Acoustic detection and / or analysis in respiratory treatment apparatus
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- RESMED PTY LTD
- Filing Date
- 2025-07-10
- Publication Date
- 2026-04-20
AI Technical Summary
Existing respiratory therapy devices face challenges in comfort, ease of use, manufacturability, and effectiveness due to issues such as poor mask fit, discomfort, and difficulty in cleaning, leading to reduced patient compliance and inconsistent sound coupling between microphones and air circuits.
The introduction of an intermediate component that connects the air delivery conduit to the respiratory treatment device, featuring a sound port and seal to facilitate sound propagation and improve acoustic coupling, along with a removable and washable design for enhanced patient compliance and device performance.
Enhances patient compliance by improving comfort and ease of use, while ensuring effective acoustic coupling and consistent sound analysis for better therapy delivery and component identification.
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Abstract
Description
[Technical Field]
[0001] A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.
[0002] 1 Cross-reference to related applications This application claims priority to U.S. Provisional Application No. 63 / 011,052, filed April 16, 2020, and U.S. Provisional Application No. 63 / 048,535, filed July 6, 2020, both of which are incorporated by reference in their entireties. [Background technology]
[0003] 2. Technical Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.
[0004] 2.2 Description of Related Art 2.2.1 The human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.
[0005] These airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, transferring oxygen from inhaled air into the venous blood and carbon dioxide outflowing. The trachea divides into the right and left main bronchi, which further divide into the terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, known as the respiratory zone. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.
[0006] A range of respiratory disorders exists, and particular disorders can be characterized by particular events, such as apnea, hypopnea, and hyperpnea.
[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall disorders.
[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events such as closure or obstruction of the upper airway during sleep. It results from an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. As a result of this disorder, affected individuals experience breathing cessation typically lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This can result in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. This syndrome is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Pat. No. 4,944,310 (Sullivan).
[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control system, resulting in alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).
[0010] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders:
[0011] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.
[0012] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.
[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.
[0014] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and only modestly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.
[0015] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.
[0016] A range of treatments are available to treat or ameliorate such diseases, and otherwise healthy individuals can also benefit from preventative treatments for respiratory disorders. However, these suffer from several deficiencies.
[0017] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).
[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they perceive one or more of the following about the device used to deliver the treatment: it is uncomfortable, difficult to use, expensive, or aesthetically unattractive.
[0019] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.
[0020] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.
[0021] 2.2.3 Treatment System These treatments may be provided by therapeutic systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.
[0022] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.
[0023] Another form of treatment system is the mandibular repositioning device.
[0024] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the treatment being applied, the patient interface may form a seal with, for example, an area of the patient's face, thereby facilitating gas delivery at a pressure sufficient to disperse with ambient pressure for treatment to occur (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure). In other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O.
[0025] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.
[0026] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).
[0027] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.
[0028] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).
[0029] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.
[0030] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Using the wrong size mask can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks can be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true when the mask must be worn during sleep.
[0031] CPAP therapy can be highly effective for certain breathing disorders if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.
[0032] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.
[0033] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.
[0034] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the above-mentioned therapies, for example, by actuating the device to generate a delivery flow of air to an interface with the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.
[0035] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., reliability, size, and weight requirements of medical devices). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.
[0036] One example of a special requirement for a particular RPT device is acoustic noise.
[0037] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744). [Table 1]
[0038] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar™ series of adult and pediatric ventilators) can provide invasive and non-invasive independent ventilation support for patients for a range of diseases (including, but not limited to, NMD, OHS, and COPD).
[0039] The ResMed Elis Accent-Aiguée® 150 ventilator and ResMed VSIII™ ventilators can provide invasive and non-invasive dependent ventilatory support suitable for adult or pediatric patients for the treatment of multiple illnesses. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.
[0040] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be significantly affected by minor changes in one or more parameters.
[0041] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient's airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.
[0042] A range of artificial humidification devices and systems are known, but they do not meet the special requirements of medical humidifiers.
[0043] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, not the patient's surroundings. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.
[0044] 2.2.3.4 Acoustic analysis Patients, caregivers, clinicians, insurance companies, or technicians may desire to collect data related to respiratory therapy, whether related to the patient, individual components used in the therapy, or the entire treatment system. There are numerous situations in which one or more parties may benefit from collecting and utilizing treatment-related data in providing respiratory therapy to a patient.
[0045] In particular, some components of a respiratory therapy system require more frequent replacement than others for effective therapy. For example, a patient interface with a silicone seal-forming portion may be replaced by the patient every few months (e.g., every three months), whereas a therapy device may be replaced or upgraded every few years (e.g., every three years). For components (e.g., patient interfaces) that are replaced relatively frequently, patients or caregivers face challenges in reliably, accurately, and cost-effectively receiving notification when the component should be replaced. When replacing a component, the patient or caregiver may need to change one or more settings in the therapy system (e.g., software settings in an RT device) so that the therapy system can take full advantage of the new component. Therefore, being able to identify components in a respiratory therapy system is important both for optimizing therapy and for informing patients and caregivers when replacement is required.
[0046] One solution is to configure a device to identify components of a respiratory therapy system configured in part by acoustic means. In particular, such a device includes structures and processes configured to analyze acoustic reflections from system components to more accurately identify those components from their "acoustic signatures."
[0047] In such devices, microphones are positioned and configured to sense sound in the air circuit, and analysis of the sound from the microphones produces an acoustic signature of the system components, thereby identifying the acoustic signature. Summary of the Invention [Problem to be solved by the invention]
[0048] Three issues can affect the quality and consistency of sound between devices and over time: variations in the relative positions of the microphone and air circuit due to manufacturing tolerances; sound escape to the surroundings; and conduction of device vibrations to the microphone during use. Improved methods for coupling microphones to air circuits are needed. [Means for solving the problem]
[0049] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.
[0050] A first aspect of the present technology relates to devices used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.
[0051] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.
[0052] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.
[0053] One aspect of the present technology is a method for manufacturing a device.
[0054] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.
[0055] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).
[0056] An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a humidifier tank that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.
[0057] Aspects of the present technology relate to an intermediate component for connecting an air delivery tube to a respiratory treatment device. The respiratory treatment device may include a pressure generator and / or a water reservoir to which the air delivery tube is connected via the intermediate component. In a broader context, the intermediate component may include any independent component or portion of a component disposed within an air flow path (airpath) or in fluid communication with the air path to receive sound from the airpath. The intermediate component may be removable, replaceable, and / or washable. In certain embodiments, when the intermediate component connects the water reservoir to the air delivery tube, the term "intermediate" in the phrase "intermediate component" may refer to this connection. However, this may also refer, at least in some specific embodiments of the described technology, that the component is disposed between a sound source and a sound sensor and provides a link between them.
[0058] In an example of the above embodiment, the water reservoir may include a cavity configured to hold a volume of water and receive a flow of breathable gas. The air delivery conduit may be configured to deliver a flow of breathable gas humidified in the water reservoir to the patient interface. The intermediate component may include: (a) an outlet end configured to connect the air delivery conduit to the intermediate component; (b) an inlet end configured to connect the water reservoir to the intermediate component, the inlet end having a central axis disposed at an angle greater than zero relative to the central axis of the outlet end; (c) a sound port configured to promote sound propagation outside the intermediate component; and (d) a port seal disposed around the sound port, the port seal configured to provide a peripheral seal on an outer surface of the intermediate component and a sound-permeable membrane configured to cover the port. (e) the membrane is flush with the inner surface of the intermediate component; (f) the membrane is impermeable to liquids and / or gases; (g) the peripheral seal formation includes a ridge configured relative to a chassis into which the intermediate component is inserted; (h) the ridge extends 0.4 to 0.8 mm above the outer surface of the intermediate component; (i) the peripheral seal formation includes a lip extending from the periphery of the port to a central axis of the port; (j) the lip extends 0.4 to 0.8 mm above the outer surface of the intermediate component; and / or (k) the lip extends diagonally from the periphery of the port above the port.
[0059]
[0003] One aspect of the present technology relates to an intermediate component for connecting an air delivery conduit to a respiratory treatment device. The air delivery conduit is configured to deliver breathable gas provided by the respiratory treatment device to a patient interface, the intermediate component including: an outlet end configured to connect the air delivery conduit to the intermediate component; an inlet end configured to connect the respiratory treatment device to the intermediate component, the inlet end having a central axis disposed at an angle greater than zero relative to a central axis of the outlet end; a sound port configured to promote sound propagation outside the intermediate component; and a port seal disposed around the sound port, the port seal configured to provide a peripheral seal on an outer surface of the intermediate component and including an acoustic membrane configured to cover the port.
[0060] In examples of the above embodiment: (a) the membrane is flush with the inner surface of the intermediate component; (b) the membrane is impermeable to liquids and / or gases; (c) the peripheral seal formation includes a ridge configured relative to a chassis into which the intermediate component is inserted; (d) the ridge extends 0.4 to 0.8 mm above the outer surface of the intermediate component; (e) the peripheral seal formation includes a lip extending from the periphery of the port to a central axis of the port; (f) the lip extends 0.4 to 0.8 mm above the outer surface of the intermediate component; (g) the lip extends obliquely from the periphery of the port above the port; and / or (h) the inlet end is configured to connect to a water reservoir, the water reservoir being disposed within the respiratory treatment device and including a cavity structured to hold a quantity of water and providing a flow of humidified breathable gas through the intermediate component to the air delivery tube.
[0061]
[0003] One aspect of the present technology relates to an apparatus for treating respiratory disorders, the apparatus including: a pressure generator configured to generate a flow of breathable gas; an air delivery conduit configured to transmit the flow of breathable gas from the pressure generator to a patient interface; an intermediate component configured to pneumatically connect the air delivery conduit to the pressure generator, the intermediate component including a port configured to facilitate propagation of sound outside the intermediate component; a sound sensor disposed outside the intermediate component and adjacent the port of the intermediate component, the sound sensor configured to sense propagated sound outside the intermediate component; and a controller. The controller is configured to: receive sound signals generated by the sound sensor due to sound sensing during operation of the apparatus, analyze the received sound signals, and provide a response based at least in part on the analysis.
[0062] In examples of the above embodiment: (a) the responding includes at least one of: recording a result of the analyzing, displaying a result of the analyzing, transmitting a result of the analyzing, and controlling operation of the pressure generator based at least in part on the analyzing; (b) further including: a water reservoir including a cavity configured to hold a quantity of water, the water reservoir receiving the flow of breathable gas such that the flow of breathable gas is humidified before being delivered to the patient interface; and a water reservoir dock constructed and arranged to receive the water reservoir in an operating position;The intermediate component is removably coupled to the water reservoir dock to receive the humidified flow of breathable gas and deliver the flow to the air delivery tube. (c) The device includes a chassis including a chassis opening, wherein a port in the intermediate component is disposed on a first side of the chassis opening and the sound sensor is positioned on a second side of the chassis opening. (d) At least one of the sensor and the port is aligned with the chassis opening. (e) The device includes at least one of a membrane and a port seal, wherein the membrane is configured to cover the port and transmit sound from inside the intermediate component to outside the intermediate component, and the port seal is positioned to provide a sealing engagement between the port and the chassis opening. (f) The membrane and the port seal include a unitary body permanently attached to the port. (g) The intermediate component is generally tubular in shape, and the water reservoir dock includes a generally tubular opening that receives the intermediate component, wherein the intermediate component and the generally tubular opening are configured for generally frictionless insertion into the opening of the intermediate component. (h) one or more engagement formations included in at least one of the intermediate component and the tubular opening are arranged such that upon insertion of the intermediate component into the opening, engagement of the at least one engagement formation near an end of the insertion path causes the intermediate component to assume an operating configuration, wherein the port seal seals both the port and the chassis opening in the operating configuration, and at least one of the sealing engagement of the port seal, the port, and the chassis and the supportive engagement provided by the at least one engagement formation is configured to inhibit forced movement of the intermediate component from the operating configuration in the absence of a significant external force; (i) one or more of the engagement formations include an elevated feature; (j) a port seal configured to surround the port, the port seal including a peripheral sealing formation including a ridge configured to abut a surface of the chassis around the chassis opening, the intermediate component being coupled to the humidifier; (k) the ridge extends 0.4 to 0.8 mm above an outer surface of the intermediate component;(l) further comprising a port seal configured to surround the port, the port seal including a peripheral seal formation including a lip configured to abut a surface of the chassis around the chassis opening when the intermediate component is coupled to the humidifier; (m) the lip extends 0.4 to 0.8 mm above an outer surface of the intermediate component; (n) the lip extends from the periphery of the port diagonally above the port to a central axis of the port; (o) the port seal covers an inner surface of the port and includes a membrane; (p) the membrane is flush with at least the inner or outer surface of the intermediate component; (q) the membrane is impermeable to liquids and / or gases; (r) the controller is configured to determine characteristics of the air delivery tube or the patient interface based on the analysis; (s) the controller is further configured to determine based on the analysis the type or size of the air delivery tube or the type or size of the patient interface coupled to the air delivery tube; (t) the intermediate component has an outlet end configured to connect the air delivery tube to the intermediate component and a water reservoir in the intermediate component. (u) an interior corner at the inlet end of the intermediate component is rounded; (v) the interior corner includes a bellows having a span between opposing sides of the bellows, the span being no more than two times the radius of the interior corner; (w) the radius of curvature of the interior corner is 0.2 to 5 mm; (x) the water reservoir includes an outlet tube including an outlet for delivering a humidified flow of breathable gas to the air delivery tube, the intermediate component sealingly interfacing the outlet tube of the water reservoir. (y) the intermediate component includes an outlet end, and a dock connector included in the air delivery tube includes a radial lip seal adapted to form a seal with the outlet end of the intermediate component, thereby pneumatically connecting the air delivery tube to the intermediate component; (z) in the device, a central axis of the port in the intermediate component is generally aligned with a central axis of a chassis opening on a first side of the chassis opening, and a sound sensor is positioned on a second side of the chassis opening less than 2 mm from the chassis opening;(aa) the sensor is generally aligned with the port and a central axis of the chassis, (ab) the intermediate component is configured to pneumatically connect the air delivery tube to the water reservoir and mechanically connect the air delivery tube to the reservoir dock; (ac) the air delivery tube is configured to electrically connect to the reservoir dock; (ad) the air delivery tube is configured to simultaneously form a mechanical connection and an electrical connection when the air delivery tube is connected to the intermediate component; (ae) a dock connector included in the air delivery tube includes retention bumps adapted to engage with respective holes in the intermediate component, thereby mechanically connecting the air delivery tube to the intermediate component; and / or (af) the device further includes a transducer configured to generate a flow signal indicative of a characteristic of the air flow, and the controller is configured to: control operation of the pressure generator; receive flow signals from the transducer and sound signals sensed by the sound sensor during operation of the pressure generator; analyze the received sound signals; and modify operation of the pressure generator based at least in part on the analysis and the flow signal.
[0063]
[0003] One aspect of the present technology relates to an intermediate component for connecting an air delivery conduit to a respiratory treatment device. The air delivery conduit is configured to deliver breathable gas provided by the respiratory treatment device to a patient interface. The intermediate component includes: an outlet end configured to connect the air delivery conduit to the intermediate component; an inlet end configured to connect the respiratory treatment device to the intermediate component; and a sound port configured to facilitate sound propagation outside the intermediate component.
[0064] In examples of the above embodiment: (a) further including at least one of the following: a sound-permeable membrane configured to cover the port, and a port seal disposed about the sound port, the port seal configured to provide a peripheral seal formation on an outer surface of the intermediate component; (b) a central axis of the inlet end is disposed at an angle greater than zero relative to a central axis of the outlet; (c) the membrane is flush with an inner surface of the intermediate component; (d) the membrane is impermeable to liquids and / or gases; (e) a ridge included in the peripheral seal formation is configured to seal the sound port against an opening in a wall of a water reservoir dock into which the intermediate component is inserted; (f) the ridge is configured to seal the sound port against an opening in a wall of the intermediate component (g) the peripheral seal formation includes a lip extending from the periphery of the port to a central axis of the port; (h) the lip extends from the periphery of the port to a central axis of the port at an angle above the port; (j) the inlet end is configured to connect to a water reservoir disposed within the respiratory treatment device and including a cavity configured to hold a quantity of water, and to provide a flow of humidified breathable gas through the intermediate component to the air delivery tube; and / or (k) at least two of the central axis of the inlet end of the intermediate component, the central axis of the outlet end of the intermediate component, and the central axis of the port are transverse to each other.
[0065] One form of the present technology relates to an apparatus that includes: a pressure generator configured to generate a flow of breathable gas; a water reservoir including a cavity configured to hold a quantity of water, the water reservoir receiving the flow of breathable gas; a water reservoir dock constructed and arranged to receive the water reservoir in an operating position; an air delivery conduit configured to deliver the flow of humidified breathable gas in the water reservoir to a patient interface; and an intermediate component removably coupled to the water reservoir dock, the intermediate component connecting the air delivery conduit to the water reservoir. an intermediate component including a port configured to connect to the air delivery tube and the water reservoir and configured to facilitate sound propagation outside the intermediate component; a sound sensor disposed adjacent the port of the intermediate component, the sound sensor configured to receive sound propagating into the intermediate component from the air delivery tube and the water reservoir; and circuitry configured to receive sound signals sensed by the sound sensor during operation of the pressure generator, analyze the received sound signals, and control operation of the pressure generator based at least in part on the analysis.
[0066] In examples of the above embodiment: (a) the intermediate component is configured to pneumatically connect the air delivery tube to the water reservoir and mechanically connect the air delivery tube to the reservoir dock; (b) further include a chassis coupled to the water reservoir dock and including a chassis opening, the port in the intermediate component being aligned with the chassis opening on a first side of the chassis opening, and the sound sensor being positioned on a second side of the chassis opening; (c) further include a port seal, the port seal being disposed around the port and configured to provide a peripheral seal formation on an outer surface of the intermediate component; (d) The peripheral seal formation includes a ridge configured to abut a surface of the chassis coupled to the water reservoir dock around the chassis opening; (e) the ridge extends 0.4 to 0.8 mm above the outer surface of the intermediate component; (f) the ridge is configured to press against the surface of the chassis when the intermediate component is in the operating position to prevent disassembly of the intermediate component without sufficient force; (g) the peripheral seal formation includes a lip configured to abut a surface of the chassis coupled to the water reservoir dock around the chassis opening; and (h) the lip extends 0.4 to 0.8 mm above the outer surface of the intermediate component.(i) the lip extends from a side of the port above at least a portion of the port, the portion of the lip extending above the port being configured to be deflected downward when the intermediate component is in an operating position such that the intermediate component cannot be disassembled without sufficient force; (j) the lip extends from the periphery of the port diagonally above the port to a central axis of the port; (k) the port seal covers an interior surface of the port and includes a membrane, the membrane being configured to cover the port and to transmit sound from inside the intermediate component to outside the intermediate component; (l) the membrane is flush with the interior surface of the intermediate component; (m) the membrane is impermeable to liquids and / or gases; (n) the circuitry is determined based on analyzing the type of air delivery tube connected to the water reservoir. (o) the circuitry is further configured to determine based on analyzing a patient interface coupled to the air delivery tube; (p) the circuitry is further configured to determine based on analyzing a patient interface coupled to the air delivery tube; (q) the intermediate component includes an outlet end configured to connect the air delivery tube to the intermediate component and an inlet end configured to connect a water reservoir to the intermediate component, wherein a central axis of the inlet end is disposed at an angle of 90° or more relative to the central axis of the outlet end; (r) the interior corner formed by the angle is rounded; (s) the interior corner formed by the angle includes a bellows including a span between opposing sides of the bellows, wherein the span is less than or equal to two times the radius of the interior corner; (t) 0.an interior corner formed by a radius of curvature of 2-5 mm; (u) the air delivery tube configured to electrically connect to the reservoir dock; (v) the air delivery tube configured to form a mechanical connection and an electrical connection when the air delivery tube is connected to the intermediate component; (w) the water reservoir including an outlet tube providing an outlet for delivering a humidified flow of breathable gas to the air delivery tube, the intermediate component including an inlet seal adapted to form a seal with the outlet tube of the water reservoir; (x) the intermediate component including a tubular body including an outlet end, the dock connector included in the air delivery tube including a radial lip seal, (y) a dock connector included in the air delivery tube includes retention bumps adapted to engage with respective holes in the intermediate component, thereby mechanically connecting the air delivery tube to the intermediate component; and / or (z) a chassis coupled to the water reservoir dock and including a chassis opening, wherein a central axis of the port in the intermediate component is aligned with a central axis of the chassis opening on a first side of the chassis opening, and a sound sensor is positioned on a second side of the chassis opening less than 2 mm from the chassis opening.
[0067] an air delivery conduit configured to deliver the air flow to a patient interface; an intermediate component removably coupled to the respiratory treatment device, the intermediate component configured to connect the air delivery conduit to the pressure generator and including a sound port configured to facilitate sound propagation outside the intermediate component; a sound sensor disposed adjacent the port of the intermediate component, the sound sensor configured to receive sound propagated into the intermediate component from the air delivery conduit and the pressure generator; and a controller configured to control operation of the pressure generator during operation of the pressure generator, receive a flow signal from the transducer and a sound signal sensed by the sound sensor; analyze the received sound signal; and modify operation of the pressure generator based at least in part on the analysis and the flow signal.
[0068] In an example of the above embodiment: (a) the intermediate component is configured to pneumatically connect the air delivery conduit to the respiratory treatment device and mechanically connect the air delivery conduit to the respiratory treatment device; (b) further including a chassis, the chassis including a chassis opening, a port in the intermediate component aligned with the chassis opening on a first side of the chassis opening, and the sound sensor positioned on a second side of the chassis opening; (c) further including a port seal, the port seal disposed around the port and configured to provide a peripheral seal formation on an outer surface of the intermediate component; (d) the peripheral seal formation includes a ridge configured to abut a surface of the chassis; (e) the ridge extends 0.4 to 0.8 mm above the outer surface of the intermediate component; (f) the ridge is configured to press against the surface of the chassis when the intermediate component is in an operating position, preventing disassembly of the intermediate component without sufficient force; (g) the peripheral seal formation includes a lip configured to abut a surface of the chassis; and (h) the lip extends 0.4 to 0.8 mm above the outer surface of the intermediate component.(i) the lip extends from a side of the port above at least a portion of the port, the portion of the lip extending above the port being configured to be biased into the port when the intermediate component is in an operating position such that the intermediate component cannot be disassembled without sufficient force; (j) the lip extends from the periphery of the port obliquely above the port to a central axis of the port; (k) the port seal covers an inner surface of the port and includes a membrane, the membrane being configured to cover the port and to transmit sound from inside the intermediate component to outside the intermediate component; (l) the membrane is impermeable to liquids and / or gases; (m) the controller controls a pressure on an air delivery tube connected to a water reservoir. (n) an intermediate component including an outlet end configured to connect the air delivery tube to the intermediate component and an inlet end configured to connect to a pressure generator, the central axis of the inlet end being at an angle of 90° or greater relative to the central axis of the outlet end; (o) a bellows having an interior corner formed by the angle, the bellows including a span between opposing sides of the bellows, the span being less than or equal to two times the radius of the interior corner; and (b) a bellows having a radius of 0.5.and an interior angle formed by a curvature that is 2 to 5 mm; (p) the air delivery tube is configured to form a mechanical and electrical connection when the air delivery tube is connected to the intermediate component; (q) the intermediate component includes a tubular body including an outlet end, and a dock connector included in the air delivery tube includes a radial lip seal, the radial lip seal adapted to form a seal against the outlet end, thereby pneumatically connecting the air delivery tube to the intermediate component; (r) the dock connector included in the air delivery tube includes retention bumps adapted to engage with respective holes in the intermediate component, thereby mechanically connecting the air delivery tube to the intermediate component; and / or (s) further including a chassis including a chassis opening, wherein a central axis of the port in the intermediate component is aligned with a central axis of the chassis opening on a first side of the chassis opening, and the sound sensor is positioned on a second side of the chassis opening less than 2 mm from the chassis opening.
[0069] One form of the present technology relates to a respiratory treatment device that includes a source of airflow at positive pressure relative to ambient air, a chassis or housing constructed and arranged to be fixed in place relative to the source in use, an inlet pneumatic connection for connection to the source to sealably receive the airflow from the source at positive pressure in use, a container for holding a body of water in use, the container configured to direct the airflow so that it contacts a surface of the water body in use, thereby allowing water vapor to transfer from the water body to the airflow in use, thereby increasing the absolute humidity of the airflow, the container including walls at least partially constructed from a material with a relatively high thermal conductivity, a heating element, a temperature sensor, a controller for controlling the heating element, and an outlet pneumatic connection for receiving the airflow with the higher absolute humidity. The chassis or housing is configured to hold the container in close proximity to the heating element, thereby transferring thermal energy from the heating element to the water body to increase the absolute humidity of the airflow. The controller is constructed and arranged to activate the heating element to heat the water without boiling it. The respiratory treatment device includes a sealed arrangement so that, in use, the pneumatic connection has a positive pressure relative to the surroundings when an air flow with elevated absolute humidity is received at the outlet.
[0070] Another aspect of the present technology relates to a CPAP system including a humidifier, a patient interface, and an air delivery tube for delivering humidified air to the patient interface. In an example, the humidifier is integrated with an RPT device configured to generate an air flow at positive pressure.
[0071] Another aspect of the present technology relates to a humidifier that includes a water reservoir including a cavity structured to hold a quantity of water, and a water reservoir dock constructed and arranged to receive the water reservoir in an operating position.
[0072] Another aspect of the present technology relates to an apparatus for humidifying a flow of breathable gas. The apparatus includes a water reservoir including a cavity structured to hold a quantity of water, a water reservoir dock constructed and arranged to receive the water reservoir in an operating position, and an air delivery conduit configured to deliver the flow of breathable gas humidified in the water reservoir to a patient interface. The air delivery conduit is constructed and arranged to form a direct pneumatic seal with the water reservoir. The air delivery conduit may include a sound port configured to promote sound propagation outside a port seal disposed around the air delivery conduit and the sound port. The port seal may include a sound port configured to provide a peripheral seal on an outer surface of the air delivery conduit and includes a sound-permeable membrane configured to cover the port.
[0073] Another aspect of the present technology relates to an apparatus for humidifying a flow of breathable gas. The apparatus includes a water reservoir including a cavity structured to hold a quantity of water, a water reservoir dock constructed and arranged to receive the water reservoir in an operating position, an air delivery conduit configured to deliver the flow of humidified breathable gas in the water reservoir to a patient interface, and an intermediate component removably and non-rotatably coupled to the water reservoir dock. The intermediate component is configured to pneumatically connect the water reservoir to the air delivery conduit. The intermediate component includes a one-piece structure of a relatively rigid material. The one-piece structure includes an inlet end adapted to interface with the water reservoir and an outlet end adapted to interface with the air delivery conduit. A dock connector included in the air delivery conduit is constructed and arranged to form a bayonet-type connection with the water reservoir dock, thereby mechanically and electrically connecting the air delivery conduit to the water reservoir dock. The intermediate component includes a sound port configured to facilitate sound propagation outside the intermediate component and a port seal disposed about the sound port, the port seal configured to provide a peripheral seal formation on an outer surface of the intermediate component and including a sound permeable membrane configured to cover the port.
[0074] Another aspect of the present technology relates to an apparatus for humidifying a flow of breathable gas. The apparatus includes a water reservoir including a cavity structured to hold a quantity of water, a water reservoir dock constructed and arranged to receive the water reservoir in an operating position, an air delivery conduit configured to deliver the flow of breathable gas humidified in the water reservoir to a patient interface, and an intermediate component removably and non-rotatably coupled to the water reservoir dock. The intermediate component is configured to pneumatically connect the air delivery conduit to the water reservoir, and the intermediate component is configured to mechanically connect the air delivery conduit to the reservoir dock. The intermediate component includes a sound port configured to promote sound propagation outside the intermediate component, and a port seal disposed around the sound port. The port seal is configured to provide a peripheral seal on an outer surface of the intermediate component and includes a sound-permeable membrane configured to cover the port.
[0075] One aspect of the present technology, a magnetic coupler, flexibly couples a microphone to an air circuit to improve sound quality and consistency in the acoustic components that characterize a respiratory therapy system. The magnetic coupler is self-aligning, ensuring consistency in the relative horizontal and vertical positions of the microphone and air circuit. The coupler also acts as a completely sealed pathway, minimizing sound escape to the surroundings. The flexibility of the coupler provides some damping of device vibrations. The coupler can be a "bellows"-type coupler, increasing vertical flexibility. Optionally, to reduce vibration transmission from the PCBA to the microphone, the microphone can be mounted on rubber feet on tabs on the PCBA that are partially surrounded by a cutout channel.
[0076] According to one aspect of the present technology, the disclosed coupler is configured to connect to a sensor and transmit sound from a port in an air circuit of an RPT device to the sensor. In some aspects of the present technology, the sensor can be coupled to a circuit board positioned above the port; the circuit board includes a channel at least partially cut out around a portion of the circuit board that supports the sensor, the coupler includes a bellows, and / or the coupler provides a magnetic connection to the air circuit.
[0077]
[0003] One aspect of the present technology relates to an apparatus for treating a respiratory condition, the apparatus including: a pressure generator configured to generate a flow of breathable gas; an air delivery conduit configured to transmit the flow of breathable gas from the pressure generator to a patient interface; an intermediate component configured to pneumatically connect the air delivery conduit to the pressure generator, the intermediate component including a port configured to facilitate propagation of sound outside the intermediate component; a sensor disposed adjacent to the port of the intermediate component, the sensor configured to sense sound propagating through the port; a flexible coupler configured to connect to the sensor and transmit sound from the port to the sensor; and a controller. The controller is configured to receive sound signals generated by the sensor due to sound sensing during operation of the apparatus, analyze the received sound signals, and provide a response based at least in part on the analysis.
[0078] In examples of the above embodiment: (a) the response includes at least one of the following: recording a result of analyzing, displaying a result of analyzing, transferring a result of analyzing, and controlling operation of a pressure generator based at least in part on analyzing; (b) the device includes a chassis including a chassis opening, wherein a port in the intermediate component is disposed on a first side of the chassis opening and the sensor is positioned on a second side of the chassis opening; (c) the device includes a circuit board disposed on the second side of the chassis opening, wherein the sensor is coupled to the circuit board; (d) the device includes a circuit board to which the sensor is coupled, wherein the coupler includes an outlet end configured to couple directly to the sensor and an inlet end configured to be removably coupled to the intermediate component; (e) at least a portion of the outlet end is directly coupled to the circuit board; (f) the outlet end includes a plurality of rubber feet configured to connect the coupler to the circuit board; (g) the circuit board includes a channel cut through the circuit board and configured to couple to the sensor for vibration isolation from the circuit board to the sensor. (h) the channel is at least partially disposed around a portion of the coupled circuit board; (i) the channel is at least partially disposed around a hole in the circuit board electrically connected to the sensor; (i) the channel forms a tab, the tab configured to deflect in a vertical direction from the surface of the circuit board; (j) the inlet end includes a first connection element configured to be removably coupled to a second connection element connected to the intermediate component; (k) the first connection element includes a magnet, and / or the second connection element includes a magnet; (l) one of the first connection element or the second connection element includes a metal ring; (m) the first connection element has a ring shape, and / or the second connection element has a ring shape; (n) the inner diameter of the first connection element is the same as the inner diameter of the second connection element; (o) the second connection element is disposed below the surface of the intermediate component around the port; (p) further including a membrane configured to cover the port and to transmit sound from the inside of the intermediate component to the outside of the intermediate component; (q) the membrane is configured to cover an end of the coupler adjacent to the intermediate component;(r) the membrane is disposed on an underside of the outer surface of the intermediate component; (s) the coupler includes an outlet end configured to couple to the sensor and an inlet end configured to couple to the intermediate component, the coupler including one or more bellows disposed between the outlet and inlet ends; (t) the one or more bellows are adapted to allow the inlet end to be displaced horizontally and / or vertically relative to the outlet end; (u) further including a circuit board to which the sensor is coupled, the coupler configured to directly engage the sensor without a direct connection to the circuit board; and / or (v) the air delivery tube is configured to deliver a flow of breathable gas from the pressure generator to the patient interface;
[0079]
[0003] One aspect of the present technology relates to an apparatus for treating respiratory disorders, the apparatus including: a pressure generator configured to generate a flow of breathable gas; an air delivery conduit configured to transmit the flow of breathable gas from the pressure generator to a patient interface; an intermediate component configured to pneumatically connect the air delivery conduit to the pressure generator, the intermediate component including a port configured to facilitate propagation of sound outside the intermediate component; a circuit board disposed adjacent to the port; a sensor assembly disposed between the circuit board and the port of the intermediate component, the sensor assembly including a sensor coupled to the circuit board and a first connecting element configured to sense propagated sound outside the intermediate component and configured to removably connect to a second connecting element disposed at least partially around the port in the intermediate component; and a controller. The controller is configured to receive sound signals generated by the sensor due to sound sensing during operation of the apparatus, analyze the received sound signals, and provide a response based at least in part on the analysis.
[0080] In examples of the above embodiment: (a) the sensor is directly coupled to the circuit board; (b) the sensor is disposed within a flexible housing, the flexible housing including a plurality of rubber feet configured to couple the flexible housing to the circuit board; (c) the end of the sensor assembly adjacent the port is configured to be displaced vertically and / or horizontally when the end of the sensor assembly adjacent the port is misaligned from the port when the intermediate component is in the assembled position; (d) the first connecting element is a magnetic ring and the second connecting element is a magnetic or metal ring and configured to removably couple the magnetic ring into the first connecting element; (e) the circuit board includes a channel cut through the circuit board and configured to removably couple the sensor assembly from the circuit board. (f) a channel is provided at least partially around a portion of the circuit board connected to the sensor assembly for isolating vibrations to the sensor; (g) the channel forms a tab including a through hole, the tab configured to deflect in a vertical direction from the surface of the circuit board; (h) the second connecting element is positioned below the surface of the intermediate component around the port; (i) further comprising a membrane configured to cover the port on the inner surface of the intermediate component or on the outer surface of the intermediate component and to transmit sound from inside the intermediate component to outside the intermediate component; and / or (j) the membrane is impermeable to liquids and / or gases.
[0081]
[0003] An aspect of one form of the present technology relates to an apparatus for treating a respiratory disorder, the apparatus including: a pressure generator configured to generate a flow of breathable gas, the pressure generator configured to pneumatically connect to an air delivery conduit configured to deliver the flow of breathable gas from the pressure generator to a patient interface, the air delivery conduit including a port configured to facilitate propagation of sound outside the air delivery conduit; a sensor configured to sense sound propagating through the port when the pressure generator is connected to the air delivery conduit; a flexible coupler configured to connect to the sensor and deliver sound from the port to the sensor; and a controller. The controller is configured to receive sound signals generated by the sensor due to sound sensing during operation of the apparatus, analyze the received sound signals, and provide a response based at least in part on the analysis.
[0082] In examples of the above embodiment: (a) the response includes at least one of the following: recording a result of analyzing, displaying a result of analyzing, transferring a result of analyzing, and controlling operation of a pressure generator based at least in part on analyzing; (b) the device includes a chassis including a chassis opening, the port being disposed on a first side of the chassis opening and the sensor being positioned on a second side of the chassis opening; (c) the device further includes a circuit board disposed on the second side of the chassis opening, the sensor being coupled to the circuit board; (d) the device further includes a circuit board to which the sensor is coupled, the coupler including an outlet end configured to couple directly to the sensor and an inlet end configured to removably couple to the air delivery tube; (e) at least a portion of the outlet end being coupled directly to the circuit board; (f) the outlet end including a plurality of rubber feet configured to connect the coupler to the circuit board; (g) the circuit board includes a channel cut through the circuit board, the channel being a portion of the circuit board coupled to the sensor for vibration isolation from the circuit board to the sensor. (h) the channel is at least partially disposed around the periphery through a hole in a circuit board electrically connected to the sensor; (i) the channel forms a tab, the tab configured to deflect in a vertical direction from a surface of the circuit board; (j) the inlet end includes a first connection element configured to removably couple to a second connection element connected to the air delivery tube; (k) the first connection element includes a magnet and / or the second connection element includes a magnet; (l) one of the first connection element or the second connection element is , including a metal ring; (m) the first connecting element has a ring shape and / or the second connecting element has a ring shape; (n) the inner diameter of the first connecting element is the same as the inner diameter of the second connecting element; (o) the second connecting element is positioned below the surface of the air delivery tube around the port; (p) the device further includes a membrane configured to cover the port and to transmit sound from inside the delivery tube to outside the delivery tube; (q) the membrane is configured to cover the end of the coupler adjacent to the delivery tube; (r) the membrane is provided below the outer surface of the delivery tube;(s) the coupler includes an outlet end configured to couple to the sensor and an inlet end configured to couple to the delivery tube, the coupler including one or more bellows disposed between the outlet end and the inlet end; (t) the one or more bellows are adapted to allow the inlet end to be displaced horizontally and / or vertically relative to the outlet end; (u) the device further includes a circuit board to which the sensor is coupled, the coupler configured to directly engage the sensor without direct connection to the circuit board; and / or (v) the device further includes an air delivery tube;
[0083] An aspect of one form of the present technology relates to an apparatus for treating respiratory ailments, the apparatus including: a pressure generator configured to generate a flow of breathable gas; an intermediate component pneumatically connected to an air delivery conduit, the intermediate component including a port configured to facilitate propagation of sound outside the intermediate component; a sensor externally attached to the intermediate component and positioned adjacent the port of the intermediate component, the sensor configured to sense sound propagating through the air delivery conduit; and a controller configured to receive sound signals generated by the sensor due to sound sensing during operation of the apparatus, analyze the received sound signals, and provide a response based at least in part on the analysis.
[0084] In examples of the above embodiment: (a) the intermediate component is configured to pneumatically connect the air delivery tube to the pressure generator; (b) the response includes at least one of: recording a result of the analyzing, displaying a result of the analyzing, transferring a result of the analyzing, and controlling operation of the pressure generator based at least in part on the analyzing; (c) the device further includes a chassis including a chassis opening, wherein the port in the intermediate component is positioned on a first side of the chassis opening and the sensor is positioned on a second side of the chassis opening. (d) the device further includes a circuit board disposed on a second side of the chassis opening, the sensor coupled to the circuit board; (e) the device further includes a flexible coupler configured to transmit sound from the port to the sensor; (f) the device further includes a circuit board to which the sensor is coupled, the coupler including an outlet end configured to directly engage the sensor and an inlet end configured to removably engage with the intermediate component; (g) one end of the coupler removably engages (or at least contacts) the intermediate component and / or the other end engages with the sensor ( (h) at least a portion of the outlet end contacts the circuit board; (i) the outlet end includes an end cap; (j) the end cap includes one or more feet configured to contact the circuit board and / or one or more connection ports for connecting the sensor to the circuit board; (k) the circuit board includes a channel cut through the circuit board and at least partially around a portion of the circuit board coupled to the sensor for vibration isolation from the circuit board to the sensor; (l) the channel is formed by a contact on the circuit board electrically connected to the sensor. (m) the channel defines a tab, the tab configured to deflect in a direction transverse to the surface of the circuit board; (n) the inlet end includes a first connection element configured to removably couple to a second connection element connected to the intermediate component; (o) the first connection element includes a magnet, and / or the second connection element includes a magnet; (p) one of the first connection element or the second connection element includes a metal ring; (q) the first connection element has a ring shape, and / or the second connection element has a ring shape;(r) the second connecting element is disposed on an underside of a surface of the intermediate component around the port; (s) the coupler includes one or more bellows disposed between the outlet end and the inlet end; (t) the one or more bellows are adapted to allow the inlet end to be displaced horizontally and / or vertically relative to the outlet end; (u) the coupler is configured to directly contact the sensor without a direct connection to the circuit board; (v) the device further includes an air delivery tube configured to deliver a flow of breathable gas from the pressure generator to the patient interface; (w) the device further includes a membrane configured to cover the port and to transmit sound from inside the intermediate component to outside the intermediate component; (x) the membrane is disposed on an underside of an outer surface of the intermediate component; (y) the device includes at least one of a membrane and a port seal, the membrane configured to cover the port and to transmit sound from inside the intermediate component to outside the intermediate component. and the port seal is positioned to provide a sealing engagement between the port and the chassis opening when the intermediate component is in an operating configuration; (z) the device further includes: a water reservoir including a cavity configured to hold a quantity of water, the water reservoir receiving a flow of breathable gas such that the flow of breathable gas is humidified before being delivered to the patient interface; and a water reservoir dock constructed and arranged to receive the water reservoir in the operating position, the intermediate component being removably coupled to the water reservoir dock to receive the humidified flow of breathable gas and deliver the flow to the air delivery tube; (aa) the intermediate component is generally tubular in shape, the water reservoir dock including a generally tubular opening that receives the intermediate component, the intermediate component and the generally tubular opening configured for generally frictionless insertion into the opening of the intermediate component;(ab) at least one engagement formation included in the intermediate component and at least one of the generally tubular openings is arranged such that upon insertion of the intermediate component into the opening, engagement of the at least one engagement formation places the intermediate component in an operating configuration, where in the operating configuration at least one of sealing engagement between the port seal and the chassis opening and supportive engagement provided by the at least one engagement formation is configured to inhibit forced movement of the intermediate component from the operating configuration in the absence of a significant external force; (ac) engagement of the at least one engagement formation occurs at a later point in the insertion path; (ad) one or more of the engagement formations includes an elevated feature that causes upward movement of at least a portion of the intermediate component; (ae) the elevated feature is located on a bottom of the tubular opening and pushes the intermediate component upward after the intermediate component has been inserted a predetermined distance into the tubular opening, reducing clearance between an upper portion of the tubular opening and the intermediate component; (af) at least one of the intermediate component and the generally tubular opening each includes a plurality of (ag) the device further includes a port seal configured to surround the port, the port seal including a peripheral seal formation including a ridge configured to abut a surface of the chassis around the chassis opening when the intermediate component is coupled to the water reservoir dock; (ah) the device further includes a port seal configured to surround the port, the port seal including a peripheral seal formation including a lip configured to abut a surface of the chassis around the chassis opening when the intermediate component is coupled to the humidifier; (ai) the lip extends from the periphery of the port diagonally above the port to a central axis of the port; (aj) the port seal covers an inner surface of the port and includes a membrane; (ak) the membrane is flush with at least the inner or outer surface of the intermediate component; (al) the membrane is impermeable to liquids and / or gases; (am) the controller is configured to determine based on analyzing characteristics of the air delivery tube or the patient interface;(an) the controller is further configured to determine, based on analyzing a type or size of the air delivery tube or a type or size of a patient interface coupled to the air delivery tube; (ao) the intermediate component includes an outlet end configured to connect the air delivery tube to the intermediate component and an inlet end configured to connect the water reservoir to the intermediate component, wherein the air path between the inlet end and the outlet end is nonlinear and includes at least one turn, and at least the turn closest to the port is curved; (ap) a central axis of the inlet end is aligned with a central axis of the outlet end (aq) the transverse air passages are substantially transverse to the central axis of the air delivery tube, defining corresponding transverse air passages, outer and inner corners, each corner including a rounded inner surface; (aq) the transverse air passages are provided between inlet end crosses adjacent the inlet end, the inlet end including an inlet seal adapted to interface with the water reservoir; (ar) the inner corner includes a bellows including a span between opposing sides of the bellows, the span being no more than two times the radius of the inner corner, and / or the inner surface of the inner corner including a radius of curvature of 0.2 to 5 mm; (as) the intermediate component connects the air delivery tube to the water reservoir. (at) the air delivery tube is configured to simultaneously form a mechanical connection and an electrical connection when the air delivery tube is connected to the intermediate component; (au) the device further includes a transducer configured to generate a flow signal indicative of a characteristic of the air flow, the controller being configured to control operation of the pressure generator and, during operation of the pressure generator, receive the flow signal from the transducer and an acoustic signal sensed by the sensor; analyze the received acoustic signal and modify operation of the pressure generator based at least in part on the analysis and the flow signal; (av) a chassis including a chassis opening extending through the chassis, the port in the intermediate component being disposed adjacent a first end of the chassis opening; and a circuit board disposed adjacent a second end of the chassis opening, the sensor being positioned on the circuit board and aligned with the chassis opening; (aw) the second end of the chassis opening includes an opening larger than the opening at the first end;(ax) the second end of the chassis opening is defined by a sidewall extending from a surface of the chassis facing the circuit board; (ay) the sensor is positioned at least partially inside the chassis opening and / or the sidewall; (az) further comprising a seal disposed between the chassis and the circuit board and adjacent the second end of the chassis opening; (aaa) the seal includes a peripheral seal formation including a lip or ridge configured to abut a surface of the circuit board adjacent the sensor; the peripheral seal formation may extend from a surface of the seal facing the circuit board and surrounding the second end of the chassis opening; (aab) further comprising a generally tubular opening in the chassis of the device to receive a generally tubular-shaped intermediate component, the intermediate component having an inlet end adapted to be inserted into the opening, an outlet end adapted to interface with an air delivery tube, a flange disposed between the inlet and outlet ends, and a flange (e.g., for the purpose of cushioning abutment with a wall of the tubular opening during insertion and for vibration during use). and one or more flexible bumpers disposed adjacent a side of the flange facing the inlet end (for dynamic absorption purposes); (aac) the intermediate component further includes a barbed tab at an end of the intermediate component opposite the outlet end, the barbed tab configured to provide a snap-fit connection with a locking member of the chassis, the one or more bumpers being pressed by the flange against a portion of the chassis during the snap-fit connection to compress the barbed tab against the locking member and thereby inhibit disengagement of the barbed tab from the locking member in the absence of a significant external force; (aad) upon initial insertion of the intermediate component into the generally tubular opening, resistance between the intermediate component and the generally tubular opening is minimized, and resistance increases during a later stage of insertion where one or more engagement features of the intermediate component engage with engagement features in the generally tubular opening of the chassis, and engagement between the engagement features of the intermediate component and the chassis opening orients the intermediate component with the opening into an operative engagement configuration;(aae) a port seal arranged to provide a sealing engagement between the port and the chassis opening in the operating position, wherein the intermediate component is positioned such that during a later stage of insertion of the intermediate component into the generally tubular opening (e.g., when the intermediate component is in the operating position), interaction between each engagement feature of the intermediate component and the chassis opening ensures sealing engagement between the port seal and a surface of the chassis surrounding the chassis opening; (aaf) a water reservoir including a cavity structured to hold a quantity of water, the water reservoir receiving the flow of breathable gas such that the flow of breathable gas is humidified before being delivered to the patient interface; and a water reservoir dock constructed and arranged to receive the water reservoir in the operating position, wherein an inlet end of the intermediate component is removably coupled to the water reservoir dock to receive the humidified flow of breathable gas and deliver the flow to the air delivery tube, the inlet end including an inlet seal, wherein the port seal connects the port and the chassis opening in the operating position; a sealing engagement between the inlet end and the chassis opening, and an inlet seal provides a sealing engagement between the inlet end and the water reservoir dock; (aag) the intermediate component further includes guide ribs on an outer surface of the intermediate component and / or guide rails on an outer surface of the intermediate component, the guide ribs and guide rails being constructed and arranged to assist in alignment and insertion of the intermediate component into the generally tubular opening in the chassis by engagement with corresponding guide slots extending into the generally tubular opening in the chassis; (aah) the guide ribs are provided on a front and upper side of the intermediate component, and the guide rails are provided on an underside of the intermediate component; (aai) the chassis includes a generally tubular opening that receives the generally tubular-shaped intermediate component, the intermediate component having an inlet end adapted to be inserted into the opening and an outlet end adapted to interface with the air delivery tube, wherein a clearance between the port seal and the chassis adjacent the chassis opening is provided upon insertion of the intermediate component into the opening, and the port seal begins to engage with the chassis after the edge of the port passes the central axis or edge of the chassis opening upon insertion of the intermediate component into the opening; (aaj) after the port seal begins to engage with the chassis, the intermediate component is further inserted a predetermined distance to bring the intermediate component into an operative configuration; (aak) further comprising a flexible housing overmolded on the sensor that displaces from the circuit board and passes at least partially through the chassis opening; and / or (aal) the pressure generator, intermediate component, controller and sensor are commonly contained by the housing of the device.
[0085] An aspect of one form of the present technology relates to an apparatus for treating a respiratory condition, the apparatus including: a pressure generator configured to generate a flow of breathable gas; an air delivery conduit configured to connect to the pressure generator, the air delivery conduit including a port configured to facilitate propagation of sound outside the air delivery conduit; a sensor disposed outside the air delivery conduit, the sensor adjacent the port in the air delivery conduit, the sensor configured to sense sound propagating through the port; and a controller configured to receive sound signals generated by the sensor due to sound sensing during operation of the apparatus, analyze the received sound signals, and provide a response based at least in part on the analysis.
[0086] In examples of the above embodiment: (a) the response includes at least one of the following: recording a result of the analyzing, displaying a result of the analyzing, transferring a result of the analyzing, and controlling operation of the pressure generator based at least in part on the analyzing; (b) the device further includes a chassis including a chassis opening, the port being disposed on a first side of the chassis opening and the sensor being positioned on a second side of the chassis opening; (c) the device further includes a circuit board disposed on the second side of the chassis opening, the sensor being connected to a circuit (d) the device further includes a flexible coupler configured to transmit sound from the port to the sensor; (e) the device further includes a circuit board to which the sensor is coupled, the coupler including an outlet end configured to directly engage the sensor and an inlet end configured to removably engage the air delivery tube; (f) one end of the coupler is removably coupled to the air delivery tube and / or the other end is coupled to the sensor; (f) at least a portion of the outlet end contacts the circuit board; (g) the outlet end includes an end cap; (g) the end cap is connected to the circuit board. (h) a channel included in the circuit board is cut through the circuit board and at least partially circumferentially extends around a portion of the circuit board coupled to the sensor for vibration isolation from the circuit board to the sensor; (i) the channel is cut through a hole in the circuit board that is electrically connected to the sensor; (j) the channel forms a tab, the tab configured to deflect in a direction transverse to a surface of the circuit board. (k) the inlet end includes a first connecting element configured to removably couple to a second connecting element connected to the air delivery tube; (l) the first connecting element includes a magnet, and / or the second connecting element includes a magnet; (m) one of the first connecting element or the second connecting element includes a metal ring; (n) the first connecting element has a ring shape, and / or the second connecting element has a barbed ring shape; (o) the second connecting element is positioned below a surface of the air delivery tube around the port; (p) the coupler includes one or more bellows positioned between the outlet end and the inlet end;(q) the one or more bellows are adapted to allow the inlet end to be displaced horizontally and / or vertically relative to the outlet end; (r) the coupler is configured to contact the sensor without a direct connection to the circuit board; (s) the device further includes an air delivery tube configured to deliver a flow of breathable gas from the pressure generator to the patient interface; (t) the device further includes a membrane configured to cover the port and to transmit sound from inside the air delivery tube to outside the air delivery tube; (u) the membrane is disposed on an underside of an outer surface of the air delivery tube; (v) the device includes a seal between the membrane and the port seal. the membrane is configured to cover the port and transmit sound from inside the air delivery tube to outside the air delivery tube, the port seal being positioned to provide a sealing engagement between the port and the chassis opening; (w) the device further includes: a water reservoir including a cavity structured to hold a quantity of water, the water reservoir receiving the flow of breathable gas such that the flow of breathable gas is humidified before being delivered to the patient interface; and a water reservoir dock constructed and arranged to receive the water reservoir in an operating position. the air delivery tube is removably coupled to the water reservoir dock to receive and deliver a humidified flow of breathable gas to the air delivery tube; (y) the air delivery tube includes at least one engagement formation arranged adjacent an end of the insertion path upon insertion of the air delivery tube into the opening such that engagement of the at least one engagement formation places the air delivery tube in an operational configuration, wherein the port seal seals both the port and the chassis opening in the operational configuration, and at least one of the sealing engagement of the port seal with the port and the chassis opening and the supporting engagement provided by the at least one engagement formation is configured to inhibit forced movement of the air delivery tube from the operational configuration in the absence of a significant external force; (z) one or more of the engagement formations includes an elevated feature;(aa) the device further includes a port seal configured to surround the port, the port seal including a peripheral seal formation including a ridge configured to abut a surface of the chassis around the chassis opening when the air delivery tube is connected to the water reservoir dock; (ab) the device further includes a port seal configured to surround the port, the port seal including a peripheral seal formation including a lip configured to abut a surface of the chassis around the chassis opening when the air delivery tube is connected to the humidifier; (ac) the lip extends from the periphery of the port diagonally above the port to a central axis of the port; (ad) the port seal covers an inner surface of the port and includes a membrane; (ae) the membrane is at least flush with an inner or outer surface of the air delivery tube; (af) the membrane is resistant to liquids and / or gases. and (ag) the controller is configured to make the determination based on analyzing a characteristic of the air delivery conduit or the patient interface; (ah) the controller is further configured to make the determination based on analyzing the type or size of the air delivery conduit or the type or size of the patient interface coupled to the air delivery conduit; and / or (ai) the device further includes a transducer configured to generate a flow signal indicative of a characteristic of the air flow, the controller being configured to: control operation of the pressure generator; receive the flow signal from the transducer and an acoustic signal sensed by the sensor during operation of the pressure generator, analyze the received acoustic signal, and modify operation of the pressure generator based at least in part on the analysis and the flow signal;
[0087] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory disorders (e.g., sleep-disordered breathing).
[0088] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.
[0089] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawings]
[0090] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: 4.1 Treatment System
[0091] [Figure 1A] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A]Outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] Diagram of the human upper airway including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3H] 3G is a cross-sectional view through the structure of FIG. 3G. The surfaces shown bound a two-dimensional hole in the structure of FIG. [Figure 3I]3G structure including two-dimensional and one-dimensional holes. Also shown are surfaces bounding the two-dimensional holes in the structure of FIG. 3G. 4.4 Respiratory Waveform [Figure 4] A model of a typical human respiratory waveform during sleep is shown. 4.5 RPT Devices and Humidifiers [Figure 5A]
[0041] Fig. 4000 shows an exploded perspective view of an RPT device 4000 in accordance with one form of the present technology. [Figure 5B] FIG. 40 shows a perspective view of an RPT device 4000 including an outlet cap 4124 with a muffler in accordance with one form of the present technology. [Figure 5C] FIG. 4 shows a perspective view of an RPT device 4000 with an integrated humidifier 5000 including a water reservoir 5110 in accordance with one form of the present technology. [Figure 5D] 1 is a schematic diagram of an air pressure path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 5E] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one aspect of the present technology. [Figure 5F] FIG. 10 is a schematic diagram of an algorithm executed in an RPT device in accordance with one form of the present technology. [Figure 5G] FIG. 1 is a schematic diagram of a humidifier in accordance with one form of the present technology. [Figure 6A] FIG. 10 is a perspective view of an integrated RPT device and humidifier including a water reservoir according to an example of the present technology. [Figure 6B] FIG. 6B is a perspective view of the integrated RPT device and humidifier of FIG. 6A, in which the water reservoir has been removed from the reservoir dock. [Figure 7]
[0033] FIG. 104 is a perspective view of a pneumatic block according to an example of the present technology. [Figure 8]FIG. 13 is an exploded view of a water reservoir including a circular metal plate according to an example of the present technology. [Figure 9] FIG. 10 is a perspective view showing a reservoir dock, an intermediate component, and an air delivery tube oriented for engagement with a lock and contact assembly provided on the intermediate component and the reservoir dock according to an example of the present technology. [Figure 10] 10 is a perspective view of the reservoir dock and air delivery tube of FIG. 9, where the air delivery tube engages with a lock and contact assembly provided on the reservoir dock in an unlocked, engaged position. [Figure 11] 10 is a perspective view of the reservoir dock and air delivery tube of FIG. 9, where the air delivery tube engages with a lock and contact assembly provided on the reservoir dock in a locked position. [Figure 12] FIG. 10 is a perspective view of the reservoir dock, intermediate components, and air delivery tube of FIG. 9. [Figure 13] FIG. 10 is an exploded view showing the reservoir dock, intermediate component, air delivery tube, and reservoir dock lock and contact assembly of FIG. 9. [Figure 14] 10 is another exploded view of the reservoir dock, intermediate component, air delivery tube, and reservoir dock lock and contact assembly of FIG. 9. [Figure 15] FIG. 10 is an exploded view of the reservoir dock of FIG. 9 and its lock and contact assembly, intermediate components and air delivery tube. [Figure 16] FIG. 10 is an enlarged top perspective view of the reservoir dock of FIG. 9 including the dock exit and lock and contact assembly. [Figure 17] FIG. 10 is an enlarged perspective view of the lock and contact assembly provided in the reservoir dock of FIG. 9, excluding intermediate components. [Figure 18] 10 is another enlarged perspective view of the lock and contact assembly provided in the reservoir dock of FIG. 9, without the intermediate components. [Figure 19] FIG. 106 is a rear perspective view showing an intermediate component according to an example of the present technology. [Figure 20] FIG. 20 is a front view of the intermediate component of FIG. 19. [Figure 21] FIG. 20 is a top view of the intermediate component of FIG. 19. [Figure 22] FIG. 20 is an exploded view of the intermediate component of FIG. 19. [Figure 23] FIG. 10 is a perspective view of a reservoir dock, an intermediate component, and an air delivery tube oriented for engagement with contact assemblies provided on the intermediate component and the reservoir dock according to an example of the present technology. [Figure 24] 24 is a perspective view of the reservoir dock, intermediate component, and air delivery tube of FIG. 23, where the air delivery tube engages with the intermediate component and contact assembly provided on the reservoir dock in a locked position. [Figure 25] FIG. 24 is a perspective view showing the reservoir dock and engaged intermediate component of FIG. 23. [Figure 26] FIG. 24 is an exploded view showing the reservoir dock, intermediate components and air delivery tube of FIG. 23. [Figure 27] 24 is a perspective view of the dock outlet of the reservoir dock of FIG. 23 with the intermediate components removed. [Figure 28A] FIG. 24 is a perspective view of an intermediate component and contact assembly provided to the reservoir dock of FIG. 23. [Figure 28B] FIG. 26 is a cross-sectional view taken along the line indicated in FIG. 25 showing the connection of an intermediate component to a reservoir dock according to an example of the present technology. [Figure 28C] This figure shows a cross section of the middle component (without the bottom tab 9795) taken along the line shown in Figure 26 according to an example of the present technology. [Figure 28D] FIG. 26 is another cross-sectional view taken along the line indicated in FIG. 25, illustrating the connection of an intermediate component to a reservoir dock according to an example of the present technology. [Figure 28E] FIG. 28D is another cross-sectional view taken through the line indicated in FIG. 28D, showing the connection of an intermediate component to a reservoir dock according to an example of the present technology. [Figure 28F] FIG. 28E is another cross-sectional view taken through the line indicated in FIG. 28D, illustrating the connection of the intermediate component to the reservoir dock and the connection of the pinch arm to the chassis according to an example of the present technology. [Figure 28G] FIG. 28F is another cross-sectional view taken through the line indicated in FIG. 28F, showing the connection of the pinch arm to the chassis according to an example of the present technology. [Figure 29] FIG. 106 is a top perspective view of an intermediate component according to an example of the present technology. [Figure 30] FIG. 30 is a bottom perspective view of the intermediate component of FIG. 29. [Figure 31] FIG. 30 is a front view of the intermediate component of FIG. 29. [Figure 32] FIG. 30 is a top view of the intermediate component of FIG. 29. [Figure 33] FIG. 30 is an exploded view of the intermediate component of FIG. 29. [Figure 34A] FIG. 136 is a perspective view of an intermediate component including a raised seal formation on a sound port according to an example of the present technology; [Figure 34B] FIG. 34B is a partial cross-sectional view of an intermediate component taken along line AA shown in FIG. 23 when the raised seal formations of FIG. 34A are aligned with corresponding chassis sound openings according to an example of the present technology. [Figure 34C] FIG. 34B is a vertical cross-sectional view taken along the line shown in FIG. 34A of a ridge seal formation according to an example of the present technology. [Figure 34D] FIG. 34D is a side cross section of the raised seal formation of FIG. 34C being compressed against a chassis according to an example of the present technology. [Figure 35A] FIG. 102 is a perspective view of an intermediate component including a lip seal formation on a sound port according to an example of the present technology; [Figure 35B] FIG. 35B is a partial cross-sectional view of an intermediate component (including the lip seal formation of FIG. 35A aligned with a corresponding chassis sound opening) taken along line AA shown in FIG. 23 according to an example of the present technology. [Figure 35C] FIG. 35B is a side cross-sectional view of a lip seal formation taken along the line shown in FIG. 35A according to an example of the present technology. [Figure 35D] FIG. 35D is a side cross section of the lip seal formation of FIG. 35C compressed against a chassis in accordance with an example of the present technology. [Figure 36A]FIG. 24 is a vertical cross-sectional view taken along line AA shown in FIG. 23 of the port seal engaging with the chassis after the intermediate component is inserted into the receiving chassis opening according to an example of the present technology. [Figure 36B] FIG. 36B is a side cross-sectional view of the intermediate component of FIG. 36A being inserted further into the receiving chassis opening to initiate engagement of the port seal with the chassis according to an example of the present technology. [Figure 36C] FIG. 36B shows a side cross-sectional view of the intermediate component of FIG. 36A fully inserted into the receiving chassis opening, with the port seal engaging the chassis, according to an example of the present technology. [Figure 36D] FIG. 30 is a side cross-sectional view of the intermediate component of FIG. 29 as it is fully inserted into the receiving chassis opening, with the port seal engaging the chassis, in accordance with an example of the present technology. [Figure 37] 1 illustrates exemplary components of a system for sound signal detection in accordance with the present technology. [Figure 38A] FIG. 10 is a perspective view of a coupler coupled between a circuit board and an intermediate component in accordance with an example of the present technology. [Figure 38B] FIG. 38B is an exploded view of a coupler coupled between the circuit board and an intermediate component shown in FIG. 38A according to an example of the present technology. [Figure 38C] 38B shows a coupler coupled to the intermediate component shown in FIG. 38A according to an example of the present technology. [Figure 38D] 13 shows a second connected element coupled to an intermediate component according to an example of the present technology. [Figure 39A] FIG. 10 is a cross-sectional view of a coupler between a circuit board and an intermediate component in accordance with an example of the present technology. [Figure 39B] FIG. 38B is an exploded view of a coupler between a circuit board and an intermediate component shown in FIG. 38A according to an example of the present technology. [Figure 39C] FIG. 10 is another exploded view of a circuit board, a sensor, a coupler, and a first connection element in accordance with an example of the present technology. [Figure 39D] FIG. 39D is a side view of the circuit board, sensor, coupler, and first connection element shown in FIG. 39C. [Figure 40A] 1 illustrates the sound escape that can occur when there is no coupler between the sensor and the intermediate component. [Figure 40B] 1 illustrates sound escape that can occur in a system including a coupler between a sensor and an intermediate component, in accordance with an example of the present technology. [Figure 41A] 13 shows a rubber interface for coupling a sensor to a circuit board according to an example of the present technology. [Figure 41B] FIG. 41B is another view of a rubber interface for coupling a sensor to the circuit board shown in FIG. 41A according to an example of the present technology. [Figure 41C] 14 shows an assembly including a circuit board, an intermediate component, and a rubber interface, which is used to removably couple a sensor to the intermediate component, according to an example of the present technology. [Figure 42A] 1 shows a circuit board including a cutout channel according to an example of the present technology. [Figure 42B] FIG. 42B is an exploded view of an assembly including a circuit board, a sensor, a connecting element, and an intermediate component as shown in FIG. 42A according to an example of the present technology. [Figure 42C] FIG. 42C is a perspective view of the assembled circuit board, sensor, connection element, and intermediate component shown in FIG. 42B according to an example of the present technology. [Figure 43] 14 shows a sensor disposed within a flexible housing according to an example of the present technology. [Figure 44] 1 illustrates an exemplary method of acoustic detection and analysis according to the present technology. DETAILED DESCRIPTION OF THE INVENTION
[0092] 5 Detailed description of examples of this technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific examples described herein, and is not intended to be limiting.
[0093] The following description is provided in connection with 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 one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples may constitute an additional example.
[0094] 5.1 Treatment In one form, the present technology includes a method for treating disordered breathing, the method including applying positive pressure to the entrance of the airways of a patient 1000.
[0095] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.
[0096] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.
[0097] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 (see, for example, FIGS. 1A-1C).
[0098] 5.3 Patient Interface 3A shows a non-invasive patient interface 3000 in accordance with one aspect of the present technology, including the following functional features: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.
[0099] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.
[0100] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.
[0101] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.
[0102] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.
[0103] 5.4 RPT Device An exploded view of an RPT device 4000 in accordance with one form of the present technology is shown in Figure 5A. The RPT device 4000 may include mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms. The RPT device 4000 may be configured to generate an airflow that is delivered to a patient's airway for the treatment of one or more respiratory ailments, for example, as described anywhere herein.
[0104] In one form, the RPT device 4000 is constructed and arranged to deliver airflow 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.
[0105] The RPT device 4000 may include an outer housing having one or more panel(s) (e.g., a main panel (e.g., outer housing 4010), a front panel 4012, and a side panel 4014). The RPT device 4000 may also include an outlet cap with muffler 4124, as shown in FIGS. 5A and 5B. The outlet cap with muffler 4124 may be removable and replaceable with a water reservoir 5110 (see FIG. 5C). In such a configuration, the RPT device 4000 may be considered to include an integrated humidifier 5000. Thus, the RPT device 4000 may be used with or without humidification, depending on whether the water reservoir 5110 or the outlet cap with muffler 4124 is attached, respectively. The structure and operation of the muffler 4124 is similar to the end cap muffler described in 2015 / 089582, which is incorporated herein by reference in its entirety. Preferably, the RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. In one form, the RPT device 4000 includes a pressure generator 4140, which may be received within a pneumatic block 4020 coupled to the chassis 4016.
[0106] Further examples and details of exemplary RPT devices are described in PCT Publication No. WO2015 / 089582.
[0107] The air pressure path of the RPT device 4000 (such as that shown in FIG. 5D ) may include an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (preferably a blower 4142) capable of supplying air at positive pressure, and an outlet muffler 4124 (or a water reservoir 5110 if humidification is desired). One or more sensors or transducers 4270 (e.g., pressure and flow sensors) may be provided within the air pressure path. The air pressure path may include an anti-spillback valve 4160 to prevent water from flowing back from the humidifier 5000 into the electrical components of the RPT device 4000.
[0108] 5E, the RPT device 4000 can have an electrical power source 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, one or more protection circuits 4250, a memory 4260, a sensor / transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202 (see, e.g., FIG. 5A). In one alternative, the RPT device 4000 can include more than one PCBA 4202.
[0109] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In an alternative, one or more of the following components may be arranged as their own separate units.
[0110] 5.4.1.1 Air filter(s) An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.
[0111] In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .
[0112] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.
[0113] 5.4.1.2 Muffler(s) An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.
[0114] In one form of the present technology, an inlet muffler 4122 is positioned in the pneumatic path upstream of a pressure generator 4140 .
[0115] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.
[0116] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, 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 WO 2013 / 020167.
[0117] The pressure generator 4140 is under the control of the therapy device controller 4240 .
[0118] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.
[0119] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that sends or forwards data to the RPT device).
[0120] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the sound and / or airflow in the RPT device (e.g., flow rate, pressure, or temperature at that point in the air pressure path).
[0121] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.
[0122] In one form of the present technology, one or more transducers 4270 may be located within an RPT device.
[0123] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass, or band-pass filtering).
[0124] 5.4.1.4.1 Flow Sensor A flow sensor 4274 according to the present technology may be based on a differential pressure transducer (eg, SDP600 series differential pressure transducers from SENSIRION).
[0125] In one form, a signal indicative of the flow rate from the flow sensor 4274 is received by the central controller 4230.
[0126] 5.4.1.4.2 Pressure Sensors A pressure sensor 4272 according to the present technology can be placed in fluid communication with the pneumatic path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.
[0127] In one form, the signal from the pressure sensor 4272 is received by the central controller 4230.
[0128] 5.4.1.4.3 Motor Speed Converter In one form of the present technology, a motor speed transducer 4276 may be used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor).
[0129] 5.4.1.4.4 Ambient Light Sensor 4278 Because the RPT device 4000 is often used in a bedroom environment (e.g., just before or while the patient 1000 goes to sleep), it may be important to always ensure that any light-emitting features of the RPT device 4000 are not overly bright.
[0130] In one form of the present technology, an ambient light sensor 4278 is used for determination of light levels in the ambient area around the RPT device 4000. The ambient light signal from the ambient light sensor 4278 may be provided as an input to the central controller 4230, for example, for adjusting the brightness of the display or any other light-emitting features (e.g., the backlight of the input device 4220 or any notification lights).
[0131] The display 4294 may be configured to operate at one of a number of predetermined brightness settings, the selection of which may be made according to the signal output of the ambient light sensor 4278.
[0132] 5.4.1.4.5 Sound Sensor In one form of the present technology, the transducer 4270 can include a sound sensor. The sound sensor can be a microphone and configured to generate a signal indicative of sound in the RPT device. The sound sensor can be configured to convert sounds audible and / or inaudible to the patient into an electrical signal. The sound sensor can generate an analog or digital signal.
[0133] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., towards the motor 4144).
[0134] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.
[0135] In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.
[0136] 5.4.2.2 Input Devices In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a human to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.
[0137] In one form, input device 4220 may be constructed and arranged to allow a human to select values and / or menu options.
[0138] 5.4.2.3 Central Controller In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.
[0139] Suitable processors may include x86 INTEL processors, such as processors based on the ARM® Cortex®-M processor from ARM Holdings (e.g., the STM32 series of microcontrollers from ST MICROELECTRONIC). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series microcontrollers from ST MICROELECTRONICS) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by TEXAS INSTRUMENTS) may also be suitable.
[0140] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.
[0141] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.
[0142] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220 and the humidifier 5000.
[0143] The central controller 4230 may be configured to provide output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.
[0144] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein (e.g., one or more algorithms 4300 expressed as a computer program stored in, such as, a non-transitory computer-readable storage medium (e.g., memory 4260)). In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some methods may be performed by a remotely located device. For example, the remotely located device may determine ventilator control settings or detect respiratory-related events through analysis of recorded data (e.g., from any of the sensors described herein).
[0145] 5.4.2.4 Clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230 .
[0146] 5.4.2.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330 and forms part of the algorithm 4300 executed by the central controller 4230.
[0147] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.
[0148] 5.4.2.6 Protection circuit The one or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.
[0149] 5.4.2.7 Memory In accordance with one form of the present technology, the RPT device 4000 includes memory 4260 (e.g., non-volatile memory). In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.
[0150] Memory 4260 may be located on PCBA 4202. Memory 4260 may take the form of EEPROM or NAND flash.
[0151] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (eg, a memory card made in accordance with the Secure Digital (SD) standard).
[0152] In one form of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium on which are recorded computer program instructions (e.g., one or more algorithms 4300) embodying one or more of the methods described herein.
[0153] 5.4.2.8 Data communication systems In one form of the present technology, a data communications interface 4280 is provided and connected to the central controller 4230. The data communications interface 4280 may be connectable to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.
[0154] In one form, the data communication interface 4280 is part of the central controller 4230. In another form, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.
[0155] In one form, remote external communications network 4282 is the Internet. Data communications interface 4280 may use wired communications (e.g., via Ethernet or fiber optics) or may use wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.
[0156] In one form, the local external communications network 4284 uses one or more communications standards (eg, Bluetooth or Consumer Infrared Protocol).
[0157] In one form, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by an appropriately authorized person (e.g., a clinician).
[0158] The local external device 4288 may be a personal computer, a cell phone, a tablet or a remote control.
[0159] 5.4.2.9 Optional displays and output devices, including warnings Output devices 4290 according to the present technology may take the form of one or more of visual, audio and tactile units. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.
[0160] 5.4.2.9.1 Display Driver The display driver 4292 receives as input characters, symbols or images to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols or images.
[0161] 5.4.2.9.2 Display Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol.
[0162] 5.4.3 RPT Device Algorithm As noted above, in some forms of the present technology, the central controller 4230 may be configured to embody one or more algorithms 4300 expressed as a computer program recorded in a non-transitory computer-readable storage medium (e.g., memory 4260). The algorithms 4300 are typically grouped into groups called modules (see, e.g., FIG. 5F).
[0163] 5.4.3.1 Pre-processing module A pre-processing module 4310 in accordance with one form of the present technology receives as input a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) and performs one or more process steps to calculate one or more output values that are used as inputs to another module (e.g., a therapy engine module 4320).
[0164] In one form of the present technology, the output values include interface or mask pressure Pm, respiratory flow Qr, and leak flow Ql.
[0165] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: pressure compensation 4312, ventilation flow estimation 4314, leak flow estimation 4316, and respiratory flow estimation 4318.
[0166] 5.4.3.1.1 Pressure compensation In one form of the present technology, a pressure compensation algorithm 4312 receives as an input a signal indicative of the pressure in the pneumatic path proximal to the outlet of the pneumatic block. The pressure compensation algorithm 4312 estimates the pressure drop through the pneumatic circuit 4170 and provides as an output the estimated pressure Pm in the patient interface 3000.
[0167] 5.4.3.1.2 Estimation of ventilation flow rate In one form of the present technology, an airflow estimation algorithm 4314 receives as input an estimated pressure Pm in the patient interface 3000 and estimates the airflow Qv of air out of the vent 3400 in the patient interface 3000.
[0168] 5.4.3.1.3 Leakage flow rate estimation In one form of the present technology, a leak flow estimation algorithm 4316 receives as input the total flow Qt and the ventilation flow Qv and provides as output an estimate of the leak flow Ql, hi one form, the leak flow estimation algorithm estimates the leak flow Ql by calculating the average difference between the total flow Qt and the ventilation flow Qv over a period long enough to include several respiratory cycles (e.g., about 10 seconds).
[0169] In one form, the leak flow estimation algorithm 4316 provides a leak flow Ql as an output and receives as inputs the total flow Qt, ventilation flow Qv, and estimated pressure Pm in the patient interface 3000 by calculating the leak conductance and determining the leak flow Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the low-pass filtered quotient of the non-ventilated flow equal to the difference between the total flow Qt and the ventilation flow Qv and the low-pass filtered square root of the pressure Pm, with the low-pass filter time constant having a value sufficient to include several respiratory cycles (e.g., about 10 seconds). The leak flow Ql may be estimated as a function of the product of the leak conductance and the pressure Pm.
[0170] 5.4.3.1.4 Respiratory flow estimation In one form of the present technology, the respiratory flow estimation algorithm 4318 receives as input the total flow Qt, the ventilation flow Qv and the leak flow Ql and estimates the air respiratory flow Qr to the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.
[0171] 5.4.3.2 Treatment Engine Module In one form of the present technology, the therapy engine module 4320 receives as inputs one or more of the pressure in the patient interface 3000, Pm, and the respiratory flow of air to the patient, Qr, and provides one or more therapy parameters as outputs.
[0172] In one form of the present technology, the treatment parameter is a treatment pressure, Pt.
[0173] In one form of the present technology, the treatment parameters are one or more of the amplitude of pressure change, base pressure, and target ventilation.
[0174] In various embodiments, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.
[0175] 5.4.3.2.1 Phase Determination In one form of the present technology, the RPT device 4000 does not determine the phase. In one form of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow Qr and provides as an output Φ the phase of the patient's 1000 current respiratory cycle.
[0176] In some forms, the phase output Φ, known as discrete phase determination, is a discrete variable. One implementation of discrete phase determination results in a binary phase output Φ with a value of inspiration or expiration. This value is represented, for example, as 0 and 0.5 revolutions when the onset of spontaneous inspiration and expiration, respectively, is detected. The "triggering" and "cycling" RPT device 4000 effectively performs discrete phase determination because the trigger and cycle points are the instants at which the phase changes from inspiration to inspiration and inspiration to expiration, respectively. In one implementation of binary phase determination, the phase output Φ is determined to have a discrete value of 0 (thereby "trigging" the RPT device 4000) when respiratory flow Qr has a value greater than a positive threshold, and a discrete value of 0.5 revolutions (thereby "cycling" the RPT device 4000) when respiratory flow Qr has a value greater than a negative threshold. The inspiration time Ti and expiration time Te may be typical values estimated over many respiratory cycles of time spent with phase Φ equal to 0 (indicating inspiration) and 0.5 (indicating expiration), respectively.
[0177] Another implementation of the discrete phase determination results in a three-valued phase output Φ with one value of inspiration, pause during inspiration, and expiration.
[0178] In other forms, known as continuous phase determination, the phase output Φ is a continuous variable, varying, for example, between 0 and 1 revolution or 0 and 2π radians. An RPT device 4000 with continuous phase determination may trigger and cycle when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one implementation of continuous phase determination, the continuous value of phase Φ is determined using fuzzy logic analysis of the respiratory flow Qr. The continuous value of phase determined in this implementation is often referred to as the "fuzzy phase." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow Qr: 1. If respiratory flow drops to zero and then increases rapidly, the phase is 0 revolutions. 2. If respiratory flow is large and positive and stable, the phase is 0.25 revolutions. 3. If respiratory flow is zero and then falls rapidly, the phase is 0.5 revolutions. 4. If respiratory flow is large and stable, the phase is 0.75 revolutions. 5. If respiratory flow is zero and stable and the 5 second low pass filtered absolute value of respiratory flow is large, the phase is 0.9 revolutions. 6. If respiratory flow is positive and the phase is exhalation, the phase is 0 revolutions. 7. Respiratory flow is negative, phase is inspiration, phase is 0.5 revolutions. 8. If the 5 second low-pass filtered absolute value of respiratory flow is large, the phase increases at a constant rate equal to the patient's respiratory rate low-pass filtered by a 20 second time constant.
[0179] The output of each rule can be represented as a vector whose phase is the result of the rule and whose magnitude is the fuzzy range for which the rule is true. The fuzzy range for respiratory flow, such as "high" or "stable," is determined by an appropriate membership function. The results of the rules are represented as vectors and then combined by some function, such as taking the centroid. In such combinations, the rules may be weighted equally or differently.
[0180] In another implementation of continuous phase determination, the phase Φ, like the inspiration time Ti and expiration time Te, is first estimated separately from the respiratory flow Qr as described above. The continuous phase Φ at any instant is determined as half the fraction of inspiration time Ti that has elapsed since the previous trigger instant, or 0.5 revolutions, plus the fraction of expiration time Te that has elapsed since the previous cycle instant (whichever is more recent).
[0181] 5.4.3.2.2 Waveform determination In one form of the present technology, the therapy parameter determination algorithm 4329 provides a nearly constant therapy pressure throughout the patient's respiratory cycle.
[0182] In another form of the present technology, a therapy control module 4330 controls a pressure generator 4140 to provide a therapy pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ).
[0183] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having values in the range [0,1] for the domain of the phase values Φ provided by the phase determination algorithm 4321 to be used by the treatment parameter determination algorithm 4329.
[0184] In one embodiment, suitable for a discrete or continuous phase, the waveform template Π(Φ) is a square wave template having a value of 1 for phase values up to 0.5 revolutions and a value of 0 for phase values above 0.5 revolutions. In one embodiment, suitable for a continuous phase, the waveform template Π(Φ) includes two smoothly curved sections (i.e., a smoothly curved (e.g., raised cosine) rise from 0 to 1 for phase values up to 0.5 revolutions, and a smoothly curved (e.g., exponential) fall from 1 to 0 for phase values above 0.5 revolutions). In one embodiment, suitable for a continuous phase, the waveform template Π(Φ) is based on a square wave, but has a smooth rise from 0 to 1 for phase values up to a "rise time" below 0.5 revolutions, and a smooth fall from 1 to 0 for phase values within a "fall time" after 0.5 revolutions, with a "fall time" below 0.5 revolutions.
[0185] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates depending on the settings of the RPT device. Each waveform template Π(Φ) in the library may be provided as a look-up table of values Π versus phase values Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) "on the fly" using a predetermined functional form, perhaps parameterized by one or more parameters (e.g., the time constant of an exponential curve portion). The parameters of the functional form may be predetermined or may depend on the current state of the patient 1000.
[0186] In some forms of the present technology suitable for the discrete binary phase of inspiration (Φ=0 revolutions) or expiration (Φ=0.5 revolutions), the waveform determination algorithm 4322 calculates the waveform template Π "on the fly" as a function of the discrete phase Φ and time t measured from the most recent trigger instant. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) in two parts (inspiration and expiration) as follows:
[0187]
number
[0188] Here, Π i (t) and Π e (t) are the inspiratory and expiratory portions of the waveform template Π(Φ,t). In one such embodiment, the inspiratory portion Π i (t) is a smooth rise from 0 to 1 parameterized by the rise time, Π e (t) is a smooth decline from 1 to 0 parameterized by the decline time.
[0189] 5.4.3.2.3 Ventilation determination In one embodiment of the present technology, the ventilation determination algorithm 4323 receives the respiratory flow rate Qr as an input and determines a measurement indicative of the current patient ventilation Vent.
[0190] In some implementations, the ventilation determination algorithm 4323 determines a measurement of the ventilation Vent, which is an estimate of the actual patient ventilation. In such an implementation, it may take half of the absolute value of the respiratory flow rate Qr, which is optionally filtered by a low-pass filter (e.g., a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).
[0191] In other implementations, the ventilation determination algorithm 4323 determines a measurement of the ventilation Vent that is roughly proportional to the actual patient ventilation. In such an implementation, the peak respiratory flow rate Qpeak is estimated at the inspiratory portion of the cycle. Through the above and many other procedures including sampling the respiratory flow rate Qr, measurements roughly proportional to ventilation are obtained, but in these measurements, the fluctuations in the flow waveform shape are not so large (where the shapes of two breaths are taken to be the same as when the flow waveforms of the normalized breaths are similar in time and amplitude). To give some simple examples, there are the median of the positive respiratory flow rate, the median of the absolute value of the respiratory flow rate, and the standard deviation of the flow rate. Any linear combination of any order statistics of the absolute value of the respiratory flow rate using positive coefficients (and even some using both positive and negative coefficients) is roughly proportional to ventilation. As another example, it is the average of the respiratory flow rate at the central K-th percentage of the inspiratory portion, where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are highly proportional to ventilation.
[0192] 5.4.3.2.4 Determination of Inspiratory Flow Limitation In one embodiment of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the range of inspiratory flow limitation.
[0193] In one form, the inspiratory flow limitation determination algorithm 4324 receives as an input the respiratory flow signal Qr and provides as an output a metric of the extent to which the inspiratory portion of the breath exhibits inspiratory flow limitation.
[0194] In one form of the present technology, the inspiration portion of each breath is identified by a zero-crossing detector. A number of evenly spaced points (e.g., 65) representing time points are interpolated by an interpolator along the inspiration flow-time curve for each breath. The curve described by these points is then scaled to have unit length (duration / period) and unit area by a scaler, thereby eliminating the effects of changes in breathing rate and depth. The scaled breath is then compared in a comparator to a pre-stored template (similar to the inspiration portion of the breath shown in FIG. 6A) representing a normal, unobstructed breath. If, at any time during inspiration, the breath deviates from this template due to, for example, coughing, exhaling, swallowing, and hiccuping, as determined by a test element, the breath is rejected by exceeding a specified threshold (typically one scale unit). For data without rejection, a running average of the first such scaled point is calculated by the central controller 4230 for several preceding inspiration events. This is repeated for the second such point over the same inspiration event, and so on. Thus, for example, 65 scaled data points may be generated by the central controller 4230 to represent a moving average of several preceding inspiratory events (e.g., three events). Hereinafter, this moving average of continuously updated (e.g., 65) point values will be referred to as the "scaled flow rate" and denoted by Qs(t). Alternatively, a single inspiratory event may be used instead of the moving average.
[0195] From the scaled flow rate, two geometric factors relevant to determining partial occlusion can be calculated.
[0196] Shape factor 1 is the ratio of the mean of the median (e.g., 32) scaled flow points to the mean of the global (e.g., 65) scaled flow points. If this ratio exceeds 1, the breath is considered normal. If this ratio is less than 1, the breath is considered obstructed. A ratio of approximately 1.17 is considered the threshold between partially obstructed and unobstructed breathing, and equates to a level of obstruction that allows for the maintenance of adequate oxygenation in a typical patient.
[0197] Shape factor 2 is calculated as the mean square deviation from unit scaled flow over the mean (e.g., 32) points. A mean square deviation of approximately 0.2 units is considered normal. A mean square deviation of zero is considered a totally flow-limited breath. The closer the mean square deviation is to zero, the more the breath is considered to be flow-limited.
[0198] Shape elements 1 and 2 may be used alternatively or in combination. In other forms of the present technology, the number of sampled points, breaths, and midpoints may be different from those described above. Additionally, the thresholds may also be different from those described above.
[0199] 5.4.3.2.5 Apnea and Hypopnea Determination In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for determining the presence of apneas and / or hypopneas.
[0200] In one form, the apnea / hypopnea decision algorithm 4325 receives as an input the respiratory flow signal Qr and provides as an output a flag indicating whether an apnea or hypopnea has been detected.
[0201] In one form, apnea is detected when a function of respiratory flow Qr falls below a flow threshold for a predetermined period of time. This function may determine peak flow, a relatively short-term average flow, or a flow intermediate between the relatively short-term average and peak flow (e.g., RMS flow). The flow threshold may be a relatively long-term measurement of flow.
[0202] In one form, hypopnea is detected when a function of respiratory flow Qr falls below a second flow threshold for a predetermined period of time. This function may determine peak flow, a relatively short-term average flow, or a flow intermediate between the relatively short-term average and peak flow (e.g., RMS flow). The second flow threshold may be a relatively long-term measurement of flow. The second flow threshold is higher than the flow threshold used to detect apnea.
[0203] 5.4.3.2.6 Snoring Determination In one form of the present technology, a central controller 4230 executes one or more snore determination algorithms 4326 for determining the snore range.
[0204] In one form, the snore determination algorithm 4326 receives as an input the respiratory flow signal Qr and provides as an output a measure of the extent to which snoring is present.
[0205] The snore determination algorithm 4326 may include determining the strength of the flow signal within the range of 30-300 Hz. Additionally, the snore determination algorithm 4326 may include filtering the respiratory flow signal Qr to reduce background noise (e.g., the sound of airflow in the system from the blower).
[0206] 5.4.3.2.7 Determining Airway Patency In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the extent of airway patency.
[0207] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the output of the signal within a frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak within this frequency range is taken as indicative of an airway patency. The absence of a peak is taken as an indication of an airway closure.
[0208] In one embodiment, the frequency range in which the peak is sought is the frequency range of a small forced oscillation at the therapeutic pressure Pt. In one implementation, the forced oscillation is at a frequency of 2 Hz with an amplitude of approximately 1 cmH2O.
[0209] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the presence or absence of a cardiogenic signal, the absence of which is taken as an indication of airway obstruction.
[0210] 5.4.3.2.8 Determining target ventilation In one form of the present technology, the central controller 4230 takes as input a measurement of the current ventilation, Vent, and executes one or more target ventilation determination algorithms 4328 for the determination of a target value, Vtgt, for the ventilation measurement.
[0211] In some forms of the present technology, there is no target ventilation determination algorithm 4328 and the target value Vtgt is predetermined, for example obtained by hard coding during configuration of the RPT device 4000 or by manual entry via the input device 4220.
[0212] In other forms of the present technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates a target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.
[0213] In some forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as a high percentage and less than the typical recent ventilation Vtyp. The high percentage in such forms can be in the range (80%, 100%), or (85%, 95%), or (87%, 92%).
[0214] In other forms of adaptive servo-ventilation, the target ventilation, Vtgt, is calculated as a value slightly greater than one multiple of the typical recent ventilation, Vtyp.
[0215] Typical recent ventilation Vtyp is a value that current ventilation Vent measurements over multiple time instants over some predetermined time scale tend to be distributed around and clustered (i.e., a measure of the central tendency of current ventilation measurements in recent history). In one implementation of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case must be longer than the time scale of a Cheyne-Stokes ramp-up and ramp-down cycle. The target ventilation determination algorithm 4328 may determine typical recent ventilation Vtyp from current ventilation Vent measurements using any of a variety of well-known measures of central tendency. One such measure is the output of a low-pass filter on current ventilation Vent measurements, with a time constant equal to 100 seconds.
[0216] 5.4.3.2.9 Determination of Treatment Parameters In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for determining one or more treatment parameters using values returned from one or more of the other algorithms in the treatment engine module 4320.
[0217] In one form of the present technology, the therapy parameter is the instantaneous therapy pressure Pt. In one implementation of this form, the therapy parameter determination algorithm 4329 determines the therapy pressure Pt using the following equation:
[0218]
number
[0219] where: ● A is the amplitude, ● Π(Φ,t) is the waveform template value (ranging from 0 to 1) at the current value of phase Φ and time t; ● P0 is the base pressure.
[0220] If the waveform determination algorithm 4322 provides the waveform template Π(Φ,t) as a lookup table of values Π indexed by the phase Φ, the treatment parameter determination algorithm 4329 applies equation (1) by locating the closest lookup table entry to the current value Φ of the phase returned from the phase determination algorithm 4321 or by interpolating between two entries that span the current value Φ of the phase.
[0221] The values of amplitude A and base pressure P0 may be set by the treatment parameter determination algorithm 4329 depending on the selected respiratory pressure treatment mode as described below.
[0222] 5.4.3.3 Treatment Control Module The therapy control module 4330 according to one aspect of the present technology receives as input therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver airflow from the pressure generator 4140 in accordance with these therapy parameters.
[0223] In one form of the present technology, the treatment parameter is a treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow from the pressure generator 4140 such that the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt.
[0224] 5.4.3.4 Fault Condition Detection In one form of the present technology, the central controller 4230 executes one or more methods for detecting a fault condition (fault condition detection algorithm 4340). The fault condition detected by the one or more methods may include at least one of the following: ● Power outage (no power or power shortage) ● Converter failure detection ● Unable to detect the presence of components ● Operating parameters are outside the recommended range (e.g., pressure, flow, temperature, PaO2) • Failure of test alerts to produce detectable warning signals.
[0225] When a fault condition is detected, the corresponding fault condition detection algorithm 4340 signal signals the presence of a fault by one or more of the following: ● Initiation of audible, visual and / or kinetic (e.g., vibration) warnings. ● Sending messages to external devices Incident logging
[0226] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).
[0227] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.
[0228] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., central controller 4230). An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.
[0229] 5.6 Oxygen Delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.
[0230] 5.7 Humidifier 5.7.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 5C) for changing 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 ambient air) and increase the temperature of the air stream before delivery to the patient's airways.
[0231] 5.7.2 RPT Devices and Humidifiers 6A, 6B, and 7 show an integrated RPT device and humidifier 6000 according to an example of the present technology. In the example shown, the integrated RPT device and humidifier 6000 includes a water reservoir dock 6050 constructed and arranged to receive a water reservoir 6100 (also referred to as a humidifier tub or humidifier reservoir). In the example shown, the integrated RPT device and humidifier 6000 includes a humidifier integrated with the RPT device such that components performing the functions of the RPT device and components performing the functions of the humidifier are included in the pneumatic block 7100 of the RPT device. For example, as shown in FIG. 7, the reservoir dock 6050 is integrated with the pneumatic block 7100 of the RPT device to provide an integral unit, and the reservoir dock 6050 is constructed and arranged to receive the water reservoir 6100.
[0232] It should be understood that in an alternative arrangement, the humidifier (e.g., reservoir dock 6050) may be provided separately to the RPT device (e.g., pneumatic block 7100). In such an arrangement, an additional interface may be used to connect the humidifier (e.g., reservoir dock 6050) to the RPT device (e.g., pneumatic block 7100).
[0233] In the RPT device, a blower is supported within the pneumatic block 7100. The blower is constructed and arranged to generate a flow or supply of air at a positive pressure (e.g., in the range of 2-50 cmH2O). In one example, the blower may include a single-stage design or a multi-stage design (e.g., a two or more stage design). The blower is operable to draw a supply of air into the pneumatic block 7100 (e.g., through one or more intake openings in the pneumatic block) and into its inlet (blower inlet) to provide a supply of pressurized air at its outlet (blower outlet). Examples and details of an exemplary blower are described in PCT Patent Application Publication No. WO 2013 / 020167, which is incorporated herein by reference in its entirety. The blower outlet communicates with a humidifier (e.g., the inlet of the water reservoir 6100).
[0234] The pneumatic block 7100 includes a chassis assembly 7300 (e.g., including an upper chassis and a lower chassis). The chassis assembly 7300 includes a chassis inlet (not shown) and a chassis outlet 7320 (see, e.g., FIGS. 25 and 27). In examples, the pneumatic block 7100 may be enclosed by an external housing including one or more panels and / or one or more user inputs / displays (see, e.g., FIGS. 6A and 6B). The chassis assembly 7300 supports and / or houses the internal components of the pneumatic block 7100 (e.g., a blower). The chassis assembly 7300 also supports a printed circuit board assembly (PCBA) 7600. The printed circuit board assembly (PCBA) 7600 may include one or more components and features described with reference to PCBA 4202. The chassis assembly 7300 and the internal components of the pneumatic block cooperate to form a pneumatic airflow path extending from the chassis inlet to the blower inlet of the blower, and from the blower outlet of the blower to the chassis outlet 7320. The chassis outlet 7320 is adapted to communicate with the reservoir dock 6050 and the inlet of the water reservoir 6100 when the water reservoir is received in the reservoir dock 6050. The reservoir dock 6050 is also constructed and arranged to allow communication between the outlet of the water reservoir 6100 and the air circuit 4170, as described in more detail below.
[0235] 5.7.3 Humidifier components 5.7.3.1 Water reservoir 6A, 6B, and 8 show a water reservoir 6100 according to one example of the present technology. The water reservoir 6100 may be configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 6100 may be configured to contain a predetermined maximum amount of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the water reservoir is configured to hold several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml), although it should be understood that other volumes of liquid may also be utilized (e.g., at least 100 ml). In another form, the humidifier may be configured to receive a water supply from an external water source (e.g., a building's water supply system).
[0236] In the illustrated example, the water reservoir 6100 includes a reservoir base 6112 (also referred to as a reservoir body, humidifier tube base, or humidifier tub body) and a reservoir lid 6114 (also referred to as a humidifier tub lid) removably coupled to the reservoir base 6112. A deformable seal may be provided on the reservoir lid and / or reservoir base. When the reservoir lid 6114 is coupled to the reservoir base 6112, the seal is constructed and arranged to engage the reservoir lid 6114 and the reservoir base 6112, thereby sealing the lid and base and preventing water from escaping from the water reservoir. The reservoir lid 6114 may be constructed to be completely removable from the reservoir base 6112, thereby facilitating patient access, for example, for cleaning the interior of the reservoir base and / or reservoir lid. In another example, the reservoir lid 6114 can be permanently attached to the reservoir base 6112 .
[0237] According to one embodiment, the water reservoir 6100 is configured to humidify the air flow from the RPT device as the air flow passes through the RPT device. In one form, the water reservoir 6100 can be configured to promote a tortuous path for the air flow through the reservoir while ensuring that the air flow contacts a volume of water in the reservoir. For example, the water reservoir 6100 can include one or more flow elements (e.g., baffles to promote a tortuous flow path).
[0238] As described in more detail below, the water reservoir 6100 may be removably coupled to the reservoir dock 6050. In an example, insertion / removal of the water reservoir may be provided along a path described in a front-to-back direction. In another example, at least a portion of the path for insertion / removal of the water reservoir may extend in a bottom-up direction (e.g., at least a portion of the insertion path includes a slope or drop-down to an operating position).
[0239] The water reservoir 6100 may also be configured to inhibit liquid release from the reservoir, for example, when the reservoir is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air stream to be humidified by the humidifier is often pressurized, the reservoir may also be configured to prevent loss of air pressure through leakage and / or flow impedance.
[0240] Reservoir Base As shown in FIG. 8, the reservoir base 6112 includes a body 6140 that includes a plurality of walls and conductive portions 6150, typically on the bottom of the walls, to form a chamber or cavity that holds a volume of water.
[0241] The reservoir base 6112 is constructed and arranged to engage or interface with the reservoir lid 6114 .
[0242] The reservoir base 6112 may be constructed and arranged to retain the reservoir lid 6114 to the reservoir base 6112 (eg, a hinge arrangement and / or a snap-fit locking tab that releasably retains the reservoir lid to the reservoir base).
[0243] Conductive part The conductive portion 6150 is configured to allow efficient heat transfer from a heating element (e.g., heater plate 6080 of reservoir dock 6050 shown in FIG. 6B) to a volume of liquid in the reservoir. In one form, the conductive portion may be arranged as a plate, although other shapes may be suitable. All or part of the conductive portion may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.
[0244] Conductive parts including metal plates and / or thin films In examples, the conductive portion 6150 may include a metal plate, a thin non-metallic film (also referred to as a film plate or film base), or a hybrid laminate arrangement of a metal plate and a thin non-metallic film. As described below, the conductive portion 6150 is configured to be thermally coupled to the heater plate 6080 of the reservoir dock 6050 to enable heat transfer from the heater plate 6080 to the volume of liquid in the water reservoir 6100.
[0245] 5.7.3.2 Reservoir Dock The reservoir dock 6050 may be provided to the chassis assembly 7300 of the RPT device and is configured and arranged to receive the water reservoir 6100. In some arrangements, the reservoir dock 6050 may include a locking feature (e.g., a locking lever or tab configured to retain the water reservoir 6100 within the reservoir dock 6050).
[0246] The reservoir dock 6050 includes a body that forms a cavity that receives the water reservoir 6100. As best shown in FIG. 27 , the rear wall of the reservoir dock 6050 includes a chassis outlet 7320 (also referred to as a dock inlet) that is constructed and arranged to receive a pressurized air flow from an outlet of an RPT device to be delivered to the water reservoir 6100. The reservoir dock 6050 may also include a dock outlet that is constructed and arranged to connect to or otherwise interface with an air delivery tube 4170 or an intermediate component that connects to the air delivery tube 4170 (e.g., intermediate component 6700, intermediate component 8700, or intermediate component 9700). In an example of the present technology, the reservoir dock 6050 may enable the air delivery tube 4170 to form a direct pneumatic connection to the water reservoir 6100, thereby delivering a pressurized air flow humidified in the water reservoir 6100 directly from the water reservoir 6100 to the air delivery tube 4170.
[0247] The body of the reservoir dock 6050 includes a plurality of walls and a heating element (e.g., heater plate 6080) disposed on the bottom one of the walls to form a cavity that receives the water reservoir 6100.
[0248] 5.7.3.3 Water Reservoir to Reservoir Dock Connection In use, the water reservoir 6100 is removably coupled to the reservoir dock 6050 by insertion of the water reservoir 6100 into the reservoir dock 6050. When the water reservoir is positioned for direct engagement with the air delivery conduit 4170, the inlet seal (or inlet) of the inlet tube 6120 of the water reservoir 6100 is constructed and arranged to provide a face seal with the chassis outlet 7320 (dock inlet) of the reservoir dock 6050 when the water reservoir 6100 is coupled to the reservoir dock 6050. Similarly, the outlet seal 6132 of the outlet tube 6130 (or outlet) of the water reservoir 6100 is constructed to provide a face seal with the air circuit or air delivery tube 4170 (e.g., to avoid air pressure loss due to leakage). In the illustrated example, the water reservoir 6100 is constructed and arranged to form a direct pneumatic seal with the air delivery conduit 4170, completely bypassing the RPT device and reservoir dock 6050. The reservoir dock 6050 facilitates this direct connection, but does not form part of it.
[0249] Removing the RPT device and reservoir dock 6050 from the air delivery pathway eliminates the presence of internally disposed connecting components between the water reservoir 6100 and the air delivery conduit 4170. This makes sterilization much easier as it eliminates the need to disassemble and sterilize such connecting components. In this way, the water reservoir 6100 is the only component of the RPT device that requires replacement and sterilization when preparing the device for a different user.
[0250] When the water reservoir 6100 is inserted into the reservoir dock 6050 and reaches the operating position, the conductive portion 6150 of the water reservoir 6100 is aligned with and in thermal contact with the heater plate 6080 of the reservoir dock 6050, allowing heat transfer from the heater plate 6080 to the water in the water reservoir 6100 (e.g., the surface of the conductive portion 6150 engages or contacts the surface of the heater plate 6080). A biasing mechanism can be introduced to press the water reservoir and the heater plate against each other, thereby varying the level of thermal contact between the conductive portion and the heater plate. In one example, a spring element is provided in the water reservoir, and the reservoir dock and / or heater plate can be positioned to bias the water reservoir and the heater plate against each other, allowing for increased contact pressure and improved thermal contact.
[0251] The chassis outlet 7320 (dock inlet) is configured to receive a pressurized air flow from the RPT device's blower and to deliver the air flow into the water reservoir 6100 via the water reservoir's 6100 inlet tube 6120. As the air passes through the water reservoir 6100, moisture (i.e., water vapor) is added to the air flow, and this humidified air flow exits the water reservoir through the outlet tube 6130. From the outlet tube 6130, the air flow is delivered directly into the air delivery tube 4170 to deliver the humidified air flow to the patient.
[0252] 5.7.3.4 Guide Structure for Insertion / Removal In examples, a dock engagement portion provided by an exterior portion of the water reservoir 6100 is constructed and arranged to interface with and engage with a reservoir engagement portion of the reservoir dock 6050. In examples, the water reservoir 6100 and the reservoir dock 6050 may include guide structure to facilitate insertion, removal, and alignment of the water reservoir 6100 with the reservoir dock 6050.
[0253] 6B, opposing sides of the water reservoir 6100 along the dock engagement portion may include guide surfaces (e.g., provided by guide rails 6200) that are positioned to engage corresponding guide surfaces (e.g., provided by guide slots 6060) along the reservoir engagement portion of the reservoir dock 6050 to guide the water reservoir 6100 into the reservoir dock 6050.
[0254] In an example, as shown in FIG. 6B, the water reservoir 6100 can be inserted / removed (eg, by sliding or pushing / pulling only) along a path that extends laterally (ie, front-to-back) into and out of the cavity of the reservoir dock 6050.
[0255] In another example, at least a portion of the path for inserting / removing the water reservoir may extend in a downward-upward direction, for example, at least a portion of the path for inserting the water reservoir into the dock includes a sloped portion (e.g., a rise or fall into the operating position).
[0256] For example, the guide structure of the water reservoir 6100 and the reservoir dock 6050 can be constructed and arranged to provide for an initial horizontal or angled insertion of the water reservoir and a subsequent drop to the final operating position. In an example, the reservoir dock can provide a sloped surface and an inner lip located on the bottom surface of the dock. The water reservoir must pass over this inner lip to drop to the operating position. The passed edge and / or the drop itself can effectively lock the water reservoir in the operating position. Additional locking features can be used. Such a "push and drop" configuration includes movement of a tub having components in both horizontal and vertical directions. The optional lip can ensure that the base of the water reservoir engages with a single edge or small surface (rather than on a much larger surface) when inserted into the reservoir dock. This reduces the possibility of any wear and tear on the heater plate. A spring element may be positioned (e.g., between the reservoir dock and the water reservoir) to increase the contact pressure between the water reservoir and the heater plate (e.g., to improve thermal contact between the reservoir base plate and the dock heater plate).
[0257] 5.7.3.5 Retention Features 6B, the water reservoir 6100 can include a latch 6400 configured to releasably engage a recessed slot 6055 in the reservoir dock 6050 to releasably retain the water reservoir 6100 in an operating position within the reservoir dock 6050. Such a locking arrangement prevents the water reservoir from disengaging from the dock, and in some arrangements, such disengagement of the water reservoir can be facilitated by the relatively high actuatable pressure within the dock during operation of the device.
[0258] In the illustrated example, the latch 6400 is provided as a separate and distinct structure from the water reservoir 6100 and then secured or otherwise secured to the water reservoir 6100 in the operative position. For example, the latch 6400 comprises a pre-formed structure secured to the reservoir lid 6114 or to another portion of the water reservoir 6100. In an example, the latch 6400 comprises a plastic or thermoplastic polymer material.
[0259] 5.7.3.6 Air Delivery Tube to Reservoir Dock Connection In an example, as shown in, for example, Figures 9-15, the air delivery tube 4170 includes a tube portion 4500, a dock connector / cuff 4600 (outlet connector) that connects the air delivery tube 4170 to the reservoir dock 6050 and / or water reservoir 6100, and a patient interface connector / cuff (inlet connector shown in Figures 1A-1C) that connects the air delivery tube 4170 to the patient interface 3000.
[0260] In examples, the dock connector 4600 is constructed and arranged to form a mechanical and / or electrical connection to the reservoir dock 6050, and to form a pneumatic connection with the water reservoir 6100 and / or reservoir dock 6050. These connections allow the air delivery conduit 4170 to be positioned and secured to the reservoir dock 6050 or water reservoir 6100, to provide power, information and control signals to the heating element and transducer associated with the air delivery conduit 4170, and / or to flow humidified pressurized gas from the water reservoir 6100 to the patient interface 3000. During engagement of the air delivery conduit 4170 with the water reservoir 6100 and reservoir dock 6050, these connections may be formed simultaneously, or the connections may be formed such that, for example, one of the pneumatic, mechanical, or electrical connections is completed before the other.
[0261] The dock connector 4600 of the air delivery tube 4170 includes retention features that provide a fixed, non-rotatable connection with the dock outlet 6090 of the reservoir dock 6050 .
[0262] In one example, the air delivery tube 4170 may include multiple wires (e.g., configured to heat the air within the air delivery tube and / or transmit signals from one or more transducers (e.g., temperature sensors, flow sensors) to a controller of the RPT device) spirally wound around the axis of the air delivery tube 4170 (e.g., along the tube portion 4500 of the air delivery conduit 4170).
[0263] In an example, the air delivery tube 4170 may include four wires (e.g., two wires for powering one or more heating elements and two wires for connecting a temperature sensor / transducer), however, it should be understood that other numbers of wires may be used (e.g., two wires, three wires, or five or more wires).
[0264] In an example, the dock connector 4600 of the air delivery tube 4170 includes a contact assembly including contacts that, in use, engage with contacts provided on the reservoir dock 6050 to form an electrical connection with the reservoir dock at the dock outlet to provide power and / or control signal transmission. In an example, contacts on the dock connector 4600 may be bonded to wires extending along the air delivery tube 4170. In another example, at least some of these contacts are not associated with wires extending along the air delivery tube 4170 but are characterized by their own independent and / or unique electrical properties (e.g., resistance, conductance). Such independent and / or unique electrical properties may be used to identify one or more elements of the tube / patient interface system or properties of these elements.
[0265] In an example, the dock outlet 6090 of the reservoir dock 6050 includes a contact assembly that communicates with power and electrical signaling within the reservoir dock (e.g., PCBA 7600). In an example, the number of contacts included in the contact assembly corresponds to the number of contacts (four contacts) provided on the dock connector 4600 of the air delivery tube 4170.
[0266] Because each contact or combination of contacts within the contact assembly of the air delivery tube 4170 may have unique electrical characteristics, in examples, the contact assembly of the air delivery tube 4170 may be used as an identifier for various parameters of the air delivery tube 4170 and / or patient interface. For example, the contact assembly may be configured to provide identification of the type of air delivery tube 4170 (e.g., unheated tube, heated tube, tube containing a heat and moisture exchanger (HME), unknown tube), size of the air delivery tube (e.g., 15 mm, 19 mm), presence and type of HME, type of patient interface connected to the tube, etc. Data from the identification may be communicated and utilized by a controller, for example, to optimize operation of the RPT device, humidifier, facilitate data collection, etc. For example, the controller may be configured to recognize the unique identifying features provided by the contact assembly so that the controller can recognize specific characteristics of the air delivery tube 4170 coupled to the reservoir dock 6050, thereby enabling the controller to automatically configure the RPT device and / or humidifier for optimized operation.
[0267] 5.7.3.6.1 Bayonet-type connections and intermediate components 9-22 show another example of the connection of the air delivery conduit 4170 to the reservoir dock 6050 and the water reservoir 6100. In this example, an intermediate component 6700 is removably coupled to the reservoir dock 6050. The intermediate component 6700 is configured to pneumatically connect the water reservoir 6100 to the air delivery conduit 4170, thereby enabling a flow of pressurized air humidified in the water reservoir 6100 to be delivered from the water reservoir 6100 through the intermediate component 6700 to the air delivery conduit 4170. Also in this example, the dock connector 4600 of the air delivery conduit 4170 is constructed and arranged to form a bayonet-type connection with the reservoir dock 6050, thereby mechanically and / or electrically connecting the air delivery conduit 4170 to the reservoir dock 6050. That is, the bayonet-type connection allows for placement and securing of the air delivery tube 4170 to the reservoir dock 6050 and / or for providing power, information and control signals to the heating elements and transducers associated with the air delivery tube 4170.
[0268] 5.7.4 Humidifier Transducer(s) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5G. The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier transducer may be located external to the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.
[0269] 5.7.4.1 Pressure Transducers One or more pressure transducers 5212 may be provided to the humidifier 5000 in addition to or instead of the pressure sensor 4272 provided in the RPT device 4000.
[0270] 5.7.4.2 Flow Converter In addition to or instead of a flow sensor 4274 provided in the RPT device, one or more air flow transducers 5214 may be provided in the humidifier 5000.
[0271] 5.7.4.3 Temperature Converters The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures (e.g., the temperature of the heating element 5240 and / or the temperature of the air flow downstream of the humidifier outlet). In some forms, the humidifier 5000 may further include a temperature sensor 5216 that detects the temperature of the ambient air.
[0272] 5.7.4.4 Humidity Transducer In one form, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.
[0273] 5.7.5 Heating elements As shown in FIG. 6B and other figures, a heater plate 6080 is used for heat transfer to the water reservoir. In the illustrated example, the heater plate may form part of the reservoir dock 6050 and may be located on or near the base of the reservoir dock. At least the top layer of the heater plate includes a hard, scratch-resistant surface (which may be formed, for example, by a nickel-chromium alloy, stainless steel, or anodized aluminum). This heater plate may transfer heat from a heating element. The heating element may include a heat-generating component, such as an electrical resistance heating track. One suitable example of a heating element is a layered heating element, such as that described in PCT Patent Application Publication No. WO 2012 / 171072, the entire contents of which are incorporated herein by reference.
[0274] 5.7.6 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5G. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may communicate with the central controller 4230.
[0275] In one form, the humidifier controller 5250 may receive measurements of properties (e.g., temperature, humidity, pressure, and / or flow rate) as inputs (e.g., measurements of airflow, water in the water reservoir 5110 and / or in the humidifier 5000). The humidifier controller 5250 may also be configured to run or implement a humidifier algorithm and / or deliver one or more output signals.
[0276] As shown in FIG. 5G, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).
[0277] 5.8 Intermediate Components 9-22, an intermediate component 6700 is provided in the dock outlet 6090 of the reservoir dock 6050, thereby pneumatically connecting the water reservoir 6100 to the air delivery tube 4170. In the illustrated example, removably coupling the intermediate component 6700 to the reservoir dock 6050 allows for disassembly of the intermediate component 6700 for cleaning, sterilization, and / or replacement (e.g., for multi-patient multi-use (MPMU) applications).
[0278] 9-22 , the intermediate component 6700 includes a tubular body 6705. The tubular body 6705 includes an inlet end 6710 adapted to interface with the water reservoir 6100 and an outlet end 6720 adapted to interface with the air delivery tube 4170. The intermediate component 6700 also includes retention and alignment features that are constructed and arranged to align the intermediate component 6700 with the reservoir dock 6050 and provide a removable, non-rotatable connection with the reservoir dock 6050. Additionally, the intermediate component 6700 includes a port 6730 (e.g., a pressure port for insertion of a sensor to measure air pressure at the dock outlet 6090 or a sound port for transmitting sound from within the intermediate component 6700 to a sensor external to the intermediate component 6700). The port 6730 includes a port seal 6735 that provides a sealed interface between the sensor (e.g., a pressure sensor or sound sensor) and the intermediate component 6700. As described later in this text, an acoustically transparent cover (e.g., in the form of a membrane covering the port 6730) may also be provided in the arrangement. The body of the cover may be integral with the body of at least one of the ports 6730 and the port seal 6735.
[0279] In the illustrated example (see, e.g., FIG. 22 ), the tubular body 6705 (including the inlet end 6710 and the outlet end 6720) includes a first portion or base mold constructed of a relatively rigid material (e.g., a thermoplastic polymer (e.g., PC, ABS)) along with retention and alignment features. A second portion or overmold included in the port seal 6735 is constructed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone) applied (e.g., by overmolding) to the first portion. Thus, the intermediate component 6700 provides a substantially rigid structure (e.g., for durability for MPMU applications).
[0280] In the illustrated example, the inlet end 6710 is disposed at an angle relative to the outlet end 6720. For example, the axis of the inlet end is disposed at approximately 90° relative to the axis of the outlet end. However, it should be understood that other suitable angles are possible (e.g., the axis of the inlet end is disposed at approximately 45° relative to the axis of the outlet end).
[0281] The free end of the inlet end 6710 includes a flange or lip 6712 that surrounds the tube opening. The flange or lip 6712 provides a contact surface 6715. When the water reservoir 6100 is coupled to the reservoir dock 6050, the outlet seal 6132 of the outlet tube 6130 (or outlet) of the water reservoir 6100 is structured to engage and provide a face seal with the contact surface 6715 of the inlet end 6710. In another embodiment, the seal between the outlet tube 6130 (or outlet) of the water reservoir 6100 and the contact surface 6715 of the inlet end 6710 may be an integral part of the inlet end 6710 or may be a seal separate from the outlet tube 6130 or the inlet end 6710. In the illustrated example, the contact surface 6715 includes a taper into the tube opening (e.g., to improve sealing and prevent leakage).
[0282] The outlet end 6720 may include an ISO taper (eg, a 22 mm outer diameter ISO taper) for connection to the air delivery conduit 4170 .
[0283] With respect to the retention and alignment features, the intermediate component 6700 includes a pair of resilient pinch arms 6740 (i.e., cantilevered spring arms). Each of the springs or pinch arms 6740 may include a barbed end or tab 6745. The barbed end or tab 6745 is structured to provide a snap-fit connection to a respective locking member (e.g., protrusion 6750) provided within the cavity of the reservoir dock 6050, as shown in FIG. 12. The intermediate component 6700 also includes a guide rail 6760. The guide rail 6760 is structured and arranged to assist in proper alignment and insertion of the intermediate component 6700 into the reservoir dock 6050 by engaging with a corresponding guide slot 6755 extending into the cavity of the reservoir dock 6050, as shown in FIGS. 12, 16, and 18. Additionally, the intermediate component 6700 includes a flange 6770 disposed between the inlet end 6710 and the outlet end 6720. The flange 6770 aids in placement or positioning of the intermediate component 6700 within the reservoir dock 6050 (by abutting against a flange or wall on the reservoir dock 6050) (e.g., the flange acts as a stop during insertion). The flange 6770 of the intermediate component 6700 may include one or more cutouts or recesses 6772 (e.g., to accommodate fasteners or protrusions along a flange or wall on the reservoir dock 6050).
[0284] When the intermediate component 6700 is inserted into the dock opening 6091 of the reservoir dock 6050, the intermediate component 6700 is oriented to engage its guide rails 6760 with the guide slots 6755. The guide slots 6755 align and guide the intermediate component 6700 into the operating position. Additionally, the non-circular profile of the dock opening 6091 and / or the opening provided by the lock and contact assembly 6900 at the dock opening 6091 facilitates reorienting the intermediate component 6700 during insertion. When the intermediate component 6700 reaches the operating position, the barbed end or tab 6745 of the spring or pinch arm 6740 is configured and arranged to engage the upper and / or rear side of each protrusion 6750 (see, for example, FIG. 12 ). Each barbed end 6745 and / or each protrusion 6750 may include a tapered portion to facilitate engagement into the operating position. In examples, engagement of the spring or pinch arm 6740 with the protrusion 6750 may provide sensory feedback (e.g., an audible click) indicating correct connection. This snap-fit connection releasably secures the intermediate component 6700 to the reservoir dock 6050. To disengage the intermediate component 6700, the spring or pinch arm 6740 may be manually pressed together (e.g., with or without a tool) to cause the spring or pinch arm 6740 and its barbed end 6745 to resiliently deflect against the bias and move to an unlocked position (i.e., moving the barbed end 6745 out of engagement with the protrusion 6750 allows the intermediate component 6700 to be removed from the reservoir dock 6050).
[0285] After this connection is established, the cooperation of the retention and alignment features provided by the intermediate component 6700 / reservoir dock 6050 allows for a removable, non-rotatable connection of the intermediate component 6700 to the dock outlet 6090 of the reservoir dock 6050. Also, after connection, the spring or pinch arm 6740 of the intermediate component 6700 is locked into the cavity of the reservoir dock 6050 to prevent, for example, the intermediate component 6700 from becoming dislodged when the water reservoir 6100 is received in the reservoir dock 6050.
[0286] When the intermediate component 6700 is connected to the dock outlet 6090 of the reservoir dock 6050, the inlet end 6710 and its contact surface 6715 protrude into the cavity of the reservoir dock 6050 to allow engagement with an outlet seal of the outlet tube 6130 (or outlet) of the water reservoir 6100 (see, e.g., FIG. 12 ). Similarly, the outlet end 6720 of the intermediate component 6700 extends into and / or protrudes from the cavity of the reservoir dock 6050 to allow engagement with the air delivery tube 4170 (see, e.g., FIG. 9 ). Further, the port 6730 of the intermediate component 6700 is oriented, for example, upward, to interface with a sensor associated with a PCBA positioned above the intermediate component 6700 in the operative configuration of the RPT device.
[0287] 5.8.1 Bayonet-Type Lock and Contact Assembly 9-18 , the lock and contact assembly 6900 is provided at the dock exit 6090 of the reservoir dock 6050 to mechanically and electrically connect the reservoir dock 6050 to the air delivery conduit 4170. In the illustrated example, the lock and contact assembly 6900 includes a bayonet-type connection that is constructed and arranged to locate and secure the air delivery conduit 4170 to the reservoir dock 6050 and to form mechanical, pneumatic, and electrical (for both power and control signals) connections. The lock and contact assembly 6900 may be separate from the RPT device 6000 or may be integrated with the RPT device 6000.
[0288] As shown in Figures 17 and 18, the lock and contact assembly 6900 includes a base 6910, an (electrical) contact assembly 6950 provided on the base, and a cover 6970 provided on the base 6910 to enclose at least a portion of the electrical contact assembly 6950.
[0289] The base 6910 of the lock and contact assembly 6900 includes a rear wall 6912 that is secured to one or more walls surrounding the dock opening 6091, e.g., via one or more fasteners, to secure the base 6910 in the dock exit 6090 of the reservoir dock 6050. As shown in FIGS. 17 and 18 , the rear wall 6912 includes, e.g., a non-circular opening 6915. This opening 6915 aligns with the dock opening 6091 to allow insertion and connection of the intermediate component 6700 as described above (e.g., the non-circular opening 6915 is adapted to receive an intermediate component 6700 with a non-circular profile). The non-circular profile assists the user in orienting and aligning the intermediate component 6700 and the lock and contact assembly 6900 during insertion. Additionally, as described above, the rear wall 6912 provides a stop for the intermediate component 6700 during assembly; for example, at least a portion of the flange 6770 of the intermediate component 6700 may abut the rear wall 6912.
[0290] The base 6910 of the lock and contact assembly 6900 includes an annular sidewall 6920. The annular sidewall 6920 projects axially outward from the rear wall 6912. When the intermediate component 6700 is connected to the reservoir dock 6050, the outlet end 6720 of the intermediate component 6700 and the annular sidewall 6920 cooperate to form a channel 6780 that receives the air delivery conduit 4170. A retaining wall 6930 projects radially outward from the annular sidewall 6920 along a portion of the circumference of the annular sidewall (e.g., along a portion of the upper side of the annular sidewall). A gap is provided in the annular sidewall 6920 along a portion of the circumference of the annular sidewall to form a recess 6940 that connects to the channel 6780 (see FIGS. 9 and 18 ). The recess 6940 is disposed adjacent to and counterclockwise from the retaining wall 6930. As described below, the recess 6940 and retaining wall 6930 are configured and arranged such that a portion of the dock connector 4600 of the air delivery tube 4170 is inserted into the recess 6940 and then rotated clockwise to move to the rear side of the retaining wall 6930, thereby establishing a locking engagement between the air delivery tube and the dock.
[0291] Further retention and alignment features (e.g., recesses and / or grooves) are provided around the periphery of the annular sidewall 6920. These retention and alignment features (e.g., recesses and / or grooves) are constructed and arranged to interact with corresponding features on the dock connector 4600 of the air delivery tube 4170 upon engagement, as described below.
[0292] 17 , the electrical contact assembly 6950 is supported by the base 6910 adjacent the retaining wall 6930. The contact assembly 6950 communicates with power and electrical signaling within the reservoir dock 6050 (e.g., PCBA7600). As shown, the contact assembly 6950 includes a support member 6952 and a plurality of contacts (e.g., four contacts). With this arrangement, when the air delivery tube 4170 is rotated clockwise (to lockingly engage with the dock), the tube's contact assembly moves into contact with the assembly 6950, thereby enabling replacement of the power, control, and RPT device (e.g., PCBA7600).
[0293] 5.8.2 Dock Connector As shown in Figures 9-11, the dock connector 4600 of the air delivery tube 4170 is structured to form a pneumatic connection with the intermediate component 6700 and a mechanical and electrical connection with a lock and contact assembly 6900 provided on the reservoir dock 6050.
[0294] In the illustrated example, the dock connector 4600 includes a tubular base portion 4640 and a lock and contact assembly 4660 disposed on the base portion 4640 .
[0295] 5.8.3 Direct Plug-in Connections and Intermediate Components 23-36C show another example of an intermediate component 9700 for connecting an air delivery conduit 4170 to a reservoir dock 6050 and a water reservoir 6100 in accordance with one form of the present technology. In this example, the intermediate component 9700 is removably coupled to the reservoir dock 6050. The intermediate component 9700 is configured to pneumatically connect the water reservoir 6100 to the air delivery conduit 4170, thereby enabling a flow of pressurized air humidified in the water reservoir 6100 to be delivered from the water reservoir 6100 via the intermediate component 9700 to the air delivery conduit 4170. Also in this example, the intermediate component 9700 is configured to mechanically connect to the air delivery conduit 4170, thereby positioning and releasably holding the air delivery conduit 4170 in the reservoir dock 6050. Further, in this example, the air delivery tube 4170 is constructed and arranged to form an electrical connection with the reservoir dock 6050 so that power and control signals are provided to the heating element and sensory data from the transducer associated with the air delivery tube 4170 is provided to the reservoir dock 6050.
[0296] 9-22 (wherein the dock connector 4600 was pneumatically sealed to the intermediate component 6700 and mechanically connected to the reservoir dock 6050), in the example of FIGS. 23-26 the dock connector 4600 of the air delivery tube 4170 forms both a pneumatic seal and a mechanical (locking) connection with the intermediate component 9700. Combining the pneumatic and mechanical connections into one component allows for improved dimensional tolerances, which may allow for a more reliable and easier to manufacture dock connector 4600, and may also allow for a reduced size of the dock connector 4600.
[0297] Intermediate components 23, 25, 26 and 25A, the intermediate component 9700 is a separate component provided at the dock outlet 6090 of the reservoir dock 6050, pneumatically connecting the water reservoir 6100 to the air delivery tube 4170 and mechanically connecting the air delivery tube 4170 to the reservoir dock 6050. In the illustrated example, the intermediate component 9700 is removably coupled to the reservoir dock 6050, allowing the intermediate component 9700 to be disassembled for cleaning, sterilization and / or replacement (e.g., for multi-patient multi-use (MPMU) applications).
[0298] 26 and 29-33, the intermediate component 9700 includes a generally tubular body 9705 including an inlet end 9710 and an outlet end 9720. An inlet seal 9715 is provided at the inlet end 9710 (FIG. 33) that is adapted to interface with the water reservoir 6100, and an outlet end 9720 that is adapted to interface with the air delivery tube 4170. The tubular body 9705 also includes retention and alignment features that are constructed and arranged to align the intermediate component 9700 with the reservoir dock 6050 and to provide a removable, non-rotatable connection with the reservoir dock 6050.
[0299] Additionally, the tubular body 9705 includes a port 9730 in the form of an opening, for example, for communication with a sensor or transducer. This sensor or transducer measures sound propagating through the port 9730 and can be any type of microphone, pressure sensor (e.g., resistive, capacitive, piezoelectric, optical, or other technology-based). The port 9730 includes a port seal 9735 around the opening, thereby providing a sealed interface between the intermediate component 9700 and the chassis opening 7380 (associated with the sensor) (see FIGS. 32-36C). Additionally, the intermediate component 9700 includes a retention feature constructed and arranged to provide a locking, yet detachable, connection with the dock connector 4600 of the air delivery tube 4170.
[0300] In the illustrated example (see, e.g., FIG. 33), the tubular body 9705 (including the inlet end 9710, the outlet end 9720, and the retention and alignment features) comprises a first portion or base mold constructed of a relatively rigid material (e.g., a thermoplastic polymer (e.g., PC, ABS)), and the inlet seal 9715 and the port seal 9735 comprise a second portion or overmold constructed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone) that is provided on the first portion (e.g., by overmolding).
[0301] In the illustrated example, the inlet seal 9715 is disposed at an angle relative to the outlet end 9720. For example, the axis of the opening in the inlet seal 9715 is disposed at approximately 90° relative to the axis of the opening in the outlet end 9720 (see FIG. 32). However, it should be understood that other suitable angles are possible (e.g., the axis of the inlet seal 9715 is disposed at approximately 45° relative to the axis of the outlet end 9720).
[0302] When the water reservoir 6100 is coupled to the reservoir dock 6050, the inlet seal 9715 of the intermediate component 9700 is constructed and arranged to engage and provide a face seal against a contact surface along the outlet end of the outlet conduit 6130 (or outlet) of the water reservoir 6100. Such engagement seals the outlet flow path, allowing humidified air to flow out of the water reservoir 6100 and into the intermediate component 9700 for delivery to the air delivery conduit 4170. As shown, the inlet seal 9715 may include a bellows-type arrangement that provides a level of decoupling between the intermediate component 9700 and the water reservoir 6100 via resilient compression. If an outlet cap muffler 4124 ( FIG. 5B ) is used in place of the water reservoir, a similar sealing engagement is provided between the inlet seal 9715 of the intermediate component 9700 and an opening in the outlet cap muffler.
[0303] In another embodiment, the seal between the outlet tube 6130 (or outlet) of the water reservoir 6100 and the intermediate component 9700 may be an integral part of the outlet tube 6130 or may be a sealing part separate from the outlet tube 6130 or the intermediate component 9700.
[0304] The outlet end 9720 may include an ISO taper (eg, a 22 mm outer diameter ISO taper) for connection to the air delivery conduit 4170 .
[0305] For retention and alignment features for aligning and retaining the intermediate component 9700 relative to the reservoir dock 6050, the intermediate component 9700 includes a resilient pinch arm 9740 (i.e., a cantilever spring arm). The spring or pinch arm 9740 may include a barbed end or tab 9745 structured to provide a snap-fit connection with a locking member (e.g., a crossbar 9750 provided within a cavity in the reservoir dock 6050) (see FIGS. 27 and 36C). The intermediate component 9700 also includes a guide rail 9760 (along the underside of the intermediate component 9700) and a guide rib 9761 (along the front upper side of the intermediate component 9700). The guide rails 9760 and guide ribs 9761 are structured and arranged to assist in correct alignment and insertion of the intermediate component 9700 into the reservoir dock 6050 by engaging with corresponding guide slots 9755 extending into the cavity of the reservoir dock 6050 (see, for example, Figures 27, 28B and 30).
[0306] Additionally, the intermediate component 9700 includes a flange 9770 disposed between the inlet end 9710 and the outlet end 9720. The flange 9770 aids in the placement or positioning of the intermediate component 9700 within the reservoir dock 6050 (by abutting against a wall of the reservoir dock 6050) (e.g., the flange acts as a stop during insertion, as shown in FIG. 28E ). As shown in FIGS. 28D, 28E, and 33, the flange 9775 (e.g., constructed of a thermoplastic elastomer (TPE) or silicone) may be provided on the flange 9770 to soften the abutment with the reservoir dock opening during insertion and to absorb vibrations during use. In addition to minimizing vibration of the intermediate component 9700, the flexibility of the bumpers ensures that the spring force generated after the bumps are depressed pushes the barbed tabs 9745 rearward, ensuring that the tabs are always in locking engagement with the crossbar 9750. This minimizes the possibility of vibration and disengagement in the locking engagement between the barbed tabs 9745 and the crossbar 9750. In the illustrated example, a first bumper 9775 is provided on the upper side of the intermediate component 9700 and a second bumper 9775 is provided on the lower side of the intermediate component 9700 (see FIG. 28D). In an example, the bumpers 9775 may be overmolded onto the tubular body 9705 along with the inlet seal 9715 and the port seal 9735 (see FIG. 33). The bumper 9775 may be part of the reason why, when the intermediate component 9700 is inserted into the tubular opening in the reservoir dock 6050, the intermediate component experiences increased resistance where the bumper engages with portions of the reservoir dock opening during the later stages of insertion.
[0307] For the retention feature that retains the dock connector 4600 of the air delivery tube 4170 to the intermediate component 9700, the intermediate component 9700 includes a partial annular sidewall 9790 (see FIG. 30 ). The partial annular sidewall 9790 projects outwardly from the flange 9770 along the outlet end 9720. As shown in FIG. 30 , the outlet end 9720 and the partial annular sidewall 9790 cooperate to form an annular channel 9780 that receives the air delivery tube 4170. Each of two opposing sides of the partial annular sidewall 9790 includes a hole or recess 9792 ( FIG. 30 ) that is adapted to receive a respective retention bump 4644 ( FIG. 26 ) on the dock connector 4600 of the air delivery tube 4170 upon engagement. In the illustrated example, a gap is provided within (along the upper side of) the partial annular side wall 9790 to accommodate and facilitate electrical connection of the dock connector 4600 of the air delivery tube 4170.
[0308] Also provided on the intermediate component 9700 is a lower tab 9795 ( FIG. 30 ). This lower tab 9795 projects outwardly and downwardly from the partial annular side wall 9790 along (along the underside of) a portion of the circumference of the partial annular side wall 9790. The lower tab 9795 may function as a finger or push tab to facilitate insertion or withdrawal of the intermediate component 9700 into or from the reservoir dock 6050. Additionally, the lower tab 9795 may be configured and arranged to cover or conceal one or more fasteners (e.g., screws) or edges between the outer shroud and chassis components of the integrated RPT device and the humidifier 6000 (see FIGS. 23 and 26 ).
[0309] When the intermediate component 9700 is inserted into the dock opening 6091 of the reservoir dock 6050, the intermediate component 9700 is oriented so that its guide rails 9760 and guide ribs 9761 engage with the respective guide slots 9755. The guide slots 9755 properly align and guide the intermediate component 9700 into the operating position (see, e.g., FIG. 26 ). The non-circular profiles of the dock opening 6091 and the partially annular sidewall 9790 of the intermediate component 9700 also facilitate proper orientation of the intermediate component 9700 during insertion. When the intermediate component 9700 reaches the operating position, the barbed end or tab 9745 of the spring or pinch arm 9740 is configured and arranged to engage the underside of the crossbar 9750 (see, e.g., FIGS. 25 , 28F, and 28G ). The barbed end 9745 and / or crossbar 9750 may include a tapered portion to facilitate engagement in the operating position (see, e.g., FIG. 28F). In examples, engagement of the spring or pinch arm 9740 with the crossbar 9750 (e.g., FIGS. 25, 28F, and 28G) may provide sensory feedback (e.g., an audible click) indicating correct connection. This snap-fit connection releasably secures the intermediate component 9700 to the reservoir dock 6050. As shown in FIGS. 28C and 28F, one side 9746 of the barbed end 9745 may be angled relative to the opposing side of the barbed end 9745. When the chassis (e.g., crossbar 9750) engages the angled surface 9746 of the barbed end 9745, the barbed end 9745 may deflect under force during insertion of the intermediate component 9700 until the portion of the chassis that engages the side surface 9746 extends past the side surface 9746. To disengage the intermediate component 9700, the spring or pinch arm 9740 may be manually pressed (e.g., with or without a tool) toward the rear of the reservoir dock 6050. Such pressure may cause the spring or pinch arm 9740 and barbed end 9745 to resiliently deflect and move to an unlocked position (i.e., in this position, the barbed end 9745 disengages from the crossbar 9750, allowing the intermediate component 9700 to be removed from the reservoir dock 6050).In some examples, a groove 9747 (see, e.g., Figures 28G and 29) may be included in the barbed end 9745, allowing the barbed end 9745 to be gripped with an instrument (e.g., a flat-head screwdriver) to disengage the barbed end 9745 from the reservoir dock 6050.
[0310] 28C and 28G, the pinch arm 9740 may be disposed at an angle relative to the central axis of the tubular body 9705. The pinch arm 9740 may be angled such that the angle between the axis of the opening of the inlet end 9710 and the pinch arm 9740 is less than 90°. The angled pinch arm 9740 may allow for increased retention compared to a pinch arm 9740 that is not angled relative to the central axis of the tubular body 9705.
[0311] After the intermediate component 9700 is inserted and locked into the dock opening 6091 of the reservoir dock 6050, cooperation of the retention and alignment features provided by the intermediate component 9700 / reservoir dock 6050 allows for a removable, non-rotatable connection of the intermediate component 9700 to the dock outlet 6090 of the reservoir dock 6050. Additionally, once connected, the spring or pinch arm 9740 of the intermediate component 9700 engages in a locking manner within the cavity of the reservoir dock 6050, thereby preventing the intermediate component 9700 from becoming dislodged (for example, when the water reservoir 6100 is received within the reservoir dock 6050).
[0312] When the intermediate component 9700 is connected to the dock outlet 6090 of the reservoir dock 6050, its inlet seal 9715 protrudes into the cavity of the reservoir dock 6050 to allow engagement with the outlet tube 6130 (or outlet) of the water reservoir 6100 (see FIG. 25 ). Similarly, the outlet end 9720, together with the partial annular sidewall 9790 and its hole 9792, extend into and / or protrude from the cavity of the reservoir dock 6050 to allow engagement with the air delivery tube 4170 (see, e.g., FIGS. 23 and 28A ). Furthermore, the port 9730 and its port seal 9735 are oriented to interface with the chassis opening 7380 associated with the sensor (e.g., upward as shown in FIGS. 34B and 35B ).
[0313] 5.8.4 Sound propagation in intermediate components As described above, the intermediate component 9700 facilitates connection between the conduits of the air circuit 4170 and the RPT device (e.g., the reservoir dock 6050 and / or the water reservoir 6100). The intermediate component 9700 according to aspects of the present technology includes a port 9730 (e.g., a sound port) that facilitates sound propagation from the intermediate component 9700 to a sensor 4270 (e.g., a microphone) disposed within the RPT device. The sensor 4270 may be externally attached to the intermediate component 9700. While externally attached, the sensor 4270 may be disposed outside the intermediate component 9700 and / or port 9730, or may be inside (e.g., fully or partially inserted into) the intermediate component 9700 and / or port 9730. Thus, sound that may reach the intermediate component 9700 from any portion of the patient interface 300, RPT device 400, humidifier 500, and / or air circuit 4170 may be transmitted to a sensor 4270 (e.g., a microphone) located within the RPT device. As described in more detail below, analysis of the sensed sound may determine the feature of each portion (e.g., air circuit 4170) and / or its interior from which the sound originates. The structure and dimensions of the intermediate component 9700 are configured to enhance sound propagation inside the intermediate component 9700 and to the port 9730. Intermediate body variations are discussed herein (6700 and 9700). For example, the intermediate component 6700 shown in FIGS. 19-22 included electrical connections through a secondary body (e.g., lock and contact assembly 6900) and a non-circular membrane. However, intermediate body variations 6700 and 9700 behave in a similar manner due to the sound propagation design intent.
[0314] As shown in FIGS. 28C, 29, and 31-36C, the intermediate component 9700 includes a port 9730 that facilitates transmission of a portion of sound propagating in the air flow path to the sensor 4270. Specifically, the port 9730 allows a portion of the sound in the air flow path to be transmitted by the intermediate component 9700 through the port 9730, via a corresponding chassis opening 7380 in the chassis, and to the sensor 4270 (e.g., a microphone (see FIG. 37) disposed within the chassis). The chassis opening 7380 may be provided in a portion of the chassis that forms a water reservoir dock (e.g., reservoir dock 6050) that receives the humidification tank. Thus, the chassis opening 7380 may correspond to an opening in the water reservoir dock. In other examples, the chassis opening 7380 may be provided in another portion of the chassis. For example, the chassis opening 7380 may be provided in a portion of the chassis 7300 that is a different component from the water reservoir dock. 32 and 33, the port 9730 includes an opening in the wall of the intermediate component 9700 and is disposed near the inlet end 9710. The axis associated with the port 9730 (e.g., an axis that is generally transverse to the plane in which the port opening extends) can be disposed at about 90° relative to the axis of the opening at the outlet end 9720 and / or at about 90° relative to the axis of the opening at the inlet end 9710 (see FIGS. 26, 28C, and 36C).
[0315] The size of the port can be selected based on the parameters of the sound signal to be detected. These can be sound signals generated directly by any of the components in the RPT system (e.g., the RPT device, humidifier, air circuit, and patient interface) and / or sound signals generated at one location that propagate to and are reflected from a specific target component. The size of the cavity into which the sound travels from the intermediate component 9700 and reaches after passing through the port 9730 is also important. In one example, such a cavity can be formed by the walls of the intermediate component 9700 and the PCBA 7600 supporting the sensor 4270, as shown schematically in FIG. 37 . Increasing the size of the port 9730 can introduce spatial averaging and reduce spatial resolution, but can increase the sound signal reaching the sensor and improve the signal-to-noise ratio. If the signal-to-noise ratio is adequate, a smaller port size can be preferable for preserving higher-resolution signal information (e.g., related to sound reflected from smaller geometric features). The larger port 9730 and the large adjacent cavity formed by the port may lead to a discontinuity in the cross-sectional area or acoustic impedance of the flow path within the intermediate component and disruption of signal propagation. Reducing external noise (e.g., noise from vibrations in the PCBA 7600 supporting the sensor 4270) may reduce the aperture of the port, leading to improved spatial resolution and reduced signal disruption.
[0316] In accordance with one form of the present technology, the size of the port may be configured to be large enough to allow an appropriate target signal level for a sensor 4270 located outside of the intermediate component 9700, but not so large as to unacceptably compromise the spatial resolution and / or waveguide properties of the signal path through the intermediate component 9700. In accordance with one form of the present technology, the cross section of the port 9730 may be between 0.75 and 180 mm. 2 For example, in one form of the present technology, port 9730 may be rounded and have a diameter of 1 mm to 15 mm.
[0317] According to one form of the present technology shown in FIGS. 34 and 35 , the port 9730 is covered by a thin silicone membrane 9732. The membrane 9732 is intended to transmit sound propagation along the airpath (airflow) to the sensor while keeping the sensor isolated from the airflow. For this reason, the membrane can be permeable to sound but is preferably impermeable to liquids and / or gases. Due to this arrangement, removing or decontaminating the intermediate component 9700 (or any other component in or fluidly connected to the airpath but positioned to allow sound transmission to a shielded sensor positioned outside the airpath) eliminates the need to remove and clean the sensor itself, since the sensor was not in the airpath and therefore not exposed to contaminants. In some examples, the membrane 9732 is made as large in diameter (or other cross-sectional dimension) and as thin as possible. Such dimensions increase the amount of target signal (directly generated or reflected noise) transmitted across the membrane. In some examples, the membrane 9732 may have a thickness of 0.05 to 3 mm; or 0.1 to 1 mm; or 0.1 to 0.3 mm, and a diameter of 1 to 15 mm. In some examples, the membrane 9732 may have a thickness of 0.1 to 0.2 mm, and a diameter of 1 to 15 mm. In some examples, the membrane 9732 may have a thickness of approximately 0.2 mm, and a diameter of 1 to 15 mm, and in one example, a diameter of approximately 8 mm. These exemplary dimensions allow sound to travel sufficiently across the membrane 9732 while simultaneously limiting leakage of sound signals across the wall of the intermediate component 9700 (to which the membrane is attached). In some examples, the membrane may be disposed so as to be planar with the inner surface of the intermediate component 9700. The membrane 9732 may be formed as a single, integral component with the port seal 9735, or may be disposed separately from the port seal 9735. The membrane 9732 may or may not be in mechanical contact with the port seal 9735. In the embodiment shown in Figures 34 and 35, the membrane 9732 is formed with the port seal 9735 as one unitary component.
[0318] According to one form of the present technology, the port 9730 may be provided without the membrane 9732 and / or port seal 9737. As noted above, one benefit of providing the membrane 9732 is that it prevents air from entering the chassis from the intermediate component, thereby isolating the electronic components on the PCBA from the airflow gases. This prevents humidified and / or contaminated air from entering the microphone chamber, protecting the electronics from moisture or contaminated air (e.g., containing bodily fluids such as mucus). From a therapeutic performance perspective, it is desirable to control leakage when providing PAP therapy. The presence of the membrane reduces unintended leakage from the system. An arrangement in which the port 9730 is provided without the membrane 9732 is also possible. In this case, air can be prevented from entering the chassis from the intermediate component 9700 by directing high-pressure bleed to the inside of the chassis. Alternatively, an encapsulated sensor may be introduced into the air path. In this case, the sensor may be encapsulated (e.g., encapsulated in a membrane of silicone, rubber, or another material that transmits sound vibrations therethrough and is simultaneously decontaminable (e.g., washable)). Such a sensor may be a permanent part of the intermediate component 9700 or any other component that is located in or fluidly connected to the air path and to which the sensor may be attached. Because the sensor is encapsulated, it can be removed and washed along with each intermediate component. In this case, the electrical terminals of the sensor must be located for disconnection and reconnection during the disassembly / assembly process.
[0319] However, aside from restricting air movement, the use of the membrane 9732 may provide other benefits (e.g., infection control and avoiding damage to the circuitry of the PCBA7600). If a membrane 9732 is used, it may be beneficial for the membrane to be as flexible and lightweight as possible for transmission of a wide range of signal frequencies. In accordance with one form of the present technology, a suitable mass and stiffness may be determined by the density and dimensions of the membrane 9732 and the pressure gradient across the membrane. In accordance with one form of the present technology, a port 9730 with a diameter of 5 mm and a thickness in the range of 0.1-0.4 mm or approximately 0.3 mm may provide a reasonable compromise between being thick enough to avoid structural failure and thin enough to allow adequate sound transmission.
[0320] 34A-35D , a port seal 9735 according to various examples of the present technology is provided. The peripheral seal formation (ridge or lip) provided by the port seal 9735 may be part of the membrane 9732 or may be provided separately from the membrane 9732. The peripheral seal formation may include a radial seal configured to engage (e.g., as a face seal) and resiliently deform around the chassis opening 7380 against a surface of the chassis above the intermediate component 9700.
[0321] The port seal 9735 may surround the port 9730 and may protrude beyond the port 9730. As shown in FIGS. 34A-35D , the port seal 9735 protrudes from the port 9730 above the outer surface of the intermediate component 9700. In use, when the intermediate component 9700 is inserted into an operating location, the port 9730 may be aligned with the chassis opening 7380, thereby providing a sealed path for acoustic signals (from the intermediate component 9700, through the port 9730 and membrane 9732, and through the chassis opening 7380) with the sensor 4270 positioned on the opposite side of the chassis opening 7380.
[0322] A central axis of the port 9730 in the intermediate component 9700 may be generally aligned with a central axis of the chassis opening 7380 on a first side of the chassis opening 7380 (see FIGS. 35A-36C ), and the sensor 4270 may be provided on a second side of the chassis opening 7380. The sensor 4270 may be generally aligned with the central axis of the port 9730 and / or the chassis opening 7380. The axes of the port 9730, the chassis opening 7380, and the sensor 4270 may be generally aligned, such that in the operating configuration, the distance between any two of them is less than 5 mm, preferably less than 4 mm, even more preferably less than 3 mm, even more preferably less than 2 mm, and most preferably less than 1 mm.
[0323] As described above, when the intermediate component 9700 is assembled (by insertion of the intermediate component 9700 into the dock opening 6091 of the reservoir dock 6050), the port seal 9735 is brought into contact with the periphery of the chassis opening 7380. Because the port seal 9735 contacts the periphery of both the intermediate component 9700 and the chassis opening 7380, when the intermediate component 9700 is assembled, the periphery of both the port 9730 and the chassis opening 7380 is sealed by the port seal 9735. This minimizes the lateral escape of sound signals transmitted through the membrane 9732 into the space between the intermediate component wall and the chassis wall. In addition to preventing sound from the sealed sound path from leaking laterally into the space 9743 between the wall of the intermediate component 9700 and the chassis wall, the peripheral lip of the port seal 9735 also prevents external noise from entering the sealed signal path.
[0324] 34A-34D show an example of a port seal 9735. The port seal 9735 uses a ridge to provide a compression-type seal against the chassis wall in accordance with an example of the present technology. FIGS. 34B and 34C are cross-sectional views of an example of a ridge without compression. FIG. 34D shows the ridge being compressed by the wall of the chassis 7300. The port seal 9735 that provides the compression seal can include an overmold constructed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone) and provided (e.g., by overmolding) to the intermediate component 9700. The port seal 9735 can extend from and / or include a membrane 9732. The membrane 9732 is provided along the inner wall of the port 9730 at or near the inner surface of the intermediate component 9700 and protrudes from the port 9730 above the outer surface 9707 of the intermediate component 9700 (e.g., near the edge of the port 9730). The portion of the port seal 9735 that projects above the outer surface of the intermediate component 9700 may include a raised seal 9737. The raised seal 9737 provides a spherical sealing contact between the port seal 9735 and the chassis in use. In some examples, one or more additional raised seals (e.g., concentrically arranged) may be provided around the raised seal 9737.
[0325] The cross section of the raised seal 9737 above the outer surface of the intermediate component 9700 may be rounded and extend outward from the periphery of the port 9730 a predetermined distance D4 (see FIG. 34C ) before joining with a surface that is the top surface or an extension of the intermediate component wall. D4 may be 1.2 to 2.8 mm, 1.8 to 2.2 mm, or approximately 2 mm. The sides of the raised seal 9737 may be tapered on either side away from the rounded top. The slope toward the center of the port 9730 may be higher than the slope away from the port 9730. The portion of the raised seal 9737 extending outward from the periphery of the port 9730 may be at an angle A1 relative to the outer surface of the intermediate component 9700. The angle A1 is between 10 and 35 degrees, in some instances between 20 and 25 degrees, and in some instances 22 degrees. The outwardly extending portion of the raised seal 9737 may extend outward at an angle and may terminate at the top surface of the intermediate component 9700 (which may correspond to a nearby surface of the edge of the port 9730 or another outer surface of the intermediate component 9700).
[0326] In some examples, the port seal 9735 may include one or more connectors 9739 (see FIG. 34C ) adjacent to the raised seal 9737. The raised seal 9737 extends in one or more directions and / or connects to other features (e.g., the bumper 9775 and / or the inlet seal 9715 (see FIG. 34A )). The top surfaces of the one or more connectors 9739 may be flush with portions of the outer surface of the intermediate component 9700. In one example, the connectors 9739 may extend around the entire periphery of the raised seal 9737. The raised seal 9737 may extend upwardly a predetermined distance D1 (see FIG. 34C ) above the plane of the connectors 9739. The predetermined distance D1 may be 0.4 to 0.8 mm or approximately 0.6 mm.
[0327] In use, the portion of the raised seal 9737 above the outer surface of the intermediate component 9700 can be compressed a predetermined distance D2 against the chassis and then bottom out. In some examples, the material of the port seal 9735 above the outer surface 9707 of the intermediate component 9700 (e.g., near the edge of the port 9730) can be configured to compress approximately 20-40% of its height, and in some examples approximately 30% of its height. In some examples, the port seal 9735 can extend a predetermined distance D3 (see FIG. 34C ) above the outer surface 9707 of the intermediate component 9700 (e.g., near the edge of the port 9730). Distance D3 can be 1-1.5 mm, 1.2-1.3 mm, or approximately 1.24 mm. In some examples, the nominal seal interference (a measure of seal deformation under compression, which may correspond to D2) may be 0.09 mm to 0.59 mm, 0.15 mm to 0.5 mm, or approximately 0.34 mm.
[0328] The compressive, spherical, sealing contact of the raised seal 9737 may allow the intermediate component 9700 to be tightly positioned when it reaches its operating position during assembly and / or may prevent the intermediate component 9700 from disassembling in the absence of significant external force. In some examples, the compression of the port seal 9735 may keep the intermediate component 9700 in place even when the barbed end 9745 disengages from the crossbar 9750, which may facilitate easier removal of the intermediate component 9700 from the reservoir dock 6050.
[0329] The example port seal 9735 shown in Figures 35A-35D provides a lip-type seal in accordance with another example of the present technology. Figures 35B and 35C show an example lip seal without compression (e.g., not pressed against the chassis 7300), and Figure 34D shows the lip seal compressed by the chassis 7300. The port seal 9735 providing the lip seal may include an overmolding constructed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone) provided by (e.g., overmolding) onto the intermediate component 9700. As shown in Figures 35A-35D, the port seal 9735 may extend from and / or include a membrane 9732. The membrane 9732 may be disposed along the inner wall of the port 9730 at or near the inner surface of the intermediate component 9700 to line the inner surface of the port 9730 and may protrude from the port 9730 above the outer surface 9707 of the intermediate component 9700 (e.g., near the edge of the port 9730). The portion of the port seal 9735 that protrudes above the outer surface of the intermediate component 9700 may include a lip seal 9742. The lip seal 9742 provides a spherical sealing contact between the port seal 9735 and the chassis in use. In some examples, one or more additional lip seals may be disposed around the lip seal 9742.
[0330] A cross section of the lip seal 9742 above the outer surface of the intermediate component 9700 can be aligned with the inner surface of the port 9730 and / or can provide a lip that extends concentrically around the port 9730 toward the center of the port 9730. In some examples, the lip can be disposed at a predetermined angle A2 (see FIG. 35C ) relative to the upper outer surface of the intermediate component 9700. The angle A2 can be 10 to 35 degrees, 15 to 25 degrees, and / or approximately 20 degrees. The lip seal 9742 can extend a predetermined distance D5 (see FIG. 35C ) in the upward direction from the lower surface of the intermediate component 9700. The distance D5 can be approximately 1.3 to 1.7 mm, 1.4 to 1.6 mm, or 1.56 mm. The thickness T1 (see FIG. 35C ) of the lip seal 9742 can be approximately 0.2 to 0.6 mm, 0.35 to 0.45 mm, or 0.4 mm. In some examples, the end of the lip seal 9742 that extends above the port 9730 is rounded. The dimensions of the lip seal 9742 and / or the angle at which the lip seal 9742 is disposed may be selected to improve acoustic sealing and / or reduce bulking of the lip seal during use. In some examples, the lip may extend directly above or may be angled away from the center of the port 9730.
[0331] The lip seal 9742 can extend a predetermined distance D8 (see FIG. 35C) from an edge of the port 9730 at a predetermined angle A2. The predetermined distance D8 can be bounded by the edge where the top surface of the lip seal 9742 meets a surface or an extension of a surface of the intermediate component 9700. The distance D8 can be in the range of 0.1 to 3.5 mm, in the range of 0.15 to 3 mm, or approximately 2 mm.
[0332] In some examples, the port seal 9735 may include one or more connectors 9739 adjacent to the lip seal 9742 and extending in one or more directions and / or connecting to other features (e.g., bumper 9775 and / or inlet seal 9715 (see FIG. 35A)). The top surface of the one or more connectors 9739 may be flush with a portion of the outer surface of the intermediate component 9700. In one example, the connectors may extend around the entire circular perimeter of the lip seal 9742. The lip seal 9742 may extend upwardly from the top surface of the intermediate component 9700 a predetermined distance D6 (see FIG. 35C), which is 0.4 to 0.8 mm or approximately 0.66 mm above the plane of the connectors 9739.
[0333] In use, a portion of the lip seal 9742 above the outer surface of the middle component 9700 can be compressed and / or deflected toward the chassis toward the port 9730. In some examples, the lip seal 9742 can be deflected a predetermined distance D7 (see FIG. 35C ) before bottoming out. This distance D7 is between 0.1 and 0.6 mm or between 0.15 and 0.41 mm. In some examples, the lip seal 9742 can have a nominal seal interference of approximately 0.41 mm, a minimum seal interference of approximately 0.15 mm, and / or a maximum seal interference of approximately 0.66 mm.
[0334] The lip seal 9742 may help hold the intermediate component 9700 in place when the intermediate component 9700 reaches an operating position during assembly and / or may prevent the intermediate component 9700 from coming apart in the absence of significant external force.
[0335] Two types of seal formations have been disclosed above. In providing a compression seal with the port seal 9735 and the raised seal 9737 (see FIGS. 34A-34D), the cross section of the seal formation that protrudes above the face of the intermediate component 9700 is more rounded than the lip seal 9742. Due to the mass of the raised seal 9737, the raised seal 9737 may compress more easily, leading to reduced friction when the intermediate component 9700 is inserted inside the chassis. In another example of a lip seal ( FIGS. 34A-34D ), the portion of the lip seal 9742 that protrudes above the face of the intermediate component 9700 is a thin-walled lip that may exhibit limited bending and flexibility when compressed. The lip seal 9742 may create significant friction between the intermediate component 9700 and the surrounding chassis wall when the intermediate component 9700 is inserted inside the chassis 7300.
[0336] As described above, raised seal 9737 or lip seal 9742 acoustically insulates the signal path in which it is sealed from the remaining space 9743 between intermediate component 9700 and chassis 7300. When intermediate component 9700 is positioned within chassis 7300 for use, the distance between chassis 7300 and the surface of intermediate component 9700 or connecting portion 9739 defines space 9743 (see FIG. 35C ) and may be 0.15-0.4 mm, 0.2-0.3 mm, or 0.25 mm.
[0337] In some examples of the present technology, the port seal 9735 may be provided on a surface of the chassis 7300. In this example, the port seal 9735 may be provided on the chassis 7300 rather than on the intermediate component 9700. The port seal 9735 may be provided to be provided within the chassis opening 7380. The port seal 9735 in the chassis opening 7380 may include a peripheral sealing formation (ridge or lip) that is configured to engage and resiliently deform against the surface of the intermediate component that is under the chassis opening 7380 and around the port 9730 (e.g., as a face seal).
[0338] The features inside the intermediate component 9700 provide for propagation of sound waves (e.g., reflection, refraction, and / or attenuation) inside the intermediate component 9700 and to the port 9730. The features inside the intermediate component 9700 provided by examples of the present technology assist in conveying a useful reflected signal from the air circuit 4170 (e.g., tubing and / or mask) to the sensor 4270 via the port 9730.
[0339] As shown, the air path between the inlet and outlet ends of the intermediate component 9700 is nonlinear and includes at least one turn. In accordance with one form of the present technology, the inner corners of the intermediate component 9700 are curved for proper propagation within the intermediate component 9700. In some examples, at least one of these turns closest to the port may be curved. In one example of the present technology, all of the inner corners of the intermediate component 9700 are curved. Sharp corners (e.g., 90° angles) can degrade the level and quality of the sound signal, even as the overall sound level increases due to turbulence caused by the sharp corners. Adding curvature to the corners (e.g., outer corner 9714, and particularly inner corner 9712) can improve the quality of the sound signal.
[0340] 28C shows a cross section of an intermediate component 9700 in accordance with an example of the present technology. As shown in FIG. 28C, the outer corner 9714 and / or the inner corner 9712 formed between the body of the intermediate component 9700 and the inlet seal 9715 are curved. In some examples, the inlet seal 9715 at the inlet end 9710 (see FIG. 32) can be disposed at an angle relative to the outlet end 9720 and / or the body of the intermediate component 9700. This angle can be approximately 90 degrees or can exceed 90 degrees.
[0341] In some examples, the radius of curvature formed by the inner corner 9712 may be 0.2 mm to 6.5 mm, 0.3 mm to 4 mm, 0.4 mm to 3 mm (e.g., 0.4 mm or 2 mm), although the range may also be 1.5 to 6.5 mm (2.5 to 5 mm), etc.
[0342] A rounded corner (e.g., inner corner 9712) may be provided as part of one or more seal bellows of the inlet seal 9715. As shown in FIG. 28C , the seal bellows of the inlet seal 9715 may include an inner surface 9712B and an outer surface 9712C. The curvature of the inner surface 9712B may determine the manner of sound propagation inside the intermediate component 9700. The radius of the outer surface 9712C may be approximately 0.2-0.6 mm or 0.4 mm. The radius of the inner surface 9712B may be approximately 1.5-6.5 mm, 2.5-5 mm, or 2 mm. In some examples, the radius of the outer surface may be 0.4 mm and the radius of the inner surface may be 2 mm. In some examples of the present technology, the radius of the outer surface may be less than the radius of the inner surface radius. In some examples, the span 9712D between opposing sides of the seal bellows in the intermediate component 9700 may be less than twice the radius of the inner surface radius.
[0343] Although the port 9730 and port seal 9735 are described above with reference to the intermediate component 9700, one or more features of the port 9730 and port seal 9735 may be provided within the intermediate component 6700, a portion of a conduit within the air circuit 4170, or the dock connector 4600 (e.g., instead of the port 6730 shown in FIG. 22).
[0344] 5.8.5 Intermediate Component Seal Insertion Friction Reduction Features The arrangement of the intermediate component 9700 and the dock exit 6090 of the RPT device 6000 ensures that for most of the length of the path along which the intermediate component 9700 is inserted into the dock exit 6090, the path is slightly wider than the diameter of the intermediate component 9700 and the port seal 9735 (e.g., a silicone ridge or lip of the port seal 9735) does not interact with the path walls. This ensures relatively friction-free insertion of the intermediate component 9700 into the dock exit 6090. In some examples of the present technology, an elevated bottom of the chassis path and / or a downward extension at the bottom of the intermediate component can be configured to push the intermediate component 9700 upward (relative to the direction of initial movement of the intermediate component 9700). In this example, this occurs just before the intermediate component 9700 is locked into an operating position (e.g., via the pinch arm 9740). The upward pressure causes the port seal 9735 (eg, a silicone peripheral lip) to move into engagement with the chassis, sealing around the chassis opening 7380 .
[0345] In some examples, only at the very end of the path, just before the intermediate component 9700 is fully locked into the operating position, the elevated positioning of the bottom of the path may push the intermediate component 9700 upward into the operating configuration. In this example, due to the particular configuration of the port seal 9735, the intermediate component 9700, and the chassis opening 7380, a user experiences increased resistance at the very end of the insertion path when inserting the intermediate component 9700 into the chassis opening 7380. This resistance may occur where a smaller diameter opening is provided in the intermediate component 9700 (e.g., one or more features of the intermediate component (e.g., the bumper)), resulting in additional friction between a ridge or lip of the port seal 9735 and the chassis wall.
[0346] 36A-36C show a particular sequence of events when an intermediate component 9700 is inserted into a receiving reservoir dock 6050 (e.g., a dock exit 6090 of the reservoir dock 6050) in accordance with an example of the present technology. As shown, in the particular illustrated example, both the intermediate component and the receiving opening are generally tubular in shape. The intermediate component 9700 includes guide rails 9760 (FIG. 36B) (along the underside of the intermediate component 9700) and guide ribs 9761 (FIG. 36B) (along the front upper side of the intermediate component 9700). The guide rails 9760 and guide ribs 9761 are constructed and arranged to assist in proper alignment and insertion of the intermediate component 9700 into the reservoir dock 6050 by engaging corresponding guide slots 9755 extending into the cavity of the reservoir dock 6050. When the intermediate component 9700 is inserted into the reservoir dock 6050, the guide rails 9760 and / or guide ribs 9761 track through the chassis guide slots 9755 (shown in FIGS. 28B, 28D, and 28E). As shown in FIG. 36A and described in the text above, clearance is provided between the port seal 9735 (e.g., a silicone ridge or lip of the port seal 9735) and the chassis when the intermediate component 9700 is initially inserted into the reservoir dock 6050. The clearance between the port seal 9735 and the chassis 7300 reduces intermediate component 9700 assembly forces and / or reduces and / or avoids excessive deformation of the port seal 9735.
[0347] FIG. 36B illustrates the initiation of engagement between the intermediate component 9700 and each opening of the receiving reservoir dock 6050 at one or more (in this case, three) engagement formation points L1, L2, and L3 (see FIG. 36C for engagement formation points L1-L3). At the locations marked by each of these points, a structural feature (e.g., a guide rail, rib, or bumper) of the intermediate component 9700 engages with a dock opening engagement feature (e.g., the lower edge of the arm 9740 engages with the ramped ridge 9757 at L1, the edge of the guide rail 9760 engages with the higher portion of the guide slot 9755 at L2, etc.) while the intermediate component 9700 is progressing toward full engagement with the dock opening. Engagement at these points can occur simultaneously or sequentially, and is intended to guide the intermediate component 9700 toward the fully engaged configuration. In this configuration, the barbed ends 9745 securely lock into their respective flange / dock openings on the chassis, and the port seal 9735 reliably seals the port 9730. As a result, in accordance with examples of the present technology, the port seal 9735 (e.g., a silicone ridge or lip of the port seal 9735) also begins to engage with the chassis 7300. As shown in FIGS. 36A and 35B , after the port edge 9730 passes the central axis and / or edge of the chassis opening 7380, the port seal 9735 begins to engage with the chassis 7300. The snap-fit connection of the intermediate component 9700 (e.g., provided by the spring or pinch arm 9740 of the barbed ends or tabs 9745) may glide up an angled ridge 9757 provided in the bottom of the chassis, after which the snap-fit connection is made. As the snap-fit connection glides upward (guided by the elevated path provided at one or more of the three engagement formation points L1-L3), the port seal 9735 begins to engage with the chassis adjacent the chassis opening 7380. After sliding upward over the angled ridge 9757, the snap-fit connection may move a predetermined distance (e.g., 1 mm) before fully engaging with the snap. The angled ridge 9757 may be provided at an angle of 15-25 degrees, 18-22 degrees, or 20 degrees.In one example, the angled ridge 9757 may be at an angle of approximately 20 degrees and may span a predetermined distance D9, where D9 is 1.5-2.5, 1.8-2.2 mm, or 2 mm.
[0348] 36C shows the port seal 9735 (e.g., a silicone ridge or lip of the port seal 9735) engaging with the chassis in a fully assembled position, according to an example of the present technology. One or more features in the intermediate component 9700 and / or the chassis opening can be configured to effect engagement of these two components by pressing the intermediate component 9700 upward into the chassis opening 7380 and / or ensuring a reliable engagement and acoustic seal in the fully assembled configuration. For example, compressive engagement of the port seal 9735 may be effected and / or controlled by one or more of the following: one or both of the lower edges of the arm 9740 and / or the angled ridge 9757 at the cantilever snap-fit location (L1) engaging the edge of the guide rail 9760 with the higher portion (L2) of the guide slot 9755 (raising the intermediate component and minimizing rocking motion); and / or an interacting and / or inwardly (upwardly) extending tab or flange at a corresponding portion of the chassis that engages the lower tab 9795 at location (L3) engaging an outwardly / downwardly extending tab or flange of the lower tab 9795. The engagement of each element at locations L1, L2, and L3 may occur substantially simultaneously or sequentially. There is no particularly preferred order, so long as effective final engagement is achievable.
[0349] Additionally or alternatively, the increased resistance during the later insertion phase may be partially created by any of the bumpers 9775 (which may also be considered engagement formations or engagement features), one or more of the engagements at locations L1-L3, but these engagement formations may be part of an arrangement that guides the intermediate component into sealing engagement with the opening of the water reservoir and into the final operative configuration.
[0350] 36C, the location of the widened portion of the guide rail 9760 at the chassis location (L2) may correspond vertically to the location of the edge 9730 of the port, the edge of the port seal 9735, and / or the ridge or lip of the port seal 9735. Engagement at point L2 between the guide rail 9760 and the opposing engagement formations raises the intermediate component vertically into the chassis opening 7380 to provide a seal between the port seal 9735 and the surface of the chassis surrounding the chassis opening. In other examples, the location of engagement formation point L2 may be closer to the dock opening and may correspond to the central axis of the chassis opening 7380 (not shown in FIG. 36C).
[0351] The combination of supportive engagement at at least one of the above engagement formation points, combined with the supportive engagement provided by the port seal between the intermediate component 9700 and the reservoir dock 6050, is configured to inhibit forced movement of the intermediate component 9700 and thus failure of the port sealing arrangement in the absence of significant external force. While a single engagement point (e.g., L1 or L2 in FIG. 36C ) may be sufficient for stable engagement, due to the large forces that may be applied to the intermediate component during use (due to a user pulling on the tubing), using more than one engagement formation point (e.g., all three points L1, L2, and L3 shown in FIG. 36C ) may be advantageous in improving the mechanical stability of the arrangement. Providing multiple engagement points (at least some of which result in an elevated position of the intermediate component or at least a portion of which may be elevated) may help ensure a robust and consistent seal at 9730, even when a patient applies pressure to the arrangement (and thus the intermediate component 9700) due to pulling on the tubing during treatment. Additionally, the robust support of the intermediate component makes it easier to install and remove the attached tube from the intermediate component.
[0352] Due to the specific structure of the sealing configuration, the intermediate component 9700, and the receiving opening, the user encounters some resistance when inserting the intermediate component 9700 into the chassis opening only at the end of the insertion path, where the intermediate component 9700 encounters a smaller diameter opening (created by the high engagement points L1-L3). This minimized friction facilitates easier insertion of the intermediate component into the dock exit 6090 of the reservoir dock 6050. Additionally, the described process of guided insertion and flexible port seal allows for insertion and sealing with relatively high mechanical tolerances, reducing the likelihood of damage to the membrane 9732 and / or port seal 9735.
[0353] 36A-36C, the engagements at points L1-L3 (in the illustrated example, the high points) are generally part of the reservoir dock opening that receives the intermediate component, but one or more of these may be formed as part of the intermediate component or as part of a third component.
[0354] 36A-36C, the intermediate component 9700 at the end of its insertion path is elevated and sealingly engaged with the chassis opening by the port seal 9735. Examples of the present technology include performing a similar acoustically transparent engagement without the assistance of the port seal 9735 and / or membrane 9732. In these examples, as the elevated position of the intermediate component 9700 changes, the port 9730 of the intermediate component 9700 and the chassis opening 7380 may approximate or even abut. In some examples of the present technology, the elevation of the adjacent surface of the port 9730 of the intermediate component 9700 and / or the surface of the chassis 7300 adjacent the chassis opening 7380 may provide the adjacent or abutting engagement.
[0355] As described above, the functions of the three engagement points L1-L3 are as follows: (a) to elevate and move the intermediate component 9700 into sealing engagement with the chassis opening 7380; and / or (b) to reliably lock the intermediate component 9700 into the engagement configuration. In configurations included in the present technology, the chassis opening 7380 is not located above the intermediate component 9700 (as shown in FIGS. 36A-36C ), but is located in another direction / location around the intermediate component 9700 (e.g., on the side or below the intermediate component 9700). In these examples, the location of the port 9730 is located on the intermediate component 9700 to correspond to the location of the chassis opening 7380.
[0356] The engagement forming points L1-L3 may be moved so that one or more of them are located on a side of the intermediate component 9700 opposite the location of the port 9730. In these examples, the engagement forming points L1-L3 are not "high" points because they bias movement of the intermediate component 9700 in other directions (e.g., sideways). Even if the chassis opening 7380 is located laterally (particularly on the underside of the intermediate component 9700), the function of the engagement forming points L1-L3 is to urge the intermediate component 9700 in a particular direction and to lock the intermediate component 9700 into the engagement configuration. Depending on the location of the chassis opening 7380, the function of the engagement forming points L1-L3 to urge the intermediate component 9700 into the chassis opening 7380 may be provided, at least in part, by gravity.
[0357] In examples involving an associated port seal (i.e., port seal 6735 or port seal 9735) at the port 9730 of the intermediate component 9700, one or more engagement formation points L1-L3 may also have the task of providing a stable sealing engagement between the intermediate component port 9730, the chassis opening 7380, and the port seal. In examples of the present technology, the port seal (e.g., port seal 6735 or port seal 9735) is part of the intermediate component 9700, part of the membrane 9732, part of the chassis opening 7380, and / or is a separate element.
[0358] The chassis opening 7380 may have a smaller opening than the port 9730 and / or the opening formed by the port seal 9735. In some examples, the chassis opening 7380 may include an inner surface that allows for a change in cross-sectional profile. In the inner surface profile shown in FIG. 36D , the opening at a first end 7380 of the chassis opening adjacent the port 9730 is smaller than a second end of the chassis opening 7380 opposite the first end. The chassis opening 7380 may have a circular shape with a first diameter formed at the first end and a circular opening at the second end with a second diameter larger than the first diameter. In some examples, the second diameter may be equal to the diameter of the port 9730 and / or the opening formed by the port seal 9735. A larger opening may be necessary to accommodate a sensor that may be larger than the opening on the first end. The opening on the first end may be smaller to reduce the possibility of ingress of contaminants onto the sensor and / or other components on the circuit board.
[0359] A particular cross-sectional profile feature (in this case, the two openings mentioned in the paragraph above) may be formed in the chassis wall. However, a second (or additional) opening may also be formed by providing a flange on the top surface of the chassis, thereby forming a sidewall 7390 surrounding the chassis opening 7380 formed in the chassis wall. Such optional sidewall 7390, shown in FIG. 36D , extends from the face of the chassis 7300 to the PCBA 7600 and provides a second end having a second diameter. The sidewall 7390 may improve the acoustic seal between the PCBA 7600 and the first end of the chassis opening 7380, providing audio integrity for microphone reception. The inner wall of the chassis opening 7380 imposes a different profile between the first and second ends, which have different diameters. In the profile shown in FIG. 36D , the chassis opening 7380 is flared on the outer surface, thereby defining two different diameters on two opposing sides of the chassis wall.
[0360] 36D , the sensor can be disposed adjacent to and / or at least partially inside the second end of the chassis opening 7380. In some examples, the sensor 4270 can be spaced or extend away from the PCBA 7600 such that the sensor 4270 is disposed substantially entirely inside the chassis opening 7380. A seal constructed of silicone, a thermoplastic material, or another flexible material can be provided at the interface between the chassis wall opening and the PCB and / or between the chassis wall opening and the detector.
[0361] 5.9 Acoustic Analysis and Detection An RPT device (4000 or 6000) according to aspects of the present technology may be configured to identify physical characteristics of the air circuit 4170 of the RPT system and / or physical characteristics within the air circuit 4170 of the RPT system (e.g., conduits and / or mask) based on detection of acoustic signals propagating along at least a portion of the air circuit 4170 (e.g., conduits and / or mask). An example of acoustic detection for a respiratory treatment apparatus is described in PCT Patent Application No. WO2010 / 091462, which is incorporated herein by reference in its entirety.
[0362] The RPT device may identify physical properties of and / or within the air circuit 4170 using sounds generated by the RPT device (e.g., noise from an impeller and / or blower motor, or other mechanical sounds activated by the device assembly (e.g., insertion of a humidifier reservoir)). Such sounds travel downstream, for example, along a conduit to a mask. Similarly, the system may utilize environmental noise traveling down the air path of the RPT device. Some of the sounds generated by the device may be reflected from various physical features along the air circuit 4170 (e.g., conduits and mask) and return along the conduit to the RPT device, forming an "echo" signal. The "echo" signal may be viewed as a filtered reflection of a signal associated with a particular feature, and the filter may be viewed as a reflective frequency response function of the particular feature. Those skilled in the art will appreciate that a frequency response function is a complex spectrum of an impulse response function and may be used to define the response of a physical feature (e.g., a reflective response to an incident excitation signal).
[0363] The sensor 4270 (e.g., a microphone) (see FIG. 37) may be configured to detect a sound signal. In some examples, the sensor 4270 may be configured for detection of a combination of the original source signal and the returned sound ("echo" signal). The sensor 4270 may be disposed within the interior space of the RPT device 4000. Circuitry (e.g., an integrated circuit and / or a processor) coupled to the sensor 4270 may be configured to determine physical properties of and / or within the air circuit 4170 based on the detected sound. In some examples, the circuitry may be configured to transmit a signal to the processor. Signal processing may be used to estimate a reflected impulse response function of one or more physical features of interest, and the further one or more impulse response functions may be classified using a classification system. In some examples, the circuitry may be configured to compare the detected returned sound with the originally generated sound and subtract one or more parameters of a downstream system based on the difference between the two. For example, the circuitry can be configured to determine, for example, the type of conduit and / or mask used in the system, the presence of an obstruction in the air circuit 4170, and leaks in the air circuit 4170. In some examples, signal processing can be distributed, such as by digitizing the acoustic signal with an integrated digital sensor, which is then sent to a separate processor where an impulse response function is estimated. The estimated impulse response function can then be sent to another processor for physical feature classification. In another example, the RPT device can be connected to a network of other devices, either locally or remotely located, and any combination of processing can be performed on the other devices.
[0364] According to aspects of the present technology, the sensor 4270 may be located in an interior space of the RPT device 4000 adjacent a conduit of the air circuit 4170 or within a feature connecting the conduit to a humidifier and / or pressure generator. The port 6730 (9730) is provided to facilitate the transmission of incident and / or reflected sound to the sensor 4270. In some examples of the present technology, an intermediate component 9700 connecting the air circuit 4170 to the RPT device 4000 (e.g., via a connection to the reservoir dock 6050 and / or water reservoir 6100) may include a sound port 9730 to facilitate the transmission of sound (originally generated and / or reflected) to the sensor 4270.
[0365] FIG. 37 shows example components of a system for detecting sound signals according to the present technology. The generated sound (GS) may originate from one or more components in the integrated RPT device and humidifier 6000 (or RPT device 4000). This sound may be generated due to the operation of the blower 4142. The generated sound may propagate to the air circuit 4170 directly or via one or more other components. As shown in FIG. 37, the sound propagates to the air circuit 4170 via the water reservoir 6100 and intermediate component 9700. A portion of the generated sound GS in the air circuit 4170 may be reflected along the air circuit 4170 and / or patient interface 3000 from various physical features. The reflected sound may return along the conduit to the RPT device 6000. A portion of the generated sound may be reflected from different locations within the signal propagation path (including the conduit, mask, and / or patient).
[0366] A sensor 4270 (e.g., a microphone) is provided within the RPT device to sense the emitted sound GS and the reflected sound RS. As shown in FIG. 37 , the sensor 4270 is positioned proximate to the port 9730 of the intermediate component 9700. The sensor 4270 may be coupled to the PCBA 7600 such that the sensor 4270 is positioned a predetermined distance above the port 9730. The sensor 4270 may also be coupled to other circuitry on the PCBA 7600 or to another PCBA (including processing circuitry configured to subtract one or more parameters of the air circuit 4170 based on the sensed sound). Vibrations in the PCBA 7600 may be picked up by the sensor 4270, resulting in degradation of the detected “echo” signal. To reduce the occurrence of such vibrations, one or more mass elements / spring elements / sound damping elements (e.g., rubber and / or silicone washers) can be used when fastening the PCBA7600 to the chassis, which can dampen some of the vibrations of the PCBA7600 and improve reception of the "echo" signal.
[0367] In accordance with one form of the present technology, the sensor 4270 (e.g., a microphone) is spaced a predetermined distance from the port 9730. In one example, the sensor 4270 (e.g., a microphone) is spaced as close as possible to the port 9730. This predetermined distance may be measured from a plane defined for the sensor 4270 by the exit of the chassis opening 7380. In some examples, this predetermined distance may be measured from the sensor 4270 to an interior surface of the intermediate component 9700, at which the membrane 9732 may extend. However, these distances are not particularly critical in the design, as resonance results in equal incident and reflected waves.
[0368] The predetermined distance may be determined based on the wavelength of the highest frequency the system is configured to resolve. In some examples, the sensor 4270 may be located at a distance that is approximately 1 / 4 of the signal wavelength resolved by the system. For example, if the system is configured to sense and process a highest frequency of approximately 10 kHz (3.5 cm wavelength), the coupling of the sensor 4270 may be located at a distance of 1 / 4 of the wavelength (e.g., near or slightly less than 1 cm) to avoid resonance in the coupling guide between the intermediate component and the microphone. While the distances specified above are typically less than 1 cm, in some examples, the sensor 4270 may be located up to 2 cm from the opening in the intermediate component 9700.
[0369] If the sensor 4270 is placed near a signal path discontinuity, it may result in strong reflections that may mask reflections from various features in the conduit and / or patient interface that would otherwise be detected based on the reflected signal. In some examples of the present technology, the sensor 4270 may be placed from the nearest signal path discontinuity in a manner that is farther away from the maximum distance between any two target physical features (e.g., those in the detected patient interface or conduit). In this configuration, a clearer time separation is provided between components of the impulse response function (IRF) associated with the conduit and / or patient interface and the pressure generator in the RPT device. The IRF is the system response to a unit impulse input. In this configuration, the system may provide detection of features smaller than this distance, independent of the characteristics of the pressure generator IRF.
[0370] One approximation for the maximum distance between physical features within the patient interface (or conduit) is the maximum dimension of the patient interface or component (or conduit) of the patient interface when the components are connected via a waveguide. Typically, the end of the intermediate component 9700 is serially connected to the other components. The outlet of the intermediate component is typically connected to the air circuit, and the inlet end of the intermediate component is connected to the inlet end of the outlet tube of the water reservoir. These connections can shift the signal propagation path discontinuity from the inlet end of the intermediate component to the inlet end of the outlet tube of the water reservoir 6100. For detection of small masks, the distance between the sensor 4270 and the inlet end of the outlet tube of the water reservoir 6100 is typically at least 2-6 cm. For detection of large masks, the distance between the sensor 4270 and the inlet end of the outlet tube of the water reservoir 6100 is typically at least 4-15 cm. If such a muffler is used instead of a water reservoir, similar considerations apply to the dimensions of the outlet tube of the outlet cap muffler 4124 (e.g., the length of the outlet tube (which determines the distance between the sensor 4270 and the inlet end of the outlet tube)). In another embodiment of the present technology, the IRF of the RPT device can be characterized and filtered out from the recorded microphone signal to reduce the effects of such dimensions.
[0371] According to one form of the present technology, to completely separate the mask IRF from the pressure generator IRF, the distance between the sensor 4270 and the inlet end of the outlet tube of the water reservoir 6100 should be greater than the largest dimension of the mask. For example, if the mask has a 40 cm connecting tube and cuff used to attach the mask and connecting tube to a standard length of tubing, the dimension should be greater than 40 cm plus the length of the other mask components. However, other arrangements are possible. If the distance between the sensor 4270 and the nearest discontinuity is not greater than the largest dimension of the mask, the mask signature may appear as a reflected and attenuated superimposed mask signature (i.e., a secondary reflection of the mask signature from the device discontinuity). This composite signature may be useful solely as mask identification information. For example, if the distance between the sensor and the nearest discontinuity becomes significantly small, the IRF superimposition can be algorithmically taken into account for cases where the pressure generator IRF is consistent or deterministic. An example of an IRF based acoustic feature detection system is described in PCT Patent Application Publication No. WO2010 / 091462, which is incorporated herein by reference in its entirety.
[0372] In some examples of the present technology, a seal 9800 (e.g., constructed of a thermoplastic elastomer (TPE) or silicone) may be provided between the PCBA 7600 and the chassis 7300 (see, e.g., FIG. 36D ). A main portion of the seal 9800 may form a sealing wall adjacent to and at least partially surrounding the side wall 7390. The wall portion of the seal 9800 may partially or completely surround the side wall 7390. The side wall 7390 extends from the chassis and provides an opening facing the PCBA 7600. The sensor 4270 may be aligned with and / or at least partially within the opening in the chassis facing the PCBA 7600.
[0373] In one example, the seal may further include a "ceiling" portion that faces the PCBA7600 and extends above and into the area enclosed by the sealing wall and adjacent sidewall 7390, effectively forming a ceiling above both the sealing wall and sidewall 7390. An opening may be provided in this ceiling portion to allow sound to pass through the interior from the chassis opening 7380 to the sensor. Alternatively, as shown in FIG. 36D , the ceiling portion of the seal 9800 may have an opening on the side facing the PCBA7600 that faces the opening formed by the sidewall 7390. The opening in the seal 9800 allows the sensor 4270 mounted on the PCBA7600 to be at least partially positioned in the chassis opening formed by the sidewall 7390. The seal 9800 may include a peripheral seal formation 9805 that surrounds the periphery of the opening in the seal 9800. 36D, a peripheral seal formation 9805 can be provided on the outer edge of the sidewall 7390. The peripheral seal formation 9805 can provide a compression-type seal against the PCBA 7600 during assembly of the PCBA 7600 and chassis 7300. A portion of the chassis 7300 adjacent the sidewall 7390 presses the seal 9800 against the PCBA 7600 during assembly.
[0374] The seal 9800 and / or the peripheral seal formation 9805 may prevent external noise from entering the chassis opening and / or may reduce the transmission of vibrations between the PCBA 7600 and the chassis 7300. The seal 9800 and / or the port seal 9735 provide an acoustic seal to guide sound to the sensor. The peripheral seal formation 9805 may include a ridge seal formation as described with reference to Figures 34A-34D or a lip seal formation as described with reference to Figures 35A-35D.
[0375] The seal 9800 may be attached to the PCBA 7600 and / or the chassis 7300 using adhesive or mechanical means (e.g., screws or bolts). In some examples, the seal 9800 may be secured by being pressed onto the PCBA 7600 by the chassis 7300 without the use of adhesive or mechanical means.
[0376] 5.9.1 Communication between the sensor and intermediate components As described above with reference to FIG. 37 , a sensor 4270 (e.g., a microphone) is mounted on the PCBA 7600 for sensing sound in the air path. The sound reaches the sensor 4270 through a port 9730 in the intermediate component 9700 or another portion of the air circuit 4170 (e.g., a conduit). The port 9730 may include a membrane and / or a port seal. The sound may be transmitted from the membrane through the port seal to an opening 7380 in the chassis 7300. The sensor 4270 is mounted on the PCBA 7600 below and / or within the opening 7380. Analysis of the sound from the sensor 4270 determines one or more characteristics of the RPT device and / or one or more characteristics of the air circuit 4170.
[0377] A variety of issues can affect the quality of sound transmitted to and sensed by the sensor 4270 and / or analytical consistency over time between RPT devices, such as variations in the relative positions of features of the sensor 4270 and the air circuit 4170 (e.g., intermediate component 9700, port 9730, port seal 9735, and / or membrane 9732, as described above with reference to FIGS. 34A-36C) due to manufacturing tolerances and / or component wear; the escape of sound to the ambient air after passing through the port 9730 and / or chassis opening 7380; and / or vibrations of the RPT device components (e.g., PCBA 7600) and / or air circuit 4170 during use transmitted to the sensor 4270.
[0378] According to an example of the present technology (see FIGS. 38A-39D), a coupler 8750 configured to flexibly couple the sensor 4270 to a feature of the air circuit 4170 (e.g., a port and / or a membrane provided in an intermediate component or another portion of the air circuit) improves sound quality and consistency. The coupler 8750 is configured to self-align to ensure consistency in relative positioning (e.g., horizontally and / or vertically) of the sensor 4270 with respect to the port 8830 and / or membrane 8732. The coupler 8750 may be a magnetic coupler including one or more magnets to align and hold the coupler 8750 in place. The coupler 8750 also functions as a completely sealed path to minimize sound escape to the surroundings. In this regard, the coupler provides at least some guidance along the path to the sensor. Because the coupler 8750 is flexible, at least some vibrations of the air circuit 4170 components (e.g., intermediate component 8700 and / or PCBA7600) are damped. To reduce vibration transmission from the PCBA 7600 to the sensor 4270, the sensor 4270 may be mounted using one or more damping features (e.g., rubber feet) on tabs on the PCBA 7600, which may be partially curved with cutout channels. The coupler 8750 may be "bellows" shaped for additional vertical flexibility.
[0379] Although features related to coupling the sensor 4270 to the air circuit 4170 have been described with reference to coupling the sensor 4270 to an intermediate component, the features related to coupling the sensor 4270 to the air circuit 4170 may also be included in implementations in which the sensor 4270 is directly or indirectly coupled to another portion of the air circuit 4170 (e.g., a conduit or a mask). For example, the features related to coupling the sensor 4270 to the air circuit 4170 may apply to examples in which the sensor 4270 is coupled to a port (e.g., an opening covered by a membrane) in a conduit of the air circuit 4170. In this example, the sensor 4270 may be mounted independently or may be mounted on the PCBA7600 inside the RPT device housing or on another PCBA7600 outside the RPT device housing.
[0380] In the context of the above paragraph, the term "intermediate component" (e.g., intermediate component 6700, intermediate component 8700, or intermediate component 9700) may be considered to actually cover any component that links the sound source to the air circuit and detector. In this sense, the term "intermediate" may be considered to be used in the context of being between the sound source and the sensor to provide an acoustic link between the two, and is not necessarily limited to a component disposed between the conduit and the blower. Thus, in some examples of the present technology, the intermediate component may be pneumatically connected to, but not within, the pathway between the blower and the conduit of the air circuit 4170 (see, e.g., FIG. 37). In one such example, the intermediate component may connect to an opening in a tube of the air circuit and connect to the sensor via a port and seal provided in the intermediate component.
[0381] In other examples, the intermediate component may be located inside the housing of the RPT device along with other components (eg, a pressure generator, a humidifier, a circuit board, and / or a sensor).
[0382] 5.9.1.1 Sensor Positioning and Sound Path Alignment As noted above, in some examples of the present technology, the sensor 4270 (e.g., a microphone) is located a predetermined distance from the port 8830 in the intermediate component 8700. In some examples, the sensor 4270 is located as close as possible to the port (e.g., port 8830) in a particular location. However, due to manufacturing tolerance variations, component wear, and variations in the positioning of features of the air circuit 4170 (e.g., the position of the intermediate component 8700 when inserted into the receiving chassis opening), the relative positioning (e.g., horizontally and / or vertically) of the sensor 4270 with respect to the port 8830 and / or membrane 8732 may differ for the same component used in different RPT devices or may change over time when components are replaced or reassembled before use (e.g., after cleaning).
[0383] 38A-39D, a coupler 8750 according to the present technology couples a sensor 4270 to an intermediate component 8700. The coupler 8750 is configured to align the sensor 4270 with a port 8830 in the intermediate component 8700 when the intermediate component 8700 is inserted into an RPT device (e.g., the dock outlet 6090 of the reservoir dock 6050 shown in FIGS. 11-13).
[0384] In some examples, intermediate component 8700 may include one or more of the features described with reference to intermediate component 6700 ( FIGS. 13-15 and 19-22 ) and / or intermediate component 9700 (see FIGS. 23-36C ) or may correspond to intermediate component 6700 or intermediate component 9700. Similarly, intermediate component 6700 or intermediate component 9700 may include one or more of the features described with reference to intermediate component 8700.
[0385] The coupler 8750 is positioned between and coupled to the PCBA 7600 and the intermediate component 8700. The coupler 8750 is removably coupled to the intermediate component 8700. Although FIGS. 38A-39D show the coupler 8750 coupled to the intermediate component 8700, in some examples of the present technology, the coupler 8750 may be removably coupled to another component (e.g., a conduit) of the air circuit 4170 (e.g., a conduit that includes an opening (to allow sound to reach the sensor 4270 positioned outside the air circuit 4170)).
[0386] The coupler 8750 includes a body 8752. The body 8752 may be a tubular body and includes an inlet end 8756 adapted to interface with the intermediate component 8700 and an outlet end 8758 adapted to interface with the sensor 4270 and / or PCBA 7600. The coupler 8750 may be constructed of a relatively soft material (e.g., a thermoplastic elastomer (TPE) or silicone). The body 8752 may include one or more bellows 8754 disposed between the inlet end 8756 and the outlet end 8758. The one or more bellows 8754 may be adapted to horizontally and / or vertically dispose the inlet end 8756 relative to the outlet end 8758 and may be secured to the sensor 4270 and / or PCBA 7600 (without interfering with the coupling).
[0387] In one form of the present technology, the material of the coupler 8750 may be flexible, allowing the inlet end 8756 to be displaced horizontally and / or vertically relative to the outlet end 8758 (without disrupting the connection). In this example, the horizontal and / or vertical displacement due to the flexibility of the material may be provided in addition to or instead of the one or more bellows 8754.
[0388] An opening 8764 included in the outlet end 8758 is configured to engage with a sensor 4270 provided on the PCBA 7600. The opening 8764 in the outlet end 8758 may correspond to the shape and size of the sensor 4270 (e.g., sensor housing 4271). The sensor 4270 may be press-fit into the opening 8764 in the outlet end 8758 and / or may be glued or cold-welded to secure the sensor 4270 to the coupler 8750. The sensor 4270 may be removably coupled within the opening 8764.
[0389] The outlet end 8758 may include a flange 8759 adapted to abut a portion of the sensor 4270 and / or a portion of the PCBA7600 surrounding the sensor. The flange 8759 may extend from the body 8752 and may extend outward from a central axis of the body 8752 and / or may extend from the body 8752 toward a central axis of the body 8752. In one example, the outlet end 8758 may be coupled to the sensor 4270 (without directly contacting the PCBA7600). In another example, at least a portion of the outlet end of the coupler 8750 may contact the PCBA7600. In another example, the outlet end 8758 may contact (and / or be attached to) the PCBA7600, but the body of the sensor 4270 is offset a predetermined distance from the PCBA7600 so that the sensor is attached to the PCBA7600 rather than being directly disposed on it. In this example, the outlet end may be closed, one or more rubber feet (see rubber feet 8788 in Figures 41A-41C) may be provided on the outlet end 8758 to connect the coupler 8750 to the PCBA7600, and one or more ports 8786 may be made available to route electrical wires to connect the sensor to the PCBA7600.
[0390] The inlet end 8756 includes a coupling portion 8760 adapted to receive a first connecting element 8762. The coupling portion 8760 may include a flange including a complementary shape that corresponds to the shape of the first connecting element 8762. In some examples, the first connecting element 8762 may be a ring and is adapted to be press-fit into the flange and provided on a portion of the body 8752 that extends through the flange. The first connecting element 8762 may be glued or cold welded to the inlet end 8756. In some examples, the inlet end 8756 may be overmolded onto the first connecting element 8762 such that the first connecting element 8762 is encapsulated by the inlet end 8756.
[0391] The first connecting element 8762 is adapted to removably connect to a second connecting element 8766 disposed on or within the intermediate component 8700. The first connecting element 8762 and / or the second connecting element 8766 may include magnets adapted to connect to each other. In some examples, one of the first connecting element 8762 and the second connecting element 8766 includes a magnet, and the other of the first connecting element 8762 and the second connecting element 8766 includes a metallic material adapted to connect to the magnet. The shape of the first connecting element 8762 may correspond to the shape of the second connecting element 8766. In one example, the shape and size of the first connecting element 8762 may be the same as the shape and size of the second connecting element 8766. In one example, the shape of the first connecting element 8762 may be the same as the shape of the second connecting element 8766, and the size of the second connecting element 8766 may be larger than the first connecting element 8762.
[0392] The second connecting element 8766 is provided on a surface of the intermediate component 8700 (e.g., see FIG. 39B ) or disposed under at least a portion of a surface of the intermediate component 8700 (e.g., see FIG. 39A ). The second connecting element 8766 is attached (e.g., glued or cold welded) to the intermediate component 8700. The second connecting element 8766 may be a ring and is positioned around the port 8830 in the face of the intermediate component 8700. The second connecting element 8766 may be positioned such that a central axis of the second connecting element 8766 is common with the central axis 8830 of the port. In some examples, the opening of the port 8830 may correspond in shape and / or size to an opening in the second connecting element 8766 and / or the first connecting element 8762.
[0393] In some examples, the second connecting element 8766 can be provided underneath a membrane 8732 or another element (e.g., a silicone ring-shaped element) adapted to cover at least a portion of the second connecting element 8766 (e.g., along the circumference of the ring). The membrane 8732 or other element can be coupled to a surface of the intermediate component 8700 adjacent the outer periphery of the second connecting element 8766. The membrane can be a thin-walled silicone membrane that is sonoporous and impermeable to liquids and / or gases. The membrane 8732 can have a shape and / or size that corresponds to the outer shape and / or size of the first connecting element 8762 and / or the second connecting element 8766. As shown in FIGS. 38B, 39A, and 39B, the membrane 8732 can be circular and can extend beyond the second connecting element 8766 in some examples of the present technology.
[0394] In some examples of the present technology, the membrane 8732 can include one or more features of the membrane 9732 described above (see, for example, FIGS. 34A-36C). In some examples of the present technology, the membrane 8732 can be provided on an inner surface of the intermediate component 8700 (see, for example, membrane 9732 shown in FIGS. 34A-36C).
[0395] In some examples of the present technology, the membrane 8732 can be configured to cover an end of the coupler 8750 adjacent to the intermediate component 8700. For example, the membrane can be provided between the end of the coupler 8750 and the first connecting element 8762.
[0396] In some examples of the present technology, the second connecting element 8766 can be provided as part of or inside the port seal (see port seal 9735 shown in FIGS. 34A-36C). In this example, the second connecting element 8766 can be provided within a portion of the port seal 9735 or below a portion of the port seal 9735. For example, the second connecting element 8766 can be provided within the raised seal 9737, the lip seal 9742, the connecting portion 9739, or the underside of the connecting portion 9739.
[0397] In some examples of the present technology, other mechanical couplings (eg, mechanical coupling methods, temporary adhesive methods, or suction methods) may be used to removably couple the coupler 8750 to the intermediate component 8700.
[0398] As shown in FIG. 39A , the coupler 8750 can extend from the PCBA 7600 to the port 8830 through a chassis opening 7380 in the chassis 7300. In some examples, at least a portion of the sensor 4270 can extend into or through the chassis opening 7380. FIG. 36D shows the PCBA 7600 positioned above the chassis opening 7380 and the sensor 4270 supported by the PCBA 7600 extending at least partially into the chassis opening 7380. In some examples, the center of the sensor can be aligned with the central axis of the chassis opening 7380. In another arrangement, the intermediate component can not directly connect the pressure generator to the air delivery tube, but can be pneumatically connected to both. Also, in another arrangement, there can be no chassis wall disposed between the opening of the intermediate component and the sensor. Again, the above description is applicable, but in the context of a direct connection between the opening of the intermediate component and PCBA7600 (see, e.g., FIG. 37) or another component with an acoustic sensor mounted on top.
[0399] When the intermediate component 8700 is inserted into the receiving reservoir dock 6050 and positioned in place (see, e.g., FIGS. 36A-36C ), the inlet end 8756 of the coupler 8750 may not be horizontally and / or vertically aligned with the port 8830. The suction and connection properties between the first and second connection elements 8762, 8766 and the one or more bellows 8754 allow the inlet end 8756 to be displaced horizontally and / or vertically, allowing the first connection element 8762 to be aligned with and connect to the second connection element 8766 when the first and second connection elements 8762, 8766 are adjacent to one another. The alignment of the first connection element 8762 and the second connection element 8766 (e.g., by having a common axis), and any additional elements that may be provided in the connection arrangement, may provide a path for sound to travel directly from the intermediate component 8700 to the sensor 4270 (without any of the elements making mechanical contact with the chassis 7300 or the PCBA 7600). In the aligned state, the port 8830, the first connection element 8762, and the second connection element 8766 may have a common longitudinal axis.
[0400] The alignment of inlet end 8756 with port 8830 provides an aligned path for sound from intermediate component 8700 to travel through port 8830 to sensor 4270. This path is provided consistently even when the final position of intermediate component 8700 relative to the fixed position of sensor 4270 varies.
[0401] 5.9.1.2 Features that reduce sound leakage The coupler 8750 also functions as a completely sealed path to minimize sound escape to the surroundings. FIG. 40A illustrates the sound escape that can occur when there is no coupler 8750 between the sensor 4270 and the intermediate component 8700. As shown in FIG. 40A , after sound passes through the membrane 8732, the sound is directed toward the sensor 4270. However, if horizontal misalignment occurs between the sensor 4270 and the membrane 8732 and / or port 8830, some of the sound may be directed to the side of the sensor 4270, causing a reduction in the sound captured by the sensor 4270 and affecting the quality of the captured sound. If the vertical alignment changes, more or less sound may be directed to the side of the sensor 4270.
[0402] FIG. 40B illustrates sound leakage that can occur in a system including a coupler 8750 between a sensor 4270 and an intermediate component 8700, according to an example of the present technology. The self-alignment of the coupler 8750 with the port 8830 in the intermediate component 8700 provides a sealed path for sound to travel from the intermediate component 8700 to the sensor 4270. As shown in FIG. 40B, in the absence of vertical and / or horizontal misalignment, sound leakage to the sides of the sensor 4270 can be nearly eliminated. Thus, the coupler 8750 acts as a completely sealed path to minimize sound leakage to the surroundings.
[0403] 5.9.1.3 Vibration-reducing features Vibrations in the components of the RPT device and / or air circuit 4170 can degrade the quality of the sound captured by the sensor 4270. The flexibility of the coupler 8750 provided by the material of the coupler 8750 and / or bellows 8754 attenuates at least some of the vibrations generated in and / or transmitted through the air circuit 4170 to the sensor 4270.
[0404] Vibrations that can cause degradation of the detected "echo" signal can also be transmitted from the PCBA7600 to the sensor 4270. The PCBA7600, connected to the chassis, picks up vibrations caused by components of the RPT device (e.g., a blower motor). As mentioned above, to reduce the occurrence of such vibrations within the PCBA7600, one or more damping elements (e.g., rubber and / or silicone washers) can be used to fasten the PCBA7600 to the chassis to dampen any vibrations of the PCBA7600 and improve reception of the "echo" signal.
[0405] 5.9.1.3.1 Rubber Interface Another feature that may be included in other examples disclosed herein is providing one or more damping elements in fastening the sensor 4270 to the PCBA7600 to dampen vibrations transmitted from the PCBA7600 to the sensor 4270. FIGS. 41A-41C show a rubber interface 8780 for coupling the sensor 4270 to the PCBA7600. The rubber interface 8780 is provided between the sensor 4270 and the PCBA7600. The rubber interface 8780 may function as a vibration damper. The flexible housing provided by the rubber interface 8780 supports the sensor 4270 and isolates vibrations from the PCBA7600. The rubber interface 8780 may also reduce vibrations transmitted from the intermediate component 8700 to the sensor 4270.
[0406] The rubber interface 8780 may include a tubular body 8782 with an interface opening 8784 at one end and a closed end 8785. While Figures 41A-41C illustrate the rubber interface 8780 including tubular interior and exterior shapes, examples of the present technology are not limited thereto and may include other shapes (e.g., square or rectangular interior or exterior shapes).
[0407] The interface opening 8784 can be configured to receive and retain the sensor 4270 (not shown in FIGS. 41A-41C) at least inside the rubber interface 8780. In some examples, a portion of the sensor 4270 can extend from the tubular body 8782. In some examples, the sensor 4270 can be disposed inside the rubber interface 8780 without extending outside the tubular body 8782.
[0408] One or more connection ports 8786 may be provided on the closed end 8785 of the rubber interface 8780 adjacent the PCBA 7600. One or more connections (not shown in FIGS. 41A-41C) between circuit elements on the PCBA 7600 and electrical connections on the sensor 4270 may be routed through the one or more connection ports 8786.
[0409] The rubber interface 8780 can include a plurality of rubber feet 8788 on the closed end 8785. The plurality of rubber feet 8788 are configured to offset the closed end of the rubber interface 8780 from the PCBA 7600 and couple the rubber interface 8780 to the PCBA 7600. The rubber feet 8788 can reduce the contact area between the PCBA 7600 and the rubber interface 8780, leading to a reduction in the amount of vibration transmitted from the PCBA 7600 to the sensor 4270.
[0410] In one example of the present technology, the rubber interface 8780 can be configured to engage with the outlet end 8758 of the coupler 8750 shown in Figures 38A-39D. In this example, the rubber interface 8780 can correspond to the sensor housing 4271 shown in Figure 39A.
[0411] In another example of the present technology, the rubber interface 8780 can correspond to a coupler 8750 configured to couple the sensor 4270 to the intermediate component 8700 (see FIG. 41C ). In this example, the rubber interface 8780 can include a first connection element 8762 (not shown in FIG. 41C ) that is provided inside the rubber interface 8780 or attached to an interface opening 8784. The first connection element 8762 is configured to couple to a second connection element 8766 (not shown in FIG. 41C ) that is provided in or on a surface of the intermediate component 8700. In this example, the rubber interface 8780 provides coupling to the intermediate component 8700 while also providing vibration damping of vibrations from the intermediate component 8700 to the PCBA 7600.
[0412] 5.9.1.3.2 Channel Cutouts in Circuit Boards Another feature for reducing vibrations transmitted to the sensor 4270 may be included in other examples disclosed herein and includes providing one or more channels 8900 cut out in the PCBA 7600. These channels 8900 reduce / dampen vibrations from the PCBA 7600 within the sensor 4270. The channels 8900 are cut through the thickness of the PCBA 7600. FIGS. 42A-42C show examples of channels 8900 cut out in the PCBA 7600. The width of the cutout of the channels 8900 may correspond to the thickness of the PCBA 7600.
[0413] The PCBA 7600 includes conductive tracks 7602 configured to connect to the sensor 4270 and to transmit signals to other components located on and / or remote from the PCBA 7600. The PCBA 7600 includes through holes 7604 configured to couple the head of the sensor 4270 to the conductive tracks 7602. The channel 8900 is at least partially disposed around the through holes 7604 located on a hanging tab 8910 of the PCBA 7600 formed by the channel 8900. The conductive tracks 7602 extend from the through holes 7604 to the other components via connections 8920 on the tabs 8910.
[0414] The channel 8900 reduces the amount of vibration transmitted to the sensor 4270. While some vibration to the sensor 4270 may be transmitted through the connection 8920, vibration transmitted to the hanger tab 8910 is significantly reduced.
[0415] In some examples, in addition to vibration reduction, the tab 8910 may deflect vertically due to the attraction resulting from the coupling of the first connection element 8762 and the second connection element 8766 to align with the sensor 4270 coupled to the tab 8910. For example, the attractive force between the first connection element 8762 and the second connection element 8766 may cause the tab 8910 to deflect downward, thereby positioning the sensor 4270 closer to the port 8830 (than would be the case without the channel 8900). The sensor 4270 shown in FIGS. 42B and 42C may include the first connection element 8762 or may include a coupler 8750 for connection to the second connection element 8766.
[0416] In some examples of the present technology, cutout channels providing tabs may be provided at each location where PCBA 7600 connects to the chassis. In this example, the tabs provided by the cutout channels may reduce vibrations transmitted from the chassis to PCBA 7600.
[0417] 5.9.1.4 Flexible Sensor Housing Another feature that may improve sensor positioning and sound escape and / or vibration mitigation is to provide the sensor 4270 within a flexible housing 8800. Figure 43 shows a sensor 4270 disposed within a flexible housing 8800 according to an example of the present technology. One or more of the features shown in Figure 43 may be provided in other examples of the present technology disclosed herein.
[0418] 43 , the sensor 4270 is disposed within a flexible housing 8800, with the sensor 4270 provided at one end of the flexible housing 8800. One end of the housing 8800 includes a connection portion 8810 configured to couple the flexible housing 8800 to the PCBA 7600. The connection portion 8810 may include a plurality of posts 8814 adapted to engage with through holes in the PCBA 7600 and secure the flexible housing 8800 to a surface of the PCBA 7600. A flexible wire 8820 is coupled to the sensor 4270 within the flexible housing 8800 and runs along the length of the flexible housing 8800, inside the flexible housing 8800, to the end of the flexible housing 8800 that includes the connection portion 8810. Flexible wires 8820 provide connections between sensors 4270 and components on and / or off of PCBA7600.
[0419] The flexible housing 8800 may comprise molded silicone or rubber and may be overmolded onto the sensor 4270 and / or flexible wire 8820. The flexible housing 8800 is adapted to flex when subjected to a force, for example, to the end of the flexible housing 8800 that includes the sensor 4270.
[0420] In use, when the intermediate component 8700 (or another air circuit component including the port 8830) is inserted, the end of the flexible housing 8800 including the sensor 4270 may be pushed by the inserted intermediate component 8700, thereby deflecting the flexible housing 8800 from its equilibrium position. The deflection of the flexible housing 8800 allows the intermediate component 8700 to engage with the chassis (without damaging the sensor 4270) in the fully assembled position (see, for example, FIGS. 36A-36C ). In the fully assembled position, the flexible housing 8800 and sensor 4270 are aligned with the port 8830, allowing the flexible housing 8800 to deflect back to its equilibrium position. In this position, the sensor 4270 may be positioned inside the port 8830 and / or the intermediate component 8700. When the intermediate component 8700 is removed, the flexible housing 8800 may be pushed by the sides of the port 8830 and deflected from its equilibrium position, allowing the intermediate component 8700 to be removed without damaging the sensor 4270.
[0421] 43, in the fully assembled position, the end of the flexible housing 8800 that includes the sensor 4270 is positioned at least partially inside the port 8830. In some examples, a portion of the sensor 4270 can be provided under an outer surface of the middle component 8700 and under an inner surface of the middle component 8700 (see FIG. 43).
[0422] The flexible housing 8800 allows the sensor 4270 to be positioned at least partially inside the port 8830, inside the intermediate component 8700 and / or adjacent to the membrane 8732, leading to improved quality of sound captured by the sensor 4270.
[0423] One or more features may be included in the port 8830 and / or flexible housing 8800 configured to reduce wear on the port 8830 and / or flexible housing 8800 and / or allow for gradual deflection of the flexible housing 8800. For example, as shown in FIG. 43 , the flexible housing 8800 may include a rounded edge 8816 and / or a chamfered edge 8832 of the port 8830 to reduce wear and / or allow for gradual deflection of the flexible housing 8800. In some examples, the edge 8816 may be chamfered and / or the edge 8832 is rounded.
[0424] Although not shown in FIG. 43, a port seal (ie, port seal 9735 ) including a raised seal 9737 or a lip seal 9742 may be provided between the intermediate component 8700 and the surface of the chassis 7300 .
[0425] 5.9.2 Exemplary Methods of Acoustic Detection and Analysis FIG. 44 illustrates an exemplary method of acoustic detection and analysis according to the present technology. One or more of the above operations may be performed by hardware circuitry (e.g., a processor) and / or software. In step 1002, an RPT device is controlled to provide a flow of breathable gas to the patient via the air circuit 4170. Control of the RPT device may include controlling the operation of at least one of a blower, a humidifier, and tubing. Operation of the RPT device may generate soun...
Claims
1. A device for the treatment of respiratory diseases, A pressure generator configured to produce a breathable gas flow; A reservoir dock including a dock opening; An intermediate component configured to be removably inserted into the dock opening, wherein the intermediate component is positioned to receive the breathable gas flow when fully inserted into the dock opening, and is configured to be pneumatically connected to a patient air delivery tube, and the intermediate component includes a port configured to facilitate the propagation of sound from the inner region of the intermediate component to the outer region of the intermediate component; and A sensor provided in a fixed position and positioned to align with the port when the intermediate component is fully inserted into the dock opening, wherein the sensor is positioned at a predetermined distance from the port and is configured to detect sound propagated from the port when the intermediate component is fully inserted into the dock opening; A device including a device.
2. Further comprising a chassis, A portion of the chassis is positioned between the sensor and the intermediate component, The chassis opening is formed in the chassis and is aligned with both the sensor and the port. The apparatus according to claim 1, wherein the chassis opening is arranged to allow sound to propagate from the port through the chassis opening to the sensor when in use.
3. Further comprising a port seal provided between the intermediate component and the sensor, The apparatus according to claim 2, which provides a sealed interface between the port and the chassis opening when the intermediate component is fully inserted into the dock opening.
4. The apparatus according to claim 3, wherein the port seal includes a periphery sealing forming portion including a lip configured to contact the surface of the chassis around the chassis opening when the intermediate component is fully inserted into the dock opening.
5. The port seal includes a film formed together with the port seal as an integral unit, The apparatus according to claim 3 or 4, wherein the membrane is configured to cover the port when in use and to propagate sound from the area inside the intermediate component to the area outside the intermediate component.
6. The apparatus according to claim 5, wherein the integrated unit forming the port seal and the film comprises silicone.
7. The apparatus according to claim 5 or 6, wherein the membrane is impermeable to liquids and / or gases.
8. The intermediate component and the dock opening include at least one pair of interlocking engagement forming portions, The apparatus according to claim 3, wherein the at least pair of interlocking engagement forming portions are arranged such that, when the intermediate component is inserted into the dock opening, the engagement of the at least pair of interlocking engagement forming portions causes the intermediate component to be fully inserted into the dock opening.
9. The apparatus according to claim 8, wherein when the intermediate component is in the operating configuration, the port seal is sealed and engaged with the chassis around the chassis opening.
10. The apparatus according to any one of claims 1 to 3, further comprising a membrane configured to cover the port when in use and to propagate sound from the inner region of the intermediate component to the outer region of the intermediate component.
11. The apparatus according to claim 10, wherein the membrane is configured to prevent the breathable gas flow from coming into direct contact with the sensor during use.
12. The apparatus according to claim 10 or 11, wherein the membrane comprises silicone.
13. Further comprising a circuit board disposed on the second side of the chassis opening, The port is located on the first side of the chassis opening, The apparatus according to claim 2, wherein the sensor is connected to the circuit board.
14. The apparatus according to any one of claims 1 to 13, further comprising a flexible coupler configured to facilitate the transmission of sound from the port to the sensor during use.
15. The apparatus according to any one of claims 2 to 14, wherein the intermediate component comprises a flange positioned between the inlet end and the outlet end of the intermediate component to assist in the positioning of the intermediate component within the dock opening.
16. The apparatus according to any one of claims 15, wherein the flange functions as a stop when the intermediate component is inserted into the dock opening.
17. The apparatus according to claim 15 or 16, wherein the intermediate component further comprises one or more flexible bumpers provided adjacent to the flange facing the inlet end.
18. The intermediate component is provided with a tab on a part of the intermediate component that is opposite to the exit end, The apparatus according to any one of claims 15 to 17, wherein the tab is constructed to provide a snap-fit connection with the locking member of the chassis.
19. A water reservoir comprising a cavity structured to hold a certain amount of water, wherein the water reservoir receives a stream of breathable gas so that the stream of breathable gas is humidified before being delivered to a patient interface; and A water reservoir dock with a structure and arrangement that allows the water reservoir to be received in the operating position. It further includes, The apparatus according to any one of claims 1 to 17, wherein the intermediate component is detachably connected to the water reservoir dock to receive a humidified flow of the breathable gas and to deliver the humidified flow of the breathable gas to the patient air delivery tube.
20. The apparatus according to claim 19, wherein the intermediate component is configured to connect the patient air delivery tube to the water reservoir dock pneumatically and to connect the patient air delivery tube to the water reservoir dock mechanically.