Assembly for diverting liquid from breathing devices

Abstract

An apparatus for preventing water ingress into a medical device having a housing is provided. Such water ingress can occur, for example, from a connected humidifier. The apparatus comprises an end cap including at least one opening for selective connection with a compatible accessory. The end cap is constructed from panels that cooperate to provide an internal fluid passageway for diverting water from the point of ingress to the exterior of the housing.

Description

Technical Field

[0001] [1 Assembly for diverting liquid from a breathing device] [2 Cross-reference to related applications] This application claims the benefit of Australian Patent Application No. 2020903918, filed on October 29, 2020, the entire content of which is incorporated herein by reference.

Background Art

[0002] [3 Background of the technology] [3.1 Field of the technology] This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. This technology also relates to medical devices or apparatuses and their use. This technology further relates to an assembly for preventing liquid ingress into a medical device, particularly a respiratory therapy device.

[0003] [3.2 Description of related technologies] [3.2.1 The human respiratory system and its disorders] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airways.

[0004] The airways contain a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, which enables the transfer of oxygen from the inhaled air into the venous blood and the transfer of carbon dioxide in the opposite direction. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. The airways further divide and connect to the respiratory bronchioles and ultimately the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory region. See Non-Patent Document 1.

[0005] There are various respiratory disorders. Certain disorders may be characterized by certain events (e.g., apnea, hypopnea, and hyperpnea).

[0006] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory dysfunction, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disorders (NMD), and chest wall disorders.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including obstruction or closure of the upper airway during sleep. This is a result of a combination of an abnormally small upper airway and a normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharynx during sleep. When affected, a patient's breathing typically stops for periods of 30 to 120 seconds, sometimes as many as 200 to 300 times a night. This often results in excessive daytime sleepiness and can contribute to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, although those affected may not be aware of the problem. See Patent Document 1.

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, which includes periods of rhythmic alternation of increasing and decreasing ventilation, known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. CSR can be harmful because of the repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, which cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2.

[0009] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders:

[0010] Patients with respiratory failure (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0011] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses a group of lower respiratory tract diseases that share certain characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0013] Neuromuscular diseases (NMDs) are a broad term encompassing numerous disorders and illnesses that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage that leads to inability to walk, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over years but with only a mild reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include increased general weakness, difficulty swallowing, shortness of breath during exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0014] Chest wall disorders are a group of thoracic deformities that cause a failure of the connection between the respiratory muscles and the rib cage. The disorders are usually characterized by restrictive disorders and share the potential for prolonged hypercapnic respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] Various therapies have been used to treat or improve such diseases. Furthermore, even otherwise healthy individuals can utilize such therapies to prevent the onset of respiratory problems. However, these therapies have numerous shortcomings.

[0016] [3.2.2 Therapy] A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) have been used to treat one or more of the aforementioned respiratory disorders.

[0017] [3.2.2.1 Respiratory pressure therapy] Respiratory pressure therapy (as opposed to negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)) involves applying a controlled target pressure, nominally positive relative to the atmosphere, to the airway inlet throughout the patient's entire respiratory cycle.

[0018] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as an air pressure splint, preventing upper airway obstruction by pushing the soft palate and tongue forward and backward against the posterior oropharyngeal wall. Treatment of OSA with CPAP therapy can be voluntary, and patients may choose not to follow the therapy if they notice one or more of the following about the devices used to deliver such therapy: discomfort, difficulty of use, high cost, and poor aesthetics.

[0019] Non-invasive ventilation (NIV) assists a patient's breathing by providing ventilatory support through the upper airway to perform some or all of the work of breathing and / or maintain adequate oxygen levels throughout the body. Ventilation support is provided through a non-invasive patient interface. NIV has been used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0021] [3.2.2.2 Flow Therapy] Not all respiratory therapies aim to deliver prescribed therapeutic pressures. Some respiratory therapies aim to deliver prescribed ventilatory volume by delivering an inspiratory flow profile, possibly superimposed on a positive baseline pressure, over a target duration. In other cases, the patient's airway interface is "open" (unsealed), and respiratory therapy may supplement only the patient's own spontaneous breathing with a flow of regulated or concentrated gas. In one example, high-flow therapy (HFT) involves delivering a continuous, heated, humidified airflow at the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that can be maintained nearly constant throughout the entire 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 of air at the airway inlet improves ventilation efficiency by flushing or pushing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes called dead space therapy (DST). Other benefits may include increased warmth and humidification (perhaps due to the benefits of secretion management) and the possibility of a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate can follow a fluctuating profile throughout the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe a continuous flow of oxygen-enriched gas delivered to the patient's airways at a specified oxygen concentration (21% to 100%, the oxygen fraction of the ambient air) and a specified flow rate (e.g., 1 liter / minute (LPM), 2 LPM, 3 LPM, etc.).

[0023] [3.2.2.3 Replacement Oxygen] For a particular patient, oxygen therapy may be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized air flow. When adding oxygen to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When adding oxygen to HFT, the resulting therapy is referred to as HFT with supplemental oxygen.

[0024] [3.2.3 Respiratory Therapy System] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosis, or monitoring without treating a disease.

[0025] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0026] Another form of therapy system is a jaw restoration device.

[0027] [3.2.3.1 Respiratory Pressure Therapy (RPT) Device] A respiratory pressure therapy (RPT) device can be used individually or as part of a system to deliver one or more of the aforementioned therapies, such as by operating the device to generate an air flow for delivery to an interface in the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, an RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0028] Pneumatic generators are known for a variety of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that are not met by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may have deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0029] One example of a specific requirement for a particular RPT device is acoustic noise.

[0030] Table of noise output levels for conventional RPT devices (measured for only one sample in CPAP mode at 10 cmH2O using the test method specified in ISO 3744). [Table 1]

[0031] One known RPT device used to treat sleep-disordered breathing is the S9 sleep therapy system manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can treat a number of diseases (to name few, NMD, OHS, and COPD) by providing invasive and non-invasive, independent ventilation assistance to a variety of patients.

[0032] The ResMed Elisee® 150 ventilator and the ResMed VSIII® ventilator can treat a wide range of diseases by providing invasive and non-invasive dependent ventilation assistance suitable for adult or pediatric patients. These ventilators offer volumetric and pneumatic ventilation modes using single-branch or double-branch circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface as described above.

[0033] RPT devices may include, for example, high-flow therapy devices configured to provide high-flow therapy. In this regard, some respiratory therapies may aim to deliver a prescribed respiratory volume by delivering an inspiratory flow profile, possibly superimposed on a positive baseline pressure, over a target duration. In other cases, the interface to the patient's airways is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a flow of regulated or concentrated gas. In one example, high-flow therapy (HFT) is the delivery of a continuous, heated, humidified airflow at the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that is maintained nearly 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 of air at the airway inlet improves ventilation efficiency by flushing or pushing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes called dead space therapy (DST). Other benefits may include increased warmth and humidification (perhaps due to the benefits of secretion management) and the possibility of a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate can follow a fluctuating profile throughout the respiratory cycle.

[0034] Device designers may be presented with countless options. Design criteria often conflict, meaning that certain design choices may deviate significantly from convention, or even be unavoidable. Furthermore, the comfort and effectiveness of a particular design may be highly sensitive to even minor changes in one or more parameters.

[0035] [3.2.3.2 Air Circuit] An air circuit is a conduit or tube constructed and positioned to allow airflow to move between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) during use. In some cases, an air circuit may have separate branches for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0036] [3.2.3.3 Humidifier] Delivering airflow without humidification can lead to airway dryness. When a humidifier is used with the RPT device and patient interface, humidifying gas is produced, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, applying warm air to the facial area within and around the patient interface generally provides greater comfort than cool air. Therefore, humidifiers often have the capability to humidify the airflow as well as heat it.

[0037] While various artificial humidification devices and systems are known, they may not meet the specific requirements of medical humidifiers.

[0038] Medical humidifiers are typically used in places where patients may be sleeping or at rest (e.g., hospitals) to increase the humidity and / or temperature of an airflow relative to the ambient air as needed. Medical humidifiers placed by the bedside can be small. They may be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the surrounding environment. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled by the patient through breathing, but these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0039] While numerous medical humidifiers are known, they may have one or more defects. Some medical humidifiers may provide insufficient humidification, while others may be difficult or inconvenient for patients to use. Furthermore, in conventional humidifier tanks, liquid can spill due to patient error or accident, and this liquid may then come into contact with the electrical components or delicate mechanical parts of the RPT device. This could cause patient injury and / or device malfunction. Therefore, the electrical and mechanical components of the RPT device must be protected from water ingress, especially when connected to a humidifier.

[0040] [3.2.3.4 Oxygen Source] Experts in this field have long recognized that exercise in patients with respiratory failure offers long-term benefits, including slowing disease progression, improving quality of life, and extending patient lifespan. However, most static forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Therefore, the need for mobility has long been recognized. Until recently, this mobility was facilitated using cylinders or small compressed oxygen tanks mounted on carts with wheels. These tanks have the disadvantages of having a limited oxygen capacity and being heavy (weighing about 50 pounds when mounted).

[0041] Oxygen concentrators have been used for approximately 50 years to supply oxygen for respiratory therapy. Conventional oxygen concentrators are heavy and bulky, making them difficult and impractical to carry during normal walking activities. Recently, manufacturers of large, stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can theoretically produce an unlimited supply of oxygen. Miniaturizing these devices for mobility requires a diverse system for producing condensed oxygen-enriched gas. To minimize weight, size, and power consumption, POCs strive to make the utilization of the oxygen they produce as efficient as possible. This can be achieved by delivering oxygen as a series of pulses or "boluses," timing each bolus to coincide with the start of inspiration. This therapeutic mode is known as pulsed or demand-driven (oxygen) delivery (POD) and is in contrast to the conventional continuous flow delivery, which is more suitable for stationary oxygen concentrators. [Prior art documents] [Patent Documents]

[0042] [Patent Document 1] U.S. Patent No. 4944310 [Patent Document 2] U.S. Patent No. 6532959 [Patent Document 3] International Publication No. 2012 / 171072 [Patent Document 4] International Publication No. 2018 / 094452 [Patent Document 5] U.S. Patent No. 7866944 [Patent Document 6] U.S. Patent No. 8638014 [Patent Document 7] U.S. Patent No. 8636479 [Patent Document 8] International Publication No. 2013 / 020167 [Patent Document 9] U.S. Patent No. 8733349 [Non-patent literature]

[0043] [Non-Patent Document 1] "Respiratory Physiology" by John B. West, Lippincott Williams & Wilkins (9th edition, published in 2012) [Overview of the Initiative]

[0044] "4. A brief explanation of the technology" This technology relates to providing medical devices used for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, and possesses one or more of the following advantages: improved comfort, cost-effectiveness, efficacy, ease of use, and manufacturability.

[0045] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0046] Another aspect of this technology relates to a method used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0047] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0048] A further aspect of this technology is to provide a liquid diversion assembly suitable for use between a humidifier and an RPT device, for example, comprising multiple panels. These panels are constructed to form one or more internal passages when connected. These passages are configured to divert liquid from the humidifier, away from the internal components of the RPT device, and through the RPT device housing into the ambient environment. The passages may be formed around any inlet / outlet, connecting component, or electrical connector in a variety of configurations.

[0049] One embodiment of the present technology is a fluid diversion assembly for a medical device including a housing. The fluid diversion assembly includes an end cap that works in conjunction with the housing, the end cap includes at least one opening for selective connection with a compatible accessory, and the end cap includes at least one internal fluid passage that communicates with the at least one opening to divert the fluid to the outside of the housing.

[0050] In the example, the end cap may include a plurality of panels, each having an internal surface and an external surface, and the plurality of panels are joined together to form the end cap, defining at least one internal fluid passage between them. In the example, the plurality of panels include a proximal panel that is near the medical device during use and includes a first internal surface and a first external surface, and a distal panel that is near the medical device during use and includes a second internal surface and a second external surface. In the example, the fluid diversion assembly includes at least one wall extending between the first internal surface and the second internal surface, and the internal fluid passage is at least partially defined by the at least one wall, the first internal surface and the second internal surface.

[0051] In the example, the proximal panel includes at least one recess within a first internal surface, and at least one opening is located between the second external surface and the second internal surface of the distal panel, with the at least one recess substantially aligned with the at least one opening. In the example, at least one wall extends along the first and second internal surfaces and substantially surrounds the at least one recess, and the at least one wall includes a gap at the lower position of the at least one recess, the gap being configured to allow liquid to flow from the internal fluid passage to the outside of the end cap. In the example, the lower surface of the at least one recess is angled from an upper position to a lower position on the first internal surface.

[0052] In the example, the proximal panel may include guide projections surrounding at least one recess, the guide projections protruding from a first inner surface toward a second inner surface, and an air gap is maintained between the guide projections and the second inner surface. In the example, the guide projection may include a radially outward-facing surface and a radially inward-facing surface that intersect at an apex. In the example, each guide projection may include a raised base surrounding a recess and a guide projection extending from the raised base. In the example, a flat portion may be provided between the radially outward edge of the raised base and the guide projection.

[0053] In the example, at least one wall may include a first wall extending from a first internal surface and a second wall extending from a second internal surface, and when the proximal and distal panels are connected, the first and second walls are configured to cooperate to form an internal fluid passage.

[0054] In the example, the panels are joined together to form a single unit. In the example, the panels may be joined by mechanical means (e.g., the use of fasteners and / or engineering fits) and / or adhesive (e.g., thermal bonding such as heat riveting or ultrasonic welding).

[0055] In the example, the compatible accessory could be a humidifier. In the example, the medical device could be a ventilator.

[0056] One aspect of one embodiment of the present technology is a device for supplying a breathable gas flow under positive pressure for respiratory therapy, the device comprising: a pressure generator for generating a breathable gas flow and supplying the flow to an outlet; a housing for at least the pressure generator; and a liquid diversion assembly substantially as described herein, wherein the end cap of the liquid diversion assembly is configured to be fixed to the housing for at least the pressure generator.

[0057] One aspect of one embodiment of the present technology is a respiratory therapy system comprising a device for supplying a breathable gas flow at positive pressure for respiratory therapy, substantially as described herein, and a humidifier device for changing the absolute humidity of the airflow for delivery to the entrance of a patient's airway, the change being compared to the absolute humidity of ambient air, and the humidifier device being configured to be selectively coupled to the device for supplying a breathable gas flow through at least one opening of an end cap.

[0058] In the example, the apparatus includes an end cap that works in conjunction with the housing. In the example, the end cap is configured to selectively connect to a chamber and a reservoir. In the example, the end cap is positioned to form a seal together with the housing. In the example, the end cap forms a physical barrier between the pneumatic block and the optional chamber and reservoir.

[0059] Of course, some embodiments may form subordinate embodiments of this technology. Furthermore, various subordinate embodiments and / or embodiments can be combined in various ways to constitute further embodiments or subordinate embodiments of this technology.

[0060] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0061] [5. Brief Description of the Drawings] This technology is illustrated non-limitingly as an example in the diagrams of the attached drawings, and in the drawings, similar reference numbers refer to similar elements, including: [5.1 Respiratory Therapy System] [Figure 1A]The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow that receives positively pressurized air supplied from an RPT device 4000. The air from the RPT device 4000 is regulated in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bedmate 1100 is also shown. The patient is sleeping in a supine position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives positive-pressure air supplied 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. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000 in the form of a full-face mask that receives positive-pressure air supplied 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 is sleeping in a lateral sleeping position. [5.2 RPT device] [Figure 2A] This shows an RPT device based on one form of this technology. [Figure 2B] This is a schematic diagram of the pneumatic passage of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the pneumatic passage between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 2C] A schematic diagram of an electrical component of an RPT device based on one embodiment of this technology. [Figure 2D] This is a schematic diagram of an algorithm implemented in an RPT device using one form of this technology. [Figure 2E]This flowchart illustrates a method implemented using the therapy engine module shown in Figure 2D, which is one form of this technology. [5.3 Humidifier] [Figure 3A] An isometric view of a humidifier based on one embodiment of this technology is shown. [Figure 3B] This figure shows an isometric view of a humidifier according to one embodiment of this technology, illustrating the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 3C] A schematic diagram of a humidifier based on one form of this technology is shown. [Figure 3D] A cross-sectional view of a humidifier based on one embodiment of this technology is shown. [5.4 Liquid flow separation assembly] [Figure 4A] This diagram shows an exploded isometric view of an RPT device, which, in conjunction with a liquid flow separation assembly, is further connected to a humidifier, as part of one embodiment of this technology. [Figure 4B] Figure 4A shows an exploded isometric view of a liquid flow separation assembly, one embodiment of this technology. [Figure 4C] Figure 4B shows an isometric view of the liquid flow separation assembly, illustrating the inner surface of the distal panel. [Figure 4D] Figure 4B shows an isometric view of the liquid flow separation assembly, illustrating the outer surface of the distal panel. [Figure 4E] Figure 4B shows an isometric view of the liquid flow separation assembly, illustrating the internal surface of the proximal panel. [Figure 4F] Figure 4B shows an isometric view of the liquid flow separation assembly, illustrating the external surface of the proximal panel. [Figure 4G] Figure 4B shows an isometric view of the liquid flow separation assembly, illustrating the internal surface of the proximal panel. [Figure 4H] Figure 4B shows an isometric view of the liquid flow separation assembly, illustrating the inner surface of the distal panel. [Figure 4I] Figure 4B shows a cross-sectional view of the liquid flow separation assembly. [Figure 5A] This shows an exploded isometric view of another example of a liquid flow splitting assembly using one embodiment of this technology. [Figure 5B] This shows an isometric view of the inner surface of the distal panel of the liquid flow distribution assembly. [Figure 5C]This shows an end view of the inner surface of the distal panel of a liquid flow separation assembly. [Figure 5D] This shows an isometric view of the internal surface of the proximal panel of the liquid flow distribution assembly. [Figure 5E] This shows an end view of the outer surface of the proximal panel of the liquid flow distribution assembly. [Figure 5F] This shows an isometric view of the recesses within the inner surface of the proximal panel of the liquid flow distribution assembly. [Figure 5G] This shows a cross-sectional view of a recess within the inner surface of the proximal panel of a liquid flow distribution assembly. [Figure 5H] A cross-sectional view of the liquid flow separation assembly is shown. [Modes for carrying out the invention]

[0062] [6. Detailed explanation of the technology example] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and that these examples are subject to change. It should also be understood that the terminology used in this disclosure is intended solely to illustrate the specific examples discussed herein and is not limiting.

[0063] The following description is provided in relation to a variety of examples that may share one or more common properties and / or features. It should be understood that one or more features of any example may be combined with one or more features of another example or any other example. In addition, any single feature or combination of features in any of the examples may constitute further examples.

[0064] [6.1 Humidifier] [6.1.1 Overview of Humidifiers] Respiratory humidifiers are available in a variety of forms and may be standalone devices connected to an RPT device via an air circuit, integrated with an RPT device, or configured to connect directly to an associated RPT device. While known passive humidifiers provide a certain level of comfort, for patient comfort, heated humidifiers can generally be used to provide sufficient humidity and temperature to the air. In an example, the humidifier includes a water reservoir or tank with a capacity of several hundred milliliters (ml), a heating element for heating the water in the reservoir, a control unit that allows for variation in the level of humidification, a gas inlet for receiving gas from a flow generator or RPT device, and a gas outlet adapted to connect to an air circuit that delivers the humidified gas to the patient interface.

[0065] Heat passover humidification is a common form of humidification used with RPT devices. In such humidifiers, the heating element may be incorporated within a heater plate (which is in thermal contact with and located beneath the water reservoir). Heat is then transferred from the heater plate to the water reservoir, primarily by conduction. As the airflow from the RPT device passes over the heated water in the reservoir, water vapor is incorporated into the airflow. The ResMed H4i® and H5i® humidifiers are examples of such heat passover humidifiers used in combination with the ResMed S8 and S9 CPAP devices, respectively.

[0066] Other types of humidifiers may also be used (e.g., bubble humidifiers or diffuser humidifiers, jet humidifiers, or wicking humidifiers). In bubble humidifiers or diffuser humidifiers, air conducts beneath the surface of the water and forms bubbles as it returns to the top. Jet humidifiers produce aerosols of water, and baffles or filters can be used to remove or evaporate particles before they leave the humidifier. Wicking humidifiers use absorbent materials such as sponges or paper to absorb water by capillary action. The absorbent material is placed adjacent to or inside at least a portion of the airflow path to allow water within the absorbent material to evaporate and be taken into the airflow.

[0067] An alternative form of humidification is provided by the ResMed HumiCare® D900 humidifier, which uses CounterStream® technology, directing airflow over a large surface area in a first direction while supplying heated water to the large surface area in the opposite, second direction. The ResMed HumiCare® D900 humidifier can be used with a variety of invasive and non-invasive ventilators.

[0068] In one embodiment of this technology, a humidifier 5000 (for example, as shown in Figure 3A) is provided to change the absolute humidity of the air or gas to be delivered to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and temperature of the airflow (relative to the ambient air) before delivery to the patient's airway.

[0069] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some embodiments, as shown in Figures 3A and 3B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006 adapted to receive the humidifier reservoir 5110 and which may include a heating element 5240.

[0070] [6.1.2 Humidifier components] [6.1.2.1 Water Reservoir] In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain volume of liquid, such as water, to evaporate for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum volume of water to provide sufficient humidification for at least the duration of a respiratory therapy session (e.g., an overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other configurations, the humidifier 5000 may be configured to receive water from an external water source (e.g., a building's water supply system).

[0071] In one embodiment, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 as the airflow passes through it. In one embodiment, the water reservoir 5110 may be configured to facilitate the airflow's movement within a meandering path that penetrates the reservoir 5110 while in contact with a certain volume of water inside it.

[0072] In one embodiment, the reservoir 5110 may be removable from the humidifier 5000 in an outward direction, for example, as shown in Figures 3A and 3B.

[0073] The reservoir 5110 may also be configured to prevent liquid from flowing out when the reservoir 5110 is displaced and / or rotated, for example, through any opening and / or between its subcomponents, from its normal operating orientation. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent leakage and / or loss of air pressure due to flow impedance.

[0074] [6.1.2.2 Conductive parts] In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed volume of liquid within the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be appropriate. The conductive portion 5120, in whole or in part, may consist of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved by a less conductive material in an appropriate geometry.

[0075] [6.1.2.3 Humidifier Reservoir Dock] In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 3B) configured to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking feature (for example, a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0076] [6.1.2.4 Water level indicator] The humidifier reservoir 5110 may include a water level indicator 5150, as shown in Figures 3A and 3B. 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 of the volume 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 (e.g., 25%, 50%, or 75%), or a volume (e.g., 200 ml, 300 ml, or 400 ml).

[0077] [6.1.2.5 Humidifier Transducer (Single or Multiple)] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 in place of, or in addition to, the transducer 4270 described above. The humidifier transducer 5210 may include one or more of the following: an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in Figure 3C. The humidifier transducer 5210 may produce one or more output signals that can be transmitted to a controller (e.g., a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier transducer may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while transmitting output signals to the controller.

[0078] [6.1.2.5.1 Pressure Transducer] One or more pressure transducers 5212 may be provided in the humidifier 5000 in place of, or in addition to, the pressure sensors 4272 provided in the RPT device 4000. 6.1.2.5.2 Flow Transducer

[0079] One or more flow transducers 5214 may be provided in the humidifier 5000 in place of, or in addition to, the flow sensors 4274 provided in the RPT device 4000. 6.1.2.5.3 Temperature Transducer

[0080] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure the temperature of one or more (e.g., of the heating element 5240 and / or the airflow downstream of the humidifier outlet 5004). In some embodiments, the humidifier 5000 may further include a temperature sensor 5216 for detecting the temperature of the ambient air.

[0081] [6.1.2.5.4 Humidity Transducer] In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas, such as ambient air. In some embodiments, the humidity sensors 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors.

[0082] [6.1.2.6 Heating elements] In some cases, a heating element 5240 may be supplied to a humidifier 5000 to provide heat input to one or more of a certain volume of water and / or airflow in a humidifier reservoir 5110. The heating element 5240 may include heat-generating components such as an electrically resistive heating track. One suitable example of a heating element 5240 is a layered heating element, for example, described in Patent Document 3, which is incorporated herein by reference in its entirety.

[0083] In some configurations, the heating element 5240 may be provided within the humidifier base 5006, where heat may be supplied to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 3B.

[0084] [6.1.2.7 Humidifier Controller] In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250, as shown in Figure 3C. In one embodiment, the humidifier controller 5250 is part of the central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller and may communicate with the central controller 4230.

[0085] In one embodiment, the humidifier controller 5250 may receive, for example, measurements of airflow, water in the reservoir 5110, and / or characteristics of the humidifier 5000 (e.g., temperature, humidity, pressure, and / or flow rate) as input. The humidifier controller 5250 may also be configured to run or implement a humidifier algorithm and / or deliver one or more output signals.

[0086] As shown in Figure 3C, the humidifier controller 5250 may include one or more controllers, for example, 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 heated element controller 5252 configured to control the temperature of the heated element 5240.

[0087] [6.1.3 Liquid ingress from humidifiers] According to one aspect of this technology, the humidifier 5000 may have a body including an external housing 5300. In one example, the housing 5300 may be formed of two parts (an upper part 5302 and a lower part 5304). The body of the humidifier 5000 further includes a chassis 5310.

[0088] References to chassis in this specification should be understood to mean the support frame of the structure, i.e., one or more other components, more specifically, a structural element configured to support one or more internal components of the humidifier 5000. References to housing should be understood to mean an element that covers or protects the other components of the structure. In one example, the housing 5300 is provided to cover or protect the chassis 5310 at least partially. In an alternative example, the humidifier 5000 may include a housing 5310 configured to function as the chassis 5310. In an alternative example, the humidifier 5000 may include the chassis 5310 but not the separate housing itself.

[0089] In the example, the humidifier 5000 includes a removable container in the form of a water reservoir 5110. The chassis 5310 is configured to position and support the removable reservoir 5110 when in use. In the example shown in Figure 3D, the reservoir 5110 is inserted and removed from the end of the humidifier. In an alternative example, the reservoir 5110 may be removed from the side (i.e., outward) of the humidifier 5000, or from above or below (i.e., vertically). Patent Document 4 describes exemplary configurations for a humidifier having a removable water reservoir, the entire contents of which are incorporated herein by reference.

[0090] In an alternative example, the chassis 5310 may include a chamber that functions as a water reservoir 5110 (i.e., not removable, but integrated with the chassis 5310).

[0091] There are various situations in which water from reservoir 5110 can pass through chamber inlet port 5314 (including situations where humidifier 5000 or the stand on which it is placed is struck hard, creating a splashing effect, or situations where humidifier 5000 is lightly struck when moved or reorienting it).

[0092] According to one aspect of this technology, as shown in Figure 3D, the humidifier 5000 includes a closing element in the form of a chassis cap 5330. In this example, the chassis cap 5330 is configured to seal the humidifier housing 5300 and the humidifier chassis 5310, as further described below.

[0093] In this example, the chassis cap 5330 includes an air inlet port 5334 configured to be connected to an airflow source, such as an RPT device 4000, under positive pressure.

[0094] In some configurations, a gas passage provided between the air inlet port 5334 and the chamber inlet port 5314 forms a liquid trap 5380 for holding a certain volume of water spilled through the chamber inlet port 5314.

[0095] There are various situations in which water from the reservoir 5110 may pass through the chamber inlet port 5314 (including situations in which the humidifier 5000 or the stand on which it is placed is struck forcefully, creating a splashing effect, or situations in which the humidifier 5000 is lightly struck when it is moved or reoriented). A liquid trap 5380 is provided to hold a certain volume of this spilled water and reduce the possibility of the water reaching other components upstream of the system (more specifically, the RPT device 4000).

[0096] An advantage of the embodiments of the liquid diversion assembly described herein is that a simple, cost-effective, and user-friendly mechanism is obtained to prevent damage to the RPT device that may result from the humidifier being "sloshed around" or "bumped" (which cause liquid to flow from the reservoir 5110 through the chamber inlet port 5314 into the pneumatic block 4020 (which houses the motor 4144 and various sensors in addition to power supply)). This liquid flow may be caused by direct splashing, leakage at a non-watertight connection in the air inlet passage 5334, or both.

[0097] [6.2 Therapy] In one embodiment, the technology includes a method for treating respiratory distress, which involves applying positive pressure to the airway entrance of patient 1000.

[0098] In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0099] In certain applications of this technology, mouth breathing is restricted, limited, or prevented.

[0100] [6.3 Respiratory Therapy Systems] In one embodiment, the technology includes a respiratory therapy system for the treatment of respiratory disorders. The respiratory therapy system may include an RPT device 4000 that supplies airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0101] [6.4 RPT Devices] An RPT device 4000 according to one aspect of this technology includes mechanical components, pneumatic components, and / or electrical components, and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway to treat one or more respiratory diseases described elsewhere in this document.

[0102] In one embodiment, the RPT device 4000 is constructed and positioned 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.

[0103] The RPT device may have an external housing 4010 formed of two parts (an upper part 4012 and a lower part 4014). Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 supporting one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0104] The pneumatic passage of the RPT device 4000 may include one or more pneumatic passage items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124, and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0105] One or more of the air passage items may be located within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be located within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of a chassis 4016.

[0106] The RPT device 4000 may include a power supply unit 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202.

[0107] [6.4.1 Mechanical and pneumatic components of RPT devices] An RPT device may include one or more of the following components within an integrated unit. In one alternative configuration, one or more of the following components may each be located as separate units.

[0108] [6.4.1.1 Air Filter (Single or Multiple)] An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0109] In one embodiment, the inlet air filter 4112 is located upstream of the pressure generator 4140 at the beginning of the pneumatic passage.

[0110] In one embodiment, the outlet air filter 4114, for example, an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0111] [6.4.1.2 Muffler (singular or plural)] An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0112] In one embodiment of this technology, the inlet muffler 4122 is located upstream of the pressure generator 4140 in the pneumatic passage.

[0113] In one embodiment of this technology, the outlet muffler 4124 is located in the pneumatic passage between the pressure generator 4140 and the patient interface 3000.

[0114] [6.4.1.3 Pressure Generator] In one embodiment of this technology, the pressure generator 4140 for producing an airflow or supply at positive pressure 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 within a volute. When delivering respiratory pressure therapy, the blower may deliver the supply of air at a rate of, for example, up to about 120 liters / minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O. The blower may be described in any one of the following patent documents: Patent Document 5; Patent Document 6; Patent Document 7; and Patent Document 8 (the contents of which are incorporated herein by reference in their entirety).

[0115] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0116] 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.

[0117] [6.4.1.4 Transducer (singular or plural)] The transducer may be located inside or outside the RPT device. The external transducer may be located on, for example, an air circuit (e.g., a patient interface), or may form part of it. The external transducer may take the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0118] In one embodiment of this technology, one or more transducers 4270 may be located upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 may be constructed and positioned to generate signals representing the characteristics of the airflow at that point in the pneumatic path, such as flow rate, pressure, or temperature.

[0119] In one embodiment of this technology, one or more transducers 4270 may be located in close proximity to the patient interface 3000.

[0120] In one configuration, the signal from transducer 4270 is filtered, for example, by low-pass, high-pass, or band-pass filtering.

[0121] [6.4.1.4.1 Flow Sensor] The flow sensor 4274 based on this technology may be based on a differential pressure transducer, for example, a differential pressure transducer from SENSIRION's SDP600 series.

[0122] In one configuration, the signal generated by the flow sensor 4274 and representing the flow rate is received by the central controller 4230.

[0123] [6.4.1.4.2 Pressure Sensor] The pressure sensor 4272 in this technology is positioned to communicate with both the pneumatic passage and the fluid. A suitable example of a pressure sensor is a transducer from the HONEYWELL ASDX series. A suitable alternative pressure sensor is a transducer from the GENERAL ELECTRIC NPA series.

[0124] In one configuration, the signal generated by the pressure sensor 4272 is received by the central controller 4230.

[0125] [6.4.1.4.3 Motor Speed ​​Transducer] In one embodiment of this technology, a motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be a speed sensor, such as a Hall effect sensor.

[0126] [6.4.1.5 Anti-spillback valve] In one embodiment of this technology, the anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the motor 4144.

[0127] [6.4.1.6 Liquid Flow Diversion Assembly] In one embodiment of this technology, as shown in Figure 4A, the housing 4010 includes a closing element in the form of an end cap 6012. In this example, the end cap 6012 is configured to seal the housing 4010 and can be selectively connected to a compatible medical device (e.g., a humidifier 5000 as further described below).

[0128] In one embodiment best shown in Figure 4B, the end cap 6012 includes at least one connecting component 6038, which includes a gas opening 6035 configured to communicate fluidly with the outlet of the pneumatic block 4020 when in use; at least one opening 6034; and at least one recess 6036, where at least one opening 6034, recess 6036, and connecting component 6038 are configured to facilitate selective connection to the humidifier 5000. In other embodiments of the Art, there are multiple possible embodiments of the external portion including one or more different configurations of the opening 6034, the connecting component 6038, and / or the recess 6036 (for example, as illustrated in the exemplary end cap 6012 shown in Figure 5A).

[0129] In one embodiment of this technology, the end cap 6012 includes at least one internal channel in fluid communication with at least one opening 6034 (also referred to herein as an internal fluid passage) to divert liquid "spilled" from a selectively connected humidifier 5000, or alternatively, liquid accidentally spilled by the user onto the RPT device, to the outside of the housing 4010. In further embodiments, the end cap 6012 may include multiple internal channels for diverting liquid from multiple openings, connecting components, or recesses, and may be configured in a variety of forms depending on the nature of the selective, compatible accessory or medical device. Thus, in this specification, the end cap 6012 is referred to as a liquid diversion assembly.

[0130] In one embodiment, the end cap 6012 may be constructed from a plurality of panels, for example, a proximal panel 6016 and a distal panel 6024. Each panel is referred to as having an internal surface (e.g., surfaces 6018 and 6026, respectively) and an external surface (e.g., surfaces 6022 and 6030, respectively). These panels 6016, 6024 may be assembled such that during operational orientation, the proximal panel 6016 is proximal to the electrical components of the medical device 4000, and the distal panel 6024 is distal to the electrical components of the medical device 4000 (i.e., closer to them when selectively coupled to the humidifier 5000). These panels 6016, 6024 are mechanically, thermally, or ultrasonically bonded to form the end cap 6012. In an alternative embodiment, one or more additional panels may be included within the end cap 6012. In further alternative forms, a single panel may be constructed with an internal configuration similar to that described herein, for example, by molding or 3D printing (i.e., providing one or more internal channels).

[0131] A proximal panel 6016 provided in one embodiment of the present technology includes an internal surface 6018 configured to include at least one projection that forms a guide wall 6020. The guide wall 6020 may project from the internal surface 6018 of the panel 6016 at a substantially perpendicular angle, but projections at other angles may also be appropriate. The proximal panel 6016 may further include at least one recess 6036. In use, such a recess 6036 may receive a fastening element of the humidifier 5000 (e.g., a barbed latch inserted through an opening 6034 and configured to hook onto the internal surface 6026 of the distal panel 6024) or a component of an electrical connector (e.g., a PCB assembly connected to a wire harness, to which complementary electrical connectors may be connected). In such an example, the at least one projection forming the guide wall 6020 may extend from a position related to the area defined by the at least one recess 6036. In some embodiments, at least the guide wall 6020 may include one or more upper portions extending along the internal surface 6018 at a position above at least one recess 6036 when the end cap 6012 is in an operational or use orientation. In some embodiments, at least the guide wall 6020 may include one or more outer portions extending along the internal surface 6018 at a position on the side of at least one recess 6036. For example, in the example shown in Figure 4E, the outer portions may connect between the two upper portions. In some embodiments, at least one guide wall 6020 may substantially surround at least one recess 6036. In some embodiments, at least one guide wall 6020 may extend beyond the periphery of at least one recess 6036, for example, to connect to the periphery of panel 6016.

[0132] In some embodiments of this technology, at least one guide wall 6020 may be molded from the same material as the proximal panel 6016, although the guide wall 6020 may also be formed from a flexible material (e.g., silicone) or, alternatively, constructed from a hydrophobic film.

[0133] In one embodiment, the end cap 6012 may include a distal panel 6024 located distal to the medical device 4000. The distal panel 6024 may include a connecting opening 6040 configured to receive a connecting component 6038 (for example, shaped to fit around the connecting component 6038). The distal panel 6024 may include an internal surface 6026 configured to include at least one projection that provides a positioning feature 6028. The at least one positioning feature 6028 may extend at an angle substantially perpendicular to the internal surface 6026 of the panel 6024. The distal panel 6024 may further include at least one opening 6034 between the internal surface 6026 and the external surface 6030. The at least one positioning feature 6028 may extend from a position associated with the region defined by the at least one opening 6034. In some forms, the positioning feature 6028 may substantially surround at least one opening 6034.

[0134] In the example, the distal panel 6024 may further include a peripheral wall 6029. The peripheral wall 6029 may extend along at least a portion of the peripheral portion of the panel 6024 at an angle substantially perpendicular to the internal surface 6026 of the panel 6024. In the example, the peripheral wall 6029 may extend along the internal surface 6026 of the panel 6024 at a position radially outward of the opening 6034. In the example, the peripheral wall 6029 may extend along the internal surface 6026 of the panel 6024 at a position radially outward of at least one guide wall 6034. In the example, a portion of the peripheral wall 6029 may extend along the internal surface 6026 of the panel 6024 at a position above at least one guide wall 6020. In the example, a portion of the surrounding wall 6029 may extend along the inner surface 6026 of the panel 6024 at a position offset outward from at least one guide wall 6020 (i.e., to the side of the guide wall(s) 6020).

[0135] During operation, liquid can penetrate the RPT device 4000 in numerous ways. Liquid ingress may occur around the end cap 6012 if the user accidentally splashes or lightly taps the device with liquid, or through one or more openings 6034 and recesses and 6036 if used without a connected humidifier. When connected to a humidifier 5000, liquid can flow from the reservoir 5110 (for example, through a non-watertight connector cooperating with one or more openings 6034). If liquid penetrates the device from the humidifier 5000 around the end cap 6012 or through a non-watertight connector, according to some embodiments of the art, an end cap 6012 is provided that includes multiple panels 6016, 6024. When the proximal 6016 and distal 6024 panels are connected into the end cap 6012, the internal surfaces 6018 and 6026 and at least one guide wall 6020 cooperate to form at least one internal fluid passage 6041 within the end cap 6012, as illustrated in the cross-sectional view of Figure 4I. In the example, a positioning feature(single or multiple) 6028 may cooperate with at least one guide wall 6020 to provide a watertight seal. In an alternative example, a positioning feature(single or multiple) 6028 may interact with the guide wall(single or multiple) 6020 to position the panels 6016 and 6024 relative to each other, thereby creating a seal between the guide wall(single or multiple) 6020 and the internal surface 6026 of the distal panel 6024.

[0136] In the examples shown in Figures 4B to 4I, the internal fluid passage 6041 has a watertight perimeter that contains liquid that enters through the opening 6034 and recess 6036, and functions as a channel that diverts any liquid that enters towards the underside or lower portion of the end cap 6012, where the watertight perimeter has a gap 6039 that allows the liquid to escape to the outer surface of the RPT device housing 4010 by gravity, capillary action or other natural forces. Thus, the infiltrated liquid is diverted away from the sensitive electrical components of the RPT device 4000, as described below. One or more of the lower surfaces of the recess 6036 may also be curved upward (or more generally, angled from an upper position to a lower position on the internal surface 6018), as shown in Figure 4I, so that any infiltrated liquid does not accumulate in the recess 6036 but flows out through the internal fluid passage 6041 towards the underside of the end cap 6012 by the action of gravity.

[0137] In some cases, one or more of the surfaces forming the fluid passages are coated with a hydrophobic material to facilitate faster diversion of the liquid to the outside of the housing 4010.

[0138] While the exemplary end cap 6012 in Figures 4B to 4I has been described with reference to the guide wall 6020 provided on the inner surface 6018 of the proximal panel 6016 and the positioning feature(single or multiple) 6028 and surrounding wall 6029 provided on the inner surface 6026 of the distal panel 6024, it should be understood that in alternative examples, the reverse arrangement, or a combination thereof, may be used to provide internal fluid passages(single or multiple).

[0139] Figure 5A shows another example of a closure element in the form of an end cap 6012 according to an aspect of the present technology. In this example, the end cap 6012 is configured to selectively connect to a compatible medical device (e.g., a humidifier 5000) to seal its housing 4010. As generally described above, the end cap 6012 is configured to facilitate selective connection to the humidifier 5000.

[0140] In this example, the end cap 6012 includes a proximal panel 6016 having an internal surface 6018 and an external surface 6022, and a distal panel 6024 having an internal surface 6026 and an external surface 6030. In this example, the distal panel 6024 includes an electrical connector recess 6042 within its external surface 6030 (i.e., protruding from the internal surface 6026). The proximal panel 6016 includes an electrical connector opening 6044 through which the electrical connector recess 6042 protrudes. The electrical connector PCB assembly 6046 is mounted on a standoff of the electrical connector recess 6042 on the external side of the proximal panel 6016. When in use, the electrical connector is inserted into the electrical connector recess 6042 and interfaces with the corresponding connector connected to the PCB assembly 6046.

[0141] In this example, the distal panel 6024 includes a plurality of openings 6034. On the inner surface 6026 of the distal panel 6024, a plurality of positioning features 6028 are provided around each opening 6034 and extend at an angle substantially perpendicular to the inner surface 6026 of the panel 6024. In this example, the positioning features 6028 may be provided at upper and / or lower positions relative to each opening 6034. In this example, the length of the upper and / or lower positioning features 6028 across the inner surface 6026 (i.e., outward direction) may be less than the width of the associated opening 6034. In this example, the positioning features 6028 may be provided at one or more outer positions relative to each opening 6034 (i.e., one or more sides of the opening 6034). In the illustrated example (see, for example, Figure 5C), the positioning feature portions 6028 are separate (i.e., not connected to each other) and have gaps between them.

[0142] In the example, the distal panel 6024 may further include a peripheral wall 6029. The peripheral wall 6029 may extend along at least a portion of the peripheral portion of the panel 6024 at an angle substantially perpendicular to the internal surface 6026 of the panel 6024. In the illustrated example (see, for example, Figure 5C), the peripheral wall 6029 extends around the peripheral portion of the panel 6024 and has a peripheral wall gap 6048 located below the opening 6034.

[0143] In this example (see, for example, Figure 5D), the proximal panel 6016 includes guide projections 6050 protruding from the inner surface 6018 of panel 6016. In this example, the guide projections 6050 surround each of the recesses 6036. Referring to Figure 5F, in this example, the guide projections 6050 include a raised base 6052 and a guide projection 6054 extending from the raised base 6052. In this example, the guide projection 6054 has a radially outward-facing surface and a radially inward-facing surface that taper toward each other and intersect at a sharp apex; however, it should be understood that in alternative examples, the apex may be rounded or flat. In this example, a flat portion is provided between the radially outward edge of the raised base 6052 and the guide projection 6054. In the alternative example, the guide projection 6054 may extend directly from the internal surface 6018 (i.e., the guide projection 6050 may not include the raised base 6052).

[0144] Referring to Figure 5D, in this example, the proximal panel 6016 includes a positioning wall 6056 protruding from the internal surface 6018 of panel 6016. The positioning wall 6056 extends along the internal surface 6018 at a radially outward position relative to the recess 6036 and aligns with the perimeter wall 6029 of the distal panel 6024 when formed as an end cap 6012. The positioning wall 6056 also includes a positioning wall gap 6058 substantially aligned with the perimeter wall gap 6048 of the distal panel 6024.

[0145] Referring to Figures 5G and 5H, when the end cap 6012 is formed by joining the proximal panel 6016 and the distal panel 6024, an internal fluid passage 6041 is formed between them. The surrounding wall 6029 and the positioning wall 6056 cooperate to form a seal, more specifically, around the periphery of the internal fluid passage 6041 that extends around the entire surface including the opening 6034 and recess 6036, except for the gap 6039 created by the positioning wall gap 6058 and the surrounding wall gap 6048 at the lower position. In this example, the seal extends around the connecting component 6038 and the connecting opening 6040. Liquid entering the internal fluid passage 6041 can flow through the gap 6039 outside the end cap 6012. Referring particularly to Figure 5G, in this example, liquid moving downward toward or out of the recess 6036 is guided by the shaped surface of the guide projection 6050 toward the internal surface 6026 and flows down the internal fluid passage 6041 toward the gap 6039.

[0146] [6.4.2 Electrical components of RPT devices] [6.4.2.1 Power supply] The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0147] In one embodiment of this technology, the power supply 4210 provides power only to the RPT device 4000. In another embodiment of this technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0148] [6.4.2.2 Input Devices] In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials, enabling a person to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. In one embodiment, the buttons, switches, or dials may be physically connected to an external housing 4010, or in another embodiment, they may be wirelessly connected to a receiver electrically connected to a central controller 4230.

[0149] In one embodiment, the input device 4220 may be constructed and configured to allow a person to select values ​​and / or menu options.

[0150] [6.4.2.3 Central Controller] In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0151] Suitable processors may include x86 Intel processors, processors based on ARM® Cortex®-M processors from ARM Holdings (e.g., STM32 series microcontrollers from ST MICROELECTRONICS). In certain alternative forms of this technology, 32-bit RISC CPUs such as STR9 series microcontrollers from ST MICROELECTRONICS manufactured by TEXAS INSTRUMENTS, or 16-bit RISC CPUs such as processors from the MSP430 family of microcontrollers may also be suitable.

[0152] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0153] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 includes discrete electronic components.

[0154] The central controller 4230 may be configured to receive input signals (one or more) from one or more transducers 4270, one or more input devices 4220, and humidifiers 5000.

[0155] The central controller 4230 may be configured to provide output signals (one or more) to one or more of the output devices 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0156] In some embodiments of this technology, the central controller 4230 is configured to implement one or more methodologies described herein (e.g., one or more algorithms 4300 expressed as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260). In some embodiments of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methodologies may be performed by a remotely located device. For example, a remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing stored data (e.g., from any of the sensors described herein).

[0157] [6.4.2.4 Clocks] The RPT device 4000 may include a clock 4232 connected to the central controller 4230.

[0158] [6.4.2.5 Therapeutic Device Controllers] In one embodiment of this technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0159] In one embodiment of this technology, the therapy 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.

[0160] [6.4.2.6 Protection circuit] One or more protection circuits 4250 in this technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0161] [6.4.2.7 Memory] According to one embodiment of this technology, the RPT device 4000 includes a memory 4260, for example, a non-volatile memory. In some embodiments, the memory 4260 may include a battery-powered static RAM. In some embodiments, the memory 4260 may include a volatile RAM.

[0162] Memory 4260 may be located on PCBA4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0163] As an addition or alternative, the RPT device 4000 may include a removable form of memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.

[0164] In one embodiment of this technology, the memory 4260 functions as a non-temporary computer-readable storage medium that stores computer program instructions representing one or more methodologies (e.g., one or more algorithms 4300) described herein.

[0165] [6.4.2.8 Data Communication System] In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0166] 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 processor.

[0167] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0168] In one configuration, the local external communication network 4284 utilizes one or more communication standards (e.g., Bluetooth or consumer infrared protocol).

[0169] In one embodiment, the remote external device 4286 is one or more computers, for example, a cluster of networked computers. In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, a person with appropriate authorization, such as a clinician, can access such a remote external device 4286.

[0170] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control.

[0171] [6.4.2.9 Optional output devices including displays and alarms] The output device 4290 according to this technology may take the form of one or more of visual, auditory, and tactile units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0172] [6.4.2.9.1 Display Driver] The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input and converts them into commands to display these characters, symbols, or images on the display 4294.

[0173] [6.4.2.9.2 Display] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an 8-segment display, in which case the display driver 4292 translates each character or symbol (e.g., the digit "0") into eight logical signals indicating whether each of the eight segments should be activated to display a particular character or symbol.

[0174] [6.4.3 RPT Device Algorithm] As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300 expressed as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260. The algorithms 4300 are grouped into groups generally called modules.

[0175] In other forms of this technology, part or all of the algorithm 4300 may be implemented by a controller of an external device (e.g., a local external device 4288 or a remote external device 4286). In such a form, data representing input signals and / or intermediate algorithm outputs required for part of the algorithm 4300 executed on the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such a form, part of the algorithm 4300 executed on the external device may be represented as a computer program stored in a non-temporary computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute part of the algorithm 4300.

[0176] In this configuration, therapeutic parameters generated by an external device via the therapeutic engine module 4320 (when this configuration forms part of an algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 and sent to the therapeutic control module 4330.

[0177] [6.5 Air Circuit] An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and arranged to allow airflow to move between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0178] In particular, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be called an air delivery tube. In some cases, the circuit may have separate branches for inhalation and exhalation. In other cases, a single branch is used.

[0179] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air within the air circuit, for example, to maintain or increase the temperature of the air. The heating elements may take the form of a heated wire circuit and may include one or more transducers, such as temperature sensors. In one embodiment, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may communicate with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heated wire circuit is described in Patent Document 9, which is incorporated herein by reference in its entirety.

[0180] [6.5.1 Delivery of Refill Gas] In one embodiment of this technology, a supplemental gas, such as oxygen 4180, can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface.

[0181] [6.6 Glossary] For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. In other forms of this technology, alternative definitions may apply.

[0182] [6.6.1 General] Air: In certain forms of this technology, air may be interpreted as meaning the atmosphere, and in other forms of this technology, air may be interpreted as meaning a combination of several other breathable gases (e.g., oxygen-rich air).

[0183] Surroundings: In certain forms of this technology, the term surroundings is interpreted to mean (i) the area outside the treatment system or patient, and (ii) the environment directly surrounding the treatment system or patient.

[0184] For example, the ambient humidity for a humidifier could be the humidity of the air directly surrounding the humidifier (e.g., the humidity in the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0185] In another example, ambient pressure could be the pressure directly surrounding the body or the pressure outside the body.

[0186] In certain contexts, ambient (e.g., acoustic) noise may be considered as background noise levels within the room where the patient is located, rather than noise generated by, for example, an RPT device or emitted from a mask or patient interface. Ambient noise may originate from sources outside the room.

[0187] Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy that automatically adjusts the therapeutic pressure between a minimum and maximum limit, for example, with each breath, depending on the presence or absence of signs of a short-dose brain event (SDB).

[0188] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's entire respiratory cycle. In some forms, the pressure at the airway entrance is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increasing in response to the detection of signs of partial upper airway obstruction and decreasing if signs of partial upper airway obstruction are not present).

[0189] Humidifier: The term humidifier is interpreted as a humidifying device that is constructed and positioned, or consists of a physical structure, to provide a therapeutically beneficial amount of water (H2O) vapor into the airflow in order to improve a patient's medical respiratory illness.

[0190] Leak: The term leak is interpreted as an unintended flow of air or liquid.

[0191] Patient: A person, regardless of whether they have a respiratory illness or not.

[0192] Pressure: Force per unit area. Pressure is expressed as cmH2O, gf / cm². 2It can be expressed in a variety of units, including hectopascals. 1 cmH2O is 1 g-f / cm³. 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2 (=1 millibar to 0.001 atm). Unless otherwise specified in this specification, pressure is given in units of cmH2O.

[0193] The pressure within the patient interface is denoted by the symbol Pm, while the therapeutic pressure, representing the target value to be achieved by the interface pressure Pm at the present time, is denoted by the symbol Pt.

[0194] Respiratory pressure therapy (RPT): Applying air to the airway entrance at a therapeutic pressure that is typically positive relative to the atmosphere.

[0195] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0196] [6.6.1.1 Materials] Silicone or silicone elastomer: synthetic rubber. In this specification, reference to silicone refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products marketed under this trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. 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 by ASTM D2240.

[0197] Polycarbonate is a thermoplastic polymer of bisphenol A carbonate.

[0198] [6.6.1.2 Mechanical properties] Elasticity: The ability of a material to absorb energy when it undergoes elastic deformation and release that energy when the load is removed.

[0199] Elastic: Releases virtually all energy when the load is removed. Examples include certain silicones and thermoplastic elastomers.

[0200] Hardness: The material's ability to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size). "Soft" materials may include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure. "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0201] 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 (e.g., compression, tension, bending, or torsion). A structure or component may offer different resistances in different directions. The opposite of stiffness is flexibility.

[0202] A flimsy structure or component: A structure or component whose shape changes (e.g., bends) within a relatively short period of time (e.g., 1 second) when it is required to support its own weight.

[0203] Rigid structures or components: Typically, structures or components that do not substantially change shape when subjected to the loads they face during use. An example of such an application might be setting up and maintaining a patient interface in a sealed relationship with the entrance to the patient's airway under a pressure load of approximately 20-30 cmH2O.

[0204] For example, an I-beam may exhibit different bending stiffness (resistance to bending load) in the first direction compared to a second orthogonal direction. In another example, a structure or component may be flexible in the first direction and rigid in the second direction.

[0205] [6.6.2 Structure Shape] Products based on this technology may include one or more three-dimensional mechanical structures, such as a mask cushion or an impeller. The three-dimensional structure may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, position, function or any other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contact (e.g., outer) surface and separate non-face-contact (e.g., bottom or inner) surfaces. In yet another example, the structure may include a first surface and a second surface.

[0206] To facilitate the description of the surface and three-dimensional structure shapes, the inventors first consider a cross-section passing through the surface of the structure at point p. The outward normal vector at p points away from the surface. In some examples, the inventors describe the surface from the perspective of a hypothetical small person standing upright on the surface.

[0207] [6.6.2.1 Curvature in one dimension] The curvature of a plane curve at p can be described as having a sign (e.g., positive, negative) and magnitude (e.g., the radius of the circle that touches the curve at 1 / p).

[0208] Positive curvature: When a curve at point p curves toward its outward normal, the curvature at that point is interpreted as positive (a hypothetical small person would have to walk uphill to leave point p). Such curves are often called concave.

[0209] Zero curvature: If the curve at point p is a straight line, the curvature is interpreted as zero (a hypothetical small person could walk away from point p on flat ground without going up or down).

[0210] Negative curvature: If a curve at point p curves away from its outward normal, the curvature in that direction at that point is interpreted as negative (a hypothetical small person would have to walk downhill to leave point p).

[0211] [6.6.2.2 Curvature of a Two-Dimensional Surface] The description of the shape at a given point on a two-dimensional surface using this technique may include multiple normal cross-sections. These cross-sections may cut the surface in a plane containing an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross-section produces a plane curve with a corresponding curvature. The different curvatures at that point may have the same or different signs. Each curvature at that point may, for example, have a relatively small magnitude.

[0212] Principal curvature and direction: The direction in the normal plane where the curvature of a curve takes its maximum and minimum values ​​is called the principal direction.

[0213] A region on a surface: A set of connected points on a surface. A set of points within a region may have similar properties, such as curvature or sign.

[0214] Saddle region: A region where the principal curvatures have opposite signs at each point (i.e., one is positive and the other is negative) (a hypothetical person could walk uphill or downhill depending on the direction they are facing).

[0215] Dome region: A region where the principal curvatures have the same sign at each point (for example, both are positive ("concave dome"), or both are negative ("convex dome")).

[0216] Cylindrical region: A region where one principal curvature is zero (or zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0217] Planar region: A region of a surface where both principal curvatures are zero (or zero, for example, within manufacturing tolerances).

[0218] Surface edge: The boundary or limit of a surface or area.

[0219] Path: In certain forms of this technology, “path” is interpreted as a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of this technology, “path” can be described, for example, as a route or course involving a set of points on a surface. (For a hypothetical person, a path is where they walk on the surface, similar to a garden path).

[0220] Path Length: In certain forms of this technology, “path length” is interpreted to mean the distance along the surface from f(0) to f(1) (i.e., the distance along the path on the surface). There can be more than one path between two points on the surface, and such paths may have different path lengths. (For a hypothetical person, the path length is the distance that person should walk along the path on the surface).

[0221] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar region, there is a distance on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there can be no path with the same path length as the straight-line distance between two points. (For a hypothetical person, straight-line distance corresponds to the "shortest" distance).

[0222] [6.6.2.3 Hole] A surface may have one-dimensional holes (e.g., holes bounded by planar or spatial curves). A thin-walled structure having holes (e.g., a film) can be described as having one-dimensional holes.

[0223] A structure may have two-dimensional holes (e.g., holes bounded by a surface). For example, an inflatable tire has two-dimensional holes bounded by the inner surface of the tire. In another example, a bladder having a cavity for air or gel may have two-dimensional holes. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or outlet) and a two-dimensional hole bounded by the inner surface of the conduit.

[0224] [6.7 Other Notes] Some of the disclosures in this patent document include material protected by copyright. The copyright holder will not object if someone reproduces this patent document or the patent disclosures, provided that such reproductions are included in the patent files or records of the Patent Office, but otherwise, all copyrights are reserved.

[0225] Unless otherwise explicitly indicated in the context, if a range of values ​​is provided, it is understood that each value intervening between the upper and lower limits of that range, up to one-tenth of the lower limit unit, and any other stated or intervening values ​​within that stated range, are included in this technique. The upper and lower limits of these intervening ranges, which may be independently contained within an intervening range, are also included in this technique, subject to any specifically excluded limits within the stated range. If the stated range includes one or both of the limits, the range excluding one or both of those included limits is also included in this technique.

[0226] Furthermore, where a value(s) is described herein as being implemented as part of the Art, unless otherwise stated, such value(s) may be approximations and may be used with any appropriate number of significant digits to the extent permitted or required in the practical technical implementation.

[0227] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this art pertains. Any methods and materials similar to or equivalent to those described herein may also be used in the implementation or testing of this art, although this specification describes only a limited number of exemplary methods and materials.

[0228] While certain materials are described as suitably used in constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, all components described herein are understood to be manufacturable and can be manufactured together or separately.

[0229] Note that, as used herein and in the appended claims, the singular forms ("a," "an," and "the") include their plural equivalents unless explicitly indicated otherwise in the context.

[0230] All publications mentioned herein are incorporated herein in their entirety by reference to disclose and describe the methods and / or materials that are the subject matter of those publications. Publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present art does not have prior rights to such publications by prior invention. Furthermore, the dates of the publications provided may differ from the actual publication dates, and publication dates may need to be independently verified.

[0231] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may exist, be used, or be combined with other elements, components, or steps that are not explicitly referenced.

[0232] The subject matter titles used in the detailed descriptions are included solely for the convenience of reader reference and should not be used to limit the subject matter found throughout this disclosure or the claims. The subject matter titles should not be used in interpreting the claims or the limitations of the claims.

[0233] The techniques described in this specification have been presented with reference to specific examples, but it should be understood that these examples are illustrative only of the principles and applications of the techniques. In some instances, terms and symbols may suggest specific details that are not necessary for the implementation of the technology. For example, the terms "first" and "second" may be used, but unless otherwise specified, these terms are not intended to indicate any order and may be used to distinguish separate elements. Further, process steps in a methodology may be described or illustrated in an order, but such ordering is not required. One skilled in the art will recognize that such ordering may be changed and / or that the acts may be performed even simultaneously or synchronously.

[0234] Therefore, it should be understood that numerous changes may be made to the examples without departing from the spirit and scope of the technology, and other arrangements may be devised.

Description of Reference Numerals

[0235] 1000 patients 1100 roommates 4000 RPT devices 4010 external housing 4012 upper part 4014 lower part 4015 panel 4016 chassis 4018 handle 4020 pneumatic block 4110 air filter 4112 inlet air filter 4114 outlet air filter 4120 muffler 4122 inlet muffler 4124 outlet muffler 4140 pressure generator 4142 blower 4144 motor 4160 anti-spillback valve 4170 air circuit 4180 Supplementary Oxygen 4200 Electrical Components 4202 Printed Circuit Board Assembly (PCBA) 4210 Power Supply Unit 4220 Input Device 4230 Central Controller 4232 Clock 4240 Therapy Device Controller 4250 Protection Circuit 4260 Memory 4270 Transducer 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed Transducer 4280 Data Communication Interface 4282 Remote External Communication Network 4284 Local External Communication Network 4286 Remote External Device 4288 Local External Device 4290 Output Device 4292 Display Driver 4294 Display 4300 Algorithm 4310 Preprocessing Module 4312 Interface Pressure Estimation Algorithm 4314 Ventilation Flow Estimation 4316 Leakage Flow Estimation 4318 Respiratory Flow Estimation 4320 Therapy Engine Module The Phase Determination Algorithm 4322 Waveform Determination Algorithm 4323 Ventilation Determination Algorithm 4324 Inspiratory Flow Limitation Determination Algorithm 4325 Apnea / Hypopnea Determination Algorithm 4326 Snoring Determination Algorithm 4327 Airway Patency Determination Algorithm 4328 Target Ventilation Determination Algorithm 4329 Therapy Parameter Determination Algorithm 4330 Therapy Control Module 4340 Method 5000 Humidifier 5002 Humidifier Inlet 5004 Humidifier Outlet 5006 Humidifier Base 5110 Reservoir 5120 Conductive Portion 5130 Humidifier Reservoir Dock 5135 Lock Lever 5150 Water Level Indicator 5210 Humidifier Transducer 5212 Air Pressure Sensor 5214 Air Flow Transducer 5216 Temperature Sensor 5240 Heating Element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Air Circuit Controller 5302 Upper Portion 5304 Lower Portion 5310 Chassis 5314 Chamber Inlet Port 5330 Chassis Cap 5334 Air Inlet Port 5380 Liquid Trap 6012 End Cap 6016 Proximal Panel 6018 Inner Surface of Proximal Panel 6020 Guide Wall 6022 Outer Surface of Proximal Panel 6024 Distal Panel 6026 Inner Surface of Distal Panel 6028 Positioning Feature 6029 Peripheral Wall 6030 Outer Surface of Distal Panel 6034 Opening 6035 Gas Opening 6036 Recess 6038 Connecting Components 6039 Gap 6040 Connecting opening 6041 Internal fluid passage 6042 Electrical connector recess 6044 Electrical connector opening 6046 Electrical Connector PCB Assembly 6048 Surrounding wall gap 6050 Guide projection 6052 Raised base 6054 Guide projection 6056 Positioning wall 6058 Positioning wall gap

Claims

1. A liquid flow divider assembly for a medical device including a housing, wherein the liquid flow divider assembly is Includes an end cap that works in conjunction with the housing, The end cap is, A proximal panel located near the medical device during use, comprising a first internal surface and a first external surface; A distal panel located distal to the medical device during use, comprising a second internal surface and a second external surface; At least one wall extending between the first inner surface and the second inner surface; At least one opening for selective connection with an accessory, wherein the at least one opening is located between a second outer surface and a second inner surface of the distal panel; Includes, It includes at least one internal fluid passage that is at least partially formed by at least one wall, the first internal surface, and the second internal surface, The end cap has a gap between at least one internal fluid passage and the outside of the end cap, and the gap is located below at least one of the openings. A liquid diversion assembly in which at least one of the internal fluid passages is in fluid communication with at least one of the openings to divert the liquid to the outside of the end cap through the gap.

2. The liquid flow divider assembly according to claim 1, wherein the proximal panel includes at least one recess within the first inner surface, the at least one recess being substantially aligned with the at least one opening.

3. The liquid diversion assembly according to claim 2, wherein the at least one wall extends along the first and second internal surfaces to substantially surround the at least one recess, and the at least one wall includes the gap at a position below the at least one recess, the gap being configured to allow liquid to flow from the internal fluid passage to the outside of the end cap.

4. The liquid flow divider assembly according to claim 2 or 3, wherein the lower surface of at least one recess is angled from an upper position to a lower position on the first inner surface.

5. The liquid flow divider assembly according to any one of claims 2 to 4, wherein the proximal panel includes guide projections surrounding each of the at least one recess, the guide projections protruding from the first inner surface toward the second inner surface, and an air gap is maintained between the guide projections and the second inner surface.

6. The liquid flow divider assembly according to claim 5, wherein the guide projection includes a surface facing outward in the radial direction and a surface facing inward in the radial direction that intersect at the apex.

7. The liquid flow divider assembly according to claim 5 or 6, wherein each guide projection includes a raised base surrounding the recess and a guide projection extending from the raised base.

8. The liquid flow divider assembly according to claim 7, wherein a flat portion is provided between the radially outward edge of the raised base and the guide projection.

9. The liquid flow divider assembly according to any one of claims 1 to 8, wherein the at least one wall includes a first wall extending from the first internal surface and a second wall extending from the second internal surface, and the proximal panel and the distal panel are configured such that, when connected, the first wall and the second wall cooperate to form the internal fluid passage.

10. The liquid flow divider assembly according to any one of claims 1 to 9, wherein the proximal panel and the distal panel are joined together to form a single integrated portion.

11. The liquid flow divider assembly according to any one of claims 1 to 10, wherein the accessory is a humidifier.

12. The liquid flow divider assembly according to any one of claims 1 to 11, wherein the medical device is a ventilator.

13. A device for supplying a positive pressure flow of breathable gas for respiratory therapy, wherein the device is A pressure generator that generates the breathable gas flow and supplies the flow to an outlet; A housing for at least the pressure generator; Apparatus comprising a liquid flow diversion assembly according to any one of claims 1 to 12, wherein the end cap of the liquid flow diversion assembly is configured to be fixed to at least the housing that houses the pressure generator.

14. A device for supplying a breathable gas flow at positive pressure for respiratory therapy, according to claim 13, A humidifier device for changing the absolute humidity of an airflow to be delivered to the entrance of a patient's airway, wherein the change is compared with the absolute humidity of the ambient air, and the humidifier device is configured to be selectively connected to the device to supply a breathable gas flow through at least one opening of the end cap, A respiratory therapy system, including a respiratory treatment system.

Images