Device for maintaining humidity in patient interfaces

Abstract

A patient interface for sealing a delivery airflow to alleviate sleep apnea may include: a sealing formation structure for forming a pneumatic seal with an inlet to a patient's airway; a positioning and stabilizing structure for maintaining a sealed contact between the sealing formation structure and a region surrounding the inlet to the patient's airway; an inflation chamber pressurized during use at a pressure exceeding ambient pressure; a connection port for delivering a breathable gas flow to the patient interface; and means disposed within a breathing chamber, the breathing chamber being at least partially defined by the sealing formation structure and the inflation chamber, wherein the means divides the breathing chamber into a rear chamber and an anterior chamber, and wherein the means includes a plurality of orifices such that the turbulence of air in the rear chamber is less than the turbulence of air in the anterior chamber.

Description

[0001] This application is a divisional application of application No. 201910308168.1, filed on April 23, 2015, entitled "Apparatus for Maintaining Humidity in a Patient Interface". Application No. 201910308168.1 is a divisional application of application No. 201580033915.5 (international application No. PCT / AU2015 / 050191), filed on April 23, 2015, entitled "Apparatus for Maintaining Humidity in a Patient Interface". Technical Field

[0002] This application claims priority to Australian Provisional Application No. AU2014901476, filed on 23 April 2014, the entire contents of which are incorporated herein by reference. Background Technology

[0003] This technology relates to the detection, diagnosis, treatment, prevention, and improvement of one or more respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. 2.2 Background Technology

[0005] 2.2.1 The Human Respiratory System and Its Disorders

[0006] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0007] The airways consist of a series of branching tracheae, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and expelling carbon dioxide. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2011 by John B. West, Lippincott Williams & Wilkins.

[0008] A range of breathing disorders are present. Some disorders can be characterized by specific events, such as respiratory arrest, insufficiency, and hyperventilation.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. This condition causes the affected patient to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can result in cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Because of the repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive microarousing from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without any other known cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath during exercise, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage lasting more than several months and leading to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases: characterized by worsening muscle damage lasting more than several years and only slightly shortening life expectancy (e.g., limb-girdle muscular dystrophy, facial-shoulder-arm muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, difficulty swallowing, shortness of breath during exercise and at rest, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.

[0014] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and carry the potential for chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments have been used to treat or alleviate these conditions. Furthermore, these treatments can be used by other healthy individuals to prevent respiratory distress. However, these treatments have many drawbacks.

[0016] 2.2.2 Treatment

[0017] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). CPAP is hypothesized to act as an pneumatic splint, preventing upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to comply if they find the device used to provide such treatment uncomfortable, difficult to use, expensive, or unsightly.

[0018] Non-invasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe adequately and / or maintain appropriate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is provided via a patient interface. NIV has been used to treat CSR, OHS, COPD, MD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.

[0019] Invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] 2.2.3 Diagnostic and Treatment Systems

[0021] These treatments can be provided by treatment systems or devices. Systems and devices can also be used to diagnose conditions without treating them.

[0022] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] Another type of treatment system is the mandibular repositioning device.

[0024] 2.2.3.1 Patient Interface

[0025] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O into the airway.

[0026] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The mandible or jawbone can move relative to the other bones of the skull. The entire head can move during the duration of respiratory therapy.

[0027] Due to these challenges, some face shields suffer from one or more of the following problems: protrusion, unsightly appearance, high cost, disproportionate design, difficulty in use, and discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. For example, face shields designed solely for pilots, face shields designed as part of personal protective equipment (such as filtering face shields), SCUBA face shields, or face shields designed for administering anesthetics may be acceptable for their original purpose, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment. This is especially true if the face shield is worn during sleep.

[0028] Assuming patient compliance, CPAP therapy is very effective in treating certain breathing difficulties. Patients may not comply if the mask is uncomfortable or difficult to use. Since patients are generally advised to wash their masks regularly, they may not wash their masks if they are difficult to clean (e.g., difficult to assemble or disassemble), which could affect patient compliance.

[0029] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0030] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0031] 2.2.3.1.1 Sealing Formation Part

[0032] The patient interface may include a seal-forming portion. Because it comes into direct contact with the patient's face, the shape and construction of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0033] The patient interface is partially characterized according to the design intent of the sealing portion to engage with the face during use. In one form of patient interface, the sealing portion may include two sub-parts to engage with corresponding left and right nostrils. In another form of patient interface, the sealing portion may include a single element surrounding both nostrils during use. Such a single element may be designed, for example, to cover the upper lip region and bridge of the nose region of the face. In one form of patient interface, the sealing portion may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing portion may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0034] A seal that works effectively in one area of ​​a patient's face may not be suitable for another, for example, due to the different shapes, structures, variations, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0035] Certain seal-forming components can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming components of the mass-produced patient interface, one or both must be adapted to form a seal.

[0036] One type of seal-forming portion extends around the periphery of a patient interface and, when force is applied to the patient interface while the seal-forming portion engages face-to-face with the patient's face, serves to seal the patient's face. The seal-forming portion may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming portion, if the fit is insufficient, a gap will exist between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0037] Another type of seal-forming part includes a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming part, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming part does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0038] Another type of sealing component may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0039] Another form of sealant can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0040] A series of patient interface sealing technologies are disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310, WO2006 / 074,513, and WO2010 / 135,785.

[0041] One form of nasal pillow is found in Adam Circuit, manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett.

[0042] ResMed Limited has manufactured the following products, including nose pillows: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO2005 / 063,328 and WO2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of full-face masks); International Patent Application WO2009 / 052,560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0043] 2.2.3.1.2 Positioning and Stability

[0044] The sealing portion of the patient interface used in positive air pressure therapy is subjected to the corresponding force of air pressure to disrupt the seal. Therefore, various techniques have been used to position the sealing portion and maintain it in a sealed relationship with the appropriate part of the face.

[0045] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0046] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and difficulty in use.

[0047] 2.2.3.1.3 Vent Replacement Technology

[0048] Some forms of patient interface systems may include ventilation ports to allow flushing of exhaled carbon dioxide. Ventilation ports allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment. Ventilation ports may include orifices through which gas can flow when a mask is used. Many such ventilation ports are noisy. Others may become blocked during use, thus providing insufficient flushing. Some ventilation ports may, for example, disrupt the sleep of the patient's bed partner 1100 through noise or concentrated airflow.

[0049] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. US2009 / 0044808.

[0050] The noise level of the existing face mask (ISO17510-2:2007, pressure of 10cmH2O at 1m) is measured.

[0051]

[0052]

[0053] (*Only one sample was used, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.) The sound pressure levels of various objects are shown below.

[0054]

[0055] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0056] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, medical air pressure generators have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0057] One example of a specific requirement for certain RPT devices is noise.

[0058] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0059]

[0060] One known RPT device for treating sleep-disordered breathing is the ResMed S9 Sleep Therapy System. Another example of an RPT device is a ventilator, such as the ResMed Stellar. TM The series of adult and pediatric ventilation machines can provide invasive and non-invasive, non-dependent ventilation support for a range of patients to treat a variety of conditions, such as, but not limited to, NMD, OHS, and COPD.

[0061] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators offer volumetric and pressure-dependent ventilation modes with single-channel or dual-channel circuits. RPT devices typically include a pressure generator, such as an electric blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow to the patient's airway can be supplied under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0062] 2.2.3.3 Humidifier

[0063] Delivering an unhumidified airflow can lead to airway dryness. Humidifiers with an RPT device and patient interface produce humidified gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the surrounding facial area is generally more comfortable than cold air. A range of artificial humidification devices and systems are known; however, they may not meet the specific requirements of medical humidifiers.

[0064] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air when needed, typically in areas where patients may sleep or rest (e.g., in hospitals). Medical humidifiers intended for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0065] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0066] 2.2.3.4 Heat and Humidity Exchanger (HME)

[0067] HMEs can be used in passive humidification during RPT therapy. HMEs work by partially recovering heat and moisture present in the patient's exhaled air. Before inhalation, this heat and moisture can be passively retained and recirculated to the patient as the breathable airflow passes through the HME. Therefore, using an HME can provide most patients with the required moisture and humidity (generally considered to be greater than 10 mg / L) during RPT therapy to minimize any harmful effects associated with RPT therapy and unhumidified ambient air, while avoiding the need for heated humidifier systems. Using an HME instead of a heated humidifier also reduces the likelihood of blockage caused by condensation in the air delivery tubing. Heat and moisture exchangers are typically made of foam, paper, or other materials that can serve as condensation and absorption surfaces. Typically, the material carries hygroscopic salts to improve moisture retention. Suitable salts include calcium chloride.

[0068] When selecting a suitable HME, careful consideration must be given to the material, sweep length (thickness), flow area and internal surface area of ​​the HME, as well as the integrated mask airflow or vent design to provide an effective passive humidification system. These factors are important for ensuring that an appropriate level of humidification is achieved while attempting to minimize the impact on PAP treatment delivered to the patient.

[0069] Passive humidification needs to be provided to patients during PAP treatment, while minimizing the negative impact on patient treatment, insufficient CO2 removal, and reducing the overall volume and weight of the patient interface.

[0070] 2.2.3.5 Mandibular repositioning

[0071] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes it after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0072] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0073] In this design, the length of the connecting rod is chosen so that the mandible remains in an advanced position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will then determine the length of the connecting rod.

[0074] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (e.g., ResMed Narval CC) TM The MRD (Mandibular Joint Retention Device) is designed to hold the mandible in an forward position. This device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0075] 2.2.4 Monitoring System

[0076] Polysomnography (PSG) is a routine system used for the diagnosis and prediction of cardiopulmonary diseases. PSG typically involves placing 15 to 20 contact sensors on the body to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), and electrooculograms (EOG). However, while they may be suitable for their usual application in clinical settings, such systems are complex and can be expensive, and / or may be uncomfortable or impractical for patients trying to sleep at home.

[0077] Device designers have an virtually unlimited number of options to design products or systems. Conflicting design standards often mean that certain design choices are either unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency can be highly sensitive to small, subtle changes in one or more parameters. Summary of the Invention

[0078] This technology aims to provide medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0079] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0080] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0081] One aspect of this technology in certain forms is used to provide methods and / or devices for improving patient compliance with respiratory therapy.

[0082] Another aspect of this technology relates to a patient interface for providing a pressurized, breathable airflow to a patient's airway for the treatment of respiratory disorders. The patient interface may include a sealing structure for forming a pneumatic seal with the inlet of the patient's airway, an inflation chamber, and a device or insert disposed within the inflation chamber to divide the inflation chamber into a pre-chamber and a post-chamber, wherein the device or insert includes a plurality of orifices to allow gas to flow between the pre-chamber and post-chamber, and wherein, in use, the gas in the post-chamber exhibits less turbulence than the gas in the pre-chamber.

[0083] One form of this technology includes a patient interface comprising a device having at least one orifice, the device having a predetermined surface area, the device including at least one orifice having a predetermined size; the device being disposed along a flow path of a breathable airflow; wherein the predetermined size of the at least one orifice and the predetermined surface area of ​​the device are selected such that a predetermined amount of breathable airflow passes through the at least one orifice; and wherein the device is non-heat-absorbing or heat-resistant and non-moisture-absorbing or moisture-resistant, and the device alters the airflow toward the mucosal surface of the patient's airway, thereby reducing the rate of heat and moisture loss from the mucosal surface.

[0084] In one example, airflow can be directed away from the mucosal surface. This can be achieved by changing the airflow from turbulent to laminar flow. By directing a predetermined amount of breathable gas through at least one orifice to change turbulence to laminar flow, the rate of heat and moisture loss from the mucosal surface can be reduced. During RPT treatment, turbulence in the breathable airflow delivered to the mucosal surface of the patient's airway can cause moisture evaporation from the surface and ultimately lead to dryness. Dryness of the mucosal surface affects respiratory comfort. The aim of this technology is to provide a patient interface that includes means for preventing dryness on the mucosal surface of the patient's airway during RPT treatment to promote respiratory comfort. This means can modify the breathable airflow delivered to the patient, changing the airflow from turbulent to more laminar or less turbulent, which will result in reduced evaporation at the mucosal surface. This means can function by directing air through an orifice sized to allow an appropriate amount of breathable gas to flow through to provide RPT treatment to induce the desired turbulence reduction. The orifice size can also be configured to change the breathable airflow from turbulence to a sufficiently level laminar flow, thereby reducing the rate of heat and moisture loss from the mucosal surface. The device can also include a sufficiently large surface area to guide adequate breathable gas through the orifice. It is also desirable to prevent dryness of the mucosal surface of the patient's airway to a level sufficient to maintain breathing comfort without requiring an HME or any other additional humidification, such as through a humidifier.

[0085] In another aspect of this technology, the number and size of the orifices can be selected such that the breathable airflow can be guided through the orifices within a predetermined pressure range set by the RPT device to ensure reduced or minimized obstruction of the patient's airway, despite increased flow resistance due to the presence of the device in the flow path. In another aspect of this technology, the number and size of the orifices can be selected such that the breathable airflow can be guided through the orifices within a predetermined pressure range set by the RPT device to ensure reduced or minimized obstruction of the patient's airway without significantly impeding CO2 exhalation or CO2 flushing through the patient, which could lead to CO2 accumulation and CO2 re-inhalation in the inflation chamber.

[0086] Another aspect of this technology includes a patient interface with a bend in fluid communication with the connection port, wherein the device is disposed within the bend. In another aspect of this technology, the connection port may be in fluid communication with an air delivery conduit for delivering a breathable airflow, wherein the device may be disposed within the air delivery conduit in the path of the breathable airflow. The aim of this technology is to provide a device that can be positioned anywhere in the path of the breathable airflow during RPT treatment to reduce turbulence of the breathable airflow toward the mucosal surface of the patient's airway.

[0087] In another aspect of one form of this technology, a predetermined surface area of ​​the device is selected to guide all breathable airflow through the orifice. The aim of this technology is to physically interfere with and guide the laminar flow of breathable airflow on the mucosal surface of the patient's airway to prevent evaporation at the surface and ultimately prevent dryness.

[0088] Another aspect of this technology is that the patient interface also includes a ventilation port for flushing exhaled air from the patient interface. In use, the device can be positioned in the flow path of the breathable airflow between the ventilation port and the inlet of the patient's airway. Preferably, the device can be positioned close to the patient's airway to minimize its impact on the physical disturbance of the breathable airflow.

[0089] Another aspect of this technology is that the patient interface also includes an inflatable chamber divided by the device into a first anterior chamber and a second posterior chamber, configured to be in fluid communication with the inlet of the patient's airway. The device can be disposed within the inflatable chamber, spanning the entire cross-sectional surface area of ​​the inflatable chamber. The device can be disposed within the inflatable chamber to minimize the resistance to the breathable airflow, because the inflatable chamber can have a larger volume for accommodating the device compared to a connection port, tubing, or bend.

[0090] Another aspect of this technology relates to the device, wherein the device physically interferes with the expiratory airflow to increase the humidity in the second rear chamber to a predetermined absolute humidity. The predetermined absolute humidity may be greater than 10 mg / L. It is desirable to provide a device for physically interfering with the expiratory airflow to retain moisture in the second rear chamber of the patient interface, such that the moisture is close to the inlet of the patient's airway for re-delivery. It is also desirable to provide a moisture level equal to the predetermined absolute humidity, which is sufficient to prevent drying of the mucosal surfaces in the patient's airway, thereby preventing respiratory discomfort.

[0091] It should be understood that the increase in absolute humidity compared to the patient interface without the device can result in a reduction in humidity loss from the second rear chamber. The absolute humidity in the second rear chamber increases through the patient's exhalation, which is humidified by the mucosal surfaces of the patient's airway, and this moisture loss can be caused by the expulsion of humidified gas from the inflation chamber.

[0092] Another aspect of this technology includes a device comprising at least one orifice of a predetermined size, wherein the predetermined size of the at least one orifice is selected such that a predetermined amount of breathable gas flows through the orifice to deliver a breathable airflow at a predetermined pressure level. The predetermined pressure level can be between 2 cm H₂O and 40 cm H₂O. The predetermined size of the orifice can be selected to increase the permeability of the device to the breathable airflow. Permeability can be increased by increasing the front flow region of the orifice. The front flow region is the surface area of ​​the device on the front side of the device facing away from the patient airway inlet. The permeability of the device can also be increased by increasing the number of orifices. It is desirable to provide a device that does not significantly impede the breathable airflow to maintain a predetermined pressure level. In RPT therapy, particularly for PAP therapy in the treatment of OSA and other SDB conditions, a therapeutic level of pressure needs to be delivered to the inlet airway. Therefore, it is also desirable to provide a device including an orifice to prevent significant pressure loss when delivering a pressurized airflow of breathable gas to the patient interface, such that the therapeutic level of pressure is maintained and delivered to the inlet of the patient airway.

[0093] Another aspect of this technology relates to a device comprising an orifice of a predetermined size, the size of which is selected to allow an expiratory airflow through the orifice for CO2 flushing at a predetermined level through a ventilation port. The orifice may include an inner surface profile configured to direct the expiratory airflow through the ventilation port for CO2 flushing. The predetermined size of the orifice can be selected to increase the permeability of the device to the expiratory airflow for CO2 flushing. Permeability can be increased by increasing the backflow region of the orifice. The backflow region of the orifice can be increased by increasing the size of the orifice on the rear side of the device. The permeability of the device can also be increased by increasing the number of orifices. It is desirable to provide a device that does not impede the expiratory airflow for adequate CO2 flushing. Impeding the expiratory airflow for CO2 flushing to the ventilation port results in an increase in CO2 concentration in the patient interface and will effectively lead to CO2 rebreathing. Therefore, it is also desirable to provide a device comprising an orifice through which the expiratory airflow passes, wherein the device has increased permeability to the expiratory airflow for adequate CO2 flushing.

[0094] Another aspect of this technology is the device, wherein the device is a flexible diaphragm. Alternatively, the device is a fabric formed of woven fibers, wherein the fibers form multiple holes between adjacent fibers. The device can also be a mesh structure. The device can be a thin, flexible structure that does not occupy a considerable volume along the flow path of RPT treatment (e.g., in the inflatable chamber of the patient interface). This thin structure allows for reduced flow resistance during RPT treatment and also allows for easier placement of the device within a fixed volume of space along the flow path. Furthermore, the flexibility of the device allows for easy manipulation to conform to the internal volume of the patient interface.

[0095] Another aspect of this technology is the device, wherein the device has a reduced thickness to reduce flow resistance to the breathable airflow. The thickness can be in the range of about 0.5 cm to 1 cm. The thickness can also be in the range of 1 mm to 0.5 cm. The thickness can be less than 1 mm. A thinner device can occupy a smaller volume in the inflation chamber of the patient interface, reducing its impact on flow resistance and its impact on the volume required to accommodate a portion of the patient's face. Therefore, it is desirable to provide a device with a reduced thickness to reduce the impact on flow resistance to both the breathable and expiratory airflows and to effectively reduce the volume occupied by the device in the inflation chamber. It is also desirable to provide a device that effectively reduces the drying of the mucosal surface of the patient's airway compared to an HME, while having less flow resistance and occupying a smaller volume in the patient interface. HMEs are heat- and moisture-absorbing, thus requiring a certain volume of absorbent substrate to achieve the desired level of humidity. In contrast, the prospect of this technology is to prevent the drying of the mucosal surface of the patient's airway and to re-deliver moisture from exhaled air to the patient without requiring heat- and moisture-absorbing materials.

[0096] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow to an inlet of a patient airway including at least one inlet of the patient's nostrils under a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in use within the range of about 4 cm H2O to about 30 cm H2O above ambient air pressure throughout the patient's respiratory cycle when the patient is asleep, in order to alleviate sleep-disordered breathing. The patient interface may include: a sealing-forming structure for forming a pneumatic seal with the inlet of the patient's airway; a positioning and stabilizing structure for maintaining the sealing-forming structure in sealed contact with the area surrounding the inlet of the patient's airway while maintaining a therapeutic pressure at the inlet of the patient's airway; an inflation chamber for pressurizing under pressure exceeding ambient pressure during use; a connection port for delivering a breathable airflow into the patient interface; and a device having a predetermined surface area including at least one orifice of a predetermined size; the device being arranged along the flow path of the breathable gas to physically interfere with the flow; wherein the predetermined size of the at least one orifice and the predetermined surface area of ​​the device are selected to allow a predetermined amount of breathable gas to flow through the at least one orifice; and wherein the device is non-heat-absorbing and non-moisture-absorbing, and the device reduces the rate of heat and moisture loss from the mucosal surface by guiding a predetermined amount of breathable gas through the at least one orifice to change the breathable airflow flowing towards the mucosal surface of the patient's airway from turbulent to laminar flow.

[0097] In the example, (a) the patient interface may further include a bend in fluid communication with the connection port, wherein the device is disposed within the bend; (b) the patient interface may further include an air delivery conduit for delivering a breathable airflow to the patient interface, the air delivery conduit being in fluid communication with the connection port, and wherein the device is disposed within the conduit; (c) the patient interface may further include a gas exhaust vent configured to allow CO2 exhaled by the patient to flow to the outside of the patient interface to minimize CO2 re-breathed by the patient; (d) the device, in use, may be disposed in the flow path of the breathable airflow between the vent and the inlet of the patient's airway; (e) the device may be disposed within an inflation chamber such that the inflation chamber is divided into a first pre-chamber and (f) The device can physically interfere with the expiratory airflow to increase the humidity in the second rear chamber to a predetermined absolute humidity, (g) the device can physically interfere with the expiratory airflow by slowing the expiratory airflow into the first pre-chamber for re-delivery to the inlet of the patient's airway, (h) the predetermined absolute humidity can be greater than 10 mg / L, (i) a predetermined size can be selected for each of at least one orifice to substantially maintain a predetermined pressure level as the breathable airflow flows through the orifice, (j) the predetermined pressure level can be between 2 cm H2O and 40 cm H2O, (k) a predetermined size can be selected for at least one orifice to maintain a predetermined pressure level by increasing the permeability of the device to the breathable airflow. At a constant pressure level, (l) permeability can be increased by increasing the forward flow zone of the orifice; (m) the forward flow zone of the orifice can be increased by increasing the size of the orifice on the front side of the device; (n) at least one orifice can be multiple orifices, and the permeability of the device can be increased by increasing the number of orifices; (o) a predetermined size of the orifice can be selected to allow an exhaled airflow through the orifice for CO2 flushing at a predetermined level through the ventilation port; (p) the orifice may include an inner surface profile configured to direct the exhaled airflow to the ventilation port for CO2 flushing; (q) a predetermined size of the orifice can be selected to increase the permeability of the device to the exhaled airflow for CO2 flushing, and permeability can be increased by increasing the backward flow zone of the orifice; (r) the size of the orifice on the rear side of the device can be increased. The device can be configured to increase the number of pores in the following ways: (s) at least one pore may include multiple pores, and the permeability of the device can be increased by increasing the number of pores; (t) the device may be a flexible diaphragm; (u) the device may be a fabric formed of woven fibers, and the fibers may form multiple pores between adjacent fibers; (v) the device may be a mesh structure; (w) the device may include a material selected from any of the group consisting of synthetic materials, thermoplastic elastomers, or hydrophobic polymers; (x) the device may have a predetermined thickness selected to reduce the flow resistance of the breathable airflow; (y) the predetermined thickness of the device may be in the range of about 0.5 cm to 1 cm; (z) the predetermined thickness of the device may be in the range of about 1 mm to 0.Within a 5cm range, the predetermined thickness of the (aa) device can be less than 1mm, and / or the predetermined size of the (bb) device can be selected to fit within the inflatable chamber of the patient interface.

[0098] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow under a continuous positive pressure relative to ambient air pressure to an inlet of a patient airway including at least one inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure in use within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure during the entire respiratory cycle of the patient while the patient is asleep, in order to alleviate sleep-disordered breathing. The patient interface may include: a sealing-forming structure for forming a pneumatic seal with the inlet of a patient's airway; a positioning and stabilizing structure for maintaining the sealing-forming structure in sealed contact with the area surrounding the inlet of the patient's airway while maintaining a therapeutic pressure at the inlet of the patient's airway; an inflation chamber for pressurizing at a pressure exceeding ambient pressure during use; a connection port for delivering a breathable airflow into the patient interface; and a means disposed within the breathing chamber, wherein the breathing chamber is at least partially defined by the sealing-forming structure and the inflation chamber when the sealing-forming structure is in sealed contact with the area surrounding the inlet of the patient's airway, wherein the means divides the breathing chamber into a rear chamber and an anterior chamber, and wherein the means includes a plurality of orifices such that the turbulence of the air in the rear chamber is less than the turbulence of the air in the anterior chamber.

[0099] In the example, (a) the device can be positioned, shaped, and sized such that air in a breathing chamber moving between the posterior and anterior chambers passes through only a plurality of orifices; (b) the device can be shaped and sized such that at least a portion of the peripheral edge region of the device substantially conforms to the inner surface of at least one of the sealing structure and the inflation chamber; (c) the peripheral edge region can form a pneumatic seal against the inner surface of at least one of the sealing structure and the inflation chamber; (d) the entire peripheral edge region of the device can substantially conform to the inner surface of at least one of the sealing structure and the pressurization chamber; and (e) the patient interface may further include at least one portion of the peripheral edge region of the device conforming to the inner surface of the sealing structure and the inflation chamber. (f) The gap between the inner surfaces of at least one of the sealing structure and the inflation chamber; (g) At least a portion of the peripheral edge region of the device can be fixedly attached to the inner surface of at least one of the sealing structure and the inflation chamber; (h) At least a portion of the peripheral edge region of the device can be detachably attached to the inner surface of at least one of the sealing structure and the inflation chamber; (i) At least one of the multiple holes in the device can be consistent in size, shape and density; (j) Each of the multiple holes can have a rear region adjacent to the rear chamber and a front region adjacent to the front chamber.

[0100] (k) The rear region of each of the plurality of holes may be greater than, less than or equal to the front region of each of the plurality of holes; (l) The flow path through each of the plurality of holes may be linear or nonlinear; (m) The device may include a material resistant to moisture absorption and / or heat absorption; (n) The material may be any one of the group consisting of nylon, polycarbonate, silicone, polyurethane, thermoplastic elastomers, hydrophobic polymers, and other synthetic materials; (o) The device may include a single, continuous, and homogeneous sheet of material.

[0101] (p) The device may have a mesh structure, a foam structure, or a woven structure; (q) The device may be disposed within a breathing chamber such that the volume of the rear chamber is greater than, less than, or equal to the volume of the anterior chamber; (r) The patient interface may further include a ventilation port for flushing gas from the patient interface; (s) The ventilation port may be disposed on a bend in the inflation chamber or the patient interface such that gas from the anterior chamber is flushed through the ventilation port; and / or (t) The ventilation port and the connection port may be disposed opposite to the patient airway inlet relative to the device.

[0102] Of course, the parts of each aspect can form sub-aspects of the present invention. In addition, the sub-aspects and / or aspects of the aspects can be combined in any way and also constitute other aspects or sub-aspects of the present invention.

[0103] Other features of the invention will become apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0104] This technology is illustrated in the accompanying drawings by way of example rather than limitation, wherein the same reference numerals denote similar elements, including:

[0105] 4.1 Processing System

[0106] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nasal pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown.

[0107] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0108] Figure 1CA system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. 4.2 Respiratory System and Facial Anatomy

[0109] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0110] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0111] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0112] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, lower nasal septum, upper lip, lower lip, supramental point, bridge of the nose, apex of the nostrils, lower base of the ear, and upper base of the ear. The vertical and anteroposterior directions are also marked.

[0113] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0114] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and sagittal plane.

[0115] Figure 2G A side view showing the surface features of the nose.

[0116] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0117] Figure 2I The diagram shows the medial anatomy of the nose from the sagittal plane, approximately a few millimeters in diameter, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0118] Figure 2JA frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal turbinate bones, as well as the maxilla and mandible, are also labeled.

[0119] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0120] Figure 2L The frontal lateral view of the nose is shown.

[0121] 4.3 Patient Interface

[0122] Figure 3 One form of patient interface according to this technology is shown.

[0123] 4.4RPT device

[0124] Figure 4A An RPT device of one form according to the present technology is shown.

[0125] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated.

[0126] Figure 4C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.

[0127] Figure 4D This is another schematic diagram of the electrical components of an RPT device according to one form of the present technology.

[0128] 4.5 Humidifier

[0129] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0130] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0131] Figure 5C A schematic diagram of one form of humidifier according to the present technology is shown.

[0132] 4.6 Respiratory waveform

[0133] Figure 6 The diagram shows a typical breathing waveform of a person while sleeping.

[0134] 4.7 Embodiments of this technology

[0135] Figure 7A A side view of a patient receiving a pressurized breathable flow from a patient interface according to an embodiment of the present technology is shown.

[0136] Figure 7B A side view of a patient receiving a pressurized breathable flow from a device-equipped patient interface according to an embodiment of the present technology is shown.

[0137] Figure 8A A side view of a patient with a patient interface including a device according to an embodiment of the present technology is shown.

[0138] Figure 8B A side view of a patient with a patient interface including a device according to an embodiment of the present technology is shown.

[0139] Figure 8C A side view of a patient with a patient interface including a device according to an embodiment of the present technology is shown.

[0140] Figure 9A A perspective view of an embodiment of a device according to this technology is shown.

[0141] Figure 9B A perspective view of an embodiment of a device according to this technology is shown.

[0142] Figure 10A A rear view of a patient with a patient interface according to an embodiment of the present technology is shown.

[0143] Figure 10B A rear view of a patient with a patient interface including a device according to an embodiment of the present technology is shown.

[0144] Figure 11 A graph showing the average absolute humidity in the rear of the device in the patient interface based on different device materials according to embodiments of the present technology is presented.

[0145] Figure 12A A front perspective view of a model of a sealing structure and an air chamber for a patient interface according to an embodiment of the present technology is shown. The patient interface includes an air vent, a connection port, and devices.

[0146] Figure 12B A front perspective view of a model of a sealing structure and an air chamber for a patient interface according to an embodiment of the present technology is shown. The patient interface includes an air vent, a connection port, and devices.

[0147] Figure 13A This shows the effect of computational fluid dynamics when the airflow generated by the patient is zero. Figure 12A and 12B Flow velocity modeling was performed within the model (without the device).

[0148] Figure 13B This shows the effect of computational fluid dynamics when the airflow generated by the patient is zero. Figure 12A and 12B Flow velocity modeling is performed within the model (with device).

[0149] Figure 14A The results show that when the airflow generated by the patient is 10 L / min, the computational fluid dynamics program can achieve the following: Figure 12A and 12B Flow velocity modeling was performed within the model (without the device).

[0150] Figure 14B The results show that when the airflow generated by the patient is 10 L / min, the computational fluid dynamics program can achieve the following: Figure 12A and 12B Flow velocity modeling is performed within the model (with device).

[0151] Figure 15A This shows the effect of computational fluid dynamics when the airflow generated by the patient is zero. Figure 12A and 12B The velocity streamlines simulated within the model (without the device).

[0152] Figure 15B This shows the effect of computational fluid dynamics when the airflow generated by the patient is zero. Figure 12A and 12B The velocity streamlines simulated within the model (with apparatus).

[0153] Figure 16A The results show that when the airflow generated by the patient is 10 L / min, the computational fluid dynamics program can achieve the following: Figure 12A and 12B The simulated velocity streamlines in the model (without the device).

[0154] Figure 16B The results show that when the airflow generated by the patient is 10 L / min, the computational fluid dynamics program can achieve the following: Figure 12A and 12B The velocity streamlines simulated in the model (with apparatus). Detailed Implementation

[0156] Before describing the invention in further detail, it should be understood that the invention is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0157] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may form further instances. Detailed Implementation

[0158] Before describing the invention in further detail, it should be understood that the invention is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0159] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may form further instances.

[0160] 5.1 Treatment

[0161] In one form, the technology includes a method for treating respiratory distress, the method comprising the step of applying positive pressure to the inlet of the airway of a patient 1000.

[0162] In some embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0163] In some embodiments of this technology, mouth breathing is defined, restricted, or prevented.

[0164] 5.2 Treatment System

[0165] In one form, the technology includes an instrument or device for treating respiratory disorders. The instrument or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000.

[0166] 5.3 Patient Interface

[0167] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a sealing formation structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, and a connection port 3600 for connection to an air circuit 4170. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing formation structure 3100 is configured to surround an inlet to the patient's airway to facilitate the supply of positive pressure air to the airway.

[0168] 5.3.1 Sealing Formation Structure

[0169] In one form of this technology, the sealing forming structure 3100 provides a sealing forming surface and may additionally provide a cushioning function.

[0170] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, and elastic material such as silicone.

[0171] In one embodiment, the sealing structure includes a sealing flange and a support flange. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange 3110 in use to prevent it from bending. In use, the sealing flange 3110 is readily responsive to system pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight sealing engagement with the surface.

[0172] In one embodiment, the sealing portion of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and configured to form a seal with the corresponding nostril of the patient's nose.

[0173] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow-connecting structure of the present invention includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate the formation of a universal connection structure, which is adjustable with relative movement of displacement and angular motion between the truncated cone and the nasal pillow-connecting structure. For example, the position of the truncated cone can be axially moved toward the handle-connecting structure.

[0174] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0175] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that forms a seal on the chin region of the patient's face during use.

[0176] 5.3.2 Inflation Chamber

[0177] In the sealed area formed during use, the air chamber 3200 has a perimeter whose shape complements the surface contour of a typical human face. During use, the boundary edges of the air chamber are in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend along the entire perimeter of the air chamber 3200 during use.

[0178] 5.3.3 Positioning and Stabilization Structure 3300

[0179] The sealing portion 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by positioning and stabilizing structure 3300.

[0180] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one embodiment, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one embodiment, the positioning and stabilization structure 3300 includes at least one strip with a rectangular cross-section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strip.

[0181] In one form of this technology, the positioning and stabilizing structure 3300 includes a band constructed of laminated material comprising a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the band. In another form, the fabric outer layer includes a loop material for engagement with a hook-shaped material portion.

[0182] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured in use to withstand tensile forces and guide forces to ensure a sealed contact between the pad and a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0183] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0184] 5.3.4 Ventilation port

[0185] In one embodiment, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled carbon dioxide.

[0186] One form of the ventilation port 3400 according to the present invention includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0187] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in the decoupling structure 3500, such as the rotating shaft 3510.

[0188] 5.3.5 Decoupling Structure

[0189] In one form, the patient interface 3000 includes at least one decoupling structure 3500, such as a swivel shaft 3510 or a ball-and-socket joint.

[0190] 5.3.6 Connection Port

[0191] Connection port 3600 allows connection to air circuit 4170.

[0192] 5.3.7 Forehead Stent

[0193] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0194] 5.3.8 Anti-asphyxiation valve

[0195] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0196] Port 5.3.9

[0197] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to provide supplemental oxygen. In another embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0198] 5.3.10 Includes patient interface 3000 of device 6000.

[0199] In the prior art, a certain amount of gas generated by the RPT device 4000 can be provided to the patient 1000, as described elsewhere herein. These prior art patient interfaces 3000 may include a ventilation port 3400 to allow flushing or expulsion of exhaled air to guide CO2 out of the patient's airway 1004, thereby preventing the patient 1000 from inhaling gas containing excessively high concentrations of CO2. When the patient 1000 inhales a certain amount of gas generated by the RPT device during respiration, the mucosal surfaces of the patient's airway 1004 are moistened upon inhalation and remain thereon once exhaled air is exhaled. However, flushing or expulsion of exhaled air with a higher concentration of CO2 can expel the moisture from the patient's mucosal surfaces along with the CO2. During a treatment session, for example, when the patient is asleep, this can lead to dryness of the mucosal surfaces, which can cause discomfort.

[0200] The prior art has addressed this problem by providing a humidifier 5000, described in more detail elsewhere herein, to increase the moisture supplied to the patient interface airflow 700 for treatment. In other words, the humidifier 5000 can be understood as replenishing moisture lost via the exchange airflow 7004 by providing moisture in the airflow 7000 supplied to the patient. While the humidifier 5000 can effectively reduce dryness in the patient's airway 1004 during treatment, the humidifier 5000 may require a moisture source, power supply, and control system to coordinate the operation of the humidifier 5000 with the RPT device 4000 to provide the patient with the desired level of humidity and treatment. Therefore, it is desirable to provide an alternative solution to the problem of moisture loss during treatment without the requirements associated with the humidifier 5000.

[0201] According to one aspect of the present technology, a non-invasive patient interface 3000 includes a device 6000. The device 6000 may be non-heat-absorbing or heat-resistant, and / or the device 6000 may be non-moisture-absorbing or moisture-resistant.

[0202] According to one embodiment of the present technology, the device 6000 may be disposed within the inflation chamber 3200 of the patient interface 3000. The device 6000 may also be located in a breathing chamber, which is at least partially defined by the sealing formation 3100 and the inflation chamber 3200. Alternatively, the device 6000 may be disposed within the decoupling structure 3500 or a bend in the patient interface 3000. Alternatively, the device 6000 may be disposed within an air circuit 4170. The device 6000 may be configured to direct a breathable airflow 7000 through at least one orifice 6002 to reduce turbulence of the airflow 7000 toward the mucosal surface of the patient airway 1004, thereby reducing dryness of the mucosal surface.

[0203] The device may include a plurality of orifices 6002 of predetermined sizes. The device 6000 may be disposed between the connection port 3600 and the inlet 1006 of the patient airway 1004, such that it guides part or all of the breathable airflow 7000 through the orifices 6002. The device 6000 may include a predetermined surface area to physically interfere with and guide all the airflow 7000 through the orifices 6002. Furthermore, the expiratory airflow 7002 from the patient airway 1004 may be guided out of the inflation chamber 3200 via the orifices 6002 in the opposite direction and guided out of the ventilation port 3400 as a flushing or exchange airflow 7004.

[0204] In one embodiment, the device 6000 divides the inflation chamber 3200 into a first pre-chamber 6004 and a second rear chamber 6006. The second rear chamber 6006 is positioned adjacent to the inlet 1006 of the patient airway 1004. The device 6000 can physically interfere with the expiratory flow 7002 to increase the humidity in the second rear chamber 6006 to a predetermined absolute humidity, thereby re-moistening the mucosal surface of the patient airway 1004. The humidified patient expiratory flow 7002 can be slowed to prevent it from flowing into the first pre-chamber 6004, thereby increasing the humidity in the second rear chamber 6006 for resupply to the inlet of the patient airway 1004. Thus, by reducing the velocity of the expiratory flow 7002 within the inflation chamber 3200, and by forcing the expiratory flow 7002 through the orifice 6002 from the second rear chamber 6006 into the first pre-chamber 6004, turbulence in the second rear chamber 6006 can be reduced. It should be understood that device 6000 can reduce the velocity or kinetic energy of airflow 7000 by blocking its flow to the second rear chamber 6006, which in turn reduces turbulence in the airflow. Reducing turbulence in the second rear chamber 6006, in turn, reduces mixing between the expiratory airflow 7002 and the less moist breathable airflow 7000 from the RPT device 4000. Therefore, moisture loss from the expiratory airflow 7002 is reduced, and a large portion of the moisture can ultimately remain in the second rear chamber 6006, which can be used to humidify the air inhaled by patient 1000, preventing the patient's airway 1004 from drying out. Furthermore, by retaining more moisture in the second rear chamber 6006, less moisture is transferred to the first anterior chamber 6004 and ultimately lost from the inflation chamber 3200 via, for example, the exchange airflow 7004. The absolute humidity within the second rear chamber 6006 can reach greater than 10 mg / L.

[0205] In one embodiment, the sealing structure 3100 of the patient interface 3000 may be configured to seal a portion of the face of the patient 1000 to provide a breathable airflow 7000 to the RPT at a therapeutic pressure level for treating conditions such as sleep apnea. The breathable airflow 7000 flows from the connection port 3600 into the inflation chamber 3200, passes through the orifice 6002 of the device 6000, and then reaches the inlet of the patient airway 1004. The permeability of the device 6000 to the breathable airflow 7000 can be increased to maintain a predetermined pressure level as the breathable airflow 7000 passes through the orifice 6002, thereby avoiding significant loss of therapeutic pressure before reaching the inlet of the patient airway 1004. The predetermined pressure level may be between 2 cm H2O and 40 cm H2O. Permeability can be increased by enlarging the forward flow region of the orifice 6002. The forward flow region of the orifice 6002 is the area on the front side of the device 6000 where the orifice is located to allow the breathable airflow 7000 to pass through the orifice 6002. The forward flow zone can be selected by choosing orifices 6002 with predetermined dimensions. Alternatively, the permeability of the device 6000 to the breathable airflow 7000 can be improved by increasing the number of orifices 6002. Therefore, the area of ​​the orifices 6002 on the front side of the device 6000 and the number of orifices 6002 are two factors that determine the forward flow zone of the device 6000.

[0206] In one embodiment, the device 6000 may be positioned between the ventilation port 3400 and the patient 1000, such that the expiratory flow 7002 flows through the orifice 6002 of the device 6000 and then exits the ventilation port 3400 as a ventilator flow 7004 for CO2 flushing. The permeability of the device 6000 to the expiratory flow 7002 can be improved so that the expiratory flow 7002 passes through the orifice 6002 for a predetermined level of CO2 flushing. The permeability to the expiratory flow 7002 can be improved by increasing the backflow area of ​​the orifice 6002. The desired backflow area of ​​the device 6000 can be selected by choosing orifices 6002 with a predetermined size. Furthermore, permeability can be improved by increasing the number of orifices 6002. Therefore, the area of ​​the orifice 6002 on the rear side of the device 6000 and the number of orifices 6002 are two factors determining the backflow area of ​​the device 6000.

[0207] In another configuration, each of the orifices 6002 may include an inner surface profile configured to direct an expiratory flow 7002 toward the ventilation port 3400 for a predetermined level of CO2 flushing. The predetermined level of CO2 flushing or ventilation flow 7004 is sufficient to prevent the harmful re-inhalation of large amounts of CO2, such as arousal during RPT in SDB treatment.

[0208] In one embodiment, the device 6000 can be a flexible diaphragm, such as... Figure 8AAs shown. Alternatively, the device 6000 may be a textile formed of woven fibers, wherein the fibers form a plurality of holes 6002 between adjacent fibers, as shown. Figure 8B As shown. In another form, the device 6000 can be a mesh structure, such as... Figure 8C As shown.

[0209] Figure 9A and Figure 9B Two perspective views of devices 6000 according to the present technology are shown. It is evident that device 6000 has a plurality of holes 6002. The holes 6002 may have a uniform size and shape throughout the device 6000. Alternatively, the size of the holes 6002 may be different in different regions of the device 6000, the shape of the holes 6002 may also be different in different regions of the device 6000, and / or the density of the holes 6002, i.e., the number of holes 6002 per unit area of ​​the surface of the device 6000, may be different in different regions of the device 6000.

[0210] Furthermore, the device 6000 may be shaped such that its periphery substantially conforms to the inner surface of the inflation chamber 3200 to achieve a secure fit within the patient interface 3000. The device 6000 may be secured to the interior of the inflation chamber 3200 by friction fit, press fit, slide fit, adhesive, molding and / or clips or other connecting structures. Alternatively, the device 6000 may be integrally formed with the inflation chamber 3200, such that both the device 6000 and the inflation chamber 3200 comprise a single, uniform, continuous piece of material.

[0211] According to a further example, device 6000 may be made of a non-heat-absorbing or heat-resistant material, and / or device 6000 may be non-hygroscopic or hygroscopic. The material of device 6000 may be any of the group consisting of nylon, polycarbonate, silicone, polyurethane, thermoplastic elastomers, hydrophobic polymers, and other synthetic materials. Alternatively, device 6000 may include materials constituting a heat and moisture exchanger, such as paper. However, in this case, device 6000 may be too thin to effectively perform heat and moisture exchange to achieve the predetermined level of humidification. Therefore, device 6000 primarily relies on the ability to guide the breathable airflow 7000 to reduce turbulence of the airflow toward the mucosal surface of the patient's airway 1004, thereby reducing the dryness of the mucosal surface.

[0212] In one embodiment, according to one example of the present technology, the thickness of device 6000 may be less than 1 cm. According to another embodiment of the present technology, the thickness of device 6000 may be less than 0.5 cm. According to yet another embodiment of the present technology, the thickness of device 6000 may be less than 1 cm. Device 6000 can occupy only a small volume within the inflation chamber 3200 to reduce its impact on the breathable airflow 7000, the expiratory airflow 7002 from the patient, and / or the exchange airflow 7004. Device 6000 can reduce dryness of the mucosal surface of the patient's airway 1004, thereby avoiding respiratory distress, achieving the same effect as powered humidification or the use of an HME. However, device 6000 will no longer require any external power source, and when compared to an HME that can provide similar respiratory comfort through heat and moisture exchange, device 6000 can occupy only a significantly smaller size and volume. Occupying a smaller volume can have the effect of reducing impedance on the breathable airflow 7000, which leads to pressure loss during RPT for SDB treatment. The smaller device 6000 also has reduced resistance to the expiratory flow 7002 and / or the CO2 flushing flow 7004 to the ventilation port 3400. Furthermore, the smaller device 6000 allows for additional space within the patient interface 3000 to accommodate a portion of the patient's face when compared to using an in-mask HME.

[0213] Figure 11 The increase in mean absolute humidity is shown when measured in use within the rear chamber 6006 of the patient interface 3000, which includes the device 6000. As shown, absolute humidity is measured in the patient interface 3000 adjacent to the inlet of the patient airway 1004. The patient interface can be: 1) a patient interface 3000 without the device 6000; 2) a patient interface 3000 including the device 6000, which comprises HME material; and 3) a patient interface 3000 including the device 6000 in the form of a braided material that is non-heat-absorbing or heat-resistant and non-moisture-absorbing or moisture-resistant. The results show a significant increase in absolute humidity, with optimal results observed for the patient interface including the device 6000 in the form of a non-heat-absorbing or heat-resistant and non-moisture-absorbing or moisture-resistant braided material.

[0214] Figure 12A and 12BAn experimental device or model 3900 is shown for measuring the turbulence of a breathable airflow 7000 in a simulated patient interface system with and without the device 6000. The experimental device 3900 includes a simulated patient airway inlet 1002, a simulated ventilation port 3400, and a simulated connection port 3600. The volume of the experimental device 3900 can also be understood as being at least partially defined by a simulated form of a sealing structure 3100 and an inflation chamber 3200. In other words, the experimental device 3900 can be understood as simulating a breathing chamber at least partially defined by the sealing structure 3100 and the inflation chamber 3200 when placed on a patient's face.

[0215] Figures 13A to 16B The results of measuring turbulence or airflow in test apparatus 3900 using a computational fluid dynamics program are shown. The results show that in test apparatus 3900 including device 6000, gas turbulence is significantly reduced by device 6000 compared to test apparatus 3900 without device 6000. Although Figure 12A and Figure 12B The experimental equipment 3900 with device 6000 is shown, but it should be understood that... Figure 13A , Figure 14A , Figure 15A and Figure 16A Flow velocity modeling was depicted in experimental setup 3900 without device 6000, while Figure 13B , Figure 14B , Figure 15B and Figure 16B The flow velocity modeling was described in the experimental apparatus 3900 with device 6000.

[0216] Figure 13A and Figure 13B The airflow velocities in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's expiratory airflow 7002 through the simulated inlet 1002 is zero, and a breathable airflow 7000 enters the test device 3900 via the connection port 3600. (The last sentence appears to be incomplete and possibly refers to a different simulation.) Figure 13B As can be seen from the diagram, the test equipment 3900 includes device 6000, and the turbulence in the rear chamber 6006 is reduced compared to the front chamber 6004.

[0217] Figure 14A and Figure 14B The airflow velocities in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's expiratory airflow 7002 through the simulated inlet 1002 is positive, meaning the patient is exhaling, and a breathable airflow 7000 enters the test device 3900 via the connection port 3600. (The last sentence appears to be incomplete and possibly refers to a different topic.) Figure 13BAs can be seen from the diagram, the test equipment 3900 includes device 6000, and the turbulence in the rear chamber 6006 is reduced compared to the front chamber 6004.

[0218] Figure 15A and Figure 15B The airflow streamlines in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's expiratory airflow 7002 through the simulated inlet 1002 is zero, and a breathable airflow 7000 enters the test device 3900 via the connection port 3600. (The last sentence appears to be incomplete and possibly refers to a different simulation.) Figure 15B As can be seen from the diagram, the test equipment 3900 includes device 6000, and the turbulence in the rear chamber 6006 is reduced compared to the front chamber 6004.

[0219] Figure 16A and Figure 16B The airflow streamlines in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's expiratory airflow 7002 through the simulated inlet 1002 is positive, meaning the patient is exhaling, and a breathable airflow 7000 enters the test device 3900 via the connection port 3600. (The last sentence appears to be incomplete and possibly refers to a different topic.) Figure 16B As can be seen from the diagram, the test equipment 3900 includes device 6000, and the turbulence in the rear chamber 6006 is reduced compared to the front chamber 6004.

[0220] 5.4RPT device

[0221] According to one aspect of the present technology, an RPT device 4000 includes mechanical and pneumatic components 4100, electrical components 4200, and is configured to execute one or more algorithms 4300. The RPT device may have an outer housing 4010, which is configured in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0222] The pneumatic path of the RPT device 4000 may include one or more air path components, such as an inlet air filter 4112, an inlet silencer 4122, and a pressure generator 4140 capable of supplying positive pressure air.

[0223] (e.g., blower 4142), outlet silencer 4124, and one or more converters 4270, such as pressure sensor 4272 and flow rate sensor 4274.

[0224] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0225] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0226] 5.4.1 Mechanical & Pneumatic Components of the RPT Unit

[0227] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0228] 5.4.1.1 Air Filter

[0229] One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.

[0230] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140. See Figure 4b.

[0231] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the pneumatic block 4020 and the patient interface 3000. See Figure 4b.

[0232] 5.4.1.2 Muffler

[0233] In one embodiment of this technology, the inlet silencer 4122 is disposed in the pneumatic path upstream of the pressure generator 4140. See Figure 4b.

[0234] In one embodiment of this technology, the outlet silencer 4124 is disposed in the pneumatic path between the pressure generator 4140 and the patient interface 3000. See Figure 4b.

[0235] 5.4.1.3 Pressure Generator 4140

[0236] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers enclosed in a volute. The blower is capable of delivering an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cm H2O to about 20 cm H2O, or in other forms up to about 30 cm H2O. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167.

[0237] The pressure generator 4140 is controlled by the treatment device controller 4240.

[0238] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0239] 5.4.1.4 Converter

[0240] The transducer can be located inside or outside the RPT device. An external transducer can be located on, for example, the air circuit, such as the patient interface, or be part of it. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0241] In one form of this technology, one or more converters 4270 are disposed upstream and / or downstream of pressure generator 4140. The one or more converters 4270 may be configured and arranged to measure characteristics such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0242] In one form of this technology, one or more converters 4270 may be located adjacent to the patient interface 3000.

[0243] In one configuration, the signal from converter 4270 can be filtered by low-pass filtering, high-pass filtering, or band-pass filtering.

[0244] 5.4.1.4.1 Flow Converter

[0245] The flow sensor 4274 according to this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.

[0246] In one configuration, a signal representing the flow rate, such as the total flow rate Qt, is received from the flow rate converter 4274 via a central controller 4230.

[0247] 5.4.1.4.2 Pressure Sensor 4272

[0248] The pressure sensor 4272 according to this technology is configured in fluid communication with the pneumatic path. A suitable pressure sensor is one from the HONEYWELL ASDX series. Alternatively, a suitable pressure sensor is one from the GENERALELECTRIC NPA series.

[0249] In one configuration, a signal from a pressure sensor 4272 is received via a central controller 4230.

[0250] 5.4.1.4.3 Motor speed sensor

[0251] In one embodiment of this technology, a motor speed sensor 4276 is used to determine the rotational speed of motor 4144 and / or blower 4142. The motor speed signal from the motor speed sensor 4276 can be provided to the treatment device controller 4240. The motor speed sensor 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0252] 5.4.1.5 Anti-overflow valve

[0253] In one embodiment of this technology, an anti-backflow valve is positioned between the humidifier 5000 and the pneumatic block 4020.

[0254] The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0255] 5.4.1.6 Air Circuit

[0256] According to one aspect of the technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow between two components, such as a pneumatic block 4020 and a patient interface 3000.

[0257] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, the circuit may have separate branches for inhalation and exhalation.

[0258] In other cases, use a single branch.

[0259] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be connected to a controller such as a central controller 4230 or a humidifier controller 5250. An embodiment of a control circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. US / 2011 / 0023874, which is incorporated herein by reference in its entirety.

[0260] 5.4.1.7 Oxygen Delivery

[0261] In one form of this technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path.

[0262] For example, upstream of the pneumatic block 4020, it is then delivered to the air circuit 4170 and / or the patient interface 3000.

[0263] 5.4.2 Electrical Components of the RPT Device

[0264] 5.4.2.1 Power Supply

[0265] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0266] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0267] 5.4.2.2 Input Device

[0268] 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 to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one embodiment, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another embodiment, the buttons, switches, or dials can wirelessly communicate with a receiver electrically connected to a central controller 4230.

[0269] In one configuration, the input device 4220 may be constructed or arranged to allow a user to select values ​​and / or menu options. 5.4.2.3 Central Controller

[0270] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0271] Suitable processors may include x86 Intel processors, based on ARM International Technology (ARM)

[0272] Holdings Processor processors, such as those from STMicroelectronics (ST)

[0273] The technology utilizes the STM32 series microcontrollers from Microelectronics. In some alternative forms, such as the 32-bit RISC CPU from STMicroelectronics' STR9 series microcontrollers, or the 16-bit RISC CPU from Texas Instruments' MSP430 series microcontrollers, the same approach is possible.

[0274] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0275] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0276] The central controller 4230 can be configured to receive input signals from one or more converters 4270 and one or more input devices 4220.

[0277] The central controller 4230 can be configured to provide output signals to one or more output devices 4290, treatment device controller 4240, data communication interface 4280 and humidifier controller 5250.

[0278] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as computer programs, which are stored in a non-transitory computer-readable storage medium, such as memory 4260. In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device. For example, the remote positioning device may determine the control settings of the ventilator or detect respiratory-related events by analyzing stored data from, for example, any of the sensors described herein.

[0279] 5.4.2.4 Clock

[0280] RPT device 4000 may include clock 4232, which is connected to central controller 4230.

[0281] 5.4.2.5T Treatment Device Controller

[0282] In one form of this technology, the treatment device controller 4240 is a control module 4330, which constitutes part of the algorithm 4300 executed by the central controller 4230.

[0283] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit.

[0284] For example, in one configuration, the MC33035 brushless DC motor controller manufactured by ON Semiconductor is used.

[0285] 5.4.2.6 Protection Circuit

[0286] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0287] 5.4.2.7 Memory

[0288] According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0289] The memory 4260 can be located on PCBA 4202. The memory 4260 can be an EEPROM or a NAND flash memory.

[0290] In the form of flash memory.

[0291] Optionally or additionally, the RPT device 4000 includes a removable memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.

[0292] In one form of this technology, memory 4260 is used as a non-transitory computer-readable storage medium storing computer program instructions representing one or more methods described herein, such as one or more algorithms 4300.

[0293] 5.4.2.8 Data Communication System

[0294] In one embodiment of this technology, a data communication interface 4280 is provided, which is connected to a central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0295] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0296] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0297] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0298] In one form, the remote external device 4286 may be one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, this remote external device 4286 may be accessible to appropriately authorized personnel (e.g., a clinician).

[0299] The local external device 4288 can be a personal computer, mobile phone, tablet, or remote control device.

[0300] 5.4.2.9 Includes optional display and alarm output devices.

[0301] The output device 4290 according to this technology can take the form of one or more visual, auditory, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0302] 5.4.2.9.1 Display Driver

[0303] The display driver 4292 receives characters, symbols, or images as input for display on the display 4294 and converts them into commands that cause the display 4292 to display those characters, symbols, or images.

[0304] 5.4.2.9.2 Monitor

[0305] Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (e.g., the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0306] 5.5 Humidifier

[0307] 5.5.1 Overview of Humidifiers

[0308] In one form of this technology, a humidifier 5000 (e.g., as shown in Figure 5a) is provided to change the absolute humidity of the air or gas delivered to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0309] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, as shown in Figures 5a and 5b, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0310] 5.5.2 Mechanical Components of the Humidifier

[0311] 5.5.2.1 Water Storage Tank

[0312] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) volume for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water volume to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0313] According to one aspect, the water reservoir 5110 is configured to add moisture to the airflow from the RPT device 4000 when airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow traveling in a curved path through the reservoir 5110 when in contact with the water volume therein.

[0314] In one configuration, the reservoir 5110 can be removed from the humidifier 5000, for example, in a lateral direction as shown in Figures 5a and 5b.

[0315] The reservoir 5110 may also be configured to prevent liquid from flowing out through any of the holes and / or from its sub-components when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent leakage and

[0316] / or loss of aerodynamic pressure due to flow resistance.

[0317] 5.5.2.2 Air Guide Section

[0318] According to one arrangement, the reservoir 5110 includes a vent 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the vent 5120 may be a plate, but other shapes are equally applicable. All or part of the vent 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0319] 5.5.2.3 Humidifier reservoir base

[0320] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (as shown in FIG. 5b) configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking mechanism, such as a locking lever 5135 configured to retain the reservoir 5110 in the reservoir base 5130.

[0321] 5.5.2.4 Water level indicator

[0322] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5a-5b. In some forms, the water level indicator 5150 may provide one or more indications to a user (such as a patient or caregiver) regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0323] 5.5.3 Humidifier Electrical & Thermal Components

[0324] The humidifier 5000 may include several electrical and / or thermal components, such as those listed below.

[0325] 5.5.3.1 Humidifier Converter

[0326] In addition to or in addition to the converter 4270 described above, the humidifier 5000 may include one or more humidifier converters (sensors) 5210. As shown in FIG5c, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that can communicate with a controller (such as a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier converter may be externally configured to the humidifier 5000 when communicating the output signal to the controller.

[0327] 5.5.3.1.1 Pressure Transmitter

[0328] In addition to the pressure converter provided in the RPT device 4000, one or more pressure converters 5212 may be provided to the humidifier 5000.

[0329] 5.5.3.1.2 Flow Converter

[0330] In addition to the flow converter 4274 provided in the RPT device 4000, one or more flow converters 5214 may be provided to the humidifier 5000.

[0331] 5.5.3.1.3 Temperature Converter

[0332] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may further include a temperature sensor 5216 for detecting the ambient air temperature.

[0333] 5.5.3.1.4 Humidity Converter

[0334] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas (such as ambient air). In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0335] 5.5.3.2 Heating element

[0336] In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to one or more of the water capacity in humidifier reservoir 5110 and / or to airflow. Heating element 5240 may include heat-generating components, such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0337] In some forms, the heating element 5240 may be provided in the humidifier base 5006, wherein heat may be provided to the humidifier reservoir 5110 primarily by conduction, as shown in FIG5b.

[0338] 5.5.3.3 Humidifier Controller

[0339] According to one arrangement of the present technology, the humidifier 5000 shown in FIG. 5c may include a humidifier controller 5250. In one form, the humidifier controller 5250 may be part of a central controller 4230. In another form, the humidifier controller 5250 may be a standalone controller that can communicate with the central controller 4230.

[0340] In one configuration, the humidifier controller 5250 may receive, for example, measured values ​​of characteristics of air and water flow (such as temperature, humidity, pressure, and / or flow rate) in the storage unit 5110 and / or the humidifier 5000 as input. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0341] As shown in Figure 5c, the humidifier controller may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heated element controller 5252 configured to control the temperature of the heated element 5240.

[0342] 5.6 Respiratory waveform

[0343] Figure 6 This diagram shows a model of a typical breathing waveform during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow. Although parameter values ​​can vary, typical breathing can be approximated by the following: Tidal volume (Vt)

[0344] 0.5L, inspiratory time (Ti) 1.6s, peak inspiratory flow rate (Qpeak) 0.4L / s, expiratory time (Te)

[0345] 2.4s, peak expiratory flow rate (Qpeak) -0.5L / s. The total duration of respiration (Ttot) is approximately 4s. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM), with a ventilation volume (Vent) of approximately 7.5 liters per minute. A typical work cycle (the ratio of Ti to Ttot) is approximately 40%.

[0346] 5.7 Vocabulary

[0347] To achieve the purpose of disclosing the technology of this invention, one or more of the following definitions may be applied in certain forms of the invention. In other forms of the invention, alternative definitions may be applied.

[0348] 5.7.1 General Rules

[0349] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0350] Environment: In certain forms of the present invention, the term environment may have the following meanings: (i) the exterior of the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient. For example, the ambient humidity relative to the humidifier may be the air humidity directly surrounding the humidifier.

[0351] For example, relative to the environment of the humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0352] In another instance, the environment pressure It can be pressure directly around the body or pressure outside the body.

[0353] In some forms, the environment (e.g., acoustics) noise This can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0354] Continuous positive airway pressure (CPAP) therapy: CPAP therapy is considered to mean applying a continuous positive air supply to the airway inlet at a constant pressure relative to the atmosphere. The pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in the absence of such an indication.

[0355] Patient: A person, whether or not they have a respiratory illness.

[0356] Automated Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0357] 5.7.2 Aspects of the respiratory cycle

[0358] Breathing apnea: According to some definitions, breathing apnea is said to have occurred when airflow drops below a predetermined threshold for a sustained period (e.g., 10 seconds). Breathing apnea is also said to have occurred when, despite the patient's efforts, some obstruction of the airway prevents airflow. Central breathing apnea is said to have occurred when breathing apnea is detected due to reduced or absent breathing effort, even though the airway is open. Mixed breathing apnea occurs when reduced or absent breathing effort coincides with airway obstruction.

[0359] Respiratory rate: The patient’s spontaneous respiratory rate, usually measured in breaths per minute.

[0360] Duty cycle: The ratio of inspiratory time (Ti) to total respiratory time (Ttot).

[0361] Effort (breathing): Breathing effort will be described as the work done by a spontaneous breather in attempting to breathe.

[0362] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0363] Flow limitation: Flow limitation is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow limitation occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow limitation. Flow limitation occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow limitation.

[0364] Inhalation waveforms limited by flow rate type:

[0365] (i) Flat: having an upward section followed by a relatively flat section, followed by a downward section.

[0366] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0367] (iii) Chair-shaped: has a single local peak at the leading edge, followed by a relatively flat portion.

[0368] (iv) Inverted chair shape: with a relatively flat portion followed by a single local peak at the trailing edge.

[0369] Insufficient breathing: Preferably, insufficient breathing is considered as a reduction in flow rate, but not a cessation of flow rate.

[0370] In one form, insufficiency can be described as having occurred when the flow rate drops below a threshold for a sustained period of time. Central insufficiency is described as having occurred when insufficiency is detected due to reduced respiratory effort. In one form in adults, any of the following can be considered as insufficiency:

[0371] (i) A 30% reduction in the patient's breathing lasts for at least 10 seconds, plus a corresponding 4% reduction in saturation; or

[0372] (ii) The patient’s breathing is reduced (but at least 50%) for at least 10 seconds, accompanied by a decrease in saturation of at least 3% or arousal.

[0373] Hyperventilation: The flow rate increases to a level higher than normal.

[0374] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0375] Airway openness: The degree to which the airway is open, or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, by using a value of -1 for open and a value of zero (0) for closed (obstructed).

[0376] Positive end-expiratory pressure (PEEP): The pressure in the lungs above atmospheric pressure at the end of expiration.

[0377] Peak flow (Qpeak): The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0378] Respiratory flow, air flow, patient air flow, respiratory air flow (Qr): These synonymous terms can be understood as the RPT device’s estimate of respiratory air flow, as opposed to “real respiratory flow” or “real respiratory air flow”, which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0379] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort.

[0380] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0381] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0382] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of the respiratory flow waveform and the start of the subsequent inspiratory portion of the respiratory flow waveform.

[0383] Typical recent ventilation: Recent values ​​on some predetermined time scale tend to cluster around the ventilation values; that is, a measure of the central tendency of recent ventilation values.

[0384] Upper airway obstruction (UAO): This includes both partial and complete upper airway obstruction. This can be associated with a state of flow restriction, where the flow level increases only slightly or even decreases with an increase in the pressure gradient across the upper airway (Starling resistance behavior).

[0385] Ventilation volume (Vent): A measurement of the total amount of gas exchanged by a patient's respiratory system. A measurement of ventilation volume can include one or both of the inspiratory and expiratory flow rates per unit time. When expressed in volumes per minute (V / min), this quantity is often referred to as "minute ventilation volume." Minute ventilation volume is sometimes given only in volume form and is understood as volumes per minute.

[0386] 5.7.3 RPT Device Parameters

[0387] Flow rate: The instantaneous volume (or mass) of air delivered per unit time. When flow rate and ventilation rate have the same volumetric or mass scale per unit time, flow rate is measured over a shorter time period. In some cases, the reference for flow rate will be a scalar reference, i.e., a quantity that has only a magnitude. In other cases, the reference for flow rate will be a vector reference, i.e., a quantity that has both magnitude and direction. In its scalar case, flow rate can be nominally positive for the inspiratory portion of a patient's respiratory cycle and therefore negative for the expiratory portion. Flow rate will be given by the symbol Q.

[0388] 'Flow rate' is sometimes simply abbreviated as 'flow'. Total flow rate (Qt) is the airflow leaving the RPT device. Ventilation flow rate (Qv) is the airflow leaving the ventilation port to allow exhaled gas flushing. Leakage flow rate (Ql) is the leakage flow rate from the patient interface system. Respiratory flow rate (Qr) is the airflow received into the patient's respiratory system.

[0389] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one instance, a leak can occur due to an incomplete seal between the mask and the patient's face. In another instance, a leak can occur in a bend in the conduit leading to the surrounding environment.

[0390] Noise, conducted (acoustic): In this article, conducted noise refers to noise delivered to the patient through a pneumatic path (such as the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0391] Noise, radiated (acoustic): In this article, radiated noise refers to noise delivered to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0392] Noise, ventilation (acoustic): Ventilation noise in this article refers to noise generated by the flow of air through any ventilation opening (e.g., a ventilation opening in a patient interface).

[0393] Pressure: The force per unit area. Pressure can be expressed in units (including cm²H₂O, gf / cm²). 2 Measurements are taken within the range of 1000 kilopascals (H2O). 1 cm H2O equals 1 g⁻¹ / cm³. 2 It is approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in cm H2O. Pressure at the patient interface is given by the symbol Pm, while treatment pressure is given by the symbol Pt, which represents the target value obtained at the current moment through the mask pressure Pm.

[0394] Sound power: The energy carried by a sound wave per unit time. Sound power is proportional to the square of the sound pressure level multiplied by the area of ​​the wavefront. Sound power is usually given in decibels (SWL), that is, relative to a reference power (usually taken as 10). -12 (Watt) decibels.

[0395] Sound pressure level (SPL): The local deviation from ambient pressure at a given moment caused by sound waves propagating through a medium. SPL is usually given in decibels (dB), that is, the pressure relative to a reference pressure considered the threshold of human hearing (usually taken as 20 × 10⁻⁶). -6 Pascal (Pa) in decibels.

[0396] 5.7.4 Terminology used for ventilators

[0397] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable target ventilation volume instead of a fixed target ventilation volume. The variable target ventilation volume can be determined from some characteristics of the patient, such as the patient's respiratory characteristics.

[0398] Standby frequency: The ventilator parameter that sets the minimum respiratory rate (typically measured in breaths per minute) that the ventilator will deliver to the patient if not caused by spontaneous respiratory effort.

[0399] Cyclic: Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a patient who is breathing spontaneously, the ventilator is said to be cyclic at the end of the inspiratory portion of the respiratory cycle to stop delivering breaths.

[0400] EPAP: Baseline pressure, which is added to the pressure that varies during breathing to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0401] IPAP: The desired mask pressure that the ventilator will attempt to achieve during the inspiratory phase of breathing.

[0402] Pressure support: Indicates the pressure increase during inspiratory breathing that exceeds the pressure increase during expiratory breathing, and generally refers to the pressure difference between the maximum pressure during inspiratory breathing and the minimum pressure during expiratory breathing (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference that the ventilator is planned to achieve, rather than the difference it actually achieves.

[0403] Servo ventilator: A ventilator that measures the patient’s ventilation volume, has a target ventilation volume, and adjusts the pressure support level to bring the patient’s ventilation volume toward the target ventilation volume.

[0404] Spontaneous / Timed (S / T): A mode of ventilator or other device that attempts to detect spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0405] Swing difference: an equivalent term for pressure support.

[0406] Triggered: When a ventilator delivers air to a patient who is breathing spontaneously, it is said to be triggered at the beginning of the respiratory phase of the respiratory cycle by the patient's effort.

[0407] Typical recent ventilation: Typical recent ventilation (Vtyp) is a value around which recent measurements of ventilation on a predetermined time scale tend to cluster. For example, a measurement of the central tendency of recent historical ventilation measurements can be a suitable value for typical recent ventilation.

[0408] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0409] 5.7.5 Facial Anatomy

[0410] Alar: The outer wall or "wing" of each nostril (plural: alar).

[0411] Alar tip: the outermost point on the ala of the nose.

[0412] Nasal wing curve (or nasal apex) point: the last point on the curved baseline of each nasal wing, found in the crease formed by the junction of the nasal wing and the cheek.

[0413] Auricle: The entire visible external part of the ear.

[0414] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0415] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0416] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0417] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (the two lines intersect at the lower point of the nasal septum).

[0418] Frankfurt plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0419] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane of the forehead.

[0420] External nasal cartilage: generally a triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0421] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0422] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril is nostril (or nasal eye). Nostrils are separated by the nasal septum.

[0423] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0424] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0425] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0426] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0427] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0428] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0429] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0430] The nasal ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0431] Sagittal plane: A vertical plane that runs from the front (front) to the back (back) and divides the body into the right and left halves.

[0432] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0433] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and divides into the anterior part of the nasal cavity.

[0434] Posterosuperior lateral segment: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (superior) lip.

[0435] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0436] Mandibular alveolar seat: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point.

[0437] 5.7.6 Anatomical Structure of the Skull

[0438] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0439] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0440] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla extends upward from the side of the nose and forms part of the lateral boundary.

[0441] Nasal bones: The nasal bones are two oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0442] Nasal root: the intersection of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0443] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0444] The eye socket is the bony cavity in the skull that houses the eyeball.

[0445] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0446] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0447] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protruding parts of the cheeks.

[0448] 5.7.7 Anatomical Structure of the Respiratory System

[0449] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0450] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0451] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0452] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular: "nasal conchae"). The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0453] Pharynx: The pharynx located below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the larynx), and the laryngopharynx (hypopharynx).

[0454] 5.7.8 Materials

[0455] Silicone resin or silicone elastomer: synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0456] Polycarbonate: A transparent thermoplastic polymer, typically bisphenol A carbonate.

[0457] 5.7.9 Patient Interface Aspects

[0458] Anti-asphyxiation valve (AAV): A component or sub-assembly of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0459] A bend in the conduit is a duct that directs the airflow by changing direction at an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be less than 90 degrees. The conduit can have an approximately circular cross-section. In yet another form, the conduit can have an elliptical or rectangular cross-section.

[0460] Frame: The frame is generally considered to refer to a mask structure that bears tensile loads between two or more connection points with head straps. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0461] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. Preferably, a headband comprises an assembly of one or more support rods, straps, and reinforcing rods configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, and resilient materials, such as laminated composites of foam and fabric.

[0462] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0463] Inflation chamber: The mask inflation chamber is considered to be part of a patient interface having walls that surround a volume of space, which, during use, contains air pressurized to above atmospheric pressure. A housing may form part of the walls of the mask inflation chamber.

[0464] Sealing: The noun form ("sealing") will be considered to refer to a structure or barrier that intentionally prevents airflow through the interface between two surfaces. The verb form ("sealing") will be considered to mean resisting airflow.

[0465] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0466] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0467] Support: A support is considered to be a structural component designed to increase the compressibility of another component in at least one direction.

[0468] Rotating shaft: (noun) a sub-assembly of an assembly configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotating shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotating element may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the assembly preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotating shaft.

[0469] Lacing: Lacing will be considered as a structural component designed to resist tension.

[0470] Ventilation port: (noun) A structure that allows intentional airflow from inside the mask or duct to ambient air, for example, to allow the flushing of exhaled air.

[0471] 5.7.10 Terminology related to the patient interface

[0472] (Surface) Curvature: A surface region with a saddle-shaped curvature that curves upward in one direction and downward in two other directions is said to have negative curvature. A surface region with a dome-shaped curvature that curves in the same way in both principal directions is said to have positive curvature. A flat surface is considered to have zero curvature.

[0473] Soft: A quality of a material, structure, or composite material that is one or more of the following:

[0474] It easily adapts to finger pressure.

[0475] • Causes it to lose its shape when supporting its own weight.

[0476] It is not rigid.

[0477] • Can be elastically stretched or bent with little effort.

[0478] The quality of softness can have associated directions, so a particular material, structure or composite material can be soft in a first direction but hard or rigid in a second direction (e.g., a second direction orthogonal to the first direction).

[0479] Elastic: It can essentially deform elastically within a relatively short time period (e.g., 1 second) and release virtually all of its energy upon unloading.

[0480] Rigid: It will not easily deform under finger pressure and / or tension or load typically encountered when establishing and maintaining a seal between the patient interface and the patient's airway inlet.

[0481] Semi-rigid: This means having sufficient rigidity to remain essentially undeformed under the mechanical forces typically applied during respiratory pressure therapy.

[0482] Other notes

[0483] This patent document contains a portion of copyrighted material. Because it appears in the patent office's patent documents or records, the copyright holder does not object to any person making a copy of this patent document or the patent disclosure, but otherwise retains all copyright rights.

[0484] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within the scope of this invention. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this invention, but are subject to any explicitly excluded boundaries within the range. When the range includes one or both of these boundaries, the range excluding one or both of those included boundaries is also included within the scope of this invention.

[0485] Furthermore, in cases where one or more values ​​described in the present invention are implemented as part of the present invention, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technology for any suitable valid number of digits.

[0486] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of the techniques of this invention, a limited number of exemplary methods and materials are described herein.

[0487] When a particular material is deemed preferably used for constructing a component, an obvious alternative material with similar properties is used as its substitute. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0488] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a (an)” and “the” as used herein and in the appended claims include their plural equivalents.

[0489] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein provide only disclosures prior to the filing date of this application. None of this document should be construed as an admission by prior invention that the present invention was not entitled to pre-existing technology in such publications. Furthermore, the publication dates provided may differ from the actual publication dates, and independent verification may be required.

[0490] The terms “comprises” and “comprising” should be interpreted as meaning that an element, component, or step referenced in a non-exclusive manner may be presented, used, or combined with other elements, components, or steps not explicitly referenced.

[0491] The main headings used in the detailed description are included for the reader's convenience only and should not be used to limit the subject matter of the invention as found throughout the disclosure or claims. These headings should not be used to interpret the scope or limitation of the claims.

[0492] Although the invention has been described with reference to specific embodiments, it should be understood that these examples are merely illustrative of the principles and applications of the invention. In some instances, proper nouns, terms, and symbols may imply specific details not required for practicing the invention. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise specified, but rather to distinguish different elements. Furthermore, although the process steps in a method may be described or illustrated in a certain order, this order is not necessary. Those skilled in the art will recognize that this order can be modified, and / or aspects of the order can be performed simultaneously or even concurrently.

[0493] Therefore, it should be understood that various modifications can be made to the exemplary instances and other arrangements can be designed without departing from the spirit and scope of the present invention.

[0494] 5.9 List of Reference Symbols

[0495]

[0496]

[0497]

[0498]

Claims

1. A patient interface for sealingly delivering an airflow to a patient airway inlet including at least one inlet of a patient's nostril under a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in use within a range of 4 cm H2O to 30 cm H2O above ambient air pressure throughout the patient's respiratory cycle when the patient is asleep, to alleviate sleep apnea, the patient interface comprising: A sealing structure is configured to contact and seal against the patient’s face in the region surrounding the patient’s airway inlet; An inflation chamber configured to be pressurized in use at a pressure exceeding ambient pressure, wherein when the sealing structure makes sealed contact with a region surrounding the patient's airway inlet, the sealing structure and the inflation chamber at least partially form a breathing chamber, and a connection port is located on the inflation chamber and configured to deliver an airflow to the breathing chamber; A positioning and stabilizing structure is configured to maintain a sealing contact between the sealing-forming structure and the region surrounding the patient's airway inlet; A ventilation port, configured to flush out gas from the breathing chamber, the ventilation port comprising a plurality of orifices; and The device, located within the breathing chamber, is positioned such that, in use, the ventilation port and the connection port are opposite the patient's airway inlet relative to the device. The device has multiple openings to allow airflow into the breathing chamber from the connection port and to allow exhaled air from the patient to pass through the device. The device is shaped and sized such that at least a first portion of the outer peripheral edge region of the device substantially conforms to the inner surface of at least one of the sealing structure and the inflation chamber, and Wherein, a second portion of the outer peripheral edge region of the device is radially recessed into the first portion, such that at least one gap is formed between the outer peripheral edge region of the device and the inner surface of at least one of the sealing structure and the inflation chamber.

2. The patient interface according to claim 1, comprising a bend connected to the connection port.

3. The patient interface according to claim 2, wherein, The ventilation port is located on the bend.

4. The patient interface according to claim 1, wherein, The air exchange port is located on the air filling chamber.

5. The patient interface according to claim 1, including an anti-asphyxiation valve.

6. The patient interface according to claim 1, wherein, The device includes heat and moisture exchanger (HME) material.

7. The patient interface according to claim 6, wherein, The heat and moisture exchanger is made of paper.

8. The patient interface of claim 1, wherein at least some airflow passes through the hole.

9. The patient interface according to claim 8, wherein, All airflow passes through the hole.

10. The patient interface according to claim 1, wherein, The device consists of a flexible diaphragm, a fabric or mesh structure formed of woven fibers.

11. The patient interface according to claim 1, wherein, The device is shaped and sized such that at least a first portion of the outer peripheral edge region of the device substantially conforms to the inner surface of the inflation chamber.

12. The patient interface according to claim 11, wherein, The device is secured to the inflation chamber by friction fit, press fit, slide fit, adhesive, molding and / or clips.

13. The patient interface according to claim 1, wherein, The device is integrally formed with the air chamber.

14. The patient interface according to claim 1, wherein, The device and the inflation chamber are made of a single piece of uniform and continuous material.

15. The patient interface according to claim 1, wherein, The device comprises a material that is resistant to moisture absorption and / or heat absorption.

16. The patient interface according to claim 15, wherein, The material is any one of the group consisting of nylon, polycarbonate, silicone resin, polyurethane, thermoplastic elastomer and hydrophobic polymer.

17. The patient interface of claim 1, wherein the size and shape of the hole are consistent throughout the device.

18. The patient interface of claim 1, wherein the size of the hole is different in different regions of the device. The shape of the hole is different in different regions of the device, and / or The density of the pores is different in different regions of the device.

19. A respiratory pressure therapy (RPT) system, comprising: The patient interface as described in claim 1; A respiratory pressure therapy device, comprising a controllable blower configured to generate an airflow that is continuously positive relative to ambient air pressure; and An air circuit, pneumatically connected to the patient interface and the respiratory pressure therapy device, delivers a continuous positive pressure airflow from the respiratory pressure therapy device to the patient interface relative to ambient air pressure.

20. The respiratory pressure therapy system according to claim 19, wherein, The respiratory pressure therapy system does not include a humidifier.

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