Portable assembly device for assembling a patient interface

Abstract

The utility model discloses a portable assembly equipment for assembling patient interface, and the patient interface is used for delivering breathable gas to the patient. The assembly equipment can be portable, and can include a first assembly component and a second assembly component, the first assembly component includes a first receiving area configured to receive at least a portion of the patient interface, and the second assembly component includes a second receiving area configured to receive at least a portion of the adhesive layer. The first assembly component can be configured to engage with the second assembly component to position the first receiving area adjacent to the second receiving area, thereby applying the adhesive layer to a seal-forming structure of the patient interface to form an assembled patient interface. The adhesive layer can be configured to adhere the assembled patient interface to the patient's face.

Description

Technical Field

[0001] This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. This technology relates to a sealing-forming structure for a patient interface that forms a seal with the patient's airway via an adhesive surface. This technology also relates to a patient interface having a mechanism for facilitating mouth closure during use. Background Technology

[0002] 1.2 Description of related technologies

[0003] 1.2.1 The human respiratory system and its disorders

[0004] The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0005] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar regions of the lungs are where gas exchange occurs and are called the respiratory zones. See John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0006] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

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

[0008] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these have many drawbacks.

[0009] One of the main challenges in respiratory therapy is compliance, also known as adherence. Patients may need to wear the patient interface for extended periods as part of respiratory therapy. The bulky and / or obtrusive nature of the patient interface often leads to patient interruptions due to discomfort, inconvenience, or sleep disturbance. In particular, it is difficult to ensure that infants and children do not have their patient interfaces removed during respiratory therapy.

[0010] 1.2.2 Therapy

[0011] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0012] 1.2.2.1 Respiratory pressure therapy

[0013] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or chest tubes).

[0014] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP therapy can be voluntary; therefore, patients may choose not to adhere to treatment if they find one or more of the devices used to provide this therapy to be uncomfortable, difficult to use, expensive, or unsightly.

[0015] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive respiratory disease (NMD), and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0016] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively and can be delivered using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0017] 1.2.3 Respiratory Therapy System

[0018] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0019] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and / or data management.

[0020] 1.2.3.1 Patient Interface

[0021] The patient interface can be used to connect a breathing device to its wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth, via a tube to the mouth, or via a tracheostomy tube into the patient's trachea. Depending on the therapy to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the therapy.

[0022] Typically, face mask systems serve as patient interfaces for delivering airflow. These systems usually consist of an inflatable chamber that is secured to the patient's face via a hood. The inflatable chamber, together with the patient's face, encloses a volume of space that accommodates the patient's facial features, such as their nose and / or mouth. The inflatable chamber is often made of a rigid material. These aspects of some conventional patient interface designs can make sleeping while wearing the interface inconvenient, uncomfortable, and potentially cause claustrophobia.

[0023] Besides mask systems commonly used in respiratory therapy, other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0024] Certain masks may be clinically disadvantageous for this technique, for example, if they obstruct airflow through the nose and only allow it through the mouth.

[0025] Some face masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[0026] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during respiratory therapy.

[0027] Due to these challenges, some face shields present one or more problems: they are obtrusive, unsightly, expensive, poorly fitting, difficult to use, and uncomfortable, especially when worn for extended periods or when patients are unfamiliar with a system. Wearing the wrong size face shield can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those used for administering anesthetics are tolerable for their original applications; however, wearing such face shields for extended periods (e.g., several hours) can be unintentionally uncomfortable. As previously mentioned, this discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0028] If the patient adheres to the therapy, CPAP therapy is very effective in treating certain breathing difficulties. If the mask is uncomfortable or difficult to use, the patient may not adhere to the therapy.

[0029] Patients are generally advised to wash their face masks regularly. If washing is necessary, or if the mask is difficult to wash (e.g., difficult to assemble or disassemble), patients may not wash their mask, which could affect patient compliance.

[0030] While masks designed for other applications (such as pilots) may not be suitable for treating sleep-disorder breathing, masks designed for treating sleep-disorder breathing may be suitable for other applications.

[0031] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0032] 1.2.3.1.1 Sealing Formation Structure

[0033] Patient interfaces may include seal-forming structures. Because the seal-forming structures come into direct contact with the patient's face, their shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0034] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element that surrounds both nostrils during use. This single element may be designed, for example, to cover the upper lip region and / or the bridge of the nose region. These different types of patient interfaces can be identified by various names used by their manufacturers, including nasal pads, nasal pillows, and nasal sprays.

[0035] In one form of patient interface, the sealing structure may include an element that surrounds the mouth region during use, for example, by forming a seal on the lower lip region of the face. In another form of patient interface, the sealing structure may include a single element that surrounds both nostrils and mouth regions during use. These patient interfaces may be referred to in the art as oral pads, oronasal pads, or full-face pads.

[0036] A seal that works in one area of ​​a patient's face may be unsuitable in another, for example, due to the different shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0037] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0038] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface in face-to-face engagement. The seal-forming structure may include an air- or fluid-filled pad, or a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure incorporates wing seals made of a thin material positioned around the periphery of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming section, additional force may be required to achieve a seal if the fit between the face and the mask is poor; otherwise, the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or buckle during use, causing leakage.

[0040] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0041] Another form of seal formation can be achieved using adhesives. For typical therapeutic pressures (e.g., up to 20 cmH2O), seals formed by adhesives are generally highly efficient, with little or no leakage.

[0042] The adhesive on the sealant may lose its adhesiveness with repeated use and over time. Therefore, it may be necessary to replace the adhesive on the sealant. Due to its adhesive nature, replacing the adhesive can be a tedious and difficult task to perform efficiently, and doing so may leave residue on the user's hands. The adhesive may also tend to cause the sealant to undesirably adhere to itself, another part of the patient interface, or another object. The sealant may be difficult to remove, and once removed, the adhesive's effectiveness may decrease.

[0043] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Pty Ltd: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785. Examples of patient interfaces including sealing structures using adhesives to achieve a seal are disclosed in PCT Publication WO 2023 / 015340, the contents of which are incorporated herein by reference.

[0044] One form of nasal pillow is found in the Adam circuitry manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0045] ResMed Limited has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Limited describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (describes ResMed Limited's SWIFT...) TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0046] 1.2.3.1.2 Positioning and Stability

[0047] A sealing structure for a patient interface used in positive air pressure therapy is subjected to stress from air pressure that could disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain a tight seal with appropriate portions of the face.

[0048] One technique involves using adhesives. An example of using adhesives to position and stabilize a patient interface with a sealing formation on the face is disclosed in PCT Publication WO 2023 / 015340, the contents of which are incorporated herein by reference. One advantage of using adhesives to position and stabilize the sealing formation on a patient's face is that it avoids the need for a headgear (discussed below), which can be uncomfortable, claustrophobic, and increases manufacturing cost and complexity. However, as previously mentioned, the use of adhesives known in the art has several disadvantages.

[0049] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more problems such as poor fit, bulkiness, discomfort, and inconvenience. They tend to be less airtight than adhesive-based seal-forming structures. Furthermore, straps and / or stabilizing straps often leave marks on the face when used overnight.

[0050] 1.2.3.1.3 Pressurized air duct

[0051] In one type of treatment system, pressurized airflow is provided to the patient interface via a conduit in an air circuit fluidly connected to the patient interface, such that when the patient interface is positioned over the patient's face during use, the conduit extends forward from the patient's face out of the patient interface. This may sometimes be referred to as a "tube-down" configuration.

[0052] The catheter that connects to the interface in front of the patient's face can sometimes easily get tangled in the bedding.

[0053] 1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0054] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned therapies, such as by operating the device to generate an airflow for delivery to an interface in the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow-based therapies such as HFT). Therefore, an RPT device can also function as a flow-based therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0055] 1.2.3.3 Air Circuit

[0056] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as the RPT device and the patient interface, during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0057] 1.2.3.4 Humidifier

[0058] Delivering an airflow without humidifying it can lead to airway dryness. Using a humidifier with an RPT device and patient interface generates humidified gas, which minimizes dryness of the nasal mucosa and increases airway comfort for the patient. Additionally, in cooler climates, warm air applied to the area inside and around the patient interface on the face is generally more comfortable than cold air.

[0059] 1.2.3.5 Vent Technology

[0060] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., into the environment). Utility Model Content

[0061] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use, and manufacturability.

[0062] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0063] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0064] One aspect of this technology is a patient interface that includes a sealing formation structure configured to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's airway.

[0065] Another aspect of this technology is a patient interface that includes a sealing structure having an opening that allows a breathable gas flow to be delivered to an inlet at least in the patient's nostrils.

[0066] Another aspect of this technology is a patient interface that includes a sealing formation structure, the sealing formation structure further including at least one adhesive surface configured to adhere to an area surrounding the entrance of the patient's airway on the patient's face during use to form a seal.

[0067] One aspect of this technology is a patient interface comprising an inflation chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port configured to receive a flow of breathable gas at the therapeutic pressure for the patient to breathe.

[0068] In one form of this technology, the sealing structure is configured to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0069] Another aspect of this technology is a patient interface having a peripheral shape complementary to the peripheral shape of the intended wearer. In one embodiment, the seal-forming structure is configured to have a peripheral shape complementary to the region of the patient's face surrounding the entrance to the patient's airway to form a seal. The region to which the seal-forming structure is to adhere may be referred to as the target seal region. In one embodiment, the seal-forming structure is configured such that the region of the patient's face includes the area of ​​the patient's face adjacent to or surrounding the nostrils.

[0070] According to one aspect of the present invention, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include an inflatable chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure. The inflatable chamber may include an inflatable chamber inlet port configured to receive a flow of breathable gas at the therapeutic pressure for the patient to breathe. The patient interface may further include a sealing formation structure disposed on the inflatable chamber. The sealing formation structure may be configured to form a seal with an inlet area of ​​the patient's face surrounding the patient's nostrils. The sealing formation structure may have an opening therein, allowing a flow of breathable gas to be delivered to the inlet of the patient's nostrils. The sealing formation structure may be configured to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The sealing formation structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face during use to form a seal. The patient interface may further include a vent structure to allow continuous flow of gas exhaled by the patient from the interior of the inflatable chamber to the environment. The vent structure may be configured to maintain the therapeutic pressure in the inflatable chamber during use.

[0071] In some forms, the seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient’s face during use to form a seal.

[0072] According to one aspect of the present invention, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include an inflatable chamber pressurizable to a therapeutic pressure at least 6 cmH2O above ambient air pressure. The inflatable chamber may include an inflatable chamber inlet port configured to receive a flow of breathable gas at the therapeutic pressure for the patient to breathe. The patient interface may further include a sealing formation structure. This sealing formation structure may be configured to form a seal with an inlet area of ​​the patient's face surrounding the patient's airway. The sealing formation structure may have an opening therein, allowing a flow of breathable gas to be delivered to an inlet at least one of the patient's nostrils. The sealing formation structure may be configured to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface may further include a vent structure to allow continuous flow of gas exhaled by the patient from the interior of the inflatable chamber to the environment. The vent structure may be configured to maintain the therapeutic pressure in the inflatable chamber during use. The sealing formation structure may include at least one patient-facing adhesive surface configured to adhere to an area of ​​the patient's face during use to form a seal. The sealing structure may further include at least one non-patient-facing adhesive surface formed around the opening and configured to adhere to the patient-facing side of the inflation chamber. The sealing structure may also include a non-patient-facing removable layer positioned on the non-patient-facing adhesive surface and configured to be removed before the inflation chamber adheres to the sealing structure.

[0073] In some forms, the seal-forming structure may also include a patient-facing removable layer positioned on the patient-facing adhesive surface and configured to be removed before the seal-forming structure is adhered to the patient's face.

[0074] In some forms, the non-patient-facing removable layer may have holes formed therein. When the non-patient-facing removable layer is positioned on a non-patient-facing adhesive surface, the holes may be substantially aligned with the openings.

[0075] In some forms, the non-patient-facing removable layer may include tabs configured to be grasped by a user (e.g., a patient) for removing the non-patient-facing removable layer from the sealing formation.

[0076] One aspect of certain forms of this technology is an assembly device for assembling a patient interface for delivering breathable gas to a patient. The assembly device can be configured to engage two portions of the patient interface. These two portions can be joined together using an adhesive. In some forms, the assembly device can be portable. In other forms, the assembly device can be non-portable.

[0077] According to one aspect of the present invention, a portable assembly device is provided for assembling a patient interface for delivering breathable gas to a patient. The portable assembly device may include a first assembly component, which may include a first receiving region configured to receive a first portion of the patient interface in use. The portable assembly device may also include a second assembly component, which may include a second receiving region configured to receive a second portion of the patient interface in use. The first assembly component may be configured to engage with the second assembly component to position the first receiving region adjacent to the second receiving region in a location suitable for adhering the first and second portions together to form an assembled patient interface.

[0078] In some forms, the first receiving area may include a substantially continuous surface, on which the main portion of the first part of the patient interface may substantially abut when the first portion is received by the first receiving area.

[0079] In some forms, the first receiving area may have a shape that corresponds substantially to the natural shape of the non-patient-facing surface of the sealing formation structure of the patient interface, so as to substantially maintain the shape of the sealing formation structure when the assembled patient interface is formed.

[0080] In some forms, the first receiving area may be substantially convex when the cross-section is viewed from the side.

[0081] In some forms, the first receiving region may include one or more recessed regions.

[0082] In some forms, the second receiving area may include a substantially continuous surface, on which the main portion of the patient-facing surface of the sealing structure of the patient interface may substantially abut when the first and second portions are adhered together.

[0083] In some forms, the second receiving region may have a shape that is substantially complementary to the shape of the first receiving region, such that the first and second receiving regions can be placed in an engaging configuration.

[0084] In some forms, the second receiving area may have a shape that corresponds substantially to the natural shape of the patient-facing surface of the sealing formation structure of the patient interface, which can substantially maintain the shape of the sealing formation structure when the assembled patient interface is formed.

[0085] In some forms, the second receiving area may be substantially recessed when the cross-section is viewed from the side.

[0086] In some forms, the second receiving area may include one or more raised areas.

[0087] In some forms, the first receiving region and / or the second receiving region may be formed at least partially of an elastically deformable material.

[0088] In some forms, the first assembly component may include a first retaining structure that can be configured to hold the first portion in a substantially fixed position relative to the first assembly component.

[0089] In some forms, the first retaining structure may include a recess that can be configured to substantially receive the first portion.

[0090] In some forms, the first retaining structure may include a cavity that can be configured as an inflatable chamber for receiving a patient interface.

[0091] In some forms, the second assembly component may include a second retaining structure that can be configured to hold the second portion in a substantially fixed position relative to the second assembly component.

[0092] In some forms, the second retaining structure may include a first slot and / or a second slot. The first slot may be configured to receive a first tab of the second portion or a removable layer attached thereto during use. The second slot may be configured to receive a second tab of the second portion or a removable layer attached thereto during use.

[0093] In some forms, the first assembly component and the second assembly component can be movable relative to each other, allowing the portable assembly device to have a stable configuration. In a stable configuration, the first part (when received by the first receiving area) and the second part (when received by the second receiving area) can face each other and be separated by a gap.

[0094] In some forms, the first assembly component may include an outer component and an inner component, the inner component being configured to move relative to the outer component to position a first receiving area adjacent to a second receiving area, thereby adhering the first and second portions together. The inner component may include the first receiving area.

[0095] In some forms, the portable assembly device may also include a resilient member that can be configured to return both the internal and external components to their original configuration when the force causing the internal component to move relative to the external component is removed. The original configuration may be a stable configuration.

[0096] In some forms, the first assembly component may be hingedly attached to the second assembly component.

[0097] In some forms, the first assembly component can be separated from the second assembly component.

[0098] In some forms, the second assembly component may include a first assembly portion and a second assembly portion, the first assembly portion including a second receiving region. In a configuration where the first assembly portion and the second assembly portion are connected together, the first assembly portion and the second assembly portion may together form a cavity suitable for accommodating one or more patient interface portions.

[0099] According to one aspect of the present invention, a method for assembling a patient interface for delivering breathable gas to a patient is provided. The method may include the step of positioning a first portion of the patient interface onto a first receiving region of a first assembly component of a portable assembly device. The method may further include the step of positioning a second portion of the patient interface onto a second receiving region of a second assembly component of the portable assembly device. The method may also include the step of engaging the first assembly component and the second assembly component to position the first receiving region adjacent to the second receiving region in a position suitable for adhering the first and second portions together to form an assembled patient interface.

[0100] In some forms, the step of engaging the first assembly component with the second assembly component may further include a sub-step of placing the first receiving region and the second receiving region in an engaging configuration.

[0101] In some forms, the method may further include the step of placing the first portion onto a first retaining structure of the first assembly to maintain the first portion in a substantially fixed position relative to the first assembly.

[0102] In some forms, the step of setting the first portion onto the first retaining structure may also include a sub-step of setting the first portion substantially within a recess of the first retaining structure.

[0103] In some forms, the step of setting the first part onto the first retaining structure may also include setting the air chamber of the patient interface into the cavity of the first retaining structure.

[0104] In some forms, the method may further include the step of placing the second portion onto a second retaining structure of the second assembly to maintain the second portion in a substantially fixed position relative to the second assembly.

[0105] In some forms, the step of attaching the second portion to the second retaining structure may include inserting a first tab of the second portion or a removable layer attached thereto into a first slot of the second retaining structure. In some forms, the step of attaching the second portion to the second retaining structure may also include inserting a second tab of the second portion or a removable layer attached thereto into a second slot of the second retaining structure.

[0106] In some forms, the method may further include the step of moving the first assembly and the second assembly into a stable configuration before adhering the first and second parts together. In the stable configuration, the first part (when received by the first receiving region) and the second part (when received by the second receiving region) may face each other and be separated by a gap.

[0107] In some forms, the step of moving the first assembly component and the second assembly component into a stable configuration may include rotating the first assembly component relative to the second assembly component.

[0108] In some forms, after the step of moving the first assembly component and the second assembly component into a stable configuration, the method may further include the step of moving an internal component of the first assembly component relative to an external component of the first assembly component to engage the first assembly component with the second assembly component. The internal component may include a first receiving area.

[0109] In some forms, after the first and second parts are adhered together, the method may include the step of removing a removable layer from the second part to expose the adhesive surface of the second part for adhering the assembled patient interface to the patient's face.

[0110] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity and vision, or by a person with limited experience in using this type of medical device.

[0111] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects within an aspect can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0112] Other features of the present technology will become apparent from the following detailed description, summary of the specification, drawings and claims. Attached Figure Description

[0113] The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including:

[0114] Figure 1 A system is shown that includes a patient 1000 wearing a patient interface 3000 who receives a positive pressure air supply from an RPT device 4000. The patient is sleeping in a side-lying position.

[0115] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0116] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0117] Figure 2C It is a frontal view of a face with several identifiable surface anatomical features, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the lips. It also indicates the upward, downward, radially inward, and radially outward directions.

[0118] Figure 2D It is a side view of the head with several identifiable surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge, supraauricular base, and subauricular base. The vertical and horizontal directions are also indicated.

[0119] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.

[0120] Figure 2F A bottom view of the nose with several identifiable features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, subnasal point, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0121] Figure 2G A side view showing the surface features of the nose.

[0122] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0123] Figure 2I An anatomical view of the nasal region, approximately a few millimeters from the midsagittal plane, is shown, with particular emphasis on the medial crus of the septal cartilage and the greater alar cartilage.

[0124] Figure 2J A frontal view of the skull skeleton, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal concha bones, as well as the maxilla and mandible, are also indicated.

[0125] Figure 2KThis diagram shows a lateral view of the skull, including the outline of the head surface and several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0126] Figure 2L The frontal lateral view of the nose is shown.

[0127] Figure 3 A patient interface of one form according to the present technology is shown, configured to adhere to a flange region of a patient's face.

[0128] Figure 4A A perspective view of a patient interface that is adhered to a patient's face in one form according to the present technology is shown.

[0129] Figure 4B It shows Figure 4A A side view of the patient interface.

[0130] Figure 5 This is a perspective view of a patient interface that is adhered to the wing fold area of ​​a patient's face in accordance with one form of this technology.

[0131] Figure 6 This is a front view illustration of another form of patient interface according to the present technology.

[0132] Figure 7 yes Figure 20 The patient interface shown is a perspective view of another component.

[0133] Figure 8 yes Figure 20 The diagram shows an exploded view of the patient interface.

[0134] Figure 9 This is an exploded view illustration of another form of patient interface according to this technology before assembly.

[0135] Figure 10 This is an exploded view illustration of another form of patient interface according to the present technology.

[0136] Figure 11 yes Figure 23 The patient interface shown is a perspective view when worn by a patient.

[0137] Figure 12A It shows Figure 10 The patient interface shown is part of the assembly view (top of the figure) and an exploded view (bottom of the figure).

[0138] Figure 12B A perspective view of one form of adhesive layer according to the present technology is shown.

[0139] Figure 13 A perspective view of a second assembly component of an assembly device according to one form of the present technology is shown.

[0140] Figure 14 A perspective view of the internal components of a first assembly part of an assembly device according to the present technology is shown.

[0141] Figure 15 A perspective view of the outer component of the first assembly part of an assembly device according to one form of the present technology is shown.

[0142] Figure 16 A top perspective view of the assembled equipment in an open configuration is shown.

[0143] Figure 17 It shows Figure 16 The bottom perspective view of the assembled device in the open configuration.

[0144] Figure 18 It shows Figure 16 The side view of the assembled device in the open configuration.

[0145] Figure 19 A top perspective view of the assembled equipment in a closed configuration is shown.

[0146] Figure 20 It shows Figure 19 A bottom perspective view of the assembly equipment in a closed configuration.

[0147] Figure 21 It shows Figure 19 A side view of the assembled equipment in a closed configuration.

[0148] Figure 22 A top perspective view of the assembly equipment in its assembly configuration is shown.

[0149] Figure 23 It shows Figure 22 The bottom perspective view of the assembly equipment in the assembly configuration.

[0150] Figure 24 It shows Figure 22 A side view of the assembly equipment in its assembly configuration.

[0151] Figure 25 A top perspective view of the first assembly component of an assembly device according to another form of the present technology is shown.

[0152] Figure 26 It shows Figure 25 Bottom perspective view of the first assembled component.

[0153] Figure 27 The assembly with the patient interface is shown. Figure 25 Top perspective view of the first assembled component.

[0154] Figure 28 A top perspective view of a second assembly component of an assembly device according to another form of the present technology is shown.

[0155] Figure 29 It shows Figure 28 Bottom perspective view of the second assembly component.

[0156] Figure 30 It shows the assembly with the adhesive layer. Figure 28 Bottom perspective view of the second assembly component.

[0157] Figure 31 A top perspective view of the assembly equipment in an engaging configuration is shown.

[0158] Figure 32 It shows Figure 31 Bottom perspective view of the assembly equipment in the meshing configuration.

[0159] Figure 33 It shows Figure 31 Bottom view of the assembly equipment in the meshing configuration.

[0160] Figure 34 It shows Figure 31 A side view of the assembly equipment in a meshing configuration.

[0161] Figure 35 It shows removable attachment Figure 28 Bottom perspective view of the assembled patient interface on the second assembly component.

[0162] Figure 36 A top perspective view of another form of assembly equipment according to this technology is shown.

[0163] Figure 37 It shows Figure 36 Bottom perspective view of the assembly equipment.

[0164] Figure 38 It shows Figure 36 A side view of the assembly equipment.

[0165] Figure 39 It shows Figure 36 Bottom perspective view of the outer components of the second assembly part and the first assembly part of the assembly equipment.

[0166] Figure 40 It shows Figure 36 Top perspective view of the internal components of the first assembly part of the assembly equipment.

[0167] Figure 41 A top perspective view of an assembly device in an open configuration according to this technology is shown.

[0168] Figure 42 It shows Figure 41 Bottom perspective view of the assembly equipment.

[0169] Figure 43 A top perspective view of an assembly device in an open configuration according to this technology is shown.

[0170] Figure 44 Showing another open configuration Figure 43 Top perspective view of the assembled equipment.

[0171] Figure 45 A cross-sectional view of a portion of an assembly device according to another form of the present technology is shown.

[0172] Figure 46 It shows Figure 45 Top perspective view of a portion of the assembly equipment shown.

[0173] Figure 47 A cross-sectional view of a portion of an assembly device according to another form of the present technology is shown. Detailed Implementation

[0174] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and the specific examples described herein may vary. It should also be understood that the terminology used in this invention is only for describing the specific examples discussed herein and is not intended to be limiting.

[0175] The following description relates to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Furthermore, any single feature or combination of features from any of the examples may constitute another example.

[0176] 4.1 Therapy

[0177] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.

[0178] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0179] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0180] 4.2 Respiratory Therapy System

[0181] In some forms, such as Figure 1 As shown, this technology includes a respiratory therapy system 2000 for treating respiratory disorders. The respiratory therapy system 2000 may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0182] exist Figure 1 In the illustrated embodiment, the RPT device 4000 is portable and can be carried by the patient 1000, for example, attached to the patient's clothing. In an alternative embodiment of this technology (not shown in the figures), the RPT device is configured to rest on a nearby surface, such as a bedside table, during use.

[0183] In addition, the respiratory therapy system 2000 may include a humidifier to change the absolute humidity of the air or gas delivered to the patient relative to ambient air. Typically, the humidifier is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0184] 4.3 Patient Interface

[0185] According to certain aspects of this technology, such as Figures 3 to 12B The patient interface 3000 shown includes at least some of the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, and an air vent 3400.

[0186] In some forms, functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged to surround the inlet of the patient's airway in order to maintain positive pressure at the inlet of the patient's airway 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0187] The air chamber 3200 can be formed by one or more modular components (e.g., pad module 3150 together with sealing forming structure 3100), and in this sense, it or they can be replaced by different components, such as components of different sizes and / or shapes.

[0188] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0189] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure higher than that of the environment, for example at least 2, 4, 6, 10 or 20 cmH2O relative to the environment.

[0190] 4.3.1 Sealing Formation Structure

[0191] In one form of this technology, the patient interface 3000 includes a sealing structure 3100 configured to form a seal with a region of the patient's face. The sealing structure 3100 is thus configured to secure an air chamber 3200 in a sealing engagement with respect to the patient's face. The sealing structure 3100 may form an opening to allow a flow of breathable gas to be delivered to an inlet at least the patient's nostrils.

[0192] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the location of the patient interface on the face and the shape of the patient's face.

[0193] In some forms of this technology, the seal-forming structure 3100 is configured such that the shape of the target seal-forming area substantially matches or resembles the shape of the area of ​​the patient's face to which the seal-forming structure 3100 is attached in use, and / or is constructed to be flexible enough to deform to do so. This facilitates a greater degree of seal on the patient's face and, in the case of a seal-forming structure adhered to the patient's face, avoids the adhesive surface 3102 pulling on the underlying skin when the patient interface 3000 is used.

[0194] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0195] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicone or thermoplastic elastomer (TPE).

[0196] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 that is suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0197] Further details of certain forms of sealing structures according to the present technology are described below. Other aspects of the sealing structures according to the present technology are described in more detail in PCT Publication WO2023 / 015340, the contents of which are incorporated herein by reference.

[0198] 4.3.1.1 Sealing Mechanism

[0199] 4.3.1.1.1 Adhesives

[0200] Some forms of the seal-forming structure 3100 of this technology are configured to adhere to one or more areas of a patient's face by providing an adhesive on the adhesive surface 3102 of the seal-forming structure 3100, so as to form a seal with the area of ​​the patient's face surrounding the entrance to one or more patient airways. For example, Figures 3 to 12B The sealing structures 3100 in the middle are all configured to seal the nasal airway around the patient 1000.

[0201] The adhesive-based attachment of the seal-forming structure 3100 to the patient's face allows for a highly airtight seal. This high-quality seal improves the effectiveness of positive pressure ventilation therapy (PPV) because the desired pressure can be maintained within the patient interface. Furthermore, the high-quality seal reduces the total power required by the RPT device 4000 to maintain the pressure of the breathable gas within the patient interface 3000. When the seal-forming structure 3100 is adhered to the patient's face, an additional positioning and stabilization structure, such as a head covering, is not required.

[0202] 4.3.1.1.2 Other sealing mechanisms

[0203] In this configuration, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on its underside within the inflation chamber 3200, thereby promoting a tight seal with the face. The pressure-assisted mechanism can function in conjunction with elastic tension in the positioning and stabilizing structure.

[0204] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the boundary edge of the sealing flange and the inflation chamber 3200 and extends over at least a portion of the path around the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange during use and prevent it from buckling.

[0205] In one embodiment, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure 3300.

[0206] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0207] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0208] 4.3.1.2 Sealed area on the patient's face

[0209] In some forms of this technology, the sealing structure 3100 forms a seal with an area of ​​the patient's face surrounding the entrance to the patient's nostrils during use. In some forms, the sealing structure 3100 forms a seal around the entrance to the patient's nasal airway (i.e., one or both nostrils) but not around the patient's mouth.

[0210] exist Figures 3 to 12B In an exemplary form of the technology shown, the sealing structure 3100 can be configured to seal the upper part of the patient's lips. The patient interface 3000 can leave the patient's mouth uncovered. The patient interface 3000 can deliver air or a supply of breathable gas to both nostrils of the patient 1000 without delivering it to the mouth. This type of patient interface can be identified as a nasal mask only.

[0211] One form of the nasal mask according to this technology is conventionally recognized as a nasal mask, having a sealing formation structure 3100 configured to surround the nose on the patient's face and seal above the bridge of the nose. The nasal mask is typically triangular in shape. In one form, the non-invasive patient interface 3000 includes the sealing formation structure 3100, which, in use, forms a seal against the upper lip region (e.g., the supralipal region), against at least a portion of the nasal ridge above the patient's bridge or nasal protuberance, and against each lateral surface of the patient's face, such as near the nasolabial folds. This type of patient interface 3000 can deliver an air or breathable gas supply to both nostrils of a patient 1000 through a single orifice.

[0212] Another form of nose mask can seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose pad" mask, and the sealing forming structure 3100 can be identified as a "nose pad". In one form, for example, as... Figures 3 to 12BAs shown, the sealing structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils during use. The sealing structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing the patient's nasal ala. The sealing structure 3100 can seal the upper part of the patient's lips. The shape of the sealing structure 3100 can be configured to match or closely fit the lower side of the patient's nose and may not contact the nasal bridge region of the patient's nose or any portion of the patient's nose above the nasal protuberance. In one form of nasal pad, the sealing structure 3100 includes a bridge portion that divides the opening into two orifices, each orifice supplying air or breathable gas to a corresponding patient nostril during use. The bridge portion can be configured to contact or abut against the patient's columella during use for a seal. Alternatively, the sealing structure 3100 may include a single opening to provide air or breathable gas flow to both of the patient's nostrils.

[0213] A more detailed description will now be given of the area of ​​the patient's face sealed by the sealing-forming structure 3100 during use, in certain forms of this technology where the sealing-forming structure is configured to adhere to the patient's face during use.

[0214] exist Figure 3 In the illustrated embodiment, the sealing structure 3100 is configured to adhere to an area of ​​the patient's face immediately surrounding the nostrils. These areas may include (see [reference]). Figure 2F The nasal flap region 3141 (i.e., the region adjacent to the nostril and which may generally face downwards); the uppermost region of the supralipal region 3142, which may include the subnasal point and / or the region immediately below the subnasal point; and the anterior region of the nose, which is below, for example, immediately below, the nasal protuberance 3143. In the lateral direction, the sealing structure 3100 extends slightly below the alar ridge region 3144, for example, the region immediately adjacent to the middle of the junction between the alar ridge and the nasolabial groove. In the illustrated technical form, the sealing structure 3100 does not adhere to a significant portion of the lateral region of the alar, although in some forms, or for some faces, it may adhere to the lower region of the lateral region of the alar. Furthermore, Figure 3 The sealing structure 3100 does not adhere to the nasal protrusion.

[0215] exist Figure 3 In the illustrated embodiment, the area on the patient's face to which the sealing structure 3100 adheres is a band that completely surrounds the patient's two nostrils. The width of the band can be approximately constant around its perimeter.

[0216] It has been found that when patient 1000 changes their position, by Figure 3The sealing-forming structure 3100 of the illustrated form covers a facial area that does not substantially alter its shape because, compared to the cheek or chin area, this facial area primarily comprises cartilage and bone and has relatively little adipose tissue. This facial area typically also lacks facial hair or has very little facial hair (e.g., some facial hair may be present on the uppermost region of the upper lip 3142). The sealing-forming structure 3100 adhered to this area may be particularly advantageous for patients 1000 with upper lip hair.

[0217] It was also found that, by Figure 3 The area of ​​the face covered by the sealing structure 3100 of the technical form shown has relatively small variations in shape among patients in a representative population sample (including various types of patients).

[0218] In addition, this area (which may be called the wing region) is relatively small because it surrounds the nostrils directly.

[0219] In another exemplary form, such as Figure 4A and Figure 4B As shown, the sealing structure 3100 is configured to adhere to a facial region, which is larger than... Figure 3 The area shown extends further upwards and includes the lateral region of the alar. In some forms, the sealing structure 3100 is configured to adhere to the lateral region of the alar and may also extend radially outwards sufficiently to adhere in use to a cheek region adjacent to the alar ridge, such as the region between the alar and the nasolabial fold. The sealing structure 3100 may also adhere to... Figure 3 The sealing structure adheres to the area of ​​the face. With Figure 3 Compared to the sealing structure, Figure 4A and Figure 4B The larger adhesion area of ​​the sealing structure can increase the amount of adhesion and result in less leakage, but may cause more discomfort to the patient.

[0220] In another exemplary form, such as Figure 5 As shown, the sealing structure 3100 is configured to adhere to the patient's face more than Figure 3 , Figure 4A and Figure 4BThe sealing structure adheres to a larger area. In this form, the sealing structure adheres to an area extending upwards to the wing fold region; that is, when the sealing structure adheres to the patient's face, the uppermost portion of the sealing structure adheres to the patient's wing fold. This form of sealing structure 3100 may additionally or alternatively adhere to the main portion of the upper lip. Furthermore, this form of sealing structure 3100 may additionally or alternatively adhere to the nasal protuberance region, which may include a point directly above the nasal protuberance. In the lateral direction, this form of sealing structure 3100 adheres to the area of ​​the patient's cheek adjacent to the nasal ala, including the area between the nasal ala and the nasolabial fold, and the sealing structure 3100 can completely cover the nasal ala in use. The sealing structure 3100 may also adhere to... Figure 3 , Figure 4A and / or Figure 4B The sealing structure forms the area of ​​the surface to which it adheres. Alternatively, with Figure 3 , Figure 4A and / or Figure 4B Compared to some areas where the sealing structure adheres, Figure 5 The sealing structure can be configured to adhere to some areas positioned radially outward from the nostrils.

[0221] Figures 6 to 12A The technology shown is also configured to seal the area around the patient's nostrils and the area of ​​the patient's face nearby.

[0222] 4.3.1.3 Composition of the sealing structure

[0223] In some forms of this technology, the seal-forming structure 3100 is made of a material having one or more of the following properties: biocompatibility; softness; flexibility; stretchability; and optionally elasticity. In exemplary forms of this technology, the seal-forming structure 3100 is formed of silicone resin or thermoplastic elastomer (TPE). In other forms, the seal-forming structure 3100 is formed of textiles, fabrics, and / or foam materials.

[0224] In the technical form of using an adhesive to adhere the sealing structure 3100 to the patient's face, any form of adhesive can be used, and the adhesive can be applied to any suitable substrate, which may include materials such as those described above, such as silicone or TPE. For example, a rubber zinc oxide adhesive can be used. In other forms, other adhesives can be used, such as acrylic or acrylate adhesives, or silicone adhesives.

[0225] The adhesive may be provided in the form of an adhesive layer 3190 (e.g., adhesive tape), wherein the adhesive has been provided on a substrate (i.e., the tape) to form an adhesive surface 3102, which may advantageously be used as a seal-forming structure 3100 or a portion thereof, or may be readily attached to the seal-forming structure 3100. Examples of suitable tapes are 3M™ Nexcare™ tape and Leukoplast tape. In some forms, the material may include a rayon substrate on which the adhesive is applied. In one form, the seal-forming structure may be formed from, or may include, 3M™ product number 2484 (which uses a silicone adhesive, “Hi-Tack 3M Medical Silicone Adhesive”), 3M™ Medical Tape 9833 (which uses an acrylic / acrylate adhesive), or similar types of products or products having a similar structure. Multilayer tapes or products may be used to form the seal-forming structure 3100.

[0226] exist Figures 6 to 9 In the illustrated embodiment, the sealing structure 3100 may include a flange 3105 connected to the patient-facing (or rearward) side of the inflation chamber 3200. The flange 3105 may extend radially outward from an opening in the patient-facing side of the inflation chamber 3200 in all directions. The flange 3105 may be formed, for example, of silicone or TPE, and in some embodiments may be formed of the same material used to form the inflation chamber 3200; for example, the flange 3105 may be integrally formed with the inflation chamber 3200. In these embodiments, an adhesive may be applied to the patient-facing side of the flange 3105. In these embodiments, a large or primary portion of the adhesive surface 3102 of the sealing structure 3100 may be on or aligned with the patient-facing side of the flange 3105. For example, in these embodiments, the adhesive surface 3102 may not extend radially outward from the flange 3105, contrary to other embodiments described later.

[0227] In some forms, such as Figures 8 to 12A As shown, the adhesive can be carried by the patient-facing side of the flange 3105 and can be provided on one or more adhesive layers 3190. Each layer 3190 can cover the main portion of the patient-facing side of the flange 3105, such as substantially all of the patient-facing side of the flange 3105.

[0228] In some forms, such as Figure 6 , Figure 8 and Figure 9 As shown, flange 3105 can be formed as a single component, and in some forms, this single component can be integrally formed with inflation chamber 3200. In other forms, for example... Figures 10 to 12AIn the illustrated technical form, flange 3105 can be formed from an assembly of two or more components, such as a first flange region integrally connected to the inflation chamber 3200 and a second flange region formed of a different material, which can be included as part of adhesive layer 3190. In other forms, such as... Figure 11 As shown, the flange 3105 can be formed entirely from the adhesive layer 3190.

[0229] Each adhesive layer 3190 may have a hole formed therein, for example, in the central region. The size and shape of the hole may be configured to substantially match the opening in the sealing structure 3100 and the opening in the patient-facing side of the inflation chamber 3200, so as to align with these openings during assembly of the patient interface 3000 and allow a flow of breathable gas through these openings and holes to reach the patient's airway. Each adhesive layer 3190 may also have a notch 3110, as described below.

[0230] In some forms, each adhesive layer 3190 is formed of a double-sided adhesive tape, i.e., a tape with adhesive on both surfaces of the substrate. The double-sided nature of the tape can be achieved either by a tape supplied in this form by the supplier or by applying additional adhesive to the non-adhesive side of the original single-sided adhesive tape.

[0231] exist Figure 8 In the illustrated configuration, the seal-forming structure 3100 includes a single layer of double-sided adhesive tape 3190. The non-patient-facing side of this layer 3190 adheres to the patient-facing side of the flange 3105. The patient interface 3000 may include a patient-facing removable layer 3120 configured to cover the patient-facing side of the adhesive layer 3190 until the patient is ready to adhere the seal-forming structure 3100 to their face. The patient-facing removable layer 3120 can be removed from the adhesive layer 3190 before the seal-forming structure 3100 is adhered to the face. Replacement portions of the adhesive layer 3190 may be provided to the patient to replace the flange 3105 with each use of the patient interface 3000 or after several uses.

[0232] exist Figure 10 In the illustrated configuration, the sealing structure 3100 includes a single-layer, single-sided adhesive tape 3190. The sealing structure 3100 may include an adhesive material ring 3122 for adhering the inflation chamber 3200 to the sealing structure 3100. The adhesive material ring 3122 may be located on the non-patient-facing side of the layer 3190 and surrounds an opening in the sealing structure 3100 through which breathable gas is delivered to the patient during use. Similarly, a replacement portion of the adhesive layer 3190 may be provided for the patient to replace it each time the patient interface 3000 is used or after several uses.

[0233] In other forms, such as Figure 9As shown, the sealing structure 3100 includes multiple adhesive layers 3190, such as two layers formed by layers 3190a and 3190b. When the sealing structure 3100 is assembled, the non-patient-facing side of the first layer 3190a can adhere to the patient-facing side of the flange 3105, the non-patient-facing side of the second layer 3190b can adhere to the patient-facing side of the first layer 3190a, and when the patient interface 3000 is used, the patient-facing side of the second layer 3190b can adhere to the patient's face. Before assembling the sealing structure 3100, the non-patient-facing side of the first layer 3190a can be covered by a non-patient-facing removable layer 3180 to protect the adhesive before assembly, and the patient-facing side of the second layer 3190b can be covered by a patient-facing removable layer 3120 to protect the adhesive before assembly. This multi-layered assembly (e.g., layers 3180, 3190a, 3190b, and 3120) can be supplied to the inflation chamber 3200 respectively. In addition, multiple such layered components can be provided, and patients can replace the layered components for different uses of the patient interface 3000, for example, the layered components can be replaced every night or every few nights.

[0234] In some forms, the second layer 3190b may be a tape particularly suited for adhesion to a patient's skin, such as medical tape, while the first layer 3190a may be more suited for adhesion to the flange 3105. In some forms, the medical tape used as the second layer 3190b may not be double-sided, so a double-sided first layer 3190a may be used to adhere the medical tape to the inflation chamber 3200.

[0235] exist Figure 9 In the form shown, the size and shape of each adhesive layer 3190a and 3190b can be set to be similar to the size and shape of the patient-facing side of the flange 3105, such that each layer 3190 covers the main part of the patient-facing area of ​​the flange 3105, but does not extend radially outward from the edge of the flange.

[0236] In some forms, the fluid adhesive may be applied, for example, in the form of a spray, to the surface of the sealing structure 3100.

[0237] 4.3.1.4 Shape Retainer

[0238] In some forms of this technology, the patient interface 3000 may include one or more shape retainers 3170. The shape retainer may be configured to promote the retention of the shape of the sealing structure 3100 before it is made to adhere to the patient's face, for example, to a degree sufficient to prevent the sealing structure 3100 from wrinkling, folding, or sagging in a manner that would make it difficult for the patient 1000 to attach the sealing structure 3100 to their face.

[0239] One or more shape retainers 3170 may be one or more components, assemblies, or structures formed into a shape and / or made of a material to provide a predetermined level of stiffness suitable for promoting shape retention of the sealing formation 3100. In some forms, one or more shape retainers 3170 are included as part of the sealing formation 3100. In other forms, shape retainers 3170 may be attached to the sealing formation 3100 to promote shape retention of the sealing formation 3100, for example by hardening one or more areas of the sealing formation 3100.

[0240] In some forms, the inflation chamber 3200 can be formed to be more rigid than the sealing structure 3100, and the sealing structure 3100 is disposed on the inflation chamber to help maintain the shape of the sealing structure 3100. The area of ​​the sealing structure 3100 connected to the inflation chamber 3200 can maintain its shape through the relatively rigid inflation chamber 3200, and this can also help maintain the shape of other parts of the sealing structure 3100.

[0241] In other forms, for example Figures 6 to 9 As shown, the removable layer 3120 can help maintain the shape of the sealing formation 3100 before the removable layer 3120 is removed. In order to function in this way, the removable layer 3120 can be formed to be relatively rigid compared to the sealing formation 3100; for example, the removable layer 3120 can be formed from a relatively rigid material and / or shape.

[0242] Figures 10 to 12A The exemplary patient interface 3000 shown is another form of the present technology, wherein the patient interface 3000 includes at least one shape retainer 3170 configured to facilitate shape retention of the seal-forming structure 3100 before it is formed and adhered to the patient's face. In these forms, the shape retainer 3170 includes a ring extending around a major portion of the outer periphery of the seal-forming structure 3100. The shape retainer 3170 serves to provide shape retention to a radially outer region of the seal-forming structure 3100, thereby facilitating all seal-forming structures 3100 to retain their shape until the shape retainer 3170 is removed.

[0243] Figures 10 to 12AThe shape retainer 3170 may be formed of a material and / or have a shape such that the shape retainer 3170 is more rigid than the sealing formation 3100. For example, the shape retainer 3170 may be formed of a material that is thicker than the material used to form the sealing formation 3100. Alternatively or additionally, the shape retainer 3170 may be formed of a material that is harder than the material used to form the sealing formation 3100. In some exemplary forms, the shape retainer 3170 may be provided with additional rigid structures to provide additional rigidity, such as rigid ribs. The shape retainer 3170 may not be so rigid that its shape cannot be changed by the patient, such that the patient can still bend the shape retainer 3170 and the sealing formation 3100 when the patient interface 3000 is adhered to their face. In this respect, the shape retainer 3170 may be described as semi-rigid. In one example, the shape retainer 3170 may be formed of paper, such as kraft paper.

[0244] exist Figures 10 to 12A In the illustrated embodiment, the shape retainer 3170 is configured to be positioned on the non-patient-facing side of the sealing structure 3100. For example, the shape retainer 3170 may adhere to the non-patient-facing side of the sealing structure 3100. In some embodiments, an adhesive may be used to adhere the shape retainer 3170 to the sealing structure 3100. In such embodiments, the adhesive may be applied to the patient-facing side of the shape retainer 3170, or to the non-patient-facing side of the sealing structure 3100, or both. The strength of the adhesive may be relatively low to allow the shape retainer 3170 to be easily removed by the patient from the sealing structure 3100. In other embodiments, the shape retainer 3170 may be weakly held in place relative to the sealing structure 3100 by the natural adhesion between the sealing structure 3100 and the shape retainer 3170. The advantage of positioning the shape retainer 3170 on the non-patient-facing side of the sealing structure 3100 is that the patient can position the sealing structure 3100 on their face while the shape retainer 3170 is still in place. Then, once the sealing structure 3100 adheres to the face, the shape retainer 3170 can be removed, as... Figure 11 This happened in the example.

[0245] In other forms, the shape retainer 3170 may be positioned on the patient-facing side of the sealing structure 3100. These forms of retention mechanisms may be the same as or similar to the form described above where the shape retainer 3170 is positioned on the non-patient-facing side of the sealing structure 3100. The advantage of this type of form is that the same adhesive surface of the sealing structure 3100 used to adhere the sealing structure 3100 to the patient's face can be used to hold it in place before the shape retainer 3170 is removed.

[0246] exist Figures 10 to 12A In the illustrated form, the shape retainer 3170 includes a ring extending around a major portion of the outer periphery of the sealing structure 3100. In some forms, the shape retainer 3170 is positioned around the outermost radial portion of the sealing structure 3100, while in other forms, the shape retainer 3170 is positioned in the form of a ring around the outermost radial portion of the sealing structure 3100, but not necessarily at the outermost portion of the entire periphery of the sealing structure 3100.

[0247] As a ring, the shape retainer 3170 has a hole formed on the radially inner side of the ring. Furthermore, when the shape retainer 3170 is mounted to the sealing structure 3100, the area of ​​the sealing structure 3100 not facing the patient may not be covered by the shape retainer 3170; that is, a gap may exist between the proximal patient periphery of the inflation chamber 3200 and the radially inner edge of the shape retainer 3170. It has been found that this form of shape retainer may be more advantageous than a shape retainer 3170 that covers all or most of the non-patient-facing side of the sealing structure 3100, because in the latter case, the shape retainer 3170 may provide too much rigidity to the sealing structure 3100, making it difficult to apply to the face.

[0248] exist Figure 10 and Figure 12A In the exemplary embodiment shown, the patient interface 3000 may include an adhesive material ring 3122 on the non-patient-facing side for adhering the air chamber 3200 to the sealing formation 3100. The adhesive material ring 3122 may be covered by a non-patient-facing removable layer 3180 to protect the adhesive before the air chamber 3200 comes into contact with the adhesive material ring 3122. In this embodiment, an annular gap exists between the adhesive material ring 3122 and the shape retainer 3170, and due to this gap, the annular region of the non-patient-facing side of the sealing formation 3100 may not be covered by the shape retainer 3170.

[0249] The shape retainer 3170 can have a constant radial thickness around the ring, or as... Figure 10 and Figure 12AAs shown, the radial thickness of the shape retainer 3170 can vary around the ring. The radial thickness of the shape retainer 3170 can be thicker in areas where a greater amount of shape retention will benefit. For example, the outer region of the shape retainer 3170, located to the outer region of the sealing structure 3100 (from the perspective of when the sealing structure 3100 is in its proper position on the patient's face), can be radially thicker than other regions, such as the lower and upper inner regions of the shape retainer 3170. The outer regions of the sealing structure 3100 can benefit more from the shape retention shown in the illustrated form because these regions have a larger area than the lower and upper inner regions of the sealing structure 3100, and are therefore more prone to lifting or wrinkling when the patient attaches the sealing structure 3100 to their face.

[0250] 4.3.1.5 Non-patient-facing removable layers

[0251] As has been explained, in some forms of the present technology, the seal-forming structure 3100 may include a non-patient-facing removable layer 3180 to protect the non-patient-facing side of the layer from an adhesive, such as layer 3190, before the layer of the seal-forming structure is adhered to the patient-facing side of the flange 3105 or to the inflation chamber 3200. Figure 9 and Figure 12A An exemplary form of a non-patient-facing removable layer 3180 is shown. The non-patient-facing removable layer 3180 may also be referred to as a "release liner".

[0252] exist Figure 12A In this example, the non-patient-facing side of layer 3190 may carry an adhesive material ring 3122 for adhering layer 3190 to flange 3105 or inflation chamber 3200. The adhesive material ring 3122 may be covered by a non-patient-facing removable layer 3180 to protect the adhesive before the inflation chamber 3200 comes into contact with the adhesive material ring 3122. In such examples, the non-patient-facing removable layer 3180 may similarly be annular to completely cover the adhesive material ring 3122, but it may not cover other areas of the non-patient-facing side of the band 3190. That is, the non-patient-facing removable layer 3180 may have a hole formed therein. When the non-patient-facing removable layer 3180 is positioned to cover the adhesive material ring 3122, this hole may be substantially aligned with a hole in the band 3190, i.e., sealing the opening in the forming structure 3100 through which breathable gas is delivered to the patient when the patient interface 3000 is used.

[0253] 4.3.2 Inflation Chamber

[0254] In certain forms of this technology, the air chamber 3200 is configured to receive a flow of breathable gas at a therapeutic pressure for patient respiration from the air circuit 4170. The air chamber can be configured to be pressurized to a therapeutic pressure at least 6 cmH2O above ambient air pressure, and in some forms to a pressure of about 20 cmH2O or 30 cmH2O.

[0255] In one embodiment, in the area where a seal is formed during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a normal person's face. The complementary shape of the periphery of the air chamber 3200 can be configured to facilitate proper positioning of the patient interface 3000 against the patient's face during use.

[0256] Alternatively, in some forms, the air chamber 3200 may be custom-formed for an individual patient. Alternatively, the air chamber 3200 of the patient interface 3000 may be selected from a variety of possible forms of the air chamber 3200, wherein an appropriate air chamber for an individual patient is selected as best suited for them.

[0257] In use, the boundary edge of the inflation chamber 3200 is positioned very close to the adjacent surface of the face. The sealing structure 3100 provides actual contact with the face. The sealing structure 3100 can extend around the entire periphery of the inflation chamber 3200 during use.

[0258] The inflation chamber 3200 may include at least two openings. One opening, which may be formed on the patient-facing or rear-facing side of the inflation chamber 3200, allows pressurized gas to flow from the internal volume of the inflation chamber 3200 to the patient's airway through the sealing formation 3100. This opening may also allow exhaled gas from the patient to flow into the inflation chamber 3200. Another opening, which may be referred to as the inflation chamber inlet port 3202, is configured to allow breathable gas to flow into the inflation chamber 3200 from the air circuit 4170. In some forms, the inflation chamber inlet port 3202 may be located on the side of the inflation chamber 3200 opposite to the patient in use, i.e., the front side of the inflation chamber 3200. In other forms, the patient interface may include one or more inflation chamber inlet ports 3202 located on the outer surfaces (e.g., left and right sides) of the inflation chamber 3200.

[0259] In some forms, for example in Figures 6 to 11 In the illustrated configuration, the inflation chamber 3200 can be configured such that the size and shape of the opening in the patient-facing side of the inflation chamber 3200 are set to cover both nostrils of the patient when using the patient interface 3000. In these configurations, the size and shape of the opening can approximately match the area on the lower side of the patient's nose formed by the patient's nostrils and the patient's columella, and is positioned adjacent to this area during use (see [reference]). Figure 2FThe opening can be formed by the rear edge 3210 of the inflation chamber 3200, and the inflation chamber 3200 can be configured such that, in use, the edge 3210 is located near and in front of the outer edge, rear edge, and anterior edge of the patient's nostril.

[0260] The rear side of the inflation chamber 3200 can be shaped to complement the lower side of the patient's nose, allowing the inflation chamber 3200 to be positioned against the lower side of the patient's nose during use. Figures 6 to 11 In the illustrated configuration, the rear side of the inflation chamber 3200 may be formed by an edge 3210 surrounding an opening on the patient-facing side of the inflation chamber 3200. In some examples, the rear side of the inflation chamber 3200 may lie on a saddle-shaped surface, where "saddle-shaped" herein refers to a geometric surface on which lines are convex in one direction and concave in another direction orthogonal to the first direction. More specifically, the rear side of the inflation chamber 3200 may be concave in a direction relative to the lateral aspect of the patient's face, such that the patient's columella extends into the concave groove, as... Figure 11 As shown. The rear side of the inflation chamber 3200 can be convex in the anterior-posterior direction, so that the convex peak extends towards the outer edge of the patient's nostril, again as... Figure 11 As shown.

[0261] When the sealing structure 3100 is assembled with the inflation chamber 3200, the sealing structure 3100, which can be formed of a flexible material, can be deformed into a shape similar to that of the inflation chamber 3200. As shown in the figure, for example in… Figures 6 to 11 In this process, the sealing structure 3100 may have a saddle-shaped, patient-facing surface before making sealing contact with the patient's face.

[0262] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of translucent materials can reduce the obtrusiveness of the patient interface and help improve adherence to the therapy.

[0263] In some forms, the inflation chamber 3200 is made of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0264] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, textiles, foam, etc.). For example, in one example, it may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.7 MPa or lower, for example, a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0265] In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material, such as silicone or TPE.

[0266] 4.3.3 Connection between the inflation chamber and the sealing structure

[0267] The inflation chamber 3200 can be connected to the sealing structure 3100. In some forms, the inflation chamber 3200 is directly connected to the sealing structure 3100. For example, the inflation chamber 3200 can be connected to the sealing structure 3100 via a mechanical joint using an adhesive, or the inflation chamber 3200 and the sealing structure 3100 can be integrally formed. In other forms, the inflation chamber 3200 can be indirectly connected to the sealing structure 3100, for example, via another component.

[0268] 4.3.3.1 Adhesive connection

[0269] In some forms, the two parts of the patient interface 3000 can be adhered together with an adhesive. For example, in some forms, such as Figures 10 to 12A As shown, the inflatable chamber 3200 can be attached to the sealing structure 3100 using an adhesive. As described above, the adhesive on the non-patient-facing side of the sealing structure 3100 can be adhered to the patient-facing side of the inflatable chamber 3200, such as edge 3210. One or more adhesive layers 3190 can be positioned between the non-patient-facing side of the sealing structure 3100 and the inflatable chamber 3200 to adhere the two components together. Alternatively, the first flange region can be adhered to the second flange region. In some forms, one or more adhesive layers 3190 can be formed on the same component as the adhesive layer that adheres the sealing structure 3100 to the patient's face.

[0270] 4.3.4 Vent

[0271] In some forms of this technology, the patient interface 3000 includes a ventilation port 3400 configured and arranged to allow flushing of exhaled gas, such as carbon dioxide. The ventilation port 3400 can be implemented by a ventilation port structure that can be formed or provided in any one or more components of the patient interface 3000.

[0272] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The airway 3400 is configured such that the ventilation flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0273] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 5 to about 80 holes, or about 10 to about 40 holes, or about 20 to about 25 holes.

[0274] In some forms of this technology, for example, Figure 5 As shown, the vent 3400 can be located in the inflation chamber 3200.

[0275] Alternatively, the vent 3400 may be located in the air circuit 4170 that delivers a flow of breathable gas from the RPT device 4000 to the inflation chamber 3200, for example, in a portion of the air circuit 4170 located near the inflation chamber 3200.

[0276] Port 4.3.4.1

[0277] In some forms of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In some forms, this allows a clinician to supply supplemental oxygen. In one form, this allows direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0278] 4.3.4.2 Respiration - Atmospheric ventilation

[0279] In some forms of this technology, the patient interface 3000 may include a ventilation port 3400 configured to employ at least two configurations. In one configuration, which may be referred to as an open configuration, the ventilation port 3400 allows the patient to inhale and exhale through the ventilation port 3400 without significant resistance, or with a resistance level that is largely imperceptible to the patient. In another configuration, which may be referred to as a closed configuration, the ventilation port 3400 is more blocked than in the open configuration. In some forms, in the closed configuration, the ventilation port 3400 allows exhaled gas to flush from the interior of the inflation chamber 3200 into the environment while substantially maintaining the pressure within the inflation chamber relative to the environment. In other forms, in the closed configuration, the ventilation port may substantially block all gas flushing through the ventilation port, instead, exhaled gas is exhausted through a separate ventilation port structure. This ventilation port 3400 may be referred to as a “breathing-atmosphere” ventilation port (BTA ventilation port).

[0280] Whether the BTA vent is configured to be open or closed can be based on the pressure of the breathable gas supply from the RPT device 4000 to the patient interface 3000. The BTA vent can be configured to be open when no breathable gas is supplied, or when the breathable gas flow is supplied below a certain threshold, such as below a treatment pressure level like 6 cmH2O. The BTA vent can be configured to be closed when the breathable gas flow is supplied above a certain threshold, such as above a treatment pressure level like 6 cmH2O.

[0281] Further description of a patient interface system is provided in PCT application PCT / US2012 / 055148, which includes a ventilation port that can be considered to function in the manner described above as a BTA ventilation port, the contents of which are incorporated herein by reference.

[0282] In one application, a BTA vent can be used in a patient interface system, where the BTA vent is configured to be open when the patient first puts on the patient interface 3000 and when the RPT device 4000 detects that the patient is awake. In this configuration, the RPT device may not supply a breathable gas flow, or may be configured to supply a small breathable gas flow to help flush exhaled CO2 out of the inflation chamber 3200. Once the RPT device 4000 detects that the patient has fallen asleep, a breathable gas flow can be supplied at therapeutic pressure, causing the BTA vent to be in a closed configuration.

[0283] 4.3.4.2.1 Anti-suffocation valve

[0284] One form of BTA ventilation port is an anti-asphyxiation valve (AAV), which is typically used in patient interfaces covering the nose and mouth as a measure to mitigate the risk of asphyxiation. In the event of interruption of the supply of breathable gas to the airway of the inflation chamber 3200 and / or the patient 1000, the AAV ensures airway ventilation to the patient 1000. In some forms of this technology, the patient interface 3000 may include a conventional design of the AAV used as a BTA ventilation port, as described above.

[0285] 4.4 Assembly Equipment

[0286] In some forms of this technology, an assembly device 6000 is provided to assist in assembling a patient interface 3000. Specifically, the assembly device 6000 can be used to adhere two parts of the patient interface 3000 together, for example, to apply an adhesive layer 3190 to the patient interface 3000, or to adhere a sealing formation 3100 to an inflation chamber 3200. As previously mentioned, it may be necessary to assemble the patient interface 3000, or to update the adhesive on the patient interface 3000 that adheres it to the patient's face, and this can be difficult to perform efficiently. The assembly device 6000 according to this technology can help achieve this.

[0287] Figures 13 to 47 Three exemplary forms of the assembly equipment 6000 are shown. These are merely illustrative examples, and other forms of the technology may also be provided based on the description below.

[0288] 4.4.1 Assembled Components

[0289] In some forms of this technology, for example, Figures 13 to 47 As shown, the assembly device 6000 may include a first assembly component 6002 and a second assembly component 6004. Assembly components 6002 and 6004 are configured to receive individual parts of the patient interface 3000 and then come together to assemble the two parts. Using the assembly device 6000 to perform this work can make the assembly process easier, for example by helping to align the parts for proper assembly. The device 6000 can also help ensure that the assembly process is always repeatable for multiple correct assemblies.

[0290] For example, a first assembly component 6002 may be configured to receive a first portion of the patient interface 3000, and a second assembly component 6004 may be configured to receive a second portion of the patient interface 3000. It should be understood that, unless explicitly required herein, "receiving" a portion of the patient interface in an assembly component means that at least some portions of that portion are received by the corresponding assembly component. A portion of the received portion may be a small part of that portion, or it may be a considerable portion. A portion may be received by engaging with or otherwise physically associating with the corresponding assembly component.

[0291] The first and second portions of the patient interface 3000, assembled by adhering them together using assembly equipment 6000, can be any two parts or sub-assemblies of the patient interface 3000 bonded together. The second portion of the patient interface 3000 may include a first adhesive surface facing the patient and a second adhesive surface facing away from the patient. The first adhesive surface may be configured to adhere the patient interface to the patient's face, and the second adhesive surface may be configured to adhere the second portion to the first portion. In some forms, such as in… Figure 8 In the case of the assembly device 6000 shown, the first part may be a sub-assembly consisting of an inflation chamber 3200 and a sealing formation structure 3100, and the second part may be an adhesive layer 3190 having a non-patient-facing adhesive surface and a patient-facing adhesive surface. In use, when the first assembly component 6002 is engaged with the second assembly component 6004, for example when assembly components 6002 and 6004 are joined together, the adhesive layer 3190 may be applied to the sealing formation structure 3100 of the patient interface 3000. In other forms, for example in… Figure 10 In the case of the first part, the first portion may be an air chamber 3200, and the second portion may be at least a portion of the sealing structure 3100. The air chamber 3200 may be connected to, for example, integrally formed therewith, the first flange region. The sealing structure 3100 may include an adhesive material ring 3122 and / or an adhesive layer 3190. In use, when the first assembly component 6002 is engaged with the second assembly component 6004, for example, when the assembly components 6002 and 6004 are joined together, the adhesive material ring 3122 may adhere to the air chamber 3200 (e.g., adhere to the first flange region of the flange 3105). In other forms, the air chamber 3200 may include an adhesive surface on the patient-facing surface of the air chamber 3200, for example, the air chamber may include one or more adhesive layers mounted on the patient-facing surface of the air chamber 3200a to adhere the air chamber 3200 to the sealing structure 3100.

[0292] Exemplary forms of the patient interface 3000 that can be assembled using the assembly device 6000 can be any of the previously described technical forms. In particular, the assembly device 6000 can be adapted for the assembly of the patient interface 3000, such as... Figures 3 to 12BAs illustrated by way of example, the patient interface includes at least one adhesive layer 3190 on the patient-facing side of the sealing formation 3100 for adhering the assembled patient interface 3000 to the patient's face during use, and for adhering together two parts of the patient interface 3000 to assemble them. For example, the adhesive layer 3190 can be applied to the remaining parts of the patient interface 3000 by adhering the adhesive layer 3190 to another part of the patient interface 3000 (e.g., the sealing formation 3100 and / or the inflation chamber 3200). In the example, the adhesive layer 3190 may have adhesive surfaces on both sides, i.e., the patient-facing side and the non-patient-facing side. (It should be understood that the patient-facing side and the non-patient-facing side are not always facing and non-facing the patient respectively, depending on the position of the adhesive layer at any given moment. However, for convenience, these labels are used to identify the respective sides and to reference their orientation when the patient wears the patient interface 3000.) In some configurations, prior to the assembly process, a patient-facing removable layer 3120 may cover the patient-facing side of the adhesive layer 3190, and a non-patient-facing removable layer 3180 may cover the non-patient-facing side of the adhesive layer 3190.

[0293] In some forms, such as those shown, the first assembly component 6002 may include a first region 6100, and the second assembly component 6004 may include a second region 6200. The respective assembly components are configured such that, in use, when the first assembly component 6002 is engaged with the second assembly component 6004, the first region 6100 can be positioned facing the second region 6200.

[0294] 4.4.2 Receiving Area

[0295] The first region 6100 may further include a first receiving region 6110 configured to receive a first portion of the patient interface 3000 in use. That is, the first receiving region 6110 may have a structure that allows a first portion of the patient interface 3000 (e.g., the inflation chamber 3200 or a sub-assembly including at least a portion of the inflation chamber 3200 and the sealing structure 3100) to be conveniently placed near and / or held by the region 6110. In some forms, the first receiving region 6110 may include a substantially continuous surface against which a portion (e.g., a main portion) of the non-patient-facing surface of the sealing structure 3100 of the patient interface 3000 substantially abuts when the first portion is received by the first receiving region 6110. In some forms, the portion of the sealing structure 3100 adjacent to the first receiving region 6110 may be integrally connected to a first flange region of the inflation chamber 3200. A substantially continuous surface helps ensure that force is applied to a large portion of the surface of the first portion when the second portion adheres to the first portion, as described below.

[0296] Alternatively or additionally, the first receiving region 6110 may have a shape that substantially corresponds to the natural shape of the non-patient-facing side of the sealing forming structure 3100. "Natural shape" can be considered as the shape of the component without torsional forces. For example, in order to substantially correspond to... Figures 6 to 10 The shape of some examples of the sealing structure 3100 shown, wherein the sealing structure 3100 has a substantially concave non-patient-facing side, when viewed in cross-section from the side direction, as... Figure 16 , Figure 25 , Figure 36 , Figure 41 and Figure 44 The first receiving region 6110 shown may be substantially convex. When the patient interface 3000 is worn, this lateral orientation may correspond to a direction that spans the sealing structure 3100 in an inside-outside direction relative to the patient. The convex shape of the first receiving region 6110 may be configured to correspond to a recessed shape (e.g., the same shape but inverted) of the non-patient-facing side of the sealing structure 3100, such that the sealing structure 3100 may be positioned in close proximity to the first receiving region 6110. In some forms, the first receiving region 6110 may also include one or more recessed regions 6112, which may be positioned to correspond to the convex regions of the non-patient-facing side of the sealing structure 3100. In some forms, the recessed region 6112 may be positioned at opposite top and bottom regions of the first receiving region 6110, where “top” and “bottom” herein correspond to regions that are adjacent to the sealing structure 3100 when received by the first receiving region 6110, and are respectively positioned at an upper inner position and a lower inner position on the patient’s face when placed on the patient’s face. The first receiving region 6110 may also include a cavity 6124 to accommodate the inflation chamber 3200 in use, such that the inflation chamber 3200 remains substantially undeformed when the first assembly component 6002 engages with the second assembly component 6004. The cavity 6124 may be located in the central region of the first receiving region 6110 and has a shape complementary to the shape of the inflation chamber 3200. In some forms, cavity 6124 may be a through hole in the first receiving area 6110, while in other forms, cavity 6124 may be a blind hole in the first receiving area 6110.

[0297] Turning now to the second assembly component 6004, the second region 6200 may further include a second receiving region 6210, which is configured to receive a second portion of the patient interface 3000 in use, such as part of the adhesive layer 3190 and / or the sealing formation structure 3100. That is, the second receiving region 6210 has a structure that allows the second portion to be conveniently placed in the vicinity of and / or held by the region.

[0298] In some forms, the second receiving region 6210 may include a substantially continuous surface on which the main portion of the second portion (e.g., the non-patient-facing surface of the sealing forming structure 3100) substantially abuts when the first and second portions adhere together in use. A substantially continuous surface helps ensure that force is applied to a large portion of the surface of the second portion when it adheres to the first portion, as described below.

[0299] Alternatively or alternatively, the shape of the second receiving region 6210 may be substantially complementary to the shape of the first receiving region 6110; for example, the two regions may have the same but inverted contours. This allows the first and second receiving regions to be positioned in an engaging configuration relative to each other, i.e., the corresponding surfaces are in a closely abutting configuration.

[0300] In some forms, as a result of complementary shapes, the second receiving region 6210 may have a shape substantially corresponding to the natural shape of the patient-facing side of the sealing structure 3100. In some forms, the shape of the non-patient-facing side of the sealing structure 3100 is the same as or very similar to the patient-facing side of the sealing structure, but inverted. It should be noted that this shape may or may not be complementary to the natural shape of the adhesive layer 3190. In some forms, the adhesive layer 3190 may have a flat natural shape, and when the adhesive layer 3190 is pushed into contact with the sealing structure 3100, it may be twisted into a shape matching the shape of the sealing structure 3100, as described below. In other forms, the adhesive layer 3190 may have a natural shape matching the shape of the sealing structure 3100.

[0301] For example, in order to basically correspond Figures 6 to 10 The shapes of some examples of the sealing structure 3100 shown, wherein the sealing structure 3100 has a substantially convex patient-facing side, when viewed in cross-section from the same lateral direction as previously described, are as follows: Figure 16 , Figure 29 , Figure 36 and Figure 41The second receiving region 6210 shown may be substantially recessed. In some forms, the second receiving region 6210 may also include one or more protruding regions 6114, which may be positioned to correspond to the patient-facing recessed region of the sealing forming structure 3100. These protruding regions may also be positioned to correspond to the recessed region 6112 of the first receiving region 6110 as described above.

[0302] The first and second assembly components are configured such that when the first and second receiving regions are engaged, the desired alignment between the first and second portions of the patient interface 3000 is achieved. This facilitates reliable and repeatable adhesion of the first and second portions together in a predetermined position.

[0303] 4.4.3 Maintaining the structure

[0304] In some forms of this technology, the first assembly component 6002 may further include a first retaining structure 6120 to hold a first portion of the patient interface 3000 in a substantially fixed position relative to the first assembly component 6002 during use, during assembly of the patient interface 3000. Various retaining mechanisms may be used in different forms, and in some forms, the first retaining structure 6120 may include multiple retaining mechanisms. In some forms, when the first portion of the patient interface 3000 is received by the first receiving region 6110, the first retaining structure 6120 may impede or prevent lateral movement of the first portion (i.e., movement substantially parallel to the surface of the first receiving region 6110). The first retaining structure 6120 may or may not prevent the first portion of the patient interface 3000 from moving into or out of the first receiving region 6110 (i.e., in a direction perpendicular to the surface of the first receiving region 6110). In the illustrated form, the first retaining structure 6120 may include a cavity 6124 configured to receive at least a portion of the inflation chamber 3200. The size and shape of the cavity 6124 can be configured to prevent or limit lateral movement of the air chamber 3200 when it is received in the cavity.

[0305] Alternatively or alternatively, for example in Figures 13 to 35 In some forms, the first retaining structure 6120 may include one or more wall segments positioned around the periphery of the sealing structure 3100 when the sealing structure 3100 is received in the first receiving region 6110. In some forms, the first receiving region 6110 may include a recess 6122 in which the sealing structure 3100 is received, and the walls surrounding the recess 6122 may serve to substantially prevent or limit lateral movement of the sealing structure 3100.

[0306] In other forms, for example in Figures 36 to 44 In some forms, the first retaining structure 6120 may include one or more wall sections positioned around the periphery of a first flange region of the flange 3105 when the inflation chamber 3200 is received in the first receiving region 6110. In some forms, the first receiving region 6110 may include a recess 6122 in which the flange 3105 is received, and the wall surrounding the recess 6122 may serve to substantially prevent or limit lateral movement of the inflation chamber 3200 during use.

[0307] In other forms of this technology, the first retaining structure 6120 may include one or more clips for engaging with a first portion of the patient interface 3000.

[0308] In some forms of this technology, the second assembly component 6004 may further include a second retaining structure 6220 to hold a second portion of the patient interface 3000 (e.g., adhesive layer 3190 and / or seal-forming structure 3100) in a substantially fixed position relative to the second assembly component 6004 during use, during assembly of the patient interface 3000. In some forms, the second retaining structure 6220 may include one or more slots to receive corresponding portions of the second portion, such as adhesive layer 3190, a removable layer attached to adhesive layer 3190, seal-forming structure 3100, or a removable layer 3120 attached to seal-forming structure 3100. For example, in Figures 25 to 35 and Figures 36 to 41 In an exemplary form, the second assembly component 6004 includes a first slot 6222 configured to receive a first tab 3194 (e.g., attached to the adhesive layer 3190) of a patient-facing removable layer 3120. Figure 12B (As shown). The second retaining structure 6220 may also include a second slot 6224 configured to receive a second tab 3196 of the patient-facing removable layer 3120 attached to the adhesive layer 3190 (also shown). Figure 12B (As shown in the diagram). The first slot 6222 and the second slot 6224 can be positioned substantially opposite to each other, i.e., such that the adhesive layer 3190 can be positioned between the slots. This arrangement can achieve particular stability in holding the adhesive layer 3190 in place during use.

[0309] In some forms, one or both of the first assembly component 6002 and the second assembly component 6004 may include a portion of a fastening mechanism to hold them in a fixed position relative to each other. For example, the first assembly component 6002 may also include a first fastening member 6130, and the second assembly component 6004 may also include a second fastening member 6230. When the first assembly component 6002 and the second assembly component 6004 engage with each other, for example, when the first receiving region 6110 and the second receiving region 6210 are in an engaged configuration, they can be fastened together. Alternatively, they can be fastened together when the first receiving region 6110 and the second receiving region 6210 are engaged, but in a configuration in which a gap exists separating the first receiving region 6110 and the second receiving region 6210, as described further below.

[0310] 4.4.4 Assembly Method

[0311] The assembly device 6000 can now be used to assemble the patient interface 3000 in certain forms of this technology.

[0312] Initially, the first and second parts of the patient interface 3000 could be separated from each other. For example... Figure 12B As illustrated by way of example, adhesive layer 3190 may be disposed on one or more back layers. For example, patient-facing removable layer 3120 and / or non-patient-facing removable layer 3180 may cover the adhesive surface of adhesive layer 3120.

[0313] The first portion of the patient interface 3000 can be received by the first receiving area 6110 of the first assembly component 6002. For example, as in... Figures 13 to 47 In the illustrated configuration, the first assembly component 6002 can be positioned such that the first receiving area 6110 faces upward, and the first portion of the patient interface 3000 can be placed on the first receiving area 6110. The first portion of the patient interface 3000 can also be held by the first holding structure 6120.

[0314] Furthermore, the second portion of the patient interface 3000 can be received by the second receiving area 6210 of the second assembly component 6004. For example, as in Figures 13 to 47 In the illustrated technical configuration, the second assembly component 6004 can be positioned such that the second receiving region 6210 is substantially facing upwards, and the second portion can be placed on the second receiving region 6210. The second portion can also be held by the second retaining structure 6220. If a non-patient-facing removable layer 3180 exists on the non-patient-facing side of the second portion, that layer can be removed.

[0315] The first assembly component 6002 and the second assembly component 6004 can then be engaged. For example, the two components can be joined together. In some forms, joining the two components together can include a direct physical engagement between the parts of the components, such as interlocking of connecting portions. In other forms, joining the two components together can include bringing the two parts of the components close together, such as substantially adjacent. When engaging the first assembly component 6002 and the second assembly component 6004, the first receiving region 6110 and the second receiving region 6210 are positioned adjacent to each other. In some forms, when in an engaged configuration, the first receiving region 6110 and the second receiving region 6210 can be in an engaged configuration. As will be described in more detail below, in some exemplary forms, the first receiving region 6110 and the second receiving region 6210 can face each other and be separated by a gap. This configuration can be a stable configuration, i.e., the assembly device 6000 can be configured such that the first assembly component 6002 and the second assembly component 6004 can be held in the relative position where the gap exists without applying a holding force to the assembly device 6000.

[0316] The engagement of the first receiving region 6110 and the second receiving region 6210 can cause the second portion to contact the first portion of the patient interface 3000. In some forms, this contact configuration can occur after the first assembly component 6002 and the second assembly component 6004 have been brought together. In the contact configuration, at least a portion of the first and second portions (e.g., the sealing forming structure 3100 and the adhesive layer 3190) is located between the first receiving region 6110 and the second receiving region 6210. Contact between the adhesive surfaces of the first and second portions, such as contact between the non-patient-facing surface of the adhesive layer 3190 and the patient-facing side of the sealing forming structure 3100, or contact between the adhesive layer 3190a or 3122 and the first flange region of the flange 3105, can cause the first and second portions to adhere together.

[0317] To achieve and / or enhance adhesion, it may be beneficial or necessary for the user to apply additional force to force the two assembled parts together.

[0318] After the first and second parts are glued together to form the assembled patient interface 3000, the first assembly component 6002 and the second assembly component 6004 can be separated. For example... Figure 35As shown, due to the second retaining structure 6220, such as the first tab 3194 and the second tab 3196, the assembled patient interface 3000 can remain attached to the second assembly component 6004, continuing to secure the sealing forming structure 3100, or adhesive layer 3190 or a removable layer attached thereto, and thus the remainder of the assembled patient interface adhered to the sealing forming structure 3100 and / or adhesive layer 3190, to the second assembly component 6004. The patient 1000 can then disengage the assembled patient interface 3000 from the second retaining structure 6220, for example, by sliding the first tab 3194 and the second tab 3196 out of the first slot 6222 and the second slot 6224, respectively. In other forms, such as without the second retaining structure 6220, the assembled patient interface 3000 can remain on the first assembly component 6002 when the first assembly component 6002 is separated from the second assembly component 6004.

[0319] The patient interface 3000 can then be mounted on the patient's face by adhering the patient-facing side of the sealing structure 3100 to the patient's face. If the patient-facing removable layer 3120 covers the patient-facing side of the adhesive layer 3190 or 3190b, it is removed to expose the adhesive surface of the adhesive layer for adhesion to the patient's face.

[0320] 4.4.5 Further description of exemplary forms of assembly equipment

[0321] Figures 13 to 24 A first exemplary form of the assembly equipment 6000 is shown. Figures 25 to 35 A second exemplary form of the assembly equipment 6000 is shown. Figures 36 to 40 A third exemplary form of the assembly equipment 6000 is shown. Figures 41 to 47 Another exemplary form of the assembly equipment 6000 is shown. Many features and functions of these forms have been described. Further details regarding the arrangement, configuration, and operation of the first, second, and third forms of the assembly equipment 6000 are given below.

[0322] 4.4.5.1 First exemplary form of assembly equipment

[0323] In a first exemplary form, the assembly device 6000 includes a two-part first assembly component 6002, wherein the first assembly component 6002 includes an inner component 6008 and an outer component 6006. The inner and outer components can be configured to move relative to each other, and in doing so, a first receiving region 6110 can be positioned adjacent to a second receiving region 6210 to apply an adhesive layer 3190 to the sealing formation structure 3100.

[0324] In an exemplary form, as shown in the figures, the outer member 6006 may take the form of a sleeve positioned around the outer periphery of the inner member 6008. The upper end of the sleeve may be open, such that the upper surface of the inner member 6008 is not covered by the outer member 6006. A first region 6100 of the first assembly member 6002 may be located on the upper surface of the inner member 6008, as shown. The first region 6100 includes a first receiving region 6110, and the inner member 6008 may therefore include the first receiving region 6110. In this form of assembly device 6000, the first retaining structure 6120 includes a recess 6122 in addition to the cavity 6124. The sealing forming structure 3100 is configured to be substantially located within the recess 6122. Therefore, the first receiving region 6110 can be considered as the surface of the inner member 6008 substantially within the recess 6122.

[0325] The inner member 6008 and the outer member 6006 can move relative to each other with a sliding motion, for example, moving along the axis of the sleeve when the outer member 6006 is in the form of a sleeve. During this relative movement, the upper surface of the inner member 6008 can remain uncovered by the outer member 6006. To achieve this, the outer member 6006 can be configured to fit snugly around the inner member 6008 to allow relative movement between the two components. In some forms, one of the inner or outer member may include one or more recesses, and the other may include one or more protrusions, which, along with the recesses, are configured to allow the protrusions to engage with and slide along the recesses.

[0326] In a stable configuration of the first assembly component 6002, i.e., a configuration that can be maintained without the application of force, the upper surface of the inner component 6008 can be recessed from the upper end of the outer component 6006.

[0327] The first assembly component 6002 may include a resilient member 6010 configured to return the outer component 6006 and the inner component 6008 to their original configuration. In some forms, the original configuration may be the stable configuration described above. The resilient member 6010 may take the form of any one or more resilient members configured to act between the outer component 6006 and the inner component 6008. Figure 14 , Figure 17 , Figures 18 to 20 and Figures 21 to 24As shown, in the illustrated form, the elastic member 6010 is an elastic band, a portion of which is attached to the inner member 6008, and another portion surrounds the guide member 6300 of the outer member 6006. The point at which the elastic member 6010 is attached to the inner member 6008 can be substantially at the same height as the guide member 6300 from the bottom edge 6502 of the inner member 6008. This ensures that the elastic member 6010 has minimal tension when the inner member 6008 and the outer member 6006 are in their original stable configuration with the upper surface of the inner member recessed from the upper end of the outer member. When the outer member 6006 is pushed toward the bottom edge 6502 of the inner member 6008, the elastic member 6010 stretches as the guide member 6300 moves away from the point where the elastic member 6010 is attached to the inner member 6008. The stretched elastic member 6010 has tension that causes the outer member 6006 to spring back to its initial position. In some forms, the first assembly component 6002 may be configured such that the elastic member 6010 is under tension when the inner and outer components are in their original stable configuration. This ensures that when no force is applied to move the inner and outer components relative to each other, they return entirely to their original configuration. The inner component 6006 and the outer component 6008 may include one or more stops to prevent the inner component from moving relative to the outer component beyond its original configuration.

[0328] In this exemplary form of the present technology, the first assembly member 6002 is hingedly attached to the second assembly member 6004; that is, the assembly device 6000 may include a hinge 6030 connecting the second assembly member 6004 to the first assembly member 6002. More specifically, the second assembly member 6004 may be connected to the outer member 6006 via the hinge. In a closed configuration, the second assembly member 6004 may abut against the upper end of the outer member 6006 and may substantially cover the upper end of the sleeve-shaped outer member 6006. Therefore, in this form, the second assembly member 6004 can be considered as a cover for the first assembly member 6002.

[0329] Assembly equipment 6000 may include a fastening mechanism to hold the second assembly component 6004 in a closed configuration. In the illustrated form, the second assembly component 6004 includes a second fastening member 6230, which, in the closed configuration, can be secured to a first fastening member 6130 disposed on an external component 6006.

[0330] Figures 16 to 18The configuration of the assembly device 6000 is shown, wherein the second assembly component 6004 is in an open position relative to the outer component 6006 (i.e., the cover is open), thereby providing access to the first receiving area 6110 and the second receiving area 6210. A first portion of the patient interface 3000 may be disposed to the first receiving area 6110 of the inner component 6008. In one example, the first portion may be in the form of a sub-component including an inflation chamber 3200 and a sealing formation 3100, such as Figure 6 , Figure 8 and Figure 9 As shown, the sealing structure 3100 can be substantially located within the recess 6122, and the inflation chamber 3200 can be substantially located within the cavity 6124. That is, the recess 6122 can be large enough to receive all the sealing structures 3100. In the form without the recess 6122, the first receiving area 6110 can be large enough to receive all the sealing structures 3100. Furthermore, the second portion can be in the form of an adhesive layer 3190, which can be disposed on the second assembly component 6004, for example by inserting a first tab 3194 through the first slot 6222 and a second tab 3196 through the second slot 6224. In another example, the first portion can be in the form of an inflation chamber 3200 including a first flange region, such as Figure 10 and Figure 12A As shown, the inflation chamber 3200 can be substantially located within the cavity 6124. In this example, the second part can be in the form of a sealing structure 3100, which includes a plurality of adhesive layers 3190a and 3190b.

[0331] Figures 19 to 21 A closed configuration of the assembly device 6000 is shown. In this configuration, the second assembly component 6004 and the outer component 6006 are closed together (i.e., the cover is closed) by rotating the second assembly component 6004 toward the outer component 6006 about the hinge 6030. Furthermore, as previously described, the second assembly component 6004 is secured in the closed position relative to the outer component 6006 by engaging the first fastening member 6130 and the second fastening member 6230.

[0332] In this closed configuration, and when the inner and outer components are in their original stable configuration, the first receiving region 6110 and the second receiving region 6210 are positioned facing each other and separated by a gap. This gap is caused by the indentation of the upper surface of the inner component 6008 relative to the upper end of the outer component 6006. This means that in this configuration, the patient-facing side (second surface) of the sealing structure 3100 and the non-patient-facing side 3126 of the adhesive layer 3190 face each other, with a gap between the sealing structure 3100 and the adhesive layer 3190.

[0333] Figures 22 to 24 An assembly configuration of the assembly device 6000 is shown. In this configuration, the outer member 6006, together with the second assembly component 6004 located on the upper end of the outer member 6006, is pushed downward. This causes the second assembly component 6004 and the outer member 6006 to move downward relative to the inner member 6008, and causes the second receiving area 6210 to move into engagement with the first receiving area 6110. This eliminates the gap between the sealing forming structure 3100 and the non-patient-facing side 3126 of the adhesive layer 3190, and causes the adhesive layer to be secured to the sealing forming structure 3100 of the patient interface 3000, thereby forming the assembled patient interface 3000, as described above. When the downward force is released from the top of the second assembly component 6000, the elastic member 6010 causes the assembly device 6000 to return to its stable configuration. The cover can then be opened, and the assembled patient interface 3000 can be retrieved for use.

[0334] 4.4.5.2 A second exemplary form of assembly equipment

[0335] In a second exemplary form of the assembly equipment 6000, such as Figures 25 to 35 As shown, the first assembly component 6002 and the second assembly component 6004 can be separate components. In use, they can be joined together to apply the adhesive layer 3190 to the sealing formation structure 3100 of the patient interface 3000.

[0336] In some forms, the first region 6100 of the first assembly component 6002 includes a first receiving region 6110. The shape of the first receiving region 6110 may be as previously described, and it may include a cavity 6124 for receiving the first portion, such as at least a portion of an inflation chamber 3200 in use. In use, a second portion (e.g., a sealing formation 3100) is configured to be placed on the first receiving region 6110, such as... Figure 27 As shown.

[0337] The first assembly component 6002 may further include a first fastening member 6130 configured to fasten the first assembly component and the second assembly component together. The first fastening member 6130 may include one or more protruding members or one or more recessed members, each protruding or recessed member configured to mate with a corresponding member on the second assembly component 6004. In the illustrated example, the first fastening member 6130 includes two protrusions at the diagonally distal end of the first region 6100.

[0338] In some forms, the second region 6200 of the second component 6004 includes a second receiving region 6210. As already described, the second receiving region 6210 of the second assembly component 6004 may have a shape substantially complementary to the shape of the first receiving region 6110, such that the two regions can be joined together, for example, in an interlocking configuration, with the sealing forming structure 3100 and the adhesive layer 3190 sandwiched between the first receiving region 6110 and the second receiving region 6210. This allows the shape of the sealing forming structure 3100 to be maintained when a compressive force is applied to the sealing forming structure 3100 to adhere the adhesive layer 3190 thereto. The shape of the inflation chamber 3200 may also remain unchanged when the inflation chamber 3200 is received in the cavity 6124, and when the first assembly component 6002 and the second assembly component 6004 are joined together to form the assembled patient interface 3000.

[0339] The second assembly component 6004 may further include a second fastening member 6230 configured to fasten the first and second assembly components together. The second fastening member 6230 may include one or more protruding members or one or more recessed members, each protruding or recessed member configured to mate with a corresponding member on the first assembly component 6002. In the illustrated example, for example... Figure 28 As shown, the second fastening member 6230 includes two holes at the diagonally distal end of the second assembly member 6004. The second fastening member 6230 is configured to receive the first fastening member 6130 in use to maintain engagement between the first assembly member 6002 and the second assembly member 6004. Fastening members 6130 and 6230 also facilitate alignment between the first and second assembly members.

[0340] like Figure 30 As shown, in use, the second assembly component 6004 receives a second portion, such as adhesive layer 3190, or a patient-facing removable layer attached to adhesive layer 3190, which can be held by a second retaining structure 6220, such as a first tab 3194 and a second tab 3196 that can be inserted into a first slot 6222 and a second slot 6224 of the second assembly component 6004, respectively. The non-patient-facing side 3126 of adhesive layer 3190 is configured to face away from the second region 6200, such that when the first receiving region 6110 and the second receiving region 6210 are arranged to face each other, the patient-facing side (second surface) facing side 3126 of the sealing forming structure 3100 is sealed.

[0341] When the first fastening member 6130 is received by the second fastening member 6230 and the first assembly member 6002 presses against the second assembly member 6004, the first assembly member 6002 engages with the second assembly member 6004. This causes the first and second parts to adhere together, thereby forming the assembled patient interface 3000.

[0342] The second assembly component 6004 may include one or more snap-fit ​​members 6232, which may be configured to attach to a portion (such as a notch) of the first assembly component 6002 to maintain engagement between the first assembly component 6002 and the second assembly component 6004. The snap-fit ​​members may be located on a side edge 6242 of the second assembly component 6004. The snap-fit ​​members 6232 may be configured to attach to a corresponding member on the first assembly component 6002, which may be positioned at a corresponding location on its side edge 6142.

[0343] 4.4.5.3 Third exemplary form of assembly equipment

[0344] In a third exemplary embodiment, the assembly device 6000 includes a first assembly component 6002, a second assembly component 6004, and one or more resilient members 6010. The first assembly component 6002 may include an inner member 6008 and an outer member 6006. The first assembly component 6002 may be hingedly attached to the second assembly component 6004. For example, as illustrated in the present art, the outer member 6006 of the first assembly component 6002 may be hingedly attached to the second assembly component 6004. For example, the hinge 6030 attaching the outer member 6006 and the second assembly component 6004 may be a movable hinge, thus the outer member 6006 and the second assembly component 6004 may be formed together as a single component, such as... Figure 39 As shown. In other forms, the outer component 6006 of the first assembly component 6002 and the second assembly component 6004 may be separate components connected by hinges.

[0345] The second assembly component 6004 can rotate about a hinge toward the first assembly component 6002 to change the assembly device 6000 from an open configuration to a closed configuration. As in the first exemplary form, the second assembly component 6004 can be considered as a cover for the first assembly component 6002.

[0346] The first assembly component 6002 may include one or more first alignment structures 6232A, 6233A, 6234A, which may engage with one or more second alignment structures 6232, 6233, 6234, which are included as part of the second assembly component 6004 to align the second assembly component 6004 with the first assembly component 6002 in a closed configuration. Figure 36-40 In the illustrated form, each of the first alignment structures includes one or more protrusions, and the second alignment structure includes one or more openings, each configured to receive one of the protrusions of the first alignment structure. The alignment structures can engage with each other by snap-fit, friction fit, or other suitable engagement method. In an alternative form of the present technology, each of the second alignment structures may include one or more protrusions, and the first alignment structure may include one or more openings, each configured to receive one of the protrusions of the second alignment structure. In use, the alignment structures can facilitate alignment between the first and second assembly components, which helps ensure that the first and second portions of the patient interface 3000 adhere together in the desired manner. The alignment structures can also, or alternatively, serve to fasten the first assembly component 6002 to the second assembly component 6004 (and thus can alternatively be referred to as fastening structures).

[0347] The inner component 6008 and the outer component 6006 of the first assembly component 6002 can be configured to move relative to each other. Figures 36 to 40 In the illustrated embodiment, the inner member 6008 includes a post 6038 extending upward from the base 6502. The outer member 6006 may include an aperture 6036, and the aperture 6036 may be configured to receive at least a portion of the post 6038, i.e., the post 6038 may engage within the aperture 6036. The inner member 6008 and the outer member 6006 may move relative to each other, for example, sliding along the longitudinal axis of the aperture 6036 (which may also correspond to the longitudinal axis of the post 6038) when the outer member 6006 includes the aperture 6036. During this relative movement, the upper surface of the inner member 6008 may remain uncovered by the outer member 6006. To achieve this, the aperture 6036 of the outer member 6006 may be configured to fit tightly around the post 6038 of the inner member 6008.

[0348] In some forms, one of the internal or external components may include one or more recesses, and the other may include one or more protrusions, which are configured to engage with each other and allow sliding movement of the internal component 6008 relative to the external component 6006. In the illustrated form of the present technology, the external component 6006 may include a wall 6310 that may extend substantially downward from the edge of the aperture 6036 in a direction away from the upper surface of the external component and extend toward the internal component 6008 when the components are assembled. The wall 6310 may extend about a portion or all of the circumference of the aperture 6036. The wall 6310 may include one or more first guide members 6304 on an inwardly facing surface. The post 6038 may include one or more second guide members 6306 on a side-outwardly facing wall. Each of the one or more first guide members 6304 may be configured to engage with each of the one or more second guide members 6306 to facilitate sliding movement of the internal component 6008 substantially sliding relative to the external component 6006 during use. In the illustrated embodiment of this technology, there are four first guide members 6304 that can engage with four second guide members 6306 during use. Alternatively, other numbers of first guide members 6304 may engage with corresponding numbers of second guide members 6306.

[0349] The first assembly component 6002 may include a first region 6100, which may further include a first receiving region 6110 and / or a first retaining structure 6120. The first receiving region 6110 may be at least partially formed substantially on the upper surface of the internal component 6008. For example, the first receiving region 6110 may include the upper surface of a pillar 6038. The first receiving region 6110 may include a recess 6122 and / or a cavity 6124. Figures 36 to 40 In the exemplary technical form shown, a cavity 6124 is formed on the upper surface of the column 6038.

[0350] In some forms, the first region 6100 may also include the upper surface of the outer member 6006. In a stable configuration of the inner and outer members, the upper surface of the column 6038 of the inner member 6008 may be recessed from the upper surface of the outer member 6006 to form a recess 6122 as previously described, the edge of which is formed by the upper portion of the wall 6310.

[0351] The internal and external components can be configured such that the recess 6122 can receive at least a portion of the flange 3105 in use. The cavity 6124 can be configured to receive at least a portion of the inflation chamber 3200 in use. For example, when the inflation chamber 3200, including the flange 3105, is positioned in the first receiving region 6110, the flange 3105 can be substantially flush with the remainder of the first region 6100 (which can be substantially provided by the external component 6006). The advantage of this configuration is that the flange 3105 and / or the inflation chamber 3200 can be protected from deformation forces when the first assembly component 6002 and the second assembly component 6004 are engaged together to form the assembled patient interface 3000.

[0352] Alternatively, the upper surface of the column 6038 of the inner member 6008 may be configured to be substantially aligned with the upper surface of the outer member 6006 in use, in a stable (open or closed) configuration, to form a first region 6100, which includes a first receiving region 6110 and a first holding region 6120.

[0353] The first region 6100 may also include an indicator 6126 to indicate the location of the inflation chamber 3200 in use. In the example shown, the indicator 6126 is located on the upper surface of the outer member 6006 on either side of the first receiving region 6110.

[0354] The second assembly component 6004 may include a second region 6200, which may further include a second receiving region 6210 and / or a first slot 6222 and a second slot 6224. A sealing structure 3100 including adhesive layers 3190b, 3190a (or 3122) may be received by the second receiving region 6210 during use. A removable layer 3120 of the sealing structure 3100 (configured to cover the patient-facing side of the adhesive layer 3190a) may include a first tab 3194 and a second tab 3196, which may be received by the first slot 6222 and the second slot 6224, respectively, during use. Indicators 6226 and 6228 may indicate to the user the position where the tabs are inserted during use. For example, indicators 6226 and 6228 may be located on the surface of the second region 6200.

[0355] The orientation of the sealing structure 3100 when received by the second receiving region 6210 allows the adhesive layer 3190a to face the first region 6100 during use, and the patient-facing removable layer 3120 to face the second region 6200. If the adhesive layer 3190a (or 3122) is protected by a non-patient-facing removable layer 3180, that layer can be removed before or after the sealing structure 3100 is received by the second receiving region 6210 to expose the adhesive layer 3190a (or 3122).

[0356] The internal component 6008 and the external component 6006 can be configured to move from a closed stable configuration to an assembled configuration relative to each other, and in doing so, the first receiving area 6110 can be positioned adjacent to the second receiving area 6210 to adhere the sealing forming structure 3100 to the inflation chamber 3200.

[0357] The first assembly component 6002 may include one or more elastic members 6010 configured to return the outer component 6006 and the inner component 6008 to their original configuration. In some forms, the original configuration may be the stable configuration described above. The one or more elastic members 6010 may take any form of elastic member configured to act between the outer component 6006 and the inner component 6008. Figure 38 and Figure 40 As shown, in this illustrated form, one or more elastic members 6010 include two springs 6010. (As...) Figure 40 As shown, each spring 6010 can extend upward from the base 6502 and can be located on either side of the post 6038. The lower portion of each spring 6010 can be attached to the base 6502 of the inner member 6008, or each spring 6010 can be integrally formed with the base 6502, for example, by molding. In other forms, the spring 6010 can act on the base 6502 without being directly connected to it. The upper portion of the spring 6010 can be configured to act on a corresponding bearing surface 6302 of the outer member 6006. Figure 39 As shown, each bearing surface 6302 may be located on the underside of the outer member 6006 and may be located on either side of the orifice 6036 and / or the wall 6310.

[0358] When the inner member 6008 and the outer member 6006 are in their original stable configuration, the elastic member 6010 can be configured to be relatively uncompressible. When the outer member 6006 is pushed downward, i.e., towards the bottom edge 6502 of the inner member 6008, the elastic member 6010 can be configured to compress under the pushing force. In the illustrated form of this technology, the upper surface of the second assembly member 6004 includes an indicator 6236 to instruct the user to press or push the second assembly member 6004 downward, such that in the closed configuration, force is transmitted through the second assembly member 6004 and the outer member 6006 to the elastic member 6010, which is then compressed.

[0359] The compressed elastic member 6010 has a stored force that causes the outer member 6006 to spring back to its initial position once the downward force is removed. The inner member 6006 and the outer member 6008 may include one or more stops to prevent the inner member from moving relative to the outer member beyond the original configuration. For example, each first guide member 6304 may include a stop that can be configured to engage with a corresponding stop of each second guide member 6306 to ensure that sliding movement between the inner member 6008 and the outer member 6006 does not extend beyond their relative positions in the original or stable configuration.

[0360] In the open position, the second assembly component 6004 provides access to the first receiving region 6110 and the second receiving region 6210. An inflation chamber 3200 can be disposed in the first receiving region 6110, and a sealing forming structure 3100 can be disposed in the second receiving region 6210. In the closed configuration of the assembly device 6000, the second assembly component 6004 and the outer component 6006 are closed together (i.e., the cover is closed) by rotating the second assembly component 6004 about the hinge 6030 toward the outer component 6006. Furthermore, the second assembly component 6004 can be aligned and / or secured in the closed position relative to the outer component 6006, as previously described, by engaging each of one or more first alignment components 6232, 6233, 6234 with each of one or more corresponding second alignment components 6232A, 6233A, 6234A.

[0361] In this closed configuration, and when the internal and external components are in their original stable configuration, the first receiving region 6110 and the second receiving region 6210 can be positioned facing each other with a gap separating them. This means that the patient-facing side of the first flange region and the non-patient-facing side of the sealing structure 3100 including the adhesive layer 3190a (or 3122) face each other in this configuration, with a gap between the first flange region and the adhesive layer 3190a (or 3122) of the sealing structure 3100.

[0362] In the assembly configuration, the outer member 6006, together with the second assembly component 6004 located on the upper end of the outer member 6006, is pushed downward. This causes the second assembly component 6004 and the outer member 6006 to move downward relative to the inner member 6008, and causes the second receiving region 6210 to move into engagement with the first receiving region 6110. This eliminates the gap between the first flange region and the adhesive layer 3190a (or 3122) of the sealing forming structure 3100, and causes the inflation chamber 3200 to adhere to the sealing forming structure 3100, thereby forming the assembled patient interface 3000. When the downward force is released from the top of the second assembly component 6000, the elastic member 6010 causes the assembly device 6000 to return to its stable configuration. The cover or the second assembly component 6004 can then be opened, and the assembled patient interface 3000 can be retrieved for use.

[0363] 4.4.6 Two-part second assembly component

[0364] In some forms of this technology, for example, Figures 41-44 As shown, the second assembly component 6004 can be formed in two parts. That is, the second assembly component 6004 may include a first assembly portion 6062 and a second assembly portion 6064. The first assembly portion 6062 may include a second receiving area 6210.

[0365] In some forms, the first assembly portion 6062 and the second assembly portion 6064 are movable relative to each other to adopt certain configurations. In some forms, in one of these configurations, the first assembly portion 6062 and the second assembly portion 6064 can be connected together, and they can together form a cavity. This cavity can be adapted to house certain components, such as one or more portions of the patient interface 3000. In some forms, the assembly components can be configured such that the cavity can be adapted to house a sealing formation 3100, such as... Figure 43 As shown. Since patients can use the new sealing formation structures 3100 regularly, it may be convenient to keep them in the storage cavity within the assembly device 6000.

[0366] like Figures 41-44 As shown, in the example, the first assembly portion 6062 may be a curved panel shape, and the central portion of the first assembly portion 6062 includes a second receiving region 6210 on one side. The shape of the second receiving region 6210 may be as previously described. The second assembly portion 6064 may be formed as a cover with a concave surface, capable of connecting to the first assembly portion 6062 around the peripheral region of the corresponding assembly portion, and when in this connection configuration, a cavity is formed between the two portions.

[0367] In some forms, such as Figures 41-44As shown, the first assembly portion 6062 and the second assembly portion 6064 can be hingedly connected at a hinge 6068, for example, along the respective sides of the first and second assembly portions. Rotation of these portions relative to each other about the hinge 6068 enables the opening and closing of the cavity. In some forms, such as those shown, the hinge 6068 can be a movable hinge formed as a thin section of an integrally molded part between the two assembly portions. In other forms, the first and second assembly portions can be separately molded components, with the hinge 6068 connecting them. The hinged connection between the two assembly portions ensures that the portions are held together during use and prevents the user from losing one or both portions. In other forms, the first assembly portion 6062 and the second assembly portion 6064 can be completely separate and formed of multiple portions configured to allow the assembly portions to be interconnected by interlocking or friction-fit connections.

[0368] In some forms, the first assembly portion 6062 and the first assembly component 6002 may be hingedly connected at a hinge 6030, for example, along the respective sides of the respective portion and component. In some forms, such as Figures 41-44 As shown, the hinged connection can be any hinged connection other than the hinged connection between the first assembly portion 6062 and the second assembly portion 6064. Alternatively, in some forms, a hinge 6030 can be provided instead of a hinge 6068. In some forms, the first assembly portion 6062 can be hinged to an outer member 6006 of the first assembly component 6002, for example, along one side of it. Rotating the first assembly portion 6062 relative to the first assembly component 6002 about the hinge 6030 brings the first receiving area and the second receiving area together, as previously described. In some forms, such as as shown, the hinge 6030 can be a movable hinge formed as a thin portion of the integrally molded part between the first assembly portion 6062 and the first assembly component 6002. In other forms, the first assembly portion 6062 and the first assembly component 6002 can be separately molded components, with the hinge 6030 connecting them. The hinged connection between the first assembly portion 6062 and the first assembly component 6002 ensures that portion 6062 and component 6002 are held together during use and prevents the user from losing one or both. In other forms, the first assembly portion 6062 and the first assembly component 6002 may be completely separate and formed in multiple parts, which are configured to allow them to be interconnected by interlocking or friction-fit connections.

[0369] In some forms, for example Figures 41-44As shown, hinge 6068 can be positioned on one side of assembly device 6000, and hinge 6030 can be positioned on the opposite side of assembly device 6000. That is, hinge 6068 can be disposed along one side of the first assembly portion 6062, while hinge 6030 can be disposed along the opposite side of the first assembly portion 6062. This facilitates the assembly of patient interface 3000.

[0370] When a user wants to assemble the patient interface 3000, they can begin with the assembly device 6000 in a fully closed configuration, i.e., the first assembly portion 6062 and the second assembly portion 6064 are closed, forming a cavity between them, and the first assembly portion 6062 covers the upper surface of the first assembly component 6002. The user can first open it by rotating the second assembly portion 6064 about the hinge 6068. This opens the cavity (…). Figure 43 An exemplary configuration of this open configuration is shown, allowing the user to access one of the sealing formation structures 3100 stored in the cavity. The user can then close the second assembly portion 6064 by rotating it back about the hinge 6068 to engage with the first assembly portion 6062.

[0371] The user can then open the first assembly portion 6062 relative to the first assembly member 6002 by rotating the first assembly portion 6062 relative to the first assembly member 6002 about the hinge 6030. In some forms, such as Figures 41-44 As shown, the first assembly portion 6062 and the second assembly portion 6064 rotate together with respect to the first assembly component 6002. In the illustrated form, this can be conveniently implemented as a continuation of the movement that closes the second assembly portion 6064 onto the first assembly portion 6062, as described above. Once opened, the assembly of the patient interface 3000 can be performed as already described above, for example regarding... Figure 36-40 .

[0372] In order to adhere the sealing structure 3100 to the inflation chamber 3200, a downward force is applied to the top of the assembly device 6000 when in the closed configuration. Figures 41-44 In the illustrated technical form, a cavity exists between the two assembly portions forming the second assembly component 6002. To allow a user to apply a downward force to the central region of the top surface of the second assembly portion 6064 without causing bending or buckling of the top surface of the second assembly portion 6064, a bracket 6060 can be provided to span across the inner side of the top surface of the second assembly portion 6064 and the top surface of the first assembly portion 6062. In some forms, for example... Figures 41-44As shown, the bracket 6060 is attached to the top surface of the first assembly portion 6062 and projects vertically outward from that top surface. However, in other forms, the bracket 6060 may be attached to the inside of the top surface of the second assembly portion 6064 and project vertically outward from that inside. The bracket 6060 may be in the form of an elongated member, such as a rod. The bracket 6060 may be integrally formed with or attached to a corresponding assembly portion. The bracket 6060 may be sized to be narrower than the opening in the central region of the sealing structure 3100, allowing one or more sealing structures 3100 to be stored with the bracket 6060 passing through the opening. This helps to maintain the sealing structure 3100 in the desired position during storage.

[0373] 4.4.7 Feedback on the assembly of components

[0374] In some forms of this technology, the assembly device 6000 may be configured to provide the user with some form of feedback regarding whether the first assembly component 6002 and the second assembly component 6004 have been properly engaged during use of the assembly device to assemble the patient interface 3000.

[0375] In some forms of this technology, for example, Figure 45 and Figure 46 As shown, feedback can be provided in the form of touch and / or hearing. Figure 45 and Figure 46 The assembly equipment 6000 shown is similar to Figures 36 to 40 and Figures 41 to 44 As shown in the diagram. Similar to those forms, the first assembly component 6002 may include an outer component 6006 and an inner component 6008 configured to move relative to each other. During use of the assembly device 6000, when moved relative to each other, a first receiving area 6110 may be positioned adjacent to a second receiving area 6210 to adhere the seal-forming structure 3100 to the inflation chamber 3200, i.e., when the inner and outer components are in the assembly configuration. The assembly device 6000 may include two or more components that contact each other via movement of the outer component 6006 relative to the inner component 6008 between an original configuration and an assembly configuration (as previously described), wherein such contact has the property of generating tactile and / or auditory feedback that can be detected by a user.

[0376] exist Figure 45 and Figure 46In the example, each of the outer member 6006 and the inner member 6008 includes a protrusion positioned and arranged to contact each other by the movement of the outer and inner members relative to each other into an assembled configuration. In other forms, only one of the outer member 6006 and the inner member 6008 may include such a protrusion. Protrusions of this type can be positioned and arranged in the same manner to contact a portion of another member. The contact between the protrusions can produce an audible sound and / or tactile feedback to the user.

[0377] like Figure 45 and Figure 46 As shown, the protrusion 6040 can extend outward from a portion of the internal member 6008. Figure 45 and Figure 46 In the example, the protrusion 6040 extends laterally outward from the post 6038, although it may extend from other parts of the inner member 6008 in other forms. In the form shown, the protrusion 6040 is a relatively flat tab whose width (i.e., the dimension perpendicular to the height of the post 6038) is significantly greater than its height (i.e., the dimension parallel to the height of the post 6038). During use, when in contact with a portion of the inner member 6008 (e.g., its protrusion), the protrusion 6040 is capable of deflecting downward and / or upward. This can produce audible and / or tactile feedback that can be detected by the user.

[0378] like Figure 45 As shown, the protrusion 6042 can extend inwardly from a portion of the outer member 6006. Figure 45 In the example, protrusion 6042 extends laterally inward from the inner surface of the outer wall of outer member 6006. In the form shown, protrusion 6042 is in the form of a rounded projection protruding from the inner surface of the outer wall of outer member 6006. In use, the roundness of the projection helps protrusion 6040 move past protrusion 6042. Protrusion 6042, or the component mounted thereon, can elastically deform to prevent abutment when two protrusions move past each other. For example, protrusion 6042 can be mounted on arm 6044, which is mounted to the inner surface of the outer wall of outer member 6006. Arm 6044 can be mounted to the outer wall at one end (i.e., cantilever) to allow the arm to move in and out. Protrusion 6042 can be mounted at or near the distal end of the arm, from where it is mounted to the outer wall.

[0379] Protrusions 6040 and 6042 can be positioned relative to each other such that they contact each other when the outer member 6006 moves relative to the inner member 6008 between the original configuration and the assembled configuration. For example, protrusions 6040 and 6042 can be positioned on the same side of the assembly device 6000. In some forms, similar protrusions 6040 and 6042 can be provided on multiple sides of the assembly device 6000 so that the protrusions can contact each other regardless of the orientation of the outer member 6006 onto the inner member 6008. In some forms, multiple protrusions 6040 can be provided, such as two protrusions extending outward from opposite sides of the post 6038, such as... Figure 45 As shown, a single protrusion 6042 may be provided. Alternatively, multiple protrusions 6042 may be provided, while a single protrusion 6040 may be provided.

[0380] In some forms, protrusions 6040 and 6042 may be positioned relative to each other such that contact between them, and the resulting auditory / tactile feedback, occurs near the limits of movement of the outer member 6006 relative to the inner member 6008, i.e., at or near the positions of the outer and inner members corresponding to the assembly configuration. For example, with Figure 45 and Figure 46 As in the exemplary form shown, protrusion 6040 may be located near the bottom of post 6038 and near the base 6502 of inner member 6008, and protrusion 6042 may be positioned flush with or nearly flush with the bottom edge of the outer wall of outer member 6006. This positioning of the protrusion helps the user know when the first receiving area 6110 is adjacent to the second receiving area 6210, and therefore when the sealing forming structure 3100 and the inflation chamber 3200 contact to adhere them together.

[0381] During movement of the outer member 6006 relative to the inner member 6008, contact between the two protrusions 6040 and 6042 can result in an increase in the level of force required to move the protrusions relative to each other. Depending on the shape of the protrusions, this may be true for the relative movement of the inner and outer members in both directions (i.e., toward and away from the assembly configuration). The increased level of force required to move the inner and outer members from their assembly configuration back to their original configuration can help maintain pressure between the first receiving area 6110 and the second receiving area 6210 to aid in the adhesion and sealing of the forming structure 3100 and the inflation chamber 3200, even if the user slightly relaxes the force that caused the first and second assembly members to come together.

[0382] Exemplary mechanisms for providing auditory and / or tactile feedback to a user have been described with respect to a technical form similar to the third exemplary form previously described; however, it should be understood that similar mechanisms may also be used in other forms, including those similar to the first and second exemplary forms.

[0383] In other forms of this technology, another form of feedback, such as visual feedback, can be provided to the user to indicate the correct engagement of the first and second assembly components. In some exemplary forms, the first assembly component 6002 and the second assembly component 6004 may include visual indicators positioned where they are visible to the user of the device, and positioned such that when the outer component 6006 and the inner component 6008 are in the assembly configuration, the visual indicators provide the user with visual indication of this, such as the visual indicators aligning with each other. Alternatively, the assembly device 6000 may include one or more lights configured to illuminate to indicate the correct engagement of the first assembly component 6002 and the second assembly component 6004. For example, sensors may be provided to detect when the first assembly component 6002 and the second assembly component 6004 have moved close enough together, such as when the outer component 6006 and the inner component 6008 are in the assembly configuration, and thus cause one or more lights to illuminate.

[0384] 4.4.8 Elastically Deformable Receiving Area

[0385] In some forms of this technology, the first receiving region 6110 and / or the second receiving region 6210 are at least partially formed of an elastically deformable material. The assembly device 6000 can be configured such that when the first assembly component 6002 and the second assembly component 6004 are engaged and brought together, the deformable material is flattened. This flattening has the effect of slightly spreading the deformable material, such that the forces applied to the sealing forming structure 3100 and the adhesive layer 3190 to bring them into adhesive contact are spread more uniformly across their surface areas than might be possible in other cases.

[0386] In some examples, such as Figure 41 As shown, the second receiving region 6210 may be at least partially formed of an elastically deformable material. For example, the second assembly component 6004 may include a gasket 6050 having a surface that forms part or all of the second receiving region 6210. The gasket 6050 may be formed of an elastically deformable material, such as a rubber, such as latex, natural rubber, or a synthetic rubber, such as silicone rubber.

[0387] The gasket 6050 can be disposed on the second assembly component 6004, for example, by inserting it into the hole 6052 in the second assembly component 6004, such as... Figure 47As shown. In an alternative embodiment, the gasket 6050 may be disposed in a recess in the surface of the second assembly 6004. The gasket 6050 may be mounted to the second assembly 6004 by friction fit or interlocking arrangement, which can advantageously utilize the deformability of the gasket 6050 to allow the gasket to be attached to the second assembly. In an alternative embodiment, an adhesive may be used to adhere the gasket 6050 to the second assembly 6004.

[0388] The gasket 6050 can be shaped such that, when disposed on the second assembly 6004, the surface of the gasket 6050 is adjacent to or substantially adjacent to a surrounding surface region of the second assembly 6004 to form a second region 6200. In some forms, such as Figure 47 As shown, the surface of the gasket 6050 facing the first assembly component 6002 may protrude slightly beyond the surrounding area of ​​the second assembly component 6004. This ensures that the gasket 6050 contacts the sealing formation 3100 first during the assembly process and also provides space for the gasket 6050 to deform slightly when the first and second assembly components are brought together.

[0389] The gasket 6050 is sized such that it has a width in some outer directions, and in some forms, in all outer directions, that is similar to or slightly larger than the width of the sealing structure 3100 in the corresponding directions. Therefore, when the second receiving region 6210 contacts the sealing structure 3100 during use, the gasket 6050 may be the only, or essentially the only, part of the second receiving region 6210 that contacts the sealing structure 3100. This helps to provide a uniformly distributed force on the surface of the sealing structure 3100.

[0390] like Figure 47As shown, in some forms, the pad 6050 may be attached to the bracket 6060, for example, it may be integrally formed with the bracket. In the illustrated form, the first assembly portion 6062 of the second assembly member 6004 may include an insert 6066, wherein the insert 6066 is a component that includes the pad 6050 at one end and the bracket 6060 at the other end. The intermediate portion of the insert 6066 between the pad 6050 and the bracket 6060 is configured to be positioned in a hole 6052 in the second assembly member 6004. In some forms, the insert 6066 may be an integrally formed component, while in other forms, it may be an assembly of a sub-part. In use, when a user applies downward force on the top of the second assembly portion 6064, particularly in the intermediate section of the second assembly portion 6064 near the end of the second assembly portion 6064 close to the inner surface of the second assembly portion 6064, this force is transmitted downward through the bracket 6060 to the pad 6050. This allows the user to cause deformation of the gasket 6050 while pushing the sealing structure 3100 downwards, although in some technical forms, such as those shown, the gasket cannot be directly contacted during use.

[0391] One such technical form has been described in which the second receiving region 6210 may be formed at least partially of an elastically deformable material. In other forms, instead of forming the second receiving region in this way, or in addition to forming the second receiving region in this way, the first receiving region 6110 may be formed at least partially of an elastically deformable material. For example, the region of the first assembly 6002 adjacent to or surrounding the cavity 6124 to accommodate the inflation chamber 3200 may be formed of an elastically deformable material, such as those previously described. Similarly, this region may be formed as a separate component mounted on the remainder of the first assembly 6002 by friction fit, interlocking, or adhesive connection.

[0392] 4.4.9 Portability

[0393] In certain forms of this technology, such as in the case of the assembly device 6000 in all forms shown in the accompanying drawings, the assembly device 6000 is portable. This can be understood to mean that the assembly device 6000 can have a size and weight such that it can be easily moved and carried by a typical human without mechanical assistance. That is, the portability of the assembly device 6000 distinguishes these forms of technology from other types of machines that are relatively large and can be used to assemble patient interfaces in industrial environments (e.g., factories), under which these machines would not be described as portable.

[0394] In some forms, the total mass of the assembly equipment 6000 can be in the range of 50-400 g. For example, in some forms, the total mass of the assembly equipment 6000 can be less than about 400 g. In other forms, the total mass of the assembly equipment 6000 can be less than about 200 g. The total mass of the assembly equipment 6000 can be less than about 100 g.

[0395] In some forms, the dimensions (e.g., length, depth, height) of the assembly equipment 6000 can be in the range of approximately 40 mm to 300 mm. In some forms, the dimensions of the assembly equipment 6000 can be no greater than approximately 300 mm. In other forms, the dimensions of the assembly equipment 6000 can be no greater than approximately 200 mm. In still other forms, the dimensions of the assembly equipment 6000 can be no greater than approximately 150 mm.

[0396] In some forms, the assembly device 6000 may be formed of one or more materials suitable for realizing a portable device, such as a device having dimensions and mass falling within the aforementioned range. For example, in some forms, the first assembly component 6002 and the second assembly component 6004 may be formed at least partially of one or more plastics, such as polycarbonate or polypropylene, or of other polymers, such as silicone.

[0397] In other forms of this technology, the assembly equipment 6000 can be configured as a non-portable device.

[0398] 4.5 Air Circuit

[0399] In one embodiment, the patient interface 3000 may be included as part of a patient interface system 5000, which also includes an air circuit 4170. The air circuit 4170 is configured to deliver breathable gas to the patient interface 3000 for delivery to the airway of the patient 1000. For example, Figure 1 The air circuit 4170 of the technical form shown delivers breathable gas from the RPT device 4000 to the inflation chamber 3200.

[0400] The first end of the air circuit 4170 can be connected to the air chamber inlet port 3202. The second end of the air circuit 4170, which is opposite to the first end, can be connected to the RPT device 4000.

[0401] In an exemplary form of this technology, the air circuit 4170 is flexible.

[0402] In some configurations, the geometry of the air circuit 4170 can depend on the flow parameters of the breathable gas supplied from the RPT device 4000 to the patient. For example, in the case of the RPT device 4000, the diameter of the air circuit 4170 can be relatively small, as the RPT device is configured to provide a breathable gas supply at a relatively low pressure (e.g., 2 to 6 cmH2O), i.e., low-pressure therapy. The diameter of the air circuit 4170 can also be relatively large for use with an RPT device 4000 configured to supply breathable gas at a higher pressure (e.g., 6 to 20 cmH2O).

[0403] 4.6RPT device

[0404] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms, all or part of any of the methods described herein. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0405] In some configurations, the RPT device 4000 can be configured to deliver an airflow to the patient interface 3000 at a positive pressure relative to the environment. The RPT device 4000 can also be configured to deliver air at a therapeutic pressure, such as at least 6 cmH2O relative to the environment. A conventional RPT device 4000 can be used for this purpose.

[0406] In other forms, the RPT device 4000 can be configured to deliver a flow or air to the patient interface 3000 at a lower pressure (but still positive relative to the environment), for example, 2 to 6 cmH2O relative to the environment. Respiratory therapy systems incorporating the RPT device 4000 that delivers airflow at such pressure can be used to provide low-level therapy. For example, such systems can be used to treat or improve snoring or other mild breathing conditions. Compared to RPT devices capable of delivering air at higher pressures, such as those suitable for treating obstructive sleep apnea, such systems can be manufactured less expensively, use less power, and are more compact.

[0407] Figure 1 A respiratory therapy system 2000 including the RPT device 4000 of the type just described is shown. Figure 1 In the form shown, breathable gas is delivered to the patient interface 3000 RPT device 4000, which is compact and therefore portable, i.e., can be carried by the patient during use, for example, attached to the patient's person or clothing. For example, in use, the RPT device 4000 can be strapped around the patient's neck or arm, or carried in a pocket.

[0408] Breathable gas from the RPT device 4000 can be delivered to the patient interface 3000 via an air circuit 4170. An inlet port 3202 of the inflation chamber 3200 can be connected to one end of the air circuit 4170, and the other end of the air circuit 4170 is connected to the RPT device. Because the air supply flow rate and / or pressure can be lower than that of a conventional RPT device 4000 (e.g., a CPAP device), the air circuit 4170 can have a reduced diameter compared to a conventional air circuit. For example, in some forms, the air circuit 4170 can have a diameter in the range of 5-15 mm, such as 10 mm. A smaller diameter tube provides greater resistance to airflow compared to a larger diameter tube, but this is acceptable if the flow rate and / or pressure to be delivered is also lower. A smaller diameter tube may be ideal because it is less bulky and obtrusive, easier to store or package, and cheaper to manufacture.

[0409] 4.7 Glossary

[0410] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0411] 4.7.1 General Concepts

[0412] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-containing air.

[0413] Environment: In some forms of this technology, the term environment will be considered to mean (i) outside the treatment system or the patient, and (ii) immediately adjacent to the treatment system or the patient.

[0414] For example, the ambient humidity relative to a humidifier can be the humidity of the air immediately adjacent to the humidifier, such as the humidity inside the patient's bedroom. This ambient humidity can differ from the humidity outside the patient's bedroom.

[0415] In another example, environmental stress can be stress that is either close to the body or outside the body.

[0416] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, in addition to noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0417] Automated Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD (sleep-disordered breathing) event.

[0418] Continuous positive airway pressure (CPAP) therapy: a respiratory pressure therapy in which the treatment pressure is kept 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 will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.

[0419] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate will be a scalar quantity, i.e., a quantity that only has magnitude. In other cases, a reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0420] Flow therapy: Breathing therapy involves delivering a flow of air to the inlet of the airway at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the patient’s respiratory cycle.

[0421] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory condition.

[0422] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak might occur in a swivel bend leading to the environment.

[0423] Conducted noise (acoustics): In this document, conducted noise refers to noise transmitted to the patient through pneumatic paths, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at one end of the air circuit.

[0424] Radiated noise (acoustics): In this document, radiated noise refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0425] Vent noise (acoustic): Vent noise in this document refers to the noise generated by the airflow through any vent (such as the vent hole of a patient interface).

[0426] Oxygen-enriched air: Air with an oxygen concentration greater than that of atmospheric air (21%), for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes abbreviated as “oxygen”.

[0427] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0428] Patient: A person, regardless of whether they have a respiratory illness.

[0429] Pressure: Force per unit area. Pressure can be expressed in units ranging from cmH2O, gf / cm2, to hectopascals. 1 cmH2O equals 1 gf / cm2 and is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m2 = 1 millibar to 0.001 atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0430] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0431] Respiratory pressure therapy: Applying a therapeutic pressure, normally positive relative to the atmosphere, to the airway inlet.

[0432] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0433] 4.7.1.1 Materials

[0434] Silicone resin or silicone elastomer: Synthetic rubber. In this specification, references to silicone resin refer to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0435] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0436] 4.7.1.2 Mechanical Properties

[0437] Resilience: The ability of a material to absorb energy when it deforms elastically and to release energy when it is unloaded.

[0438] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicone resins and thermoplastic elastomers.

[0439] Hardness: The ability of a material to resist deformation (described, for example, by Young's modulus or by an indentation hardness scale measured on a standardized sample size).

[0440] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0441] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and can be, for example, not easily deformed under finger pressure.

[0442] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistance in different directions. The opposite of stiffness is flexibility.

[0443] Flexible structures or components: structures or components that change shape (e.g., bend) when supported by their own weight for a relatively short period of time, such as 1 second.

[0444] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting up and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a load of approximately 20 to 30 cmH2O.

[0445] For example, an I-beam may have a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, a structure or component may be flexible in the first direction and rigid in the second direction.

[0446] 4.7.2 Anatomy

[0447] 4.7.2.1 Facial Anatomy

[0448] Ala: the outer wall or "wing" of each nostril (plural: alar).

[0449] Alar tip: the outermost point on the ala of the nose.

[0450] Alar curvature (or alar ridge) point: the last point at the base of the curvature of each alar, found in the crease where the alar connects to the cheek.

[0451] Auricle: The entire visible external part of the ear.

[0452] (Nasal) Bone framework: The bony framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0453] (Nasal) Cartilaginous Framework: The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0454] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0455] Columellar angle: The angle between a line drawn through the midpoint of the nostril cavity and a line drawn perpendicular to the Frankfurt horizontal plane and intersecting the subnasal point.

[0456] Frankfurt Plane: A line extending from the lowest point of the orbital margin to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0457] The glabella is the most prominent point in the midsagittal plane of the forehead, located on the soft tissue.

[0458] Lateral nasal cartilage: a roughly triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0459] Lip, lower lip (midpoint of the lower lip):

[0460] Lip, upper (midpoint of the upper lip):

[0461] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane, which contains three or four small cartilages of the alar.

[0462] Nostrils (nares / nostrils): Roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal septum (naris / nostril). Nostrils are separated by the nasal septum.

[0463] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0464] Nasolabial angle: The angle between the columella and the upper lip (which intersect at the subnasal point).

[0465] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0466] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0467] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in an external view of the rest of the head.

[0468] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0469] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0470] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0471] Sagittal plane: A vertical plane running from the front (anterior) to the back (posterior). The midsagittal plane is the sagittal plane that divides the body into left and right halves.

[0472] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0473] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0474] Lower edge of the nasal ala: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (upper) lip.

[0475] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0476] Supramental point: The point with the greatest concavity located on the midline of the lower lip, between the midpoint of the lower lip and the premental point of the soft tissue.

[0477] Skull Anatomy

[0478] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area known as the forehead.

[0479] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0480] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral border.

[0481] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the bridge of the nose through their connection point.

[0482] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the depression at the top of the bridge of the nose.

[0483] Occipital bone: The occipital bone is located in the dorsal and lower parts of the skull. It includes the foramen magnum, an oval-shaped cavity through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0484] The eye socket is the bony cavity in the skull that houses the eyeball.

[0485] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0486] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0487] Cheekbones: The face consists of two cheekbones, which are located on the upper and outer parts of the face and form the protrusions of the cheeks.

[0488] 4.7.3 Patient Interface

[0489] Anti-asphyxiation valve (AAV): A component or sub-assembly of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0490] Bend: A bend is an example of a structure that guides the axis of an airflow traveling through it 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. A bend can have a generally circular cross-section. In another form, a bend can have an oval or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removed from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled onto the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0491] Frame: The frame is generally considered to refer to the mask structure that bears tensile loads between two or more connection points with the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0492] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0493] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having a wall that at least partially surrounds a volumetric space containing air pressurized to above atmospheric pressure during use. A shell may form part of the wall of the mask inflation chamber.

[0494] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or achieve "sealing" between them without requiring a separate "sealing" element itself.

[0495] Shell: A shell is generally considered to refer to a curved, relatively thin structure with bending, tensile, and compressive stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0496] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0497] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0498] Rotary shaft (noun): A sub-assembly of a component configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery conduits, the sub-assembly of the component preferably comprises a pair of mating cylindrical conduits. During use, there may be little or no airflow leakage from the rotary shaft.

[0499] Lacing (noun): A structure designed to resist tension.

[0500] Ventilation port (noun): A structure that allows air to flow from the inside of a mask or conduit into ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate from about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure.

[0501] 4.8 Other Notes

[0502] This patent document contains a portion of copyrighted material. The copyright holder does not object to anyone faxing or copying the patent document or patent disclosure appearing in the patent office's patent files or records, but otherwise reserves all copyright.

[0503] Unless the context explicitly specifies otherwise and where a range of values ​​is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other said or intermediate value within the range, are included in this technique. The upper and lower limits of these intermediate ranges (which may be independently included within the intermediate range) are also included in this technique, but are subject to any explicit exclusions within the range. Where the range includes one or both limitations, the range excluding any one or both of those included limitations is also included in this technique.

[0504] Furthermore, where one or more values ​​are stated herein as part of the implementation of this technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used to any suitable significant number to the extent that the actual technical implementation allows or requires.

[0505] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0506] When a particular material is identified for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured, and therefore may be manufactured together or separately.

[0507] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” as used herein and in the appended claims include their plural equivalents.

[0508] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology is not entitled to any prior disclosure by virtue of a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0509] The terms “comprises” and “comprising” should be understood as referring to each element, component or step in a non-exclusive manner, indicating that the referenced element, component or step may exist or be used, or may be combined with other elements, components or steps not expressly referenced.

[0510] The headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. These headings should not be used to interpret the scope or limit of the claims.

[0511] Although the technology has been described herein with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details not required for practicing the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or that aspects thereof can be performed simultaneously or even concurrently.

[0512] Therefore, it should be understood that various modifications can be made to the illustrative examples and other arrangements can be designed without departing from the spirit and scope of this technology.

Claims

1. A portable assembly apparatus for assembling a patient interface, characterized in that, The patient interface is used to deliver breathable gas to a patient, wherein the portable assembly device includes: A first assembly component, the first assembly component including a first receiving area configured to receive a first portion of the patient interface in use; and The second assembly component includes a second receiving area configured to receive a second portion of the patient interface during use. The first assembly component is configured to engage with the second assembly component to position the first receiving area adjacent to the second receiving area in a position suitable for adhering the first portion and the second portion together to form an assembled patient interface.

2. The portable assembly device according to claim 1, characterized in that, The first receiving area includes a substantially continuous surface, and when the first portion is received by the first receiving area, the main portion of the first portion of the patient interface substantially abuts against the surface.

3. The portable assembly device according to claim 1, characterized in that, The first receiving area has a shape that substantially corresponds to the natural shape of the non-patient-facing surface of the sealing formation structure of the patient interface, so as to substantially maintain the shape of the sealing formation structure when the assembled patient interface is formed.

4. The portable assembly device according to claim 3, characterized in that, When viewed from the side, the first receiving area is substantially convex.

5. The portable assembly device according to claim 4, characterized in that, The first receiving area includes one or more recessed areas.

6. The portable assembly device according to any one of claims 1 to 3, characterized in that, The second receiving area includes a substantially continuous surface, and when the first and second portions are adhered together, the main portion of the patient-facing surface of the sealing structure of the patient interface substantially abuts against the surface.

7. The portable assembly device according to any one of claims 1 to 3, characterized in that, The second receiving region has a shape that is substantially complementary to the shape of the first receiving region, such that the first receiving region and the second receiving region can be placed in an engaging configuration.

8. The portable assembly device according to any one of claims 1 to 3, characterized in that, The second receiving area has a shape that substantially corresponds to the natural shape of the patient-facing surface of the sealing formation structure of the patient interface, so as to substantially maintain the shape of the sealing formation structure when the assembled patient interface is formed.

9. The portable assembly device according to claim 8, characterized in that, When viewed from the side, the second receiving area is substantially recessed.

10. The portable assembly device according to claim 9, characterized in that, The second receiving area includes one or more raised areas.

11. The portable assembly device according to any one of claims 1 to 3, characterized in that, The first receiving area and / or the second receiving area are at least partially formed of a material capable of elastic deformation.

12. The portable assembly device according to any one of claims 1 to 3, characterized in that, The first assembly component includes a first retaining structure configured to hold the first portion in a substantially fixed position relative to the first assembly component.

13. The portable assembly device according to claim 12, characterized in that, The first retaining structure includes a recess configured to substantially receive the first portion.

14. The portable assembly device according to claim 12, characterized in that, The first retaining structure includes a cavity configured to receive an inflatable chamber from the patient interface.

15. The portable assembly device according to any one of claims 1 to 3, characterized in that, The second assembly component includes a second retaining structure configured to hold the second portion in a substantially fixed position relative to the second assembly component.

16. The portable assembly device according to claim 15, characterized in that, The second retaining structure includes a first slot and a second slot, the first slot being configured to receive a first tab of the second portion or a removable layer attached thereto, and the second slot being configured to receive a second tab of the second portion or a removable layer attached thereto during use.

17. The portable assembly device according to any one of claims 1 to 3, characterized in that, The first assembly component and the second assembly component are movable relative to each other, such that the portable assembly device has a stable configuration in which the first part when received by the first receiving area and the second part when received by the second receiving area face each other and are separated by a gap.

18. The portable assembly device according to claim 17, characterized in that, The first assembly component includes an outer component and an inner component, the inner component being configured to move relative to the outer component to position the first receiving area adjacent to the second receiving area, thereby adhering the first part and the second part together, wherein the inner component includes the first receiving area.

19. The portable assembly device according to claim 18, characterized in that, It also includes an elastic member configured to return the outer member and the inner member to their original configuration when the force causing the inner member to move relative to the outer member is removed.

20. The portable assembly device according to any one of claims 1 to 3, characterized in that, The first assembly component is hingedly attached to the second assembly component.

21. The portable assembly device according to any one of claims 1 to 3, characterized in that, The first assembly component is separated from the second assembly component.

22. The portable assembly device according to any one of claims 1 to 3, characterized in that, The second assembly component includes a first assembly portion and a second assembly portion, the first assembly portion including the second receiving area, wherein in a configuration where the first assembly portion and the second assembly portion are connected together, the first assembly portion and the second assembly portion together form a cavity suitable for storing one or more patient interface portions.

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