Pneumatic block for respiratory pressure treatment device

Abstract

An apparatus for providing positive pressure air to a patient for respiratory therapy includes a pneumatic block including at least first and second blower subassemblies and a common chassis assembly configured to support each of the at least first and second blower subassemblies. The at least first blower subassembly and the second blower subassembly are structurally different from each other in at least one aspect. Each of the at least first blower subassembly and the second blower subassembly includes a corresponding blower configured to generate a flow of air at a treatment pressure. The common chassis assembly and the first blower subassembly form a first configuration of the pneumatic block, and the common chassis assembly and the second blower subassembly form a second configuration of the pneumatic block. The air flow path and chamber arrangement in the first configuration is different from the air flow path and chamber arrangement in the second configuration.

Description

[0001] This application is a divisional application of the invention patent application with application number 201980082926.0, application date December 12, 2019, and invention name “Pneumatic block for respiratory pressure therapy device”. The invention patent application 201980082926.0 is an application entering the Chinese national phase of PCT international application PCT / IB2019 / 060726.

[0002] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office file or records, but otherwise reserves all copyright rights whatsoever.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This application claims the benefit of U.S. Provisional Application No. 62 / 779,135, filed December 13, 2018, which is incorporated herein by reference in its entirety. 2 Background technology 2.1 Technical Field

[0005] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0006] 2.2 Description of related technologies

[0007] 2.2.1 Human respiratory system and its disorders

[0008] The human respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0009] The airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to pass from inspired air into the venous blood and expel carbon dioxide. The trachea divides into the left and right main bronchi, which ultimately divide into terminal bronchioles.

[0010] The bronchi constitute the conducting airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See Respiratory Physiology, 9th edition, published by John B. West, Lippincott Williams & Wilkins, 2012.

[0011] There is a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0012] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0013] Obstructive sleep apnea (OSA) is a form of sleep disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Complications are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0014] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of boom-and-bust ventilation called CSR cycles. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. CSR can be harmful because of the repeated lack of oxygen. In some patients, CSR is associated with repeated arousals from sleep, which leads to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0015] Respiratory failure is a term for respiratory diseases in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0016] Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath during exercise.

[0017] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other known causes of hypoventilation. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0018] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that have certain common features. These diseases include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0019] Neuromuscular disease (NMD) is a broad term that encompasses many diseases and ailments that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of ambulation, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive types: (i) rapidly progressive disorders characterized by muscle damage that worsens over months and leads to death within years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders characterized by muscle damage that worsens over years and slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0020] The chest wall is a group of deformities of the thorax that result in inefficient connections between the respiratory muscles and the thorax. These disorders are usually characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0021] A range of therapies have been used to treat or ameliorate such conditions. In addition, such therapies can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0022] 2.2.2 Treatment methods

[0023] Various therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV) have been used to treat one or more of the above-mentioned respiratory disorders.

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated by CPAP can be voluntary, so if the patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0025] Non-invasive ventilation (NIV) provides ventilation support to patients through the upper airway to help them breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in the form of OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0026] Non-invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0027] 2.2.3 Treatment system

[0028] These treatments can be provided by a therapeutic system or device.Such systems and devices can also be used to screen, diagnose or monitor a condition without treating it.

[0029] The therapy system may include a respiratory pressure therapy device (RPT device), air circuit, humidifier, patient interface, and data management.

[0030] Another form of treatment system is a mandibular repositioning device.

[0031] 2.2.3.1 Patient interface

[0032] The patient interface can be used to engage the respiratory apparatus to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of ​​the patient's face, for example, to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway.

[0033] Certain other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from high pressure outside, rather than maintaining air at a higher pressure than the environment inside.

[0034] Certain masks may be clinically disadvantageous to the present technology, for example where they block airflow through the nose and only allow it through the mouth.

[0035] Certain masks may be uncomfortable or impractical for the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0036] Certain masks may not be feasible for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0037] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0038] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for long periods of time or when the patient is not familiar with the system. Incorrect mask size can lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with therapy. This is even more true if the mask is worn during sleep.

[0039] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0040] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed for treating sleep-disordered breathing may be suitable for other applications.

[0041] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0042] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0043] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the above-mentioned various therapies, for example by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0044] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0045] An example of a special requirement for certain RPT devices is noise.

[0046] Table of noise output levels of existing RPT devices (a sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0047] RPT device name A-weighted sound pressure level dB(A) Year(approx.) <![CDATA[C series Tango TM > 31.9 2007 <![CDATA[C Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape of the humidifier TM I]]> 31.1 2005 <![CDATA[S9AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0048] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. A ventilator such as the ResMed Stellar TM The range of adult and pediatric ventilators can provide support for invasive and non-invasive independent ventilation for a range of patients for the treatment of a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0049] ResMed Elisée TM 150 ventilator and ResMed VS III TMRespirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and pressure ventilation modes with single-limb or double-limb circuits. RPT devices typically include a pressure generator, such as a blower driven by an electric motor or a compressed gas reservoir, and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as described above via an air circuit.

[0050] The designer of the device may be presented with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0051] 2.2.3.3 Humidifier

[0052] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, which is often applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0053] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of a medical humidifier.

[0054] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to the ambient air when needed, usually where a patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

[0055] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0056] 2.2.3.4 Data Management

[0057] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as if the patient has used their RPT device in accordance with one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate the use over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0058] There are other aspects of patient treatment that may benefit from the communication of treatment data to third parties or external systems.

[0059] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone. 3. Summary of the invention

[0060] The present technology is intended to provide a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0061] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0062] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0063] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0064] One aspect of one form of the present technology is a method of making a device.

[0065] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, a person with limited dexterity and vision, or a person with limited experience using medical devices of this type.

[0066] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (e.g., around the individual's home).

[0067] One aspect of the present technology relates to an apparatus for providing positive pressure air to a patient for respiratory therapy. The apparatus includes a pneumatic block including a chassis assembly configured to support each of a plurality of blower subassemblies, the corresponding mounting plates of the blower subassemblies dividing the pneumatic block into different muffler chambers.

[0068] Another aspect of the present technology relates to a device for providing positive pressure air for respiratory therapy to a patient. The device includes a pneumatic block, which includes at least a first blower subassembly and a second blower subassembly and a common chassis assembly configured to support each of the at least first blower subassembly and the second blower subassembly. The at least first blower subassembly and the second blower subassembly are structurally different from each other in at least one aspect. Each of the at least first blower subassembly and the second blower subassembly includes a corresponding blower configured to generate an air flow at a treatment pressure. The common chassis assembly and the first blower subassembly form a first configuration of the pneumatic block, and the common chassis assembly and the second blower subassembly form a second configuration of the pneumatic block. Each of the first and second configurations of the pneumatic block forms an air flow path extending from a chassis inlet to a chassis outlet. Each of the first and second configurations of the pneumatic block forms a chamber arrangement including a plurality of chambers along the air flow path. The air flow path and the chamber arrangement of the first configuration of the pneumatic block are different from the air flow path and the chamber arrangement of the second configuration of the pneumatic block.

[0069] Another aspect of the present technology relates to an apparatus for providing positive pressure air for respiratory therapy to a patient. The apparatus includes a pneumatic block. The pneumatic block forms a chamber arrangement including a plurality of chambers along an air flow path. In one example, the plurality of chambers are arranged in more than one plane. In one example, at least one chamber extends in a first plane and at least one chamber extends in a second plane vertically spaced apart from the first plane. In one example, the chamber arrangement includes three inlet muffler chambers and one outlet chamber along the air flow path. In one example, one of the three inlet muffler chambers extends in a first plane, and the remaining two of the three inlet muffler chambers and the outlet muffler chamber extend in a second plane vertically spaced apart from the first plane.

[0070] Another aspect of the present technology relates to an apparatus for providing positive pressure air for respiratory therapy to a patient. The apparatus includes a pneumatic block. The pneumatic block forms a chamber arrangement including a plurality of chambers along an air flow path. In one example, the chamber arrangement includes at least one inlet muffler chamber positioned upstream of a blower inlet of a blower and an outlet chamber positioned downstream of a blower outlet of the blower. In one example, the chamber arrangement includes at least two inlet muffler chambers positioned upstream of a blower inlet of a blower and an outlet chamber positioned downstream of a blower outlet of the blower. In one example, the chamber arrangement includes three inlet muffler chambers positioned upstream of a blower inlet of a blower and an outlet chamber positioned downstream of a blower outlet of the blower. In one example, a first of the three inlet muffler chambers receives air from a chassis inlet, and a blower is disposed in a second of the three inlet muffler chambers and receives air from a third of the three inlet muffler chambers at a blower inlet. In one example, the outlet chamber is adapted to communicate with an inlet of a water reservoir for humidification.

[0071] The methods, systems, devices and apparatus described herein can be implemented to improve the functionality of a processor, such as a processor of a dedicated computer, a respiratory monitor and / or a respiratory therapy device. In addition, the methods, systems, devices and apparatus described herein can provide improvements in the art of automated management, monitoring and / or treatment of respiratory conditions including, for example, sleep-disordered breathing.

[0072] Of course, a part of these aspects may form a sub-aspect of the present technology. In addition, each aspect in the sub-aspect and / or aspect may be combined in various ways, and also constitute other aspects or sub-aspects of the present technology.

[0073] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. 4. Description of the drawings

[0074] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0075] 4.1 Treatment system

[0076] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0077] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0078] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying sleeping position.

[0079] 4.2 Respiratory system and facial anatomy

[0080] Figure 2A A schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0081] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0082] 4.3 Patient Interface

[0083] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0084] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3C The curvature magnitude shown is relatively large in comparison.

[0085] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3B The curvature magnitude shown is relatively small in comparison.

[0086] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0087] Figure 3EA schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3F The curvature magnitude shown is relatively small in comparison.

[0088] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0089] Figure 3G A surface is shown having a structure with a one-dimensional hole on the surface. The plane curves shown form the boundaries of the one-dimensional hole.

[0090] Figure 3H Shown through Figure 3G The surface shown is in the cross section of the structure. Figure 3G Two-dimensional holes are defined in the structure.

[0091] Fig. 3I Shows Figure 3G A perspective view of the structure of includes two-dimensional holes and one-dimensional holes. Also shown is the Figure 3G The surface of the two-dimensional holes is defined in the structure.

[0092] 4.4 Respiratory waveform

[0093] Figure 4 A model of a typical breathing waveform of a person while sleeping is shown.

[0094] 4.5RPT device and humidifier

[0095] Figure 5A Shown is an exploded perspective view of an RPT device in accordance with one form of the present technology.

[0096] Figure 5B A perspective view of an RPT device 4000 including an outlet muffler 4124 in accordance with one form of the present technology is shown.

[0097] Figure 5C A perspective view of an RPT device 4000 having an integrated humidifier 5000 including a water reservoir 5110 is shown in accordance with one form of the present technology.

[0098] Figure 5Dis a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0099] Figure 5E is a schematic diagram of the electrical components of an RPT device according to one form of the present technology.

[0100] Fig. 5F is a schematic diagram of an algorithm implemented in a RPT device according to one form of the present technology.

[0101] Figure 5G A schematic diagram of a humidifier according to one form of the present technology is shown.

[0102] Figure 6 is a perspective view of an RPT device having an integrated humidifier including a water reservoir according to an example of the present technology.

[0103] Figure 7 yes Figure 6 Perspective view of an RPT device and integrated humidifier with the water reservoir removed from the reservoir base.

[0104] Figure 8 is a perspective view of a pneumatic block and PCBA according to one example of the present technology.

[0105] Fig. 9 yes Figure 8 Exploded view of the pneumatic block.

[0106] Fig.10 is a bottom view of a top chassis of a chassis assembly according to one example of the present technology.

[0107] Fig.11 yes Fig.10 Bottom perspective view of the top chassis.

[0108] Fig.12 is a top view of a bottom chassis of a chassis assembly according to one example of the present technology.

[0109] Fig.13 yes Fig.12 A top perspective view of the bottom chassis.

[0110] Fig.14 is a cross-sectional view of a chassis assembly according to one example of the present technology.

[0111] Fig.15 is a cross-sectional view of a chassis assembly according to one example of the present technology.

[0112] Fig.16 is a perspective view of a first blower subassembly according to an example of the present technology.

[0113] Fig.17 yes Fig.16 Exploded view of the first blower subassembly.

[0114] Fig.18 is a perspective view of a first blower subassembly with outlet foam according to an example of the present technology.

[0115] Fig.19 is another perspective view of a first blower subassembly having outlet foam according to an example of the present technology.

[0116] Fig. 20 is a perspective view showing the assembly of the inlet foam, outlet foam, and first blower subassembly to the bottom chassis of the chassis assembly according to one example of the present technology.

[0117] Fig.21 is another perspective view showing the assembly of a first blower subassembly to a bottom chassis of a chassis assembly according to one example of the present technology.

[0118] Fig. 22 is a perspective view showing the assembly of a top chassis to a bottom chassis with a first blower subassembly according to one example of the present technology.

[0119] Fig.23 is a perspective view showing a bottom chassis with a first blower subassembly according to one example of the present technology.

[0120] Fig.24 is a perspective view showing the assembly of a PCBA to a chassis assembly according to one example of the present technology.

[0121] Fig.25 is a side view showing air entering a pneumatic block via an inlet opening according to one example of the present technology.

[0122] Fig.26 is a cross-sectional view showing air circulating within a first inlet muffler chamber of a pneumatic block according to one example of the present technology.

[0123] Fig. 27 is a cross-sectional view showing air circulating within a second inlet muffler chamber of a pneumatic block according to one example of the present technology.

[0124] Fig.28 is a cross-sectional view showing air circulating within a third inlet muffler chamber of a pneumatic block according to one example of the present technology.

[0125] Fig.29 is a cross-sectional view showing air passing through a blower and entering and exiting an outlet chamber of a pneumatic block according to one example of the present technology.

[0126] Fig.30 is a cross-sectional view of a complete pneumatic block including a first blower subassembly and a protruding outlet chamber according to an example of the present technology.

[0127] Fig.31 is another cross-sectional view of a complete pneumatic block including a first blower subassembly according to an example of the present technology.

[0128] Fig.32 is another cross-sectional view of a complete pneumatic block including a first blower subassembly according to an example of the present technology.

[0129] Fig.33 is another cross-sectional view of a complete pneumatic block including a first blower subassembly according to an example of the present technology.

[0130] Fig.34 is a perspective view of a second blower subassembly according to an example of the present technology.

[0131] Fig.35 yes Fig.34 Exploded view of the second blower subassembly.

[0132] Fig.36 is an exploded view of a blower and suspension of a second blower subassembly according to an example of the present technology.

[0133] Fig.37 is another perspective view of a second blower subassembly according to an example of the present technology.

[0134] Fig.38 is another perspective view of a second blower subassembly according to an example of the present technology.

[0135] Fig.39 is a perspective view showing the assembly of a second blower subassembly to a bottom chassis of a chassis assembly according to one example of the present technology.

[0136] Fig.40 is a perspective view showing the assembly of a top chassis to a bottom chassis with a second blower subassembly according to one example of the present technology.

[0137] Fig.41 is a perspective view showing the assembly of a PCBA to a chassis assembly according to one example of the present technology.

[0138] Fig.42is a cross-sectional view showing a complete pneumatic block including a second blower subassembly according to one example of the present technology.

[0139] Fig.43 is a cross-sectional view showing air circulating within a first inlet muffler chamber of a pneumatic block according to one example of the present technology.

[0140] Fig.44 is a cross-sectional view showing air circulating within a second inlet muffler chamber of a pneumatic block according to one example of the present technology.

[0141] Fig.45 is a cross-sectional view showing air passing through a blower and entering and exiting an outlet chamber of a pneumatic block according to one example of the present technology.

[0142] Fig.46 is a cross-sectional view of a complete pneumatic block including a second blower subassembly and a protruding outlet chamber according to an example of the present technology.

[0143] Fig.47 is another cross-sectional view of a complete pneumatic block including a second blower subassembly according to an example of the present technology.

[0144] Fig.48 is another cross-sectional view of a complete pneumatic block including a second blower subassembly according to an example of the present technology.

[0145] Fig.49 is a cross-sectional view showing the arrangement of a flow sensor according to one example of the present technology.

[0146] Fig.50 is a bottom view of a top chassis of a chassis assembly showing flow ports and pressure ports according to an example of the present technology.

[0147] Fig.51 is a cross-sectional view showing the arrangement of a pressure sensor according to an example of the present technology.

[0148] Fig.52 is a cross-sectional view showing a sealing portion for a flow sensor according to an example of the present technology.

[0149] Fig.53 is a cross-sectional view showing a sealing portion for a flow sensor according to another example of the present technology.

[0150] Fig.54 is a perspective view of a chassis assembly and a pressure sensor seal according to an example of the present technology.

[0151] Fig.55 FIG. 1 is a diagram showing a chassis assembly connected to an example according to the present technology. Fig.54 Cross-sectional view of the pressure sensor seal.

[0152] Fig.56 FIG. 1 is a diagram showing a chassis assembly connected to an example according to the present technology. Fig.54 Cross-sectional view of the pressure sensor seal and PCBA of the pressure sensor.

[0153] Fig.57 is a schematic diagram showing a first configuration of a pneumatic block according to an example of the present technology.

[0154] Fig.58 It passes through Fig.57 Schematic diagram of a first plane of a first configuration of the pneumatic block.

[0155] Fig.59 It passes through Fig.57 Schematic diagram of a second plane of a first configuration of the pneumatic block.

[0156] Fig.60 is a schematic diagram showing a second configuration of a pneumatic block according to an example of the present technology.

[0157] Fig.61 It passes through Fig.60 Schematic diagram of a first plane of a second configuration of the pneumatic block. 5. Specific implementation methods

[0158] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may be varied. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0159] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features may constitute another example.

[0160] 5.1 Treatment

[0161] In one form, the present technology includes a method for treating a breathing disorder, the method comprising the step of applying positive pressure to an airway entrance of a patient 1000 .

[0162] In certain examples of the present technology, a supply of air under positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0163] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0164] 5.2 Treatment system

[0165] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000, see, Figures 1A to 1C .

[0166] 5.3 Patient Interface

[0167] Figure 3A A non-invasive patient interface 3000 according to one aspect of the present technology is shown, which includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. When in use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of air under positive pressure to the airway.

[0168] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0169] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 6 cmH2O relative to ambient.

[0170] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 10 cmH2O relative to ambient.

[0171] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 20 cmH20 relative to ambient.

[0172] 5.4 RPT device

[0173] Figure 5A An exploded view of an RPT device 4000 according to one aspect of the present technology is shown. The RPT device 4000 may include mechanical, pneumatic, and / or electrical components and be configured to execute one or more algorithms. The RPT device 4000 may be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0174] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0175] The RPT device 4000 may include an external housing having one or more panels (e.g., a main panel 4010, a front panel 4012, and side panels 4014). Figure 5A and 5B As shown, the RPT device 4000 may also include an outlet muffler 4124. The outlet muffler 4124 may be removable and replaced with a water reservoir 5110 (see Figure 5C ). In this form, the RPT device 4000 may be considered to include an integrated humidifier 5000. Thus, the RPT device 4000 may be used with or without humidification, depending on whether a water reservoir 5110 or an outlet muffler 4124 is attached, respectively. Preferably, the RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. In one form, the RPT device 4000 includes a pressure generator 4140, which may be housed in a pneumatic block 4020 coupled to the chassis 4016.

[0176] Further examples and details of exemplary RPT devices are described in PCT Publication No. WO 2015 / 089582, which is incorporated herein by reference in its entirety.

[0177] The pneumatic path of the RPT device 4000 (e.g., Figure 5D 41) may include an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (preferably a blower 4142) capable of supplying air at a positive pressure, and an outlet muffler 4124 (or a water reservoir 5110 if humidification is required). One or more transducers 4270, such as pressure sensors and flow sensors, may be included in the pneumatic path. The pneumatic path may also include an anti-spillback valve 4160 to prevent water from the humidifier 5000 from overflowing back into the electrical components of the RPT device 4000.

[0178] As shown in Figure 5E, the RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 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 (e.g., see Figure 5A). In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0179] 5.4.1 Mechanical and pneumatic components of the RPT device

[0180] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be provided as separate units.

[0181] 5.4.1.1 Air filter

[0182] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0183] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0184] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0185] 5.4.1.2 Silencer

[0186] An RPT device according to one form of the present technology may include a silencer 4120 , or a plurality of silencers 4120 .

[0187] In one form of the present technology, the inlet muffler 4122 is positioned in the pneumatic path upstream of the pressure generator 4140 .

[0188] In one form of the present technology, an outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0189] 5.4.1.3 Pressure generator

[0190] In one form of the present technology, the pressure generator 4140 for generating an air flow or air supply under positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be positioned in a volute. The blower may deliver an air supply, for example, at a rate of up to about 120 liters per minute and at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and U.S. Patent Application Publication No. WO 2013 / 020167.

[0191] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0192] In other words, the pressure generator 4140 may be a piston driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0193] 5.4.1.4 Converter

[0194] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be located, for example, on or form part of an air circuit such as a patient interface. An 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.

[0195] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal representative of a characteristic of the air flow (e.g., flow, pressure, or temperature at that point in the pneumatic path).

[0196] In one form of the present technology, one or more transducers 4270 may be positioned proximal to the patient interface 3000 .

[0197] In one form, the signal from converter 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0198] 5.4.1.4.1 Flow sensor

[0199] A flow sensor according to the present technology may be based on a differential pressure transducer 4274, such as the SDP600 series differential pressure transducer from SENSIRION.

[0200] In one form, a signal representing flow from flow sensor 4274 may be received by the central controller 4230.

[0201] 5.4.1.4.2 Pressure sensor

[0202] A pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the ASDX series of HONEYWELL. An alternative suitable pressure sensor is a transducer from the NPA series of GENERALELECTRIC.

[0203] In one form, signals from the pressure sensors may be received by the central controller 4230 .

[0204] 5.4.1.4.3 Motor speed converter

[0205] In one form of the present technology, a motor speed converter is used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed converter 4276 may be provided to the treatment device controller 4240. The motor speed converter 4276 may be, for example, a speed sensor such as a Hall effect sensor.

[0206] 5.4.1.5 Anti-overflow valve

[0207] In one form of the present technology, an anti-spillback valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to the motor 4144, for example.

[0208] 5.4.2 RPT device electrical components

[0209] 5.4.2.1 Power supply

[0210] The power source 4210 may be positioned inside or outside of the outer housing 4010 of the RPT device 4000 .

[0211] In one form of the present technology, power supply 4210 provides power only to RPT device 4000. In another form of the present technology, power supply 4210 provides power to both RPT device 4000 and humidifier 5000.

[0212] 5.4.2.2 Input device

[0213] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessed via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, may be in wireless communication with a receiver that is electrically connected to a central controller 4230.

[0214] In one form, input device 4220 may be constructed or arranged to allow a person to select values ​​and / or menu options.

[0215] 5.4.2.3 Central Controller

[0216] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0217] Suitable processors may include x86 Intel processors, A processor of a processor such as the STM32 series microcontroller from ST MICROELECTRONIC. In some alternative forms of the present technology, a 32-bit RISC CPU such as the STR9 series microcontroller from ST MICROELECTRONICS, or a 16-bit RISC CPU such as the MSP430 series microcontroller from TEXAS INSTRUMENTS may also be suitable.

[0218] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0219] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0220] The central controller 4230 may be configured to receive input signals from one or more converters 4270 , one or more input devices 4220 , and the humidifier 5000 .

[0221] The central controller 4230 may be configured to provide output signals to one or more output devices 4290 , the treatment device controller 4240 , the data communication interface 4280 , and the humidifier 5000 .

[0222] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as computer programs stored in a non-transitory computer readable storage medium such as memory 4260. In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some of the methods may be performed by a remotely located device. For example, the remotely located device may determine a control set point for the ventilator or detect a breathing-related event by analyzing stored data such as from any of the sensors described herein.

[0223] 5.4.2.4 Clock

[0224] The RPT device 4000 may include a clock connected to the central controller 4230 .

[0225] 5.4.2.5 Treatment device controller

[0226] In one form of the present technology, the treatment device controller 4240 is a treatment control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0227] In one form of the present technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0228] 5.4.2.6 Protection circuit

[0229] One or more protection circuits 4250 in accordance with the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0230] 5.4.2.7 Memory

[0231] According to one form of the present technology, the RPT device 4000 includes memory 4260, such as non-volatile memory. In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0232] Memory 4260 may be located on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash memory.

[0233] Additionally or alternatively, the RPT device 4000 includes memory 4260 in a removable form, such as a memory card made in accordance with the Secure Digital (SD) standard.

[0234] In one form of the present technology, the memory 4260 serves as a non-transitory computer-readable storage medium on which are stored computer program instructions representing one or more of the methods described herein, such as one or more algorithms 4300 .

[0235] 5.4.2.8 Data Communication System

[0236] In one form of the present technology, a data communication interface 4280 is provided and connected to the central controller 4230. The data communication interface 4280 may be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connected to a remote external device 4286. The local external communication network 4284 may be connected to a local external device 4288.

[0237] In one form, the data communications interface 4280 is part of the central controller 4230. In another form, the data communications interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0238] In one form, remote external communication network 4282 is the Internet. Data communication interface 4280 may be connected to the Internet using wired communication (eg, via Ethernet or fiber optic) or wireless protocols (eg, CDMA, GSM, LTE).

[0239] In one form, the local external communications network 4284 utilizes one or more communications standards, such as Bluetooth or consumer infrared protocols.

[0240] In one form, the remote external device 4286 can be one or more computers, such as a cluster of network computers. In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by appropriately authorized personnel (such as a clinician).

[0241] The local external device 4288 may be a personal computer, a mobile phone, a tablet or a remote control device.

[0242] 5.4.2.9 Output devices including optional displays and alarms

[0243] Output devices 4290 according to the present technology may take the form of one or more of visual, audio, and tactile units.The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0244] 5.4.2.9.1 Display Driver

[0245] The display driver 4292 receives as input characters, symbols, or images for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0246] 5.4.2.9 Display

[0247] 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 eight-segment display, in which case the display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals indicating whether the eight corresponding segments are to be activated to display the particular character or symbol.

[0248] 5.4.3RPT device algorithm

[0249] As described above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 expressed as computer programs stored in a non-transitory computer-readable storage medium (e.g., memory 4260). The algorithms 4300 are generally grouped into groups called modules, see, e.g., Fig. 5F .

[0250] 5.4.3.1 Preprocessing Module

[0251] A pre-processing module 4310 according to one form of the present technology receives as input a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) and performs one or more processing steps to calculate one or more output values ​​to be used as input to another module (e.g., a treatment engine module 4320).

[0252] In one form of the present technology, the output values ​​include interface or mask pressure Pm, respiratory flow Qr and leak flow Ql.

[0253] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: pressure compensation 4312 , ventilation flow estimation 4314 , leak flow estimation 4316 , and respiratory flow estimation 4318 .

[0254] 5.4.3.1.1 Pressure compensation

[0255] In one form of the present technology, the pressure compensation algorithm 4312 receives as input a signal indicative of the pressure in the pneumatic path proximal to the pneumatic block outlet. The pressure compensation algorithm 4312 estimates the pressure drop through the air circuit 4170 and provides as output an estimated pressure Pm in the patient interface 3000.

[0256] 5.4.3.1.2 Ventilation Flow Estimation

[0257] In one form of the present technology, the ventilation flow estimation algorithm 4314 receives as input an estimated pressure Pm in the patient interface 3000 and estimates a ventilation flow Qv of air from the vent 3400 in the patient interface 3000 .

[0258] 5.4.3.1.3 Leakage flow estimation

[0259] In one form of the present technology, the leak flow estimation algorithm 4316 receives the total flow Qt and the ventilation flow Qv as inputs and provides an estimate of the leak flow Ql as output. In one form, the leak flow estimation algorithm estimates the leak flow Ql by averaging the difference between the total flow Qt and the ventilation flow Qv over a period of time long enough to include several respiratory cycles (e.g., about 10 seconds).

[0260] In one form, the leak flow estimation algorithm 4316 receives as input the total flow Qt, the ventilation flow Qv, and the estimated pressure Pm in the patient interface 3000, and provides as output a leak flow Ql by calculating a leak conductance and determining the leak flow 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 non-ventilation flow equal to the difference between the total flow Qt and the ventilation flow Qv and the low-pass filtered square root of the pressure Pm, where the low-pass filter time constant has a value long enough to include several respiratory cycles (e.g., about 10 seconds). The leak flow Ql can be estimated as the product of the leak conductance and the pressure Pm function.

[0261] 5.4.3.1.4 Respiratory flow estimation

[0262] In one form of the present technology, the respiratory flow estimation algorithm 4318 receives as input the total flow Qt, the ventilation flow Qv, and the leak flow Ql, and estimates the air respiratory flow Qr to the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.

[0263] 5.4.3.2 Treatment Engine Module

[0264] In one form of the present technology, therapy engine module 4320 receives as input one or more of pressure Pm in patient interface 3000 and air respiratory flow Qr to the patient, and provides as output one or more therapy parameters.

[0265] In one form of the present technology, the treatment parameter is the treatment pressure Pt.

[0266] In one form of the present technology, the therapy parameter is one or more of pressure amplitude, basal pressure, and target ventilation.

[0267] In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328 and therapy parameter determination 4329.

[0268] 5.4.3.2.1 Phase determination

[0269] In one form of the present technology, the RPT device 4000 is phase indeterminate.

[0270] In one form of the present technology, the phase determination algorithm 4321 receives as input a signal indicative of respiratory flow Qr and provides as output the phase Φ of the current respiratory cycle of the patient 1000.

[0271] In some forms, referred to as discrete phase determination, the phase output Φ is a discrete variable. One embodiment of discrete phase determination provides a two-value phase output Φ having an inspiratory or expiratory value upon detection of the onset of spontaneous inspiration and expiration, respectively, such as values ​​represented as 0 and 0.5 revolutions, respectively. An RPT device 4000 that performs "triggering" and "cycling" effectively performs discrete phase determination because the trigger and cycle points are the moments of phase change from exhalation to inspiration and from inspiration to exhalation, respectively. In one embodiment of two-value phase determination, when the respiratory flow Qr has a value exceeding a positive threshold, the phase output Φ is determined to have a discrete value of 0 (thereby "triggering" the RPT device 4000), and when the respiratory flow Qr has a value more negative than a negative threshold, the phase output Φ is determined to have a discrete value of 0 (thereby "cycling" the RPT device 4000). The inspiratory time Ti and the expiratory time Te can be estimated as typical values ​​over many respiratory cycles of the time spent with the phase equal to 0 (indicating inspiration) and 0.5 (indicating exhalation), respectively.

[0272] Another embodiment of discrete phase determination provides a three-valued phase output Φ having a value of one of inspiration, mid-inspiratory pause, and expiration.

[0273] In other forms referred to as continuous phase determination, the phase output Φ is a continuous value, such as varying from 0 to 1 turn or 0 to 2p radians. The RPT device 4000 performing continuous phase determination can trigger and cycle when the continuous phase reaches 0 and 0.5 turns, respectively. In one embodiment of continuous phase determination, fuzzy logic analysis of the respiratory flow Qr is used to determine the continuous value of the phase Φ. The continuous value of the phase determined in this embodiment is generally referred to as a "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow Qr:

[0274] 1. If the respiratory flow is zero and increases rapidly, the phase is 0 turns.

[0275] 2. If the respiratory flow is largely positive and stable, the phase is 0.25 turns.

[0276] 3. If the respiratory flow is zero and decreases rapidly, the phase is 0.5 turns.

[0277] 4. If the respiratory flow is largely negative and stable, the phase is 0.75 turns.

[0278] 5. If the respiratory flow is zero and stable and the 5-second low-pass filtered absolute value of the respiratory flow is large, the phase is 0.9 turns.

[0279] 6. If the respiratory flow is positive and it is the exhalation phase, the phase is 0 revolutions.

[0280] 7. If the respiratory flow is negative and it is the inspiratory phase, the phase is 0.5 turns.

[0281] 8. If the absolute value of a 5 second low pass filter of the respiratory flow is large and the phase increases at a steady rate equal to the patient's respiratory rate, then the low pass filter has a time constant of 20 seconds.

[0282] The output of each rule can be represented as a vector whose phase is the result of the rule and whose magnitude is the ambiguity of the rule being true. The ambiguity of respiratory flow "large", "stable", etc. is determined using appropriate membership functions. The results of the rules, represented as vectors, are then combined by some function, such as taking the centroid. In such a combination, the rules can be weighted equally, or differently.

[0283] In another embodiment of continuous phase determination, the phase Φ is first estimated discretely from the respiratory flow Qr as described above, as are the inspiratory time Ti and the expiratory time Te. The continuous phase Φ at any time can be determined as half of the proportion of the inspiratory time Ti that has passed since the previous trigger time, or 0.5 turns plus half of the proportion of the expiratory time Te that has passed since the previous cycle time (whichever is newer).

[0284] 5.4.3.2.2 Waveform determination

[0285] In one form of the present technology, the therapy parameter determination algorithm 4329 provides an approximately constant therapy pressure throughout the patient's breathing cycle.

[0286] In other forms of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapy pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ).

[0287] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) with a value in the range of [0,1] over the domain of the phase value Φ provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0288] In one form applicable to discrete or continuous valued phases, the waveform template Π(Φ) is a square wave template having a value of 1 for phase values ​​up to and including 0.5 turns, and having a value of 0 for phase values ​​above 0.5 turns. In one form applicable to continuous valued phases, the waveform template Π(Φ) includes two smoothly curved portions, namely a smoothly curved (e.g., raised cosine) rise from 0 to 1 for phase values ​​up to 0.5 turns, and a smoothly curved (e.g., exponential) decay from 1 to 0 for phase values ​​above 0.5 turns. In one form applicable to continuous valued phases, the waveform template Π(Φ) is based on a square wave, but has a smooth rise from 0 to 1 for phase values ​​up to a "rise time" of less than 0.5 turns, and smoothly falls from 1 to 0 for phase values ​​within a "fall time" of less than 0.5 turns after 0.5 turns.

[0289] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates based on the set value of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table of value Π relative to phase value Φ. In other forms, the waveform determination algorithm 4322 calculates a "real-time" waveform template Π(Φ) using a predetermined functional form that may be parameterized by one or more parameters (e.g., a time constant of an exponential curve portion). The parameters of the functional form may be predetermined or depend on the current state of the patient 1000.

[0290] In some forms of the present technology applicable to discrete two-valued phases for inspiration (Φ=0 turns) or exhalation (Φ=0.5 turns), the waveform determination algorithm 4322 calculates a "real-time" waveform template P as a function of both the discrete phase Φ and the 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) in both parts (inspiration and exhalation) as follows:

[0291]

[0292] where Π i (t) and Π e (t) is the inspiratory and expiratory portion of the waveform template Π(Φ,t). In one such form, the inspiratory portion of the waveform template Π i (t) is a smooth rise from 0 to 1 parameterized by the rise time, and the exhalation part of the waveform template Π e(t) is a smooth decline from 1 to 0 parameterized by the fall time.

[0293] 5.4.3.2.3 Ventilation volume determination

[0294] In one form of the present technique, the ventilation volume determination algorithm 4323 receives the respiratory flow Qr as an input and determines a measured value indicating the current patient ventilation volume Vent.

[0295] In some embodiments, the ventilation volume determination algorithm 4323 determines a measured value of the ventilation volume Vent, which is an estimate of the actual patient ventilation volume. One such embodiment is to filter half of the absolute value of the respiratory flow Qr optionally by a low-pass filter (such as a second-order Bessel low-pass filter with an angular frequency of 0.11 Hz).

[0296] In other embodiments, the ventilation volume determination algorithm 4323 determines a measured value of the ventilation volume Vent, which is approximately proportional to the actual patient ventilation volume. One such embodiment estimates the peak respiratory flow Qpeak during the inspiratory portion of the cycle. This and many other procedures involving sampling the respiratory flow Qr produce measured values that are approximately proportional to the ventilation volume, provided that the flow waveform shape does not vary greatly (here, when the flow waveforms of normal breaths in terms of time and amplitude are similar, the shapes of two breaths are considered similar). Some simple examples include the median of the respiratory flow being positive, the median of the absolute value of the respiratory flow, and the standard deviation of the flow. Any linear combination of any order statistics of the absolute value of the respiratory flow using positive coefficients, and even some that use both positive and negative coefficients simultaneously, is approximately proportional to the ventilation volume. Another example is the average of the respiratory flow at the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. If the flow shape remains constant, there can be any number of measured values that are exactly proportional to the ventilation volume.

[0297] 5.4.3.2.4 Inspiratory flow limit determination

[0298] In one form of the present technique, the central controller 4230 executes an inspiratory flow limit determination algorithm 4324 for determining the degree of inspiratory flow limit.

[0299] In one form, the inspiratory flow limit determination algorithm 4324 receives the respiratory flow signal Qr as an input and provides as an output a measure of the degree of inspiratory flow limit exhibited by the inspiratory portion of the breath.

[0300] In one form of the present technology, the inspiratory portion of each breath is identified by a zero crossing detector. A number of evenly spaced points (e.g., sixty-five) representing the time points are interpolated along the inspiratory flow-time curve for each breath by an interpolator. The curve described by the points is then scaled by a scaler to have unit length (duration / cycle) and unit area to remove the effects of changing breathing rate and depth. The scaled breath is then compared in a comparator to a graph representing a flow rate similar to Figure 6 . As determined by the test element, breaths from this template that deviate from a specified threshold (usually 1 scaling unit) at any time during inspiration due to coughing, sighing, swallowing, and hiccups are rejected. For data that are not rejected, the moving average of the first such scaling point is calculated by the central controller 4230 for several preceding inspiratory events. This is repeated for the second such point on the same inspiratory event, and so on. Thus, for example, sixty-five scaling data points are generated by the central controller 4230, and these data points represent the moving average of several preceding inspiratory events, such as three events. The moving average of the continuously updated values ​​of (e.g., sixty-five) points is hereinafter referred to as "scaled flow", named Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average.

[0301] From the scaled flow, two shape factors relevant to determining partial blockage can be calculated.

[0302] Shape Factor 1 is the ratio of the average of the middle (e.g., thirty-two) scaled flow points to the average overall (e.g., sixty-five) scaled flow points. If this ratio exceeds 1, the breath will be considered normal. If the ratio is 1 or less, the breath will be considered obstructed. A ratio of about 1.17 is considered the threshold between partially obstructed and unobstructed breaths and is equivalent to a degree of obstruction that will allow adequate oxygenation to be maintained in a typical patient.

[0303] Shape Factor 2 is calculated as the RMS deviation from unit scaled flow taken at an intermediate (e.g., thirty-two) point. An RMS deviation of about 0.2 units is considered normal. A zero RMS deviation is considered a completely flow-restricted breath. The closer the RMS deviation is to zero, the more flow-restricted the breath will be considered.

[0304] Form factors 1 and 2 may be used as alternatives or in combination. In other forms of the present technology, the number of sampling points, the number of breaths, and the number of intermediate points may be different from those described above. Furthermore, the thresholds may be different from those described.

[0305] 5.4.3.2.5 Determination of apnea and hypopnea

[0306] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0307] The apnea / hypopnea determination algorithm 4325 receives as input the respiratory flow signal Qr and provides as output a flag indicating that an apnea or hypopnea has been detected.

[0308] In one form, when the function of respiratory flow Qr falls below a flow threshold for a predetermined period of time, apnea may be considered detected. The function may determine a peak flow, a relatively short-term average flow, or an intermediate flow of a relatively short-term average flow and a peak flow (e.g., RMS flow). The flow threshold may be a measure of a relatively long-term flow.

[0309] In one form, when the function of respiratory flow Qr falls below a second flow threshold within a predetermined time period, hypopnea may be detected. The function may determine a peak flow, a relatively short-term average flow, or an intermediate flow of a relatively short-term average flow and a peak flow (e.g., RMS flow). The second flow threshold may be a measure of a relatively long-term flow. The second flow threshold is greater than a flow threshold for detecting apnea.

[0310] 5.4.3.2.6 Snoring Determination

[0311] In one form of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the level of snoring.

[0312] In one form, the snoring determination algorithm 4326 receives as input a signal of respiratory flow Qr and provides as output a measure of the degree to which snoring is present.

[0313] The snore determination algorithm 4326 may include a step of determining the flow signal strength in the range of 30 to 300 Hz. In addition, the snore determination algorithm 4326 may include a step of filtering the signal of the respiratory flow Qr to reduce background noise (eg, the sound of air flow from a blower in the system).

[0314] 5.4.3.2.7 Determination of airway patency

[0315] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining airway patency.

[0316] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the power of the signal within a frequency range of about 0.75 Hz and about 3 Hz. The presence of a peak in this frequency range is considered to indicate an open airway. The absence of a peak is considered to be an indication of a closed airway.

[0317] In one form, the frequency range in which the peak is sought is the frequency of a small forced oscillation in the process pressure Pt. In one embodiment, the forced oscillation has a frequency of 2 Hz and an amplitude of approximately 1 cmH2O.

[0318] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is considered indicative of airway closure.

[0319] 5.4.3.2.8 Determination of target ventilation

[0320] In one form of the present technology, the central controller 4230 takes as input a measured value of the current ventilation Vent and executes one or more target ventilation determination algorithms 4328 to determine a target value Vtgt for the measured ventilation.

[0321] In some forms of the present technology, there is no target ventilation determination algorithm 4328 and the target value Vtgt is predetermined, for example by hard coding during configuration of the RPT device 4000 or by manual entry via the input device 4220.

[0322] In other forms of the present technology, such as adaptive servo-ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.

[0323] In some forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as a high proportion of the typical recent ventilation Vtyp but less than Vtyp. The high proportion in such forms may be in the range of (80%, 100%), or (85%, 95%), or (87%, 92%).

[0324] In other forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated to be slightly greater than a multiple of the typical recent ventilation Vtyp.

[0325] The typical recent ventilation Vtyp is the value around which the distribution of the current ventilation Vent measurements at multiple moments within some predetermined time scale tends to cluster, that is, a measure of the central tendency of the current ventilation measurements in the recent history. In one embodiment of the target ventilation determination algorithm 4328, the recent history is on the order of a few minutes, but in any case should be longer than the time scale of the tidal increase and decrease cycle. The target ventilation determination algorithm 4328 can use a variety of known central tendency measures to determine the typical recent ventilation Vtyp from the current ventilation Vent measurements. One such measurement is the output of a low pass filter on the current ventilation Vent measurements, with a time constant equal to 100 seconds.

[0326] 5.4.3.2.9 Treatment parameter determination

[0327] In some forms of the present 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.

[0328] In one form of the present technology, the treatment parameter is the instantaneous treatment pressure Pt. In one embodiment of this form, the treatment parameter determination algorithm 4329 determines the treatment pressure Pt using the formula

[0329] Pt=AΠ(Φ,t)+P0 (1)

[0330] in:

[0331] A is the amplitude,

[0332] Π(Φ,t) is the waveform template value (in the range 0 to 1) at the current value of phase Φ and time t, and

[0333] P0 is the base pressure.

[0334] If the waveform determination algorithm 4322 provides the waveform template Π(Φ,t) as a numerical Π lookup table indexed by phase Φ, the treatment parameter determination algorithm 4329 applies formula (1) by locating the nearest lookup table entry to the phase current value Φ returned by the phase determination algorithm 4321, or by interpolating across two entries of the phase current value Φ.

[0335] Depending on the selected respiratory pressure therapy mode, the values ​​of amplitude A and basal pressure P0 may be set by therapy parameter determination algorithm 4329 in the following manner.

[0336] 5.4.3.3 Treatment Control Module

[0337] The therapy control module 4330 according to one aspect of the present technology receives therapy parameters as input from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver air flow in accordance with the therapy parameters.

[0338] In one form of the present technology, the therapy parameter is a therapy pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver an air flow with a mask pressure Pm at the patient interface 3000 equal to the therapy pressure Pt.

[0339] 5.4.3.4 Fault Condition Detection

[0340] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detecting a fault condition. The fault condition detected by the one or more methods 4340 may include at least one of the following:

[0341] Power failure (no power, or insufficient power)

[0342] Converter fault detection

[0343] Unable to detect the presence of parts

[0344] Operating parameters outside the recommended range (e.g. pressure, flow, temperature, PaO2)

[0345] The test alarm fails to produce a detectable alarm signal.

[0346] Upon detecting a fault condition, the corresponding algorithm 4340 signals the presence of a fault by one or more of the following:

[0347] Activate audible, visual and / or dynamic (e.g. vibration) alarms

[0348] Send messages to external devices

[0349] Recording events

[0350] 5.5 Air circuit

[0351] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that, when in use, is constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000 .

[0352] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0353] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0354] 5.5.1 Oxygen delivery

[0355] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , the air circuit 4170 , and / or the patient interface 3000 .

[0356] 5.6 Humidifier

[0357] 5.6.1 Overview of Humidifier

[0358] In one form of the present technology, a humidifier 5000 (e.g., Figure 5C ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0359] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet for receiving an air flow, and a humidifier outlet for delivering a humidified air flow. The humidifier 5000 may also include a humidifier base, which may be adapted to receive the humidifier reservoir and include a heating element.

[0360] 5.6.2 RPT device and humidifier

[0361] Figures 6 to 8 A humidifier 6000 according to an example of the present technology is shown. As shown, the humidifier 6000 includes a reservoir dock 6050 constructed and arranged to accommodate a water reservoir 6100. In the example shown, the humidifier 6000 is integrated with the RPT device 7000, such that the pneumatic block 7100 of the RPT device 7000 includes components that perform the functions of the RPT device 7000 and components that perform the functions of the humidifier 6000. For example, Figure 8As shown, the reservoir base 6050 is integrated with the pneumatic block 7100 of the RPT device to provide an integral unit, and the reservoir base 6050 is constructed and arranged to accommodate the water reservoir 6100.

[0362] It should be understood that the humidifier 6000 (eg, the reservoir base 6050) can be provided in an alternative arrangement separately from the RPT device 7000. In such an arrangement, an additional interface can be used to connect the humidifier 6000 (eg, the reservoir base 6050) to the RPT device 7000.

[0363] See for example Fig.30 and Fig.46 , the RPT device 7000 includes a blower 7200B1 or 7200B2 supported within the pneumatic block 7100. Each blower is constructed and arranged to generate a positive pressure (e.g., about 2 to 50 cmH2O) air flow or air supply. Each blower is operable to draw the air supply through one or more inlet openings in the pneumatic block into the pneumatic block 7100 and its inlet (blower inlet), and provide a pressurized air supply at the outlet (blower outlet). The blower outlet is connected to the humidifier 6000 (e.g., the inlet of the water reservoir 6100).

[0364] The pneumatic block 7100 according to one example of the present technology is configured and arranged to support different blowers, for example, depending on the desired treatment. In the illustrated example, see, for example Fig.30 and Fig.46 , the pneumatic block 7100 is configured and arranged to support a selected one of at least two different blowers 7200B1 or 7200B2. For example, the pneumatic block 7100 can be configured and arranged to support a first type of blower 7200B1, for example, configured for CPAP or APAP therapy; and the pneumatic block 7100 can be configured and arranged to support a second type of blower 7200B2, for example, configured for bi-level therapy. However, it should be understood that the pneumatic block 7100 can be configured and arranged to support a selected one or more than two different blowers. In one instance, each blower can include a single-stage design or a multi-stage design, for example, a two-stage or more stage design.

[0365] Pneumatic block

[0366] like Figures 34 to 38As shown, the pneumatic block 7100 includes a chassis assembly 7300, which includes an upper or top chassis 7300T (also referred to as an upper or top housing) and a lower or bottom chassis 7300B (also referred to as a lower or bottom housing). The chassis assembly 7300 includes a chassis inlet 7310, for example, located in the bottom chassis 7300B, and a chassis outlet 7320, for example, located in the top chassis 7300T. In one example, see, for example, Figures 6 to 7 , an external housing 8002 including one or more panels and / or one or more user inputs / displays may enclose the pneumatic block 7100 .

[0367] The chassis assembly 7300 supports and / or houses the internal components of the pneumatic block 7100, which includes, for example, a selected blower subassembly 7400SUB1 or 7400SUB2 (each including a blower 7200B1 or 7200B2 and a corresponding support structure 7500SS1 or 7500SS2) depending on the desired treatment. The chassis assembly 7300 also supports a printed circuit board assembly (PCBA) 7600.

[0368] The chassis assembly 7300 cooperates with multiple internal components of the pneumatic block (e.g., multiple selected blower subassemblies 7400SUB1 or 7400SUB2) to form a pneumatic air flow path that extends from the chassis inlet 7310 to the blower inlet of the blower 7200B1 or 7200B2 and from the blower outlet of the blower 7200B1 or 7200B2 to the chassis outlet 7320.

[0369] As described below, the pneumatic air flow path includes a tortuous path that may extend in more than one plane from chassis inlet 7310 to chassis outlet 7320. The pneumatic air flow path may vary, for example, depending on the blower subassembly 7400SUB1 or 7400SUB2 selected to be supported within chassis assembly 7300.

[0370] Additionally, chassis assembly 7300 and internal components of the pneumatic block (eg, selected blower subassembly 7400SUB1 or 7400SUB2) cooperate to form multiple chambers along the air flow path, thereby, for example, reducing the noise output of the RPT device 7000.

[0371] Chassis components

[0372] The top chassis 7300T and the bottom chassis 7300B are connected to each other to form an aerodynamic block cavity 7350. The aerodynamic block cavity 7350 is constructed and arranged to support the selected blower subassembly 7400SUB1 or 7400SUB2.

[0373] In addition, the top chassis 7300T and the bottom chassis 7300B are connected to each other to form a reservoir base 6050 which is configured to accommodate the water reservoir 6100.

[0374] like Fig.14 and 15 As best shown in FIG. 7 , the top chassis 7300T includes a pneumatic block portion 7350T that forms a top portion of the pneumatic block cavity 7350 and a base portion 6050T that forms a portion of the reservoir base 6050. Fig.12 , 13 As best shown in FIGS. 14 and 15 , the bottom chassis 7300B includes a pneumatic block portion 7350B forming a bottom portion of the pneumatic block cavity 7350 and a base portion 6050B forming a portion of the reservoir base 6050 .

[0375] In the example shown, the top chassis 7300T and the bottom chassis 7300B include the same material. For example, the top chassis 7300T includes a first portion or base mold 7301T composed of a relatively rigid material (e.g., a thermoplastic polymer such as PC, ABS, etc.), and a second portion or overmold 7302T composed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone) that is disposed on the first portion 7301T (e.g., by overmolding). In the example shown, the overmold 7302T is disposed on the inner surface of the base mold 7301T along the pneumatic block portion 7350T (inner wall), however, it should be understood that the overmold can be disposed on other surfaces of the base mold.

[0376] Similarly, the bottom chassis 7300B includes a first portion or base mold 7301B composed of a relatively rigid material (e.g., a thermoplastic polymer such as PC, ABS, etc.), and a second portion or overmold 7302B composed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone) that is disposed on the first portion 7301B (e.g., by overmolding). In the illustrated example, the overmold 7302B is disposed on the inner surface of the base mold 7301B along the pneumatic block portion 7350B (inner wall), however, it should be understood that the overmold may be disposed on other surfaces of the base mold.

[0377] like Fig.14 and 15 As best shown in FIG. 7 , the overmolding 7302T, 7302B on the top chassis and the bottom chassis can provide noise damping properties to attenuate wall radiated noise, and provide sealing properties to provide a sealed interface between the top chassis and the bottom chassis, i.e., seal the pneumatic block cavity 7350.

[0378] In an alternative example, the top chassis and bottom chassis 7300T, 7300B may comprise different materials, for example, the top chassis 7300T comprises 10% glass-filled PC and the bottom chassis 7300B comprises PC / ABS.

[0379] For example, see Figure 8 , the upper wall of the top chassis 7300T is constructed and arranged to support the PCBA 7600. As described below, the upper wall includes an opening that allows sensors (e.g., flow sensors, pressure sensors) on the PCBA 7600 to extend into and communicate with the pneumatic block cavity 7350.

[0380] The top chassis 7300T includes a chassis outlet 7320 adapted to communicate with the inlet of the water reservoir 6100 when the water reservoir is received in the water reservoir base 6050. The top chassis 7300T also includes an opening 7330 to support one or more components configured and arranged to allow communication between the outlet of the water reservoir 6100 and the air circuit 4170.

[0381] The bottom chassis 7300B includes a side wall having a plurality of inlet openings 7340 that provide a chassis inlet 7310. The plurality of openings 7340 allow for adequate airflow while preventing the ingress of larger objects. A recessed chamber 7342 is provided in the bottom chassis 7300B in communication with the plurality of openings 7340. The recessed chamber 7342 leads to a long inlet tube 7345 in communication with the pneumatic block cavity 7350. In use, air flows into the recessed chamber 7342 through the plurality of openings 7340, and from the recessed chamber 7342 through the long inlet tube 7345 into the pneumatic block cavity 7350. In one example, the side wall having the inlet opening 7340 may be in the form of a removable door that is constructed and arranged to removably retain and support an inlet air filter within the recessed chamber 7342. In use, the inlet air filter is arranged to filter air entering the pneumatic block cavity 7350. Additionally, the inlet air filter may be configured to reduce noise radiated back through the chassis inlet 7310 .

[0382] The top chassis 7300T and the bottom chassis 7300B each include structures for positioning and supporting each of at least two different blower subassemblies 7400SUB1 or 7400SUB2. Figures 10 to 13As shown, the top chassis 7300T includes internal locating grooves 7360T1, 7360T2 (e.g., each formed by spaced-apart sidewalls), while the bottom chassis 7300B includes internal locating grooves 7360B1, 7360B2 (e.g., each formed by spaced-apart sidewalls). Each internal locating groove 7360T1, 7360T2, 7360B1, 7360B2 is constructed and arranged to receive and support a corresponding plate of the blower subassembly 7400SUB1 or 7400SUB2.

[0383] For example, see Fig.12 and 13 , the bottom chassis 7300B includes a plurality of internal ribs 7365 axially spaced between internal locating grooves. In one example, the internal ribs 7365 are constructed and arranged to at least partially surround the blower 7200B2 of the blower subassembly 7400SUB2, for example, to increase the rigidity of the housing and provide support, impact resistance and / or damping properties for the blower. In one example, the top chassis 7300T may also include one or more internal ribs, for example, for housing rigidity and blower support.

[0384] In addition, the side walls of the bottom chassis 7300B are constructed and arranged to provide a support structure for the chassis plate 7510SS1 of the blower subassembly 7400SUB 1. For example, the side walls of the bottom chassis 7300B include one or more support surfaces, flanges and / or ribs along the perimeter of the pneumatic block portion 7350B, which is arranged to engage and support the chassis plate 7510SS1 of the blower subassembly 7400SUB 1.

[0385] In one example, the reservoir base 6050 formed by the top chassis 7300T and the bottom chassis 7300B may include a guide structure 6060 to facilitate alignment and connection of the water reservoir 6100. For example, each side of the reservoir base 6050 may include a guide structure 6060 in the form of a track to define an assembly path for the water reservoir 6100, see, for example Figure 7 .

[0386] The top chassis 7300T and the bottom chassis 7360B may be connected to each other in any suitable manner, such as mechanical fasteners, mechanical interlocks, and / or snap-fit ​​connections.

[0387] Blower subassembly

[0388] As described above, chassis assembly 7300 is configured to position and support a selected one of at least two different blower subassemblies 7400SUB1 or 7400SUB2 that are structurally different from each other in at least one aspect, for example, depending on the desired treatment. In other words, chassis assembly 7300 includes common components between the first configuration and the second configuration of the RPT device (i.e., the first configuration including the first blower subassembly 7400SUB1 and the second configuration including the second blower subassembly 7400SUB2).

[0389] The first blower subassembly 7400SUB1 includes a first type of blower 7200B1 configured, for example, for CPAP or APAP therapy. The second blower subassembly 7400SUB2 includes a second type of blower 7200B2 configured, for example, for bi-level therapy. As described below, the air flow path and the arrangement of chambers along the air flow path vary depending on the blower subassembly 7400SUB1 or 7400SUB2 selected for support within the chassis assembly 7300.

[0390] First blower subassembly

[0391] like Figures 34 to 38 As shown, the first blower subassembly 7400SUB1 includes a first blower 7200B1 and a support structure 7500SS1 that supports the first blower 7200B1 within a chassis assembly 7300 .

[0392] In the example shown, the first blower 7200B1 comprises a three-stage design constructed and arranged to generate a positive pressure (eg, up to about 30 cmH2O, such as about 4 to 30 cmH2O) air flow or air supply.

[0393] The first blower 7200B1 includes a housing including an axial air inlet 7210B1 (blower inlet) and an axial air outlet 7220B1 (blower outlet) between which are positioned three stages having three corresponding impellers (i.e., a first impeller and a second impeller positioned on one side of the motor, and a third impeller positioned on the other side of the motor). However, other suitable impeller arrangements are possible. Each impeller is followed by a set of stator blades that are constructed and configured to direct the air flow to the next stage. The blower housing is relatively rigid and forms a substantially sealed structure that is constructed and arranged to seal the air flow passing through the interior of the first blower from the pneumatic block cavity.

[0394] Further examples and details of the first blower 7200B1 are described in PCT Publication No. WO 2013 / 020167, which is incorporated herein by reference in its entirety.

[0395] The support structure 7500SS1 includes a chassis plate 7510SS1, an outlet plate assembly 7530SS1, and a flow plate assembly 7550SS1.

[0396] The flow plate assembly 7550SS1 includes a base plate 7552SS1, a flow tube array 7554SS1, and a blower suspension 7556SS1 (inlet end suspension) supported in an opening disposed in the base plate 7552SS1. In addition, a sealing lip or sealing flange 7558SS1 is disposed along an edge or periphery of the base plate 7552SS1.

[0397] In one instance, the substrate 7552SSl and flow tube array 7554SSl include a first portion or base mold formed of a relatively rigid material (e.g., a thermoplastic polymer), and the blower suspension 7556SSl and sealing lip 7558SS1 include a second portion or overmold formed of a relatively soft material (e.g., TPE or silicone) that is disposed on the first portion (e.g., by overmolding).

[0398] In one example, the flow plate assembly 7550SS1 is formed as a separate and distinct structure from the chassis plate 7510SS1 and then connected to the chassis plate 7510SS1. For example, the chassis plate 7510SS1 includes a positioning groove 7512SS1 (e.g., formed by spaced-apart sidewalls) to position and support the flow plate assembly 7550SS1. As shown, the base plate 7552SS1 of the flow plate assembly 7550SS1 extends substantially perpendicular to the chassis plate 7510SS1 when connected to the chassis plate 7510SS1. In addition, the base plate 7552SS1 of the flow plate assembly 7550SS1 can be fixed to the chassis plate 7510SS1, for example, via a clamping structure (e.g., a flexible tab on the base plate 7552SS1 inserted into a corresponding opening on the chassis plate 7510SS1).

[0399] The outlet plate assembly 7530SS1 includes a base plate 7532SS1 and a blower hanger 7536SS1 (outlet end hanger) supported in an opening provided in the base plate 7532SS1. In addition, a sealing lip or sealing flange 7538SS1 is provided along an edge or periphery of the base plate 7532SS1.

[0400] In one example, the outlet plate assembly 7530SS1 is integrally formed with the chassis plate 7510SS1. As shown, the base plate 7532SS1 extends generally perpendicular to the chassis plate 7510SS1.

[0401] The chassis plate 7510SS1 also includes a flow tube 7515SS1. In this example, the flow tube 7515SS1 includes an axis extending generally perpendicular to the chassis plate 7510SS1.

[0402] In one instance, the chassis plate 7510SS1 and the base plate 7532SS1 include a first portion or base mold formed of a relatively rigid material (e.g., a thermoplastic polymer), and the blower suspension 7536SS1 and the sealing lip 7538SS1 include a second portion or overmold formed of a relatively soft material (e.g., TPE or silicone) that is disposed on the first portion (e.g., by overmolding).

[0403] A sealing lip or sealing flange 7518SS1 may also be provided along an edge or perimeter of the chassis plate 7510SS1, such as an overmold formed from a relatively soft material (eg, TPE or silicone).

[0404] The first blower 7200B1 is suspended between the flow plate assembly 7550SS1 and the outlet plate assembly 7530SS1 by the support structure 7500SS1. The flow plate assembly 7550SS1 and the outlet plate assembly 7530SS1 each include a blower suspension 7556SS1, 7536SS1, which cooperate to support the first blower 7200B1 within the chassis assembly 7300, provide sealing for the air path, isolate vibrations of the first blower 7200B1, and provide shock resistance. The blower suspension 556SS1, 7536SS1 can provide additional springs and damping to isolate vibrations and provide shock resistance. Specifically, the flow plate assembly 7550SS1 provides an inlet end suspension 7556SS1 to support the first blower 7200B1 adjacent to the blower inlet 7210B1, and the outlet plate assembly 7530SS1 provides an outlet end suspension 7536SS1 to support the first blower 7200B1 adjacent to the blower outlet 7220B1, i.e., the suspensions are positioned at each end of the first blower 7200B1. This arrangement also provides a keying feature to ensure repeatable alignment of the first blower 7200B1 within the first blower subassembly 7400SUB1.

[0405] In one example, if Fig.37 and 38As shown, the base plate 7552SSl of the flow plate assembly 7550SSl and / or the base plate 7532SSl of the outlet plate assembly 7530SSl may each include one or more flanges 7560SSl along the periphery of the blower suspension 7556SS1, 7536SS1, for example to serve as a rigid stop or bump stop to limit the range of movement provided by the blower suspension 7556SS1, 7536SS1.

[0406] In one example, the first blower 7200B1 may be inserted or otherwise assembled into the flow plate assembly 7550SS1, and then the first blower 7200B1 may be inserted or otherwise assembled into the outlet plate assembly 7530SS1. As described above, the flow plate assembly 7550SS1 may be secured to the chassis plate 7510SS1 (i.e., by locating and securing the base plate 7552SS1 of the flow plate assembly 7550SS1 within the locating slot 7512SS1 of the chassis plate 7510SS1) to form the first blower subassembly 7400SUB1.

[0407] In addition, the acoustic foam (ie, outlet foam 7570SS1) is held by the chassis plate 7510SS1 to increase acoustic resistance and reduce noise. In the illustrated example, the chassis plate 7510SS1 includes a retaining arm 7513SS1 adapted to engage in a slot provided in the outlet foam 7570SS1.

[0408] Assemble the first blower subassembly to the chassis assembly

[0409] The first blower subassembly 7400SUB1 is assembled to the chassis assembly 7300 to form a first configuration of the pneumatic block 7100, for example, configured for CPAP or APAP therapy.

[0410] Figures 20 to 24 The first blower subassembly 7400SUB1 is shown assembled to the chassis assembly 7300. Fig. 20 As shown in FIG. 1 , acoustic foam (i.e., inlet foam 7700) is placed into the pneumatic block portion 7350B of the bottom chassis 7300B to increase acoustic resistance and reduce noise. In the example shown, the inlet foam 7700 includes a generally U-shape that is adapted to extend along the sidewalls of the pneumatic block portion 7350B. Fig. 20 and 21 As shown, the first blower subassembly 7400SUB1 together with the outlet foam 7570SS1 retained thereon is then lowered onto the bottom chassis 7300B. Fig. 22 and 23As shown, the edge of the chassis plate 7510SS1 is supported along the perimeter of the pneumatic block portion 7350B by one or more of a support surface, a ledge, and / or a rib. Fig.30 , the underside of the chassis plate 7510SS1 may include a support plate 7519SSl arranged to engage the bottom wall of the bottom chassis 7300B to further support the first blower subassembly 7400SUB1 within the bottom chassis 7300B.

[0411] like Fig. 22 As shown, the top chassis 7300T is then lowered onto the bottom chassis 7300B, ensuring that the base plate 7552SS1 of the flow plate assembly 7550SS1 and the base plate 7532SS1 of the outlet plate assembly 7530SS1 engage in the corresponding internal positioning grooves 7360T1, 7360T2 in the top chassis 7300T to position and support the first blower subassembly 7400SUB1 in the top chassis 7300T. The top chassis 7300T and the bottom chassis 7300B can be fixed to each other in any suitable manner, for example, by mechanical fasteners (e.g., screws) and / or fixing clips.

[0412] Finally, if Fig.24 As shown, PCBA 7600 is attached to the upper wall of top chassis 7300, for example, via mechanical fasteners (e.g., screws) outside of pneumatic block cavity 7350. In the example shown, PCBA 7600 includes a flow sensor and a pressure sensor in communication with pneumatic block cavity 7350.

[0413] The electrical connection between the PCBA 7600 and the first blower 7200B1 may be made via a flexible circuit board (FCB), a flexible printed circuit (FPC), and / or a flexible flat cable (FFC), which extends from the first blower 7200B1 within the pneumatic block cavity 7350 to the PCBA 7600 .

[0414] Chamber arrangement and pneumatic air flow path provided by the first blower subassembly

[0415] See for example Fig.30 , when assembled, the first blower subassembly 7400SUB1 and the chassis assembly 7300 cooperate to provide a first configuration of the pneumatic block 7100, including three inlet muffler chambers IC1, IC2, IC3 and an outlet chamber OC along the air flow path.

[0416] In the example shown, Figures 42 to 48As shown, the chassis plate 7510SS1 and the bottom chassis 7300B cooperate to form the first inlet silencer chamber IC1; the chassis plate 7510SS1, the substrate 7552SS1 of the flow plate assembly 7550SS1, the substrate 7532SS1 of the outlet plate assembly 7530SS1 and the top chassis 7300T cooperate to form the second inlet silencer chamber IC2; the chassis plate 7510SS1, the substrate 7552SS1 of the flow plate assembly 7550SS1 and the top chassis 7300T cooperate to form the third inlet silencer chamber IC2; and the chassis plate 7510SS1, the substrate 7532SS1 of the outlet plate assembly 7530SS1 and the top chassis 7300T cooperate to form the outlet chamber OC.

[0417] In the example shown, each chamber IC1, IC2, IC3, OC is sealed. Fig.30 , sealed along the perimeter of the chassis plate 7510SS1 and base plates 7532SS1 , 7552SS1 via overmolded sealing lips 7518SS1 , 7538SS1 , 7558SS1 (e.g., silicone), with controlled compression against the top chassis 7300T and bottom chassis 7300B.

[0418] In the example shown, see for example Fig.30 , the bottom of the RPT device 7000 includes a bottom surface defining a bottom plane BP, which is substantially horizontal when the RPT device 7000 is in the working orientation. As shown, in the first configuration of the pneumatic block 7100, the first blower 7200B1 is arranged so that the axis AX1 of the first blower 7200B1 (extending through the air inlet 7210B1 and the air outlet 7220B1) is parallel to the bottom plane BP. That is, when the RPT device 7000 is in the working orientation, the axis AX1 of the first blower 7200B1 extends in a substantially horizontal plane.

[0419] In the illustrated example, the pneumatic block 7100 is provided in a first configuration. The pneumatic air flow path of the first configuration includes a tortuous path extending from the chassis inlet 7310 to the chassis outlet 7320, which extends in more than one plane. For example, the first inlet muffler chamber IC1 extends in a first plane, and the second inlet muffler chamber IC2, the third inlet muffler chamber IC3, and the outlet chamber OC extend in a second plane spaced vertically upward from the first plane, see, for example, Fig.30 , 32 and 33.

[0420] As shown, the air flow path of the first configuration of the pneumatic block 7100 is constructed and arranged so that air is introduced through the inlet opening 7340 (see, for example, Fig.25) into the chassis assembly 7300 and into the recessed chamber 7342 (e.g., including an inlet air filter as discussed above), from the recessed chamber 7342 through the long inlet tube 7345, and as Fig.26 Shown entering the first inlet muffler chamber IC1. The long inlet tube 7345 is relatively long to allow for reduced noise (due to high inertia) as air flows from the inlet opening 7340 to the first inlet muffler chamber IC1. The large inlet foam 7700 in the first inlet muffler chamber IC1 increases acoustic resistance and reduces inlet noise.

[0421] like Fig. 27 and 31 As shown, air flows from the first inlet silencer chamber IC1 to the second inlet silencer chamber IC2 via flow tube 7515SS1 in chassis plate 7510SS1. Flow tube 7515S1 is relatively long to allow for noise reduction. As shown, the first blower 7200B1 is supported in the second inlet silencer chamber IC2 and receives air from the third inlet silencer chamber IC3 at the blower inlet 7210B1.

[0422] like Fig.28 As shown, air flows from the second inlet muffler chamber IC2 to the third inlet muffler chamber IC3 via the flow tube array 7554SS1 provided by the flow plate assembly 7550SS1. The third inlet muffler chamber IC3 receives air from the flow tube array 7554SS1 and delivers the air to the blower inlet 7210B1 of the first blower 7200B1.

[0423] The blower suspension 7556SS1 of the flow plate assembly 7550SS1 can be fixed to the first blower 7200B1 in any suitable manner (e.g., wrapped around an inlet flange provided at the blower inlet 7210B1 of the first blower 7200B1). The blower suspension 7556SS1 is sealed along the blower inlet 7210B1, thereby sealing the blower inlet 7210B1 with the second inlet muffler chamber IC2 and providing an air path for air from the third inlet muffler chamber IC3 to enter the blower inlet 7210B1. In addition, in the illustrated example, the blower suspension 7556SS1 provides a structure such as a gusset portion that allows flexibility and relative movement to isolate vibrations of the first blower 7200B1 and provide shock absorption.

[0424] The flow tube array 7554SS1 includes a plurality of flow tubes 7555SS1 that are constructed and arranged to extend from the base plate 7552SS1 to the second inlet muffler chamber IC2, for example, the flow tubes 7555SS1 extend substantially perpendicular to the base plate 7552SS1. Thus, the air flow path extends from the second inlet muffler chamber IC2, through the flow tube array 7554SS1, and into the third inlet muffler chamber IC3. The flow tubes 7555SS1 are constructed and arranged to allow laminar flow, provide a defined pressure drop, and provide sufficient length to reduce noise.

[0425] In the illustrated example, the flow tube array 7554SS1 includes 12 spaced apart flow tubes 7555SS1, for example, generally arranged in three rows of four tubes per row. However, it should be understood that other suitable numbers of tubes 7555SS1 are possible (e.g., one or more flow tubes, for example, 5 to 15 flow tubes), and the tubes 7555SS1 may be arranged in other suitable manners (e.g., aligned in rows and / or columns, circular arrangements).

[0426] In the example shown, each of the plurality of flow tubes 755551 includes a circular cross-sectional shape, however it should be understood that each tube may include other cross-sectional shapes, for example, circular or non-circular. Moreover, each of the plurality of flow tubes 7555SS1 may include any suitable length, diameter, wall thickness, and cross-sectional area, for example, depending on the desired noise characteristics. In addition, the plurality of flow tubes 755551 may include flow tubes of equal length and / or unequal length.

[0427] The first inlet muffler chamber IC1, the second inlet muffler chamber IC2, and the third inlet muffler chamber IC3 cooperate to increase compliance and reduce inlet noise along the air flow path to the blower inlet 7210B1 of the first blower 7200B1.

[0428] The air flows through the first blower 7200B1 so as to provide a positive pressure air flow at the blower outlet 7220B1 of the first blower 7200B1. Fig.29 As shown, the outlet chamber OC receives pressurized air exiting from the blower outlet 7220B1 of the first blower 7200B1. The pressurized air from the outlet chamber OC exits the pneumatic block via the chassis outlet 7320. In one example, the outlet chamber OC of the first configuration of the pneumatic block 7100 can be at a positive pressure of up to about 30 cmH2O.

[0429] The blower suspension 7536SS1 of the outlet plate assembly 7530SS1 can be fixed to the first blower 7200B1 in any suitable manner (e.g., wrapped around an outlet flange of the blower outlet 7220B1 provided on the first blower 7200B1). The blower suspension 7556SS1 is sealed along the blower outlet 7220B1, thereby sealing the blower outlet 7220B1 with the second inlet muffler chamber IC2 and providing an air path for the air leaving the blower outlet 7220B1 to enter the outlet chamber OC. In addition, in the illustrated example, the blower suspension 7536SS1 provides a structure such as a gusset portion that allows flexibility and relative movement to isolate vibrations of the first blower 7200B1 and provide shock absorption.

[0430] The outlet chamber OC is relatively large to increase compliance and reduce outlet noise, for example, to attenuate outlet or forward conduction noise. In addition, see, for example Fig.30 , the outlet foam 7570SSl (supported by the chassis plate 7510SS1) in the outlet chamber OC increases the acoustic resistance and reduces the outlet noise.

[0431] In one example, the acoustic foam may be disposed in one or more of the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, the third inlet muffler chamber IC3, and the outlet chamber OC, for example, the acoustic foam is disposed in each of the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, the third inlet muffler chamber IC3, and the outlet chamber OC. In one example, the acoustic foam is disposed in the first and third inlet muffler chambers IC1, IC3, and the outlet chamber OC, i.e., not disposed in the second inlet muffler chamber IC2. However, it should be understood that alternative arrangements of the acoustic foam are possible.

[0432] In the illustrated example, the bottom tray outlet 7320 can be in communication with the inlet of the water reservoir 6100 when the water reservoir 6100 is received in the reservoir base 6050. In an alternative example, the bottom tray outlet 7320 can be in direct communication with the air circuit 4170.

[0433] Figures 57 to 59 is a schematic diagram schematically illustrating a vertically offset chamber arrangement of a first configuration of a pneumatic block and a pneumatic air flow path of a first configuration of a pneumatic block. Fig.57 As shown, the first inlet muffler chamber IC1 extends in a first plane PL1, and the second inlet muffler chamber IC2, the third inlet muffler chamber IC3 and the outlet chamber OC extend in a second plane PL2 vertically spaced upward from the first plane PL1. Fig.58 is a schematic diagram through the first plane PL1, Fig.59 is a schematic diagram passing through the second plane PL2.

[0434] Figures 57 to 59 Included are arrows showing exemplary air flow paths through the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, the third inlet muffler chamber IC3, and the outlet chamber OC. Fig.58 As shown, air enters the first inlet chamber IC1 in the first plane PL1, for example, via a chassis inlet. Fig.57 As shown, the air then flows from the first inlet chamber IC1 in the first plane PL1 to the second inlet chamber IC2 in the second plane PL2 via flow tube 7515SS1, for example. Fig.59 As shown, air flows from the second inlet chamber IC2 in the second plane PL2 to the third inlet chamber IC3 in the second plane PL2 via the flow tube array 7554SS1, for example. The air passes through the third inlet chamber IC3 in the second plane PL2 to the blower inlet 7210B1 of the first blower 7200B1 located in the second inlet chamber IC2 in the second plane PL2. Fig.59 As shown, the air flows in the second plane PL2 through the first blower 7200B1 located in the second inlet chamber IC2 and out in the second plane PL2 into the outlet chamber OC. The pressurized air from the outlet chamber OC leaves the pneumatic block via the chassis outlet.

[0435] like Figures 57 to 59 As shown, the air flow paths of the first configuration of the pneumatic block extend from the chassis inlet to the chassis outlet in different directions and in different planes. For example, the air flow direction at the chassis inlet (see Fig.58 ) is transverse to the airflow direction at the chassis outlet (see Fig.59 ) extension. In addition, Fig.59 As shown, the air flow extends in a substantially J-shape through the second inlet chamber IC2, the third inlet chamber IC3 and the outlet chamber OC in the second plane PL2, wherein the air flow flows from the second inlet chamber IC2 to the third inlet chamber IC3, extends in a direction opposite to the air flow flowing from the third inlet chamber IC3, passes through the blower in the second inlet chamber IC2, and enters the outlet chamber OC.

[0436] Second blower subassembly

[0437] like Figures 34 to 38 As shown, the second blower subassembly 7400SUB2 includes a second blower 7200B2 and a support structure 7500SS2 that supports the second blower 7200B2 within the chassis assembly 7300 .

[0438] In the example shown, the second blower 7200B2 comprises a two-stage design constructed and arranged to generate a positive pressure (eg, up to about 50 cmH2O, such as about 4 to 50 cmH2O) air flow or air supply.

[0439] The second blower 7200B2 includes a housing including an axial air inlet 7210B2 (blower inlet) and an axial air outlet 7220B2 (blower outlet) between which a second stage having two corresponding impellers (i.e., a first impeller positioned on one side of the motor, and a second impeller positioned on the other side of the motor) is positioned. However, other suitable impeller arrangements are possible. Each impeller is followed by a set of stator blades that are constructed and configured to direct the air flow to the next stage.

[0440] In the illustrated example, the second blower 7200B2 is mounted within a suspension 7250B2, for example comprising silicone, which forms a substantially sealed structure that is configured and arranged to seal the air flow passing through the interior of the second blower 7200B2 from the pneumatic block cavity 7350. In addition, the suspension 7250B2 forms a shield to isolate blower vibrations, provides shock absorption, and is provided with a keying feature to ensure repeatable alignment of the second blower 7200B2 within the second blower subassembly 7400SUB2.

[0441] Further examples and details of the second blower 7200B2 are described in U.S. Patent No. 8,636,479, which is incorporated herein by reference in its entirety.

[0442] The support structure 7500SS2 includes an outlet plate assembly 7530SS2 and a flow plate assembly 7550SS2.

[0443] The flow plate assembly 7550SS2 includes a base plate 7552SS2, a flow tube array 7554SS2, and a blower suspension 7556SS2 (inlet end suspension) supported in an opening disposed in the base plate 7552SS2. In addition, a sealing lip or sealing flange 7558SS2 is disposed along an edge or periphery of the base plate 7552SS2.

[0444] In one instance, the base plate 7552SS2 and flow tube array 7554SS2 include a first portion or base mold formed of a relatively rigid material (e.g., a thermoplastic polymer), and the blower suspension 7556SS2 and sealing lip 7558SS2 include a second portion or overmold formed of a relatively soft material (e.g., TPE or silicone) that is disposed on the first portion (e.g., by overmolding).

[0445] The outlet plate assembly 7530SS2 includes a base plate 7532SS2 and a blower hanger 7536SS2 (outlet end hanger) supported in an opening provided in the base plate 7532SS2. In addition, a sealing lip or sealing flange 7538SS2 is provided along an edge or periphery of the base plate 7532SS2.

[0446] In one instance, the base plate 7532SS2 includes a first portion or base mold formed of a relatively rigid material (e.g., a thermoplastic polymer), and the blower suspension 7536SS2 and the sealing lip 7538SS2 include a second portion or overmold formed of a relatively soft material (e.g., TPE or silicone) that is disposed on the first portion (e.g., by overmolding).

[0447] The second blower 7200B2 is suspended between the flow plate assembly 7550SS2 and the outlet plate assembly 7530SS2 by the support structure 7500SS2. The flow plate assembly 7550SS2 and the outlet plate assembly 7530SS2 each include a blower suspension 7556SS2, 7536SS2, which cooperate to support the second blower 7200B2 within the chassis assembly 7300, provide sealing for the air path, isolate the vibration of the second blower 7200B2, and provide shock resistance. The blower suspension 556SS2, 7536SS2 can provide additional springs and damping to isolate vibration and provide shock resistance. Specifically, the flow plate assembly 7550SS2 provides an inlet end suspension 7556SS2 to support the second blower 7200B2 adjacent to the blower inlet 7210B2, and the outlet plate assembly 7530SS2 provides an outlet end suspension 7536SS2 to support the second blower 7200B2 adjacent to the blower outlet 7220B2, i.e., the suspension is positioned at each end of the second blower 7200B2. This arrangement is also provided with a keying feature to ensure repeatable alignment of the second blower 7200B2 within the second blower subassembly 7400SUB2.

[0448] In one example, if Fig.37 and 38 As shown, the base plate 7552SS2 of the flow plate assembly 7550SS2 and / or the base plate 7532SS2 of the outlet plate assembly 7530SS2 may each include one or more flanges 7560SS2 along the periphery of the blower suspension assembly 7556SS2, 7536SS2, for example to serve as a rigid stop or bump stop to limit the range of movement provided by the blower suspension 7556SS2, 7536SS2.

[0449] In one example, the second blower 7200B2 can be inserted or otherwise assembled into the flow plate assembly 7550SS2, and then the second blower 7200B2 can be inserted or otherwise assembled into the outlet plate assembly 7530SS2. In one example, the second blower 7200B2 can be assembled to the flow plate assembly 7550SS2 using a locating support tab 7252B2 provided to the suspension 7250B2, for example, by pulling the locating support tab 7252B2 through the blower suspension 7556SS2 to engage the inlet flange of the second blower 7200B2 with the blower suspension 7556SS2. In one example, the second blower 7200B2 can be assembled to the outlet plate assembly 7530SS2 using the outlet funnel 7254B2 disposed on the suspension 7250B2, such as by pulling the outlet funnel 7254B2 through the blower suspension 7536SS2 to engage the outlet funnel 7254B2 associated with the blower outlet of the second blower 7200B2 with the blower suspension 7536SS2.

[0450] Assemble the second blower subassembly to the chassis assembly

[0451] The second blower subassembly 7400SUB2 is assembled to the chassis assembly 7300 to form a second configuration of the pneumatic block 7100, for example, configured for bi-level therapy.

[0452] Figures 39 to 41 The second blower subassembly 7400SUB2 is shown assembled to the chassis assembly 7300. Fig.39 As shown, the second blower subassembly 7400SUB2 is first lowered onto the bottom chassis 7300B. As shown, the base plate 7552SS2 of the flow plate assembly 7550SS2 and the base plate 7532SS2 of the outlet plate assembly 7530SS2 are arranged to engage in the corresponding internal positioning grooves 7360B1, 7360B2 of the bottom chassis 7300B, so as to position and support the second blower subassembly 7400SUB2 in the bottom chassis 7300B. In addition, the internal ribs 7365 provided in the bottom chassis 7300B can also support the suspension 7250B2 and the second blower 7200B2 in the bottom chassis 7300B.

[0453] In one example, acoustic foam (ie, inlet foam) may be placed into the aerodynamic block portion of the bottom chassis 7300B to increase acoustic resistance and reduce noise.

[0454] like Fig.40As shown, the top chassis 7300T is then lowered onto the bottom chassis 7300B, ensuring that the base plate 7552SS2 of the flow plate assembly 7550SS2 and the base plate 7532SS2 of the outlet plate assembly 7530SS2 are engaged in the corresponding internal positioning grooves 7360T1, 7360T2 in the top chassis 7300T to position and support the second blower subassembly 7400SUB2 in the top chassis 7300T. The top chassis 7300T and the bottom chassis 7300B can be fixed to each other in any suitable manner, for example, by mechanical fasteners (e.g., screws) and / or fixing clips.

[0455] Finally, if Fig.41 As shown, PCBA 7600 is attached to the upper wall of top chassis 7300, for example, via mechanical fasteners (e.g., screws) outside of pneumatic block cavity 7350. As described above, PCBA 7600 includes a flow sensor and a pressure sensor arranged to communicate with pneumatic block cavity 7350.

[0456] The electrical connection between the PCBA 7600 and the second blower 7200B2 may be made via a flexible circuit board (FCB), a flexible printed circuit (FPC), and / or a flexible flat cable (FFC), which extends from the second blower 7200B2 within the pneumatic block cavity 7350 to the PCBA 7600 . Figures 34 to 38 An example of a flexible flat cable 7260B2 extending from a second blower 7200B2 is shown.

[0457] Chamber arrangement and pneumatic air flow path provided by the second blower subassembly

[0458] See for example Fig.36 , when assembled, the second blower subassembly 7400SUB2 and the chassis assembly 7300 cooperate to provide a second configuration of the pneumatic block 7100, including two inlet muffler chambers IC1, IC2 and an outlet chamber OC along the air flow path.

[0459] In the example shown, Figures 42 to 48 As shown, the bottom chassis 7300B, the top chassis 7300T, the substrate 7552SS2 of the flow plate assembly 7550SS2 and the substrate 7532SS2 of the outlet plate assembly 7530SS2 cooperate to form the first inlet silencer chamber IC1; the bottom chassis 7300B, the top chassis 7300T and the substrate 7552SS2 of the flow plate assembly 7550SS2 cooperate to form the second inlet silencer chamber IC2; and the top chassis 7300T, the bottom chassis 7300B and the substrate 7532SS2 of the outlet plate assembly 7530SS2 cooperate to form the outlet chamber OC.

[0460] In the example shown, each chamber IC1, IC2, OC is sealed along the perimeter of the base plate 7532SS2, 7552SS2 via an overmolded sealing lip 7538SS2, 7558SS2 (eg, silicone) in controlled compression against the top chassis 7300T and bottom chassis 7300B.

[0461] In the example shown, see for example Fig.46 , the bottom of the RPT device 7000 includes a bottom surface defining a bottom plane BP, which is substantially horizontal when the RPT device 7000 is in the working orientation. As shown, in the second configuration of the pneumatic block 7100, the second blower 7200B2 is arranged so that the axis AX2 of the second blower 7200B2 (extending through the air inlet 7210B2 and the air outlet 7220B2) is parallel to the bottom plane BP. That is, when the RPT device 7000 is in the working orientation, the axis AX2 of the second blower 7200B2 extends in a substantially horizontal plane.

[0462] In the illustrated example, the pneumatic air flow path of the second configuration of the pneumatic block 7100 includes a tortuous path extending from the chassis inlet 7310 to the chassis outlet 7320. In one example, for example, see Fig.46 , the air flow path extends substantially in one plane, for example, the first inlet muffler chamber IC1 , the second inlet muffler chamber IC2 and the outlet chamber OC extend in one plane.

[0463] As shown, the air flow path of the second configuration of the pneumatic block 7100 is constructed and arranged so that air is introduced through the inlet opening 7340 (see, for example, Fig.25 ) into the chassis assembly 7300 and into the recessed chamber 7342, from the recessed chamber 7342 through the long inlet tube 7345, and as Fig.42 and 43 As shown entering the first inlet muffler chamber IC1. The long inlet tube 7345 is relatively long to allow for noise reduction (due to high inertia) when air flows from the inlet opening 7340 to the first inlet muffler chamber IC1. In one example, an inlet foam may be provided in the first inlet muffler chamber IC1 to increase acoustic resistance and reduce inlet noise.

[0464] like Fig.44As shown, air flows from the first inlet muffler chamber IC1 to the second inlet muffler chamber IC2 via the flow tube array 7554SS2 provided by the flow plate assembly 7550SS2. The second inlet muffler chamber IC2 receives air from the flow tube array 7554SS2 and delivers the air to the blower inlet 7210B2 of the second blower 7200B2. As shown, the second blower 7200B2 is supported in the first inlet muffler chamber IC1 and receives air from the second inlet muffler chamber IC2 at the blower inlet 7210B2. In one example, an inlet foam can be provided in the second inlet muffler chamber IC2 to increase acoustic resistance and reduce inlet noise.

[0465] The blower suspension 7556SS2 of the flow plate assembly 7550SS2 can be fixed to the second blower 7200B2 in any suitable manner (e.g., wrapped around an inlet flange of the blower inlet 7210B2 provided at the second blower 7200B2). The blower suspension 7556SS2 is sealed along the blower inlet 7210B2, thereby sealing the blower inlet 7210B2 with the first inlet muffler chamber IC1 and providing an air path for the air from the second inlet muffler chamber IC2 to enter the blower inlet 7210B2. In addition, in the illustrated example, the blower suspension 7556SS2 provides a structure such as a gusset portion that allows flexibility and relative movement to isolate the vibration of the second blower 7200B2 and provide shock absorption.

[0466] The flow tube array 7554SS2 includes a plurality of flow tubes 7555SS2 that are constructed and arranged to extend from the base plate 7552SS2 to the first inlet muffler chamber IC1, for example, the flow tubes 7555SS2 extend substantially perpendicular to the base plate 7552SS2. Thus, the air flow path extends from the first inlet muffler chamber IC1, through the flow tube array 7554SS2, and into the second inlet muffler chamber IC2. The flow tubes 7555SS2 are constructed and arranged to allow laminar flow, provide a defined pressure drop, and provide sufficient length to reduce noise.

[0467] In the illustrated example, the flow tube array 7554SS2 includes 12 spaced apart flow tubes 7555SS2, for example, generally arranged in four rows of three tubes per row. However, it should be understood that other suitable numbers of tubes 7555SS2 are possible (e.g., one or more flow tubes, for example, 5 to 15 flow tubes), and the tubes 7555SS2 can be arranged in other suitable ways (e.g., aligned in rows and / or columns, circular arrangements).

[0468] In the example shown, each of the plurality of flow tubes 755552 includes a circular cross-sectional shape, however it should be understood that each tube 755552 may include other cross-sectional shapes, for example, circular or non-circular. Moreover, each of the plurality of flow tubes 7555SS2 may include any suitable length, diameter, wall thickness, and cross-sectional area, for example, depending on the desired noise characteristics. In addition, the plurality of flow tubes 755552 may include flow tubes of equal length and / or unequal length.

[0469] The first inlet muffler chamber IC1 and the second inlet muffler chamber IC2 cooperate to increase compliance and reduce inlet noise along the air flow path to the blower inlet 7210B2 of the second blower 7200B2.

[0470] The air flows through the second blower 7200B2 so that a positive pressure air flow is provided at the blower outlet 7220B2 of the second blower 7200B2. Fig.45 As shown, the outlet chamber OC receives pressurized air exiting from the blower outlet 7220B2 of the second blower 7200B2. The pressurized air from the outlet chamber OC exits the pneumatic block via the chassis outlet 7320. In one example, the outlet chamber OC of the second configuration of the pneumatic block 7100 can be at a positive pressure of up to about 50 cmH2O.

[0471] The blower suspension 7536SS2 of the outlet plate assembly 7530SS2 can be fixed to the second blower 7200B2 in any suitable manner (e.g., wrapped around the outlet funnel 7254B2 of the suspension 7250B2 associated with the blower outlet 7220B2 of the second blower 7200B2). The blower suspension 7536SS2 is sealed along the blower outlet 7220B2, thereby sealing the blower outlet 7220B2 with the first inlet muffler chamber IC1 and providing an air path for the air leaving the blower outlet 7220B2 to enter the outlet chamber OC. In addition, in the illustrated example, the blower suspension 7536SS2 provides a structure such as a gusset portion that allows flexibility and relative movement to isolate vibrations of the second blower 7200B2 and provide shock absorption.

[0472] The outlet chamber OC is relatively large to increase compliance and reduce outlet noise. In addition, acoustic foam (ie, outlet foam) may be provided in the outlet chamber OC to increase acoustic resistance and reduce outlet noise.

[0473] In one example, the acoustic foam may be disposed in one or more of the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, and the outlet chamber OC, for example, the acoustic foam is disposed in each of the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, and the outlet chamber OC. It should be understood that alternative arrangements of the acoustic foam are possible.

[0474] In the illustrated example, the bottom tray outlet 7320 can be in communication with the inlet of the water reservoir 6100 when the water reservoir 6100 is received in the reservoir base 6050. In an alternative example, the bottom tray outlet 7320 can be in direct communication with the air circuit 4170.

[0475] Figures 60 to 61 is a schematic diagram schematically illustrating a chamber arrangement of a second configuration of a pneumatic block and a pneumatic air flow path of a second configuration of a pneumatic block. Fig.60 As shown, the first inlet muffler chamber IC1 , the second inlet muffler chamber IC2 and the outlet chamber OC all extend in one plane PL1 . Fig.61 It passes through Fig.60 Schematic diagram of the planar PLI.

[0476] Fig.61 Included are arrows showing exemplary air flow paths through the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, and the outlet chamber OC. As shown, air enters the first inlet chamber IC1, for example, via a chassis inlet. The air then flows from the first inlet chamber IC1 to the second inlet chamber IC2, for example, via a flow tube array 7554SS2. The air passes through the second inlet chamber IC2 to the blower inlet 7210B2 of the second blower 7200B2 positioned in the first inlet chamber IC1. The air flows through the second blower 7200B2 positioned in the first inlet chamber IC1 and exits into the outlet chamber OC. The pressurized air from the outlet chamber OC exits the pneumatic block via a chassis outlet.

[0477] like Fig.61 As shown, the air flow path of the second configuration of the pneumatic block extends in different directions from the chassis inlet to the chassis outlet. For example, the air flow direction at the chassis inlet extends transversely to the air flow direction at the chassis outlet. Fig.61 As shown, the airflow extends through the first inlet chamber IC1, the second inlet chamber IC2 and the outlet chamber OC in a roughly J-shape, wherein the airflow flows from the first inlet chamber IC1 to the second inlet chamber IC2, extends in the opposite direction to the airflow flowing through the first inlet chamber IC1, passes through the blower in the first inlet chamber IC1, and enters the outlet chamber OC.

[0478] Flow Sensors and Pressure Sensors

[0479] As described above, PCBA 7600 includes flow sensor 7610 and pressure sensor 7620 to monitor and control air flow and pressure in pneumatic block 7100. The upper wall of top chassis 7300T includes a plurality of openings or ports P1, P2, P3 (see, for example, Fig. 9 , 15 , 50), which allows sensors 7610, 7620 to communicate with the pneumatic block cavity 7350.

[0480] In the example shown, Fig.49 As shown, the flow sensor 7610 includes a pair of sensors 7610A, 7610B connected to corresponding flow sensor ports P1, P2 in the top chassis 7300T. Fig.50 , these flow sensor ports P1, P2 are arranged on opposite sides of the flow plate assemblies 7550SS1, 7550SS2, that is, arranged on opposite sides of the internal positioning groove 7360T1 of the top chassis 7300T suitable for supporting the flow plate assemblies 7550SS1, 7550SS2. The pair of sensors 7610A, 7610B are sealed in the corresponding flow sensor ports P1, P2, for example, via the overmolding 7302T (inner wall) provided on the inner surface of the top chassis 7300T.

[0481] For example, Fig.49 and 52 As shown, the overmolding 7302T of the top chassis 7300T is provided with a first sealing portion 7305SP1 along the flow sensor port P1 and a second sealing portion 7305SP2 along the flow sensor port P2. As shown, each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 is provided with a tubular sealing surface or interface 7306, which is suitable for sealingly engaging along the outer surface of the corresponding flow sensor 7610A, 7610B. The outer end of each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 includes a chamfered edge 7307 to facilitate the engagement of each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 with the corresponding flow sensor 7610A, 7610B, that is, the chamfered edge 7307 guides the corresponding flow sensor 7610A, 7610B to engage with the corresponding tubular sealing surface 7306.

[0482] However, the first seal 7305SP1 and the second seal 7305SP2 may have alternative geometric shapes configured to seal with the respective flow sensors 7610A, 7610B. Fig.53In the alternative example shown, each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 is provided with an inner tubular portion 7312 and an outer ring portion 7314 protruding radially inward relative to the inner tubular portion 7312. The outer end of each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 includes an annular groove 7316, which provides a flexing space for the outer ring portion 7314. The flexing space provided by the annular groove 7316 is configured and arranged to allow the outer ring portion 7314 to elastically deflect radially outward so as to facilitate the outer ring portion 7314 of each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 to engage with the corresponding flow sensor 7610A, 7610B. In addition, such elastic deflection of the outer ring portion 7314 provides a bias for sealing the outer ring portion 7314 with the corresponding flow sensor 7610A, 7610B.

[0483] In the first configuration of the pneumatic block 7100, the flow sensor 7610 is connected to the corresponding flow sensor ports P1, P2 to measure the pressure drop between the second chamber IC2 and the third chamber IC3 in the pneumatic block, that is, the bypass flow, which is proportional to the pressure difference between the second chamber IC2 and the third chamber IC3. That is, one sensor of the pair of sensors 7610B of the flow sensor is arranged to measure the first pressure in the second chamber IC2, and the other sensor of the pair of sensors 7610A of the flow sensor is arranged to measure the second pressure in the third chamber IC3 to determine the air flow.

[0484] In the second configuration of the pneumatic block, the flow sensor 7610 is connected to the corresponding flow sensor ports P1, P2 to measure the pressure drop between the first chamber IC1 and the second chamber IC2 in the pneumatic block, i.e., the bypass flow, which is proportional to the pressure difference between the first chamber IC1 and the second chamber IC2. That is, one sensor of the pair of sensors 7610B of the flow sensor is arranged to measure the first pressure in the first chamber IC1, and the other sensor of the pair of sensors 7610A of the flow sensor is arranged to measure the second pressure in the second chamber IC2 to determine the air flow.

[0485] In the example shown, Fig.50 and 51 As shown, pressure sensor 7620 is connected to pressure sensor port P3 on top chassis 7300T. Fig.50, the pressure sensor port P3 is arranged on the outlet chamber side formed by the outlet plate assemblies 7530SS1, 7530SS2, that is, arranged on one side of the internal positioning groove 7360T2 of the top chassis 7300T suitable for supporting the outlet plate assemblies 7530SS1, 7530SS2. The pressure sensor 7620 is sealed in the pressure sensor port P3, for example, via the overmolding 7302T (inner wall) provided on the inner surface of the top chassis 7300T.

[0486] For example, Fig.51 As shown, the overmold 7302T of the top chassis 7300T is provided with a seal 7308 along the pressure sensor port P3. As shown, the seal 7308 is provided with a tubular sealing surface or interface 7309, which is adapted to sealably engage along the outer surface of the pressure sensor 7620.

[0487] In the first and second configurations of the pneumatic block, the pressure sensor 7620 is arranged to measure the pressure in the outlet chamber OC in the pneumatic block, for example to measure the static pressure perpendicular to the direction of air flow.

[0488] In one example, a secondary pressure sensor, for example, may be provided to provide a secondary measurement of the pressure in the outlet chamber OC. In one example, if the primary pressure sensor 7620 or the secondary pressure sensor reads abnormally, the controller will initiate shutdown of the RPT device. The secondary pressure sensor may act as a backup so that the RPT device does not rely on a single sensor or a single failure condition, for example, to increase safety.

[0489] Figures 54 to 56 A pressure sensor seal 7800 is shown that is constructed and arranged to sealingly engage both a primary pressure sensor 7620 and a secondary pressure sensor 7621 disposed on a PCBA 7600. In this example, the pressure sensor seal 7800 is formed as a separate and distinct structure from the top chassis 7360T (e.g., a separately molded component of silicone) and then connected to the top chassis 7360T.

[0490] like Fig.55 As shown, the pressure sensor seal 7800 includes a base 7810, a first sealing portion 7820SP1 and a second sealing portion 7820SP2 supported by the base 7810, and a central connecting portion 7830 to facilitate alignment and releasable connection of the pressure sensor seal 7800 with the top chassis 7300T.

[0491] As shown, each of the first and second sealing portions 7820SP1, 7820SP2 includes a port engaging side 7822 and a sensor engaging side 7824. Each port engaging side 7822 is provided with a tubular sealing surface or interface 7823 adapted to sealingly engage along an outer surface of a corresponding sleeve 7325 to form a pressure sensor port P3, P4 in a base mold 7301T (e.g., a thermoplastic polymer (e.g., PC, ABS)) of the top chassis 7300T.

[0492] Each sensor engagement side 7824 includes a concertina-type interface 7825 having one or more folds to facilitate engagement with a corresponding pressure sensor 7620, 7621. In use, the multiple folding interface 7825 is configured and arranged to axially compress and / or flex laterally to align and seal along the outer surface of the corresponding pressure sensor 7620, 7621. This flexibility provided by the multiple folding interface 7825 accommodates any manufacturing tolerances of the top chassis 7300T and the PCBA 7600. For example, the multiple folding interface 7825 can accommodate any misalignment between the sensor 7620, 7621 and the corresponding sleeve 7325, for example, so that the sensor 7620, 7621 is not pushed laterally, which may change the reading or damage the PCBA 7600.

[0493] In the illustrated example, the inwardly extending folds of the multi-fold interface 7825 are provided with sealing surfaces 7826 that are adapted to sealingly engage respective pressure sensors 7620 , 7621 .

[0494] In the example shown, the central connection portion 7830 is provided with a tubular surface or interface 7832 adapted to engage along the outer surface of a mounting post 7327 formed in the base mold 7301T of the top chassis 7300T. Such engagement facilitates alignment of the first and second sealing portions 7820SP1, 7820SP2 with the corresponding sleeves 7325 of the top chassis 7300T and releasably secures the pressure sensor seal 7800 to the top chassis 7300T, for example, via friction engagement.

[0495] In the illustrated example, the base 7810 is provided with thickened walls along at least a portion of the perimeter of the pressure sensor seal 7800 that are adapted to be supported within a recess 7329 on the outer side of the top chassis 7300T.

[0496] Fig.56A pressure sensor seal 7800 is shown connected to the top chassis 7300T and sealingly engaged with the sleeve 7325 and the pressure sensors 7620, 7621, thereby pneumatically connecting the pressure sensors 7620, 7621 with the outlet chamber OC in the pneumatic block. As shown, the middle portion of each seal 7820SP1, 7820SP2 can form at least a portion of the passage between the corresponding pressure sensor 7620, 7621 and the corresponding sleeve 7325 for the pressure sensor ports P3, P4.

[0497] In an alternative example, one or more portions of the pressure sensor seal 7800 may be integrated with the overmold 7302T of the top chassis 7300T.

[0498] 5.6.3 Humidifier components

[0499] 5.6.3.1 Water storage tank

[0500] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a liquid (e.g., water) volume to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum water volume so as to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. 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.

[0501] According to one aspect, the water reservoir 5110 is configured to add humidity to the air flow from the RPT device 4000 as the air flow travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the air flow to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0502] According to one form, the reservoir 5110 is removable from the humidifier 5000, for example in a lateral direction.

[0503] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any holes and / or between its subcomponents, such as when the reservoir 5110 is displaced and / or rotated from its normal working orientation. Since the air flow to be humidified by the humidifier 5000 is generally pressurized, the reservoir 5110 may also be configured to avoid loss of pneumatic pressure through leakage and / or flow resistance.

[0504] 5.6.3.2 Conductive part

[0505] According to one arrangement, the reservoir 5110 includes a conductive portion that is configured to allow efficient transfer of heat from the heating element to the liquid content in the reservoir 5110. In one form, the conductive portion may be arranged as a plate, but other shapes may also be equally applicable. All or part of the conductive portion may be made of a thermally conductive material, such as aluminum (e.g., having a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm or 3 mm), another thermally conductive metal or some plastic. In some cases, suitable thermal conductivity may be achieved with a material of appropriate geometry having a lower conductivity.

[0506] 5.6.3.3 Humidifier reservoir base

[0507] In one form, the humidifier 5000 may include a humidifier reservoir base configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base may include a locking structure, such as a locking lever configured to retain the reservoir in the humidifier reservoir base.

[0508] 5.6.3.4 Water level indicator

[0509] The humidifier reservoir 5110 may include a water level indicator. In some forms, the water level indicator 5150 may provide a user (such as the patient 1000 or a caregiver) with one or more indications of the amount of water volume in the humidifier reservoir 5110. The one or more indications provided by the water level indicator may include an indication of a maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0510] 5.6.3.5 Humidifier converter

[0511] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducers 4270 described above. Figure 5G As shown, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that may be communicated with a controller, such as the central controller 4230 and / or the humidifier controller 5250. In some forms, the humidifier converter may be disposed externally to the humidifier 5000 (such as in the air circuit 4170) when communicating the output signals to the controller.

[0512] 5.6.3.5.1 Pressure converter

[0513] In lieu of or in addition to the pressure sensor 4272 provided in the RPT device 4000 , one or more pressure transducers 5212 may be provided in the humidifier 5000 .

[0514] 5.6.3.5.2 Flow converter

[0515] In lieu of or in addition to the flow sensor 4274 provided in the RPT device 4000 , one or more flow transducers 5214 may be provided in the humidifier 5000 .

[0516] 5.6.3.5.3 Temperature converter

[0517] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the air flow downstream of the humidifier outlet. In some forms, the humidifier 5000 may further include a temperature sensor 5216 for detecting the ambient air temperature.

[0518] 5.6.3.5.4 Humidity converter

[0519] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas (such as ambient air). In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0520] 5.6.3.6 Heating elements

[0521] In some cases, a heating element 5240 can be provided to the humidifier 5000 to provide heat input to one or more of the water volumes in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 can include a heat generating component, such as a resistive electric heating rail. A suitable example of the heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0522] In some forms, the heating element 5240 may be disposed in the humidifier base, where heat may be provided to the humidifier reservoir 5110 primarily by conduction.

[0523] 5.6.3.7 Humidifier controller

[0524] According to one arrangement of the present technology, Figure 5GThe humidifier 5000 shown in FIG. 5 may include a humidifier controller 5250. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may communicate with the central controller 4230.

[0525] In one form, the humidifier controller 5250 may receive as input, for example, measurements of properties of the air flow, water flow (such as temperature, humidity, pressure and / or flow) in the reservoir 5110 and / or the humidifier 5000. The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0526] like Figure 5G As shown in , 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 heating element controller 5252 configured to control the temperature of the heating element 5240.

[0527] 5.7 Respiratory waveform

[0528] Figure 4 A model of a typical breathing waveform of a person while sleeping is shown. The horizontal axis is time and the vertical axis is respiratory flow. While the parameter values ​​may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak expiratory flow Qpeak 0.4 L / s, expiratory time Te 2.4 s, peak expiratory flow Qpeak -0.5 L / s. The total duration of the breath Ttot is approximately 4 s. A person typically breathes at a rate of approximately 15 breaths per minute (BPM), while the ventilation volume is approximately 7.5 L per minute. A typical duty cycle (ratio of Ti to Ttot) is approximately 40%.

[0529] 5.8 Glossary

[0530] For purposes of this technical disclosure, one or more of the following definitions may apply in certain forms of the technology. In other forms of the technology, alternative definitions may apply.

[0531] 5.8.1 General terms

[0532] Air: In some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0533] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0534] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, such as the humidity within the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0535] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0536] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0537] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of an SBD event.

[0538] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0539] Flow rate: The instantaneous volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, reference to flow rate will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow rate will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate may be given the symbol Q. "Flow rate" is sometimes referred to simply as "flow" or "airflow".

[0540] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The total flow, Qt, is the air flow that leaves the RPT device. The ventilation flow, Qv, is the air flow that leaves the vent to allow for flushing of exhaled gases. The leakage flow, Ql, is the flow that leaks from the patient interface system or elsewhere. The respiratory flow, Qr, is the air flow that is received into the patient's respiratory system.

[0541] Humidifier: The word humidifier will be understood to refer to a humidifying device constructed and arranged or configured to have a physical structure capable of providing therapeutically beneficial amounts of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0542] Leakage: The word leakage is to be considered as undesired air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return elbow to the ambient environment.

[0543] Noise, conducted (acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0544] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0545] Noise, ventilatory (acoustic): Ventilatory noise in this document refers to the noise generated by the flow of air through any vent, such as the vent of a patient interface.

[0546] Patient: A person, whether or not they have a respiratory illness.

[0547] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascals. 1 cmH2O is equal to 1 g-f / cm 2 , which is approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in cmH2O.

[0548] The pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0549] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0550] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0551] 5.8.1.1 Materials

[0552] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, references to silicone refer 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), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.

[0553] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0554] 5.8.1.2 Mechanical properties

[0555] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0556] Resilient: Releases substantially all of its energy when unloaded. Includes, for example, some silicones and thermoplastic elastomers.

[0557] Hardness: The ability of a material to resist deformation inherently (described, for example, by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0558] • "Soft" materials may include silicone or thermoplastic elastomers (TPE), and may deform easily, for example under finger pressure.

[0559] • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example under finger pressure.

[0560] Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending or torsion. The structure or component may provide different resistance in different directions.

[0561] Floppy structure or component: A structure or component that will change shape, such as bend, when supporting its own weight for a relatively short period of time, such as 1 second.

[0562] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads normally encountered in use. An example of such use is the ability to establish and maintain a sealing relationship between a patient interface and the entrance to a patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0563] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction compared to a second orthogonal direction.In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0564] 5.8.2 Respiratory cycle

[0565] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to a decrease or absence of respiratory effort despite a patent airway. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0566] Respiratory Rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0567] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0568] Effort (breathing): The work done by a spontaneous breather in an attempt to breathe.

[0569] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0570] Flow Limitation: Flow limitation is to be considered a state in the patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0571] Types of flow-limited inspiratory waveforms:

[0572] (i) Flattened: (i) Having a rise followed by a relatively flat portion and then a fall.

[0573] (ii) M-shape: (ii) has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0574] (iii) Chair shape: (iii) has a single local peak at the leading edge followed by a relatively flat portion.

[0575] (iv) Reverse chair shape: (iv) has a relatively flat section followed by a single local peak, with the peak located at the trailing edge.

[0576] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow rather than a cessation of flow. In one form, hypopnea is considered to occur when flow decreases below a threshold for a sustained period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0577] (i) The patient's respiration decreases by 30% for at least 10 seconds with an associated 4% desaturation; or

[0578] (ii) The patient has a decrease in breathing (but less than 50%) lasting at least 10 seconds with an associated desaturation or arousal of at least 3%.

[0579] Hyperpnea: Increased air flow to above normal levels.

[0580] Inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0581]

[00136] Patency (airway): The degree to which an airway is open or the degree to which an airway is open. An open airway is open. Airway patency can be quantified, for example with a value (1) for open, and a value of zero (0) for closed (obstructed).

[0582] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0583] Peak Flow (Q Peak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0584] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow", which is the actual respiratory flow experienced by the patient, usually expressed in liters / minute.

[0585] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is exerted. In principle, the inspiratory volume Vi (the amount of air inhaled) is equal to the expiratory volume Ve (the amount of air exhaled), so a single tidal volume Vt can be defined to be equal to either volume. In practice, the tidal volume Vt is estimated as some combination, such as the average of the inspiratory volume Vi and the expiratory volume Ve.

[0586] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0587] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0588] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0589] Typical Recent Ventilation: The value around which values ​​of recent ventilation tend to cluster over some predetermined time scale, ie, a measure of the central tendency of values ​​of recent ventilation.

[0590] Upper airway obstruction (UAO): includes partial and total upper airway obstruction. This may be associated with a state of flow limitation, where flow increases only slightly, or even decreases, as the pressure difference across the upper airway increases (Starling impedance behavior).

[0591] Ventilation (Vent): A measurement of the total amount of gas exchanged by a patient's respiratory system. Measurements of ventilation may include one or both of inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes given simply as volume, and is understood to be the volume per minute.

[0592] 5.8.3 Ventilation

[0593] Adaptive servo ventilator (ASV): A servo ventilator with a variable rather than fixed target ventilation. The variable target ventilation may be derived from some characteristics of the patient, such as the patient's breathing characteristics.

[0594] Backup Rate: A parameter of a ventilator that determines the minimum rate of breaths (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by a spontaneous respiratory effort.

[0595] Cyclic: The termination of the inspiratory phase of a ventilator. When a ventilator is delivering a breath to a spontaneously breathing patient, the ventilator is considered to cycle to stop delivering a breath at the end of the inspiratory portion of the respiratory cycle.

[0596] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the intra-breath varying pressures are added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0597] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion. If the pressure waveform template Π(Φ) is zero at the end of exhalation, that is, Π(Φ) = 0, when Φ = 1, then EEP is equal to EPAP.

[0598] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0599] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually means the difference between the maximum and base pressure during inspiration (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0600] Servomotor: A ventilator that measures patient ventilation, has a target ventilation and adjusts the level of pressure support to bring the patient's ventilation to the target ventilation.

[0601] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0602] Swing: A term equivalent to pressure support.

[0603] Triggered: When the ventilator delivers breathed air to a spontaneously breathing patient, it is considered to be triggered at the beginning of the breath portion of the breathing cycle through the patient's effort.

[0604] 5.8.4 Patient Interface

[0605] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0606] Elbow: An elbow is an example of a structure that redirects the axis of the air flow directed therethrough at an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an elliptical or rectangular cross-section. In some forms, the elbow may be rotatable, for example, about 360 degrees, relative to a mating component. In some forms, the elbow may be removable from a mating component, for example, via a snap connection. In some forms, the elbow may be assembled to a mating component via a disposable snap during manufacturing, but may not be removed by the patient.

[0607] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0608] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear includes a collection of one or more support bars, straps, and reinforcement bars configured to position and maintain a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.

[0609] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0610] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the wall of the mask plenum.

[0611] Seal: can be a noun form referring to a structure ("seal") or a verb form referring to an effect ("to seal"). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' therebetween without requiring a separate 'seal' element itself.

[0612] Shell: Shell will be taken to mean a curved and relatively thin structure having bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0613] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0614] Braces: Braces will be considered to be structural components designed to increase the compression resistance of another component in at least one direction.

[0615] Swivel (noun): A subassembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of the component preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel when in use.

[0616] Tie (noun): A structure designed to resist tension.

[0617] Vent (noun): A structure that allows air flow from the interior of a mask or duct to ambient air to effectively flush exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the therapy pressure.

[0618] 5.8.5 Shape of the structure

[0619] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other feature. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an 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., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0620] To help describe the shape of three-dimensional structures and surfaces, we first consider a cross section through a point p on the surface of the structure. Figures 3B to 3F , which show examples of cross sections at a point p on the surface and the resulting plane curve. Figures 3B to 3F The outward normal vector at p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is described from the point of view of an imaginary person standing upright on the surface.

[0621] 5.8.5.1 Curvature in one dimension

[0622] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0623] Positive curvature: If the curve at p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person were to leave that point p, they would have to walk uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0624] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally without going up or down). Figure 3D .

[0625] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person were to leave that point p, they would have to go downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0626] 5.8.5.2 Curvature of a Two-Dimensional Surface

[0627] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane that includes the outward normal ("normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a magnitude, such as a relatively small magnitude. Figures 3B to 3F The plane curve in can be an example of such multiple cross sections at specific points.

[0628] Principal curvatures and principal directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values ​​are called principal directions. Figures 3B to 3F In the example of Figure 3B and the minimum value appears at Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0629] Region of a surface: A connected set of points on a surface. The points in a region can have similar characteristics, such as curvature or sign.

[0630] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other sign is negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0631] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0632] Cylindrical region: A region where one of the principal curvatures is zero (or is zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0633] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0634] Edge of a surface: The boundary or limit of a surface or area.

[0635] Path: In some forms of the present technology, a 'path' will be taken to mean a path in a mathematical-topological sense, e.g. a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course comprising, e.g., a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0636] Path length: In some forms of the present technology, 'path length' will be considered to be the distance along the surface from f(0) to f(1), i.e. the distance along a path on the surface. There may be more than one path between two points on the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0637] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. In a planar region, there can be a path on the surface that has the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there can be no path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.)

[0638] 5.8.5.3 Space curve

[0639] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be thought of as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix that is a left-handed helix. A typical human right ear includes a helix that is a right-handed helix. The edges of structures, such as the edges of membranes or impellers, can follow space curves. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Twist has a sign and a magnitude. The twist at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0640] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point as well as the magnitude. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell from her vehicle at a particular point, the direction of the tangent vector is the direction she would be traveling.

[0641] Unit Normal Vector: This tangent vector itself changes as the imaginary person moves along the curve. The unit vector that points in the same direction as the tangent vector changes is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0642] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule, or alternatively by the left-hand rule.

[0643] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector.

[0644] Space Curve Twist: The twist of a space curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies within the plane has zero twist. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of twist (e.g., a gently inclined spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of twist (e.g., a steeply inclined spiral path).

[0645] Referring to the right-hand rule, a space curve that faces the right-hand binormal direction can be considered to have a right-hand positive twist. A space curve that faces away from the right-hand binormal direction can be considered to have a right-hand negative twist (eg, a left-hand helix).

[0646] Likewise, referring to the left-hand rule, a space curve oriented in the direction of the left-hand binormal can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus, a left-handed positive phase is equivalent to a right-handed negative phase.

[0647] 5.8.5.4 Holes

[0648] A surface may have one-dimensional pores, for example pores defined by planar curves or by spatial curves. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. See, e.g. Figure 3G A one-dimensional hole in a structured surface is shown, bounded by a planar curve.

[0649] A structure may have two-dimensional pores, such as pores defined by a surface. For example, a pneumatic tire has a two-dimensional pore defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel may have a two-dimensional pore. In yet another example, a conduit may include (e.g., at its inlet or at its outlet) a one-dimensional pore and a two-dimensional pore defined by the inner surface of the conduit. See also through Fig. 3I The two-dimensional pores of the structure shown are bounded by the surfaces shown.

[0650] 5.9 Other notes

[0651] Unless the context clearly indicates and provides a numerical range, it is understood that each intervening value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other stated or intervening value in the stated range are broadly included in the present technology. The upper and lower limits of these intermediate ranges may be independently included in the intermediate ranges and are also included in the present technology, but are subject to any explicitly excluded limits in the stated ranges. In the case where the stated range includes one or both of the stated limits, the present technology also includes ranges excluding either or both of those included limits.

[0652] Furthermore, where a value or values ​​are described herein for implementation as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated and that such values ​​may be used to any appropriate number of significant digits as permitted or required by practical technical implementation.

[0653] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the technology, a limited number of representative methods and materials are described herein.

[0654] When a specific material is identified for use in constructing a component, obvious alternative materials having similar properties are substituted therefor. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

[0655] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0656] All publications mentioned herein are incorporated herein in their entirety by reference, to disclose and describe methods and / or materials as the subject of those publications. Providing the publications discussed herein is only for the disclosures before the filing date of the present application. Anything herein should not be construed as admitting that the present technology is not entitled to the priority of these publications due to previous inventions. In addition, the publication date provided may be different from the actual publication date, which may need to be confirmed separately.

[0657] The terms "comprises" and "comprising" should be understood to refer to each element, component or step in a non-exclusive manner, indicating that the marked elements, components or steps may be present or utilized, or in combination with other elements, components or steps that are not marked.

[0658] The subject headings used in the detailed description are for the convenience of the reader and should not be used to limit the subject matter that can be found in the disclosure or claims as a whole. The subject headings should not be used to interpret the scope of the claims or the limitations of the claims.

[0659] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments only illustrate the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method may be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order may be modified, and / or aspects of the order may be performed simultaneously or even synchronously.

[0660] It is therefore to be understood that numerous modifications may be made to the exemplary embodiments described and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0661] 5.10 Reference Symbols List

[0662]

[0663]

[0664]

[0665]

[0666]

[0667]

[0668]

[0669]

Claims

1. An apparatus for providing positive pressure air to a patient for respiratory therapy, the apparatus comprising: Pneumatic block, comprising: at least a first blower subassembly and a second blower subassembly that are structurally different from one another in at least one aspect, each of the at least first blower subassembly and the second blower subassembly comprising a corresponding blower configured to generate an air flow at a therapeutic pressure; and a common chassis assembly configured to support each of the at least first and second blower subassemblies, wherein the common chassis assembly and the first blower subassembly form a first configuration of the pneumatic block, and the common chassis assembly and the second blower subassembly form a second configuration of the pneumatic block, Wherein each of the first and second configurations of the aerodynamic blocks forms an air flow path extending from a chassis inlet to a chassis outlet. wherein each of the first and second configurations of the pneumatic block forms a chamber arrangement including a plurality of chambers along the air flow path, and The air flow paths and chamber arrangement of the first configuration of the pneumatic block are different from the air flow paths and chamber arrangement of the second configuration of the pneumatic block.

2. The apparatus of claim 1, wherein each of the at least first blower subassembly and the second blower subassembly includes a respective support structure to support the respective blower within the common chassis assembly.

3. The apparatus of claim 2, wherein each support structure is configured and arranged to sealingly separate the air flow path into the plurality of chambers.

4. Apparatus according to any one of claims 2 to 3, wherein each support structure comprises a flow tube array comprising a plurality of flow tubes allowing air to flow from one chamber to an adjacent chamber.

5. The apparatus of any one of claims 2 to 3, wherein each support structure includes a blower suspension to support the corresponding blower within the support structure and isolate vibrations.

6. Apparatus according to any one of claims 1 to 5, wherein the second configuration of the pneumatic block comprises two inlet muffler chambers and one outlet chamber along the air flow path.

7. An apparatus for providing positive pressure air to a patient for respiratory therapy, the apparatus comprising: Pneumatic block, comprising: at least a first blower subassembly and a second blower subassembly that are structurally different from one another in at least one aspect, each of the at least first blower subassembly and the second blower subassembly comprising a corresponding blower configured to generate an air flow at a therapeutic pressure; and a common chassis assembly configured to support each of the at least first and second blower subassemblies, wherein the common chassis assembly and the first blower subassembly form a first configuration of the pneumatic block, and the common chassis assembly and the second blower subassembly form a second configuration of the pneumatic block, Wherein each of the first and second configurations of the aerodynamic blocks forms an air flow path extending from a chassis inlet to a chassis outlet. wherein each of the first and second configurations of the pneumatic block forms a chamber arrangement including a plurality of chambers along the air flow path, and Wherein the first configuration of the pneumatic block is configured for CPAP or APAP therapy and the second configuration of the pneumatic block is configured for bi-level therapy.

8. The apparatus of claim 7, wherein the common chassis assembly includes a reservoir base constructed and arranged to receive a water reservoir.

9. The apparatus of claim 8, wherein the first and second configurations of the pneumatic blocks each include at least two inlet muffler chambers positioned upstream of a blower inlet of the corresponding blower.

10. An apparatus according to claim 9, wherein the first configuration of the pneumatic block includes three inlet muffler chambers, wherein a first inlet muffler chamber of the three inlet muffler chambers receives air from the chassis inlet, and wherein the corresponding blower is arranged in a second inlet muffler chamber of the three inlet muffler chambers and receives air from a third inlet muffler chamber of the three inlet muffler chambers at the blower inlet.

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