Respiratory pressure therapy system

Abstract

To provide medical devices used in diagnosis, amelioration, treatment or prevention of respiratory disorders.SOLUTION: The present technology is directed to a respiratory pressure therapy system, that includes: a plenum chamber pressurizable to a therapeutic pressure above ambient air pressure; a seal-forming structure to form a seal for an entrance to a patient's airways to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a positioning and stabilizing structure constructed and arranged to provide an elastic force for holding the seal-forming structure in a therapeutically effective position on the patient's head; a blower configured to generate the flow of air and pressurize the plenum chamber to the therapeutic pressure, the blower having a motor, the blower being connected to the plenum chamber in such a way that the blower is suspended from the patient's head and that the axis of rotation of the motor is substantially perpendicular to the patient's sagittal plane; and a power supply configured to provide electrical power to the blower.SELECTED DRAWING: Figure 6A

Description

Technical Field

[0001] 1 Cross - reference to Related Applications This application claims the benefit of Australian Provisional Application No. 2016902914, filed on July 25, 2016, Australian Provisional Application No. 2016904093, filed on October 11, 2016, US Provisional Application No. 62 / 458,862, filed on February 14, 2017, and US Provisional Application No. 62 / 512,445, filed on May 30, 2017, the entire contents of each of which are incorporated herein by reference. for reference.

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

Background Art

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

[0004] These airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they extend deeper into the lungs. The primary function of the lungs is gas exchange, which involves taking oxygen from the air into the venous blood and removing carbon dioxide. The trachea divides into the right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. Further division of the airways results in respiratory bronchioles, which eventually become alveoli. Gas exchange takes place in the alveolar region of the lungs, and this region is called the respiratory region. See also: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory diseases exist. Certain diseases can be characterized by specific onsets (e.g., apnea, respiratory depression, and hyperventilation).

[0006] 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.

[0007] 2.2.2 Treatment A variety of therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV)) are used to treat one or more of the respiratory diseases mentioned above.

[0008] 2.2.3 Treatment System These treatments may be provided by treatment systems or devices. Such systems and devices may also be used to diagnose diseases without treating them.

[0009] The treatment system may include a respiratory pressure therapy device (RPT device), air circuitry, humidifier, patient interface, and data management.

[0010] Another form of treatment system is the mandibular repositioning device.

[0011] 2.2.3.1 Patient Interface A patient interface may be used to provide the wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway inlet. Airflow may be provided through a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface may form a seal with, for example, the area of ​​the patient's face, thereby providing sufficient pressure dispersion along with the ambient pressure for the execution of the therapy. This facilitates gas delivery (for example, at a positive pressure of approximately 10 cmH2O relative to ambient pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not contain a seal sufficient to facilitate the delivery of gas to the airway at a positive pressure of approximately 10 cmH2O.

[0012] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used to deliver one or more of the above-mentioned therapies, for example, by generating an airflow to the airway inlet. This airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0013] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be satisfied by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0014] One example of a specific requirement for a particular RPT device is acoustic noise.

[0015] [Table 1]

[0016] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another embodiment of an RPT device is the ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide assistance for invasive and non-invasive independent breathing for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

[0017] The ResMed Elisee® 150 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 offer volumetric and pneumatic ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0018] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters.

[0019] 2.2.3.3 Humidifier When the delivery of the air flow is performed without humidification, it can lead to drying of the airway. When a humidifier is used together with the RPT device and the patient interface, humidified gas is generated, thus minimizing the drying of the nasal mucosa and increasing the comfort of the patient airway. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to cold air.

[0020] 2.2.3.4 Data Management For clinical reasons, there may be a need to obtain data to determine whether a patient for whom respiratory therapy has been prescribed "is compliant" (e.g., whether the patient is following certain "compliance rules" with their RPT device). As an example of compliance rules for CPAP therapy, for a patient to be considered compliant, the patient needs to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, the provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate the usage rate over a given period, and compare this with the compliance rules. When a healthcare provider determines that a 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.

[0021] In a patient's treatment, there may be other ways to benefit from the communication of treatment data to a third party or an external system.

[0022] In the case of existing processes for communicating and managing such data, one or more of high cost, time-consuming, and high error proneness may occur.

[0023] 2.2.3.5 Ventilation Technology Some forms of treatment systems may include a ventilation portion for expelling the exhaled carbon dioxide. This ventilation portion may enable gas flow from the internal space (e.g., the plenum chamber) of the patient interface to the outside (e.g., the surroundings) of the patient interface. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0024] BRIEF DESCRIPTION OF THE TECHNOLOGY The present technology relates to the provision of medical devices used in the diagnosis, improvement, treatment or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability. MEANS FOR SOLVING THE PROBLEM

[0025] The first aspect of the present technology relates to a device used in the diagnosis, improvement, treatment or prevention of respiratory diseases.

[0026] Another aspect of the present technology relates to a method used in the diagnosis, improvement, treatment or prevention of respiratory disorders.

[0027] One aspect of a particular form of the present technology is to provide a method and / or device for improving patient compliance with respect to respiratory treatment.

[0028] One aspect of a particular form of the present technology is an easy-to-use medical device for people who, for example, have not received medical training, are not very dexterous or lack insight, or have limited experience using this type of medical device.

[0029] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around their home).

[0030] One embodiment of this technology is a patient interface that can be cleaned at the patient's home, for example, with soapy water, and does not require any special cleaning equipment.

[0031] The methods, systems, devices, and apparatus described herein may enable improvements in the functionality of processors (e.g., processors in purpose-specific computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the methods, systems, devices, and apparatus described herein may enable improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0032] Another aspect of this technology relates to a respiratory pressure therapy (RPT) system including a patient interface and a pressure generator. The pressure generator is supported above the patient's head by the patient interface during use.

[0033] Another aspect of the present technology relates to a pressure generator having a single motor and a single shaft, wherein each end of the shaft is positioned at the corresponding end of the motor. The pressure generator may further include at least one pressure stage associated with each end of the shaft, each pressure stage including an impeller and a stator.

[0034] Another aspect of the present technology relates to a blower including a blower inlet at each side and at least one blower outlet located between the blower inlets. The blower outlet extends in an annular manner around at least a portion of the perimeter of the blower.

[0035] Another aspect of the present technology relates to a respiratory pressure therapy (RPT) system. The RPT system comprises: a plenum chamber pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; a seal-forming structure constructed and positioned to form a seal over the area of ​​the patient's face surrounding the entrance to the patient's airway, thereby delivering a gas flow at the therapeutic pressure to at least the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use; and a positioning and stabilizing structure constructed and positioned to provide elastic force for holding the seal-forming structure in a therapeutically effective position on the patient's head. The stabilizing structure includes a tie, the lateral portion of which is constructed and positioned to rest in a region of the patient's head above the base of the ear when in use, and the upper portion of which is constructed and positioned to rest in a region of the patient's head within the region of the parietal bone when in use, wherein the positioning and stabilizing structure includes a positioning and stabilizing structure having a non-rigid release portion; a blower configured to generate a gas flow and pressurize the plenum chamber to a therapeutic pressure, the blower having a motor, the blower being connected to the plenum chamber such that the blower is suspended from the patient's head when in use and the axis of rotation of the motor is generally perpendicular to the patient's sagittal plane; and a power supply configured to supply power to the blower.

[0036] (a) The seal-forming structure may be constructed such that no part of it enters the patient's oral cavity during use. (b) The seal-forming structure may not extend into the patient's airway. (c) The plenum chamber may not cover the eyes during use. (d) The blower may be at least partially housed within the plenum chamber. (e) The plenum chamber may include at least one housing section. (e) The plenum chamber may include at least two housing sections that are at least partially separable so that the blower can be removed from the plenum chamber. (f) The at least two housing sections may be joined on one side in a clamshell configuration so that the plenum chamber can be opened and closed. (g) The RPT system may include a sealing structure between at least two housing sections. (h) The plenum chamber may include at least one mounting structure for attaching a positioning and stabilizing structure to secure the RPT system to the patient's head during use. (i) The plenum chamber may include a plenum chamber outlet through which a gas flow is directed from the blower to at least the entrance of the patient's nostrils during use. (j) A seal-forming structure may be connected to the plenum chamber at the plenum chamber outlet. (k) The plenum chamber may include a port configured to be connected to at least one of a pressure transducer and a replenishment gas source. (l) A seal-forming structure may include: a pair of nasal puffs or nasal pillows, each of which is constructed and positioned to form a seal with each nostril of the patient's nose; a seal-forming structure which, in use, forms a seal on the nasal bridge region or nasal ridge region of the patient's face, and forms a seal on the upper lip region of the patient's face; or a seal-forming structure which, in use, forms a seal on the nasal bridge region or nasal ridge region of the patient's face, and forms a seal on the chin region of the patient's face. (m) The RPT system may include a heat and moisture exchanger (HME) located downstream of the gas flow and blower within the plenum chamber. (n) The RPT system may not include a vent so that the patient exhales against the gas flow through the blower during use, and the patient's exhaled air exits the RPT system through the blower inlet.(o) The power source may include a battery. The battery may include at least one electrochemical cell. (p) The battery may be supported by a positioning and stabilization structure on the region of the patient's head adjacent to the parietal bone. (q) The battery may be housed within the positioning and stabilization structure. (r) The RPT system may include at least one wire supported by the positioning and stabilization structure. At least one wire provides electrical communication between the blower and the battery. (s) At least one wire may be housed within the side of the positioning and stabilization structure. (t) The RPT system may include at least one tube that is in fluid communication with the plenum chamber at a first end and in fluid communication with the pressure transducer at a second end, and at least one tube may be housed within the side of the positioning and stabilization structure. (u) The seal-forming structure may include an elastic deformation material chamber that is less rigid than the plenum, and a portion of the seal-forming structure may substantially enclose the plenum chamber and the blower while leaving at least the blower inlet exposed. (v) The shape and dimensions of the seal-forming structure may be set and the elastic deformation material of the seal-forming structure may be selected to at least partially isolate the patient's head from vibrations and reduce noise generated from the blower during use. (w) The RPT system may include a cover containing an elastic deformation material chamber that is less rigid than the plenum chamber. This cover substantially encloses the plenum chamber and the blower while leaving at least the blower inlet exposed. (x) The shape and dimensions of the cover may be set and the elastic deformation material of the cover may be selected to at least partially isolate the patient's head from vibrations and reduce noise generated from the blower during use. (y) The RPT system may include a control system that controls the blower during use. (z) The control system may include a flexible printed circuit board component (PCBA), the PCBA including a microprocessor. (aa) The microprocessor may be programmed to perform at least one of closed-loop pressure control, flow rate estimation, and automatic adjustment of expiratory pressure release based on sensed pressure data, and / or (bb) the control system may include a drive circuit for controlling the power supply separately from the blower.

[0037] Another aspect of this technology relates to a blower for a respiratory pressure therapy (RPT) system. The blower is configured to generate a gas flow at a therapeutic pressure of at least 6 cmH2O, exceeding the ambient air pressure. The blower may include: a motor having a first end and a second end; a shaft having a first shaft end extending from the first end of the motor and a second shaft end extending from the second end of the motor; a first impeller and a second impeller arranged in series on the first shaft end and the second shaft end, respectively, such that both the first and second impellers are driven simultaneously by the motor; and a first stator corresponding to the first end and the second end of the motor, the first stator being positioned downstream of the first impeller and upstream of the second impeller along the gas flow generated by the blower during use. A first stator; second stators corresponding to the first end and the second end of the motor, respectively, the second stators being positioned downstream of the second impeller in the gas flow generated by the blower during use; end caps having a shape and dimensions such as to at least partially enclose each first impeller and at least partially define the blower inlet; blower outlets positioned downstream of each second stator; and a flow path for moving the gas flow from each blower inlet, through each first impeller, through each first stator through each second impeller, and out through each second stator through each blower outlet.

[0038] In the embodiment, (a) each first stator may include a plurality of first stator blades, which radially direct the gas flow from the first impeller to the first stator opening, reduce the velocity of the gas flow from the first impeller, and increase the pressure of the gas flow from the first impeller. (b) The plurality of first stator blades may include long first stator blades and short first stator blades, the long first stator blades may extend further radially inward than the short first stator blades, and the long and short first stator blades may alternate circumferentially around the first stator. (c) Each long first stator blade and each short first stator blade may include a curved section that is backward with respect to the rotational direction of the corresponding first impeller, and each long first stator blade and each short first stator blade may include a straight section that extends radially inward from the curved section, and the straight section of each long first stator blade may extend further radially inward than the straight section of each short first stator blade. (d) Each first stator may include a first stator opening located downstream of a plurality of first stator blades to direct the gas flow toward a second impeller. (e) Each first stator may include a first stator shroud that axially directs the gas flow toward the first stator opening from the first impeller. The corresponding first impeller is positioned adjacent to the first stator shroud. (f) Each first stator may include a first stator housing, and each second impeller and each second stator may be at least partially housed within the corresponding first stator housing such that the gas flow passes through the second impeller, through the second stator, and also through the first stator housing along the flow path. (g) Each first stator housing may at least partially define a corresponding blower outlet. (h) Each first stator housing may include a mounting structure for connecting the blower to the RPT system. (i) Each mounting structure may include a pair of mounting rails extending around the outer circumference of each first stator housing. (j) Each end cap may be constructed to reduce noise and vibration.(k) Each end cap may include a rigid material that provides structural integrity and a less rigid, elastically deformable material overmolded onto the rigid material to reduce sound and vibration. (l) Each first and second impeller may include an impeller hub, impeller blades extending radially from the impeller hub, and an impeller shroud. (m) Each impeller blade may include a first impeller blade portion extending only radially and a second impeller blade portion extending radially and axially. (n) The first impeller blades of each of the first and second impellers may have a fixed cross-section and may be radially inward relative to the second impeller blades, while the second impeller blades may have a variable cross-section and may be radially outward relative to the first impeller blades, and the fixed cross-section of the first impeller blades may be thinner than the variable cross-section of the second impeller blades. (o) Each impeller shroud may include a first impeller shroud portion extending only in the radial direction and a second impeller shroud portion extending in the radial and axial directions. (p) The impeller blades of each first and second impeller may advance relative to the rotational direction during operation. (q) Each second stator may include a top ring, a base ring, and a plurality of second stator blades joining the top ring and the base ring. The plurality of second stator blades may direct the gas flow radially and axially from the second impeller to the blower outlet, reduce the measure of the gas flow from the second impeller, and increase the pressure of the gas flow from the second impeller. (r) Each of the plurality of second stator blades may have a constant depth in the radial direction and an increasing width in the peripheral direction from the top ring to the base ring, and / or, (s) each top ring may include a top ring recess, and each base ring may include a base ring recess, allowing flexible printed circuit board components (PCBAs) to pass through the interior of the top ring recess and the base ring recess.

[0039] Another aspect of this technology relates to a blower for a respiratory pressure therapy (RPT) system. The blower is configured to generate an airflow at a therapeutic pressure of at least 6 cmH2O, exceeding the ambient air pressure. The blower may include: a motor having a first end and a second end; a shaft having a first shaft end extending from the first end of the motor and a second shaft end extending from the second end of the motor; impellers positioned on the first shaft end and the second shaft end, respectively, such that both impellers are driven simultaneously by the motor; and stators corresponding to the first end and the second end of the motor, respectively, the stators being positioned downstream of the impellers in use along the airflow generated by the blower. A fan outlet located downstream of each stator, and housings corresponding to the first end and the second end of the motor, each housing being shaped and sized to at least partially enclose each impeller and each stator and to at least partially define a fan inlet, and each housing being shaped and sized to at least partially define corresponding fan outlets such that the fan outlets are adjacent to each other, and a passage for moving airflow from each fan inlet, through each impeller, through each stator, and out through each fan outlet. A passage for moving airflow from each fan inlet, through each impeller, through each stator, and out through each fan outlet.

[0040] In the embodiment, (a) each impeller and each second impeller are at least partially housed within a corresponding housing such that airflow travels along the flow path and passes through the impeller and also through the housing via the stator. (b) Each housing may at least partially define a corresponding blower outlet. (c) Each housing may include a mounting structure for connecting the blower to the RPT system. (d) Each mounting structure may include a pair of mounting rails extending around the outer circumference of each housing. (e) Each housing may be constructed to reduce noise and vibration. (k) Each housing may include a rigid material that provides structural integrity and a low-rigidity elastic deformation material overmolded into the rigid material to reduce noise and vibration. (g) Each impeller may include an impeller hub, impeller blades extending radially from the impeller hub, and an impeller shroud. (h) Each impeller blade may include a first impeller blade portion extending only in the radial direction and a second impeller blade portion extending in the radial and axial directions. (i) The first impeller blade portion of each impeller blade of the first impeller and each second impeller may have a constant cross-section and may be radially inward relative to the second impeller blade portion, and (j) the second impeller blade portion may have a variable cross-section and may be radially outward relative to the first impeller blade portion. (k) The constant cross-section of the first impeller blade portion may be thinner than the variable cross-section of the second impeller blade portion. (l) Each impeller shroud may include a first impeller shroud portion extending only in the radial direction and a second impeller shroud portion extending in the radial and axial directions. (m) The impeller blades of each impeller may advance relative to the direction of rotation during operation. (n) Each stator may include a top ring, a base ring, and a plurality of stator blades joining the top ring and the base ring. (o) The plurality of stator blades may direct the airflow radially and axially from the impeller to the fan outlet, reduce the velocity of the airflow from the impeller, and increase the pressure of the airflow from the impeller.(p) Each of the stator blades may have a constant depth in the radial direction and an increasing width in the peripheral direction from the top ring to the base ring, and / or (q) each top ring may include a top ring recess, each base ring may include a base ring recess, and flexible printed circuit board components (PCBAs) may pass through the interior of the top ring recesses and base ring recesses.

[0041] Another aspect of the present technology relates to a ventilation assembly for releasing gas from a plenum chamber into an atmosphere. The ventilation assembly includes: a base; at least one vent extension extending from the base and defining at least partially a passage; at least one vent extending from the passage into an atmosphere through the at least one vent extension; and at least one flexible membrane attached to the at least one vent extension, the at least one flexible membrane configured to cover at least one vent in a closed position to prevent gas release from the passage into an atmosphere, and the at least one flexible membrane configured to allow gas release from the passage into an atmosphere by not covering at least one vent in an open position.

[0042] In the embodiment, (a) at least one vent extension may include an internal vent surface, and each at least one vent extends through the internal vent surface into the passage. (b) at least one flexible membrane may be attached to at least one vent extension on the internal vent surface. (c) at least one vent extension may include an external vent surface, and each at least one vent extends through the external vent surface into the atmosphere. (d) at least one vent extension may include an internal surface, and the vent extension may have a generally triangular cross-section formed by the internal vent surface, the external vent surface and the internal surface. (e) the internal vent surface may be inclined downward into the interior of the ventilation assembly relative to the pressurized gas flow passing through the passage. (f) At least one vent extension may include two diametrically opposed vent extensions, and at least one flexible membrane may include two flexible membranes, each of which is attached to a corresponding one of the two diametrically opposed vent extensions, and the ventilation assembly may include a divider positioned between the two diametrically opposed vent extensions to form a first passage and a second passage. (g) The two flexible membranes may not come into contact with the divider in the open position. (h) At least one flexible membrane may be constructed of an elastically deformable material, and / or, (i) at least one flexible membrane may be cantilevered to at least one vent extension. It can be supported.

[0043] Another aspect of the present technology relates to a respiratory pressure therapy (RPT) system. The RPT system comprises: at least one housing portion that at least partially defines a plenum chamber pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; a seal-forming structure constructed and positioned to form a seal over the area of ​​the patient's face surrounding the entrance to the patient's airway, thereby delivering airflow at the therapeutic pressure to at least the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use; and a positioning and stabilizing structure constructed and positioned to provide elastic force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including ties. The lateral portion of the tie is constructed and positioned to rest in a region of the patient's head above the base of the ear when in use, and the upper portion of the tie is constructed and positioned to rest in a region of the patient's head within the region of the parietal bone when in use, wherein the positioning and stabilizing structure includes a positioning and stabilizing structure having a non-rigid release portion; a blower configured to generate airflow and pressurize the plenum chamber to a therapeutic pressure, the blower having a motor, the blower being connected to the plenum chamber such that the blower is suspended from the patient's head when in use and the axis of rotation of the motor is generally perpendicular to the patient's sagittal plane; and a power supply configured to supply power to the blower, wherein at least one housing portion includes the ventilation assembly described in the embodiments of the two paragraphs above.

[0044] Of course, some of the above embodiments may form sub-embodiments of the present technology. Furthermore, various combinations of sub-embodiments and / or various other embodiments may constitute even further embodiments or sub-embodiments of the present technology.

[0045] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0046] 4. Brief Description of the Drawings This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: 4.1 Treatment System [Figure 1] Figure 1 shows a system including patient 1000 wearing a patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels to patient 1000 along an air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine sleeping position. 4.2 Respiratory System and Facial Anatomy [Figure 2] Figure 2 shows an overview of the human respiratory system, including the nose and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. 4.3 Patient Interface [Figure 3] Figure 3 shows a patient interface in the form of a nasal mask, representing one embodiment of this technology. 4.4 RPT Device [Figure 4A] An RPT device 4000 conforming to one form of this technology is shown. [Figure 4B] This is a schematic diagram of the pneumatic path of an RPT device 4000 according to one embodiment of this technology. The upstream and downstream directions are indicated. [Figure 4C] This is a schematic diagram of the electrical components of an RPT device 4000 according to one aspect of this technology. 4.5 Respiratory Waveform [Figure 5] Figure 5 shows a model of a typical human respiratory waveform during sleep. 4.6 Respiratory Pressure Therapy (RPT) System [Figure 6A] Figure 6A is a schematic lateral view of a patient wearing an RPT system according to one embodiment of this technology. [Figure 6B] Figure 6B is a perspective view of the pressure generation feature of an RPT system according to one embodiment of this technology. [Figure 6C] Figure 6C is a cross-sectional view of the pressure generation feature of an RPT system according to one embodiment of this technology. [Figure 6D] Figure 6D shows a modified example with the upper housing removed. [Figure 6E] Figure 6E shows a modified example with the upper housing removed. [Figure 7A] Figure 7A is a perspective view of a blower in an RPT system according to one embodiment of this technology. [Figure 7B] Figure 7B is a perspective view of a partially disassembled blower in an RPT system according to one embodiment of this technology. [Figure 7C] Figure 7C is another perspective view of a partially disassembled blower of an RPT system according to one embodiment of this technology. [Figure 7D] Figure 7D is another perspective view of a partially disassembled blower of an RPT system according to one embodiment of this technology. [Figure 7E] Figure 7E is a cross-sectional view of a blower in an RPT system according to one embodiment of this technology. [Figure 7F] Figure 7F is an exploded view of a blower in an RPT system according to one embodiment of this technology. [Figure 8A] Figure 8A is a perspective view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 8B] Figure 8B is another perspective view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 8C] Figure 8C is another perspective view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 8D] Figure 8D is a side view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 8E] Figure 8E is a cross-sectional view of the impeller of a blower in an RPT system taken along line 8E in Figure 8D, according to one embodiment of the present technology. [Figure 8F] Figure 8F is a cross-sectional view of the impeller of a blower in an RPT system taken along line 8F in Figure 8D, according to one embodiment of this technology. [Figure 8G] Figure 8G is a cross-sectional view of the impeller of a blower in an RPT system taken along line 8G in Figure 8D, according to one embodiment of this technology. [Figure 8H] Figure 8H is a cross-sectional view of the impeller of a blower in an RPT system taken along line 8H in Figure 8D, according to one embodiment of the present technology. [Figure 8I] Figure 8I is a cross-sectional view of the impeller of a blower in an RPT system taken along line 8I in Figure 8D, according to one embodiment of this technology. [Figure 8J] Figure 8J is a cross-sectional view of the impeller of an RPT system blower taken along line 8J in Figure 8D, according to one embodiment of this technology. [Figure 8K] Figure 8K is a plan view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 8L] Figure 8L is a cross-sectional view of the impeller of a blower in an RPT system taken along line 8L in Figure 8K, according to one embodiment of this technology. [Figure 8M] Figure 8M is a cross-sectional view of the impeller of a blower in an RPT system taken along line 8M in Figure 8K, according to one embodiment of this technology. [Figure 9A] Figure 9A is a perspective view of the first stator of a blower in an RPT system according to one embodiment of this technology. [Figure 9B] Figure 9B is a side view of the first stator of a blower in an RPT system according to one embodiment of this technology. [Figure 9C] Figure 9C is a plan view of the first stator of a blower in an RPT system according to one embodiment of this technology. [Figure 9D] Figure 9D is a plan view of the first stator of a blower in an RPT system, in which the upper stator shroud according to one embodiment of the present technology is shown by dashed lines. [Figure 9E] Figure 9E is a cross-sectional view of the first stator of the blower of an RPT system taken along line 9E-9E in Figure 9D, according to one embodiment of the present technology. [Figure 9F] Figure 9F is a cross-sectional view of the first stator of the blower of an RPT system taken along line 9F-9F in Figure 9D, according to one embodiment of the present technology. [Figure 10A]Figure 10A is another cross-sectional view of a partially disassembled blower of an RPT system according to one embodiment of the present technology. [Figure 10B] Figure 10B is a perspective view of one end of a partially disassembled blower in an RPT system according to one embodiment of this technology. [Figure 10C] Figure 10C is a cross-sectional view of one end of a partially disassembled blower of an RPT system taken along line 10C-10C in Figure 10A, according to one embodiment of the present technology. [Figure 10D] Figure 10D is a side view of the first stator of a blower in an RPT system according to one embodiment of this technology. [Figure 10E] Figure 10E is a cross-sectional view of the first stator of the blower of an RPT system taken along line 10E-10E in Figure 10D, according to one embodiment of the present technology. [Figure 11A] Figure 11A is a perspective view of the second stator of a blower in an RPT system according to one embodiment of this technology. [Figure 11B] Figure 11B is another perspective view of the second stator of the blower in an RPT system according to one embodiment of this technology. [Figure 11C] Figure 11C is another perspective view of the second stator of the blower in an RPT system according to one embodiment of the present technology. [Figure 12A] Figure 12A is a plan view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 12B] Figure 12B is a perspective view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 13A] Figure 13A is a plan view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 13B] Figure 13B is a perspective view of the impeller of a blower in an RPT system according to one embodiment of this technology. [Figure 14] Figure 14 is an exploded view of a blower in an RPT system according to one embodiment of this technology. [Figure 15A] Figure 15A is a frontal perspective view of a patient wearing an RPT system according to one embodiment of this technology. [Figure 15B] Figure 15B is another frontal perspective view of a patient wearing the RPT system according to one embodiment of this technology. [Figure 15C] Figure 15C is a rear perspective view of a patient wearing an RPT system according to one embodiment of this technology. [Figure 16A] Figure 16A is a frontal perspective view of a patient wearing an RPT system according to one embodiment of this technology. [Figure 16B] Figure 16B is another perspective view of a patient wearing an RPT system according to one embodiment of this technology. [Figure 17] Figure 17 is a perspective view of an RPT system according to one embodiment of this technology. [Figure 18A] Figure 18A is a side view of a ventilation assembly according to one embodiment of the present technology. [Figure 18B] Figure 18B is a top perspective view of a ventilation assembly according to one embodiment of this technology. [Figure 18C] Figure 18C is a cross-sectional perspective view of a ventilation assembly according to one embodiment of this technology. [Figure 18D] Figure 18D is a bottom perspective view of a ventilation assembly according to one embodiment of this technology. [Figure 18E] Figure 18E is a top view of a ventilation assembly according to one embodiment of the present technology. [Figure 18F] Figure 18F is a side cross-sectional view of a neutral ventilation assembly according to one embodiment of the present technology. [Figure 18G] Figure 18G is a side cross-sectional view of a ventilation assembly during ventilation according to one embodiment of the present technology. [Figure 18H] Figure 18H is a side cross-sectional view of the ventilation assembly as the pressurized gas flow passes through the ventilation assembly to the patient according to one embodiment of the present technology. [Figure 19A] Figure 19A shows an impeller according to one embodiment of this technology. [Figure 19B] Figure 19B is a cross-sectional view of the impeller shown in Figure 19A. [Figure 19C] Figure 19C is an isometric view of the impeller shown in Figure 19A. [Figure 19D] Figure 19D is an elevation view of the impeller shown in Figure 19A. [Figure 19E] Figure 19E is an elevation view of the impeller shown in Figure 19A, and shows the cross-sections taken for Figures 19F to 19N. [Figure 19F] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19G] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19H] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19I] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19J] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19K] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19L] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19M] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19N] Figures 19F to 19N are plan views of an impeller according to one embodiment of this technology in various cross-sections, as shown in Figure 19E. [Figure 19O] Figure 19O is an elevation view of an impeller according to one embodiment of this technology. [Figure 19P] Figure 19P is an isometric view of the impeller shown in Figure 19O. [Figure 19Q] Figure 19Q is a plan view of the impeller shown in Figure 19O, and shows the cross-sections taken for Figures 19R to 19S. [Figure 19R] Figures 19R to 19S show cross-sections of the impeller as shown in Figure 19Q. [Figure 19S] Figures 19R to 19S show cross-sections of the impeller as shown in Figure 19Q. [Figure 19T] Figure 19T is an isometric view of an impeller according to one embodiment of this technology. [Figure 19U] Figure 19U is an exploded view of the impeller shown in Figure 19T. [Figure 19V] Figure 19V is an isometric view of the bottom of the impeller shown in Figure 19T. [Figure 19W] Figure 19W is an exploded view of the impeller shown in Figure 19V. [Figure 19X] Figure 19X is a cross-sectional view of the impeller as shown in Figure 19T. [Figure 19Y] Figure 19Y is an isometric view of an impeller according to one embodiment of this technology. [Figure 19Z] Figure 19Z is an isometric view of the bottom of the impeller shown in Figure 19Y. [Figure 19AA] Figure 19AA is a plan view of the impeller shown in Figure 19Y, and shows the cross-sections taken for Figures 19DD to 19EE. [Figure 19BB] Figure 19BB is an exploded view of the impeller shown in Figure 19Y. [Figure 19CC] Figure 19CC is another exploded view of the impeller shown in Figure 19Y. [Figure 19DD] Figures 19DD to 19EE show cross-sections of the impeller as shown in Figure 19AA. [Figure 19EE] Figures 19DD to 19EE show cross-sections of the impeller as shown in Figure 19AA. [Figure 19FF] Figure 19FF shows a cross-section of a blower for an RPT device including an impeller according to one embodiment of this technology. [Figure 19GG] Figure 19GG is an enlarged view of the blower shown in Figure 19FF. [Modes for carrying out the invention]

[0047] 5. Detailed Description of Examples of the Technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0048] The following description is provided in relation to a variety of embodiments that may share one or more common properties 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 any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0049] 5.1 Treatment In one embodiment, the technology includes a method for treating respiratory diseases. The method includes the step of applying positive pressure to the airway entrance of 1000 patients.

[0050] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0051] In certain embodiments of this technology, mouth breathing is restricted, limited, or prevented.

[0052] 5.2 Treatment System In one embodiment, the 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.

[0053] Figure 6A is a schematic diagram showing a respiratory pressure therapy (RPT) system fitted to a patient, according to an example of this technology. The RPT system includes a blower 4142 (Figure 6B) that provides a gas flow to the patient at a pressure higher than the ambient air, a sealing structure 3100 that forms a seal with the entrance to the patient's airway, a plenum chamber 3200 (Figure 6B) that supports the blower 4142 and is pressurized by the blower 4142 during treatment, a tie side of a positioning and stabilization structure 3303, a tie top of a positioning and stabilization structure 3304, a tie rear of a positioning and stabilization structure 3305 for securing the RPT system to the patient during treatment, and a power supply 4210 for driving the blower and other optional electrical components. The following sections describe in detail the various components of the exemplary RPT system.

[0054] According to an example of the present technology shown in Figure 6A, the RPT system is fully self-contained and can be worn by the patient. In other words, all the components necessary for RPT therapy are integrated into a single system that can be worn by the patient's head during therapy and directed as a whole. Conventionally, an RPT system includes a patient interface 3000 worn by the patient. The RPT system includes a plenum chamber 3200 that is pressurized to therapeutic pressure along with the gas flow, a seal-forming structure 3100 that forms a seal with the entrance to the patient's airway to provide a substantially sealed path for the gas flow, and a positioning and stabilizing structure 3300 that secures the seal-forming structure 3100 and the plenum chamber 3200 during use. In such conventional systems, these are the only components that are actually supported on the patient's head. An example of these conventional systems is shown in Figure 1.

[0055] The Respiratory Pressure Therapy (RPT) device 4000 is also incorporated into conventional systems that generate a gas flow at a higher pressure than the ambient air. This is due to the pressure and flow rate required for appropriate treatment. Therefore, the RPT device 4000 is typically a relatively large device and is typically provided as a separate device supported near the patient rather than on the patient during treatment. In other words, in the case of conventional RPT devices 4000, the appropriate treatment pressure and flow rate can only be generated by such a large device, and due to technical constraints, the size and weight are relatively large, making it difficult for the patient to comfortably wear the RPT device during use. For this reason, the RPT device 4000 is typically placed on the patient's nightstand or similar structure to keep the RPT device 4000 nearby. The patient is typically in bed with the patient interface 3000 attached, and since the RPT device 4000 is positioned nearby, an air circuit 4170 is also provided to provide pressurized gas flow from the RPT device 4000 to the patient interface 3000. Furthermore, in the case of conventional RPT devices 4000, an air circuit 4170 is required for gas flow delivery to the patient, and since it is positioned at a distance from the patient, the RPT device 4000 needs to be powerful enough to account for the pressure loss associated with directing the gas flow downward from the air circuit 4170 to the patient interface 3000.

[0056] The overall configuration described above has been the standard in respiratory therapy for decades, and this technology represents an improvement that allows patients to comfortably wear the entire RPT system during treatment. In the features detailed below, we describe how the various components can be reduced to a size and weight sufficient for patient comfort when the entire system is positioned on the head during sleep when using the RPT system for the treatment of sleep-disordered respiratory disorders.

[0057] An example of the present technology shown in Figure 6A is a respiratory pressure therapy (RPT) system including a plenum chamber 3200 capable of pressurizing to a therapeutic pressure of at least 6 cmH2O, exceeding ambient air pressure. The RPT system also includes a seal-forming structure 3100 constructed and positioned to form a seal against a region of the patient's face surrounding the entrance to the patient's airway, thereby ensuring that the gas flow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils. The seal-forming structure 3100 may be constructed and positioned to maintain the therapeutic pressure within the plenum chamber 3200 for the entire respiratory cycle of the patient during use. A positioning and stabilizing structure 3300 may also be provided, constructed and positioned to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure 3300 may include at least one tie. The lateral portion of the tie 3303 may be constructed and positioned to rest in a region of the patient's head above the base of the ear during use. The upper portion of the tie 3304 may be constructed and positioned to rest in a region of the patient's head in the region of the parietal bone during use. The posterior Thai portion 3305 may be constructed and positioned to rest in the area of ​​the patient's head within the occipital region during use. The positioning and stabilizing structure 3300 may include a non-rigid release section. The RPT system may also include a blower 4142 configured to generate gas flow and pressurize the plenum chamber 3200 to therapeutic pressure. The blower 4142 may be connected to the plenum chamber 3200 so that it is supported from the patient's head during use. The blower 4142 may be positioned relative to the patient's head during use so that the rotation axis of the motor 4145 is perpendicular to the patient's sagittal plane. A power supply 4210 for providing power to the blower 4142 may also be provided within the RPT system. The plenum chamber 3200, the seal-forming structure 3100, and the blower 4142 may be positioned so that they do not extend beyond the patient's chin prominence during use.

[0058] Figures 15-15C and 16A-16C show other examples of the RPT system of this technology. Figure 17 shows the RPT system without the positioning and stabilization structure 3300 in isolation (i.e., not fitted by a patient). Examples of these include the main components described above and the main components detailed below (e.g., the seal forming structure 3100, the plenum chamber, the positioning and stabilization structure 3300, the blower 4142 (this (Not shown in the figures) a ventilation assembly 3400, a power supply 4210, and a central control unit 4230. These examples are described in further detail below.

[0059] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of this technology includes the following functional modes: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent or vent assembly 3400, and a forehead support 3700. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway to facilitate positive pressure air supply to the airway.

[0060] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0061] In some forms of this technology, the patient interface 3000 can be constructed and positioned to provide an air supply with a positive pressure of at least 6, 10, or 20 cmH2O relative to the surroundings.

[0062] As described above, the RPT system of this technology may be understood to include several basic elements of a conventional patient interface 3000, which are further detailed below (e.g., a seal-forming structure 3100, a plenum chamber 3200, and a positioning and stabilization structure 3300). An exemplary RPT system of this technology is an improvement over a conventional patient interface 3000 by adding a blower 4142 directly to the patient interface 3000 (e.g., on the plenum chamber 3200) to provide a pressurized gas flow. Thus, the blower 4142 may be understood to be suspended or supported by the patient interface over the patient's head. A power supply 4210 may be provided directly to the patient interface 3000 (e.g., on the positioning and stabilization structure 3300) to supply power to the blower 4142 and any other components as needed. By placing the blower 4142 and power supply 4210 on the patient interface 3000, the need for an air circuit 4170 and any other wires or connections extending from the patient is eliminated. Therefore, undesirable influences and forces on the patient interface 3000 (e.g., pipe drag caused by the air circuit 4170) can be reduced or eliminated.

[0063] 5.3.1 Seal-forming structure In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a cushioning function. The target seal-forming region is the region in the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient in a given treatment session, depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0064] In a specific embodiment of this technology, the seal-forming structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0065] The seal-forming structure 3100 according to this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0066] In another embodiment of this technology, the RPT system provides a sealing engagement of the seal-forming structure 3100 together with the entrance(s) to the patient's airway, thereby providing airtightness only above the patient's head. For example, the seal-forming structure 3100 may include a prong or nasal insert inserted into the patient's nostril, and the prong or nasal insert is shaped and sized to provide a sufficiently rigid connection so that the RPT system can be supported by only a sufficiently rigid connection. Thus, the positioning and stabilizing structure 3300 described below can be completely eliminated from the RPT system, or the positioning and stabilizing structure 3300 can be at least further simplified.

[0067] The seal-forming structure 3100 of this technology may include a silicone cushion. This silicone cushion encloses the blower 4142 and connects to the plenum chamber 3200 so that the blower 4142 is supported by the positioning and stabilizing structure 3300 and the seal-forming structure 3100 when in use. In other words, the seal-forming structure 3100 may be configured to suspend the RPT system by providing a position for supporting and engaging the patient's face. Thus, the seal-forming structure 3100 can isolate vibrations generated from the blower 4142 from the patient's face.

[0068] The seal-forming structure 3100 of this technology may be constructed so that no part of it enters the patient's oral cavity during use. Furthermore, the seal-forming structure 3100 of this technology may be constructed so that it does not extend into the patient's airway. As described above, the seal-forming structure 3100 of this technology may include a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and positioned to form a seal with each nostril of the patient's nose. The seal-forming structure 3100 of this technology may form a seal on the nasal bridge region or nasal ridge region of the patient's face during use, and may form a seal on the upper lip region of the patient's face during use. The seal-forming structure 3100 of this technology may form a seal on the nasal bridge region or nasal ridge region of the patient's face during use, and may form a seal on the chin region of the patient's face during use.

[0069] The seal-forming structure 3100 of this technology may include an elastic deformation material that is less rigid than the plenum chamber 3200. For example, the elastic deformation material may be silicone rubber (e.g., liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR)). A portion of the seal-forming structure 3100 can substantially enclose the plenum chamber 3200 and the blower 4142 while leaving at least the inlet 4143 of the blower 4142 exposed. The seal-forming structure 3100 is shaped and sized to at least partially isolate the patient's head from vibrations and reduce noise generated from the blower 4142 during use. The elastic deformation material of the seal-forming structure 3100 may be selected to at least partially isolate the patient's head from vibrations and reduce noise generated from the blower 4142 during use.

[0070] The high elastic deformability of the seal-forming structure 3100 can help absorb the movement of heavier components (e.g., blower 4142) by the RPT system, thereby holding the RPT system in place during use. Otherwise, if the rigidity of the seal-forming structure 3100 at the interface with the patient's head is too high, the connection may be disrupted by the patient's movement. Furthermore, constructing the seal-forming structure 3100 from a material with vibration isolation and / or reduction properties may be advantageous if the motor 4145 of the blower 4142 is capable of high rotational speeds (e.g., 50,000 rpm to 80,000 rpm) and / or if the control system can frequently change the rotational speed during treatment (so that the RPT system moves relative to the patient's head due to torque associated with speed changes). Thus, the vibration reduction properties of the material can help isolate the patient's head from situations where disruptive forces would normally be transferred to the patient's head. In addition, reducing the inertia of the blower (e.g., from reducing the impeller diameter) can further improve the performance of the seal-forming structure 3100.

[0071] Alternatively, the RPT system uses a less rigid, elastically deformable material than the plenum chamber 3200. This may include a cover constructed by the same method. This cover can substantially enclose the plenum chamber 3200 and the blower 4142 while leaving at least the inlet 4143 of the blower 4142 exposed. The cover is shaped and sized to at least partially isolate the patient's head from vibrations and reduce noise generated by the blower 4142 during use. The elastic deformation material of the cover may be selected to at least partially isolate the patient's head from vibrations and reduce noise generated by the blower 4142 during use. In this alternative example, the seal-forming structure 3100 may be provided together with the above features or may be a separate component from the cover. Such a structure may be advantageous because it allows for the optimization of the material, shape, and dimensions of the seal-forming structure 3100 to suit the intended function, while also optimizing the cover material, shape, and dimensions to suit the intended function.

[0072] Examples shown in Figures 15A-15C, 16A-16C, and 17 include seal-forming structures 3100. In these examples, the seal-forming structures 3100 take the form of a nasal pillow, each individually sealing with the corresponding nostrils. However, other modifications are also possible (e.g., a nasal cushion that provides pressurized gas flow to the patient's nostrils (not the oral cavity), a nasal cradle cushion that provides pressurized gas flow to the patient's nostrils (not the oral cavity), which seals at the base of the patient's nose and does not extend above the bridge or tip of the patient's nose, a full-face cushion with a single opening that provides pressurized gas flow to the patient's nostrils and oral cavity, or a mouth-nasal cushion with separate openings that separately provide pressurized gas flow to the patient's nose and oral cavity).

[0073] In the examples shown in Figures 15A-15C, 16A-16C, and 17, the seal-forming structure 3100 is connected to the plenum chamber 3200 in the upper housing portion 4132. This connection may be permanent (i.e., the seal-forming structure 3100 cannot be separated from the upper housing portion 4132 (without damaging one or both parts)) or the seal-forming structure 3100 may be removable for cleaning or replacement. In a modified example of a permanent connection, the seal-forming structure 3100 may be made of a flexible material (e.g., liquid silicone rubber) and may be overmolded onto the upper housing portion 4132. Alternatively, the permanent connection may be formed by molding the seal-forming structure 3100 onto the upper housing portion 4132 such that a mechanical interlock is formed. In the example of a removable connection, the upper housing portion 4132 and the seal-forming structure 3100 may include structures that form a mechanical interlock that can be separated by deforming one or both of the upper housing portion 4132 and the seal-forming structure 3100.

[0074] 5.3.2 Plenum Chamber The plenum chamber 3200 of an exemplary RPT system may be formed by at least one housing section. In the example shown in Figures 6A-6C, the plenum chamber 3200 is formed by an upper housing section 4132 and a lower housing section 4133. In this example, the blower 4142 may be at least partially housed within the plenum chamber 3200 so that the plenum chamber 3200 is pressurized by the gas flow generated by the blower 4142 when the blower 4142 is in operation. The upper housing section 4132 may also have a plenum chamber outlet 4131. The gas flow generated by the blower 4142 may, during use, travel through the plenum chamber 3200 and the plenum chamber outlet 4131 to at least the entrance of the patient's nostrils. Actual contact with the face is provided by a seal-forming structure 3100. The seal-forming structure 3100 may be joined and extend at least around the entire periphery of the plenum chamber outlet 4131 during use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous material piece.

[0075] The upper housing section 4132 and the lower housing section 4133 house the blower 4142 in a plenum. The housing(s) may be at least partially separable so that they can be removed from the chamber 3200. For example, the housing(s) may be joined on one side in a clamshell configuration so that the plenum chamber 3200 can be opened and closed to allow removal of the blower(s) 4142. Conveniently, the user can then select from a number of patient interfaces to be used with the blower(s) 4142 according to their preference.

[0076] According to some forms of this technology, the kit may include a blower 4142 and one of several plenum chambers 3200 configured to receive the blower 4142 and / or a plurality of positioning and stabilizing structures 3300. The kit may include further components (e.g., a power supply) that allow the user to configure and / or assemble the RPT system for use according to their preferences for the kit.

[0077] The housing portion(s) of the plenum chamber 3200 may also include at least one sealing structure for sealing between the upper housing portion 4132 and the lower housing portion 4133 and / or along the separation line of the clamshell arrangement configuration described above.

[0078] In another example of this technology, the entire plenum chamber 3200 (e.g., between the upper housing portion 4132 and the lower housing portion 4133) may be made of an elastically deformable material (e.g., silicone). The plenum chamber 3200 in this example may include two separate pieces (i.e., the upper housing portion 4132 and the lower housing portion 4133) joined together to form the plenum chamber 3200, or the plenum chamber 3200 may include a single structure (e.g., the upper housing portion 4132 and the lower housing portion 4133 are formed from a single piece of homogeneous material).

[0079] In certain forms of this technology, the plenum chamber 3200 is constructed from at least partially transparent material (e.g., transparent polycarbonate). The use of transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent material may also help clinicians confirm the placement and function of the patient interface.

[0080] In a specific embodiment of this technology, the plenum chamber 3200 is composed of at least partially translucent material. The use of translucent material can reduce the intrusiveness of the patient interface and help improve compliance with treatment.

[0081] In one embodiment, the plenum chamber 3200 may include a lower housing portion 4133 constructed from a flexible vibration-damping material (e.g., silicone) and an upper housing portion 4132 constructed from a rigid material (e.g., polycarbonate). Alternatively, Figures 6D and 6E show a modified example in which the upper housing portion 4132 is omitted. In this case, the seal-forming structure 3100 is directly connected to the lower housing portion 4133, thereby reducing dead space within the plenum chamber 3200.

[0082] Furthermore, the heat and humidity exchanger (HME) 6000 shown in Figure 6E is located within the lower housing section 4133 and is supported by the HME holding structure 4135.

[0083] The plenum chamber 3200 may also include at least one mounting structure 4130 for attaching a positioning and stabilization structure 3300 to secure the RPT system to the patient's head during use. An example shown in Figures 6A–6C shows a mounting structure 4130 integrally formed with the lower housing 4133 as a single piece of homogeneous material. The mounting structure 4130 is plenum chamber It may also be a separate component attached to the housing portion of the canvas 3200. The mounting structure 4130 may be joined to the positioning and stabilization structure 3300 by clips, or by looping straps of the positioning and stabilization structure through the corresponding mounting structure 4130.

[0084] The RPT system of this technology may also include a heat and moisture exchanger (HME) that absorbs heat and moisture from the patient's exhaled gas. The heat and moisture absorbed by the HME during treatment are then sent to the gas flow generated by the blower 4142 to humidify the gas flow before it reaches the patient's airway. By providing an HME in the RPT system, the need for conventional electric humidification can be reduced. As shown in the example in Figures 6A to 6C, the HME may be located within the plenum chamber 3200 so as to be in the gas flow and downstream of the blower 4142. As can be seen in Figure 6B, the HME retaining structure 4135 is provided on the lower housing 4133 to hold the HME within the plenum chamber 3200, but the HME retaining structure 4135 may be provided on the upper housing 4132, or may be part of the HME, or may be a completely separable part. As described below, the reason the HME is located downstream of the plenum chamber 3200 and blower 4142 is that, because the RPT system is not ventilated, the patient's exhaled gas may move along the same path in the opposite direction to the therapeutic gas flow generated by blower 4142. Therefore, both inhaled and exhaled gases pass through the HME.

[0085] The HME in this technology may be made of foamed or paper material. Other porous materials are also possible. Therefore, the HME can also function as a filter.

[0086] The examples shown in Figures 15A-15C, 16A-16C, and 17 include a plenum chamber 3200 formed by an upper housing portion 4132 and a lower housing portion 4133. In the example shown in Figures 6A-6C, the upper housing portion 4132 and the lower housing portion 4133 are separate parts and may be joined to form the plenum chamber 3200 and allow access to internal components. However, in the examples shown in Figures 15A-15C, 16A-16C, and 17, the upper housing portion 4132 and the lower housing portion 4133 are a single, integrated part that forms the plenum chamber 3200.

[0087] In the examples shown in Figures 16A to 16C and Figure 17, the upper housing portion 4132 includes a ventilation assembly 3400, which is described in further detail below. The ventilation assembly 3400 allows the patient to expel exhaled CO2 by releasing gas into the atmosphere, thereby avoiding unwanted CO2 rebreathing. The examples shown in Figures 15A to 15C do not include the ventilation assembly 3400.

[0088] 5.3.3 Positioning and stabilization structure The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the positioning and stabilization structure 3300 during use, for example, when the RPT device is operating and / or not operating.

[0089] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while they are sleeping.

[0090] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release portion located between the front portion and the rear portion of the positioning and stabilizing structure 3300. This release portion is not compressible and may be, for example, a flexible or flimsy strap. The release portion is present so that when a patient lies down with their head on a pillow, the force to the rear is transmitted along the positioning and stabilizing structure 3300. It is constructed and positioned in such a way that the seal is not interfered with.

[0091] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap composed of a laminate of a woven patient contact layer, a foamed inner layer, and a woven outer layer.

[0092] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., extendable with elasticity) strap.

[0093] In some forms, the positioning and stabilization structure 3300 may be configured to enable or assist in the transmission of at least one of power and / or signals. For example, the positioning and stabilization structure 3300 may include or be supported on top of itself a conductive part configured to enable electrical communication through its interior.

[0094] In the example of the RPT system shown in Figure 6A, the positioning and stabilization structure 3300 may include at least one wire 3301 supported by the positioning and stabilization structure 3300. The wire(s) 3301 may provide electrical communication between the blower 4142 and the power supply 4210 (e.g., a battery), for example, power and / or signal transmission. The wire(s) 3301 may be housed within the side portion 3303 of the positioning and stabilization structure 3300 (e.g., one or more ties passing above or below the base of the patient's ear). The wire(s) 3301 may have a relatively thin cross-section so as not to be inconspicuous or uncomfortable to the patient. The wire(s) 3301 may be configured to have relatively low rigidity compared to the surrounding positioning and stabilization structure 3300, thereby not significantly interfering with the fit between the positioning and stabilization structure and the patient's face. In one example, the wire(s) 3301 may take the form of a flexible printed circuit (FPC). This configuration is beneficial because it allows patients to receive respiratory therapy using the RPT system while also getting a comfortable night's sleep.

[0095] For example, the thickness of the wire 3301 may be less than 3 mm. The thickness of the wire 3301 can be made thin, such as 0.5 mm, 0.2 mm, or 0.1 mm, which makes it possible to make the side portion 3303 flexible and / or thin, allowing it to easily conform to the shape of the patient's face or head without discomfort. The wire 3301 may be covered within the side portion 3303 by being encapsulated or coated in, for example, silicone, foam, or cloth material. The power supply 4210 may be provided on the upper part 3304 of the positioning and stabilizing structure 3300 such that the wire(s) 3301 extend from the power supply 4210 to the blower 4142 through the side portion of the tie 3303. Of course, the wire 3301 may include one or more layers (for example, for insulation and / or further shielding) in addition to its conductive portion (e.g., a polyester layer in the FPC).

[0096] The positioning and stabilization structure 3300 may also include at least one tube 3302. These tubes 3302 are in fluid communication with the plenum chamber 3200 via a port 4134 at a first end and via a pressure transducer at a second end. These tubes(s) 3302 may be housed within the side portion 3303 of the positioning and stabilization structure 3300 (for example, one or more ties passing above or below the basal point of the patient's ear).

[0097] The positioning and stabilization structure 3300 may also include a rigidizer arm to increase the rigidity of the lateral tie joined to the plenum chamber 3200 in the mounting structure 4130. Since the entire RPT system can be supported over the patient's head, the positioning and stabilization structure 3300 alone, made of relatively soft, flexible material, may have sufficient rigidity to support the RPT system (particularly the blower 4142, plenum chamber 3200, and seal-forming structure 3100) during use. The rigidizer arm is located in the positioning and stabilization structure 3300. By adding the rigidizer to the lateral tie, the weight of the RPT system can be more appropriately supported in the desired position, and only exceptional external forces can interfere with the sealed engagement with the patient's airway. The rigidizer can also at least partially cover the wire 3301 (e.g., one side of the wire 3301 or the encapsulating wire).

[0098] Furthermore, since the length of at least one tie of the positioning and stabilizing structure 3300 can be adjusted, the patient can set the tension generated from the positioning and stabilizing structure 3300. Thus, the patient can ensure a comfortable fit of the RPT system (e.g., the positioning and stabilizing structure 3300) while maintaining a proper seal and desired position.

[0099] Examples shown in Figures 15A-15C and 16A-16C include a positioning and stabilization structure 3300. The positioning and stabilization structure 3300 in these examples may include lateral sections 3303 extending along each side of the patient's head. The lateral sections 3303 may pass above the patient's ears. The lateral sections 3303 may pass below the patient's eyes. The positioning and stabilization structure 3300 in these examples may include a rear section 3305 that may be adjustable. For example, the rear section 3305 may include a tab 3306 that forms a hook-and-loop connection for securing the rear section 3305 at a desired length. The rear section 3305 may include either a hook or a loop material, and the tab 3306 may include the other of the hook-and-loop material. An adjustment mechanism 3308 may also be provided to allow the upper section 3304 to be adjusted to accommodate different sizes and shapes of patient heads.

[0100] The positioning and stabilization structure 3300 in the examples shown in Figures 15A-15C and 16A-16C may also include one or more wires 3301 that enable power supply from the power supply 4210 to the blower 4142. The wire(s) 3301 may also provide control signals from the central control unit 4230 to the blower 4142. In addition, if one or more sensors are provided (e.g., pressure sensors in the plenum chamber 3200), one or more sensors may communicate signals to the central control unit 4230 via the wire(s) 3301. The wire(s) 3301 may be secured to the side 3303 and / or top 3304 by one or more retainers 3307. Furthermore, the central control unit 4230 may be secured to the positioning and stabilization structure 3300 (e.g., on the side 3303 or top 3304) by one or more retainers 4231. Furthermore, the power supply 4210 may be fixed to the positioning and stabilization structure 3300 at the side 3303 or top 3304 by one or more retainers (not shown). The power supply 4210 and / or the central control unit 4230 may be housed together with a housing. This housing is connected to the positioning and stabilization structure 3300, for example, by retainers, adhesive or other methods (e.g., overmolding).

[0101] 5.3.4 Ventilation In one embodiment, the patient interface 3000 includes a vent or vent assembly 3400 configured and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0102] In certain configurations, the vent or vent assembly 3400 is configured to allow a continuous vent flow from the inside of the plenum chamber 3200 to the atmosphere when the pressure inside the plenum chamber is positive relative to the atmosphere. The vent or vent assembly 3400 is configured to maintain the therapeutic pressure inside the plenum chamber during use, while ensuring that the vent flow rate is large enough to reduce patient rebreathing of exhaled CO2.

[0103] One embodiment of the ventilation section or ventilation assembly 3400 according to this technology includes a plurality of holes (for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0104] The ventilation section or ventilation assembly 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation section or ventilation assembly 3400 may be located within a release structure (e.g., a swivel).

[0105] The exemplary RPT systems shown in Figures 6A to 6C may not include a vent (for example, the plenum chamber 3200 may not be ventilated). Therefore, the patient may only exhale through the blower 4142 in a direction opposite to the direction of the therapeutic gas flow generated by the blower 4142 during use (for example, while the blower 4142 is in operation), and the patient's exhaled air exits the RPT system through the blower inlet 4143. Thus, the exhaled air flow passes through the blower 4142 and is vented to the atmosphere. Furthermore, as the overall gas flow passes through the blower 4142, the direction of the patient's exhaled air flow may be reversed during the patient's exhalation phase because it exceeds the flow generated by the blower 4142. To facilitate the airflow of exhaled air through the blower 4142 and blower inlet 4143, the blower 4142 may be positioned near the plenum chamber outlet 4131 and the seal-forming structure 3100, thereby positioning the blower 4142 near the patient. In such a configuration, the blower 4142 should be positioned close enough so that the patient's inspiration begins after the exhaled air has exited the RPT system. Furthermore, the RPT system may be configured so that breathing through the blower inlet 4143 is possible with minimal air resistance.

[0106] By positioning the blower 4142 near the patient and allowing exhalation to occur only through the blower 4142 and the blower inlet 4143, consideration of the airflow is eliminated, thus reducing the overall flow rate that the blower 4142 must generate. In other words, there is no air leakage during the patient's inhalation that would otherwise be driven by the gas flow generated by the blower 4142. This configuration also allows for increased efficiency of the blower 4142 because the length of the flow path between the blower 4142 and the patient (i.e., through the plenum chamber) is reduced due to reduced pressure loss and leakage.

[0107] In another alternative, ventilation of the RPT system may be performed by electronically or pneumatically operated vents to improve the efficiency of the RPT system (e.g., blower 4142) by reducing unwanted ventilation leakage and flow path length. A suitable example of an electronically operated vent is described in PCT Patent Application Publication WO2013040198.

[0108] As described above, the upper housing portion 4132 in the example shown in Figures 16A-16C and Figure 17 may include a ventilation assembly 3400. The ventilation assembly 3400 may include only a number of holes through one or more sides of the upper housing portion 4132 that are open regardless of the patient's respiratory phase and / or the operation of the blower 4142. In other words, the ventilation assembly 3400 allows for continuous gas exit from the plenum chamber 3200. Alternatively, the ventilation assembly 3400 may facilitate selective ventilation based, for example, the patient's respiratory phase and / or the operation of the blower 4142.

[0109] The ventilation assembly 3400 shown in Figures 18A to 18H enables this selective ventilation. The ventilation assembly 3400 may include a base 3404. The base 3404 may be permanently or removablely attached to the upper housing 4132 (for example, for replacement or cleaning), or the upper housing 4132 may form the base 3404.

[0110] The base 3404 may include ventilation extensions 3403 extending from the base 3404. In the example described, two ventilation extensions 3403 are provided, one on each side of the base 3404. Each ventilation extension 3403 may include an external ventilation surface 3401 facing or adjacent to the atmosphere or facing away from the plenum chamber 3200. Each ventilation extension 3403 may also include an internal ventilation surface 3407 facing or adjacent to the plenum chamber 3200. Each ventilation extension 3403 may also include an internal surface 3408. In cross-section, the ventilation extension 3403 may generally have a triangular shape, with the external ventilation surface 3401, the internal ventilation surface 3407 and the internal surface 3408 forming the sides of the triangulation. However, it should be understood that each of these surfaces may be flat or curved (convex or concave). Each vent extension 3403 may include one or more vents 3402 extending between the internal vent surface 3407 and the external vent surface 3401. The vent(s) 3402 may follow a linear or nonlinear path through the vent extension 3403. The vent(s) 3402 allow gas to be delivered to the atmosphere through the interior during ventilation, as described below.

[0111] The ventilation assembly 3400 may also include a divider 3406 that divides the ventilation assembly 3400 into two equal parts. Furthermore, a flexible membrane or flap 3405 may be attached to each ventilation hole extension 3403. The flexible membrane or flap 3405 can cover the ventilation hole(s) 3402 during the inhalation phase to avoid pressurized release into the atmosphere, thereby reducing the pressure within the plenum chamber 3200. The flexible membrane 3405 may be relatively thin and be elastically deformable due to air pressure. The flexible membrane 3405 may be formed from an elastically deformable material (e.g., liquid silicone rubber). The flexible membrane 3405 may be permanently attached to the internal ventilation hole surface 3407 of the ventilation hole extension 3403 by adhesive or overmolding. The flexible membrane 3405 can be cantilevered to the internal ventilation hole surface 3407 of the ventilation hole extension portion 3403 so as to cover the ventilation holes (one or more) 3402 with the flexible membrane 3405.

[0112] Furthermore, the internal vent surface 3407 is angled in the direction of pressurized gas flow from the blower 4142 so that it is biased to the closed position. However, due to the cantilevered attachment of the vent extension 3403 to the internal vent surface 3407, the flexible membrane 3405 can be forced to move to a position where it opens the vent 3402 to the atmosphere by the flow from the patient's exhaled breath, which is relatively small in size.

[0113] The divider 3406 is shown as a rectangular column in the example described. However, the divider 3406 may have inclined or curved sides facing the corresponding ventilation hole extension 3403.

[0114] Furthermore, in the example, the flexible membrane 3405 is dimensioned in the longitudinal direction of the divider 3406 so as to substantially cover the entire passage between the divider and the ventilation hole extension 3403. In another example, it should be understood that the flexible membrane 3405 does not need to extend substantially to the entire width of the passage in the longitudinal direction of the divider.

[0115] Furthermore, the flexible membrane 3405 in the example is illustrated as a continuous flap that is not hollow. However, the flexible membrane 3405 may include one or more holes for fine adjustment of the possible flow rate.

[0116] Additionally, flexible printed circuit boards and / or wires for power supply and / or control of the blower 4142 may pass through the divider 3406.

[0117] Figures 18F to 18H show the operation of the ventilation assembly 3400. Although no other RPT system components are shown, it should be understood that the ventilation assembly 3400 is mounted on the upper housing 4132 as described above when in use. In each figure, the blower 4142 is located above the ventilation assembly 3400, and it should be understood that when generating a pressurized gas flow, the gas flow moves downward through the ventilation assembly 3400 to the patient on the opposite side of the ventilation assembly 3400.

[0118] Figure 18F shows the ventilation assembly 3400 in a neutral state with no airflow. Therefore, the flexible membrane 3405 is in an undeformed state. The figure illustrates how the flexible membrane 3405 covers the ventilation holes 3402 to prevent air movement from the plenum chamber 3200 to the atmosphere or vice versa. However, the flexible membrane 3405 may be attached to the ventilation hole extension portion 3403 so that a small gap is created between the flexible membrane 3405 and the internal ventilation hole surface 3407 in the undeformed state, allowing a small amount of airflow to pass through the ventilation holes 3402. Alternatively, as shown in Figure 18F, the dimensions of the flexible membrane 3405 can be such that it does not engage with the divider 3406 in the undeformed state, thereby allowing airflow between the divider 3406 and the flexible membrane 3405. Alternatively, the flexible membrane 3405 may be sized to engage with the divider 3406 in its non-deformed state, in which case airflow between the divider 3406 and the flexible membrane 3405 is avoided.

[0119] Figure 18G shows the ventilation assembly 3400 during ventilation (e.g., during patient exhalation). Figure 18G shows how the ventilation flow 3409 coming from the direction of the patient displaces and / or deforms the flexible membrane 3405, exposing the internal ventilation hole surface 3407 and causing the ventilation hole 3402 to open or no longer be blocked by the flexible membrane 3405. The ventilation flow 3409 can be generated by the force of the patient's exhalation. By cantilevering the flexible membrane 3405 from the internal ventilation hole surface 3407 beyond the ventilation hole 3402 so that the flexible membrane 3405 rests on the ventilation hole 3402, the force of the ventilation flow 3409 displaces and / or deforms the flexible membrane 3405, thereby opening the ventilation hole 3402 and allowing the ventilation flow 3409 to exit into the atmosphere. The thickness and material of the flexible membrane 3405 should be such that it is easily deformable enough to be displaced and / or deformed by the patient's exhalation (even when encountering flow from the opposite direction from the blower 4142). The flexible membrane 3405 may also be sized so as not to engage with the divider 3406 during the exhalation phase, as shown in Figure 18G, thereby allowing airflow between the divider 3406 and the flexible membrane 3405. Alternatively, the flexible membrane 3405 may be sized to engage with the divider 3406 when deformed by exhalation, in which case airflow between the divider 3406 and the flexible membrane 3405 is avoided, and the full magnitude of the exhalation force is ensured for the release of gas (e.g., exhaled CO2) into the atmosphere.

[0120] Figure 18H shows the ventilation assembly 3400 during the inhalation phase. In this figure, the pressurized gas flow 3410 from the blower 4142 presses the flexible membrane 3405 to a position relative to the surface of the internal ventilation holes. At this position, the ventilation holes 3402 are closed, and the pressurized gas flow 3410 is directed towards the patient for inhalation and not lost in the atmosphere. It should also be understood that the flexible membrane 3405 can occupy this position not only during inhalation, but also at any point in time when the blower 4142 is generating the pressurized gas flow 3410 and the patient is not exhaling. The material and dimensions (e.g., thickness) of the flexible membrane 3405 are selected so as to allow sufficient pressurized gas flow 3410 from the blower 4142 to move to a position where the pressurized gas flow 3410 can reach the patient by displacing and / or deforming the flexible membrane 3405 to close the vent holes 3402 and open the passage between the divider 3406 and the vent hole extension 3403. The internal vent hole surface 3407 may also be angled such that it inclines inward or downward into the interior of the vent assembly 3400 relative to the direction of the pressurized gas flow 3410.

[0121] The ventilation assembly 3400 shown in Figures 18A to 18H is advantageous because it can selectively open and close the ventilation holes 3402 in response to the patient's respiratory phase and / or the operation of the blower 4142, and the ventilation assembly does this passively. In other words, complexity is reduced because there is no need for separately actuated parts to open and close the ventilation holes. Furthermore, the ventilation assembly 3400 of this technology can be cleaned simply by rinsing it with water. The flexible membrane 3405 deforms sufficiently to receive water that displaces the flexible membrane 3405 and clean the entire assembly. Moreover, because there are no further complex actuated parts, the entire ventilation assembly 3400 can be easily rinsed without damaging it.

[0122] Furthermore, the ventilation assembly 3400 may include a diffuser material on the external vent surface 3401 that diffuses the gas flow from the vent(s) 3402 into the atmosphere, thereby reducing noise and jetting.

[0123] Other ventilation configurations can also be considered as applications of this technology. For example, the ventilation configuration disclosed in Figures 33 to 35 of U.S. Patent Application Publication 2014 / 0305431A1 can also be incorporated into the RPT system of this technology.

[0124] 5.3.5 Connection Ports In one embodiment, the patient interface 3000 includes a connection port 3600 for connection to an air circuit 4170.

[0125] 5.3.6 Forehead support In one embodiment, the patient interface 3000 includes a forehead support 3700. The example of the technology shown in Figures 6A to 6C does not include a forehead support. Although the forehead support is not shown in Figures 6A to 6C, it may be provided within the RPT system (for example, in a plenum chamber 3200 extending from the RPT system). The forehead support may be added to improve the stability of the RPT system on the patient's head during use by adding another separate contact point.

[0126] 5.3.7 Suffocation prevention valve In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve.

[0127] 5.3.8 Ports In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this enables a clinician to supply supplemental oxygen. In one embodiment, this enables direct measurement of the gas (e.g., pressure) within the plenum chamber 3200.

[0128] The plenum chamber 3200 may also include a port 4134 configured to be connected to at least one of a pressure transducer and a supplemental gas source. The pressure transducer, as further detailed below, may provide data about the conditions inside the plenum chamber during operation. This data may be used by the control system to control the blower 4142. The supplemental gas source may provide supplemental oxygen to the patient, for example, as prescribed by a clinician.

[0129] 5.4 RPT Devices An RPT device 4000 according to one aspect of this technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms. 000 may be configured to generate an airflow delivered to the patient's airway for the treatment of one or more of the respiratory conditions described in any of the documents herein.

[0130] In one embodiment, the RPT device 4000 is constructed and configured to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, at least 10 cmH2O, or at least 20 cmH2O. In another embodiment, the RPT device 4000 may be constructed and configured to deliver an airflow in the range of -60 L / min to +80 L / min while maintaining a positive pressure of at least 6 cmH2O, at least 10 cmH2O, or at least 20 cmH2O.

[0131] The pneumatic path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0132] One or more of the air passage items may be housed within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be housed within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0133] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central control unit 4230, a treatment 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 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202.

[0134] 5.4.1 RPT Devices: Mechanical and Pneumatic Components An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units. An RPT device may include one or more pneumatic components 4100.

[0135] An RPT device according to one embodiment of this technology may include one or more air filters 4110 and / or one or more mufflers 4120.

[0136] 5.4.1.1 Pressure Generator In one embodiment of this technology, the pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4145 having one or more impellers housed in a volute. For example, the blower 4142 may include a brushless DC motor 4145 having one or more impellers and stator blades housed in a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications. In this specification, the entirety of the following documents is incorporated for reference: U.S. Patent Nos. 7,866,944, 8,638,014, 8,636,479 and PCT Patent Application Publication WO2013 / 020167.

[0137] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0138] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0139] 5.4.1.1.1 Blower 4142 of this technology The blower 4142 of this technology may include a series of stages of small-diameter impellers in a parallel flow path. Such a parallel stage arrangement allows the blower 4142 to generate sufficient flow while enabling a reduction in the size of the blower 4142 and a reduction in the noise it generates. As shown in Figures 7A to 7F, the exemplary blower 4142 includes two sets of first pressure stages 4136 and second pressure stages 4137, each set arranged in parallel on each side of the motor 4145. In other words, the blower 4142 may include two sets of stages in a substantially mirror configuration relative to the axial direction of the motor 4145. Although the exemplary blower 4142 is shown with two stages arranged in series on each side, it is conceivable that only one stage may be present on each side of the blower 4142. Alternatively, more than two pressure stages may be provided on each side of the blower. In further alternative examples, asymmetrical pressure stages may be provided. For example, one stage may be provided on one side of the blower 4142, and two stages on the other side of the blower 4142. These stages themselves may be asymmetrical in that the stator and impeller of any given stage can be distinguished from those of other stages.

[0140] The fan 4142 may be used in a respiratory pressure therapy (RPT) system and may be configured to generate airflow at a therapeutic pressure of at least 6 cmH2O, exceeding the ambient air pressure. Exemplary fans 4142 and RPT systems disclosed in Figures 6A to 14 may be used to treat sleep-disordered respiratory symptoms (e.g., sleep apnea) and may also be used to treat other respiratory problems not necessarily related to sleep (e.g., COPD). The fan 4142 may include a motor 4145 having a first end and a second end (shown in simple external shape). The fan 4142 may generally have a cylindrical shape. The first impeller 4150 and the second impeller 4160 may be arranged in series on a shaft 4146 such that both first impellers 4150 and both second impellers 4160 are driven simultaneously by the motor 4145.

[0141] Each pair of impellers at either end of the motor 4145 is configured to generate gas flows in opposite directions to each other; therefore, while driven by the same shaft, each opposing impeller 4150 and 4160 may have a mirror geometry. Thus, for example, impellers 4150 and 4160 located at the first end of the shaft 4146 of the motor 4145 may each include forward blades located at the second end or the opposite end of the shaft 4146 of the motor 4145, and impellers 4150 and 4160 may have different (mirror) geometries. In other words, since both ends of the shaft 4146 rotate in the same direction when the motor 4145 is operating, the impellers 4150 and 4160 at each end of the shaft may advance in the forward direction relative to the rotation direction of the shaft 4146, thereby generating gas flows in the same direction from both sides of the blower 4142.

[0142] The blower 4142 may also include a first stator 4180 corresponding to the first end and the second end of the motor 4145, respectively. The first stator 4180 may be positioned downstream of the first impeller 4150 and upstream of the second impeller 4160 along the airflow generated by the blower during use. The blower 4142 may also include a second stator 4190 corresponding to the first end and the second end of the motor 4145, respectively, the second stator 4190 being positioned downstream of the second impeller 4160 along the airflow generated by the blower 4142 during use.

[0143] The blower 4142 may also include end caps 4144. The end caps 4144 are shaped and sized to at least partially enclose each first impeller 4150. Each end cap 4144 may also at least partially define the blower inlets 4143 on each side of the blower 4142. The blower 4142 may also include blower outlets 4141 located downstream of each second stator (for example, at the center of the blower 4142 or axially toward the center of the blower 4142). A flow path 4138 may be defined through the blower 4142 for allowing airflow from each blower inlet 4143 through each first impeller 4150, through each first stator 4180 through each second impeller 4160, and out through each second stator 4190 through each blower outlet 4141. The blower outlet 4141 may extend in an annular manner around all or part of the perimeter 4142 of the blower.

[0144] Figure 7A shows an example of a blower 4142 according to the present technology, separated from housing sections 4132 and 4133. For example, the mounting rail 4183 on the exterior of the first stator housing 4184 of the first stator 4180 is visible. Also visible are the blower outlet 4141 and a portion of the second stator 4190 leading to the blower outlet 4141. Figure 7A also includes other parts of the blower 4142 (for example, the end cap 4144 that defines the blower inlet 4143 and partially encloses the first impeller 4150). As can be seen from Figure 7A, the structure of the blower 4142 is mirrored or symmetrical such that each half of the blower 4142 may contain identical (mirror) parts.

[0145] Therefore, the blower 4142 may include two sets of inlets and outlets. That is, one set of inlets 4143 (e.g., two inlets) is located at opposite ends of the blower 4142 and directed toward the opposite ends of the blower 4142, and one set of outlets 4141 (e.g., two outlets) is located at or toward the center of the blower 4142 in the axial direction of the blower 4142.

[0146] Figure 7B shows an exemplary blower 4142 similar to Figure 7A, but the end cap 4144 is omitted to show the first impeller 4150. Furthermore, portions of the first stator blades 4186 and 4187 of the first stator 4180 are also visible. As will be described in more detail below, while the first pressure stage gas flow is generated by spinning, the first impeller 4150 passes through the volume defined by the end cap 4144, then through the first stator blades 4186 and 4187, and reaches the second impeller 4160 for the second compression stage.

[0147] Figure 7C shows another diagram of an exemplary blower 4142, including the end cap 4144 and the first impeller 4150. In the diagram, the first stator shroud 4182 of the first stator 4180 is visible. Furthermore, larger portions of the first stator blades 4186 and 4187 are also visible. During the first compression stage 4136, the gas flow generated by the spinning of the first impeller 4150 passes under the first stator shroud 4182A and between the first stator blades 4186 and 4187 before reaching the second impeller 4160 for the second compression stage 4137.

[0148] Figure 7D is another diagram of the exemplary blower 4142, with the first stator 4180 omitted. In this diagram, the second impeller 4160 and the second stator 4190 (e.g., the second stator blades 4191) can be seen in more detail. The characteristics of these individual components are described in further detail below.

[0149] Figure 7E is a cross-sectional view of an exemplary blower 4142 as shown in Figure 7A, where the cross-section is cut along the plane containing the rotation axis of the motor 4145. In this figure, the blower input The portion of the flow path through which the gas from inlet 4143 exits from blower outlet 4141 after passing through both compression stages can be observed.

[0150] Figure 7F is an exploded view of an exemplary blower 4142.

[0151] 5.4.1.1.1.1 Pressure stages 4136 and 4137 In one exemplary configuration, each pair of pressure stages 4136 and 4137, corresponding to two impeller / stator pairs, can deliver a flow of up to approximately 40 L / min, powered by a motor 4145 operating at, for example, 65,000 rpm. Therefore, by combining the pressure stages 4136 and 4137 in parallel on each side of the blower 4142, it becomes possible to deliver approximately 80 L / min at a therapeutic pressure of approximately 10 or 15 cmH2O. In this example, the motor 4145 has an outer diameter of 13 mm and a length of 37 mm, and the blower 4142 has an outer diameter of 18 mm and a length of 46 mm. Further impellers may be added in series to each pressure stage to generate even higher pressures.

[0152] 5.4.1.1.1.2 Motor 4145 The blower 4142 may include a motor 4145 in the form of a single brushless DC motor. The motor 4145 may include a shaft 4146. The shaft 4146 protrudes axially from each end to drive the corresponding impellers on each side. It should be understood that the ends of the shaft 4146 can mirror the shapes of the impeller and stator because they spin in the same direction when the blower 4142 is operating, but can otherwise be identical on the opposite side of the blower 4142. The motor 4145 of this technology can operate in the range from a minimum of approximately 5,000 rpm or approximately 10,000 rpm to a maximum of approximately 50,000 rpm to approximately 80,000 rpm, producing a maximum torque of approximately 0.5 mN-m to approximately 1 mN-m and a maximum power of approximately 3 W to 6 W. In the example shown, one motor is illustrated that drives both sets of pressure stages 4136 and 4137 on each side of the blower 4142. However, the blower 4142 may include two motors 4145, each driving a single set of pressure stages 4136 and 4137.

[0153] 5.4.1.1.1.3 Impellers 4150 and 4160 An exemplary first impeller 4150 is shown in Figures 8A to 8L, but it should be understood that each second impeller 4160 may be identical to the corresponding first impeller 4150. Alternatively, each first impeller 4150 and each second impeller 4160 may be designed distinctly to optimize the flow rate and pressure generated based on their relative positions in the flow path 4138. Whether designed in different ways or identically, each first impeller 4150 and each second impeller 4160 may include an impeller hub 4153, impeller blades 4151 extending radially from the impeller hub 4153, and an impeller shroud 4152. The impeller hub 4153 is part of the impeller 4150 and joins the impeller 4150 to the corresponding end of the shaft 4146.

[0154] When the impeller 4150 rotates, the impeller blades 4151 direct the gas flow outward in the radial direction. Each impeller blade 4151 may have a first impeller blade portion 4154 extending only in the radial direction, and a second impeller blade portion 4155 extending radially, tangentially, and axially (or radially and axially only). The first impeller blade portion 4154 may have a fixed cross-section and may be positioned radially inward relative to the second impeller blade portion 4155. The second impeller blade portion 4155 may have a variable cross-section and may be positioned radially outward relative to the first impeller blade portion 4154. A constant cross-section of the first impeller blade 4154 can be made thinner at any point than the variable cross-section 4155 of the second impeller blade. The thickness of the variable cross-section of the second impeller blade 4155 is radially from the first impeller blade 4154. It can increase outward and decrease further outward in the radial direction.

[0155] The impeller blades 4151 of each first impeller 4150 and each second impeller 4160 may advance forward relative to the rotational direction 4139 during operation or be curved forward. Alternatively, the impeller blades 4151 of each first impeller 4150 and each second impeller 4160 may move backward relative to the rotational direction 4139 during operation or be curved backward.

[0156] The impeller shroud 4152 prevents the incoming gas flow from moving axially along the impeller blades 4151, thereby spinning the gas tangentially while the impeller blades 4151 redirect the gas flow radially. Each impeller shroud 4152 may include a first impeller shroud section 4156 extending only radially and a second impeller shroud section 4157 extending radially and axially. The impeller shroud 4152 may also include a notch that allows the impeller to be molded along a dividing line.

[0157] The first impeller blades 4154 of the impeller 4150, shown in Figures 8A to 8M, can be linear in order to maximize their cross-sectional area, thereby minimizing entry losses at the blower inlet 4143. In fact, as can be seen in Figure 7A, the first impeller blades 4154 are exposed through the blower inlet 4143 to draw in air. Furthermore, the forward curvature of the second impeller blades 4155 allows pressure to be generated through relatively high tangential velocities. In addition, since the flow from the impeller 4150 propagates axially, the axial movement of the flow is promoted, and as a result, beneficially, it becomes possible to increase the axial velocity that can convert the stators 4180 and 4190 into further pressure. To explain the concept of further axial extension, the idea is that the longer the airflow is present in the area where work is being done by the impeller 4150 (for example, via centrifugal effect), the greater the amount by which the stators 4180 and 4190 convert the increase in airflow velocity into pressure. Further axial extension also means that the airflow is present in the area where work is being done by the impeller 4150 (and thus pressure is being generated via centrifugal effect) for a longer period of time.

[0158] Figures 12A and 12B show another example of the first impeller 4150 according to the present technology. This first impeller 4150 is similar to the first impeller 4150 described above in that it includes basic structural components (e.g., the first impeller blades 4151, the first impeller shroud 4152, and the first impeller hub 4153). However, the first impeller blades 4151 and the first impeller shroud 4152 are made of different shapes in the examples in Figures 12A and 12B. For example, with respect to the cross-section of the first impeller blades 4151, the radial thickness between the first impeller blade portion 4154 and the second impeller blade portion 4155 remains constant. Furthermore, the curvature of the second impeller blade section 4155 is steeper in the examples shown in Figures 12A and 12B. Moreover, the second impeller blade section 4155 does not extend axially in the examples shown in Figures 12A and 12B. Similarly, the first impeller shroud 4152 does not extend axially from the impeller hub 4153 in the examples shown in Figures 12A and 12B. In other words, the first impeller shroud 4152 is generally flat, at least on the side opposite the first impeller blade 4151. The impeller blades 4151 of the impeller 4150 in Figures 12A and 12B may advance relative to the rotational direction 4139 during operation or may be curved in the forward direction. Alternatively, the impeller blades 4151 of the impeller 4150 in Figures 12A and 12B may be able to move backward relative to the rotational direction 4139 during operation, or may be curved in the rearward direction.

[0159] The exemplary first impeller 4150 shown in Figures 13A and 13B is the first impeller blade Except for the shape of the root 4151, it is similar to the first impeller 4150 shown in Figures 12A and 12B. In the exemplary first impeller 4150 of Figures 13A and 13B, the radial curvature of the first impeller blades 4151 is continuous and steeper. However, as with the first impeller 4150 of Figures 12A and 12B, and the first impeller 4150 of Figures 13A and 13B, the cross-sectional thickness of the first impeller blades 4151 is constant in the radial direction. The impeller blades 4151 of the impeller 4150 of Figures 13A and 13B may advance relative to the rotational direction 4139 during operation or may be curved in the forward direction. Alternatively, the impeller blades 4151 of the impeller 4150 in Figures 13A and 13B may be reversed relative to the rotational direction 4139 during operation, or may be curved in the rearward direction. As described above, either the first impeller 4150 shown in Figures 12A and 12B or Figures 13A and 13B may be used in both the first pressure stage 4136 and the second pressure stage 4137. In other words, both pressure stages 4136 and 4137 include the same impeller for the first impeller 4150 and the second impeller 4160. Alternatively, different impeller designs may be used in the first pressure stage 4136 and the second pressure stage 4137, respectively.

[0160] The first impeller blades 4154 of the impeller 4150, shown in Figures 12A and 12B, can be linear in a way that maximizes the cross-sectional area, thereby minimizing entry losses at the blower inlet 4143. In fact, as can be seen in Figure 7A, the first impeller blades 4154 are exposed through the blower inlet 4143 to draw in air. Furthermore, the forward curvature of the second impeller blades 4155 can generate pressure through relatively high tangential velocities.

[0161] 5.4.1.1.1.4 Impeller 500 Examples of impellers using this technology are shown in Figures 19A to 19EE. The impellers may be suitable for use in centrifugal blowers, for example, as described in any part of this specification.

[0162] Impeller 500 may include one or more of the following: • A set of impeller blades 510, each impeller blade 510 including a leading edge 511 and a trailing edge 512, • A first shroud and / or a second shroud (for example, an upper shroud 520 and / or a lower shroud 525 that at least partially define the flow path 540 through the impeller), A hub 530 for coupling an impeller to a motor, the hub 530 may be held, for example, by interference fit to the rotor or motor shaft of the motor, but any number of other known holding mechanisms may also be suitable.

[0163] If the impeller 500 includes a first shroud and a second shroud, the first and second shrouds may be arranged such that the axial distance between them generally decreases radially toward the outer part of the impeller.

[0164] Figures 19A to 19N show an impeller 500 according to an example of the present technology. As shown, the impeller blades 510 included in the impeller 500 are arranged between a first or upper shroud 520 and a second or lower shroud 525 and connected to the first or upper shroud 520 and the second or lower shroud 525. In the illustrated example, the lower shroud 525 extends to a hub 530 adapted to receive the rotor of the motor.

[0165] In the illustrated example, the upper shroud 520 is substantially non-planar. For example, the upper shroud 520 may be tapered radially with respect to the axial direction of the impeller. For example, the upper shroud 520 may include a frustoconical shape. The upper shroud 520 is the upper shroud The shroud includes an outer edge that defines the diameter D of the shroud and an inner edge that defines a central opening providing the impeller inlet 522. The impeller inlet wall 521 extends along the inner edge to define the periphery of the impeller inlet 522. The free end of the inlet wall 521 provides the leading edge 523 of the impeller inlet 522. In this configuration, the upper shroud 520 extends outward around the impeller, so the diameter D of the upper shroud is the same as the diameter of the impeller. However, in other configurations, the upper shroud 520 does not have to extend outward around the impeller, but may cover only a portion of the impeller blades, for example.

[0166] In the illustrated example, the lower shroud 525 is substantially planar. As shown in the illustration, the outer edge of the lower shroud 525 defines a diameter substantially similar to the diameter D defined by the outer edge of the upper shroud 520. In one example, the diameter D of the impeller is less than approximately 50 mm.

[0167] The upper shroud 520 and the lower shroud 525 work together to define a flow path 540 between them through the impeller. The flow path 540 extends from the impeller inlet 522 on the inside of the impeller to the impeller outlet 524 on the outside of the impeller. The flow path 540 may include multiple channels. Each channel is at least partially defined by the upper shroud 520 and the lower shroud 525 and the impeller blades 510.

[0168] In the illustrated example, the flow path 540 defined between the upper shroud 520 and the lower shroud 525 is structured to narrow from the impeller inlet 522 to the impeller outlet 524 (normal to the airflow direction). That is, the gap or distance between the upper shroud 520 and the lower shroud 525 is reduced or tapered in the direction from the impeller inlet to the impeller outlet.

[0169] In other words, the upper shroud 520 and the lower shroud 525 are configured such that the flow path is narrower axially on the outer side of the impeller than on the inner side. That is, the axial distance between the upper shroud 520 and the lower shroud 525 can generally be reduced radially toward the outer side of the impeller. For example, Figure 19B shows exemplary axial distances d1 and d2 between the upper shroud 520 and the lower shroud 525. d1 along the inner side of the impeller is greater than d2 along the outer side of the impeller, and the axial distance decreases radially from d1 to d2. Furthermore, the upper shroud 520 and the lower shroud 525 are configured such that the axial distance between them at the outlet of the impeller (i.e., d2) is smaller than the radial dimension at the inlet.

[0170] Therefore, an impeller according to an embodiment of this technology may include a flow path 540 comprising a plurality of channels. Each channel is configured such that its height decreases along the direction of the airflow passing through it.

[0171] 5.4.1.1.1.4.1 Impeller entrance The impeller according to this technology may include a relatively large impeller inlet size as a ratio to the impeller diameter D. In one embodiment, the impeller inlet 522 may be defined by the periphery of an upper shroud 520, for example, as shown in Figure 19B, with the inlet wall 521 of the upper shroud 520 shown in cross-section.

[0172] Generally, increasing the size of the impeller inlet in a centrifugal blower while maintaining other dimensions (e.g., impeller diameter) can be disadvantageous. This is because such an increase can lead to a reduction in the effective diameter of the impeller, which allows centrifugal energy to be transferred to the airflow generation passing through the blower. In other words, enlarging the impeller inlet can lead to a configuration where the pressure generated by the blower is insufficient.

[0173] However, in the case of RPT device applications, for example, a smaller device is desirable for aesthetic reasons, ease of placement at the bedside, and portability, and designers may want to reduce the impeller size. However, reducing the impeller diameter increases the velocity of the airflow passing through the impeller, which negatively impacts impeller noise and efficiency due to aerodynamic behavior caused by the increased velocity.

[0174] As mentioned elsewhere, RPT devices are relatively unique in that they are small and quiet, making them suitable for bedside / nighttime / sleeptime use while ensuring sufficient pressure and flow generation for respiratory therapy. For applications in small, possibly portable RPT devices, it has been found that a reduction in impeller diameter can be achieved by a relative increase in the impeller inlet diameter.

[0175] In one embodiment, an impeller with a diameter D of less than 50 mm may include an impeller inlet 522. The diameter of the impeller inlet 522 (d as shown in Figure 19A) inlet The diameter of the impeller is at least 50% of the impeller diameter. In one example, the impeller may have a diameter D of 40 mm and an impeller inlet diameter d inlet These are 20mm, 22mm, or 24mm.

[0176] According to another aspect of this technology, the area around the impeller inlet wall 521 or the impeller inlet 522 may include a relatively large radius to improve the overall performance of the impeller and / or the fan. Increasing the radius in a portion of the area facing the incoming airflow into the impeller may lead to improved efficiency because the airflow remains attached to the inlet wall 521.

[0177] In one embodiment, the leading edge around the impeller inlet 522 (e.g., the leading edge 523 at the free end of the inlet wall 521 of the upper shroud 520 (as best shown in Figure 19B)) includes a cross-sectional shape with a radius of at least 0.5 mm. In another embodiment, the radius of the leading edge of the first or upper shroud 520 exceeds 70% of the maximum thickness of the body of the first shroud 520 (e.g., exceeding 85%, 100%, or 115%). In another embodiment, the radius of the leading edge 523 of the first or upper shroud 520 exceeds the maximum thickness of the body of the first shroud 520. In another embodiment, the leading edge of the first or upper shroud 520 includes a cross-sectional shape with a radius of at least 1% of the diameter D of the impeller. During use, even if airflow enters the impeller inlet 522 of the impeller, for example, to reduce noise and improve efficiency, detachment of the radius or its vicinity is prevented.

[0178] 5.4.1.1.1.4.2 Impeller Blades The impeller 500 may include a plurality of impeller blades 510. In the illustrated example, the impeller includes 11 blades 510. However, it should be understood that the impeller may include any other appropriate number of blades (e.g., 3 or more blades (e.g., 5 to 20 blades (e.g., 7 blades, 11 blades, 13 blades))).

[0179] Each impeller blade 510 extends from the hub 530 to the outer edge of the impeller. Each impeller blade may be connected to the upper shroud 520 and the lower shroud 525. Each impeller blade includes a leading edge 511 and a trailing edge 512. It should be understood that the terms “leading edge” and “trailing edge” are used in the conventional sense in aeronautics and other fields, and refer to parts of the wing (not the “edge” in the narrow geometric sense).

[0180] For example, the "leading edge" may refer to the portion of the impeller blade that first comes into contact with the air entering the impeller. Similarly, the "trailing edge" may refer to the portion of the impeller blade that last comes into contact with the air exiting the impeller.

[0181] In the illustrated example, the impeller blades 510 are positioned between the upper shroud 520 and the lower shroud 525. As shown in the illustration, each blade 510 is covered by the upper shroud 520 such that a first edge 515 along the outer part of the blade contacts the upper shroud 520 and a leading edge 511 along the inner part of the blade is exposed through the impeller inlet 522 (i.e., the leading edge 511 extending between the inlet wall 521 and the hub 530 defines the inlet 522 into the impeller). Each blade 510 is covered by the lower shroud 525 such that a second edge 517 contacts the lower shroud 525 and the hub 530 along its entire length. The trailing edge 512 is exposed through the impeller outlet 524 between the outer ends of the upper shroud 520 and the lower shroud 525.

[0182] In the illustrated example, each blade 510 extends to the outer edges of the upper shroud 520 and the lower shroud 525. For example, the blade 510 extends beyond the upper shroud 520 and the lower shroud 525. In another example, the blade 510 may extend beyond the outer edges of the upper shroud 520 and the lower shroud 525 or may extend to a point where it does not reach the outer edges of the upper shroud 520 and the lower shroud 525.

[0183] According to one aspect of this technology, the leading edge 511 and / or trailing edge 512 of the impeller blade 510 can be extremely thin, thereby reducing turbulence and noise at the inlet and outlet of the impeller. In one example, the thickness of the leading edge 511 and / or trailing edge 512 of the impeller blade 510 may be less than about 0.2 mm (for example, less than about 0.1 mm when measured at the thinnest part or at the outermost (i.e., the downstream) part). Furthermore, a unique feature of RPT devices is that in some impeller designs, reducing the size of the leading (and / or trailing) edge visually has a positive effect on the airflow of the impeller and the efficiency of the RPT device.

[0184] In one example, the cross-sectional thickness of each blade 510 may be variable, for example, along at least a portion of its length in the plan view, or it may be tapered. For example, as shown in Figures 19K to 19N, the outer portion of each blade 510 may include a cross-sectional thickness that is tapered toward the trailing edge 512.

[0185] Furthermore, as shown in Figures 19K to 19N, each blade 510 may be curved and / or have a curved outer surface along, for example, at least a portion of its length in the plan view. For example, as shown in Figures 19K to 19N, the outer portion of each blade 510 may have a curved surface 519 along its length toward the trailing edge 512, for example, to smooth the airflow path for turbulence and thus noise reduction.

[0186] Furthermore, as shown in Figures 19K to 19N, the flow path defined between adjacent blades 510 is structured to expand, for example, along at least a portion of its length in the plan view. For example, as shown in Figures 19K to 19N, the flow path defined between adjacent blades 510 is structured to expand toward the trailing edge 512 (for example, to increase pressure).

[0187] As shown in the cross-sections in Figures 19C, 19P, or 19K to 19N, the impeller blades 510 can be inclined. For example, the leading edge 511 of each blade 510 can be inclined at an angle greater than 45 degrees with respect to, for example, the hub 530 or the motor axis.

[0188] In the examples shown in Figures 19A to 19N, the trailing edge 512 extends substantially parallel to the axis of the hub 530.

[0189] In some embodiments, as shown in Figures 19O to 19S, the impeller blade 510 may include one or more serrations. For example, the leading edge 511 and / or trailing edge 512 may include one or more serrations arranged along the leading edge 511 and / or trailing edge 512. Several examples of suitable possible arrangements of leading edge serrations and / or trailing edge serrations are described in PCT Patent Application Publication No. WO2016 / 201516, which is incorporated herein by reference.

[0190] 5.4.1.1.1.4.3 Impeller Structure Many conventional impellers (particularly those in the field of respiratory pressure therapy devices) are manufactured by injection molding of polymer materials. Typical reasons for this are listed below (without limitation): • In particular, the cost of each component decreases as production volume increases. • Because injection molding allows for a smooth surface finish, turbulence generation can be minimized. • The high reproducibility of molded parts ensures consistency and quality control, and • The use of low-density (and relatively high-rigidity and high-strength) plastics helps minimize mass and rotational inertia, making it easier to achieve high acceleration and deceleration.

[0191] Due to the use of injection molding, achieving specific impeller geometries can be extremely difficult or impossible with injection molding alone. For example, in the case of an impeller with curved air-receiving blades and upper and lower shrouds, manufacturing using the injection molding process can be extremely difficult. That is, it is impossible to remove the molding tool after the part has been molded because the tool and the part are intertwined after molding.

[0192] In another example, injection-molded plastic parts may require a minimum wall thickness to allow the molten plastic being injected into the mold without the need for excessive pressure.

[0193] In some cases, an impeller comprising one or more of the embodiments described herein may be manufactured using a different manufacturing method or structure, and some of the elimination of the aforementioned disadvantages is related to such a method.

[0194] Additive manufacturing

[0195] In one embodiment, the impeller according to this technology may be manufactured by additive manufacturing (also known as "3D printing"), in which metallic materials (e.g., titanium, aluminum, or stainless steel) may be used.

[0196] In many applications, and in some cases with RPT devices, metal impellers may be disadvantageous compared to polymer impellers due to increased rotational inertia. As mentioned above, increasing the rotational inertia of the impeller increases the torque required for acceleration and deceleration, which may necessitate a higher capacity motor driving the impeller. Consequently, the motor size may increase, and thus the power supply and / or battery requirements may also increase.

[0197] However, if the impeller is relatively small, some of these problems can be mitigated, making the use of metal materials more feasible. If the impeller diameter increases, the corresponding rotational inertia decreases by the fourth power of the diameter reduction, as shown below:

number

[0198] Therefore, advantageously, additive manufacturing techniques using metallic materials have proven to be particularly suitable for this application and size, enabling the achievement of the highly efficient geometry described herein.

[0199] In some cases, a material (e.g., a metallic material) with the same / similar coefficient of thermal expansion as the rotor (e.g., motor shaft) may be selected (e.g., the shaft and impeller may contain the same metal or metallic material). This ensures that when the impeller is press-fitted onto the rotor, one or more uniform thermal expansions occur between these two joining rotating parts. As a result, the integrity of the interference fit can be maintained even in the event of temperature changes (which can fluctuate more significantly in the motor than in ambient air, for example).

[0200] Multiple-part structure

[0201] For example, according to one embodiment of this technology shown in Figures 19T to 19EE, the impeller 500 may include multiple parts.

[0202] In some forms, one part may contain a different material from another part. For example, the first part may contain a deformable elastic material, and the second part may contain a rigid material. In one example, the rigid material may be a plastic material, and the elastic material may be an elastomer material such as a silicone material.

[0203] In the examples shown in Figures 19Y to 19EE, the first molded part or portion (i.e., the first impeller portion 500-1) may be structured and arranged in such a way that it is bonded to a second molded part or portion (i.e., the second impeller portion 500-2) in order to manufacture the impeller 500. The first impeller portion 500-1 may include a deformable elastic material (e.g., an elastomer material (e.g., silicone) that can be bonded to the second impeller portion 500-2 which includes a rigid material (e.g., rigid plastic)). For example, in the manufacturing process, the second impeller portion 500-2 may first be produced (e.g., molded), and then the first impeller portion 500-1 may be overmolded onto the second impeller portion 500-2. Other forms of bonding (e.g., chemical bonding or mechanical bonding) may be suitable for parts that are not overmolded.

[0204] As shown in the figure, the first impeller part 500-1 includes a plurality of impeller blades 510 (i.e., the inner side of the upper shroud or the first part 520-1, including the inlet wall 521 that defines the periphery of the impeller inlet 522) which are part of the upper shroud 520, and a part of the lower shroud 525 (i.e., the outer side of the lower shroud or the first part 525-1). The second impeller part 500-2 includes a part of the upper shroud 520 (i.e., the outer side of the upper shroud or the second part 520-2), a hub 530 structured to be coupled to the front rotor, a part of the lower shroud 525 (i.e., the inner side of the lower shroud or the second part 525-2), and an inner blade part 513. The inner blade part 513 is adapted to be received in a corresponding opening 514 provided in the impeller blade 510, for example, to add rigidity to the impeller blade 510.

[0205] When the first impeller part 500-1 is overmolded onto the second impeller part 500-2 for the manufacture of the impeller 500, the inner part 520-1 and the outer part 520-2 cooperate to form the upper shroud 520, the outer part 525-1 and the inner part 525-2 cooperate to form the lower shroud 525, and internal rigidity is imparted to the impeller blade 510 by the inner blade part 513 (i.e., a rigid material is imparted to the impeller blade 510 by the inner blade part 513). In such an arrangement, the impeller blade 510 and its leading edge 511 and trailing edge 512 include an elastomeric material (e.g., silicone), and the hub 530 includes a rigid material for coupling to the rotor.

[0206] With such a structure, the impeller can be manufactured with the desired advantageous aerodynamic features described herein and can be injection molded. That is, by using such a structure, the first impeller portion 500-1 (e.g., including silicone) can be elastically deformed to remove it from the injection molding tool, so that the manufacturer can extract the "core presence" of the injection molding tool. More advantageously, such a material (e.g., silicone) of the first impeller portion 500-1 enables the inner wall portion to be manufactured with a material other than plastic, thereby enabling the manufacture of, for example, the thin impeller blade leading edge 511 and / or trailing edge 512 as described above.

[0207] Also, instead of constructing the entire impeller from a deformable elastic material, by strategically using such a deformable elastic material, impeller manufacturing can be assisted, sufficient overall structural integrity for durability can be obtained, and deformation during operation is also limited.

[0208] In other forms, the impeller can include a plurality of portions. Each portion does not necessarily include different materials from each other.

[0209] In the examples shown in Figures 19T to 19X, the first impeller portion 500-1 and the second impeller portion 500-2 may be molded separately or assembled or fastened together. In one example, the first portion and the second portion may each comprise a rigid material (e.g., rigid plastic (e.g., PEEK (also known as polyetheretherketone))). In yet another example, the first portion may comprise a deformable elastic material (e.g., elastomer material (e.g., silicone)), and the second portion may comprise a rigid material (e.g., rigid plastic). For example, the first portion 500-1 (i.e., the first molded part or portion) may comprise an upper shroud 520, an impeller blade 510, and a first fastening portion 550. The second part 500-2 (i.e., the second molded part or component) may include the hub 530, the lower shroud 525, and the second fastening portion 555. The first impeller portion 500-1 and the second impeller portion 500-2 are fastened together by assembling the first fastening portion 550 to the second fastening portion 555.

[0210] In the illustrated example, the first fastening portion 550 includes a hub portion 550-1 and radially extending projections 550-2 spaced apart around the hub portion 550-1 (see, for example, Figure 19W). The second fastening portion 555 includes an annular slot 555-1 around the hub 530 adapted to receive the hub portion 550-1 of the first fastening portion 550 during assembly, and the second fastening portion 555 includes radially extending slots 555-2 adapted to receive each projection 550-2 of the first fastening portion 550 during assembly (for example, to avoid relative rotation). However, it should be understood that the first fastening portion 550 and the second fastening portion 555 may include other fastening configurations for fastening, interlocking, or other forms of interface between the first and second impeller portions.

[0211] These two parts, 500-1 and 500-2, are joined, for example, by snap-fitting, gluing, welding, etc. The impeller 500 can be fastened or secured in any number of other suitable ways to produce it. Furthermore, in some forms, these two parts 500-1 and 500-2 can be positioned to further enhance the connection between the parts of the impeller 500 by coupling the assembled impeller 500 onto the motor (e.g., via the motor shaft). For example, if the hub 530 of the impeller 500 is coupled to the rotor or motor shaft (e.g., by press fitting), the fastening (e.g., snap fitting) between these two parts 500-1 and 500-2 can be supported and fastened by such hub coupling, for example, the snap fitting fastening can be fastened by press fitting coupling of the hub to the rotor.

[0212] Of course, it is understood that impellers are not limited to those consisting of two parts, but that any number of parts can be assembled for the manufacture of an impeller.

[0213] 5.4.1.1.1.4.4 Exemplary blower Figure 19FF shows a blower 600 for an RPT device including an impeller 500 according to one embodiment of the present technology. In the illustrated embodiment, the blower 600 includes a two-stage design constructed and configured to generate an airflow or supply at positive pressure (e.g., in the range of 4–30 cmH2O). In one example, the RPT device is configured to deliver the airflow from the outlet to be delivered to the patient at a pressure of 4–30 cmH2O and an overall sound power level of less than 50 dB(A), thereby reducing all disturbances to the patient's sleep quality. However, in alternative embodiments, the blower may also include a single-stage design, a three-stage design, or a design with four or more stages.

[0214] As shown in the figure, the blower 600 includes a housing 610 which includes an axial air inlet (blower inlet) 612 and an axial air outlet (blower outlet) 614. Between the axial air inlet (blower inlet) 612 and the axial air outlet (blower outlet) 614 are two stages which include corresponding impellers 500 (i.e., a first impeller 500 located on one side of the motor 620 and a second impeller 500 located on the other side of the motor 620). The motor 620 includes a rotor 625 to which the impellers 500 are coupled. The impellers 500 are configured to be rotated by the rotor 625 to deliver the airflow from the inlet 612 to the outlet 614. However, other suitable impeller configurations are possible. Following each impeller 500, a pair of stator blades may be provided which are constructed and configured to direct the airflow to the next stage or outlet.

[0215] In one embodiment, the housing 610 may include a plurality of housing parts (e.g., a first housing part including an inlet 612, a second housing part including an outlet 614, and an intermediate housing part (e.g., a stationary component providing stator vanes that direct airflow). These intermediate housing parts are interconnected (e.g., by welding) to form a substantially sealed structure.

[0216] Further embodiments and details of the blower are described in PCT Patent Application Publication WO2013 / 020167, which is incorporated herein by reference.

[0217] According to one aspect of this technology, the radius of a portion of the housing 610 adjacent to each impeller 500 may substantially correspond to the radius of the leading edge 523 of the impeller inlet wall 521 of the impeller 500. For example, as best shown in Figure 19GG, a portion of the housing 610 adjacent to the blower inlet 612 includes a generally curved surface (e.g., a concave surface 615). This generally curved surface (e.g., a concave surface 615) is spaced apart from and adjacent to a generally curved surface (e.g., a convex surface 527) provided on the leading edge 523 of the impeller inlet wall 521. In one example, such a generally concave surface 615 of the housing 610 is adjacent to a generally convex surface provided on the leading edge 523 of the impeller inlet wall 521. It includes a radius substantially corresponding to the radius of the shaped surface 527.

[0218] The substantially corresponding radii and configuration of the curved channel 650 formed between the housing 610 and the surfaces 615 and 527 of the impeller 500, and such a curved channel 650 terminating at a point where its tangent generally points downward (i.e., toward the impeller adjacent to the short arrow A1 in Figure 19GG), helps the circulating phenomenon (indicated by the long arrow A2 in Figure 19GG) to enter the impeller inlet 522 smoothly. In other words, the curved channel 650 formed by the corresponding curved surfaces 615 and 527 of the housing 610 and the impeller 500 directs the circulating phenomenon into the impeller inlet 522.

[0219] 5.4.1.1.1.5 Stator 4180 and 4190 Similar to the impellers 4150 and 4160, the blower 4142 may include multiple stators corresponding to each impeller. Figures 9A–9F and 10A–10E show the features of an exemplary first stator 4180 corresponding to the first impeller 4150. These features form the first pressure stage 4136. The first stator 4180 may include multiple first stator blades 4187 and 4188. These multiple first stator blades 4187 and 4188 radially direct the airflow from the first impeller 4150 toward the first stator opening 4186, reducing the velocity of the airflow from the first impeller 4150 and increasing the pressure of the airflow from the first impeller 4150.

[0220] The first stator blades 4187 and 4188 can be distinguished as a long first stator blade 4187 and a short first stator blade 4188. As shown in Figures 9D, 10C, and 10E, the long first stator blade 4187 extends further radially inward than the short first stator blade 4188. The long first stator blade 4187 and the short first stator blade 4188 are also shown to be alternately arranged around the first stator 4180 in the circumferential direction. The long first stator blade 4187 and the short first stator blade 4188 may each include a curved section 4181. The curved section 4181 may be curved or curved to receive airflow backward relative to the rotational direction 4139 of the corresponding first impeller 4150. Alternatively, the curved section 4181 may be curved or forward relative to the rotational direction 4139 of the corresponding first impeller 4150. The curved sections 4181 of each long first stator blade 4187 and each short first stator blade 4188 may be the same shape, or the curved sections 4181 may be different in shape so that curved sections 4181 of different shapes are alternately arranged around the first stator 4180 in the outer circumference. Each long first stator blade 4187 and each short first stator blade 4188 may include a straight section 4185 extending radially inward from the curved section 4181. As shown in Figures 9D, 10C, and 10E, the straight sections 4185 of each long first stator blade 4187 may extend further radially inward than the straight sections 4185 of each short first stator blade 4188. The radially inward end of the long first stator blade 4187 may be approximately 1.8 mm from the axis of rotation of the shaft 4146. The radially inward end of the short first stator blade 4188 may be approximately 4.5 mm from the axis of rotation of the shaft 4146. The radius of the first stator blades 4187 and 4188 (i.e., the radius at the outermost point of the curved section) may be 9.5 mm. The first stator 4180 may also include a shaft opening 4189. Through the shaft opening 4189, the shaft 4146 reaches the first impeller 4150.

[0221] Each first stator 4180 may also include a first stator opening 4186 positioned downstream of the first stator blades 4187 and 4188 to direct airflow toward the second impeller 4160. The first stator opening 4186 may also be at least partially defined by a first stator undershroud 4182B. By 82B, the gas flow is directed radially through the first stator blades 4187 and then through the first stator opening 4186, thereby preventing the gas flow from the first impeller 4150 from traveling axially perpendicular to the second impeller 4160. Each first stator 4180 may also include a first stator top shroud 4182A. The first stator top shroud 4182A directs the airflow from the first impeller 4150 axially to the first stator opening 4186 by preventing the gas flow from flowing axially under the first impeller shroud 4152 and back. The corresponding first impeller 4150 may be positioned adjacent to the first stator top shroud 4182A.

[0222] Each first stator 4180 may also include a first stator housing 4184 that at least partially defines the flow path 4138. Each second impeller 4160 and each second stator 4190 may be at least partially housed within the corresponding first stator housing 4184 such that the airflow moving along the flow path 4138 passes through the second impeller 4160 and through the second stator 4190 to also pass through the first stator housing 4184. In other words, the second pressure stage 4137 may be located within the first stator housing 4184. Thus, each first stator housing 4184 may at least partially define the corresponding blower outlet 4141.

[0223] Furthermore, each first stator housing 4184 may include a mounting structure 4183 for connecting the blower 4142 to the RPT system. In the example described, each mounting structure 4183 takes the form of a pair of mounting rails 4184 extending around the outer circumference of each first stator housing. As described above, the lower housing portion 4133 may take the form of a clamshell and encloses the blower 4142 so that mounting rails 4183 facilitate mounting to the plenum chamber 3200, as shown in Figure 6B.

[0224] As described above, each second pressure stage 4137 may be housed in a corresponding first stator housing 4184, and each such second pressure stage 4137 may include a second impeller 4160 (described above) and a second stator 4190. The second stator 4190 may include a top ring 4192, a base ring 4194, and a plurality of second stator blades 4191 between the top ring 4192 and the base ring 4194. The second stator blades 4191 can direct the airflow from the second impeller 4160 radially and axially toward the blower outlet 4141, reduce the velocity of the airflow from the second impeller 4160, and increase the pressure of the airflow from the second impeller 4160. As shown in Figures 11A and 11B, each second stator blade may have a constant depth D in the radial direction, and its width W may increase in the peripheral direction from the top ring 4192 to the base ring 4194.

[0225] The top ring 4192 may also include a top ring recess 4195, and the base ring 4194 includes a base ring recess 4196. The top ring recess 4195 and the base ring recess 4196 allow flexible printed circuit board components (PCBAs) to pass through their interiors to provide power and control signals to the motor 4145. As shown in Figures 6B, 7E, and 10A, the motor 4145 is also at least partially housed within the second stator 4190. Thus, the motor 4145 can partially define the internal boundary of the flow path 4138.

[0226] The second stator 4190 may also at least partially define the blower outlet 4141. In FIGS. 11A to 11C, it can be seen that the corresponding second stator blade 4191 is joined to the base ring 4194 by the second stator outlet rib 4193. Thus, after the gas flow passes through the second stator blade 4191, the air flow exits the blower 4142 and enters the plenum chamber 3200 between the second stator outlet ribs 4193 through the blower outlet 4141. As can be seen from FIG. 6B, for example, the blower outlet 4141 may be axially disposed in the vicinity of the center of the blower 4142.

[0227] 5.4.1.1.1.6 End cap 4144 At each shaft end of the blower 4142, the end cap 4144 may also be provided to enclose the first pressure stage 4136 (including at least a portion of the first impeller 4150 and the first stator 4180). The end cap 4144 may at least partially define the blower inlet 4143 for each shaft end of the blower 4142. In other words, the airflow for the first pressure stage 4136 may be drawn in through the blower inlet 4143 defined by the end cap 4144. Each end cap 4144 may be constructed to reduce noise and / or vibration. Each end cap 4144 may be formed from a rigid material and a low-rigidity elastic deformation material that provides structural integrity, overmolded into a rigid material to reduce noise and / or vibration. Other housing structures of the blower 4142 (e.g., the first stator housing 4184) are also the outermost parts of the blower 4142 and may be formed from similar structures for noise and vibration reduction. The end cap 4144 may be formed integrally with the housing structure of the blower 4142 (e.g., the first stator housing 4184) in one piece from the same material, or together with the housing structure of the plenum chamber 3200 (e.g., the lower housing section 4133). Alternatively, the end cap 4144 may be mounted on the lower housing section 4133 in isolation from the blower 4142. Membranes or other flexible structures may be provided between the end cap 4144 and other blower components to reduce noise and vibration.

[0228] Alternatively, in addition to the passive noise reduction measures described above, an active noise cancellation function can be provided at either the blower 4142 or the plenum chamber 3200 (for example, by employing a microphone in the RPT device).

[0229] 5.4.1.1.1.7 Single-stage pressure generator Figure 14 shows another example of a blower 4142 according to the present technology, including a single compression stage on each side of a motor 4145. The motor 4145 may have a single shaft 4146 protruding from each end to drive a corresponding impeller 4160. Each impeller 4160 may be associated with a stator 4190 on each side of the motor 4145. The blower 4142 may also have a housing 4148 on each side, together with a blower inlet 4143 and a mounting structure 4183, for securing the blower 4142 to the plenum chamber 3200. Each housing 4148 may enclose a corresponding impeller 4160 and a corresponding stator 4190. The impeller 4160 and stator 4190 in this example may include any of the features described in the above example. While it may be necessary to operate the motor 4145 in this example at a higher speed to generate the same flow rate and pressure as the two-stage example described above, this single-stage modification can offer a lighter and more compact design that is less intrusive and lighter for the patient.

[0230] 5.4.1.2 Converters (multiple) The converter may be located inside the RPT device or outside the RPT device. The external converter may be located on an air circuit, for example, or form part of an air circuit (e.g., a patient interface). The external converter may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves the data RPT device).

[0231] In one embodiment of this technology, one or more transducers 4270 (e.g., one or more of those listed above) may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 transmit signals indicating the characteristics of the airflow (e.g., the point in the pneumatic path). It can be constructed and arranged to generate flow rate, pressure, or temperature in the field.

[0232] 5.4.1.2.1 Flow Sensor The flow sensor 4274 according to this technology can be obtained based on a differential pressure transducer (for example, an SDP600 series differential pressure transducer from SENSIRION).

[0233] 5.4.1.2.2 Pressure Sensor The pressure sensor 4272 according to this technology can be arranged in communication with both a pneumatic path and a fluid 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 GENERAL ELECTRIC NPA series.

[0234] 5.4.1.2.3 Motor Speed ​​Converter In one embodiment of this technology, a motor speed converter 4276 may be used to determine the rotational speed of the motor 4145 and / or the blower 4142.

[0235] 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.

[0236] In the exemplary RPT system shown in Figures 6A-6C, the power supply 4210 may take the form of a battery having at least one electrochemical cell. The power supply 4210 in battery form may be supported by a positioning and stabilization structure 3300 on the region of the patient's head adjacent to the parietal bone. The power supply 4210 in battery form may also be housed within the positioning and stabilization structure 3300. In other words, the power supply 4210 in battery form may be at least partially enclosed by the material of the positioning and stabilization structure 3300. When the power supply 4210 in battery form is fully enclosed by the positioning and stabilization structure 3300, the positioning and stabilization structure 3300 may include an opening that provides access to the power supply 4210, and the opening may be closed by hook-and-loop fasteners, buttons, snaps, etc.

[0237] In the example of a battery-type power supply 4210, the battery may be shaped to generally conform to the shape of the corresponding part of the patient's head. By shaping the battery in this way, the power supply 4210 can be kept relatively inconspicuous, minimizing any disturbance to the patient. The positioning and stabilization structure 3300 may also include one or more mounting points for add-on functions for the power supply 4210 (e.g., a replacement battery).

[0238] 5.4.2.2 Input Devices In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials for human interaction with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. In one embodiment, the buttons, switches, or dials may be physically connected to an external housing 4010, or in another embodiment, they may be wirelessly connected to a receiver electrically connected to a central control unit 4230.

[0239] In the example of this technology shown in Figures 6A to 6C, for example, one or more input devices 4220 as described above are located in the upper housing portion 4132 or the lower housing portion 41 of the plenum chamber. It may be provided on 33, or on the positioning and stabilization structure 3300.

[0240] 5.4.2.3 Central Control System In one embodiment of this technology, the central control unit 4230 is one or more processors suitable for controlling the RPT device 4000.

[0241] In some embodiments of this technology, the central control unit 4230 is configured to embody one or more methods described herein (e.g., one or more algorithms expressed as computer programs recorded in a non-temporary computer-readable recording medium (e.g., memory 4260)). In some embodiments of this technology, the central control unit 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methods may be performed by remotely located devices. For example, a remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein).

[0242] In the examples shown in Figures 6A to 6C, the RPT system may include a control system for controlling the blower 4142, and the control system may include one or more of the features described in the paragraph above in this chapter. The control system may include, for example, a flexible printed circuit board component (PCBA) including a microprocessor as described above. The microprocessor may be programmed to perform at least one of the following: closed-loop pressure control based on sensed pressure data, flow rate estimation, and automatic adjustment of expiratory pressure release. The control system may also be a drive circuit that controls the power supply 4210 separately from the blower 4142.

[0243] 5.4.2.4 Memory In one embodiment of this technology, the RPT device 4000 includes a memory 4260 (e.g., non-volatile memory). In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0244] Memory 4260 may be located on PCBA4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0245] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (for example, a memory card manufactured in accordance with the Secure Digital (SD) standard).

[0246] In one embodiment of this technology, the memory 4260 functions as a non-temporary computer-readable recording medium. Computer program instructions (e.g., one or more algorithms) representing one or more methods described herein are recorded on this recording medium.

[0247] 5.4.2.5 Data Communication System In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central control unit 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0248] In one embodiment, the data communication interface 4280 is part of the central control unit 4230. In another embodiment, the data communication interface 4280 is part of the central control unit 4 230 is separate from the above and may include an integrated circuit or processor.

[0249] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet® or optical fiber) or wireless protocols (e.g., CDMA, GSM®, LTE) to connect to the Internet.

[0250] In one embodiment, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth® or Consumer Infrared Protocol).

[0251] In one embodiment, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by a properly authorized person (e.g., a clinician).

[0252] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control.

[0253] 5.4.3 RPT Device Algorithm As described above, in some forms of this technology, the central control unit 4230 may be configured to embody one or more algorithms represented as computer programs recorded in a non-temporary computer-readable recording medium (e.g., memory 4260). These algorithms are typically grouped into groups called modules.

[0254] 5.4.4 Oxygen Delivery In one embodiment of this technology, supplemental oxygen 4001 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0255] 5.5 Glossary For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Other definitions may also apply in other forms of this technology.

[0256] 5.5.1 General Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen-rich atmosphere).

[0257] Atmosphere: In certain forms of this technology, the term “atmosphere” should be understood to mean (i) the area outside the treatment system or patient, and (ii) the area directly surrounding the treatment system or patient.

[0258] For example, the atmosphere surrounding humidifiers humidity This could be the humidity of the air directly surrounding the humidifier (for example, the humidity inside the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0259] In another embodiment, the ambient pressure may be the pressure directly surrounding or outside the body.

[0260] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, RPT devices or masks or patient interfaces. Ambient noise may originate from sources outside the room.

[0261] Automatic positive airway pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0262] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increased in response to the detection of signs of partial upper airway obstruction and decreased in the absence of such indications).

[0263] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be denoted by the sign Q. Flow rate is sometimes simply called "flow" or "airflow."

[0264] Humidifier: The term "humidifier" is interpreted as a humidifying device that is constructed, positioned, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor into the airflow to improve a patient's medical respiratory condition.

[0265] Leakage: The term "leakage" is taken to mean an unintended flow of air. In one embodiment, leakage may occur due to an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur at the circumferential elbow to the surroundings.

[0266] Patient: A person who has or does not have a respiratory illness.

[0267] Pressure: Force per unit area. Pressure can be expressed and measured in various units (e.g., cmH2O, gf / cm²). 2 , and hectopascals). 1 cmH2O is 1 g-f / cm³ 2 This is equal to approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0268] Respiratory pressure therapy (RPT): Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive pressure relative to the atmosphere.

[0269] 5.5.1.1 Materials Silicone or silicone elastomer: synthetic rubber. In this specification, when silicone is referred to, it refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the product line sold under this registered trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of exemplary forms of LSR, as measured by ASTM D2240, is approximately 35 to approximately 45.

[0270] Polycarbonate is a thermoplastic polymer of bisphenol A carbonate.

[0271] 5.5.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0272] Elastic: Releases virtually all energy upon unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0273] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size). "Flexible" materials may include silicone or thermoplastic elastomers (TPEs) that are easily deformable, for example, under finger pressure. "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0274] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may provide different resistance in different directions.

[0275] Floppy structure or component: A structure or component that changes shape (e.g., bends) within a relatively short period of time (e.g., 1 second) when subjected to its own weight.

[0276] Rigid structure or component: A structure or component that remains substantially unchanged in shape when subjected to loads typically encountered during use. An example of such an application might be setting up and maintaining a patient interface in a sealed state against the patient's airway inlet under a pressure load of, for example, approximately 20-30 cmH2O.

[0277] In one embodiment, an I-beam may have different bending stiffnesses (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another embodiment, a structure or component may be floppy in the first direction and rigid in the second direction.

[0278] 5.5.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway is open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0279] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0280] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0281] 5.5.3 Anatomy 5.5.3.1 Anatomical structure of the face Nostrils: Generally, ellipsoidal pterygoides form the entrance to the nasal cavity. The singular form of nostril (nares) is nostril (naris). These nostrils are separated by the nasal septum.

[0282] Subbase of the ear: The lowest point where the auricle attaches to the skin of the face.

[0283] Ear base point: The highest point where the auricle attaches to the skin of the face.

[0284] Sagittal plane: A vertical plane that extends from the front (front) to the back (back), dividing the main body into a right half and a left half.

[0285] 5.5.3.2 Anatomical structure of the skull Occipital bone: The occipital bone is located in the posterior and inferior part of the skull. The occipital bone contains the foramen magnum, an oval opening through which the intracranial cavity is connected to the vertebral canals. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0286] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0287] 5.5.3.3 Anatomical structure of the respiratory system Nasal cavity: The nasal cavity (or nasal fossa) is a large, air-filled space located in the center of the face, above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called the nasal conchae or nasal bones. The nose is located anterior to the nasal cavity, and posteriorly it connects to the nasopharynx via the posterior nostrils.

[0288] 5.5.4 Patient Interface Anti-choking valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0289] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed for use on the head. For example, headgear may include a collection of one or more struts, ties, and stiffeners configured to position and hold a patient interface in place on the patient's face for the delivery of respiratory therapy. Some ties may be formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0290] Membrane: The term "membrane" is typically used to mean a thin-walled element, preferably one that offers little resistance to bending and little resistance to stretching.

[0291] Plenum Chamber: The term "mask plenum chamber" is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, where the air in the volume is pressurized to exceed atmospheric pressure when in use. A shell may form part of the wall of the mask plenum chamber.

[0292] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to the effect of sealing. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without requiring a separate "seal" element itself.

[0293] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the rigidity of another component in at least one direction.

[0294] Support: A support increases the compressive resistance of another component in at least one direction. It is understood to mean a structural component designed in a certain way.

[0295] Thai (noun): A structure designed to resist tension.

[0296] Ventilation (noun): A structure that allows air to flow into the surrounding air inside a mask or conduit, enabling clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve flow rates of approximately 10 liters / minute to 100 liters / minute, depending on the mask design and treatment pressure.

[0297] 5.6 Other Notes Some of the disclosures in this patent document include content that is protected by copyright. The copyright holder retains all copyrights to any other purpose, except that any reproduction of this patent document or this patent disclosure by fax by any person is permitted if it is included in the patent files or records of the Japan Patent Office.

[0298] Unless otherwise clearly indicated by the context or provided for a range of values, it is understood that 1 / 10 of the lower limit, the interval between the upper and lower limits of the range, and each intervention value for any other stated values ​​or intervention values ​​within the stated range are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits within the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding either or both of these stated limits is also included in this technique.

[0299] Furthermore, where values ​​(one or more) are embodied in this specification as part of the Art, unless otherwise specified, it is understood that such values ​​may be approximated and used to any appropriate number of significant figures as permitted or required by the practical technical implementation.

[0300] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as those commonly understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0301] While certain materials are described as suitably used in constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are understood to be manufacturable and therefore can be manufactured collectively or individually.

[0302] 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 indicates otherwise.

[0303] All published documents cited herein are used for disclosure and description of methods and / or materials that are the subject of those documents, and are incorporated for reference only. The published documents cited herein are provided solely for the purposes of their disclosure prior to the filing date of this application. Nothing in this specification should be construed as acknowledging or acknowledging that the present technology is not prior to such published documents for the purpose of prior patents. Furthermore, the dates of the published documents cited herein may differ from the actual dates of the published documents and may require individual verification.

[0304] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, and the description Indicates that an element, component, or step may exist, be used, or be combined with other elements, components, or steps that are not explicitly stated.

[0305] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0306] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish separate elements. Furthermore, while the descriptions or examples of process steps in the methods may be given in order, such order is not required. Those skilled in the art will recognize that such order is changeable and / or that such actions can be performed simultaneously or even synchronously.

[0307] Therefore, it should be understood that numerous modifications are possible in the exemplary embodiments, and other configurations may be devised, without deviating from the intent and scope of this technology. [Explanation of Symbols]

[0308] 5.7 List of reference codes Planar curve 301D Surface 302D Impeller 500 First impeller section 500-1 Second impeller section 500-2 Impeller blade 510 Impeller blade leading edge 511 Impeller blade trailing edge 512 Inner blade section 513 Opening 514 First end 515 Second end 517 curved surface 519 Upper Shroud 520 Upper Shroud, Part 1, 520-1 Upper Shroud, Part 2, 520-2 Entrance wall 521 Impeller entrance 522 Leading edge 523 Impeller outlet 524 Lower shroud 525 Lower shroud, part 1, 525-1 Lower shroud, second section 525-2 curved surface 527 Hub 530 Flow path 540 First fastening section 550 Hub section 550-1 Protrusion 550-2 Second fastening section 555 Ring slot 555-1 Slot 555-2 Blower 600 Housing 610 Blower inlet 612 Blower outlet 614 curved surface 615 Motor 620 Rotor 625 Channel 650 patient 1000 1000 patients in sleep Bedmate: 1100 Headbox 2000 Ground electrode ISOG 2010 Respiratory inductance plethysmogram 2040 Respiratory inductance plethysmogram 2045 Oral and nasal cannula 2050 Body position sensor 2060 Patient Interface 3000 Seal-forming structure 3100 Plenum Chamber 3200 Edge 3210 Peripheral edge 3220 Positioning and stabilization structure 3300 Wire 3301 tube 3302 Thai side 3303 Upper Thailand 3304 Thai rear 3305 Tab 3306 Wire retainer 3307 Adjustment mechanism 3308 Ventilation assembly 3400 External ventilation hole surface 3401 Ventilation hole 3402 Ventilation hole extension section 3403 Base 3404 flexible membrane 3405 Divider 3406 Internal ventilation hole surface 3407 Interior 3408 Ventilation flow 3409 Pressurized flow 3410 Connection port 3600 Forehead support part 3700 RPT device 4000 Supplemental oxygen 4001 External housing 4010 Top 4012 Lower part 4014 Panel 4015 Chassis 4016 Handle 4018 Pneumatic block 4020 Pneumatic component 4100 Air filter 4110 Inlet air filter 4112 Outlet air filter 4114 Muffler 4120 Entrance muffler 4122 Exhaust muffler 4124 Mounting structure 4130 Plenum Chamber Exit 4131 Upper housing section 4132 Lower housing section 4133 Pressure port 4134 Heat and humidity exchanger (HME) holding structure 4135 First pressure stage 4136 Second pressure stage 4137 Channel 4138 Direction of rotation 4139 Pressure generator 4140 Blower outlet 4141 Blower 4142 Blower inlet 4143 End cap 4144 Motor 4145 Shaft 4146 Housing 4148 First impeller 4150 First impeller blade 4151 First impeller shroud 4152 First impeller hub 4153 First impeller blade section 4154 Second impeller blade section 4155 First impeller shroud section 4156 Second impeller shroud section 4157 Second impeller 4160 Air circuit 4170 Heated air circuit 4171 First stat 4180 Curved section 4181 First stator upper shroud 4182A First stator under shroud 4182B Mounting rail 4183 First stator housing 4184 Straight section 4185 First stator opening 4186 Long first stator blade 4187 Short first stator blade 4188 Shaft opening 4189 Second status 4190 Second stator vane 4191 Top Ring 4192 Second stator outlet rib 4193 Base ring 4194 Top ring recess 4195 Base ring recess 4196 Electrical components 4200 Printed circuit board assembly 4202 power supply 4210 Input device 4220 Central control unit 4230 Retainer 4231 Clock 4232 Treatment device controller 4240 Protection circuit 4250 Memory 4260 Converter 4270 Pressure sensor 4272 Flow sensor 4274 Motor speed converter 4276 Data communication interface 4280 Remote external communication network 4282 Local external communication network 4284 Remote external device 4286 Local external device 4288 Output device 4290 Display driver 4292 Display 4294 method 4500 Step 4520 Step 4530 Step 4540 Step 4550 Step 4560 Humidifier 5000 Humidifier inlet 5002 Humidifier outlet 5004 Humidifier base 5006 Water Reservoir 5110 Humidifier reservoir 5110 Conductive portion 5120 Humidifier reservoir dock 5130 Lock lever 5135 Water level indicator 5150 Humidifier converter 5210 Pressure transducer 5212 Flow converter 5214 Temperature converter 5216 Humidity sensor 5218 heating element 5240 Humidifier controller 5250 Central humidifier controller 5251 Heating element controller 5252 Air circuit controller 5254 Monitoring device 7100

Claims

1. A fan for a respiratory pressure therapy (RPT) system, The blower is configured to generate airflow at a therapeutic pressure at least 6 cmH₂O above the ambient air pressure: A motor having a first end and a second end, A shaft having a first shaft end extending from the first end of the motor and a second shaft end extending from the second end of the motor, A pair of impellers, each having an impeller positioned at a corresponding end of the first shaft and the second shaft, such that both impellers are driven simultaneously by the motor, A pair of stators, each corresponding to one of the first and second ends of the motor, wherein the pair of stators is positioned downstream of the corresponding impeller in line with the airflow in the treatment pressure generated by the blower during use. A blower outlet located downstream of each of the stators, A pair of housings, each corresponding to one of the first and second ends of the motor, each housing being shaped and sized to at least partially enclose one of the corresponding impeller and stator and to at least partially define a blower inlet, and each housing being shaped and sized to at least partially define a corresponding blower outlet such that the blower outlets are adjacent to each other and extend annularly around at least a portion of the blower, A flow path for moving the aforementioned airflow from each of the blower inlets, passing it through one of the corresponding impellers, and exiting through one of the corresponding stators to one of the blower outlets, A blower comprising the components mentioned above.

2. The blower according to claim 1, wherein each of the impellers and each of the stators are at least partially housed within the corresponding housing such that the airflow moves along the flow path and passes through the impeller, through the stator, and also through the housing.

3. The blower according to claim 1 or claim 2, wherein each of the housings includes a mounting structure for connecting the blower to a respiratory pressure therapy (RPT) system.

4. The blower according to claim 3, wherein each of the mounting structures further includes a pair of mounting rails extending around the outer circumference of each of the housings.

5. The blower according to any one of claims 1 to 4, wherein each of the housings is constructed to reduce sound and vibration.

6. The blower according to any one of claims 1 to 5, wherein each of the housings comprises a rigid material that provides structural integrity and a low-rigidity elastic deformation material overmolded onto the rigid material to reduce sound and vibration.

7. The blower according to any one of claims 1 to 6, wherein each of the impellers includes an impeller hub, impeller blades extending radially from the impeller hub, and an impeller shroud.

8. The blower according to claim 7, wherein each of the impeller blades includes a first impeller blade portion extending only in the radial direction and a second impeller blade portion extending in the radial and axial directions.

9. The first impeller blade portion of each of the impeller blades of the first and second impellers has a certain cross-section and is radially inward relative to the second impeller blade portion. The second impeller blade portion has a variable cross-section and is radially outward relative to the first impeller blade portion. The blower according to claim 8, wherein the constant cross-section of the first impeller blade is thinner than the variable cross-section of the second impeller blade.

10. The blower according to any one of claims 7 to 9, wherein each of the impeller shrouds includes a first impeller shroud portion extending only in the radial direction and a second impeller shroud portion extending in the radial and axial directions.

11. The blower according to any one of claims 7 to 10, wherein each of the impeller blades of the impeller moves forward relative to the direction of rotation during operation.

12. Each of the stators further includes a top ring, a base ring, and a plurality of stator blades that join the top ring and the base ring, The blower according to any one of claims 1 to 11, wherein the plurality of stator blades radially and axially direct the airflow from one corresponding impeller to one corresponding blower outlet, reduce the velocity of the airflow from one corresponding impeller, and increase the pressure of the airflow from one corresponding impeller.

13. The blower according to claim 12, wherein each of the plurality of stator blades has a constant depth in the radial direction and its width increases in the peripheral direction from the top ring to the base ring.

14. The blower according to claim 12 or 13, wherein each of the top rings includes a top ring recess, and each of the base rings includes a base ring recess, and flexible printed circuit board components (PCBAs) can pass through the interiors of the top ring recess and the base ring recess.

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