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] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.

[0002] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 779,135, filed December 13, 2018, the entirety of which is incorporated herein by reference. [Background technology]

[0003] 2. Technology Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

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

[0005] These airways contain a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

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

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes such as closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. Due to this condition, affected patients typically experience breathing cessation lasting 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The condition is common, especially in middle-aged overweight men, but patients are asymptomatic. See US Pat. No. 5,399,363.

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, followed by alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. Because of the repeated hypoxia, CSR can be harmful. In some patients, CSR is accompanied by recurrent sleep arousals, which cause severe insomnia, increased sympathetic activity, and increased afterload. See US Pat. No. 5,399,633.

[0010] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or breathe out enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

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

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

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in the normal elasticity of the lungs. Examples of COPD include 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 diseases (NMD) is a broad term that encompasses numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified as rapidly and slowly progressive: (i) rapidly progressive disorders, characterized by muscle damage that worsens over 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 damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0015] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive defects and share the potential for long-term hypercapnic respiratory insufficiency. Scoliosis and / or kyphoscoliosis can lead to severe respiratory insufficiency. Symptoms of respiratory insufficiency include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.

[0016] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.

[0017] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, including continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and invasive ventilation (IV).

[0018] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

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

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

[0021] 2.2.3 Treatment system These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0022] The treatment system may 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 may be used to provide a wearer with an interface to a respiratory appliance, for example by providing airflow to an airway inlet. Airflow may 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 being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby providing a pressure at which there is sufficient dispersion with atmospheric pressure for therapy to be performed (e.g., approximately 10 cmH above atmospheric pressure). 2 In other forms of therapy, such as oxygen delivery, the patient interface provides a pressure of approximately 10 cmH 2 They may not contain a sufficient seal to facilitate delivery of the gas supply to the airways at positive O pressures.

[0025] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0026] Certain masks may be clinically unsuitable for use with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0027] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.

[0028] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).

[0029] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0030] These challenges may result in one or more of the following: some masks may be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if the wear time is long or the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to poor compliance, poor comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may result in poor patient compliance with the treatment. This is especially true if the mask must be worn while sleeping.

[0031] CPAP therapy is highly effective in treating certain respiratory diseases if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks 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 patient compliance.

[0032] Masks for other uses (e.g., for aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[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 may be used individually or as part of a system to deliver one or more of the therapies described above, for example by actuating the device to generate an air delivery flow to an interface to the airway. This air flow may be pressurized. Examples of RPT devices include CPAP devices and mechanical 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 applications have specific requirements that cannot be met by more common air pressure generators (e.g., medical equipment reliability, size, and weight requirements). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

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

[0037] Table of noise output levels of conventional RPT devices (10cmH in CPAP mode using only one sample, using the test method specified in ISO3744) 2 (Measured at 100°C). [Table 1]

[0038] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide invasive and non-invasive independent breathing support for patients for a range of conditions (including, but not limited to, NMD, OHS, and COPD).

[0039] The ResMed Elisaee® 150 ventilator and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators provide volumetric and pressure ventilation modes with single or dual limb circuits. RPT devices typically include a pressure generator (e.g., a powered blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered at positive pressure to the patient's airway. The outlet of the RPT device is connected via an air circuit to a patient interface as described above.

[0040] A device designer may be presented with a myriad of choices. Often, design criteria conflict, making certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment may be significantly affected by minor changes in one or more parameters.

[0041] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to drying of the airway. When a humidifier is used with the RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0042] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0043] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when necessary. Bedside medical humidifiers may be small. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, and not the patient's surroundings. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, but these systems also humidify and / or heat the entire room, which may be uncomfortable for the occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0044] Although a number of medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, i.e., some of such medical humidifiers provide inadequate humidification and others are difficult or inconvenient for the patient to use.

[0045] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory treatment is "compliant" (e.g., whether the patient complies with one or more "compliance rules" with their RPT device). One example of a compliance rule for CPAP treatment may require a patient to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient 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 a usage rate over a period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0046] There may be other aspects of a patient's care that would benefit from communication of treatment data to third parties or external systems.

[0047] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone. [Prior art documents] [Patent documents]

[0048] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Patent Document 3] U.S. Patent No. 7,866,944 [Patent Document 4] U.S. Patent No. 8,638,014 [Patent Document 5] U.S. Pat. No. 8,636,479 [Patent Document 6] International Publication No. 2013 / 020167 [Patent Document 7] U.S. Patent Application No. 8,733,349 [Patent Document 8] International Publication No. 2012 / 171072 Summary of the Invention [Means for solving the problem]

[0049] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability. A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0050] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0051] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0052] One aspect of the present disclosure is a method for manufacturing a device.

[0053] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

[0054] One aspect of one form of the present technology is a portable RPT device that a person can carry with them (eg, 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 including a pneumatic block including a chassis assembly configured to support each of a number of blower subassemblies, the pneumatic block being divided into different muffler chambers by corresponding mounting plates of the blower subassemblies.

[0056] Another aspect of the present technology relates to an apparatus for providing a patient with positive air pressure for respiratory therapy. The apparatus includes a pneumatic block including at least a first blower subassembly and a second blower subassembly and a common chassis assembly configured to support the at least the first blower subassembly and the second blower subassembly, respectively. The at least the first blower subassembly and the second blower subassembly are structurally different from each other in at least one aspect. The at least the first blower subassembly and the second blower subassembly each include a corresponding blower configured to generate an airflow at a therapeutic pressure. The common chassis assembly and the first blower subassembly form a first configuration of the pneumatic block, and the common chassis assembly and the second blower subassembly form a second configuration of the pneumatic block. The first and second configurations of the pneumatic block each form an airflow path extending from a chassis inlet to a chassis outlet. The first and second configurations of the pneumatic block each form a chamber arrangement including a plurality of chambers along the airflow path. The air flow passages and chamber arrangement of the first configuration of the pneumatic block differ from the air flow passages and chamber arrangement of the second configuration of the pneumatic block.

[0057] Another aspect of the present technology relates to an apparatus for providing a patient with positive air pressure for respiratory therapy. The apparatus includes a pneumatic block. The pneumatic block forms a chamber arrangement along an air flow path including a plurality of chambers. 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 vertically spaced apart from the first plane. In an example, the chamber arrangement includes three inlet muffler chambers and an outlet chamber along the air flow path. One of the three inlet muffler chambers extends in a first plane and two of the three inlet muffler chambers and the outlet chamber extend in a second plane vertically spaced apart from the first plane.

[0058] Another aspect of the present technology relates to an apparatus for providing a patient with positive air pressure for respiratory therapy. The apparatus includes a pneumatic block. The pneumatic block forms a chamber arrangement including a plurality of chambers along an air flow path. In an example, the chamber arrangement includes at least one inlet muffler chamber positioned upstream of a blower inlet of the blower and an outlet chamber positioned downstream of a blower outlet of the blower. In an example, the chamber arrangement includes at least two inlet muffler chambers positioned upstream of a blower inlet of the blower and an outlet chamber positioned downstream of a blower outlet of the blower. In an example, the chamber arrangement includes three inlet muffler chambers positioned upstream of a blower inlet of the blower and an outlet chamber positioned downstream of a blower outlet of the blower. In an example, a first of the three inlet muffler chambers receives air from a chassis inlet, and a blower is disposed in a second of the three inlet muffler chambers and receives air at the blower inlet from a third of the three inlet muffler chambers. In an example, the outlet chamber is adapted to communicate with an inlet of a water reservoir for humidification.

[0059] The described methods, systems, devices and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory treatment device). Additionally, the described methods, systems, devices and apparatus enable advances in the art of automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0060] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

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

[0062] 4. Brief Description of the Drawings The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference symbols include like elements: [Brief description of the drawings]

[0063] [Figure 1A] 4.1 Treatment System Figure 1A shows a system including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] 1B shows a system including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C]1C includes a system including a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. [Figure 2A] 4.2 Respiratory System and Facial Anatomy Figure 2A shows an overview of the human respiratory system, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] FIG. 2B is a diagram of the human upper airway including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 3A] 4.3 Patient Interface FIG. 3A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3B is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in 3C. [Figure 3C] Figure 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] 3D is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and where the curvature value is zero. [Figure 3E] Figure 3E is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in Figure 3F. [Figure 3F]Figure 3F is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in Figure 3E. [Figure 3G] Figure 3G shows the surface of a structure with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3H] Figure 3H is a cross-sectional view through the structure of Figure 3G. The surfaces shown bound a two-dimensional hole in the structure of Figure 3G. [Figure 3I] Figure 3I is a perspective view of the structure of Figure 3G including a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of Figure 3G are illustrated. [Figure 4] 4.4 Respiration Waveform Figure 4 shows a model of a typical human respiration waveform during sleep. [Figure 5A] 4.5 RPT Devices and Humidifiers FIG. 5A shows an exploded perspective view of an RPT device in accordance with one form of the present technology. [Figure 5B] FIG. 5B shows a perspective view of an RPT device 4000 including an outlet muffler 4124 in accordance with one form of the present technology. [Figure 5C] FIG. 5C shows a perspective view of an RPT device 4000 with an integrated humidifier 5000 including a water reservoir 5110 in accordance with one form of the technology. [Figure 5D] 5D is a schematic diagram of an air pressure path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items disposed in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 5E] FIG. 5E is a schematic diagram of the electrical components of an RPT device in accordance with one aspect of the present technology. [Figure 5F]FIG. 5F is a schematic diagram of an algorithm executed in an RPT device in accordance with one form of the present technology. [Figure 5G] FIG. 5G is a schematic diagram of a humidifier in accordance with one form of the present technology. [Figure 6] FIG. 6 is a perspective view of an RPT device with an integrated humidifier including a water reservoir according to an embodiment of the present technology. [Figure 7] FIG. 7 is another perspective view of the RPT device and integrated humidifier of FIG. 6, in which the water reservoir has been removed from the reservoir dock. [Figure 8] FIG. 8 is a perspective view of a pneumatic block and PCBA according to an embodiment of the present technology. [Figure 9] FIG. 9 is an exploded view of the pneumatic block of FIG. [Figure 10] FIG. 10 is a bottom view of an upper chassis of a chassis assembly in accordance with one embodiment of the present technology. [Figure 11] 11 is a bottom perspective view of the upper chassis of FIG. [Figure 12] FIG. 12 is a top view of a lower chassis of a chassis assembly in accordance with an embodiment of the present technology. [Figure 13] 13 is a top perspective view of the lower chassis of FIG. 12. FIG. [Figure 14] FIG. 14 is a cross-sectional view of a chassis assembly in accordance with one embodiment of the present technology. [Figure 15] FIG. 15 is a cross-sectional view of a chassis assembly in accordance with one embodiment of the present technology. [Figure 16] FIG. 16 is a perspective view of a first blower subassembly according to an embodiment of the present technology. [Figure 17] 17 is an exploded view of the first blower subassembly of FIG. 16. FIG. [Figure 18] FIG. 18 is a perspective view of a first blower subassembly with outlet foam according to an embodiment of the present technology. [Figure 19] FIG. 19 is another perspective view of a first blower subassembly with outlet foam according to an embodiment of the present technology. [Figure 20] FIG. 20 is a perspective view showing the assembly of an inlet foam, an outlet foam, and a first blower subassembly to a lower chassis of a chassis assembly according to an embodiment of the present technology. [Figure 21] FIG. 21 is another perspective view showing the assembly of a first fan subassembly to a lower chassis of a chassis assembly according to an embodiment of the present technology. [Figure 22] FIG. 22 is a perspective view showing assembling an upper chassis to a lower chassis along with a first blower subassembly according to an embodiment of the present technology. [Diagram 23] FIG. 23 is a perspective view of a lower chassis along with a first blower subassembly according to an embodiment of the present technology. [Figure 24] FIG. 24 is a perspective view illustrating assembly of a PCBA to a chassis assembly according to an embodiment of the present technology. [Diagram 25] FIG. 25 is a side view showing air entering a pneumatic block through an inlet opening according to an embodiment of the present technology. [Figure 26] FIG. 26 is a cross-sectional view showing air circulation within a first inlet muffler chamber of a pneumatic block according to an embodiment of the present technology. [Figure 27] FIG. 27 is a cross-sectional view showing air circulation within a second inlet muffler chamber of a pneumatic block according to an embodiment of the present technology. [Figure 28] FIG. 28 is a cross-sectional view showing air circulation within a third inlet muffler chamber of a pneumatic block according to an embodiment of the present technology. [Figure 29] FIG. 29 is a cross-sectional view showing air passing through a blower and exiting an exit chamber of a pneumatic block according to an embodiment of the present technology. [Diagram 30] FIG. 30 is a cross-sectional view of a completed pneumatic block including a first blower subassembly and an outlet chamber (highlighted) according to an embodiment of the present technology. [Diagram 31] FIG. 31 is another cross-sectional view of a completed pneumatic block including a first blower subassembly in accordance with an embodiment of the present technology. [Diagram 32] FIG. 32 is another cross-sectional view of a completed pneumatic block including a first blower subassembly in accordance with an embodiment of the present technology. [Diagram 33] FIG. 33 is another cross-sectional view of a completed pneumatic block including a first blower subassembly in accordance with an embodiment of the present technology. [Diagram 34] FIG. 34 is a perspective view of a second blower subassembly according to an embodiment of the present technology. [Diagram 35] FIG. 35 is an exploded view of the second blower subassembly of FIG. [Diagram 36] FIG. 36 is an exploded view of a blower and suspension of a second blower subassembly according to an embodiment of the present technology. [Figure 37] FIG. 37 is another perspective view of a second blower subassembly according to an embodiment of the present technology. [Figure 38] FIG. 38 is another perspective view of a second blower subassembly according to an embodiment of the present technology. [Figure 39] FIG. 39 is a perspective view showing a state in which a second blower subassembly is assembled to a lower chassis of a chassis assembly according to an embodiment of the present technology. [Diagram 40] FIG. 40 is a perspective view showing assembling an upper chassis to a lower chassis along with a second blower subassembly according to an embodiment of the present technology. [Diagram 41] FIG. 41 is a perspective view illustrating assembly of a PCBA to a chassis assembly according to an embodiment of the present technology. [Diagram 42] FIG. 42 is a cross section view showing a completed pneumatic block including a second blower subassembly according to an embodiment of the present technology. [Diagram 43] FIG. 43 is a cross section showing air circulation within a first inlet muffler chamber of a pneumatic block according to an embodiment of the present technology. [Diagram 44] FIG. 44 is a cross section showing air circulation within a second inlet muffler chamber of a pneumatic block according to an embodiment of the present technology. [Diagram 45]FIG. 45 is a cross section showing air passing through a blower and exiting an exit chamber of a pneumatic block according to an embodiment of the present technology. [Figure 46] FIG. 46 is a cross-sectional view of a completed pneumatic block including a second blower subassembly and an outlet chamber (highlighted) according to an embodiment of the present technology. [Figure 47] FIG. 47 is another cross-sectional view of a completed pneumatic block including a second blower subassembly according to an embodiment of the present technology. [Figure 48] FIG. 48 is another cross-sectional view of a completed pneumatic block including a second blower subassembly according to an embodiment of the present technology. [Figure 49] FIG. 49 is a cross-sectional view showing an arrangement of a flow sensor according to an embodiment of the present technology. [Figure 50] FIG. 50 is a bottom view of the upper chassis of a chassis assembly showing flow and pressure ports according to an embodiment of the present technology. [Figure 51] FIG. 51 is a cross-sectional view showing an arrangement of a pressure sensor according to one embodiment of the present technology. [Figure 52] FIG. 52 is a cross-sectional view showing a sealing portion of a flow sensor according to an embodiment of the present technology. [Figure 53] FIG. 53 is another cross section showing a sealing portion of a flow sensor according to an embodiment of the present technology. [Figure 54] FIG. 54 is a perspective view of a chassis assembly and pressure sensor seal according to an embodiment of the present technology. [Figure 55] FIG. 55 is a cross-sectional view showing the pressure sensor seal of FIG. 54 connecting to a chassis assembly according to an embodiment of the present technology. [Figure 56] FIG. 56 is a cross-sectional view of the pressure sensor seal of FIG. 54 connecting to a pressure sensor of a PCBA and chassis assembly according to an embodiment of the present technology. [Figure 57] FIG. 57 is a schematic diagram showing a first configuration of a pneumatic block according to an embodiment of the present technology. [Figure 58]FIG. 58 is a schematic view through a first plane of a first configuration of the pneumatic block of FIG. 57. [Figure 59] FIG. 59 is a schematic view through a second plane of the first configuration of the pneumatic block of FIG. 57. [Figure 60] FIG. 60 is a schematic diagram showing a second configuration of a pneumatic block according to an embodiment of the present technology. [Figure 61] FIG. 61 is a schematic view through a first plane of a second configuration of the pneumatic block of FIG. 60. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0064] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0065] The following description is provided in conjunction with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0066] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to an entrance to the airways of a patient 1000.

[0067] In a particular embodiment of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both 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, for example, FIGS. 1A-1C).

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

[0071] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0072] A patient interface 3000 in accordance with one form of the present technology may have a circumferential 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0073] A patient interface 3000 in accordance with one form of the present technology may be configured to provide at least 10 cmH 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0074] A patient interface 3000 in accordance with one form of the present technology may be configured to provide at least 20cmH 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0075] 5.4 RPT Devices An exploded view of an RPT device 4000 in accordance with one form of the present technology is shown in Figure 5A. The RPT device 4000 may include mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms. The RPT device 4000 may be configured to generate an airflow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described anywhere herein, for example.

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

[0077] The RPT device 4000 may include an exterior housing having one or more panel(s) (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 Figures 5A and 5B. The outlet muffler 4124 may be removable and may be replaced with a water reservoir 5110 (see Figure 5C). In such a configuration, the RPT device 4000 may be considered to include an integrated humidifier 5000. Thus, the RPT device 4000 may be used with or without humidification depending on whether the water reservoir 5110 or the outlet muffler 4124 are attached, respectively. Preferably, the RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. In one form, the RPT device 4000 includes a pressure generator 4140 , which may be received within a pneumatic block 4020 coupled to the chassis 4016 .

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

[0079] The pneumatic path of the RPT device 4000 (e.g., as shown in FIG. 5D ) may 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 and flow sensors) may be provided in the pneumatic path. The pneumatic path may include an anti-spillback valve 4160 to prevent water from flowing back from the humidifier 5000 into the electrical components of the RPT device 4000.

[0080] As shown in Figure 5E, the RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202 (see, e.g., Figure 5A). In one alternative, the RPT device 4000 can include more than one PCBA 4202.

[0081] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In one alternative, one or more of the following components may be disposed as their own separate units.

[0082] 5.4.1.1 Air filter(s) An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

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

[0084] In one form, an outlet air filter 4114 (eg, antibacterial factor) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

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

[0086] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.

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

[0088] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower controls the delivery of the air supply, for example, at a rate of up to about 120 liters / minute, at a pressure of about 4 cmH. 2 O~about 20cmH 2 Positive pressure in the range of O2 or about 30 cmH2O2 or other forms 2 The blower can be described in any one of U.S. Patent Nos. 5,233,633, 5,233,645, 5,233,655, 5,233,665, and 5,233,665, which are incorporated herein by reference in their entireties.

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

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

[0091] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar movement sensor that transmits or moves data RPT device).

[0092] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure or temperature at that point in the pneumatic path).

[0093] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.

[0094] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass or band-pass filtering).

[0095] 5.4.1.4.1 Flow Sensors A flow sensor 4274 according to the present technology may be based on a differential pressure transducer (eg, an SDP600 series differential pressure transducer from SENSIRION).

[0096] In one form, a 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 Sensors A pressure sensor 4272 according to the present technology can be placed in fluid communication with the pneumatic path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[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 ​​Converters In one form of the present technology, a motor speed transducer 4276 may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0100] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

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

[0102] In one form of the present technology, the power supply 4210 powers only 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 Devices In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a human to interact with the device. The buttons, switches or dials may be physical or software devices accessible via a touch screen. The buttons, switches or dials may be physically connected to the external housing 4010 in one form or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.

[0104] In one form, the input device 4220 may be constructed and arranged to allow 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 may include x86 INTEL processors, such as processors based on the ARM® Cortex®-M processor from ARM Holdings (e.g., the S®32 series of microcontrollers from ST Microelectronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series of microcontrollers from ST Microelectronics) 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 present technology, the central controller 4230 is configured to implement one or more methods described herein (e.g., one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer readable recording medium (e.g., memory 4260)). In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some methods may be performed by a remotely located device. For example, the remotely located device may determine ventilator control settings or detect breathing-related events by analysis of 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 present technology, the therapy device controller 4240 is a therapy control module 4330 and forms part of the algorithms 4300 executed by the central controller 4230.

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

[0115] 5.4.2.6 Protection circuit The one or more protection circuits 4250 in accordance with the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0116] 5.4.2.7 Memory In accordance with one form of the present technology, the RPT device 4000 includes a memory 4260 (e.g., non-volatile memory). In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

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

[0118] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (eg, a memory card made in accordance with the Secure Digital (SD) standard).

[0119] In one form of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium on which are stored computer program instructions embodying one or more of the methods described herein (e.g., one or more algorithms 4300).

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

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

[0122] In one form, the remote external communications network 4282 is the Internet. The data communications interface 4280 may use wired communications (e.g., via Ethernet or fiber optics) or may use wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0123] In one form, the local external communications network 4284 uses one or more communications standards (eg, Bluetooth or Consumer Infrared Protocol).

[0124] In one form, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one form, 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 an appropriately authorized person (e.g., a clinician).

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

[0126] 5.4.2.9 Optional displays and output devices, including alarms Output devices 4290 according to the present technology may take the form of one or more of visual, audio and tactile units. The visual display may be a Liquid Crystal Display (LCD) or a Light Emitting Diode (LED) display.

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

[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 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the number "0") into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol.

[0129] 5.4.3 RPT Device Algorithm As noted above, in some forms of the present technology, the central controller 4230 may be configured to embody one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., memory 4260). The algorithms 4300 are typically grouped into groups called modules (see, e.g., FIG. 5F).

[0130] 5.4.3.1 Pre-processing module A pre-processing module 4310, according to one form of the present technology, receives as input a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) and performs one or more process steps to calculate one or more output values ​​that are used as inputs to another module (e.g., a therapy engine module 4320).

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

[0132] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: pressure compensation 4312, ventilation flow estimation 4314, leak flow estimation 4316, and respiratory flow estimation 4318.

[0133] 5.4.3.1.1 Pressure compensation In one form of the present technology, a pressure compensation algorithm 4312 receives as an input a signal indicative of 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 pneumatic circuit 4170 and provides as an output the estimated pressure Pm in the patient interface 3000.

[0134] 5.4.3.1.2 Estimation of air flow rate In one form of the present technology, an airflow estimation algorithm 4314 receives as input an estimated pressure Pm in the patient interface 3000 and estimates the airflow Qv of air out of the vent 3400 in the patient interface 3000.

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

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

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

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

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

[0140] In one form of the present technology, the therapy parameters are one or more of: amplitude of pressure change, base pressure, and target ventilation.

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

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

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

[0144] In some forms, the phase output Φ, known as discrete phase determination, is a discrete variable. One implementation of discrete phase determination results in a binary phase output Φ with a value of inspiration or expiration. This value is represented as, for example, values ​​of 0 revolutions and 0.5 revolutions when the onset of spontaneous inspiration and expiration, respectively, is detected. The RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination because the trigger point and cycle point are the instants at which the phase changes from expiration to inspiration and inspiration to expiration, respectively. In one implementation of binary phase determination, the phase output Φ is determined to have a discrete value of 0 (thereby "triggers" the RPT device 4000) when the respiratory flow Qr has a value above a positive threshold, and a discrete value of 0.5 revolutions (thereby "cycles" the RPT device 4000) when the value of respiratory flow Qr is more negative than a negative threshold. The inspiration time Ti and expiration time Te may be typical values ​​estimated over many respiratory cycles of the time spent with phase Φ equal to 0 (indicating inspiration) and 0.5 (indicating expiration), respectively.

[0145] Another implementation of the discrete phase decision provides a three-valued phase output Φ with one value of inspiration, pause during inspiration, and expiration.

[0146] In other forms, the phase output Φ, known as continuous phase determination, is a continuous variable, varying, for example, between 0 revolutions and 1 revolution or 0 to 2π radians. An RPT device 4000 with continuous phase determination may trigger and cycle when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one implementation of continuous phase determination, the continuous value of phase Φ is determined using fuzzy logic analysis of respiratory flow Qr. The continuous value of phase determined in this implementation is often referred to as "fuzzy phase." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to respiratory flow Qr: 1. If respiratory flow drops to zero and then increases rapidly, the phase is 0 revolutions. 2. If respiratory flow is large positive and stable, the phase is 0.25 revolutions. 3. If respiratory flow is zero and rapidly decreasing, the phase is 0.5 revolutions. 4. If respiratory flow is large negative and stable, the phase is 0.75 revolutions. 5. If respiratory flow is zero and stable and the 5 second low pass filtered absolute value of respiratory flow is large, then the phase is 0.9 revolutions. 6. If respiratory flow is positive and the phase is expiration, the phase is 0 revolutions. 7. Respiratory flow is negative, phase is inspiration, phase is 0.5 revolutions. 8. If the 5 second low pass filtered absolute value of respiratory flow 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 whose phase is the result of the rule and whose magnitude is the fuzzy range for which the rule is true. The fuzzy range for which respiratory flow is "high", "stable", etc. is determined by an appropriate membership function. The results of the rules are represented as vectors and then combined by some function such as taking the centroid. In such a combination, the rules may be weighted equally or differently.

[0148] In another implementation of the continuous phase determination, the phase Φ, as well as the inspiration time Ti and expiration time Te, are first estimated separately from the respiratory flow Qr as described above. The continuous phase Φ at any instant in time is determined as half the fraction of the inspiration time Ti that has elapsed since the previous trigger instant, or 0.5 revolutions, plus the fraction of the expiration time Te that has elapsed since the previous cycle instant (whichever is the more recent instant).

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

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

[0151] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having values ​​in the range [0,1] for the domain of phase values ​​Φ provided by the phase determination algorithm 4321 to be used by the treatment parameter determination algorithm 4329.

[0152] In one embodiment, suitable for discrete or continuous phases, the waveform template Π(Φ) is a square wave template having a value of 1 for phase values ​​up to 0.5 revolutions and a value of 0 for phase values ​​beyond 0.5 revolutions. In one embodiment, suitable for continuous phases, the waveform template Π(Φ) includes two smoothly curved portions (i.e., a smoothly curved (e.g., rising cosine) rise from 0 to 1 for phase values ​​up to 0.5 revolutions, and a smoothly curved (e.g., exponential) fall from 1 to 0 for phase values ​​beyond 0.5 revolutions). In one embodiment, suitable for continuous phases, the waveform template Π(Φ) is based on a square wave, but has a smooth rise from 0 to 1 for phase values ​​up to a "rise time" below 0.5 revolutions, and a smooth fall from 1 to 0 for phase values ​​within a "fall time" after 0.5 revolutions, with a "fall time" below 0.5 revolutions.

[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 depending on the settings of the RPT device. Each waveform template Π(Φ) in the library may be provided as a lookup table value Π for a 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, perhaps parameterized by one or more parameters (e.g., time constants of exponential curved portions). 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:

number

[0155] where Πi(t) and Πe(t) are the inspiratory and expiratory portions of the waveform template Π(Φ,t). In one such form, the inspiratory portion of the waveform template Πi(t) is a smooth rise from 0 to 1 parameterized by the rise time, and the expiratory portion of the waveform template Πe(t) 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, a ventilation determination algorithm 4323 receives as input the respiratory flow, Qr, and determines a measurement indicative of the current patient ventilation, Vent.

[0157] In some embodiments, the ventilation determination algorithm 4323 determines a measurement of the ventilation Vent, which is an estimate of the 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 the ventilation Vent that is highly proportional to the 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 highly 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 to be the same as 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 approximately proportional to ventilation. As another example, it is the average of the respiratory flow rate at the central K percentage (with respect to time) of the inspiratory portion, where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are highly proportional to ventilation with high accuracy.

[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 the 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 measurement of the range in which the inspiratory portion of the breath indicates an inspiratory flow limitation.

[0161] In one form of the technology, the inspiration portion of each breath is identified by a zero-crossing detector. A number of evenly spaced (e.g., 65) points, indicating time points, are interpolated by an interpolator along the inspiration flow-time curve for each breath. The curve described by these points is then scaled by a scaler to have unit length (duration / period) and unit area, thereby removing the effects of changes in breathing rate and depth. The scaled breath is then compared in a comparator to a pre-stored template (similar to the inspiration portion of the breath shown in FIG. 6A) indicative of a normal, unobstructed breath. If at any time during inspiration the breath deviates from this template due to, for example, coughing, exhaling, swallowing, and hiccuping as determined by the test element, beyond a specified threshold (typically one scale unit), the breath is rejected. For data that was not rejected, a running average of the first such scaled point is calculated by the central controller 4230 for the preceding several inspiration events. This is repeated for the second such point over the same inspiration event, and so on. So, for example, 65 scaled data points are generated by the central controller 4230 to represent a moving average of several preceding inhalation events (e.g., 3 events). Hereinafter, the moving average of the continuously updated (e.g., 65) point values ​​is referred to as the "scaled flow" and denoted by Qs(t). Alternatively, a single inhalation event may be used instead of the moving average.

[0162] From the scaled flow rates, two shape factors relevant to determining partial occlusion can be calculated.

[0163] Shape factor 1 is the ratio of the average of the median (e.g., 32) scaled flow points to the average of the global (e.g., 65) scaled flow points. If this ratio exceeds 1, the breath is considered normal. If this ratio is less than 1, the breath is considered obstructed. A ratio of approximately 1.17 is considered the threshold between partially obstructed and unobstructed breaths, and equates to a certain level of obstruction that allows for the maintenance of adequate oxygenation in a typical patient.

[0164] Shape factor 2 is calculated as the mean square deviation from unit scaled flow over the mean (e.g., 32) points. A mean square deviation of approximately 0.2 units is considered normal. A mean square deviation of zero is considered a totally flow-limited breath. The closer the mean square deviation is to zero, the more the breath is considered to be flow-limited.

[0165] Shape elements 1 and 2 may be used alternatively or in combination. In other forms of the present technology, the number of sampled points, breaths and midpoints may be different from those described above. Additionally, the thresholds may be different from those described above.

[0166] 5.4.3.2.5 Apnea and hypopnea determination In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for determining the presence of apnea and / or hypopnea.

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

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

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

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

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

[0172] The snore detection algorithm 4326 may include determining the strength of the flow signal in the range of 30-300 Hz. Additionally, the snore determination algorithm 4326 may include filtering the respiratory flow signal Qr to reduce background noise (e.g., airflow sounds in the system from the blower).

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

[0174] In one form, the airway patency determination algorithm 4327 receives as an input the respiratory flow signal Qr 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 taken as indicative of an airway patency. The absence of a peak is taken as an indication of an airway closure.

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

[0176] In one form, the airway patency determination algorithm 4327 receives as an input the respiratory flow signal Qr and determines the presence or absence of a cardiogenic signal, the absence of which is taken as an indication of airway obstruction.

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

[0178] In some forms of the present technology, there is no target ventilation determination algorithm 4328 and the target value Vtgt is predetermined, for example obtained by hard coding during configuration of the RPT device 4000 or by manual entry via 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 a 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 high percentage and a value less than the typical recent ventilation Vtyp. The high percentage in such forms can be in 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 slightly more than a multiple of the typical recent ventilation, Vtyp.

[0182] Typical recent ventilation Vtyp is a value around which measurements of current ventilation Vent over multiple time instants over some predetermined time scale tend to be clustered (i.e., a measure of the central tendency of measurements of current ventilation in the recent history). In one implementation of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case should be longer than the time scale of a Cheyne-Stokes ramp-up and ramp-down cycle. The target ventilation determination algorithm 4328 may determine typical recent ventilation Vtyp from measurements of current ventilation Vent using any of a variety of well-known measures of central tendency. One such measure is a low pass filter output for measurements of 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 determining 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 implementation of this form, the treatment parameter determination algorithm 4329 determines the treatment pressure, Pt, using the following equation:

number

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

[0186] If the waveform determination algorithm 4322 provides the waveform template Π(Φ) as a lookup table of values ​​Π indexed by the phase Φ, the treatment parameter determination algorithm 4329 applies equation (1) by locating the closest lookup table entry to the current value Φ of the phase returned from the phase determination algorithm 4321 or between two entries that span the current value Φ of the phase.

[0187] The values ​​of amplitude A and base pressure P0 may be set by the treatment parameter determination algorithm 4329 depending on the respiratory pressure treatment mode selected as described below.

[0188] 5.4.3.3 Treatment Control Module A treatment control module 4330 according to one aspect of the present technology receives treatment parameters from a treatment parameter determination algorithm 4329 of the treatment engine module 4320 as input and controls the pressure generator 4140 to deliver airflow from the pressure generator in accordance with these treatment parameters.

[0189] In one form of the present technology, the treatment parameter is a treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow such that the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt.

[0190] 5.4.3.4 Detecting Fault Conditions In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detection of a fault condition. The fault condition detected by the one or more methods 4340 may include at least one of the following: ● Power outage (no power or insufficient power) ● Converter failure detection ● Unable to detect the presence of a component ● Operating parameters are outside the recommended range (e.g., pressure, flow, temperature, PaO2) • Failure of a test alert to produce a detectable warning signal.

[0191] When a fault condition is detected, the corresponding algorithm 4340 signal the presence of the fault by one or more of the following: ● Initiating audible, visual and / or kinetic (e.g. vibration) warnings. ● Sending messages to external devices Incident logging

[0192] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (eg, the RPT device 4000 and the patient interface 3000).

[0193] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0194] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., central controller 4230). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent No. 6,399,343, which is incorporated herein by reference in its entirety.

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

[0196] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the 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 stream before delivery to the patient's airway.

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

[0198] 5.6.2 RPT Devices and Humidifiers 6-8 show a humidifier 6000 according to one embodiment of the present technology. In the illustrated example, the humidifier 6000 includes a water reservoir dock 6050 constructed and arranged to receive a water reservoir 6100. In the illustrated example, the humidifier 6000 is integrated with the 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 constructed and arranged to receive the water reservoir 6100.

[0199] It should be appreciated that in an alternative arrangement, the humidifier 6000 (e.g., the reservoir dock 6050) may be provided separately to 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, e.g., FIG. 30 and FIG. 46). Each blower provides a flow or supply of air at a positive pressure (e.g., about 2-50 cmH 2 Each blower is constructed and arranged to generate a supply of air in the range of 0 to 100 sq. m. (range 0 to 100 sq. m). Each blower is operable to draw a supply of air into the pneumatic block 7100 (e.g., through one or more inlet openings in the pneumatic block) and into its inlet (blower inlet) to provide a supply of pressurized air at its outlet (blower outlet). The blower outlet communicates with the humidifier 6000 (e.g., the inlet of the water reservoir 6100).

[0201] A pneumatic block 7100 according to an example of the present technology is configured and arranged to support different blowers, for example depending on the treatment required. In the illustrated example, the pneumatic block 7100 is configured and arranged to support a selected one of at least two different blowers 7200B1 or 7200B2 (see, for example, FIG. 30 and FIG. 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 bi-level treatment). However, it should be understood that the pneumatic block 7100 may be configured and arranged to support a selected blower or more than two different blowers. In an example, each blower may 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 Figures 8-15, 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 may be enclosed by an exterior housing 8002 that includes one or more panels and / or one or more user inputs / displays (see, for example, Figures 6 and 7).

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

[0204] The chassis assembly 7300 and the internal components of the pneumatic block (e.g., a selected blower subassembly 7400SUB1 or 7400SUB2) cooperate to form a pneumatic airflow path extending from the chassis inlet 7310 to the blower inlet of blower 7200B1 or 7200B2, and from the blower outlet of blower 7200B1 or 7200B2 to the chassis outlet 7320.

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

[0206] Additionally, the chassis assembly 7300 and internal components (e.g., selected blower subassemblies 7400SUB1 or 7400SUB2 of the pneumatic block) cooperate to form multiple chambers along the air flow path, for example to reduce 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 constructed and arranged to support a selected blower subassembly 7400SUB1 or 7400SUB2.

[0208] Additionally, 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 Figures 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 Figures 12, 13, 14 and 15, the lower chassis 7300B includes a pneumatic block portion 7350B that forms a lower portion 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 material. For example, the upper chassis 7300T includes a first part or base mold 7301T made of a relatively hard material (e.g., a thermoplastic polymer (e.g., PC, ABS)) and a second part or overmold 7302T provided (e.g., by overmolding) on ​​the first part 7301T and made 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 with the pneumatic block portion 7350T (inner skin), but it should be understood that the overmold may be provided on other surfaces of the base mold.

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

[0212] As best shown in Figures 14 and 15, overmolds 7302T and 7302B on the upper chassis 7300T and lower chassis 7300B can provide noise attenuation properties to attenuate wall-radiated noise and sealing properties to provide a sealing interface between the upper and lower chassis (i.e., a sealed pneumatic block cavity 7350).

[0213] In another example, the upper chassis 7300T and the lower chassis 7300B may comprise different materials, for example, the upper chassis 7300T comprises 10% glass filled PC and the lower chassis 7300B comprises PC / ABS.

[0214] The top wall of the upper chassis 7300T is constructed and arranged to support the PCBA 7600 (see, e.g., FIG. 8). As described below, openings are included in the top wall to allow sensors (e.g., flow sensors, pressure sensors) on the PCBA 7600 to protrude into 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 allow communication between the outlet of the water reservoir 6100 and the air circuit 4170.

[0216] The lower chassis 7300B includes a sidewall with a number of inlet openings 7340 that provide the chassis inlet 7310. The number of openings 7340 allow sufficient airflow while avoiding intrusion of larger objects. A recessed chamber 7342 is provided in the lower chassis 7300B that communicates with the number of openings 7340. The recessed chamber 7342 leads to an elongated inlet tube 7345 that communicates with the pneumatic block cavity 7350. In use, air flows into the recessed chamber 7342 through the number of openings 7340, and from the recessed chamber 7342 through the elongated inlet tube 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, constructed and arranged to hold and support (in a removable manner) an inlet air filter within the recessed chamber 7342. In use, the inlet air filter is positioned to filter air entering the pneumatic block cavity 7350. The inlet air filter may also be constructed to reduce radiated noise returning through the chassis inlet 7310.

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

[0218] The lower chassis 7300B includes internal ribs 7365 spaced axially between the internal locating grooves (see, e.g., FIGS. 12 and 13). In one example, the internal ribs 7365 are constructed and arranged to at least partially enclose the blower 7200B2 of the blower subassembly 7400SUB2 (e.g., to increase case stiffness and provide support, impact resistance and / or damping properties for the blower). In an example, the upper chassis 7300T may also include one or more internal ribs (e.g., for case stiffness and blower support).

[0219] Additionally, the sidewalls of the lower chassis 7300B are constructed and arranged to provide a support structure for the chassis plate 7510SS1 of the blower subassembly 7400SUB1. For example, the sidewalls 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 and support the chassis plate 7510SS1 of the blower subassembly 7400SUB1.

[0220] In an example, the reservoir dock 6050 formed by the upper chassis 7300T and the lower chassis 7300B may include guide structures 6060 to facilitate alignment and connection of the water reservoir 6100. For example, each side of the reservoir dock 6050 may include guide structures 6060 in the form of rails to define an assembly path for the water reservoir 6100 (see, e.g., FIG. 7).

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

[0222] Blower Sub-Assembly As noted above, the chassis assembly 7300 is structured to position and support a selected one of at least two different blower subassemblies 7400SUB1 or 7400SUB2 that are structurally distinct from one another in at least one aspect (e.g., depending on the required treatment). That is, the chassis assembly 7300 includes a common component between a first configuration and a second configuration of the RPT device. That is, the first configuration includes a first blower subassembly 7400SUB1 and the second configuration includes a second blower subassembly 7400SUB2.

[0223] The first blower subassembly 7400SUB1 includes a first type of blower 7200B1 (e.g., configured for CPAP or APAP therapy). The second blower subassembly 7400SUB2 includes a second type of blower 7200B2 (e.g., configured for bi-level therapy). As described below, the air flow path and chamber arrangement along the air flow path differs depending on the selected blower subassembly 7400SUB1 or 7400SUB2 supported within the chassis assembly 7300.

[0224] First Blower Subassembly As shown in FIGS. 16 to 19, the first fan subassembly 7400SUB1 includes a first fan 7200B1 and a support structure 7500SS1 for supporting the first fan 7200B1 within the chassis assembly 7300.

[0225] In the illustrated example, the first blower 7200B1 provides a flow or supply of air at a positive pressure (e.g., up to about 30 cmH 2 O, for example, about 4 to 30 cmH 2 The three-stage design is constructed and arranged to produce

[0226] The first blower 7200B1 includes a housing including 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) are disposed three stages with three corresponding impellers (i.e., a first impeller and a second impeller positioned on one side of the motor, and a third impeller positioned on the other side of the motor). However, other suitable impeller arrangements are possible. Each impeller is followed by a set of stator vanes constructed and arranged to direct the airflow to the next stage. The blower housing is relatively rigid and forms a substantially sealed structure constructed and arranged to hermetically separate the airflow through the interior of the first blower from the pneumatic block cavity.

[0227] Further examples and details of first blower 7200B1 are described in PCT Publication No. WO2013 / 020167, the entirety of which is incorporated herein by reference.

[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 7556SS1 (inlet end suspension) supported within an opening in the base plate 7552SS1. In addition, a sealing lip or flange 7558SS1 is provided along an edge or periphery 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 constructed of a relatively hard material (e.g., a thermoplastic polymer), and the blower suspension 7556SS1 and the sealing lip 7558SS1 include a second portion or overmold attached (e.g., by overmolding) to the first portion and constructed 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 distinct structure from the chassis plate 7510SS1 and then connected thereto. For example, the chassis plate 7510SS1 includes positioning grooves 7512SS1 (e.g., formed by spaced apart 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 secured to the chassis plate 7510SS1 via, for example, a clip structure (e.g., flexible tabs on the base plate 7552SS1 inserted into respective openings on the chassis plate 7510SS1).

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

[0233] In the example, the outlet plate assembly 7530SS1 is formed as 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 also includes a 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 portion or base mold constructed of a relatively hard material (e.g., a thermoplastic polymer), and the blower suspension 7536SS1 and the sealing lip 7538SS1 include a second portion or overmold attached (e.g., by overmolding) to the first portion and constructed of a relatively soft material (e.g., TPE or silicone).

[0236] Additionally, a sealing lip or sealing flange 7518SS1 may be provided along the edge or periphery of the chassis plate 7510SS1 (eg, an overmold constructed from a relatively soft material such as TPE or silicone).

[0237] The first blower 7200B1 is suspended between the flow plate assembly 7550SS1 and the outlet plate assembly 7530SS1 by a support structure 7500SS1. The flow plate assembly 7550SS1 and the outlet plate assembly 7530SS1 each include a blower suspension 7556SS1, 7536SS1. The blower suspension 7556SS1, 7536SS1 cooperate to support the first blower 7200B1 within the chassis assembly 7300, provide air path sealing, isolate vibrations of the first blower 7200B1, and provide shock resistance. The blower suspension 7556SS1, 7536SS1 may provide additional springing and damping that allows for vibration isolation and provides shock resistance. Specifically, the flow plate assembly 7550SS1 provides an inlet end suspension 7556SS1 that supports the first blower 7200B1 adjacent the blower inlet 7210B1, and the outlet plate assembly 7530SS1 provides an outlet end suspension 7536SS1 that supports the first blower 7200B1 adjacent the blower outlet 7220B1 (i.e., a suspension is provided at each end of the first blower 7200B1). Such an arrangement also provides a key feature for ensuring repeatable alignment of the first blower 7200B1 within the first blower subassembly 7400SUB1.

[0238] In an example, as shown in Figures 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 suspensions 7556SS1 and 7536SS1, for example to act as rigid or bump stops to limit the range of motion permitted by the blower suspensions 7556SS1 and 7536SS1.

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

[0240] Additionally, an acoustic foam (i.e., outlet foam 7570SS1) is retained by the chassis plate 7510SS1 for increased acoustic resistance and reduced noise. In the illustrated example, the chassis plate 7510SS1 includes a retention arm 7513SS1 adapted to engage within a slot provided in the outlet foam 7570SS1. Assembling the First Blower Subassembly to the Chassis Assembly

[0241] A first blower subassembly 7400SUB1 is assembled to the chassis assembly 7300 to form a first configuration 7100 of a pneumatic block (eg, one configured for CPAP or APAP therapy, for example).

[0242] 20-24 show the assembly of the first blower subassembly 7400SUB1 to the chassis assembly 7300. As shown in FIG. 20, an acoustic foam (i.e., inlet foam 7700) is placed into the pneumatic block portion 7350B of the lower chassis 7300B for increased acoustic resistance and reduced noise. In the illustrated example, the inlet foam 7700 includes a generally U-shaped shape adapted to extend along the sidewall of the pneumatic block portion 7350B. Next, as shown in FIG. 20 and FIG. 21, the first blower subassembly 7400SUB1 is lowered onto the lower chassis 7300B along with the outlet foam 7570SS1 held to the first blower subassembly 7400SUB1. As shown in FIG. 22 and FIG. 23, the edge of the chassis plate 7510SS1 is supported along the periphery of the pneumatic block portion 7350B by one or more of a support surface, a ledge and / or a rib. In addition, a support plate 7519SS1 may be provided on the underside of the chassis plate 7510SS1. The support plate 7519SS1 is positioned to engage a lower wall of the lower chassis 7300B to further support the first blower subassembly 7400SUB1 within the lower chassis 7300B (see, for example, FIG. 30).

[0243] Thereafter, as shown in Figure 22, the upper chassis 7300T is lowered onto the lower chassis 7300B such that the base plate 7552SS1 of the flow plate assembly 7550SS1 and the base plate 7532SS1 of the outlet plate assembly 7530SS1 are engaged within respective internal positioning grooves 7360T1 and 7360T2 in the upper chassis 7300T to position and support the first blower subassembly 7400SUB1 within the upper chassis 7300T. The upper and lower chassis 7300T and the lower chassis 7300B may be held together in any suitable manner, for example, via mechanical fasteners (e.g., screws) and / or retaining clips.

[0244] 24, the PCBA 7600 is attached to a top 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 flow and pressure sensors in communication with the pneumatic block cavity 7350.

[0245] The electrical connection between the PCBA7600 and the first blower7200B1 may be via a flexible circuit board (FCB), a flexible printed circuit (FPC) and / or a flexible flat cable (FFC) extending from the first blower7200B1 to the PCBA7600 within the pneumatic block cavity7350. Chamber arrangement and pneumatic airflow path provided by first blower subassembly

[0246] When assembled, the first blower subassembly 7400SUB1 and the chassis assembly 7300 cooperate to provide a first configuration 7100 of a 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 Figures 26 to 33, the chassis plate 7510SS1 and the lower chassis 7300B cooperate to form a first inlet muffler chamber IC1; the chassis plate 7510SS1, the base plate 7552SS1 of the flow plate assembly 7550SS1, the base plate 7532SS1 of the outlet plate assembly 7530SS1, and the upper chassis 7300T cooperate to form a 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 a third inlet muffler chamber IC2; and the chassis plate 7510SS1, the base plate 7532SS1 of the outlet plate assembly 7530SS1, and the upper chassis 7300T cooperate to form an outlet chamber OC.

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

[0249] In the illustrated example (see, for example, FIG. 30), at the bottom 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 orientation. As shown, in the first configuration of the pneumatic block 7100, the first blower 7200B1 is positioned 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 in a generally horizontal plane when the RPT device 7000 is in the operating orientation.

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

[0251] As shown, the air flow path of the first configuration of the pneumatic block 7100 is constructed and arranged such that air enters the chassis assembly 7300 through the inlet opening 7340 (see, e.g., FIG. 25) and into the recessed chamber 7342 (including, e.g., an inlet air filter as discussed above), travels from the recessed chamber 7342 through the long inlet tube 7345, and into the first inlet muffler chamber IC1 shown in FIG. 26. The relatively long length of the long inlet tube 7345 allows for noise reduction (due to high inertance) as it travels from the inlet opening 7340 to the first inlet muffler chamber IC1. Providing a large amount of inlet foam 7700 in the first inlet muffler chamber IC1 leads to increased acoustic resistance and reduced inlet noise.

[0252] Air travels from the first inlet muffler chamber IC1 to the second inlet muffler chamber IC2 through flow tubes 7515SS1 in the chassis plate 7510SS1, as shown in Figures 27 and 31. The flow tubes 7515SS1 are relatively long, which allows for noise reduction. As shown, the first blower 7200B1 is supported in the second inlet muffler chamber IC2 and receives air at the blower inlet 7210B1 from the third inlet muffler chamber IC3.

[0253] Air travels from the second inlet muffler chamber IC2 to the third inlet muffler chamber IC3 through a flow tube array 7554SS1 provided by the flow plate assembly 7550SS1, as shown in Figure 28. 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 7556SS1 of the flow plate assembly 7550SS1 may be secured to the first blower 7200B1 in any suitable manner (e.g., wrapped around an inlet flange on the blower inlet 7210B1 of the first blower 7200B1). The blower suspension 7556SS1 provides a seal along the blower inlet 7210B1, sealing it off from the second inlet muffler chamber IC2 and providing 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 7556SS1 provides structure (e.g., gussets) that allow flexibility and relative movement to isolate vibrations of the first blower 7200B1 and provide shock absorption.

[0255] The flow tube array 7554SS1 includes a plurality of flow tubes 7555SS1 constructed and arranged to extend from the base plate 7552SS1 into the second inlet muffler chamber IC2 (e.g., the flow tubes 7555SS1 extend generally perpendicular to the base plate 7552SS1). Thus, an airflow path extends from the second inlet muffler chamber IC2 through the flow tube array 7554SS1 and into the third inlet muffler chamber IC3. The flow tubes 7555SS1 are constructed and arranged to provide laminar flow, provide a defined pressure drop, and provide a length sufficient for noise reduction.

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

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

[0258] The first inlet muffler chamber IC1, the second inlet muffler chamber IC2 and the third inlet muffler chamber IC3 cooperate to provide improved compliance and reduced inlet noise 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 an 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 an example, the outlet chamber OC of the first configuration of the pneumatic block 7100 is approximately 30 cmH. 2 Positive pressure up to O

[0260] The blower suspension 7536SS1 of the outlet plate assembly 7530SS1 may be secured to the first blower 7200B1 in any suitable manner (e.g., wrapped around an outlet flange provided to the blower outlet 7220B1 of the first blower 7200B1). The blower suspension 7536SS1 provides a seal along the blower outlet 7220B1, sealing it off from the second inlet muffler chamber IC2 and providing an air path for air to exit the blower outlet 7220B1 to the outlet chamber OC. Also, in the illustrated embodiment, the blower suspension 7536SS1 provides structure (e.g., gussets) that allow flexibility and relative movement to isolate vibrations of the first blower 7200B1 and provide shock absorption.

[0261] The exit chamber OC is relatively large, allowing for improved compliance and reduced exit noise (e.g., attenuation of exit noise or forward conducted noise), and the provision of exit foam 7570SS1 (supported by chassis plate 7510SS1) within the exit chamber OC allows for increased acoustic resistance and reduced exit noise (see, e.g., FIG. 30).

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

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

[0264] 57-59 are schematic diagrams showing the vertically offset chamber arrangement configuration of the first configuration of the pneumatic block and the 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] 57-59 include arrows showing an exemplary air flow path through the first inlet chamber IC1, the second inlet chamber IC2 and 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 a chassis inlet. It then travels 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 a flow tube 7515SS1, as shown in FIG. 57. As shown in FIG. 59, air travels 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 a flow tube array 7554SS1. The air travels through the third inlet chamber IC3 in the second plane PL2 to the blower inlet 7210B1 of the first blower 7200B1 positioned in the second inlet chamber IC2 in the second plane PL2. The air travels through a first blower 7200B1 positioned in a second inlet chamber IC2 in a second plane PL2 and exits into an outlet chamber OC in the second plane PL2 as shown in Figure 59. The pressurized air from the outlet chamber OC exits the pneumatic block via a chassis outlet.

[0266] As shown in Figures 57-59, the air flow paths of the first configuration of the pneumatic block extend from the chassis inlet to the chassis outlet in different directions and in different planes. For example, the direction of air flow at the chassis inlet (see Figure 58) extends transversely to the direction of air flow at the chassis outlet (see Figure 59). Also, as shown in Figure 59, air extends in a generally J-shaped configuration in the second plane PL2 through the second and third inlet chambers IC2 and IC3 and the outlet chamber OC, with the air flow moving from the second inlet chamber IC2 to the third inlet chamber IC3, which extends in the opposite direction to the air moving from the third inlet chamber IC3, through the blower in the second inlet chamber IC2, and into the outlet chamber OC.

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

[0268] In the illustrated example, the second blower 7200B2 provides a flow or supply of air at a positive pressure (e.g., up to about 50 cmH 2 O, for example, about 4 to 50 cmH 2 The invention includes a two-stage design constructed and arranged to produce

[0269] 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) are disposed two stages with 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). However, other suitable impeller arrangements are possible. Each impeller is followed by a set of stator vanes constructed and arranged to direct the airflow to the next stage.

[0270] In the illustrated example, the second blower 7200B2 is mounted within a suspension 7250B2 (e.g., comprising silicone). The suspension 7250B2 forms a substantially sealed structure constructed and arranged to sealingly isolate the airflow moving within the interior of the second blower 7200B2 from the pneumatic block cavity 7350. Additionally, the shroud formed by the suspension 7250B2 provides a key feature for isolating blower vibrations, providing shock absorption, and ensuring repeatable alignment of the second blower 7200B2 within the second blower subassembly 7400SUB2.

[0271] Further examples and details of the second blower 7200B2 are described in U.S. Patent Application Publication No. 2007 / 0139994, the entirety of which is incorporated herein by reference.

[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 7556SS2 (inlet end suspension) supported within an opening 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 constructed of a relatively hard material (e.g., a thermoplastic polymer), and the blower suspension 7556SS2 and the sealing lip 7558SS2 include a second portion or overmold attached (e.g., by overmolding) to the first portion and constructed 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 7536SS2 (outlet end suspension) supported within an opening in the base plate 7532SS2. In addition, a sealing lip or sealing flange 7538SS2 is provided along an edge or periphery of the base plate 7532SS2.

[0276] In one embodiment, the base plate 7532SS2 includes a first portion or base mold constructed of a relatively hard material (e.g., a thermoplastic polymer), and the blower suspension 7536SS2 and the sealing lip 7538SS2 include a second portion or overmold attached (e.g., by overmolding) to the first portion and constructed 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 exit plate assembly 7530SS2. The flow plate assembly 7550SS2 and the exit plate assembly 7530SS2 each include a blower suspension 7556SS2, 7536SS2. The blower suspension 7556SS2, 7536SS2 cooperate to support the second blower 7200B1 within the chassis assembly 7300, provide air path sealing, isolate vibrations of the second blower 7200B2, and provide shock resistance. The blower suspension 7556SS2, 7536SS2 may provide additional springing and damping that allows for vibration isolation and provides shock resistance. Specifically, the flow plate assembly 7550SS2 provides an inlet end suspension 7556SS2 that supports the second blower 7200B2 adjacent the blower inlet 7210B2, and the outlet plate assembly 7530SS2 provides an outlet end suspension 7536SS2 that supports the second blower 7200B2 adjacent the blower outlet 7220B2 (i.e., a suspension is provided at each end of the second blower 7200B2). Such an arrangement also provides key features for ensuring repeatable alignment of the second blower 7200B2 within the second blower subassembly 7400SUB2.

[0278] In an example, as shown in Figures 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 suspensions 7556SS2 and 7536SS2, for example, to act as rigid or bump stops to limit the range of motion provided by the blower suspensions 7556SS2 and 7536SS2.

[0279] In an example, the second blower 7200B2 may be inserted or otherwise assembled to the flow plate assembly 7550SS2, after which the second blower 7200B2 may be inserted or otherwise assembled to the outlet plate assembly 7530SS2. In an example, the second blower 7200B2 may be assembled to the flow plate assembly 7550SS2 using positioning support tabs 7252B2 provided on the suspension 7250B2 (e.g., by pulling the positioning support tabs 7252B2 through the blower suspension 7556SS2 to engage the inlet flange of the second blower 7200B2 with the blower suspension 7556SS2). In an example, the second blower 7200B2 can be assembled to the outlet plate assembly 7530SS2 using an outlet funnel 7254B2 attached to the suspension 7250B2 (e.g., by pulling the outlet funnel 7254B2 through the blower suspension 7536SS2 to engage the outlet funnel 7254B2 associated with the blower outlet of the second blower 7200B2 with the blower suspension 7536SS2). Assembling the Second Blower Subassembly to the Chassis Assembly

[0280] Assembling the second blower subassembly 7400SUB2 to the chassis assembly 7300 forms a second configuration of the pneumatic block 7100 (eg, configured for bi-level treatment).

[0281] 39-41 show the assembly of the second blower subassembly 7400SUB2 to the chassis assembly 7300. First, as shown in FIG. 39, the second blower subassembly 7400SUB2 is lowered 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 arranged to engage with the respective internal positioning grooves 7360B1 and 7360B2 in the lower chassis 7300B and position and support the second blower subassembly 7400SUB2 in 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 in the lower chassis 7300B therein.

[0282] In an example, acoustic foam (ie, inlet foam) may be placed within the pneumatic block portion of the lower chassis 7300B to increase acoustic resistance and reduce noise.

[0283] Thereafter, as shown in Figure 40, the upper chassis 7300T may be lowered onto the lower chassis 7300B, causing the base plate 7552SS2 of the flow plate assembly 7550SS2 and the base plate 7532SS2 of the outlet plate assembly 7530SS2 to engage with respective internal positioning grooves 7360T1 and 7360T2 in the upper chassis 7300T to position and support the second blower subassembly 7400SUB2 within the upper chassis 7300T. The upper and lower chassis 7300T and the lower chassis 7300B may be held together in any suitable manner, for example, via mechanical fasteners (e.g., screws) and / or retaining clips.

[0284] 41, the PCBA7600 is attached (e.g., via mechanical fasteners (e.g., screws)) to a top wall of the upper chassis 7300T outside of the pneumatic block cavity 7350. As described above, the PCBA7600 includes flow and pressure sensors disposed in communication with the pneumatic block cavity 7350.

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

[0286] When assembled, the second blower subassembly 7400SUB2 and the chassis assembly 7300 cooperate to provide a second configuration 7100 of a 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 Figures 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 a 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 a 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 an outlet chamber OC.

[0288] In the illustrated example, chambers IC1, IC2 and OC are sealed, respectively, via overmolded sealing lips 7538SS2 and 7558SS2 (e.g., silicone) along the periphery of base plates 7532SS2 and 7552SS2, which provide controlled compression against the upper and lower chassis 7300T and 7300B.

[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 actuation orientation. As shown, in the second configuration of the pneumatic block 7100, the second blower 7200B2 is positioned such that an 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 in a generally horizontal plane when the RPT device 7000 is in the actuation orientation.

[0290] In the illustrated example, the pneumatic airflow path of the second configuration of the pneumatic block 7100 includes a serpentine path extending from a chassis inlet 7310 to a chassis outlet 7320. In the example, the air flow 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, the air flow path of the second configuration of the pneumatic block 7100 is constructed and arranged such that air enters the chassis assembly 7300 through the inlet opening 7340 (see, e.g., FIG. 25) and into the recessed chamber 7342, travels from the recessed chamber 7342 through the long inlet tube 7345, and into the first inlet muffler chamber IC1 shown in FIGS. 42 and 43. The relatively long length of the long inlet tube 7345 allows for noise reduction (due to high inertance) as it travels from the inlet opening 7340 to the first inlet muffler chamber IC1. In an example, providing inlet foam in the first inlet muffler chamber IC1 may allow for increased acoustic resistance and reduced inlet noise.

[0292] Air travels from the first inlet muffler chamber IC1 to the second inlet muffler chamber IC2 through a flow tube array 7554SS2 provided by the flow plate assembly 7550SS2 as shown in FIG. 44. The second inlet muffler chamber IC2 receives air from the flow tube array 7554SS2 and delivers the air to a blower inlet 7210B2 of the second blower 7200B2. As shown, the second blower 7200B2 is supported in the first inlet muffler chamber IC1 and receives air from the second inlet muffler chamber IC2 at the blower inlet 7210B2. In an example, providing an inlet foam in the second inlet muffler chamber IC2 may enable increased acoustic resistance and reduced inlet noise.

[0293] The blower suspension 7556SS2 of the flow plate assembly 7550SS2 may be secured to the second blower 7200B2 in any suitable manner (e.g., wrapped around an inlet flange on the blower inlet 7210B2 of the second blower 7200B2). The blower suspension 7556SS2 provides a seal along the blower inlet 7210B2, sealing it off from the first inlet muffler chamber IC1 and providing 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 7556SS2 provides structure (e.g., gussets) that allow flexibility and relative movement to isolate vibrations of the second blower 7200B2 and provide shock absorption.

[0294] The flow tube array 7554SS2 includes a plurality of flow tubes 7555SS2 constructed and arranged to extend from the base plate 7552SS2 into the first inlet muffler chamber IC1 (e.g., the flow tubes 7555SS2 extend generally perpendicular to the base plate 7552SS2). Thus, an airflow path extends from the first inlet muffler chamber IC1 through the flow tube array 7554SS2 and into the second inlet muffler chamber IC2. The flow tubes 7555SS2 are constructed and arranged to provide laminar flow, provide a defined pressure drop, and provide a length sufficient for noise reduction.

[0295] In the illustrated example, the flow tube array 7554SS2 includes twelve spaced apart flow tubes 7555SS2 (e.g., generally arranged as four rows of three tubes), however, it should be understood that other suitable numbers of tubes 7555SS2 are possible (e.g., one or more flow tubes, e.g., between 5 and 15 flow tubes) and that the tubes 7555SS2 can be arranged in other suitable manners (e.g., aligned in rows and / or columns, in a circular configuration).

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

[0297] The first inlet muffler chamber IC1 and the second inlet muffler chamber IC2 cooperate to enable improved compliance and reduced 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 an 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 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 an example, the outlet chamber OC of the second configuration of the pneumatic block 7100 is approximately 50 cmH 2 Positive pressure up to O can be applied.

[0299] The outlet plate assembly 7530SS2 of the blower suspension 7536SS2 may be secured to the second blower 7200B2 in any suitable manner (e.g., around the periphery of the outlet funnel 7254B2 of the suspension 7250B2 associated with the blower outlet 7220B2 of the second blower 7200B2). The blower suspension 7536SS2 provides a seal along the blower outlet 7220B2, sealing it off from the first inlet muffler chamber IC1 and providing an air path for air to exit the blower outlet 7220B2 to the outlet chamber OC. Additionally, in the illustrated embodiment, the blower suspension 7536SS2 provides structure (e.g., gussets) that allow flexibility and relative movement to isolate vibrations of the second blower 7200B2 and provide shock absorption.

[0300] The relatively large size of the exit chamber OC may allow for improved compliance and reduced exit noise, and acoustic foam (i.e., exit foam) may be provided to the exit chamber OC to allow for increased acoustic resistance and reduced exit noise.

[0301] In an example, the acoustic foam may be provided in one or more of the first and second inlet muffler chambers IC1 and IC2 and the outlet chamber OC (e.g., acoustic foam provided in each of the first and second inlet muffler chambers IC1 and IC2 and the outlet chamber OC). It should be understood that other arrangements of the acoustic foam are possible.

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

[0303] 60-61 are schematic diagrams 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 showing an exemplary air flow path through the first and second inlet chambers IC1 and IC2 and the exit chamber OC. As shown, air enters the first inlet chamber IC1, for example, via a chassis inlet. The air then travels from the first inlet chamber IC1 to the second inlet chamber IC2, for example, via a flow tube array 7554SS2. The air travels through the second inlet chamber IC2 to a blower inlet 7210B2 of a second blower 7200B2 positioned in the first inlet chamber IC1. The air travels through the second blower 7200B2 positioned in the first inlet chamber IC1 and exits into the exit chamber OC. The pressurized air from the exit chamber OC exits the pneumatic block via a chassis outlet.

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

[0306] Flow and Pressure Sensors As mentioned above, the PCBA 7600 includes a flow sensor 7610 and a pressure sensor 7620 for monitoring and controlling air flow and pressure in the pneumatic block 7100. In the top wall of the upper chassis 7300T, openings or ports P1, P2 and P3 (see, e.g., Figures 9, 15 and 50) are provided that allow 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 in communication with respective flow sensor ports 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 an 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 (internal skin) provided to the inner surface of the upper chassis 7300T.

[0308] For example, as shown in Figures 49 and 52, an overmold 7302T of the upper chassis 7300T provides a first sealing portion 7305SP1 along flow sensor port P1 and a second sealing portion 7305SP2 along flow sensor port P2. As shown, the first sealing portion 7305SP1 and second sealing portion 7305SP2 each provide a tubular sealing surface or interface 7306 adapted for sealing engagement along an outer surface of each flow sensor 7610A and 7610B. Chamfered edges 7307 on the outer ends of the first sealing portion 7305SP1 and the second sealing portion 7305SP2, respectively, facilitate engagement of the first sealing portion 7305SP1 and the second sealing portion 7305SP2 with each of the flow sensors 7610A and 7610B (i.e., the chamfered edges 7307 guide each of the flow sensors 7610A and 7610B into engagement with each of the tubular sealing surfaces 7306).

[0309] However, the first sealing portion 7305SP1 and the second sealing portion 7305SP2 may have other geometries configured for sealing with the respective flow sensors 7610A and 7610B. For example, in another example as shown in FIG. 53, the first sealing portion 7305SP1 and the second sealing portion 7305SP2 each provide 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 end of each of the first sealing portion 7305SP1 and the second sealing portion 7305SP2, an annular groove portion 7316 is provided that provides a bending space for the outer ring portion 7314. The flex space provided by the annular groove 7316 is constructed and arranged to elastically deflect the outer ring portion 7314 radially outwardly, thereby facilitating engagement of the outer ring portion 7314 of each of the first and second sealing portions 7305SP1 and 7305SP2 with each of the flow sensors 7610A and 7610B. Moreover, such elastic deflection of the outer ring portion 7314 provides a bias for sealing the outer ring portion 7314 with each of the flow sensors 7610A and 7610B.

[0310] In a first configuration of the pneumatic block 7100, a flow sensor 7610 communicates with each flow sensor port P1 and P2 to measure the pressure drop between the second chamber IC2 and the third chamber IC3 in the pneumatic block (i.e., to divert flow proportional to the pressure difference between the second chamber IC2 and the third chamber IC3). That is, for determining the airflow rate, one of the pair of sensors 7610B of the flow sensor is positioned to measure a first pressure in the second chamber IC2 and the other of the pair of sensors 7610A of the flow sensor is positioned to measure a second pressure in the third chamber IC3.

[0311] In a second configuration of the pneumatic block, a flow sensor 7610 communicates with each flow sensor port P1 and P2 to measure the pressure drop across the first and second chambers IC1 and IC2 in the pneumatic block (i.e., to divert flow in proportion to the pressure difference between the first and second chambers IC1 and IC2). That is, for determining the airflow rate, one of the pair of sensors 7610B of the flow sensor is positioned to measure a first pressure in the first chamber IC1 and the other of the pair of sensors 7610A of the flow sensor is positioned to measure a second pressure in the second chamber IC2.

[0312] In the illustrated example, as shown in Figures 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 disposed on the side of the outlet chamber 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, Figure 50). The pressure sensor 7620 is sealed in the pressure sensor port P3 via an overmold 7302T (internal skin) provided on the inner surface of the upper chassis 7300T.

[0313] 51, an overmold 7302T of the upper chassis 7300T provides a sealing portion 7308 along the pressure sensor port P3. As shown, the sealing portion 7308 provides a tubular sealing surface or interface 7309 adapted for sealing engagement with an outer surface of the pressure sensor 7620.

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

[0315] In examples, a secondary pressure sensor may be provided to allow for a secondary measurement of pressure, for example, in the outlet chamber OC. In examples, if there is an abnormal reading in the primary pressure sensor 7620 or the secondary pressure sensor, the controller initiates a shutdown of the RPT device. The secondary pressure sensor may act as a backup so that the RPT device is not dependent on a single sensor or a single failure condition, for example, for increased safety.

[0316] 54-56 show a pressure sensor seal 7800 constructed and arranged to sealingly engage both a primary pressure sensor 7620 and a secondary pressure sensor 7621 on a PCBA 7600. In this example, the pressure sensor seal 7800 is formed as a separate and individual structure (a separately molded (e.g., silicone) component) from 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, the first sealing portion 7820SP1 and the second sealing portion 7820SP2 each include a port engaging side 7822 and a sensor engaging side 7824. Each port engaging side 7822 provides a tubular sealing surface or interface 7823 that is adapted to sealingly engage along an outer surface of each spigot 7325 for pressure sensor ports P3 and P4 formed in a base mold 7301T (e.g., a thermoplastic polymer (e.g., PC, ABS)) of the upper chassis 7300T.

[0319] At each sensor-engaging side 7824, a bellows-type interface 7825 is provided with one or more folds 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 engagement along the outer surface of each pressure sensor 7620 and 7621. The flexibility provided by such bellows-type interface 7825 can accommodate any manufacturing tolerances of the upper chassis 7300T and PCBA 7600. For example, the bellows-type interface 7825 can accommodate misalignment between the sensors 7620 and 7621 and the respective spigots 7325, thereby avoiding, for example, forced lateral movement of the sensors 7620 and 7621 that could result in a change in reading or damage to the PCBA 7600.

[0320] In the illustrated example, an inwardly extending fold in bellows interface 7825 provides a sealing surface 7826 adapted for sealing engagement with 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 an outer surface of a mounting post 7327 formed in a base mold 7301T of the upper chassis 7300T. Such engagement facilitates alignment of the first and second sealing portions 7820SP1 and 7820SP2 with respective spigots 7325 of the upper chassis 7300T and releasably secures (e.g., via frictional engagement) the pressure sensor seal 7800 to the upper chassis 7300T.

[0322] In the illustrated example, the base portion 7810 provides a thick wall along at least a portion of the periphery of the pressure sensor seal 7800 which is adapted to be supported within a recess 7329 on the exterior of the upper chassis 7300T.

[0323] 56 is connected to the upper chassis 7300T and sealingly engages the spigot 7325 and the pressure sensors 7620 and 7621 to pneumatically connect the pressure sensors 7620 and 7621 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 portion of the passage between each pressure sensor 7620 and 7621 and each spigot 7325 for pressure sensor ports P3 and P4.

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

[0325] 5.6.3 Humidifier Components 5.6.3.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidification of the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's 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 another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0326] According to one embodiment, 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 promote the air flow traveling a tortuous path through the reservoir 5110 while the air flow contacts a volume of water in the reservoir 5110.

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

[0328] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

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

[0330] 5.6.3.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock may include a locking feature (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 may include a water level. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator may include an indication of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0332] 5.6.3.5 Humidifier Transducer(s) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducers 4270 described above. The humidifier transducers 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5G. The humidifier transducers 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 transducers may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signals to the controller.

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

[0334] 5.6.3.5.2 Flow Converters In addition to or instead of the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided to the humidifier 5000.

[0335] 5.6.3.5.3 Temperature Converters The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures (e.g., the temperature of the heating element 5240 and / or the temperature of the air flow downstream of 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 Transducers 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 positioned toward the humidifier outlet to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or may be a relative humidity sensor.

[0337] 5.6.3.6 Heating elements In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the volume of water to the airflow. 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 a layered heating element, such as that described in U.S. Patent No. 6,399,633, which is incorporated herein by reference in its entirety.

[0338] In some forms, the heating element 5240 may be mounted in a humidifier base where heat may be transferred to the humidifier reservoir 5110 primarily 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 may be in communication 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 airflow, water in the reservoir 5110 and / or in the humidifier 5000). The humidifier controller 5250 may also be configured to run 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 human respiratory waveform during sleep. The horizontal axis is time and the vertical axis is respiratory flow. Since parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume, Vt, 0.5L; inhalation time, Ti, 1.6 seconds; peak inhalation flow, Qpeak, 0.4L / sec; exhalation time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5L / sec. The total duration of the breath, Ttot, is about 4 seconds. Humans typically breathe about 15 times per minute (BPM) and the ventilation, Vent, is about 7.5L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.

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

[0344] 5.8.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

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

[0346] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such ambient humidity may differ from the humidity outside the room in which the patient sleeps.

[0347] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.

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

[0349] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0350] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased 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 may refer to an instantaneous quantity. In some cases, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" for short.

[0352] In the example of a patient's breath, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle, and therefore negative for the exhalation portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Ventilator flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0353] Humidifier: The word "humidifier" refers to a device that delivers a therapeutically beneficial amount of water (H2O) to improve the medical respiratory condition of a patient. 2 O) is construed to mean a humidification device constructed, arranged, or configured with a physical structure capable of providing steam to an air stream.

[0354] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, a leak may occur due to an imperfect seal between the mask and the patient's face. In another embodiment, a leak may occur at the elbow to the perimeter.

[0355] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic path (e.g., the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0356] Noise Emission (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target according to ISO 3744.

[0357] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vents in a patient interface).

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

[0359] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH 2 O, gf / cm 2 , and hectopascals). 1cmH 2 O is 1g-f / cm 2 , approximately 0.98 hectopascals. In this specification, pressure is measured in cmH 2 It is awarded in units of O.

[0360] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this moment, is given the symbol Pt.

[0361] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, typically a positive pressure relative to the atmosphere.

[0362] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0363] 5.8.1.1 Materials Silicone or Silicone Elastomer: Synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (in a family of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45 as measured by ASTM D2240.

[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 to release the energy when unloaded.

[0366] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0367] Hardness: The ability of a material to resist deformation within itself (as described, for example, by Young's Modulus or the indentation hardness scale measured over a standardized sample size). - "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and do not easily deform under finger pressure, for example.

[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, extension, bending, or torsion). A structure or component may offer different resistance in different directions.

[0369] Floppy Structure or Component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0370] Rigid structure or component: a structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application is a patient interface that is approximately 20-30 cmH 2 It can be set up and maintained in a sealed manner against the patient airway entrance under O2 pressure loading.

[0371] As one example, an I-beam may include a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction, hi another example, a structure or component may be floppy in a first direction and stiff in a second direction.

[0372] 5.8.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a certain threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0373] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0374] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0375] Effort (Respiration): Respiratory effort is said to refer to the movement made by a person's spontaneous breathing in an attempt 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 understood to be a situation in a patient's breathing where an increase in effort by the patient does not cause a corresponding increase in flow rate. If flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, it can be referred to as expiratory flow limitation.

[0378] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area and then a downswing. (ii) M-shaped: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat region between the two peaks. (iii) Chair-like: Has a single local peak that occurs at the rising edge and is followed by a relatively flat region. (iv) Inverted chair shape: A relatively flat region is followed by a single local peak, which occurs on the trailing edge.

[0379] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when there is a sustained period of reduced flow below a threshold rate. When hypopnea is detected due to a reduction in respiratory effort, central hypopnea is said to occur. In one form in adults, hypopnea may be considered when any of the following occur: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting for at least 10 seconds and associated with at least 3% desaturation or arousal occurs.

[0380] Hyperventilation: An increase in flow to a level higher than normal.

[0381] Inspiration 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 inspiration 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. Airway patency may be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

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

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

[0385] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): these terms may be understood to refer to the RPT device's estimate of respiratory airflow and are used in contrast to "true respiratory flow" or "true respiratory airflow", which is the patient's actual respiratory flow, usually expressed in liters / minute.

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

[0387] (Inspiration) 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 around which the most recent values ​​of ventilationVent tend to cluster over a given time scale (i.e., the degree to which the most recent values ​​of ventilation tend to be central).

[0391] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0392] Vent: A measurement of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inhaled and exhaled airflow per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.

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

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

[0395] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop breath delivery.

[0396] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressure is added within a breath to produce the desired mask pressure the ventilator is attempting 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 portion 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), then 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 portion of the breath.

[0399] Pressure Support: A number indicating the increase in pressure during ventilator inhalation followed by exhalation of the same ventilator, and generally refers to the pressure difference between the maximum inhalation pressure and the base pressure (e.g., PS=IPAP-EPAP). In some contexts, pressure support refers to the difference the ventilator tries to achieve (rather than the difference it actually achieves).

[0400] Servo-ventilator: a ventilator that has patient ventilation and has target ventilation, and adjusts the level of pressure support to approximate the patient ventilation to the target ventilation.

[0401] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.

[0402] Swing: A term equivalent to pressure assistance.

[0403] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.

[0404] 5.8.4 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive rebreathing of CO2 by the patient by venting to atmosphere in a fail-safe manner.

[0405] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable, for example, about 360 degrees, relative to the mating component. In certain forms, the elbow may be removable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap at the time of manufacture, but cannot be removed by the patient.

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

[0407] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed to be used on the head. For example, the headgear may include a collection of one or more posts, ties and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0408] Membrane: Membrane is taken to mean a typically thin-walled element, preferably offering substantially no resistance to bending and resistance to stretching.

[0409] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0410] Seal: When used as a noun ("seal") it can refer to a structure, and when used as a verb ("seal") it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0411] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0412] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending stiffness of another component in at least one direction.

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

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

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

[0416] Venting: (noun): A structure that allows airflow to the ambient air inside a mask or conduit, allowing clinically effective flushing of exhaled gases. For example, flow rates of about 10 liters / minute to about 100 liters / minute may be used for clinically effective flushing, depending on mask design and treatment pressure.

[0417] 5.8.5 Shape of structure A product of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be differentiated with labels to describe the orientation, location, function or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

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

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

[0420] Positive curvature: If 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, he or she would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.

[0421] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, he can walk on a horizontal plane that is neither pointing up nor down). See Figure 3D.

[0422] Negative curvature: If 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 were to walk away from point p, he would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.

[0423] 5.8.5.2 Two-dimensional surface curvature The description of a shape at a given point on a two-dimensional surface according to the present technique may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane that includes the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each of the curvatures at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0424] Principal curvature and direction: The directions of the normal plane in which the curvature of the curve has a maximum and a minimum value are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0425] Surface region: A collection of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0426] Saddle region: a region where the principal curvatures at each point have opposite signs (i.e., one side has a positive sign and the other a negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0427] Dome Area: A region where the principal curvatures at every point have the same sign: both positive ("concave dome") or both negative ("convex dome").

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

[0429] Planar Region: Region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0430] Surface Edge: the boundary or limit of a surface or area.

[0431] Path: In certain forms of the technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A fictional person's path is a place to walk on a surface, similar to a path in a garden.)

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

[0433] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance "as the crow flies.")

[0434] 5.8.5.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, i.e., it has no end point. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks 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) may trace a space curve. In general, a space curve may be described by the curvature and twist at each point on the space curve. Twist is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve may be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0435] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character was flying along a curve and fell off his vehicle at a particular point, the direction of the tangent vector is the direction he would be traveling.

[0436] Unit normal vector: If a fictional character is moving along a curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It 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 the left-hand rule.

[0438] Tangent plane: A plane that contains a unit tangent vector and a unit principal normal vector.

[0439] Torsion of a Space Curve: The torsion of a space curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangent plane. A space curve that lies in the plane has zero torsion. If the space curve deviates from the tangent plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangent plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path).

[0440] With reference to the right-hand rule, a space curve that bends towards the right-hand binormal can be seen as having a positive right-hand twist. A space curve that bends away from the right-hand binormal can be seen as having a negative right-hand twist (e.g., a left-handed spiral).

[0441] Similarly, with reference to the left-hand rule, a space curve oriented in a left-handed binormal direction can be thought of as having a positive left-handed twist (e.g., a left-handed spiral), where the positive left-handed direction corresponds to the negative right-handed direction.

[0442] 5.8.5.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a plane or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3G are bounded by a plane curve.

[0443] A structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire's inner surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 3I and bounded by a surface as shown.

[0444] 5.9 Other Notes Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of the range, the unit of the lower limit, and any other stated or intervening value of the stated range is encompassed by the technology. The upper and lower limits of these intervening ranges, which are independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0445] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise indicated, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0446] Unless otherwise specified, all technical and scientific terms herein 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 herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0447] Although particular materials are described as being preferred for use in the construction of components, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0448] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0449] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology has not antedated such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

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

[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 in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the limitations of the claims.

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

[0453] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0454] 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Seal forming structure 3200 Plenum Chamber 3300 Positioning and stabilizing structure 3400 Ventilation section 3600 Connection Port 3700 Forehead support 4000 RPT Devices 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 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4171 Air Circuit 4180 Supplemental Oxygen 4200 Electrical Components 4202 PCBA 4210 Power supply 4220 Input Device 4230 Central Controller 4232 Watch 4240 Therapeutic 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 communications network 4286 Remote External Device 4288 local foreign device 4290 output device 4292 Display Driver 4294 Display 4300 Algorithm 4310 Pre-processing module 4312 Pressure Compensation Algorithm 4314 Airflow Estimation Algorithm 4316 Leakage flow rate estimation algorithm 4318 Respiratory flow estimation algorithm 4320 Treatment Engine Module 4321 Phase Determination Algorithm 4322 Waveform Determination Algorithm 4323 Ventilation Decision Algorithm 4324 Inspiratory Flow Limitation Decision Algorithm 4325 Apnea / hypopnea decision algorithm 4326 Snoring Determination Algorithm 4327 Airway Patency Determination Algorithm 4329 Treatment Parameter Decision Algorithm 4330 Treatment Control Module 4340 method 5000 humidifier 5110 Humidifier Reservoir 5210 Humidifier Converter 5212 Pressure Transducer 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 section 6050B Dock section 6060 Guide structure 6100 Water Reservoir 7000 RPT Devices 7100 Pneumatic Block 7200B1 First Blower 7200B2 Second Blower 7210B1 Blower inlet 7210B2 Blower inlet 7220B1 Blower outlet 7220B2 Blower outlet 7250B2 Suspension system 7252B2 Support tab 7254B2 Funnel 7260B2 Flexible Flat Cable 7300 Chassis Assembly 7300T upper chassis 7300B Lower Chassis 7301T Base mold 7301B Base Mold 7302T Overmolding 7302B Overmolding 7305SP1 First sealing part 7305SP2 Second sealing part 7306 Closed surface 7307 Beveled Edge 7308 Sealing part 7309 Closed surface 7310 Chassis Entrance 7312 Inner tubular section 7314 Outer ring part 7316 Annular groove 7320 Chassis Exit 7325 Spigot 7327 Mounting Post 7329 Recess 7330 Opening 7340 Inlet opening 7342 Recessed Chamber 7345 Inlet tube 7350 Pneumatic Block Cavity 7350T Block section 7350B Block section 7360T1 Positioning groove 7360T2 Positioning groove 7360B1 Positioning groove 7360B2 Positioning groove 7365 Internal rib 7400SUB1 First Blower Sub-Assembly 7400SUB2 Second Blower Subassembly 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 system 7536SS2 Blower suspension system 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 system 7556SS2 Blower suspension system 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 part 7820SP1 First sealing part 7820SP2 Second sealing part 7822 Port engagement side 7823 Closed surface 7824 Sensor engagement side 7825 Bellows type interface 7826 Closed surface 7830 Central Connection 7832 Tubular surface 8002 Outer Housing

Claims

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

2. The apparatus of claim 1 , wherein the at least first and second fan subassemblies each include a corresponding support structure for supporting the corresponding fan within the common chassis assembly.

3. The apparatus of claim 2 , wherein each support structure is constructed and arranged to sealingly separate the air flow passage into the multiple chambers.

4. 4. The apparatus of claim 2 or 3, wherein each support structure comprises a flow tube array including a plurality of flow tubes that allow air to move from one chamber to an adjacent chamber.

5. An apparatus as claimed in any one of claims 2 to 4, wherein each support structure includes a fan suspension for supporting and vibrationally isolating the corresponding fan within the support structure.

6. An apparatus as claimed in any preceding claim, wherein the first configuration of the pneumatic block includes three inlet muffler chambers and an outlet chamber along the air flow path.

7. The apparatus of claim 6 , wherein the chambers of the first arrangement of pneumatic blocks are disposed in more than one plane.

8. 8. The apparatus of claim 7, wherein one of the three inlet muffler chambers extends in a first plane and the remaining two of the three inlet muffler chambers and the outlet chamber extend in a second plane spaced vertically from the first plane.

9. An apparatus as claimed in any preceding claim, wherein the second configuration of the pneumatic block includes two inlet muffler chambers and an outlet chamber along the air flow path.

10. The apparatus of claim 9 , wherein the chambers of the second arrangement of pneumatic blocks are disposed in one plane.

11. 11. The apparatus of claim 1, wherein a first configuration of the pneumatic block is configured for CPAP or APAP therapy and a second configuration of the pneumatic block is configured for bi-level therapy.

12. An apparatus according to any preceding claim, wherein the common chassis assembly includes a reservoir dock constructed and arranged to receive a water reservoir.

13. 13. The apparatus of claim 1, wherein each of the first and second arrangements of pneumatic blocks includes at least two inlet muffler chambers positioned upstream of a blower inlet of the corresponding blower.

14. 14. The apparatus of claim 13, wherein the first configuration of pneumatic block includes three inlet muffler chambers, a first of the three inlet muffler chambers receiving air from the chassis inlet, and the corresponding blower is disposed in a second of the three inlet muffler chambers and receives air at the blower inlet from a third of the three inlet muffler chambers.

15. 15. The apparatus of claim 13 or 14, wherein the second configuration of the pneumatic block includes two inlet muffler chambers, a first of the two inlet muffler chambers receiving air from the chassis inlet, and the corresponding blower is provided in the first of the two inlet muffler chambers and receives air at the blower inlet from a second of the two inlet muffler chambers.

16. The apparatus of any one of claims 1 to 15, further comprising a PCBA supported by the pneumatic block external to the air flow path.

17. 17. The apparatus of claim 16, wherein the common chassis assembly includes one or more ports that allow one or more sensors mounted to the PCBA to communicate with the air flow path.

18. The apparatus of any one of claims 1 to 17, further comprising an acoustic foam disposed within one or more of the plurality of chambers.

19. 19. The apparatus of any one of claims 1 to 18, wherein the common chassis assembly includes an upper chassis and a lower chassis forming a pneumatic block cavity configured to receive the at least first and second blower subassemblies, respectively.

20. 20. The apparatus of claim 19, wherein the upper chassis and the lower chassis each include an elastomeric overmold along an interior surface thereof that provides a seal for the pneumatic block cavity.

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