Humidifier heat exchanger with a flexible frame for the interface patient

Abstract

To provide a medical device for screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.SOLUTION: A patient interface is provided which includes: a plenum chamber pressurizable to a therapeutic pressure, the plenum chamber comprising two plenum chamber connectors; a seal-forming structure arranged to seal with a region of a patient's face; a positioning and stabilizing structure comprising two conduits each configured to connect to a corresponding one of the plenum chamber connectors; a vent assembly having a plurality of vent holes configured to allow a continuous flow of gases exhaled by the patient from within the plenum chamber to ambience throughout the patient's respiratory cycle; and a heat and moisture exchanger (HMX) assembly including an HMX frame and a material that is supported by the HMX frame such that the flow of air entering the plenum chamber from the plenum chamber connectors passes through the material before entering the patient's airways.SELECTED DRAWING: Figure 57

Description

Technical Field

[0001] 1. Cross - reference to Related Applications Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if someone reproduces this patent document or this patent disclosure by fax, provided it is as described in the patent files or records of the Patent Office and for the intended purpose, but retains all copyrights for other purposes.

[0002] 2. Background of the Technology 2.1 Field of the Technology This application claims the priority of Australian Provisional Application No. 2020903663, filed on October 9, 2020, the content of which is incorporated herein by reference.

[0003] This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory - related disorders. This technology also relates to medical devices or apparatuses and their use.

Background Art

[0004] 2.2. Description of Related Technologies 2.2.1 The Human Respiratory System and Its Disorders The body's respiratory system facilitates gas exchange. The nostrils and mouth are the entrances to the patient's airway.

[0005] These airways include a series of bronchial tubes that become narrower, shorter, and more numerous as they proceed deeper into the lungs. The main function of the lungs is to perform gas exchange, thereby allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi make up the conducting airways and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. For more information on this, refer to "Respiratory Physiology," 9th edition, by John B. West, Lippincott Williams & Wilkins, published in 2012.

[0006] There are various respiratory disorders. Certain disorders can be characterized by specific symptoms (e.g., apnea, hypopnea, and hyperventilation).

[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0008] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by events that involve the obstruction or closure of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue area, as well as the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such a condition, affected patients generally stop breathing 200 - 300 times per night, sometimes for a duration of 30 - 120 seconds. As a result, excessive daytime sleepiness often occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disorder, particularly common in middle-aged overweight men, but patients may not have any awareness of the symptoms. Refer to U.S. Patent No. 4,944,310 to Sullivan.

[0009] In order to treat or improve such diseases, a certain range of treatments are used. Furthermore, in other respects, healthy individuals can also advantageously utilize such treatments for the prevention of respiratory failure. However, there are multiple defects in these.

[0010] 2.2.2 Treatment A variety of respiratory treatments (e.g., Continuous Positive Airway Pressure (CPAP) treatment, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT)) are used for the treatment of one or more of the above-mentioned respiratory disorders.

[0011] 2.2.2.1 Respiratory Pressure Treatment Respiratory pressure treatment is the application of supplying air to the entrance of the airway at a target pressure that is controlled to be nominally positive with respect to the atmosphere over the entire respiratory cycle of the patient (in contrast to negative pressure treatments such as, for example, tank ventilators or cuirass).

[0012] Continuous Positive Airway Pressure (CPAP) is used to treat Obstructive Sleep Apnea (OSA). As its mechanism of action, continuous positive airway pressure can act as an air pressure sprint and prevent upper airway closure by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall. Since the treatment of OSA by CPAP treatment can be spontaneous, patients may choose not to comply with the treatment if they notice one or more of the following about the device used to administer such treatment: uncomfortable, difficult to use, expensive, aesthetically unappealing, etc.

[0013] Non-invasive ventilation (NIV) provides ventilation support to a patient via the upper airway by completing some or all of the breathing work to assist the patient's breathing and / or maintain sufficient oxygen levels in the body. Ventilation assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0014] Invasive ventilation (IV) provides ventilation assistance to patients who are no longer able to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0015] 2.2.3 Respiratory therapy system These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosis, or monitoring without treating the disease.

[0016] A respiratory therapy system can include one of a respiratory pressure therapy (RPT) device, an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0017] Another form of treatment system is a mandibular position change device.

[0018] 2.2.3.1 Patient interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an air flow to the entrance of the airway. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the treatment applied, the patient interface can be sealed, for example, to an area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure together with the ambient pressure for treatment execution (e.g., at a positive pressure that is, for example, about 10 cmH2O higher than the ambient pressure).

[0019] In the case of other treatment modalities such as oxygen delivery, the patient interface may not include sufficient seal to facilitate delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface is configured to deliver air to the nostrils (and clearly avoid a complete seal). An example of such a patient interface is a nasal cannula.

[0020] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a mask for purely decorative purposes, it may not be able to maintain an appropriate pressure. A mask system used for underwater swimming or diving may be configured to protect against water intrusion from a higher external pressure and not maintain internal air at a pressure higher than the surroundings.

[0021] Certain masks may not be clinically preferred in the present technology (for example, when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0022] In certain masks, when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips, it may be uncomfortable or impractical in the present technology.

[0023] Certain masks may be impractical for use during sleep (for example, when sleeping on the side in bed with the head on a pillow).

[0024] The design of the patient interface has multiple challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head includes bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0025] As a result of these problems, depending on the mask, especially when the wearing time is long or the patient is unfamiliar with the system, it may be subject to one or more of excessive pressure, aesthetically undesirable, costly, poor fit, difficult to use, and discomfort. When an incorrectly sized mask is used, it can lead to reduced compliance, reduced comfort, and reduced patient prognosis. Masks designed as part of a pilot-only mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask may be tolerable for their original use, but in the case of such masks, they may be unacceptably uncomfortable for long-term (e.g., several hours) wear. Due to such discomfort, patient compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0026] CPAP treatment is extremely effective in the treatment of certain respiratory disorders when the patient has consented to the treatment. If the mask is uncomfortable or difficult to use, the patient may not consent to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0027] In the case of masks for other uses (e.g., pilots), they may not be suitable for use in the treatment of sleep apnea, so masks designed for use in the treatment of sleep apnea may be suitable for other uses.

[0028] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0029] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the seal-forming structure makes direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0030] The patient interface can be partially characterized according to the design intent when the seal-forming structure is adapted to engage with the face during use. In one form of the patient interface, the seal-forming structure can include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to be placed, for example, on the upper lip region and the nasal bridge region of the face. In one form of the patient interface, the seal-forming structure can include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both the nostril region and the oral region during use. These different types of patient interfaces can be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0031] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variability, and sensitive regions in different regions of the patient's face. For example, in the case of the structure of swimming goggles, a seal is made by placing them on the patient's forehead, but they may be inappropriate for use on the patient's nose.

[0032] A particular seal-forming structure can be designed for mass production to be suitable, comfortable, and effective, with one design being adaptable to a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface such that the seal-forming structure seals the patient's face, it may be necessary to adapt one or both of them.

[0033] Certain types of seal-forming structures extend around the perimeter of a patient interface and are intended to seal against a patient's face when a force is applied to the patient interface while the seal-forming structure is engaged facing the patient's face. The seal-forming structure can include an air or fluid filled cushion, or can include a formed or formed surface of an elastomeric seal element, such as rubber. In the case of this type of seal-forming structure, if the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force may be required to position the patient interface against the face and seal between them, which can lead to leakage without such force. With additional force, it can lead to discomfort for the patient during use.

[0034] Another type of seal-forming structure uses a relatively thin flap disposed around the perimeter of a mask to provide a self-sealing action against a patient's face when positive pressure is applied within the mask. Similar to the types of seal-forming structures described in the above paragraph, if the size and shape of the seal-forming structure do not exactly correspond to the size and shape of the patient's face, additional force may be required for sealing against the patient's face, which can lead to leakage in the mask without such force. With additional force, it can lead to discomfort for the patient during use. Further, if the size and shape of the seal-forming structure do not exactly correspond to the patient's size and shape, it can lead to wrinkles or buckling due to the relative thinness of the seal-forming structure during use, which can result in leakage.

[0035] Another type of seal-forming structure e can include friction fit elements inserted into the nostrils, for example, and there are also patients who find these seal-forming structures uncomfortable.

[0036] Another form of seal-forming structure can use an adhesive portion to obtain a seal. Among patients, there are also patients who always feel that it is inconvenient to attach or remove the adhesive portion to their face.

[0037] Regarding a patient interface seal formation structure technology within a certain range, the following disclosures are available: Patent Application (Assignee: ResMed Limited, Kwok et al.), International Publication No. WO1998 / 004310A1 (Davidson et al.), International Publication No. WO2006 / 074513A1 (Dravitzki et al.), International Publication No. WO2010 / 135785A1.

[0038] One form of nasal pillows can be found in the ADAM circuit manufactured by Puritan - Bennett Corporation. Discussions about another nasal pillow or nasal puff are described below: U.S. Patent No. 4,782,832 to Trimble et al. (Assignee: Puritan - Bennett Corporation).

[0039] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask, and MIRAGELIBERTY™ Full Face Mask. The following patent applications (Assignee: ResMed Limited) describe examples of nasal pillow masks: Gunaratnam et al., International Publication No. WO2004 / 073778A1 (describing aspects such as the form of ResMed Limited's SWIFT® Nasal Pillow); Guney et al., U.S. Published Application No. 2009 / 0044808A1 (describing aspects such as the form of ResMed Limited's SWIFT® LT Nasal Pillow); Davidson et al., International Publication No. WO2005 / 063328A1 and Lubke et al., International Publication No. WO2006 / 130903A1 (describing aspects such as the form of ResMed Limited's MIRAGELIBERTY™ Full Face Mask); Rummery et al., International Publication No. WO2009 / 052560A1 (describing aspects such as the form of ResMed Limited's SWIFT® FX Nasal Pillow).

[0040] 2.2.3.1.2 Positioning and Stabilization The seal-forming structure of the patient interface used in positive pressure therapy is subject to the corresponding force of air pressure, which hinders the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0041] In one technique, an adhesive part is used. See, for example, U.S. Publication No. 2010 / 0000534A1 to Kooij et al. However, when using an adhesive part, there may be discomfort.

[0042] In another technique, one or more straps and / or stabilization harnesses are used. Many such harnesses are adversely affected by one or more of poor fit, bulkiness, discomfort, and difficulty in handling.

[0043] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices A respiratory pressure therapy (RPT) device can be used individually or as part of a system to deliver one or more of the above-mentioned multiple therapies, for example, by operating the device to generate an air delivery flow to the interface to the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, the RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0044] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Also, even devices designed for medical treatment may be troubled by drawbacks including one or more of comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0045] As an example of special requirements for a specific RPT device, there is minimization of acoustic noise considering the possibility that the patient is asleep during operation.

[0046] Table of noise output levels of conventional RPT devices (measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744, for only one sample) [Table 1]

[0047] As one known RPT device used for the treatment of sleep apnea, there is the S9 sleep therapy system (manufacturer: ResMed Limited). As another example of an RPT device, there is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar™ series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive non-dependent ventilation for patients over a range for the treatment of multiple diseases (including, without limitation, NMD, OHS, and COPD).

[0048] The Elise Accutronic® 150 ventilator and the VS III® ventilator manufactured by ResMed Limited can provide assistance for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of multiple diseases. With these ventilators, volume ventilation mode and pressure ventilation mode using single or double limb circuits can be obtained. An RPT device typically includes a pressure generator such as an electric blower or a compressed gas reservoir and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0049] Device designers can be presented with countless options. Since design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Additionally, the comfort and effectiveness of a particular aspect can also be greatly affected by minor changes in one or more parameters.

[0050] 2.2.3.3 Air Circuit The air circuit is a conduit or tube constructed and arranged such that, during use, the air flow moves between two components of the respiratory therapy system (e.g., the RPT device and the patient interface). In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single-limb air circuit is used for both inhalation and exhalation.

[0051] 2.2.3.4 Humidifier If the delivery of the air flow is done without humidification, it can lead to drying of the airway. When a humidifier is used with the RPT device and the patient interface, humidified gas is generated, thus minimizing drying of the nasal mucosa and increasing the comfort of the patient's airway. Additionally, in a cooler climate, generally adding warm air to the facial area around the patient interface results in higher comfort compared to cold air. Therefore, humidifiers often have the ability not only to heat the air flow but also to humidify the air flow. Furthermore, with the increase in air temperature, the possible amount of water vapor generation also increases.

[0052] Various artificial humidification devices and systems are known, but these may not meet the special requirements of medical humidifiers.

[0053] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, typically when a patient is sleeping or resting (e.g., in a hospital). A medical humidifier placed near a patient's head may be small. A medical humidifier can be configured to humidify and / or heat only the air stream delivered to the patient without humidifying and / or heating the patient's surrounding environment. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air inhaled by the patient, but these systems may also humidify and / or heat the entire room, which can cause discomfort to the occupants. Additionally, medical humidifiers may be subject to more stringent safety constraints than industrial humidifiers.

[0054] A number of medical humidifiers are known, but these humidifiers suffer from one or more drawbacks. In the case of such medical humidifiers, some have inappropriate humidification, while others are difficult or inconvenient for patients to use.

[0055] 2.2.3.5 Data Management For clinical reasons, data may be obtained to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is using their RPT device in accordance with one or more "compliance rules"). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device (e.g., a healthcare provider) can manually obtain data describing the patient's treatment with the RPT device, calculate the usage rate over a given period, and compare this to the compliance rule. The healthcare provider may notify a third party that the patient is compliant if it determines that the patient has used their RPT device in accordance with the compliance rule.

[0056] In the treatment of patients, there may be other ways of benefiting from the communication of treatment data to third parties or external systems.

[0057] In the case of existing processes for communicating and managing such data, one or more of high cost, time-consuming, and susceptibility to errors may occur.

[0058] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a ventilation section for expelling the breathed carbon dioxide. This ventilation section may enable a gas flow from the internal space of the patient interface (e.g., within the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0059] This ventilation section may include an orifice, and when using a mask, gas may flow through the orifice. Many such ventilation sections make noise. In other cases, they may become blocked during use, resulting in insufficient expulsion. In some cases of ventilation sections, for example due to noise or airflow concentration, the sleep of patient 1000 and roommate 1100 may be disturbed.

[0060] ResMed Limited has developed a number of improved mask ventilation technologies. See International Application No. WO1998 / 034665 A1 by Kwok, International Application No. WO 2000 / 078381 A1 by Gunaratnam et al., U.S. Patent No. 6,581,594 B1 by Drew et al., U.S. Application No. 2009 / 0050156 A1 by Ng et al., and U.S. Application No. 2009 / 0044808 A1 by Guney et al.

[0061] Table of conventional mask noise (ISO17510-2:2007, at 1 m under a pressure of 10 cmH2O) [Table 2]

[0062] (Measure with a single sample at 10 cmH2O in CPAP mode using the test method specified in ISO3744)

[0063] List the sound pressure values of various subjects as follows:

Table 3

[0064] 2.2.3.7 Humidification exchanger (HMX) technology When performing various forms of respiratory therapy as described above, patients may be susceptible to the effects of drying of the internal airway channels. For example, in CPAP therapy, it is necessary to provide a continuously pressurized air flow to the patient at a pressure higher than the ambient pressure. However, when such a continuous air flow reaches a high level in relation to the positive air pressure, it can cause drying of the patient's airway. Such drying can cause discomfort and may consequently have an adverse effect on the patient's treatment compliance.

[0065] In order to minimize the effects of drying in these forms of respiratory therapy, the air flow provided to the patient can be humidified and then delivered to the patient. As described above, in certain forms of humidification technology, in the operation of actively providing humidified air to the patient to reduce the effects of drying, the water reservoir is heated and air is passed over its surface to increase the absolute humidity of the air (i.e., water vapor from the reservoir is sent into the air). Subsequently, the humidified air is sent to the patient via the air circuit. To avoid condensation (also known as rainout) during the transport of water vapor in the air circuit to the patient, the air circuit may be heated. In the case of these forms of technology, it is often necessary to fill the reservoir with water before treatment and then provide the reservoir to the RPT system, which enables heating of the water and humidification of the air for treatment. The reservoir often requires regular cleaning, has a risk of overflow, and can be particularly problematic in the context of electrical components, and the patient may need to refill the reservoir before use.

[0066] If a pre-supplied water source (e.g., a reservoir filled with water) and input power for water heating become unnecessary, several benefits can be obtained. For example, since the space for the water reservoir and the heating plate becomes unnecessary, the RPT device can be downsized. Since the electrical energy consumption during water heating is eliminated, the reduction of electrical costs is also possible. Also, the number of electrical components in the RPT device can be reduced, and the cost and complexity of the electrical components are decreased. Further, since there is no need to fill, empty, and clean the water reservoir, the ease of use of the RPT device can be increased. The risk of overflow can also be reduced. Also, since the operation of the humidification setting becomes unnecessary, the operation of the RPT device can be simplified.

[0067] During operation, the patient exhales (breathes out) air that has been heated in the patient's body and has absorbed water vapor from the patient's airway. The heat and moisture in the exhaled breath are captured by the HMX material(s). That is, since the exhaled breath is ventilated to the atmosphere after passing through the HMX material(s), the HMX material(s) is heated by the relatively warm exhaled breath and adsorbs water vapor from the relatively high-humidity exhaled breath. During inhalation, the flow of pressurized air passes through the HMX material(s) in the direction opposite to the exhaled breath and then reaches the patient's airway, and the source of the incoming air is often the ambient air. Therefore, when the flow of pressurized air passes through the HMX material(s) before reaching the patient's airway, it is released from the HMX material(s), absorbs moisture in the form of water vapor, and is heated by the heat released from the HMX material(s). SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0068] 3. Summary of the Invention The present technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory disorders, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0069] A first aspect of the present technology relates to an apparatus for use in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0070] Another aspect of the present technology relates to a method for use in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0071] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0072] Another aspect of the present technology relates to a patient interface that may include a plenum chamber, a seal-forming structure, and a positioning and stabilization structure. The patient interface may further include a ventilation structure. The patient interface may be further configured to keep the patient's mouth exposed, or, if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe ambient air through the plenum chamber inlet port when there is no pressurized air flow.

[0073] Another aspect of one form of the present technology is a plenum chamber that can be pressurized to a treatment pressure that is at least 4 cmH2O higher than the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive an airflow at the treatment pressure for breathing by a patient, a seal-forming structure constructed and arranged to seal with a facial region of the patient that at least partially surrounds an airway inlet of the patient, the seal-forming structure having apertures for delivering an airflow at the treatment pressure to at least the patient's nostrils during use, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, a positioning and stabilization structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including a strap, the strap being constructed and arranged to be placed at least in part over a region of the patient's head that is above the superior tragus of the patient's head during use, a ventilation structure configured to allow a continuous gas flow exhaled by the patient to move from the interior of the plenum chamber to the ambient, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, and being configured to leave the patient's mouth exposed, or, in the case where the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the ambient through the plenum chamber inlet port when there is no flow of pressurized air.

[0074] Another aspect of the technology is a plenum chamber that can be pressurized to a treatment pressure at least 4 cmH2O higher than the ambient air pressure by an air flow of treatment pressure for breathing by a patient, the plenum chamber including a plenum chamber further including two plenum chamber connectors, a seal-forming structure constructed and arranged to seal with a facial region of the patient that at least partially surrounds an airway inlet of the patient, and a positioning and stabilization structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure further including two conduits, each conduit being configured to be connected to a corresponding one of the plenum chamber connectors, a ventilation assembly having a plurality of ventilation holes configured to allow the patient to continuously flow the gas exhaled from the plenum chamber to the surroundings throughout the patient's breathing cycle, an HMX frame and a material, the material being configured to adsorb water vapor from the patient's exhaled gas and desorb water vapor into the air flow of treatment pressure, and a humidification and heat exchange (HMX) assembly supported by the HMX frame in the plenum chamber such that at least a part of the air flow of treatment pressure entering the plenum chamber from the plenum chamber connectors passes through the material before entering the patient's airway, related to a patient interface.

[0075] Another aspect of the present technology is a plenum chamber that can be pressurized to a therapeutic pressure at least 4 cmH2O higher than the ambient air pressure by an air flow of therapeutic pressure for breathing by a patient, the plenum chamber further including two plenum chamber connectors each disposed on a corresponding side surface of the plenum chamber and configured to receive an air flow of therapeutic pressure, a seal-forming structure connected to the plenum chamber, the seal-forming structure being constructed and arranged to seal with a facial region of the patient that at least partially surrounds the patient's airway inlet, having holes for delivering an air flow of therapeutic pressure to at least the patient's nostrils during use, and being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's breathing cycle, a positioning and stabilization structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure further including two conduits, each conduit being configured to be disposed on a corresponding side surface of the patient's head during use and being configured to be connected to a corresponding one of the plenum chamber connectors, a ventilation assembly connected to the plenum chamber and having a plurality of ventilation holes, the plurality of ventilation holes being configured to allow the gas exhaled by the patient from the plenum chamber to flow continuously to the surroundings throughout the patient's breathing cycle, and being sized and shaped to maintain the therapeutic pressure within the plenum chamber during use, a humidification and heat exchange (HMX) assembly connected to the ventilation assembly, the HMX assembly including an HMX frame and a material disposed on the HMX frame, the material being configured to adsorb water vapor from the patient's exhaled gas and desorb water vapor into the air flow of therapeutic pressure, and the HMX frame being supported within the plenum chamber such that at least a portion of the air flow of therapeutic pressure entering the plenum chamber from the plenum chamber connector passes through the material before entering the patient's airway, and the patient interface being configured to keep the patient's mouth exposed, or,When the seal forming structure is configured to seal around the patient's nose and mouth, the patient interface relates to a patient interface configured to allow the patient to breathe from the environment when there is no airflow of therapeutic pressure.

[0076] In any example of the aspects described in the foregoing paragraphs, (a) the material may include a foam or paper. (b) the material may include a salt applied to the surface of the material. (c) the material may be removable from the HMX frame. (d) the HMX assembly may be removable from within the plenum chamber. (e) the ventilation assembly may be removably connected to the plenum chamber. (f) the ventilation assembly and the HMX assembly may be removably integrated from the plenum chamber as a unit. (g) the HMX assembly may be removable from the ventilation assembly. (h) the ventilation assembly may include a ventilation body and a ventilation cap attached to the ventilation body. (i) the ventilation hole may be formed between the ventilation body and the ventilation cap. (j) the ventilation body may include a ventilation hole configured such that a continuous flow of the patient's exhaled gas passes through the ventilation body and then enters the atmosphere through the ventilation hole. (k) the ventilation assembly may include a ventilation diffusion material disposed between the ventilation body and the ventilation cap. (l) the ventilation body may include a spacer for distancing the ventilation diffusion material from the ventilation hole and abutting the ventilation cap. (m) one of the plenum chamber and the ventilation body may include one or more direction indicating protrusions, and the other of the plenum chamber and the ventilation body may include one or more direction indicating recesses configured to receive one of the corresponding direction indicating protrusions when the ventilation body is attached to the plenum chamber. (n) one of the plenum chamber and the ventilation body may include a connection lip, and the other of the plenum chamber and the ventilation body may include a connection passage configured to receive the connection lip and removably attach the ventilation body to the plenum chamber. (o) the plenum chamber may include a receiving hole configured to receive the ventilation assembly, and the HMX assembly may be inserted into the interior of the plenum chamber through the receiving hole. (p) the HMX frame may be made of a flexible material. (q) the flexible material may be silicone rubber or a thermoplastic elastomer.(r) The material may be disposed within the plenum chamber such that an airflow of therapeutic pressure must pass through the material before entering the patient's airway. (q) The material may be disposed within the plenum chamber such that the patient's exhaled gas must pass through the material before being discharged to the surroundings through the ventilation holes. (r) The material may be disposed within the plenum chamber such that at least a portion of the airflow of therapeutic pressure bypasses the material before entering the patient's airway. (s) The material may be disposed within the plenum chamber such that at least a portion of the patient's exhaled gas bypasses the material before being discharged to the surroundings through the ventilation holes. (t) The HMX frame forms HMX frame holes, and a peripheral portion of the material may be disposed on the HMX frame such that gas flowing through the material passes through the HMX frame holes. (u) The HMX frame may include an HMX rim connected to the ventilation assembly. (v) The HMX frame may include one or more HMX struts joined to the HMX rim. (w) Each of the HMX struts may be linear. (x) Each of the HMX struts may be curved. (y) The HMX rim may be directly joined to the HMX frame. (z) One or more slots may be formed through the attachment structure, and each of the slots may be configured to receive a corresponding one of the HMX struts. (aa) The material may be permanently attached to the HMX frame. (bb) The material may be attached to the HMX frame by one or more of an adhesive, overmolding the HMX frame onto the material, and a retainer for holding the material to the HMX frame. (cc) The material may further include a rear surface that faces the patient's face during use, and the rear surface may be bent forward so as not to contact the patient's face during use. (dd) The seal-forming structure may include a sealing lip configured to seal against the HMX frame.(ee) The sealing lip may include a sealing lip bypass opening configured such that at least a portion of the airflow of the therapeutic pressure bypasses the material before entering the patient's airway and at least a portion of the patient's exhaled gas bypasses the material before being discharged to the surroundings through the ventilation holes. (ff) The sealing lip may be configured to seal the entire periphery of the HMX frame such that all of the airflow of the therapeutic pressure passes through the material before entering the patient's airway and all of the patient's exhaled gas passes through the material before being discharged to the surroundings through the ventilation holes. (gg) The seal-forming structure may be configured such that the patient's mouth is not covered and may include a nasal pillow or a nasal cradle. And / or (hh) The seal-forming structure may be configured to seal around the patient's nose and mouth and may further include one or two nostrils configured to be pneumatically connected to the patient's nostrils during use and an oral aperture configured to be pneumatically connected to the patient's mouth during use.

[0077] Another aspect of the present technology relates to a respiratory pressure therapy (RPT) system including a patient interface of any of the aspects and examples described in the preceding paragraphs, a respiratory pressure therapy (RPT) device configured to generate an airflow of therapeutic pressure, and an air circuit configured to connect the RPT device and the patient interface to direct the airflow of therapeutic pressure from the RPT device to the patient interface. In a further example, the RPT system may not include a humidifier.

[0078] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0079] One aspect of one form of the present technology is a method of manufacturing an apparatus.

[0080] One aspect of a particular form of the present technology is an easy-to-use medical device, for example, for a person who has not received medical training, a person who is not very skillful or lacks insight, or a person with limited experience in using this type of medical device.

[0081] One aspect of one form of the present technology is a portable RPT device that can be carried by a human, for example, around the human's home.

[0082] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soapy water at the patient's home without the need for special cleaning utensils. One aspect of one form of the present technology is a humidifier tank that can be cleaned, for example, with soapy water at the patient's home without the need for special cleaning utensils.

[0083] The above-described methods, systems, devices, and apparatuses can be implemented to improve the functions of processors such as specific-purpose computers, respiratory monitors, and / or respiratory treatment devices. Also, the above-described methods, systems, devices, and apparatuses can provide improvements in the technical field of automatic management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep apnea.

[0084] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of each of the sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0085] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0086] 4. Brief Description of the Drawings The present technology is illustrated by way of non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements.

[0087]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

【Figure It is a cross-sectional view through the structure of FIG. 24. The illustrated surface bounds a two-dimensional hole in the structure of FIG. 24. ​ It is a perspective view of the structure of FIG. 24 including a two-dimensional hole and a one-dimensional hole. Also, the surface bounding the two-dimensional hole in the structure of FIG. 24 is shown. ​ A mask having an inflatable bladder as a cushion is shown. ​ It is a cross-sectional view of the mask of FIG. 27, showing the inner surface of the bladder. The inner surface bounds a two-dimensional hole in the mask. ​ A further cross-section through the mask of FIG. 27 is shown. The inner surface is also shown. ​ The left-hand rule is shown. ​ The right-hand rule is shown. ​ Shows the left ear including the left ear helix. ​ Shows the right ear including the right ear helix. ​ Shows a right - hand helix. ​ It is a diagram of a mask including the sine of the twist of a space curve defined by the edge of a seal film in different regions of the mask. ​ It is a diagram of the plenum chamber 3200 showing the sagittal plane and the central contact surface. ​ It is a view behind the plenum chamber of FIG. 36. The direction in the figure is perpendicular to the central contact surface. In FIG. 37, by the sagittal plane, the plenum chamber is bisected into the left - hand side and the right - hand side. ​ It is a cross - sectional view through the plenum chamber of FIG. 37, and this cross - section is taken in the sagittal plane shown in FIG. 37. The "central contact" surface is shown. The central contact surface is perpendicular to the sagittal plane. The orientation of the central contact surface corresponds to the orientation of the chord 3210. The chord 3210 is placed on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., the upper point 3220 and the lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface can contact both the upper point and the lower point. ​ Shows the state where the plenum chamber 3200 of FIG. 36 is in the use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face when the plenum chamber is in the use position. The central contact surface generally corresponds to the "face of the face" when the plenum chamber is in the use position. In FIG. 38, the plenum chamber 3200 is of the nasal mask type, the upper point 3220 is located approximately on the selion, and the lower point 3230 is located on the upper lip. 4.4RPT device ​ Shows an RPT device according to one form of the present technology. ​Schematic diagram of the pneumatic path of the RPT device according to one form of the present technology. The upstream and downstream directions are shown with reference to the blower and the patient interface. Regardless of the actual flow direction at a particular point in time, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 4.5 Respiratory waveform ​ Shows a model of a typical respiratory waveform of a human during sleep. 4.6 Example of a patient interface according to the present technology ​ Perspective view of a patient interface worn by a patient according to an example of the present technology. ​ Perspective view of a patient interface according to an example of the present technology. ​ Rear perspective view of a patient interface according to an example of the present technology. ​ Perspective view of a patient interface according to another example of the present technology. ​ Rear view of a patient interface according to another example of the present technology. ​ Perspective view of a seal-forming structure, a plenum chamber, and a ventilation part of a patient interface according to another example of the present technology. ​ Rear perspective view of a seal-forming structure and a plenum chamber of a patient interface according to another example of the present technology. ​ Front view of a seal-forming structure, a plenum chamber, and a ventilation part of a patient interface according to another example of the present technology. ​ Rear view of a seal-forming structure and a plenum chamber of a patient interface according to another example of the present technology. ​ Side view of a seal-forming structure, a plenum chamber, and a ventilation part of a patient interface according to another example of the present technology. ​Cross-sectional view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology, taken along line 53-53 of FIG. 51. ​ Cross-sectional view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology, taken along line 54-54 of FIG. 51. ​ Cross-sectional view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology, taken along line 55-55 of FIG. 52. ​ Cross-sectional view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology, taken along line 56-56 of FIG. 52. ​ Exploded view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology. ​ Rear perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ Perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ Another perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ Side view of an HMX and a ventilation assembly according to an example of the present technology. ​ Side perspective view of an HMX and an exhaust assembly according to an example of the present technology. ​ Rear perspective view of an HMX assembly according to an example of the present technology. ​ Perspective view of an HMX assembly according to an example of the present technology. ​ Another perspective view of an HMX assembly according to an example of the present technology. ​ Another rear perspective view of an HMX assembly according to an example of the present technology. ​ Rear perspective view of an HMX frame according to an example of the present technology. ​ Perspective view of an HMX frame according to an example of the present technology. ​ Perspective view of an HMX material according to an example of the present technology. ​ Side view of an HMX material according to an example of the present technology. ​ Perspective view of a ventilation part according to an example of the present technology. ​ Rear perspective view of a ventilation part according to an example of the present technology. ​ Side view of a ventilation part according to an example of the present technology. ​ Top view of a ventilation part according to an example of the present technology. ​ Rear perspective view of an HMX and a ventilation assembly according to another example of the present technology. ​ Top view of an HMX and a ventilation assembly according to an example of the present technology. ​ Side view of an HMX and a ventilation assembly according to an example of the present technology. ​ Another rear perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ Rear perspective view of an HMX assembly according to an example of the present technology. ​ Perspective view of an HMX assembly according to an example of the present technology. ​ Rear perspective view of an HMX frame according to an example of the present technology. ​ Perspective view of an HMX frame according to an example of the present technology. ​ Front view of a seal formation structure, a plenum chamber, and a ventilation part of a patient interface according to another example of the present technology. ​ Front view of a seal formation structure, a plenum chamber, and a ventilation part of a patient interface according to another example of the present technology. ​A cross-sectional view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology, taken along line 85-85 of FIG. 84. ​ A cross-sectional view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology, taken along line 86-86 of FIG. 84. ​ A cross-sectional view of a seal-forming structure, a plenum chamber, and a ventilation portion of a patient interface according to another example of the present technology, taken along line 87-87 of FIG. 84. ​ A rear perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ A perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ Another perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ Another rear perspective view of an HMX and a ventilation assembly according to an example of the present technology. ​ A side view of an HMX and a ventilation assembly according to an example of the present technology. ​ A rear view of an HMX and a ventilation assembly according to an example of the present technology. ​ A perspective view of a ventilation portion according to an example of the present technology. ​ A rear perspective view of a ventilation portion according to an example of the present technology. ​ A side view of a ventilation portion according to an example of the present technology. ​ Another rear perspective view of a ventilation portion according to an example of the present technology. ​ A rear perspective view of an HMX frame according to an example of the present technology. ​ A perspective view of an HMX frame according to an example of the present technology. ​ A rear perspective view of an HMX material according to an example of the present technology. ​Perspective view of an HMX material according to an example of the present technology. ​ Cross-sectional view taken along line 102-102 of FIG. 84 of a seal-forming structure, a plenum chamber, an HMX assembly, and a ventilation section of a patient interface according to another example of the present technology. ​ Cross-sectional view taken along lines 103, 104-103, 104 of FIG. 84 of a seal-forming structure, a plenum chamber, and a ventilation section of a patient interface according to another example of the present technology. ​ Cross-sectional view taken along lines 103, 104-103, 104 of FIG. 84 of a seal-forming structure and a plenum chamber according to another example of the present technology.

Mode for Carrying Out the Invention

[0088] 5. Mode for Carrying Out the Invention Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific examples described herein and are not limiting.

[0089] The following description is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples can be used to configure further examples.

[0090] 5.1 Treatment In one form, the present technology includes a method for treating a respiratory disorder, the method including pressurizing air to a positive pressure with respect to the environment and guiding the pressurized air to the airway inlet of a patient 1000.

[0091] In certain examples of the present technology, an air supply at positive pressure relative to the surroundings is provided to the patient's nasal passages via one or both of the nostrils. In further examples, in addition to the nasal route, a positive pressure air supply may be provided to the mouth.

[0092] In certain examples of the present technology, mouth breathing is restricted, limited, or impeded.

[0093] 5.2 Respiratory Therapy System In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may comprise an RPT device 4000 for supplying an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0094] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes, as functional aspects, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation assembly 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be implemented by one or more physical components. In some forms, one physical component may implement one or more functional aspects. In use, the seal-forming structure 3100 is installed to surround the entrance to the patient's airway so as to maintain positive pressure at the entrance to the patient's airway. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0095] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0096] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure at least 20 cmH2O higher than the surroundings.

[0097] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O higher than the ambient.

[0098] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O higher than the ambient.

[0099] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O higher than the ambient.

[0100] As shown in FIGS. 43 to 47, a non-invasive patient interface 3000 according to one aspect of the present technology includes, as functional aspects, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation assembly 3400, a connection port 3600 of one form for connecting to an air circuit 4170 (see, for example, FIGS. 1A to 1C), and a forehead support 3700. In this example, the seal-forming structure 3100 and the plenum chamber 3200 are provided by a cushion module 3150.

[0101] 5.3.1 Seal-forming structure In one embodiment of the present technology, the seal-forming structure 3100 includes a target seal-forming region and may further include a buffering function. The target seal-forming region is a region where sealing can occur in the seal-forming structure 3100. The region where the seal actually occurs (i.e., the actual seal surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface 3000 on the face, the tension in the positioning and stabilization structure 3300, and the shape of the patient's face).

[0102] In one form, the target seal-forming region is disposed on the outer surface of the seal-forming structure 3100.

[0103] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0104] The seal-forming structure 3100 according to the present technology can be constructed from a soft, flexible, and elastic material (e.g., silicone).

[0105] In certain forms of the present technology, a system is provided that includes a plurality of seal-forming structures 3100. Each seal-forming structure 3100 is configured to accommodate different sizes and / or shapes. For example, the system can include one form of the seal-forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0106] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure 3100 includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure within the plenum chamber 3200 acting on its underside to form a tight seal engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilization structure.

[0107] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm). This member extends around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends along at least a portion of the surrounding peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0108] In one form, the seal-forming structure can include a compression seal portion or a gasket seal portion. In use, the compression sealing portion or the gasket sealing portion is constructed and arranged to be in a compressed state, for example, due to elastic tension in the positioning and stabilization structure.

[0109] In one form, the seal-forming structure includes a tension portion. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0110] In one form, the seal-forming structure includes a region having an adhesive surface or an adhesive bonding surface.

[0111] In a particular form of the present technology, the seal-forming structure can include one or more of a pressure assist seal flange, a compression seal portion, a gasket seal portion, a tension portion, and a portion having an adhesive surface or an adhesive bonding surface.

[0112] 5.3.1.2 Nasal bridge or nasal sill region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or the nasal sill region of the patient's face during use.

[0113] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the nasal bridge region or the nasal sill region of the patient's face during use.

[0114] 5.3.1.3 Upper lip region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0115] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the upper lip region of the patient's face during use.

[0116] 5.3.1.4 Jaw region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0117] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the jaw region of the patient's face during use.

[0118] 5.3.1.5 Forehead region In one form, the seal-forming structure forms a seal over the forehead region of the patient's face during seal use. In such a form, the plenum chamber may cover the eyes during use.

[0119] 5.3.1.6 Nasal pillows In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0120] A nasal pillow according to one aspect of the present technology includes a frustum of a cone that forms a seal at least in part under the patient's nose, a stem, and a flexible region connecting the frustum of the cone at the lower side of the frustum to the stem. Further, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible regions can act together to facilitate a gimbal structure that accommodates relative movement (both displacement and angle) between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone can be displaced axially towards the structure to which the stem is connected.

[0121] In one form, the seal-forming structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal pillows or nasal cushions, each nasal pillow or nasal cushion being constructed and arranged to form a seal with a respective nostril of the patient's nose. FIGS. 46 and 47 show a patient interface 3000 having a seal-forming structure 3100 provided by a pillow cushion module 3160. The pillow cushion module 3160 includes a pair of nasal pillows 3165. In this example, the same positioning structure 3300 as shown in FIGS. 43-45 is used to bring the pillow cushion module 3160 into sealing contact with the patient's nose. The same concepts and features of the positioning and stabilization structure 3300 described with reference to the cradle cushion module 3150 are applicable to a positioning and stabilization structure 3300 (or other types of cushion modules, such as a full-face cushion module, an oro-nasal cushion module, an ultra-compact full-face cushion module, a nasal cushion module, etc.) configured to be used with the pillow cushion module 3160.

[0122] A nasal pillow 3165 according to one aspect of the present technology includes a frustum of a cone at least a portion of which forms a seal under the patient's nose, a stem, and a flexible region connecting the frustum of the cone at the lower side of the frustum of the cone to the stem. Further, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible regions can act together to facilitate a flexible joint structure that accommodates relative movement (both displacement and angle) between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone can be displaced axially towards the structure to which the stem is connected.

[0123] 5.3.1.7 Nasal Cradle In one form, as shown, for example, in FIGS. 43 - 45, the seal - forming structure 3100 is configured to form a seal with the lower side of the nose around the nostrils of the patient 1000 and optionally the upper lip during use. This type of seal - forming structure can be referred to as a "cradle cushion" or a "sub - nasal mask". The shape of the seal - forming structure may be configured to conform to or closely follow the lower side of the patient's nose, i.e., the contour and angles of the seal - forming structure may be substantially parallel to the nasolabial angle of the patient. In one form of the nasal cradle cushion, the seal - forming structure includes a bridge portion that defines two orifices for supplying air or breathable gas to different nostrils of the patient during use. The bridge portion may be configured to contact or seal against the patient's nasal septum during use. In some forms of the technology, the seal - forming structure 3100 is configured to form a seal on the lower side of the patient's nose without contacting the nasal bridge region of the patient's nose. In some examples, the patient interface can include a seal - forming structure 3100 in the form of a cradle cushion as described in U.S. Publication No. 2020 / 0054850 A1, the entire disclosure of which is incorporated herein by reference.

[0124] 5.3.1.8 Nasal Mask Cushion In one form, the non - invasive patient interface 3000 includes a seal - forming structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use. For example, the patient interface 3000 shown in FIG. 1B is such a case. This seal - forming portion supplies air or breathable gas to the two nostrils of the patient 1000 via a single orifice. Such a seal - forming structure can be referred to as a "nasal cushion" or a "nasal mask". In some examples of the present technology, the positioning and stabilization structure 3300 shown in FIGS. 43 - 47 can be used to hold the nasal cushion in a sealed position on the patient's face.

[0125] 5.3.1.9 Full - Face Mask Cushion In one form, the patient interface 3000 includes a seal-forming portion that forms a seal at the jaw region, nasal bridge region, and cheek regions of the patient's face during use. For example, the patient interface 3000 shown in FIG. 1C is such a case. This seal-forming portion supplies air or breathable gas to the patient's nostrils and oral cavity via a single orifice. This type of seal-forming structure can be referred to as a "full-face mask". In some examples of the present technology, the positioning and stabilization structure 3300 shown in FIGS. 43-47 can be used to hold the full-face cushion in a sealed position on the patient's face.

[0126] 5.3.1.10 Mouth-nose mask cushion In another form, the patient interface 3000 includes a nasal seal-forming structure such as a nasal cushion or a nasal cradle cushion, and an oral seal-forming structure (which can be referred to as an "oral cushion" or an "oral mask") configured to form a seal around the patient's mouth during use. Such a mask supplies air or breathable gas to the patient's nostrils and the patient's mouth via separate orifices during use. This type of seal-forming structure 3100 may be referred to as a "mouth-nose cushion" or an "ultra-compact full-face cushion". In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as one component. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a cradle cushion as described in International Application WO 2019 / 183680 A1, the entire content of which is incorporated herein by reference.

[0127] 5.3.2 Prenum chamber The plenum chamber 3200 has a perimeter shaped complementary to the surface profile of an average human face in the region where a seal is formed during use. During use, the peripheral edge of the plenum chamber 3200 is positioned proximate to the adjacent surface of the face. The actual contact with the face is provided by the seal forming structure 3100. The seal forming structure 3100 may extend around the entire periphery of the lenum chamber 3200. In some forms, the plenum chamber 3200 and the seal forming structure 3100 are formed from a single homogeneous sheet of material.

[0128] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. In such forms, treatment compliance can be improved because the pressure is often reduced and / or the comfort of the wearer is increased.

[0129] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material can reduce the pressure of the patient interface and can assist in improving compliance with treatment. The use of a transparent material can assist the clinician in viewing the placement and function of the patient interface.

[0130] In certain forms of the present technology, the plenum chamber 3200 is composed of a translucent material. The use of a translucent material can reduce the pressure of the patient interface and can assist in improving compliance with treatment.

[0131] In one example of the present technology, the plenum chamber 3200 may be composed of a relatively flexible material such as silicone rubber. In a further example, the seal-forming structure 3100 and the plenum chamber may be composed of a single homogeneous material, such as a relatively flexible material such as silicone rubber. In a further example, the seal-forming structure 3100 and the plenum chamber 3200 may be formed as one part, but the materials of each part may have different mechanical properties. For example, both may be made of silicone rubber, and the seal-forming structure 3100 may have a lower hardness than the plenum chamber 3200. The plenum chamber 3200 may also include a tube connector 3202 for connecting to a corresponding tube to receive pressurized air, as shown in FIGS. 43 to 47.

[0132] 5.3.3 Positioning and stabilization structure The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in the sealing position during use by a positioning and stabilization structure 3300.

[0133] In one form, the positioning and stabilization structure 3300 holds the patient interface 3000 against the patient's head with sufficient force to at least overcome the effect of the positive pressure within the plenum chamber 3200 pushing the seal-forming structure 3100 away from the face.

[0134] In one form, the positioning and stabilization structure 3300 holds the patient interface 3000 against the patient's head with sufficient force to overcome the effect of gravity on the patient interface 3000.

[0135] In one form, the positioning and stabilization structure 3300 holds the patient interface 3000 against the patient's head and applies a force as a safety margin to overcome the potential impact of force disruption to the patient interface 3000 due to tube dragging or accidental interference with the patient.

[0136] In one embodiment of the present technology, the positioning and stabilization structure 3300 is configured to be worn by a patient during sleep. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness so as to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0137] In one embodiment of the present technology, the positioning and stabilization structure 3300 is configured such that it does not have an overly large or bulky size that would interfere with a patient sleeping in a supine sleep position with the patient's head resting on a pillow in the posterior region of the patient's head.

[0138] In one embodiment of the present technology, the positioning and stabilization structure 3300 is configured such that it does not have an overly large or bulky size that would interfere with a patient sleeping in a lateral sleep position with the patient's head resting on a pillow in the lateral region of the patient's head.

[0139] In one embodiment of the present technology, the positioning and stabilization structure 3300 includes a release portion disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This release portion is not resistant to compression and can be, for example, a flexible or pliable strap. The release portion is constructed and arranged such that when the patient lies with their head on a pillow, the presence of the release portion can avoid a situation where a force to the rear is transmitted along the positioning and stabilization structure 3300 and inhibits the seal.

[0140] In one embodiment of the present technology, the positioning and stabilization structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0141] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap that is extendable (e.g., extendable with elasticity). For example, the strap can be configured to be pinned and taut during use to direct a force that causes the seal-forming structure to adhere to a portion of the patient's face. In one example, the strap can be configured as a tie.

[0142] In one form of the present technology, the positioning and stabilization structure includes a first tie, and the first tie is constructed and arranged such that at least a portion of its lower edge moves upward and covers a portion of the parietal bone without covering the occipital bone and reaches the upper ear base point of the patient's head during use. For example, the first tie can be provided as part of a patient interface that includes a cradle cushion, a nasal pillow, a nose cushion, a full-face cushion, or an oro-nasal cushion. For example, as shown in FIGS. 43 to 47, the positioning and stabilization structure 3300 includes a first tie in the form of a tube 3350 that lies on top of the patient's head.

[0143] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a portion of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head during use.

[0144] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move away from each other.

[0145] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and, for example, non-rigid. An advantage of this aspect is that when the patient is sleeping, the strap is more comfortable when the patient lies on their side. As shown in FIGS. 43 to 47, the positioning and stabilization structure 3300 includes a bendable strap 3310. The strap 3310 can be considered a back strap. The strap 3310 has sufficient flexibility to comfortably rest on the patient's head by bypassing the back of the patient's head even when tension is applied during use.

[0146] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable such that water vapor can pass through the interior.

[0147] In certain forms of the present technology, a system including a plurality of positioning and stabilization structures 3300 is provided. Each positioning and stabilization structure 3300 is configured to provide a holding force for accommodating different sizes and / or shapes. For example, the system may include a form of the positioning and stabilization structure 3300 suitable for a large-sized head rather than a small-sized head and suitable for another small-sized head rather than a large-sized head.

[0148] 5.3.3.1 Headgear Tube In some forms of the present technology, the positioning and stabilization structure 3300 includes one or more tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 to the patient's airway from the RPT device, for example, via the plenum chamber 3200 and the seal forming structure 3100. In the form of the present technology shown in FIGS. 43-47, the positioning and stabilization structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the seal forming structure 3100. The tubes 3350 are an integral part of the positioning and stabilization structure 3300 of the patient interface 3000 and position and stabilize the seal forming structure 3100 of the patient interface at an appropriate part of the patient's face (e.g., the nose and / or mouth). Thereby, air from the conduit of the air circuit 4170 is provided for connection to the connection port 3600 of the patient interface at a position other than in front of the patient's face (which can be inconvenient and / or not visible to some people). The pair of tubes 3350 has several advantages (described below), but in some examples, the positioning and stabilization structure 3300 includes only a single tube 3350 configured to cover the patient's head on one side. A strap or other stabilizing component can be provided on the other side of the patient's head between the tip of the single tube 3350 and the seal forming structure 3100 to apply a balancing force to the seal forming structure 3100.

[0149] For the delivery of pressurized air from the air circuit 4170 to the patient's airway, the air is contained within the headgear tubes 3350 and sent through the headgear tubes 3350, so the positioning and stabilization structure 3300 can be described as being inflatable. It is understood that it is not necessary to make all components of the positioning and stabilization structure 3300 inflatable. For example, in the example shown in FIGS. 43-47, the positioning and stabilization structure 3300 includes the inflatable headgear tubes 3010 and 3350 and the non-inflatable strap 3310.

[0150] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or rear of the patient's head. For example, in the forms of the present technology shown in FIGS. 43 - 47, the connection port 3600 is located at the top of the patient's head. In this example, the patient interface 3000 includes an elbow 3610 to which the connection port 3600 is provided. The elbow 3610 is rotatable relative to the positioning and stabilization structure 3300 to position and stabilize the movement of the conduit connected to the connection port 3600 separate from the positioning and stabilization structure 3300. Additionally or alternatively, the conduit connected to the connection port 3600 is rotatable relative to the elbow 3610. In the example shown, the elbow 3610 includes a rotatable conduit connector, and the conduit of the air circuit 4170 may be connected to the rotatable conduit connector so as to rotate about its longitudinal axis relative to the elbow 3610.

[0151] A patient interface in which the connection port is not positioned in front of the patient's face may be advantageous because there are patients who consider the connection of the conduit to the patient interface in front of the face to be obtrusive and obstructive when it occurs. For example, a conduit connected to the patient interface in front of the face may be prone to entanglement with bedding or bed linen (especially when the conduit extends downward from the patient interface during use). In a form of the technology using a patient interface in which the connection port is positioned near the top of the patient's head during use, the patient may be more easily or comfortably lie or sleep in one or more of the following positions: a lateral or side - lying position; a supine position (i.e., a position lying on the back with the face generally upward); and a prone position (i.e., a position lying face - down with the face generally downward). Further, when the conduit is connected in front of the patient interface, a problem known as tubing drag may be exacerbated, in which case, due to the desirable pulling force generated from the conduit in patient interface treatment, it leads to detachment from the face.

[0152] In the form of the present technology shown in FIGS. 43 to 47, the positioning and stabilization structure 3300 includes two tubes 3350, each tube 3350 being disposed on a different side of the patient's head during use and extending through the respective cheek region, above the respective ear (above the upper ear base of the patient's head), to the elbow 3610 at the top of the head of the patient 1000. This form of the present technology may be advantageous when the patient lies on their side during sleep and one of the tubes is compressed, blocking or partially blocking the flow of gas along the tube, while the other tube remains open and supplies pressurized gas to the patient. In other examples of the present technology, the patient interface 3000 may include a different number of tubes, such as one tube, or three or more tubes. In an example where the patient interface has one tube 3350, the single tube 3350 is disposed on one side of the patient's head (e.g., across the cheek region) during use, and the strap forms part of the positioning and stabilization structure 3300 and is disposed on the other side of the patient's head (e.g., across another region) during use to assist in fixing the patient interface 3000 to the patient's head.

[0153] In the form of the present technology shown in FIGS. 43 to 47, the two tubes 3350 are fluidly connected to each other and to the connection port 3600 at their upper ends. In one embodiment, the two tubes are integrally formed, and in other embodiments, these tubes are separate components that are connected together during use and can be disconnected, for example, for cleaning or storage. When separate tubes are used, they may be indirectly integrally connected. For example, each tube may be connected to a T-shaped conduit having two conduit arms that can be fluidly connected to the tube 3350 and a third conduit arm or opening that functions as the connection port 3600 and can be connected to the air circuit 4170 during use. The connection port 3600 may include an elbow 3610 received within the central fluid connection opening 3390 of the two integrally formed tubes 3350. The elbow 3610 can be housed within a ring within the fluid connection opening 3390 and may be configured to rotate within the ring. The fluid connection opening 3390 itself may also serve as the connection port 3600.

[0154] The tube 3350 can be formed of a semi-rigid material, such as an elastomeric material like silicone. The tube may be in a natural preformed shape and can be bent or moved into other shapes when a force is applied to the tube. For example, the tube is generally arcuate or curved having a shape approximating the contour between the top of the patient's head and the nose or oral region.

[0155] In some examples, the positioning and stabilization structure 3300 may include a sleeve 3364 that captures the tube 3350. For example, as shown in FIGS. 43-47, the sleeve 3364 is provided on a non-extendable tube section 3363. In some examples, the patient interface 3000 may not include the sleeve 3364, and in other examples, the patient interface 3000 may include a sleeve 3364 that covers more or all of the tube 3350. The sleeve 3364 may be formed to conform to the bent shape of the tube 3350. In some examples, the sleeve 3364 is formed from a smooth fabric. The tube 3364 can contact the patient's face more comfortably than the tube 3350 without any covering.

[0156] As described in U.S. Patent No. 6,044,844 (incorporated herein by reference), the tube 3350 can be crush-resistant so that if either is crushed during use (e.g., crushed between the patient's face and pillow), the flow of breathable gas through the tube is avoided. Since the pressurized gas in the tube functions as a sprint to avoid or at least withstand the crushing of the tube during use, a crush-resistant tube is not necessary in all cases. A case where a crush-resistant tube can be advantageous is when there is only a single tube such that the single tube is blocked during use, in which case the gas flow is restricted and the treatment stops or the effectiveness decreases.

[0157] In certain forms of the present technology, one or more portions of the tube 3350 can be stiffened by one or more stiffening elements or stiffening compensating elements. Examples of stiffening elements are listed below: a section of the tube 3350 that is relatively thicker in wall thickness than other sections; a section of the tube 3350 formed from a material that is relatively higher in stiffness than the material forming other sections; and rigid members attached to the inside or outside of a portion of the tube or embedded in a portion of the tube. The use of such stiffening elements assists in controlling the manner in which the positioning and stabilization structure 3300 functions during use, for example, when the tube 3350 is more likely to deform when subjected to a force application and when the shape of the tube 3350 is more likely to be maintained when a force is applied. Therefore, by selecting the location where such a stiffening element is disposed within the tube 3350, it can assist in promoting comfort when the patient interface 3000 is worn and can assist in maintaining a good seal in the nose seal forming structure 3100 during use. The stiffening element or stiffening compensating element can be provided within the positioning and stabilization structure 3300 configured to support a relatively heavy seal forming structure (e.g., a full face or oro-nasal cushion assembly).

[0158] The tubes 3350 in the technical configurations shown in FIGS. 43 to 47 each have a length between 15 and 30 cm, for example between 20 and 27 cm. In one example, the length of each tube is about 26 cm. In another example, the length of each tube is about 23 cm. The length of the tube is selected to be appropriate for the size of a typical patient's head. For example, when the upper end of the tube 3350 traverses the side of the head along a generally arcuate path and crosses the patient's cheek region near the region close to the vertex of the head where the upper end of the tube 3350 is located, as shown in FIGS. 43 to 47, it is the distance between the upper end of the tube 3350 and the opening of the patient's airway where the lower end of the tube 3350 is connected to the cradle cushion module 3150 (or the pillow cushion module 3160). As will be described in more detail below, the patient interface 3000 is configured such that the length of the tube 3350 varies in some technical configurations, and the above lengths can be applied to the tube in a contracted state, an extended state, or a neutral state. It should be understood that the length of the tube 3350 depends on the length of other components within the patient interface 3000, such as the length of the arm of the T-shaped conduit to which the upper end of the tube 3350 is connected and / or the size of the plenum chamber 3200.

[0159] 5.3.3.1.1 Positioning of the headgear components Each tube 3350 may be configured to receive an air flow from the connection port 3600 at the vertex of the patient's head and deliver the air flow to a seal-forming structure at the patient's airway inlet. In the example of FIGS. 43 to 47, at least one tube 3350 extends over the patient's ear across the patient's cheek region between the seal-forming structure 3100 and the connection port 3600. That is, a portion of the tube 3350 connected to the cushion module covers the upper jaw region of the patient's head during use, and a portion of the tube 3350 covers the region of the patient's head above the upper ear base point of the patient's head during use. Each of the one or more tubes 3350 can also be positioned over the patient's sphenoid bone and / or temporal bone, and one or both of the patient's frontal bone and parietal bone. The connection port 3600 and the elbow 3610 may be positioned above the patient's parietal bone, frontal bone, or the junction between them during use.

[0160] An exemplary form of the technique shown in FIGS. 43 - 47 has a tube 3350 that bends around the upper part of the patient's head with a relatively small curvature in the sagittal plane from the upper end of the tube 3350 to the point where the strap 3310 is connected to the tube 3350, and the upper end of the tube 3350 is connected to the elbow 3610 at the top of the head. Between the point where the rear headgear strap 3310 is connected to the tube 3350 and the lower end of the tube 3350 where the tube 3350 is connected to the cradle cushion module 3150 in front of the airway below the patient's nose, the tube 3350 bends forward between the patient's ear and eye and passes through the cheek region.

[0161] The degree to which the patient interface 3000 fits an individual patient can be changed by varying the length of the tube 3350, and alternatively or additionally, by changing the position of the patient interface 3000 or a portion thereof on the patient's head. For example, a patient interface 3000 having a tube 3350 of a certain length can be adjusted to fit the patient better by moving a portion of the positioning and stabilization structure 3300 in the direction of the rear or front of the patient's head. For example, by positioning the junction of the tube 3350 on the patient's head more forward (i.e., forward direction), a patient interface 3000 having a tube 3350 of a certain length can fit a larger head than when the junction of the tube 3350 is located more rearward (i.e., rearward direction). In most patients, when the junction of the tube 3350 is positioned forward, the upper part of the tube 3350 is located over a smaller portion of the patient's head than when the junction of the tube 3350 is located rearward.

[0162] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is disposed at a series of positions across the top of the patient's head, such that the patient interface 3000 is positioned to conform to the comfort or fit of an individual patient. One way to achieve this to form an effective seal with the patient's face regardless of the position of the connection port 3600 on the patient's head is to decouple the movement of the upper portion of the patient interface 3000 from the lower portion of the patient interface 3000. Such decoupling can be achieved, for example, using a mechanism that allows parts of the headgear tube 3350 to move or curve easily relative to other parts of the patient interface 3000. This mechanism will be described below.

[0163] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 is substantially positioned at the apex of the patient's head. The connection port 3600 can be positioned within the sagittal plane and can be aligned with the suprameatal point in a plane parallel to the coronal plane. The suprameatal point is recognized in FIG. 2D. As described below, in some forms of the present technology, the positioning and stabilization structure 3300 is configured to be worn at different positions such that the connection port 3600 can be positioned approximately 20 mm in front of or approximately 20 mm behind the sagittal plane near the top of the patient's head relative to the suprameatal point.

[0164] In some examples of the present technology, the connection port 3600 can be positioned within the sagittal plane and can be aligned with the junction between the frontal bone and the parietal bone. The connection port 3600 may be positioned substantially above the junction of the coronal suture and the sagittal suture. In such a configuration, the upper portion of the tube 3350 may be positioned over and / or along a portion of the coronal suture. However, as described above, the patient has the ability to move the connection port 3600 forward or backward to adjust the cooperation of the patient interface 3000.

[0165] The advantage provided by covering the patient's head with the tube 3350 slightly forward of the uppermost point (e.g., at or near the coronal suture) is that it reduces the risk of the tube 3350 riding up posteriorly during use. In many patients, there is a recess or "dip" where the coronal suture converges with the sagittal suture. The positioning and stabilization structure 3300 can be particularly stable when the tube 3350 is located within this dip. Thus, in some examples, the tube 3350 is configured to have an appropriate curvature and / or bending ability so as to be positioned over the coronal suture.

[0166] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is normally located under the nose and sealed around the lower periphery of the nose. The positioning and stabilization structure 3300 may be constructed and arranged to draw the seal-forming structure 3100 into the patient's face under the nose using a seal force vector having a posterior and upward direction (e.g., a posterior-superior direction). The seal force vector having a posterior-superior direction facilitates the seal-forming structure 3100 forming a good seal with the lower periphery of the patient's nose and the surface of the patient's face facing the front on either side of the patient's nose and upper lip.

[0167] For example, in many examples, the positioning and stabilization structure 3300 may be configured such that the upper portion of the tube 3350 is located slightly forward of the uppermost point across the patient's head. In some patients, this may cause the tube 3350 to be angled forward rather than vertically aligned (e.g., in the coronal plane) as it is located within a slight recess at or near the cranial coronal suture. In such examples, the tension within the strap 3310 can be adjusted by the patient to balance the forces and achieve an optimal seal force vector.

[0168] In certain examples of the present technology, the tube 3350 is configured to receive the strap 3310 at a position above and near the patient's ear. If the strap 3310 is connected to the tube 3350 at a high position relative to the patient's head, the strap 3310 may tend to ride up on the back of the patient's head. Further, the strap 3310 may form an overly large angle with respect to the upper portion of the headgear tube 3350, such that the patient may need to tighten the strap 3310 excessively, resulting in excessive tension in both the positioning and stabilization structures, which may make it easier for the strap 3310 to ride up on the back of the patient's head. Accordingly, the connection between the strap 3310 and the tube 3350 is set as low as possible such that the tube 3350 is not pulled into contact with the patient's ear when the strap 3310 is tightened, but is advantageously positioned sufficiently away from the top of the patient's ear.

[0169] 5.3.3.1.2 Fluid connection of the headgear tube The two tubes 3350 are fluidly connected to the plenum chamber 3200 at their lower ends. In the example of FIGS. 43-47, the tubes 3350 form a fluid connection with the cradle cushion module 3150 and the seal forming structure 3100. In a particular form of the technology, the connection between the tube 3350 and the cradle cushion module 3150 is achieved by the connection of two rigid components, whereby the patient can easily connect the two components in a reliable manner. "Reassurance clicks" or similar audible and tactile feedback can be easily used by the patient or the patient can easily know that the tube is correctly connected to the cradle cushion module 3150. In one form, the tube 3350 is formed of silicone and the lower end of each silicone tube 3350 is overmolded onto a rigid connector, such as by polypropylene, polycarbonate, nylon, etc. The rigid connector can include a male fitting feature configured to connect to a female fitting feature on the cradle cushion module 3150. Alternatively, the rigid connector can include a female fitting feature configured to connect to a male fitting feature on the cradle cushion module 3150. The same connection method for connecting the tube 3350 to the cradle cushion module 3150 can also be applied to the connection between the tube 3350 and the nose cushion module 3150 or other plenum chamber 3200 or seal forming structure 3100.

[0170] In another embodiment, compression seals are used to connect each tube 3350 to the cradle cushion module 3150. For example, an elastically flexible (e.g., silicone) tube 3350 without a rigid connector needs to be slightly extruded to reduce its diameter so that it can be fitted into a port within the plenum chamber 3200, and the inherent elasticity of the silicone can push the tube 3350 outward to airtight seal the tube 3350 to the port. In a hard-hard engagement between the tube 3350 and the port, a pressure-activated seal such as a peripheral sealing flange may be used. When pressurized gas is supplied through the tube 3350, the sealing flange is pressed against the joint between the tube and the inner peripheral surface of the port of the plenum chamber 3200, strengthening the seal between them. If the port is soft and the pipe 3350 is provided with a rigid connector, the above-described pressure-activated seal can also be used to ensure that the connection is airtight. In another example, each tube 3350 is formed of an elastically flexible material (e.g., silicone), and the elastically flexible material is overmolded onto a rigid connector, whereby the elastically flexible material fits onto the rigid connector and itself functions as a gasket to seal the connection between the tube 3350 and the cradle cushion module 3150 around the periphery of the air flow passage entering the plenum chamber 3200 of the cradle cushion module 3150 from the tube 3350.

[0171] Using a similar connection mechanism, the tube 3350 can be fluidly connected to a T-shaped upper member that defines the connection port 3600 or is connectable to the connection port 3600 in some forms of the present technology. In one embodiment, a rotary elbow connected to the connection port 3600 is rotatable to move a port sizing mechanism that reduces or increases the size of the port into which the tube 3350 is inserted, improving the fit of the tube by increasing or decreasing the compression force and reducing unintended leakage.

[0172] 5.3.4 Ventilation Assembly In one form, the patient interface 3000 includes a ventilation assembly 3400 constructed and arranged to permit the expulsion of exhaled gas, such as carbon dioxide.

[0173] In certain forms, the ventilation assembly 3400 is configured to permit a continuous flow of ventilation from within the plenum chamber 3200 to the ambient while the pressure within the plenum chamber is positive relative to the ambient. The ventilation assembly 3400 is configured such that, during use, the magnitude of the ventilation flow rate is large enough to reduce rebreathing by the patient of exhaled CO2 while maintaining the therapeutic pressure within the plenum chamber.

[0174] As shown in FIGS. 43 to 57, the ventilation assembly 3400 can be disposed in the plenum chamber 3200. The plenum chamber 3200 may include a receiving hole 3204 for receiving the ventilation assembly 3400 which may include a ventilation body 3403. In the illustrated example, the plenum chamber 3200 includes a connection lip 3201, and the ventilation body 3403 includes a connection passage 3408 that receives the connection lip 3201 to connect the ventilation body 3403 to the plenum chamber 3200. The connection may be permanent by means of an adhesive or overmolding the plenum chamber 3200 onto the ventilation body 3403, or the ventilation body 3403 may be removably connected to the plenum chamber 3200 such that the connection lip 3201 and the connection passage 3408 are separable. Further, in another example, the ventilation body 3403 may have a connection lip received within a connection passage to the plenum chamber 3200. The plenum chamber 3200 may further include one or more direction indicating protrusions 3203 located on the connection lip 3201, and the ventilation body 3403 may include one or more direction indicating recesses 3407 for receiving the corresponding direction indicating protrusions 3203 to indicate that the ventilation body 3403 is assembled to the plenum chamber 3200 in the proper direction. Further, in another example, the ventilation body 3403 may have one or more direction indicating protrusions received by one or more corresponding direction indicating recesses of the plenum chamber 3200 to indicate that the ventilation body 3403 is assembled to the plenum chamber 3200 in the proper direction. Further, the ventilation body 3403 and the receiving hole 3204 may have an elliptical shape.

[0175] The ventilation assembly 3400 may include a ventilation hole 3402 that allows gas to continuously flow out into the atmosphere throughout the patient's breathing cycle, as shown in FIGS. 71-74. The ventilation cap 3401 may be connected to the ventilation body 3403, and the ventilation hole 3402 may be formed between the ventilation cap 3401 and the ventilation body 3403. The ventilation cap 3401 may be permanently joined to the ventilation body 3403, or the ventilation cap 3401 may be removable. The ventilation body 3403 may include a ventilation body hole 3405 that allows gas to be discharged from the inside of the plenum chamber 3200 and then discharged into the atmosphere through the gap of the ventilation body 3402.

[0176] A ventilation diffusion material 3404 is disposed between the ventilation cap 3401 and the ventilation body 3403 to diffuse the gas flow before it reaches the atmosphere through the ventilation hole 3402, allowing it to pass through the ventilation body hole 3405 and reducing the jet and noise generated when the flow passes through the ventilation assembly 3400. The ventilation body 3403 may include a spacer 3406 that spaces the ventilation diffusion material 3404 away from the ventilation body hole 3405. The side of the ventilation diffusion material 3404 facing the spacer 3406 is supportable against the ventilation cap 3401 to hold the ventilation diffusion material 3404 in place within the ventilation assembly 3400. The ventilation diffusion material 3404 may be a porous material such as a foam or a fiber network.

[0177] The ventilation body 3403 may be made of a material with higher rigidity than the plenum chamber 3200. This makes the ventilation body 3403 less likely to be crushed when subjected to force, preventing the ventilation body hole 3405 and the ventilation hole 3402 from being blocked. The ventilation cap 3401 may be made of a material with higher rigidity than the plenum chamber 3200, and this material may be the same as or different from the material of the ventilation body 3403.

[0178] The ventilation gas 3403 may further include a mounting structure 3409 disposed on one side within the plenum chamber 3200 when the ventilation assembly 3400 is assembled to the plenum chamber 3200. The mounting structure 3409 may form a channel for receiving the HMX rim 3806 of the HMX assembly 3800, as described below. The mounting structure 3409 enables the HMX rim 3806 to be connected to the ventilation assembly 3400 such that the ventilation assembly 3400 and the HMX assembly 3800 jointly form the HMX and ventilation assembly 3500. The HMX and ventilation assembly 3500, that is, the integrated ventilation assembly 3400 and HMX assembly 3800, can be removed from the plenum chamber 3200 as one unit. The mounting structure 3409 may be constructed such that the HMX assembly 3800 can be removed therefrom. This enables, for example, the ventilation assembly 3400 and / or the HMX assembly 3800 to be replaced at the same or different intervals.

[0179] [[ID=⑷]]5.3.5 Humid Heat Exchanger (HMX) Assembly Figures 48 to 104 show the HMX assembly 3800 according to an example of the present technology. As described above, the HMX assembly 3800 is connected to the ventilation assembly 3400 to form the HMX and ventilation assembly 3500, and the HMX and ventilation assembly 3500 may be connected to the plenum chamber 3200.

[0180] Figures 58 - 62, 77 - 80, and 88 - 93 illustrate examples of the HMX and the ventilation assembly 3500. In these examples, the ventilation body 3403 includes an attachment structure 3409 in the form of a plurality of structures on the rear side of the ventilation body 3403 that receives the HMX rim 3806. The HMX frame 3802, the HMX rim 3806, and the HMX strut 3804 (if applicable) may be composed of a relatively flexible single homogeneous material such as silicone rubber or thermoplastic elastomer (TPE), and the ventilation body 3403 including the attachment structure 3409 may be composed of a relatively rigid material, so that the HMX rim 3806 can be bent and stretched to be attached to the attachment structure 3409 in order to attach the HMX frame 3802 to the ventilation body 3403. The HMX rim 3806 can also form an HMX rim hole 3807 through which gas can pass before reaching the ventilation body hole 3405. The HMX rim 3806 may have a shape similar to that of the ventilation body 3403, such a shape being elliptical in the first two examples of this case and polygonal in the third example. The HMX material 3850 may have a shape corresponding to the HMX rim 3806 such that the HMX material 3850 fits completely within the HMX rim 3806.

[0181] One or more HMX struts 3804 may extend from the HMX rim 3806 and connect the HMX rim 3806 to the HMX frame 3802. Alternatively, the HMX struts 3804 may be omitted and the HMX frame 3802 may be directly connected to the HMX rim 3806. The first example in FIGS. 48-70 includes straight HMX struts 3804. The second example in FIGS. 75-82 has similar features to the first example, but the HMX struts 3804 are curved. The third example in FIGS. 83-104 does not include the HMX struts 3804. In the first and second examples, two HMX struts 3804 are present, which allow the HMX frame 3802 that supports the HMX material 3850 to pivot laterally in response to forces applied by the patient's face, for example, during movement. The straight HMX struts 3804 of the first example may be flexible due to the nature of the relatively flexible material, and the curved HMX struts 3804 of the second example can allow for additional flexibility since the curvature allows for buckling. The curved HMX struts 3804 can also provide an elastic function of absorbing forces on the HMX frame 3802 and separating the HMX frame 3802 from the HMX rim 3806 and the ventilation body 3403. Otherwise, the seal formation structure 3100 is connected to the plenum chamber 3200, and the plenum chamber 3200 is connected to the ventilation body 3403, which may break the seal. The attachment structure 3409 may be formed with a plurality of slots 3410 corresponding to the number of HMX struts 3804 for receiving the HMX struts 3804 when the HMX rim 3806 is assembled to the ventilation body 3403.

[0182] Due to the flexibility of the HMX frame 3802 and the HMX material 3850, these parts can be deformed to fit through the receiving hole 3204 and restore to their original size and shape within the plenum chamber 3200, which can make the assembly into the plenum chamber 3200 relatively easy. As a result, the HMX assembly 3800 has a relatively small external contour and, due to its inherently small size, can be used with a patient interface 3000 that cannot accommodate large receiving holes 3204 such as a nose cradle and nasal pillows. As shown in the cross-sectional views of FIGS. 53, 54, 85-87, and 102-104, the HMX assembly 3800 is larger than the receiving hole 3204 and is flexible, so it can still be inserted into the plenum chamber 3200. Further, when the plenum chamber 3200 is composed of a relatively flexible material (such as silicone rubber), the receiving hole 3204 can also be deformed to allow the insertion of the HMX assembly 3800. These same aspects also facilitate the removal of the HMX assembly 3800 from the plenum chamber 3200.

[0183] The HMX material 3850 disposed on or supported by the HMX frame 3802 is a foam, such as an open-cell foam, or paper. The foam or paper may be further treated with salt to absorb more moisture than in the case of just the porosity of the foam or paper.

[0184] The HMX 3850 material may be relatively flexible. The flexible HMX material 3850 and the flexible HMX frame 3802 can adapt the HMX assembly 3800 to various shapes and / or sizes of the seal-forming structure 3100. When the HMX assembly 3800 is located inside the plenum chamber 3200, the HMX frame 3802 and / or the HMX material 3850 can contact the seal-forming structure 3100 without deformation, or the HMX frame 3802 and the HMX material 3850 can be positioned close to the seal-forming structure 3100. In either case, when the patient wears the patient interface 3000, the seal-forming structure 3100 can deform into the HMX frame 3802 and / or the HMX material 3850 as the patient's face contacts the patient contact surface 3101, and the flexible characteristics of the HMX frame 3802 and the HMX material 3850 enable one or both of these components to deform to minimize patient discomfort. The HMX assembly 3800 may be applied in a free-size form such that one size of the HMX and ventilation assembly 3500 can be assembled to different patient interface 3000 configurations (e.g., nasal cradle, nasal pillow, nasal, nasal-oral), and these configurations can further have different sizes (e.g., small, medium, large), and the flexible structure enables the HMX and ventilation assembly 3500 to be comfortable for the patient in all patient interface 3000 configurations to which it is applied. Both the HMX frame 3802 and the HMX material 3850 may be shaped to have a positive curvature on their respective rear sides so as to conform more easily and comfortably to the patient's face. The HMX material 3850 may have a front surface 3854 with a negative curvature. The HMX material 3850 can have a rear surface 3852 with a positive curvature. The HMX material 3850 can have a uniform thickness between the rear surface 3852 and the front surface 3854, or the thickness may vary, for example, be thinnest at the center and thicker at the side edges, or be thickest at the center and thinner at the side edges.Furthermore, the rear surface 3852 may be directly accessible through one or more seal-forming structure holes 3102, whereby the humidified and pressurized air that has passed through the HMX material 3850 is discharged through the seal-forming structure holes 3102 for the patient's inhalation, and the exhaled gas can return to the rear surface 3852 through the one or more seal-forming structure holes 3102.

[0185] The HMX material 3850 can be attached to the HMX frame 3802 around the outer peripheral surface 3856 of the HMX material 3850. In the illustrated example, the outer peripheral surface 3856 does not extend beyond the HMX frame 3802, but in an alternative example, the outer peripheral surface 3856 may extend beyond the HMX frame 3802. The HMX material 3850 can be attached to the HMX frame 3802 by one or more of an adhesive, overmolding the HMX frame 3802 onto the HMX material 3850, and a holding mechanism that holds the HMX material 3850 to the HMX frame 3802. For example, if the HMX frame 3802 is made of TPE, the HMX frame 3802 can be overmolded onto the HMX material 3850, and if the HMX frame 3802 is made of silicone rubber, the HMX frame 3802 can be adhered to the HMX material 3850. The connection between the HMX material 3850 and the HMX frame 3802 may be permanent or removable. When the HMX material 3850 has reached the end of its life (after a certain amount of use, the ability to adsorb and desorb moisture may begin to decline), the HMX material 3850 and the HMX frame 3802 can be discarded together and replaced with new parts.

[0186] The seal formation structure 3100 and / or the plenum chamber 3200 may have internal features that hold the HMX frame 3802 and the HMX material 3850 in place to optimize the performance of the HMX material 3850 and the fit of anthropometric measurements during treatment. FIGS. 85-87 and FIGS. 102-104 show a sealing lip 3103 that engages the HMX frame 3802 to seal the entire periphery of the HMX frame 3802. Such an arrangement can direct all incoming pressurized air flow from the tube connector 3202 directly into the atmosphere via the ventilation assembly 3400 or reach the patient through the HMX material 3850 after passing through the HMX frame holes 3803. This ensures that all pressurized air reaching the patient can adsorb moisture from the HMX material 3850 before reaching the patient's airway. Further, all gases exhaled by the patient must pass through the HMX material 3850 in such an arrangement before entering the atmosphere through the ventilation assembly 3400. In a further example, one or more sealing lip bypass openings 3104 may be formed in the sealing lip 3103 such that the sealing lip 3103 does not engage and seal the entire periphery of the HMX frame 3802. This allows a portion of the pressurized air traveling towards the patient and a portion of the gases exhaled by the patient to bypass the HMX material 3850. The presence or absence of the one or more sealing lip bypass openings 3104 and the size and shape (if present) of the sealing lip bypass openings 3104 allow for optimizing the humidification of the incoming pressurized air flow.

[0187] 5.3.6 Disengagement Structure(s) In one form, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or ball and socket). For example, the patient interface 3000 shown in FIGS. 43-47 includes an elbow 3610 configured as a swivel relative to the positioning and stabilization structure 3300. In this example, the elbow 3610 is configured to rotate about an axis concentric with a circular opening within the positioning and stabilization structure 3300. In some examples of the present technology, the elbow 3610 may form part of a ball socket joint of the positioning and stabilization structure 3300. For example, a ring having a partially spherical inner surface may be provided in the positioning and stabilization structure 3300 and configured to receive the elbow 3610. The elbow 3610 can have a partially spherical outer surface complementary to the partially spherical inner surface of the ring, thereby enabling the elbow 3610 to rotate about multiple axes relative to the ring.

[0188] 5.3.7 Connection Port The connection port 3600 enables connection to the air circuit 4170. In the exemplary patient interface 3000 shown in FIGS. 43-47, the elbow 3610 is in the form of the connection port 3600. For reduction of tubing drag on the positioning and stabilization structure 3300, the elbow 3610, as a decoupling structure, decouples the movement of the air circuit 4170 from the positioning and stabilization structure 3300.

[0189] 5.3.8 Forehead Support In one form, the patient interface 3000 includes a forehead support 3700. In one form, the patient interface 3000 does not include a forehead support 3700. Advantageously, the exemplary patient interface 3000 shown in FIGS. 43-47 includes the positioning and stabilization structure 3300. The positioning and stabilization structure 3300 can hold the seal forming structure 3100 in the sealing position (without connection to a forehead support or any frame or strap member disposed at eye level in front of the patient's face).

[0190] 5.3.9 Anti-Suffocation Valve In one form, the patient interface 3000 includes an anti-asphyxia valve.

[0191] 5.3.10 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics (e.g., pressure) of the gas within the plenum chamber 3200.

[0192] 5.4 RPT Device The RPT device 4000 according to one aspect of the present technology includes mechanical arrangement elements, pneumatic arrangement elements, and / or electrical arrangement elements, and is configured to execute one or more algorithms such as all or part of the methods described herein. The RPT device 4000 may be arranged to generate an air flow for delivery to a patient's airway, and may be arranged, for example, to treat one or more of the respiratory states described elsewhere herein.

[0193] In one form, the RPT device 4000 is constructed and arranged to be able to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0194] The RPT device may have an external housing 4010. The external housing 4010 may be formed by two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 may include one or more panels 4015. The RPT device 4000 may include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0195] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air under positive pressure, an outlet muffler 4124, and one or more transducers 4270 such as a pressure sensor and a flow sensor.

[0196] One or more of the air path items may be disposed within a removable integral structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within an external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or formed as part of the chassis 4016. The pneumatic block 4020 may include one or more pneumatic components 4100.

[0197] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include two or more PCBA 4202.

[0198] 5.4.1 Mechanical and Pneumatic Components of the RPT Device The RPT device may include one or more of the following arrangement elements in an integral unit. In an alternative form, one or more of the following arrangement elements may be installed as separate units, respectively.

[0199] 5.4.1.1 Air Filter The RPT device according to one form of the present technology may include one or more air filters 4110.

[0200] In one form, the inlet air filter 4112 is located at the start of the pneumatic path upstream of the pressure generator 4140.

[0201] In one form, the outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0202] 5.4.1.2 Muffler(s) The RPT device according to one form of the present technology may include one or more mufflers 4120. [[ID=X]]

[0203] [[ID=X]] In one form of the present technology, the inlet muffler 4122 is located within the pneumatic path upstream of the pressure generator 4140. [[ID=X]]

[0204] [[ID=X]] In one form of the present technology, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800. [[ID=X]]

[0205] [[ID=X]] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 for generating an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impeller may be arranged in a scroll shape. The blower can deliver an air supply, for example, at a speed of up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms, at a positive pressure in the range of up to about 30 cmH2O when delivering respiratory pressure therapy. The blower may be one described in any one of 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, the entire contents of which are incorporated herein by reference. [[ID=X]]

[0206] [[ID=X]] The pressure generator 4140 is in a state controlled by the treatment device controller. [[ID=X]]

[0207] [[ID=X]] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air storage tank), or a bellows.

[0208] 5.4.1.4 Transducer(s) The transducer(s) may be inside or outside the RPT device. An external transducer may be provided in, for example, an air circuit, such as a patient interface, or may form part thereof. The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0209] In one form of the technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 may be constructed and arranged to generate a signal representing a characteristic of the air flow, such as the flow rate, pressure, or temperature, at that point in the pneumatic path.

[0210] In one form of the technology, one or more transducers 4270 may be located in proximity to the patient interface 3000 or 3800.

[0211] In one form, the signal from the transducer 4270 may be filtered, such as by low-pass filtering, high-pass filtering, or band-pass filtering.

[0212] 5.4.1.5 Anti-spillback valve In one form of the technology, an anti-spillback valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example, towards the motor 4144.

[0213] 5.5 Air circuit An air circuit according to one aspect of the present technology is a conduit or tube configured and arranged such that, in use, an air flow can move between two arrangement elements of a respiratory therapy system (e.g., the RPT device 4000 and the patient interface 3000 or 3800).

[0214] In particular, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb is used.

[0215] In some forms, the air circuit 4170 can include one or more heating elements arranged to heat the air within the air circuit, for example to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers such as a temperature sensor. In one aspect, the heating wire circuit may be spirally wound around the axis of the air circuit 4170. The heating element can communicate with a controller such as the central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent No. 8,733,349, which is hereby incorporated by reference in its entirety.

[0216] 5.5.1 Delivery of Supplemental Gas In one form of the present technology, an auxiliary gas, such as oxygen 4180, is delivered to one or more points within the pneumatic path, such as upstream of the pneumatic block 4020, the air circuit 4170, and / or the patient interface 3000 or 3800.

[0217] 5.6 Humidifier 5.6.1 Overview of the Humidifier In one form of the present technology, a humidifier 5000 is provided for altering the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of an air flow before delivery to the patient's airway.

[0218] The humidifier 5000 may include a humidifier water reservoir, a humidifier inlet for receiving an air stream, and a humidifier outlet for delivering a humidified air stream. In some forms, the inlet and outlet of the humidifier reservoir may be the inlet and outlet of the humidifier, respectively. The humidifier 5000 may be further configured to receive a humidifier water tank and may further include a humidifier base having a heating element.

[0219] 5.7 Respiratory waveform Figure 42 shows a model of a typical respiratory waveform of a human during sleep. The horizontal axis represents time and the vertical axis represents respiratory flow rate. Although the parameter values may vary, typical respiration may have approximate values of tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow rate Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow rate Qpeak -0.5 L / s. The total respiratory time Ttot is about 4 s. Typically, a person breathes at a rate of about 15 breaths per minute (BPM) and has a ventilation volume of about 7.5 L / min. The typical ratio of Ti to Ttot, which is the duty cycle, is about 40%.

[0220] 5.8 Terms For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.

[0221] 5.8.1 General Air: In certain forms of the present technology, air may be considered to mean the atmosphere, and in other forms of the present technology, air may be considered to mean other combinations of a portion of breathable gas, such as oxygen-enriched air.

[0222] Ambient: In certain forms of the present technology, the term ambient is considered to mean (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0223] For example, the ambient humidity for a humidifier can be the humidity of the air directly surrounding the humidifier, e.g., the humidity of the room in which the patient is sleeping. Such ambient humidity may be different from the humidity outside the room in which the patient is sleeping.

[0224] In another example, the ambient pressure can be the pressure directly surrounding the body or outside the body.

[0225] In certain forms, the ambient noise (e.g., acoustic) is considered to be the noise level of the room in which the patient is located, and is not, for example, the noise generated by the RPT device or emitted from the mask or patient interface. The ambient noise can originate from outdoor sources.

[0226] Auto Positive Airway Pressure (APAP) therapy: A form of CPAP therapy in which the treatment pressure is automatically adjustable, for example, from breath to breath, between a minimum and a maximum, depending on the presence or absence of signs of SDB onset.

[0227] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure varies between different respiratory cycles of the patient, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing when there are no signs of partial upper airway obstruction.

[0228] Flow rate: The amount (or mass) of air sent per unit time. The flow rate can refer to an instantaneous amount. In some cases, the reference to flow rate is a reference to a scalar quantity, i.e., a quantity having only magnitude. In other cases, the reference to flow rate is a reference to a vector quantity, i.e., a quantity having both magnitude and direction. The flow rate may be denoted by the symbol Q. "Flow rate" may simply be written as "flow" or "airflow".

[0229] Flow therapy: A respiratory therapy that involves delivering an airflow to the airway inlet at a controlled flow rate, typically positive throughout the patient's respiratory cycle, called the therapy flow rate.

[0230] Humidifier: The term "humidifier" is considered to mean a humidifying device that is arranged, installed, or has a physical structure such that it can provide a therapeutically beneficial amount of water (H2O) vapor to the airflow to improve the patient's medical respiratory condition.

[0231] Leak: The term "leak" is considered to be an unintended airflow. In one example, a leak can occur as a result of an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the swivel elbow to the surroundings.

[0232] Conduction (acoustic) noise: As used herein, conduction noise refers to noise carried to the patient by the air pressure path, such as the air circuit or patient interface, and the air within it. In one form, conduction noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0233] Radiation (acoustic) noise: As used herein, radiation noise refers to noise carried to the patient by the ambient air. In one form, radiation noise can be quantified by measuring the volume / pressure level of the object in question in accordance with ISO3744.

[0234] Ventilation (acoustic) noise: As used herein, ventilation noise refers to noise generated by an airflow through any ventilation part, such as a ventilation hole in the patient interface.

[0235] Patient: A human being, whether or not suffering from a respiratory condition.

[0236] Pressure: Force per unit area. Pressure can be expressed in a range of units including cmH2O, g-f / cm 2 and hectopascals. 1 cmH2O is 1 g-f / cm 2equal to about 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atm). Unless otherwise stated herein, pressure is given in units of cmH2O.

[0237] Respiratory Pressure Therapy (RPT): Application of supplying air to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0238] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0239] 5.8.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. In this specification, reference to silicone is reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC manufactured by DuPont (included in a series of products sold under this trademark). Another manufacturer of LSR is Wacker. Unless otherwise specified, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0240] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0241] 5.8.1.2 Mechanical Properties Elasticity: The ability of a material to absorb energy when elastically deformed and release energy when released.

[0242] Elastic: Releases substantially all energy upon unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0243] Hardness: The resistance of a material to deformation (e.g., described in terms of Young's modulus, an indentation hardness scale measured with a standardized sample size). · The "soft" material may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. · The "hard" material may include polycarbonate, polypropylene, steel or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0244] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending or torsion). A structure or component may provide different resistance in different directions. The opposite of stiffness is flexibility.

[0245] Soft structure or component: A structure or component that changes shape (such as bending) in a relatively short time (such as 1 second) when supporting its own weight.

[0246] Rigid structure or component: A structure or component that does not substantially change shape when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a state of sealing the patient airway inlet under a pressure load of, for example, approximately 20 - 30 cmH2O.

[0247] As an example, an I - beam may include different flexural rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0248] 5.8.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when the flow rate falls below a predetermined threshold for a certain period, for example, 10 seconds. Obstructive apnea is said to occur when a partial obstruction of the airway prevents airflow despite the patient's effort. Central apnea is said to occur when apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea occurs when a decrease or absence of respiratory effort coincides with an obstructed airway.

[0249] Respiratory rate: The rate of the patient's spontaneous breathing, usually measured as the number of breaths per minute.

[0250] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0251] Respiratory effort: The work of breathing for a person breathing spontaneously.

[0252] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow until the start of the inspiratory flow.

[0253] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow until the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0254] Airway patency: The degree to which the airway is open or the extent of the open airway. The patent airway is open. Airway patency can be quantified, for example, with a value of one (1) for an open state and a value of zero (0) for a closed (obstructed) state.

[0255] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure in the lungs that exists at the end of expiration.

[0256] Respiratory flow, patient airflow rate, respiratory airflow rate (Qr): These terms can be understood to refer to an estimate of the respiratory flow by an RPT device, as distinct from the "true respiratory flow" or "true respiratory flow rate". The "true respiratory flow" or "true respiratory flow rate" is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0257] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no extra effort is being exerted. In principle, since the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), a single tidal volume Vt can be defined as equal to either quantity. In practice, the tidal volume Vt is estimated as a combination of a portion of the inspiratory volume Vi and the expiratory volume Ve, for example, as an average.

[0258] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0259] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0260] (Total) time (Ttot): The total time from the start of one inspiratory portion of the respiratory flow waveform to the start of the next inspiratory portion of the respiratory flow waveform.

[0261] Ventilation: A measure of the amount of gas exchanged by a patient's respiratory system. Measures of ventilation can include one or both of the inspiratory and expiratory flow rates per unit time. When expressed as a volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation may simply be given as a volume and is understood to be the volume per minute.

[0262] 5.8.3 Biological Structure 5.8.3.1 Facial Biological Structure Alar: The outer wall or "wing" of each nostril (plural: alar)

[0263] Alar point: The outermost point of the alar.

[0264] Alar curvature (or alar apex) point: The last point of the flexion baseline of each alar, located at the crease where the alar joins the cheek.

[0265] Auricle: The entire visible external part of the ear.

[0266] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nose of the frontal bone.

[0267] (Nasal) cartilage skeleton: The nasal cartilage skeleton includes the nasal septum, lateral cartilage, main cartilage, and accessory cartilage.

[0268] Columella: A skin band that separates the nasal cavities and extends from the front of the nasal cavity to the upper lip.

[0269] Columella angle: The angle between the line passing through the midpoint of the nostril and the subnasal point and the line perpendicular to the Frankfurt plane.

[0270] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the lobule point of the left ear. The lobule is the deepest point of the depression above the lobule of the auricle.

[0271] Glabella: Located on the soft tissue, it is the most prominent point on the mid-sagittal plane of the forehead.

[0272] Lateral nasal cartilage: Generally a triangular cartilage plate. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the major alar cartilage.

[0273] Major alar cartilage: A cartilage plate located below the lateral nasal cartilage. The major alar cartilage is curved around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing 3 - 4 small cartilages of the alae.

[0274] Nostrils: Substantially oval-shaped holes that form the entrances to the nasal cavities. The singular form of nares is naris (nostril). The nostrils are separated by the nasal septum.

[0275] Naso-labial sulcus or naso-labial fold: A skin fold or groove that separates the cheek from the upper lip and extends from both sides of the nose to the corners of the mouth.

[0276] Nasolabial angle: The angle between the columella and the upper lip, which intersects at the subnasal point.

[0277] Superior ear base: The uppermost attachment point of the auricle to the facial skin.

[0278] The uppermost point of attachment of the auricle to the skin of the upper ear base and face.

[0279] Nasal tip: The most prominent point or tip of the nose, identifiable in a lateral view of the rest of the head.

[0280] Philtrum: A midline groove that runs from the lower border of the nasal septum to the apex of the lip in the upper lip area.

[0281] Pogonion: Located in the soft tissue, at the mid-anterior most point of the jaw.

[0282] Ridge (nasal): The nasal ridge is a midline protrusion of the nose, extending from the selion to the apex.

[0283] Sagittal plane: A vertical plane from anterior (front) to posterior (rear). The midsagittal plane is the sagittal plane that divides the body into left and right halves.

[0284] Therion: The most concave point on the soft tissue, covering the frontonasal suture area.

[0285] Nasal Septal Cartilage (Nose): The nasal septal cartilage forms part of the nasal septum, separating the front of the nasal cavity.

[0286] Alar sinus: the point on the lower edge of the base of the nasal alar where it joins the skin of the upper lip.

[0287] Subnasal point: Located on the soft tissue at the midsagittal confluence of the columella and upper lip.

[0288] The most concave point on the midline of the lower lip between the supraminal point, the midpoint of the lower lip, and the soft tissue pogonion.

[0289] 5.8.3.2 Skull anatomy Frontal bone: The frontal bone contains a large vertical portion called the prefrontal scale, which corresponds to the area called the forehead.

[0290] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony prominence of the lower jaw that forms the jaw.

[0291] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla projects upward through the side of the nose and forms part of its lateral boundary.

[0292] The nasal bones are two small oval bones that vary in size and shape among different individuals. The nasal bones are arranged side by side in the central part of the face and form the "bridge" of the nose by their junction.

[0293] Nasion: The area of depression at the intersection of the frontal bone and the two nasal bones, just between the eyes and above the nasal bridge.

[0294] Occipital bone: The occipital bone is located at the lower back part of the skull. It contains an oval hole, the foramen magnum, through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0295] Orbit: The bony cavity in the skull that houses the eyeball.

[0296] Parietal bone: The parietal bones are the bones that, when joined, form the top and sides of the skull.

[0297] Temporal bone: The temporal bones are at the bottom and sides of the skull and support the part of the face called the temple.

[0298] Zygomatic bone: The face includes two zygomatic bones located at the upper and side parts of the face that form the cheek prominences.

[0299] 5.8.3.3 Structure of the Respiratory System Diaphragm: A sheet of muscle that spans the bottom of the thoracic cavity. The diaphragm separates the thoracic cavity, which houses the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0300] The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0301] Lung: The human respiratory organ. The conducting zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0302] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space located above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical ridge called the nasal septum. On both sides of the nasal cavity are three horizontal extensions called conchae (singular "concha") or turbinates. In front of the nasal cavity is the nose, the back of which merges with the nasopharynx through the posterior nares.

[0303] Pharynx: A part of the throat located directly below the nasal cavity, above the esophagus and larynx. The pharynx is usually divided into three parts: the epipharynx (the nasal part of the pharynx), the mesopharynx (the oral part of the pharynx), and the hypopharynx.

[0304] 5.8.4 Patient Interface Anti-asphyxia valve (AAV): A component or subassembly of a mask system that reduces the risk of a patient rebreating carbon dioxide CO2 by opening to the atmosphere in a fail-safe manner.

[0305] Elbow: An elbow is an example of a structure that guides the axis of the air flow <!--1514-->to change direction by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a substantially circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In a particular form, the elbow can be rotatable relative to the mating component, for example, by about 360 degrees. In a particular form, the elbow can be removable from the mating component, for example, via a snap connection. In a particular form, the elbow can be assembled to the mating component via a one-time snap during manufacture, while being non-removable by the patient.

[0306] Frame: The frame is taken to mean a mask structure that supports tensile loads between two or more points connecting the headgear. The mask frame can be a non-airtight load support structure in the mask. However, some forms of the mask frame may be airtight.

[0307] Headgear: The headgear is a positioning and stabilization structure designed for the head. For example, the headgear may include a set of one or more struts, ties, and reinforcements configured to position and hold a patient interface in place for respiratory therapy on the patient's face. Some ties may be formed from a flexible, flexible, and elastic material such as a laminate composite of foam and fabric.

[0308] Membrane: The membrane is typically taken to mean a thin element, preferably substantially resistant to bending and resistant to stretching and contraction.

[0309] Pleated chamber: The mask pleated chamber is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of the space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell can form part of the wall of the mask pleated chamber.

[0310] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("seal"), it can refer to its effect. Two elements can be constructed and / or arranged to "seal" or achieve a "seal" between them without the need for separate "seal" elements themselves.

[0311] Shell: The shell is taken to mean a relatively thin, curved structure having bending, tensile, and compressive rigidity. For example, the curved structure wall of the mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0312] Reinforcing member: A reinforcing member is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0313] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0314] Swivel (noun): A sub-assembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel can be configured to rotate through an angle less than 360 degrees. When used in connection with an air delivery conduit, the sub-assembly of components preferably includes a pair of mating cylindrical conduits. In use, there is little or no leakage of air flow from the swivel.

[0315] Tie (noun): A structure designed to resist tension.

[0316] Ventilation section (noun): A structure that allows air flow to pass from inside the mask or conduit to the ambient air, clinically effectively flushing out exhaled gas. For example, in a clinically effective expulsion, a flow rate of about 10 liters per minute to about 100 liters per minute can be used depending on the mask design and treatment pressure.

[0317] 5.8.5 Shape of the structure The product according to this technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be limited by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the direction, position, function, or some other characteristic of the associated surface. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contact (e.g., outer) surface and a separate non-face-contact (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

[0318] To facilitate the description of the three-dimensional structure and the shape of the surface, first, consider a cross-section that crosses the surface of the structure at point p. Referring to FIGS. 17 to 21, an example of the cross-section at point p on the surface and the resulting planar curve are shown. FIGS. 17 to 21 also show the outward normal vector at p. The outward normal vector at point p points in the direction away from the surface. In some examples, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0319] 5.8.5.1 Curvature in One Dimension The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle that just touches the curve at p). Positive curvature: When the curve at p bends towards the outer normal, the curvature at that point is considered positive (when the fictional small person leaves point p, they have to walk uphill). See FIGS. 17 (relatively large positive curvature compared to FIG. 18) and FIG. 18 (relatively small positive curvature compared to FIG. 17). Such curves are generally called concave curves.

[0320] Zero curvature: When the curve at p is a straight line, the curvature is considered zero (when the fictional small person leaves point p, they can walk horizontally without going up or down). See FIG. 19.

[0321] Negative curvature: When the curve at p moves away from the outer normal, the curvature in that direction at that point is considered negative (if a virtual little person were to leave point p, they would have to walk downhill). See Figure 20 (relatively small negative curvature compared to Figure 21) and Figure 21 (relatively large negative curvature compared to Figure 20). Such curves are generally called convex curves.

[0322] 5.8.5.2 Curvature of a two-dimensional surface The description of the shape at a given point on a two-dimensional surface according to the present technology may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (for example, relatively small). The planar curves in Figures 17 to 21 may be examples of such a plurality of cross-sections at a specific point.

[0323] Principal curvature and direction: The directions of the normal planes in which the curvature of a curve takes on its maximum and minimum values are called the principal directions. In the examples of Figures 17 to 21, since the maximum curvature occurs in Figure 17 and the minimum in Figure 21, Figures 17 and 21 are cross-sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0324] Region of the surface: A connected series of points on the surface. The set of points within the region may have similar characteristics such as curvature and sign.

[0325] Saddle region: A region where at each point, the principal curvatures have opposite signs, i.e., one is positive and the other is negative. (Depending on the direction a virtual person is facing, they may have to walk uphill or downhill).

[0326] Dome region: A region where at each point the principal curvatures have the same sign, for example, both positive ("concave dome") or both negative ("convex dome").

[0327] Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0328] Planar region: A region of a surface where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0329] Edge of a surface: The boundary or limit of a surface or region.

[0330] Path: In certain embodiments of the present technology, a "path" is considered to mean a path in the mathematical topological sense, for example, a continuous space curve on a surface from f(0) to f(1). In certain embodiments of the present technology, a "path" can be described as, for example, a route or course that includes a set of points on a surface. (The path of a fictional person is where one walks on the surface and is similar to a garden path).

[0331] Path length: In certain embodiments of the present technology, "path length" is considered to mean the distance along the surface from f(0) to f(1), that is, the distance along a path on the surface. There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance that one has to walk on the surface along the path).

[0332] Straight-line distance: The straight-line distance is the distance between two points on a surface regardless of the surface. On a planar region, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, the straight-line distance corresponds to the "distance a crow flies").

[0333] 5.8.5.3 Space curve Space curve: Unlike a plane curve, a space curve is not necessarily on a specific plane. A space curve can be closed, i.e., it has no endpoints. A space curve can be considered as a one-dimensional piece in three-dimensional space. A fictional person walking along the strand of a DNA helix is walking along a space curve. A typical human left ear contains a left-handed helix (see Fig. 32). A typical human right ear contains a right-handed helix (see Fig. 33). Fig. 34 shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the state of a curve generated from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with reference to the tangent, normal, and binormal vectors at that point.

[0334] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at the point specifies the direction and amplitude from the point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional person flies along a curve and falls out of a vehicle at a particular point, the direction of the tangent vector is the direction in which she is moving.

[0335] Unit normal vector: As a fictional person moves along a curve, the tangent vector itself also changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0336] Binormal unit vector: The binormal unit vector is perpendicular to the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (e.g., see Fig. 31) or the left-hand rule (see Fig. 30).

[0337] Contact plane: A plane containing the unit tangent vector and the unit principal normal vector. See Figs. 30 and 31.

[0338] Torsion of a space curve: The torsion of a point on a space curve is the magnitude of the rate of change of the unit binormal vector at that point. This measures the degree of deviation from the osculating plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the osculating plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (for example, a gently sloping helical path). When the deviation from the osculating plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (for example, a steeply sloping helical path). Referring to FIG. 34, since T2>T1, the amount of torsion near the top coil of the helix in FIG. 34 is greater than the amount of torsion of the bottom coil of the binormal in FIG. 34.

[0339] Referring to the right - hand rule of FIG. 31, a space curve that bends in the direction of the right - hand binormal can be regarded as having a positive torsion in the right - hand direction (for example, a right - hand helix as shown in FIG. 34). A space curve that faces away from the right - hand binormal direction can be regarded as having a negative torsion of the right - hand (for example, a left - hand helix).

[0340] Similarly, referring to the left - hand rule (see FIG. 3O), a space curve that faces in the left - hand binormal direction can be regarded as having a positive torsion of the left - hand (for example, a left - hand helix). Thus, the positive direction of the left - hand corresponds to the negative direction of the right - hand. Refer to FIG. 35.

[0341] 5.8.5.4 Holes A surface can have one - dimensional holes (for example, holes bounded by a planar curve or a space curve). In the case of a thin structure (for example, a membrane) containing holes, this structure can be described as having one - dimensional holes. For example, refer to the state where the one - dimensional holes in the surface of the structure shown in FIG. 24 are bounded by a planar curve.

[0342] The structure can have two-dimensional holes (e.g., holes bounded by a surface). For example, an inflatable tire has two-dimensional holes bounded by the inner surface of the tire. In another example, a bladder with a cavity for air or gel can have two-dimensional holes. See, for example, the cushion of FIG. 27 and the exemplary cross-sections of FIGS. 28 and 29 in FIG. 3N where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit can include one-dimensional holes (e.g., at its inlet or its outlet) and can include two-dimensional holes bounded by the inner surface of the conduit. Also see the two-dimensional holes passing through the structure shown in FIG. 26 and bounded by a surface as illustrated.

[0343] 5.9 Other Notes Unless the context clearly dictates otherwise, when a range of values is provided, each intervening value between the upper and lower limits of that range to one-tenth of the unit of the lower limit, and any other stated value or intervening value within that range, is included within the present technology. The upper and lower limits of these intervening ranges, which may be independently included within the intervening ranges, are also included within the present technology, subject to any explicitly excluded limitations within the stated range. When the stated range includes one or both of the limitations, ranges excluding one or both of those included limitations are also included in the present technology.

[0344] Furthermore, if one or more values are described herein as being implemented as part of the present technology, unless otherwise stated, such values may be approximated and such values may be utilized to any appropriate significant digits to the extent that practical technical implementations may permit or require it.

[0345] 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. In the practice or testing of the present technology, methods and materials similar or equivalent to those described herein may be used, although a limited number of exemplary methods and materials are described herein.

[0346] When a particular material is identified as being used to position an element, an obvious alternative material having similar properties may be used as a substitute. Further, unless specified to the contrary, any and all of the positioning elements described herein are understood to be manufacturable and may be manufactured together or separately.

[0347] It should be noted that, as used in this specification and the appended claims, unless the context clearly dictates otherwise, the singular forms also include their plural counterparts.

[0348] All publications mentioned in this specification are hereby incorporated by reference in their entirety for the purpose of disclosing and describing the methods and / or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the technology of the present invention has a right to antedate such publications by virtue of prior invention. Further, the publication dates provided may be different from the actual publication dates which may need to be independently verified.

[0349] The terms "comprising" and "including" should be interpreted in a non-exclusive manner to refer to elements, positioning elements, or steps, indicating that the referenced elements, positioning elements, or steps may be present or combined with other elements, positioning elements, or steps not explicitly referenced.

[0350] The headings of the subject matter used in the detailed description are included only for ease of reference by the reader and should not be used to limit the subject matter found throughout the present disclosure or claims. The headings of the subject matter should not be used in the interpretation of the claims or limitations of the claims.

[0351] The techniques described in this specification have been described with reference to specific examples, but it should be understood that these examples merely illustrate the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not necessary to practice the technique. For example, the terms "first" and "second" may be used, but unless otherwise specified, they are not intended to indicate order and may be used to distinguish different elements. Further, the process steps in a methodology may be described or illustrated in an order, but such ordering is not required. One of ordinary skill in the art will recognize that such ordering may be modified and / or the acts may be performed simultaneously or synchronously.

[0352] Accordingly, it should be understood that numerous modifications may be made to the exemplary examples and other arrangements may be devised without departing from the spirit and scope of the present technology.

Explanation of Reference Signs

[0353] 5.10. Explanation of Reference Signs 1000 Patient 1100 Roommate 3000 Patient Interface 3100 Seal Formation Structure 3102 Seal Molding Structure Hole 3103 Sealing Lip 3104 Sealing Lip Bypass Opening 3150 Stand Cushion Module 3160 Pillow Cushion Module 3201 Connection Lip 3202 Tube Connector 3203 Direction Indicator Projection 3204 Receptacle Hole 3210 Direction Indicator Projection 3220 Receptacle Hole 3230 String 3220 Upper Point 3230 Lower Point 3300 Positioning and Stabilization Structure 3310 Strap 3350 tube 3363 Non-extendable tube section 3364 Sleeve 3390 Fluid Connection Opening 3400 Ventilation Assembly 3401 Ventilated Cap 3402 Ventilation hole 3403 Ventilation body 3404 Ventilation diffusion material 3405 Ventilation body hole 3406 Spacer 3407 Directional indicator recess 3408 Connecting passage 3409 Mounting structure 3410 Slots 3500 HMX and Ventilation Assembly 3600 connection port 3610 Elbow 3700 Forehead support 3800 HMX Assembly 3802 HMX frame 3803 HMX frame hole 3804 HMX Prop 3806 HMX rim 3807 HMX rim hole 3850 HMX material 3852 Rear 3854 Front 3856 Outer surface 4000 RPT devices 4010 Outer Housing 4012 Upper 4014 Lower 4015 Panel 4016 chassis 4018 Handle 4020 Pneumatic Block 4100 Pneumatic Components 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Outlet muffler 4140 Pressure generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air circuit 4180 Supplementary gas 4200 Electrical components 4202 PCBA 4210 Power supply 4220 Input device 4230 Central controller 4270 Converter 5000 Humidifier

Claims

1. A patient interface, comprising: An air flow of treatment pressure that is at least 4 cmH ２ O higher than the ambient air pressure for breathing by a patient, a plenum chamber capable of being pressurized to a treatment pressure, the plenum chamber further including a plenum chamber opening configured to receive the air flow of the treatment pressure, a seal-forming structure connected to the plenum chamber, the seal-forming structure being constructed and arranged to seal a facial region of the patient that at least partially surrounds the patient's airway inlet, having apertures for delivering a therapeutic pressure air flow to at least the patient's nostrils during use, and being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a positioning and stabilization structure comprising a strap configured to hold the seal-forming structure in a therapeutically effective position on the patient's head; a ventilation assembly connected to the plenum chamber and having a plurality of ventilation apertures, the plurality of ventilation apertures being configured to allow the patient to continuously flow the gas exhaled from the plenum chamber to the surroundings throughout the patient's respiratory cycle, and being sized and shaped to maintain the therapeutic pressure within the plenum chamber during use; a humidification and heat exchange (HMX) assembly connected to the ventilation assembly, the HMX assembly including an HMX frame and a material disposed on the HMX frame, the material being configured to adsorb water vapor from the patient's exhaled gas and desorb water vapor into the therapeutic pressure air flow, the material being supported by the HMX frame within the plenum chamber such that at least a portion of the therapeutic pressure air flow entering the plenum chamber passes through the material before entering the patient's airway, and the HMX frame being composed of a flexible material; and the patient interface being configured to leave the patient's mouth exposed, or, when the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface being configured to allow the patient to breathe from the environment in the absence of a therapeutic pressure air flow.

2. The patient interface according to claim 1, wherein the material further comprises a foam or paper.

3. The patient interface according to claim 1 or 2, wherein the material further comprises a salt applied to a surface of the material.

4. The patient interface according to any one of claims 1 to 3, wherein the material is removable from the HMX frame.

5. The patient interface according to any one of claims 1 to 3, wherein the material is permanently attached to the HMX frame.

6. The patient interface according to any one of claims 1 to 3, wherein the material is attached to the HMX frame by one or more of an adhesive, overmolding the HMX frame onto the material, and a retainer for holding the material to the HMX frame.

7. The patient interface according to any one of claims 1 to 5, wherein the HMX assembly is removable from within the phrenic chamber.

8. The patient interface according to any one of claims 1 to 7, wherein the ventilation assembly is removably connected to the phrenic chamber.

9. The patient interface according to any one of claims 1 to 8, wherein the ventilation assembly and the HMX assembly are removably together from the phrenic chamber.

10. The patient interface according to any one of claims 1 to 9, wherein the HMX assembly is removable from the ventilation assembly.

11. The patient interface according to any one of claims 1 to 10, wherein the ventilation assembly includes a ventilation body and a ventilation cap attached to the ventilation body.

12. The patient interface according to claim 11, wherein the ventilation hole is formed between the ventilation body and the ventilation cap.

13. The patient interface according to claim 11 or 12, wherein the ventilation body further includes a ventilation body hole configured to allow a continuous flow of the patient's exhaled gas to pass through the ventilation body and then into the atmosphere through the ventilation body hole.

14. The patient interface according to claim 13, wherein the ventilation assembly includes a ventilation diffusion material disposed between the ventilation body and the ventilation cap.

15. The patient interface according to claim 14, wherein the ventilation body includes a spacer for distancing the ventilation diffusion material from the ventilation body hole and abutting the ventilation cap.

16. One of the phrenic chamber and the ventilation body includes one or more direction indicating protrusions, The other of the plenum chamber and the ventilation body includes one or more direction indicating recesses configured to receive one of the corresponding direction indicating protrusions when the ventilation body is attached to the plenum chamber. The patient interface according to any one of claims 11 to 15.

17. One of the plenum chamber and the ventilation body includes a connection lip, The other of the plenum chamber and the ventilation body includes a connection passage configured to receive the connection lip and removably attach the ventilation body to the plenum chamber. The patient interface according to any one of claims 11 to 16.

18. The HMX frame includes an HMX rim connected to the ventilation assembly, The ventilation body includes an attachment structure configured to receive the HMX rim for attaching the HMX frame to the ventilation body. The patient interface according to any one of claims 11 to 17.

19. The HMX frame includes one or more HMX struts joined to the HMX rim, One or more slots are formed through the attachment structure, and each of the slots is configured to receive a corresponding one of the HMX struts of the HMX struts. The patient interface according to claim 18.

20. The plenum chamber includes a receiving hole configured to receive the ventilation assembly, and the HMX assembly is inserted into the interior of the plenum chamber through the receiving hole. The patient interface according to any one of claims 1 to 17.

21. The flexible material is silicone rubber or a thermoplastic elastomer. The patient interface according to any one of claims 1 to 20.

22. The material is disposed in the plenum chamber such that an airflow of treatment pressure must pass through the material before entering the patient's airway. The patient interface according to any one of claims 1 to 21.

23. The material is disposed in the plenum chamber such that at least a portion of the airflow of treatment pressure bypasses the material before entering the patient's airway. The patient interface according to any one of claims 1 to 21.

24. The patient interface according to any one of claims 1 to 23, wherein the material is disposed within the plenum chamber such that the patient's exhaled gas must pass through the material before being discharged to the surroundings through the ventilation holes. **Claim 25** The patient interface according to any one of claims 1 to 23, wherein the material is disposed within the plenum chamber such that at least a portion of the patient's exhaled gas bypasses the material before being discharged to the surroundings through the ventilation holes. **Claim 26** The HMX frame forms HMX frame holes, The patient interface according to any one of claims 1 to 25, wherein an outer peripheral portion of the material is disposed on the HMX frame such that the gas flowing through the material passes through the HMX frame holes. **Claim 27** The patient interface according to any one of claims 1 to 26, wherein the HMX frame includes an HMX rim connected to the ventilation assembly. **Claim 28** The patient interface according to claim 27, wherein the HMX frame includes one or more HMX struts joined to the HMX rim. **Claim 29** The patient interface according to claim 28, wherein each of the HMX struts is linear. **Claim 30** The patient interface according to claim 28, wherein each of the HMX struts is curved. **Claim 31** The patient interface according to claim 27, wherein the HMX rim is directly joined to the HMX frame. **Claim 32** The patient interface according to any one of claims 1 to 6, wherein the material further includes a rear surface that faces the patient's face during use, and the rear surface is bent forward so as not to contact the patient's face during use. **Claim 33** The patient interface according to any one of claims 1 to 32, wherein the seal-forming structure includes a sealing lip configured to seal against the HMX frame. **Claim 34** The patient interface according to claim 33, wherein the sealing lip includes a sealing lip bypass opening configured to bypass the material before at least a portion of the airflow of the treatment pressure enters the patient's airway and before at least a portion of the patient's exhaled gas is discharged to the surroundings through the ventilation holes. **Claim 35** The sealing lip is configured to seal the entire perimeter of the HMX frame such that all treatment pressure air flow passes through the material before entering the patient's airway and all of the patient's exhaled gas passes through the material before exiting to the surroundings through the ventilation holes. The patient interface according to claim 33.

36. The seal-forming structure is configured such that the patient's mouth is not covered and further includes a nasal pillow or nasal cradle. The patient interface according to any one of claims 1 to 35.

37. The seal-forming structure is configured to seal around the patient's nose and mouth and further includes one or two nasal holes configured to be pneumatically in communication with the patient's nostrils during use and a mouth hole configured to be pneumatically in communication with the patient's mouth during use. The patient interface according to any one of claims 1 to 35.

38. A respiratory pressure therapy (RPT) system, a patient interface according to any one of claims 1 to 37, a respiratory pressure therapy (RPT) device configured to generate a treatment pressure air flow, an air circuit configured to connect the RPT device and the patient interface to direct a treatment pressure air flow from the RPT device to the patient interface, and a respiratory pressure therapy (RPT) system that does not include a humidifier.

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