Peripheral device detection method and apparatus
By introducing detection circuits into the respiratory therapy system to detect the connection status of the air circuit and the patient interface, the existing system's shortcomings in comfort, cost and therapeutic effectiveness are solved, and more efficient respiratory therapy provision and management are achieved.
Patent Information
- Application Number
- CN202380041196.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-05-19
- Filing Date
- 2023-05-18
- Publication Date
- 2024-12-31
AI Technical Summary
Existing respiratory therapy systems have shortcomings in terms of comfort, cost, efficacy, ease of use and manufacturability, especially in the presence of noise, blockage and difficulty in detecting treatment effectiveness in air circuits and data management.
A respiratory therapy system including a detection circuit is designed to detect the connection state by using a detection circuit between the air circuit and the patient interface and adjust the provision of gas flow when necessary to improve the comfort and therapeutic effectiveness of the system, while Optimize the design of the air circuit to reduce noise and blockage.
Improves the comfort and therapeutic effectiveness of respiratory therapy systems, reduces the frequency of noise and blockage, simplifies data management, and enhances the manufacturability and user experience of the system.
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Figure CN119233841A_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit of Australian Provisional Application No. 2022901340, the entire contents of which are incorporated herein by reference. Technical Background Technical Field
[0003] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses. Background Art
[0005] The human respiratory system and its disorders
[0006] The human respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.
[0007] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air to the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea is divided into the left main bronchi and the right main bronchi, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to respiratory bronchioles and eventually to alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. See John B. West, published by Lippincott Williams & Wilkins in 2012, Respiratory Physiology, 9th edition.
[0008] therapy
[0009] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT) have been used to treat one or more of the above-mentioned respiratory disorders.
[0010] Respiratory pressure therapy
[0011] Respiratory pressure therapy is the application of air supplied to the entrance of the airway at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank or breastplate ventilator).
[0012] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, and therefore patients may choose not to comply with therapy if they find that the devices used to provide such therapy are uncomfortable, difficult to use, expensive, and unsightly.
[0013] Non-invasive ventilation (NIV) provides ventilation support to patients through the upper airway to help them breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in the form of OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.
[0014] Invasive ventilation (IV) provides ventilation support to patients who are no longer able to breathe effectively, and may be provided using a tracheostomy tube or an endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved.
[0015] Flow therapy
[0016] Not all respiratory therapies are intended to deliver prescribed therapy pressures. Some respiratory therapies are intended to deliver prescribed respiratory volumes by delivering inspiratory flow distribution (possibly superimposed on a positive baseline pressure) within a target duration. In other cases, the interface to the patient's airway is "open" (unsealed) and respiratory therapy can only supplement the patient's own spontaneous breathing with regulated or enriched gas flow. In one example, high flow therapy (HFT) is to provide a continuous, heated, humidified air flow to the entrance of the airway through an unsealed or opened patient interface to maintain a substantially constant "therapy flow" throughout the breathing cycle. The therapy flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD and other respiratory disorders. A mechanism of action is that the high flow air at the entrance of the airway improves ventilation efficiency by flushing or flushing out exhaled CO2 from the patient's anatomical dead space. Accordingly, HFT is sometimes referred to as dead space therapy (DST). Other benefits can include the possibility of elevated warmth and humidification (possibly beneficial to secretion management) and moderate increases in airway pressure. As an alternative to a constant flow, the therapy flow can follow a curve that varies with the respiratory cycle.
[0017] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air delivered to a patient's airway at a specific oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air) at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).
[0018] Supplemental oxygen
[0019] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized air flow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.
[0020] Respiratory therapy systems
[0021] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.
[0022] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.
[0023] Patient Interface
[0024] The patient interface can be used to engage the respiratory device to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can form a seal with, for example, an area of the patient's face to facilitate delivery of gas at a pressure sufficiently different from the ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids complete sealing. An example of such a patient interface is a nasal cannula.
[0025] Respiratory Pressure Therapy (RPT) Devices
[0026] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the above-mentioned therapies, such as by operating the device to generate an air flow for delivery to an interface of the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Accordingly, an RPT device can also act as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.
[0027] Air pressure generators are known in a variety of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size, and weight requirements for medical devices. In addition, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.
[0028] An example of a special requirement for certain RPT devices is acoustic noise.
[0029] Table of noise output levels of existing RPT devices (one sample only, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).
[0030]
[0031] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar 1000 and 1000 ventilators for adults and pediatrics, are available. TM series, which can provide invasive and non-invasive non-dependent ventilatory support to a range of patients for the treatment of a variety of conditions such as but not limited to NMD, OHS and COPD.
[0032] ResMed Elisée T 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators provide volume ventilation mode and pressure ventilation mode through a single or double limb circuit. The RPT device typically includes a pressure generator (such as a motor-driven blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway at a positive pressure. The outlet of the RPT device is connected to a patient interface such as those described above via an air circuit.
[0033] The designer of a device may be faced with making an infinite number of choices. Design criteria often conflict, meaning that some design choices are out of the ordinary or unavoidable. Furthermore, some aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.
[0034] Air circuit
[0035] An air circuit is a conduit or tube that is constructed and arranged to allow air flow to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface, in use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation, respectively. In other cases, a single branch air circuit is used for both inhalation and exhalation.
[0036] The design of an air circuit presents a number of challenges. The air circuit must allow the patient to move as freely as possible to avoid feeling "tethered" to the bed. Therefore, an air circuit with some ability to extend along its length may be useful. However, if the air circuit reacts to internal changes in pressure by deforming, this may be uncomfortable for the patient and may also affect the ability of the RPT to accurately estimate one or more variables at the patient interface, such as pressure at the interface and / or flow of leakage.
[0037] The weight of the air circuit should be as low as possible to reduce the tendency to pull the patient interface away from the patient's face. However, the air circuit must have a large enough inner diameter to have a low enough impedance to flow at the required flow rate, and must also be rigid enough to avoid collapse under the patient's weight.
[0038] One way to increase the compressive strength of the air circuit is to provide the outer surface of the air circuit with a rib shape, such as a spiral rib. The cross-section of such ribs is usually substantially circular. However, this configuration may be prone to snagging when dragged over a surface (e.g., if the tube is dragged over items of bedroom furniture when a patient turns over), and / or may produce unpleasant noises.
[0039] One solution that seeks to overcome the shortcomings of standard air circuits is to use a lighter, more flexible tube (sometimes referred to as a "stub") between the patient interface and the main air circuit. In some examples, the stub may have a "bellows-shaped" cross-section to allow it to be easily extended.
[0040] The short tube may be lighter, more crushable and / or more easily deformed by internal pressure than the main air circuit, but these disadvantages are mitigated by the relatively short length of the short tube (typically about 50 cm) and the fact that the short tube is located near the patient interface.
[0041] One disadvantage of systems using short tubes is that a connector is required between the short tube and the main air circuit. This connector can be relatively heavy and can also increase the cost of the system.
[0042] humidifier
[0043] Delivering an air stream without humidification may result in airway drying. A humidifier is used with the RPT device and patient interface to produce humidified gas that minimizes drying of the nasal mucosa and increases airway comfort for the patient. Additionally, in colder climates, warm air, which is often applied to the facial area in and around the patient interface, is more comfortable than cool air.
[0044] Data Management
[0045] There may be clinical reasons for obtaining data to determine whether a patient receiving a respiratory therapy has been "compliant" with the therapy, such as if the patient has used their RPT device in accordance with one or more "compliance rules." An example of a compliance rule for CPAP therapy is that a patient needs to use the RPT device for at least four hours each night for 21 out of 30 consecutive days to be considered compliant. To determine a patient's compliance, a provider of the RPT device (such as a healthcare provider) may manually obtain data describing the therapy for a patient using the RPT device, calculate usage over a predetermined time period, and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.
[0046] There may be other aspects of a patient's therapy that could benefit from communicating therapy data to a third party or external system.
[0047] Existing processes for transmitting and managing this data can be one or more costly, time consuming, or prone to errors.
[0048] Ventilation technology
[0049] Some forms of therapeutic systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to the exterior of the patient interface (eg, to the environment).
[0050] Screening, diagnostic and surveillance systems
[0051] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves clinical experts to apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep-disordered breathing involves two nights of observation of the patient in the clinic, one night for pure diagnosis, and the second night for titration of treatment parameters by the clinician. Therefore, PSG is both expensive and inconvenient. Specifically, it is not suitable for screening / diagnosis / monitoring sleep-disordered breathing at home.
[0052] Screening and diagnosis generally describe the identification of a condition based on its signs and symptoms. Screening generally gives a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis yields clinically actionable information. Screening and diagnosis are often one-time processes, while monitoring the progression of a condition can continue indefinitely. Some screening / diagnostic systems are only suitable for screening / diagnosis, while some can also be used for monitoring.
[0053] Clinical experts can adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or the patient may not be able to afford the clinical expert. Different clinical experts may disagree on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times.
[0054] Treatment Effects
[0055] During the treatment of respiratory diseases, it is necessary to maintain the therapeutic delivery of breathable gases to the patient interface. The effective delivery of these breathable gases requires that each component of the respiratory therapy system works together correctly to provide effective treatment. However, in practice, various factors can reduce the effectiveness of the treatment provided.
[0056] Many respiratory therapies are administered over a period of hours, for example, CPAP therapy used to treat sleep apnea is often administered overnight to help keep the patient's airway open and patent during sleep.
[0057] A variety of external factors can affect whether a respiratory therapy system provides effective treatment. For example, the air circuit may become blocked or disconnected during use, such as due to the patient moving and blocking the air conduit while sleeping. Other examples include the patient interface shifting on the patient's face and / or the seal of the patient's airway being broken.
[0058] Some of these external factors can be detected and processed by algorithms. For example, a pressure drop in a respiratory therapy system can be at least partially offset by increasing the pressure of the breathable gas provided by the RPT device. However, while the pressure drop can be detected, it is difficult to associate the pressure drop with any specific cause. Therefore, it is difficult to determine whether the system is still providing effective therapy.
[0059] Some algorithms that attempt to account for changes in the respiratory system may result in negative consequences for the patient. For example, attempting to correct for air pressure drops in a humidification system by increasing the flow from the flow generator may cause the water contained in the humidifier tank to be depleted more quickly. Once depleted, the patient must refill the humidifier tank (which can be inconvenient) or may experience discomfort from dry airways. Another negative consequence of increasing air pressure or flow is that it typically increases the noise generated by the flow generator and the noise generated by air escaping from components of the respiratory therapy system. This may prevent the patient and others nearby from falling asleep or reduce the quality of sleep.
[0060] Some patients also use several different patient interfaces with their respiratory therapy systems. This helps alleviate or reduce the occurrence of pressure sores caused by prolonged contact of the patient interface with the patient's facial area. These interfaces may require different flow generator settings in order to provide optimized respiratory therapy treatment.
[0061] It is an object of the present invention to at least partially address one or more of the foregoing problems, or at least to provide the public with a useful choice. Summary of the invention
[0062] The present technology is intended to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders that have improved one or more of comfort, cost, efficacy, ease of use and manufacturability.
[0063] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.
[0064] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.
[0065] An aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.
[0066] One form of the present technology includes an air circuit for a respiratory therapy system. The air circuit may include a conduit configured to receive a flow of breathable gas from a respiratory therapy device in use. The air circuit may also include a first cuff disposed to a first end of the conduit to facilitate connection to a peripheral device in use. The air circuit may also include a second cuff disposed to a second end of the conduit to facilitate connection to the respiratory therapy device in use. The air circuit may also include a detection circuit configured to facilitate detection of one or more components connected to the air circuit. The detection circuit may also be configured to detect the presence or absence of the peripheral device in use, and to transmit information about the presence or absence of the peripheral device to the respiratory therapy device.
[0067] Another aspect of one form of the present technology is a respiratory therapy system. The respiratory therapy system may include a respiratory therapy device configured to generate a breathable gas flow. The respiratory therapy system may also include an air circuit configured to receive the breathable gas flow from the respiratory therapy device. The respiratory therapy system may also include a patient interface configured to facilitate delivery of the breathable gas to the patient's airway during use. The air circuit may also include a detection circuit configured to detect one or more features of the patient interface and transmit information about the patient interface to the respiratory therapy device. The respiratory therapy device may also be configured to provide the breathable gas flow when the information indicates that the patient interface has been connected to the air circuit. The respiratory therapy device may also be configured not to provide the breathable gas flow when the information indicates that the patient interface has been disconnected from the air circuit.
[0068] Another aspect of one form of the present technology is a patient interface for use in a respiratory therapy system. The patient interface may include a plenum chamber that encloses a certain volume of space. The patient interface may also include a connection port that is configured to receive a flow of breathable gas from an air circuit during use and to deliver the flow of breathable gas to the plenum chamber. The patient interface may also include a seal-forming structure that is configured to provide an air seal around an entrance to a patient's airway and to direct the flow of breathable gas from the plenum chamber to the patient's airway during use. The patient interface may also include at least one identification feature that allows a detection circuit within the air circuit to detect when the patient interface is connected to the air circuit.
[0069] Another aspect of one form of the present technology is a respiratory therapy device. The respiratory therapy device may include a flow generator configured to generate a flow of breathable gas. The respiratory therapy device may also include an outlet configured to deliver the flow of breathable gas to an air circuit during use. The flow generator may also include a detection circuit configured to detect connection or disconnection of the air circuit to the outlet. The respiratory therapy system may also be configured to provide the flow of breathable gas when the air circuit is connected and not provide the flow of breathable gas when the air circuit is disconnected.
[0070] In an example of the present technology, the detection circuit may include a switch. For example, the switch may be configured to engage with the identification feature to close or open a circuit.
[0071] In an example of the present technology, the detection circuit may include two or more electrical contacts that are electrically connected or disconnected by the identification feature on the patient interface when the patient interface is connected to the air circuit in use. For example, the feature may include an electrical short circuit, one or more passive electronic components (such as resistors, capacitors, and inductors), active electronic components (including rectifiers, regulators, microcontrollers, resonant circuits, signal generators), or switching elements (such as transistors).
[0072] In other examples, the detection loop can include one or more components of a radio frequency identification (RFID) circuit. For example, the detection loop can include a complete RFID reading circuit, or alternatively include an antenna for an RFID reading circuit. The RFID reading circuit can be configured to communicate with an RFID feature (such as a transceiver or tag) in the patient interface to facilitate detection of the patient interface.
[0073] In other examples, the detection circuit may include one or more components configured to detect the presence of a magnetic field. For example, the detection circuit may include a Hall effect sensor or a reed switch. Accordingly, the identification feature may be a device configured to provide a magnetic field (such as a permanent magnet or an electromagnet).
[0074] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity and vision, or by a person with limited experience in using medical devices of this type.
[0075] Of course, a part of these aspects may form a sub-aspect of the present technology. In addition, each sub-aspect and / or aspect in a sub-aspect and / or aspect may be combined in various ways, and also constitute additional aspects or sub-aspects of the present technology.
[0076] Other features of the present technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0077] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to similar elements, including:
[0078] Respiratory therapy systems
[0079] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. Also shown is a bed partner 1100. The patient is sleeping in a supine sleeping position.
[0080] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000.
[0081] Figure 1C A system is shown including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. The patient is sleeping in a side-lying sleeping position.
[0082] Respiratory system and facial anatomy
[0083] Figure 2A A schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.
[0084] Patient Interface
[0085] Figure 3A A patient interface in the form of a nasal mask in accordance with one form of the present technology is shown.
[0086] RPT Device
[0087] Figure 4A One form of RPT device according to the present technology is shown.
[0088] Figure 4Bis a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to a blower and a patient interface. The blower is defined as upstream of the patient interface, and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.
[0089] Figure 4C is a schematic diagram of the electrical components of an RPT device according to one form of the present technology.
[0090] Figure 4D is a schematic diagram of an algorithm implemented in an RPT device according to one form of the present technology.
[0091] Figure 4E This is an example of a form according to the present technology. Figure 4D A flowchart of a method performed by a therapy engine module.
[0092] humidifier
[0093] Figure 5A An isometric view of a humidifier according to one form of the present technology is shown.
[0094] Figure 5B An isometric view of a humidifier according to one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.
[0095] Figure 5C A schematic diagram of a humidifier according to one form of the present technology is shown.
[0096] Respiratory waveform
[0097] Fig. 6A A typical breathing waveform model of a person while sleeping is shown.
[0098] Peripheral device detection
[0099] Fig. 7A An example of an air circuit according to one form of the present technology is shown.
[0100] Figure 7B Shows Fig. 7A A perspective view of the end of an air circuit.
[0101] Figure 7C Shows Fig. 7A Side view of the end of the air circuit.
[0102] Fig.7D Shows Fig. 7A A perspective view of the end of an air circuit.
[0103] Figure 8 An RPT device according to the present technology is shown.
[0104] Fig. 9A An end of an air circuit including a detection circuit in accordance with the present technology is shown.
[0105] Fig. 9B Shows Fig. 9A A cross-sectional view of the end of an air circuit is shown.
[0106] Fig. 10A A cross-sectional view of an exemplary patient interface to air circuit connection using conductors to facilitate detection is shown.
[0107] Fig. 10B A cross-sectional view of an exemplary patient interface to air circuit connection using a resistor to facilitate detection is shown.
[0108] Fig. 10C A cross-sectional view of an exemplary patient interface to air circuit connection using a capacitor to facilitate detection is shown.
[0109] Fig. 10D A cross-sectional view of an exemplary patient interface to air circuit connection using an inductor to facilitate detection is shown.
[0110] Fig. 10E A cross-sectional view of an exemplary patient interface to air circuit connection using multiple resistors to facilitate detection is shown.
[0111] Fig.10F A cross-sectional view of an exemplary patient interface to air circuit connection using resistors and capacitors to facilitate detection is shown.
[0112] Figure 10G A cross-sectional view of an exemplary patient interface to air circuit connection using capacitors and inductors to facilitate detection is shown.
[0113] Fig. 10H An end view of a connection port in accordance with the present technology is shown, illustrating an example of how terminals may be provided to a patient interface.
[0114] Fig.10I An end view of a connection port in accordance with the present technology is shown, illustrating another example of how terminals may be provided to a patient interface.
[0115] Fig.10JA cross-sectional view of an exemplary patient interface to air circuit connection using multiple terminals to determine insertion depth in accordance with the present technology is shown.
[0116] Figure 10K A cross-sectional view of an exemplary patient interface to air circuit connection using longitudinally positioned terminals to determine insertion depth in accordance with the present technology is shown.
[0117] Fig.11A Shown is a cross-sectional view of an exemplary patient interface to air circuit connection using magnetic detection technology in accordance with the present technology.
[0118] Fig. 11B Shown is a cross-sectional view of an exemplary patient interface to air circuit connection using magnetic detection technology in accordance with the present technology.
[0119] Fig. 11C Shown is a cross-sectional view of an exemplary patient interface to air circuit connection using magnetic detection technology in accordance with the present technology.
[0120] Fig.12 Shown is a cross-sectional view of an exemplary patient interface to air circuit connection using radio frequency (RF) detection technology in accordance with the present technology.
[0121] Fig.13 Shown is a cross-sectional view of an exemplary patient interface to air circuit connection using mechanical sensing techniques in accordance with the present technology.
[0122] Fig.14 A perspective view of an exemplary patient interface in accordance with the present technology is shown.
[0123] Fig.15 A perspective view of a heated air circuit including multiple wires in accordance with the present technology is shown. DETAILED DESCRIPTION
[0124] Before further describing the present technology in 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 only used to describe the specific examples discussed herein and is not intended to be limiting.
[0125] The following description is provided about each example that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any example can constitute another example.
[0126] therapy
[0127] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an entrance to the airway of a patient 1000 .
[0128] In certain examples of the present technology, a positive pressure air supply is provided to the patient's nasal passages via one or both nostrils.
[0129] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.
[0130] Respiratory therapy systems
[0131] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800 .
[0132] Patient Interface
[0133] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to maintain a positive pressure at the entrance of the patient's airway 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.
[0134] The unsealed patient interface 3800 in the form of a nasal cannula includes nasal prongs 3810a, 3810b that can deliver air to the corresponding nostrils of the patient 1000 via corresponding orifices in the tip thereof. Such nasal prongs generally do not form a seal with the inner or outer skin surface of the nostrils. This type of interface produces one or more gaps that exist by design (intentionally) during use, but they are generally not fixed in size, so that they may change unpredictably due to movement during use. Unlike other types of mask-based respiratory therapy systems, this can provide complex pneumatic variables for the respiratory therapy system when pneumatic control and / or evaluation is achieved. The air to the nasal prongs can be delivered by one or more air supply lumens 3820a, 3820b coupled to the nasal cannula type unsealed patient interface 3800. The lumens 3820a, 3820b lead to the respiratory therapy device from the nasal cannula type unsealed patient interface 3800 via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, in which the RPT device generates air flow at a controlled flow rate rather than a controlled pressure. The "vent" or gap at the unsealed patient interface 3800 is a passage between the ends of the prongs 3810a and 3810b of the nasal cannula type unsealed patient interface 3800 that leads to the atmosphere via the patient's nostrils, through which excess airflow escapes to the environment.
[0135] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.
[0136] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide a positive pressure relative to ambient (eg, a positive pressure of at least 2, 4, 6, 10, or 20 cmH2O relative to ambient) air supply.
[0137] Vent
[0138] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases (eg, carbon dioxide).
[0139] In some forms, the vent 3400 is configured to allow a continuous flow of ventilation from the interior of the plenum chamber 3200 to the environment while the pressure within the plenum chamber is positive relative to the environment. The vent 3400 is configured so that the vent flow is of a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.
[0140] One form of a vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.
[0141] The vent 3400 may be located in the plenum 3200. Alternatively, the vent 3400 is located in a decoupling structure (e.g., a swivel). An example of a swivel elbow assembly may be substantially as described in International Publication No. WO 2017 / 049357 A1, the entire contents of which are incorporated herein by reference.
[0142] Decoupling structure
[0143] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket. The decoupling structure may take the form of an elbow, a swivel, a ball and socket, or other curved (e.g., bent) component. The elbow may be configured to rotate relative to the patient interface, thereby at least partially decoupling rotational forces applied to the air circuit 4170 from the patient interface 3000.
[0144] Connection Ports
[0145] The connection port 3600 allows connection to the air circuit 4170 .
[0146] In use, air circuit 4170 may be connected to connection port 3600 to allow a flow of breathable gas to be delivered from the RPT device to the patient's airway. The connection port may be provided as part of a decoupling structure.
[0147] Sealing structure
[0148] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where a seal actually occurs (the actual sealing surface) may vary over time and from patient to patient within a given course of treatment, depending on a number of factors including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.
[0149] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .
[0150] In some forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material (e.g., silicone rubber).
[0151] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, elastic material such as silicone.
[0152] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each of which is configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for a large-sized head but not for a small-sized head, and another form of seal-forming structure that is suitable for a small-sized head but not for a large-sized head.
[0153] Sealing mechanism
[0154] In one form, the seal forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on the underside of the sealing flange within the interior of the plenum 3200 to urge it into tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.
[0155] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the path of the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange in use to prevent it from bending.
[0156] In one form, the seal-forming structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged to be in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.
[0157] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained in tension, for example, by an adjacent region of the sealing flange.
[0158] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.
[0159] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.
[0160] Nose bridge or nasal ridge area
[0161] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over a nasal bridge or nasal ridge region of the patient's face.
[0162] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal over a nasal bridge or nasal ridge region of a patient's face in use.
[0163] Upper lip area
[0164] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.
[0165] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.
[0166] Chin area
[0167] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the chin region of the patient's face.
[0168] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on a chin region of a patient's face in use.
[0169] Frontal area
[0170] In one form, the seal-forming structure forms a seal on the forehead region of the patient's face in use. In such forms, the inflatable chamber can cover the eyes in use.
[0171] Nasal pillows
[0172] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each nasal puff or pillow being constructed and arranged to form a seal with a corresponding nostril of the patient's nose.
[0173] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal on the underside of a patient's nose; a handle; and a flexible region located on the underside of the frustoconical body and connecting the frustoconical body to the handle. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the base of the handle. These flexible regions can work together to facilitate a universal joint structure that accommodates displacement and angular relative movement of the frustoconical body and the structure to which the nasal pillows are connected. For example, the frustoconical body can be axially displaced toward the structure to which the handle is connected.
[0174] Inflatable room
[0175] The plenum 3200 has a perimeter shaped to complement the surface contour of an average human face in the area where a seal will be formed in use. In use, the edge of the plenum 3200 is positioned to abut against the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the plenum 3200 in use. In some forms, the plenum 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.
[0176] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.
[0177] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.
[0178] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.
[0179] Positioning and stabilizing structures
[0180] The seal-forming structure 3100 of a patient interface 3000 of the present technology may be maintained in a sealed position by a positioning and stabilising structure 3300 during use.
[0181] In one form, the positioning and stabilising structure 3300 provides a retaining force at least sufficient to overcome the effect of the positive pressure in the plenum 3200 to lift off the face.
[0182] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .
[0183] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.
[0184] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with the manner in which it is worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one band having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat band.
[0185] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back of the patient's head on a pillow.
[0186] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side-lying sleeping position with the side area of the patient's head on a pillow.
[0187] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible or floppy band. The decoupling portion is constructed and arranged such that when the patient rests their head on the pillow, the presence of the decoupling portion prevents forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.
[0188] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the belt. In one form, the fabric outer layer comprises a loop material to engage with the hook material portion.
[0189] In some forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be in a tensioned state during use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strap can be configured as a tie.
[0190] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that in use at least a portion of its lower edge passes above the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.
[0191] In one form of the present technology suitable for a pure nasal mask or a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that in use at least a portion of its upper edge passes below the subauricular base of the patient's head and covers the occipital bone of the patient's head or is located below the occipital bone of the patient's head.
[0192] In one form of the present technology suitable for a pure nasal mask or a full-face mask, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to move away from each other.
[0193] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a bendable and, for example, non-rigid belt. An advantage of this aspect is that the belt is more comfortable for the patient when the patient is sleeping.
[0194] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a band configured to be breathable to allow moisture to transfer through the band.
[0195] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each of which is configured to provide retention forces to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads but not for small-sized heads, and another form of positioning and stabilizing structure that is suitable for small-sized heads but not for large-sized heads.
[0196] port
[0197] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.
[0198] RPT Device
[0199] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electronic components and is configured to execute one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more of the respiratory conditions described elsewhere in this document.
[0200] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.
[0201] The RPT device can have an outer housing 4010 formed of two parts: an upper part 4012 and a lower part 4014. In addition, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.
[0202] The pneumatic path of the RPT device 4000 can include one or more air path items, such as an air inlet filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.
[0203] One or more of the air path items may be located within a removable integral structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.
[0204] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.
[0205] RPT device mechanical and pneumatic components
[0206] The RPT device may include one or more of the following components in an integral unit. In the alternative, one or more of the following components may be located as respective separate units.
[0207] Air Filter
[0208] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.
[0209] In one form, the air inlet filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140 .
[0210] In one form, an outlet air filter 4114 (eg, an antimicrobial filter) is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800 .
[0211] Muffler
[0212] An RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120 .
[0213] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140 .
[0214] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800 .
[0215] Pressure generator
[0216] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.
[0217] The pressure generator 4140 may be under the control of the therapy device controller 4240 .
[0218] In other forms, the pressure generator 4140 may be a piston driven pump, a pressure regulator connected to a high pressure source (e.g., a compressed air reservoir), or a bellows.
[0219] Transducer
[0220] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be located, for example, on or form part of an air circuit (e.g., a patient interface). An external transducer may be in the form of a non-contact sensor such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.
[0221] In one form of the present technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal representative of a characteristic of the air flow, such as flow, pressure, or temperature at that point in the pneumatic path.
[0222] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800 .
[0223] In one form, the signal from the transducer 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.
[0224] Flow Sensors
[0225] A flow sensor 4274 according to the present technology may be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION of Switzerland.
[0226] In one form, a signal generated by the flow sensor 4274 and representing flow is received by the central controller 4230.
[0227] Pressure Sensors
[0228] A pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the ASDX series of HONEYWELL. An alternative suitable pressure sensor is a transducer from the NPA series of GENERALELECTRIC.
[0229] In one form, a signal generated by the pressure sensor 4272 and representative of pressure is received by the central controller 4230 .
[0230] Motor speed transducer
[0231] In one form of the present technology, a motor speed transducer 4276 is 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 such as a Hall effect sensor.
[0232] Anti-overflow valve
[0233] In one form of the present technology, an anti-overflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-overflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., toward the motor 4144).
[0234] RPT device electrical components
[0235] power supply
[0236] The power source 4210 may be located inside or outside the outer housing 4010 of the RPT device 4000 .
[0237] In one form of the present technology, the power supply 4210 provides power only to the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.
[0238] Input Devices
[0239] 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 person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touch screen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may be in another form in wireless communication with a receiver electrically connected to a central controller 4230.
[0240] In one form, input device 4220 may be constructed and arranged to allow a person to select values and / or menu options.
[0241] Central Controller
[0242] In one form of the present technology, the central controller 4230 is a processor or multiple processors suitable for controlling the RPT device 4000.
[0243] Suitable processors may include x86 Intel processors, A processor of a processor, such as the STM32 series microcontroller from STMicroelectronics. In some alternative forms of the present technology, a 32-bit RISC CPU (such as the STR9 series microcontroller from ST MICROELECTRONICS) or a 16-bit RISC CPU (such as a processor of the MSP430 series microcontroller manufactured by TEXASINSTRUMENTS) may also be applicable.
[0244] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.
[0245] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.
[0246] The central controller 4230 may be configured to receive input signals from one or more transducers 4270 , one or more input devices 4220 , and the humidifier 5000 .
[0247] The central controller 4230 may be configured to provide output signals to one or more of the output device 4290 , the therapy device controller 4240 , the data communication interface 4280 , and the humidifier 5000 .
[0248] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that may be implemented with processor control instructions represented as a computer program stored in a non-transitory computer-readable storage medium, such as 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 control settings for the ventilator or detect a breathing-related event by analyzing stored data, such as from any of the sensors described herein.
[0249] clock
[0250] The RPT device 4000 may include a clock 4232 connected to a central controller 4230 .
[0251] Therapy Device Controllers
[0252] In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330 which forms part of an algorithm 4300 executed by the central controller 4230 .
[0253] 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.
[0254] Memory
[0255] According to one form of the present technology, the RPT device 4000 includes a memory 4260, such as a non-volatile memory. In some forms, the memory 4260 may include static RAM powered by a battery. In some forms, the memory 4260 may include volatile RAM.
[0256] Memory 4260 may be located on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash memory.
[0257] Additionally or alternatively, the RPT device 4000 includes memory 4260 in a removable form, such as a memory card manufactured in accordance with the Secure Digital (SD) standard.
[0258] In one form of the present technology, the memory 4260 acts as a non-transitory computer-readable storage medium having stored thereon computer program instructions representing one or more of the methods described herein, such as one or more algorithms 4300 .
[0259] Output devices including optional display, alarm
[0260] 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.
[0261] Display Driver
[0262] The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input, and converts them into commands that cause the display 4294 to display the characters, symbols, or images.
[0263] monitor
[0264] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol (such as the digit "0") into eight logic signals that indicate whether the eight corresponding segments are to be activated to display the particular character or symbol.
[0265] RPT device algorithm
[0266] As described above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium, such as memory 4260. The algorithms 4300 are generally grouped into groups called modules.
[0267] In other forms of the present technology, some portion or all of the algorithm 4300 may be implemented by a controller of an external device, such as a local external device 4288 or a remote external device 4286. In this form, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm 4300 to be executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such forms, the portion of the algorithm 4300 to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute the portion of the algorithm 4300.
[0268] In such forms, therapy parameters generated by the external device via the therapy engine module 4320 (if such form part of the algorithm 4300 executed by the external device) may be transmitted to the central controller 4230 to be passed to the therapy control module 4330 .
[0269] Air circuit
[0270] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to travel between two components (such as the RPT device 4000 and the patient interface 3000 or 3800) in use.
[0271] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there may be separate branches of the circuit for inhalation and exhalation, respectively. In other cases, a single branch is used.
[0272] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.
[0273] The air circuit 4170 may include one or more cuffs 7006 , 7010 to facilitate connecting the air circuit 4170 to the patient interface 3000 and / or the RPT device 4000 .
[0274] humidifier
[0275] Humidifier Overview
[0276] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A ) to change the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before the air flow is delivered to the patient's airway.
[0277] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 may be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which may be adapted to accommodate the humidifier reservoir 5110 and include a heating element 5240.
[0278] Respiratory waveform
[0279] Fig. 6A A typical breathing waveform model of a person while sleeping is shown. The horizontal axis is time, and the vertical axis is respiratory flow. Although the parameter values may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5 L, inhalation time Ti 1.6 s, peak inspiratory flow Qpeak 0.4 L / s, exhalation time Te 2.4 s, peak expiratory flow Qpeak -0.5 L / s. The total duration of breathing Ttotal is about 4 s. People usually breathe at a rate of about 15 breaths per minute (BPM), and the ventilation volume Vent is about 7.5 L / min. A typical ratio of duty cycle Ti to Ttotal is about 40%.
[0280] Respiratory therapy mode
[0281] Various respiratory therapy modes can be achieved through the disclosed respiratory therapy system, including CPAP, bi-level therapy, and high flow therapy.
[0282] Peripheral device detection
[0283] Certain forms of the present technology involve automatically detecting peripheral devices connected to a flow generator. For example, these peripheral devices may include an air circuit 4170, a patient interface 3000, a humidifier 5000, and components thereof.
[0284] Fig. 7A , Figure 7B , Figure 7C , Fig.7D 7E and 7F illustrate an air circuit 4170 in accordance with the present technology. The air circuit includes a conduit 7002 for conveying a flow of breathable gas between an RPT device 4000 (such as a flow generator) and a peripheral device (such as a patient interface 3000).
[0285] The first end 7004 of the conduit 7002 may be provided with a first cuff 7006 that is configured to physically and fluidically connect the conduit to other components of the respiratory therapy system, such as a peripheral device (such as the patient interface 3000) or components thereof, during use. For example, the first cuff 7006 may be configured to fluidically and / or mechanically connect to a connection port 3600 that may be provided on an elbow or swivel of the patient interface 3000.
[0286] In many applications of the present technology, it may be advantageous for the first cuff 7006 to be connected to a peripheral device, such as a patient interface 3000, via a friction fit connection. In other words, the first cuff 7006 may be releasably connected to a connection port of the patient interface 3000 via a press fit connection or a connection without a latch or locking mechanism. This may allow the air circuit to be disconnected in the event that a pulling force is applied to the air circuit, such as a patient attempting to leave the flow generator while the air circuit and patient interface 3000 remain connected. Other examples where it may be advantageous to automatically disconnect the air circuit from the patient interface 3000 include situations where the flow generator is about to fall, such as being knocked off a table, or where the patient needs to get out of bed in the middle of the night.
[0287] In other forms (eg, pediatric masks), it may be advantageous for the first end 7004 of the air circuit to be connected to a peripheral device (such as the patient interface 3000) using a locking mechanism (such as a clip, a snap-fit connection, or a bayonet-type fitting).
[0288] The second end 7008 of the conduit 7002 may be configured to be connected to the RPT device 4000 (such as a flow generator) in use, and may be provided with a second cuff 7010. In the example shown, the second cuff 7010 is provided with a first locking half 7012 that is configured to engage with a second locking half 8006 on the RPT device 4000 as shown in FIG8 . The first locking half 7012 and the second locking half 8006 together provide a locking mechanism that, in use, secures the second end 7008 of the air circuit 4170 to the RPT device 4000. In the example shown, the locking mechanism is configured such that rotation of the second cuff 7010 relative to the RPT device 4000 engages or alternatively disengages the first locking half 7012 with the second locking half 8006. Accordingly, when the locking mechanism is engaged, the air circuit is locked or otherwise secured to the RPT device 4000 such that disconnection, whether intentional or accidental, is not possible without first rotating the second cuff 7010 in the opposite direction.
[0289] In the example shown, clockwise rotation of the second cuff 7010 relative to the RPT device 4000 engages the locking mechanism, thereby securing the air circuit 4170 to the RPT device. Counterclockwise rotation of the second cuff 7010 relative to the RPT device 4000 causes the locking mechanism to disengage or otherwise release from the RPT device 4000, thereby allowing the air circuit 4170 to be removed from the RPT device 4000. However, in other forms, other locking mechanisms (such as clips) and snap-fit connections (such as those known to those skilled in the art) may be used to connect the second end 7008 of the conduit 7002 to the RPT device 4000. Additionally, in some forms of the present technology, the second cuff 7010 may be configured to not include a locking mechanism, but rather may use a friction fit in a manner similar to the first cuff 7006.
[0290] In some examples of the present technology, the air circuit 4170 may also include terminals 7014. These terminals 7014 may be connected to Figure 8 The electrical contacts 8004 on the RPT device 4000 are shown to correspond, for example, the terminals 7014 can be arranged so that the relative position of the electrical contacts 8004 on the RPT device 4000 and the position of the terminals on the air circuit 4170 can ensure that, when the air circuit 4170 is engaged with the RPT device, these terminals are in electrical communication with the electrical contacts 8004. For example, when the second cuff 7008 is connected to the RPT device 4000, and / or when the first locking half 7012 is engaged with the second locking half 8006, the electrical contacts 8004 on the RPT device 4000 can be configured to engage with the terminals on the air circuit 4170.
[0291] In use, the electrical connection of the electrical contacts 8004 to the terminals 7014 can facilitate the delivery of electrical current from the RPT device 4000 to the heating wire loop within the air circuit 4170, thereby providing a heated air circuit 4170 that will be familiar to those skilled in the art. An example of a heated air circuit 4170 is Fig.15 The heating wire loop 4170 may include conductors 10002A, 10002B, 10002C positioned along the length of the catheter, for example, these conductors may be positioned within the ribs 7016 of the spiral catheter 7002, or positioned within the grooves 7018 between the ribs 7016.
[0292] In some forms of the air circuit 4170, additional use of electrical terminals can facilitate communication with a thermistor or other suitable temperature measurement circuit within the air circuit 4170. The thermistor can allow the temperature within the air circuit 4170 to be measured, for example, adjacent to a peripheral device at the first end 7004 of the air circuit 4170, so that temperature control adjustments can be made within the RPT device 4000 or humidifier to maintain an optimal temperature at the peripheral device. Additional details of the use of thermistors within the air circuit 4170 can be found in U.S. Patent Publication No. 2010 / 0116272A1, the entire contents of which are incorporated herein by reference. In the examples described in this document, communication with the thermistor can be achieved using dedicated wires within the air circuit 4170 that are separate from the heating wire loop.
[0293] It should be understood that the air circuits described herein may also include features such as gripping portions 7020, identification components 7022 such as color coding or labels, and indicia 7024 such as connection instructions.
[0294] Figure 8 An exemplary RPT device 4000 is shown for use as a flow generator configured to provide a flow of breathable gas in use. The RPT device 4000 includes a tubular connector 8002 that serves as an outlet for the flow of breathable gas from the RPT device 4000. In use, the second cuff 7010 of the air circuit 4170 is configured to engage with the tubular connector 8002 to facilitate delivery of the flow of breathable gas through the air circuit 4170 to a peripheral device or patient interface 3000.
[0295] Figure 8 The RPT device 4000 also includes electrical contacts 8004 in the form of pins that engage with electrical terminals on the air circuit 4170 to enable power transfer and / or communication between the air circuit 4170 and the RPT device, for example, by using a heating wire loop or other electrical conductor within the air circuit 4170 during use. An example of an air circuit 4170 including a heating wire loop is shown in FIG. Fig.15 shown.
[0296] Figure 8 The RPT device 4000 includes a second locking half 8006 that is configured to engage with the first locking half 7012 on the air circuit 4170 to provide the locking mechanism described above.
[0297] In one form of the present technology, an electrical interface is formed between electrical terminals on the air circuit 4170 and electrical contacts 8004 on the RPT device 4000. The electrical interface is used to communicate information about the air circuit 4170 or a peripheral device connected thereto (such as the patient interface 3000) to the RPT device 4000.
[0298] Detection circuit
[0299] In an example of the present technology, the air circuit 4170 includes a detection circuit that is configured to relay information to the RPT device. In some forms, the information may relate to the air circuit 4170, a connected peripheral device (such as the patient interface 3000), and / or the connection status or connection quality between the air circuit 4170. For example, the detection circuit may be configured to transmit the information using one or more of the wires in the air circuit 4170, or alternatively using one or more wireless technologies (including but not limited to Bluetooth TM , WiFi, RFID or NFC) to transmit the information.
[0300] Fig. 9A and Fig. 9B A first end 7004 of an air circuit 4170 according to the present technology is shown, which in this form is the end of the air circuit 4170 that is configured to be connected to a peripheral device (such as a patient interface 3000) in use. In the illustrated example, the air circuit 4170 includes a fixture 9002 that houses or otherwise contains a detection circuit 9008. The fixture 9002 is shown as extending radially inward from the inner wall 9004 of the first cuff 7006 toward the longitudinal axis of the air circuit 4170. However, the foregoing should not be viewed as limiting the present technology. For example, the detection circuit 9008 may be housed within the wall 9006 of the second cuff, or extend inwardly or outwardly from the first cuff 7006.
[0301] Fig. 9B Shows Fig. 9A 4170. In this example, a detection circuit 9008 can be seen within the fixture 9002. In some examples described herein, the detection circuit 9008 includes a printed circuit board containing electronic components 9010 configured to detect one or more parameters of a connected peripheral device as described herein.
[0302] The first cuff 7006 may include an electrical connector 9012 that provides a connection between the detection circuit 9008 and one or more wires within the catheter 7002 .
[0303] In use, the first cuff 7006 can engage with the connection port 3600 on the patient interface 3000. The connection port 3600 can engage with the inner wall 9004 of the first cuff 7006 to provide an airtight connection. Once the first cuff 7006 has fully engaged with the connection port 3600, the stop surface 9014 can prevent the connection port 3600 from being further inserted.
[0304] In some forms of the present technology, other features of the first cuff 7006 may include: a curved inlet 9016 to facilitate easier connection to peripheral devices, such as allowing for less precise alignment between the first cuff 7006 and the elbow on the patient interface 3000; and a seal retention strip 9018 or a narrower area of the inner wall 9004 that can engage with the connection port 3600 to provide an airtight seal. It should be understood that in some forms, any one or more of the features of the first cuff 7006 may also be used on the second cuff 7010 to facilitate an airtight connection between the second cuff 7010 and the tubular connector 8002 on the RPT device 3000.
[0305] Passive Detection
[0306] In examples of the present technology, the detection loop includes electrical conductors that, when electrically connected through an electrical short, a resistive component, or any other electronic component, allow for detection of one or more parameters of a connected peripheral device.
[0307] An example of a detection configuration 10000 that facilitates peripheral device detection and / or connection to one or more of the peripheral devices is as follows: FIG. 10A to FIG. 10K In each of these examples, the detection loop 9008 includes two or more conductors 10002A, 10002B, 10002C having exposed electrical terminals 10004A, 10004B, 10004C configured to contact one or more electrical terminals 10006A to 10006F (or components thereof, such as the connection port 3600) in the peripheral device 3000. In each of Examples 10A to 10H, the electrical terminals 10004A, 10004B, 10004C extend toward the interior of the inner wall 9004 of the first cuff 7006, while the electrical terminals 10006A, 10006B, 10006C extend toward the exterior of the peripheral device (such as from the connection port 3600 of the patient interface 3000).
[0308] In use, the first cuff 7006 can be engaged with the connection port 3600 until the end 10008 of the connection port 3600 engages the stop surface 9014. When engaged, the electrical terminals 10004A, 10004B, 10004C in the first cuff 7006 can contact corresponding electrical terminals 10006A, 10006B, 10006C in the connection port 3600 to complete the circuit.
[0309] Fig. 10A One form of the present technology is shown in which electrical conductors in the air circuit 4170 are bridged by conductors 10010 in the peripheral device or patient interface 3000. When the air circuit 4170 is properly engaged to the peripheral device or patient interface 3000, the conductors 10010 in the peripheral device or patient interface 3000 complete the circuit between the electrical terminals 10004A, 10004B, thereby enabling detection that a proper connection has been made.
[0310] exist Fig. 10B In the form of, the peripheral device includes a resistive element 10012 that provides resistance between conductors in the peripheral device. When the peripheral device is connected to the air circuit 4170, the resistive element 10012 can be electrically connected between the electrical terminals 10004A, 10004B to facilitate, for example, detecting the connection state by detecting current flow or resistance value. In addition, by using resistive elements 10012 with different resistance values in different peripheral devices, the resistance value can be measured to detect which peripheral device (e.g., patient interface 3000) is connected. Techniques for measuring resistance are known to those skilled in the art, such as by measuring the current at a given supply voltage or connecting the resistive element 10012 as part of a voltage divider and measuring the resulting voltage.
[0311] Similarly, techniques for measuring impedance (including inductance and capacitance) will be known to those skilled in the art and may be applied in some form. For example, Fig. 10C and Fig. 10D The form shown in the example is Fig. 10B The invention also provides a method for operating the device in a similar manner, wherein the resistive element 10012 is replaced by a capacitive component 10014 or an inductive component 10016, respectively. For example, the capacitive component 10014 can be configured as a capacitor, such as two conductive elements in a peripheral device, with an insulating material between the two conductive elements. The inductive component 10016 can be provided by an inductor, such as a wire coil with a known inductance. The capacitive component 10014 and the inductive component 10016 can be electrically connected to the electrical terminals 10006A, 10006B using any suitable method, including wires or a printed circuit board (PCB).
[0312] In use, methods known to those skilled in the art may be used, including determining capacitance or inductance values by measuring impedance provided to one or more AC waveforms. Accordingly, these examples allow peripheral device connection detection and identification by using different capacitance components and inductance components in different peripheral devices.
[0313] Fig. 10E An example is shown in which three or more conductors 10006A, 10006B, 10006C in a peripheral device (e.g., a patient interface 3000) are used as part of a detection loop 9008 for determining a connection state and for peripheral device identification. In the example shown, the electrical terminals 10004A, 10004B, 10004C in the air circuit 4170 are connected to a voltage divider formed by a plurality of resistive elements 10012 in the peripheral device. Accordingly, by using different resistive elements 10012 with different resistance values, different voltages can be generated by the voltage divider. These different voltages can be configured to correspond to different peripheral devices (such as a patient interface 3000), thereby facilitating detection and identification of the connected peripheral device.
[0314] It should be understood that while the foregoing examples are shown as having two or three conductors, this should not be viewed as a limitation of the present technology and that in some examples more conductors may be used, while in other examples the conductors shown may be shared with conductors used for other purposes (such as heated air circuit 4170). For example, referring to Fig. 10E , the first conductor 10002A can be a heating conduit wire that provides voltage to the voltage divider, the second conductor 10002B can be a relatively low impedance return wire, and the third conductor 10002C can be a signal line for receiving the divided voltage and relaying the divided voltage to the RPT device 4000.
[0315] Fig.10F and 10G Forms of the present technology including RC and LC resonant circuits are shown separately, where detection and identification of peripheral device components can be achieved by determining the resonant frequency using methods known to those skilled in the art. For example, a peripheral device (such as a patient interface 3000) may include a resonant circuit that is tuned to a specific resonant frequency to facilitate detection and / or identification of the peripheral device by the detection loop 9008. In some examples, the resonant circuit may include one or more inductors electrically connected in parallel with one or more capacitors. In other examples, the resonant circuit may include one or more capacitors electrically connected in series with one or more resistors.
[0316] Although the foregoing examples are shown as having discrete terminals in the peripheral device and air circuit 4170, respectively, this should not be considered a limitation of the present technology. For example, conductors may be provided around the perimeter of the first cuff 7006 or the peripheral device to allow peripheral device detection in any orientation. Fig. 10H and Fig.10I Examples of end views of a connection port 3600 of two versions of a patient interface 3000 in accordance with the present technology are shown, wherein the electrical terminals 10006A, 10006B, 10006C are disposed around the perimeter of the connection port 3600 .
[0317] Fig. 10H A first electrical terminal 10006A is shown extending around less than half of the circumference (e.g., between 40% and 49% of the circumference) of the connection port 3600 (or elbow of the patient interface), and a second electrical terminal 10006B extending substantially the same distance around the circumference on the directly opposite half of the connection port 3600. In other words, the terminals 10006A, 10006B are equally spaced around the circumference of the connection port 3600. These electrical terminals 10006A, 10006B are electrically insulated from each other by a small insulating gap 10007 around the circumference of the connection port 3600. The insulating gap 10007 can be smaller than the size of the corresponding terminals 10004A, 10004B on the air circuit 4170 to ensure that the terminals do not electrically bridge or connect the electrical terminals 10006A, 10006B during use.
[0318] Fig.10I An example is shown that includes three electrical terminals 10006A, 10006B, 10006C extending around less than one-third of the circumference (e.g., between 25% and 32% of the circumference). The terminals are equally spaced and separated from each other by insulating gaps. Fig. 10H Electrical isolation in a similar manner.
[0319] Fig.10J An example is shown in which a peripheral device or patient interface 3000 includes a plurality of electrical terminals 10006A, 10006B, 10006C, 10006D arranged along the length of a connection port 3600 of a first cuff 7006 and capable of being contacted at various locations along the length of the connection port or first cuff 7006. For example, by arranging multiple of any one or more of a conductor, resistor, capacitor, or inductor element between each of the terminals, the degree or depth of engagement of the first cuff 7006 with the connection port 3600 may be detected. It should be understood that while a plurality of terminals are shown on the peripheral device or patient interface 3000, it may be advantageous to arrange the plurality of terminals along the first cuff 7006 as this may allow the peripheral device or patient interface 3000 to be produced more cheaply.
[0320] exist Figure 10K In another example of the present technology shown, the electrical terminals 10006A, 10006B on the peripheral device or patient interface 3000 can have an elongated profile that extends longitudinally along the connection port 3600 or a portion of the connection port. For example, the electrical terminals 10006A, 10006B can be configured to extend along at least 50% of the length of the connection port 3600. Similarly, the electrical terminals 10004A, 10004B on the first cuff 7006 can have an elongated profile that extends along the first cuff 7006 or a portion of the first cuff (such as along the inner wall 9004 of the first cuff 7006). For example, the electrical terminals 10004A, 10004B can be configured to extend from the curved entrance 9016 to the stop surface 9014 of the first cuff or a portion of the way therein (such as at least 50% of the distance thereof).
[0321] Although the foregoing examples are performed using discrete electronic components and terminals, this should not be considered a limitation of the present technology. Figure 10K , the resistive component shown may be provided by a strip of resistive material such as carbon or graphite. In this example, the insertion distance between the first cuff 7006 and the connection port 3600 may determine the amount of resistive material (and therefore the resistance) between the conductors of the air circuit 4170, and thus the use of a single resistive material / component may provide insertion information.
[0322] Magnetic detection
[0323] Another feature of the present technology is to provide means for determining peripheral device detection using a magnetic field.
[0324] exist Fig.11A In one example of the present technology shown, a peripheral device (such as a patient interface 3000) is provided with a magnetic component 11002 or multiple magnetic components. For example, the magnetic component 11002 is a component that generates a magnetic field. This may include a magnetic coating, a ring magnet, a discrete magnet, an electromagnet, or any combination thereof. The magnetic component 11002 can be positioned within any portion of the peripheral device or patient interface 3000, such as within the connection port 3600.
[0325] The corresponding detection circuit 9008 may be provided with one or more electronic components 9010 configured to respond to a magnetic field, for example, these magnetic field devices may include a Hall effect sensor, a magnetometer or a reed switch. The detection circuit 9008 may be positioned or otherwise arranged so that when a peripheral device is connected or disconnected from the air circuit 4170 in use, the corresponding connection or disconnection can be detected in the detection circuit 9008.
[0326] For example, the detection circuit 9008 may be positioned within the inner wall 9006 of the first cuff, extend to the interior or exterior of the inner wall 9006, or positioned within a fixture 9008 as described herein. Similarly, the magnetic component 11002 should be positioned in the peripheral device in such a manner that the magnetic field generated by the magnetic component can be received and detected by the detection circuit 9008 in use.
[0327] In one example, the magnetic component 11002 is provided as part of an elbow on the patient interface 3000, and the detection circuit 9008 is provided as part of the first cuff 7008 of the air circuit 4170. Accordingly, when the elbow is connected to the first cuff 7008, the detection circuit is able to detect the presence of a magnetic field and relay that information to the RPT device 4000 accordingly.
[0328] In another example, the magnetic component 11002 can be releasably attached to a peripheral device or patient interface 3000 and can be configured to be attached to the peripheral device using an adhesive, a clip, or any other suitable retaining mechanism. For example, the magnetic component can be releasably attached to a decoupling structure, an elbow, an inflatable chamber, a frame, or any other component of a patient interface.
[0329] These magnetic techniques can be used to detect the connection or disconnection of the air circuit 4170 to the peripheral device (i.e., by determining the presence or absence of a magnetic field). In addition, in some forms of the present technology, different peripheral devices can be detected and identified by varying the positioning, polarity, and strength of the magnetic components used between different peripheral devices.
[0330] In yet another example of the present technology, the strength of the magnetic field detection can be used as an indication of the quality of the connection or the depth of insertion. For example, as the coupling between the air circuit 4170 to the peripheral device improves, the distance between the magnetic component and the magnetic field detection device can be reduced.
[0331] For example, a Hall effect sensor may be used to measure magnetic field strength and relay that information to the RPT device 4000 as a digitized value and / or as a voltage. If the measured magnetic field strength is below a first predetermined threshold, the RPT device 4000 may be configured to perform an action associated with a disconnected peripheral device (such as patient interface 3000), such as stopping or not initiating the flow of breathable gas. If the measured magnetic field strength is above a second predetermined threshold, the RPT device 4000 may be configured to perform an action associated with a properly connected peripheral device or patient interface 3000, such as initiating, resuming, or continuing to deliver the flow of breathable gas. If the measured magnetic field strength is between the first predetermined threshold and the second predetermined threshold, the RPT device 4000 may be configured to perform an action associated with a partially connected peripheral device or patient interface 3000, such as notifying the patient.
[0332] In other examples, the detection circuit 9008 may be provided with one or more reed switches configured to switch between an open state and a closed state in the presence of a magnetic field of a predetermined magnetic field strength. In this way, the connection state of the peripheral device or patient interface 3000 can be transmitted to the RPT device 4000 and actions can be performed accordingly. In some examples, one or more reed switches can be provided to detect a lower magnetic field strength, which indicates that the connected peripheral device is not fully connected. For example, a first reed switch can be provided with a first magnetic field strength threshold indicating that the peripheral device is poorly connected, and a second reed switch can be provided with a second magnetic field strength threshold indicating that the peripheral device is correctly connected. Accordingly, all three states can be transmitted to the RPT device 4000. For example, when both reed switches are disconnected, an open circuit can be provided to the RPT device 4000, which indicates that the peripheral device is not connected. When the peripheral device is partially connected, the first reed switch can be closed to connect an electronic component, such as a resistor, a capacitor, or an inductor, between the wires 10002A, 10002B in the air circuit 4170. This component can be detected by the RPT device and action can be performed accordingly. When the peripheral device is properly connected to the air circuit 4170, the second reed switch can be closed to provide a second electronic component or short circuit in parallel with the first electronic component, thereby causing a change in impedance that can be detected at the RPT device 4000 to allow the RPT device 4000 to perform an action accordingly.
[0333] In each of the foregoing examples, it should be understood that the threshold value may be provided or adjusted by changing the relative positioning of the magnetic component 11002 and / or the detection loop component. In other examples, the detection loop component may be provided with a different threshold value or an adjustable threshold value that may be tuned to accommodate a particular peripheral device / air loop 4170 configuration. In other examples, the detection loop may be configured to transmit only programmed threshold value changes to the RPT device 4000. In other examples, the RPT device 4000 includes an adjustable threshold value that may be adjusted as desired.
[0334] The polarity of the magnetic component 11002 may be detected using methods known to those skilled in the art, such as using Hall effect sensors, magnetometers, or reed switches located on different axes within the detection loop 9008. Accordingly, in one form of the present technology, a certain type of peripheral device (such as a nasal mask) may be provided with a magnetic component 11002 having a first polarity, and a second type of peripheral device (such as a full face mask) may be provided with a magnetic component 11002 having a second polarity, and the detection loop 9008 described herein may be configured to relay the peripheral device type information to the RPT device 4000 so that the RPT device 4000 can perform an action accordingly (such as changing the flow rate of the flow generator).
[0335] In another example of the present technology, a Hall effect latch may be used. For example, the peripheral device may include one or more magnetic components 11002 that provide a first polarity magnetic field and a second polarity magnetic field. In use, these magnetic fields may be configured so that during the connection of the air circuit 4170 to the peripheral device, the first magnetic field is dominant at the detection circuit 9008. For example, this can be achieved by the relative positioning of the magnetic component 11002 relative to the Hall effect latch. The signal can be detected using any of the components described herein, but in one example of the present technology, the magnetic field is configured to switch the Hall effect latch to an open state. The second polarity magnetic field is configured to dominate at the detection circuit 9008 once connected, causing the Hall effect latch to enter a closed state. The Hall effect latch remains in a closed state until the removal or partial removal of the peripheral device causes the first magnetic field to become dominant at the detection circuit 9008, which will restore the Hall effect latch to a disconnected state. Accordingly, the RPT device 4000 is able to determine when the peripheral device is properly connected, or when it has been disconnected or partially disconnected.
[0336] In each of the foregoing examples, any suitable method known to those skilled in the art (including digital communications such as serial ports, I 2 C, SPI, CAN, Ethernet, Wi-Fi, Bluetooth, etc.), to associate the information detected by the detection loop 9008 to the RPT device 4000. Alternatively, for example, using an analog signal (such as voltage), the magnetic field strength can be transmitted as an absolute voltage ranging between 0V and 5V, and the polarity of the voltage can be used to transmit the polarity of the magnetic component 11002.
[0337] It should be understood that the magnetic components mentioned herein include permanent magnets as temporary magnetic materials and electromagnets. For example, in one embodiment of the present technology, power may be provided to the peripheral device or patient interface 3000 via one or more wires in the air circuit 4170. This power may be used to power the electromagnet, and the resulting magnetic field strength is detected by a detection circuit as described herein.
[0338] One advantage of using magnetic technology is that the magnetic component 11002 may not need to be in contact with the magnetic detection circuit 9008, and thus the magnetic components and detection circuits described herein may be positioned in any suitable location, including but not limited to: within the wall of the first cuff 7006 or a peripheral device such as a patient interface 3000, for example by overmolding or a similar process; on the inner or outer wall of the cuff 7006 or patient interface 3000, for example by using fasteners or adhesives; or in a fixture 9002 as described herein.
[0339] Fig. 11BAn example of the present technology is shown where an air circuit 4170 includes conductors 10002A, 10002B having ferromagnetic components, including ferrous materials or otherwise including components having a relative magnetic permeability greater than 1. For example, a steel strip may be included in the air circuit 4170, or in the case of a heated conduit, one or more of the wires in the heating wire loop may be constructed of iron containing an alloy such as an aluminum-iron alloy. These ferrous conductors may be used to couple the magnetic field from the magnetic device to the detection circuit of the RPT device 4000. Accordingly, this may enable a less expensive air circuit 4170 that facilitates peripheral device detection in the absence of a dedicated detection circuit as described herein.
[0340] It may be advantageous to position the conductors 10002A, 10002B on two or more sides of the magnetic component 11002, thereby facilitating conduction of both magnetic poles to the detection loop. For example, the conductors 10002A, 10002B may be positioned so that each conductor is located on an opposite side of the magnetic component 11002 when the peripheral device and the first cuff 7006 are connected. In another example, the first conductor 10002A may be configured to be substantially located in a first axis, and the second conductor 10002B may be configured to be substantially located in a second axis, the first axis being approximately 90 degrees to the second axis. The magnetic component may be arranged at a 45 degree angle relative to the first axis and the second axis, so that at least a portion of the corresponding positive and negative magnetic fields can be magnetically coupled through the conductors 10002A, 10002B.
[0341] exist Fig. 11C In yet another example of the present technology shown, the air circuit 4170 is provided with a detection circuit 9008 and one or more magnetic components 11002. In use, a portion of a peripheral device (such as a patient interface 3000) is inserted into the first cuff 7006, causing the position of one or more of the magnetic components 11002 to change relative to the detection circuit 9008. For example, the magnetic component 11002 can be an annular magnet, or otherwise include an annular component. The magnetic component 11002 can be movably coupled to the inner wall 9004 of the first cuff 7006 so that the magnetic component can move longitudinally along the length of the first cuff 7006. The magnetic component 11002 can be biased toward the end of the first end 7004 using at least one base element 11004 or a resiliently deformable component (such as a spring).
[0342] In use, insertion of a peripheral device, such as the patient interface 3000, into the first cuff 7006 may cause the end 10008 of the peripheral device to engage the magnetic component 11002 or a movable component carrying the magnetic component, thereby facilitating the magnetic component 1102 to be pushed inwardly toward the detection circuit 9008. This movement may be detected as a change in magnetic field strength and may therefore be used to determine the positioning of the peripheral device relative to the first cuff 7006.
[0343] The foregoing techniques allow the present techniques to be used to detect the insertion depth of a peripheral device, such as patient interface 3000, without requiring any modifications to the peripheral device and are therefore backwards compatible with existing peripheral devices.
[0344] RF Detection
[0345] exist Fig.12 In yet another example of the present technology shown, a peripheral device (such as a patient interface 3000) may include a radio frequency (RF) transponder or tag 12002. The RF tag 12002 may be programmed to store information about the peripheral device (such as a model number or date of manufacture). This information may be read using an RF transceiver as part of the detection loop 9008 as described herein.
[0346] In one example of the present technology, the RF transceiver is provided by the detection loop 9008. That is, the detection loop includes an RF antenna, a drive circuit, and electronics configured to read information from and / or write information to the RF tag 12002. The RF transceiver can be powered by one or more electrical conductors in the air loop 4170 and can be configured to transmit peripheral device information to the RPT device 4000 using any of the wired or wireless methods described herein.
[0347] In alternative forms of the present technology, the detection loop 9008 may be configured to include an RF antenna circuit and operably connected to one or more other RF components within the RPT device 4000 using one or more conductors within the air loop 4170. For example, the RPT device 4000 may include a drive circuit and electronics configured to read information from and / or write information to the RF tag 12002.
[0348] One advantage of the use of radio frequency technology as described herein may be that the RF tag may be updated with additional information during use. For example, the additional information includes the number of cycles, hours, or days that a peripheral device (such as patient interface 3000) has been used. This may be used to generate reminders about when the peripheral device should be replaced.
[0349] It should be understood that the RF tag 12002 need not be located in close proximity to the detection loop 9008, as the detection loop can be configured to provide an RF field capable of wirelessly reading the information on the tag. Accordingly, the use of RF technology can advantageously allow for less precise positioning of the peripheral device relative to the first cuff 7006, while still allowing for detection of whether the peripheral device and the first cuff 7006 are connected.
[0350] Backward Compatibility
[0351] In examples of the present technology using heated air circuit 4170, it may be advantageous for heated air circuit 4170 to continue to operate when connected to a peripheral device that does not have some of the components or features described herein that can be used to detect peripheral components. In other words, air circuit 4170 may include technology that enables the use of mechanical components to detect peripheral devices. An example of this is Fig. 11C shown.
[0352] Another example of mechanical testing is Fig.13 1004, wherein the detection circuit 9008 includes a switch 13002. In use, the switch 13002 engages a feature (such as the end of the connection port 3600) on a peripheral device (such as a patient interface 3000) to complete the circuit. The switch 13002 can be biased to an open position or a closed position so that when the patient interface 3000 is removed, the switch automatically changes a state that can be detected by the detection circuit 9008.
[0353] In other examples of the present technology, a peripheral device (such as a patient interface 3000) can be provided with a releasable magnetic component 11002 that can be attached to facilitate the magnetic detection techniques described herein. For example, the magnetic component 11002 can be clipped to or otherwise secured to the peripheral device to facilitate magnetic detection as described herein.
[0354] Another application of the foregoing technology is to provide a system that allows for automatic configuration of RPT device 4000 settings based on detection of known peripheral devices. For example, flow, humidity settings, etc. can be automatically set for a given peripheral device or patient interface 3000. These settings can be further customized based on the user. In the event that the detection loop cannot detect the peripheral device, the present technology can prompt the user to manually identify the connected peripheral device, or configure the flow settings themselves. In some applications, there may be a default configuration file for peripheral devices that cannot be detected, so that manual configuration is not required.
[0355] Detection Example
[0356] Although the foregoing disclosure is primarily directed to detecting peripheral components that are typically connected to the end of the air circuit 4170, this should not be viewed as limiting the present technology. For example, components of the present technology (such as the detection circuit described herein) may alternatively be located in the RPT device 4000 and configured to detect the connection of any component (such as the air circuit 4170, humidification component, oxygenation component, or gas source, etc.) to the RPT device 4000.
[0357] Similarly, while the present disclosure discusses detecting the patient interface 3000 at the end of the air circuit 4170 , the present technology is similarly applicable to detecting other peripheral components (such as a stub) that may be connected to the end of the air circuit 4170 .
[0358] Additionally, the present technology may be used to detect and in some cases identify multiple peripheral devices, for example, the technology described herein may be used to identify the type of air circuit 4170 used and the peripheral device and provide an indication of the relative coupling therebetween.
[0359] It should also be understood that while the examples described herein are described with respect to the first cuff 7006 being connected to the patient interface 3000, in some examples of the present technology, the present technology may be used to detect the removal of any component of the patient interface 3000. For example, Fig.14 A patient interface 3000 is shown having a removable connection port 3600. The detection circuit 9008 described herein may be configured to detect any portion of the patient interface 3000, such as by positioning a magnetic component 11002 or an RF tag 12002 on the patient interface 3000. In other examples, the techniques described herein (such as using a switch or passive detection techniques) may be used to detect a connection between the connection port 3600 and the patient interface 3000. In other words, the connection port 3600 may be electrically connected to the air circuit 4170 in use to facilitate the transmission of the connection status between the connection port 3600 and the patient interface 3000 to the RPT device 4000 in use.
[0360] action
[0361] The RPT device 4000 may be configured to perform one or more actions upon detecting any one or more of the following: a peripheral device being connected or disconnected; a certain type of device being identified; a change in connection quality, or a connection quality being above or below a predetermined threshold. In some forms of the present technology, the one or more actions may include any one or more of the following actions:
[0362] Generate an alarm, such as a visual or audible alarm.
[0363] A message (such as a visual message output on a display, or an audio message) is generated, or a message is sent to an external device.
[0364] Changing one or more operating parameters of the RPT device, such as changing the flow rate, any one or more parameters related to heating of the air circuit 4170, or humidification of the air.
[0365] Stop or start the operation of the RPT device 4000.
[0366] Log or otherwise record information.
[0367] One advantage of certain forms of the present technology is that, for example, a patient may disconnect the air circuit 4170 from a peripheral device or patient interface 3000 in the middle of the night to go to the bathroom (whether this is accomplished by disconnecting the air circuit 4170 from the connection port 3600 / elbow or by disconnecting the connection port 3600 / elbow from the patient interface). This disconnection may be detected using the techniques described herein, and the RPT device 4000 may be deactivated until a connection is detected again. Similarly, when the air circuit is connected, the RPT device may be automatically activated.
[0368] In another example of the present technology, the detection circuit 9008 can provide feedback to the RPT device 4000 that there is a poor connection between the air circuit 4170 and the peripheral device or patient interface 3000. The RPT device 4000 can then determine the appropriate action to perform. For example, if the RPT device 4000 can provide an audio or visual alarm. If the RPT device 4000 detects that the patient has fallen asleep or the time is a time when the patient may have fallen asleep, the RPT device 4000 can generate a silent alarm and / or record the information and / or send the information to an external device to provide feedback after the patient wakes up.
[0369] In another example of the present technology, the RPT device 4000 may be configured to avoid waking the patient during deep sleep or REM sleep of the patient and to wake the patient during light sleep of the patient's sleep cycle, for example, to resolve connectivity issues.
[0370] Another feature of the present technology is the ability to log peripheral device connection data to correlate leaked information due to incorrect peripheral device connections. Accordingly, the present technology may allow improvements to peripheral devices, air circuits, and / or user instructions over time.
[0371] Another feature of the present technology is to feed peripheral device connection quality information to the algorithm used to control the flow generator. Accordingly, flow adjustments can be made to account for changes in peripheral device / air circuit connection quality.
[0372] Glossary
[0373] For purposes of this technology disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.
[0374] General Concepts
[0375] Air: in some forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology, air may be taken to mean some other combination of breathable gases, such as oxygen-enriched air.
[0376] Environment: In certain forms of the present technology, the term environment will be taken to mean both (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.
[0377] For example, the ambient humidity relative to the humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity within the room where the patient is sleeping. Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.
[0378] In another example, ambient pressure may be the pressure immediately adjacent to or external to the body.
[0379] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, rather than, for example, noise generated by the RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources external to the room.
[0380] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjusted (eg, breath-by-breath) between a minimum and a maximum limit, depending on an indication of the presence or absence of an SDB event.
[0381] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure may be substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the entrance to the airway is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.
[0382] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate will be references to a scalar quantity, i.e. a quantity having only magnitude. In other cases, references to flow rate will be references to a vector quantity, i.e. a quantity having both magnitude and direction. Flow rate may be given by the symbol Q. "Flow rate" is sometimes simply abbreviated to "flow" or "airflow".
[0383] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The device flow Qd is the flow of air leaving the RPT device. The total flow Qt is the flow of air and any supplemental gas that reaches the patient interface via the air circuit. The ventilation flow Qv is the flow of air leaving the vent to allow flushing of exhaled gases. The leakage flow Ql is the flow that leaks from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the patient's respiratory system.
[0384] Flow Therapy: Respiratory therapy that involves delivering air flow to the airway entrance at a controlled flow rate, called the therapy flow, which is usually positive throughout the patient's respiratory cycle.
[0385] Humidifier: The term humidifier shall be deemed to mean a humidifying device constructed and arranged or configured with a physical structure to be able to provide a therapeutically beneficial amount of water (H2O) vapor to an air flow to relieve a patient's medical respiratory condition.
[0386] Leak: The term leak is to be considered as unintended air flow. In one example, a leak may occur due to an incomplete seal between the mask and the patient's face. In another example, a leak may occur in the swivel elbow leading to the environment.
[0387] Conducted noise (acoustics): Conducted noise in this document refers to the noise transmitted to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.
[0388] Radiated noise (acoustics): Radiated noise in this document refers to the noise transmitted to the patient by the ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.
[0389] Vent Noise (Acoustics): Vent noise in this document refers to the noise generated by the flow of air through any vent, such as the vent hole of a patient interface.
[0390] Oxygen-enriched air: air having an oxygen concentration greater than that of atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-enriched air" is sometimes abbreviated to "oxygen."
[0391] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.
[0392] Patient: A person, whether or not they have a respiratory condition.
[0393] Pressure: force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm2, and hectopascals. 1 cmH2O is equal to 1 g-f / cm2 and is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m2 = 1 millibar ~ 0.001 atmosphere). In this specification, unless otherwise stated, pressure is given in cmH2O.
[0394] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the interface pressure Pm at the current moment.
[0395] Respiratory Pressure Therapy: The application of a supply of air to the entrance of the airways at a therapeutic pressure that is usually positive relative to atmosphere.
[0396] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.
[0397] Material
[0398] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (including the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.
[0399] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.
[0400] Patient Interface
[0401] Anti-Asphyxia Valve (AAV): A component or subassembly of a mask system that reduces the risk of the patient rebreathing too much CO2 by opening to the atmosphere in a safe manner.
[0402] Elbow: An elbow is an example of a structure that directs the axis of air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross-section. In another form, the elbow may have an elliptical or rectangular cross-section. In certain forms, the elbow may be rotatable relative to a mating component, for example approximately 360 degrees. In certain forms, the elbow may be removable from a mating component, for example via a snap connection. In certain forms, the elbow may be assembled to a mating component via a disposable snap during manufacturing, but may not be removable by the patient.
[0403] Frame: A frame will be considered to mean a mask structure that bears tensile loads between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.
[0404] Headgear: Headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, headgear may include a collection of one or more supports, straps, and reinforcements configured to position and hold a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.
[0405] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.
[0406] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume which, in use, has air pressurised to above atmospheric pressure therein. The housing may form part of the wall of the mask plenum.
[0407] Seal: can be a noun form referring to a structure ("seal") or a verb form referring to the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without requiring a separate 'seal' element itself.
[0408] Shell: Shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.
[0409] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.
[0410] Strut: A strut will be considered a structural component designed to increase the compression resistance of another component in at least one direction.
[0411] Swivel (n): A subassembly of components configured to rotate preferably independently about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. In use, little or no air flow leaks from the swivel.
[0412] Tie (noun): A structure designed to resist tension.
[0413] Vent: (noun): A structure that allows air to flow from the interior or conduit of a mask to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the therapy pressure.
[0414] Other Notes
[0415] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office patent file or records, but otherwise reserves all copyright rights whatsoever.
[0416] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value to one-tenth of the unit of the lower limit between the upper and lower limits of the range and any other stated or intervening values in the stated range are encompassed in the present technology. The upper and lower limits of these intermediate ranges (which may independently be included in the intermediate ranges) are also encompassed in the present technology, but are subject to any explicitly excluded limitations in the stated ranges. Where the stated range includes one or both limits, ranges excluding either or both of those included limits are also encompassed in the present technology.
[0417] Furthermore, where a value or values are described herein as being implemented as part of the present technology, it should be understood that such values may be approximate unless otherwise indicated and that such values may be used with any suitable significant figures to the extent that practical technical implementation may permit or require it.
[0418] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the technology, a limited number of exemplary methods and materials are described herein.
[0419] When a specific material is identified as being used to construct a component, obvious alternative materials having similar properties may be used as substitutes. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.
[0420] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.
[0421] All publications mentioned herein are incorporated herein by reference in their entirety, to disclose and describe methods and / or materials as the subject of those publications. The publications discussed herein are provided only for their disclosures before the filing date of the present application. This article should not be construed as admitting that the present technology is not entitled to be earlier than such disclosures due to prior inventions. In addition, the publication date provided may be different from the actual publication date, which may need to be confirmed independently.
[0422] The terms "comprises" and "comprising" should be understood to refer to each element, component or step in a non-exclusive manner, indicating that the marked elements, components or steps may be present or utilized, or in combination with other elements, components or steps not explicitly marked.
[0423] The subject headings used in the detailed description are included only for the convenience of the reader and should not be used to limit the subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.
[0424] Although the technology herein has been described with reference to specific examples, it should be understood that these examples are merely illustrations of the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to represent any order, but can be used to distinguish different elements. In addition, although the process steps in the method can be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects thereof can be performed simultaneously or even synchronously.
[0425] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.
[0426] Reference numerals list
[0427]
[0428]
[0429]
[0430]
Claims
1. An air circuit for a respiratory therapy system, the air circuit comprising: a conduit configured, in use, to receive a flow of breathable gas from a respiratory therapy device; a first cuff provided to a first end of the catheter to facilitate connection to a peripheral device in use; a second cuff provided to a second end of the conduit to facilitate connection to the respiratory therapy device in use; and Detection circuit, Wherein the detection circuit is configured to detect the presence or absence of the peripheral device in use, and to transmit information about the presence or absence of the peripheral device to the respiratory therapy device.
2. The air circuit of claim 1, wherein the first cuff is configured to connect to a patient interface.
3. The air circuit of claim 2, wherein the first cuff is configured to connect to a connection port on the patient interface.
4. The air circuit of any one of the preceding claims, wherein the second cuff is configured to connect to a tubular connector on the respiratory therapy device.
5. An air circuit according to any one of the preceding claims, wherein the detection circuit comprises an electrical conductor which, when electrically connected, provides a signal indicative of connection to the peripheral device.
6. The air circuit of claim 5, wherein the electrical conductor is configured to be electrically connected to one or more passive components in the peripheral device.
7. The air circuit of any one of the preceding claims, wherein the first cuff comprises two or more electrical terminals configured to connect to corresponding terminals in the peripheral device.
8. The air circuit of any one of the preceding claims, wherein the second cuff comprises two or more electrical terminals configured to connect to corresponding terminals in the respiratory therapy device.
9. The air circuit according to any one of the preceding claims, wherein the detection circuit is configured to detect magnetic components in the peripheral device.
10. The air circuit of claim 9, wherein the detection circuit comprises a Hall effect sensor, a magnetometer, or a reed switch.
11. An air circuit according to any one of the preceding claims, wherein the detection circuit is arranged in the first cuff.
12. The air circuit of any one of the preceding claims, wherein the detection circuit comprises a switch configured to detect insertion or removal of the peripheral device from the cuff.
13. A respiratory therapy system, comprising: a respiratory therapy device configured to generate a flow of breathable gas; an air circuit configured to receive the flow of breathable gas from the respiratory therapy device; and a patient interface configured to facilitate, in use, delivery of the breathable gas from the air circuit to an airway of a patient, wherein the air circuit includes a detection circuit configured to detect one or more characteristics of the patient interface and transmit information about the patient interface to the respiratory therapy device, Wherein the respiratory therapy device is configured to provide the flow of breathable gas when the information indicates that the patient interface is connected to the air circuit and not provide the flow of breathable gas when the information indicates that the patient interface is disconnected from the air circuit.
14. The respiratory therapy system of claim 13, wherein the detection loop includes an electrical conductor that, when electrically connected, provides a signal indicative of connection with the peripheral device.
15. The respiratory therapy system of claim 14, wherein the electrical conductor is configured to electrically connect to one or more passive components in the peripheral device.
16. The respiratory therapy system of any one of claims 13 to 15, wherein the first cuff comprises two or more electrical terminals configured to connect to corresponding terminals in the peripheral device.
17. The respiratory therapy system of any one of claims 13 to 16, wherein the second cuff comprises two or more electrical terminals configured to connect to corresponding terminals in the respiratory therapy device.
18. The respiratory therapy system of any one of claims 13 to 17, wherein the detection circuit is configured to detect magnetic components in the peripheral device.
19. The respiratory therapy system of claim 18, wherein the detection circuit comprises a Hall effect sensor, a magnetometer, or a reed switch.
20. The respiratory therapy system of claims 13-19, wherein the detection circuit is disposed in the first cuff.
21. The respiratory therapy system of any one of claims 13 to 20, wherein the detection circuit comprises a switch configured to detect connection or removal of the peripheral device from the cuff.
22. A patient interface for use in a respiratory therapy system, the patient interface comprising: An air-filled chamber, wherein the air-filled chamber encloses a space of a certain volume; a connection port configured, in use, to receive a flow of breathable gas from an air circuit and to deliver the flow of breathable gas to the plenum chamber; a seal-forming structure configured to provide an air seal about an entrance to an airway of a patient and, in use, direct the flow of breathable gas from the plenum to the airway of the patient; At least one identification feature that allows a detection circuit within the air circuit to detect when the patient interface is connected to the air circuit.
23. A patient interface according to claim 22, wherein the identification feature comprises one or more passive components.
24. A patient interface according to claim 22 or 23, wherein the identification feature is configured to provide a magnetic field detectable by the detection circuit.
25. A respiratory therapy device, comprising: a flow generator configured to generate a flow of breathable gas; and an outlet configured, in use, to deliver the flow of breathable gas to an air circuit, wherein the flow generator comprises a detection circuit configured to detect connection or disconnection of the air circuit with the outlet, and Wherein the flow generator is configured to provide the flow of breathable gas when the air circuit is connected and not provide the flow of breathable gas when the air circuit is disconnected.
26. The respiratory therapy system of claim 25, wherein the detection circuit includes an electrical conductor that, when electrically connected, provides a signal indicative of connection to the air circuit.
27. The respiratory therapy system of claim 26, wherein the electrical conductor is configured to electrically connect to one or more passive components in the air circuit.
28. The respiratory therapy system of any one of claims 25 to 27, wherein the detection circuit is configured to detect magnetic components in the air circuit.
29. The respiratory therapy system of claim 28, wherein the detection circuit comprises a Hall effect sensor, a magnetometer, or a reed switch.
