Patient Interface

Abstract

The patient interface includes one or more electronic components for monitoring, diagnosing, and / or treating the patient, the one or more electronic components being disposed within or on one or more of the plenum chamber, the seal-forming structure, and the positioning and stabilizing structure of the patient interface, and the patient interface including and / or being in communication with a power system for providing power to the one or more electronic components.

Description

Technical Field

[0001] The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. The present technology also relates to medical devices or apparatuses and their use.

[0002] 〔Cross-reference to Related Applications〕 This application claims the rights of Singapore Patent Application No. 10202010467U filed on October 22, 2021, the entire content of which is incorporated herein by reference.

Background Art

[0003] The Human Respiratory System and Its Disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway. [[ID=2C]]

[0004] These airways include a series of bronchial tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is to exchange gases, thereby allowing oxygen to move from inhaled air into venous blood and carbon dioxide to move in the opposite direction. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. When the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See Non-Patent Document 1 for this.

[0005] There are various respiratory disorders. Certain disorders may be characterized by certain incidences (e.g., apnea, hypopnea, and hyperventilation).

[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), a form of sleep-disordered breathing (SDB), is characterized by events involving obstruction or closure of the upper airway during sleep. This results from a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of this condition, affected individuals typically experience 200 to 300 cessations of breathing per night, sometimes lasting 30 to 120 seconds. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, although patients often experience no symptoms. See Patent Document 1 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, periodic increases and decreases in ventilation known as CSR cycles. 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 recurrent sleep-wake cycles, which cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2 (Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders, referring to a condition in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders:

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

[0011] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and aroused chronic hypercapnia, with no other known cause of hypoventilation. Symptoms include shortness of breath, morning headaches, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by long-term smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0013] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified into rapidly progressive and slowly progressive types. (i) Rapidly progressive diseases are characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers). (ii) Degenerative or slowly progressive diseases are characterized by muscle damage that worsens over several years, but with only a mild shortening of life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). The following are symptoms of respiratory failure in NMD: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0014] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments are used to treat or improve such diseases. Furthermore, healthy individuals in other respects can also benefit from such treatments to prevent respiratory failure. However, these treatments have several drawbacks.

[0016] treatment A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the above-mentioned respiratory disorders.

[0017] Respiratory pressure therapy Respiratory pressure therapy is the application of supplying air to the airway entrance at a controlled target pressure that is nominally positive to the atmosphere throughout the patient's entire respiratory cycle (in contrast to negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)).

[0018] Continuous positive airway pressure (CPAP) is used to treat obstructive sleep apnea (OSA). Its mechanism of action involves continuous positive airway pressure acting as an air pressure splint, while simultaneously preventing upper airway obstruction by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall. Since CPAP treatment for OSA can be voluntary, patients may choose not to adhere to treatment if they find one or more of the devices used to provide such treatment uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0019] Non-invasive ventilation (NIV) provides ventilatory support to a patient via the upper airway to assist the patient's breathing and / or maintain adequate oxygen levels in the body by completing some or all of the respiratory work. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided through a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0021] flow therapy Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a predetermined respiratory volume by delivering an inspiratory flow profile that overlaps as much as possible with a positive baseline pressure over a target duration. In other cases, the interface to the patient's airways is "open" (not sealed), and respiratory therapy with a controlled or high-concentration gas flow may be used only as an aid to the patient's own spontaneous breathing. For example, high-flow therapy (HFT) involves delivering a continuous flow of heated, humidified air to the airways through an open or unsealed patient interface at a "therapeutic flow rate" that is maintained nearly constant throughout the respiratory cycle. The therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT is used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or washing away exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes called deadspace therapy (DST). Other benefits may include improved warmth and humidification (perhaps due to the benefits of secretion control), as well as a gradual increase in airway pressure. Instead of a constant flow rate, the therapeutic flow rate can follow a fluctuating profile throughout the respiratory cycle.

[0022] Other forms of flow therapy include long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air at a specific oxygen concentration (oxygen fraction of ambient air, from 21% to 100%) delivered to the patient's airways at a specific flow rate (e.g., 1 liter / minute (LPM), 2 LPM, 3 LPM, etc.).

[0023] Supplemental oxygen For a particular patient, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplemental oxygen to a pressurized air stream. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. The treatment with oxygen added to HFT is referred to as HFT with supplemental oxygen.

[0024] Respiratory therapy system These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating a disease.

[0025] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0026] Patient interface Using a patient interface, an interface to a breathing apparatus can be provided to a wearer, for example, by providing an air stream to an inlet to the airway. The air stream can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the treatment applied, the patient interface can promote gas delivery at a pressure significantly different from the ambient pressure, for example, a positive pressure of about 10 cmH2O relative to the ambient pressure, by forming a seal with a part of the patient's face, and can effectively perform the treatment. In the case of other treatment modalities such as oxygen delivery, the patient interface may not include sufficient sealing to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface delivers air to the nostrils and is arranged not to be particularly completely sealed. An example of such a patient interface is a nasal cannula.

[0027] Certain other mask systems may be functionally unsuitable in this field. For example, masks intended purely for decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water ingress from higher external pressures but not to maintain internal air at pressures higher than the ambient pressure.

[0028] For example, if a mask blocks airflow through the nose and only allows airflow through the mouth, certain masks may be clinically undesirable in this technology.

[0029] In certain masks, if the patient must insert a portion of the mask structure into their mouth and create and maintain a seal through their lips, this technology may be uncomfortable or impractical.

[0030] Certain masks may be impractical for use while sleeping (for example, when sleeping on your side in bed with your head on a pillow).

[0031] Designing patient interfaces presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Because the head contains bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. Specifically, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0032] As a result of these challenges, some masks may be intrusive, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Using an incorrectly sized mask can lead to decreased compliance, reduced comfort, and poor patient outcomes. While pilot masks, personal protective equipment (e.g., filter masks), masks designed as part of a SCUBA mask, or masks used for anesthesia may be suitable for their original purpose, they can be uncomfortable and undesirable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially if the mask needs to be worn during sleep.

[0033] CPAP therapy is highly effective in treating certain respiratory disorders when the patient consents to the treatment. Patients may refuse treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may be unable to clean the mask, which can affect patient compliance.

[0034] Masks designed for other purposes (e.g., for pilots) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes.

[0035] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0036] seal-forming structure The patient interface may include a seal-forming structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration directly affect the effectiveness and comfort of the patient interface.

[0037] Patient interfaces can be partially characterized according to the design intent when the seal-forming structure is designed to engage with the face during use. In one form of patient interface, the seal-forming structure may 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 patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the nasal bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region by forming a seal, for example, on the lower lip region of the face during use. In one form of patient interface, the seal-forming structure may include a single element that surrounds both the nostril region and the mouth 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 mouth-nasal masks by their manufacturers.

[0038] A seal-forming structure that may be effective in one area of ​​a patient's face may be unsuitable in another area, for example, due to differences in the shape, structure, variability, and sensitivity of the patient's face. For instance, a swimming goggle seal covering a patient's forehead may not be suitable for use on the patient's nose.

[0039] Some seal-forming structures can be designed for mass production so that a single design can fit a variety of different facial shapes and sizes, allowing for comfortable and effective use. To form a seal, it is necessary to adapt one or both the patient's facial shape and the mass-produced patient interface seal-forming structure to the extent that there is a mismatch between them.

[0040] Certain types of seal-forming structures extend around the periphery of a patient interface and are intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap may form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0041] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-airtight seal to the patient's face when positive pressure is applied inside the mask. Similar to the previously described type of seal-forming structure, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not conform to the shape of the patient, wrinkles or buckling may occur in the seal-forming structure during use, which may cause leakage.

[0042] Other types of seal-forming structures may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these uncomfortable.

[0043] Another form of seal-forming structure may use an adhesive portion to obtain a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive portion from their face.

[0044] A series of patient interface seal formation structures are disclosed in patent applications, Patent Document 3, Patent Document 4, and Patent Document 5, which have been assigned to ResMed Limited.

[0045] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 6 (Trimble et al.), which was transferred to Puritan-Bennett Corporation.

[0046] 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. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: Patent Document 7 (in particular describing the features of ResMed Limited's SWIFT® nasal pillow), Patent Document 8 (in particular describing the features of ResMed Limited's SWIFT® LT nasal pillow); Patent Documents 9 and 10 (in particular describing the features of ResMed Limited's MIRAGE LIBERTY® full face mask); and Patent Document 11 (in particular describing the features of ResMed Limited's SWIFT® FX nasal pillow).

[0047] Positioning and stabilization

[0048] The seal-forming structures of patient interfaces used in positive pressure therapy are subjected to corresponding air pressure forces, which can impair the seal. Therefore, various techniques have been used to position the seal-forming structures and maintain a proper seal relationship with the appropriate part of the face.

[0049] In one technology, adhesive joints are used. For example, see Patent Document 12. However, when adhesive joints are used, discomfort may occur.

[0050] In other technologies, one or more straps and / or stabilization harnesses are used. Many such harnesses suffer from one or more of the following: poor fit, bulkiness, discomfort, and cumbersome handling.

[0051] Respiratory pressure therapy (RPT) devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the above-described therapies, for example, by activating the device to generate an airflow to the airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0052] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that are not met by more general pneumatic generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may suffer from drawbacks including one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0053] One example of a specific requirement for a particular RPT device is acoustic noise.

[0054] [Table 1]

[0055] A well-known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System from ResMed Limited. Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide invasive and non-invasive independent ventilation assistance for a range of patients to treat many medical conditions (e.g., NMD, OHS, and COPD, but not limited to these).

[0056] The ResMed Eliseee® 150 ventilator and the ResMedVS III® ventilator can provide invasive and non-invasive dependent ventilation assistance suitable for adult or pediatric patients for the treatment of multiple medical conditions. These ventilators provide volumetric ventilation and pneumatic ventilation modes using single or dual limb circuits. The RPT device typically includes a pressure generator, such as an electric blower or compressed gas reservoir, and is configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to the patient interface described above via an air circuit.

[0057] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may deviate significantly from convention, or even be unavoidable. Furthermore, the comfort and effectiveness of a particular design can be greatly affected by even minor changes in one or more parameters.

[0058] Air circuit An air circuit is a conduit or tube constructed and positioned so that, during use, airflow moves between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, separate limbs of the air circuit may exist for inhalation and exhalation. In other cases, a single-limbed air circuit is used for both inhalation and exhalation.

[0059] humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and enhancing patient airway comfort. Furthermore, in cooler climates, warm air applied to the facial area within and around the patient interface is generally more comfortable than cold air.

[0060] While various artificial humidification devices and systems are known, they may not meet the specific requirements of medical humidifiers.

[0061] Medical humidifiers are used to increase the humidity and / or temperature of the airflow relative to the surrounding air when needed, typically when the patient is sleeping or resting (e.g., in a hospital). Medical humidifiers placed by the bedside may be small. Medical humidifiers may be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the surrounding environment. For example, room-type systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air inhaled by the patient, but these systems may also humidify and / or heat the entire room, which can cause discomfort to the occupants. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0062] While numerous medical humidifiers are known, these humidifiers suffer from one or more shortcomings. Some medical humidifiers provide insufficient humidification, while others are difficult or inconvenient for patients to use.

[0063] oxygen source Experts in this field recognize that exercise in patients with respiratory failure offers long-term benefits, including slowing disease progression, improving quality of life, and extending patient lifespan. However, most stationary exercises, such as treadmills and stationary bikes, are too strenuous for these patients. Therefore, the need for mobility has long been recognized. Until now, this mobility has been facilitated by using small compressed oxygen tanks or cylinders mounted on carts with small wheels. The drawbacks of these tanks are that the amount of oxygen is finite and they are heavy, weighing approximately 50 pounds when loaded.

[0064] Oxygen concentrators have been used for approximately 50 years to supply oxygen for respiratory therapy. Conventional oxygen concentrators were bulky and heavy, making them impractical for normal walking and other activities. In recent years, companies that manufacture large, stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that, theoretically, they can supply an unlimited amount of oxygen. To miniaturize and make these devices portable, various systems necessary for producing oxygen-enriched gases are condensed. POCs strive to utilize the generated oxygen as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses or "boli," with the timing of each boli coincided with the start of inhalation. This therapeutic mode is known as pulsed oxygen delivery (POD) or demand mode, in contrast to conventional continuous flow delivery, which is more suitable for stationary oxygen concentrators.

[0065] Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (for example, whether the patient is using their RPT device in accordance with one or more "compliance rules"). For example, a compliance rule for CPAP therapy might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. If the healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, they may notify third parties that the patient is compliant.

[0066] Other ways in which patient treatment can benefit from the communication of treatment data to third parties or external systems may exist. For example, having performance data such as data indicating the impact of treatment on the patient and / or data indicating patient interface functionality is useful for enabling greater control over treatment.

[0067] Existing processes for communicating and managing such data are often one or more processes that are costly, time-consuming, and prone to errors.

[0068] Ventilation technology Some forms of therapeutic systems may include a vent for expelling exhaled carbon dioxide. This vent may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0069] These vents may include orifices, through which gas can flow when the mask is in use. Many of these vents are noisy. In other cases, they may become blocked during use, resulting in insufficient airflow. In some cases, the sleep of a patient's bedmate may be disturbed, for example, due to noise or concentrated airflow.

[0070] ResMed Limited has developed several improved mask ventilation technologies. See Patent Documents 13, 14, 15, 16, and 17.

[0071] [Table 2]

[0072] [Table 3]

[0073] Screening, diagnostic, and monitoring systems Polysomnography (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders, and typically requires specialized clinical staff for system application. In PSG, typically 15-20 tactile sensors are placed on the patient to record various bodily signals such as electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing requires the patient to be observed over two nights in a clinic; the first night is purely for diagnosis, and the second night is for treatment parameter titration by the clinician. Therefore, PSG is costly and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable for home use.

[0074] Generally, screening and diagnosis involve identifying a condition based on its signs and symptoms. Screening typically provides true / false results indicating whether a patient's SDB (Science Data Bank) is severe enough to warrant further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are designed solely for screening / diagnosis, while others can also be used for monitoring.

[0075] Clinical professionals can appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Clinical professionals may have differing opinions regarding a patient's condition. Furthermore, a particular clinical professional may apply different criteria depending on the time period. [Prior art documents] [Patent Documents]

[0076] [Patent Document 1] U.S. Patent No. 4944310 [Patent Document 2] U.S. Patent No. 6532959 [Patent Document 3] International Publication No. 1998 / 004310 [Patent Document 4] International Publication No. 2006 / 074513 [Patent Document 5] International Publication No. 2010 / 135785 [Patent Document 6] U.S. Patent No. 4782832 [Patent Document 7] International Publication No. 2004 / 073778 [Patent Document 8] U.S. Patent Application Publication No. 2009 / 0044808 [Patent Document 9] International Publication No. 2005 / 063328 [Patent Document 10] International Publication No. 2006 / 130903 [Patent Document 11] International Publication No. 2009 / 052560 [Patent Document 12] U.S. Patent Application Publication No. 2010 / 0000534 [Patent Document 13] International Patent Application Publication No. 1998 / 034665 [Patent Document 14] International Patent Application Publication No. 2000 / 078381 [Patent Document 15] U.S. Patent No. 6581594 [Patent Document 16] U.S. Patent Application Publication No. 2009 / 0050156 [Patent Document 17] U.S. Patent Application Publication No. 2009 / 0044808 [Non-patent literature]

[0077] [Non-Patent Document 1] The 9th edition of "Respiratory Physiology" by John B. West, Lippincott Williams & Wilkins, published in 2012. [Overview of the Initiative]

[0078] This technology relates to providing medical devices used in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, wherein these medical devices have one or more of the following advantages: improved comfort, cost-effectiveness, efficacy, ease of use, and manufacturability.

[0079] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0080] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0081] One aspect of several forms of this technology is to provide a method and / or apparatus for improving respiratory therapy compliance in patients.

[0082] One embodiment of the present technology is a patient interface comprising one or more electronic components for monitoring, diagnosing and / or treating a patient, wherein the one or more electronic components are located in or on one or more of the plenum chamber, seal-forming structure, and positioning and stabilizing structure of the patient interface, and the patient interface comprises a power system for supplying power to the one or more electronic components and / or is capable of communicating with the power system.

[0083] In some embodiments of this technology, the patient interface includes a plenum chamber having a plenum chamber inlet port that is capable of pressurizing a therapeutic pressure at least 4 cmH2O higher than the ambient air pressure and has dimensions and structure for receiving an airflow at the therapeutic pressure for the patient to breathe; a seal-forming structure constructed and positioned to form a seal with the patient's facial region surrounding the patient's airway inlet, having a hole therein so that an airflow at the therapeutic pressure is delivered to at least one inlet of the patient's nostrils, and constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire course of the patient's respiratory cycle in use; a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head; and one or more electronic components disposed in or on one or more of the plenum chamber, seal-forming structure, and positioning and stabilizing structure for monitoring, diagnosing, and / or treating the patient, wherein the patient interface includes a power system for supplying power to the one or more electronic components and / or is capable of communicating with the power system.

[0084] In one embodiment, the power system includes an energy collection system that converts energy generated during the use of the patient interface into electrical energy to power one or more electronic components. The energy collection system can directly supply electrical energy to one or more electronic components and / or charge an electrical energy storage device (e.g., a battery or capacitor) that does so. This eliminates or eliminates the need for a separate power source or recharging mechanism.

[0085] For example, the energy generated during the use of the patient interface may be one or more of the following: mechanical energy generated by or during respiration, mechanical energy generated by patient movement, mechanical energy from airflow within the patient interface, and thermal energy from the patient's skin and / or exhaled breath.

[0086] In one embodiment of this technology, the energy collection system includes at least one energy collection device located within the pneumatic path of the patient interface. For example, this may be located at an air inlet of the patient interface, such as within a plenum chamber inlet port, or it may be located within the plenum chamber adjacent to the plenum chamber inlet port.

[0087] At least one energy collection device may include a turbine generator. The turbine generator may include a rotor containing a plurality of turbine blades and a plurality of magnets arranged around the rotor. In some embodiments, the turbine generator includes a sealed stator assembly housing a plurality of coils, and the stator assembly is arranged around the rotor.

[0088] At least one energy collection device may include a turbine generator. The turbine generator may include a rotor comprising a plurality of turbine blades and a plurality of magnets positioned toward the base of the turbine blades. In some embodiments, the stator coil may be embedded in a stationary shaft on which the rotor rotates.

[0089] In some configurations, placing magnets near the base of the turbine blades can generate lower rotor inertia (compared to, for example, placing the magnet bodies facing around the turbine blades). This allows the turbine blades to rotate even with relatively low airflow.

[0090] The energy collection system may optionally or additionally include at least one piezoelectric thin film. For example, at least one piezoelectric thin film may be mounted or positioned within a plenum chamber and / or a seal-forming structure and / or a positioning and stabilization structure.

[0091] The energy collection system may, alternatively or additionally, include at least one thermoelectric generator (TEG) module.

[0092] For example, at least one TEG module may be placed within a positioning and stabilization structure. At least one TEG module may be positioned to be in contact with the patient's skin. In another example, at least one TEG module is positioned such that its first face is exposed inside the plenum chamber, and its second face, opposite to the first, is exposed to the surroundings.

[0093] In some forms of this technology, the power system includes an external charging circuit configured to charge an electrical energy storage device.

[0094] For example, the external charging circuit may be a component of a respiratory pressure therapy device configured to deliver airflow to the plenum chamber. In some embodiments, the external charging circuit may be connected to an electrical energy storage device via one or more cables incorporated in or over an air circuit connecting the respiratory pressure therapy device and the plenum chamber.

[0095] In some forms of this technology, one or more electronic components include one or more sensors and / or one or more actuators.

[0096] In some configurations, at least one sensor and / or at least one actuator may be partially exposed to the periphery on the outer surface of the positioning and stabilizing structure and / or partially exposed to the patient contact surface of the positioning and stabilizing structure so as to come into contact with the patient's skin during use.

[0097] In some configurations, at least one sensor and / or at least one actuator is at least partially embedded between the outer layer of the positioning and stabilizing structure and the patient contact layer.

[0098] In some forms of current technology, at least one sensor and / or at least one actuator consists of a circuit formed at least partly by one or more conductive wires and / or one or more conductive ink traces.

[0099] In some forms of this technology, one or more electronic components include a wireless communication interface for transmitting data from one or more sensors to one or more external computing devices, and / or receiving data from one or more external computing devices at one or more actuators.

[0100] For example, one or more sensors and / or one or more actuators include one or more accelerometers, giroscopists, humidity sensors, temperature sensors, microphones, cameras, pulsation oximeters, EEG sensors, EMG sensors, EOG sensors, touch sensors, vibration devices, and audio output devices.

[0101] Another aspect of one form of this technology is a patient interface molded or constructed to have a circumferential shape complementary to the circumferential shape of the intended wearer.

[0102] One embodiment of this technology is a method for manufacturing an apparatus.

[0103] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0104] One embodiment of this technology is a portable RPT device that can be carried by a person around their home, for example.

[0105] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment.

[0106] The methods, systems, devices, and apparatus described above may be implemented to improve the functionality of processors such as computers, respiratory monitors, and / or respiratory therapy devices for specific purposes. Furthermore, the methods, systems, devices, and apparatus described above can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including sleep-disordered breathing, for example.

[0107] Another aspect of one embodiment of the present technology includes a patient interface, the patient interface being a plenum chamber capable of pressurizing a therapeutic pressure at least 4 cmH2O higher than ambient air pressure, the plenum chamber including a plenum chamber inlet port having dimensions and structure for receiving an airflow at therapeutic pressure for the patient to breathe; a seal-forming structure positioned to form a seal with the patient's facial region and constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use so that an airflow at therapeutic pressure is delivered to at least one inlet of the patient's nostrils; a positioning and stabilizing structure providing force to hold the seal-forming structure in a therapeutically effective position on the patient's head; and a power system for converting energy generated during use of the patient interface into converted electrical energy for powering at least a portion of the patient interface, the power system wherein the energy generated during use of the patient interface is one or more of the following: mechanical energy generated by or during breathing, mechanical energy generated by the patient's movement, mechanical energy from the airflow within the patient interface, and thermal energy from the patient's skin and / or exhalation.

[0108] In some configurations, the power system supplies a DC voltage to at least a portion of the patient interface.

[0109] In some forms, a) at least a portion of the patient interface is an electrical energy storage device electrically connected to a power system and configured to supply electrical energy to the power system; b) the power system is configured to supply converted electrical energy to the electrical energy storage device and to recharge the electrical energy storage device; c) an external charging circuit is electrically connected to the electrical energy storage device and configured to supply electrical energy to the electrical energy storage device; d) at least a portion of the patient interface further includes one or more electronic components for monitoring, diagnosing and / or treating the patient; e) one or more electronic components directly receive electrical energy from the power system; and / or f) one or more electronic components directly receive electrical energy from the electrical energy storage device.

[0110] In some forms, at least a portion of the patient interface further includes one or more electronic components for monitoring, diagnosing, and / or treating the patient, positioned in or on one or more of the plenum chamber, seal-forming structures, and positioning and stabilizing structures.

[0111] In some forms, a) at least one energy collecting device includes a turbine generator, b) the turbine generator includes a rotor including a plurality of turbine blades and a plurality of magnets arranged around the rotor, c) the turbine generator includes a sealed stator assembly housing a plurality of coils, the stator assembly arranged around the rotor, d) the sealed stator assembly further includes a plurality of bobbins, the plurality of coils being wound around the plurality of bobbins, e) the number of bobbins of the plurality of bobbins is equal to the number of magnets of the plurality of magnets, f) the turbine generator is positioned at the air inlet of the patient interface upstream of the patient when in use, and / or g) the turbine generator is positioned at the air outlet of the patient interface downstream of the patient when in use.

[0112] In some embodiments, a) at least one energy collection system comprises at least one piezoelectric thin film; b) at least one piezoelectric thin film is mounted or positioned within a plenum chamber and / or a seal-forming structure and / or a positioning and stabilizing structure; c) the piezoelectric thin film is a sensor and is configured to measure patient snoring by sensing vibration and / or noise; d) the piezoelectric thin film is positioned at an air inlet of a patient interface upstream of the patient when in use; e) the piezoelectric thin film is positioned at an air outlet of a patient interface downstream of the patient when in use; f) at least one piezoelectric thin film is sandwiched between layers of a positioning and stabilizing structure; and / or g) at least one piezoelectric thin film is configured to bend with movement within the positioning and stabilizing structure.

[0113] In some embodiments, a) at least one energy collection system includes at least one thermoelectric generator (TEG) module; b) at least one TEG module is positioned to be at least partially exposed and in contact with the patient's skin; c) at least one TEG module is positioned within a positioning and stabilizing structure; and d) at least one TEG module is positioned such that a first face of the TEG module is exposed inside the plenum chamber and a second face opposite the first face is exposed to the periphery.

[0114] Of course, some of these embodiments can form sub-embodiments of the present technology. Furthermore, each of the lower embodiments and / or embodiments can be combined in various ways to constitute further embodiments or lower embodiments of the present technology.

[0115] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0116] This technology is illustrated non-limitingly as an example in the attached drawings. In the drawings, similar reference numerals include the following similar elements. Respiratory therapy system [Figure 1A] The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. A bed partner 1100 is also shown. The patient is sleeping in a supine position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. [Figure 1C] The system includes patient 1000 wearing patient interface 3000. This system takes the form of a full-face mask and receives positive-pressure air supplied from RPT device 4000. The air from the RPT device is humidified in humidifier 5000 and delivered to patient 1000 through air circuit 4170. The patient is sleeping in a lateral sleeping position. Respiratory system and facial anatomical structure. [Figure 2A] This diagram outlines the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face, including several features of surface anatomical structures, such as the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and cheirion. Superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankforth horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and the median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilages, nasal septal cartilages, greater alar cartilages, lesser alar cartilages, nasal sesamoid cartilages, nasal bone, epidermis, adipose tissue, the frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I] This shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] This is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is illustrated. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] Shows the anterolateral aspect of the nose. Patient interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the magnitude of curvature shown in Figure 3C. [Figure 3C] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D]This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G] The mask cushion, including two pillows, is shown. The outer surface of the cushion is shown. The edges of the surface are shown. The dome and saddle regions are illustrated. [Figure 3H] The mask cushion is shown. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional hole in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surfaces that define the two-dimensional holes in the structure are also shown. [Figure 3L] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] Shows the left ear, including the left ear spiral. [Figure 3R] Shows the right ear, including the right ear spiral. [Figure 3S] The right hand demonstrates a spiral. [Figure 3T] This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing film in different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the sagittal plane and the central contact surface. [Figure 3V] Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the plenum chamber is divided into left and right halves by the sagittal plane. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the sagittal plane. The orientation of the central contact surface corresponds to the orientation of chord 3210. Chord 3210 rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the position for use on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the midline sagittal plane of the face when the plenum chamber is in the position for use. The central contact surface generally corresponds to the "face plane" when the plenum chamber is in the position for use. In Figure 3X, the plenum chamber 3200 is part of a nasal mask, with the upper point 3220 located approximately on the serion and the lower point 3230 located on the upper lip. [Figure 3Y] This figure shows a patient interface in the form of a nasal cannula, which is one embodiment of this technology. [Figure 4] An example of this technology is shown in a top-view perspective of a patient interface. [Figure 5] This is a frontal perspective view of a patient interface based on an example of this technology. [Figure 6A] This is a frontal perspective view of a patient interface worn by a patient, as an example of this technology. [Figure 6B] This is a front view of a patient interface worn by a patient, as an example of this technology. [Figure 7A] This figure shows the positioning and stabilization structure of the patient interface at the first usage position on the patient's head according to one embodiment of this technology. [Figure 7B] As part of the patient interface, Figure 7A shows the positioning and stabilization structure in the second use position on the patient's head. [Figure 8] Figure 7A is a schematic cross-sectional view of a part of the positioning and stabilization structure. [Figure 9A] This is a block diagram of a patient interface that includes multiple electronic modules powered by rechargeable batteries charged by an external charging circuit. [Figure 9B] This figure shows the first configuration for supplying power to the electronic components of the patient interface shown in Figure 9A. [Figure 9C] This figure shows a second configuration for supplying power to the electronic components of the patient interface shown in Figure 9A. [Figure 9D] Figure 9A is a schematic diagram of the third configuration for supplying power to the electronic components of the patient interface. [Figure 10] This is a block diagram of a patient interface that includes multiple electronic modules supplied with electrical energy by an energy collection system. [Figure 11A] This is an exploded view showing an example of a patient interface energy acquisition device. [Figure 11B] Another diagram showing the various components of the energy collection device in Figure 11A. [Figure 11C] This is a plan view of a partially assembled energy collection device. [Figure 11D] This is a plan view of an energy collection device in its fully assembled form. [Figure 11E] This is a front view of an example of a rotor replacement. [Figure 12A] The first series of voltage signals from a patient interface incorporating a piezoelectric thin-film-based energy collection device is shown. [Figure 12B] The second series of voltage signals from a patient interface, including an energy acquisition device based on a piezoelectric thin film, is shown. (RPT device) [Figure 13A] This shows an RPT device based on one form of this technology. [Figure 13B] This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with reference to the blower and patient interface. Regardless of the actual flow direction at a particular time, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Articles located within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface. [Figure 13C] This is a schematic diagram of the electrical components of an RPT device according to one embodiment of this technology. [Figure 13D] This is a schematic diagram of an algorithm implemented in an RPT device using one form of this technology. [Figure 13E] This flowchart illustrates a method implemented by the treatment engine module shown in Figure 13D, which is one form of this technology. (Humidifier) [Figure 14A] An isometric view of a humidifier based on one embodiment of this technology is shown. [Figure 14B] This diagram shows an equidistant view of a humidifier according to one embodiment of this technology, and the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 14C] This shows an outline of a humidifier based on one form of this technology. [Modes for carrying out the invention]

[0117] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in this disclosure are for illustrative purposes only and are not limiting.

[0118] The following description is provided in relation to a variety of examples that may share one or more common properties and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any of these examples may lead to further examples.

[0119] treatment In one embodiment, the technology includes a method for treating respiratory disorders. The method includes the step of applying positive pressure to the airway entrance of patient 1000. In certain examples of this technology, a positive-pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0120] In certain examples of this technology, mouth breathing is restricted, limited, or prevented.

[0121] Respiratory therapy system In one embodiment, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an air circuit 4170 and an RPT device 4000 that supplies airflow to a patient 1000 via a patient interface 3000 or 6000.

[0122] Patient Interface A non-invasive patient interface 3000 according to one aspect of this technology includes, as functional modes, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway so as to maintain positive pressure at the entrance to the patient's airway 1000. Therefore, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy. An example of such a patient interface 3000 is shown in Figure 3A.

[0123] Figures 4 and 5 show a patient interface 3000 according to another example of the present technology. The patient interface 3000 includes a seal-forming structure 3100 connected to a plenum chamber 3200. The plenum chamber 3200 may have one or more vents 3400.

[0124] The patient interface 3000 in Figures 4 and 5 may include a positioning and stabilizing structure 3300, which includes a conduit 3301. The conduit 3301 is used for two purposes: 1) to position and stabilize the patient interface 3000 on the patient's head in a therapeutically effective position during use, and 2) to supply pressurized breathable gas to the plenum chamber 3200. Therefore, the conduit 3301 is constructed of a flexible and biocompatible material and can also form a hollow structure. The conduit 3301 can be connected to the entire plenum chamber 3200 with a clip 3303 to allow for air connection. The conduit 3301 also includes a strap connector 3302 for connecting to a strap (not shown) that passes behind the patient's head during use. The conduit 3301 also includes a flexible portion 3304 that provides flexibility to accommodate different sizes and shapes of the patient's head and body. The patient interface 3000 includes an elbow connector 3305 for connecting a decoupling structure 3500. The elbow connector 3305 may be hollow to allow gas from the conduit 3301 to pass through the decoupling structure 3500, through the elbow connector 3305, and into the conduit 3301.

[0125] In one embodiment, the patient interface 3000 includes at least one disconnection structure 3500, such as a swivel or bulbous socket. The disconnection structure 3500 may be in the form of an elbow. The disconnection structure 3500 may include a rotary joint connected to an air circuit 4170 and a patient interface connector (not shown) connected to the patient interface 3000. The patient interface connector can allow rotation of the disconnection structure 3500 relative to the patient interface 3000. The disconnection structure 3500 also includes vents 3401. These vents 3401 allow compressed gas delivered to the patient interface 3000 to flow. Patient exhaust CO2 can also escape to the atmosphere through the vents 3401 of the disconnection structure 3500. In another example, the vents are provided as add-on components and are adapters in the form of relatively short, flexible or rigid conduits (2-10 cm) with holes that are attached to the patient interface 3000, such as by connecting to the disconnection structure 3500. Short conduits can be sold with the patient interface and include a suitable number of holes to allow for the discharge of pressurized gas, thereby adjusting the therapeutic pressure to a suitable level for a given patient interface 3000. The CO2 vent and the extraction vent may have the same or different capacities; for example, the extraction vent may provide a higher or lower flow rate than the CO2 vent.

[0126] Figures 6A and 6B show the patient interface 3000 worn by a patient. The strap 3306 can be connected to the strap connector 3302 to secure the patient interface 3000 to the desired sealing position for treatment.

[0127] Further description of an exemplary patient interface 3000, incorporated by full reference in this specification, is provided, and its attributes can be applied to this technology.

[0128] An unsealed patient interface 3800 in the form of a nasal cannula includes nasal prongs 3810, 3810 that can deliver air to the corresponding nostrils of a patient 1000 through corresponding holes at their tips. Such nasal prongs generally do not form a seal with the inner or outer skin surface of the nostrils. Air to the nasal prongs can be delivered by one or more air supply cavities 3820a, 3820b coupled to the nasal cannula-type unsealed patient interface 3800. The cavities 3820a, 3820b are led from the nasal cannula-type unsealed patient interface 3800 through an air circuit to a respiratory therapy device. The unsealed patient interface 3800 is particularly suitable for the delivery of flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. The “vent” of the unsealed patient interface 3800 is a passage to the atmosphere through the patient’s nostrils between the ends 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800, and excess airflow is released into the surrounding environment through this vent.

[0129] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy. A patient interface 3000, according to one form of this technology, is constructed and positioned to supply air at a positive pressure higher than the ambient pressure. A patient interface 3000 according to one form of this technology is constructed and positioned to supply air at a positive pressure at least 2 cmH2O higher than the surroundings. A patient interface 3000 in one form of this technology is constructed and positioned to provide a supply of air at a positive pressure at least 4 cmH2O higher than the surrounding environment. A patient interface 3000 according to one embodiment of this technology is constructed and positioned to supply air at a positive pressure at least 6 cmH2O higher than the surrounding environment. A patient interface 3000 in one form of this technology is constructed and positioned to supply air at a positive pressure at least 8 cmH2O higher than the surrounding environment. A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings. A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings.

[0130] seal-forming structure In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a buffering function. The target seal-forming region is the region in the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may change from day to day and from patient to patient in a given treatment session due to various factors such as the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0131] In one embodiment, the target seal-forming region is located on the outer surface of the seal-forming structure 3100. In a particular form of this technology, the seal-forming structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0132] The seal-forming structure 3100 according to this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0133] In a particular embodiment of this technology, a system is provided comprising a plurality of seal-forming structures 3100, each configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads.

[0134] Sealing mechanism In one embodiment, the seal-forming structure includes a sealing flange using a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 acting beneath it to form a tight, sealed engagement with the face. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0135] In one embodiment, 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 approximately 1 mm (e.g., approximately 0.25 mm to approximately 0.45 mm). This member extends around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around the periphery of at least a portion of its length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use.

[0136] In one embodiment, the seal-forming structure may include a compression seal or a gasket seal. During use, the compression seal or gasket seal is constructed and positioned such that it is compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0137] In one embodiment, the seal-forming structure includes a tensioning portion. During use, the tensioning portion is held taut by, for example, an adjacent region of the sealing flange.

[0138] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0139] In a particular embodiment of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0140] Area of ​​the bridge of the nose or nasal ridge In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used on the nasal bridge or nasal ridge region of the patient's face.

[0141] In one embodiment, the seal-forming structure includes a saddle region positioned to form a seal when used on the nasal bridge or nasal ridge region of the patient's face.

[0142] Upper lip In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used on the upper lip region (i.e., supra-lip) of the patient's face.

[0143] In one embodiment, the seal-forming structure includes a saddle region positioned to form a seal when used on the upper lip area of ​​the patient's face.

[0144] Jaw region In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used on the jaw region of the patient's face.

[0145] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the jaw region of the patient's face when in use.

[0146] forehead area In one embodiment, the seal-forming structure forms a seal when used on the forehead area of ​​the patient's face. In this embodiment, the plenum chamber may cover the eye when in use.

[0147] nose pillow In one embodiment, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each of which is constructed and positioned to form a seal with each nostril of the patient's nose.

[0148] A nasal pillow according to one aspect of this technology includes a frustocone, at least a portion of which forms a seal on the underside of the patient's nose; a handle; and a flexible region connecting the lower part of the frustocone to the handle. Furthermore, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the handle. The flexible regions work together to facilitate a universal joint structure that adapts to relative movement (both displacement and angle) between the frustocone and the structure to which the nasal pillow is connected. For example, the frustocone can be displaced axially toward the structure to which the handle is connected.

[0149] Plenum Chamber The plenum chamber 3200 has a perimeter shape that is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire circumference of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0150] In some forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. In such forms, the pressure is often reduced and / or the wearer's comfort is increased, which can improve treatment compliance.

[0151] In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of transparent materials can reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent materials may also help clinicians confirm the placement and function of the patient interface.

[0152] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby helping to improve compliance with treatment.

[0153] Positioning and stabilization structure The seal-forming structure 3100 of the patient interface 3000 of this technology may be held in the sealing position during use by the positioning and stabilization structure 3300.

[0154] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure effect of the plenum chamber 3200 that separates from the face.

[0155] In one embodiment, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome the gravitational force acting on the patient interface 3000.

[0156] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (for example, those resulting from tube dragging or accidental interference with the patient interface).

[0157] In one embodiment of this technology, a positioning and stabilization structure 3300 is provided, configured to be worn by a patient during sleep. In one example, 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 example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0158] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0159] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the side of their head resting on a pillow.

[0160] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release section positioned between the front portion and the rear portion of the positioning and stabilizing structure 3300. This release section is not compressible and may be, for example, a flexible or pliable strap. The release section is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release section transmits force to the rear along the positioning and stabilizing structure 3300, thereby disrupting the seal.

[0161] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0162] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., extendable with elasticity) strap. For example, the strap may be configured to be taut when in use to direct the force that causes the seal-forming structure to adhere to a portion of the patient's face. In one example, the strap may be configured as a tie.

[0163] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, during use, at least a portion of its lower edge passes over the patient's head to the upper base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0164] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie. The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior foot of the patient's head and covers the occipital bone of the patient's head or rests on the underside of the occipital bone of the patient's head.

[0165] In one embodiment of the technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect the first tie and the second tie in such a way that the tendency of the first tie and the second tie to move away from each other is reduced.

[0166] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient is lying down while sleeping.

[0167] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable in order to allow water vapor to pass through the strap.

[0168] In one embodiment of this technology, as shown in Figures 7A and 7B, the positioning and stabilization structure 6300 of the patient interface 6000 may have an integrated connection port 6600 to facilitate conversion from a non-therapeutic configuration in which the positioning and stabilization structure is worn as a headband, as shown in Figure 7A, to a therapeutic configuration as shown in Figure 7B. The positioning and stabilization structure 6300 can be connected to an air circuit 4170 that communicates with the plenum chamber 6200 via the connection port 6600.

[0169] Many different forms of connection between the air circuit 4170 and the connection port 6600 are possible, provided that a substantially airtight seal is formed to prevent or significantly reduce pressure leakage during treatment. For example, the port 6600 may include a magnetic element 6610 located on its inner surface to connect to a corresponding magnetic element on a connector located at one end of the air circuit 4170. In another example, the connector of the air circuit may be attached to the connection port 6600 by a snap fit (e.g., annular snap fit or cantilever snap fit, both of which may be rigid-to-rigid or rigid-to-elastic) or a friction fit.

[0170] As shown in Figure 7A, the positioning and stabilization structure 6300 includes an upper fabric portion 6310 with an elastic circumferential band for attachment to the patient's head during use. A first lower fabric portion 6320 is articulated to (e.g., integrated with) the upper fabric portion 6310 and extends from the upper fabric portion 6310. The positioning and stabilization structure 6300 is used to apply force to the seal-forming structure 6100, as shown in Figure 7B. The seal-forming structure 6100 may be a nasal mask having a plenum chamber 6200. Other types of masks, such as full-face masks and nasal-mouth masks, can also be used as part of the patient interface in conjunction with the positioning and stabilization structure 6300.

[0171] In this example, the positioning and stabilizing structure 6300 is formed as a strap having a front portion 6302 and a rear portion 6304, the front portion 6302 having a first fork portion (intersection 6312, 6314) such that the first fork forms the first portion of the upper fabric portion 6310 and the second fork forms the first lower fabric portion 6320. Thus, as shown in Figure 7A, the upper fabric portion 6310 forms a first strap or strap that can surround the patient's forehead when in use, and the first lower fabric portion 6320 forms a second strap or strap that is extendable downward to directly or indirectly engage with the seal-forming structure 6100 to provide a force to hold the seal-forming structure 6100 in an effective therapeutic position on the patient's head.

[0172] In some embodiments of this technology, as shown in Figure 7B, the posterior portion 6304 may further include a branched portion comprising a first posterior portion 6306 as a second part of the upper fabric portion 6310 and a second posterior or lower portion 6308 as a second lower fabric portion. The branching of the posterior portion 6304 can provide tension to the posterior or spaced-out positions adjacent to the occipital bone of the patient's head or occipital bone, thereby achieving greater support and providing greater adjustability so that the patient can better position the positioning and stabilizing structure 6300 for greater comfort.

[0173] In some embodiments of this technology, a system is provided comprising multiple positioning and stabilizing structures 3300, each positioning and stabilizing structure 3300 configured to provide holding forces corresponding to different ranges of size and / or shape. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads but not for small-sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small heads but not for large heads.

[0174] Sensor and actuator placement for patient interface In some forms of this technology, the patient interface may have one or more sensors and / or actuators positioned within the patient interface to measure the patient's physiological and sleep data. The one or more sensors and one or more actuators may be embedded within the patient interface 3000 or 6000, for example, between the fiber layers of the headgear of the patient interface, or mounted on the inner and / or outer surfaces of the headgear 3300, 6300, or other components of the patient interface. For example, the one or more sensors and / or actuators may be incorporated into other components such as the positioning and stabilizing structure 3300, 6300, and / or the seal-forming structure 3100, 6100, or the plenum chamber 3200, 6200.

[0175] Advantageously, sensors embedded in the patient interface can assist in collecting physiological indicators such as sleep-related data and vital data, which can be used to determine improvements in sleep and health by comparing data before and after the start of treatment. These data can be processed, and patients can be informed of how their sleep is improving with treatment. For example, before starting treatment, a patient can wear a positioning and stabilization structure 6300 with integrated sensors as a headband, as shown in Figure 7A, and physiological and sleep data can be recorded while the patient is sleeping (and during the day in the case of physiological data). After the start of treatment, with the positioning and stabilization structure 6300 in the treatment configuration shown in Figure 7B, further physiological and sleep data can be recorded and compared with data recorded before the start of treatment. Physiological and sleep data can be transmitted to an external computing device such as the patient's smartphone, and / or a monitoring server operated or accessible by a clinician or other healthcare provider.

[0176] The patient can wear the positioning and stabilization structure 6300 as a headband and receive data-driven feedback (e.g., via an application running on the patient's smartphone) on how the treatment is actually helping, allowing for smoother adaptation and greater patient compliance. The collected data may also be used to determine the collective level sleep and / or physiological characteristics of a queue of one or more patients receiving respiratory therapy, thereby allowing for better customization of treatment for patients belonging to a particular category or optimization of the operation of the RPT device 4000.

[0177] In some forms of this technology, measuring patient-side functional parameters using sensors integrated into and / or attached to the mask can provide improved active feedback-based control of the RPT device 4000 to which the patient interface is connected, for example, improved feedback control of the pressure generator 4140 of the RPT device 4000 (Figure 13B).

[0178] For example, referring to Figures 7B and 8, the upper fabric portion 6310 of the positioning and stabilizing structure 6300 may integrate several electronic modules (actuators and / or sensors) 6354, 6356, 6358, and 6360 therein. While it is understood that the processor module 6350 may be located elsewhere within the positioning and stabilizing structure 6300, it may also be integrated within the positioning and stabilizing structure 6300, and more generally, within the upper fabric portion 6310. The processor module may be located within the holding structure 6380. The processor module 6350 may have an integrated transceiver for transmitting data to and from an external computing device. To power the various electronic components of the positioning and stabilizing structure 6300 (sensors / actuators 6354-6360 and the processor module 6350), an electrical energy storage device such as a battery module 6352 may be further included. In some forms of this technology, other electrical energy storage devices such as supercapacitors may be used.

[0179] As shown in Figure 8, the sensors and associated electronic devices may be at least partially integrated between the fabric layers of the upper fabric portion 6310. For example, various sensor / actuator modules and / or associated circuits, a processor module 6350, and a battery module 6352 can be placed between the inner fabric layer 6370 that comes into contact with the patient and the outer fabric layer 6372 that does not come into contact with the patient.

[0180] Sensor and / or actuator modules incorporated into the positioning and stabilization structure 6300 can electrically communicate with the processor module 6350 and the battery module 6352, for example, via a bus 6365. The bus 6365 may be positioned between two insulating layers 6366, which provide electrical insulation and prevent the intrusion of moisture such as sweat absorbed by the internal fabric layer 6370. For example, the insulating layer 6366 may be a non-conductive polymer or elastomer film, or other electrically insulating materials may be used.

[0181] In some embodiments of this technology, an insulating layer can be provided between at least some electronic components of the positioning and stabilizing structure 6300, which tend to generate heat during use. Therefore, the insulating layer helps to enhance patient comfort. For example, the layer 6366 closest to the inner layer 6370 that comes into contact with the patient may be thermally insulating or electrically insulating, or an additional thermally insulating layer may be inserted between the electrically insulating layer 6366 and the inner layer 6370. In some examples, the inner layer 6370 itself may be thermally insulating.

[0182] In some embodiments of this technology, sensor and / or actuator modules 6354-6360 and their associated circuits, as well as other modules including processor module 6350 and battery module 6352, can be housed within retaining structures 6380-6390 fixed to insulating layer 6366 and / or internal fabric layer 6370. For example, each retaining structure 6380-6390 may electrically communicate with bus 6365 and include electrical contacts for electrically connecting the circuits of the sensor modules (or associated circuits) to bus 6365, and therefore may also be electrically connected to battery module 6352 and processor module 6350. In some examples, communication between modules 6350-6360 and bus 6365 may be via conductive ink traces and / or conductive wires woven into or integrated with fabric layers 6370 and / or 6372. In some embodiments, electrical contacts and / or circuit traces may be included only in the outer layer 6372 so as not to be affected by patient sweat during use.

[0183] In some examples, modules 6350-6360 may be removed from sensor retaining structures 6380-6390 to allow specific modules to be replaced with other modules having different functions, or with modules that have stopped working or reached the end of their lifecycle. For example, modules 6350-6360 (and / or circuit modules 6355, 6357, 6359, 6361, 6363 (if applicable) to which they are electrically coupled) can be detachably mounted in sensor retaining structures 6380-6392. For this purpose, the outer surfaces of the modules can form frictional mating with the inner surfaces of the walls of the sensor retaining structures 6380-6390, or snap mating with the walls or other inner or outer parts of the sensor retaining structures, such as annular snap mating or cantilever snap mating. In some embodiments, modules 6350-6360 can be retained within their respective retaining structures 6380-6390 using non-mechanical coupling, such as magnetic coupling.

[0184] In some embodiments of this technology, the retaining structures 6380-6390 may include pockets formed in the upper fabric portion 6310 (for example, by forming notches in the outer layer 6372 or the inner layer 6370), and modules 6350-6360 (or associated circuits) may be inserted for electrical coupling to the bus 6365.

[0185] The battery module 6352 may include a rechargeable battery. The battery can be charged, for example, by connecting to an external power source via a micro USB or USB-C port on the battery module 6352 (for example, this port is exposed by the outer fabric layer 6372) or by induction. In some embodiments, the battery module 6352 may be a disposable battery, for example, located in a pocket 6382 of the upper fabric portion 6310, which can be removed by the patient and replaced with a new battery.

[0186] In some embodiments of this technology, one or more sensor modules and / or actuator modules may be completely enclosed between the fabric layers 6370, 6372 such that no part of one or more sensor modules is exposed. For example, actuator module 6360 may be coupled to correlation circuit 6361 housed within sensor holding structure 6390. Actuator module 6360 and circuit module 6361 are completely located between the fabric layers 6370, 6372. In another example, sensor module 6356 and associated circuit 6357 can be completely located between the fabric layers 6370, 6372. An example of a sensor module 6356 that can be completely embedded is an accelerometer or a gyroscope.

[0187] In some embodiments of this technology, a sensor module or actuator module can be at least partially exposed. For example, a humidity sensor 6358 coupled to a circuit module 6359 can be at least partially exposed to the surroundings via an outer fabric layer 6372 to measure the humidity around a patient. For this purpose, the outer fabric layer 6372 may include an aperture that can expose the surface of the humidity sensor 6358. In another example, a sensor 6354 coupled to a circuit 6355 may have a surface exposed via an inner fabric layer 6370 (e.g., via an aperture formed therein) so that the sensor surface can come into contact with the patient's skin when the positioning and stabilizing structure 6300 is fitted to the patient. The sensor 6354 may be, for example, a pulse oximeter.

[0188] As stated above, the electronic components are structurally modular and, in at least some cases, interchangeable with other components. However, in some forms of this technology, one or more electronic components (e.g., sensors or actuators) may be knitted or otherwise integrated into the material of the upper fabric portion 6310, such as the outer fabric layer 6372 or the inner fabric layer 6370, and / or other parts of the positioning and stabilizing structure 6300, such as the lower fabric portion 6320, and / or one or both of the rear portions 6306, 6308. This allows sensors to be distributed over a wider area to obtain more information and / or more accurate measurements.

[0189] In some embodiments of this technology, the sensor may include a capacitive sensor, a resistive sensor, or a touch sensor such as a tactile switch 6362, and may have associated circuitry that allows the sensor to be used as a “pause” button. For example, the touch sensor 6362 may be incorporated into an exposed area of ​​the positioning and stabilizing structure 6300 or the seal forming structure 6100. In one example, the touch sensor 6362 may be positioned on the upper fabric portion 6310, as shown in Figure 8. As previously mentioned, the touch sensor 6362 can communicate with the processor / transceiver 6350, and signals recorded by the touch sensor 6362 and the circuit module 6363 (when the touch sensor 6362 is in “on” mode) can be transmitted by the processor / transceiver 6350 to an external device such as the pressure generator 4140 of the RPT device 4000.

[0190] For example, if a patient has a suitable patient interface 6000 and wishes to make a call, or if they wake up in the middle of the night and feel uncomfortable due to the positive pressure in the plenum chamber 6200, a brief, continuous touch can activate the touch sensor 6362 into “pause” mode. Circuit module 6359 can detect such contact and send a pause signal to the pressure generator 4140 (e.g., via the data communication interface 4280, Figure 13C) to immediately reduce the flow rate to a very low value (e.g., enough to avoid a feeling of suffocation). When “pause” mode is released, this is detected by circuit module 6363 and another signal is sent to the pressure generator 4140 so that the ramp-up algorithm implemented by the RPT device 4000 is reset.

[0191] Some forms of this technology may include one or more sensors to determine the patient's sleep position and movement before and / or during respiratory therapy. In some forms, the determined sleep position and movement can be used to adjust the operation of the pressure generator 4140 and / or provide the patient with sensory stimuli to change position. For example, if one or more sensors detect a number of apnea and / or hypopnea events exceeding a certain threshold and / or a decrease in blood oxygen concentration (whether or not the pressure generator 4140 is operating at that time), this may indicate back sleep. One or more actuators may receive an activation signal based on the detection, which can cause one or more actuators to generate vibration or other tactile stimuli to sufficiently stimulate the patient and thereby switch the patient to a different sleep position.

[0192] For example, the positioning and stabilization structure 6300 or the seal-forming structure 6100 may incorporate an accelerometer and / or gyroscope (not shown). The accelerometer and / or gyroscope may be completely enclosed between the fabric layers 6370 and 6372 of the upper fabric portion 6310, for example, as shown in 6360 of Figure 8. Both the accelerometer and gyroscope can communicate with the processor / transceiver 6350 to transmit the data they record to the RPT device 4000 to adjust the operation of the pressure generator 4140.

[0193] Measurements recorded by the accelerometer can be used to determine the patient's sleeping position and adjust treatment accordingly. If the patient is detected to be sleeping on their back, the pressure generator 4140 can slowly increase the treatment pressure to prevent sleep apnea events. If sleeping on one's side is detected, the treatment pressure can be reduced. If an upright position (reading before bed, wearing a mask, etc.) is detected, the flow rate and pressure may be sufficient to avoid suffocation.

[0194] Measurements recorded by a gyroscope can be used to determine the patient's movement and adjust treatment accordingly. If a large amount of movement is detected, it indicates that the patient may be awake, and the treatment pressure can be kept sufficiently low to avoid suffocation. Once the movement subsides, the treatment pressure can be increased very slowly to avoid discomfort.

[0195] In some forms of this technology, accelerometer and / or gyroscope measurements can be used to determine the patient's sleep stage, and the pressure generator 4140 can be turned on or off accordingly. For example, if treatment is started while the patient is awake, they may have difficulty falling asleep. Therefore, if the accelerometer and / or gyroscope measurements indicate a wakefulness or light sleep stage, the pressure generator 4140 is kept in an "off" or "dormant" state, and then, if the measurements indicate that the patient is in a deep sleep stage, the pressure generator 4140 is turned on (typically with a gradual increase). Conversely, if treatment is started and it is detected that the patient has switched from deep sleep to light sleep, the pressure generator 4140 can be dormant, for example, until the patient falls back into deep sleep.

[0196] In some forms of this technology, a pulse oximeter incorporated into the positioning and stabilization structure 6300 may be used to assess sleep health. For example, a pulse oximeter 6354 and associated circuitry 6355 may be incorporated into the upper fabric portion 6310 of the positioning and stabilization structure 6300, as shown in Figure 8. The pulse oximeter 6354 is exposed through an aperture in the inner fabric layer 6370 to contact the skin of the patient's forehead. Measurements recorded by the pulse oximeter 6354 may be used to determine blood oxygen saturation levels and heart rate while the patient interface 6000 is being worn, and this data may be transmitted to an external computing device such as an RPT device 4000 or a smartphone, another mobile computing device, or the patient's laptop or desktop computing system. Time-series data may be integrated to provide the patient with feedback on their health level and to provide advice for subsequent treatment (e.g., by a clinician).

[0197] For example, the Apnea-Hypopnea Index (AHI) can be determined based on sensor measurements, which clinicians use to classify the severity of sleep apnea. AHI calculation can use a combination of data from different sensors, such as blood oxygen levels and heart rate (e.g., measured by a PPG sensor), as well as chest movement (e.g., measured by an accelerometer and / or gyroscope). The AHI value is used to determine when "apnea" occurs.

[0198] Therefore, by tracking AHI over a period of time, clinicians can determine whether a patient has sleep apnea and provide details on the severity. Furthermore, by analyzing AHI data together with other sensor data, clinicians can not only correlate the frequency of apnea with specific sleeping positions (e.g., supine or lateral), but also adjust CPAP therapy to the patient's specific needs. For example, oral breathing volume can be detected using temperature and / or humidity sensors placed in the plenum chamber of the patient interface and a corresponding designated nasal mask or full-face mask. Furthermore, based on the sensor measurements, settings for the pressure generator 4140 that produce the optimal flow rate for the patient can be recommended. For example, a clinician can set a higher pressure (or equivalently, a higher flow rate) for a patient in whom a high rate of apnea or hypopnea events is detected. The designated flow rate may also depend on the patient's anatomical structure, for example, if the patient has a more collapsible upper airway.

[0199] In some forms of this technology, the EEG sensor may be positioned on a positioning and stabilizing structure 6300, for example, an upper fabric portion 6310. The EEG sensor may be partially exposed, similar to the pulse oximeter 6354 in Figure 8, so as to be in contact with the skin of the patient's forehead. Typically, the EEG sensor includes multiple EEG electrodes that generate analyzable signals to detect sleep stages. The signals can be transmitted (via the processor / transceiver 6350) to an external device such as the patient's smartphone, and the sleep stage, cycle, and duration information can be used to provide the patient with feedback on how sleep therapy is progressing and to provide advice to improve their health. For example, EEG sensor measurements can be used to determine precise sleep durations to enable more accurate determination of the occurrence of apnea or awakening from sleep, such as during sleep studies.

[0200] In some forms of this technology, sleep stage information can be transmitted to an RPT device 4000, which can then be used by a pressure generator 4140 to adjust therapeutic pressure to avoid arousal or obstructive events.

[0201] In some forms of this technology, sleep stage information can be used to enhance white / pink noise and / or binaural beats to activate sleep. These can be generated by audio devices embedded in the patient interface 6000 itself, or by external devices that receive trigger signals from the patient interface 6000 via the processor / transceiver 6350. For example, one or more micro bone conduction speakers can be incorporated into the temple area of ​​the upper fabric portion 6310.

[0202] In some forms of this technology, the positioning and stabilizing structure 6300 can incorporate electromyography (EMG) and / or electrooculography (EOG) sensors. The EMG and EOG sensor signals can be analyzed to determine the occurrence of the REM sleep phase. Similar to the example incorporating the EEG sensor, the sleep phase information determined by the EMG / EOG sensor can be used to provide feedback to the patient on how sleep therapy is progressing, to adjust the pressure generator 4140 to avoid arousal or obstructive events, or to activate one or more audio devices to generate noise that enhances sleep.

[0203] At least several EMG / EOG sensors may be incorporated into the upper fabric portion 6310. For example, a ground electrode and a reference electrode may be provided in the upper fabric portion 6310, for example, in its front portion, and exposed through corresponding apertures in the inner layer 6370 so that they can contact the patient's forehead. In another example, the ground electrode may be located in the rear portion 6306 of the upper fabric portion 6310, or in the second lower fabric portion 6308, so that the ground electrode is positioned behind the patient's ear when in use. Further electrodes can be provided, each electrode having a cable with one end mounted and / or extending within the upper fabric portion 6310 or the lower fabric portion of the first 6320 or second 6308, and the other end mounted on an electrode patch that the patient can position on their temple and below their eye, providing two additional measurement channels.

[0204] In some embodiments of this technology, an acoustic sensor such as a microphone, such as a MEMS microphone or an electret microphone, or a piezoelectric thin-film based transducer may be incorporated into the patient interface 6000 to detect snoring. For example, the microphone may be positioned in or on the inner surface of the plenum chamber 6200, or on the outer surface adjacent to the patient's nostrils. The microphone is coupled to a communication interface to enable data communication to the pressure generator 4140 of the RPT device 4000, and the pressure generated thereby can be adjusted. For example, when a mild snoring noise pattern is detected, the treatment pressure can be gradually increased to prevent an obstructive event. When the snoring noise pattern is eliminated, the treatment pressure can be reduced.

[0205] In some forms of this technology, the patient interface 6000 may incorporate humidity and temperature sensors, for example, on the inner surface of the plenum chamber 6200, to monitor the temperature and humidity within the plenum chamber 6200. The sensors may be coupled to a communication interface for transmitting humidity and temperature data to the RPT device 4000 and the humidifier 5000 to adjust their operation. The power of the pressure generator 4140 and the humidifier 5000 can be adjusted to prevent the accumulation of condensate. For example, the humidifier 5000 may be activated in stages and / or its heater power level may be controlled so that it can then be irrigated with normal air while maintaining a sufficient moisture level to prevent dry mouth (as measured by the humidity sensor).

[0206] In some embodiments of this technology, the pressure sensor may be located within the plenum chamber 6200, for example, on the inner surface of the plenum chamber 6200. This allows the pressure sensor to monitor the air pressure within the plenum chamber 6200 and send signals to the pressure generator 4140 to dynamically adjust the pressure and flow rate. This optimizes the response of the pressure generator 4140 to the patient's breathing pattern.

[0207] In some forms of this technology, a CO2 sensor can be placed inside the plenum chamber 6200. For example, the CO2 level inside the plenum chamber 6200 can be monitored. When a slight increase in the CO2 level is detected, an electromechanical vent (not shown) is opened, allowing for a higher level of air flushing from the plenum chamber 6200. Furthermore, a slight increase in the CO2 level can signal a pressure generator 4140 to slightly increase the flow rate to flush the CO2. This can be done dynamically to minimize patient discomfort.

[0208] In some embodiments of this technology, a combination of sensors and actuators is provided to achieve localized temperature changes, thereby improving patient comfort. For example, an EEG sensor and / or pulse oximeter may be provided on the upper fabric portion 6310 (e.g., as shown in 6354 of Figure 8), and a temperature sensor and / or humidity sensor may be provided on the upper fabric portion 6310 (e.g., as shown in 6358 of Figure 9C). Signals from the EEG and / or PPG sensors may be analyzed to detect sleep states, and signals from the temperature and / or humidity sensors may be used to assess ambient comfort. One or more Peltier elements may be placed, for example, on a wristband in a wearable form and coupled to a circuit that communicates with EEG / PPG and temperature / humidity sensors to receive signals indicating sleep states and ambient comfort, and the Peltier elements are activated to locally heat or cool the body (e.g., the wrist) to help the patient maintain a comfortable sleep state.

[0209] In some forms of this technology, tactile feedback elements (e.g., micro-vibration motors) can be incorporated into a patient interface 6000, such as the temple region (e.g., upper fabric portion 6310) of a positioning and stabilizing structure 6300. The tactile feedback elements can transmit vibrations to the patient to produce a sedative effect. For example, a processor module 6350 may monitor heart rate data from a pulse oximeter 6354, and if the data exceeds a threshold, it may send a trigger signal to a tactile feedback element to vibrate at a rate several times lower than the patient's current heart rate to help lower the heart rate. In another example, as described above, if it is detected that the patient is in a sleep position associated with an apnea or hypopnea event, the tactile feedback elements can be used to influence the patient's sleep position.

[0210] In some forms of this technology, one or more micro thermoelectric generators (TEGs) may be incorporated into the patient interface 6000 to generate a potential difference using the difference between the patient's body temperature and the ambient temperature, and thus to power various electronic components of the patient interface 6000 (sensors, actuators, processors, etc.). For example, a micro TEG may be located within the upper fabric portion 6310 and exposed through an aperture in the inner layer 6370 to contact the patient's forehead.

[0211] In some forms of this technology, multiple sensors can be integrated into a single module. For example, an accelerometer and a gyroscope can be integrated into a single package.

[0212] While various sensors and actuators have been described as being incorporated into the patient interface 6000 shown in Figures 7A, 7B, and 8, it should be understood that they may be incorporated in a similar manner into any other patient interface 3000 disclosed herein.

[0213] Power systems for patient interfaces and headgear As described above, the patient interface 3000 or 6000 and / or the positioning and stabilization structure for the patient interface (also referred to herein as the headgear) may include one or more electronic components such as sensors, actuators, and processors. Such components may be incorporated into the patient interface 3000, 6000 as one or more actuator modules 6354-6360, for example, as shown in Figure 8.

[0214] As described above, one or more electronic components can be powered by an electrical energy storage device such as a rechargeable battery or a supercapacitor. In some forms of this technology, the patient interface may include a power system that can directly power one or more electrical components and / or charge a battery or supercapacitor for that purpose, and / or communicate with the power system.

[0215] Figure 9A is a schematic block diagram of a patient interface 7000 including one or more electronic components powered by a power system. The patient interface 7000 includes a battery 7020 (e.g., a rechargeable battery), a communication module 7030, and two sensor modules 7040 and 7050. Each sensor module 7040, 7050 may include multiple sensor assemblies. For example, sensor module 7040 may incorporate temperature, humidity, ambient light, and / or acoustic sensors. For example, sensor module 7050 may include an accelerometer, gyroscope, pulse oximeter, and / or blood pressure sensor. Any of these sensor assemblies may be included alternatively on another sensor, or on an additional sensor (not shown). Furthermore, other sensor assemblies not specified above may be included on at least one sensor 7040, 7050 and / or individual sensors. The communication module 7030 may include one or more of the following interfaces: Bluetooth® interface, Near Field Communication (NFC®) interface, and WiFi® interface. The patient interface 7000 may include a positioning and stabilization structure that matches the positioning and stabilization structure of the patient interface 3000 or the patient interface 6000, and the sensors of modules 7040 and 7050 may include any of the sensors described above with respect to the patient interface 6000.

[0216] The battery 7020 supplies power to one or more of the modules 7030, 7040, 7050 via a power line 7072 and a ground line 7070. The modules 7030, 7040, 7050 are synchronized with each other via a clock signal 7076 and transfer data to each other via a data line 7074.

[0217] In some examples, as shown in FIGS. 9A - 9D, the power system can include a charger circuit 7010 that is external to the patient interface 7000 but can communicate, either wired or wirelessly, with the rechargeable battery 7020 of the patient interface 7000. For example, the charger circuit 7010 may form part of the RPT device 4000 or communicate with the RPT device 4000.

[0218] In one example, as schematically shown in FIG. 9B, the charger circuit 7010 is connected to the rechargeable battery 7020 via a wired connection. For example, a power cable may be wound (spirally or otherwise) outside the air circuit 4170 such that its ends are connected to the terminals of the battery 7020. A data cable may also be wound outside the air circuit 4170 (e.g., within an insulating extrusion) to connect to the battery 7020 and / or any other module 7030, 7040, 7050. Alternatively, data can be communicated between the battery 7020 and the charger circuit 7010 via another device such as Bluetooth (registered trademark) or NFC (registered trademark), e.g., via the communication module 7030.

[0219] In some forms of the present technology, the power and / or data cables may pass through a conduit disposed on the outer surface of the air circuit 4170 or even within the air circuit 4170.

[0220] The data connection between the charging circuit 7010 and the battery 7020 can be used to control the charging of the battery 7020 in various ways. For example, a charging algorithm can be implemented in the battery 7020 such that when a certain low battery threshold is reached, the battery 7020 sends an alarm to the charging circuit 7010 to start charging. For example, the battery 7020 can also send charging information (and other information) to other nearby devices via wireless communication.

[0221] The connection of the power supply and / or data cable extending from the charging circuit 7010 to the patient interface 7000 can be realized in various ways. For example, the cable can terminate at the end of the air circuit 4170 that connects electrical contacts connected to an air inlet connection port (e.g., port 3600 of the patient interface 3000 or port 6600 of the patient interface 6000) via a slip ring, and the terminals of the port can communicate electrically in sequence with the battery 7020 or other electrical components of the patient interface 7000. Thereby, the electrical connection is maintained while the end of the air circuit 4170 rotates within the port.

[0222] In some embodiments of this technology, as shown in Figure 9C, the charger circuit 7010 may be configured to charge the battery 7020 via a wireless power transmission method. For example, near-field wireless power transmission can be achieved by an inductive charging circuit of the charger circuit 7010 working in cooperation with a charging coil located in the headgear or other part of the patient interface 7000. For example, the inductive charging circuit may be located within the RPT device 4000 so that the patient can place it on the RPT device 4000 when not using the headgear to charge the rechargeable battery of the headgear. In some embodiments, the patient interface 7000 may include a magnetic alignment feature for automatically aligning the battery 7020 with the charging circuit 7010. For example, the magnetic alignment feature may include one or more magnets attracted by a magnetic field generated by the RPT device 4000, for example, one or more magnets attracted by one or more magnets located near the location of the charging circuit 7010. Alternatively, the charging circuit 7010 may charge the battery 7020 using a far-field or radiated wireless power transmission method such as WiFi®-based power transmission. The battery 7020 can transfer data to the charging circuit 7010 via Bluetooth®, NFC®, etc.

[0223] In some embodiments of this technology, as shown in Figure 9D, the charger circuit 7010 can be connected to the battery 7020 via any form of standard connection device, such as a USB-C or mini-USB cable 7080. This allows the charger circuit 7010 to be used to charge the battery 7020, although other standard charging devices independent of the RPT device 4000 (e.g., a smartphone charger) can be used to charge the battery 7020. In these embodiments, the patient interface 7000 may be substantially independent of the RPT device 4000 for the purpose of supplying power to the electronic components of the patient interface 7000. Thus, the portability of the patient interface 7000 is improved when the patient interface (or at least its headgear) is used only for monitoring and not for therapeutic purposes. In the embodiments shown in Figures 9B and 9C, data can be transmitted to the charger circuit 7010 via Bluetooth®, NFC®, etc., as needed.

[0224] In some forms of this technology, the power system may include an energy collection system. The energy collection system is configured to convert non-electrical energy, such as mechanical or thermal energy, generated during the use of the patient interface, into electrical energy for powering one or more electrical components. Advantageously, providing an energy collection system provides an alternative or additional energy source for powering one or more electrical components and / or for providing auxiliary power when electrical energy storage devices have low capacity. Furthermore, the energy collection system can reduce the need to recharge batteries or supercapacitors that power one or more electronic components.

[0225] For example, as shown in Figure 10, a patient interface 7000 is shown that has the same overall configuration as the patient interface 7000 in Figure 9A. However, in Figure 10, the patient interface 7000 is not connected to an external power source and incorporates an energy collection system 7060. The energy collection system 7060 is electrically coupled to a battery 7020 and electronic modules 7030, 7040, and 7050. The energy collection system 7060 can directly supply power to modules 7030, 7040, and 7050 and / or charge the battery 7020 so that the battery 7020 can power the modules.

[0226] Of course, it should be understood that in some forms of this technology, the patient interface may include an energy collection system 7060 or may be configured to communicate with an external charging circuit 7010 to charge the battery 7020.

[0227] In one embodiment of this technology, a turbine generator can be located within the pneumatic path of the patient interface. The turbine generator is constructed and positioned to convert mechanical energy from the airflow into electric current during use of the patient interface. For example, the turbine generator may be located at the air inlet of the patient interfaces 3000, 6000 (and may be rotated, for example, by a pressurized airflow directed toward the patient). In some embodiments of this technology, the turbine generator is located within a connection port 3600 or 6600 that connects the patient interfaces 3000, 6000 to the air circuit 4170. This allows the turbine generator to receive the most likely airflow and thus generate the highest possible current. Alternatively, the turbine generator may be located within a discoupling structure 3500. In some embodiments of this technology, the turbine generator may be located in alignment with the vents of the patient interfaces 3000, 6000, or may be part of the vents of the patient interfaces 3000, 6000. In some configurations, the vent and turbine generator can be positioned upstream of the patient so that pressurized air flows through them. In other configurations, the vent and turbine generator can be positioned downstream of the patient (for example, in a vent that expels exhaled gases into the surroundings).

[0228] In one embodiment, the turbine generator can be positioned within the air inlet or connection port 3600, 6600 of the patient interface 3000, 6000, substantially perpendicular to the direction of pressurized air flow. For example, the turbine generator can rotate around an axis substantially parallel to the direction of pressurized air flow.

[0229] In another configuration, multiple turbine generators may be located within the air inlets and / or connection ports 3600, 6600 of the patient interfaces 3000, 6000. The turbine generators can be spaced apart from one another along the pressurized air flow path.

[0230] One configuration of the turbine generator 8000 is shown in Figures 11A to 11D. The turbine generator 8000 includes a rotor assembly 8100 constructed and positioned to rotate around an axis 8200 within a stator assembly which includes an inner portion 8300 housed in a casing 8400 and sealed by a cover 8500. The cover 8500, in combination with the casing 8400, seals the coil windings 8310 and protects them from the ingress of moisture and particulate matter.

[0231] The ends of the shaft 8200 are housed in the respective apertures 8510 of the inner portion 8300 covers 8500 and 8330, allowing the rotor 8100 to rotate within the stator assembly. The shaft 8200 can form a friction fit with apertures 8510 and 8330, and a gap fit with aperture 8120, which extends through the rotor assembly 8100. Alternatively, the shaft 8200 can form a friction fit with rotor aperture 8120 and a gap fit with apertures 8330 and 8510 to provide rotational capability for the rotor assembly 8100.

[0232] In some configurations, the axis may be configured to be supported at only one end, like a cantilever beam. Such an arrangement helps to reduce noise by constraining the support rib element (e.g., rib 8520) to the side of the energy collector.

[0233] In some embodiments, the inner portion 8300 includes a plurality of bobbins 8308 extending around it (see, for example, Figure 11A). Each bobbin 8308 has a cylindrical portion around which windings can be wound to form a coil of stator assembly windings. In other examples, the shape of at least one bobbin 8308 may be different (e.g., having an angular shape or an elliptical circumference).

[0234] In some embodiments of this technology, a single-wire winding scheme is used to maximize the generated voltage. The single wire is first wound multiple times on one bobbin 8308, then multiple times on the next bobbin 8308, and so on, continuing from one bobbin 8308 to the next, with the winding directions of the continuous coils 8310 being opposite to each other. As shown in Figure 11C, once all the coils are wound, the wire may have first ends 8312 and second ends 8314 that can pass through the stator casing 8400 to connect to, for example, one or more electronic components via additional circuits such as a rectifier circuit and / or a voltage stabilization circuit. In some embodiments of this technology, the rectifier circuit and / or voltage stabilization circuit may be located within the housing of the turbine generator 8000, for example, within the casing 8400.

[0235] In other configurations, instead of a single wire wound around all bobbins 8308, two or more wires may be configured to be wound around the bobbins 8308 in series and / or parallel for the desired voltage and current output.

[0236] This circuit can be connected to terminals extending from the turbine generator 8000 so as to contact terminals located within the patient interface 3000 or 6000, or to terminals located on the outer surface of the turbine generator 8000, and the terminals can be electrically connected to one or more electronic components. For example, terminals located within the patient interface can be connected to wires or other conductors extending within the conduit 3301 of the patient interface 3000 and / or along the upper fabric portion 6310 or lower fabric portion 6320 of the patient interface 6000.

[0237] In some forms of this technology, thin wires can be used to form the stator coil to accommodate as many turns as possible so that the highest possible voltage can be generated. For example, a 0.1 mm wire can be used. In another example, a 0.22 mm wire can be used. In this way, it is possible to generate voltages exceeding 5V so that a booster is not required to operate one or more electronic components of the patient interface 3000, 6000.

[0238] The rotor assembly 8100 includes a substantially cylindrical rotor body having a rotor aperture 8120 extending through it. In some embodiments, the rotor aperture 8120 may extend through the center of the cylindrical rotor body, but in other examples, the rotor aperture 8120 may be offset from the center. The rotor body includes a plurality of turbine blades 8130. It should be understood that the shape (angle and contour) and number of the blades 8130 may be optimized during respiratory therapy to ensure low-noise operation when pressurized air rotates the rotor 8100 (e.g., by pressurized air entering the air inlets of the patient interfaces 3000, 6000 via the air circuit 4170 and / or by exhaled air exiting the patient's nostrils or mouth). For example, the angle of attack of the blades 8130 may be configured such that the torque generated by the rotor assembly 8100 is sufficient to overcome the force associated with the induced magnetic field from the stator coil and generate a desired voltage.

[0239] The rotor body further includes multiple peripheral grooves 8110 in which the corresponding magnets can be accommodated. Once the magnets are inserted, the grooves 8110 can be sealed to prevent the ingress of dust and moisture.

[0240] In some embodiments of this technology, the magnets in adjacent grooves 8110 have opposing magnetic poles facing the winding. The number of coil bobbins 8308 may be the same as the number of magnets, and the angular pitch may also be the same. The coil axis and magnet axis may be arranged radially, respectively. In some examples, the magnet axis may be arranged radially and the coil axis may be arranged tangentially.

[0241] As shown in FIG. 11E, an alternative form of the rotor body 9000 can have magnets 9004 disposed toward the base of the blades 9008 (rather than in the grooves 8110 near the periphery of the rotor as shown in FIGS. 11A and 11B). In some forms, the magnets 9004 of the rotor body 9000 may likewise be positioned within the grooves (e.g., such that they are removable), and / or may be fixed to the housing 9002 or other portions of the rotor body 9000.

[0242] In some forms, the magnets 9004 may be covered in the same manner as the magnets within the above-described grooves to limit the ingress of dust and moisture.

[0243] The magnets 9004 may be arranged in a similar configuration to the magnets described as being inserted into the grooves 8110. For example, the magnets 9004 of adjacent blades 9008 have opposing poles that face the stator coil 9012.

[0244] In some forms, the stator coil 9012 of the rotor body 9000 can be embedded in the rotor body 9000. The fixed coil 9012 can function as a fixed axis about which the rotor 9000 rotates. The coil 9012 can be formed of one or more wires as described above.

[0245] In some forms, the magnets 9004 are disposed closer to the bottom of the turbine blades 9008, as shown in FIG. 11E, which can generate a lower rotor inertia (e.g., the position of the center of gravity is closer to the center of the rotor body 9000), and thus can be rotated better even at a relatively low air flow rate (e.g., the torque required to generate rotation in the turbine blades 9008 is smaller).

[0246] To assemble the turbine generator 8000, the inner section 8300 can be placed inside the casing 8400, and then the rotor assembly 8100 can be placed inside the inner section 8300. The shaft 8200 can be inserted into the through-hole 8120 of the rotor assembly 8100 and the aperture 8330 of the inner section. At this stage, the coil 8310 of the stator assembly remains exposed. The cover 8500 is then attached to the casing 8400 so that the shaft 8200 is located inside the aperture 8510 of the cover, and the rim 8530 of the cover seals the space where the coil 8310 resides. The cover 8500 may be secured to the casing 8400 by any suitable method, such as a snap fit or threads. In some embodiments of this technology, a gasket (not shown) can be placed on the rim 8530 to further reduce the possibility of moisture ingress.

[0247] Since both the rotor assembly 8100 and the stator assembly (including the combination of the casing 8400, inner section 8300, and cover 8500) are sealed, the ingress of moisture and dust can be minimized. Therefore, the turbine generator can be maintained in the correct position within the patient interface 3000, 6000 during the normal cleaning cycle of the patient interface. This is more convenient for the patient as it does not need to be removed.

[0248] As described above, the turbine generator 8000 operates by converting mechanical energy from the airflow into rotational energy, and then converting that rotational energy into electrical energy through a current induced in the coil 8310 by the rotating magnets of the rotor 8100. To achieve this, it is desirable to minimize the flow impedance. In some embodiments of this technology, this is achieved by providing a support structure for the shaft 8200 that has the minimum surface area. For example, as shown in Figures 11A to 11D, the shaft 8200 may be supported on the cover 8500 side by three ribs 8520 extending from the central ring 8515 to the rim 8530 of the cover 8500.

[0249] In some embodiments of this technology, two ribs 8520 can extend from the central ring 8515 to the rim 8530. In other embodiments, three or more ribs 8520 can be provided. Generally, providing an odd number of ribs 8520 (and vice versa) when the number of blades 8130 is even may be advantageous because it provides an asymmetry that tends to reduce the amount of noise generated when the blades 8130 pass over the ribs 8520.

[0250] Rib 8520 is manufactured to be as thin as possible to minimize flow impedance while providing the necessary support to the shaft. Rib 8520 does not extend radially from ring 8515 as shown in the figure, but is slightly offset. This is to reduce the possibility of turbulence occurring as air flows through the turbine generator 8000, thereby reducing noise generation. The offset arrangement of rib 8520 tends to guide the airflow to smooth it, for example, by changing the direction of the airflow or by reducing the amount of turbulence and inducing more laminar flow by decreasing the airflow velocity. Further smoothing of the airflow can be achieved, for example, by providing a curved or angled surface on rib 8520.

[0251] Similar to the cover 8500, the inner portion 8300 of the stator assembly may have a minimum surface area support structure, such as three ribs 8320 having substantially the same configuration as the ribs 8520 of the cover 8500.

[0252] The turbine generator 8000 can be connected to a circuit for modulating and / or converting its output voltage before connecting to one or more electronic components of the patient interface 3000, 6000. For example, a full-bridge rectifier with a capacitor can be used to convert the output AC voltage to a DC power supply.

[0253] Test results using an 8-blade, 8-pole example show that when the turbine generator is placed in an air circuit 4170 connected to an RPT device 4000, it can generate voltages up to 8V at a pressure setting of 20cmH2O.

[0254] In some forms of this technology, the energy collection system may include at least one piezoelectric thin film. The piezoelectric thin film may be used to generate an electric current in response to changes in airflow during use (e.g., input of pressurized air from the RPT device 4000 and / or exhalation from the patient) and the patient's body movements. The deflection of the piezoelectric thin film generates a voltage that depends on the magnitude and speed of the deflection. Advantageously, the piezoelectric thin film itself can also function as a sensor in which the voltage output indicates vibration and / or noise (e.g., due to snoring).

[0255] The piezoelectric thin film can be positioned in or on various assemblies of the patient interface 3000, 6000. For example, the piezoelectric thin film can be positioned within the plenum chamber 3200, 6200, for example, in an air inlet adjacent to the plenum chamber, so as to be positioned within the path of the airflow generated by the RPT device 4000 during use. The piezoelectric thin film thus positioned is used to collect energy and detect vibrations. In another example, the piezoelectric thin film may be mounted on the inner surface of the seal-forming structure 3100 or integrated with the inner surface of the seal-forming structure 3100 for energy collection and motion sensing. In yet another example, the piezoelectric thin film may be mounted between layers of ties or straps of the positioning and stabilizing structure 3300, 6300, or pinched, or in contact with another part of the user's face, so that the movement of the user's facial muscles during breathing or other movements causes the piezoelectric thin film to bend, thereby generating electrical energy. In another embodiment, the piezoelectric thin film may be positioned within the plenum chambers 3200, 6200 adjacent to the outlet to the plenum chamber (e.g., a vent that discharges exhaled air into the surroundings) so as to be positioned in the path of exhaled air (e.g., carbon dioxide) from the plenum chamber.

[0256] In some configurations, the patient interface 3000, 6000 can include both the turbine generator 8000 and the piezoelectric thin film (for example, one of them). This allows for more energy collection and / or energy collection at multiple locations within the flow path.

[0257] In some forms of this technology, the energy collection system may include one or more thermoelectric generators. The thermoelectric generators can be used to convert thermal energy into electrical energy, which can then be used to power various electrical components of the patient interface 3000, 6000.

[0258] In some configurations, the thermoelectric generator may be positioned on a portion of the patient interface 3000, 6000 adapted to come into contact with the patient during use. For example, the thermoelectric generator can be positioned on a portion of the positioning and stabilization structure 3300, 6300. The thermoelectric generator can utilize the heat emitted from the patient's skin and convert it into electrical energy. The thermoelectric generator may also be positioned on the seal-forming structure 3100, 6100, either alternatively or additionally, to capture heat emitted from the patient's skin.

[0259] Alternatively or additionally, thermoelectric generators may be located within the plenum chambers 3200 and 6200 of the respective patient interfaces 3000 and 6000. The thermoelectric generator can convert heat from exhaled breath into electrical energy, which can then be used to power various electrical components.

[0260] Figures 12A and 12B show examples of measurements recorded by two piezoelectric thin films that form part of the patient interface's energy collection system. The first piezoelectric thin film is located within the plenum chamber 3200 in the pneumatic path near the inlet, and the second piezoelectric thin film is located along the inner surface of the seal-forming structure 3100.

[0261] In Figure 12A, the patient's breathing pattern includes a sequence of normal breathing, followed by respiratory arrest, and then sudden inspiration. Since the average amplitude of the piezoelectric thin film in the air path during arrest is zero, respiratory arrest is detected as a deviation from the normal breathing mode. Among the signals detected by the buffer (seal-forming structure) piezoelectric thin film, sudden suction can be detected as a spike. In some forms, this allows collectors based on piezoelectric thin films to function as snoring and / or breath-stopping detectors (i.e., to detect breath-stopping).

[0262] Figure 12B shows a normal breathing sequence followed by simulated snoring. During the snoring phase, the signal detected by the air path piezoelectric thin film remains unchanged, but a spike occurs in the signal detected by the buffer piezoelectric thin film. Ventilation

[0263] In one embodiment, the patient interface 3000 includes a vent 3400 constructed and positioned to allow the expulsion of exhaled gases, such as carbon dioxide.

[0264] In certain configurations, the vent 3400 is configured to allow a continuous airflow from the inside of the plenum chamber 3200 to the surroundings while the pressure inside the plenum chamber is positive relative to the surroundings. The vent 3400 is configured to maintain the therapeutic pressure inside the plenum chamber during use while ensuring that the airflow is large enough to reduce patient rebreathing of exhaled CO2.

[0265] One embodiment of the ventilation section 3400 according to this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0266] The ventilation section 3400 may be located on the plenum chamber 3200. Alternatively, the ventilation section 3400 may be located on a release structure, for example, to swivel.

[0267] As described above, one or more of the energy collectors described above (e.g., turbine generator 8000, piezoelectric thin film, and / or thermoelectric generator) can be positioned in close proximity to the ventilation section 3400 to convert the flushing gas into electrical energy.

[0268] In some configurations, the energy harvester may be located within the plenum chambers 3200, 6200 between the patient and the vent 3400. In other words, the patient may be upstream of the energy harvester, and the vent 3400 may be downstream of the energy harvester. In this way, exhaled CO2 can be expelled from the vent 3400, preventing rebreathing. As air flows from the patient's mouth toward the vent 3400, the air passes through the energy harvester, allowing for the recapture of some energy.

[0269] In some configurations, the vents of patient interfaces 3000, 6000 may be extraction vents that can expel pressurized air into the surroundings before reaching the patient (i.e., they may be different vents from the CO2 exhaust vents described above). For example, the full-face mask 3000 shown in Figure 1C and the nasal mask shown in Figures 1B and 3A may be connected to the same RPT device 4000. In some configurations, the RPT device 4000 may include a sensor or user input to determine which version of the mask is connected. In another version, the RPT device 4000 may provide a single output for a given pressure. In other words, the RPT device can output a determined pressure to achieve a given pressure in the corresponding plenum chamber, regardless of which patient interface is connected.

[0270] In some configurations, the volume of the plenum chamber 3200 of the full-face mask 3000 may be larger than the volume of the plenum chamber 3200 of the nasal mask 3000. Therefore, the plenum chamber 3200 of the nasal mask may be subjected to overpressure (e.g., a pressure higher than the required pressure). To solve this problem, the vent 3400 can be positioned within a swivel so that air is discharged into the ambient environment before entering the plenum chamber 3200. This allows the pressure inside the plenum chamber 3200 to be reduced to the desired pressure.

[0271] Using the extraction unit in this manner is inefficient because it can waste electrical energy that would otherwise be used to generate a stronger airflow (i.e., pressurized air is expelled into the surroundings before the patient is able to inhale). The turbine generator 8000 (as described above) can be positioned near the swivel and can replenish and / or replace the extraction unit.

[0272] For example, the airflow passing through the turbine generator 8000 can have its pressurized airflow velocity reduced, thereby lowering the airflow pressure. This allows the airflow pressure to be reduced to a desired pressure and / or the amount of airflow discharged from the vent to be reduced.

[0273] In some configurations, the energy collector may be used in conjunction with the vent 3400 and extraction vent to improve the efficiency of the system (for example, to recapture more energy that would otherwise otherwise escape the system). However, the patient interfaces 3000, 6000 may include only one of these energy collectors, or not.

[0274] Uncoupling structure In one embodiment, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or a bulbolar fovea).

[0275] Connection port Connection port 3600 allows connection to the air circuit 4170.

[0276] forehead support In one embodiment, the patient interface 3000 includes a forehead support portion 3700.

[0277] choking prevention valve In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve.

[0278] port In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows direct measurement of the gas properties (e.g., pressure) within the plenum chamber 3200.

[0279] RPT device An RPT device 4000 according to one aspect of this technology includes mechanical placement elements, pneumatic placement elements and / or electrical placement elements, and is configured to perform one or more algorithms 4300, such as all or part of the methods described herein. The RPT device 4000 may also be configured to generate an airflow for delivery to a patient's airway, for example, to treat one or more respiratory conditions described elsewhere in this specification.

[0280] In one embodiment, the RPT device 4000 is constructed and configured to deliver an airflow 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.

[0281] The RPT device may have an external housing 4010 formed in two parts, an upper part 4012 and a lower part 4014. Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 comprises a chassis 4016 supporting one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0282] The pneumatic path of the RPT device 4000 may include one or more air path members such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124, and one or more transducers 4270 such as a pressure sensor 4272 and a flow sensor 4274. One or more of the air passage items may be located within a removable, integrated structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0283] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapeutic device control device 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative configuration, the RPT device 4000 may include two or more PCBAs 4202.

[0284] Mechanical and pneumatic components of RPT devices An RPT device may include one or more of the following placement elements in a single unit. In an alternative configuration, one or more of the following placement elements may be installed as separate units.

[0285] air filter An RPT device according to one embodiment of this technology may include one air filter 4110 or multiple air filters 4110.

[0286] In one embodiment, the inlet air filter 4112 is located at the starting point of the air pressure path upstream of the pressure generator 4140.

[0287] In one embodiment, an outlet air filter 4114, such as an antimicrobial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0288] Scarves (multiple scarves possible) An RPT device according to one embodiment of this technology may include one or more mufflers 4120.

[0289] In one embodiment of this technology, the inlet muffler 4122 is located in the air pressure path upstream of the pressure generator 4140.

[0290] In one embodiment of this technology, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0291] pressure generator In one embodiment of this technology, the pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be arranged in a spiral configuration. When delivering respiratory pressure therapy, the blower can deliver an air supply in any form, for example, at a speed up to about 120 L / min, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or up to about 30 cmH2O. The blower may be described in any one of U.S. Patent No. 7866944, U.S. Patent No. 8638014, U.S. Patent No. 8636479, and International Publication No. 2013 / 020167, the entire contents of which are incorporated herein by reference.

[0292] The pressure generator 4140 can be under the control of the treatment device controller 4240.

[0293] In other configurations, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air source), or a bellows.

[0294] A pressure generator is sometimes also called a flow generator, at least in some contexts.

[0295] Converter(s) The transducer may be located inside or outside the RPT device. The external transducer may be, for example, located on an air circuit or form part of a patient interface. The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0296] In one embodiment of this technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and configured to generate signals representing the characteristics of the airflow, such as flow rate, pressure, or temperature at that point in time within the pneumatic path.

[0297] In one embodiment of this technology, one or more transducers 4270 may be located in close proximity to the patient interface 3000 or 3800.

[0298] In one embodiment, the signal from the converter 4270 may be filtered, for example, by low-pass, high-pass, or band-pass filtering.

[0299] Flow sensor The flow sensor 4274 based on this technology can be based on a differential pressure transducer such as the SDP600 series differential pressure transducer from SENSIRION. In one configuration, the signal representing the flow rate, generated by the flow sensor 4274, is received by the central controller 4230.

[0300] pressure sensor The pressure sensor 4272 using this technology is positioned in a location that communicates with both the pneumatic path and the fluid. One example of a suitable pressure sensor is the Honeywell ASDX series sensor. Another suitable pressure sensor is the GE NPA series sensor. In one configuration, the pressure signal generated by the pressure sensor 4272 and representing the pressure is received by the central controller 4230.

[0301] Motor speed converter In one embodiment of this technology, the motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 may be supplied to the treatment device controller 4240. The motor speed transducer 4276 may be a speed sensor, such as a Hall effect sensor.

[0302] Anti-spillback valve In one embodiment of this technology, the anti-spillback valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the motor 4144.

[0303] Electrical components of RPT devices power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0304] In one embodiment of this technology, the power supply 4210 provides power only to the RPT device 4000. In another embodiment of this technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000. In yet another embodiment of this technology, the power supply 4210 provides power to one or more electronic components of the patient interfaces 3000 and 6000.

[0305] Input device In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials for enabling human-device interaction. The buttons, switches, or dials may be physical devices or software devices accessible via a touchscreen. In one embodiment, the buttons, switches, or turntables may be physically connected to an external housing 4010, and in another embodiment, they may communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0306] In one embodiment, the input device 4220 may be constructed and positioned to allow a human to select a value and / or a menu option.

[0307] Central controller In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0308] Suitable processors may include x86 Intel processors, processors based on ARM Holdings' ARM® Cortex®-M processors, such as ST MICROELECTRONIC's STM32 series microcontrollers. In certain alternative forms of this technology, 32-bit RISCCPUs such as ST MICROELECTRONICS' STR9 series microcontrollers, or 16-bit RISCCPUs such as processors in Texas Instruments' MSP430 microcontroller series, may also be suitable.

[0309] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0310] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 comprises separate electronic components.

[0311] The central controller 4230 may be configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and a humidifier 5000.

[0312] The central controller 4230 may be configured to provide output signals to one or more of the output device 4290, the treatment device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0313] In some forms of this technology, the central controller 4230 is configured to implement one or more algorithms 4300, which can be implemented by one or more methods described herein, for example, by processor control instructions represented as computer programs stored in a non-temporary computer-readable storage medium (e.g., memory 4260). In some forms of this technology, the central controller 4230 may be integrated into the RPT device 4000. However, in some forms of this technology, some methodologies may be performed by a remotely located device. For example, a remotely located device may determine control settings for a ventilator or detect respiratory-related incidents by analyzing data stored in one of the sensors described herein, etc.

[0314] clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230.

[0315] Therapeutic device controller In one embodiment of this technology, the therapeutic device controller 4240 is a therapeutic control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0316] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an ONSEMI MC33035 brushless DC motor controller is used.

[0317] protection circuit One or more protection circuits 4250 according to this technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0318] memory According to one embodiment of this technology, the RPT device 4000 includes a memory 4260, for example, a non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0319] Memory 4260 may be located in PCBA4202. Memory 4260 may be in the form of EEPROM or NAND flash.

[0320] Alternatively or additionally, the RPT device 4000 may include, in the form of, a removable memory 4260 such as a memory card manufactured in accordance with the Secure Digital (SD) standard.

[0321] In one embodiment of this technology, the memory 4260 functions as a non-temporary computer-readable storage medium that stores computer program instructions representing one or more methodologies described herein, such as one or more algorithms 4300.

[0322] Data communication system In one embodiment of this technology, a data communication interface 4280 connected to a central controller 4230 is provided. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0323] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0324] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may connect to the Internet using wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0325] In one configuration, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth® or the Consumer Infrared Protocol.

[0326] In one embodiment, the remote external device 4286 is one or more computers, for example, a cluster of networked computers. In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be available to appropriately authorized persons, such as clinicians.

[0327] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control device.

[0328] Output devices include optional displays and alarms.

[0329] The output device 4290 according to this technology may take the form of one or more of a visual unit, an auditory unit, and a tactile unit. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0330] Display driver The display driver 4292 receives characters, symbols, or images intended to be displayed on the display 4294 as input and converts them into commands to display them on the display 4294.

[0331] display The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an 8-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the shape "0") into eight logical signals indicating whether to activate eight corresponding segments to display a particular character or symbol.

[0332] RPT Device Algorithm As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300, which are represented as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260. The algorithms 4300 are generally classified into groups referred to as modules.

[0333] In other forms of this technology, some or all of the algorithm 4300 may be implemented by a controller of an external device, such as a local external device 4288 or a remote external device 4286. In such a form, data representing input signals and / or intermediate algorithm outputs required for part of the algorithm 4300 to be executed on the external device may be communicated to the external device via a local external communication network 4284 or a remote external communication network 4282. In such a form, part of the algorithm 4300 to be executed on the external device may be represented as a computer program stored in a non-temporary computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute part of the algorithm 4300.

[0334] In this configuration, treatment parameters generated by an external device via the treatment engine module 4320 (which in this configuration are part of an algorithm 4300 executed by the external device) can be communicated to the central controller 4230 so as to be transmitted to the treatment control module 4330.

[0335] Preprocessing module In one embodiment of this technology, the preprocessing module 4310 receives signals from a transducer 4270, for example, a flow sensor 4274 or a pressure sensor 4272, as input, and performs one or more process steps to calculate one or more output values ​​to be used as input to another module, for example, a therapeutic engine module 4320.

[0336] In one embodiment of this technology, the output values ​​include interface pressure Pm, airflow rate Qv, breathing rate Qr, and leakage rate Ql.

[0337] In various forms of this technology, the preprocessing module 4310 includes one or more algorithms from among the interface pressure estimation algorithm 4312, the airflow estimation algorithm 4314, the leak flow estimation algorithm 4316, and the breathing flow estimation algorithm 4318.

[0338] Interface pressure estimation In one embodiment of this technology, the interface pressure estimation algorithm 4312 receives as input a signal from a pressure sensor 4272 indicating the pressure in the pneumatic path near the outlet of the pneumatic block (device pressure Pd) and a signal from a flow sensor 4274 indicating the flow rate of the airflow exiting the RPT device 4000 (device flow rate Qd). The device flow rate Qd can be used as the total flow rate Qt in the absence of supplemental gas 4180. The interface pressure estimation algorithm 4312 estimates the pressure drop P through the air circuit 4170. For a specific air circuit 4170, the correlation between the pressure drop P(Q) and the pressure drop characteristic P and the total flow rate Qt can be simulated. The interface pressure estimation algorithm 4312 then provides the estimated pressure, Pm, as output to the patient interface 3000 or 3800. The pressure Pm, within the patient interface 3000 or 3800 is estimated to be the device pressure Pd minus the air circuit pressure drop P.

[0339] Flow rate estimation for ventilation section In one embodiment of this technology, the ventilation flow rate estimation algorithm 4314 receives the estimated pressure Pm at the patient interface 3000 or 3800 as input from the interface pressure estimation algorithm 4312, and estimates the ventilation flow rate of air Qv from the ventilation section 3400 at the patient interface 3000 or 3800. For a specific ventilation section 3400 in use, the dependence of the ventilation flow rate Qv on the interface pressure Pm can be modeled by the ventilation characteristic Qv(Pm).

[0340] Leakage flow rate estimation In one embodiment of this technology, the leak flow rate estimation algorithm 4316 takes the total flow rate, Qt, and the aeration flow rate Qv as input and estimates the leak flow rate Ql. In one embodiment, the leak flow rate estimation algorithm estimates the leak flow rate Ql by calculating the average of the difference between the total flow rate Qt and the aeration flow rate Qv over a sufficiently long period of time, for example 10s, which includes several breathing cycles.

[0341] In one embodiment, the leak flow rate estimation algorithm 4316 takes the total flow rate Qt, the permeable flow rate Qv, and the estimated pressure Pm as inputs from the patient interface 3000 or 3800, supplies the leak flow rate Ql as an output, calculates the leak conductance, and determines the leak flow rate Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered unpermeable flow rate equal to the difference between the total flow rate Qt and the permeable flow rate Qv, and the low-pass filtering square root of the pressure Pm, where the low-pass filtering time constant has a value long enough to include several breathing cycles, for example, about 10 seconds. The leak flow rate Ql can be estimated as a function of the product of the leak conductance and the pressure Pm.

[0342] Respiratory flow estimation In one embodiment of this technology, the respiratory flow rate estimation algorithm 4318 takes the total flow rate Qt, the inlet flow rate Qv, and the leakage flow rate Ql as inputs and estimates the respiratory flow rate of air, Qr, to the patient by subtracting the inlet flow rate Qv and the leakage flow rate Ql from the total flow rate Qt.

[0343] Treatment engine module In one embodiment of this technology, the treatment engine module 4320 receives one or more of the following as inputs: pressure Pm within the patient interface 3000 or 3800 and the air breathing flow rate Qr to the patient, and provides one or more treatment parameters as outputs. In one form of this technology, the treatment parameter is the treatment pressure Pt.

[0344] In one embodiment of this technology, the treatment parameters are one or more of the following: pressure fluctuation amplitude, base pressure, and target ventilation.

[0345] In various forms, the therapeutic engine module 4320 includes one or more algorithms from among the phase determination algorithm 4321, waveform determination algorithm 4322, ventilation determination algorithm 4323, inspiratory flow limitation determination algorithm 4324, apnea / hypopnea determination algorithm 4325, snoring determination algorithm 4326, airway patency determination algorithm 4327, target ventilation determination algorithm 4328, and therapeutic parameter determination algorithm 4329.

[0346] Phase determination In one embodiment of this technology, the RPT device 4000 does not determine the phase.

[0347] In one embodiment of this technology, the phase determination algorithm 4321 receives signals indicating respiratory flow rate and Qr as input and provides the phase Φ of the current respiratory cycle of patient 1000 as output.

[0348] In some forms, this is called discrete phase determination, and the phase output is a discrete variable. One embodiment of discrete phase determination provides a binary phase output having values ​​for inhalation or exhalation, for example, 0 and 0.5 turns, respectively, when the start of spontaneous inhalation and exhalation are detected, respectively. The “trigger” and “loop” RPT device 4000 can efficiently perform discrete phase determination because the trigger and loop points are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one embodiment of binary phase determination, the phase output is determined to a discrete value of 0 if the respiratory flow rate Qr is above a positive threshold (thus “triggering” the RPT device 4000), and to a discrete value of 0.5 turns if the respiratory flow rate Qr is below a negative threshold (thus “cycling” the RPT device 4000). The inspiratory time Ti and expiratory time Te can be estimated as typical values ​​for many respiratory cycles, with the time spent in stages equal to 0 (representing inspiration) and 0.5 (representing expiration), respectively.

[0349] Another embodiment of discrete phase determination provides a tri-phase output having one of the following values: inhalation, pause during inhalation, and exhalation.

[0350] In another form called continuous phase determination, the phase output is a continuous variable such as a change from 0 to 1 revolution or from 0 to 2 radians. The RPT device 4000 performing continuous phase determination can be triggered and looped when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one embodiment of continuous phase determination, a continuous value of the phase is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous phase value determined in this embodiment is generally called the "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr.

[0351] 1. If the respiratory flow rate is zero and then rapidly increases, the phase will rotate 0 times. 2. If the respiratory flow rate is stable at the same rate, the phase should be set to 0.25 rotations. 3. If the respiratory flow rate is zero and rapidly decreases, the phase should be set to 0.5 rotations. 4. If the respiratory flow rate is large and stable, the phase should be set to 0.75 rpm. 5. When the respiratory flow rate is stable at zero and the absolute value of the respiratory flow rate after 5 seconds of low-pass filtering is large, the phase is 0.9 rpm. 6. When the respiratory flow rate is positive and the phase is expiratory, the phase is 0 rotations. 7. When the respiratory flow rate is negative and the phase is inspiratory, the phase is 0.5 rotations. 8. If the absolute value of the respiratory flow rate after 5 seconds of low-pass filtering is large, the phase increases at a steady rate equal to the patient's respiratory rate and is low-pass filtered with a time constant of 20 seconds.

[0352] The output of each rule can be represented as a vector having a phase, which is the result of the rule, and a magnitude, which is the degree of ambiguity to which the rule is true. The respiratory flow rate is the degree of blurring, such as "high" or "stable," and is determined by an appropriate membership function. The results of the rules are represented as vectors and are joined by several functions, such as centroid. In this combination, the weights of the rules may be equal or different.

[0353] In another embodiment of continuous phase determination, the phase Φ is first discretely estimated based on the respiratory flow rate Qr from the inspiratory time Ti and expiratory time Te, as described above. The continuous phase at any given time can be obtained by adding 0.5 rotations to half the proportion of the inspiratory time Ti elapsed since the previous trigger time, or half the proportion of the expiratory time Te elapsed since the previous cycle time (whichever time is closer).

[0354] Waveform determination In one embodiment of this technology, the treatment parameter determination algorithm 4329 provides a nearly constant treatment pressure throughout the patient's entire respiratory cycle.

[0355] In another embodiment of this technology, the treatment control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that changes according to the phase of the patient's respiratory cycle using a waveform template.

[0356] In one form of this technique, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having values ​​in the range [0,1] on the region of phase values ​​provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0357] In one form, applicable to discrete or continuous phases, the waveform template Π(Φ) is a square wave template where the value is 1 for phase values ​​less than 0.5 turns and 0 for phase values ​​greater than or equal to 0.5 turns. In the form suitable for continuous phases, the waveform template Π(Φ) has two smoothly curved portions, i.e., the smoothly curved portion (e.g., rising cosine) where the phase value rises from 0 to 1 up to 0.5 turns, and the smooth bend (e.g., exponentially for phase values ​​greater than 0.5 turns) decays from 1 to 0. In the form suitable for continuous phases, the waveform template Π(Φ) is based on a square wave, but the phase value rises smoothly from 0 to less than 0.5 turns for a "rise time", and during the "fall time" after 0.5 turns, the phase value falls smoothly from 1 to 0, with a "fall time" of less than 0.5 turns.

[0358] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a waveform template library according to the settings of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table of values ​​Π for a phase value Φ. In other forms, the waveform determination algorithm 4322 uses a predetermined functional form (which may be parameterized by one or more parameters (e.g., time constants of the exponential curve portion)) to calculate the waveform template Π(Φ) "dynamically". The parameters of the functional form may be predetermined or may depend on the current state of patient 1000.

[0359] In some forms of this technology, it is applied to discrete binary phases of inhalation (Φ=0 rotations) or exhalation (Φ=0.5 rotations), and the waveform determination algorithm 4322 calculates the waveform template Π "dynamic" as a function of discrete phase Φ and time t measured since the most recent trigger moment. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) as two parts (inhalation and exhalation) as follows:

[0360]

number

[0361] Here, Πi(t) and Πe(t) are the expiratory and inspiratory portions of the waveform template Π(Φ,t). In one embodiment, the inspiratory portion Πi(t) of the waveform template is a smooth rise from 0 to 1, parameterized by the rise time, and the expiratory portion Πe(t) of the waveform template is a smooth fall from 1 to 0, parameterized by the fall time.

[0362] Ventilation decision In one embodiment of this technology, the ventilation determination algorithm 4323 receives the respiratory flow rate Qr as input and determines a measured value that represents the current patient ventilation Vent.

[0363] In some embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is an estimate of the actual patient's ventilation. In such an embodiment, the absolute value of the respiratory flow rate, Qr, is halved and, alternatively, filtered through a low-pass filter such as a second-order Bezier low-pass filter having a corner frequency of 0.11 Hz.

[0364] In other embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is substantially proportional to the actual patient ventilation. In such an embodiment, the peak respiratory flow rate Qpeak of the estimated cycle inhalation interval is realized. Many other programs, including this program and the sampling of the respiratory flow rate Qr, generate measurements that are approximately proportional to the ventilation volume on the assumption that the shape of the flow waveform does not change much (where here, if the respiratory flow waveforms that are normalized temporally and amplitude-wise are similar, the shapes of both breaths are considered to be similar). Simple examples include the median of the positive respiratory flow rate, the median of the absolute value of the respiratory flow rate, and the standard deviation of the flow rate. Any linear combination of any order statistic of the absolute value of the respiratory flow rate using a positive coefficient, and even some combinations using both positive and negative coefficients, are also approximately proportional to the ventilation volume. Another example is the average value of the respiratory flow rate at the K-th ratio (time) in the middle of the inhalation part, where 0 < K < 1. When the flow shape does not change, there are arbitrarily multiple measurements that are proportional to the completeness of ventilation.

[0365] Measurement of inspiratory flow limitation In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 to determine the degree of inspiratory flow limitation.

[0366] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input and provides, as an output, a measure of the degree to which the inspiratory portion of the breath indicates an inspiratory flow limitation.

[0367] In one embodiment of this technology, the inspiratory portion of each breath is identified by a zero-crossing detector. Along the inspiratory flow-time curve of each breath, an interpolator interpolates multiple equally spaced points (e.g., 65) representing each time point are interpolated. The curve described by the points is then scaled scalarly to have a uniform length (duration / cycle) and uniform area to eliminate the effects of changes in respiratory rate and depth. The scaled breath is then compared in a comparator to a pre-stored template representing a normal open breath, similar to the inspiratory portion of the breath shown in Figure 6A. Any breath that deviates from this template by a predetermined threshold (usually 1 proportional unit) at any point during inspiration, such as a cough, sigh, swallow, or belch, as determined by the test element, is rejected. For data that is not rejected, the central controller 4230 calculates the moving average of the first such scaled points of the first few inspiratory events. For such second points, this is repeated for the same inspiratory event, and so on. Therefore, for example, 65 scaled data points are generated by the central controller 4230, representing the moving average of the first few inspiratory events (e.g., three events). The moving average of the continuously updated (e.g., 65) points is hereafter referred to as the "scaled flow rate" and is specified as Qs(t). Alternatively, a single inspiratory event may be used instead of the moving average.

[0368] From the scaling flow rate, two shape factors related to the determination of partial occlusion can be calculated.

[0369] The shape factor of 1 is the ratio of the average of the intermediate (e.g., 32) scaling flow points to the average of the total (e.g., 65) scaling flow points. A ratio greater than 1 indicates normal respiration. A ratio less than or equal to 1 indicates respiratory obstruction. A ratio of approximately 1.17 is used as a threshold between partial and acrobatic respiration and is equivalent to the degree of obstruction that allows for adequate oxygenation in a typical patient.

[0370] The shape factor 2 is calculated as the mean square deviation from the unit scaling flow rate and is defined as exceeding the median value (e.g., 32). A mean square deviation of approximately 0.2 units is considered normal. A mean square deviation of zero is considered to represent completely flow-restricted breathing. The closer the mean square deviation is to zero, the more flow-restricted the breathing is.

[0371] Shape factors 1 and 2 can be used as alternatives or in combination. In other forms of this technique, the number of sampling points, breathing points, and intermediate points may differ from those described above. Also, the threshold may differ from the threshold described.

[0372] Determining Apnea and Hypopnea In one embodiment of this technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0373] In one form, the apnea / hypopnea determination algorithm 4325 receives a respiratory flow signal Qr as input and provides a flag as output indicating that apnea or hypopnea has been detected.

[0374] In one form, apnea can be detected when the respiratory flow rate (Qr) function falls below a flow threshold over a predetermined period of time. This function can be used to determine the peak flow rate, the relative short-term mean flow rate, or the midpoint flow rate between the relative short-term mean and peak flow rates, such as the RMS flow rate. The flow threshold may be a relatively long-term measure of flow rate.

[0375] In one embodiment, hypopnea is detected if the function of respiratory flow rate Qr falls below a second flow threshold within a predetermined time. This function can determine the peak flow rate, the relative short-term average flow rate, or the intermediate flow rate between the relative short-term average and peak flow rates, such as the RMS flow rate. The second flow threshold may be a relatively long-term measure of flow rate. The second flow threshold is greater than the flow threshold for detecting apnea.

[0376] Determining snoring In one embodiment of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 to determine the degree of snoring.

[0377] In one form, the snoring determination algorithm 4326 takes a respiratory flow signal Qr as input and provides a measure of the degree of snoring presence as output.

[0378] The snoring determination algorithm 4326 may include a step of determining the intensity of the flow signal in the range of 30 to 300 Hz. Furthermore, the snoring determination algorithm 4326 may include a step of filtering the respiratory flow signal Qr to reduce background noise, such as sound from the airflow in the blower system.

[0379] Airway patency determination In one embodiment of this technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency.

[0380] In one configuration, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the power of the signal in the frequency ranges of approximately 0.75 Hz and 3 Hz. The appearance of a peak within this frequency range indicates that the airway is open. The absence of a peak is thought to indicate airway closure.

[0381] In one embodiment, the frequency range for determining the peak is the frequency of small forced oscillations at the treatment pressure Pt. In one embodiment, the frequency of the forced oscillation is 2 Hz, and the amplitude is approximately 1 cmH2O.

[0382] In one configuration, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is considered a sign of airway atresia.

[0383] Determining the target ventilation In one embodiment of this technology, the central controller 4230 takes the current ventilation measurement Vent as input and executes one or more target ventilation determination algorithms 4328 to determine a target value Vtgt for the ventilation measurement.

[0384] In some forms of this technology, the target ventilation determination algorithm 4328 is absent, and the target value Vtgt is predetermined, for example, by hardcoding during the configuration of the RPT device 4000, or by manual input via the input device 4220.

[0385] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp that represents the patient's typical recent ventilation.

[0386] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a high percentage of the typical recent ventilation Vtyp, but smaller. This high percentage may be within the range of (80%, 100%), (85%, 95%), or (87%, 92%).

[0387] In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a unit multiple that is slightly larger than the typical recent ventilation Vtyp.

[0388] A typical recent ventilation Vtyp is a value that represents the tendency of the distribution of current ventilation Vent at multiple temporal moments on a given time scale to converge; i.e., it is a measure of the concentration trend of current ventilation in the recent past. In the implementation of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case it must be longer than the time scale of the Cheyne-Stokes upper and lower quarter cycles. The target ventilation determination algorithm 4328 can use any of various known concentration trend measurements to determine a typical recent ventilation Vtyp from the current ventilation measurement Vent. One such measurement is the output of a low-pass filter on the current ventilation Vent measurement, with a time constant equal to 100 seconds.

[0389] Determination of treatment parameters In some forms of this technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0390] In one embodiment of this technology, the treatment parameter is the instantaneous treatment pressure Pt. In one embodiment of this technology, the treatment parameter determination algorithm 4329 determines the treatment pressure Pt using an equation.

[0391]

number

[0392] Here, A is amplitude. Π(Φ,t) is the current phase value Φ and the waveform template value (in the range of 0 to 1) at time t. P0 is the base pressure.

[0393] If the waveform determination algorithm 4322 provides a waveform template Π(Φ,t) as a lookup table of values ​​Π indexed by phase Φ, the treatment parameter determination algorithm 4329 applies equation (1) by either locating the lookup table entry closest to the current phase value Φ returned by the phase determination algorithm 4321, or by interpolating between two entries that cross the current phase value Φ.

[0394] Depending on the selected respiratory pressure therapy mode, the values ​​of amplitude A and base pressure P0 can be set as follows by the therapy parameter determination algorithm 4329.

[0395] Treatment control module In one aspect of this technology, the treatment control module 4330 receives treatment parameters as input from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 and controls the pressure generator 4140 to deliver airflow according to the treatment parameters.

[0396] In one embodiment of this technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 so that the interface pressure Pm at the patient interface 3000 or 3800 delivers an airflow equal to the treatment pressure Pt.

[0397] Detection of fault conditions In one embodiment of this technology, the central controller 4230 performs one or more methods 4340 for detecting a fault condition. The fault conditions detected by one or more methods 4340 include at least one of the following:

[0398] Power off (Power off or insufficient power off) Sensor failure detection Failure to detect the presence of a part. Operating parameters exceeding recommended ranges (e.g., pressure, flow rate, temperature, PaO2) The test alarm cannot generate a detectable alarm signal. When a fault condition is detected, the corresponding algorithm 4340 notifies of the presence of the fault by one or more of the following signals: Initiation of audio, visual, and / or dynamic (such as vibration) alarms. Sending messages to external devices Event logging

[0399] Air circuit An air circuit according to one aspect of this technology is a conduit or tube configured and positioned to allow airflow to move between two placement elements of a respiratory therapy system (e.g., an RPT device 4000 and a patient interface 3000 or 3800) during use.

[0400] In particular, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may also be referred to as an air delivery tube. In some cases, separate limbs of the air circuit may exist for inhalation and exhalation. Otherwise, a single limb is used.

[0401] In some embodiments, the air circuit 4170 may comprise one or more heating elements arranged to heat the air within the air circuit, for example, to maintain or increase the temperature of the air. The heating elements may be in the form of heating wire circuits and may include one or more transducers, such as temperature sensors. In one embodiment, the heating wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may communicate with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent No. 8,733,349, which is incorporated herein by reference in its entirety.

[0402] In some configurations, cables for transmitting power or data can be incorporated into the air circuit 4170, for example, by winding the cables around the outer surface of the air circuit 4170. For example, such wound cables may be held in place by one or more layers of fibrous material.

[0403] Auxiliary gas delivery In one embodiment of this technology, an auxiliary gas, such as oxygen 4180, is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020, the air circuit 4170, and / or the patient interface 3000 or 3800.

[0404] humidifier Humidifier Overview In one embodiment of the present technology, a humidifier 5000 (for example, as shown in Figure 5A) is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and the temperature of the airflow (relative to the ambient air) before delivering the air to the patient's airway.

[0405] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some embodiments, as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further comprise a humidifier base 5006 adapted to receive the humidifier reservoir 5110 and which may comprise a heating element 5240.

[0406] Humidifier parts Water storage In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a certain amount of liquid (e.g., water) to evaporate in order to humidify the airflow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as a night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml of water. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0407] In one embodiment, the reservoir 5110 is configured to increase the humidity of the airflow from the RPT device 4000 as the airflow passes through the RPT device 4000. In one embodiment, the reservoir 5110 may be configured to encourage the air to pass through the reservoir 5110 in a meandering path while in contact with the amount of water in the reservoir 5110.

[0408] In one embodiment, the water reservoir 5110 can be removed laterally from the humidifier 5000, for example, as shown in Figures 5A and 5B.

[0409] The reservoir 5110 may also be configured to prevent liquid from leaking out, such as when the reservoir 5110 is displaced and / or rotated from its normal operating direction, such as through any opening and / or between its subcomponents. Since the airflow humidified by the humidifier 5000 is always pressurized, the reservoir 5110 may be configured to prevent leakage and / or loss of air pressure due to flow impedance.

[0410] Conduction part In one configuration, the reservoir 5110 includes a conduction section 5120 configured to enable efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one embodiment, the conduction section 5120 may be arranged in a plate shape, but other shapes may also be preferred. All or part of the conduction section 5120 may be made of a thermally conductive material such as aluminum (e.g., about 2 mm thick, 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 can be achieved with a less conductive material in a suitable shape.

[0411] Humidifier water tank dock In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (shown in Figure 5B) configured to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking mechanism, such as a locking lever 5135, configured to hold the reservoir 5110 within the humidifier reservoir dock 5130.

[0412] Water level indicator The humidifier water reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 can provide a user, such as a patient 1000 or a caregiver, with one or more indications of the amount of water in the humidifier water reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a predetermined maximum volume of water, any portion thereof (e.g., 25%, 50%, 75%), or volume (e.g., 200ml, 300ml, 400ml).

[0413] Humidifier converter The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 in place of or in addition to the transducer 4270. The humidifier transducer 5210 may comprise one or more of the following: an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in Figure 5C. The humidifier transducer 5210 may generate one or more output signals that can be communicated to a controller such as a central controller 4230 and / or a humidifier controller 5250. In some embodiments, the humidifier transducer may be located outside the humidifier 5000 (e.g., within the air circuit 4170) when the output signals are transmitted to the controller.

[0414] Pressure transducer In addition to, or instead of, the pressure sensor 4272 provided on the RPT device 4000, one or more pressure transducers 5212 can be provided on the humidifier 5000.

[0415] Flow converter In addition to, or instead of, the flow sensor 4274 provided on the RPT device 4000, one or more flow converters 5214 may be provided on the humidifier 5000.

[0416] Temperature converter The humidifier 5000 may be equipped with one or more temperature transducers 5216. One or more temperature sensors 5216 may be configured to measure one or more temperatures, such as the heating element 5240 and / or the airflow downstream of the humidifier outlet 5004. In some embodiments, the humidifier 5000 may further be equipped with temperature sensors 5216 to detect the temperature of the ambient air.

[0417] Humidity converter In one embodiment, the humidifier 5000 may be equipped with one or more humidity sensors 5218 to detect the humidity of a gas such as ambient air. In some embodiments, the humidity sensors 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors.

[0418] Heating element In some cases, the heating element 5240 may be provided in the humidifier 5000 to provide heat input to at least a portion of the water in the humidifier reservoir 5110 and / or to the airflow. The heating element 5240 may comprise heat-generating components such as an electrical resistance heating track. A preferred example of the heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. 2012 / 171072 (International Publication No. 2012 / 171072), which is incorporated herein by reference in whole.

[0419] In some configurations, the heating element 5240 may be located within the humidifier base 5006, and heat may be supplied to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B.

[0420] Humidifier controller In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250, as shown in Figure 5C. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230. In one embodiment, the humidifier controller 5250 may receive as input, for example, measured values ​​for airflow, water characteristics in the water tank 5110 and / or humidifier 5000 (such as temperature, humidity, pressure and / or flow rate). The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0421] As shown in Figure 5C, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heated element controller 5252 configured to control the temperature of the heated element 5240.

[0422] Screening, diagnostic, and monitoring systems overview At least some forms of this technology enable screening, diagnosis, and / or monitoring of sleep states using sensors integrated into a patient interface. The sensors can be located within a positioning and stabilization structure of the patient interface, such as the positioning and stabilization structure 6300 in Figures 4A and 4B, and / or within the plenum chamber of the patient interface.

[0423] For example, as described above, a sensor-enabled positioning and stabilization structure in the form of a headband, such as the positioning and stabilization structure 6300, can be worn by the patient as a separate headgear before treatment begins, and sensor measurements can be recorded during sleep. Sensor measurements can be used to accurately monitor sleep stages and sleep positions, track vital signs and other physiological indicators, and detect events such as apnea and hypopnea. Clinicians can use sleep and physiological data to diagnose sleep disorders and recommend appropriate treatment. Furthermore, the same parameters can be monitored by sensors during treatment and compared to parameters before treatment (or in the early stages of treatment) to allow patients and clinicians to evaluate the efficacy of the treatment.

[0424] As described above, physiological and sleep data can be recorded by one or more sensors in the patient interface and transmitted to an external computing device such as the patient's smartphone, and / or to a monitoring server operated or accessible by the clinician or other healthcare provider.

[0425] In some forms of this technology, a pulse oximeter incorporated into the positioning and stabilization structure 6300 may be used to determine oxygen saturation levels and heart rate while the patient interface 6000 is being worn, and this data may be transmitted to an external computing device such as a smartphone, another mobile computing device, or the patient's laptop or desktop computing system. Time-series data may be integrated to provide feedback on the patient's health level and advice for subsequent treatment (e.g., by a clinician), for example, based on the AHI determination described above, the AHI may be used in combination with other sensor measurements to determine the time and frequency of apnea events and the optimal treatment for the patient.

[0426] Other sensors that can be incorporated into the screening, diagnostic, and / or monitoring system, including the sensor-enabled patient interface, include, but are not limited to, EEG sensors for detecting sleep states, EMG and EOG sensors for determining occurrence during REM sleep stages; microphones for detecting snoring or other sounds indicating sleep disturbance; and humidity, temperature, pressure, and / or CO2 sensors, respectively, located inside the plenum chamber 6200 of the patient interface.

[0427] Next, we will describe some exemplary applications of the sensor-enabled patient interface.

[0428] Polysomnography Polysomnography (PSG) is a monitoring process that typically involves various different sensors and associated equipment, making it difficult even for specialists to set up. A typical PSG system includes a headbox that receives and records signals from EOG electrodes, electroencephalogram (EEG) electrodes, ECG electrodes, submental electromyogram (EMG) electrodes, snoring sensors, respiratory inductance plethysmograms (respiratory effort sensors) on chest straps, respiratory inductance plethysmograms (respiratory effort sensors) on abdominal bands, nasooral cannulas with oral thermistors, photoelectric volumetric meters (pulse oximeters), and positional sensors. The electrical signals are referenced to a grounding electrode (ISOG) located in the center of the forehead.

[0429] As described above, some or all of the sensors used by the PSG system may be located within a positioning and stabilization structure (e.g., 6300) and / or a plenum chamber (e.g., 6200), so that a sensor-enabled patient interface 6000, such as the patient interface 6000, can replace some or all of the functions of an existing PSG system. For example, EOG, EEG, ECG, and EMG electrodes, a microphone (functioning as a snoring sensor), a PPG sensor, an accelerometer, and / or a gyroscope (functioning as a body position sensor) may be located in the upper textile portion 6310 and / or the lower textile portions 6308, 6320 of the positioning and stabilization structure 6300. A ground electrode may also be provided (e.g., in the lower textile portion 6308 for placement behind the patient's ear, as described above).

[0430] By integrating the sensors with the patient interface 6000, PSG implementation becomes much simpler, as in at least some examples, patients can easily wear the patient interface 6000 for treatment without requiring additional configuration or with minimal additional steps (e.g., without manually positioning various electrodes for EEG / EMG / EOG sensors).

[0431] Hidden surveillance system In one example, one or more accelerometers and / or one or more gyroscopes and / or one or more other motion sensors can be placed within the positioning and stabilization structure 6300. The motion sensors are configured to generate one or more signals representing the movement of the patient's body, and a signal representing the movement of the patient's breathing can be obtained.

[0432] Respiratory polysomnography Polysomnography (RPG) is a general term for simplified forms of polysomnography (PSG) that do not include electrical signals (EOG, EEG, EMG), snoring, or positional sensors. Generally, RPG includes at least chest motion signals from a respiratory inductance plethysmogram (motion sensor) on a chest strap, nasal pressure signals sensed via a nasal cannula, and oxygen saturation signals from a pulse oximeter (e.g., a pulse oximeter). The three RPG signals or channels are received by an RPG headbox.

[0433] Sensor-enabled patient interfaces, such as patient interface 6000, can replace some or all of the functions of existing RPG systems. For example, accelerometer and / or gyroscope measurements from sensors mounted on the headgear 6300 can be used as proxies for chest motion signals. Nasal pressure signals can be measured by pressure sensors mounted inside a pressure chamber, for example, mounted on the inner surface of the pressure chamber, so as to be adjacent to the patient's nostrils when in use. Oxygen saturation signals can be measured by PPG sensors mounted on the headgear 6300, for example, as shown in 6355 in Figure 9C. The proxy chest motion signals, nasal pressure signals, and oxygen saturation signals can be received by the onboard processor 6350 of patient interface 6000 and / or transmitted to an external computing device for analysis in the same manner as conventional RPG signals.

[0434] In a specific configuration, the nasal pressure signal is a suitable substitute for the nasal flow signal generated by a flow transducer fitted to a sealed nasal mask, and the shape of the nasal pressure signal corresponds to that of the nasal flow signal. When the patient's mouth remains closed, i.e., there is no mouth leakage, the nasal flow rate is equal to the respiratory flow rate.

[0435] Portable oxygen concentrator Portable oxygen concentrators can utilize PSA (PSA). Pressure swing adsorption may involve using one or more compressors to increase the gas pressure in a canister containing particles of a gas separation adsorbent placed in a “sieve bed”. As the pressure increases, certain molecules in the gas may be adsorbed onto the gas separation adsorbent. By removing a portion of the gas in the canister under pressurized conditions, unadsorbed molecules can be separated from the adsorbed molecules. The gas separation adsorbent can be regenerated by reducing the pressure which reverses the adsorption of molecules from the adsorbent. Further details relating to oxygen concentrators are described, for example, in U.S. Published Patent Application No. 2009-0065007, “Oxygen Concentrator and Method,” published on 12 March 2009, which is incorporated herein by reference.

[0436] Ambient air typically contains approximately 78% nitrogen and 21% oxygen, with the remainder consisting of argon, carbon dioxide, water vapor, and other trace gases. When a mixed gas, such as air, passes under pressure through a tank containing a gas separation adsorption layer that adsorbs nitrogen more strongly than oxygen, some or all of the nitrogen remains in the bed, and the gas exiting the tank is oxygen-rich. When the bed reaches the limit of its nitrogen adsorption capacity, it can be regenerated by reducing the pressure to release the adsorbed nitrogen. It is then ready to perform another cycle to produce oxygen-enriched air. By alternating the canisters in a two-canister system, one canister separates oxygen while the other is purifying (continuously separating oxygen and nitrogen). In this way, the oxygen-enriched air can be stored in a storage container or other pressurized container or conduit connected to the tank for various applications, such as supplying supplemental oxygen to patients.

[0437] Respiratory therapy mode Various respiratory therapy modes can be implemented by the disclosed respiratory therapy system.

[0438] CPAP therapy In some embodiments of respiratory pressure therapy, the central controller 4230 sets the therapeutic pressure Pt according to the therapeutic pressure equation (1) as part of the therapeutic parameter determination algorithm 4329. In one such embodiment, the amplitude A is also zero, and therefore the therapeutic pressure Pt (representing the target value that the interface pressure Pm should achieve at this point) is the same as the base pressure P0 throughout the respiratory cycle. This embodiment is often categorized under the heading of CPAP therapy. In such embodiments, the therapeutic engine module 4320 does not need to determine the phase Φ or waveform template Π(Φ).

[0439] In CPAP therapy, the base pressure P0 may be a hardcoded constant value, or a constant value manually entered into the RPT device 4000. Alternatively, the central controller 4230 can repeatedly calculate the base pressure P0 as a function of an indicator or measurement of sleep-disordered breathing, such as one or more of the following: flow limitation, apnea, hypopnea, snoring, or snoring, which are returned by the corresponding algorithm in the treatment engine module 4320. This alternative therapy is sometimes called APAP therapy.

[0440] Figure 4E is a flowchart showing how method 4500 is performed by the central controller 4230 to continuously calculate the base pressure P0 as part of the APAP therapy implementation of the treatment parameter determination algorithm 4329 when pressure support A is also zero.

[0441] Method 4500 begins in step 4520, in which the central controller 4230 compares the apnea / hypopnea measurement to a first threshold and determines whether the apnea / hypopnea measurement has exceeded the first threshold indicating apnea / hypopnea for a predetermined period of time. If so, Method 4500 proceeds to step 4540; otherwise, Method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares the airway patency measurement to a second threshold. If the airway patency measurement exceeds the second threshold indicating an open airway, the detected apnea / hypopnea is considered central, and Method 4500 proceeds to step 4560; otherwise, the apnea / hypopnea is considered obstructive, and Method 4500 proceeds to step 4550.

[0442] In step 4530, the central controller 4230 compares the flow limit measurement to a third threshold. If the flow limit measurement exceeds the third threshold, indicating that the inspiratory flow is being restricted, method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560.

[0443] In step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment ΔP, provided that the obtained treatment pressure Pt does not exceed the maximum treatment pressure Pmax. In one embodiment, the predetermined pressure increment δP and the maximum treatment pressure Pmax are 1 cmH2O and 25 cmH2O, respectively. In another embodiment, the pressure increment δP can be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In another embodiment, the maximum treatment pressure Pmax can be as low as 15 cmH2O and as low as 35 cmH2O, or as low as 20 cmH2O and as low as 30 cmH2O. Method 4500 then returns to step 4520.

[0444] In step 4560, the central controller 4230 reduces the base pressure P0, provided that the reduced base pressure P0 does not fall below the minimum treatment pressure Pmin. Method 4500 then returns to step 4520. In one embodiment, the reduction is proportional to the value of P0-Pmin, and therefore the reduction of P0 to the minimum treatment pressure Pmin is exponential without any detected events. In one embodiment, the proportionality constant is set such that the time constant τ for the exponential reduction of P0 is 60 minutes and the minimum treatment pressure Pmin is 4 cmH2O. In other embodiments, the time constant τ can be less than 1 minute, less than 300 minutes, or less than 5 minutes, less than 180 minutes. In other embodiments, the minimum treatment pressure Pmin can be as low as 0 cmH2O and as low as 8 cmH2O, or as low as 2 cmH2O and as low as 6 cmH2O. Alternatively, the reduction of P0 can be predetermined to be linear in reducing P0 to the minimum treatment pressure Pmin without any detected events.

[0445] Bilevel therapy In other embodiments of this form of the technology, the value of amplitude A in equation (1) may be positive. When determining the therapeutic pressure Pt using equation (1) with a positive amplitude A, the therapeutic parameter determination algorithm 4329 oscillates the therapeutic pressure Pt between two values ​​or levels in synchronization with the spontaneous respiratory effort of patient 1000, and this implementation is called bilevel therapy. That is, based on the typical waveform template Π(Φ,t) described above, the therapeutic parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (referred to as IPAP) at the start of inspiration and during inspiration, and decreases the therapeutic pressure Pt to the base pressure P0 (referred to as EPAP).

[0446] In some forms of bilevel therapy, IPAP is a therapeutic pressure with the same purpose as the therapeutic pressure in CPAP therapy mode, while EPAP is IPAP minus amplitude A, having a "smaller" value (some cmH2O), and is sometimes called expiratory pressure release (EPR). This form is sometimes called CPAP therapy with EPR and is often considered more comfortable than direct CPAP therapy. In CPAP therapy with EPR, one or both of IPAP and EPAP may be hardcoded constant values, or they may be constant values ​​manually entered into the RPT device 4000. Alternatively, the therapeutic parameter determination algorithm 4329 can iteratively calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the therapeutic parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of the sleep-disordered breathing index or measurement returned by the corresponding algorithm in the therapeutic engine module 4320, in a manner similar to the calculation of the base pressure P0 in APAP therapy described above.

[0447] In other forms of bilevel therapy, amplitude A is large enough for the RPT device 4000 to complete some or all of the patient's breathing motion. In this form, called pressure-supported ventilation, amplitude A is called pressure support or swing. In pressure-supported ventilation, IPAP is base pressure P0 + pressure support A, and EPAP is base pressure P0.

[0448] In some forms of pressure-supported ventilation (also known as fixed-pressure-supported ventilation), the predetermined pressure support value at which pressure support A is fixed, for example, 10 cmH2O, is set by the RPT device 4000, which can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input using the input device 4220.

[0449] In other forms of pressure-supported ventilation (broadly referred to as servo ventilation), the treatment parameter determination algorithm 4329 takes as input some of the currently measured or estimated parameters of the respiratory cycle (e.g., the currently measured ventilation) and a target value for the respiratory parameter (e.g., the target ventilation Vtgt), and iteratively adjusts the parameters of equation (1) so that the currently measured value for the respiratory parameter approaches the target value. In a form of servo ventilation called adaptive servo ventilation (ASV) used to treat CSR, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated by the target ventilation determination algorithm 4328 from a typical recent ventilation Vtyp, as described above.

[0450] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method that iteratively calculates pressure support A to bring the current measured values ​​of respiratory parameters closer to target values. One such control method is proportional-integral (PI) control. In one embodiment of PI control applied to an ASV mode where the target ventilation Vtgt is set slightly smaller than a typical ventilation Vtyp in recent times, pressure support A is iteratively calculated as follows:

[0451]

number

[0452] Here, G is the gain of PI control. A larger value of gain G can result in positive feedback in the treatment engine module 4320. A smaller gain value G may leave untreated CSR or central sleep apnea. In some embodiments, the gain G is fixed at a predetermined value, e.g., -0.4 cmH2O / (L / min) / sec. Alternatively, the gain G may vary between treatment sessions, starting small and increasing session by session until it reaches a value that substantially cancels CSR. In such embodiments, conventional methods of retrospectively analyzing the parameters of the treatment session may be employed to assess the severity of CSR during the treatment session. In other embodiments, the gain G may vary depending on the difference between the current ventilation measurement Vent and the target ventilation Vtgt.

[0453] Other servo ventilation control methods applicable by the treatment parameter determination algorithm 4329 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0454] The value of pressure support A calculated by equation (2) can be extracted within the range defined as [Amin, Amax]. In this embodiment, by default, pressure support A is located at minimum pressure support Amin until the current ventilation Vent falls below the target ventilation Vtgt, at which point A begins to increase and returns to Amin only when the ventilation exceeds Vtgt again.

[0455] The pressure support limits Amin and Amax are set by the RPT device 4000, for example, by hardcoding them during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0456] In pressure-supported ventilation therapy mode, EPAP is the base pressure P0. EPAP may be a constant value defined or determined during titration, similar to the base pressure P0 in CPAP therapy. Such a constant EPAP can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input via the input device 4220. This alternative therapy is sometimes called fixed EPAP pressure-supported ventilation therapy. Clinicians may titrate a given patient's EPAP using PSG during a titration session to prevent obstructive apnea, similar to titrating the base pressure P0 in constant CPAP therapy, thereby maintaining an open airway for pressure-supported ventilation therapy.

[0457] Alternatively, the treatment parameter determination algorithm 4329 can iteratively calculate the base pressure P0 during pressure-supported ventilation therapy. In such embodiments, the treatment parameter determination algorithm 4329 iteratively calculates EPAP as a function of one or more sleep-disordered breathing indicators or measurements returned by the corresponding algorithm in the treatment engine module 4320, e.g., flow limitation, apnea, hypopnea, patency, and snoring. The continuous calculation of EPAP is similar to a clinician manually adjusting EPAP during an EPAP titration session, so this process may also be called automated titration of EPAP, and the treatment mode may also be called automated titrated EPAP pressure-supported ventilation therapy, or automated EPAP pressure-supported ventilation therapy.

[0458] high flow therapy In other forms of respiratory therapy, the airflow pressure is not controlled as in respiratory pressure therapy. Conversely, the central controller 4230 controls the pressure generator 4140 to deliver an airflow controlled by a therapeutic or target flow rate Qtgt, which is typically positive throughout the patient's respiratory cycle, with the device flow rate Qd being positive. This form is usually grouped under the title of flow therapy. In flow therapy, the therapeutic flow rate Qtgt may be a hardcoded constant value or a constant value manually entered into the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, this therapy is generally called high-flow therapy (HFT). Alternatively, the therapeutic flow rate may be a curve Qtgt(t) that changes according to the respiratory cycle.

[0459] Glossary For the purposes of this technical disclosure, one or more of the following definitions may apply in certain forms of the Technology. Alternative definitions may apply in other forms of the Technology.

[0460] overview Air: In certain forms of this technology, air may be considered to mean the atmosphere, and in other forms of this technology, air may be considered to mean other combinations of some breathable gases, such as oxygen-enriched air.

[0461] Surroundings: In certain forms of this technology, the term surroundings is considered to mean (i) outside the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0462] For example, the ambient humidity for a humidifier could be the humidity of the air directly surrounding the humidifier, such as the humidity of the room where the patient is sleeping. Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0463] In another example, ambient pressure could be pressure directly surrounding or outside the body.

[0464] In certain contexts, ambient (e.g., acoustic) noise may be considered the background noise level within the room where the patient is located, excluding noise generated, for example, by an RPT device or emitted from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[0465] Automatic positive airway pressure (APAP) therapy is a type of CPAP therapy in which the treatment pressure is automatically adjusted between the minimum and maximum limits, for example, from breath to breath, depending on the presence or absence of signs of short-circuit lung disease (SDB).

[0466] Continuous positive airway pressure (CPAP) therapy is a respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure changes between different respiratory cycles of the patient, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing when there are no signs of partial upper airway obstruction.

[0467] Flow rate: The amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate is to a scalar quantity, i.e., a quantity that has only magnitude. In other cases, a reference to flow rate is to a vector quantity, i.e., a quantity that has both magnitude and direction. The symbol Q may be assigned to flow rate. "Flow rate" may be simply written as "flow" or "airflow".

[0468] In the example of patient respiration, the flow rate can be nominally positive with respect to the inspiratory portion of the patient's respiratory cycle and negative with respect to the expiratory portion of the patient's respiratory cycle. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface through the air circuit. Vent flow rate Qv is the flow rate of air leaving the vent to allow the exhaled gas to be pushed out. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air taken into the patient's respiratory system.

[0469] Flow therapy is a respiratory therapy that involves delivering air to the airway entrance at a controlled flow rate called therapeutic flow rate, which is typically positive throughout the patient's entire respiratory cycle.

[0470] Humidifier: The term humidifier is considered to mean a humidifying device that is arranged, installed, or has a physical structure that can provide a therapeutically beneficial amount of water (H2O) vapor to the airflow in order to improve a patient's medical respiratory condition.

[0471] Leakage: The term "leakage" refers to an unintended flow of air. In one example, leakage may occur as a result of an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow to the surroundings.

[0472] Conducted (acoustic) noise: Conducted noise as used herein refers to noise carried to the patient by air pressure paths, such as air circuits and patient interfaces, and the air within them. In one embodiment, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0473] Radiated (acoustic) noise: In this specification, radiated noise refers to noise carried to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the volume / pressure level of the object in question in accordance with ISO 3744.

[0474] Ventilation (acoustic) noise: In this specification, ventilation noise refers to noise generated by airflow passing through any ventilation opening, such as a vent in the patient interface.

[0475] Oxygen-enriched air: Air with an oxygen concentration higher than atmospheric concentration (21%), such as at least approximately 50%, at least approximately 60%, at least approximately 70%, at least approximately 80%, at least approximately 90%, at least approximately 95%, at least approximately 98%, or at least approximately 99% oxygen. "Oxygen-enriched air" is sometimes abbreviated as "oxygen."

[0476] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0477] A patient is a person, regardless of whether or not they are suffering from respiratory problems.

[0478] Pressure: Force per unit area. Pressure is expressed as cmH2O, gf / cm². 2 It can be expressed in units including hectopascals. 1 cmH2O is 1 g-f / cm 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2 (=1 millibar to 0.001 atm). Unless otherwise specified in this specification, pressure is given in units of cmH2O.

[0479] The pressure within the patient interface is denoted by the symbol Pm, and the therapeutic pressure, which represents the target value achieved by the interface pressure Pm at the current moment, is denoted by the symbol Pt.

[0480] Respiratory pressure therapy involves supplying air to the airway entrance at a processing pressure that is typically positive relative to atmospheric pressure.

[0481] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing function.

[0482] material Silicone or silicone elastomer: synthetic rubber. In this specification, reference to silicone means reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured using ASTM D2240.

[0483] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0484] Mechanical properties Elasticity: The ability of a material to absorb energy when it undergoes elastic deformation and release energy when it is deformed.

[0485] Elastic: Releases virtually all energy upon unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0486] Hardness: The material's resistance to deformation (described by Young's modulus measured on a standardized sample size, indentation hardness scale, etc.).

[0487] "Flexible" materials may include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure.

[0488] "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0489] 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, extension, bending, or torsion). A structure or component may provide different resistance in different directions. The opposite of stiffness is flexibility.

[0490] Soft structure or component: A structure or component whose shape changes (bends, etc.) in a relatively short time (e.g., 1 second) when supported by its own weight.

[0491] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered during use. An example of such an application may be setting up and maintaining a patient interface in a manner that seals the patient airway inlet under a pressure load of, for example, approximately 20-30 cmH2O.

[0492] For example, an I-beam may have different bending stiffnesses (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0493] Respiratory cycle Apnea: According to some definitions, apnea occurs when airflow falls below a predetermined threshold for a certain period, for example, 10 seconds. Obstructive apnea occurs when a partial obstruction of the airway impedes airflow despite the patient's effort. Central apnea occurs when apnea is detected due to decreased or absent respiratory effort despite the airway remaining patent. Mixed apnea occurs when decreased or absent respiratory effort coincides with an obstructed airway.

[0494] Respiratory rate: This is the rate of a patient's spontaneous breathing, usually measured as respiratory rate per minute.

[0495] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0496] Effort (breathing): This refers to the effort a person puts into breathing, which is a voluntary action.

[0497] The exhalation portion of the respiratory cycle: This is the period from the start of the exhalation flow to the start of the inhalation flow.

[0498] Flow limitation: Flow limitation is considered a situation in a patient's respiration where an increase in the patient's effort does not result in a corresponding increase in flow rate. When flow limitation occurs during the inspiratory portion of the respiratory cycle, it may be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, it may be described as expiratory flow limitation.

[0499] Types of flow-limiting inspiratory waveforms: (i) Flattening: An upward trend continues, followed by a relatively flat period, and then a downward trend follows. (ii) M-shaped: It has a total of two local peaks, one on the leading edge and one on the trailing edge, with a relatively flat section between these two peaks. (iii) Chair shape: It has a single local peak, which is located on the leading edge and is followed by a relatively flat section. (iv) Reverse chair shape: A relatively flat area is followed by a single local peak, which is located on the trailing edge.

[0500] Respiratory depression: According to some definitions, respiratory depression is considered to be a decrease in flow rate, but not a cessation of flow. In one form, respiratory depression may be said to have occurred when the flow rate decreases and falls below a threshold rate for a certain period of time. When respiratory depression is detected due to a decrease in respiratory effort, it is said to have occurred. In one form in adults, any of the following may be considered respiratory depression: (i) A 30% reduction in patient respiration for at least 10 seconds, and associated 4% desaturation; or (ii) A decrease in patient respiration for at least 10 seconds (but less than 50%), and associated desaturation or excitation of at least 3%. Hyperventilation: An increase in blood flow to a higher level than normal.

[0501] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0502] Patency (airway): The degree to which the airway is open, or the extent to which the airway is open. A patent airway is open. Airway patency can be quantified, for example, as a value of 1 when it is patent, and as a value of 0 when it is closed (obstructed).

[0503] Positive end-expiratory pressure (PEEP): This is the pressure in the lungs at the end of exhalation that is greater than the atmospheric pressure.

[0504] Peak flow rate (Q peak): This is the maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0505] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to estimates of respiratory flow rate by an RPT device, and are different from "true respiratory flow rate" or "true respiratory flow rate." "True respiratory flow rate" or "true respiratory flow rate" is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0506] Tidal volume (Vt): This is the volume of air inhaled or exhaled during normal breathing, without any extra effort. In principle, the inspiratory volume Vi (volume of inhaled air) is equal to the expiratory volume Ve (volume of exhaled air), so a single tidal volume Vt can be defined as being equal to either volume. In practice, tidal volume Vt is estimated as a combination of some of the inspiratory volume Vi and expiratory volume Ve, for example, as an average.

[0507] (Inspiratory) time (Ti): This is the duration of the inspiratory portion of the respiratory flow waveform.

[0508] (Expiratory) time (Te): This is the duration of the expiratory portion of the respiratory flow waveform.

[0509] (Total) Time (Ttot): This is the total time from the start of one inspiratory portion of the respiratory flow waveform to the start of the next inspiratory portion of the respiratory flow waveform.

[0510] Typical recent ventilation: A measure of the central trend of recent ventilation values, where recent ventilation values ​​(Vent) tend to cluster around a given timescale.

[0511] Upper airway obstruction (UAO): This includes both partial and complete upper airway obstruction. This can be associated with a flow-limiting condition in which flow may increase slightly or even decrease as the pressure difference across the upper airway increases (behavior of Stirling resistance).

[0512] Ventilation: A measure of the amount of gas exchanged by a patient's respiratory system. Measures of ventilation may include either or both inspiratory and expiratory flow rates per unit time. When expressed as volume per minute, this amount is often called "minute ventilation." Minute ventilation may simply be given as volume and understood as volume per minute.

[0513] respirator Adaptive servo ventilators (ASVs) are servo ventilators that have a changeable target ventilation rather than a fixed one. The changeable target ventilation can be learned from certain characteristics of the patient, such as the patient's respiratory characteristics.

[0514] Backup rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator will provide to the patient if not triggered by spontaneous respiratory effort.

[0515] Cycled: This refers to the end of the inspiratory phase of a ventilator. When a ventilator is delivering breath 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 delivering breath.

[0516] Positive expiratory airway pressure (EPAP): This is the base pressure that generates the desired interface pressure that a ventilator attempts to achieve in a given time, through the application of varying pressures during respiration.

[0517] End-expiratory pressure (EEP): This is the desired interface pressure that a ventilator attempts to achieve at the end of the expiratory portion of exhalation. When Φ=1, and the pressure waveform template Π(Φ) is set to zero at the end of exhalation, i.e., Π(Φ)=0, then EEP is equal to EPAP.

[0518] Positive Inspiratory Airway Pressure (IPAP): This is the maximum desired interface pressure that a ventilator attempts to achieve during the inspiratory portion of respiration.

[0519] Pressure support: A numerical value indicating that the inspiratory pressure of a ventilator has risen above the expiratory pressure of the ventilator. It generally represents the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some situations, pressure support refers to the difference the ventilator attempts to achieve, rather than the difference it actually achieves.

[0520] Servo ventilator: A ventilator that measures patient ventilation, has a target ventilation level, and adjusts the level of pressure support to guide patient ventilation toward the target ventilation.

[0521] Spontaneous / Timed (S / T): This is a mode of a ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. If the device does not detect breathing within a specified period, the device automatically starts delivering air.

[0522] Swing: This term is equivalent to pressure support.

[0523] Trigger: A trigger occurs when a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator) delivers a certain amount of breathable gas to a spontaneously breathing patient. Due to the patient's efforts, triggers usually occur at or near the start of the respiratory portion of the respiratory cycle.

[0524] Biological structure Biological structure of the face

[0525] Wing: The outer wall of each nostril or "wing" (complex number: alar)

[0526] The outermost point on the ala of the nose: the outermost point on the nostril.

[0527] Wing curvature (or nasal apex) point: The last point of the bending baseline of each nostril, found in the fold formed when the nostril meets the cheek.

[0528] Auricle: The entire part of the ear that is visible from the outside.

[0529] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0530] (Nasal) cartilage skeleton: The cartilage skeleton of the nose includes the nasal septum, lateral cartilage, main cartilage, and accessory cartilage.

[0531] The columella is a strip of skin that separates the nostrils, extending from the tip of the nose to the upper lip.

[0532] Columella angle: The angle at which a line passing through the midpoint of the nostril intersects the subnasal point with a line perpendicular to the Frankfort horizontal line.

[0533] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point of the notch located above the external tragus.

[0534] Glabella: Located on soft tissue, this is the point on the forehead where the sagittal plane is most prominent.

[0535] Lateral nasal cartilage: A roughly triangular cartilage plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0536] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. The greater alar cartilage curves around the anterior part of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four pterygoid cartilages.

[0537] Nostrils: The roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is naris (nostril). The nostrils are separated by the nasal septum.

[0538] Naso-labial sulcus or naso-labial fold: A fold or groove of skin that separates the cheek from the upper lip, extending from both sides of the nose to the corners of the mouth.

[0539] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasal point.

[0540] Inferior auricular point: The lowest point where the auricle attaches to the facial skin. The highest point where the auricle attaches to the skin of the face at the base of the ear.

[0541] Nasal tip: The most prominent point or tip of the nose, which can be identified in a lateral view of the rest of the head.

[0542] Philtrum: The midline groove extending from the lower edge of the nasal septum to the apex of the upper lip.

[0543] Point of deepest concavity: Located in the soft tissue, at the midpoint of the anteriormost part of the jaw.

[0544] Nasal ridge (nose): The nasal ridge is a projection along the midline of the nose, extending from the selion to the nasal tip.

[0545] Sagittal plane: The vertical plane from the front (front) to the back (back). The median sagittal plane is the sagittal plane that divides the body into left and right halves.

[0546] Serion: The most concave point located on soft tissue, covering the frontonasal suture region.

[0547] Septal cartilage (nose): The nasal septum cartilage forms part of the nasal septum and separates the anterior part of the nasal cavity.

[0548] Paranasal alae: Points located on the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper lip.

[0549] Infranasal point: Located in soft tissue, this is the point where the columella in the midline sagittal plane meets the upper lip.

[0550] The most concave point on the midline of the lower lip between the suprachin point (midpoint of the lower lip) and the soft tissue pogonion.

[0551] Biological structure of the skull Frontal bone: The frontal bone includes the frontal squama, a large vertical portion corresponding to the area known as the forehead.

[0552] Mandible: The mandible forms the lower part of the jaw. The chin tori is a bone that forms the jawbone.

[0553] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla projects upward through the side of the nose and forms part of its lateral boundary.

[0554] Nasal bones: The nasal bones are two small, oval-shaped bones that vary in size and shape from individual to individual. The nasal bones are located side by side in the central and lateral parts of the face, and their joint forms the "ridge" of the nose.

[0555] Nasion: The area of ​​depression between the eyes and just above the bridge of the nose, at the intersection of the frontal bone and the two nasal bones.

[0556] Occipital bone: The occipital bone is located in the lower posterior part of the skull. The nadion contains an oval-shaped opening, the foramen magnum, through which the cranial cavity leads to the vertebral canal. The curved plate behind the foramen magnum is the occipital squama.

[0557] Orbit: The cavity in the skull that houses the eyeball.

[0558] Parietal bone: The parietal bones are the bones that, when joined, form the top and sides of the skull.

[0559] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the temples of the face.

[0560] Zygomatic bones: The face includes two zygomatic bones located on the upper and lateral parts of the face, which form the cheekbones.

[0561] Structure of the respiratory system Diaphragm: A single muscle that runs across the bottom of the rib cage. 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, drawing air into the lungs.

[0562] Larynx: The larynx, or vocal organ, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0563] Lungs: The human respiratory system. The conduction region of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0564] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space located in the center of the face, above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On either side of the nasal cavity are three horizontal extensions called the nasal conchae (singular "concha") or nasal concha (turbinates). Anterior to the nasal cavity is the nose, whose dorsal portion merges with the nasopharynx via the posterior nostrils.

[0565] The pharynx is a part of the throat located directly below the nasal cavity, above the esophagus and larynx. The pharynx is usually divided into three parts: the nasopharynx (the nasal part of the pharynx), the mesopharynx (the oral part of the pharynx), and the hypopharynx.

[0566] Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of a patient rebreathing excessive carbon monoxide-2 by releasing it to the atmosphere in a fail-safe manner.

[0567] Elbow: An elbow is a structure that guides an airflow axis to change direction by an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a substantially circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In certain embodiments, an elbow may be rotatable, for example, about 360 degrees relative to a meshing component. In certain embodiments, an elbow may be detachable from a meshing component, for example, via a snap connection. In certain embodiments, an elbow may be assembled to a meshing component via a one-time snap during manufacturing, but cannot be detached by the patient.

[0568] Frame: The term "frame" is taken to mean a mask structure that supports tensile loads between two or more points connecting the headgear. The mask frame can be an airtight load-supporting structure within the mask. However, some forms of mask frames may be airtight.

[0569] Headgear: Headgear refers to a form of positioning and stabilizing structure designed for use on the head. For example, headgear may include a set of one or more struts, ties, and stiffeners, which are configured to position and hold the patient interface in the appropriate position on the patient's face for respiratory therapy. Some ties are formed from flexible and resilient materials, such as laminated composites of foam and fabric.

[0570] Membrane: The term "membrane" is typically used to mean a thin-walled element, preferably one that offers little resistance to bending and little resistance to stretching.

[0571] Plenum Chamber: The term "mask plenum chamber" is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, where the air in the volume is pressurized to exceed atmospheric pressure when in use. A shell may form part of the wall of the mask plenum chamber.

[0572] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to its effect. Two elements can be constructed and / or arranged to achieve a "seal" or a "seal" between them, without requiring a separate "seal" element itself.

[0573] Shell: A shell is a relatively thin, curved structure that possesses bending stiffness, tensile stiffness, and compressive stiffness. For example, the curved structural walls of a mask can be a shell. In some forms, a shell can be faceted. In some forms, a shell can be airtight. In some forms, a shell may not be airtight.

[0574] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0575] Strut: A strut is considered a structural component designed to increase the compressive strength of other components in at least one direction.

[0576] Swivel (noun): A subassembly of components configured to rotate preferably independently and preferably under low torque around a common axis. In one embodiment, the swivel may be configured to rotate at an angle of at least 360 degrees. In another embodiment, the swivel may be configured to rotate at an angle of less than 360 degrees. When used in connection with an air delivery conduit, the subassembly of components preferably includes a pair of cylindrical conduits. During use, there may be little to no leakage of airflow from the swivel.

[0577] Thai (noun): A structure designed to resist tension.

[0578] Ventilation section (noun): A structure that allows air to flow from inside the mask or through conduits into the ambient air, clinically effective in flushing out exhaled air. For example, in clinically effective exhalation, flow rates of approximately 10 liters / min to 100 liters / min may be used, depending on the mask design and therapeutic pressure. Shape of structure

[0579] Products based on this 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 may be distinguished using labels to describe the orientation, position, function or any other characteristic of the associated surface. For example, the structure may include one or more of a front, back, inner, and outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In yet another example, the structure may include a first surface and a second surface.

[0580] To facilitate the description of the three-dimensional structure and surface shape, we first consider a cross-section of the structure's surface at point p. Figures 3B to 3F show examples of cross-sections at point p on the surface and the resulting planar curves. Figures 3B to 3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In several examples, this surface is described from the perspective of a hypothetical small person standing upright on the surface.

[0581] Curvature in one dimension The curvature of a plane curve at p can be described by its sign (positive, negative, etc.) and magnitude (for example, 1 / the radius of the circle tangent to the curve at p).

[0582] Positive curvature: If a curve at point p curves towards its outer normal, the curvature at that point is considered positive (if a hypothetical small person leaves point p, they would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are generally called concave curves.

[0583] Zero curvature: If the curve at point p is a straight line, the curvature is considered zero (a hypothetical small person leaving point p can walk horizontally without going up or down). See Figure 3D.

[0584] Negative curvature: If the curve at point p deviates from its outer normal, the curvature at that point in that direction is considered negative (if a hypothetical small person leaves point p, they must walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are generally called convex curves.

[0585] Curvature of a two-dimensional surface The description of the shape at a given point on a two-dimensional surface using this technique may include multiple perpendicular cross-sections. These cross-sections can cut the surface in a plane containing an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross-section results in a planar curve with a corresponding curvature. The different curvatures at that point may have the same or different signs. Each curvature at that point has a magnitude (e.g., relatively small). The planar curves in Figures 3B to 3F may be examples of such multiple cross-sections at a particular point.

[0586] Principal curvature and direction: The direction of the normal plane in which the curvature of a curve takes its maximum and minimum values ​​is called the principal direction. In the example in Figures 3B to 3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F; therefore, Figures 3B and 3F are cross-sections in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0587] A surface region: A series of connected points on a surface. A set of points within a region may have similar properties, such as curvature and sign.

[0588] Saddle region: A region where the principal curvatures have opposite signs at each point, i.e., one is positive and the other is negative. (Depending on the direction a hypothetical person is facing, they may be walking uphill or downhill.)

[0589] Dome region: A region where the principal curvatures at each point have the same sign, for example, both are positive ("concave dome") or negative ("convex dome").

[0590] Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0591] Planar region: A region of a surface where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0592] Surface edge: The boundary or limit of a surface or area.

[0593] Path: In certain forms of this technology, “path” is considered to mean a path in a mathematical topological sense, for example, a continuous spatial curve from f(0) to f(1) on a surface. In certain forms of this technology, “path” can be described, for example, as a route or course containing a set of points on a surface. (A hypothetical person’s path is the places they walk on the surface, similar to a path in a garden.)

[0594] Path length: In certain forms of this technology, "path length" is considered to mean the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of a hypothetical person is the distance they must walk along the path on the surface.)

[0595] Straight-line distance: Straight-line distance is the distance between two points on a surface, regardless of the surface itself. On a planar region, there exists a distance on the surface edge with the same path length as the straight-line distance between two points on the surface. On a non-planar surface, no path with the same path length as the straight-line distance between two points can exist. (For a hypothetical person, straight-line distance corresponds to the distance a crow "flies".)

[0596] space curve Spatial curves: Unlike plane curves, spatial curves do not necessarily lie on a specific plane. Spatial curves can be closed; that is, they have no endpoint. Spatial curves can be considered as one-dimensional pieces of three-dimensional space. A hypothetical person walking along a DNA helix would walk along a spatial curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edges of structures (e.g., the edges of a membrane or impeller) can follow a spatial curve. In general, a spatial curve can be described by its curvature and torsion at each point on the curve. Torsion is a measure of the manner in which a curve originates from a plane. Torsion has a sign and magnitude. Torsion at a point on a spatial curve can be characterized by referring to the tangent, normal, and binormal vectors at that point.

[0597] Tangent Unit Vector (or Unit Tangent Vector): For each point on a curve, the vector of the point specifies the direction and amplitude from the point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person flies along a curve and falls from a car at a specific point, the direction of the tangent vector will be the direction in which the person is moving.

[0598] Unit Normal Vector: When a hypothetical figure moves along a curve, the tangent vector itself also changes. The unit vector that points in the same direction as the changing tangent vector is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0599] Binormal Unit Vector: The binormal unit vector is perpendicular to the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (see Figure 3O).

[0600] Contact plane: A plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0601] Twist of a spatial curve: The twist of a spatial curve at a given point is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation of the curve from the tangent plane. A spatial curve lying in a plane has zero twist. If the deviation of the spatial curve from the tangent plane is relatively small, the magnitude of the twist of the spatial curve is relatively small (e.g., a gently sloping spiral path). If the deviation of the spatial curve from the tangent plane is relatively large, the magnitude of the twist of the spatial curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, since T2 > T1, the amount of twist near the upper coil of the spiral in S in Figure 3 is greater than the amount of twist of the lower coil of the spiral in Figure 3S.

[0602] Referring to the right-hand rule in Figure 3P, a spatial curve curving toward the direction of the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 3S). A spatial curve pointing away from the direction of the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0603] Similarly, referring to the left-hand rule (see Figure 3O), a spatial curve pointing in the direction of the left-hand binormal can be considered to have a positive left-hand twist (e.g., a left-hand spiral). Thus, the positive direction of the left hand corresponds to the negative direction of the right hand. See Figure 3T.

[0604] hole A surface may have one-dimensional holes (e.g., holes bounded by planar or spatial curves). In the case of a thin structure containing holes (e.g., a film), this structure can be described as having one-dimensional holes. See, for example, the one-dimensional holes in the surface of the structure shown in Figure 3I, bounded by planar curves.

[0605] A structure may 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 example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in Figure 3L, and the exemplary cross-section of Figure 3L in Figures 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may contain a one-dimensional hole (e.g., at its inlet or outlet) and a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole that passes through the structure shown in Figure 3K and is bounded by a surface as shown.

[0606] Other precautions Some of the disclosures in this patent document contain copyrighted material. The copyright holder retains all copyrights to any other purpose, except if any person reproduces this patent document or this patent disclosure by fax, provided that it is included in the patent files or records of the Japan Patent Office.

[0607] Unless otherwise explicitly indicated by the context, if a range of values ​​is provided, it is understood that each intervening value up to one-tenth of the lower limit between the upper and lower limits of that range, and any other stated values ​​or intervening values ​​within that range, are included in this Technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening range, are also included in this Technology, subject to any explicitly excluded restrictions within the stated range. If the stated range includes one or both of the restrictions, the range excluding one or both of those included restrictions is also included in this Technology.

[0608] Furthermore, where one or more values ​​are described herein as being implemented as part of the technology, unless otherwise stated, these values ​​may be approximations, and it should be understood that these values ​​may be used up to any appropriate and effective number to the extent that is permissible or required for the actual technical implementation.

[0609] Furthermore, “near,” “substantially,” “about,” or any similar terms used herein represent a range of + / - 5 to 10% of the value.

[0610] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art. In the practice or testing of this art, similar or equivalent methods and materials as those described herein may be used, but only a limited number of exemplary methods and materials are described herein.

[0611] When a particular material is identified as being used to position an arrangement element, an obvious alternative material having similar properties may be used as a substitute. Furthermore, unless otherwise specified, any and all arrangement elements described herein are understood to be manufacturable and can be manufactured together or separately.

[0612] When used herein and in the appended claims, the singular form includes its plural equivalent unless the context explicitly indicates otherwise.

[0613] All publications referenced herein are incorporated herein by whole-word by reference to disclose and describe the methods and / or materials that are the subject matter of those publications. Publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as admitting that the art of the present invention does not have prior rights to such publications by prior invention. Furthermore, the publication dates provided may differ from the actual publication dates which may need to be independently verified.

[0614] The terms “includes” and “includes” should be interpreted as referring to elements, placement elements, or steps in a non-exclusive manner, indicating that the referenced element, placement element, or step may exist with or be combined with other elements, placement elements, or steps that are not explicitly referenced.

[0615] Subject headings used in the detailed descriptions are included solely for the convenience of reader reference and should not be used to limit the subject matter found throughout this disclosure or the claims. Subject headings should not be used in interpreting the claims or limitations of the claims.

[0616] The techniques described herein are explained with reference to specific examples, but it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may mean certain details that are not necessary for practicing the techniques. For example, the terms “first” and “second” may be used, but unless otherwise specified, they are not intended to indicate order and may be used to distinguish different elements. Furthermore, process steps in a methodology may be described or illustrated in order, but such ordering is not required. Those skilled in the art will recognize that such ordering may be modified, and / or that the embodiments may occur simultaneously or synchronously.

[0617] Therefore, it should be understood that numerous modifications may be made to the exemplary examples, and other arrangements may be devised without deviating from the spirit and scope of this technology. [Explanation of Symbols]

[0618] 3000 Patient Interfaces 3100 Seal-forming structure 3200 Plenum Chamber 3300 Positioning and stabilization structure

Claims

1. A patient interface for delivering airflow to a patient for the treatment of sleep-disordered breathing, wherein the patient interface comprises: At least 6 cmH higher than ambient air pressure ２ A plenum chamber that forms at least partially an internal space pressurized to a high therapeutic pressure, and includes a plenum chamber inlet port having dimensions and structure for receiving an airflow from a flow generator at a therapeutic pressure for a patient to breathe for the treatment of sleep-disordered breathing, A seal-forming structure constructed and positioned to form a seal with the patient's facial region surrounding the patient's airway entrance, having a hole therein so that an airflow at therapeutic pressure is delivered to at least one entrance of the patient's nostrils, and constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle in use; A positioning and stabilizing structure that provides force to hold the seal-forming structure in an effective therapeutic position on the patient's head, One or more electronic components for monitoring and / or diagnosing a patient are disposed in or on one or more of the plenum chamber, the seal-forming structure, and the positioning and stabilizing structure. A power system for converting energy generated during the use of the patient interface into electrical energy for powering one or more of the electronic components, wherein the power system includes at least one energy collection device, and the at least one energy collection device includes a turbine generator, Equipped with, The energy generated during use of the patient interface includes mechanical energy generated by passing the airflow from the flow generator to the turbine generator during use and while providing the airflow to the internal space of the plenum chamber. The turbine generator is located downstream of the flow generator and upstream of the internal space, forming a patient interface.

2. The patient interface according to claim 1, wherein the power system supplies a DC voltage to one or more of the electronic components.

3. The patient interface according to claim 1 or 2, wherein the power system is configured to charge an electrical energy storage device, and one or more of the electronic components are connected to the electrical energy storage device.

4. The patient interface according to any one of claims 1 to 3, wherein the turbine generator is located within the connection port of the patient interface.

5. The patient interface according to any one of claims 1 to 4, wherein the turbine generator is located at the air inlet of the patient interface.

6. The patient interface according to any one of claims 1 to 3, wherein the turbine generator is located at the plenum chamber inlet port or located within the plenum chamber adjacent to the plenum chamber inlet port.

7. The patient interface according to any one of claims 1 to 6, wherein the at least one energy collection device includes two or more energy collection devices positioned at the air outlet of the patient interface.

8. The patient interface according to claim 7, further comprising a vent configured to discharge air into the surrounding environment.

9. The patient interface according to any one of claims 1 to 8, wherein the turbine generator comprises a rotor including a plurality of turbine blades and a plurality of magnets arranged around the rotor.

10. The patient interface according to claim 9, wherein the turbine generator includes a sealed stator assembly housing a plurality of coils, the sealed stator assembly being positioned around the rotor.

11. The patient interface according to claim 9 or 10, wherein the magnet is located near the base of the turbine blade.

12. The patient interface according to any one of claims 1 to 11, wherein the power system includes at least one piezoelectric thin film.

13. The patient interface according to claim 12, wherein the at least one piezoelectric thin film is mounted or positioned within the plenum chamber and / or the seal-forming structure and / or the positioning and stabilization structure.

14. The patient interface according to any one of claims 1 to 13, wherein the power system includes at least one thermoelectric generator (TEG) module.

15. The patient interface according to claim 14, wherein the at least one TEG module is located within the positioning and stabilization structure.

16. The patient interface according to claim 15, wherein the at least one TEG module is positioned to be in contact with the patient's skin.

17. The patient interface according to any one of claims 14 to 16, wherein the at least one TEG module is arranged such that a first surface of the TEG module is exposed inside the plenum chamber and a second surface opposite to the first surface is exposed to the surroundings.

18. The patient interface according to any one of claims 3 to 17, wherein the power system includes an external charging circuit configured to charge an electrical energy storage device.

19. The patient interface according to claim 18, wherein the external charging circuit is a component of a respiratory pressure therapy device configured to deliver the airflow to the plenum chamber.

20. The patient interface according to claim 19, wherein the external charging circuit is connected to the electrical energy storage device via one or more cables incorporated in or on an air circuit connecting the respiratory pressure therapy device and the plenum chamber.

21. The patient interface according to any one of claims 1 to 20, wherein the one or more electronic components include one or more sensors and / or one or more actuators.

22. The patient interface according to claim 21, wherein the at least one sensor and / or the at least one actuator are partially exposed to the periphery on the outer surface of the positioning and stabilizing structure and / or are partially exposed to the patient contact surface of the positioning and stabilizing structure so as to come into contact with the patient's skin when in use.

23. The patient interface according to claim 21 or 22, wherein the at least one sensor and / or the at least one actuator is at least partially embedded between the outer layer of the positioning and stabilizing structure and the patient contact layer.

24. The patient interface according to any one of claims 21 to 23, wherein the at least one sensor and / or the at least one actuator includes a circuit formed at least partially by one or more conductive wires and / or one or more conductive ink traces.

25. The patient interface according to any one of claims 21 to 24, wherein the one or more electronic components include a wireless communication interface for transmitting data from the one or more sensors to the one or more external computing devices, and / or for receiving data from the one or more external computing devices by the one or more actuators.

26. The patient interface according to any one of claims 21 to 25, wherein the one or more sensors and / or the one or more actuators include one or more of the following: an accelerometer, a gyroscope, a humidity sensor, a temperature sensor, a microphone, a camera, a pulse oximeter, an EEG sensor, an EMG sensor, an EOG sensor, a touch sensor, a vibration device, and an audio output device.

Images