System and method for active electric power management in medical device
Patent Information
- Application Number
- JP2025009221
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-06-03
- Filing Date
- 2025-01-22
- Publication Date
- 2025-11-28
AI Technical Summary
Patient interface design in existing respiratory therapy devices present several challenges, including unsuitable size, low comfort, complex use, high cost, and unsuitable during prolonged use or sleep, resulting in low patient compliance.
Adaptive power management technology is used in respiratory therapy devices to monitor the characteristics of air flow through sensors and adjust the power of heating elements to optimize the power use of the equipment and the comfort of the equipment.
It improves the comfort and effectiveness of respiratory therapy equipment, reduces power consumption, extends the service life of the equipment, and increases the patient's compliance.
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Abstract
Description
[Technical field]
[0001] 1 Cross-references to related patents and applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 745,909, filed October 15, 2018, and U.S. Provisional Patent Application No. 62 / 856,348, filed June 3, 2019, both of which are incorporated by reference in their entireties.
[0002] This application is related to the following commonly assigned U.S. patents and patent applications, each of which is incorporated by reference in its entirety herein: U.S. patent application Ser. No. 14 / 472,651 (entitled "Power Management in Respiratory Treatment Apparatus"); U.S. patent application Ser. No. 15 / 710 / 879 (entitled "Humidification of Respiratory Gases"); U.S. Patent No. 8,844,522 (entitled "Power Management in Respiratory Treatment Apparatus"); and U.S. Patent No. 9,802,022 (entitled "Humidification of Respiratory Gases").
[0003] 2. Technology Background 2.1 Technology field The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory related diseases. The present technology also relates to medical devices or apparatus and their uses. More particularly, the technology described herein relates to power management in medical devices or apparatus. [Background technology]
[0004] 2.2 Technology Background 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways.
[0005] These airways contain a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.
[0006] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.
[0007] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD) and chest wall diseases.
[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes affected patients to pause in breathing, typically for 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The condition is common, especially in middle-aged, overweight men, but patients are asymptomatic. See U.S. Pat. No. 4,944,310 (Sullivan).
[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, followed by alternating periods of waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. Because of the repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep arousals that cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).
[0010] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or breathe out enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:
[0011] Patients with respiratory failure (a type of respiratory insufficiency) may experience abnormal shortness of breath during exercise.
[0012] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.
[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in the normal elasticity of the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.
[0014] Neuromuscular diseases (NMD) is a broad term that encompasses numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified as rapidly and slowly progressive: (i) rapidly progressive disorders, characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.
[0015] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive defects and share the potential for long-term hypercapnic respiratory insufficiency. Scoliosis and / or kyphoscoliosis can lead to severe respiratory insufficiency. Symptoms of respiratory insufficiency include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.
[0016] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.
[0017] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, including continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and invasive ventilation (IV).
[0018] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.
[0019] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist in breathing by performing some or all of the respiratory functions and / or to maintain adequate oxygen levels in the body. Ventilatory support is provided through a non-invasive patient interface. NIV is used to treat forms of CSR and respiratory failure such as OHS, COPD, NMD, and chest wall disorders. In some forms, it may improve the comfort and effectiveness of these treatments.
[0020] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheotomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.
[0021] 2.2.3 Treatment system These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.
[0022] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.
[0023] Another form of treatment system is a mandibular repositioning device.
[0024] 2.2.3.1 Patient Interface The patient interface may be used to provide the wearer with an interface to the respiratory appliance, for example by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal, for example, with an area of the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion with ambient pressure for therapy to be performed (e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure). In other forms of therapy, such as oxygen delivery, 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.
[0025] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.
[0026] Certain masks may be clinically unsuitable for use with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).
[0027] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.
[0028] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).
[0029] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.
[0030] These challenges may result in one or more of the following: some masks may be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if the wear time is long or the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to poor compliance, poor comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may result in poor patient compliance with the treatment. This is especially true if the mask must be worn while sleeping.
[0031] CPAP therapy is highly effective in treating certain respiratory diseases if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.
[0032] Masks for other uses (e.g., for aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.
[0033] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.
[0034] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices may be used individually or as part of a system to deliver one or more of the therapies described above, for example by actuating the device to generate an air delivery flow to an interface to the airway. This air flow may be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.
[0035] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., medical equipment reliability, size, and weight requirements). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.
[0036] One example of a special requirement of a particular RPT device is acoustic noise.
[0037] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744). [Table 1]
[0038] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide invasive and non-invasive independent breathing support for patients for a range of conditions (including, but not limited to, NMD, OHS, and COPD).
[0039] The ResMed Elisee® 150 and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators provide volume and pressure ventilation modes with single or dual limb circuits. RPT devices typically include a pressure generator (e.g., a motorized blower or compressed gas reservoir) and are configured to deliver an airflow to the patient's airway. In some cases, the airflow may be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface as described above.
[0040] A device designer may be presented with a myriad of choices. Often, design criteria conflict, making certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment may be significantly affected by minor changes in one or more parameters.
[0041] One design option for such devices is to provide one type of power source within the device. The type of power source may determine the amount of power available for the components of the device, the weight and size of the device, and the cost. Although it is desirable to make the device smaller and lighter, the amount of available power is reduced when the size of the power source is reduced. In other situations, the type of power available in the device is already determined, but it is desirable to provide additional subsystem components. Examples of subsystem components include, for example, a blower, a heating plate, a heating tube, or other components (e.g., a communication module). These additional subsystem components may need to use limited power provided by the power source already provided within the device. Therefore, it is desirable to enable efficient power management of the power source within the device, especially in devices where the power source may not have enough power to simultaneously power all the device components and subsystem components.
[0042] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to drying of the airway. When a humidifier is used with the RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.
[0043] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.
[0044] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when necessary. Bedside medical humidifiers may be small. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, and not the patient's surroundings. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, but these systems also humidify and / or heat the entire room, which may be uncomfortable for the occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.
[0045] Although a number of medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, i.e., some of such medical humidifiers provide inadequate humidification and others are difficult or inconvenient for the patient to use.
[0046] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory treatment is "compliant" (e.g., whether the patient complies with one or more "compliance rules" with their RPT device). One example of a compliance rule for CPAP treatment may require a patient to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate a usage rate over a period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.
[0047] There may be other aspects of a patient's care that would benefit from communication of treatment data to third parties or external systems.
[0048] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone.
[0049] 2.2.3.5 Mandibular repositioning Mandibular repositioning devices (MRDs) or mandibular advancement devices (MADs) are a treatment option for sleep apnea and snoring. They are adjustable oral appliances available from dentists or other suppliers that hold the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices that are inserted into the oral cavity before the patient sleeps and removed afterwards. As such, MRDs are not designed for full-time wear. MRDs may be custom made or manufactured in standard forms and include bite impression sites designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls to reduce airway collapse and reduce palate vibration.
[0050] In certain examples, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the upper jaw or maxilla, and a lower splint intended to engage or mate with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.
[0051] In such a design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to vary the level of protrusion of the mandible. The dentist can determine the level of protrusion required for the mandible, which in turn determines the length of the connecting rod.
[0052] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC® MRD, are designed to hold the mandible in an anterior position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. As such, the device is configured to minimize or avoid any movement of one or more of the teeth.
[0053] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., the surroundings).
[0054] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked when in use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or airflow concentration.
[0055] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.
[0056] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 2]
[0057] ( * (Only one sample was measured at 10cmH2O in CPAP mode using the test method specified in ISO3744)
[0058] The sound pressure values of various objects are listed below. [Table 3]
[0059] 2.2.4 Screening, diagnostic and surveillance systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, which typically requires expert clinical staff for system application. In PSG, typically 15-20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG)). For PSG of sleep-disordered breathing, patients need to be observed for two nights in a specialized hospital; the first night is purely for diagnosis, and the second night is required for titration of treatment parameters by the clinician. Therefore, PSG is expensive and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable at home.
[0060] In general, screening and diagnosis are the identification of disease by signs and symptoms of the disease. Screening usually produces a true / false result indicating whether or not a patient's SDB warrants further investigation, whereas diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of the disease can continue indefinitely. Some screening / diagnostic systems are adapted for screening / diagnosis only, while some can be used for monitoring as well.
[0061] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is not available or cannot be paid. Different clinical experts may have different opinions about a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. Summary of the Invention [Means for solving the problem]
[0062] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.
[0063] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.
[0064] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.
[0065] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.
[0066] One form of the present technology involves providing adaptive power management within a respiratory treatment device.
[0067] Another aspect of one form of the present technology involves providing adaptive power management within a respiratory treatment device that provides a flow of pressurized gas that can be heated and / or humidified.
[0068] One form of the present technology involves providing adaptive power management of multiple components located within a medical device (e.g., a device used in screening, diagnosing, monitoring, ameliorating, treating or avoiding a respiratory disorder).
[0069] One aspect of one form of the present technology is a portable RPT device that a person can carry with them (eg, around the home).
[0070] Another aspect of the present technology relates to a respiratory treatment device that includes: a power source; a pressure generator configured to generate an airflow; a heating element configured to heat the generated airflow; one or more sensors configured to generate a sensor signal indicative of a characteristic of the airflow; and a processing system. The processing system may be configured to: receive the sensor signal; determine a control signal for control of the heating element based on the received sensor signal; receive a signal corresponding to a current drawn by the pressure generator; receive a signal corresponding to a current drawn by the heating element; generate a novel control signal for control of the heating element based on (1) the signal corresponding to the current drawn by the pressure generator, (2) the signal corresponding to the current drawn by the heating element, (3) the determined control signal for the heating element, and (4) the power of the power source; and control operation of the heating element using the novel control signal for control of the heating element.
[0071] In an embodiment, (a) the power that can be drawn by the pressure generator and the heating element together exceeds the output capability of the power supply; (b) if the sum of the current drawn by the pressure generator and the current that the heating element would draw using the determined control signal for the heating element exceeds a maximum current of the power supply, generating a new control signal such that the new control signal causes the heating element to draw a current that is lower than the current that would be drawn by the determined control signal; (c) if the sum of the current drawn by the pressure generator and the current that the heating element would draw using the determined control signal for the heating element does not exceed the maximum current of the power supply, generating a new control signal such that the new control signal causes the heating element to draw a current that is higher than the current that would be drawn by the determined control signal; (d) at least one of the one or more sensors is configured to generate a sensor signal indicative of a temperature of the airflow, and the processing system is further configured to control the pressure generator based on the sensor signal indicative of the temperature of the airflow; and (e) at least one of the one or more sensors is configured to generate a sensor signal indicative of a pressure of the airflow. (f) at least one of the one or more sensors is a flow sensor configured to generate a sensor signal indicative of a pressure of the airflow, and the processing system is configured to control the pressure generator based on the sensor signal indicative of the airflow flow, and the control signal for the control of the heating element is determined based on the sensor signal indicative of the airflow flow; (g) the airflow can be delivered to the patient interface via a tube (e.g., a flexible tube) coupled to the flow generator; (h) the generated control signal for the control of the heating element is controlled to accumulate a heat deficit in a period of time and return the accumulated heat deficit in a subsequent period of time; (i) the generated control signal for the control of the heating element decreases the heat generated by the heating element in a first period of time and increases the heat generated by the heating element in a second period of time after the first period of time; and / or (j) during the first period of time, the power of the power source is lower than the power consumed by the pressure generator and the heating element, and / or during the second period of time, the power of the power source isMore than the power consumed by the pressure generator and heating elements.
[0072] Another aspect of the present technology relates to an apparatus for treating a respiratory disorder in a patient, the apparatus including: a power source; a pressure generator configured to generate a flow of breathable gas for the treatment of a respiratory disorder; a humidifier configured to store a water supply and include a first heating element configured to heat the water supply for humidification of the breathable gas; a second heating element configured to heat the humidified breathable gas in a hose configured to deliver the humidified breathable gas to a patient; a transducer configured to generate a flow signal indicative of a characteristic of the flow of breathable gas; and a controller. The controller may be configured to: determine a first control signal for control of the first heating element and a second control signal for control of the second heating element based on the flow signal; determine whether a power to be used by the device exceeds a peak power of the power source based on (1) a current drawn by the pressure generator measured during operation of the pressure generator, (2) the first control signal, and (3) the second control signal; if it is determined that the power to be used by the device exceeds the peak power of the power source, modifying the first control signal and / or the second control signal to decrease the power used by the first heating element and / or the second heating element; if it is determined that the power to be used by the device does not exceed the peak power of the power source, modifying the first control signal and / or the second control signal to increase the power used by the first heating element and / or the second heating element.
[0073] In an embodiment, (a) the first control signal and the second control signal are pulse width modulated signals; (b) the first control signal is a first pulse width modulated signal and the second control signal is a second pulse width modulated signal that is offset in time from the first pulse width modulated control signal; (c) if it is determined that the power to be used by the device will not exceed a peak power of the power source, modifying the first control signal and the second control signal to increase the power used by the first heating element and the second heating element in a manner that favors the second heating element; and (d) ) if it is determined that the power to be used by the apparatus will exceed the peak power of the power source, modifying the first control signal and the second control signal to reduce the power used by the first heating element and the second heating element in a manner that favors the second heating element; (e) the first control signal is a first current set point provided to a proportional, proportional-derivative, or proportional-integral controller configured to control operation of the second heating element, and the second control signal is a ratio controller configured to control operation of the second heating element. a second current set point provided to the proportional-derivative controller, proportional-integral controller or proportional-integral controller; (d) determining whether the power to be used by the device exceeds the peak power of the power source includes determining whether a sum of (1) a current drawn by the device without current drawn by the first heating element and the second heating element, (2) a current that the first heating element could draw using the determined first control signal, and (3) a current that the second heating element would draw using the determined second control signal exceeds a maximum current that can be provided from the power source; (e) the flow signal corresponds to a respiratory cycle of the patient during use of the device, and the first control signal and the second control signal are determined to control an offset of peak power operation of the first heating element and the second heating element based on the flow signal; (f) the power of the power source is lower than the power drawn simultaneously by the pressure generator, the first heating element, and the second heating element; and / or (g) the humidified breathable gas in the hose is delivered to the patient via a patient interface coupled to the hose.
[0074] Another aspect of the present technology relates to a respiratory treatment device including: a flow generator configured to provide a flow of breathable gas to a patient; an accessory device including a tube heater and a humidifier heater; a power source; and a controller coupled to the flow generator, the accessory device, and the power source. The controller may be configured to: control operation of the flow generator, the delivery tube heater, and the humidifier heater; determine a first pulse-width modulated control signal for control of the delivery tube heater and a second pulse-width modulated control signal for control of the humidifier heater; and increase the duty cycle of the first pulse-width modulated control signal and the second pulse-width modulated control signal if it is determined that the rated current of the power source does not exceed the current that would be drawn by the flow generator, the delivery tube heater when the determined first pulse-width modulated control signal is applied to the delivery tube heater, and the humidifier heater when the determined second pulse-width modulated control signal is applied to the humidifier heater.
[0075] In an embodiment, (a) the controller is further configured to reduce the duty cycle of the first pulse-width modulated control signal and the second pulse-width modulated control signal if it is determined that the rated current of the power source exceeds a current that would be drawn by the flow generator, the delivery tube heater when the determined first pulse-width modulated control signal is applied to the delivery tube heater, and the humidifier heater when the determined second pulse-width modulated control signal is applied to the humidifier heater; (b) the first pulse-width modulated control signal is offset in time from the second pulse-width modulated control signal; and / or (c) the flow generator is coupled to a patient interface via a tube for providing a flow of breathable gas to the patient.
[0076] Another aspect of the present technology relates to a respiratory treatment device including: a flow generator configured to provide a flow of breathable gas to a patient; an accessory device including a tube heater and a humidifier heater; a power source; and a controller coupled to the flow generator, the accessory device, and the power source. The controller may be configured to: control operation of the flow generator, the delivery tube heater, and the humidifier heater; determine a first pulse-width modulated control signal for control of the delivery tube heater and a second pulse-width modulated control signal for control of the humidifier heater; and increase the duty cycle of the first pulse-width modulated control signal and the second pulse-width modulated control signal if it is determined that the rated current of the power source does not exceed the current that would be drawn by the flow generator, the delivery tube heater when the determined first pulse-width modulated control signal is applied to the delivery tube heater, and the humidifier heater when the determined second pulse-width modulated control signal is applied to the humidifier heater.
[0077] In an embodiment, (a) the controller is further configured to reduce the duty cycle of the first pulse-width modulated control signal and the second pulse-width modulated control signal if it is determined that the rated current of the power source exceeds a current that would be drawn by the flow generator, the delivery tube heater when the determined first pulse-width modulated control signal is applied to the delivery tube heater, and the humidifier heater when the determined second pulse-width modulated control signal is applied to the humidifier heater; and / or (b) the first pulse-width modulated control signal is offset in time from the second pulse-width modulated control signal; and / or (c) the flow generator is coupled to a patient interface via a tube for providing a flow of breathable gas to the patient.
[0078] Another aspect of the present technology relates to a method of operating a respiratory treatment device to generate a flow of breathable gas for the treatment of a respiratory disorder, the method including: measuring a characteristic of the airflow with a transducer; determining by the controller and based on the measured characteristic a first control signal for control of a pressure generator configured to generate a flow of breathable gas for the treatment of a respiratory disorder, a second control signal for control of a first heating element disposed in a humidifier configured to store a supply of water for humidifying the breathable gas, and a third control signal for control of a second heating element configured to heat the humidified breathable gas in a hose configured to deliver the humidified breathable gas to a patient; determining by the controller and based on (1) a current drawn by the pressure generator measured upon control of the pressure generator with the first control signal and (2) a current drawn by the second heating element measured upon control of the pressure generator with the first control signal. and (3) a third control signal, determining whether the power to be used by the respiratory treatment device exceeds a peak power of a power source used to power the respiratory treatment device; if it is determined that the power to be used by the respiratory treatment device exceeds the peak power of the power source, modifying by the controller the second control signal and / or the third control signal to decrease the power used by the first heating element and / or the second heating element; and if it is determined that the power to be used by the respiratory treatment device does not exceed the peak power of the power source, modifying by the controller the second control signal and / or the third control signal to increase the power used by the first heating element and / or the second heating element.
[0079] Another aspect of the present technology relates to a non-transitory storage medium having stored therein an information processing program for controlling the operation of a respiratory treatment device configured to generate a flow of breathable gas for the treatment of a respiratory disorder. When executed, the program causes the respiratory treatment device to: receive from a transducer a characteristic of the flow of breathable gas; determine based on the characteristic of the flow of breathable gas a first control signal for control of a pressure generator configured to generate the flow of breathable gas, a second control signal for control of a first heating element disposed in a humidifier configured to store a supply of water for humidifying the breathable gas, and a third control signal for control of a second heating element configured to heat the humidified breathable gas in a hose configured to deliver the humidified breathable gas to a patient; (1) determine a pressure generated by the pressure generator measured upon control of the pressure generator using the first control signal; determining whether the power to be used by the respiratory treatment device exceeds a peak power of a power source used to power the respiratory treatment device based on the current, (2) the second control signal, and (3) the third control signal; if it is determined that the power to be used by the respiratory treatment device exceeds the peak power of the power source, modifying the second control signal and / or the third control signal to decrease the power used by the first heating element and / or the second heating element; and if it is determined that the power to be used by the device does not exceed the peak power of the power source, modifying the second control signal and / or the third control signal to increase the power used by the first heating element and / or the second heating element.
[0080] Another aspect of the present technology relates to a respiratory treatment device that includes a power source; a flow generator configured to provide a flow of breathable gas to a patient; one or more heating elements; a processing system including at least one processor, the processing system configured to determine a heating control signal for control of the one or more heating elements and a flow control signal for control of the flow generator; and hardware circuitry. The hardware circuitry may be configured to receive a heating control signal for control of the one or more heating elements; determine a power consumption signal indicative of total power consumption based on operation of the flow generator and the one or more heating elements; and output a modified heating control signal for control of the one or more heating elements based on the power consumption signal.
[0081] In an embodiment, (a) the hardware circuitry is configured to output a received heating control signal for control of one or more heating elements without modification if the power consumption signal is above a predetermined value, and to output a modified heating control signal for control of one or more heating elements if the power consumption signal is below a predetermined value, (b) the hardware circuitry is configured to generate a pulse width modulated power signal based on the power consumption signal. The modified heating control signal is generated by combining the pulse width modulated power signal with the received heating control signal, (c) the hardware circuitry is configured to generate a pulse width modulated power signal based on the power consumption signal, and includes a logic gate for each received heating control signal. The logic gate is configured to generate the modified heating control signal by combining each received heating control signal with the pulse width modulated power signal, and (d) the hardware circuitry is further configured to receive a flow generator current signal and a current signal for the one or more heating elements. The power consumption signal is determined by summing a voltage indicative of the received flow generator current signal and a voltage indicative of the received current signal for the one or more heating elements, and / or (e) at least one of the heating elements is provided within the tube heater and at least one of the heating elements is provided within the humidifier heater.
[0082] Another aspect of the present technology relates to a respiratory treatment device. The respiratory treatment device includes a power source; a flow generator configured to provide a flow of breathable gas to a patient; one or more heating elements; hardware circuitry; and a processing system including at least one processor. The hardware circuitry may be configured to receive a flow generator current signal indicative of a current drawn by the flow generator and a current signal for the one or more heating elements indicative of a current drawn by the one or more heating elements, and determine a power consumption signal by summing a voltage indicative of the received flow generator current signal and a voltage indicative of the received current signal for the one or more heating elements. The processing system may be configured to receive the power consumption signal from the hardware circuitry; determine a flow control signal for control of the flow generator; and determine a heating control signal for control of the one or more heating elements based on the power consumption signal.
[0083] In an embodiment, (a) determining the heating control signal includes determining a pulse width modulated control signal for each of the heating elements; transmitting the determined pulse width modulated control signal to each respective heating element if the received power consumption signal is above a predetermined limit; and modifying and transmitting the determined pulse width modulated control signal to each respective heating element if the received power consumption signal is below a predetermined limit; and / or (b) the hardware circuitry is configured to buffer and amplify the received flow generator current signal; and the power consumption signal is a low pass filtered sum of a voltage indicative of the received flow generator current signal and a voltage indicative of the received current signal for the one or more heating elements.
[0084] Another aspect of the present technology relates to a respiratory treatment device that includes a power source, a pressure generator configured to generate an airflow, a heating element configured to heat the generated airflow, one or more sensors configured to generate a sensor signal indicative of a characteristic of the airflow, and a processing system configured to generate a control signal for the heating element. The heating element is controlled to accumulate a heat deficit for a period of time and to return the accumulated heat deficit for a subsequent period of time.
[0085] Another aspect of the present technology relates to a respiratory treatment device that includes a power source; a pressure generator configured to generate an airflow; a heating element configured to heat the generated airflow; one or more sensors configured to generate a sensor signal indicative of a characteristic of the airflow; and a processing system. The processing system is configured to: receive the sensor signal; determine a control signal for control of the heating element based on the received sensor signal; receive a signal corresponding to a current drawn by the pressure generator; receive a signal corresponding to a current drawn by the heating element; and control the heating element based on the signal corresponding to the current drawn by the pressure generator, the signal corresponding to the current drawn by the heating element, the determined control signal for the heating element, and the power of the power source. The heating element is controlled to accumulate a heat deficit for a period of time and to return the accumulated heat deficit for a subsequent period of time.
[0086] In examples, a flow of breathable gas is delivered to the patient coupled between the patient interface and the flow generator and / or humidifier.
[0087] The described methods, systems, devices and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory treatment device). Additionally, the described methods, systems, devices and apparatus enable advances in the art of automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep disordered breathing).
[0088] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.
[0089] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.
[0090] 4. Brief Description of the Drawings The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference symbols include like elements:
[0091] 4.1 Treatment system 1 shows a system including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position.
[0092] 2 shows a system including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000.
[0093] 3 includes a system including a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position.
[0094] 4.2 RPT Devices FIG. 4A shows an RPT device in accordance with one form of the present technology.
[0095] 4B is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items disposed in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.
[0096] FIG. 4C is a schematic diagram of electrical components of an RPT device in accordance with one form of the present technology.
[0097] FIG. 4D is a schematic diagram of an algorithm executed in an RPT device in accordance with one form of the present technology.
[0098] FIG. 4E is a flow chart illustrating a method performed by the therapy engine module of FIG. 4D in accordance with one aspect of the present technology.
[0099] 4.3 Humidifier FIG. 5A shows an isometric view of a humidifier in accordance with one form of the present technology.
[0100] FIG. 5B shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.
[0101] FIG. 5C is a schematic diagram of a humidifier in accordance with one form of the present technology.
[0102] 4.4 Active Power Management FIG. 5D shows an example architecture of a device using power provided by a power supply 4210.
[0103] FIG. 5E illustrates an example architecture for controlling the operation of multiple devices using power provided by a power source 4210.
[0104] 5F and 5G show example power measurements of components within the RPT device 4000.
[0105] FIG. 5H shows example circuitry that may be used to measure the power used by an RPT device 4000 in one form of the present technology.
[0106] FIG. 5I shows example signal waveforms for the circuitry shown in FIG. 5H.
[0107] FIG. 5J shows a power control circuitry that may be used to control a heating element based on a control signal indicative of power consumption of an RPT device 4000 in accordance with one form of the present technology.
[0108] FIG. 5K illustrates an output signal Gate-PWM duty cycle proportional to a control signal V_ctrl in accordance with one form of the present technology.
[0109] FIG. 5L shows the relationship between an output signal Gate-PWM input into an AND gate(s) and a Gated PWM output signal for a humidifier output by the AND gate(s) in accordance with one form of the present technology.
[0110] FIG. 5M illustrates a method for performing adaptive power management in one form of the present technology.
[0111] FIG. 5N illustrates a method for performing adaptive power management in another form of the present technology.
[0112] 5O and 5P show more detailed methods for performing adaptive power management in accordance with various aspects of the present technology.
[0113] 4.5 Respiratory waveform FIG. 6A shows a model of a typical human respiratory waveform during sleep.
[0114] FIG. 6B shows selected polysomnographic channels (pulse oximetry, flow, chest motion, and abdominal motion) during a patient's non-REM sleep breathing over a period typically of about 90 seconds.
[0115] FIG. 6C shows a polysomnogram of the patient before treatment.
[0116] FIG. 6D shows patient flow data as the patient experiences a series of total obstructive apneas.
[0117] Figure 6E shows the scaled inspiratory portion of a breath, where the patient is experiencing low frequency inspiratory snoring.
[0118] Figure 6F shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of flat inspiratory flow limitation.
[0119] Figure 6G shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "mesa" flat inspiratory flow limitation.
[0120] Figure 6H shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "panda ears" inspiratory flow limitation.
[0121] Figure 6I shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "chair" inspiratory flow limitation.
[0122] Figure 6J shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "reverse chair" inspiratory flow limitation.
[0123] Figure 6K shows a scaled inspiratory portion of a breath, where the patient is experiencing an example of "M-shaped" inspiratory flow limitation.
[0124] Figure 6L shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of severe "M-shaped" inspiratory flow limitation.
[0125] Figure 6M shows patient data from a patient with Cheyne-Stokes respiration. Figure 6N shows patient data from another example patient with Cheyne-Stokes respiration using the same three channels as in Figure 6M. [Brief description of the drawings]
[0126] [Figure 1] The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Diagram 2] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Diagram 3] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B]FIG. 1 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. The upstream and downstream directions are shown relative to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one form of the present technology. [Figure 4D] FIG. 1 is a schematic diagram of an algorithm executed in an RPT device in accordance with one form of the present technology. [Figure 4E] 4D according to one aspect of the present technology. [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] Shown is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] FIG. 1 is a schematic diagram of a humidifier in accordance with one form of the present technology. [Figure 5D] An example architecture of a device using power provided by a power supply 4210 is shown. [Figure 5E] 42 illustrates an exemplary architecture for controlling the operation of multiple devices using power provided by a power supply 4210. [Figure 5F] 4 shows exemplary power measurements of components within the RPT device 4000. [Figure 5G] 4 shows exemplary power measurements of components within the RPT device 4000. [Figure 5H] 40 shows example circuitry that may be used to measure the power used by an RPT device 4000 in one form of the present technology. [Figure 5I] 5C illustrates exemplary signal waveforms for the circuitry shown in FIG. 5H. [Figure 5J] Shows a power control circuit mechanism that can be used to control a heating element based on a control signal indicating the power consumption of the RPT device 4000 according to one embodiment of the present technology. [Figure 5K] Shows an output signal Gate - PWM duty cycle proportional to the control signal V_ctrl according to one embodiment of the present technology. [Figure 5L] Shows the relationship between the output signal Gate - PWM input into the AND gate(s) and the Gated PWM output signal for the humidifier output by the AND gate(s) according to one embodiment of the present technology. [Figure 5M] Shows a method for performing adaptive power management in one embodiment of the present technology. [Figure 5N] Shows a method for performing adaptive power management in another embodiment of the present technology. [Figure 5O] Shows a more detailed method for performing adaptive power management according to various embodiments of the present technology. [Figure 5P] Shows a more detailed method for performing adaptive power management according to various embodiments of the present technology. [Figure 6A] Shows a model of a typical respiratory waveform of a human during sleep. [Figure 6B] Shows selected sleep polysomnogram channels (pulse oximetry, flow, chest movement, and abdominal movement) of a patient during non - REM sleep breathing over a period typically about 90 seconds. [Figure 6C] Shows the sleep polysomnogram of a patient before treatment. [Figure 6D] Shows patient flow data when the patient is experiencing a series of total obstructive apneas. [Figure 6E] Shows the scaled inspiratory portion of the breath. Here, the patient is experiencing low - frequency inspiratory snoring. [Figure 6F] Shows the scaled inspiratory portion of the breath. Here, the patient is experiencing an example of flat inspiratory flow limitation. [Figure 6G]1 shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "mesa" flat inspiratory flow limitation. [Figure 6H] 1 shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "panda ears" inspiratory flow limitation. [Figure 6I] 1 shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "chair" inspiratory flow limitation. [Figure 6J] 1 shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "reverse chair" inspiratory flow limitation. [Figure 6K] A scaled inspiratory portion of a breath is shown, where the patient is experiencing an example of "M-shaped" inspiratory flow limitation. [Figure 6L] A scaled inspiratory portion of a breath is shown, where the patient is experiencing an example of severe "M-shaped" inspiratory flow limitation. [Figure 6M] Patient data from a patient with Cheyne-Stokes respiration is shown. [Figure 6N] Figure 6M shows patient data from another example patient with Cheyne-Stokes respiration using the same three channels as in. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0127] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.
[0128] The following description is provided in conjunction with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.
[0129] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to an entrance to the airways of a patient 1000.
[0130] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.
[0131] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.
[0132] 5.2 Treatment system In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.
[0133] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functionalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functionalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functionalities. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airway to facilitate the supply of air at positive pressure to the airway.
[0134] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.
[0135] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.
[0136] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.
[0137] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient. 5.4 RPT Devices
[0138] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to generate an airflow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described anywhere herein, for example.
[0139] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.
[0140] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions, an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.
[0141] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).
[0142] One or more of the pneumatic path items may be disposed within a removable unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.
[0143] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.
[0144] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In one alternative, one or more of the following components may be disposed as their own separate units.
[0145] 5.4.1.1 Air filter(s) An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.
[0146] In one form, the inlet air filter 4112 is positioned at the beginning of the air pressure path upstream of the pressure generator 4140 .
[0147] In one form, an outlet air filter 4114 (eg, antibacterial factor) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.
[0148] 5.4.1.2 Muffler(s) An RPT device according to one form of the present technology may include a muffler 4120 or multiple mufflers 4120.
[0149] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.
[0150] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.
[0151] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / min, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Pat. No. 7,866,944; U.S. Pat. No. 8,638,014; U.S. Pat. No. 8,636,479; and PCT Patent Application Publication WO 2013 / 020167.
[0152] The pressure generator 4140 is under the control of the treatment device controller 4240 .
[0153] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.
[0154] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves data RPT device).
[0155] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure or temperature at that point in the pneumatic path).
[0156] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.
[0157] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass or band-pass filtering).
[0158] 5.4.1.4.1 Flow Sensors A flow sensor 4274 according to the present technology may be based on a differential pressure transducer (eg, an SDP600 series differential pressure transducer from SENSIRION).
[0159] In one form, a signal indicative of the flow rate from the flow sensor 4274 is received by the central controller 4230.
[0160] 5.4.1.4.2 Pressure Sensors A pressure sensor 4272 according to the present technology can be placed in fluid communication with the pneumatic path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.
[0161] In one form, the signal from the pressure sensor 4272 is received by the central controller 4230.
[0162] 5.4.1.4.3 Motor Speed Converters In one form of the present technology, a motor speed transducer 4276 may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor).
[0163] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).
[0164] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.
[0165] 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, power is provided from the power supply 4210 to both the RPT device 4000 and to subsystem devices directly or indirectly coupled to the RPT device 4000. The subsystem devices may include a humidifier 5000 and / or a heating tube. In some implementations of the present technology, the subsystem devices may be part of the RPT device 4000.
[0166] The power supply 4210 may receive power from an external power source (e.g., an A / C or DC power source) and / or include a battery to store electricity. DC sources may include car batteries, car outlets, fuel cells, and / or solar panels. The power supply 4210 may be configured to charge the battery when an external power source is available.
[0167] The power supply 4210 may be configured to provide 30, 60, and / or 90 watts of power. The power supply 4210 may include a converter configured to receive one form of power (e.g., from an A / C power source) and convert the power to another form (DC power) for use by the RPT device and / or one or more of the subsystem devices. In some implementations of the present technology, the power supply 4210 may include a DC converter (internal or external to the external housing 4010) to power the system or charge the battery.
[0168] The power source 4210 may include a primary power source and a secondary power source. The primary power source may be coupled to an A / C power source (e.g., 240 volts at 50 Hz A / C or 120 volts at 60 hz A / C) and / or one or more batteries. The one or more batteries may power the RPT device 4000 in the absence of an A / C power source and / or when additional power is needed for components of the RPT device 4000 and / or subsystem devices.
[0169] The power supply 4210 may not have enough power to simultaneously power the RPT device 4000 and the subsystem devices. For example, the power supply 4210 may not have enough power to simultaneously power the blower 4142, a heater (e.g., a hot plate) and a heating tube in the humidifier 5000. As described in more detail below, the RPT device 400 may include active power management (without triggering overcurrent protection of the power supply 4210) to distribute power from the power supply 4210 to the blower 4142 and one or more subsystem devices.
[0170] The power supply 4210 may include a current limiting circuit configured to limit the output power if the output current exceeds the maximum power supply rating by a specified percentage of the power supply rating (e.g., 110%, 120% or 150%).
[0171] In one example, the power supply 4210 may be rated at 24V / 65W with a 120% overcurrent protection (OCP) trigger (100ms delay) and a 150% OCP trigger (no delay). The heating plate may draw approximately 67.8W (8.5Ω±5%@25°C), the heating tube may draw approximately 57.7W (9.3-10.9Ω@20-30°C), and the blower may draw 40W, which is limited by the pressure system software. As can be seen from this example, the total current consumption of all these components is much higher than the power that the power supply 4210 can deliver. An active power management system is configured to manage the distribution of available power without tripping the overpower protection. As described in more detail below, in some implementations of the present technology, power management may be performed entirely by software.
[0172] 5.4.2.2 Input Devices In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a human to interact with the device. The buttons, switches or dials may be physical or software devices accessible via a touch screen. The buttons, switches or dials may be physically connected to the external housing 4010 in one form or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.
[0173] In one form, the input device 4220 may be constructed and arranged to allow a human to select values and / or menu options.
[0174] 5.4.2.3 Central Controller In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.
[0175] Suitable processors may include x86 INTEL processors, such as processors based on the ARM® Cortex®-M processor from ARM Holdings (e.g., the S®32 series of microcontrollers from ST Microelectronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series of microcontrollers from ST Microelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by TEXAS INSTRUMENTS) may also be suitable.
[0176] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.
[0177] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.
[0178] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and the humidifier 5000.
[0179] The central controller 4230 may be configured to provide output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.
[0180] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein (e.g., one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer readable recording medium (e.g., memory 4260)). In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some methods may be performed by a remotely located device. For example, the remotely located device may determine ventilator control settings or detect breathing-related events by analysis of recorded data (e.g., from any of the sensors described herein).
[0181] 5.4.2.4 Clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230 .
[0182] 5.4.2.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330 and forms part of the algorithms 4300 executed by the central controller 4230.
[0183] 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.
[0184] 5.4.2.6 Protection circuit The one or more protection circuits 4250 in accordance with the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.
[0185] 5.4.2.7 Memory In accordance with one form of the present technology, the RPT device 4000 includes a memory 4260 (e.g., non-volatile memory). In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.
[0186] The memory 4260 may be located on the PCBA 4202. The memory 4260 may take the form of an EEPROM or a NAND flash.
[0187] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (eg, a memory card made in accordance with the Secure Digital (SD) standard).
[0188] In one form of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium on which are stored computer program instructions embodying one or more of the methods described herein (e.g., one or more algorithms 4300).
[0189] 5.4.2.8 Data communication systems In one form of the present technology, a data communications interface 4280 is provided and connected to the central controller 4230. The data communications interface 4280 may be connectable to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.
[0190] In one form, the data communications interface 4280 is part of the central controller 4230. In another form, the data communications interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.
[0191] In one form, the remote external communications network 4282 is the Internet. The data communications interface 4280 may use wired communications (e.g., via Ethernet or fiber optics) or may use wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.
[0192] In one form, the local external communications network 4284 uses one or more communications standards (eg, Bluetooth or Consumer Infrared Protocol).
[0193] In one form, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by an appropriately authorized person (e.g., a clinician).
[0194] The local external device 4288 may be a personal computer, a cell phone, a tablet or a remote control.
[0195] 5.4.2.9 Optional displays and output devices, including alarms Output devices 4290 according to the present technology may take the form of one or more of visual, audio and tactile units. The visual display may be a Liquid Crystal Display (LCD) or a Light Emitting Diode (LED) display.
[0196] 5.4.2.9.1 Display Drivers The display driver 4292 receives as input characters, symbols or images to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols or images.
[0197] 5.4.2.9.2 Display The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the number "0") into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol. 5.4.3 RPT Device Algorithm
[0198] As noted above, in some forms of the present technology, the central controller 4230 may be configured to embody one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., memory 4260). The algorithms 4300 are typically grouped into groups called modules.
[0199] 5.4.3.1 Pre-processing module A pre-processing module 4310, according to one form of the present technology, receives as input a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) and performs one or more process steps to calculate one or more output values that are used as inputs to another module (e.g., a therapy engine module 4320).
[0200] In one form of the present technology, the output values include interface or mask pressure Pm, respiratory flow Qr, and leak flow Ql.
[0201] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: pressure compensation 4312, ventilation flow estimation 4314, leak flow estimation 4316, and respiratory flow estimation 4318.
[0202] 5.4.3.1.1 Pressure compensation In one form of the present technology, a pressure compensation algorithm 4312 receives as an input a signal indicative of the pressure in the pneumatic path proximal to the outlet of the pneumatic block. The pressure compensation algorithm 4312 estimates the pressure drop through the pneumatic circuit 4170 and provides as an output the estimated pressure Pm in the patient interface 3000.
[0203] 5.4.3.1.2 Estimation of air flow rate In one form of the present technology, an airflow estimation algorithm 4314 receives as input an estimated pressure Pm in the patient interface 3000 and estimates the airflow Qv of air out of the vent 3400 in the patient interface 3000.
[0204] 5.4.3.1.3 Estimation of leakage flow rate In one form of the present technology, a leak flow estimation algorithm 4316 receives as input the total flow Qt and the ventilation flow Qv and provides as output an estimate of the leak flow Ql. In one form, the leak flow estimation algorithm estimates the leak flow Ql by calculating the average difference between the total flow Qt and the ventilation flow Qv over a period long enough to include several respiratory cycles (e.g., about 10 seconds).
[0205] In one form, the leak flow estimation algorithm 4316 provides a leak flow Ql as an output and receives as inputs the total flow Qt, ventilation flow Qv, and estimated pressure Pm in the patient interface 3000 by calculating the leak conductance and determining the leak flow Ql to be a function of the leak conductance and pressure Pm. The leak conductance is calculated as the low-pass filtered quotient of the non-ventilated flow equal to the difference between the total flow Qt and the ventilation flow Qv, and the low-pass filtered square root of the pressure Pm, with the low-pass filter time constant having a value sufficient to include several respiratory cycles (e.g., about 10 seconds). The leak flow Ql may be estimated as a function of the product of the leak conductance and the pressure Pm.
[0206] 5.4.3.1.4 Respiratory flow estimation In one form of the present technology, the respiratory flow estimation algorithm 4318 receives as inputs the total flow Qt, the ventilation flow Qv and the leak flow Ql and estimates the air respiratory flow Qr to the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.
[0207] 5.4.3.2 Treatment Engine Module In one form of the present technology, the therapy engine module 4320 receives as inputs one or more of the pressure in the patient interface 3000, Pm, and the respiratory flow of air to the patient, Qr, and provides one or more therapy parameters as outputs.
[0208] In one form of the present technology, the treatment parameter is a treatment pressure, Pt.
[0209] In one form of the present technology, the therapy parameters are one or more of: amplitude of pressure change, base pressure, and target ventilation.
[0210] In various embodiments, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.
[0211] 5.4.3.2.1 Phase Determination In one form of the present technology, the RPT device 4000 does not determine the phase.
[0212] In one form of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow, Qr, and provides as an output, Φ, the phase of the patient's 1000 current respiratory cycle.
[0213] In some forms, the phase output Φ, known as discrete phase determination, is a discrete variable. One implementation of discrete phase determination results in a binary phase output Φ with a value of inspiration or expiration. This value is represented as, for example, values of 0 revolutions and 0.5 revolutions when the onset of spontaneous inspiration and expiration, respectively, is detected. The RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination because the trigger point and cycle point are the instants at which the phase changes from expiration to inspiration and inspiration to expiration, respectively. In one implementation of binary phase determination, the phase output Φ is determined to have a discrete value of 0 (thereby "triggers" the RPT device 4000) when the respiratory flow Qr has a value above a positive threshold, and a discrete value of 0.5 revolutions (thereby "cycles" the RPT device 4000) when the value of respiratory flow Qr is more negative than a negative threshold. The inspiration time Ti and expiration time Te may be typical values estimated over many respiratory cycles of the time spent with phase Φ equal to 0 (indicating inspiration) and 0.5 (indicating expiration), respectively.
[0214] Another implementation of the discrete phase decision provides a three-valued phase output Φ with one value of inspiration, pause during inspiration, and expiration.
[0215] In other forms, the phase output Φ, known as continuous phase determination, is a continuous variable, varying, for example, between 0 revolutions and 1 revolution or 0 to 2π radians. An RPT device 4000 with continuous phase determination may trigger and cycle when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one implementation of continuous phase determination, the continuous value of phase Φ is determined using fuzzy logic analysis of respiratory flow Qr. The continuous value of phase determined in this implementation is often referred to as "fuzzy phase." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to respiratory flow Qr: 1. If respiratory flow drops to zero and then increases rapidly, the phase is 0 revolutions. 2. If respiratory flow is large positive and stable, the phase is 0.25 revolutions. 3. If respiratory flow is zero and rapidly decreasing, the phase is 0.5 revolutions. 4. If respiratory flow is large negative and stable, the phase is 0.75 revolutions. 5. If respiratory flow is zero and stable and the 5 second low pass filtered absolute value of respiratory flow is large, then the phase is 0.9 revolutions. 6. If respiratory flow is positive and the phase is expiration, the phase is 0 revolutions. 7. Respiratory flow is negative, phase is inspiration, phase is 0.5 revolutions. 8. If the 5 second low pass filtered absolute value of respiratory flow is large, the phase increases at a constant rate equal to the patient's respiratory rate low pass filtered by a time constant of 20 seconds.
[0216] The output of each rule can be represented as a vector whose phase is the result of the rule and whose magnitude is the fuzzy range for which the rule is true. The fuzzy range for which respiratory flow is "high", "stable", etc. is determined by an appropriate membership function. The results of the rules are represented as vectors and then combined by some function such as taking the centroid. In such a combination, the rules may be weighted equally or differently.
[0217] In another implementation of the continuous phase determination, the phase Φ, like the inspiration time Ti and expiration time Te, are first estimated separately from the respiratory flow Qr as described above. The continuous phase Φ at any instant in time is then determined as half the fraction of the inspiration time Ti that has elapsed since the previous trigger instant or 0.5 revolutions plus the fraction of the expiration time Te that has elapsed since the previous cycle instant (whichever is the more recent instant).
[0218] 5.4.3.2.2 Waveform determination In one form of the present technology, the therapy parameter determination algorithm 4329 provides a nearly constant therapy pressure throughout the patient's respiratory cycle.
[0219] In another form of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapy pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ).
[0220] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having values in the range [0,1] for the domain of phase values Φ provided by the phase determination algorithm 4321 to be used by the treatment parameter determination algorithm 4329.
[0221] In one embodiment, suitable for discrete or continuous phases, the waveform template Π(Φ) is a square wave template having a value of 1 for phase values up to 0.5 revolutions and a value of 0 for phase values beyond 0.5 revolutions. In one embodiment, suitable for continuous phases, the waveform template Π(Φ) includes two smoothly curved portions (i.e., a smoothly curved (e.g., rising cosine) rise from 0 to 1 for phase values up to 0.5 revolutions, and a smoothly curved (e.g., exponential) fall from 1 to 0 for phase values beyond 0.5 revolutions). In one embodiment, suitable for continuous phases, the waveform template Π(Φ) is based on a square wave, but has a smooth rise from 0 to 1 for phase values up to a "rise time" below 0.5 revolutions, and a smooth fall from 1 to 0 for phase values within a "fall time" after 0.5 revolutions, with a "fall time" below 0.5 revolutions.
[0222] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates depending on the settings of the RPT device. Each waveform template Π(Φ) in the library may be provided as a look-up table of values Π versus phase value Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) "on the fly" using a predefined functional form, perhaps parameterized by one or more parameters (e.g., the time constant of the exponential curve portion). The parameters of the functional form may be predefined or may depend on the current state of the patient 1000.
[0223] In some forms of the present technology suitable for discrete binary phases of inspiration (Φ=0 revolutions) or expiration (Φ=0.5 revolutions), the waveform determination algorithm 4322 calculates the waveform template Π "on the fly" as a function of the discrete phase Φ and time t measured from the most recent trigger instant. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) in two parts (inspiration and expiration) as follows:
number
[0224] Here, Π i (t) and Π e (t) are the inspiratory and expiratory portions of the waveform template Π(Φ,t). In one such embodiment, the inspiratory portion Π i (t) is the smooth rise from 0 to 1 parameterized by the rise time, Π e (t) is a smooth decline from 1 to 0 parameterized by the decline time.
[0225] 5.4.3.2.3 Ventilation determination In one form of the present technology, a ventilation determination algorithm 4323 receives as input the respiratory flow, Qr, and determines a measurement indicative of the current patient ventilation, Vent.
[0226] In some embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is an estimate of actual patient ventilation. As one such embodiment, it may take half the absolute value of the respiratory flow rate Qr, which is optionally filtered by a low-pass filter (e.g., a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).
[0227]
[0226] In other embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is highly proportional to actual patient ventilation. In one such embodiment, the peak respiratory flow rate Qpeak is estimated at the inspiratory portion of the cycle. Through the above and many other procedures including sampling of the respiratory flow rate Qr, a measurement that is highly proportional to ventilation is obtained, but in these measurements, the variation in the flow waveform shape is not very large (where the shapes of two breaths are taken as being similar when the flow waveforms of the breaths normalized in time and amplitude are similar). To give some simple examples, there are the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow. Any linear combination of any order statistics of the absolute value of the respiratory flow rate using positive coefficients (and even some using both positive and negative coefficients) is approximately proportional to ventilation. As another example, it is the average of the respiratory flow rate at the central K-th percentage (with respect to time) of the inspiratory portion, where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are highly proportional to ventilation with high accuracy.
[0228] 5.4.3.2.4 Determination of Inspiratory Flow Limitation In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the range of inspiratory flow limitation.
[0229] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input and provides, as an output, a measure of the range in which the inspiratory portion of the breath indicates an inspiratory flow limitation.
[0230] In one form of the technology, the inspiration portion of each breath is identified by a zero-crossing detector. A number of evenly spaced (e.g., 65) points, indicating time points, are interpolated by an interpolator along the inspiration flow-time curve for each breath. The curve described by these points is then scaled by a scaler to have unit length (duration / period) and unit area, thereby removing the effects of changes in breathing rate and depth. The scaled breath is then compared in a comparator to a pre-stored template (similar to the inspiration portion of the breath shown in FIG. 6A) indicative of a normal, unobstructed breath. If at any time during inspiration the breath deviates from this template due to, for example, coughing, exhaling, swallowing, and hiccuping as determined by the test element, beyond a specified threshold (typically one scale unit), the breath is rejected. For data that was not rejected, a running average of the first such scaled point is calculated by the central controller 4230 for the preceding several inspiration events. This is repeated for the second such point over the same inspiration event, and so on. So, for example, 65 scaled data points are generated by the central controller 4230 to represent a moving average of several preceding inhalation events (e.g., 3 events). Hereinafter, the moving average of the continuously updated (e.g., 65) point values is referred to as the "scaled flow" and denoted by Qs(t). Alternatively, a single inhalation event may be used instead of the moving average.
[0231] From the scaled flow rates, two shape factors relevant to determining partial occlusion can be calculated.
[0232] Shape factor 1 is the ratio of the average of the median (e.g., 32) scaled flow points to the average of the global (e.g., 65) scaled flow points. If this ratio exceeds 1, the breath is considered normal. If this ratio is less than 1, the breath is considered obstructed. A ratio of approximately 1.17 is considered the threshold between partially obstructed and unobstructed breaths, and equates to a certain level of obstruction that allows for the maintenance of adequate oxygenation in a typical patient.
[0233] Shape factor 2 is calculated as the mean square deviation from unit scaled flow over the mean (e.g., 32) points. A mean square deviation of approximately 0.2 units is considered normal. A mean square deviation of zero is considered a totally flow-limited breath. The closer the mean square deviation is to zero, the more the breath is considered to be flow-limited.
[0234] Shape elements 1 and 2 may be used alternatively or in combination. In other forms of the present technology, the number of sampled points, breaths and midpoints may be different from those described above. Additionally, the thresholds may be different from those described above.
[0235] 5.4.3.2.5 Apnea and hypopnea determination In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for determining the presence of apnea and / or hypopnea.
[0236] In one form, the apnea / hypopnea detection algorithm 4325 receives as an input the respiratory flow signal Qr and provides as an output a flag indicating whether an apnea or hypopnea has been detected.
[0237] In one form, apnea is detected when a function of respiratory flow Qr falls below a flow threshold for a predetermined period of time. The function may determine a peak flow, a relatively short-term average flow, or a flow intermediate between the relatively short-term average and peak flow (e.g., RMS flow). The flow threshold may be a relatively long-term measurement of flow.
[0238] In one form, hypopnea is detected when a function of respiratory flow Qr falls below a second flow threshold for a predetermined period of time. The function may determine a peak flow, a relatively short-term average flow, or a flow intermediate between the relatively short-term average and peak flow (e.g., RMS flow). The second flow threshold may be a relatively long-term measurement of flow. The second flow threshold is higher than the flow threshold used to detect apnea.
[0239] 5.4.3.2.6 Snoring Determination In one form of the present technology, a central controller 4230 executes one or more snore determination algorithms 4326 for determining the snore range.
[0240] In one form, the snore detection algorithm 4326 receives as an input the respiratory flow signal Qr and provides as an output a measurement of the extent to which snoring is present.
[0241] The snore detection algorithm 4326 may include determining the strength of the flow signal in the range of 30-300 Hz. Additionally, the snore determination algorithm 4326 may include filtering the respiratory flow signal Qr to reduce background noise (e.g., airflow sounds in the system from the blower).
[0242] 5.4.3.2.7 Determination of airway patency In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the extent of airway patency.
[0243] In one form, the airway patency determination algorithm 4327 receives as an input the respiratory flow signal Qr and determines the output of the signal within a frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak within this frequency range is taken as indicative of an airway patency. The absence of a peak is taken as an indication of an airway closure.
[0244] In one form, the frequency range in which the peak is sought is the frequency range that results in a small forced oscillation at the therapeutic pressure Pt. In one embodiment, the forced oscillation has a frequency of 2 Hz with an amplitude of approximately 1 cmH2O.
[0245] In one form, the airway patency determination algorithm 4327 receives as an input the respiratory flow signal Qr and determines the presence or absence of a cardiogenic signal, the absence of which is taken as an indication of airway obstruction.
[0246] 5.4.3.2.8 Determining target ventilation In one form of the present technology, the central controller 4230 takes as input a measurement of the current ventilation, Vent, and executes one or more target ventilation determination algorithms 4328 for the determination of a target value, Vtgt, for the ventilation measurement.
[0247] In some forms of the present technology, there is no target ventilation determination algorithm 4328 and the target value Vtgt is predetermined, for example obtained by hard coding during configuration of the RPT device 4000 or by manual entry via the input device 4220.
[0248] In other forms of the present technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates a target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.
[0249] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a high percentage and a value less than the typical recent ventilation Vtyp. The high percentage in such forms can be in the ranges (80%, 100%), or (85%, 95%), or (87%, 92%).
[0250] In other forms of adaptive servo-ventilation, the target ventilation, Vtgt, is calculated as slightly more than a multiple of the typical recent ventilation, Vtyp.
[0251] Typical recent ventilation Vtyp is a value around which measurements of current ventilation Vent over multiple time instants over some predetermined time scale tend to be clustered (i.e., a measure of the central tendency of measurements of current ventilation in the recent history). In one implementation of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case should be longer than the time scale of a Cheyne-Stokes ramp-up and ramp-down cycle. The target ventilation determination algorithm 4328 may determine typical recent ventilation Vtyp from measurements of current ventilation Vent using any of a variety of well-known measures of central tendency. One such measure is a low pass filter output for measurements of current ventilation Vent with a time constant equal to 100 seconds.
[0252] 5.4.3.2.9 Determination of treatment parameters In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for determining one or more treatment parameters using values returned from one or more of the other algorithms in the treatment engine module 4320.
[0253] In one form of the present technology, the treatment parameter is the instantaneous treatment pressure, Pt. In one implementation of this form, the treatment parameter determination algorithm 4329 determines the treatment pressure, Pt, using the following equation: Pt = AΠ(Φ,t) + P0(1)
[0254] where: ● A is the amplitude, ● Π(Φ,t) is the waveform template value (in the range 0 to 1) at the current value of phase Φ and time t; ● P0 is the base pressure.
[0255] If the waveform determination algorithm 4322 provides the waveform template Π(Φ) as a lookup table of values Π indexed by the phase Φ, the treatment parameter determination algorithm 4329 applies equation (1) by locating the closest lookup table entry to the current value Φ of the phase returned from the phase determination algorithm 4321 or between two entries that span the current value Φ of the phase.
[0256] The values of amplitude A and base pressure P0 may be set by the treatment parameter determination algorithm 4329 depending on the respiratory pressure treatment mode selected as described below.
[0257] 5.4.3.3 Treatment Control Module A treatment control module 4330 according to one aspect of the present technology receives treatment parameters from a treatment parameter determination algorithm 4329 of the treatment engine module 4320 as input and controls the pressure generator 4140 to deliver airflow from the pressure generator in accordance with these treatment parameters.
[0258] In one form of the present technology, the treatment parameter is a treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow such that the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt.
[0259] 5.4.3.4 Detecting Fault Conditions In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detection of a fault condition. The fault condition detected by the one or more methods 4340 may include at least one of the following: ● Power outage (no power or insufficient power) ● Converter failure detection ● Unable to detect the presence of a component ● Operating parameters are outside the recommended range (e.g., pressure, flow, temperature, PaO2) • Failure of a test alert to produce a detectable warning signal.
[0260] When a fault condition is detected, the corresponding algorithm 4340 signal the presence of the fault by one or more of the following: ● Initiating audible, visual and / or kinetic (e.g. vibration) warnings. ● Sending messages to external devices Incident logging
[0261] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (eg, the RPT device 4000 and the patient interface 3000).
[0262] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.
[0263] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., central controller 4230). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated by reference in its entirety.
[0264] 5.5.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (eg, upstream of the pneumatic block 4020), the pneumatic circuit 4170 and / or the patient interface 3000.
[0265] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airway.
[0266] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.
[0267] 5.6.2 Humidifier Components 5.6.2.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidification of the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).
[0268] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to promote the air flow traveling a tortuous path through the reservoir 5110 while the air flow contacts a volume of water in the reservoir 5110.
[0269] According to one form, the reservoir 5110 may be removable from the humidifier 5000 laterally, for example as shown in Figures 5A and 5B.
[0270] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.
[0271] 5.6.2.2 Conductive Sites According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm) thick), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.
[0272] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).
[0273] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50% or 75% or an amount (e.g., 200ml, 300ml or 400ml)).
[0274] 5.6.2.5 Humidifier Transducer(s) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducers 4270 described above. The humidifier transducers 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C. The humidifier transducers 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier transducers may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signals to the controller.
[0275] 5.6.2.5.1 Pressure transducers One or more pressure transducers 5212 may be provided to the humidifier 5000 in addition to or instead of the pressure sensor 4272 provided in the RPT device 4000.
[0276] 5.6.2.5.2 Flow Converters In addition to or instead of the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided to the humidifier 5000.
[0277] 5.6.2.5.3 Temperature Converters The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures (e.g., the temperature of the heating element 5240 and / or the temperature of the air flow downstream of the humidifier outlet 5004). In some forms, the humidifier 5000 may further include a temperature sensor 5216 that detects the temperature of the ambient air.
[0278] 5.6.2.5.4 Humidity Transducers In one form, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.
[0279] 5.6.2.6 Heating elements In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the volume of water to the airflow. The heating element 5240 may include a heat-generating component, such as an electrical resistance heating track. One suitable example of the heating element 5240 is a layered heating element, for example, as described in PCT Patent Application Publication No. WO2012 / 171072, the entirety of which is incorporated herein by reference.
[0280] In some forms, the heating element 5240 may be mounted in the humidifier base 5006. In the humidifier base 5006, heat may be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in FIG.
[0281] 5.6.2.7 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may be in communication with the central controller 4230.
[0282] In one form, the humidifier controller 5250 may receive measurements of characteristics (e.g., temperature, humidity, pressure and / or flow rate) as inputs (e.g., measurements of airflow, water in the reservoir 5110 and / or in the humidifier 5000). The humidifier controller 5250 may also be configured to run or implement a humidifier algorithm and / or deliver one or more output signals.
[0283] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature central conof the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).
[0284] 5.7 Active Power Management As noted above, the power supply 4210 may not have enough power to power the RPT device 4000 and the subsystem devices simultaneously. Although it may be possible to provide a power supply 4210 with sufficient power with the RPT device 4000, a power supply with a higher power rating would be more costly, require more space, and / or be heavier. Minimizing cost, space, and / or weight in the RPT device 4000 (especially the portable RPT device 400) is desirable.
[0285] As an example, the RPT device 4000 may utilize a compact design that requires the use of a compact power source 4210 (e.g., an external power source). The compact power source 4210 may have a lower power capacity rating compared to conventional power sources. The RPT device 4000 may employ specific power management measures (without compromising performance) to work with the compact power source 2410. The RPT device 4000 may maximize utilization of the power source 4210 through dynamic management of the power demands of the RPT device 4000's subsystems (e.g., blower, humidifier, and / or functional circuits).
[0286] Implementation of the present technology allows active power management of a power source that has insufficient power to simultaneously power the RPT device 4000 and one or more subsystem devices. Active power management may include software and / or hardware configured to control the operation of the RPT device 4000 and subsystem device(s) in a manner that avoids triggering overcurrent protection of the power source 4210 (e.g., provided by the protection circuit 4250) while still providing treatment for a respiratory condition using the RPT device 4000 and subsystem devices. Hardware-based implementation of power management provides reliability but at the cost of additional components. Software-based implementation of power management reduces implementation costs but increases software complexity. In some examples, software-based implementation may require additional memory for instruction storage but may use existing processing systems to execute instructions without requiring additional processing component(s). The combined use of hardware and software implementation of power management may result in lower overall software complexity, better control than software-based methods alone, and lower cost than hardware solutions alone. Hardware implementations also require much shorter time to operate. The provision of hardware components can lead to increased processing speeds. Hardware-based implementations can be much faster than software-based implementations.
[0287] FIG. 5D illustrates an example architecture of a device using power provided from a power supply 4210. As shown in FIG. 5D, the power supply may be rated to provide 65 W of power. The controller 4230 and other components (e.g., output devices, input devices and / or sensors) included within the RPT device 4000 may use a maximum designated amount (e.g., 5 W) during operation. The blower 4142 may use up to 40 W during operation. The heater 5020 (e.g., a heating plate) within the humidifier 5000 may use approximately 67.8 W. The heating tube 4172, which includes one or more heating elements and forms at least a portion of the air circuit 4170, may use approximately 57.7 W during operation. The total power that may be consumed by the devices illustrated in FIG. 5D (when operating simultaneously) exceeds the power rating of the power supply 4210. The blower 4142, heating plate 5020 and heating tube 4172 may be controlled to use only a small portion of the power (eg, set at a lower setting) and / or to operate only during certain portions of the breathing cycle.
[0288] The RPT device 4000 may include circuitry for measuring the current in the components shown in FIG. 5D. The measured current may include: I, which indicates the current supplied from the power supply 4210; SYSTEM , which shows the current drawn by the system excluding the heating plate 5020 and the heating tube 4172. FG , I which indicates the current drawn by the heating plate 5020 PLATE , and / or I, which indicates the current drawn by the heating tube 4172 TUBE Active power management involves controlling the operation of the blower 4142, the heating plate 5020 and / or the heating tubes 4172 based on one or more of these current measurements. In some implementations of the present technology, the current drawn by the blower 4142 may be measured separately and used to control the operation of the blower and / or other devices.
[0289] In operation, therapy is delivered and the control manner of the blower 4142 is determined based on conditions sensed by one or more sensors. The blower 4142 is prioritized for power provided by the power source 4210. If the blower does not require all the power available from the power source, the excess power may be used for control of subsystem devices (e.g., the heating plate 5020 and / or the heating tube 4172). The power for the blower may vary based on the patient's breathing cycle, and the blower may not use the entire available power during the inhalation up and exhalation portions of the breathing cycle. In some circumstances, the power for the blower may suddenly change when the patient adjusts or removes the mask.
[0290] 5E illustrates an example architecture for controlling the operation of multiple devices using power provided by the power source 4210. The central controller 4230 may control the operation of the RPT device 4000 and one or more subsystem devices based on user input, sensor data, available power and / or the power rating of the power source 4210, and / or the operating characteristics of the RPT device 4000 and one or more subsystem devices (e.g., blowers, heating plates, heating tubes, or other components (e.g., communication modules)).
[0291] The central controller 4230 may perform this control based on current measurements received from one or more current sense circuits. As shown in FIG. 5E, the central controller 4230 receives current measurements from one or more current sense circuits 5302-5308. The current sense circuit 5302 may be configured to measure the current provided from the power source 4210. The current sense circuit 5304 may be configured to measure the current drawn by the blower 4142 and other subsystem devices (e.g., controllers, sensors, and / or input devices). In some examples, the current sense circuit 5304 may be configured to measure only the current drawn by the blower 4142. The current sense circuit 5306 may be configured to measure the current drawn by the heating plate 5020 (e.g., the first heating element). The current sense circuit 5308 may be configured to measure the current drawn by the heating tube 4172 (e.g., the second heating element). The central controller 4230 receives these current measurements and determines which devices (e.g., blowers, heating plates and / or heater tubes) to power and the amount of power to provide to each of these devices (without tripping the power supply's overcurrent protection).
[0292] The current sense circuits 5302-5308 may allow real-time monitoring of current in different parts of the system, thereby allowing for effective control of the device without triggering overcurrent protection of the power supply in response to changes in the device's operating conditions. The current sense circuits 5302-5308 may allow for a more accurate assessment of the power being used by the device than power consumption estimation based on predicted respiratory cycles.
[0293] One or more of the current sense circuits may include an ADC driver configured to read the current channel at a predetermined interval (e.g., every 28 μs). The current sense circuit may receive an analog signal indicative of the current and convert the analog signal to a digital signal used by the central controller 4230. In implementations of the present technology, a variety of current sense circuits known to those skilled in the art may be used to obtain the current at different locations in the system. In some implementations, a digital current sense IC may be used. The digital current sense IC may be configured to split the serial peripheral interface data.
[0294] The central controller 4230 may control the operation of the blower 4142 based on the selected respiratory pressure treatment mode. The blower is prioritized over other devices (e.g., the heating plate 5020 and the heating tube 4172) for power from the power source 4210. The central controller 4230 limits the current of the heating plate 5020 and the heating tube 4172 to keep the overall power consumption within the power range of the power source 4210. In some implementations, the power range may be limited to avoid tripping the over-power protection. In some implementations, the power range may include the power before the over-power protection is triggered on a very short time scale and averaged by the controller. The current of the heating plate and / or the heating tube is controlled fast enough to avoid triggering the power supply over-current protection (when the rate of change of the blower current is high (e.g., due to a patient disconnect or a sudden change in the patient's breathing)). The active power management loop executes faster than the blower controller loop executes. In one implementation of the present technology, the active power management may execute twice as fast (e.g., 0.5 ms) than the blower current closed loop (e.g., 1 ms).
[0295] The central controller 4230 may control the blower 4142, the heating plate 5020, and the heating tube 4172 via the blower controller 5310, the heating plate controller 5312, and the heating tube controller 5314, respectively. The central controller 4230 may determine the current settings for the devices and send the set currents to each controller. One or more of the controllers 5310-5314 may include feedback control circuits. The feedback control circuits are configured to receive the set currents for each device from the central controller 4230 and adjust the operation of the device until the measured current matches the set current for the device. In one implementation of the present technology, the controller for a particular device may change the duty cycle of a pulse width modulated control signal provided to the device until the measured current matches the set current for the device.
[0296] In some implementations, one or more of the controllers 5310-5314 may be implemented using a proportional controller (P), a proportional-derivative controller (PD), a proportional-integral controller (PI), or a proportional-integral-derivative controller (PID). These controllers may calculate and send updated control output signals each time a sample is controlled to the device. The settings determined for the PI controller(s) by active power management may be determined based on measured currents that are faster (e.g., twice as fast) than the PI controller of the blower 4142. The controllers 5310-5314 may be embedded within a central processor (e.g., a microprocessor).
[0297] Determining the settings for one or more of the controllers 5310-5314 includes determining a set point (e.g., duty cycle) for the device using a climate control algorithm and adjusting the set point based on one or more measured currents. In one example, the duty cycle set points for the heating plate 5020 and heating tubes 4172 may be determined using a climate control algorithm and then adjusted based on the measured current draw of the blower 4142. The duty cycle set points for the heating plate 5020 and heating tubes 4172 may be lowered to avoid triggering power supply overcurrent protection, or may be increased to take advantage of more available power to provide additional heat by the heating plate 5020 and / or heating tubes 4172.
[0298] The additional heat generated when power is available may be able to compensate for the lack of heat during periods when more power is needed for the blower and power is limited to the heating plate 5020 and heating tube 4172.
[0299] In some implementations, each controller 5310-5314 may include a respective associated current sense circuit 5304-5308 or may receive current measurements from each associated current sense circuit 5304-5308. The controllers 5310-5314 may use the measured currents and set currents to control the operation of each device (e.g., the duty cycle of a pulse width modulated control signal).
[0300] In some implementations of the present technology, the hot plate controller 5312 may receive the budget current for the hot plate 5020 and may adjust a pulse width modulated control signal based on the budget current and the current measured by the sense circuit 5306 (so that the entire budget current for the hot plate is used by the hot plate 5020). The hot tube controller 5314 may receive the budget current for the hot tube 4172 and may adjust a pulse width modulated control signal based on the budget current and the current measured by the sense circuit 5308 so that the entire budget current for the hot tube is used by the hot tube 4172.
[0301] In some implementations of the present technology, the pulse width modulated signals for the blower, heating plate and / or heating tube may be offset from one another. In some examples, the pulse width modulated signals may be offset as a function of the detected patient breathing cycle. An example of offsetting the peak power operation of a device is disclosed in U.S. Patent No. 8,844,522 ("Power Management in Respiratory Treatment Apparatus").
[0302] Dynamic Power Management Example
[0303] To meet the treatment demand, the power required by the blower must be guaranteed at all times without compromise. This forms the basis of dynamic power management. There may be temporary compromises in power allocation in the humidifier and the rest of the circuit. The humidifier cannot use as much power because it may absorb the remaining power that the blower does not use. If the power supply has a capacity of 65W and the blower draws 5W during treatment, the humidifier can draw up to 60W instead of being limited to a prescribed number. The three power management concepts can be implemented in the RPT device 4000 using hardware methods, software methods, or a combination of software and hardware methods.
[0304] Power management may be based on measurements of power consumed by components of the RPT device 4000. Figures 5F and 5G show example power measurements of components in the RPT device 4000. The RPT device 4000 may include current sensing and amplification circuitry for the blower 4142, the heating plate 5020 and / or the heating tube 4172. Waveforms may be measured at the output of the f amplifier during operation of the RPT device 4000. During operation of the RPT device 4000, the operating heating plate 5020 and / or the heating tube 4172 may be controlled to operate at their maximum levels.
[0305] Waveform 6010 shows the total current drawn by the RPT device 4000 (e.g., on the 24V line). Waveform 6020 shows the current sense voltage of the blower 4142 (e.g., of reverse polarity). Waveform 6030 shows the current sense voltage of the heated plate 5020. Waveform 6040 shows the current sense voltage of the heated tube 4172.
[0306] FIG. 5G shows an expanded portion of the waveforms shown in FIG. 5F. As shown in FIG. 5G, the heating tube 4172 and the heating plate 5020 share power usage. That is, the heating elements of the humidifier plate and the heating tube are turned on alternately. When the humidifier PWM (shown by waveform 6030) is turned on, the heating tube PWM (shown by waveform 6040) is turned off. Similarly, when the heating tube PWM (shown by waveform 6040) is turned on, the humidifier PWM (shown by waveform 6030) is turned off. In some examples, the PWM signals for the heating plate 5020 and the heating tube 4172 are never turned on at the same time, but can both be turned off at any time. In some examples, while one of the PWM signals for the heating plate 5020 or the heating tube 4172 is turned off, the other can be turned off for multiple cycles. As shown in FIG. 5G, the PWM signals for the heater plate 5020 and the heater tube 4172 may be turned off for a portion of the time to prevent power being drawn by both PWM signals at the same time.
[0307] The exemplary circuitry shown in Figure 5H may be used to measure the power used by the RPT device 4000. Although specific circuit components are shown in Figure 5H, these circuit components are not limiting and one or more other components providing similar functionality may be substituted.
[0308] The circuitry includes sensing, summing and filtering circuitry. The sensing circuitry may be configured to measure the current drawn by the blower 4142 and subsystem devices (e.g., the heated tube 4172 and / or the heated plate 5020). The summing circuitry may be configured to output a voltage proportional to the current drawn by the blower 4142 and subsystem devices (e.g., the heated tube 4172 and / or the heated plate 5020). The filtering circuitry may be configured to filter high frequency signals to provide an average of the total power consumption.
[0309] In FIG. 5H, the blower current sense signal may be buffered and amplified by an opamp 6050. The output of the opamp 6050 is coupled to an opamp 6052 through a resistor. Although not shown in FIG. 5H, the current sense signal from one or more subsystem devices (e.g., plate and tube) may be buffered and amplified. The opamp 6052 may receive voltages indicative of the blower current and the heating current (including the humidifier and the heating tube) and provide an output indicative of the total voltage. By carefully selecting the input resistors, the output voltage of the opamp 6052 becomes proportional to the total power consumption. The voltage may then be sent through a low pass filter (LPF). The low pass filter (LPF) includes an opamp 6054, a capacitor 6066, and a resistor 6068. The output of the LPF, V_ctrl, represents the average of the total power consumption (Power-IF). The polarity of V_ctrl may be reversible. That is, the higher V_ctrl is, the lower the total power consumption it represents. In another form of the technology, the polarity of V_ctrl cannot be reversed, i.e., the lower V_ctrl, the more power is available for consumption.
[0310] FIG. 5I shows example signal waveforms for the circuitry shown in FIG. 5H. The Motor-I, Plate-I and Tube-I waveforms show voltage values over time indicative of the current drawn by the RPT device 4000. The blower may draw more current when the patient inhales and less current when the patient exhales. The heating of the thermal plate and thermal tube is PWM signal controlled. As mentioned above, in one form of the present technology, the heating PWM signals for the plate and tube are controlled so that only one heating element is on at any time.
[0311] Sum-I represents the sum of the voltages representing the blower current and the heating current (including the humidifier and the hot tube) and is proportional to the total power consumption. Filtered Power Average represents the low pass filtered Sum-I signal. The filtered power average can be used as a control signal V_ctrl for controlling the operation of the heating element.
[0312] 5J illustrates power control circuitry that may be used to control a heating element based on a control signal indicative of power consumption of an RPT device 4000, in accordance with one form of the present technology. Although specific circuit components are illustrated in FIG. 5J, these circuit components are not intended to be limiting and one or more other components providing similar functionality may be substituted.
[0313] The power control circuitry is configured to receive a control signal V_ctrl and one or more PWM signals used to control the operation of the subsystem devices (e.g., the heating tube 4172 and / or the heating plate 5020). In one form of the present technology, the control signal V_ctrl may be provided by the circuitry shown in Figure 5H. The power control circuitry may be configured to modify one or more of the PWM signals based on the control signal V_ctrl.
[0314] In one form of the present technology, one or more of the PWM signals are modified until the control signal V_ctrl reaches a predetermined threshold indicative of a control limit. If the total power (indicated by V_ctrl) falls below the control limit, a PWM signal may be provided from the power control circuit to the subsystem device (without modification of the received PWM signal). If the total power (indicated by V_ctrl) reaches or exceeds the control limit, the power control circuit may modify one or more PWM signals.
[0315] In FIG. 5J, the voltage-controlled PWM circuit 6070 receives a control signal V_ctrl and outputs a Gate-PWM signal for control of a heat plate input signal (HeatPlate-PWM-In) and / or a heat tube input signal (HeatTube-PWM-In). The duty cycle of the output signal (Gate-PWM) is controlled by the control signal V_ctrl. In some examples, the output (Gate-PWM) may be provided at a current frequency (e.g., 100 Hz). One or more resistors, capacitors and / or voltage sources (e.g., VCC) may be used for control of the operating parameters of the voltage-controlled PWM circuit 6070.
[0316] In one example, the voltage controlled PWM circuit 607 may be configured to increase the duty cycle of the output signal Gate-PWM when the control signal V_ctrl is high (low power consumption) and decrease the duty cycle of the output signal Gate-PWM when the control signal V_ctrl is low (high power consumption). The AND gate 6072 may receive the output signal Gate-PWM and a heat plate input signal (HeatPlate-PWM-In) and may output a gated output signal (HeatPlate-PWM-Out) for the heating element in the hot plate 5020. The AND gate 6074 may receive the output signal Gate-PWM and a heat tube input signal (HeatTube-PWM-In) and may output a gated output signal (HeatTube-PWM-Out) for the heating element in the heat tube 4172. Increasing or decreasing the duty cycle of the output signal Gate-PWM increases or decreases the power provided to the heating element.
[0317] The voltage controlled PWM circuit 6070 may be configured to include one or more thresholds for controlling how the duty cycle of the output signal Gate-PWM is modified by the control signal V_ctrl. FIG. 5K illustrates the output signal Gate-PWM duty cycle proportional to the control signal V_ctrl, according to one form of the present technology. The waveform in FIG. 5K illustrates heating power control by utilizing a low frequency (100 Hz) Gate-PWM signal. The duty cycle of the low frequency (100 Hz) Gate-PWM signal is controlled by V_ctrl (which is inversely proportional to the total power consumption).
[0318] The first threshold V1 may be set such that when the control signal V_ctrl is higher than the threshold (lower than the power rating of the PSU), the output signal Gate-PWM is at 100% duty cycle (i.e., there is no power limit to the heating circuit(s)). When the control signal V_ctrl is lower than the threshold V1, the duty cycle of the output signal Gate-PWM may be reduced so that the heating circuit(s) is reduced. As shown in FIG. 5K, the threshold is set such that when the control signal V_ctrl is low (high power consumption), the output signal Gate PWM duty cycle is low and the heating PWM signal passing through the gate is reduced and thus the average heating power is also reduced. When the control signal V_ctrl is high (low power consumption), the duty cycle of the output signal Gate-PWM is high and thus the average heating power is increased.
[0319] The second threshold V2 is set such that when the control signal V_ctrl is between the first threshold V1 and the second threshold V2, the duty cycle of the output signal Gate-PWM is set to a first value (lower than 100%), and when the control signal V_ctrl is below the second threshold V2, the duty cycle of the output signal Gate-PWM is further reduced (e.g., to a second value lower than the first value).
[0320] In one form of the present technology, when the control signal V_ctrl is between the first threshold V1 and the second threshold V2, the duty cycle may be reduced below a value 100% proportional to the control signal V_ctrl, and when the control signal V_ctrl is below the second threshold V2, the duty cycle of the output signal Gate-PWM is further reduced (e.g., to 0 so that no heating power is provided to the heating element).
[0321] 5L illustrates a relationship between an output signal Gate-PWM input into an AND gate(s) and a Gated PWM output signal for the humidifier output by the AND gate(s) in accordance with one form of the present technology. As shown in FIG. 5L, when the value of the PWM gate signal is zero, the Gated PWM output signal for the humidifier will be zero and the power consumed by the heating element(s) will be zero. When the value of the PWM gate signal is non-zero, the received PWM gated humidifier signal is provided to the heating element(s).
[0322] In one form of the present technology, dynamic power management may be performed by software only. FIG. 5M illustrates a method of performing adaptive power management in one form of the present technology. The dynamic power management method may be performed by executing instructions stored in a non-transitory memory. In one example, the central controller 4230 and / or the humidifier controller 5250 may be configured to perform the operations shown in FIG. 5M. The operations in FIG. 5M are described with reference to a particular controller (e.g., the central controller 4230 and / or the humidifier controller 5250). The embodiments of the present disclosure are not limited thereto and may be performed by a single controller or additional controllers.
[0323] In step 5502, the central controller 4230 monitors the blower current in real time and calculates the average blower power consumption. The average blower power consumption may be calculated at a pre-determined frequency. In one example, the frequency may be 100 Hz. In another example, the frequency may be higher or lower depending on the workload of the humidifier controller. The frequency may be set lower as long as it does not trigger the overcurrent protection of the power supply.
[0324] In step 5504, the central controller 4230 reports the average blower power usage to the humidifier controller 5250.
[0325] In step 5506, the humidifier controller 5250 calculates a combination of the average power consumption of the heated plate 5020 and / or heated tubes 4172. The combination of the average power consumption of the heated plate 5020 and / or heated tubes 4172 may be calculated at the same frequency as the central controller 4230 that calculates the average blower power usage (e.g., 100 Hz).
[0326] In step 5508, the humidifier controller 5250 calculates an overall average power consumption. The overall average power consumption may include estimated power consumption of other circuits within the RPT device and / or devices coupled to the RPT device.
[0327] In step 5510, the overall average of power consumption is compared to the rated power capacity of the power supply unit. If the overall average of power exceeds the power supply rated power capacity (e.g., 65 W) ("Yes" in step 5510), the humidifier controller 5250 reduces the heating power to the humidifier circuit (step 5512). If the overall average of power is below the power supply rated power capacity ("No" in step 5510), the humidifier controller 5250 may increase the heating power to the humidifier circuit. If there is a need to increase the heat to be generated in the heating plate 5020 and / or the heating tube 4172, the heating power to the humidifier circuit may be increased. The increase in heating power to the humidifier circuit may be made as long as the total power remains below the rated power capacity limit of the power supply.
[0328] In one form of the technology, the software implementation may require prioritization of processing power calculations and control of the RPT device 4000 based on: a central controller 4230 calculating blower power consumption at a specified frequency, the central controller 4230 sending the blower power values to a humidifier controller 5250, and the humidifier controller 5250 calculating the total power consumption and controlling the heating power output.
[0329] In response to fluctuations in total power, software execution may need to occur faster, and if the software execution is not fast enough, the power supply unit may become temporarily overloaded and a power supply unit OCP may be triggered.
[0330] In one form of the present technology, hardware may be used to obtain the total power consumption (e.g., as indicated by V_ctrl), and software-based processing may be used to limit the power consumption. The power consumption signal V_ctrl may be connected to an A / D input of the humidifier controller 5250 (e.g., a microcontroller). This implementation allows the humidifier controller 5250 to obtain the total power consumption (without consuming a large portion of its own computational capacity).
[0331] In this example, the heating power control by the humidifier control may be similar to the operation described above with reference to Figure 5M, except that implementation using the central controller 4230 does not require the central controller 4230 to perform power usage calculations and send blower power consumption figures to the humidifier controller 5250.
[0332] 5N illustrates a method for performing adaptive power management in another form of the present technology. In one form of the present technology, the method may be performed by software and / or hardware. The method may be performed by a processing system including one or more processors. In one form of the present technology, the method may be performed at least in part by a central controller 4230.
[0333] The method includes receiving power usage data (step 5402). The power usage data may include data indicative of power available and / or being provided by the power source and / or power used by the device or by a subsystem of the medical device. The power usage data may include current provided from the power source, current drawn by the medical device, and / or current drawn by one or more subsystem devices. In one form of the present technology, the power usage data may include current provided from the power source, current drawn by the medical device (including the blower and not including the subsystem devices), current drawn by one or more components of the humidifier, and / or current drawn by one or more components of the heating tube.
[0334] The method includes determining whether the power usage exceeds the maximum power available (step 5404). This determination may be made based on the power source rating and / or the remaining charge of the power source, the received power usage data, and / or the power settings applied to one or more subsystem devices. In one form of the present technology, determining whether the power usage exceeds the maximum power usage may include whether the current drawn by the medical device and the subsystem device exceeds the maximum current that can be drawn from the power source (e.g., as determined based on the power source rating). In another form of the present technology, determining whether the power usage exceeds the maximum power usage includes determining whether the sum of the current drawn by the medical device and the target current setting of the subsystem device exceeds the maximum current that can be drawn from the power source.
[0335] If power usage exceeds the maximum available power ("Yes" at step 5404), new power settings for one or more subsystem devices may be updated (step 5412) so that the total power usage does not exceed the maximum power. If power usage does not exceed the maximum available power ("No" at step 5404), the current power settings may be maintained or adjusted so that the excess available power is used. If banking is not enabled ("No" at step 5406), the power settings are sent to the device or device controller without being updated (step 5410). If banking is enabled ("Yes" at step 5406), power setting updates may be made to one or more subsystem devices to use the excess power available from the power source.
[0336] Banking may include controlling a subsystem component with excess power such that its power consumption exceeds a previously determined power setting. The excess power may include the power available before overpower protection is triggered. For a heating element, banking may include increasing the power by generating additional heat during periods when excess power is available to compensate for heat not generated during periods when power is limited, allowing higher priority devices to be powered. Enabling banking may be based on user control and / or the type of power source connected (e.g., if a low power source is connected).
[0337] If the power provided to the subsystem component is reduced due to total power usage exceeding the maximum available power (step 5405, "yes"), a calculation may determine the amount of power to withhold due to the power limit and the amount of power to add when more power is available. The amount of power to be "debited" for the subsystem component at the time of power reduction may be obtained by subtracting the actual delivered power from the predicted power. The predicted power may indicate the system determined that the power needs to be provided to the subsystem component. The actual delivered power may indicate the power provided to the subsystem component after the reduction in the power provided to the subsystem component. If extra power is available (step 5404, "no"), banking may be enabled (step 5406, "yes") and the debited power may be added to the power already provided to the subsystem component.
[0338] In one example, periods when power is not provided to the heating element may be accumulated when power is limited to the heating element, and when extra power becomes available, additional power for the accumulated periods may be obtained by increasing the duty cycle of the power signal provided to the heating element.
[0339] Banking can be enabled when the stability of the heating control or its accuracy needs to be improved relative to the target performance.
[0340] Banking can provide an advantage in the performance of heaters that do not have feedback from a corresponding sensor. For example, in a subsystem that heats a plate to evaporate water, if there is no downstream sensor indicating the amount of water evaporation, the evaporation rate will not reach the target if heating is given low priority. Without feedback to the controller, there is no incentive to increase the overall average heating. Banking provides compensation to maintain this intended evaporation rate.
[0341] Banking can provide benefits when feedback from a sensor is low. For example, a subsystem for tube heating receives feedback from a gas temperature sensor. If heating is a low priority, the gas temperature may fall short of target. Feedback from the sensor stimulates the controller to increase response heating when power is available, but with some response delay. Banking can accelerate this response by anticipating a drop in gas temperature (before the sensor indicates it). Banking thus allows for reduced variability in the gas temperature delivered to the patient.
[0342] Updating the power settings for one or more subsystem devices (step 5412) may include determining a current setting for one or more subsystem devices. The PI controller may use the current setting to determine and update a duty cycle for each subsystem device (based on the measured current). In one form of the present technology, updating the power setting may include determining a duty cycle for each subsystem device. If the power being used exceeds the maximum power available, the current or duty cycle may be reduced. If extra power is available and banking is enabled, the current or duty cycle may be zooked.
[0343] 5O and 5P show more detailed methods for performing adaptive power management according to various forms of the present technology. In one form of the present technology, the methods may be performed by software and / or hardware. The methods may be performed by a processing system including one or more processors. In one form of the present technology, the methods may be performed at least in part by a central controller 4230. In some implementations of the present technology, the power management methods shown in FIG. 5O and 5P may be performed entirely by software.
[0344] FIG. 5O illustrates adaptive power management based on measured and set currents for subsystem devices (e.g., the hot plate 5020 and / or the hot tube 4172). The ADC driver generates a current I that indicates the measured current drawn by the system (excluding one or more subsystem devices). FGM , current I , which indicates the current drawn by a first subsystem device (e.g., the hot plate 5020) PLATE M , and / or a current I indicating the current drawn by a second subsystem device (e.g., the heating tube 4172). TUBE M The device may be configured to measure a current channel of the medical device for calculation of
[0345] The method is to determine the maximum available current I MAX This may include obtaining MAX may be based on the power supply rating. In some example implementations, I MAX may be based on the overpower protection value. MAX may be stored in memory, may be determined by software and / or hardware on some type of power source coupled to or contained within the medical device, may be determined based on power stored in the power source, and / or may be received from a power source or another component within the medical device. MAX may be dynamically changed depending on the power source connected to the flow generator (e.g., 65 W and 90 W). I for a given power source MAXmay be a fixed value (e.g., a pre-stored value for a given power source). The type of power source may be determined based on an indicator (e.g., a resistor and / or chip) included within the power source. For example, different resistor values may indicate different power sources or functions of the power source. A chip included within the power source may provide a code indicating different power sources or functions of the power source. As noted above, the power source may include an AC / DC power pack, a DC / DC converter, and / or a portable battery pack. I MAX may not take into account the overpower protection value, but in some implementations the timing of the control of the hotplate and / or hottube current is well below the OCP window before the protection circuit is tripped.
[0346] In some implementations, for example in a battery pack, I MAX may derate due to charge decay, environmental changes (e.g., temperature, pressure), cycle count and / or peak current. In some implementations, the power supply MAX Dynamically determine I MAX In some implementations, the system may be configured to provide a signal indicative of the I MAX Upon measuring the available charge and / or environmental conditions, the I MAX It may be possible to determine.
[0347] The method may include obtaining a set current for one or more subsystem devices (e.g., the heater plate 5020 and / or the heater tube 4172). In one example, the set current is determined by a heater plate current set point I PLATE SP and heating tube current set point I TUBE SP The set current may be determined based on a duty cycle set point used to control the operation of the subsystem device.
[0348] The duty cycle set points may be set according to a climate control algorithm. The climate control algorithm disclosed in U.S. Pat. No. 9,802,022 (titled "Humidification of Respiratory Gases") and the duty cycle control method disclosed in U.S. Pat. No. 8,844,522 ("Power Management in Respiratory Treatment Apparatus") may be used to set and control the duty cycle set points for the subsystem devices (e.g., the heating plate 5020 and / or the heating tube 4172). Both of these documents are incorporated herein by reference. In some implementations of the present technology, the humidifier and heating tube control algorithm disclosed in U.S. Pat. No. 9,802,022 (titled "Humidification of Respiratory Gases") in FIGS. 15-18 may be used to control the operation of the heating plate and / or the heating tube.
[0349] In one example, the duty cycle setpoint determined by the climate control algorithm for the heater plate 5020 is the heater plate current setpoint I PLATE SP and the duty cycle set point determined by the climate control algorithm for the heater tube 4172 can be converted to obtain the heater tube current set point I TUBE SP can be converted to obtain
[0350] The method shown in FIG. 5O is to use a current that is equal to the maximum available current I MAX The current being used may include determining whether the current being used exceeds a current I which indicates a measured current drawn by the system excluding one or more subsystem devices. FGM and the heating plate current set point I PLATE SP and the heater tube current set point I TUBE SPThe advantage of using current set points instead of measured currents for the hot plate and hot tube is that more accurate results may be obtained. Using measured currents may lead to inaccurate results because the measured currents are fixed in proportion to the duty cycle set by the controller and therefore may not correspond to the target of the controller.
[0351] The current being used is the maximum available current I MAX If the current being used exceeds the maximum available current I of the power supply, a new setpoint current for the heater plate and heater tube can be calculated, with a reduction in the power used by the heater plate and heater tube. In some instances, the heater tubes may be prioritized over the heater plate (e.g., by a ratio of 60% to 40%). MAX If current banking is enabled, the excess current may be used to adjust settings from one or more subsystem devices. The excess current may be calculated based on the current I FGM and the heating plate current set point I PLATE SP and the heater tube current set point I TUBE The sum of the maximum available current of the power supply, I MAX It may be calculated by subtracting from from. If extra current is available, new hot plate and heater tube current setpoint currents may be calculated to use the extra available current. In some instances, the heater tubes may be prioritized over the heater plate (e.g., by a ratio of 60 to 40%).
[0352] New Hot Plate Current Set Point I PLATE SP and heating tube current set point I TUBE SP can be used to control the hot plate and hot tube controllers. In one example, the hot plate and hot tube controllers use the measured current (e.g., I PLATE M and I TUBE M ) and the set current (e.g., I PLATE SP and I TUBE SP) The PI controller for the heating tube may include a PI controller set based on I TUBE SP and I TUBE M The heater tube duty cycle can be set based on I. The PI controller for the hot plate can be PLATE SP and I PLATE M The determined duty cycle can be applied in real time (e.g., on a cycle-by-cycle basis) to each subsystem device.
[0353] The current used is the maximum available current I of the power supply. MAX If current banking is not enabled, the existing current setting may be maintained. In this case, the existing hotplate current setpoint I PLATE SP and heating tube current set point I TUBE SP can be used to control the hot plate and hot tube controllers.
[0354] The rate of the climate control cycle can be relatively slow (e.g., every 1 s) to be adequate to manage the slow thermal response of the heated subsystem. The rate of the active power management cycle (e.g., every 500 μs) is preferably faster than the fastest increase in current consumption (by the high priority load). For example, the FG current I FGM The may increase in speed as the patient inhales, accelerating the blower and increasing airflow.
[0355] In the above example, a closed loop of the heater tube and plate heater current is used instead of the duty cycle. Although it may be easy to estimate the current drawn by the tube (or plate) according to the applied duty cycle, the disadvantage is that this calculation may be very inaccurate because the estimated current is highly dependent on the resistance tolerance and temperature of the part. For example, the amount of power that the system can deliver to the plate and tube may be lower than expected because the test results depend on the duty cycle. Such inaccuracies may lead to active power management clipping the humidifier or heater tube power too early. Using a faster current closed loop for the heater plate and / or heater tube may improve the overall performance of humidification.
[0356] In one form of the present technology, the PWM duty cycle range of the heater tubes and / or heater plate may have a duty cycle range of 0-99%. In some examples, a 100% duty cycle may be possible by the hardware.
[0357] As mentioned above, the heating tubes and / or heating plates may use a PI controller that may use the difference between a current set point and a measured current to calculate a duty cycle output for the heating tubes and / or heating plates.
[0358] The output offset of the operational amplifier used for current measurement may be very high (~160mV), making it impossible to measure currents lower than 200mA. Therefore, a PI controller may not be used at low duty cycles. If the current set point is lower than a preset value (e.g., 10% of maximum current), a fixed duty cycle (e.g., 10%) may be applied and a false current measurement may be calculated (e.g., 10% of maximum current). In some examples, the current set points may be 283mA (=10% of 2.83A) for the plate and 240mA (=10% of 2.40A) for the tube.
[0359] FIG. 5P illustrates adaptive power management based on measured current and set power for a subsystem device (e.g., heating plate 5020 and / or heating tube 4172). As described below with reference to FIG. 5P, in some implementations of the present technology, a closed loop of power control may be included. The settings of this closed loop of power control may be used for calculation of set point current of the subsystem device. The discussion of the operation shown in FIG. 5O, which is similar to the operation shown in FIG. 5P, may apply to the operation of the adaptive power management shown in FIG. 5P.
[0360] The RPT device 4000 may include a power control closed loop. The power control closed loop may be embedded in a microcontroller. The power control closed loop may use the flow generator duty cycle output as a percentage of a power set point. Each percentage may have a range of 0-100% in available power (e.g., a power range of 60W). The duty cycle applied to the plate (or tube) may be calculated by: Duty Cycle = Power Set Point / (Measured Supply Voltage * Measured I PEAK ). At low duty cycles, this formula may not be applicable since the current may never reach its peak due to the high inductance of the plates (or tube). In this situation, I PEAK cannot be measured but can be calculated using the resistance of the plate (or tube): I = measured supply voltage / resistance. The resistance can be calculated using the temperature of the plate (or tube).
[0361] As shown in FIG. 5P, in some implementations of the present technology, a power set point may be output by the climate control algorithm at a pre-determined interval (e.g., every second). The power set point is used to control the operation of the plate and tube power. The pressure system power set point and the measured power are used to determine the current set point. In adaptive power management, the tube and plate current set point may be calculated by: Current Set Point = Power Set Point / Measured Supply Voltage. The supply voltage may be measured by the pressure system software every 10 ms and used by the adaptive power management every 0.5 ms. In this implementation, the system may be able to accurately account for changes in the voltage source due to the operation of the blower.
[0362] Both the tube and plate duty cycles can be output by existing PI current closed loop controllers.
[0363] In contrast to other approaches for control of medical devices and subsystem devices, some implementations of adaptive power management according to the present technology do not predict when the patient will inhale, but use real-time power usage measurements and power settings to determine how to control the device. The present technology allows for faster detection of power usage by various subsystems of the medical device. For example, when inspiration begins, the operation of the blower is changed and detected by the sensing circuit. This change in operation can trigger a reduction in heater power so that more power is available to the blower. The blower does not have to wait for the heater power reduction before spinning up, which the patient may perceive as a delay. Power management allows for faster response, because if the heater power is held for too long, the combined current draw may exceed the power supply capacity and trigger overcurrent protection. 5.8 Respiratory waveform
[0364] FIG. 6A shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time and the vertical axis is respiratory flow. Because parameter values can vary, a typical breath may have the following approximate values: tidal volume, Vt, 0.5L; inhalation time, Ti, 1.6 seconds; peak inhalation flow, Qpeak, 0.4L / sec; exhalation time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5L / sec. The total duration of the breath, Ttot, is about 4 seconds. Humans typically breathe about 15 times per minute (BPM), with a ventilation, Vent, of about 7.5L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.
[0365] FIG. 6B shows selected polysomnographic channels (pulse oximetry, flow, chest movement, and abdominal movement) during non-REM sleep breathing in a patient treated with auto-PAP therapy and with a mask pressure of 11 cmH2O, typically taking approximately 34 breaths over a period of approximately 90 seconds. The top channel shows pulse oximetry (oxygen saturation or SpO2), with the scale ranging from 90 to 99% saturation in the vertical direction. Throughout the period shown, the patient maintained approximately 95% saturation. The second channel shows quantitative respiratory airflow, with the scale ranging from -1 to +1 LPS in the vertical direction, with exhalation being positive. Chest and abdominal movement are shown in the third and fourth channels.
[0366] FIG. 6C shows a polysomnogram of a patient before treatment. From top to bottom, there are 11 signal channels spaced over a horizontal span of 6 minutes. The top two channels are EEG (electroencephalogram) from different scalp locations. Periodic spikes in the second EEG indicate cortical arousal and related activity. The third channel below is a submental EMG (electromyogram). Increased activity around the arousal period indicates recruitment of the genioglossus muscle. The fourth and fifth channels are EOG (electrogenioglossus). The sixth channel is an electrocardiogram. The seventh channel shows pulse oximetry (SpO2) as desaturation is cycled from about 90% to less than 70%. The eighth channel is respiratory airflow using a nasal cannula connected to a differential pressure transducer. EEG arousals and increased EMG activity occur with repeated apneas of 25-35 seconds and 10-15 second bursts of recovery breathing. Channel 9 shows chest movement and channel 10 shows abdominal movement. The abdomen shows increasing movement over the length of the apnea, resulting in arousal. Both are out of alignment during arousal due to gross body movement during recovery hyperpnea. Thus, the apnea becomes obstructive and the condition is severe. The bottom channel is posture, which shows no change in this example.
[0367] FIG. 6D shows patient flow data as the patient experiences a series of total obstructive apneas. The duration of the recording is approximately 160 seconds. Flow rates range from about +1 L / s to about -1.5 L / s. Each apnea lasts approximately 10-15 seconds.
[0368] Figure 6E shows the scaled inspiratory portion of a breath, where the patient is experiencing low frequency inspiratory snoring.
[0369] Figure 6F shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of flat inspiratory flow limitation.
[0370] Figure 6G shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "mesa" flat inspiratory flow limitation.
[0371] Figure 6H shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "panda ears" inspiratory flow limitation.
[0372] Figure 6I shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "chair" inspiratory flow limitation.
[0373] Figure 6J shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of "reverse chair" inspiratory flow limitation.
[0374] Figure 6K shows a scaled inspiratory portion of a breath, where the patient is experiencing an example of "M-shaped" inspiratory flow limitation.
[0375] Figure 6L shows the scaled inspiratory portion of a breath, where the patient is experiencing an example of severe "M-shaped" inspiratory flow limitation.
[0376] Figure 6M shows patient data from a patient with Cheyne-Stokes respiration. There are three channels: pulse oximetry (SpO2); a signal indicative of flow; and chest movement. The data spans 6 minutes. The signal indicative of flow was measured using a pressure sensor connected to a nasal cannula. The patient exhibits approximately 22 seconds of apnea and approximately 38 seconds of hyperpnea. The higher frequency and lower amplitude oscillations during apnea are cardiac.
[0377] Figure 6N shows patient data from another example patient with Cheyne-Stokes respiration using the same three channels as in Figure 6M. The data spans 10 minutes. The patient exhibits approximately 30 seconds of hyperpnea and approximately 30 seconds of hypopnea.
[0378] 5.9 Glossary For purposes of this disclosure, in certain aspects of the present technology, one or more of the following definitions may apply. In other aspects of the present technology, other definitions may apply.
[0379] 5.9.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).
[0380] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean: (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.
[0381] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such ambient humidity may differ from the humidity outside the room in which the patient sleeps.
[0382] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.
[0383] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.
[0384] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.
[0385] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).
[0386] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate refer to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, references to flow rate refer to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" or "airflow" for shorthand.
[0387] In the example of a patient's breath, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle, and therefore negative for the exhalation portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Ventilator flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.
[0388] Humidifier: The word "humidifier" is to be construed as meaning a humidification device constructed, arranged or configured with a physical structure capable of providing a therapeutically beneficial quantity of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.
[0389] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, a leak may occur due to an imperfect seal between the mask and the patient's face. In another embodiment, a leak may occur at the elbow to the perimeter.
[0390] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic path (e.g., the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.
[0391] Noise Emission (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target according to ISO 3744.
[0392] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vents in a patient interface).
[0393] Patient: A person with or without respiratory disease.
[0394] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressure is given in units of cmH2O unless otherwise specified.
[0395] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this moment, is given the symbol Pt.
[0396] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, typically a positive pressure relative to the atmosphere.
[0397] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.
[0398] 5.9.1.1 Materials Silicone or Silicone Elastomer: Synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (in a family of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45 as measured by ASTM D2240.
[0399] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.
[0400] 5.9.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.
[0401] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.
[0402] Hardness: The ability of a material to resist deformation within itself (as described, for example, by Young's Modulus or the indentation hardness scale measured over a standardized sample size). - "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and do not easily deform under finger pressure, for example.
[0403] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may offer different resistance in different directions.
[0404] Floppy Structure or Component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.
[0405] Rigid Structure or Component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application may be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.
[0406] As one example, an I-beam may include a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction, hi another example, a structure or component may be floppy in a first direction and stiff in a second direction.
[0407] 5.9.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a certain threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.
[0408] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.
[0409] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.
[0410] Effort (Respiration): Respiratory effort is said to refer to the movement made by a person's spontaneous breathing in an attempt to breathe.
[0411] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.
[0412] Flow limitation: Flow limitation is understood to be a situation in a patient's breathing where an increase in effort by the patient does not cause a corresponding increase in flow rate. If the flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation may be referred to as inspiratory flow limitation. If the flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation may be referred to as expiratory flow limitation.
[0413] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area and then a downswing. (ii) M-shaped: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat region between the two peaks. (iii) Chair-like: A single local peak occurs at the rising edge, followed by a relatively flat region. (iv) Inverted chair shape: A relatively flat area is followed by a single local peak, which occurs at the trailing edge.
[0414] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when there is a sustained period of reduced flow below a threshold rate. When hypopnea is detected due to a reduction in respiratory effort, central hypopnea is said to occur. In one form in adults, hypopnea may be considered when any of the following occur: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting for at least 10 seconds and associated with at least 3% desaturation or arousal occurs.
[0415] Hyperventilation: An increase in flow to a level higher than normal.
[0416] Inspiration portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiration portion of the respiratory cycle.
[0417] Patency (Airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Airway patency may be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).
[0418] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.
[0419] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.
[0420] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): these terms may be understood to refer to the RPT device's estimate of respiratory airflow and are used in contrast to "true respiratory flow" or "true respiratory airflow", which is the patient's actual respiratory flow, usually expressed in liters / minute.
[0421] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume V i (volume of inhaled air) is the expiratory volume V e (volume of exhaled air), so a single tidal volume V t can be defined as being equal to either quantity. In practice, the tidal volume V t is some combination (e.g., intake volume V i and expiratory volume V e It is estimated as the average of
[0422] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.
[0423] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.
[0424] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.
[0425] Typical Recent Ventilation: The ventilation value around which the most recent values of ventilationVent tend to cluster over a given time scale (i.e., the degree to which the most recent values of ventilation tend to be central).
[0426] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).
[0427] Vent: A measurement of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inhaled and exhaled airflow per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.
[0428] 5.9.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation, but rather is variable. The variable target ventilation can be learned from some characteristics of the patient (e.g., the patient's breathing characteristics).
[0429] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).
[0430] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop breath delivery.
[0431] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added during the breath to produce the desired mask pressure that the ventilator attempts to achieve at a given time.
[0432] End Expiratory Pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.
[0433] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.
[0434] Pressure Support: A number indicating the increase in pressure during ventilator inhalation followed by exhalation of the same ventilator, and generally refers to the pressure difference between the maximum inhalation pressure and the base pressure (e.g., PS=IPAP-EPAP). In some contexts, pressure support refers to the difference the ventilator tries to achieve (rather than the difference it actually achieves).
[0435] Servo-ventilator: a ventilator that has patient ventilation and has target ventilation, and adjusts the level of pressure support to approximate the patient ventilation to the target ventilation.
[0436] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.
[0437] Swing: A term equivalent to pressure assistance.
[0438] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.
[0439] 5.10 Other Notes A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.
[0440] Unless otherwise clearly indicated from the context and unless a range of values is provided, it is understood that each intervening value between the upper and lower limits of the range, the unit of the lower limit, and any other stated or intervening value of the stated range is encompassed by the technology. The upper and lower limits of these intervening ranges, which are independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.
[0441] Furthermore, when a value or values are embodied herein as part of the present technology, unless otherwise indicated, it is understood that such values may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.
[0442] Unless otherwise specified, all technical and scientific terms herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.
[0443] Although particular materials are described as being preferred for use in the construction of components, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.
[0444] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.
[0445] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.
[0446] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically described.
[0447] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the limitations of the claims.
[0448] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, the terms "first" and "second" (and the like) are used, but unless otherwise specified, these terms are not intended to indicate any order, but are used to distinguish separate elements. Furthermore, although the description or illustration of the process steps in the method may be described in an order, such order is not required. Those skilled in the art will recognize that such order can be changed and / or aspects can be performed simultaneously or even synchronously.
[0449] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]
[0450] 1000 patients 1100 Bedmate 2012 Released 2410 small power supply 3000 Patient Interface 3100 Seal forming structure 3200 Plenum Chamber 3300 Structure 3400 Ventilation section 3600 Connection Port 3700 Forehead support ISO 3744 4000 RPT Devices 4010 Outer Housing 4012 Upper 4014 parts 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet Air Filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4171 Heated Air Circuit 4172 tube 4180 Supplemental Oxygen 4200 Electrical Components 4202 PCBA 4210 Power supply 4220 Input Device 4230 Central Controller 4232 Watch 4240 Therapeutic Device Controller 4250 protection circuit 4260 Memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed Converter 4280 Data Communication Interface 4282 Remote external communication network 4284 local external communications network 4286 Remote External Device 4288 local foreign device 4290 output device 4292 Display Driver 4294 Display 4300 Algorithm 4310 Pre-processing module 4312 Pressure Compensation 4314 Estimation of ventilation flow rate 4316 Estimation of leakage flow rate 4318 Respiratory flow estimation 4320 Treatment Engine Module 4321 Phase Decision 4322 Waveform determination 4323 Ventilation Decision 4324 Intake flow limit determination 4325 Apnea / hypopnea determination 4326 Snoring confirmed 4327 Airway patency determination 4328 Target ventilation determination 4329 Treatment parameter determination 4330 Treatment Control Module 4340 method 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5020 Heater 5110 Reservoir 5120 Conductive parts 5130 Humidifier Reservoir Dock 5135 Lock lever 5150 Water Level Indicator 5210 Humidifier Converter 5212 Air pressure sensor 5214 Flow Converter 5216 Temperature Converter 5218 Humidity Sensor 5240 heating element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Air Circuit Controller 5302,5304,5306,5308 Current sensing circuit 5310 Blower Controller 5312 Hot Plate Controller 5314 Tube Controller 5402 Power Usage Data Step 5404,5405,5406,5410,5412,5502,5504,5506,5508,5510,5512 steps 6010,6020,6030,6040 waveform 6050, 6052, 6054 Op Amps 6066 Capacitor 6068 resistor 6070 Voltage Controlled PWM Circuit 6072,6074 Gate
Claims
1. A respiratory treatment device, comprising: Power supply and a flow generator configured to provide a flow of breathable gas to the patient; a respiratory treatment component electrically connected to the power source; one or more controllers, a flow generator control configured to control current from the power supply to the flow generator; 1. A therapeutic component control comprising: calculating a first target operating parameter for the respiratory therapy component; a therapy component control configured to generate a control signal for controlling the respiratory therapy component based on the first target operating parameter; one or more controllers configured to execute a power consumption circuit configured to generate a power consumption signal based on power provided from the power source to components of the respiratory treatment device, including the respiratory treatment component; and a hardware logic gate configured to output a respiratory treatment component control signal for controlling operation of the respiratory treatment component, the hardware logic gate configured to receive a first input signal and a second input signal, the first input signal being based on the power consumption signal and the second input signal being based on the control signal.
2. A respiratory treatment device as described in claim 1, wherein the hardware logic gate is a hardware AND gate.
3. the first input signal is a gate pulse width modulation control signal based on the power consumption signal; 10. The respiratory treatment device of claim 1, wherein the second input signal is a pulse width modulated control signal based on the control signal.
4. A respiratory treatment device as described in claim 3, wherein the gate pulse width modulated control signal has a duty cycle proportional to the power consumption signal.
5. A respiratory treatment device as described in claim 1, wherein the hardware logic gate is further configured to combine the received first input signal with the received second input signal so that the respiratory treatment component control signal has a reduced duty cycle when the power consumption signal indicates high power consumption.
6. A respiratory treatment device as described in claim 1, wherein the respiratory treatment component includes a heat generating element configured to draw power from the power source.
7. A respiratory treatment device as described in claim 1, wherein the flow generator control operates independently of the power consumption signal.
8. A respiratory treatment device as described in claim 1, wherein the hardware logic gate modifies the second input signal based on available power after accounting for the power consumed by the flow generator.
9. A second respiratory treatment component; 10. The respiratory treatment device of claim 1, further comprising: a second hardware logic gate configured to output a second respiratory treatment component signal based on the first input signal and a third input signal.
10. A respiratory treatment device as described in claim 1, wherein the one or more controllers include a central controller configured to perform the flow generator control and separate controllers configured to perform the treatment component control.
11. A respiratory treatment device as described in claim 1, wherein the power consumption circuitry and the hardware logic gates operate at a speed faster than the speed at which the flow generator operates.
12. A respiratory treatment device as described in claim 1, wherein the respiratory treatment component regulates the flow of breathable gas based on consuming power supplied from the power source.
13. A respiratory treatment device as described in claim 12, wherein the respiratory treatment component includes a heating element configured to heat one or more water supplies to humidify the breathable gas or the flow of breathable gas.
14. A respiratory treatment device as described in claim 1, wherein the power consumption circuit includes a low-pass filter configured to filter the power consumption signal.
15. The flow generator control: receiving a target current value for the flow generator; measuring the actual current supplied to the flow generator; 10. The respiratory treatment device of claim 1, configured to adjust operation of the flow generator based on a comparison of the target current value and the measured actual current.
16. A respiratory treatment device, comprising: Power supply and a flow generator configured to provide a flow of breathable gas to the patient; a respiratory treatment component electrically connected to the power source; one or more current sensors configured to measure the current supplied to the flow generator and the current supplied to the respiratory treatment component; one or more hardware processors, running a flow generator control loop at a first speed configured to control current delivered to the flow generator based on a therapeutic goal; configured to cause an active power management loop to run at a second rate that is faster than the first rate; The active power management loop from the one or more current sensors; a first measured current supplied to the flow generator; a second measured current delivered to the respiratory treatment component; calculating a total power consumption based on the first measured current and the second measured current; and one or more hardware processors that, based on determining that the total power consumption exceeds a power threshold, control control signals delivered to the respiratory treatment components to reduce power delivered to the respiratory treatment components.
17. The one or more hardware processors further comprising: executing a climate control algorithm that determines setpoints for the respiratory therapy components; 17. The respiratory treatment device of claim 16, further configured to generate the control signal based on the climate control algorithm.