the face.

[0151] In one form, the positioning and stabilization structure 3300 provides sufficient holding force to overcome the gravitational force on the patient interface 3000.

[0152] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube dragging or accidental interference with the patient interface).

[0153] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to be worn by a patient during sleep. In one embodiment, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0154] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with a patient lying in a supine sleep position with the back of the patient's head resting on a pillow.

[0155] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with a patient lying in a lateral sleep position with the side of the patient's head resting on a pillow.

[0156] In one form of the present technology, the positioning and stabilization structure 3300 includes a release site disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This release portion is not resistant to compression and can be, for example, a flexible or flimsy strap. The release portion is constructed and arranged so as to avoid a situation where, when the patient lies with the head on the pillow, the presence of the release portion causes a force to be transmitted along the positioning and stabilization structure 3300 to the rear, interfering with the seal.

[0157] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0158] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut when in use and direct a force that causes the seal-forming structure to adhere to a portion of the patient's face. In one embodiment, the strap can be configured as a tie.

[0159] In one form of the present technology, the positioning and stabilization structure includes a first tie, and the first tie is constructed and arranged such that at least a portion of its lower edge moves upward and over the ear base point on the patient's head during use and covers a portion of the parietal bone without covering the occipital bone.

[0160] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a portion of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head.

[0161] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move in a separating direction.

[0162] In certain forms of the technology, the positioning and stabilization structure 3300 includes straps that are bendable and, for example, non-rigid. An advantage of this aspect is that the straps are more comfortable when the patient lies on their side during sleep.

[0163] In certain forms of the technology, the positioning and stabilization structure 3300 includes straps configured to be breathable such that water vapor can pass through them.

[0164] In certain forms of the technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force to accommodate different sizes and / or ranges of shapes. For example, the system can include one form of the positioning and stabilization structure 3300 that is suitable for a large-sized head rather than a small-sized head and another form that is suitable for a small-sized head rather than a large-sized head.

[0165] 5.3.4 Ventilation In one form, the patient interface 3000 includes a ventilation portion 3400 configured and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide).

[0166] In certain forms, the ventilation portion 3400 is configured to allow a continuous ventilation flow from the inside of the plenum chamber 3200 to the atmosphere when the pressure in the plenum chamber is positive relative to the atmosphere. The ventilation portion 3400 is configured such that, during use, while maintaining the treatment pressure within the plenum chamber, the magnitude of the ventilation flow is large enough to reduce the rebreathing by the patient of exhaled CO2.

[0167] One form of the ventilation portion 3400 according to the technology includes a plurality of holes (e.g., from about 20 to about 80 holes or from about 40 to about 60 holes or from about 45 to about 55 holes).

[0168] The ventilation part 3400 can be arranged in the plenum chamber 3200. Alternatively, the ventilation part 3400 is arranged in a decoupling structure (for example, a swivel).

[0169] The ventilation part 3400 provided in the plenum chamber 3200 may include a plurality of openings 3402. The openings 3402 may be arranged in two groups that are symmetric with respect to the center line of the plenum chamber 3200. The plurality of openings 3402 can reduce noise and diffuse the concentration of the ventilation flow.

[0170] The openings 3402 may be arranged close enough to the center line of the plenum chamber 3200 so that the openings 3402 are not blocked when the patient lies down and sleeps. In order to avoid weakening of the chassis in a relatively narrow part, the openings 3402 may be spaced apart from the center line.

[0171] The openings 3402 may have a circular profile.

[0172] 5.3.5 Decoupling structure(s) In one form, the patient interface 3000 includes at least one decoupling structure 3500 (for example, a swivel or ball and socket). FIGS. 8A, 8B, 9A and 9B show examples of the decoupling structure 3500 according to an example of the present technology. The decoupling structure 3500 can take the form of an elbow. The decoupling structure 3500 may include a swivel 3501 connected to the air circuit 4170 and a patient interface connector 3502 connected to the patient interface 3000. The patient interface connector 3502 may enable the tube 3503 of the decoupling structure 3500 to rotate relative to the patient interface 3000. The decoupling structure 3500 may also include a ventilation part 3400. The ventilation part 3400 of the decoupling structure 3500 may include at least one opening 3401 passing through a part of the patient interface connector 3502 and / or through a part of the tube 3503.

[0173] 5.3.6 Connection port The connection port 3600 enables connection to the air circuit 4170.

[0174] 5.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700.

[0175] 5.3.8 Anti-asphyxia valve In one form, the patient interface 3000 includes an anti-asphyxia valve.

[0176] 5.3.9 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the amount within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics (e.g., pressure) of the gas within the plenum chamber 3200.

[0177] 5.3.10 Patient interface of the present technology Figures 10 and 11 show a patient interface 3000 according to an example of the present technology. The patient interface 3000 includes a seal-forming structure 3100 according to the example described in Section 4.3.1 above. The seal-forming structure 3100 may be connected to the plenum chamber 3200 as described above. One or more ventilation parts 3400 may be provided in the plenum chamber 3200.

[0178] The patient interface 3000 may include a positioning and stabilization structure 3300 that includes a conduit 3301. The purpose of the conduit 3301 is twofold: 1) to position and stabilize the patient interface 3000 in a therapeutically effective position above the patient's head during use, and 2) to provide pressurized breathable gas to the plenum chamber 3200. For this purpose, the conduit 3301 may be constructed of a flexible biocompatible material or may form a hollow structure. The conduit 3301 may be connected to the plenum chamber 3200 by a clip 3303 so as to sandwich a pneumatic connection. The conduit 3301 may also include a strap connector 3302 for connection to a strap (not shown) that passes behind the patient's head during use. The conduit 3301 may also include a flexible portion 3304 that provides flexibility to the conduit 3301 so as to accommodate different sizes and the shape of the patient's head. Elbow connector 3305

[0179] 5.4 RPT Device An RPT device 4000 according to one aspect of the technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms. The RPT device 4000 may be configured to generate an air flow that is delivered to the patient's airway for the treatment of one or more of the respiratory states described anywhere in this document, for example.

[0180] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O or at least 10 cmH2O or at least 20 cmH2O.

[0181] The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 may 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.

[0182] The pneumatic path of the RPT device 4000 may include one or more air path items and a muffler 4120 (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air under positive pressure, an outlet muffler 4124, and one or more transducers 4270 (e.g., a pressure sensor and a flow sensor)).

[0183] One or more of the air circuit items may be arranged within a removable integrated structure herein called a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or formed as part of the chassis 4016.

[0184] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0185] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integrated unit. In an alternative form, one or more of the following components may be arranged as separate individual units.

[0186] 5.4.1.1 Air filter(s) The RPT device according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0187] In one form, the inlet air filter 4112 is arranged at the beginning of the upstream of the air pressure path of the pressure generator 4140.

[0188] In one form, the outlet air filter 4114 (e.g., antibacterial factor) is arranged between the outlet of the air pressure block 4020 and the patient interface 3000.

[0189] 5.4.1.2 Muffler(s) The RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0190] In one form of the present technology, the inlet muffler 4122 is arranged above the pressure generator 4140 within the air pressure path.

[0191] In one form of the present technology, the outlet muffler 4124 is arranged between the pressure generator 4140 and the patient interface 3000 within the air pressure path.

[0192] 5.4.1.3 Pressure generator In one aspect of the present technology, the pressure generator 4140 that generates an air flow or supply at a positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed within a volute. The blower can deliver an air supply at a speed of, for example, up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other aspects up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are hereby incorporated by reference in their entirety: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT Patent Application Publication WO2013 / 020167.

[0193] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0194] In other aspects, the 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.

[0195] 5.4.1.4 Transducer(s) The transducer may be provided inside the RPT device or outside the RPT device. An external transducer may be disposed, for example, on the air circuit or may form part of the air circuit (e.g., the patient interface). The external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that sends or moves data to the RPT device).

[0196] In one aspect of the present technology, one or more transducers 4270 may be disposed upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of the characteristics of the air flow (e.g., flow rate, pressure, or temperature at that point in the air pressure path).

[0197] In one aspect of the technology, one or more transducers 4270 may be disposed in the vicinity of the patient interface 3000.

[0198] In one aspect, signals from the transducer 4270 may be filtered (e.g., by low-pass, high-pass, or band-pass filtering).

[0199] 5.4.1.4.1 Flow Sensor The flow sensor according to the technology may be based on a differential pressure transducer (e.g., the SDP600 series differential pressure transducer from SENSIRION).

[0200] In one aspect, a signal indicating the flow rate from the flow sensor is received by the central controller.

[0201] 5.4.1.4.2 Pressure Sensor The pressure sensor according to the technology may be disposed in fluid communication with the air sensor pressure path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[0202] In one aspect, a signal from the pressure sensor may be received by the central controller.

[0203] 5.4.1.4.3 Motor Speed Transducer In one aspect of the technology, a motor speed transducer may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer may be provided to the treatment device controller. The motor speed transducer may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0204] 5.4.1.5 Anti-Spillback Valve In one form of the present technology, an anti-spillback valve 4160 can be disposed between a humidifier 5000 and a pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0205] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power Supply The power supply 4210 can be disposed inside or outside the external housing 4010 of the RPT device 4000.

[0206] In one form of the present technology, the power supply 4210 supplies power only to the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0207] 5.4.2.2 Input Device In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that enable a human to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touch screen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may wirelessly communicate with a receiver electrically connected to a central controller in another form.

[0208] In one form, the input device 4220 can be constructed and arranged to enable a human to select values and / or menu options.

[0209] 5.4.2.3 Central Controller In one form of the present technology, the central controller is one or more processors suitable for controlling the RPT device 4000.

[0210] Suitable processors can include x86 INTEL processors, such as processors based on the ARM® Cortex®-M processors from ARM Holdings (e.g., S®32 series microcontrollers from STMicroelectronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., STR9 series microcontrollers from STMicroelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by TEXAS INSTRUMENTS) may also be suitable.

[0211] In one form of the present technology, the central controller is a dedicated electronic circuit.

[0212] In one form, the central controller is an application-specific integrated circuit. In another form, the central controller includes discrete electronic components.

[0213] The central controller can be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and the humidifier 5000.

[0214] The central controller can be configured to provide output signal(s) to one or more of an output device, a treatment device controller, a data communication interface, and the humidifier 5000.

[0215] In some forms of the present technology, the central controller is configured to implement one or more of the methods described herein (e.g., one or more algorithms expressed as a computer program recorded in a non-transitory computer-readable recording medium (e.g., memory)). In some forms of the present technology, the central controller may be integrated with the RPT device 4000. However, in some forms of the present technology, some of the methods may be performed by remotely located devices. For example, a remotely located device may determine control settings for a ventilator or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein).

[0216] 5.5 Air Circuit An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that, in use, an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0217] Specifically, the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0218] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating element may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heating wire circuit may be wound helically around the axis of the air circuit 4170. The heating element may communicate with a controller (e.g., the central controller). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is hereby incorporated by reference in its entirety.

[0219] 5.5.1 Oxygen Delivery In one form of the technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0220] 5.6 Humidifier 5.6.1 Overview of the Humidifier In one form of the technology, a humidifier 5000 is provided for varying the absolute humidity of air or gas to be delivered to a patient relative to ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of an air flow before it is delivered to the patient's airway.

[0221] The humidifier 5000 can include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering the humidified air flow. In some forms, such as those shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 can be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 can further include a humidifier base 5006. The humidifier base 5006 can be adapted to receive the humidifier reservoir 5110 and can include a heating element 5240.

[0222] 5.6.2 Humidifier Components 5.6.2.1 Water Reservoir According to one arrangement, the humidifier 5000 can include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the air flow. The water reservoir 5110 can be configured to contain a predetermined maximum amount of water to provide adequate humidification over at least a respiratory therapy session (e.g., overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other forms, the humidifier 5000 can be configured to receive a water supply from an external water source (e.g., a building water supply system).

[0223] According to one aspect, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 can be configured to facilitate the movement of the air flow along a serpentine path within the reservoir 5110 while the air flow is in contact with a certain amount of water within the reservoir 5110.

[0224] According to one form, the reservoir 5110 can be removable from the humidifier 5000 in the lateral direction, as shown, for example, in FIGS. 5A and 5B.

[0225] The reservoir 5110 can also be configured to inhibit the release of liquid from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its sub-components). Since the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 can also be configured to prevent air pressure loss through leakage and / or flow impedance.

[0226] 5.6.2.2 Conductive Sites According to one arrangement, the reservoir 5110 includes a conductive site 5120 configured to enable efficient heat transfer from the heating element 5240 to a quantity of liquid within the reservoir 5110. In one form, the conductive site 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive site 5120 may be constructed of a thermally conductive material such as aluminum (e.g., having a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, suitable thermal conductivity may be achieved with a lower conductivity material of appropriate geometry.

[0227] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 configured to receive the humidifier reservoir 5110 (as shown in FIG. 5B). In some arrangements, the humidifier reservoir dock 5130 may include a locking function (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0228] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in FIGS. 5A - 5B. In some forms, the water level indicator 5150 may provide one or more indications to a user such as the patient 1000 or caregiver regarding the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include notification of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75%, or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0229] 5.6.2.5 Heating Element In some cases, the heating element 5240 can be provided to the humidifier 5000 that provides heat input to one or more of the amount of water in the humidifier reservoir 5110 and / or the amount of water to the air flow. The heating element 5240 can include a heat generating component such as an electric resistance heating track. As one suitable example of the heating element 5240, there is a layered heating element described in, for example, PCT Patent Application Publication No. WO2012 / 171072. In this specification, the entire document is incorporated by reference for reference purposes.

[0230] In some forms, the heating element 5240 can be provided into the humidifier base 5006. In the humidifier base 5006, heat can be sent to the humidifier reservoir 5110 mainly by conduction as shown in FIG. 5B.

[0231] 5.7 Respiratory waveform FIG. 6 shows a model of a typical respiratory waveform of a human during sleep. The horizontal axis is time and the vertical axis is respiratory flow rate. Since the parameter values can vary, a typical respiration can have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, Ti, 1.6 seconds, peak inspiratory flow rate, Qpeak, 0.4 L / second, expiratory time, Te, 2.4 s, peak expiratory flow rate, Qpeak, -0.5 L / second. The total duration Ttot of respiration is about 4 seconds. A human typically breathes about 15 times per minute (BPM), and the ventilation Vent is about 7.5 L / min. The ratio of a typical duty cycle, Ti to Ttot, is about 40%.

[0232] 5.8 Glossary For the purpose of disclosing the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply.

[0233] 5.8.1 General Air: In certain forms of the present technology, air can mean the atmosphere, and in other forms of the present technology, air can mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0234] Ambient: In certain forms of the present technology, the term "ambient" should be taken to mean (i) external to the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0235] For example, the ambient humidity for a humidifier can be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0236] In another example, the ambient pressure can be the pressure directly surrounding or external to the body.

[0237] In certain forms, the ambient (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, other than noise generated from, for example, the RPT device or generated from the mask or patient interface. Ambient noise can be generated from sources outside the room.

[0238] Automatic Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy that can automatically adjust the treatment pressure between a minimum and a maximum, for example, in response to the presence or absence of signs of SDB onset, during the breathing cycle.

[0239] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different breathing cycles of the patient (e.g., is increased in response to detection of signs of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0240] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. The flow rate can refer to an instantaneous amount. In some cases, when referring to the flow rate, it can refer to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to the flow rate, it can refer to a vector quantity (i.e., a quantity having both magnitude and direction). The flow rate may be given the symbol Q. The "flow rate" may also be abbreviated as "flow" for simplicity.

[0241] In an example of a patient's breathing, the flow rate can be nominally positive pressure with respect to the inhalation portion of the patient's breathing cycle and thus negative with respect to the exhalation portion of the patient's breathing cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting through the ventilation holes to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The respiratory flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0242] Humidifier: The word "humidifier" is interpreted to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve a patient's medical breathing condition.

[0243] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at the surrounding elbow.

[0244] Noise conduction (acoustic): In this document, conduction noise refers to noise conveyed to the patient through an air pressure path (e.g., an air circuit and the patient interface and the air within it). In one form, conduction noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0245] Noise emission (acoustic): In this document, emitted noise refers to noise conveyed to the patient by the surrounding air. In one form, the emitted noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0246] Noise ventilation (acoustic): In this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in the patient interface).

[0247] Patient: A person with or without a respiratory disease.

[0248] Pressure: Force per unit area. Pressure can be expressed and measured in various units (e.g., cmH2O, g-f / cm 2 , and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0249] The pressure in the patient interface is denoted by the symbol Pm, and the treatment pressure representing the target value to be achieved by the mask pressure Pm at the current time is denoted by the symbol Pt.

[0250] Respiratory pressure therapy (RPT): Addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0251] Ventilator: A mechanical device that provides pressure assistance when a patient performs part or all of the breathing motion.

[0252] 5.8.1.1 Materials Silicone or silicone elastomer: a synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molding silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise stated, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is about 35 to about 45. (Year? Required?)

[0253] Polycarbonate: a thermoplastic polymer of bisphenol A carbonate.

[0254] 5.8.1.2 Mechanical properties Elasticity: the ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0255] Elastic: releases substantially all energy during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0256] Hardness: the ability of a material to resist deformation itself (e.g., as described by the Young's modulus or the indentation hardness scale measured on a standardized sample size). · "Soft" materials may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. · "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0257] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending, or torsion). The structure or component may provide different resistances in different directions.

[0258] Flaccid structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supporting its own weight.

[0259] Rigid structure or component: A structure or component that undergoes substantially no shape change when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the patient's airway inlet under a pressure load of, for example, approximately 20 - 30 cmH2O.

[0260] As an example, an I - beam may include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be flaccid in a first direction and rigid in a second direction.

[0261] 5.8.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, e.g., 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, airflow is not allowed due to some airway obstruction. Central apnea refers to the state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to the state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0262] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0263] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0264] Effort (respiratory): Respiratory effort is said to refer to the movement performed by the spontaneous breathing of a person attempting to breathe.

[0265] Exhalation portion of the respiratory cycle: The period from the start of the exhalation flow to the start of the inhalation flow.

[0266] Flow limitation: Flow limitation is construed as a situation in a patient's respiration where an increase in the patient's effort does not cause a corresponding increase in flow. If flow limitation occurs during the inhalation portion of the respiratory cycle, the flow limitation can be referred to as an inhalation flow limitation. If flow limitation occurs during the exhalation portion of the respiratory cycle, the flow limitation can be referred to as an exhalation flow limitation.

[0267] Types of waveforms of flow-limited inhalation: (i) Flattening: After an ascent, a relatively flat portion follows, and then a descent occurs. (ii) M-shaped: Having one local peak at the rise and one local peak at the fall, with a relatively flat portion between these two peaks. (iii) Chair-shaped: Having a single local peak that occurs in the rising portion, followed by a relatively flat portion. (iv) Inverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs in the falling portion.

[0268] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold velocity continues over a duration, it is said that hypopnea has occurred. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may occur and be regarded as hypopnea: (i) A 30% decrease in the patient's respiration for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease in the patient's respiration (less than 50%) that continues for at least 10 seconds, with associated desaturation of at least 3% or arousal occurring.

[0269] Hyperpnea: The flow increases to a level higher than the normal flow rate.

[0270] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0271] Patency (airway): The degree to which the airway is open or the range over which the airway is open. Airway patency is an opening. Quantification of airway patency can be performed, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0272] Positive end-expiratory pressure (PEEP): A pressure above the atmosphere in the lungs that exists at the end of expiration.

[0273] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0274] Respiratory gas flow rate, air flow rate, patient's air flow rate, respiratory gas air flow rate (Qr): These terms can be understood to refer to the estimation of the respiratory air flow rate of an RPT device and are used in contrast to the "true respiratory flow rate" or "true respiratory gas flow rate", which is the actual respiratory flow rate of the patient, usually expressed in liters per minute.

[0275] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort.

[0276] (Inspiration) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0277] (Expiration) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0278] (Total) time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0279] Typical recent ventilation: The ventilation value (i.e., the degree of tendency of the center of the most recent values of ventilation) for which the most recent values of ventilation Vent over a given time scale tend to cluster.

[0280] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. It may be associated with a state of flow limitation in which flow may increase slightly or decrease with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0281] Ventilation (Vent): Measurement of the rate of gas exchange performed by a patient's respiratory system. Measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as volume and is understood as volume per minute.

[0282] 5.8.3 Ventilation Adaptive servo - ventilator (ASV): A servo - ventilator that has a changeable rather than a fixed target ventilation. The changeable target ventilation can be learned from some characteristic of the patient (e.g., the patient's respiratory characteristics).

[0283] Backup rate: A parameter of a ventilator that establishes the minimum respiratory rate (typically, breaths per minute) delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0284] Cycle: The end of the inspiratory phase of a ventilator. When delivering breaths from a ventilator to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle to stop breath delivery.

[0285] Expiratory positive airway pressure (EPAP): The baseline pressure to which a pressure that varies during respiration is added for the generation of a desired mask pressure that the ventilator attempts to achieve at a given time.

[0286] End - expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of a breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ) = 0 when Φ = 1), EEP is equal to EPAP.

[0287] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory part of the breath.

[0288] Pressure support: A number indicating the pressure increase during ventilator inspiration compared to ventilator expiration, mainly meaning the pressure difference between the maximum value during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support means the difference that the ventilator attempts to achieve (rather than the difference actually achieved by the ventilator).

[0289] Servo ventilator: A ventilator with patient ventilation and target ventilation, which adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0290] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath of a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period, the device automatically starts breath delivery.

[0291] Swing: A term corresponding to pressure support.

[0292] Trigger: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be triggered to deliver the breath when the patient himself / herself starts the breathing part of the breathing cycle.

[0293] Typical recent ventilation: The typical recent ventilation Vtyp is a range of values where recent ventilation measurements tend to cluster over a certain predetermined time scale. For example, a measurement of the central tendency of ventilation measurements over the recent history can be an appropriate value for the typical recent ventilation.

[0294] 5.8.4 Anatomical structure 5.8.4.1 Facial anatomical structure Alar: The outer wall or the "wing" of each nostril (plural: alar)

[0295] Alar angle:

[0296] Alare: The outermost point on the ala.

[0297] Alar curvature (or alar summit) point: The most posterior point on the curvilinear reference line of each ala, seen at the fold formed by the junction of the ala and the cheek.

[0298] Auricle: The entire visible part of the ear.

[0299] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0300] (Nasal) cartilage skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilage, the major cartilage, and the minor cartilage.

[0301] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0302] Columella angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point.

[0303] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the left ear point. The ear point is the deepest point from the upper notch to the earlobe of the auricle.

[0304] Glabella: Located in the soft tissue, the most prominent point on the mid-sagittal of the frontal region.

[0305] Lateral nasal cartilage: Generally a triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bone and the frontal process of the maxilla, and its lower peripheral edge is connected to the major alar cartilage.

[0306] Lip, lower (Lower lip: labrale inferius):

[0307] Lip, upper (Upper lip: labrale superius):

[0308] Greater alar cartilage: A plate of cartilage that is located below the lateral nasal cartilage. It curves around the front part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that includes three or four alar minor cartilages.

[0309] Nostril (Naris): Generally an oval-shaped wing hole that forms the entrance to the nasal cavity. The singular form of nostril is naris. These nostrils are separated by the nasal septum.

[0310] Nasolabial groove or nasolabial fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0311] Nasolabial angle: The angle between the nasal columella and the upper lip, which intersects with the subnasale point.

[0312] Subaurale: The lowest point of attachment of the auricle to the facial skin.

[0313] Supraaurale: The highest point of attachment of the auricle to the facial skin.

[0314] Tip of nose point: The most prominent point or tip of the nose, which can be identified in the side view of the remaining part of the head portion.

[0315] Philtrum: A midline groove that extends from the lower border of the nasal septum to the upper part of the lip in the upper lip region.

[0316] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0317] (Nasal) ridge: The nasal ridge is a midline elevation of the nose that extends from the sellion to the tip of the nose point.

[0318] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior), dividing the body into a right half and a left half.

[0319] Sellion: The most concave point on the area of the fronto-nasal suture, located on the soft tissue.

[0320] Septal cartilage (nose): The septal cartilage is part of the septum and divides the front part of the nasal cavity.

[0321] Lowest alar point: The point at the lower periphery of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0322] Subnasal point: The point located on the soft tissue where the columella joins the upper lip in the mid-sagittal plane.

[0323] Stomion: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0324] 5.8.4.2 Anatomical structure of the skull Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the region known as the forehead.

[0325] Mandible: The mandible forms the lower jaw. The gonion is a bony prominence of the jaw and forms the jaw.

[0326] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0327] Nasal bone: The nasal bones are two small rectangular bones, which vary in size and shape from person to person. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0328] Nasion: The intersection of the frontal bone and the two nasal bones, which is a concave area directly provided between the eyes and the upper side of the nasal bridge.

[0329] Occipital bone: The occipital bone is located on the back and lower part of the skull. The occipital bone includes the foramen magnum, which is an elliptical hole. Through this hole, the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0330] Orbit: A bony cavity in the skull that contains the eyeball.

[0331] Parietal bone: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0332] Temporal bone: The temporal bones are located on the base and sides of the skull and support the part of the face known as the temple.

[0333] Zygomatic bone: The two zygomatic bones included in the face are located in the upper and outer parts of the face and form the cheek prominences.

[0334] 5.8.4.3 Anatomical Structure of the Respiratory System Diaphragm: A sheet of muscle that extends over the lower part of the thorax. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0335] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0336] Lung: The respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0337] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. There are three horizontal extensions called nasal conchae or turbinate bones on the sides of the nasal cavity. There is a nose at the front of the nasal cavity, and it connects to the nasopharynx at the back through the posterior nares.

[0338] Pharynx: The part of the throat located directly below (inferior) the nasal cavity and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (midpharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0339] 5.8.5 Patient Interface Aspiration prevention valve (AAV): A component or sub - assembly of a mask system that, by opening into the atmosphere in a fail - safe manner, reduces the risk of excessive CO2 re - breathing by the patient.

[0340] Elbow: An elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a generally circular cross - section. In another form, the elbow can have an elliptical or rectangular cross - section. In a particular form, the elbow can be rotatable, for example, about 360 degrees with respect to an engaging component. In a particular form, the elbow can be removable from an engaging component, for example, via a snap connection. In a particular form, the elbow can be assembled to an engaging component via a one - time snap during manufacture while being non - removable by the patient.

[0341] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non - airtight load - supporting structure in the mask. However, some forms of the mask frame can be airtight.

[0342] Functional dead space: (Insert description here)

[0343] Headgear: The headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a collection of one or more struts, ties, and supplementary rigid members configured to position and hold a patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of a foam material and a fabric).

[0344] Membrane: The membrane is typically taken to mean a thin element, and preferably does not substantially resist bending and resists stretching and contraction.

[0345] Plenum chamber: The mask plenum chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell may form part of the wall of the mask plenum chamber.

[0346] Seal: When used as a noun ("seal"), it may refer to a structure, and when used as a verb ("seal"), it may refer to its effect. Two elements may be constructed and / or arranged to "seal" or obtain a "sealing" effect between them without the need for separate "seal" elements themselves.

[0347] Shell: The shell is taken to mean a relatively thin, curved structure having bending, tensile, and compressive rigidity. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0348] Reinforcing member: The reinforcing member is taken to mean a structural component designed to increase the stiffness or flexibility of another component in at least one direction.

[0349] Strut: The strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0350] Swerl (noun): A sub-assembly of components, configured to rotate preferably independently and preferably under low torque around a common axis. In one form, the swerl can be configured to rotate at an angle of at least 360 degrees. In another form, the swerl can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably includes a pair of cylindrical conduits in combination. In use, there is little leakage of the air flow from the swerl.

[0351] Ty (noun): A structure designed to resist tension.

[0352] Ventilation: (noun) A structure that allows air flow to the ambient air inside a mask or conduit, enabling a clinically effective washout of the exhaled gas. For example, in a clinically effective washout, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and treatment pressure.

[0353] 5.8.6 Shape of the Structure The product according to the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be limited by two-dimensional surfaces. These surfaces can be distinguished using labels to describe the direction, position, function, or some other property of the associated surface. 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 embodiment, the seal-forming structure may include a face contact (e.g., outer) surface and a separate non-face contact (e.g., lower or inner) surface. In another embodiment, the structure may include a first surface and a second surface.

[0354] To facilitate the description of the shape and surface of the three-dimensional structure, first consider the cross-section at point p through the surface of the structure. Refer to FIGS. 3B to 3F. FIGS. 3B to 3F show an example of a cross-section at point p on the surface and an example of the resulting planar curve. FIGS. 3B to 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some embodiments, this surface will be described from the perspective of a fictional little person standing upright on the surface.

[0355] 5.8.6.1 Curvature in One Dimension The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0356] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (when this fictional little person leaves point p, they need to walk uphill). Refer to FIGS. 3B (relatively large positive curvature compared to FIG. 3C) and 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often referred to as concave.

[0357] Zero curvature: When the curve at p is a straight line, the curvature is taken as zero (when this fictional little person leaves point p, they can walk on a horizontal plane that is neither uphill nor downhill). Refer to FIG. 3D.

[0358] Negative curvature: When the curve at p bends in the direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (when this fictional little person leaves point p, they need to walk downhill). Refer to FIGS. 3E (relatively small negative curvature compared to FIG. 3F) and 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often referred to as convex.

[0359] 5.8.6.2 Curvature of a Two-Dimensional Surface The description of the shape at a given point on a two-dimensional surface according to this technique may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (e.g., relatively small). The planar curves in FIGS. 3B-3F may be examples of such a plurality of cross-sections at a particular point.

[0360] Principal curvatures and directions: The directions of the normal planes in which the curvature of the curve takes its maximum and minimum values are called the principal directions. In the embodiments of FIGS. 3B-3F, since the maximum curvature occurs in FIG. 3B and the minimum occurs in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0361] Region of the surface: A set of connected points on the surface. This set of points within the region may have similar characteristics (e.g., curvature or sign).

[0362] Saddle region: A region in which the principal curvatures at each point have opposite signs (i.e., one has a positive sign and the other has a negative sign), depending on the direction in which an imaginary person walking on the uphill or downhill could face.

[0363] Dome region: A region in which the principal curvatures at each point have the same sign (both positive ("concave dome") or both negative ("convex dome")).

[0364] Cylindrical region: A region in which one principal curvature is zero (or zero within, e.g., manufacturing tolerances), and the other principal curvature is non-zero.

[0365] Plane region: A region of the surface in which both principal curvatures are zero (or zero within, e.g., manufacturing tolerances).

[0366] Edge of the surface: The boundary or limit of the surface or region.

[0367] Path: In certain embodiments of the present technology, "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve on a surface from f(0) to f(1)). In certain embodiments of the present technology, "path" can be described as a route or course that includes, for example, a set of points on a surface. (The path of a fictional person is where one walks on a surface and is similar to a garden path).

[0368] Path length: In certain embodiments of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface).

[0369] Straight-line distance: The straight-line distance is the distance between two points on a surface, without considering the surface. On a planar region, there is a distance on the edge of 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 that has the same path length as the straight-line distance between two points. (For a fictional person, the straight-line distance corresponds to the "distance a crow flies").

[0370] 5.8.6.3 Space curve Space curve: Unlike a plane curve, a space curve does not necessarily exist within any specific plane. A space curve can be closed, i.e., it has no endpoints. A space curve can be regarded as a one-dimensional piece in three-dimensional space. A fictional person walking along the strand of a DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Fig. 3Q). A typical human right ear contains a right-handed helix (see Fig. 3R). Fig. 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the shape of a curve that deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, normal vector, and binormal vector at that point.

[0371] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and magnitude from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional person is flying along a curve and falls out of their vehicle at a particular point, the direction of the tangent vector is the direction in which the person should be moving.

[0372] Unit normal vector: When a fictional person is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0373] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (e.g., see Fig. 3P) or, alternatively, the left-hand rule (Fig. 3O).

[0374] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figs. 3O and 3P.

[0375] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the osculating plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the osculating plane of the space curve is relatively small, the magnitude of the torsion of the space curve is relatively small (for example, a gently sloping helical path). When the deviation from the osculating plane of the space curve is relatively large, the magnitude of the torsion of the space curve is relatively large (for example, a steeply sloping helical path). Referring to FIG. 3S, since T2 > T1, the magnitude of the torsion near the top coil of the helix in FIG. 3S is greater than the magnitude of the torsion of the bottom coil of the helix in FIG. 3S.

[0376] Referring to the right - hand rule of FIG. 3P, a space curve that bends in the direction of the right - hand binormal can be regarded as having a positive torsion in the right - hand direction (for example, a right - hand helix as shown in FIG. 3S). A space curve that faces away from the right - hand binormal direction can be regarded as having a negative right - hand torsion (for example, a left - hand helix).

[0377] Similarly, referring to the left - hand rule (see FIG. 3O), a space curve that faces in the left - hand binormal direction can be regarded as having a positive left - hand torsion (for example, a left - hand helix). Thus, the positive left - hand direction corresponds to the negative right - hand direction. Refer to FIG. 3T.

[0378] 5.8.6.4 Holes A surface can have one - dimensional holes (for example, holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (for example, a membrane) containing holes, this structure can be described as having one - dimensional holes. For example, refer to the state where the one - dimensional holes in the surface of the structure shown in FIG. 3I are bounded by a planar curve.

[0379] The structure can have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another embodiment, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion of FIG. 3L and the exemplary cross-sections of FIG. 3L in FIGS. 3M and 3N showing the inner surface bounding the two-dimensional hole. In yet another embodiment, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole passing through the structure shown in FIG. 3K and bounded by a surface as illustrated.

[0380] 5.9 Other Notes Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided it is for the purpose of what is described in the patent file or record of the Patent Office, but retains all copyrights for other purposes.

[0381] Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other recited value or intervening value in the recited range is included in the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limitations in the recited range, they are included in the technology. If the recited range includes one or both of these limitations, ranges exceeding either or both of these recited limitations are also included in the technology.

[0382] Furthermore, when a value (singular or plural) is embodied as part of the technology herein, unless otherwise specified, it is understood that such a value can be approximated and such a value can be used to any appropriate significant digit to the extent permitted or required by the practical technical implementation.

[0383] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described in this specification can be used in the practice or testing of the technology, only a limited number of exemplary methods and materials are described herein.

[0384] Although specific materials are described as being preferably used in the construction of components, obvious alternative materials with similar properties can be used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and can be manufactured either collectively or individually.

[0385] As used in this specification and the appended claims, note that the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0386] All of the publications described herein are hereby incorporated by reference for their disclosure and description of the methods and / or materials that are the subject of these publications. The publications described herein are provided only for their disclosure prior to the filing date of this application. Nothing in this specification should be construed as an admission that the technology described herein precedes such publications as a result of prior invention. Further, the dates of the publications described may be different from the actual publication dates and may need to be individually verified.

[0387] The terms "comprises" and "comprising" are to be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps can be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0388] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the entire scope of the claims. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0389] Although the techniques in this specification have been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the implementation of the present technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, although the process steps in this method may be described or illustrated in an ordered manner, such an order is unnecessary. A person skilled in the art will recognize that such an order can be changed and / or that the manner can be performed simultaneously or even more synchronously.

[0390] Therefore, it should be understood that numerous variations are possible in the exemplary embodiments and that other arrangements can be devised without departing from the spirit and scope of the present technology.

Description of Reference Signs

[0391] 5.10 List of Reference Signs 1000 Patient 1100 Bedmate 3000 Patient Interface 3100 Seal Forming Structure 3102 Connection Region 3104 Front Opening 3106 Rear Opening 3108 Front Tie 3110 Support Structure 3112 Inner Surface 3114 Patient Contact Surface 3116 Patient Non-Contact Surface 3118 Edge part 3120 Gas chamber 3122 Under cushion 3200 Plenum chamber 3210 Tendon 3220 Upper point 3230 Lower point 3300 Positioning and stabilization structure 3301 Conduit 3302 Strap connector 3303 Clip 3304 Flexible part 3305 Elbow connector 3400 Ventilation part 3401 Opening 3402 Opening 3500 Disconnection structure 3501 Swivel 3502 Patient interface connector 3503 Tube 3600 Connection port 3700 Forehead support part 4000 RPT device 4010 External housing 4012 Upper part 4014 Lower part 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic block 4110 Air filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Outlet muffler 4140 Pressure generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air circuit 4180 Supplementary oxygen 4200 Electrical components 4202 PCBA 4210 Power supply 4220 Input device 4270 Converter 5000 Humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier base 5110 Reservoir 5120 Conductive part 5130 Humidifier reservoir dock 5135 Lock lever 5150 Water level indicator 5240 Heating element

Claims

1. 1. A seal-forming structure for a patient interface, said 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, said seal-forming structure constructed and arranged to maintain within said seal-forming structure a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle in use, said seal-forming structure constructed from a soft, flexible and resilient material, said seal-forming structure comprising an outer surface and an inner surface opposite said outer surface, said outer surface including a patient-contacting surface configured to engage and seal against the patient's facial skin, a rear opening formed in said patient-contacting surface of said seal-forming structure such that in use air flow at said therapeutic pressure is directed through said rear opening to the patient's nasal passages, the seal-forming structure includes a support structure coupled to an edge of the rear opening and to an inner surface of the seal-forming structure, the inner surface of the support structure and the inner surface of the seal-forming structure forming a continuous loop; the seal-forming structure is configured to leave the patient's oral cavity exposed; an upper portion of the seal-forming structure configured to engage the patient's nose below the patient's nasal bone; The support structure has a length in an undeformed state that is greater than a linear distance from a first location where the support structure is coupled to an edge of the rear opening to a second location where the support structure is coupled to an inner surface of the seal-forming structure.

2. The seal-forming structure of claim 1 , wherein the exterior, non-patient-contacting side defines a front opening opposite the rear opening.

3. The seal-forming structure of claim 1 or 2, wherein the support structure is curved between the first position and the second position in an undeformed state.

4. A seal-forming structure according to any one of claims 1 to 3, wherein the support structure has an increased thickness adjacent the first location and / or the second location.

5. A seal-forming structure according to any preceding claim, wherein the support structure is configured, in use, to be positioned in contact with or adjacent the bridge of the patient's nose.

6. A seal-forming structure according to any preceding claim, wherein the support structure has a different thickness than the patient-contacting surface.

7. A seal-forming structure according to any preceding claim, wherein the support structure is thicker than the patient-contacting surface.

8. A seal-forming structure as claimed in any preceding claim, wherein the support structure does not extend entirely across the rear opening.

9. the seal-forming structure at least partially defines a gas chamber; The seal-forming structure of any one of claims 1 to 8, wherein the support structure, in an undeformed state, extends into the gas chamber.

10. A seal-forming structure according to any one of the preceding claims, wherein the support structure has a variable thickness in the longitudinal direction.

11. A seal-forming structure according to any preceding claim, wherein a portion of the support structure is curved away from the patient's nose in an undeformed state.

12. 12. A seal-forming structure according to any one of claims 1 to 11, wherein a lower portion of the seal-forming structure engages the patient's upper lip, and wherein the seal-forming structure does not extend beyond the upper lip to the patient's upper lip vermilion.

13. The seal-forming structure of claim 12 , further comprising an undercushion supporting the patient-contacting surface.

14. The seal-forming structure of claim 13 , wherein a lower portion of the seal-forming structure includes the undercushion and an upper portion of the seal-forming structure does not include the undercushion.

15. 15. The seal-forming structure of claim 14, wherein the undercushion is structured to support the patient-contacting surface only against an upper lip of the patient.

16. A seal-forming structure according to any preceding claim, wherein an upper portion of the seal-forming structure is configured to engage the patient's nose below the patient's nasal tip.

17. 1. A patient interface, comprising: a plenum chamber that is pressurizable, the plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at a therapeutic pressure for breathing by a patient; A seal-forming structure according to any one of claims 1 to 16, a positioning and stabilising structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure including a tie, the tie constructed and arranged such that in use at least a portion of the tie rests against an area of ​​the patient's head above an ear base point of the patient's head; a ventilation system that allows a continuous flow of patient exhaled gases from within the plenum chamber to the surroundings, the ventilation system being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; a patient interface including

18. the plenum chamber comprises a first plenum chamber inlet port and a second plenum chamber inlet port; the positioning and stabilizing structure comprises a pair of conduits; each said conduit is configured to be positioned correspondingly to a side of the patient's head during use, each said conduit being fluidly connected to corresponding one of the first plenum chamber inlet port and the second plenum chamber inlet port; 20. A patient interface according to claim 17, comprising a decoupling structure fluidly coupled to each of the conduits, the decoupling structure configured to be connected to an air circuit for receiving air flow at the therapeutic pressure.

19. 20. A patient interface according to claim 18, wherein the ties are connected to each of the conduits.

20. 20. A patient interface according to claim 18 or 19, wherein the ventilation system comprises a first vent hole formed in the plenum chamber and a second vent hole formed in the decoupling structure.

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