Respiratory therapy device and its components with removable connection module
By designing a respiratory therapy device with removable connection modules and modular components, the shortcomings of existing devices in terms of comfort, cost, and ease of use are addressed, resulting in higher compliance and system flexibility, optimized patient interface and data management, and improved overall respiratory therapy effectiveness.
Patent Information
- Application Number
- CN202080095843.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-12-24
- Filing Date
- 2020-12-22
- Publication Date
- 2025-10-31
- Estimated Expiration
- 2040-12-22
AI Technical Summary
Existing respiratory therapy devices and systems are inadequate in terms of comfort, cost, efficiency, ease of use, and manufacturability. In particular, the design of patient interfaces and connection modules leads to poor compliance, and data management and ventilation technologies are noisy and inconvenient.
A respiratory therapy device and system has been designed, employing removable connection modules and modular components, including a pressure generator, housing, and electrical connectors, supporting multiple connection methods. It combines a portable humidifier and data management, and optimizes the design of the patient interface to improve comfort and compliance.
It improves the comfort and compliance of respiratory therapy devices, reduces costs and complexity, enhances the ease of use and manufacturability of the system, and supports the flexible application of multiple treatment modalities.
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Figure CN115088137B_ABST
Abstract
Description
[0001] 1. Cross-references to related applications
[0002] not applicable 2 Background Technology 2.1 Technical Field
[0005] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. This technology further relates to respiratory therapy devices or equipment having removable connection modules and components.
[0006] 2.2 Description of related technologies
[0007] 2.2.1 Human Respiratory System and Its Diseases
[0008] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.
[0009] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.
[0010] There are a range of respiratory diseases. Some diseases can be characterized by specific events, such as sleep apnea, hypoventilation, and hyperventilation.
[0011] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.
[0012] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It is caused by a combination of abnormally small loss of normal upper airway and muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. The syndrome is common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).
[0013] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is an impairment of the patient's respiratory control, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR can be harmful due to repetitive hypoxia. In some patients, CSR is associated with recurrent awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).
[0014] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can cover some or all of the following conditions.
[0015] Patients with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.
[0016] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.
[0017] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased air resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.
[0018] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive diseases: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive diseases: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.
[0019] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.
[0020] A range of treatments have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these treatments to prevent respiratory distress. However, these methods have many drawbacks.
[0021] 2.2.2 Treatment
[0022] Various respiratory therapies, such as continuous positive airway pressure (CPAP), noninvasive ventilation (NIV), invasive ventilation (IV), high-flow therapy (HFT), and long-term oxygen therapy (LTOT), have been used to treat one or more of the above-mentioned respiratory disorders.
[0023] 2.2.2.1 Respiratory pressure therapy
[0024] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic brachial tubes).
[0025] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.
[0026] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to assist breathing and / or maintain adequate oxygen levels by performing some or all of the work of breathing. Ventilation support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure forms such as OHS, COPD, NMD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.
[0027] Non-invasive ventilation (IV) provides ventilation support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.
[0028] 2.2.2.2 Flow Therapy
[0029] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed volume of air by delivering an inspiratory flow distribution (potentially superimposed on a positive baseline pressure) over a target duration. In others, the interface to the patient's airway is "open" (unsealed) and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains substantially constant throughout the respiratory cycle. The therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or removing exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include increased warmth and humidification (which may be beneficial for secretion management) and the possibility of a moderate increase in airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies with respiratory cycles.
[0030] Another form of mobile therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched gas to the patient's airway at a specific oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air) and at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).
[0031] 2.2.2.3 Supplementing oxygen
[0032] For some patients, oxygen therapy can be combined with respiratory pressure therapy (RPT) or high-pressure airflow (HFT) by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.
[0033] 2.2.3 Respiratory Therapy System
[0034] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.
[0035] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.
[0036] Another type of treatment system is the mandibular repositioning device.
[0037] 2.2.3.1 Patient Interface
[0038] Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway. For flow treatments such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.
[0039] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving can be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.
[0040] Certain masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow it through the mouth.
[0041] If patients need to insert part of the mask structure into their mouths to create and maintain a seal through their lips, some masks may be uncomfortable or impractical for this technique.
[0042] Some face masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.
[0043] While masks designed for other applications (such as navigators) may not be suitable for treating sleep-disordered breathing, masks designed for treating sleep-disordered breathing may be suitable for other applications.
[0044] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep, NIV, or IV.
[0045] 2.2.3.1.1 Sealing Formation Structure
[0046] The patient interface may include a seal-forming structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface.
[0047] Patient interfaces can be characterized in part by their design intent to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element that surrounds both nostrils during use. This single element may be designed, for example, to cover the supralipal and nasal bridge regions of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both the nostrils and mouth regions during use. These different types of patient interfaces may be known by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.
[0048] 2.2.3.1.2 Positioning and Stability
[0049] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of air pressure, which can disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain a sealing relationship with the appropriate part of the face.
[0050] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.
[0051] Another technique involves using one or more straps and / or stabilizing shoulder straps. Many such shoulder straps suffer from one or more problems of being unsuitable, bulky, uncomfortable, and inconvenient to use.
[0052] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device
[0053] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.
[0054] Pneumatic generators are known in a variety of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.
[0055] One example of a specific requirement for certain RPT devices is noise.
[0056] A table showing the noise output levels of an existing RPT device (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).
[0057] RPT device name A-weighted sound pressure level dB(A) Year (approximately) <![CDATA[C-Series Tango TM ]]> 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010
[0058] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar ventilator for adults and children, are also mentioned. TM This series can provide invasive and non-invasive, non-dependent ventilation support for a range of patients, treating various conditions such as, but not limited to, NMD, OHS, and COPD. Other examples of ventilators include the ResMedLumis non-invasive ventilator. TM ResMed Astral series and life support ventilators TM series.
[0059] ResMed Elisée after treatment TM 150 ventilators and treated ResMed VS III TM Ventilators provide invasive and non-invasive dependent ventilation support for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single-limb or dual-limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.
[0060] The designer of the device is presented with an infinite number of options to make. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute, subtle changes in one or more parameters.
[0061] 2.2.3.3 Air Circuit
[0062] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiratory and expiratory breathing. In other cases, a single branch air circuit is used for both inspiratory and expiratory breathing.
[0063] 2.2.3.4 Humidifier
[0064] Delivering airflow without humidification can lead to airway dryness. The use of humidifiers with an RPT device and patient interface produces humidified gas that minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air. Therefore, humidifiers typically have the ability to both heat and humidify the airflow.
[0065] Many artificial humidification devices and systems are known; however, they do not meet the specific requirements of medical humidifiers.
[0066] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air, typically in areas where patients sleep or rest (e.g., in hospitals). Medical humidifiers intended for bedside placement can be small. They can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort for the occupant. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers.
[0067] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification; some are difficult or inconvenient for patients to use.
[0068] 2.2.3.5 Oxygen Source
[0069] Experts in this field have recognized the long-term benefits of exercise for patients with respiratory failure, slowing disease progression, improving quality of life, and extending lifespan. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Consequently, the need for mobility has long been recognized. Until recently, this mobility was facilitated by the use of small compressed oxygen cylinders or tanks mounted on vehicles with trolley wheels. The disadvantages of these cylinders are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.
[0070] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and bulky, making ordinary mobile operations difficult and impractical. Recently, companies that manufacture large, stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. To make these devices highly mobile, various systems used to produce oxygen-enriched gas need to be condensed. POCs seek to utilize the oxygen they produce as efficiently as possible, minimizing weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses, or “boli,” with each dose (bolus) timed to coincide with the start of inspiration. This mode of treatment is called pulsed or on-demand (oxygen) delivery (POD), in contrast to the traditional continuous flow delivery more suited to stationary oxygen concentrators.
[0071] 2.2.3.6 Data Management
[0072] There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy has been "adherent," such as the patient having used their RPT device according to one or more "adherence rules." An example of an adherence rule for CPAP therapy is that, in order to be considered adherent, a patient is required to use the RPT device for at least 4 hours per night for at least 21 days out of a 30-day period. To determine patient adherence, the RPT device provider (e.g., a healthcare provider) may manually obtain data describing the patient's treatment using the RPT device, calculate usage over a predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can notify a third party that the patient is adherent.
[0073] There may be other aspects of patient treatment that would benefit from communication of treatment data to third-party or external systems.
[0074] Existing processes for communicating and managing such data can be expensive, time-consuming, and error-prone.
[0075] 2.2.3.7 Ventilation technology
[0076] Some forms of therapeutic systems may include vents to allow for the flushing of exhaled carbon dioxide. Vents can allow gas to flow from the internal space of the patient interface, such as an inflation chamber, to the outside of the patient interface, such as the surrounding environment.
[0077] The vent may include an opening through which gas can flow during the use of the mask. Many such vents are noisy. Others may become clogged during use and therefore provide insufficient flushing. Some vents may, for example, disrupt the sleep of the patient's bed partner by causing noise or concentrated airflow.
[0078] ResMed Limited has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.
[0079] 2.2.4 Screening, Diagnosis and Monitoring System
[0080] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves a clinical specialist in its application. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of clinical observation: one night for pure diagnosis and the second night for a clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.
[0081] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically yields a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.
[0082] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may not be available or may not be able to afford them. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. 3. Summary of the Invention
[0084] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.
[0085] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.
[0086] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.
[0087] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.
[0088] One aspect of this technology is to provide a device or system for providing respiratory therapy, the device or system including one or more removable connection modules, each removable connection module configured to establish an electrical and / or mechanical connection with one or more other systems or devices. The device or system may include a connector assembly, and each removable connection module may be configured to connect to the connector assembly. The connection modules can be interchanged according to the desired connection for a specific application of the device or system.
[0089] One aspect of this technology is to provide a removable connection module for a respiratory therapy device.
[0090] One aspect of this technology is a device for supplying a breathable airflow under positive pressure for respiratory therapy, the device comprising:
[0091] A pressure generator for generating the breathable airflow and supplying the breathable airflow to an outlet;
[0092] Housing, which at least includes the pressure generator; and
[0093] At least one electrical connector,
[0094] The housing includes a cavity configured to receive a removable connection module, and
[0095] The at least one of the electrical connectors is configured to be connected to the connection module during use.
[0096] In the example, the cavity can be located at the rear of the housing.
[0097] In the example, the cavity may include index features to ensure that the connecting module can only be inserted into the cavity in a single orientation.
[0098] In the example, the index feature could be the chamfer of the cavity.
[0099] In the example, the device may further include at least one attachment mechanism configured to selectively secure the connection module at least partially within the cavity.
[0100] In the example, the attachment mechanism may include one or more of a clip, fastener, protrusion, aperture, or magnet.
[0101] In the example, the device may further include a connector assembly, which is secured to the housing. In the example, a cavity may be provided within the connector assembly. In the example, the connection module may be configured to connect to the connector assembly during use.
[0102] In the example, the connector assembly may include at least one power connector.
[0103] In the example, the cavity may include a slot configured to receive an interface connector.
[0104] In the example, the interface connector can pass through the slot and connect to at least one electrical connector.
[0105] In the example, the cavity can have a depth between approximately 15 mm and approximately 35 mm. For example, between approximately 20 mm and approximately 30 mm. For example, approximately 25 mm.
[0106] In the example, the cavity may have a height between approximately 50 mm and approximately 80 mm. For example, between approximately 60 mm and approximately 70 mm. For example, approximately 65 mm.
[0107] In the example, the cavity can have a width between approximately 75 mm and approximately 100 mm. For example, between approximately 85 mm and approximately 95 mm. For example, approximately 90 mm.
[0108] In the example, the device may include a protective cover configured to cover at least one electrical connector during use.
[0109] Another aspect of this technology is to provide a connection module for use in a respiratory therapy device, the connection module comprising:
[0110] The housing includes a front side and a rear side; and
[0111] At least one electrical connector on the front side and at least one electrical connector on the rear side;
[0112] The housing is configured to be at least partially inserted into the cavity of the respiratory therapy device during use, and
[0113] The at least one electrical connector on the rear side is configured for connection to at least one complementary electrical connector on the respiratory therapy device.
[0114] In the example, the connection module may further include at least one attachment mechanism to secure the connection module at least partially within the cavity of the RPT device during use.
[0115] In the example, the at least one attachment mechanism may include at least one of the following: a clamp, a fastener, a protrusion, an aperture, or a magnet.
[0116] In the example, the connecting module may further include an index feature configured to ensure that the connecting module can only be inserted into the cavity in a single orientation.
[0117] In the example, the index feature can be a chamfer.
[0118] In the example, the at least one electrical connector on the front side may include at least one of the following: a USB connector, a D-type miniature connector, an Ethernet connector, an SpO2 sensor connector, and / or a remote alarm connector.
[0119] In the example, the connection module may further include a protective cover configured to selectively cover at least one electrical connector on the front side.
[0120] In the example, the housing may include an outer shell and a back panel.
[0121] In the example, the outer shell can be ultrasonically welded to the backplate.
[0122] In the example, at least one connector on the rear side may include an edge contact.
[0123] In the example, the connection module may further include an electronic printed circuit board (PCB).
[0124] In the example, the electronic PCB may include an output device in the form of a light-emitting diode.
[0125] In the example, the electronic PCB may include one or more identification components that enable the RPT device to detect and / or identify the connection module.
[0126] In the example, the connecting module may have a thickness between approximately 15 mm and approximately 35 mm. For example, between approximately 20 mm and approximately 30 mm. For example, approximately 25 mm.
[0127] In the example, the connecting module may have a height between approximately 50mm and approximately 80mm. For example, between approximately 60mm and approximately 70mm. For example, approximately 65mm.
[0128] In the example, the connecting module may have a width between approximately 75mm and approximately 100mm. For example, between approximately 85mm and approximately 95mm. For example, approximately 90mm.
[0129] Another aspect of this technology is a system for providing respiratory therapy, comprising:
[0130] The device as described herein; and
[0131] As described in this article, at least one of the connection modules.
[0132] In the example, the connection module is a first connection module, and the system further includes a second connection module as described herein, wherein the first connection module and the second connection module are interchangeably connected to the device, and wherein the first connection module includes a first set of electrical connectors, and the second connection module includes a second set of electrical connectors. The first set of electrical connectors is different from the second set of electrical connectors.
[0133] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.
[0134] One aspect of this technology is a method for manufacturing equipment.
[0135] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.
[0136] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., in a person's home).
[0137] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier canister that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment.
[0138] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.
[0139] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.
[0140] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions
[0142] The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including:
[0143] 4.1 Respiratory Therapy System
[0144] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine position.
[0145] Figure 1BA system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.
[0146] Figure 2 A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.
[0147] 4.2 Patient Interface
[0148] Figure 3 A patient interface in the form of a nasal mask according to the present technology is shown.
[0149] 4.3 RPT device
[0150] Figure 4A An RPT device of one form according to the present technology is shown.
[0151] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.
[0152] Figure 4C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.
[0153] 4.4 Humidifier
[0154] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.
[0155] Figure 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.
[0156] Figure 5C A schematic diagram of one type of humidifier according to the present technology is shown.
[0157] 4.5 Connection
[0158] Figure 6AAn RPT device of one form according to the present technology is shown.
[0159] Figure 6B It shows Figure 6A End view of the RPT device.
[0160] Figure 6C It shows Figure 6A and Figure 6B Another end view of the RPT device.
[0161] Figure 7A One form of connection module according to this technology is shown.
[0162] Figure 7B An RPT device including a connection module is shown in one form according to the present technology.
[0163] Figure 7C The removal of the connection module is shown. Figure 7A The RPT device.
[0164] Figure 7D The diagram shows the module without a connection. Figures 7A-7C The RPT device.
[0165] Figure 8A An exploded view of one form of connection module according to the present technology is shown.
[0166] Figure 8B It shows that according to Figure 8A Another exploded view of the connection module.
[0167] Figure 8C It shows Figure 8A and Figure 8B A partial sectional view of the connection module.
[0168] Figure 8D It shows Figures 8A-8C An assembly view of the connection module.
[0169] Figure 9 This is a partial cross-sectional view of another connection module according to another form of this technology.
[0170] Figure 10 A portion of one form of RPT device according to the present technology is shown.
[0171] Figure 11A A portion of one form of RPT device according to the present technology is shown.
[0172] Figure 11B A portion of another form of RPT device according to this technology is shown.
[0173] Figure 11CA portion of another form of RPT device according to this technology is shown.
[0174] Figure 11D A portion of another form of RPT device according to this technology is shown.
[0175] Figure 11E A portion of another form of RPT device according to this technology is shown.
[0176] Figure 12A A connector assembly in one form according to the present technology is shown.
[0177] Figure 12B It shows Figure 12A Rear view of the connector assembly.
[0178] Figure 12C It shows Figure 12A and Figure 12B A partial side view of the connector assembly.
[0179] 4.6 Screening, Diagnosis and Monitoring System
[0180] Figure 13 The patient undergoing polysomnography (PSG) is shown. The patient was sleeping in a supine position. 5. Detailed Implementation
[0182] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.
[0183] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.
[0184] 5.1 Treatment
[0185] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.
[0186] In some examples of this technique, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.
[0187] In some examples of this technique, mouth breathing is limited, restricted, or prevented.
[0188] 5.2 Respiratory Therapy System
[0189] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.
[0190] 5.3 Patient Interface
[0191] According to one aspect of the present technology, a noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.
[0192] The unsealed patient interface 3800 in the form of a nasal cannula includes nasal inserts 3810a and 3810b, which deliver air to the individual nostrils of a patient 1000 via corresponding orifices in their tips. These nasal inserts typically do not form a seal with the inner or outer skin surface of the nostril. Air can be delivered to the nasal inserts via one or more air supply lumens 3820a and 3820b coupled to the nasal cannula 3800. The lumens 3820a and 3820b extend from the nasal cannula 3800 to a respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. A “vent” at the unsealed patient interface 3800 is a passage between the ends of the inserts 3810a and 3810b of the cannula 3800 through the patient’s nostrils to the atmosphere; excess airflow escapes into the surrounding environment through this vent.
[0193] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.
[0194] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to the environment.
[0195] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cmH2O relative to the environment.
[0196] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cmH2O relative to the environment.
[0197] 5.4 RPT device
[0198] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, for example for treating one or more respiratory conditions described elsewhere in this document.
[0199] In one embodiment, the RPT device 4000 is constructed and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.
[0200] The RPT device may have an outer housing 4010, which is formed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.
[0201] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.
[0202] One or more air path items may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of chassis 4016.
[0203] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.
[0204] 5.4.1 Mechanical & Pneumatic Components of RPT Unit
[0205] An RPT device may include one or more of the following components in a single unit. Alternatively, one or more of the following components may be positioned as respective independent units.
[0206] 5.4.1.1 Air Filter
[0207] One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.
[0208] In one configuration, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.
[0209] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.
[0210] 5.4.1.2 Muffler
[0211] One form of RPT device according to the present technology may include one or more mufflers 4120.
[0212] In one embodiment of this technology, the inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.
[0213] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.
[0214] 5.4.1.3 Pressure Generator
[0215] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.
[0216] The pressure generator 4140 is under the control of the treatment device controller 4240.
[0217] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.
[0218] 5.4.1.4 Converter
[0219] The transducer can be located inside or outside the RPT device. An external transducer can be situated on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits data or transfers it to the RPT device.
[0220] In one form of this technology, one or more converters 4270 are located upstream and / or downstream of pressure generator 4140. The one or more converters 4270 may be configured and arranged to generate a signal representing the characteristics (e.g., flow rate, pressure, or temperature) of the airflow at that point in the pneumatic path.
[0221] In one form of this technology, one or more converters 4270 may be located near the patient interface 3000 or 3800.
[0222] In one configuration, the signal from converter 4270 can be filtered, such as by low-pass, high-pass, or band-pass filtering.
[0223] 5.4.1.4.1 Flow Sensor
[0224] The flow sensor 4274 according to this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.
[0225] In one configuration, the signal generated by the flow sensor 4274 and representing the flow rate is received by the central controller 4230.
[0226] 5.4.1.4.2 Pressure Sensor
[0227] The pressure sensor 4272 according to this technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is the converter from the HONEYWELL ASDX series. Another suitable pressure sensor is the converter from the GENERALELECTRIC NPA series.
[0228] In one configuration, the signal generated by pressure sensor 4272 is received by central controller 4230.
[0229] 5.4.1.4.3 Motor Speed Converter
[0230] In one embodiment of this technology, a motor speed converter 4276 is used to determine the rotational speed of motor 4144 and / or blower 4142. The motor speed signal from the motor speed converter 4276 can be provided to the treatment device controller 4240. The motor speed converter 4276 can be, for example, a speed sensor, such as a Hall effect sensor.
[0231] 5.4.1.5 Anti-overflow valve
[0232] In one embodiment of this technology, an anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.
[0233] 5.4.2 Electrical components of RPT device
[0234] 5.4.2.1 Power Supply
[0235] The power supply 4210 can be located inside or outside the housing 4010 of the RPT device 4000.
[0236] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.
[0237] 5.4.2.2 Input Device
[0238] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical or software devices accessible via a touchscreen. The buttons, switches, or dials can be physically connected to the housing 4010 in one form, or wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.
[0239] In one form, the input device 4220 may be constructed and arranged to allow a person to select values and / or menu options.
[0240] 5.4.2.3 Central Controller
[0241] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.
[0242] Suitable processors may include x86 Intel processors, based on ARM Holdings' processors. The processor is a processor such as ST Microelectronics' STM32 series microcontrollers. In some alternative forms of this technology, a 32-bit RISC CPU (such as the ST Microelectronics STR9 series microcontrollers) or a 16-bit RISC CPU (such as the processor of the MSP430 series microcontrollers manufactured by Texas Instruments) may also be used.
[0243] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.
[0244] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.
[0245] The central controller 4230 can be configured to receive input signals from one or more converters 4270, one or more input devices 4220, and the humidifier 5000.
[0246] The central controller 4230 can be configured to provide output signals to one or more of the output device 4290, the treatment device controller 4240, the data communication interface 4280, and the humidifier 5000.
[0247] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as a computer program stored in a non-transient computer-readable storage medium (e.g., memory 4260). In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remotely located device. For example, a remotely located device may determine the control settings of the ventilator or detect respiratory-related events by analyzing stored data (e.g., from any sensors described herein).
[0248] 5.4.2.4 Clock
[0249] RPT device 4000 may include a clock 4232 connected to central controller 4230.
[0250] 5.4.2.5 Treatment device controller
[0251] In one form of this technology, the treatment device controller 4240 is a treatment control module 4330, which forms part of an algorithm 4300 executed by the central controller 4230.
[0252] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.
[0253] 5.4.2.6 Protection Circuit
[0254] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.
[0255] 5.4.2.7 Memory
[0256] According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.
[0257] The memory 4260 can be located on PCBA 4202. The memory 4260 can be in the form of EEPROM or NAND flash memory.
[0258] Additionally or optionally, the RPT device 4000 includes a removable memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.
[0259] In one form of this technology, memory 4260 acts as a non-transient computer-readable storage medium storing computer program instructions that represent one or more methods described herein, such as one or more algorithms 4300.
[0260] 5.4.2.8 Data Communication System
[0261] In one embodiment of this technology, a data communication interface 4280 is provided, which is connected to a central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.
[0262] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.
[0263] In one embodiment, the data communication interface 4280 may be located on the connection module 7000 described herein.
[0264] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).
[0265] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.
[0266] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers. In another 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 accessed by an appropriately authorized person, such as a clinician.
[0267] The local external device 4288 can be a personal computer, mobile phone, tablet or remote control device.
[0268] 5.4.2.9 Includes optional display and alarm output devices.
[0269] The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.
[0270] 5.4.2.9.1 Display Driver
[0271] Display driver 4292 receives characters, symbols, or images to be displayed on monitor 4294 as input and converts them into commands that cause monitor 4294 to display those characters, symbols, or images.
[0272] 5.4.2.9.2 Monitor
[0273] 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., figure “0”) into eight logic signals that indicate whether to activate eight corresponding segments to display a specific character or symbol.
[0274] 5.4.3 RPT device algorithm
[0275] As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as a computer program stored in a non-transient computer-readable storage medium (e.g., memory 4260). The algorithms 4300 are generally grouped into groups called modules.
[0276] In other forms of this technology, some or all of the algorithm 4300 may be implemented by the controller of an external device, such as a local external device 4288 or a remote external device 4286. In this form, the input signals and / or intermediate algorithm outputs required to represent the portion of the algorithm 4300 to be executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In this form, the portion of the algorithm 4300 to be executed at the external device may be represented as a computer program stored in a non-transient computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute portions of the algorithm 4300.
[0277] In this configuration, treatment parameters generated by an external device via the treatment engine module 4320 (if thus forming part of the algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 for transfer to the treatment control module 4330.
[0278] 5.5 Air Circuit
[0279] According to one aspect of the art, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow between two components, such as the RPT device 4000 and the patient interface 3000 or 3800.
[0280] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be referred to as an air delivery tube. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.
[0281] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around an axis of the air circuit 4170. The heating element may be communicated with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.
[0282] 5.5.1 Supplemental Gas Delivery
[0283] In one form of this technology, supplemental gas (e.g., oxygen) 4180 is delivered to one or more points in the pneumatic path, such as upstream of pneumatic block 4020, to air circuit 4170 and / or patient interface 3000.
[0284] 5.6 Humidifier
[0285] 5.6.1 Overview of Humidifiers
[0286] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.
[0287] The humidifier 5000 may include a humidifier reservoir 5110, an inlet 5002 for receiving an airflow, and an outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be inlet 5002 and outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.
[0288] 5.6.2 Humidifier Components
[0289] 5.6.2.1 Water Storage Tank
[0290] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night's sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.
[0291] According to one aspect, the water reservoir 5110 is configured to increase the humidity of an airflow from the RPT device 4000 as airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow's travel in a curved path through the reservoir 5110 while in contact with the water volume therein.
[0292] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.
[0293] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any hole and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.
[0294] 5.6.2.2 Conductive Component
[0295] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.
[0296] 5.6.2.3 Humidifier storage base
[0297] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5BAs shown, it is configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include locking features, such as a locking lever 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.
[0298] 5.6.2.4 Water level indicator
[0299] The humidifier storage unit 5110 may include, for example: Figures 5A-5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as a patient 1000 or a caregiver) with one or more indications regarding 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 the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.
[0300] 5.6.2.5 Humidifier Converter
[0301] The humidifier 5000 may include one or more humidifier converters (sensors) 5210, other than or in addition to the converter 4270 described above. For example... Figure 5C As shown, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that can communicate with a controller, such as a central controller 4230 and / or a humidifier controller 5250. In some forms, the humidifier converter may be located external to the humidifier 5000 (e.g., in the air circuit 4170) when communicating the output signal to the controller.
[0302] 5.6.2.5.1 Pressure Transmitter
[0303] In addition to, or in place of, the pressure sensor 4272 provided in the RPT device 4000, one or more pressure converters 5212 may be provided to the humidifier 5000.
[0304] 5.6.2.5.2 Air Flow Converter
[0305] In addition to, or in place of, the flow sensor 4274 provided in the RPT device 4000, one or more flow converters 5214 may be provided to the humidifier 5000.
[0306] 5.6.2.5.3 Temperature Converter
[0307] The humidifier 5000 may include one or more temperature transducers 5216. These temperature transducers 5216 may be configured to measure one or more temperatures of, for example, the airflow downstream of the heating element 5240 and / or outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 to detect the temperature of the ambient air.
[0308] 5.6.2.5.4 Humidity Converter
[0309] In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 to detect the humidity of a gas (e.g., ambient air). The humidity sensors 5218 may be positioned toward the outlet 5004 in some manner to measure the humidity of the gas supplied from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors.
[0310] 5.6.2.6 Heating element
[0311] In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more volumes of water and / or airflow in the humidifier reservoir 5110. The heating element 5240 may include a heating component, such as a resistance-heated rail. A suitable example of the heating element 5240 is a layered heating element, such as that described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.
[0312] In some configurations, the heating element 5240 may be housed in the humidifier base 5006, where heat can be supplied primarily to the humidifier reservoir 5110 via conduction, such as... Figure 5B As shown.
[0313] 5.6.2.7 Humidifier Controller
[0314] According to the arrangement of this technology, the humidifier 5000 may include, for example: Figure 5C The humidifier controller 5250 is shown. In one form, the humidifier controller 5250 may be part of a central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230.
[0315] In one embodiment, the humidifier controller 5250 may receive measurements as inputs of characteristics of air and water flow (such as temperature, humidity, pressure, and / or flow rate) in, for example, the storage tank 5110 and / or the humidifier 5000. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.
[0316] like Figure 5C As shown, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.
[0317] 5.7 Connection
[0318] 5.7.1 Overview
[0319] According to one embodiment of the present technology, an RPT device 4000 is provided. Figure 6A , Figure 6B and Figure 6C In the example, the RPT device 4000 includes an outer housing 4010 containing a pressure generator 4140 (not shown) for generating a positive-pressure breathable airflow. For example, the pressure generator 4140 may be a controllable blower. The RPT device 4000 is provided with an inlet 5002 for receiving the airflow and an outlet 5004 for delivering the airflow to a patient to treat a respiratory disorder using one or more respiratory therapies described herein.
[0320] Figure 6B and Figure 6C It shows Figure 6A An end view of the RPT device 4000. Of particular note is the electrical connector 6002 provided to the RPT device 4000.
[0321] Electrical connector 6002 may include communication connector 6004, power connector 6006, or any combination of these connectors, wherein communication connector 6004 facilitates the transmission of information to or from the device, power connector 6006 facilitates the transmission of power to or from the device, and these connectors include hybrid connectors that facilitate power and data transmission. A button 6008 is also provided to allow the device to be powered on and off.
[0322] exist Figures 6A-6C In the example, the RPT device 4000 includes an Ethernet connector 6014, a USB-A connector 6016, a micro USB connector 6018, an SpO2 sensor connector 6020, and a five-pin remote alarm connector 6022. Each of these connectors is arranged as a group optionally protected by a protective cover 6010. The power connector 6006, button 6008, and LFO2 (low-flow oxygen input) are positioned not to be covered by the protective cover 6010; however, this should not be considered a limitation of the technology, and in other forms, these components may be covered by the protective cover 6010.
[0323] 5.7.1.1 Communication Connector
[0324] In the technical form of the RPT device 4000 that includes communication connectors, it should be understood that these connectors may include any suitable connectors known in the art. For example, the communication connector may include one or more electrical connectors, such as D-type miniature connectors (e.g., DB-9 or DE-9), USB connectors (e.g., USB Type A, B, or C connectors), Ethernet connectors (e.g., RJ-45 connectors), or any suitable communication connector.
[0325] It should be understood that the communication connector facilitates the transmission of information to or from the RPT device 4000 using any suitable communication protocol. For example, it can be used via RS-232, RS-485, SPI, I... 2 Information can be transmitted using C, USB, CAN bus, Ethernet, or any other suitable communication protocol (including proprietary protocols).
[0326] The communication connector allows the RPT device 4000 to communicate with one or more peripheral devices such as a computer, data recording device, other RPT devices 4000, humidifier 5000, smartphone, or tablet computer. In some forms of this technology, the communication connector provides a means for storing and accessing data on demand. For example, a USB connector allows files to be transferred to or from a device as needed without needing to be connected to a computer, smartphone, or tablet computer; that is, a USB connector allows files to be transferred to or from a removable storage device.
[0327] Communication connectors can be used to facilitate the transmission of data in any form. For example, data may include software update data, usage information (e.g., information about the use of the device), real-time information (e.g., treatment pressure, humidity, leakage information, forensic and / or diagnostic information (e.g., for troubleshooting or checking the health status of device 4000)), and audio or video data for providing information or alarms to the user via an external display or speaker. Furthermore, communication connectors facilitate the transmission of information during the manufacture or repair of device 4000. For example, data can be transmitted during device testing and / or during the programming or configuration of device 4000 components.
[0328] Furthermore, while the foregoing examples are described as communication connectors, this should not be considered a limitation of the technology. For example, one or more communication connectors may additionally include a power connection for supplying or receiving power from the RPT device 4000. For example, an Ethernet connection may include a Power over Ethernet (PoE) connection.
[0329] 5.7.1.2 Power Connector
[0330] In the technical form where the RPT device 4000 includes at least one power connector, it should be understood that this can include any suitable connector known in the art. For example, the power connector can include one or more electrical connectors, such as DC connectors in the form of barrel jacks, screw terminals, banana plug connections, or crimp-fit connectors. Alternatively or additionally, the RPT device 4000 can include an AC power connector, such as IEC or NEMA standard power connectors known to those skilled in the art (e.g., IEC 320C13 / C14 / C7 or NEMA 5-15-P / 1-15-P).
[0331] In this technology, a power connection can be provided as part of a communication connector. For example, as those skilled in the art will understand, power can be provided via a USB or Ethernet connection.
[0332] 5.7.1.3 Mechanical Connectors
[0333] In this technological form, the RPT device 4000 may include one or more mechanical connectors configured to mechanically connect the RPT device 4000 to another component or system, such as an air or oxygen connector. Figures 6A-6C The example provided is the low-flow oxygen connector (LFO2) 6024.
[0334] 5.7.1.4 Protective Cover
[0335] exist Figure 6B In this configuration, some electrical connectors 6002 are covered by protective covers 6010, which are designed to protect the electrical connectors 6002 when they are not in use. For example, protective covers 6010 can prevent or limit the entry of dust, dirt, or water into the electrical connectors 6002. By covering one or more of a plurality of electrical connectors 6002 with protective covers 6010, one or more electrical connectors 6002 can be in use while one or more unused connectors are covered by the protective covers. For example, one or more communication connectors can be covered by protective covers 6010, while one or more power connectors are left uncovered and available for use.
[0336] Figure 6BThe protective cover 6010 shown is pivotally connected to the housing 4010 of the RPT device 4000 via at least one hinge 6012, such as the two hinges shown. The hinge 6012 shown is formed of an elastic material such as an elastomer or polymer; however, any suitable hinge 6012 construction can be used. In one form of this technology, the protective cover 6010 and / or the hinge 6012 are formed during the molding process of at least a portion of the housing 4010, i.e., the protective cover 6010 or the hinge 6012 is integral with or has an integral construction with at least a portion of the housing 4010.
[0337] In this form of the technology, the protective cover 6010 may be omitted, and the electrical connector 6002 may be exposed. In other forms of the technology, alternative protective covers 6010 may be used. For example, the protective cover 6010 may be configured to clamp, thread, press-fit, or otherwise engage with the housing 4010 using alternative methods known to those skilled in the art. In other forms of the technology, the protective cover 6010 may not engage with the housing 4010, but may be directly supported by one or more electrical connectors 6002. For example, the protective cover 6010 may include one or more protrusions that engage with one or more electrical connectors 6002 to support the protective cover 6010.
[0338] 5.7.2 Connector Assembly
[0339] According to one or more forms of the present technology, it may be advantageous to provide one or more electrical connectors 6002 as part of connector assembly 6030. For example, electrical connector 6002 may be attached to a common support member or section of housing 4010, as will be described herein.
[0340] Connector assembly 6030 may include a plurality of electrical connectors 6002 that are mounted to or otherwise positioned within a common section of housing 4010. For example, electrical connectors 6002 may include panel mount connectors that are attached to housing 4010 by passing through and engaging apertures in housing 4010. Alternatively, these panel mount connectors may include one or more fasteners (e.g., nuts) that can be fastened to an outer or inner surface of housing 4010 to secure the connectors to housing 4010. Connector assembly 6030 may therefore include a section of housing 4010 along with one or more electrical connectors 6002.
[0341] Electrical connector 6002 may also include PCB (printed circuit board) mounted connectors. In some forms of this technology, these PCB mounted connectors may be exposed through orifices in housing 4010 without directly contacting or engaging housing 4010. In other forms of this technology, PCB mounted connectors may pass through and engage with orifices in housing 4010. For example, the connector may have a friction-fit engagement with the housing. In other forms, the connector may include sealing structures, such as flanges, O-rings, or seals, that engage with housing 4010 to provide access protection. In yet another form of this technology, housing 4010 may include sealing features, such as a flexible material (e.g., a molded polymer or elastomer overlaid) area that engages with one or more electrical connectors 6002 to provide access protection. Therefore, connector assembly 6030 may include a printed circuit board and one or more electrical connectors 6002.
[0342] In another form, electrical connector 6002 may include cable mount connectors. These cable mount connectors may be attached to housing 4010 by means of washers or other suitable mounting or strain relief features that should be known to those skilled in the art.
[0343] In yet another form, one or more electrical connectors 6002 may be panel-mounted, PCB-mounted, and / or cable-mounted.
[0344] It may be advantageous for a segment of housing 4010 containing one or more electrical connectors 6002 (i.e., connector assembly 6030) to be formed separately from the rest of housing 4010, meaning that connector assembly 6030 may include one or more electrical connectors together with the segment of housing 4010. It should be understood that while connector assembly 6030 may include a segment of housing 4010, this segment of housing may not be configured to be removed from RPT device 4000 during normal use. In other words, RPT device 4000 may include connector assembly 6030 that is secured to housing during use.
[0345] Providing one or more electrical connectors in connector assembly 6030 has many potential advantages. For example, the advantages may include:
[0346] • Simplifies the manufacture of the device; for example, the connector aperture in the connector assembly 6030 can be molded using a stretch line in the same molding direction as the connector assembly 6030, that is, the tools required to produce the device can be less complex, reducing costs, improving molding cycle time, improving part yield and the reliability of molding tools.
[0347] • Allows for streamlined assembly of the device; for example, connector assembly 6030 can be assembled and tested independently of the rest of RPT device 4000, thereby allowing for parallel manufacturing.
[0348] • Simplify the maintenance and replacement of connector 6030; for example, RPT device 4000 can be disassembled, connector assembly 6030 can be removed and replaced, and faulty units can be sent for repair, thereby minimizing the amount of time required for unit repair and reducing the level of expertise required by service personnel.
[0349] • Allows multiple product variants to be equipped with a common device housing 4010; for example, different connector assemblies 6030 can be replaced during manufacturing to produce different product variants according to market needs.
[0350] In one form of this technology, the connector assembly 6030 can be secured to the housing 4010 by engaging multiple portions of the connector assembly 6030 with multiple channels on the housing 4010. For example, when secured, the edges of the connector assembly 6030 may be located in recesses or channels in the housing 4010 of the RPT device 4000 in use. In other forms of this technology, the connector assembly 6030 can be fastened to the RPT device 4000, for example, by using one or more screws. In still other forms of this technology, the connector assembly 6030 can be joined to the housing 4010, for example, by using adhesives or welding techniques (such as ultrasonic welding).
[0351] 5.7.3 Connection Module
[0352] In addition to the advantages of providing connector assembly 6030 in RPT device 4000, one form of this technology relates to providing a modular, detachable connector assembly, referred to herein as connection module 7000. It should be understood that throughout this specification, referring to connection module 7000 as removable means that it can be removed from RPT device 4000 without disassembling or opening RPT device 4000. Connection module 7000 may be provided in addition to or in place of connector assembly 6030.
[0353] Figure 7A The diagram illustrates one form of a connection module 7000 according to the present technology. In this form, the connection module 7000 includes a housing 7002, which typically includes a front surface 7004, a rear surface 7006, a top surface 7008, a bottom surface 7010, and side surfaces 7012, 7014.
[0354] The front portion 7004 of the connection module includes one or more electrical connectors 6002 that are attached to and / or extend through an aperture 7016 in the front surface 7004.
[0355] The rear surface 7006 includes an interface connector 7018 (not shown) for electrically connecting the connection module 7000 to the RPT device 4000.
[0356] The sides 7012, 7014 of the housing 7002 include attachment mechanisms 7020 configured to secure the connection module 7000 to the RPT device 4000 in use. In the illustrated form, these attachment mechanisms 7020 are clips; however, this should not be considered a limitation of the technology, and alternative attachment mechanisms 7020 are provided in other forms of the technology. Furthermore, in other forms of the technology, the attachment mechanisms 7020 may be provided to another portion of the housing 7002, such as the rear surface 7006, the top surface 7008, and / or the bottom surface 7010.
[0357] The connection module 7000 also includes one or more index features 7022, such as chamfered features. The index features 7022 ensure that the connection module is attached to the RPT device 4000 in the correct orientation, as will be described in more detail herein.
[0358] Figures 7B-7D Examples of a connection module 7000 at various stages of connection with the RPT device 4000 are shown. In the illustrated form, the RPT device 4000 includes a cavity 7024 configured to receive the connection module 7000. The cavity 7024 is a space or recess in the outer surface of the RPT device 4000, in which the connection module 7000 or a portion thereof may be positioned. The cavity 7024 may be formed by changing the shape or orientation of the outer surface of the RPT device 4000, such as a recess in the outer surface or one or more gaps in the outer surface. Figures 7B-7D The cavity 7024 shown is provided at the rear of the RPT device 4000 (i.e., on the surface of the RPT device 4000 opposite to the user-facing side, for example, on the side where the user controls are provided). However, this should not be regarded as a limitation of the technology, and in other forms, the cavity may be in the top, bottom, front surface or side surface of the RPT device 4000.
[0359] In the illustrated form, cavity 7024 is disposed within connector assembly 6030, which includes at least one electrical connector 6002. However, this should not be considered a limitation of the technology, and in other forms, connection module 7000 may be configured to engage directly with cavity 7024 in housing, or otherwise attached to RPT device 4000 without engaging with or remaining within cavity 7024.
[0360] Positioning the connection module 7000 within the cavity 7024 in the connector assembly 6030 or the housing 4010 can be advantageous:
[0361] • A safer connection is provided between the connection module 7000 and the RPT device 4000. For example, positioning the connection module 7000 within the cavity 7024 provides greater protection against accidental disconnection due to impact or collision, especially during transport.
[0362] • By reducing or limiting the force applied to the interface connector 7018 when the RPT device 4000 or the cable connected to the electrical connector 6002 moves or twists, strain relief measures are provided on the interface connector 7018.
[0363] • Simplify the alignment of the interface connector 7018 between the connection module 7000 and the RPT device 4000, as the complementary shapes of the connection module and the housing can guide the alignment of the interface connector 7018.
[0364] • Greater access protection is provided by recessing the interface connector 7018 into the cavity 7024.
[0365] • This gives the RPT device 4000 a smooth and attractive appearance.
[0366] In this form of technology, the connection module 7000 can be fully positioned within the cavity 7024 in its connection configuration. For example, the connection module 7000 can be configured such that when received in the cavity 7024, the front surface 7004 of the connection module 7000 can be substantially aligned with or recessed from the outer surface of the housing 4010 or the connector assembly 6030.
[0367] In other forms of this technology, the connection module 7000 may be partially located within the cavity 7024. For example, the connection module 7000 may extend at least partially outward from the cavity 7024. For example, the connection module 7000 may extend outward from the cavity 7024 from about 5 mm to about 25 mm.
[0368] In other forms of this technology, the connection module 7000 can be directly connected to the connector assembly 6030 or housing 4010 of the RPT device 4000, without being located in a cavity.
[0369] In some forms of this technology, the cavity 7024 may be tilted downward relative to the RPT device 4000. For example, when the RPT device is located on a horizontal surface, the cavity may be tilted downward relative to the horizontal surface. Tilting the cavity downward can advantageously facilitate fluid discharge from the cavity, thereby improving inlet protection of the RPT device 4000.
[0370] like Figures 7A-7DAs shown, the connection module includes at least one electrical connector 6002. In the illustrated form, the connection module includes two 9-pin D miniature connectors 6015, a female USB-A connector 6016, an SpO2 (peripheral capillary oxygen saturation) sensor connector 6020, a FiO2 (fraction of inhaled oxygen) sensor connector 6017, and a remote alarm connector 6022. However, this should not be considered a limitation of the technology, and any number and arrangement of connectors can be used according to this technology.
[0371] In addition to the connectors provided on the connection module 7000, the connector assembly 6030 includes a power button 6008, a DC power connector 6006, a female USB-B connector 7023, and an LFO2 (low-flow oxygen) connector 6024. The advantages of providing separate connector assemblies on the removable connection module 7000 and the non-removable connector assembly 6030 include:
[0372] • The base or core group connector on connector assembly 6030 exists in several product variations, namely power connection 6006 and power button 6008.
[0373] • Connectors on the 7000 module that are not critical to any customer or product variant; for example, remote alarm monitoring, FiO2 or SpO2 sensor connections.
[0374] • Mechanical or pneumatic connection, such as LFO2 directly on connector assembly 6030, to simplify the interface connection 7018 between connection module 7000 and RPT device 4000 (i.e., no pneumatic connection is required).
[0375] 5.7.3.1 Attachment Mechanism
[0376] In technical forms including the removable connection module 7000, one or more attachment mechanisms 7020 may be provided to secure the connection module 7000 to the housing 4010, cavity 7024, or connector assembly 6030 of the device 4000. For the sake of simplicity, the foregoing examples describe mechanisms for attaching the connection module 7000 at least partially within the cavity 7024. However, this should not be construed as a limitation of the technology, and it should be understood that the aforementioned attachment mechanisms can be used to attach the connection module to any component of the RPT device 4000.
[0377] 5.7.3.1.1 Clip
[0378] According to one embodiment of the present technology, the attachment mechanism 7020 may include one or more clips 7026A, 7026B, such as Figures 7A-7DAs shown, in the illustrated configuration, a first clip 7026A is disposed on a first side 7012 of the connection module 7000, and a second clip 7026B is disposed on a second side 7014 of the connection module 7000. The first clip 7026A and the second clip 7026B are constructed and arranged to clip into suitable clip receiving portions of the RPT device 4000. The clips can be snap-fit connectors, press-fit connectors, or any suitable type of clip connector.
[0379] In the illustrated example, clips 7026A and 7026B extend outward from the front surface 7004 of the connection module 7000 to provide an extension that the user can engage during use. For example, the user can squeeze clips 7026A and 7026B inward toward each other to release the connection module 7000 from the RPT device 4000. Clips 7026A and 7026B may also include gripping portions or textured surfaces to further facilitate user engagement. However, this should not be considered a limitation of the technology, and in other forms of the technology, clips 7026A and 7026B may not include gripping portions or may extend beyond the connection module 7000. For example, the clips may extend along one or more sides of the connection module 7000 without extending beyond the front surface 7004 of the connection module 7000. In other forms of the technology, the clips may be disposed on a portion of the sidewall of the connection module. In some forms of the technology, it may be advantageous to provide a tool that facilitates the removal of the connection module 7000 from the RPT device. For example, a gasket can pass along the side of the connection module 7000 to release clips 7026A and 7026B from the cavity 7024. The tools required for removing the connection module 7000 can advantageously prevent tampering with the device in public environments, such as hospitals, sleep laboratories, or medical clinics.
[0380] In one embodiment of this technology, clips 7026A and 7026B may include one or more protrusions, indentations, or orifices (not shown) on their sides, which are configured to engage with corresponding protrusions, indentations, or orifices on the inner wall of cavity 7024 (not shown). In other embodiments of this technology, the clips may engage with the inner wall of the orifice via an interference fit or a friction fit.
[0381] Clips 7026A and 7026B can be resiliently attached to the connecting module 7000, such that the connecting module 7000 is inserted into the cavity 7024 and the clips are biased inward toward the connecting module 7000. This biasing can improve the engagement between the clips 7026A and 7026B and the inner wall of the cavity 7024 or its protrusions, indentations and / or orifices.
[0382] In use, in order to release the connecting module 7000 from the cavity 7024, the user can press the first clip 7026A and the second clip 7026B inward toward each other, thereby reducing the engagement force between the connecting module 7000 and the cavity 7024 or its protrusions, indentations and / or orifices.
[0383] It should be understood that although clips 7026A and 7026B are shown on the side of the connection module, in other forms of this technology, the clips may alternatively be provided on the top surface 7008 and / or the bottom surface 7010 of the connection module 7000. In yet another form, the clips may be provided on the RPT device 4000, for example, on the inner wall of the connector assembly 6030 or the cavity 7024, rather than on the connection module 7000. In yet another form of this technology, clips 7026A and 7026B may be provided on one side 7012 and 7014 of the connection module 7000, and the opposite sides 7012 and 7014 of the connection module 7000 may be secured to the cavity 7024 using any other attachment mechanism 7020 described herein.
[0384] 5.7.3.1.2 Fasteners
[0385] According to one form of the present technology, the connection module 7000 can be releasably attached to the cavity 7024 using one or more fasteners. For example, the connection module 7000 can be secured to the cavity 7024 using at least one screw or bolt, as per the description of the connection module 7000. Figures 8A-8D And 8E is described in more detail.
[0386] In one embodiment, the connecting module 7000 includes a screw or bolt, and the cavity 7024 includes threads configured to receive the screw or bolt. For example, the screw may be a wing screw, and the threads may be provided by a tightening nut, a threaded insert, or a threaded orifice. In other embodiments of the art, the cavity 7024 may include a screw or bolt extending through an orifice in the connecting module 7000. In this embodiment, securing the connecting module 7000 to the cavity 7024 can be achieved by engaging a nut or other threaded member with a screw or bolt to fasten the connecting module 7000 to the cavity 7024.
[0387] In one form of this technology, the fasteners may include wing screws, wing nuts, or other fasteners designed to be actuated without the use of tools. This can advantageously simplify the process of securing and / or removing the connection module 7000.
[0388] In another form, the fastener may include one or more security fasteners, such as tamper-proof screws sold under the Torx registered trademark. The use of security fasteners can advantageously prevent tampering with devices in public environments, such as hospitals, sleep laboratories, or medical clinics.
[0389] 5.7.3.1.3 Orifices and protrusions
[0390] According to one embodiment of the present technology, the connecting module 7000 can be attached to the cavity 7024 by engaging one or more orifices or indentations with one or more protrusions. In some embodiments, this can be a clip as described herein, i.e., the protrusion can be "clamped" into the orifice. However, in other embodiments, the protrusion can be a substantially rigid member that is inserted into the orifice during use.
[0391] For example, a protrusion may be provided on the first side of the connecting module 7000, which is configured to engage with an orifice on the inner wall of the cavity 7024 during use. In other examples, a cavity may be provided on the first side of the connecting module 7000, which is configured to engage with a protrusion on the inner wall of the cavity 7024 during use.
[0392] In some forms of this technology, the connection module can be configured such that, in order to connect it to the RPT device 4000, the user inserts a protrusion on the first side 7012 of the connection module 7000 into an orifice on the inner wall of the cavity 7024 before inserting the second side 7014 of the connection module 7000 into the cavity 7024. For example, the connection module 7000 may include a protrusion on the first side 7012 and a clip on the second side 7014 (or vice versa). In use, the user inserts the protrusion into the orifice on the first side of the cavity 7024, and then inserts the second side 7014 of the connection module 7000 into the orifice 7024 so that the clip engages with a corresponding indentation or orifice on the second side of the cavity 7024.
[0393] 5.7.3.1.4 Interface Connector
[0394] According to another embodiment of the present technology, the connection module 7000 can be connected to the cavity 7024 via an interface connector 7018. For example, retention of the connection module 7000 within the cavity 7024 can be provided by a locking or retaining feature on the interface connector 7018. Additionally or alternatively, the connection module 7000 can be retained in the cavity by friction provided by the interface connector 7018.
[0395] 5.7.3.1.5 Magnetic attraction
[0396] According to another form of this technology, the RPT device 4000 and the connection module 7000 may be provided with complementary magnetic components (not shown). Magnetic components mentioned in this specification should be understood to include ferromagnetic materials capable of magnetic attraction, as well as permanent and temporary magnets (including electromagnets).
[0397] For example, the connection module 7000 may be provided with a first magnetic component, and the RPT device 4000 may be provided with a second magnetic component. For example, the first magnetic component may be formed of a magnetic material such as steel or iron, while the second magnetic component may include a permanent magnet (such as neodymium or ceramic magnet), or vice versa.
[0398] In one form of this technology, the connection module 7000 is provided with a first magnetic member near a first side 7012 of the connection module 7000 and a second magnetic member near a second side 7014 of the connection module 7000. The first and second magnetic members can be positioned adjacent to the rear portion 7006 of the connection module. In this example, the RPT device 4000 includes a third and a fourth magnetic member, each magnetic member being positioned within or adjacent to the cavity 7024 such that when the connection module 7000 is inserted into the cavity 7024, the first magnetic member is attracted toward the third magnetic member, and the second magnetic member is attracted toward the fourth magnetic member, so as to retain the connection module 7000 at least partially within the cavity.
[0399] Using magnetic attraction to hold the connection module 7000 within the cavity 7024 has many advantages, including:
[0400] • Allows for a compact and inconspicuous attachment mechanism, especially when the magnetic attachment mechanism can be concealed within the housing 4010 of the RPT device 40000 and the connection module 7000, respectively.
[0401] • Improved access protection is provided because the attachment mechanism 7020 can be completely sealed within the housing 4010 of the RPT device 40000 and the connection module 7000, respectively.
[0402] • Provides tactile feedback to users to indicate correct attachment for quick, tool-free installation.
[0403] • Improved engagement between interface connectors 7018.
[0404] 5.7.3.1.6 Feedback Organization
[0405] In this technical form, the attachment mechanism can be configured to provide the user with affirmative audible, tactile, or sensory feedback that the connection module 7000 has been correctly inserted. This can be provided by the attachment mechanism 7020 itself, or by a feedback mechanism that should be known to those skilled in the art.
[0406] For example, when using magnetic attraction, the magnetic attraction can be very strong to quickly pull the connection module 7000 into engagement with the RPT device 4000. This rapid engagement when the connection module 7000 contacts the RPT device 4000 can provide an audible and / or tactile / haptic click.
[0407] In other forms of this technology, the connection of the interface connector 7018 can provide the user with auditory, tactile, or haptic feedback.
[0408] In another form of this technology, a tactile mechanism may be provided. For example, the inner wall of cavity 7024 may include indentations or protrusions configured to mate with corresponding indentations or protrusions in the outer surface of connection module 7000. During the insertion of connection module 7000 into cavity 7024, the engagement of the indentations and protrusions can provide the user with audible, tactile, or haptic feedback that the connection module has been correctly inserted.
[0409] In another form of this technology, feedback can be provided to the user via one or more audio or visual alarms from the RPT device 4000. For example, the RPT device can be configured to detect the connection of the connection module 7000 and generate a visual alarm using a display or light, or an audible alarm using a buzzer or speaker.
[0410] 5.7.3.1.7 combination
[0411] It should be understood that the aforementioned attachment mechanisms are not mutually exclusive, and in this art, one or more attachment mechanisms may be combined to attach the connection module 7000 to the RPT device 4000. For example, the RPT device 4000 and the connection module 7000 may include combinations of any of the following: clips, fasteners, orifices and protrusions, interface connectors, magnets, and / or feedback mechanisms.
[0412] 5.7.3.2 Structure
[0413] 5.7.3.2.1 Housing
[0414] According to one embodiment of the present technology, the connection module 7000 includes, as follows: Figure 8A and Figure 8B The multi-part housing 7002 is shown. In this example, the housing has a two-part structure consisting of an outer shell 7028 and a back panel 7030. However, this should not be considered a limitation of the technology, and in other forms, the housing 7002 can be formed in other ways. For example, in some forms, the housing 7002 may also include a two-part construction, but the side surfaces of the housing 7002 other than the back panel 7030 may be removable from the rest of the housing 7002; for example, the housing 7002 may include a removable front panel, side panel, or top panel. In other forms, the housing 7002 may include any number of separable parts, such as three, four, or more parts.
[0415] In use, the housing 7028 and the backplate 7030 are joined together to provide a compartment for accommodating the connector and the PCB 7032. The housing 7028 and the backplate 7030 can be joined together using any method known in the art, such as fasteners, clips, or adhesives.
[0416] In one form of this technology, it may be desirable to substantially seal the connecting module 7000 to prevent the ingress of water and dust. One way to achieve this is to provide a sealant on or around the mating surfaces of the housing 7028 and the backplate 7030. In other forms, a gasket or compression seal may be provided between the housing and the backplate, which is compressed during use to provide a seal. In other forms of this technology, the housing 7028 may be bonded to the backplate 7030, for example, by ultrasonic welding.
[0417] In other forms of this technology, it may be desirable to directly protect the electrical connector 6002 and PCB 7032. For example, PCB 7032 and / or the connector may be protected using a resilient, waterproof coating, such as a conformal coating or polyurethane or epoxy resin. It should be understood that this can be used in place of or to complement the previously discussed options for sealing the housing.
[0418] The connection module 7000 also includes an attachment mechanism 7020 in the form of fasteners. The fasteners are rotatably attached to a first side 7012 and a second side 7014 of the housing 7002 such that they do not pass through the sealed compartment containing the electrical connector 6002. For example, the housing 7002 may include one or more ribs 7036 on its outer surface. These ribs can be configured to receive and / or retain the fasteners 7020. This arrangement simplifies the sealing of the connection module 7000 because sealing around any moving parts is not required.
[0419] like Figure 8C As shown, housing 7002 may include one or more mounting features 7040 designed to support PCB 7032 in use. For example, in the form shown, mounting feature 7040 is a rib or protrusion formed in housing 7028 that provides a channel in which PCB 7032 can be located.
[0420] 5.7.3.2.2 Electronics
[0421] exist Figures 8A-8D In the example shown, electrical connector 6002 includes a combination of a panel mount connector and a PCB mount connector, with the panel mount connector shown as attached to the housing and the PCB mount connector mounted to PCB 7032. However, this should not be considered a limitation of the scope of the technology.
[0422] It is also evident in this example that the slot 7034 in the rear wall 7006 or backplate 7030 of housing 7002 is configured to receive interface connector 7018. In the form shown, interface connector 7018 includes edge contacts (also known as gold fingers). However, this should not be considered a limitation of the technology, and any suitable connector, including ribbon cable connectors, can be used. In yet another form of the technology, PCB 7032 may include one or more flexible PCB layers, and interface connector 7018 may be provided by extending one or more flexible PCB layers through the slot in rear surface 7006.
[0423] In this technological form, PCB 7032 may include electronic components. For example, PCB 7032 may include one or more of the following:
[0424] • Protective components, such as transient voltage suppressors;
[0425] • Filtering components, such as inductors, capacitors, and resistors;
[0426] • Communication components, such as bias resistors that keep communication lines in a known state;
[0427] • Isolation components, such as optical or inductive isolators;
[0428] • Processor, such as a microcontroller or microprocessor;
[0429] • Output devices such as LEDs, speakers, or buzzers can be provided on the connection module to indicate that it has been properly attached; and
[0430] For example, the identification component of the RPT device 4000 can communicate with the connection module 7000 to determine the type of the connection module 7000 to which it is connected (i.e., what connection has been provided).
[0431] In another embodiment of this technology, the connection module 7000 may be provided with components enabling it to communicate with, receive power from, or supply power to the RPT device 4000 without using the interface connector 7018. For example, the PCB 7032 may include components for implementing short-range wireless communication or power transfer. For example, in one embodiment, the connection module 7000 includes a wireless power transfer module configured to wirelessly transfer power to / from the RPT device 4000, for example, using inductive coupling. Alternatively or additionally, the connection module 7000 may include one or more wireless communication devices, such as Bluetooth or Wi-Fi modules, configured to transmit data to / from the RPT device 4000. The use of wireless communication and / or power transfer can advantageously allow for easier sealing of the connection module 7000.
[0432] Figure 9 Another cross-sectional view of a connection module 7000 according to another form of the present technology is shown. In this example, the interface connector 7018 is an electronic connector that includes a first mating half located on a PCB 7032 and a second complementary mating half located on an RPT device 4000.
[0433] 5.7.3.2.3 Exemplary Shape / Size
[0434] Figures 8A-8D The connecting module 7000 shown has a generally regular shape, such as a rectangular cube; however, this should not be considered a limitation of the technology. In other forms of the technology, the connecting module 7000 can have an irregular shape, such as an "L" shape. The use of an irregular shape can advantageously ensure that the connecting module 7000 is inserted into the cavity 7024 in the correct orientation, without the need for another specific indexing feature 7022 (because the shape of the connecting module 7000 itself then serves as the indexing feature).
[0435] In one embodiment of this technology, the connection module 7000 has:
[0436] • A thickness between about 15 mm and about 35 mm, for example between about 20 mm and about 30 mm, or more preferably about 25 mm.
[0437] • A height between approximately 50 mm and approximately 80 mm, for example, between approximately 60 mm and approximately 70 mm, or more preferably approximately 65 mm.
[0438] • A width between approximately 75 mm and approximately 100 mm, for example, between approximately 85 mm and approximately 95 mm, or more preferably approximately 90 mm.
[0439] It should be understood that the above dimensions are provided as examples only and do not include the dimensions of any attachment mechanism 7020 or interface connector 7018.
[0440] 5.7.4 RPT device
[0441] Figure 10 A rear view of an RPT device 4000 according to the present invention is shown. As shown, the RPT device 4000 includes a connector assembly 6030 and a cavity 7024. The connector assembly 6030 includes one or more electrical connectors 6002, and the cavity 7024 is configured to receive a connection module 7000 according to the present invention.
[0442] The RPT device 4000 includes an attachment mechanism 7020 in the form of a threaded insert, which is configured to receive threaded fasteners from the connection module 7000 during use.
[0443] Cavity 7024 includes slot 7038 configured to receive interface connector 7018 in use. It should be understood that in use, interface connector 7018 is inserted through slot 7038 to electrically connect to a corresponding connector within RPT device 4000. In other forms, the cavity may include a connector to which interface connector 7018 is attached in use. In other words, in some forms, interface connector 7018 may not pass through slot 7038.
[0444] Cavity 7024 has a shape complementary to that of connection module 7000. For example, in one form of this technology, cavity 7024 may have:
[0445] • A depth between about 15 mm and about 35 mm, for example between about 20 mm and about 30 mm, or more preferably about 25 mm.
[0446] • A height between approximately 50 mm and approximately 80 mm, for example, between approximately 60 mm and approximately 70 mm, or more preferably approximately 65 mm.
[0447] • The width is between approximately 75mm and approximately 100mm, for example, between approximately 85mm and approximately 95mm, or more preferably approximately 90mm.
[0448] 5.7.4.1 Exemplary Device
[0449] Figure 11A-11E Various forms of RPT devices 4000, including a connection module 7000 according to the present technology, are shown.
[0450] Figure 11AOne embodiment of a connector assembly 6030 including a connection module 7000 according to the present technology is shown. In this embodiment, the connection module 7000 is located within a cavity 7024 in the connector assembly 6030. The attachment mechanism 7020 is provided in the form of a clip.
[0451] Fastener 7042 is also provided, which can be used to secure the outer shell 7028 and the back plate 7030 of housing 7002 together. In other forms, fastener 7042 can be used in conjunction with a clip to secure the connecting module to cavity 7024.
[0452] exist Figure 11A In the example shown, the connector assembly is primarily occupied by the connection module 7000. That is, the connection module occupies between approximately 70% and 90% of the visible area of the connector assembly 6030. This advantageously provides space for additional connectors to be provided on the replaceable connection module 7000.
[0453] exist Figure 11A In an exemplary form of the technology shown, the connection module 7000 includes a D-type miniature connector 6015, an Ethernet connector 6014, a remote alarm connection 6022, an SpO2 sensor connection 6020, and a FiO2 sensor connection 6017. The connector assembly 6030 also includes an LFO2 connector 6024 and a DC power connector 6006.
[0454] Figure 11B Another form of the present technology is shown, wherein the attachment mechanism 7020 is provided via a fastener 7042 (not shown). In this example, the connector assembly 6030 is divided into three regions. The first region 7044A has a power button 6008 and an LFO2 connector 6024. The second region 7044B includes electronic connectors that can be present on a number of RPT devices 4000. In the illustrated example, these include a DC power connection 6006 and a USB-B connection 7023. According to the present technology, the third region 7044C provides a cavity 7024 for receiving a connection module 7000. In the illustrated exemplary form, the connection module 7000 includes a D-type miniature connector 6015, an Ethernet connector 6014, a remote alarm connection 6022, an SpO2 sensor connection 6020, and a FiO2 sensor connection 6017.
[0455] In some forms of this technology, more than one of regions 7044A-C can be configured to connect to the connection module 7000. For example, in Figure 11BIn the example, the connector located in the second region 7044B is part of the connector assembly 6030; however, in an alternative form of the technology, these connectors may be included as part of another connection module 7000, distinct from the connection module 7000 connected to the third region 7044C. In other words, according to this technology, the RPT device 4000 may include more than one connection module 7000.
[0456] Figure 11C Another form of the technology is shown, in which the connection module 7000 is held within the cavity using magnetic attraction and / or friction / interference engagement as described herein.
[0457] according to Figure 11B For example, connector assembly 6030 includes three regions 7044A-C. The first region 7044A includes a power button 6008 and an LFO2 connector 6024. The second region 7044B includes a DC power connection 6006 and a USB-B connection 7023. The third region 7044C includes a connection module 7000, which provides a D-type miniature connector 6015, an Ethernet connector 6014, a remote alarm connection 6022, an SpO2 sensor connection 6020, and a FiO2 sensor connection 6017.
[0458] Figure 11C-11E An example of a connection configuration is shown in which the connection module 7000 is located in the cavity 7024 of the connector assembly 6030, and wherein the connection module 7000 is: recessed into the cavity ( Figure 11C ); flush with the cavity ( Figure 11D ); and protrusion outward from the cavity ( Figure 11E That is, only a portion is received by the cavity.
[0459] exist Figure 11D and Figure 11E The example provides three zones 7044A-C. Zone 7044A includes a power button 6008 and an LFO2 connector 6024. Zone 7044B includes a DC power connection 6006, an Ethernet connector 6014, and a USB-B connection 7023. Zone 7044C includes a connection module 7000 providing a D-type miniature connector 6015, a remote connection 6022, an SpO2 sensor connection 6020, and a FiO2 sensor connection 6017.
[0460] 5.7.4.2 Exemplary Connector Component
[0461] Figures 12A-12COne form of connector assembly 6030 with the electrical connector 6002 removed is shown. As shown, connector assembly 6030 includes a panel 11002 or a portion of housing 4010 that is removed from the remainder of housing 4010. As previously mentioned, providing a separate panel 1102 for connector assembly 6030 can have many advantages related to the manufacture of RPT device 4000.
[0462] The connector assembly 6030 includes an attachment mechanism 7020 in the form of a threaded insert, a slot 7034 configured to receive an interface connector 7018, and an aperture 7016 configured to receive an electrical connector 6002, a mechanical connector, and a button.
[0463] Mounting posts 7046 are also provided for securing the connector assembly 6030 to the chassis or body of the RPT device 4000.
[0464] Figure 12C Provided Figure 12A and Figure 12B A side view of a portion of the connector assembly 6030. This view shows that the connector assembly 6030 is provided with a radial seal 11004 extending outwardly around the periphery of the connector assembly. This radial seal advantageously allows the connector assembly to seal against the cavity 7024 or housing 4010 of the RPT device during use. For example, the radial seal may be positioned within a recess or channel (not shown) in the housing 4010 to provide an inlet protection measure.
[0465] 5.7.5 Connecting the System
[0466] According to one form of the present technology, a connection system is provided including at least one RPT device 4000 and at least one connection module 7000.
[0467] In one form of connectivity system, the RPT device 4000 may be provided with multiple connection modules 7000 interchangeably connected to the RPT device 4000. For example, a user may want to install a first connection module by their bedside, and a second connection module that the user may use while traveling. In this way, the first connection module can remain connected to all necessary peripheral devices, and the user only needs to disconnect the RPT device 4000 from the connection module 7000. This is faster, more convenient, and less prone to errors compared to removing the cables for each connection individually.
[0468] In another form of the connection system, the RPT device 4000 may have one of a plurality of connection modules 7000, wherein each connection module 7000 includes a different set of electrical connectors 6002. For example, a connection module may be provided to the user containing only the connectors they intend or need to use. Some electrical connectors 6002 may be shared for each connection module 7000's set of electrical connectors 6002. This potentially reduces costs for the customer because they do not need to pay for connections they do not intend to use, and also reduces overall unit complexity. Conversely, more experienced users, or users who utilize more features of the device, can use more specialized connection modules to access all the features they require.
[0469] According to another form of the connection system, the service center can be equipped with multiple connection modules, which can be exchanged as needed when servicing RPT devices.
[0470] According to another form of the connection system, the RPT device can be provided without the detachable connection module 7000, and basic functions can be provided by a fixed connector on the connector assembly. In this form, the connection module 7000 can be provided separately, for example, as an upgrade to provide additional functions. Where functions are associated with the provided connection module 7000, it may be advantageous for the RPT device 4000 to detect the presence and type of the connection module to enable and / or disable software features accordingly. Therefore, in some forms of this technology, the connection module 7000 includes an identifier, and the RPT device 4000 includes an identification device configured to recognize the identifier on the connection module 7000. The identification device of the RPT device 4000 can be configured to transmit the identified identity of the connection module 7000 to the central controller 4230 or other processor on the RPT device 4000, which can be configured to adjust the functions of the RPT device 4000 accordingly.
[0471] According to another form of the connectivity system, a single connectivity module 7000 can be configured to operate with multiple RPT devices 4000. For example, a common connectivity module 7000 can be configured to work with multiple different RPT devices 4000, such as ventilators, humidifiers, and monitoring devices. Additionally or alternatively, a single connectivity module 7000 can be configured to operate with multiple models of RPT devices; for example, newer models of RPT devices 4000 may be compatible with older connectivity modules 7000.
[0472] 5.7.6 Connection Method
[0473] According to one aspect of the present technology, a method for attaching a connection module 7000 to an RPT device 4000 is provided, comprising the steps of: inserting the connection module 7000 into a cavity in the RPT device 4000, and optionally using an attachment mechanism 7020 to secure the connection module 7000 in the cavity 7024.
[0474] According to one form of the present technology, a method for removing a connection module 7000 from an RPT device 4000 is provided, comprising the steps of: optionally, releasing an attachment mechanism 7020 and removing the connection module from a cavity 7024 in the RPT device 4000.
[0475] 5.8 Screening, Diagnosis, and Monitoring System
[0476] 5.8.1 Polysomnography
[0477] Figure 13 Patient 1000 undergoing polysomnography (PSG) is shown. The PSG system includes a plasma chamber 2000 that receives and records signals from the following sensors: EOG electrode 2015; EEG electrode 2020; ECG electrode 2025; submandibular EMG electrode 2030; snoring sensor 2035; respiratory plethysmography (breathing effort sensor) on a chest strap 2040; respiratory plethysmography (breathing effort sensor) on an abdominal strap 2045; oral-nasal cannula with oral thermistor 2050; photoplethysmography (pulse oximeter) 2055; and body position sensor 2060. The electrical signal is referenced to a ground electrode (ISOG) 2010 located at the center of the forehead.
[0478] According to this technology, it may be advantageous to provide a connection module 7000 containing multiple sensors for the serous chamber. This advantageously allows the sensors to be decoupled from the PSG system. One advantage of this method is that it allows a single PSG system to be used for multiple patients without disconnecting multiple sensors. For example, each patient can be wired with multiple sensors connected to the connection module 7000. The PSG system can then be moved between patients by simply connecting it sequentially to each connection module.
[0479] 5.9 Glossary
[0480] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.
[0481] 5.9.1 Overview
[0482] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.
[0483] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.
[0484] For example, the ambient humidity relative to a humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.
[0485] In another example, environmental stress can be stress that is directly around the body or outside the body.
[0486] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or transmitted from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.
[0487] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.
[0488] Continuous positive airway pressure (CPAP) therapy: respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In some forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of an indication of partial upper airway obstruction.
[0489] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, that is, a quantity that only has a magnitude. In other cases, the reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.
[0490] In the example of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow flushing of exhaled gases. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.
[0491] Flow therapy: Breathing therapy involves delivering a controlled flow of air to the inlet of the airway at a rate known as the therapeutic flow, which is generally positive throughout the patient’s respiratory cycle.
[0492] Humidifier: The term humidifier will be considered to refer to a humidification device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.
[0493] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one example, a leak could occur due to an incomplete seal between the mask and the patient's face. In another example, a leak could occur in a rotating bend in the conduit leading to the surrounding environment.
[0494] Noise, Conducted (Acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, 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.
[0495] Noise, Radiation (Acoustics): Radiated noise in this document refers to noise transmitted to the patient through the ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.
[0496] Noise, ventilation (acoustics): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening, such as a ventilation opening for a patient interface.
[0497] Patient: A person, regardless of whether they have a respiratory illness.
[0498] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2 And it is approximately 0.98 hPa (1 hPa = 100 Pa = 100 N / m). 2= 1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.
[0499] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.
[0500] Respiratory pressure therapy (RPT): Applying an air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.
[0501] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.
[0502] 5.9.1.1 Materials
[0503] Silicone or silicone elastomer: Synthetic rubber. In this specification, the reference to silicone refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.
[0504] Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.
[0505] 5.9.1.2 Mechanical Properties
[0506] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.
[0507] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.
[0508] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or by an indentation hardness scale measured on a standardized sample size).
[0509] • "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.
[0510] • "Hard" materials can include polycarbonate, polypropylene, steel or aluminum, and are not easily deformed, for example, under finger pressure.
[0511] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.
[0512] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.
[0513] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting up and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a pressure load of approximately 20 to 30 cmH2O.
[0514] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.
[0515] 5.9.2 Respiratory and Circulatory Systems
[0516] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.
[0517] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.
[0518] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.
[0519] Effort (breathing): The work that spontaneous breathers do by trying to breathe.
[0520] The expiratory phase of the respiratory cycle: the time period from the start of expiratory flow rate to the start of inspiratory flow rate.
[0521] Flow restriction: Flow restriction is considered a state of respiratory function in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.
[0522] Types of flow-limiting inhalation waveforms:
[0523] (i) Flat: It has an upward movement, followed by a relatively flat section, followed by a downward movement.
[0524] (ii) M-shape: has two local crests, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two crests.
[0525] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.
[0526] (iv) Inverted chair shape: has a relatively flat section followed by a single local crest at the trailing edge.
[0527] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow rate, rather than a cessation of flow. In one form, insufficient breathing can be considered to occur when the flow rate drops below a threshold rate for a sustained period of time. Central insufficient breathing is considered to occur when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:
[0528] (i) The patient’s respiratory rate decreases by 30% for at least 10 seconds plus an associated 4% desaturation;
[0529] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.
[0530] Hyperventilation: Increased airflow to above normal levels.
[0531] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow rate to the start of expiratory flow rate is considered the inspiratory portion of the respiratory cycle.
[0532] Airway openness: The degree to which the airway is open or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, a value (1) for open and a value of zero (0) for closed (obstructed).
[0533] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.
[0534] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.
[0535] Respiratory flow, patient air flow, and respiratory air flow (Qr): These terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.
[0536] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to any one of these volumes. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.
[0537] (Inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.
[0538] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.
[0539] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.
[0540] Typical recent ventilation: The recent values of ventilation (Vent) tend to cluster around their respective values within a predetermined time range, which is a measure of the central tendency of recent ventilation values.
[0541] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).
[0542] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.
[0543] 5.9.3 Ventilation
[0544] Adaptive Servo-Ventilator (ASV): A type of servo ventilator with a variable, rather than a fixed, target ventilation. The variable target ventilation can be learned from some characteristics of the patient, such as the patient's breathing characteristics.
[0545] Backup rate: A ventilator parameter that determines the minimum rate of breathing (usually expressed as breaths per minute) that the ventilator will deliver to the patient if it is not triggered by spontaneous breathing effort.
[0546] Cycle: The termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator is said to cycle to stop delivering breaths at the end of the inspiratory portion of the respiratory cycle.
[0547] Expiratory positive airway pressure (EPAP): Baseline pressure, the pressure that varies within the respiratory tract is added to this baseline pressure to produce the desired interface pressure, which the ventilator will attempt to achieve at a given time.
[0548] End-expiratory pressure (EEP): The desired interface pressure that the ventilator will attempt to obtain at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0 when Φ = 1, then EEP equals EPAP.
[0549] Positive inspiratory airway pressure (IPAP): The maximum desired interface pressure that a ventilator attempts to achieve during the inspiratory phase of breathing.
[0550] Pressure support: Indicates that the pressure increase during inspiration exceeds the pressure increase during expiration, and typically means the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference the ventilator aims to achieve, rather than the difference it actually achieves.
[0551] Servo-ventilator: A ventilator that measures patient ventilation with a target ventilation and adjusts the pressure support level to bring the patient's ventilation to the target ventilation.
[0552] Spontaneous / Timed (S / T): The mode of a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device cannot detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.
[0553] Swaying: an equivalent term for pressure support.
[0554] Trigger: This is said to be triggered when the ventilator delivers air to a patient who is breathing spontaneously, during the breathing portion of the patient’s breathing cycle as they are trying to begin.
[0555] 5.9.4 Anatomy
[0556] 5.9.4.1 Facial Anatomy
[0557] Alar: The outer wall or "wing" of each nostril (plural: alar)
[0558] Nose wing angle:
[0559] Alar tip: the outermost point on the ala of the nose.
[0560] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.
[0561] Auricle: The entire visible external part of the ear.
[0562] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.
[0563] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.
[0564] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.
[0565] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).
[0566] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.
[0567] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.
[0568] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.
[0569] Lip, lower lip (midpoint of the lower lip):
[0570] Lip, upper lip (midpoint of the upper lip):
[0571] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.
[0572] Nostrils (Nares (Nostrils)): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal (naris) (nostril). Nostrils are separated by the nasal septum.
[0573] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.
[0574] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).
[0575] The lowest point on the face where the auricle attaches to the skin.
[0576] Ear point: the highest point where the auricle attaches to the facial skin.
[0577] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.
[0578] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.
[0579] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.
[0580] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.
[0581] Sagittal plane: A vertical plane running from front to back. The central sagittal plane is the sagittal plane that divides the body into the right and left halves.
[0582] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.
[0583] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.
[0584] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.
[0585] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the central sagittal plane.
[0586] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue.
[0587] 5.9.4.2 Skull Anatomy
[0588] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.
[0589] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.
[0590] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.
[0591] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.
[0592] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.
[0593] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.
[0594] The eye socket is the bony cavity in the skull that houses the eyeball.
[0595] Parietal bone: The parietal bone is the top and sides of the skull when joined together.
[0596] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.
[0597] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the prominent part of the cheek.
[0598] 5.9.4.3 Anatomy of the Respiratory System
[0599] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.
[0600] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.
[0601] Lungs: The human respiratory organ. The conduction area of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.
[0602] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.
[0603] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).
[0604] 5.9.5 Patient Interface
[0605] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.
[0606] Bend: A bend is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The bend can have an approximately circular cross-section. In another form, the bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removable from the mating component, for example, via a snap-fit connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.
[0607] Frame: The frame is generally considered to refer to the mask structure that bears tensile loads between two or more connection points to the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.
[0608] Headgear: A headgear is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headgear may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.
[0609] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.
[0610] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized therein to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.
[0611] Sealing: can refer to the noun form of a structure ("seal") or the verb form of the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve 'seal' between them, without the need for a separate 'seal' element itself.
[0612] Shell: The shell is considered to be a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.
[0613] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.
[0614] Support rod: The support rod will be considered as a structural component designed to increase the compressive strength of another component in at least one direction.
[0615] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft can be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft can be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. During use, there can be little or no airflow leakage from the rotary shaft.
[0616] Lacing (noun): A structure used to resist tension.
[0617] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.
[0618] 5.10 Other comments
[0619] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.
[0620] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also covered within this technique, subject to any specific exclusions within the stated range. Where the range includes one or two limitations, the range excluding any one or both of those included limitations is also included within this technique.
[0621] Furthermore, where one or more values are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values may be approximate and may be used with any suitable significant figure to the extent that the actual implementation of the technology may allow or require.
[0622] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.
[0623] When a particular material is set for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein should be understood as capable of being manufactured, and therefore can be manufactured together or separately.
[0624] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.
[0625] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.
[0626] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.
[0627] The subject headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. Subject headings should not be used to interpret the claims or limit their scope.
[0628] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not required for practicing the techniques described. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or shown in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.
[0629] Therefore, it should be understood that numerous modifications can be made to the exemplary examples, and that other arrangements can be designed without departing from the spirit and scope of this technology.
Claims
1. A system for providing respiratory therapy, the system comprising: Devices used to supply breathable airflow under positive pressure for respiratory therapy; First removable connection module; as well as Second removable connection module, The device said includes: A pressure generator for generating the breathable airflow and supplying the breathable airflow to an outlet; Housing, which at least includes the pressure generator; and At least one electrical connector, The housing includes a cavity configured to interchangeably receive the first removable connection module and the second removable connection module, and The at least one electrical connector is configured to be interchangeably connected to the first removable connection module and the second removable connection module during use. Each of the first removable connection module and the second removable connection module includes: The housing includes a front side and a rear side; and At least one electrical connector on the front side and at least one electrical connector on the rear side; The housing is configured to be at least partially inserted into the cavity of the device during use, and The at least one electrical connector on the rear side is configured for connection to the at least one electrical connector on the device. The first removable connection module includes a first set of electrical connectors, and the second removable connection module includes a second set of electrical connectors, wherein the first set of electrical connectors is different from the second set of electrical connectors.
2. The system of claim 1, wherein the cavity is located at the rear of the housing of the device.
3. The system of claim 1 or 2, wherein the cavity includes one or more indexing features to ensure that each connection module can only be inserted into the cavity in a single orientation.
4. The system of claim 3, wherein one or more index features include a chamfer of the cavity.
5. The system of claim 1, wherein the system further comprises at least one attachment mechanism configured to selectively secure each connection module at least partially within the cavity.
6. The system of claim 5, wherein the attachment mechanism comprises one or more of a clamp, fastener, protrusion, aperture, or magnet.
7. The system of claim 1, further comprising a connector assembly, wherein each connection module is configured to be interchangeably connected to the connector assembly in use, wherein the connector assembly is secured to the housing, and wherein the cavity is disposed in the connector assembly.
8. The system of claim 7, wherein the connector assembly includes at least one power connector.
9. The system of claim 1, wherein the cavity includes a slot configured to receive the at least one electrical connector on the rear side.
10. The system of claim 9, wherein, in use, the at least one electrical connector on the rear side passes through the slot and is connected to the at least one electrical connector of the device.
11. The system of claim 1, wherein the cavity has a depth between 15 mm and 35 mm.
12. The system of claim 1, wherein the cavity has a height between 50 mm and 80 mm.
13. The system of claim 1, wherein the cavity has a width between 75 mm and 100 mm.
14. The system of claim 1, wherein the device includes a protective cover configured to cover the at least one electrical connector of the device in use.
15. The system of claim 1, wherein the at least one electrical connector of the device includes at least one communication connector for transmitting information to or from the device.
16. The system of claim 15, wherein the at least one communication connector comprises any one or more communication connectors selected from the group consisting of: a D-type miniature connector; a USB connector; and an Ethernet connector.
17. The system of claim 1, wherein the at least one electrical connector of the device includes at least one power connector for transmitting power to or from the device.
18. The system of claim 17, wherein the at least one power connector comprises any one or more power connectors selected from the group consisting of: a DC connector; an AC connector; a USB connector; and an Ethernet connector.
19. The system of claim 1, wherein the at least one electrical connector on the front side of one or more of the first removable connection module and the second removable connection module comprises at least one of the following: a USB connector, a D-type miniature connector, an Ethernet connector, an SpO2 sensor connector, and / or a remote alarm connector.
20. The system of claim 1, further comprising a protective cover configured to selectively cover at least one electrical connector on the front side of each connection module.
21. The system of claim 1, wherein the housing of each connection module comprises an outer shell and a back plate.
22. The system of claim 21, wherein the housing is ultrasonically welded to the back plate.
23. The system of claim 1, wherein the at least one connector on the rear side of each connection module includes an edge contact.
24. The system of claim 1, wherein each of the connection modules further comprises an electronic printed circuit board.
25. The system of claim 24, wherein the electronic printed circuit board includes an output device in the form of a light-emitting diode.
26. The system of claim 24 or 25, wherein the electronic printed circuit board includes one or more identification components that enable the device to detect and / or identify the corresponding connection module.
27. The system of claim 1, wherein each of the modules has a thickness between 15 mm and 35 mm.
28. The system of claim 1, wherein each of the modules has a height between 50 mm and 80 mm.
29. The system of claim 1, wherein each of the modules has a width between 75 mm and 100 mm.
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