Bearing sleeve for a blower

Abstract

The blower comprises a rotor, a motor configured to drive the rotor, at least one bearing for rotatably supporting the rotor, a stationary component, and a bearing sleeve provided on the stationary component. The bearing sleeve is configured and arranged to support and hold the bearing on the stationary component. The bearing sleeve comprises an elastomer material and the bearing sleeve comprises one or more bumps or ribs configured to engage along the outer ring of the bearing.

Description

Technology Field

[0001] The disclosures of this patent document contain copyrighted material. The copyright owner retains all copyright rights, as indicated in the patent files or records of the Patent Office, and does not object to any faxed reproduction of the patent document or patent disclosures.

[0002] 1. Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 984,515 filed on March 3, 2020, the entirety of which is incorporated herein by reference. Background Technology

[0004] 2 Background Technology

[0005] 2.1 Technology Fields

[0006] The present invention relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory disorders. The present invention also relates to medical devices or apparatuses and their uses. The present invention also relates to a blower for generating differential pressure, and / or a pressure generating device or respiratory pressure therapy (RPT) device used, for example, to deliver respiratory therapy to a patient.

[0007] 2.2 Description of Related Technologies

[0008] 2.2.1 The human respiratory system and its disorders

[0009] The body's respiratory system enables gas exchange. The nose and mouth form the entrances to the patient's airway.

[0010] The airway contains a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into venous blood and carbon dioxide to exit in the opposite direction. The trachea divides into the right and left main bronchi, which also eventually divide into terminal bronchioles. The bronchi constitute the conducting airway and do not perform any part of gas exchange. Furthermore, the division of the airway leads to the respiratory bronchioles, which eventually reach the alveoli. The honeycomb zones of the lungs are where gas exchange takes place and are referred to as respiratory zones. Respiratory Physiology "(John B. West, Lippincott Williams & Wilkins, 9th edition published 2012).

[0011] Various respiratory disorders exist. Specific disorders may be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

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

[0013] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by events involving the obstruction or blockage of the upper airway during sleep. This results from a combination of the normally small upper airway and the usual loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected patients to stop breathing for periods typically lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. Although affected individuals may not be aware of these issues, this syndrome is a common disorder, particularly among middle-aged overweight men. See U.S. Patent No. 4,944,310 (Sullivan).

[0014] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered respiration. CSR is a respiratory regulatory disorder characterized by a rhythmic alternating cycle of waxing and waning ventilation known as the CSR cycle. CSR is characterized by the repetitive deoxygenation and reoxygenation of arterial blood. Due to repetitive hypoxia, CSR is potentially harmful. In some patients, CSR is associated with repetitive sleep awakenings, which lead to severe sleep disturbance, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0015] Respiratory failure is a comprehensive term for respiratory impairment in which the lungs are unable to inhale sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory failure may include some or all of the following disorders.

[0016] Patients with respiratory failure (a form of respiratory failure) may experience abnormal difficulty breathing during exercise.

[0017] Obese hyperventilation syndrome (OHS) is defined as severe obesity and chronic hypercapnia in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0018] Chronic Obstructive Pulmonary Disease (COPD) encompasses a group of any lower respiratory tract diseases that share specific common characteristics. These include increased resistance to air movement, a prolonged expiratory phase of breathing, and a loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath during exercise, chronic coughing, and sputum production.

[0019] Neuromuscular disease (NMD) is a broad term encompassing many conditions and diseases that impair muscle function, either directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle disorders that lead to loss of gait resulting in wheelchair dependence, difficulty swallowing, weakness of respiratory muscles, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slow-progressive types: (i) rapidly progressive disorders: characterized by muscle disorders that worsen on a monthly basis and lead to death within a few years (e.g., Amyotrophic Lateral Sclerosis (ALS) in teenagers and Duchenne muscular dystrophy (DMD)); (ii) variable or slow-progressive disorders: characterized by muscle disorders that worsen over several years and reduce life expectancy only slightly (e.g., Limb girdle, scapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include increased general weakness, dysphagia, difficulty breathing during exercise and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0020] Chest wall disorders are a group of chest deformities that result in an ineffective coupling between the respiratory muscles and the thorax. These disorders are typically characterized by restrictive defects and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include difficulty breathing during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0021] Various therapies have been used to treat or improve such diseases. Additionally, otherwise healthy individuals can use these therapies to prevent respiratory disorders from occurring. However, they have numerous disadvantages.

[0022] 2.2.2 therapy

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

[0024] 2.2.2.1 Breathing pressure therapy

[0025] Breathing pressure therapy is an application that supplies air to the entrance of the airway at a controlled target pressure, which is nominally positive pressure relative to the atmosphere, throughout the patient's breathing cycle (in contrast to negative pressure therapies such as tank ventilators or chest armored ventilators).

[0026] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint, which can prevent upper airway obstruction by, for example, pushing the soft palate and tongue toward and away from the posterior oropharyngeal wall. Treatment of OSA with CPAP therapy can be voluntary, and therefore, patients may choose not to adhere to the therapy if they find one or more of the following regarding the device used to provide such therapy: discomfort, difficulty of use, high cost, and lack of aesthetic appeal.

[0027] Non-invasive ventilation (NIV) maintains adequate oxygen levels in the body by providing ventilatory support to a patient through the upper airway to assist breathing and / or perform part or all of the respiratory action. Ventilatory support is provided through a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and efficacy of these therapies may be enhanced.

[0028] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and efficacy of these therapies may be enhanced.

[0029] 2.2.2.2 fluid therapy

[0030] Not all breathing therapies aim to deliver prescribed therapeutic pressure. Some breathing therapies aim to deliver prescribed diastolic volume by delivering an inspiratory flow profile over a target duration that may overlap with baseline positive pressure. In other cases, the interface to the patient's airway is 'open' (not sealed), and the breathing therapy may supplement only the patient's own spontaneous breathing with a flow of controlled or concentrated gas. In one example, High Flow Therapy (HFT) provides a continuous flow of heated and humidified air into the airway entrance through an unsealed or open patient interface at a "therapeutic flow" that is maintained approximately constant throughout the entire breathing cycle. The therapeutic flow is set to exceed the patient's nominal peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high air flow at the airway entrance improves ventilation efficiency by flushing or flushing out expired CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as Dead Space Therapy (DST). Other benefits may include elevated warmth and humidification (possibly beneficial for secretion management) and the potential for a moderate increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that varies over the breathing cycle.

[0031] Other forms of fluid therapy are long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air at a specified oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air) at a specified flow rate (e.g., 1 liter / min (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient's airway.

[0032] 2.2.2.3 supplemental oxygen

[0033] For certain patients, oxygen therapy may be combined with pulmonary pressure therapy or HFT by adding supplemental oxygen to a pressurized air flow. When oxygen is added to pulmonary pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplemental oxygen.

[0034] 2.2.3 Breathing therapy system

[0035] These breathing therapies may be provided by breathing therapy systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor diseases without treating them.

[0036] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0037] Another type of therapeutic system is a mandibular repositioning device.

[0038] 2.2.3.1 Patient Interface

[0039] A patient interface can be used to interface respiratory equipment with the wearer, for example, by providing airflow to the entrance of the airway. Airflow may be delivered to the nose and / or mouth through a mask, to the mouth through a tube, or to the patient's trachea through a tracheostomy tube. Depending on the therapy to be applied, the patient interface may form a seal, for example, with the patient's facial area, to facilitate the delivery of gas at a pressure that is a sufficient deviation from ambient pressure to execute the treatment—for example, at a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as oxygen delivery, the patient interface may not contain a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapies, such as nasal HFT, the patient interface is configured to blow into the nostrils but specifically to avoid a complete seal. An example of such a patient interface is a nasal cannula.

[0040] Certain other mask systems may not be functionally suitable for this application. For example, masks that are purely decorative may not be able to maintain appropriate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water penetration from higher external pressures but not to retain air inside at a pressure higher than the surroundings.

[0041] A specific mask, for example, that blocks airflow through the nose and allows only airflow through the mouth, may not be clinically desirable in this technology.

[0042] Certain masks may be uncomfortable or impractical in this technology if the patient needs to insert part of the mask structure into the mouth to create and maintain a seal through the lips.

[0043] Certain masks may be impractical to use while sleeping, for example, when sleeping on one's side in bed with the head resting on a pillow.

[0044] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly between individuals. Because the head contains bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw and mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy.

[0045] As a result of these issues, some masks, particularly when worn for extended periods or when the patient is unfamiliar with the system, suffer from one or more of the following: interference, aesthetic displeasure, high cost, poor fit, difficulty of use, and discomfort. Masks of the wrong size can lead to reduced compliance, decreased comfort, and worse patient outcomes. Masks designed solely for flight use, masks designed as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for the administration of anesthetics may be tolerable for their intended applications, but nevertheless, such masks can be undesirably uncomfortable when worn for extended periods, such as for several hours. This discomfort can lead to reduced patient compliance with the therapy. This is especially true when the mask is worn during sleep.

[0046] CPAP therapy is highly effective in treating specific breathing disorders if the patient adheres to the regimen. If the mask is uncomfortable or difficult to use, the patient may not adhere to the regimen. Since patients are often advised to wash the mask regularly, if cleaning is difficult (e.g., if it is difficult to assemble or disassemble), the patient may not wash the mask, which can affect patient compliance.

[0047] Masks for other applications (e.g., aviators) may not be suitable for use in the treatment of sleep-disordered breathing, but masks designed for use in the treatment of sleep-disordered breathing may be suitable for other applications.

[0048] For this reason, patient interfaces for CPAP delivery during sleep form a distinct field.

[0049] 2.2.3.2 Respiratory Pressure Therapy (RPT) device

[0050] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to perform one or more of the aforementioned therapies by operating the device to generate an airflow to be delivered, for example, to an interface to the airway. The airflow may be pressure-controlled (in the case of respiratory pressure therapy) or flow-controlled (in the case of flow therapies such as HFT). Thus, an RPT device may also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0051] Pneumatic generators are known for various applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that are not met by more generalized pneumatic generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may suffer from one or more drawbacks related to comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0052] An example of a special requirement for a specific RPT device is acoustic noise.

[0053] Table of noise output levels of conventional RPT devices (a single sample measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0054]

[0055] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the adult and pediatric ventilators of the ResMed Stellar™ series, can provide support for invasive and non-invasive, non-dependent ventilation to a wide range of patients to treat numerous diseases, including, but not limited to, NMD, OHS, and COPD.

[0056] The ResMed Elisee™ 150 ventilator and ResMed VS III™ ventilator can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a number of diseases. These ventilators provide volumetric and pneumatic ventilation modes with single or double limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow may be supplied to the patient's airway at positive pressure. The outlet of the RPT device is connected to a patient interface, such as that described above, via an air circuit.

[0057] Device designers may be presented with an infinite number of choices. Design criteria often conflict, meaning that certain design choices are either non-routine or inevitable. Furthermore, the comfort and efficacy of a particular modality can be highly sensitive to small, subtle changes in one or more parameters.

[0058] 2.2.3.3 air circuit

[0059] An air circuit is a conduit or tube configured and arranged to allow airflow to move between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate rims of the air circuit for inspiration and expiration. In other cases, a single-rim air circuit is used for both inspiration and expiration.

[0060] 2.2.3.4 humidifier

[0061] The delivery of airflow without humidification can dry out the airways. The use of a humidifier equipped with an RPT device and a patient interface generates humidifying gas that minimizes dryness of the nasal mucosa and increases patient airway comfort. Additionally, in cool climates, warm air, typically applied to the facial area inside and around the patient interface, is more comfortable than cold air.

[0062] Although various artificial humidification devices and systems are known, they may not meet the specific requirements of medical humidifiers.

[0063] Medical humidifiers are used to increase the humidity and / or temperature of the airflow relative to the surrounding air when necessary, typically when the patient may be sleeping or resting (e.g., in a hospital). Medical humidifiers designed for bedside placement can be small. Medical humidifiers may be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the area around the patient. For example, indoor-based systems (e.g., saunas, air conditioners, or evaporative chillers) can also humidify the air breathed by the patient, but these systems can also humidify and / or heat the entire room, which can cause discomfort to the occupants. Additionally, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0064] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide inadequate humidification, while others are difficult or uncomfortable for patients to use.

[0065] 2.2.3.5 Oxygen source

[0066] Experts in this field recognize that exercise for patients with respiratory failure offers long-term benefits, such as slowing disease progression, improving quality of life, and extending life expectancy. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Consequently, the need for mobility has long been recognized. Until recently, this mobility was facilitated by small compressed oxygen tanks or cylinders mounted on carts equipped with dolly wheels. The disadvantages of these tanks are that they hold a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0067] Oxygen concentrators have been used for about 50 years to supply oxygen for respiratory therapy. Traditional oxygen concentrators were bulky and heavy, making them difficult and impractical for daily walking activities. Recently, companies manufacturing large stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can theoretically generate an endless supply of oxygen. To make these devices smaller for mobility, various systems required for generating oxygen-enriched gas are being selected. POCs aim to utilize the generated oxygen as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen as a series of pulses or "boluses," with each bolus timed to coincide with the start of inhalation. This mode of therapy is known as pulsed oxygen delivery (POD) or demand mode, in contrast to traditional continuous flow delivery, which is more suitable for stationary oxygen concentrators.

[0068] 2.2.3.6 Data Management

[0069] There may be clinical reasons to acquire data to determine whether a patient prescribed respiratory therapy has "complied," for example, to determine that the patient has used their RPT device according to one or more "compliance rules." An example of a compliance rule for CPAP therapy is that a patient is required to use an RPT device for at least 4 hours on at least 21 nights out of 30 consecutive days to be considered to be complying. To determine patient compliance, the provider of the RPT device, such as a healthcare provider, may manually acquire data describing the patient's therapy using the RPT device, calculate usage over a predetermined period, and compare it to the compliance rules. If the healthcare provider determines that the patient has used their RPT device according to the compliance rules, the healthcare provider may notify a third party that the patient has complied.

[0070] There may be other forms of patient therapy that benefit from the communication of therapy data to a third party or external system.

[0071] Existing processes for communicating and managing such data may be expensive, time-consuming, and prone to errors.

[0072] 3. A brief overview of the technology

[0073] The present invention relates to providing a medical device used for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, having one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0074] A first aspect of the present technology relates to a device used for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0075] Another aspect of the present technology relates to a method used for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0076] A specific form of the present technology is to provide a method and / or device for improving patient compliance with breathing therapy.

[0077] One aspect of the present technology relates to a blower for generating a pressurized gas flow.

[0078] Another aspect of the present invention relates to a motor-blower comprising a motor and a centrifugal fan, wherein the centrifugal fan comprises an impeller and a housing, the housing comprises a housing inlet and a housing outlet, the motor-blower is configured to receive air flow at the housing inlet at a pressure lower than the ambient pressure and to direct air flow at the housing outlet at a pressure higher than the ambient pressure when in use, the motor has a shaft configured and arranged to rotate about a shaft axis when in use, the impeller is configured and arranged to rotate about a shaft axis when in use, the impeller comprises a plurality of blades, the housing inlet has a housing inlet center positioned on the shaft axis, and the housing outlet has a housing outlet center positioned on the shaft axis.

[0079] Another aspect of the present invention relates to an apparatus for providing positive pressure ventilation therapy to a patient breathing in a breathing cycle comprising an inspiratory portion and an expiratory portion. The apparatus comprises: a controllable motor blower configured to generate a positive pressure air supply relative to ambient pressure by rotating one or more impellers at an impeller speed; a housing for holding the motor blower, wherein the housing includes an inlet and a patient-connection port, and the patient-connection port is configured to deliver a positive pressure air supply from the motor blower to a patient interface via an air circuit when in use; a sensor for monitoring at least one of the pressure and flow rate of the positive pressure air supply and generating a sensor output; and a controller configured to adjust the operating parameters of the motor blower according to the sensor output to maintain a minimum positive pressure at the patient interface during a treatment session by causing an increase in impeller speed during the inspiratory portion of the breathing cycle and causing a decrease in impeller speed during the expiratory portion of the breathing cycle.

[0080] One aspect of the present invention relates to a motor comprising a shaft configured and arranged to rotate about a shaft axis when in use, and at least one bearing for rotatably supporting the shaft.

[0081] One aspect of the present technology relates to an RPT device comprising, for example, a blower used to deliver breathing therapy to a patient.

[0082] One aspect of the present technology relates to a blower comprising an elastomer bearing sleeve configured and arranged to support and maintain a bearing.

[0083] One aspect of the present technology relates to an elastomer bearing sleeve configured and arranged to support and hold a bearing.

[0084] One aspect of the present technology relates to a blower comprising a fixed component and an elastomer bearing sleeve comprising an overmolded connection to the fixed component.

[0085] One aspect of the present invention relates to a blower comprising a rotor, a motor configured to drive the rotor, at least one bearing for rotatably supporting the rotor, a stationary component, and a bearing sleeve provided on the stationary component. The bearing sleeve is configured and arranged to support and hold the bearing on the stationary component. The bearing sleeve comprises an elastomer material and the bearing sleeve comprises one or more bumps or ribs configured to engage along the outer ring of the bearing.

[0086] One aspect of the present invention relates to a blower comprising a rotor, a motor configured to drive the rotor, at least one bearing for rotatably supporting the rotor, a stationary component, and a bearing sleeve provided on the stationary component. The bearing sleeve is configured and arranged to support and retain the bearing on the stationary component. The bearing sleeve comprises an elastomer material, and the bearing sleeve comprises an overmolded connection to the stationary component. The bearing sleeve comprises a retaining structure configured and arranged to form a mechanical connection to the stationary component.

[0087] One aspect of the present invention relates to a blower comprising a rotor, a motor configured to drive the rotor, at least one bearing for rotatably supporting the rotor, a deflection element for providing a preload to the at least one bearing, a stationary component, and a bearing sleeve provided on the stationary component. The bearing sleeve is configured and arranged to support and hold the bearing on the stationary component. The bearing sleeve comprises an elastomer material. The bearing sleeve is configured to protrude past the bearing and to provide a space for surrounding and positioning the deflection element.

[0088] One embodiment of the present technology is a method for manufacturing a device.

[0089] One embodiment of the present technology is a portable RPT device that can be carried by a person, for example, around that person's home.

[0090] The described methods, systems, devices, and apparatus may be implemented to enhance the capabilities of processors, such as processors in computers for specific purposes, respiratory monitors, and / or respiratory therapy devices. Additionally, the described methods, systems, devices, and apparatus may provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory diseases, including, for example, sleep-disordered breathing.

[0091] Of course, some of the embodiments may form sub-modalities of the present invention. Additionally, various embodiments among the embodiments and / or sub-modalities may be combined in various ways and may also constitute additional embodiments or sub-modalities of the present invention.

[0092] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, summary, drawings, and claims. Brief explanation of the drawing

[0093] 4. Brief description of the drawing The present technology is illustrated, but not restrictively, in the drawings of the attached drawings where similar reference numerals refer to similar elements: 4.1 Breathing Therapy System FIG. 1 illustrates a system comprising a patient (1000) wearing a patient interface (3000) in the form of a nasal pillow that receives a supply of positive pressure air from an RPT device (4000). Air from the RPT device (4000) is humidified in a humidifier (5000) and delivered to the patient (1000) along an air circuit (4170). A cohabitant (1100) is also depicted. The patient is sleeping in a supine position. 4.2 Patient Interface FIG. 2a illustrates a patient interface in the form of a nasal mask according to one form of the present technology. FIG. 2b illustrates a schematic diagram of a cross-section through a structure at a specific point. The outward normal at this point is indicated. The curvature at this point has a positive sign and is relatively large compared to the magnitude of the curvature shown in FIG. 2c. FIG. 2c illustrates a schematic diagram of a cross-section through a structure at a given point. The outward normal at this point is indicated. The curvature at this point has a positive sign and is relatively small compared to the magnitude of the curvature shown in FIG. 2b. FIG. 2d illustrates a schematic diagram of a cross-section through a structure at a given point. The outward normal at this point is indicated. The curvature at this point has a value of 0. FIG. 2e illustrates a schematic diagram of a cross-section through a structure at a specific point. The outward normal at this point is indicated. The curvature at this point has a negative sign and is relatively small compared to the magnitude of the curvature shown in FIG. 2f. FIG. 2f illustrates a schematic diagram of a cross-section through a structure at a given point. The outward normal at this point is indicated. The curvature at this point has a negative sign and is relatively large compared to the magnitude of the curvature shown in FIG. 2e. Figure 2g illustrates the surface of a structure, and there is a one-dimensional hole on the surface. The shown planar curve forms the boundary of the one-dimensional hole. FIG. 2h illustrates a cross-section through the structure of FIG. 2g. The surface shown defines a two-dimensional hole of the structure of FIG. 2g. FIG. 2i shows a perspective view of the structure of FIG. 2g including a two-dimensional hole and a one-dimensional hole. Additionally, a surface defining the two-dimensional hole of the structure of FIG. 2g is shown. 4.3 RPT Device FIG. 3a illustrates an RPT device according to one form of the present technology. FIG. 3b illustrates a schematic diagram of the pneumatic path of an RPT device according to one embodiment of the present technology. Upstream and downstream directions are indicated with reference to the blower and the patient interface. Regardless of the actual flow direction at any given moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. An item located within the pneumatic path between the blower and the patient interface is downstream of the blower and upstream of the patient interface. FIG. 3c is a schematic diagram of the electrical components of an RPT device according to one embodiment of the present technology. FIG. 4 is a perspective view of a blower for an RPT device according to an example of the present technology. Figure 5 is a cross-sectional view of the blower of Figure 4. Figure 6 is an enlarged view of a part of the blower shown in Figure 5. FIG. 7 is a cross-sectional view illustrating the upper portion and bearing sleeve of a fixed component for a blower according to an example of the present technology. FIG. 8 is an exploded view illustrating the upper portion and bearing sleeve of a fixed component for a blower according to an example of the present technology. FIG. 9 is a top perspective view of the upper portion of a fixed component for a blower according to an example of the present technology. FIG. 10 is a cross-sectional view illustrating the middle part and bearing sleeve of a fixed component for a blower according to an example of the present technology. FIG. 11 is an exploded view illustrating the middle part and bearing sleeve of a fixed component for a blower according to an example of the present technology. FIG. 12 is a top perspective view of the middle portion of a fixed component for a blower according to an example of the present technology. FIG. 13 is a bottom perspective view of the middle portion of a fixed component for a blower according to an example of the present technology. Specific details for implementing the invention

[0094] 5 Detailed description of examples of this technology

[0095] Before the present technology is described in more detail, it should be understood that the present technology is not limited to the specific examples described herein and may be modified. It should also be understood that the terms used in this disclosure are intended to describe only the specific examples discussed herein and are not intended to be limiting.

[0096] The following description is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with other examples or one or more features of other examples. Additionally, any single feature of any example or any combination of features may constitute additional examples.

[0097] 5.1 Therapy

[0098] In one form, the present invention includes a method for treating a respiratory disorder, comprising the step of applying positive pressure to the entrance of the airway of a patient (1000).

[0099] In a specific embodiment of the present invention, a positive pressure air supply is provided to the patient's nasal passage through one or two nostrils.

[0100] In certain embodiments of the present technology, mouth breathing is restricted, constrained, or prevented.

[0101] 5.2 Breathing Therapy System

[0102] In one form, the present invention includes a breathing therapy system for treating respiratory disorders. The breathing therapy system may include an RPT device (4000) for supplying air flow to a patient (1000) through an air circuit (4170) and a patient interface (3000) (see, for example, FIG. 1).

[0103] 5.3 Patient Interface

[0104] FIG. 2a illustrates a non-invasive patient interface (3000) according to one embodiment of the present technology comprising the following functional modes: a seal-forming structure (3100), a plenum chamber (3200), a positioning and stabilizing structure (3300), a vent (3400), a connection port (3600) of one form for connection to an air circuit (4170), and a forehead support (3700). In some forms, the functional modes may be provided by one or more physical components. In some forms, one physical component may provide one or more functional modes. When in use, the seal-forming structure (3100) is arranged to surround the patient's airway entrance to maintain positive pressure at the patient's (1000) airway entrance(s). Thus, the sealed patient interface (3000) is suitable for the delivery of positive pressure therapy.

[0105] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for pulmonary pressure therapy.

[0106] A patient interface (3000) according to one form of the present technology is configured and arranged to provide a positive air supply of at least 6 cmH2O to the surroundings.

[0107] A patient interface (3000) according to one form of the present technology is configured and arranged to provide a positive air supply of at least 10 cmH2O to the surroundings.

[0108] A patient interface (3000) according to one form of the present technology is configured and arranged to provide a positive air supply of at least 20 cmH2O to the surroundings.

[0109] 5.4 RPT Device

[0110] FIGS. 3a through 3c illustrate an RPT device (4000) according to one embodiment of the present invention, wherein the RPT device (4000) comprises mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms. The RPT device (4000) may be configured to generate an airflow to be delivered to a patient's airway, for example, to treat one or more of the respiratory diseases described elsewhere in this specification.

[0111] In one form, the RPT device (4000) is configured and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0112] The RPT device may have an outer housing (4010) formed in two parts, an upper part (4012) and a lower part (4014). Additionally, the outer housing (4010) may include one or more panel(s) (4015). The RPT device (4000) includes a chassis (4016) that supports one or more internal components of the RPT device (4000). The RPT device (4000) may include a handle (4018).

[0113] The pneumatic path of the RPT device (4000) may include one or more air path items, for example, one or more filters (4110) (e.g., inlet air filter (4112), air outlet filter (4114)), an inlet muffler (4122), a pressure generator (4140) capable of supplying positive pressure air (e.g., a blower (4142)), an outlet muffler (4124), and one or more transducers (4270), such as a pressure sensor and a flow sensor.

[0114] One or more of the air path items may be located within a single removable structure referred to as a pneumatic block (4020). The pneumatic block (4020) may be located within an external housing (4010). In one form, the pneumatic block (4020) is supported by a chassis (4016) or formed as part thereof.

[0115] The RPT device (4000) may have a power supply (4210), one or more input devices (4220), a central controller (4230), a therapy device controller, a pressure generator (4140), one or more protection circuits, a memory, a transducer (4270), a data communication interface, and one or more output devices (4290). The electrical components (4200) may be mounted on a single printed circuit board assembly (PCBA) (4202). In an alternative form, the RPT device (4000) may include more than one PCBA (4202).

[0116] pressure generator

[0117] In one embodiment of the present invention, a pressure generator (4140) for generating a flow or supply of positive pressure air is a controllable blower (4142). For example, the blower (4142) may comprise a brushless DC motor (4144) having one or more impellers. The impellers may be positioned in a volute. When delivering breathing pressure therapy, the blower may be capable of delivering an air supply, for example, at a rate of up to about 120 liters / min, in the range of about 4 cmH2O to about 20 cmH2O, or in other forms, at a positive pressure of up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT patent application publication No. WO 2013 / 020167.

[0118] The pressure generator (4140) may be under the control of the central controller (4230) and / or the therapy device controller.

[0119] 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.

[0120] FIGS. 4 through 13 illustrate a blower (6000) for generating a positive pressure air flow or supply according to an example of the present technology. In the illustrated example, the blower (6000) provides an axially symmetric three-stage blower design. In one example, the blower (6000) may be configured to provide pressurized air in the range of up to 45 to 50 cmH2O, e.g. 2 to 50 cmH2O, e.g. 3 to 45 cmH2O, 4 to 30 cmH2O.

[0121] As best illustrated in FIGS. 5 and 6, the blower (6000) comprises an inlet cover (6010) providing an axial air inlet (6015) (blower inlet), a motor (6020) configured to drive a rotatable shaft or rotor (6030), first and second impellers (6041, 6042) provided on the rotor (6030) and located on one side of the motor (6020), and a third impeller (6043) provided on the rotor (6030) and located on the other side of the motor (6020). The blower (6000) comprises a first fixed component (6050) that includes a 1-stage stator vane (6055) and follows a first impeller (6041), a second fixed component (6060) that includes a 2-stage stator vane (6065, 6067) and follows a second impeller (6042) and surrounds a motor (6020), and a third fixed component (6080) that includes a 3-stage stator vane (6085) and follows a third impeller (6043). The third fixed component (6080) also provides an axial air outlet (6088) (blower outlet). In use, the blower (6000) can be operated to draw an air supply into the blower inlet (6015) and provide a pressurized air supply at the blower outlet (6088).

[0122] The motor (6020) includes a magnet (6022) provided on a rotor (6030) and a stator assembly (6024). The stator assembly (6024) includes a lamination stack (6026) (e.g., a plurality of laminations (e.g., composed of iron)) and a stator coil or winding (6028) (e.g., composed of copper) provided on the lamination stack (6026).

[0123] The second fixed component (6060) comprises a tube portion (6068), the tube portion (6068) encloses a magnet (6022) on a rotor (6030) that is aligned very closely with a stator assembly (6024) provided along the outer surface of the tube portion (6068). The tube portion (6068) is constructed of a material that is sufficiently "magnetically transparent" to allow a magnetic field to pass through, which enables the stator assembly (6024) along the outer surface to act on the magnet (6022) located within the tube portion (6068). Further details and examples of such an arrangement are disclosed in U.S. Patent Publication No. US-2008-0304986, the entirety of which is incorporated herein by reference.

[0124] Additional examples and details of such blower arrangements are described in PCT Publication No. WO 2013 / 020167, the entirety of which is incorporated herein by reference.

[0125] In the illustrated example, the rotor (6030) is rotatably supported by a pair of bearings (6091, 6092), such as ball bearings, which are maintained or supported by a second fixed component (6060).

[0126] In the illustrated example (see, for example, FIG. 5), the second fixed component (6060) is provided in three parts that are formed separately (e.g., molded) and then assembled together (e.g., thermal staking, mechanical interlock (e.g., tongue / groove), friction-fit, etc.). As illustrated, the second fixed component (6060) includes an upper part (6062) (also referred to as an end bell), a middle part (6064), and a lower part (6066). As described below, the upper portion (6062) is provided with an upper bearing sleeve (6100) (e.g., including an elastomer material, e.g., thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU)) configured and arranged to support and hold the upper bearing of a pair of bearings (i.e., the bearing (6091) located on the side of the second fixed component (6060) closer to the blower inlet (6015)), and the middle portion (6064) is provided with a lower bearing sleeve (6200) (e.g., including an elastomer material, e.g., TPE, TPU) configured and arranged to support and hold the lower bearing of a pair of bearings (i.e., the bearing (6092) located on the side of the second fixed component (6060) closer to the blower outlet (6088)).

[0127] As best illustrated in FIG. 6, the upper portion (6062) and the middle portion (6064) cooperate to support and hold the motor (6020) in the operating position. Additionally, the upper portion (6062) and the middle portion (6064) cooperate to form a two-stage stator vane (6065) configured to direct airflow generally axially downward and around the motor (6020), namely, the upper portion (6062) includes a first set of vanes forming the upper portion of each stator vane (6065), and the middle portion (6064) includes a second set of vanes forming the lower portion of each stator vane (6065). The lower portion (6066) is located below the motor (6020) and includes a two-stage stator vane (6067) configured to direct airflow radially toward a third stage (see, for example, FIG. 5). Additional examples and details of such stator arrangements are described in PCT Publication No. WO 2013 / 020167, the entirety of which is incorporated herein by reference.

[0128] As illustrated in FIGS. 6 through 9, the upper portion (6062) includes a cylindrical side wall (6310) that surrounds the middle portion (6064) and forms the outer wall of the blower (6000), and an end wall (6320) provided at the upper portion of the cylindrical side wall (6310). The end wall (6320) provides a radial outer opening (6330) that supports a first set of vanes forming the upper portion of each stator vane (6065), and a radial inner support portion (6340) that supports and holds the upper bearing sleeve (6100).

[0129] The end wall (6320) also includes an intermediate connecting portion (6350) connected to the intermediate portion (6064) (between the radial outer opening (6330) and the radial inner supporting portion (6340). For example, the intermediate connecting portion (6350) may be connected to the intermediate portion (6064) via column staking, that is, the intermediate portion (6064) includes stakes (6069) configured and arranged to extend through each opening (6352) of the intermediate connecting portion (6350) and then column-stake to secure the upper portion (6062) to the intermediate portion (6064). However, it should be understood that the upper portion (6062) and the intermediate portion (6064) may be connected to each other in other suitable ways.

[0130] In the illustrated example, the support portion (6340) includes a base wall (6342) and a support wall (6344) extending axially inward from the inner side of the base wall (6342). Additionally, the base wall (6342) forms a channel (6348) together with spaced side walls (6345, 6346) extending axially outward from the outer side of the base wall (6342).

[0131] As illustrated, the upper bearing sleeve (6100) is supported and held by a support portion (6340). The upper bearing sleeve (6100) includes a cylindrical or tubular sidewall (6110) that provides a cylindrical opening to support and hold the upper bearing of a pair of bearings, namely the bearing (6091). Additionally, as illustrated, the cylindrical sidewall (6110) is arranged along the radially inner surface of the support wall (6344). Additionally, the upper bearing sleeve (6100) includes a retaining structure (6120) that wraps around the support wall (6344) and into the channel (6348) to hold the upper bearing sleeve (6100) to the support portion (6340) of the upper portion (6062).

[0132] In the illustrated example, the cylindrical sidewall (6110) includes one or more annular bumps or ribs (6115) (e.g., two, three, four, or more bumps or ribs) to hold the bearing (6091) in an operating position. As illustrated, the bumps or ribs (6115) are configured and arranged to engage along the outer ring of the bearing (6091). The inner ring of the bearing (6091) is configured and arranged to engage with the rotor (6030).

[0133] In one example, the upper bearing sleeve (6100) is composed of an elastomer material, such as TPE or TPU. The elastomer bearing sleeve (6100) is positioned between the support portion (6340) and the bearing (6091) to isolate vibrations, reduce noise, and provide radial shock absorption. Additionally, the upper bearing sleeve (6100) serves as a substitute for damping or bearing grease, for example, between the support portion (6340) and the bearing (6091), which facilitates manufacturing.

[0134] The upper bearing sleeve (6100) may be permanently connected to the support portion (6340) of the upper portion (6062) (e.g., overmolded) or removablely connected (e.g., interference fit assembly).

[0135] In the illustrated example, the upper bearing sleeve (6100) and the upper portion (6062) include an overmolded configuration to form an integral integrated component. For example, the upper portion (6062) may include a first portion or base mold, and the upper bearing sleeve (6100) may include a second portion or overmolded provided to the first portion (e.g., by overmolding). In one example, the upper portion (6062) includes a material that is more rigid than the upper bearing sleeve (6100) (e.g., polycarbonate, polypropylene), e.g., TPE, TPU.

[0136] In one example, the upper bearing sleeve (6100) may be overmolded onto the upper portion (6062) so that the retaining structure (6120) provides an interference fit or mechanical interlock with the upper portion (6062). For example, the base wall (6342) of the support portion (6340) includes a plurality of holes (6343), and accordingly, during the overmolding process, the elastomer material of the upper bearing sleeve (6100) may flow into the channel (6348) to fill the channel, flow through the holes, and flow around the support wall (6344) to mechanically secure the upper bearing sleeve (6100) to the upper portion (6062). Additionally, the outer surface of the side wall (6110) may include one or more threads or protrusions configured to engage within each groove provided in the support wall (6344) to further secure the upper bearing sleeve (6100) in an operating position. Additionally, in one example, the elastomer material of the upper bearing sleeve (6100) may provide an interfacing surface that is bonded or adhered to the upper portion (6062) to improve connection with the upper portion (6062).

[0137] As illustrated in FIGS. 10 through 13, the intermediate portion (6064) comprises a tube portion (6068), a cylindrical side wall (6410) providing a radial outer opening (6430) that supports a second set of vanes forming the lower portion of each stator vane (6065), and an end wall (6420) provided at the lower end of the tube portion (6068). The end wall (6420) provides a support portion (6440) that supports and holds the lower bearing sleeve (6200). In the illustrated example, the intermediate portion (6064) may be overmolded into the stator assembly (6024) and may be collectively referred to as the stator overmolded.

[0138] In the illustrated example, the support portion (6440) includes a base wall (6442) and a support wall (6444) extending axially inward from the inner side of the base wall (6442).

[0139] As illustrated, the lower bearing sleeve (6200) is supported and held by a support portion (6440). The lower bearing sleeve (6200) includes a cylindrical or tubular sidewall (6210) that provides a cylindrical opening to support and hold the lower bearing of a pair of bearings, i.e., the bearing (6092). Additionally, as illustrated, the cylindrical sidewall (6210) is arranged along the radially inner surface of the support wall (6444). Additionally, the lower bearing sleeve (6200) includes a holding structure (6220) that wraps around the support wall (6444) to hold the lower bearing sleeve (6200) to the support portion (6440) of the middle portion (6064).

[0140] In the illustrated example, the cylindrical sidewall (6210) comprises an elongated configuration, and the upper side of the sidewall (6210) comprises one or more annular bumps or ribs (6215) (e.g., two, three, four, or more bumps or ribs) to hold the bearing (6092) in an operating position. As illustrated, the bumps or ribs (6215) are configured and arranged to engage along the outer ring of the bearing (6092). The inner ring of the bearing (6092) is configured and arranged to engage with the rotor (6030).

[0141] In the illustrated example, the lower side of the side wall (6210) (adjacent to the base wall (6442)) has no bumps or ribs, and this lower side protrudes past the bearing (6092) and provides space to surround and position a spring or deflection element (6095). As illustrated, the spring or deflection element (6095) is arranged between the base wall (6442) and the bearing (6092) to apply a preload force to the bearing (6092) (e.g., a preload on the inner ring of the ball bearing (6092)) and / or maintain alignment between the stator assembly (6024) and the magnet (6022).

[0142] In one example, like the upper bearing sleeve (6100), the lower bearing sleeve (6200) is composed of an elastomer material, such as TPE or TPU. The elastomer bearing sleeve (6200) is positioned between the support portion (6440) and the bearing (6092) to isolate vibrations, reduce noise, and provide radial shock absorption. Additionally, the lower bearing sleeve (6200) serves as a substitute for damping or bearing grease, for example, between the support portion (6440) and the bearing (6092), which facilitates manufacturing.

[0143] The lower bearing sleeve (6200) may be permanently connected to the support portion (6440) of the middle portion (6064) (e.g., overmolded) or removablely connected (e.g., interference fit assembly).

[0144] In the illustrated example, the lower bearing sleeve (6200) and the intermediate portion (6064) include an overmolded configuration to form an integral integrated component. For example, the intermediate portion (6064) may include a first portion or base mold (e.g., together with the overmolded stator assembly (6024)), and the lower bearing sleeve (6200) may include a second portion or overmolded provided to the first portion (e.g., by overmolding). In one example, the intermediate portion (6064) includes a material that is more rigid than the lower bearing sleeve (6200) (e.g., polycarbonate, polypropylene), e.g., TPE, TPU.

[0145] In one example, the lower bearing sleeve (6200) may be overmolded into the middle section (6064) so ​​that the retaining structure (6220) provides an interference fit or mechanical interlock with the middle section (6064). For example, in the illustrated example, the retaining structure (6220) is configured to wrap around the free end of the support wall (6444) to mechanically secure the lower bearing sleeve (6200) to the middle section (6064). Additionally, the outer surface of the side wall (6210) includes one or more threads or protrusions (6217) configured to engage within each groove provided in the support wall (6444) to secure the lower bearing sleeve (6200) in an operating position. Additionally, the base wall (6442) of the support portion (6440) includes a plurality of holes (6443), and accordingly, during the overmolding process, the elastomer material of the lower bearing sleeve (6200) flows through the holes to form a stake or rivet (6219) on the support wall (6444), thereby mechanically securing the lower bearing sleeve (6200) to the intermediate portion (6064). Additionally, in one example, the elastomer material of the lower bearing sleeve (6200) may provide an interfacing surface that is bonded or adhered to the intermediate portion (6064) to improve the connection with the intermediate portion (6064).

[0146] In the illustrated example, the upper portion (6062), the middle portion (6064), and the respective elastomer bearing sleeves (6100, 6200) are configured and arranged to support and align bearings (6091, 6092), which align the rotor (6030) with the axis of the blower (6000). In the illustrated example, the bearings (6091, 6092) are of the same size. However, the upper portion (6062), the middle portion (6064), and the respective elastomer bearing sleeves (6100, 6200) may be configured to support and align bearings of different sizes relative to each other.

[0147] In one example, to maintain alignment between the stator assembly (6024) and the magnet (6022), a spacer may be provided between each bearing (6091, 6092) and the magnet (6022).

[0148] Although the blower example is described as including a three-stage design, it should be understood that the example of the present technology may be applied to other stage designs, e.g., one, two, four, or more stages.

[0149] Additionally, while aspects of the present technology are described herein for application to non-invasive ventilation (NIV) treatment devices such as CPAP (e.g., RPT devices), it should be understood that aspects of the present technology may be applied to other applications where a blower is used, for example, in both positive and negative pressure applications.

[0150] 5.5 Air Circuit

[0151] An air circuit (4170) according to one embodiment of the present technology is a conduit or tube configured and arranged to allow air flow to move between two components, such as an RPT device (4000) and a patient interface (3000), when in use.

[0152] In particular, the air circuit (4170) can be fluidly connected to the patient interface and the outlet of the pneumatic block (4020). The air circuit may be referred to as an air delivery tube. In some cases, there may be separate rims of the circuit for inhalation and exhalation. In other cases, a single rim is used.

[0153] In some forms, the air circuit (4170) may include one or more heating elements configured to heat the air within the air circuit, for example, to maintain or raise the temperature of the air. The heating elements may be in the form of a heating wire circuit and may include one or more transducers, such as a temperature sensor. In one form, the heating wire circuit may be wound spirally around the axis of the air circuit (4170). The heating elements may communicate with a controller, such as a central controller (4230). An example of an air circuit (4170) including a heating wire circuit is described in U.S. Patent No. 8,733,349, the entirety of which is incorporated herein by reference.

[0154] 5.5.1 Replacement gas delivery

[0155] In one form of the present invention, a supplemental gas, e.g., oxygen (4180), is delivered to one or more points of a pneumatic path, e.g., upstream of a pneumatic block (4020), to an air circuit (4170), and / or to a patient interface (3000).

[0156] 5.6 Humidifier

[0157] 5.6.1 Humidifier Overview

[0158] In one form of the present invention, a humidifier (5000) (e.g., illustrated in FIG. 1) is provided to change the absolute humidity of air or gas to be delivered to a patient relative to the ambient air. Typically, the humidifier (5000) is used to increase the absolute humidity (relative to the ambient air) and raise the temperature of the airflow before delivery to the patient's airway.

[0159] 5.7 Glossary

[0160] For the purposes of disclosing the present technology, in certain forms of the present technology, one or more of the following definitions may be applied. In other forms of the present technology, alternative definitions may be applied.

[0161] 5.7.1 General Rules

[0162] air : In a specific form of the present technology, air may be considered to mean atmosphere, and in another form of the present technology, air may be considered to mean some other combination of breathable gases, e.g., oxygen-enriched air.

[0163] circumference In certain forms of the present invention, the term "around" shall be considered to mean (i) outside the treatment system or patient, and (ii) immediately around the treatment system or patient.

[0164] For example, the surroundings of a humidifier humidity This could be the humidity of the air immediately surrounding the humidifier, for example, the humidity of the room where the patient is sleeping. This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0165] In another example, ambient pressure can be pressure immediately around the body or outside the body.

[0166] In certain forms, ambient (e.g., acoustic) noise may be considered as the background noise level of the room where the patient is located, excluding noise generated, for example, by the RPT device or originating from the mask or patient interface. Ambient noise may be generated by sources outside the room.

[0167] Automatic Positive Airway Pressure (APAP) therapy CPAP therapy in which therapeutic pressure is automatically adjusted between breaths, for example, between minimum and maximum limits, depending on the presence or absence of indications of an SDB event.

[0168] Continuous Positive Airway Pressure (CPAP) therapy: A pulmonary pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the entrance of the airway will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will fluctuate between the patient's different breathing cycles and will increase, for example, in response to the detection of signs of partial upper airway obstruction and decrease in the absence of signs of partial upper airway obstruction.

[0169] flux : The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate will be to a scalar quantity, that is, a quantity having only magnitude. In other cases, a reference to flow rate will be to a vector quantity, that is, a quantity having both magnitude and direction. Flow rate has a symbol Q It can be given. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0170] In the example of patient respiration, the flow rate can be nominally positive during the inspiratory portion of the patient's breathing cycle and, therefore, negative during the expiratory portion of the patient's breathing cycle. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface through the air circuit. Air flow rate Qv is the flow rate of air leaving the vent to allow for the flushing of exhaled gas. Leakage flow rate Ql It is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air taken into the patient's respiratory system.

[0171] fluid therapy : A breathing therapy involving delivering airflow to the entrance of the airway at a controlled flow rate, typically referred to as a therapeutic flow rate, throughout the patient's entire breathing cycle.

[0172] humidifier The word humidifier shall be regarded as meaning a humidifying device configured and arranged, or composed of a physical structure, to provide a therapeutically beneficial amount of water (H2O) vapor to the airflow to improve a patient's medical respiratory disease.

[0173] leakage The term "leakage" will be considered as unintended airflow. In one example, leakage may occur as a result of an incomplete seal between the mask and the patient's face. In another example, leakage may occur around a swivel elbow.

[0174] Conducted (acoustic) noise In this specification, conducted noise refers to noise transmitted to a patient by pneumatic paths, such as internal air, as well as by air circuits and patient interfaces. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0175] Radiated (acoustic) noise : In this specification, radiated noise refers to noise transmitted to a patient by the surrounding air. In one form, radiated noise can be quantified by measuring the sound force / sound pressure level of the object in accordance with ISO 3744.

[0176] Acoustic noise In this specification, ventilation noise refers to noise generated by airflow through any ventilation opening, such as a ventilation hole of a patient interface.

[0177] Oxygen-incubated air : Air having an oxygen concentration higher than the oxygen concentration in the atmosphere (21%), for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes abbreviated as “oxygen”.

[0178] Medical oxygen Medical oxygen is defined as oxygen-enriched air having an oxygen concentration of 80% or more.

[0179] patient : A person, regardless of whether they have a respiratory disease.

[0180] enter : Force per unit area. Pressure is in cmH2O, g·f / cm² 2 It can be expressed in a unit range including , and hectopascals. 1 cmH2O is 1 g·f / cm² 2 It is equivalent to, and approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m² 2 = 1 millibar ~ 0.001 atm). In this specification, unless otherwise noted, pressure is given in units of cmH2O.

[0181] The pressure within the patient interface is a symbol Pm While given as, interface pressure at the current time moment Pm The treatment pressure indicating the target value achieved by the symbol Pt It is given as.

[0182] Breathing pressure therapy : Applying a supply of air at therapeutic pressure, which is typically positive pressure relative to the atmosphere, to the entrance of the airway.

[0183] ventilator : A mechanical device that provides pressure support to a patient to perform part or all of the breathing motion.

[0184] 5.7.1.1 ingredient

[0185] silicone or silicone elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC manufactured by Dow Corning (included in the range of products sold under this brand). Another manufacturer of LSR is Wacker. Unless otherwise stated, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0186] polycarbonate : Thermoplastic polymer of bisphenol-A carbonate.

[0187] 5.7.1.2 mechanical properties

[0188] elasticity : The ability of a material to absorb energy when elastically deformed and release energy when the load is released.

[0189] elastic : Releasing substantially all energy upon load release. For example, including certain silicones and thermoplastic elastomers.

[0190] hardness : The material's inherent ability to resist deformation (e.g., indentation measured at a standardized sample size) hardness (Described by scale, or Young's modulus).

[0191] ● 'Soft' materials may include silicone or thermoplastic elastomers (TPE) and can be easily deformed, for example, under finger pressure.

[0192] ● 'Rigid' materials may include polycarbonate, polypropylene, steel, or aluminum, and may not deform easily under finger pressure, for example.

[0193] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, for example, compression, tension, bending, or torsion. A structure or component may provide different resistance in different directions. The opposite of stiffness is pliability am.

[0194] Soft structures or components : A structure or component that changes shape, for example, within a relatively short period, such as 1 second, when supporting its own weight, e.g., bending.

[0195] Rigid structures or components : A structure or component whose shape does not substantially change when subjected to loads typically encountered during use. An example of such use may be, for instance, establishing and maintaining a patient interface in a sealing relationship with the entrance of a patient's airway under a load of about 20 to 30 cmH2O pressure.

[0196] As an example, an I-beam may have different bending strength (resistance to bending load) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be ductile in the first direction and rigid in the second direction.

[0197] 5.7.2 Patient Interface

[0198] Anti-suffocation valve (AAV) A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing in a patient by opening to the atmosphere in a fail-safe manner.

[0199] elbowAn elbow is an example of a structure that orients the axis of a penetrating airflow to change direction at a predetermined angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form, the elbow may have an elliptical or rectangular cross-section. In a specific form, the elbow may be rotatable, for example, about 360 degrees relative to a mating component. In a specific form, the elbow may be removable from the mating component, for example, via a snap connection. In a specific form, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but may not be removable by the patient.

[0200] Frame : The frame will be considered to mean a mask structure that supports tensile loads between two or more connection points with the headgear. The mask frame may be a non-airtight load-bearing structure of the mask. However, some forms of the mask frame may also be airtight.

[0201] headgear : Headgear shall be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, headgear may include an assembly of one or more struts, ties, and reinforcements configured to position and maintain a patient interface in place on the patient's face for the delivery of breathing therapy. Some ties are formed from soft, flexible elastic materials, such as laminated composites of foam and fabric.

[0202] Membrane The membrane will preferably be considered to mean a typically thin element that has no resistance to bending but has resistance to stretching.

[0203] Plenum chamber: A mask plenum chamber will be considered to mean a part of a patient interface having a wall that at least partially surrounds a space of a predetermined volume having air pressurized to a higher than atmospheric pressure when in use. A shell may form part of the wall of the mask plenum chamber.

[0204] seal : It may be a noun form referring to a structure ("seale"), or a verb form referring to an effect ("seal"). The two elements may be configured and / or arranged to be "sealed" between them or to perform "sealing" without requiring a separate "seale" element itself.

[0205] shell A shell is to be regarded as a curved, relatively thin structure possessing bending, tensile, and compressive strengths. For example, the curved structural walls of a mask can be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0206] reinforcement Reinforcement will be considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0207] strut A strut will be considered a structural component designed to increase the compression resistance of other components in at least one direction.

[0208] Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate at least 360 degrees. In another form, the swivel may be configured to rotate at an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. There may be little to no leakage of air flow from the swivel during use.

[0209] Thai (noun) : A structure designed to resist tension.

[0210] Ventilation hole (noun) : To clinically effectively flush exhaled gas out of the surrounding air from the inside of the mask or duct air A structure that allows flow. For example, a clinically effective wash may include a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure.

[0211] 5.7.3 Shape of the structure

[0212] A product according to the present technology may include one or more three-dimensional mechanical structures, e.g., a mask cushion or an impeller. The three-dimensional structure may be defined by two-dimensional surfaces. These surfaces may be distinguished using symbols to describe their associated surface orientation, position, function, or some other characteristics. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a surface contact (e.g., outer) surface and a separate non-surface contact (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

[0213] To facilitate the description of the shape of three-dimensional structures and surfaces, first, a predetermined point p In this, a cross-section through the surface of the structure is considered. Points on the surface p See FIGS. 2b through 2f illustrating examples of cross-sections and resulting planar curves. FIGS. 2b through 2f also p Plot the outward normal vector at. p The outward normal vector in [location] points away from the surface. In some examples, the surface is described from the perspective of a hypothetical small person standing upright on the surface.

[0214] 5.7.3.1 One-dimensional curvature

[0215] p The curvature of a planar curve in [location] has a sign (e.g., positive, negative) and magnitude (e.g., 1 / ( p It can be described as having the radius of a circle tangent to the curve.

[0216] positive curvature : p If the curve at a point points toward the outward normal, the curvature at that point will be considered positive (a hypothetical small person at the point p (If you start from there, you have to walk uphill). See Fig. 2b (relatively large amount of curvature compared to Fig. 2c) and Fig. 2c (relatively small amount of curvature compared to Fig. 2b). Such a curve is often referred to as concave.

[0217] curvature of 0 : p If the curve at is a straight line, the curvature will be considered to be 0 (an imaginary small person at the point p (If you start from there, you can walk on a horizontal plane that is neither up nor down). See Fig. 2d.

[0218] Negative curvature : pIf the curve at a point points away from the outward normal, the curvature in that direction at that point will be considered negative (a hypothetical small person at the point p (If you start from there, you must walk downhill). See Fig. 2e (relatively small negative curvature compared to Fig. 2f) and Fig. 2f (relatively large negative curvature compared to Fig. 2e). Such a curve is often referred to as convex.

[0219] 5.7.3.2 curvature of a two-dimensional surface

[0220] According to the present invention, a description of the shape at a given point on a two-dimensional surface may include a plurality of normal sections. The plurality of sections may cut the surface at a plane containing an outward normal ("normal plane"), and each section may be taken in a different direction. Each section generates a planar curve having a corresponding curvature. The different curvatures at the corresponding point may have the same sign or different sign. Each curvature at the corresponding point has a size, for example, a relatively small size. The planar curves of FIGS. 2b through 2f may be examples of such a plurality of sections at a specific point.

[0221] Principal curvature and direction : The direction of the normal plane where the curvature of the curve takes maximum and minimum values ​​is called the principal direction. In the examples of FIGS. 2b to 2f, the maximum curvature occurs in FIG. 2b and the minimum occurs in FIG. 2f, and thus FIGS. 2b and FIG. 2f are cross-sections of the principal direction. p The principal curvature at is the curvature in the principal direction.

[0222] surface area : A set of connected points on a surface. A set of points in a given area may have similar characteristics, for example, curvature or sign.

[0223] Bird area: Areas where the principal curvatures at each point have opposite signs, i.e., areas where one is positive and the other is negative (depending on the direction the virtual person rotates, they can walk uphill or downhill).

[0224] Dome area : Regions where the principal curvatures at each point have the same sign, for example, regions where both are positive ("concave dome") or both are negative ("convex dome").

[0225] Cylindrical region : An area where one principal curvature is 0 (or, for example, 0 within manufacturing tolerances) and the other principal curvature is not 0.

[0226] Planar area : An area of ​​a surface where all principal curvatures are 0 (or, for example, 0 within manufacturing tolerances).

[0227] Surface edge : Boundary or limit of a surface or area.

[0228] channel In a specific form of the present technology, 'path' refers to a path in a mathematical-topological sense, i.e., on a surface f from (0) f (1) It will be considered to mean a continuous spatial curve. In a specific form of the present invention, a ‘path’ may be described as a route or course that includes, for example, a set of points on a surface. (A virtual person’s path is where they walk on a surface, similar to a path in a garden.)

[0229] path length : In a specific form of the present technology, 'path length' is f from (0) f (1) The distance along the surface, that is, the distance along the path on the surface, will be considered to mean the distance along the path on the surface. There may be more than one path between two points on the surface, and such paths may have different path lengths. (The path length of a virtual person would be the distance they must walk along the path on the surface.)

[0230] straight line distance Straight-line distance is the distance between two points on a surface, but it is unrelated to the surface. In a planar region, there will be a path on the surface with a path length equal to the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path with a path length equal to the straight-line distance between two points. (To a hypothetical person, straight-line distance would correspond to distance 'as a straight line'.)

[0231] 5.7.3.3 spatial curve

[0232] spatial curve Unlike planar curves, spatial curves do not necessarily lie on any specific plane. Spatial curves can be closed, meaning they may have no endpoints. A spatial curve can be regarded as a one-dimensional piece in three-dimensional space. A hypothetical person walking on a strand of a DNA helix walks along a spatial curve. A typical human left ear contains a helix that is left-handed. A typical human right ear contains a helix that is right-handed. The edges of structures, such as membranes or impellers, can follow spatial curves. In general, a spatial curve can be described by the curvature and torsion at each point on the spatial curve. Torsion is a measure of how much a curve deviates from a plane. Torsion has a sign and magnitude. The torsion at a given point on a spatial curve can be characterized by referring to the tangent, normal, and binormal vectors at that point.

[0233] tangent unit vector (or unit tangent vector) For each point on a curve, the vector at that point specifies not only the direction from that point but also its magnitude. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person were flying along a curve and fell from a vehicle at a specific point, the direction of the tangent vector would be the direction of movement.

[0234] Unit normal vector As a hypothetical person moves along a curve, the tangent vector itself changes. The unit vector pointing in the same direction as the changing tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0235] binormal unit vector The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule, or alternatively, by the left-hand rule.

[0236] contact plane : A plane containing the unit tangent vector and the unit principal normal vector.

[0237] Thermal rate of a space curve : The inversion of a space curve at a given point is the magnitude of the rate of change of the unit vector of the binormal at that point. The inversion is a measure of how much the curve deviates from the plane of contact. A space curve lying on a plane has an inversion of 0. A space curve deviating from the plane of contact by a relatively small amount will have a relatively small inversion (e.g., a gently sloping spiral path). A space curve deviating from the plane of contact by a relatively large amount will have a relatively large inversion (e.g., a steeply sloping spiral path).

[0238] 5.7.3.4 hole

[0239] The surface may have one-dimensional holes, for example, holes defined by planar curves or spatial curves. A thin structure having holes (e.g., a membrane) can be described as having one-dimensional holes. Refer to one-dimensional holes in the surface of a structure, for example, illustrated in FIG. 2g, defined by planar curves.

[0240] The structure may have a two-dimensional hole, for example, a hole defined by a surface. For example, an inflatable tire has a two-dimensional hole defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel may have a two-dimensional hole. In yet another example, a conduit may include a one-dimensional hole (e.g., located at an inlet or outlet) and a two-dimensional hole defined by the inner surface of the conduit. Also, refer to the two-dimensional hole passing through the structure illustrated in FIG. 2i, defined by a surface as illustrated.

[0241] 5.8 Other Remarks

[0242] Unless otherwise clearly indicated in the context, and where a range of values ​​is provided, each intervening value up to 1 / 10 of the lower unit between the upper and lower limits of such range, and any other mentioned or intervening value of such range are understood to be included within the present description. The upper and lower limits of such intervening ranges, which may be independently included in the intervening range, are also included within the present description, subject to any specifically excluded limits in the mentioned range. Where the mentioned range includes one or all of the limits, the range excluding any or all of such included limits is also included within the present description.

[0243] Additionally, where values ​​or values ​​are referred to herein as being implemented as part of the present technology, such values ​​may be approximations unless otherwise noted, and it is understood that such values ​​may be used with any suitable number of significant digits to the extent that the actual technical implementation allows or requires them.

[0244] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this technology pertains. Any method and material similar or equivalent to that described herein may also be used in the practice or testing of this technology, but only a limited number of exemplary methods and materials are described herein.

[0245] If a specific material is identified as being used to constitute a component, an obvious alternative material having similar properties may be used as a substitute. Additionally, unless otherwise specified, it is understood that any and all components described herein may be manufactured, and accordingly may be manufactured together or individually.

[0246] It should be noted that, as used in this application and the appended claims, the singular forms (“a,” “an,” and “the”) include their plural equivalents unless the context clearly indicates otherwise.

[0247] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of such publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing in this application shall be construed as an acknowledgment that the present technology is not qualified to precede such publications due to prior art. Additionally, the provided disclosure dates may differ from the actual disclosure dates, which may need to be verified independently.

[0248] The terms "includes" and "includes" should be interpreted as referring to an element, component, or step in a non-exclusive manner, indicating that the mentioned element, component, or step may exist, be used, or be combined with other elements, components, or steps that are not explicitly mentioned.

[0249] Subject headings used in the detailed description are included solely for the reader's reference and should not be used to limit the subject matter found throughout the entire disclosure or claims. Subject headings should not be used to interpret the scope of the claims or claims limitations.

[0250] Although the technology of the present invention has been described with reference to specific examples, these examples should be understood merely as illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details that are not required to practice the technology. For example, the terms "first" and "second" may be used, but unless otherwise specified, they are not intended to indicate any order and may be used to distinguish distinct elements. Furthermore, process steps in the method may be described or illustrated in order, but such order is not mandatory. Those skilled in the art will recognize that such order may be modified and / or that modes thereof may be performed simultaneously or even synchronously.

[0251] Therefore, it should be understood that many modifications can be made to the exemplary examples and other arrangements can be devised without departing from the spirit and scope of the present technology.

[0252] 5.9 Reference Code List

[0253]

[0254]

[0255]

Claims

Claim 1 A blower comprising: a rotor; a motor configured to drive the rotor; at least one bearing for rotatably supporting the rotor; a fixed component; and a bearing sleeve provided on the fixed component, wherein the bearing sleeve is configured and arranged to support and hold the bearing on the fixed component, wherein the bearing sleeve comprises an elastomer material, wherein the bearing sleeve comprises one or more bumps or ribs configured to engage along the outer ring of the bearing, wherein the bearing sleeve comprises an overmolded connection to the fixed component, wherein the bearing sleeve comprises a retaining structure configured and arranged to form a mechanical connection to a cylindrical sidewall and the fixed component, wherein the one or more bumps or ribs are provided on the inner surface of the cylindrical sidewall, wherein the retaining structure is configured to wrap around the support wall of the fixed component, and wherein the outer surface of the cylindrical sidewall comprises one or more threads configured to engage within a respective groove provided on the support wall of the fixed component to secure the bearing sleeve in an operating position. Claim 2 A blower according to claim 1, wherein the elastomer material comprises TPE. Claim 3 A blower according to any one of claims 1 to 2, wherein the fixed component comprises a stator vane. Claim 4 A blower according to any one of claims 1 to 2, wherein the bearing sleeve comprises at least two bumps or ribs arranged between a fixed component and a bearing to isolate vibration, reduce noise, and provide shock absorption. Claim 5 A blower according to any one of paragraphs 1 to 2, wherein the bearing sleeve protrudes through one or more holes provided in a fixed component to form a stake or rivet on the fixed component. Claim 6 A blower according to any one of claims 1 to 2, further comprising a deflection element for providing a preload force to at least one bearing, wherein the bearing sleeve is configured to protrude past the bearing and provide a space for surrounding and positioning the deflection element. Claim 7 In paragraph 6, the deflection element is a blower comprising a spring. Claim 8 In paragraph 6, a blower configured such that the deflection element provides a preload to the inner ring of the bearing. Claim 9 A CPAP system for providing positive pressure gas for respiratory therapy to a patient, wherein the CPAP system comprises: an RPT device configured to supply a gas flow at therapeutic pressure, said RPT device comprising a blower according to any one of claims 1 to 2; a patient interface; and an air delivery conduit configured to pass a gas flow at therapeutic pressure from the RPT device to the patient interface. Claim 10 delete Claim 11 delete Claim 12 delete Claim 13 delete Claim 14 delete Claim 15 delete Claim 16 delete Claim 17 delete Claim 18 delete Claim 19 delete Claim 20 delete Claim 21 delete

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