Pneumatic Block for Respiratory Pressure Therapy Device

Abstract

To provide an apparatus for providing air at positive pressure for respiratory therapy to a patient.SOLUTION: The apparatus includes a pneumatic block including at least first and second blower sub-assemblies and a common chassis assembly configured to support each of the at least first and second blower sub-assemblies. The at least first and second blower sub-assemblies are different structurally from one another in at least one aspect. Each of the at least first and second blower sub-assemblies includes a corresponding blower configured to produce a flow of air at a therapeutic pressure. The common chassis assembly and the first blower sub-assembly form a first configuration of the pneumatic block, and the common chassis assembly and the second blower sub-assembly form a second configuration of the pneumatic block. The air flow path and the chamber arrangement of the first configuration is different than the air flow path and the chamber arrangement of the second configuration.SELECTED DRAWING: Figure 22

Description

Technical Field

[0001] Part of the disclosure of this patent document contains content that is subject to copyright protection. The copyright owner has no objection if someone reproduces this patent document or this patent disclosure by fax, as long as it is as described in the patent file or record of the Patent Office and for the intended purpose, but retains all copyrights for other purposes.

[0002] 1 Cross - reference to related applications This application claims the benefit of U.S. Provisional Application No. 62 / 779,135, filed on December 13, 2018. The entire disclosure of this document is incorporated herein by reference.

Background Art

[0003] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

[0004] 2.2 Description of related technologies 2.2.1 The human respiratory system and its diseases The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0005] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchioles constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is referred to as the respiratory region. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] A range of respiratory diseases exist. Certain diseases can be characterized by specific manifestations (e.g., apnea, hypopnea, and hyperpnea).

[0007] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by manifestations such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue area, as well as the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such conditions, the breathing cessation of affected patients typically lasts for 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs and can cause cardiovascular diseases and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients may have no awareness of the symptoms. See Patent Document 1.

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep disordered breathing. CSR is a disease of the patient's respiratory regulator, in which alternating periods of increasing and decreasing ventilation, known as the CSR cycle, occur periodically. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is accompanied by repetitive sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2.

[0010] Respiratory failure is a general term for respiratory disorders, referring to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory failure can include some or all of the following diseases.

[0011] Patients with respiratory failure (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0012] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases with certain common characteristics. This includes an increase in resistance to the movement of air, an extended expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0014] Neuromuscular disease (NMD) is a broad term encompassing a number of diseases and conditions that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Among NMD patients, some are characterized by progressive muscle impairment, which ultimately leads to inability to walk, confinement to a wheelchair, difficulty swallowing, reduced respiratory muscle strength, and finally death due to respiratory failure. Neuromuscular disorders can be classified into the following two categories: rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle impairment that worsens over several months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders: characterized by muscle impairment that worsens over several years and only slightly reduces the average life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory failure symptoms in NMD include: increased general debility, swallowing disorders, dyspnea during exertion and at rest, fatigue, drowsiness, headache upon waking, and difficulty with concentration and mood changes.

[0015] Thoracic wall disorders are a group of chest wall deformities that cause ineffectiveness of the connection between the respiratory muscles and the chest wall. These disorders are mainly characterized by restrictive disorders and share the possibility of long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. Respiratory failure symptoms include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, headache upon waking, fatigue, reduced quality of sleep, and loss of appetite.

[0016] To treat or improve such conditions, a range of treatments are being used. Furthermore, in other aspects, healthy individuals can also benefit from preventive treatment of respiratory diseases. However, there are several drawbacks in these.

[0017] 2.2.2 Treatment methods A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are being used for the treatment of one or more of the above respiratory diseases.

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to move forward or backward against the posterior oropharyngeal wall, continuous positive pressure ventilation therapy functions as an air sprint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used to provide the treatment, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0019] Non-invasive ventilation (NIV) provides ventilatory assistance to the patient through the upper airway and performs part or all of the respiratory function to provide respiratory assistance to the patient and / or maintain an appropriate oxygen level in the body. The ventilatory assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] Invasive ventilation (IV) provides ventilatory assistance to patients who are no longer able 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.

[0021] 2.2.3 Treatment System These treatments can be provided by a treatment system or device. Such systems and devices can also be used for screening, diagnosis, or monitoring without treating the disease.

[0022] The treatment system can include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] Another form of treatment system is a mandibular repositioning device.

[0024] 2.2.3.1 Patient Interface The patient interface can be used to provide an interface to the wearer to a breathing apparatus, for example, by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby providing a sufficient distributed pressure with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH 2 O) to facilitate gas delivery. In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of gas supply to the airway at a positive pressure of about 10 cmH 2 O.

[0025] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a purely decorative mask, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the ambient.

[0026] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks the air flow through the nose and only allows air flow through the mouth).

[0027] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a sealed state through the lips.

[0028] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on the pillow).

[0029] In the design of patient interfaces, there are multiple challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment.

[0030] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask can withstand their original uses, but in such cases of masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0031] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0032] Masks designed for the treatment of sleep apnea may be suitable for other uses in some cases, as masks for other uses (e.g., pilots) may not be suitable for the treatment of sleep apnea.

[0033] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0034] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory Pressure Therapy (RPT) devices can be used individually for the delivery of one or more of the above-described therapies or as part of a system, for example, by operating the device to generate an air delivery flow to an airway interface. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0035] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that are not satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may be defective in relation to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0036] An example of a special requirement for a particular RPT device is acoustic noise.

[0037] Table of noise output levels of conventional RPT devices (measured at 10 cmH 2 O in CPAP mode using the test method specified in ISO3744 for only 1 sample). [Table 1]

[0038] As one known RPT device used for the treatment of sleep apnea, there is the S9 sleep therapy system (manufacturer: ResMed Limited). As another example of an RPT device, there is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar® series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive independent breathing for patients for a certain range for the treatment of multiple conditions (non-limiting examples include NMD, OHS, and COPD).

[0039] The ResMed Elisaee® 150 ventilator and the ResMed VSIII® ventilator can provide assistance for invasive and non-invasive dependent breathing suitable for adult or pediatric patients for the treatment of multiple conditions. With these ventilators, volume ventilation mode and pressure ventilation mode using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (e.g., an electric blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0040] Numerous options can be presented to the device designers. Since the design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect may also be greatly affected by minor changes in one or more parameters.

[0041] 2.2.3.3 Humidifier When the delivery of the air flow is carried out without humidification, it may lead to drying of the airway. When a humidifier is used together with the RPT device and the patient interface, humidified gas is generated, so the drying of the nasal mucosa is minimized and the comfort of the patient airway is increased. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort more than in the case of cold air.

[0042] Artificial humidification devices and systems within a certain range are known, but they do not meet the special requirements of medical humidifiers.

[0043] Medical humidifiers are typically used to increase the humidity and / or temperature of the air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed at the head of the bed may be small. A medical humidifier may be configured to humidify and / or heat only the air flow delivered to the patient, and not to humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since they also humidify and / or heat the entire room, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, there may be more stringent safety constraints than industrial humidifiers.

[0044] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use.

[0045] 2.2.3.4 Data Management For clinical reasons, it may be necessary to obtain data to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate the usage rate over a given period, and compare this to the compliance rule. If the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0046] In a patient's treatment, there may be other ways to benefit from communicating treatment data to a third party or an external system.

[0047] In the case of existing processes for communicating and managing such data, one or more of high cost, time-consuming, and error-proneness may occur.

Prior Art Documents

Patent Documents

[0048]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Summary of the Invention

Means for Solving the Problems

[0049] 3 Brief Description of the Technology This technology is related to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability. The first aspect of this technology is related to devices used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory diseases.

[0050] Another aspect of this technology is related to methods used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory disorders.

[0051] One aspect of a specific form of this technology is to provide a method and / or device for improving patient compliance with respect to respiratory treatment.

[0052] One aspect of one form of this technology is a method for manufacturing a device.

[0053] One aspect of a specific form of this technology is a medical device that is easy to use for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience in using this type of medical device.

[0054] One aspect of one form of this technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0055] One 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 including a chassis assembly configured to support each of a plurality of blower sub-assemblies. The pneumatic block is divided into different muffler chambers by corresponding mounting plates of the blower sub-assemblies.

[0056] 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 including at least a first blower sub-assembly and a second blower sub-assembly, and a common chassis assembly configured to support at least the first blower sub-assembly and the second blower sub-assembly respectively. The at least first blower sub-assembly and the second blower sub-assembly are structurally different from each other in at least one aspect. The at least first blower sub-assembly and the second blower sub-assembly each include a corresponding blower configured to generate an air flow at a therapeutic pressure. The common chassis assembly and the first blower sub-assembly form a first configuration of the pneumatic block, and the common chassis assembly and the second blower sub-assembly form a second configuration of the pneumatic block. The first configuration and the second configuration of the pneumatic block each form an air flow path extending from a chassis inlet to a chassis outlet. The first configuration and the second configuration of the pneumatic block each form a chamber arrangement configuration including a plurality of chambers along the air flow path. The air flow path and the chamber arrangement configuration of the first configuration of the pneumatic block are different from the air flow path and the chamber arrangement configuration of the second configuration of the pneumatic block.

[0057] 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 configuration that includes a plurality of chambers along an air flow path. In an example, the plurality of chambers are arranged in more than one plane. In an example, at least one chamber extends in a first plane and at least one chamber extends in a second plane spaced vertically from the first plane. In an example, the chamber arrangement configuration includes three inlet muffler chambers and an outlet chamber along the air flow path. One of the three inlet muffler chambers extends in the first plane, and the remaining two of the three inlet muffler chambers and the outlet chamber extend in a second plane spaced vertically from the first plane.

[0058] 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 configuration that includes a plurality of chambers along an air flow path. In an example, the chamber arrangement configuration includes at least one inlet muffler chamber positioned upstream of the blower inlet of the blower and an outlet chamber positioned downstream of the blower outlet of the blower. In an example, the chamber arrangement configuration includes at least two inlet muffler chambers positioned upstream of the blower inlet of the blower and an outlet chamber positioned downstream of the blower outlet of the blower. In an example, the chamber arrangement configuration includes three inlet muffler chambers positioned upstream of the blower inlet of the blower and an outlet chamber positioned downstream of the blower outlet of the blower. In an example, the first inlet muffler chamber of the three inlet muffler chambers receives air from the chassis inlet, the blower is provided within the second inlet muffler chamber of the three inlet muffler chambers, and receives air from the third inlet muffler chamber of the three inlet muffler chambers at the blower inlet. In an example, the outlet chamber is adapted to communicate with the inlet of a water reservoir for humidification.

[0059] The methods, systems, devices, and apparatuses described herein can be embodied to improve functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device). Further, the methods, systems, devices, and apparatuses described can enable improvements in the technical field of automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0060] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of various ones of the sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0061] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

[0062] 4 Brief Description of the Drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include the following like elements:

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0064] 5 DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE PRESENT TECHNOLOGY Before further describing the present technology in detail, it should be understood that the present technology is not limited to the specific embodiments that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0065] The following description is provided in relation to various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment can be combined with one or more features of another embodiment or other embodiments. Additionally, any single feature or combination of features in any of these embodiments can constitute a further embodiment.

[0066] 5.1 Treatment Method In one form, the present technology includes a method for treating a respiratory disease. The method includes the step of applying a positive pressure to the entrance of the airway of patient 1000.

[0067] In a particular embodiment of the present technology, the air supply at the positive pressure is provided to the nasal passage of the patient through one or both of the nostrils.

[0068] In certain embodiments of the present technology, mouth breathing is restricted, limited, or prevented.

[0069] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 (see, e.g., FIGS. 1A - 1C).

[0070] 5.3 Patient Interface FIG. 3A shows a non - invasive patient interface 3000 according to one aspect of the present technology, including a seal - forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, one form of a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, functional modalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functional modalities. In use, the seal - forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of air at positive pressure to the airway.

[0071] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure treatment.

[0072] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH 2 2O relative to the ambient.

[0073] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH 2 2O relative to the ambient.

[0074] The patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH 2 O to the surroundings.

[0075] 5.4 RPT device An exploded view of an RPT device 4000 according to one form of the present technology is shown in FIG. 5A. The RPT device 4000 may include mechanical components, pneumatic components, and / or electrical components, and is configured to execute one or more algorithms. The RPT device 4000 may be configured to generate an air flow to be delivered to a patient's airway for treatment of one or more of the respiratory states described in any of the present documents, for example.

[0076] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH 2 O or at least 10 cmH 2 O or at least 20 cmH 2 O.

[0077] 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 a side panel 4014). The RPT device 4000 may also include an outlet muffler 4124, as shown in FIGS. 5A and 5B. The outlet muffler 4124 may be removable and may be exchanged with a water reservoir 5110 (see FIG. 5C). In such a form, the RPT device 4000 may be considered to include an integrated humidifier 5000. Thus, the RPT device 4000 can be used with or without humidification depending on whether the water reservoir 5110 or the outlet muffler 4124 is respectively attached. 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 received within a pneumatic block 4020 coupled to the chassis 4016.

[0078] Further embodiments and details of an exemplary RPT device are described in PCT Publication No. WO2015 / 089582, which is incorporated herein by reference in its entirety.

[0079] The pneumatic path of the RPT device 4000 (e.g., as shown in FIG. 5D) can include an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (preferably a blower 4142) capable of supplying air at positive pressure, and an outlet muffler 4124 (or a water reservoir 5110 if humidification is required). One or more transducers 4270 (e.g., pressure sensors and flow sensors) can be provided within the pneumatic path. The pneumatic path may also include an anti-spillback valve 4160 to prevent water from flowing back from the humidifier 5000 to the electrical components of the RPT device 4000.

[0080] As shown in FIG. 5E, the RPT device 4000 can 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, transducers 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202 (e.g., see FIG. 5A). In an alternative form, the RPT device 4000 can include more than one PCBA 4202.

[0081] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device can include one or more of the following components in an integrated unit. In an alternative form, one or more of the following components can be arranged as separate units.

[0082] 5.4.1.1 Air Filter(s) The RPT device according to one embodiment of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0083] In one embodiment, the inlet air filter 4112 is disposed at the beginning of the upstream of the air pressure path of the pressure generator 4140.

[0084] In one embodiment, the outlet air filter 4114 (e.g., antibacterial factor) is disposed between the outlet of the air pressure block 4020 and the patient interface 3000.

[0085] 5.4.1.2 Muffler(s) The RPT device according to one embodiment of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0086] In one embodiment of the present technology, the inlet muffler 4122 is disposed above the pressure generator 4140 in the air pressure path.

[0087] In one embodiment of the present technology, the outlet muffler 4124 is disposed between the pressure generator 4140 and the patient interface 3000 in the air pressure path.

[0088] 5.4.1.3 Pressure Generator In one embodiment of the present technology, the pressure generator 4140 that generates the flow or supply of air at a positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impeller may be disposed within a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH 2 O to about 20 cmH 2 O, or in other embodiments up to about 30 cmH 2 O. The blower is described in any one of Patent Documents 3, 4, 5, and 6. These patent documents are incorporated herein by reference in their entirety for reference purposes.

[0089] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0090] In other forms, the pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0091] 5.4.1.4 Transducer(s) The transducer may be provided inside the RPT device or outside the RPT device. The external transducer may be arranged, for example, on the air circuit or may form part of the air circuit (e.g., the patient interface). The external transducer can take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that sends or moves the data RPT device).

[0092] In one form of the technology, one or more transducers 4270 can be arranged upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 can be constructed and arranged to generate a signal indicative of the characteristics of the air flow (e.g., the flow rate, pressure, or temperature at that point in the air pressure path).

[0093] In one form of the technology, one or more transducers 4270 can be arranged in the vicinity of the patient interface 3000.

[0094] In one form, the signal from the transducer 4270 can be filtered (e.g., by low-pass, high-pass, or band-pass filtering).

[0095] 5.4.1.4.1 Flow Sensor The flow sensor 4274 according to the technology can be based on a differential pressure transducer (e.g., the SDP600 series differential pressure transducer from SENSIRION).

[0096] In one form, the signal indicative of the flow rate from the flow sensor 4274 is received by the central controller 4230.

[0097] 5.4.1.4.2 Pressure Sensor The pressure sensor 4272 according to the present technology can be disposed in fluid communication with the pneumatic path. As an example of a suitable pressure sensor, there is a transducer from the HONEYWELL ASDX series. As another suitable pressure sensor, there is a transducer from the NPA series from GENERAL ELECTRIC.

[0098] In one form, the signal from the pressure sensor 4272 is received by the central controller 4230.

[0099] 5.4.1.4.3 Motor Speed Converter In one form of the present technology, a motor speed converter 4276 can be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed converter 4276 can be provided to the treatment device controller 4240. The motor speed converter 4276 can be, for example, a speed sensor (e.g., a Hall effect sensor).

[0100] 5.4.1.5 Anti-Spillback Valve In one form of the present technology, an anti-spillback valve 4160 can be disposed 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 (e.g., to the motor 4144 of the blower).

[0101] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power Supply The power supply 4210 can be disposed inside or outside the external housing 4010 of the RPT device 4000.

[0102] In one form of the present technology, the power supply 4210 supplies power only to the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0103] 5.4.2.2 Input Device In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials that enable a human to interact with the device. The buttons, switches or dials can be physical devices or software devices that can be accessed via a touch screen. The buttons, switches or dials may be physically connected to the external housing 4010 in one form, or may wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.

[0104] In one form, the input device 4220 can be constructed and arranged to enable a human to select values and / or menu options.

[0105] 5.4.2.3 Central Controller In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0106] Suitable processors can include processors based on the ARM® Cortex®-M processor from ARM Holdings, x86 INTEL processors (e.g., S®32 series microcontrollers from STMicroelectronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., STR9 series microcontrollers from STMicroelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by TEXAS INSTRUMENTS) may also be suitable.

[0107] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0108] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0109] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and the humidifier 5000.

[0110] The central controller 4230 may be configured to provide output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0111] In some forms of the technology, the central controller 4230 is configured to implement one or more of the methods described herein (e.g., one or more algorithms 4300 represented as a computer program recorded in a non-transitory computer-readable recording medium (e.g., the memory 4260)). In some forms of the technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the technology, some of the methods may be performed by remotely located devices. For example, a remotely located device may determine ventilator control settings or detect respiratory related events by analyzing recorded data (e.g., from any of the sensors described herein).

[0112] 5.4.2.4 Clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230.

[0113] 5.4.2.5 Therapy Device Controller In one form of the technology, the therapy device controller 4240 is a therapy control module 4330 and forms part of the algorithm 4300 executed by the central controller 4230.

[0114] In one embodiment of the present technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0115] 5.4.2.6 Protection Circuit One or more protection circuits 4250 according to the present technology may include an electrical protection circuit, a temperature and / or pressure safety circuit.

[0116] 5.4.2.7 Memory According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260 (e.g., a non-volatile memory). In some embodiments, the memory 4260 may include a battery-backed static RAM. In some embodiments, the memory 4260 may include a volatile RAM.

[0117] The memory 4260 may be disposed on the PCBA 4202. The memory 4260 may be in the form of an EEPROM or a NAND flash.

[0118] Additionally or alternatively, the RPT device 4000 includes a removable memory 4260 (e.g., a memory card manufactured according to the Secure Digital (SD) standard).

[0119] In one embodiment of the present technology, the memory 4260 functions as a non-transitory computer-readable recording medium. Computer program instructions (e.g., one or more algorithms 4300) representing one or more methods described herein are recorded on this recording medium.

[0120] 5.4.2.8 Data Communication System In one embodiment of the present technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0121] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0122] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet or fiber optic) or a wireless protocol (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0123] In one embodiment, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth® or consumer infrared protocol).

[0124] In one embodiment, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by appropriately authorized persons (e.g., clinicians).

[0125] The local external device 4288 may be a personal computer, a mobile phone, a tablet, or a remote control.

[0126] 5.4.2.9 Optional Display, Output Device including Alarms The output device 4290 according to this technology can take one or more forms among visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0127] 5.4.2.9.1 Display Driver The display driver 4292 receives, as input, characters, symbols, or images to be displayed on the display 4294 and converts them into commands to display these characters, symbols, or images on the display 4294.

[0128] 5.4.2.9.2 Display The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an 8-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the number "0") into 8 logic signals indicating whether each of the 8 segments should be activated to display a specific character or symbol.

[0129] 5.4.3 RPT Device Algorithm As described above, in some forms of this technology, the central control device 4230 can be configured to implement one or more algorithms 4300 represented as a computer program recorded in a non-transitory computer-readable recording medium (e.g., the memory 4260). This algorithm 4300 is generally grouped into groups called modules (see, for example, FIG. 5F).

[0130] 5.4.3.1 Preprocessing Module The preprocessing module 4310 according to one embodiment 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 process steps for calculating one or more output values. These output values are used as input to another module (e.g., the treatment engine module 4320).

[0131] In one embodiment of the present technology, the output values include the interface or mask pressure Pm, the respiratory flow Qr, and the leak flow Ql.

[0132] In various embodiments of the present technology, the preprocessing 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.

[0133] 5.4.3.1.1 Pressure Compensation In one embodiment of the present technology, the pressure compensation algorithm 4312 receives, as input, a signal indicating the pressure in the pneumatic path proximal to the outlet of the pneumatic block. The pressure compensation algorithm 4312 estimates the pressure drop through the air circuit 4170 and provides, as output, the estimated pressure Pm in the patient interface 3000.

[0134] 5.4.3.1.2 Estimation of Ventilation Flow In one embodiment of the present technology, the ventilation flow estimation algorithm 4314 receives, as input, the estimated pressure Pm in the patient interface 3000, and estimates the ventilation flow Qv of air from the ventilation holes 3400 in the patient interface 3000.

[0135] 5.4.3.1.3 Estimation of Leak Flow In one embodiment of the present technology, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt and the ventilation flow rate Qv as inputs and provides an estimation of the leakage flow rate Ql as an output. In one embodiment, the leakage flow rate estimation algorithm estimates the leakage flow rate Ql by calculating the difference average between the total flow rate Qt and the ventilation flow rate Qv over a period long enough to include several respiratory cycles (e.g., about 10 seconds).

[0136] In one embodiment, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm in the patient interface 3000 as inputs and provides the leakage flow rate Ql as an output by calculating the leakage conductance and determining the leakage flow rate Ql as a function of the leakage conductance and the pressure Pm. The leakage conductance is calculated as the quotient of the low-pass filtered non-ventilation flow rate equal to the difference between the total flow rate Qt and the ventilation flow rate Qv and the low-pass filtered square root of the pressure Pm, and the low-pass filter time constant has a sufficient value to include several respiratory cycles (e.g., about 10 seconds). The leakage flow rate Ql can be estimated as a function of the product of the leakage conductance and the pressure Pm.

[0137] 5.4.3.1.4 Respiratory Flow Rate Estimation In one embodiment of the present technology, the respiratory flow rate estimation algorithm 4318 receives the total flow rate Qt, the ventilation flow rate Qv, and the leakage flow rate Ql as inputs and estimates the air respiratory flow rate Qr to the patient by subtracting the ventilation flow rate Qv and the leakage flow rate Ql from the total flow rate Qt.

[0138] 5.4.3.2 Treatment Engine Module In one embodiment of the present technology, the treatment engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 and the air respiratory flow rate Qr to the patient as inputs and provides one or more treatment parameters as outputs.

[0139] In one embodiment of the present technology, the treatment parameter is the treatment pressure Pt.

[0140] In one form of the technology, the treatment parameter is one or more of the amplitude of the pressure change, the base pressure, and the target ventilation.

[0141] In various forms, the treatment engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limit determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and treatment parameter determination 4329.

[0142] 5.4.3.2.1 Phase determination In one form of the technology, the RPT device 4000 does not determine the phase.

[0143] In one form of the technology, the phase determination algorithm 4321 receives a signal indicative of the respiratory flow rate Qr as an input and provides the phase of the current respiratory cycle of the patient 1000 as an output Φ.

[0144] In some forms, the phase output Φ, known as discrete phase determination, is a discrete variable. According to one embodiment of the discrete phase determination, a binary phase output Φ having values of inhalation or exhalation is obtained. This value is represented as values of 0 rotations and 0.5 rotations respectively when the start of spontaneous inhalation and exhalation is detected. The RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination. This is because the trigger point and the cycle point are the instants when the phase changes from exhalation to inhalation and from inhalation to exhalation respectively. In one embodiment of the binary phase determination, the phase output Φ has a discrete value of 0 when the respiratory flow rate Qr has a value exceeding a positive threshold (thereby "triggering" the RPT device 4000), and has a discrete value of 0.5 rotations when the value of the respiratory flow rate Qr is a negative value greater than the negative threshold (thereby "cycling" the RPT device 4000). The inhalation time Ti and the exhalation time Te can be typical values estimated over many respiratory cycles of the time spent with the phase Φ equal to 0 (indicating inhalation) and 0.5 (indicating exhalation) respectively.

[0145] According to another embodiment of the discrete phase determination, a three - valued phase output Φ having one value among inhalation, a pause during inhalation, and exhalation is obtained.

[0146] In other forms, the phase output Φ, known as continuous phase determination, is a continuous variable and varies, for example, between 0 rotations and 1 rotation or 0 and 2π radians. The RPT device 4000 that performs continuous phase determination can trigger and cycle when the continuous phase reaches 0 rotations and 0.5 rotations respectively. In one embodiment of the continuous phase determination, the continuous value Φ of the phase is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous value of the phase determined in this embodiment is often called the "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr: 1. When the respiratory flow rate suddenly increases after becoming zero, the phase is 0 rotations. 2. When the respiratory flow rate is a large positive value and stable, the phase is 0.25 rotations. 3. When the respiratory flow rate is zero and rapidly decreasing, the phase is 0.5 rotations. 4. When the respiratory flow rate is a large negative value and stable, the phase is 0.75 rotations. 5. When the respiratory flow rate is zero and stable, and the absolute value of the 5 - second low - pass filtered respiratory flow rate is large, the phase is 0.9 rotations. 6. When the respiratory flow rate is positive and the phase is exhalation, the phase is 0 rotations. 7. When the respiratory flow rate is negative, the phase is inhalation, and the phase is 0.5 rotations. 8. When the absolute value of the 5 - second low - pass filtered respiratory flow rate is large, the phase increases at a constant rate equal to the patient's respiratory rate low - pass filtered by a time constant of 20 seconds.

[0147] The output of each rule can be represented as a vector where the phase is the result of the rule and the magnitude is within the fuzzy range for which the rule is true. Fuzzy ranges such as "large" and "stable" for the respiratory flow rate are determined by appropriate membership functions. The results of the rules are represented as vectors and then combined by several functions such as taking the centroid. In such combinations, the rules may be weighted equally or weighted in different ways.

[0148] In another embodiment of continuous phase determination, the phase Φ is first estimated individually from the respiratory flow rate Qr as described above, similar to the inhalation time Ti and exhalation time Te. The continuous phase Φ at any instant is determined as the value obtained by adding half of the ratio of the inhalation time Ti elapsed from the previous trigger instant or 0.5 rotations to the ratio of the exhalation time Te elapsed from the previous cycle instant (whichever is the more recent instant).

[0149] 5.4.3.2.2 Waveform determination In one aspect of the present technology, the treatment parameter determination algorithm 4329 provides a substantially constant treatment pressure throughout the patient's respiratory cycle.

[0150] In another aspect of the present technology, the treatment control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that varies as a function of the phase Φ of the patient respiratory cycle according to the waveform template Π(Φ).

[0151] In one aspect of the present technology, the waveform determination algorithm 4322 provides the waveform template Π(Φ). The waveform template has values within the range of [0, 1] for the range of phase values Φ provided by the phase determination algorithm 4321 that is intended to be used by the treatment parameter determination algorithm 4329.

[0152] In one aspect, suitable for a phase that takes values either discretely or continuously, the waveform template Π(Φ) is a square wave template, having a value of 1 for phase values up to 0.5 rotations and a value of 0 for phase values exceeding 0.5 rotations. In one aspect, suitable for a phase that takes values continuously, the waveform template Π(Φ) includes two smoothly curved portions (i.e., a smooth (e.g., rising cosine) rise from 0 to 1 for phase values up to 0.5 rotations and a smooth (e.g., exponential) decrease from 1 to 0 for phase values exceeding 0.5 rotations). In one aspect, suitable for a phase that takes values continuously, 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” lower than 0.5 rotations and a smooth decrease from 1 to 0 for phase values within the “fall time” after 0.5 rotations, having a “fall time” lower than 0.5 rotations.

[0153] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates according to the settings of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table value Π for the phase value Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) "on the fly" using a predetermined functional form (possibly parameterized by one or more parameters, such as the time constant of an exponentially curved portion). The parameters of the functional form may be predetermined or may depend on the current state of the patient 1000.

[0154] In some forms of the present technology suitable for discrete binary phases of inspiration (Φ = 0 revolutions) or expiration (Φ = 0.5 revolutions), the waveform determination algorithm 4322 calculates the waveform template Π "on the fly" as a function of the discrete phase Φ and time t measured from the most recent trigger instant. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) in two parts (inspiration and expiration) as follows.

Equation

[0155] Here, Πi(t) and Πe(t) are the inspiration and expiration parts of the waveform template Π(Φ,t). In one such form, the inspiration part Πi(t) of the waveform template is a smooth rise from 0 to 1 parameterized by the rise time, and the expiration part Πe(t) of the waveform template is a smooth fall from 1 to 0 parameterized by the fall time.

[0156] 5.4.3.2.3 Ventilation determination In one form of the present technology, the ventilation determination algorithm 4323 receives the respiratory flow rate Qr as an input and determines a measurement indicative of the current patient ventilation Vent.

[0157] In some embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is an estimate of actual patient ventilation. As one such embodiment, it may take half the absolute value of the respiratory flow rate Qr, which is optionally filtered by a low-pass filter (e.g., a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).

[0158] In other embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is largely proportional to actual patient ventilation. In one such embodiment, the peak respiratory flow rate Qpeak is estimated at the inspiratory portion of the cycle. Through the above and many other procedures including sampling of the respiratory flow rate Qr, measurements that are largely proportional to ventilation are obtained, but in the case of these measurements, the fluctuations in the flow waveform shape are not so large (where the shapes of two breaths are taken as being similar when the flow waveforms of the breaths normalized in time and amplitude are similar). To give some simple examples, there are the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow rates. Any linear combination of any order statistics of the absolute value of the respiratory flow rate using positive coefficients (and even some using both positive and negative coefficients) is generally proportional to ventilation. As another example, it is the average of the respiratory flow rate at the central K-th percentage of the inspiratory portion (in terms of time), where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are highly proportional to ventilation.

[0159] 5.4.3.2.4 Determination of Inspiratory Flow Limitation In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the range of inspiratory flow limitation.

[0160] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input and provides, as an output, a measure of the range in which the inspiratory portion of the breath indicates an inspiratory flow limitation.

[0161] In one form of the present technology, the inspiratory portion of each breath is identified by a zero-crossing detector. A plurality of (e.g., 65) equally spaced points are indicative of time points and are interpolated by an interpolator along the inspiratory flow-time curve for each breath. Thereafter, the curve described by these points is scaled by a scaler to have a unit length (duration / period) and a unit area, thereby removing the effects due to changes in respiratory rate and depth. Next, the scaled breath is compared in a comparator with a pre-stored template (similar to the inspiratory portion of the breath shown in FIG. 6A) indicative of a normal unobstructed breath. At any time during inspiration, if the deviation of the breath from this template due to, for example, a cough, a sigh, a swallow, and a hiccup as determined by a test element exceeds a specified threshold (typically, 1 scale unit), the breath is rejected. For the data that was not rejected, the moving average of the first such scaled point is calculated by the central controller 4230 for several preceding inspiratory events. This is repeated for the second such point over the same inspiratory event and so on thereafter. Thus, for example, 65 scaled data points are generated by the central controller 4230, indicating the moving average of several preceding inspiratory events (e.g., 3 events). Hereinafter in this specification, the moving average of the values of continuously updated (e.g., 65) points is referred to as the "scaled flow rate" and is denoted by Qs(t). Alternatively, a single inspiratory event may be used instead of the moving average.

[0162] Two shape elements related to the determination of partial obstruction can be calculated from the scaled flow rate.

[0163] Shape element 1 is the ratio of the average of the middle (e.g., 32) scaled flow rate points to the average of the overall (e.g., 65) scaled flow rate points. If this ratio is greater than 1, the breath is considered normal. If this ratio is less than 1, the breath is considered to have an obstruction. When the ratio is about 1.17, it is considered as the threshold between partial obstruction and unobstructed breath and is equal to a level of obstruction that allows for the maintenance of appropriate oxygen supplementation in a typical patient.

[0164] Shape factor 2 is calculated as the mean square deviation from the flow rate scaled by a unit over an intermediate (e.g., 32) points. When the mean square deviation is about 0.2 units, it is regarded as normal. When the mean square deviation is zero, the respiration is regarded as overall flow-limited respiration. The closer the mean square deviation approaches zero, the more the respiration is regarded as flow-limited.

[0165] Shape factors 1 and 2 may be used alternatively or in combination. In other forms of the present technology, the number of sampled points, respiration, and intermediate points may be different from those described above. Further, the threshold value may also be different from that described above.

[0166] 5.4.3.2.5 Determination of apnea and hypopnea 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.

[0167] In one form, the apnea / hypopnea detection algorithm 4325 receives the respiratory flow signal Qr as an input and provides a flag indicating whether apnea or hypopnea has been detected as an output.

[0168] In one form, apnea is detected when the function of the respiratory flow rate Qr falls below a flow rate threshold over a predetermined period. This function may determine the peak flow rate, the average flow rate over a relatively short period, or the flow rate intermediate value of the average and peak flow rates over a relatively short period (e.g., RMS flow rate). The flow rate threshold may be a measurement of the flow rate over a relatively long period.

[0169] In one embodiment, hypopnea is detected when a function of the respiratory flow rate Qr falls below a second flow rate threshold over a predetermined period. This function may determine peak flow rate, relatively short-term average flow rate, or a flow rate intermediate value of relatively short-term average and peak flow rate (e.g., RMS flow rate). The second flow rate threshold may be a relatively long-term measurement of the flow rate. The second flow rate threshold is higher than the flow rate threshold used for apnea detection.

[0170] 5.4.3.2.6 Determination of snoring In one embodiment of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the snoring range.

[0171] In one embodiment, the snoring detection algorithm 4326 receives the respiratory flow signal Qr as an input and provides a measurement of the range in which snoring is present as an output.

[0172] The snoring detection algorithm 4326 may include the step of determining the intensity of the flow signal within the range of 30 to 300 Hz. Further, the snoring determination algorithm 4326 may include the step of filtering the respiratory flow signal Qr to reduce background noise (e.g., airflow sound in the system from a blower).

[0173] 5.4.3.2.7 Determination of airway patency In one embodiment of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the range of airway patency.

[0174] In one embodiment, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the output of the signal within a frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak within this frequency range is regarded as indicating airway opening. The absence of a peak is regarded as a sign of airway closure.

[0175] In one form, the frequency range for which the peak is sought is the frequency range that is the frequency of a small forced oscillation at the therapeutic pressure Pt. In one embodiment, the forced oscillation is at a frequency of 2 Hz with an amplitude of about 1 cmH 2 O.

[0176] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the presence or absence of a cardiac-generated signal. The absence of a cardiac-generated signal is regarded as an indication of airway closure.

[0177] 5.4.3.2.8 Determination of Target Ventilation In one form of the present technology, the central controller 4230 takes the measurement of the current ventilation Vent as an input and executes one or more target ventilation determination algorithms 4328 for determining a target value Vtgt for the ventilation measurement.

[0178] In some forms of the present technology, the target ventilation determination algorithm 4328 does not exist and the target value Vtgt is a predetermined one, obtained, for example, by hard coding at the time of configuring the RPT device 4000 or by manual input through the input device 4220.

[0179] 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.

[0180] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value that is a high percentage and less than the typical recent ventilation Vtyp. Such a high percentage of such forms can be within the ranges (80%, 100%), or (85%, 95%), or (87%, 92%).

[0181] In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value slightly above a multiple of 1 of the typical recent ventilation Vtyp.

[0182] A typical recent ventilation Vtyp is a value around which measurements of the current ventilation Vent over a plurality of time instants over some predetermined time scale are distributed and tend to cluster (i.e., a measure of the central tendency of the measurements of the current ventilation in the recent history). In one embodiment of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case must be longer than the time scale of the chain - Stokes increasing and decreasing cycles. The target ventilation determination algorithm 4328 can determine a typical recent ventilation Vtyp from the measurements of the current ventilation Vent using any of a variety of well - known measures of central tendency. One such measure is the low - pass filter output for the measurements of the current ventilation Vent, with a time constant equal to 100 seconds.

[0183] 5.4.3.2.9 Determination of treatment parameters In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for the determination of one or more treatment parameters using values returned from one or more of the other algorithms in the treatment engine module 4320.

[0184] 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 following equation.

Equation

[0185] Where: ● A is the amplitude, ● Π(Φ,t) is the waveform template value (in the range from 0 to 1) at the current value Φ of the phase and time t, ● P0 is the base pressure.

[0186] When the waveform determination algorithm 4322 provides the waveform template Π(Φ) as a look-up table of values Π indexed by the phase Φ, the treatment parameter determination algorithm 4329 locates the nearest look-up table input for the current value Φ of the phase returned from the phase determination algorithm 4321 or applies equation (1) otherwise between two inputs straddling the current value Φ of the phase.

[0187] The values of the amplitude A and the base pressure P0 can be set by the treatment parameter determination algorithm 4329 according to the respiratory pressure treatment mode selected as follows.

[0188] 5.4.3.3 Treatment control module The treatment control module 4330 according to one aspect of the present technology receives, as an input, the treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 and controls the pressure generator so as to deliver an air flow from the pressure generator 4140 according to these treatment parameters.

[0189] In one form of the present technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator so as to send an air flow in which the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt from the pressure generator 4140.

[0190] 5.4.3.4 Detection of failure states In one form of the present technology, the central controller 4230 executes one or more methods 4340 for the detection of failure states. The failure states detected by the one or more methods 4340 may include at least one of the following: ● Power outage (no power or insufficient power) ● Detection of converter failure ● Failure to detect the presence of a component ● Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2) ● Failure to test warnings to generate detectable warning signals.

[0191] When a fault condition is detected, the corresponding algorithm 4340 signal signals the presence of a fault by one or more of the following: ● Initiation of audible, visual and / or kinetic (e.g., vibratory) warnings ● Sending a message to an external device ● Logging of incidents

[0192] 5.5 Air circuit The air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000) during use.

[0193] Specifically, the air circuit 4170 can be in fluid connection with 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 limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0194] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., for maintaining or increasing the air temperature). The heating element can take the form of a heating wire circuit and can include one or more transducers (e.g., temperature sensors). In one form, the heating wire circuit can be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller (e.g., the central controller 4230). An example of an air circuit 4170 including a heating wire circuit is described in Patent Document 7. The entire content of this document is incorporated herein by reference for reference purposes.

[0195] 5.5.1 Oxygen delivery In one form of the technology, the supplemental oxygen 4180 can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0196] 5.6 Humidifier 5.6.1 Overview of the Humidifier In one form of the technology, a humidifier 5000 is provided for varying the absolute humidity of air or gas to be delivered to a patient relative to ambient air (e.g., as shown in FIG. 5C). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air flow before delivery to the patient airway.

[0197] The humidifier 5000 can include a humidifier reservoir 5110, a humidifier inlet for receiving the air flow, and a humidifier outlet for delivering the humidified air flow. The humidifier 5000 can further include a humidifier base. The humidifier base can be adapted to receive the humidifier reservoir and can include a heating element.

[0198] 5.6.2 RPT Device and Humidifier FIGS. 6-8 illustrate a humidifier 6000 according to an embodiment of the technology. In the illustrated example, the humidifier 6000 includes a water reservoir dock 6050 structured and arranged to receive a water reservoir 6100. In the illustrated example, the humidifier 6000 is integrated with an RPT device 7000 such that components performing the functions of the RPT device 7000 and components performing the functions of the humidifier 6000 are included in the pneumatic block 7100 of the RPT device 7000. For example, as shown in FIG. 8, the reservoir dock 6050 is integrated with the pneumatic block 7100 of the RPT device to provide an integrated unit, and the reservoir dock 6050 is structured and arranged to receive the water reservoir 6100.

[0199] In another arrangement, it should be understood that the humidifier 6000 (e.g., the reservoir dock 6050) may be separately provided in the RPT device 7000. In such an arrangement, an additional interface may be used to connect the humidifier 6000 (e.g., the reservoir dock 6050) to the RPT device 7000.

[0200] The RPT device 7000 includes a blower 7200B1 or 7200B2 within the pneumatic block 7100 (see, for example, FIGS. 30 and 46). Each blower is structured and arranged to generate an air flow or supply at a positive pressure (e.g., in the range of about 2 to 50 cmH 2 O). Each blower is operable to draw in an air supply into the pneumatic block 7100 (e.g., through one or more inlet openings of the pneumatic block) at its inlet (the blower inlet) and provide a pressurized air supply at its outlet (the blower outlet). The blower outlet communicates with the humidifier 6000 (e.g., the inlet of the water reservoir 6100).

[0201] The pneumatic block 7100 according to an example of the present technology is configured and arranged to support different blowers, for example, according to the required treatment. In the illustrated example, the pneumatic block 7100 is configured and arranged to support one selected from at least two different blowers 7200B1 or 7200B2 (see, for example, FIGS. 30 and 46). For example, the pneumatic block 7100 may be configured and arranged to support a blower 7200B1 of a first type (e.g., configured for CPAP or APAP treatment), and the pneumatic block 7100 may be configured and arranged to support a blower 7200B2 of a second type (e.g., configured for bilevel treatment). However, it should be understood that the pneumatic block 7100 may be configured and arranged to support one selected blower or more than two different blowers. In one embodiment, each blower may also include a single-stage design or a multi-stage design (e.g., a design with two or more stages).

[0202] Pneumatic block As shown in FIGS. 8 to 15, the pneumatic block 7100 includes a chassis assembly 7300 including an upper chassis or upper chassis 7300T (also referred to as an upper case or upper case), and a lower chassis or lower chassis 7300B (also referred to as a lower case or lower case). The chassis assembly 7300 includes a chassis inlet 7310, for example, in the lower chassis 7300B, and a chassis outlet 7320, for example, in the upper chassis 7300T. In an example, the pneumatic block 7100 can be enclosed by an external housing 8002 including one or more panels and / or one or more user inputs / displays (see, for example, FIGS. 6 and 7).

[0203] For example, depending on the required treatment, the chassis assembly 7300 supports and / or houses internal components of the pneumatic block 7100 (for example, a selected blower sub-assembly 7400SUB1 or 7400SUB2 each including a blower 7200B1 or 7200B2 and a corresponding support structure 7500SS1 or 7500SS2). The chassis assembly 7300 also supports a printed circuit board assembly (PCBA) 7600.

[0204] The chassis assembly 7300 and the internal components of the pneumatic block (for example, the selected blower sub-assembly 7400SUB1 or 7400SUB2) cooperate to form a pneumatic airflow path extending 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.

[0205] As described below, the pneumatic airflow path includes a serpentine path extending from the chassis inlet 7310 to the chassis outlet 7320. This serpentine path can extend in more than one plane. The pneumatic airflow path can be different, for example, depending on the selected blower sub-assembly 7400SUB1 or 7400SUB2 supported within the chassis assembly 7300.

[0206] Also, the chassis assembly 7300 and internal components (e.g., the selected blower sub - assemblies 7400SUB1 or 7400SUB2 of the pneumatic block) cooperate to form a plurality of chambers along the air flow path, for example, to reduce the noise output from the RPT device 7000.

[0207] Chassis assembly The upper chassis 7300T and the lower chassis 7300B are interconnected to form a pneumatic - block cavity 7350. The pneumatic - block cavity 7350 is structured and arranged to support the selected blower sub - assembly 7400SUB1 or 7400SUB2.

[0208] In addition, the upper chassis 7300T and the lower chassis 7300B are interconnected to form a reservoir dock 6050 configured to receive the water reservoir 6100.

[0209] As best shown in FIGS. 10, 11, 14, and 15, the upper chassis 7300T includes a pneumatic - block portion 7350T that forms part of the pneumatic - block cavity 7350 and a dock portion 6050T that forms part of the reservoir dock 6050. As best shown in FIGS. 12, 13, 14, and 15, the lower chassis 7300B includes a pneumatic - block portion 7350B that forms the lower part of the pneumatic - block cavity 7350 and a dock portion 6050B that forms part of the reservoir dock 6050.

[0210] In the illustrated example, the upper chassis 7300T and the lower chassis 7300B include the same materials. For example, the upper chassis 7300T includes a first part or base mold 7301T composed of a relatively hard material (e.g., a thermoplastic polymer (e.g., PC, ABS)), and a second part or overmold 7302T provided on the first part 7301T (e.g., by overmolding) and composed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone). In the illustrated embodiment, the overmold 7302T is provided on the inner surface of the base mold 7301T along the pneumatic block portion 7350T (inner skin), but it should be understood that the overmold can be provided on other surfaces of the base mold.

[0211] Similarly, the lower chassis 7300B includes a first part or base mold 7301B composed of a relatively hard material (e.g., a thermoplastic polymer (e.g., PC, ABS)), and a second part or overmold 7302B provided on the first part 7301B (e.g., by overmolding) and composed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone). In the illustrated embodiment, the overmold 7302B is provided on the inner surface of the base mold 7301B along the pneumatic block portion 7350B (inner skin), but it should be understood that the overmold can be provided on other surfaces of the base mold.

[0212] As best shown in FIGS. 14 and 15, the overmolds 7302T and 7302B on the upper chassis 7300T and the lower chassis 7300B can provide noise attenuation characteristics for attenuating wall radiation noise and sealing characteristics for providing a sealing interface (i.e., a sealed pneumatic block cavity 7350) between the upper chassis and the lower chassis.

[0213] In another example, the upper chassis 7300T and the lower chassis 7300B may include different materials. For example, the upper chassis 7300T includes 10% glass-filled PC, and the lower chassis 7300B includes PC / ABS.

[0214] The upper wall of the upper chassis 7300T is structured and arranged to support the PCBA 7600 (see, for example, FIG. 8). As described below, since an opening is included in the upper wall, sensors on the PCBA 7600 (e.g., flow sensors, pressure sensors) can protrude into the pneumatic block cavity 7350 and communicate with the pneumatic block cavity 7350.

[0215] The upper 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 reservoir dock 6050. The upper chassis 7300T also includes an opening 7330. The opening 7330 supports one or more components configured and arranged to enable communication between the outlet of the water reservoir 6100 and the air circuit 4170.

[0216] The lower chassis 7300B includes sidewalls having a plurality of inlet openings 7340 that provide a chassis inlet 7310. The plurality of openings 7340 allow for sufficient air flow while avoiding the intrusion of larger objects. The recessed chamber 7342 is provided in the lower chassis 7300B that communicates with the plurality of openings 7340. The concave chamber 7342 leads to a long inlet pipe 7345 that communicates with the pneumatic block cavity 7350. In use, when air flows into the concave chamber 7342 through the plurality of openings 7340, it flows from the concave chamber 7342 through the long inlet pipe 7345 into the pneumatic block cavity 7350. In an example, the sidewall including the inlet opening 7340 may take the form of a removable door and is structured and arranged to hold and support an inlet air filter (in a removable manner) within the concave chamber 7342. In use, the inlet air filter is arranged to filter the air entering the pneumatic block cavity 7350. Also, the inlet air filter may be structured to reduce the radiated noise returning through the chassis inlet 7310.

[0217] The upper chassis 7300T and the lower chassis 7300B each include a structure for arranging and supporting at least two different blower sub-assemblies 7400SUB1 or 7400SUB2 respectively. For example, as shown in FIGS. 10-13, the upper chassis 7300T includes internal positioning grooves 7360T1 and 7360T2 (e.g., formed by spaced sidewalls respectively), and the lower chassis 7300B includes internal positioning grooves 7360B1 and 7360B2 (e.g., formed by spaced sidewalls respectively). The internal positioning grooves 7360T1, 7360T2, 7360B1, and 7360B2 are each structured and arranged to receive and support each plate of the blower sub-assembly 7400SUB1 or 7400SUB2.

[0218] The lower chassis 7300B includes internal ribs 7365 that are axially arranged with a space between the internal positioning groove portions (see, for example, FIGS. 12 and 13). In one example, the internal ribs 7365 are structured and arranged to at least partially surround the blower 7200B2 of the blower sub-assembly 7400SUB2 (such as to increase the rigidity of the case and obtain support, shock resistance, and / or damping characteristics for the blower). In an example, the upper chassis 7300T may also include one or more internal ribs (for example, for the rigidity of the case and support of the blower).

[0219] Also, the side walls of the lower chassis 7300B are structured and arranged to provide a support structure for the chassis plate 7510SS1 of the blower sub-assembly 7400SUB1. For example, the side walls of the lower chassis 7300B include one or more support surfaces, ledges, and / or ribs along the periphery of the pneumatic block portion 7350B. The pneumatic block portion 7350B is arranged to engage with the chassis plate 7510SS1 of the blower sub-assembly 7400SUB1 and support the chassis plate 7510SS1 of the blower sub-assembly 7400SUB1.

[0220] In an example, the reservoir dock 6050 formed by the upper chassis 7300T and the lower chassis 7300B may include a guide structure 6060 for facilitating the alignment and connection of the water reservoir 6100. For example, on each side of the reservoir dock 6050, a guide structure 6060 in the form of a rail for defining an assembly path for the water reservoir 6100 may be included (see, for example, FIG. 7).

[0221] The upper chassis 7300T and the lower chassis 7300B can be connected to each other in any suitable manner (such as mechanical fasteners, mechanical couplings, and / or snap-fit connections).

[0222] Blower sub-assembly As described above, the chassis assembly 7300 is configured to position and support one selected from at least two different blower sub-assemblies 7400SUB1 or 7400SUB2 that are structurally different from each other (e.g., according to the required treatment) in at least one aspect. That is, the chassis assembly 7300 includes common components between a first configuration and a second configuration of the RPT device. That is, the first blower sub-assembly 7400SUB1 is included in the first configuration, and the second blower sub-assembly 7400SUB2 is included in the second configuration.

[0223] The first blower sub-assembly 7400SUB1 includes a first type of blower 7200B1 (e.g., configured for CPAP or APAP treatment). The second blower sub-assembly 7400SUB2 includes a second type of blower 7200B2 (e.g., configured for bilevel treatment). As described below, the air flow path and chamber arrangement configuration along the air flow path are different according to the selected blower sub-assembly 7400SUB1 or 7400SUB2 supported within the chassis assembly 7300.

[0224] The first blower sub-assembly As shown in FIGS. 16 to 19, the first blower sub-assembly 7400SUB1 includes a first blower 7200B1 and a support structure 7500SS1 for supporting the first blower 7200B1 within the chassis assembly 7300.

[0225] In the illustrated example, the first blower 7200B1 includes a three-stage design constructed and arranged to generate an air flow or supply at a positive pressure (e.g., up to about 30 cmH 2 O, e.g., in the range of about 4 to 30 cmH 2 O).

[0226] The first blower 7200B1 includes a housing that includes an axial air inlet 7210B1 (blower inlet) and an axial air outlet 7220B1 (blower outlet). Between the axial air inlet 7210B1 (blower inlet) and the axial air outlet 7220B1 (blower outlet), 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) are arranged in three stages. However, other suitable impeller arrangements are possible. Following each impeller, a set of stator vanes is provided that is constructed and configured to direct the airflow to the next stage. The blower housing is relatively rigid and forms a substantially sealed structure that is structured and arranged to hermetically separate the airflow through the interior of the first blower from the air pressure block cavity.

[0227] A further example and details of the first blower 7200B1 are described in PCT Publication No. WO2013 / 020167. In this specification, the entire document is incorporated by reference for all purposes.

[0228] The support structure 7500SS1 includes a chassis plate 7510SS1, an outlet plate assembly 7530SS1, and a flow plate assembly 7550SS1.

[0229] The flow plate assembly 7550SS1 includes a base plate 7552SS1, a flow tube array 7554SS1, and a blower suspension device 7556SS1 (inlet end suspension device) supported within an opening provided in the base plate 7552SS1. Additionally, a sealing lip or sealing flange 7558SS1 is provided along the edge or perimeter of the base plate 7552SS1.

[0230] In one embodiment, the base plate 7552SS1 and the flow tube array 7554SS1 include a first portion or base mold formed of a relatively rigid material (e.g., a thermoplastic polymer), and the blower suspension device 7556SS1 and the sealing lip 7558SS1 include a second portion or overmold provided on the first portion (e.g., by overmolding) and formed of a relatively soft material (e.g., TPE or silicone).

[0231] In one embodiment, the flow plate assembly 7550SS1 is provided as a separate and distinguishable structure from the chassis plate 7510SS1 and is then connected thereto. For example, the chassis plate 7510SS1 includes positioning grooves 7512SS1 (e.g., formed by spaced side walls) for positioning and supporting the flow plate assembly 7550SS1. As shown, the base plate 7552SS1 of the flow plate assembly 7550SS1 extends generally perpendicular to the chassis plate 7510SS1 when connected to the chassis plate 7510SS1. Also, the base plate 7552SS1 of the flow plate assembly 7550SS1 can be fixed to the chassis plate 7510SS1 via, for example, a clip structure (e.g., flexible tabs on the base plate 7552SS1 inserted into each opening on the chassis plate 7510SS1).

[0232] The outlet plate assembly 7530SS1 includes a base plate 7532SS1 and a blower suspension device 7536SS1 (outlet end suspension device) supported within an opening provided in the base plate 7532SS1. In addition, a sealing lip or sealing flange 7538SS1 is provided along the edge or periphery of the base plate 7532SS1.

[0233] In an example, the outlet plate assembly 7530SS1 is formed as a one-piece with the chassis plate 7510SS1. As shown, the base plate 7532SS1 extends generally perpendicular to the chassis plate 7510SS1.

[0234] The chassis plate 7510SS1 includes the flow tube 7515SS1. In this example, the flow tube 7515SS1 includes an axis that extends generally perpendicular to the chassis plate 7510SS1.

[0235] In one embodiment, the chassis plate 7510SS1 and the base plate 7532SS1 include a first part or base mold made of a relatively rigid material (e.g., a thermoplastic polymer), and the blower suspension 7536SS1 and the sealing lip 7538SS1 include a second part or overmold provided (e.g., by overmolding) onto the first part and made of a relatively soft material (e.g., TPE or silicone).

[0236] Also, the sealing lip or sealing flange 7518SS1 can be provided along the edge or periphery of the chassis plate 7510SS1 (e.g., an overmold made of a relatively soft material (e.g., TPE or silicone)).

[0237] 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 blower suspension devices 7556SS1, 7536SS1. The blower suspension devices 7556SS1, 7536SS1 cooperate to support the first blower 7200B1 within the chassis assembly 7300, provide sealing of the air path, isolate the vibration of the first blower 7200B1, and provide shock resistance. The blower suspension devices 7556SS1, 7536SS1 may provide additional springs and damping to enable vibration isolation and shock resistance. Specifically, the flow plate assembly 7550SS1 provides an inlet end suspension device 7556SS1 that supports the first blower 7200B1 adjacent to the blower inlet 7210B1, and the outlet plate assembly 7530SS1 provides an outlet end suspension device 7536SS1 that supports the first blower 7200B1 adjacent to the blower outlet 7220B1 (i.e., the suspension devices are provided at each end of the first blower 7200B1). Such an arrangement also provides a key feature for ensuring repeatable alignment within the first blower sub-assembly 7400SUB1 of the first blower 7200B1.

[0238] In an example, as shown in FIGS. 16 and 18, the base plate 7552SS1 of the flow plate assembly 7550SS1 and / or the base plate 7532SS1 of the outlet plate assembly 7530SS1 may each include one or more flanges 7560SS1 along the periphery of the blower suspension devices 7556SS1 and 7536SS1 so as to function as a rigid stop or a bump stop that limits the range of movement enabled, for example, by the blower suspension devices 7556SS1 and 7536SS1.

[0239] In an example, the first blower 7200B1 can be inserted into or otherwise assembled to the flow plate assembly 7550SS1, and then the first blower 7200B1 is inserted into or assembled to the outlet plate assembly 7530SS1. As described above, (i.e., by positioning and fixing the base plate 7552SS1 of the flow plate assembly 7550SS1 within the positioning groove portion 7512SS1 of the chassis plate 7510SS1), the first blower sub-assembly 7400SUB1 can be formed by fixing the flow plate assembly 7550SS1 to the chassis plate 7510SS1.

[0240] In addition, for increasing acoustic resistance and reducing noise, an acoustic foam (i.e., the outlet foam 7570SS1) is held by the chassis plate 7510SS1. In the illustrated example, the chassis plate 7510SS1 includes a retaining arm 7513SS1 adapted to engage within a slot provided to the outlet foam 7570SS1. Assembly of the First Blower Sub-Assembly to the Chassis Assembly

[0241] The first blower sub-assembly 7400SUB1 is assembled to the chassis assembly 7300 so as to form a first configuration 7100 of the pneumatic block (e.g., one configured for CPAP or APAP therapy, for example).

[0242] Figures 20 to 24 show the assembly of the first blower sub-assembly 7400SUB1 to the chassis assembly 7300. As shown in Figure 20, the acoustic foam (i.e., the inlet foam 7700) is placed into the pneumatic block portion 7350B of the lower chassis 7300B for increasing acoustic resistance and reducing noise. In the illustrated example, the inlet foam 7700 includes a generally U-shaped configuration adapted to extend along the side walls of the pneumatic block portion 7350B. Next, as shown in Figures 20 and 21, the first blower sub-assembly 7400SUB1 is lowered onto the lower chassis 7300B along the outlet foam 7570SS1 held to the first blower sub-assembly 7400SUB1. As shown in Figures 22 and 23, the edges of the chassis plate 7510SS1 are supported along the periphery of the pneumatic block portion 7350B by one or more of a support surface, ledge, and / or rib. Additionally, a support plate 7519SS1 may be provided on the lower side of the chassis plate 7510SS1. The support plate 7519SS1 is arranged to engage with the lower wall of the lower chassis 7300B to further support the first blower sub-assembly 7400SUB1 within the lower chassis 7300B (see, for example, Figure 30).

[0243] Thereafter, as shown in Figure 22, by lowering the upper chassis 7300T onto the lower chassis 7300B, the base plate 7552SS1 of the flow plate assembly 7550SS1 and the base plate 7532SS1 of the outlet plate assembly 7530SS1 are engaged within each internal positioning groove portion 7360T1 and 7360T2 in the upper chassis 7300T, enabling the first blower sub-assembly 7400SUB1 to be positioned and supported within the upper chassis 7300T. The upper chassis 7300T and the lower chassis 7300B may be held to each other in any suitable manner, for example, via mechanical fasteners (e.g., screws) and / or retaining clips.

[0244] Finally, as shown in FIG. 24, the PCBA 7600 is attached to the upper wall of the upper chassis 7300T, for example, via mechanical fasteners (e.g., screws), outside the pneumatic block cavity 7350. In the illustrated example, the PCBA 7600 includes a flow sensor and a pressure sensor that communicate with the pneumatic block cavity 7350.

[0245] The electrical connection between the PCBA 7600 and the first blower 7200B1 may be made via a flexible wiring board (FCB), a flexible printed circuit (FPC), and / or a flexible flat cable (FFC) that extends from the first blower 7200B1 within the pneumatic block cavity 7350 to the PCBA 7600. Chamber Arrangement Configuration and Pneumatic Airflow Path Provided by the First Blower Subassembly

[0246] When assembled, the first blower subassembly 7400SUB1 and the chassis assembly 7300 cooperate to provide a first configuration 7100 of the pneumatic block (including three inlet muffler chambers IC1, IC2, and IC3 and an outlet chamber OC along the air flow path) (see, for example, FIG. 30).

[0247] In the illustrated example, as shown in FIGS. 26 - 33, the chassis plate 7510SS1 and the lower chassis 7300B cooperate to form the first inlet muffler chamber IC1; the chassis plate 7510SS1, the base plate 7552SS1 of the flow plate assembly 7550SS1, and the base plate 7532SS1 of the outlet plate assembly 7530SS1 and the upper chassis 7300T cooperate to form the second inlet muffler chamber IC2; the chassis plate 7510SS1, the base plate 7552SS1 of the flow plate assembly 7550SS1, and the upper chassis 7300T cooperate to form the third inlet muffler chamber IC2; the chassis plate 7510SS1, the base plate 7532SS1 of the outlet plate assembly 7530SS1, and the upper chassis 7300T cooperate to form the outlet chamber OC.

[0248] In the illustrated example, the chamber IC1, IC2, IC3 and OC are each sealed. This sealing is performed by controlling the compression against the upper chassis 7300T and the lower chassis 7300B along the peripheries of the chassis plate 7510SS1 and the base plates 7532SS1 and 7552SS1 via overmolded sealing lips 7518SS1, 7538SS1 and 7558SS1 (e.g., silicone) (see, for example, FIG. 30).

[0249] In the illustrated example (see, for example, FIG. 30), at the lower part of the RPT device 7000, a lower surface is provided that defines a lower plane BP that is substantially horizontal when the RPT device 7000 is in the operating direction. As shown, in a first configuration of the pneumatic block 7100, the first blower 7200B1 is arranged such that the axis AX1 of the first blower 7200B1 (extending through the air inlet 7210B1 and the air outlet 7220B1) is parallel to the lower plane BP. That is, the axis AX1 of the first blower 7200B1 extends generally in a horizontal plane when the RPT device 7000 is in the operating direction.

[0250] In the illustrated example, in the pneumatic airflow path of the first configuration of the pneumatic block 7100, a serpentine path is provided. This serpentine path extends from the chassis inlet 7310 to the chassis outlet 7320 and 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, FIGS. 30, 32 and 33).

[0251] As shown in the figure, the air flow path of the first configuration of the pneumatic block 7100 is such that air enters the chassis assembly 7300 (e.g., see FIG. 25) through the inlet opening 7340 and into the concave chamber 7342 (including, for example, the inlet air filter as discussed above), then from the concave chamber 7342 through the long inlet pipe 7345 and into the first inlet muffler chamber IC1 shown in FIG. 26. Since the long inlet pipe 7345 is relatively long, noise reduction is possible when moving from the inlet opening 7340 to the first inlet muffler chamber IC1 (due to high inertia). When a large amount of inlet foam 7700 is provided in the first inlet muffler chamber IC1, it leads to an increase in acoustic resistance and a decrease in inlet noise.

[0252] As shown in FIGS. 27 and 31, air moves from the first inlet muffler chamber IC1 to the second inlet muffler chamber IC2 through the flow tube 7515SS1 in the chassis plate 7510SS1. Since the flow tube 7515SS1 is relatively long, noise reduction is possible. As shown in the figure, the first blower 7200B1 is supported within the second inlet muffler chamber IC2 and receives air at the blower inlet 7210B1 from the third inlet muffler chamber IC3.

[0253] As shown in FIG. 28, air moves from the second inlet muffler chamber IC2 to the third inlet muffler chamber IC3 through 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.

[0254] The blower suspension device 7556SS1 of the flow plate assembly 7550SS1 can be fixed to the first blower 7200B1 in any suitable manner (for example, wound around the inlet flange provided at the blower inlet 7210B1 of the first blower 7200B1). The blower suspension device 7556SS1 provides a seal along the blower inlet 7210B1, thereby sealing the blower inlet 7210B1 from the second inlet muffler chamber IC2 and obtaining an air path for air to enter the blower inlet 7210B1 from the third inlet muffler chamber IC3. Also, in the illustrated embodiment, the blower suspension device 7556SS1 provides a structure (for example, a gasket portion) that allows flexibility and relative movement to isolate the vibration of the first blower 7200B1 and provide shock absorption.

[0255] The flow tube array 7554SS1 includes a plurality of flow tubes 7555SS1 structured and arranged to extend from the base plate 7552SS1 into the second inlet muffler chamber IC2 (for example, the flow tubes 7555SS1 extend generally 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 structured and arranged to enable the provision of laminar flow, the provision of a defined pressure drop, and the provision of a length sufficient for noise reduction.

[0256] In the illustrated example, the flow tube array 7554SS1 includes twelve spaced-apart flow tubes 7555SS1 (for example, generally arranged as three rows of four tubes). However, other suitable numbers of tubes 7555SS1 (for example, one or more flow tubes, for example, 5 to 15 flow tubes) are possible, and these tubes 7555SS1 can be arranged in other suitable manners (for example, aligned in rows and / or columns, circular arrangement configuration) and it should be understood.

[0257] In the illustrated embodiment, the plurality of flow tubes 7555SS1 each include a circular cross-sectional shape, but it should be understood that the tubes may each include other cross-sectional shapes (e.g., circular or non-circular shapes). Also, the plurality of flow tubes 7555SS1 may each include any suitable length, diameter, wall thickness, and cross-sectional area, for example, depending on the desired noise characteristics. Further, the plurality of flow tubes 7555SS1 may include flow tubes of equal length and / or of unequal length.

[0258] The first inlet muffler chamber IC1, the second inlet muffler chamber IC2, and the third inlet muffler chamber IC3 cooperate to enable compliance improvement and inlet noise reduction along the air flow path to the blower inlet 7210B1 of the first blower 7200B1.

[0259] Air flows through the first blower 7200B1 such that the air flow at positive pressure is provided at the blower outlet 7220B1 of the first blower 7200B1. The outlet chamber OC receives the pressurized air exiting the blower outlet 7220B1 of the first blower 7200B1, as shown in FIG. 29. The pressurized air from the outlet chamber OC exits the pneumatic block via the chassis outlet 7320. In the example, the outlet chamber OC of the first configuration of the pneumatic block 7100 may be a positive pressure up to about 30 cmH 2 O.

[0260] The blower suspension device 7536SS1 of the outlet plate assembly 7530SS1 can be fixed to the first blower 7200B1 in any suitable manner (for example, wound around the outlet flange provided at the blower outlet 7220B1 of the first blower 7200B1). The blower suspension device 7536SS1 provides a seal along the blower outlet 7220B1, thereby sealing the blower outlet 7220B1 from the second inlet muffler chamber IC2 and obtaining an air path for air to exit from the blower outlet 7220B1 to the outlet chamber OC. Also, in the illustrated embodiment, the blower suspension device 7536SS1 provides a structure (for example, a gasket portion) that allows flexibility and relative movement to isolate the vibration of the first blower 7200B1 and provides shock absorption.

[0261] Since the outlet chamber OC is relatively large, compliance improvement and outlet noise reduction (for example, attenuation of outlet noise or forward-conducted noise) are possible. Also, by providing an outlet foam 7570SS1 (supported by the chassis plate 7510SS1) within the outlet chamber OC, an increase in acoustic resistance and reduction of outlet noise are possible (see, for example, FIG. 30).

[0262] In an example, an acoustic foam can be provided 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, acoustic foams provided 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 provided in the first inlet muffler chamber IC1, the third inlet muffler chamber IC3, and the outlet chamber OC (that is, not provided in the second inlet muffler chamber IC2). However, it should be understood that other arrangements of the acoustic foam are possible.

[0263] In the illustrated example, when the water reservoir 6100 is received within the reservoir dock 6050, the chassis outlet 7320 may communicate with the inlet of the water reservoir 6100. In another example, the chassis outlet 7320 may communicate directly with the air circuit 4170.

[0264] Figures 57-59 are schematic diagrams schematically showing a chamber arrangement configuration offset in the vertical direction of a first configuration of a pneumatic block and a pneumatic airflow path of the first configuration of the pneumatic block. For example, as shown in FIG. 57, 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 spaced vertically upward from the first plane PL1. FIG. 58 is a schematic diagram through the first plane PL1, and FIG. 59 is a schematic diagram through the second plane PL2.

[0265] Figures 57-59 include arrows showing an exemplary airflow path through the first inlet chamber IC1, the second inlet chamber IC2, the third inlet chamber IC3, and the outlet chamber OC. As shown in FIG. 58, air enters the first inlet chamber IC1 in the first plane PL1, for example, via the chassis inlet. Next, as shown in FIG. 57, the air moves from the first inlet chamber IC1 in the first plane PL1 to the second inlet chamber IC2 in the second plane PL2, for example, via the flow tube 7515SS1. As shown in FIG. 59, the air moves from the second inlet chamber IC2 in the second plane PL2 to the third inlet chamber IC3 in the second plane PL2, for example, via the flow tube array 7554SS1. The air moves through the third inlet chamber IC3 in the second plane PL2 to the blower inlet 7210B1 of the first blower 7200B1 positioned within the second inlet chamber IC2 in the second plane PL2. The air moves through the first blower 7200B1 positioned within the second inlet chamber IC2 in the second plane PL2, as shown in FIG. 59, and exits into the outlet chamber OC in the second plane PL2. The pressurized air from the outlet chamber OC exits the pneumatic block via the chassis outlet.

[0266] As shown in FIGS. 57 to 59, the air flow path of the first configuration of the pneumatic block extends from the chassis inlet to the chassis outlet in different directions and different planes. For example, the direction of the air flow at the chassis inlet (see FIG. 58) extends in a transverse direction with respect to the direction of the air flow at the chassis outlet (see FIG. 59). Also, as shown in FIG. 59, the air generally extends in a J-shaped configuration within the second plane PL2 through the second inlet chamber IC2 and the third inlet chamber IC3 and the outlet chamber OC, and the air flow moves from the second inlet chamber IC2 to the third inlet chamber IC3 extending in a direction opposite to the air moving from the third inlet chamber IC3, passes through the blower in the second inlet chamber IC2, and moves into the outlet chamber OC.

[0267] Second blower subassembly As shown in FIGS. 34 to 38, the second blower subassembly 7400SUB2 includes a second blower 7200B2 and a support structure 7500SS2 for supporting the second blower 7200B2 within the chassis assembly 7300.

[0268] In the illustrated example, the second blower 7200B2 includes a housing including an axial air inlet 7210B2 (blower inlet) and an axial air outlet 7220B2 (blower outlet). Between the axial air inlet 7210B2 (blower inlet) and the axial air outlet 7220B2 (blower outlet), 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) are arranged in two stages. However, other suitable impeller arrangement configurations are possible. Following each impeller, a set of stator vanes is provided that is constructed and configured to direct the air flow to the next stage. 2 O, for example, in the range of about 4 to 50 cmH 2 O) to generate in a positive pressure (e.g., up to about 50 cmH

[0269] ​

[0270] In the illustrated example, the second blower 7200B2 is mounted within a suspension device 7250B2 (including, for example, silicone). The suspension device 7250B2 forms a substantially sealed structure configured and arranged to hermetically separate the air flow moving within the interior of the second blower 7200B2 from the pneumatic block cavity 7350. In addition, the shroud formed by the suspension device 7250B2 provides main features for separating blower vibrations, providing shock absorption, and ensuring repeatable alignment of the second blower 7200B2 within the second blower subassembly 7400SUB2.

[0271] A further embodiment and details of the second blower 7200B2 are described in Patent Document 5. The entire document is incorporated herein by reference for all purposes.

[0272] The support structure 7500SS2 includes an outlet plate assembly 7530SS2 and a flow plate assembly 7550SS2.

[0273] The flow plate assembly 7550SS2 includes a base plate 7552SS2, a flow tube array 7554SS2, and a blower suspension device 7556SS2 (inlet end suspension device) supported within an opening provided in the base plate 7552SS2. In addition, a sealing lip or sealing flange 7558SS2 is provided along the edge or periphery of the base plate 7552SS2.

[0274] In one embodiment, the base plate 7552SS2 and the 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 device 7556SS2 and the sealing lip 7558SS2 include a second portion or overmold provided to the first portion (e.g., by overmolding) and formed of a relatively soft material (e.g., TPE or silicone).

[0275] The outlet plate assembly 7530SS2 includes a base plate 7532SS2 and a blower suspension device 7536SS2 (outlet end suspension device) supported within an opening provided in the base plate 7532SS2. Additionally, a sealing lip or sealing flange 7538SS2 is provided along an edge or perimeter of the base plate 7532SS2.

[0276] In one embodiment, 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 device 7536SS2 and the sealing lip 7538SS2 include a second portion or overmold provided to the first portion (e.g., by overmolding) and formed of a relatively soft material (e.g., TPE or silicone).

[0277] The second blower 7200B2 is suspended by a support structure 7500SS2 between the flow plate assembly 7550SS2 and the outlet plate assembly 7530SS2. The flow plate assembly 7550SS2 and the outlet plate assembly 7530SS2 each include blower suspension devices 7556SS2, 7536SS2. The blower suspension devices 7556SS2, 7536SS2 cooperate to support the second blower 7200B1 within the chassis assembly 7300, provide an airtight seal for the air path, isolate the vibration of the second blower 7200B2, and provide shock resistance. The blower suspension devices 7556SS2, 7536SS2 may provide additional springs and damping to enable vibration isolation and shock resistance. Specifically, the flow plate assembly 7550SS2 provides an inlet end suspension device 7556SS2 that supports the second blower 7200B2 adjacent to the blower inlet 7210B2, and the outlet plate assembly 7530SS2 provides an outlet end suspension device 7536SS2 that supports the second blower 7200B2 adjacent to the blower outlet 7220B2 (i.e., the suspension devices are provided at each end of the second blower 7200B2). Such an arrangement also provides a key feature for ensuring repeatable alignment of the second blower 7200B2 within the second blower subassembly 7400SUB2.

[0278] In an example, as shown in FIGS. 37 and 38, 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 devices 7556SS2 and 7536SS2 so as to function as a rigid stop or a bump stop that limits the range of motion provided by the blower suspension devices 7556SS2 and 7536SS2.

[0279] In an example, the second blower 7200B2 can be inserted into the flow plate assembly 7550SS2 or assembled in another manner, and then the second blower 7200B2 can be inserted into the outlet plate assembly 7530SS2 or assembled in another manner. In an example, the assembly of the second blower 7200B2 to the flow plate assembly 7550SS2 can be performed using the positioning support tab 7252B2 provided on the suspension device 7250B2 (for example, by pulling the positioning support tab 7252B2 through the blower suspension device 7556SS2 to engage the inlet flange of the second blower 7200B2 with the blower suspension device 7556SS2). In an example, the assembly of the second blower 7200B2 to the outlet plate assembly 7530SS2 can be performed using the outlet fan funnel 7254B2 provided on the suspension device 7250B2 (for example, by pulling the outlet fan funnel 7254B2 through the blower suspension device 7536SS2 to engage the outlet funnel 7254B2 associated with the blower outlet of the second blower 7200B2 with the blower suspension device 7536SS2). Assembly of the Second Blower Sub - assembly to the Chassis Assembly

[0280] When the second blower sub - assembly 7400SUB2 is assembled to the chassis assembly 7300, a second configuration of the pneumatic block 7100 (configured, for example, for bilevel therapy) is formed.

[0281] Figures 39 to 41 show the assembly of the second blower sub - assembly 7400SUB2 to the chassis assembly 7300. First, as shown in Figure 39, lower the second blower sub - assembly 7400SUB2 into the lower 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 engaged within the respective internal positioning groove portions 7360B1 and 7360B2 in the lower chassis 7300B and arranged to position and support the second blower sub - assembly 7400SUB2 within the lower chassis 7300B. In addition, the internal rib 7365 provided on the lower chassis 7300B can further support the suspension device 7250B2 and the second blower 7200B2 therein within the lower chassis 7300B.

[0282] In an example, by disposing an acoustic foam (i.e., inlet foam) within the pneumatic block portion of the lower chassis 7300B, an increase in acoustic resistance and reduction of noise may be made possible.

[0283] Thereafter, as shown in Figure 40, by lowering the upper chassis 7300T onto the lower chassis 7300B, the base plate 7552SS2 of the flow plate assembly 7550SS2 and the base plate 7532SS2 of the outlet plate assembly 7530SS2 are engaged with the respective internal positioning groove portions 7360T1 and 7360T2 in the upper chassis 7300T, and the second blower sub - assembly 7400SUB2 can be positioned and supported within the upper chassis 7300T. The upper chassis 7300T and the lower chassis 7300B can be held to each other in any suitable manner, for example, via mechanical fasteners (e.g., screws) and / or retaining clips.

[0284] Finally, as shown in FIG. 41, the PCBA 7600 is attached (e.g., via mechanical fasteners (e.g., screws)) outside the pneumatic block cavity 7350 to the upper wall of the upper chassis 7300T. As described above, the PCBA 7600 includes a flow sensor and a pressure sensor arranged to communicate with the pneumatic block cavity 7350.

[0285] The electrical connection between the PCBA 7600 and the second blower 7200B2 may be made via a flexible printed circuit board (FCB), a flexible printed circuit (FPC), and / or a flexible flat cable (FFC) extending from the second blower 7200B2 within the pneumatic block cavity 7350 to the PCBA 7600. FIGS. 34 - 38 show an example of a flexible flat cable 7260B2 extending from the second blower 7200B2. The pneumatic airflow path provided by the chamber arrangement configuration and the second blower sub - assembly

[0286] When assembled, the second blower sub - assembly 7400SUB2 and the chassis assembly 7300 cooperate to provide a second configuration 7100 of the pneumatic block (including two inlet muffler chambers IC1, IC2 and an outlet chamber OC along the air flow path) (see, for example, FIG. 36).

[0287] In the illustrated example, as shown in FIGS. 42 - 48, the lower chassis 7300B, the upper chassis 7300T, the base plate 7552SS2 of the flow plate assembly 7550SS2, and the base plate 7532SS2 of the outlet plate assembly 7530SS2 cooperate to form the first inlet muffler chamber IC1; the lower chassis 7300B, the upper chassis 7300T, and the base plate 7552SS2 of the flow plate assembly 7550SS2 cooperate to form the second inlet muffler chamber IC2; and the upper chassis 7300T, the lower chassis 7300B, and the base plate 7532SS2 of the outlet plate assembly 7530SS2 cooperate to form the outlet chamber OC.

[0288] In the illustrated example, the chamber IC1, IC2, and OC are each sealed. This sealing is performed along the peripheries of the base plates 7532SS2 and 7552SS2 via overmolded sealing lips 7538SS2 and 7558SS2 (e.g., silicone), and the compression against the upper chassis 7300T and the lower chassis 7300B is controlled.

[0289] In the illustrated example (see, e.g., FIG. 46), the lower portion of the RPT device 7000 includes a lower surface that defines a lower plane BP that is substantially horizontal when the RPT device 7000 is in the operating direction. As shown, in the second configuration of the pneumatic block 7100, the second blower 7200B2 is arranged such that the axis AX2 of the second blower 7200B2 (extending through the air inlet 7210B2 and the air outlet 7220B2) is parallel to the lower plane BP. That is, the axis AX2 of the second blower 7200B2 extends generally in a horizontal plane when the RPT device 7000 is in the operating direction.

[0290] In the illustrated example, the pneumatic airflow path of the second configuration of the pneumatic block 7100 includes a serpentine path extending from the chassis inlet 7310 to the chassis outlet 7320. In the example, the airflow path extends generally in one plane (e.g., the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, and the outlet chamber OC extend in one plane (see, e.g., FIG. 46)).

[0291] As shown in the figure, the air flow path of the second configuration of the pneumatic block 7100 is such that air enters the chassis assembly 7300 through the inlet opening 7340 (see, for example, FIG. 25), and then enters the concave chamber 7342, and from the concave chamber 7342, it passes through the long inlet pipe 7345 and moves into the first inlet muffler chamber IC1 shown in FIGS. 42 and 43. Since the long inlet pipe 7345 is relatively long, noise reduction is possible when moving from the inlet opening 7340 to the first inlet muffler chamber IC1 (due to high inertia). In an example, by providing an inlet foam in the first inlet muffler chamber IC1, an increase in acoustic resistance and a reduction in inlet noise may be possible.

[0292] As shown in FIG. 44, air moves from the first inlet muffler chamber IC1 to the second inlet muffler chamber IC2 through 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 in the figure, the second blower 7200B2 is supported within the first inlet muffler chamber IC1 and receives air from the second inlet muffler chamber IC2 at the blower inlet 7210B2. In an example, by providing an inlet foam in the second inlet muffler chamber IC2, an increase in acoustic resistance and a reduction in inlet noise may be possible.

[0293] The blower suspension device 7556SS2 of the flow plate assembly 7550SS2 can be fixed to the second blower 7200B2 in any suitable manner (for example, wound around the inlet flange provided at the blower inlet 7210B2 of the second blower 7200B2). The blower suspension device 7556SS2 provides a seal along the blower inlet 7210B2, thereby sealing the blower inlet 7210B2 from the first inlet muffler chamber IC1 and obtaining an air path for air to enter the blower inlet 7210B2 from the second inlet muffler chamber IC2. Also, in the illustrated embodiment, the blower suspension device 7556SS2 provides a structure (for example, a gasket portion) that allows flexibility and relative movement to isolate the vibration of the second blower 7200B2 and provide shock absorption.

[0294] The flow tube array 7554SS2 includes a plurality of flow tubes 7555SS2 structured and arranged to extend from the base plate 7552SS2 into the first inlet muffler chamber IC1 (for example, the flow tubes 7555SS2 extend generally 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 structured and arranged to enable the provision of laminar flow, the provision of a defined pressure drop, and the provision of a length sufficient for noise reduction.

[0295] In the illustrated example, the flow tube array 7554SS2 includes twelve spaced-apart flow tubes 7555SS2 (for example, generally arranged as three tubes in four rows). However, other suitable numbers of tubes 7555SS2 (for example, one or more flow tubes, for example, 5 to 15 flow tubes) are possible, and these tubes 7555SS2 can be arranged in other suitable manners (for example, aligned in rows and / or columns, circular arrangement configurations) and it should be understood.

[0296] In the illustrated embodiment, the plurality of flow tubes 7555SS2 each include a circular cross-sectional shape, but it should be understood that the tubes 7555SS2 may each include other cross-sectional shapes (e.g., circular or non-circular shapes). Also, the plurality of flow tubes 7555SS2 may each include any suitable length, diameter, wall thickness, and cross-sectional area, for example, depending on the desired noise characteristics. Further, the plurality of flow tubes 7555SS2 may include tubes of equal length and / or tubes of unequal length.

[0297] The first inlet muffler chamber IC1 and the second inlet muffler chamber IC2 cooperate to enable improved compliance and reduction of inlet noise along the air flow path to the blower inlet 7210B2 of the second blower 7200B2.

[0298] Air flows through the second blower 7200B2 such that the air flow at positive pressure is provided at the blower outlet 7220B2 of the second blower 7200B2. The outlet chamber OC receives the pressurized air exiting from the blower outlet 7220B2 of the second blower 7200B2, as shown in FIG. 45. The pressurized air from the outlet chamber OC exits the pneumatic block via the chassis outlet 7320. In the example, the outlet chamber OC of the second configuration of the pneumatic block 7100 can be pressurized to a positive pressure of up to about 50 cmH 2 O.

[0299] The fixing of the blower suspension device 7536SS2 of the outlet plate assembly 7530SS2 to the second blower 7200B2 can be performed in any suitable manner (for example, it can be performed so as to surround the outlet funnel 7254B2 of the suspension device 7250B2 associated with the blower outlet 7220B2 of the second blower 7200B2). The blower suspension device 7536SS2 provides a seal along the blower outlet 7220B2, thereby sealing the blower outlet 7220B2 from the first inlet muffler chamber IC1 and obtaining an air path for air to exit from the blower outlet 7220B2 to the outlet chamber OC. Also, in the illustrated embodiment, the blower suspension device 7536SS2 provides a structure (for example, a gasket portion) that allows flexibility and relative movement to isolate the vibration of the second blower 7200B2 and provides shock absorption.

[0300] Since the outlet chamber OC is relatively large, compliance improvement and outlet noise reduction may be possible. Also, an acoustic foam (i.e., an outlet foam) may be provided in the outlet chamber OC so as to increase acoustic resistance and reduce outlet noise.

[0301] In an example, the acoustic foam may be provided in one or more of the first inlet muffler chamber IC1, the second inlet muffler chamber IC2, and the outlet chamber OC (for example, acoustic foams provided 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 other arrangements of the acoustic foam are possible.

[0302] In the illustrated example, when the water reservoir 6100 is received in the reservoir dock 6050, the chassis outlet 7320 may communicate with the inlet of the water reservoir 6100. In another example, the chassis outlet 7320 may communicate directly with the air circuit 4170.

[0303] Figures 60 to 61 are schematic diagrams schematically showing the chamber arrangement configuration of the second configuration of the pneumatic block and the pneumatic airflow path of the second configuration of the pneumatic block. For example, as shown in FIG. 60, 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 is a schematic diagram through the plane PL1 of FIG. 60.

[0304] FIG. 61 includes arrows indicating an exemplary airflow path through the first inlet chamber IC1, the second inlet chamber IC2, and the outlet chamber OC. As shown, air enters the first inlet chamber IC1, for example, via the chassis inlet. Next, the air moves from the first inlet chamber IC1 to the second inlet chamber IC2, for example, via the flow tube array 7554SS2. The air moves through the second inlet chamber IC2 to the blower inlet 7210B2 of the second blower 7200B2 positioned within the first inlet chamber IC1. The air moves through the second blower 7200B2 positioned within 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 the chassis outlet.

[0305] As shown in FIG. 61, the airflow path of the second configuration of the pneumatic block extends in a direction different from the direction from the chassis inlet to the chassis outlet. For example, the direction in which air flows at the chassis inlet extends transversely to the direction in which air flows at the chassis outlet. Also, as shown in FIG. 61, the airflow through the first inlet chamber IC1, the second inlet chamber IC2, and the outlet chamber OC generally extends in a J-shaped configuration, with the airflow moving from the first inlet chamber IC1 to the second inlet chamber IC2, which extends in a direction opposite to the airflow moving from the first inlet chamber IC1, and passing through the blower in the first inlet chamber IC1 and moving into the outlet chamber OC.

[0306] Flow and Pressure Sensors As described above, the PCBA 7600 includes a flow sensor 7610 and a pressure sensor 7620 for monitoring and controlling the air flow and pressure in the pneumatic block 7100. Openings or ports P1, P2, and P3 (see, for example, FIGS. 9, 15, and 50) are provided in the upper wall of the upper chassis 7300T to enable communication between the sensors 7610, 7620 and the pneumatic block cavity 7350.

[0307] In the illustrated example, as shown in FIG. 49, the flow sensor 7610 includes a pair of sensors 7610A and 7610B that communicate with each flow sensor port P1 and P2 in the upper chassis 7300T. The flow sensor ports P1 and P2 are disposed on opposite sides of the flow plate assemblies 7550SS1 and 7550SS2 (i.e., on opposite sides of the internal positioning groove 7360T1 in the upper chassis 7300T adapted to support the flow plate assemblies 7550SS1 and 7550SS2) (see, for example, FIG. 50). The pair of sensors 7610A and 7610B are sealed within each flow sensor port P1 and P2, for example, via an overmold 7302T (inner skin) provided on the inner surface of the upper chassis 7300T.

[0308] For example, as shown in FIGS. 49 and 52, an overmold 7302T of the upper chassis 7300T provides 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 in the figure, each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 provides a tubular sealing surface or interface 7306 adapted to sealingly engage along the outer surfaces of the respective flow sensors 7610A and 7610B. Chamfered edge portions 7307 provided at the outer ends of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 respectively facilitate the engagement of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 with the respective flow sensors 7610A and 7610B (i.e., the chamfered edge portions 7307 induce the respective flow sensors 7610A and 7610B to engage with the respective tubular sealing surfaces 7306).

[0309] However, the first sealing portion 7305SP1 and the second sealing portion 7305SP2 may have another geometry configured for sealing with the respective flow sensors 7610A and 7610B. For example, in another example as shown in FIG. 53, each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 provides an inner tubular portion 7312 and an outer ring portion 7314 that projects radially inward relative to the inner tubular portion 7312. At the outer ends of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 respectively, an annular groove portion 7316 is provided to provide a bending space for the outer ring portion 7314. The bending space provided by the annular groove portion 7316 is configured and arranged such that the outer ring portion 7314 elastically deforms radially outward to facilitate the engagement of the outer ring portions 7314 of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 with the respective flow sensors 7610A and 7610B. Moreover, such elastic deformation of the outer ring portion 7314 provides a biasing force for sealing the outer ring portion 7314 with the respective flow sensors 7610A and 7610B.

[0310] In the first configuration of the pneumatic block 7100, the flow sensor 7610 communicates with each flow sensor port P1 and P2 and measures the pressure drop between the second chamber IC2 and the third chamber IC3 in the pneumatic block (i.e., deflects the flow in proportion to the differential pressure between the second chamber IC2 and the third chamber IC3). That is, for the determination of the air flow rate, one 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 of the pair of sensors 7610A of the flow sensor is arranged to measure the second pressure in the third chamber IC3.

[0311] In the second configuration of the pneumatic block, the flow sensor 7610 communicates with each flow sensor port P1 and P2 and measures the pressure drop between the first chamber IC1 and the second chamber IC2 in the pneumatic block (i.e., deflects the flow in proportion to the differential pressure between the first chamber IC1 and the second chamber IC2). That is, for the determination of the air flow rate, one 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 of the pair of sensors 7610A of the flow sensor is arranged to measure the second pressure in the second chamber IC2.

[0312] In the illustrated example, as shown in FIGS. 50 and 51, the pressure sensor 7620 communicates with the pressure sensor port P3 in the upper chassis 7300T. The pressure sensor port P3 is arranged on the outlet chamber side formed by the outlet plate assemblies 7530SS1 and 7530SS2 (i.e., on the side of the internal positioning groove 7360T2 in the upper chassis 7300T adapted to support the outlet plate assemblies 7530SS1 and 7530SS2) (see, for example, FIG. 50). The pressure sensor 7620 is sealed into the pressure sensor port P3 through an overmold 7302T (inner skin) provided on the inner surface of the upper chassis 7300T.

[0313] For example, as shown in FIG. 51, a sealing portion 7308 is obtained along the pressure sensor port P3 by an overmold 7302T of the upper chassis 7300T. As shown in the figure, the sealing portion 7308 provides a tubular sealing surface or interface 7309 that is adapted to sealingly engage with the outer surface of the pressure sensor 7620.

[0314] In both the first and second configurations of the pneumatic block, the pressure sensor 7620 is arranged to measure the pressure within the outlet chamber OC in the pneumatic block, for example, measuring the static pressure perpendicular to the direction of the air flow.

[0315] In an example, a secondary pressure sensor can be provided such that, for example, a secondary measurement of the pressure in the outlet chamber OC becomes possible. In an example, if there is an abnormality in the reading of the primary pressure sensor 7620 or the secondary pressure sensor, the controller initiates a shutdown of the RPT device. Since the secondary pressure sensor can function as a backup, the RPT device does not rely on a single sensor or a single failure state, for example, for safety improvement.

[0316] FIGS. 54 - 56 show a pressure sensor seal 7800 structured and arranged to sealingly engage both the primary pressure sensor 7620 and the secondary pressure sensor 7621 provided on the PCBA 7600. In this example, the pressure sensor seal 7800 is formed from the upper chassis 7300T as a separate and distinct structure (a separately molded (e.g., silicone) component) and then connected to the upper chassis 7300T.

[0317] As shown in FIG. 55, the pressure sensor seal 7800 includes a base portion 7810, a first sealing portion 7820SP1 and a second sealing portion 7820SP2 supported by the base portion 7810, and a central connection portion 7830 that facilitates alignment and releasable connection of the pressure sensor seal 7800 to the upper chassis 7300T.

[0318] As shown in the figure, the first sealing part 7820SP1 and the second sealing part 7820SP2 each include a port engagement side 7822 and a sensor engagement side 7824. Each port engagement side 7822 provides a tubular sealing surface or interface 7823. This tubular sealing surface or interface 7823 is adapted to sealingly engage along the outer surface of each spigot 7325 for the pressure sensor ports P3 and P4 formed in the base mold 7301T of the upper chassis 7300T (e.g., thermoplastic polymer (e.g., PC, ABS)).

[0319] On each sensor engagement side 7824, a bellows - type interface 7825 with one or more folds is provided to facilitate engagement with each pressure sensor 7620 and 7621. In use, the bellows - type interface 7825 is configured and arranged to compress axially and / or flex laterally for alignment and sealing along the outer surface of each pressure sensor 7620 and 7621. The flexibility provided by such a bellows - type interface 7825 allows it to accommodate any manufacturing tolerances of the upper chassis 7300T and the PCBA7600. For example, the bellows - type interface 7825 can accommodate misalignment between the sensors 7620 and 7621 and each spigot 7325, thus avoiding situations where, for example, a forced lateral movement of the sensors 7620 and 7621 could lead to a change in the reading value or damage to the PCBA7600.

[0320] In the illustrated example, a fold extending inwardly of the bellows - type interface 7825 provides a sealing surface 7826 adapted to sealingly engage each pressure sensor 7620 and 7621.

[0321] In the illustrated example, the central connection portion 7830 provides a tubular surface or interface 7832 adapted to engage along the outer surface of the mounting strut 7327 formed in the base mold 7301T of the upper chassis 7300T. Such engagement facilitates alignment of the first sealing portion 7820SP1 and the second sealing portion 7820SP2 with each spigot 7325 of the upper chassis 7300T, and the pressure sensor seal 7800 is fixed to the upper chassis 7300T in a releasable manner (e.g., via frictional engagement).

[0322] In the illustrated example, the base portion 7810 provides a thick-walled portion along at least a part of the periphery of the pressure sensor seal 7800 adapted to be supported within the recess 7329 outside the upper chassis 7300T.

[0323] The pressure sensor seal 7800 shown in FIG. 56 is connected to the upper chassis 7300T and engages in a sealed manner with the spigots 7325 and the pressure sensors 7620 and 7621, whereby the pressure sensors 7620 and 7621 are pneumatically connected to the outlet chamber OC in the pneumatic block. As shown, an intermediate portion of each sealing portion 7820SP1 and 7820SP2 can form at least a part of the passage between each pressure sensor 7620 and 7621 and each spigot 7325 for the pressure sensor ports P3 and P4.

[0324] In another example, one or more portions of the pressure sensor seal 7800 can be integrated with the overmold 7302T of the upper chassis 7300T.

[0325] 5.6.3 Humidifier Component 5.6.3.1 Water Reservoir According to one arrangement configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification over at least a respiratory therapy session (e.g., overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml or 400 ml). In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building water supply system).

[0326] According to one aspect, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to facilitate the movement of the air flow in a serpentine path in the reservoir 5110 while the air flow is in contact with a certain amount of water in the reservoir 5110.

[0327] According to one form, the reservoir 5110 may be removable from the humidifier 5000, for example, in the lateral direction.

[0328] The reservoir 5110 may also be configured to suppress liquid discharge from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its sub-components). Since the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent air pressure loss through leakage and / or flow impedance.

[0329] 5.6.3.2 Conductive sites According to one arrangement, the reservoir 5110 includes a conductive site configured to enable efficient heat transfer from the heating element to a fixed amount of liquid in the reservoir 5110. In one form, the conductive site can be arranged as a plate, although other shapes may also be suitable. All or part of the conductive site can be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, suitable thermal conductivity can be achieved with a lower conductivity material of appropriate geometry.

[0330] 5.6.3.3 Humidifier Reservoir Dock In one form, the humidifier 5000 can include a humidifier reservoir dock configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock can include a locking function (e.g., a locking lever configured to hold the reservoir 5110 within the humidifier reservoir dock).

[0331] 5.6.3.4 Water Level Indicator The humidifier reservoir 5110 can include a water level. In some forms, the water level indicator 5150 can provide one or more indications to a user such as the patient 1000 or caregiver regarding the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator can include notification of a maximum predetermined amount of water, any part thereof (e.g., 25%, 50%, or 75%, or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0332] 5.6.3.5 Humidifier Converter(s) Humidifier 5000 may include one or more humidifier converters (sensors) 5210 instead of or in addition to the above-described converter 4270. The humidifier converter 5210 may include one or more of a pneumatic pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5G. The humidifier converter 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier converter may be disposed outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.

[0333] 5.6.3.5.1 Pressure Converter One or more pressure converters 5212 may be provided to the humidifier 5000 in addition to or instead of the pressure sensor 4272 provided within the RPT device 4000.

[0334] 5.6.3.5.2 Flow Converter One or more flow converters 5214 may be provided to the humidifier 5000 in addition to or instead of the flow sensor 4274 provided within the RPT device 4000.

[0335] 5.6.3.5.3 Temperature Converter Humidifier 5000 may include one or more temperature converters 5216. One or more temperature converters 5216 may be configured to measure one or more temperatures (e.g., the temperature of the heating element 5240 and / or the temperature downstream of the air flow at the humidifier outlet). In some forms, the humidifier 5000 may further include a temperature sensor 5216 that detects the temperature of the ambient air.

[0336] 5.6.3.5.4 Humidity Converter In one form, 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 arranged towards 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, alternatively, a relative humidity sensor.

[0337] 5.6.3.6 Heating Element In some cases, the heating element 5240 may be provided to the humidifier 5000 that provides heat input to one or more of the amount of water in the humidifier reservoir 5110 and / or the amount of water to the air flow. The heating element 5240 may include a heat generating component such as an electrical resistance heating track. One suitable example of the heating element 5240 is, for example, the layered heating element described in Patent Document 8. In this specification, the entire document is incorporated by reference for reference purposes.

[0338] In some forms, the heating element 5240 may be provided into the humidifier base. In the humidifier base, heat can be sent to the humidifier reservoir 5110 mainly by conduction.

[0339] 5.6.3.7 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5G. 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 can communicate with the central controller 4230.

[0340] In one form, the humidifier controller 5250 may receive measurements of characteristics (e.g., temperature, humidity, pressure, and / or flow rate) as inputs (e.g., measurements of air flow and water in the reservoir 5110 and / or in 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.

[0341] As shown in FIG. 5G, the humidifier controller 5250 may include one or more controllers (e.g., 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).

[0342] 5.7 Respiratory waveform FIG. 4 shows a model of a typical respiratory waveform of a human during sleep. The horizontal axis is time and the vertical axis is respiratory flow rate. Since the parameter values can vary, typical respiration may have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, Ti, 1.6 s, peak inspiratory flow rate, Qpeak, 0.4 L / s, expiratory time, Te, 2.4 s, peak expiratory flow rate, Qpeak, -0.5 L / s. The total duration of respiration Ttot is about 4 s. A human typically breathes about 15 times per minute (BPM), and the ventilation Vent is about 7.5 L / min. The ratio of the typical duty cycle, Ti to Ttot, is about 40%.

[0343] 5.8 Glossary For the purposes of the disclosure of the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply.

[0344] 5.8.1 General Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0345] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0346] For example, the ambient humidity for a humidifier can be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0347] In another embodiment, the ambient pressure can be the pressure directly surrounding or outside the body.

[0348] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, for example, other than the noise generated from the RPT device or from the mask or patient interface. Ambient noise can be generated from sources outside the room.

[0349] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that can automatically adjust the therapy pressure, for example, between a minimum and a maximum limit during breathing, depending on the presence or absence of signs of SDB onset.

[0350] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapy pressure is substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different breathing cycles of the patient (e.g., increased in response to detection of signs of partial upper airway obstruction and reduced in the absence of notification of partial upper airway obstruction).

[0351] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous amount. In some cases, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). Flow rate may be assigned the symbol Q. The "flow rate" may also be abbreviated as "flow" in some cases.

[0352] In an example of a patient's breathing, the flow rate can be nominally positive pressure for the inhalation portion of the patient's breathing cycle and thus can be negative for the exhalation portion of the patient's breathing cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting through the ventilation holes to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The breathing flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0353] Humidifier: The word "humidifier" is interpreted to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H 2 O) vapor into an air stream for improving a patient's medical breathing condition.

[0354] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at the ambient elbow.

[0355] Noise Conduction (Acoustic): In this document, conductive noise refers to noise conveyed to the patient through an air pressure path (e.g., an air circuit and the patient interface and the air within it). In one form, conductive noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0356] Noise Radiation (Acoustic): In this document, radiated noise refers to noise conveyed to the patient by the ambient air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the subject in accordance with ISO3744.

[0357] Noise Ventilation (Acoustic): In this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in the patient interface).

[0358] Patient: A person with or without a respiratory disease.

[0359] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH 2 O, g-f / cm 2 , and hectopascals). 1 cmH 2 O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in units of cmH 2 O.

[0360] The pressure in the patient interface is denoted by the symbol Pm, and the therapeutic pressure representing the target value to be achieved by the mask pressure Pm at the current time is denoted by the symbol Pt.

[0361] Respiratory pressure therapy (RPT): The addition of an air supply to the airway inlet at a therapeutic pressure that is typically positive pressure with respect to the atmosphere.

[0362] Ventilator: A mechanical device that provides pressure assistance when a patient performs some or all of the breathing movements.

[0363] 5.8.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this registered trademark). Another LSR manufacturer is Wacker. Unless otherwise stated, the Shore A (or Type A) indentation hardness of the exemplary form of LSR as measured by ASTM D2240 is about 35 to about 45.

[0364] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0365] 5.8.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0366] Elastic: Substantially all energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0367] Hardness: The ability of a material to resist deformation itself (e.g., as described by the Young's modulus or the indentation hardness scale measured on a standardized sample size). ● "Soft" materials may include silicones or thermoplastic elastomers (TPE), and can be easily deformed, for example, under finger pressure. ● "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0368] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending or torsion). A structure or component may provide different resistances in different directions.

[0369] Floppy structure or component: A structure or component that changes its shape (e.g., bends) within a relatively short period (e.g., 1 second) when supported by its own weight.

[0370] Rigid structure or component: A structure or component that undergoes substantially no shape change when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the patient airway inlet at a pressure load of approximately 20 - 30 cmH 2 O.

[0371] As an example, the I-beam can include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component can be floppy in the first direction and rigid in the second direction.

[0372] 5.8.2 Respiratory Cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a duration, for example, of 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, airflow is not permitted due to some airway obstruction. Central apnea refers to a state in which apnea is detected due to a decrease or absence of respiratory effort despite an open airway. Mixed apnea refers to a state in which a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0373] Respiratory rate: The patient's spontaneous respiratory rate, usually measured as the number of breaths per minute.

[0374] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0375] Effort (respiratory): Respiratory effort is said to refer to the movement performed by a person's spontaneous respiration while attempting to breathe.

[0376] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0377] Flow limitation: Flow limitation is interpreted as a situation in a patient's respiration where an increase in the patient's effort does not cause a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0378] Types of waveforms of inspiratory flow limitation: (i) Flattening: After rising, a relatively flat portion is followed by a decline. (ii) M-shaped: Having two local peaks, one at the rise and one at the fall, with a relatively flat portion between these two peaks. (iii) Chair-shaped: Having a single local peak that occurs at the rising part, followed by a relatively flat portion. (iv) Reverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs at the falling part.

[0379] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold speed continues over a duration, it is said that hypopnea has occurred. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may be considered hypopnea: (i) A 30% decrease in patient respiration for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease in patient respiration (less than 50%) that continues for at least 10 seconds, with associated desaturation of at least 3% or arousal occurring.

[0380] Hyperpnea: The flow increases to a level higher than the normal flow rate.

[0381] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0382] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Quantification of airway patency can be done, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0383] Positive end-expiratory pressure (PEEP): A pressure above the atmosphere in the lungs that exists at the end of expiration.

[0384] Peak flow rate (Qpeak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0385] Respiratory gas flow rate, air flow rate, patient's air flow rate, respiratory gas air flow rate (Qr): These terms can be understood to refer to the estimation of the respiratory air flow rate of an RPT device, and are used in contrast to the "true respiratory flow rate" or "true respiratory gas flow rate", which is the actual respiratory flow rate of the patient, usually expressed in liters per minute.

[0386] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort. In principle, since the inspiratory volume Vi (the amount of air inhaled) is equal to the expiratory volume Ve (the amount of air exhaled), a single tidal volume Vt can be defined as equal to either amount. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inspiratory volume Vi and the expiratory volume Ve).

[0387] Inspiratory time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0388] Expiratory time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0389] Total time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0390] Typical recent ventilation: The ventilation value (i.e., the degree of tendency of the center of the most recent values of ventilation) for which the most recent values of ventilation Vent tend to cluster over a given time scale.

[0391] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. It may be related to a state of flow limitation in which the flow rate may increase slightly or decrease with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0392] Ventilation (Vent): Measurement of the gas exchange rate performed by the patient's respiratory system. The measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as a volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as a volume and is understood as a volume per minute.

[0393] 5.8.3 Ventilation Adaptive Servo-Ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation but can be changed. The changeable target ventilation can be learned from some characteristics of the patient (e.g., the patient's respiratory characteristics).

[0394] Backup rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically, the number of breaths per minute) delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0395] Cycle: The end of the inspiratory phase of the ventilator. When delivering a breath from the ventilator to a patient who is breathing spontaneously, at the end of the inspiratory part of the respiratory cycle, the ventilator is said to be cycled to stop the breath delivery.

[0396] Expiratory Positive Airway Pressure (EPAP): The base pressure to which a pressure that varies within the breath is added for the generation of the desired mask pressure that the ventilator attempts to achieve at a given time.

[0397] End Expiratory Pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory part of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ) = 0 when Φ = 1), EEP is equal to EPAP.

[0398] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory part of the breath.

[0399] Pressure support: A number indicating the pressure increase during inspiration of a ventilator when the ventilator is exhaling, mainly meaning the pressure difference between the maximum value during inspiration and the base pressure (for example, PS = IPAP - EPAP). In some contexts, pressure support means the difference that the ventilator attempts to achieve (rather than the difference actually achieved by the ventilator).

[0400] Servo ventilator: A ventilator having patient ventilation and target ventilation, which adjusts the pressure support level to bring the patient ventilation closer to the target ventilation.

[0401] Spontaneous / Triggered (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing of a spontaneously breathing patient. However, if the device cannot detect breathing within a predetermined period, the device automatically starts breathing delivery.

[0402] Swing: A term corresponding to pressure support.

[0403] Trigger: When a ventilator delivers a breath of air to a patient who is breathing spontaneously, it is said to be triggered to deliver the breath when the patient himself / herself starts the breathing part of the breathing cycle.

[0404] 5.8.4 Patient Interface Anti - asphyxia valve (AAV): A component or sub - assembly of a mask system that reduces the risk of excessive CO2 re - breathing by the patient through an opening to the atmosphere in a fail - safe manner.

[0405] Elbow: The elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a substantially circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In a particular form, the elbow can be rotatable, for example, about 360 degrees with respect to the mating component. In a particular form, the elbow can be removable from the mating component, for example, via a snap connection. In a particular form, the elbow can be assembled to the mating component via a one-time snap during manufacture while being non-removable by the patient.

[0406] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of the mask frame can be airtight.

[0407] Headgear: The headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a collection of one or more struts, ties, and supplementary stiffeners configured to position and hold a patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of a foam material and a fabric).

[0408] Membrane: The membrane is taken to typically mean a thin element, preferably substantially resistant to bending and resistant to stretching and contraction.

[0409] Pleural Chamber: The mask pleural chamber is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of the space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell can form part of the wall of the mask pleural chamber.

[0410] Seal: When used as a noun (the "seal"), it can refer to the structure, and when used as a verb (to "seal"), it can refer to its effect. The two elements can be constructed and / or arranged such that they "seal" or obtain a "sealing" effect between them without requiring a separate "seal" element itself.

[0411] Shell: The shell is taken to mean a relatively thin, curved structure having bending, tensile, and compressive rigidity. For example, the curved structure wall of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0412] Reinforcing member: The reinforcing member is taken to mean a structural component designed to increase the stiffness or flexibility of another component in at least one direction.

[0413] Strut: The strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0414] Swiivel (noun): A subassembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swivel can be configured to rotate at an angle of at least 360 degrees. In another form, the swivel can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a pair of cylindrical conduits. In use, there is little leakage of air flow from the swivel.

[0415] Tie (noun): A structure designed to resist tension.

[0416] Ventilation: (noun): A structure that allows an air flow to the ambient air inside a mask or conduit, enabling a clinically effective washout of the exhaled gas. For example, in a clinically effective washout, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and the treatment pressure.

[0417] 5.8.5 Shape of the structure The product according to the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be limited by a two-dimensional surface. These surfaces may be distinguished using labels for describing the direction, position, function, or some other property of the associated surface. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another embodiment, the seal-forming structure may include a face contact (e.g., outer) surface and a separate non-face contact (e.g., lower or inner) surface. In another embodiment, the structure may include a first surface and a second surface.

[0418] To facilitate the description of the shape of the three-dimensional structure and the surface, first consider the cross-section at a point p through the surface of the structure. See FIGS. 3B-3F. FIGS. 3B-3F show an example of a cross-section at a point p on the surface and an example of the resulting planar curve. FIGS. 3B-3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some embodiments, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0419] 5.8.5.1 Curvature in one dimension The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0420] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (if this imaginary little person walks away from point p, they need to walk uphill). See FIGS. 3B (relatively large positive curvature compared to FIG. 3C) and 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often called concave.

[0421] Zero curvature: When the curve at p is a straight line, the curvature is taken to be zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither uphill nor downhill). See FIG. 3D.

[0422] Negative curvature: When the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this imaginary little person walks away from point p, they need to walk downhill). See FIGS. 3E (relatively small negative curvature compared to FIG. 3F) and 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often called convex.

[0423] 5.8.5.2 Curvature of a two - dimensional surface The description of the shape at a given point on a two - dimensional surface according to this technique can include a plurality of vertical cross - sections. The plurality of cross - sections can cut the surface in a plane including the outward normal (the "normal plane"), and each cross - section can be taken in a different direction. As a result of each cross - section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point can have the same sign or different signs. Each curvature at that point has a magnitude (e.g., relatively small). The planar curves in FIGS. 3B - 3F can be examples of such a plurality of cross - sections at a particular point.

[0424] Principal curvature and direction: The direction of the normal plane in which the curvature of the curve takes its maximum and minimum values is called the principal direction. In the examples of FIGS. 3B to 3F, since the maximum curvature occurs in FIG. 3B and the minimum occurs in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0425] Region of the surface: A set of connected points on the surface. This set of points within the region can have similar properties (e.g., curvature or sign).

[0426] Saddle region: A region in which the principal curvatures have opposite signs (i.e., one positive sign and the other negative sign) at each point (depending on the direction in which an imaginary person walking uphill or downhill would face).

[0427] Dome region: A region in which the principal curvatures have the same sign (both positive (“concave dome”) or both negative (“convex dome”)) at each point.

[0428] Cylindrical region: A region in which one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is non - zero.

[0429] Plane region: A region of the surface in which both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0430] Edge of the surface: The boundary or limit of the surface or region.

[0431] Path: In a particular form of the present technology, “path” is taken to mean a path in the mathematical - topological sense (e.g., a continuous space curve on the surface from f(0) to f(1)). In a particular form of the present technology, “path” can be described as a route or course including, for example, a set of points on the surface. (The path of an imaginary person is the place to walk on the surface and is similar to a garden path).

[0432] Path length: In certain embodiments of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of a hypothetical person is the distance walked along the path on the surface).

[0433] Straight-line distance: The straight-line distance is the distance between two points on the surface, without considering the surface. On a planar region, there is a distance along the edge of the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path that has the same path length as the straight-line distance between two points. (For a hypothetical person, the straight-line distance corresponds to the "distance a crow flies").

[0434] 5.8.5.3 Space curve Space curve: Unlike a planar curve, a space curve does not necessarily exist within any particular plane. A space curve can be closed. That is, it has no endpoints. A space curve can be considered a one-dimensional piece of three-dimensional space. A hypothetical person walking along the strand of a DNA helix is walking along a space curve. A typical human left ear contains a left-handed helix. A typical human right ear contains a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) can follow a space curve. In general, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the manner in which a curve deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, normal vector, and binormal vector at that point.

[0435] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and a magnitude from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person is flying along a curve and falls out of their vehicle at a particular point, the direction of the tangent vector is the direction in which the person should be moving.

[0436] Unit normal vector: When an imaginary person moves along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0437] 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, the left-hand rule.

[0438] Contact plane: A plane that includes the unit tangent vector and the unit principal normal vector.

[0439] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the contact plane of the curve. The torsion of a space curve that lies in a plane is zero. When the deviation from the contact plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (e.g., a gently sloping helical path). When the deviation from the contact plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (e.g., a steeply sloping helical path).

[0440] Referring to the right-hand rule, a space curve that bends in the direction of the right-hand binormal can be regarded as having a positive torsion in the right-hand direction. A space curve that points in the direction away from the right-hand binormal direction can be regarded as having a negative torsion of the right hand (e.g., a left-handed helix).

[0441] Similarly, referring to the left-hand rule, a space curve that points in the direction of the left-hand binormal can be regarded as having a positive torsion of the left hand (e.g., a left-handed helix). Thus, the positive direction of the left hand corresponds to the negative direction of the right hand.

[0442] 5.8.5.4 Hole The surface can have one-dimensional holes (e.g., holes bounded by a planar or spatial curve). In the case of a thin structure (e.g., a membrane) that includes a hole, this structure can be described as having a one-dimensional hole. For example, refer to the manner in which the one-dimensional holes in the surface of the structure shown in FIG. 3G are bounded by a planar curve.

[0443] The structure can have two-dimensional holes (e.g., holes bounded by a surface). For example, an inflatable tire has two-dimensional holes bounded by the inner surface of the tire. In another embodiment, a bladder with a cavity for air or gel can have two-dimensional holes. In yet another embodiment, a conduit can include one-dimensional holes (e.g., at its inlet or its outlet) and can include two-dimensional holes bounded by the inner surface of the conduit. Also refer to the two-dimensional holes passing through the structure shown in FIG. 3I and bounded by a surface as shown.

[0444] 5.9 Other Considerations Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other recited value or intervening value in the recited range of the present technology is encompassed by the present technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limits in the recited range, they are encompassed by the present technology. If the recited range includes one or both of these limits, ranges exceeding either or both of these recited limits are also encompassed by the present technology.

[0445] Furthermore, when a value (singular or plural) is embodied as part of the present technology in this specification, unless otherwise specified, it is understood that such a value can be approximated and such a value can be used to any appropriate significant digit to the extent permitted or required by the practical technical implementation.

[0446] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described in this specification can be used in the practice or testing of the technology, only a limited number of exemplary methods and materials are described herein.

[0447] Although specific materials are described as being preferably used for the construction of components, obvious alternative materials with similar properties can be used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and can be manufactured either collectively or individually.

[0448] As used in this specification and the appended claims, note that the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0449] All of the publications described in this specification are hereby incorporated by reference for their disclosure and description of the methods and / or materials that are the subject of these publications. The publications described in this specification are provided only for their disclosure prior to the filing date of this application. Nothing in this specification should be construed as an admission that the technology described herein does not antedate such publications by virtue of prior invention. Further, the dates of the publications may be different from the actual publication dates, which may need to be individually verified.

[0450] The terms "comprises" and "comprising" are to be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps may be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0451] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0452] Although the techniques herein have been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, the terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, the description or illustration of the process steps in this method may be presented in an ordered manner, but such an order is not necessary. Those skilled in the art will recognize that such an order can be changed and / or that the aspects can be performed simultaneously or even synchronously.

[0453] Therefore, it should be understood that numerous variations are possible in the exemplary embodiments without departing from the spirit and scope of the technology, and that other arrangements can be devised.

Description of Reference Numerals

[0454] 1000 Patient 1100 Roommate 3000 Patient Interface 3100 Seal Forming Structure 3200 Plenum Chamber 3300 Positioning and Stabilization Structure 3400 Ventilation Port 3600 Connection Port 3700 Forehead Support 4000 RPT Device 4010 Main Panel 4012 Panel 4014 Side Panel 4016 Chassis 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet Air Filter 4120 Muffler 4122 Inlet Muffler 4124 Outlet Muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-Spillback Valve 4170 Air Circuit 4171 Air Circuit 4180 Supplementary Oxygen 4200 Electrical Components 4202 PCBA 4210 Power Supply 4220 Input Device 4230 Central Controller 4232 Clock 4240 Therapy Device Controller 4250 Protection Circuit 4260 Memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed Converter 4280 Data Communication Interface 4282 Remote External Communication Network 4284 Local External Communication Network 4286 Remote External Device 4288 Local External Device 4290 Output Device 4292 Display Driver 4294 Display 4300 Algorithm 4310 Preprocessing Module 4312 Pressure Compensation Algorithm 4314 Ventilation Flow Estimation Algorithm 4316 Leakage Flow Estimation Algorithm 4318 Respiratory Flow Estimation Algorithm 4320 Treatment Engine Module 4321 Phase Determination Algorithm 4322 Waveform Determination Algorithm 4323 Ventilation Determination Algorithm 4324 Inspiratory Flow Limitation Determination Algorithm 4325 Apnea / Hypopnea Determination Algorithm 4326 Snoring Determination Algorithm 4327 Airway Patency Determination Algorithm 4329 Treatment Parameter Determination Algorithm 4330 Treatment Control Module 4340 Method 5000 Humidifier 5110 Humidifier Reservoir 5210 Humidifier Converter 5212 Pressure Converter 5214 Flow Converter 5216 Temperature Converter 5218 Humidity Sensor 5240 Heating Element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Air Circuit Controller 6000 Humidifier 6050 Reservoir Dock 6050T Dock Part 6050B Dock Part 6060 Guide Structure 6100 Water Reservoir 7000 RPT Device 7100 Air Pressure Block 7200B1 First Blower 7200B2 Second Blower 7210B1 Blower Inlet 7210B2 Blower Inlet 7220B1 Blower Outlet Blower Outlet 7220B2 Suspension Device 7250B2 Support Tab 7252B2 Hopper 7254B2 Flexible Flat Cable 7260B2 Chassis Assembly 7300 Upper Chassis 7300T Lower Chassis 7300B Base Mold 7301T Base Mold 7301B Overmold 7302T Overmold 7302B First Sealing Part 7305SP1 Second Sealing Part 7305SP2 Sealing Surface 7306 Chamfered Edge 7307 Sealing Part 7308 Sealing Surface 7309 Chassis Inlet 7310 Inner Tubular Part 7312 Outer Ring Part 7314 Annular Groove Part 7316 Chassis Outlet 7320 Spigot 7325 Mounting Support 7327 Recess 7329 Opening 7330 Inlet Opening 7340 Concave Chamber 7342 Inlet Tube 7345 Pneumatic Block Cavity 7350 Block Part 7350T Block Part 7350B Positioning Groove Part 7360T1 Positioning Groove Part 7360T2 Positioning Groove Part 7360B1 Positioning Groove Part 7360B2 Internal Rib 7365 First Blower Sub - assembly 7400SUB1 Second Blower Sub - assembly 7400SUB2 7500SS1 Support Structure 7500SS2 Support Structure 7510SS1 Chassis Plate 7512SS1 Positioning Groove 7513SS1 Arm 7515SS1 Flow Tube 7518SS1 Sealing Lip 7519SS1 Support Plate 7530SS1 Outlet Plate Assembly 7530SS2 Outlet Plate Assembly 7532SS1 Base Plate 7532SS2 Base Plate 7536SS1 Blower Suspension Device 7536SS2 Blower Suspension Device 7538SS1 Sealing Lip 7538SS2 Sealing Lip 7550SS1 Flow Plate Assembly 7550SS2 Flow Plate Assembly 7552SS1 Base Plate 7552SS2 Base Plate 7554SS1 Flow Tube Array 7554SS2 Flow Tube Array 7555SS1 Flow Tube 7555SS2 Flow Tube 7556SS1 Blower Suspension Device 7556SS2 Blower Suspension Device 7558SS1 Sealing Lip 7558SS2 Sealing Lip 7560SS1 Flange 7560SS2 Flange 7570SS1 Outlet Foam 7600 PCBA 7610 Flow Sensor 7610A Sensor 7610B Sensor 7620 Pressure Sensor 7621 Pressure Sensor 7700 Inlet Foam 7800 Pressure Sensor Seal 7810 Base Portion 7820SP1 First Sealing Portion 7820SP2 Second Sealing Portion 7822 Port Engagement Side 7823 Sealing Surface 7824 Sensor Engagement Side 7825 Bellows-Type Interface 7826 Sealing Surface 7830 Central Connection Portion 7832 Tubular Surface 8002 Outer Housing

Claims

1. 1. An apparatus for supplying air at positive pressure to a patient for respiratory therapy, comprising: the apparatus comprising a pneumatic block; The pneumatic block is a blower subassembly including a blower configured to generate a flow of air at a therapeutic pressure, the blower includes a blower inlet and a blower outlet; a blower assembly, the blower inlet and the blower outlet being coaxially aligned with an axis of the blower; a chassis assembly defining a pneumatic block cavity configured to position and support the blower subassembly, the chassis assembly including a chassis inlet and a chassis outlet; The device, comprising: the chassis assembly includes a lower surface that defines a substantially horizontal lower plane when the device is in an operational orientation; the blower is positioned such that an axis of the blower is parallel to the lower plane when the device is in an operating orientation; the pneumatic block defines an air flow path extending from the chassis inlet to the blower inlet of the blower and from the blower outlet of the blower to the chassis outlet; the pneumatic block defines a chamber arrangement along the air flow path including a plurality of chambers; the fan subassembly including a support structure configured to support the fan within the chassis assembly; the support structure constructed and arranged to sealingly separate the air flow passage into a plurality of the chambers of the chamber arrangement; the plurality of chambers of the chamber arrangement include a first inlet muffler chamber, a second inlet muffler chamber, a third inlet muffler chamber, and an outlet chamber along the air flow path; the chambers of the chamber arrangement extend in a plurality of planes relative to the lower plane; the first inlet muffler chamber extends in a first plane, and the second inlet muffler chamber, the third inlet muffler chamber and the outlet chamber extend in a second plane spaced vertically above the first plane; the first plane and the second plane are parallel to the lower plane when the device is in an operating orientation, and the second plane is spaced vertically above the first plane relative to the lower plane; the support structure includes a flow tube configured to pass air from the first inlet muffler chamber in the first plane to the second inlet muffler chamber in the second plane; the support structure includes a flow tube array including a plurality of flow tubes configured to pass air from the second inlet muffler chamber in the second plane to the third inlet muffler chamber in the second plane; the blower is disposed in the second inlet muffler chamber in the second plane; the blower inlet of the blower is configured to receive air from the third inlet muffler chamber, and the outlet chamber is configured to receive air from the blower outlet of the blower.

2. 10. The device of claim 1, wherein the flow tube includes an axis that extends generally perpendicular to the lower plane when the device is in an actuated orientation.

3. An apparatus as described in any one of claims 1 to 2, characterized in that the first inlet muffler chamber in the first plane is configured to receive air from the chassis inlet.

4. 4. Apparatus according to any one of claims 1 to 3, characterized in that compressed air from the outlet chamber is arranged to be discharged through the chassis outlet to the pneumatic block.

5. 5. The device according to claim 1, wherein the air flow passing through the second inlet muffler chamber, the third inlet muffler chamber and the outlet chamber in the second plane extends in a J-shape.

6. An apparatus as described in any one of claims 1 to 5, characterized in that the air flow from the second inlet muffler chamber to the third inlet muffler chamber extends in the opposite direction to the air flow from the third inlet muffler chamber through the blower to the outlet chamber.

7. The first, second and third inlet muffler chambers are positioned upstream of the blower inlet of the blower; Apparatus according to any one of the preceding claims, characterized in that the outlet chamber is positioned downstream of the blower outlet of the blower.

8. 8. The apparatus of any one of claims 1 to 7, wherein the support structure includes a blower suspension configured to support and vibrationally isolate the blower.

9. 9. Apparatus according to any one of the preceding claims, characterized in that the blower is configured for CPAP or APAP treatment.

10. 10. The apparatus of any one of claims 1 to 9, wherein the chassis assembly includes a reservoir dock configured to receive a water reservoir.

11. 11. Apparatus according to any one of claims 1 to 10, characterized in that the apparatus comprises a printed circuit board assembly outside the air flow path which is supported by the pneumatic block.

12. 12. The apparatus of claim 11, wherein the chassis assembly includes one or more ports configured to communicate one or more sensors disposed on the printed circuit board assembly with the air flow path.

13. 13. Apparatus according to any one of the preceding claims, characterized in that the apparatus comprises an acoustic foam provided in one or more of the chambers of the chamber arrangement.

14. 14. The apparatus of any one of claims 1 to 13, wherein the chassis assembly includes an upper chassis and a lower chassis forming a pneumatic block cavity configured to receive the blower subassembly.

15. 15. The apparatus of claim 14, wherein said upper chassis and said lower chassis each include an elastomeric overmold along an inner surface of said upper chassis and said lower chassis for enclosing said pneumatic block cavity.

16. 16. Apparatus according to any one of the preceding claims, characterized in that the direction of airflow at the chassis inlet extends transversely to the direction of airflow at the chassis outlet.

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