Package, packaging system and storage system for patient interface

Abstract

The utility model relates to a package, a packaging system and a storage system for a patient interface. A package for a patient interface includes: a plurality of panels arranged to fold inwardly to define a housing for a patient interface, the plurality of panels including a pair of opposing side panels and a pair of opposing end panels; and a panel retaining structure arranged to prevent outward collapse of the panel such that the patient interface is maintained in a compressed state; wherein at least one of the panels includes at least one patient interface retention feature attachable to the patient interface; and wherein the panel retention structure is releasable to cause the patient interface in a compressed state to urge one or more of the panels outwardly to enable display of the patient interface in a substantially in-use configuration.

Description

[0001] This application is a divisional application of a patent application with application number 202290000517.9 (PCT / SG2022 / 050455), which was submitted to the China Patent Office on December 20, 2023, with an international application date of June 30, 2022, and the utility model name is "Packaging for Patient Interface".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of Singapore Patent Application No. 10202200444Y filed on January 17, 2022 and Singapore Patent Application No. 10202107191X filed on June 30, 2021, the entire contents of these two patent applications are hereby incorporated by reference in their entirety. Technical Field

[0004] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses. Background Art

[0005] The human respiratory system and its disorders

[0006] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0007] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air to the venous blood, while carbon dioxide moves in the opposite direction. The trachea is divided into the right main bronchi and the left main bronchi, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory region. See John B. West, Respiratory Physiology, Lippincott Williams & Wilkins, 9th edition, published in 2012.

[0008] There is a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0009] 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.

[0010] A range of therapies have been used to treat or ameliorate such conditions. In addition, such therapies can be used to prevent breathing disorders in otherwise healthy individuals. However, these therapies have a number of disadvantages.

[0011] therapy

[0012] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT) have been used to treat one or more of the above-mentioned respiratory disorders.

[0013] Respiratory pressure therapy

[0014] Respiratory pressure therapy is the application of air supplied to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank or breastplate ventilator).

[0015] Respiratory therapy systems

[0016] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0017] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0018] Patient Interface

[0019] The patient interface can be used to engage the respiratory equipment to its wearer, for example by providing an air flow to the airway entrance. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can, for example, form a seal with an area of ​​the patient's face so as to facilitate delivery of gas at a pressure sufficiently different from the ambient pressure (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids complete sealing. An example of such a patient interface is a nasal cannula.

[0020] The design of a patient interface presents many 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 is composed of bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy.

[0021] Due to these challenges, some masks are obtrusive, unsightly, expensive, ill-fitting, difficult to use, and uncomfortable, especially when worn for long periods of time or when the patient is unfamiliar with the system. A mask of the wrong size may result in reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but such masks may not be as comfortable as ideally worn for long periods of time (e.g., hours). This discomfort may result in reduced patient compliance with therapy. This is even more true if the mask is worn during sleep.

[0022] CPAP therapy is very effective for treating certain breathing disorders, provided the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their mask, and this may affect patient compliance.

[0023] Sealing structure

[0024] The patient interface may include a seal-forming structure. Since the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0025] The patient interface can be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to, for example, cover the upper lip area and the bridge of the nose area of ​​the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth area during use, for example by forming a seal on the lower lip area of ​​the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area during use. These different types of patient interfaces may be named by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal flutters, and oronasal masks.

[0026] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a seal-forming structure that may be effective in one area of ​​the patient's face may not be appropriate in another area. For example, a seal on swimming goggles that covers the patient's forehead may not be appropriate for use on the patient's nose.

[0027] Certain seal-forming structures may be designed for mass manufacturing so that one design fits and is comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must adapt to form a seal.

[0028] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface, with the seal-forming structure in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inadequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0029] Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming portion, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, causing leaks.

[0030] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these elements uncomfortable.

[0031] Another form of seal-forming structure can use adhesive to achieve the seal. Some patients may find it inconvenient to frequently apply and remove adhesive on their face.

[0032] A range of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0033] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan-Bennett, Inc. Another nasal pillow or nasal puff is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0034] ResMed Inc. has manufactured the following products that include nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillows, SWIFT TM FX Nasal Pillows and MIRAGE LIBERTY TM Full face mask. The following patent applications assigned to ResMed Ltd. describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes, inter alia, ResMed Ltd. SWIFT TM Various aspects of the nasal pillow), U.S. Patent Application 2009 / 0044808 (which describes, inter alia, the SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describing, inter alia, the MIRAGE LIBERTY TM Aspects of a full-face mask); International Patent Application WO 2009 / 052,560 (describing, inter alia, the SWIFT TM aspects of the FX Nasal Pillows).

[0035] Positioning and stabilization

[0036] The seal-forming structure of the patient interface for air positive pressure therapy is subjected to the corresponding force of the air pressure that destroys the seal. Therefore, a variety of techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0037] One technique is to use an adhesive. See, for example, US Patent Application Publication No. US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0038] Another technique is to use one or more straps and / or stabilizing straps.Many of these straps suffer from one or more problems of poor fit, bulkiness, discomfort, and inconvenience in use.

[0039] Due to, among other things, the challenges described above, positioning and stabilizing structures of a patient interface can be somewhat complex to design. It can be difficult for a user of a patient interface to understand how to properly set up and wear the patient interface without the assistance of an expert, such as a clinician. Thus, there remains a need for a patient interface that is easy to set up and use.

[0040] Respiratory Pressure Therapy (RPT) Devices

[0041] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the above-mentioned multiple therapies, such as by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Therefore, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0042] Air circuit

[0043] An air circuit is a conduit or tube that is constructed and arranged to allow air flow to travel between two components of a respiratory therapy system (such as an RPT device and a patient interface) in 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. Summary of the invention

[0044] The present technology is directed to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders that have improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0045] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0046] Another aspect of the present technology relates to a patient interface for delivering pressurized breathable gas to a patient. The patient interface includes a seal-forming structure for sealing around an entrance to a patient's airway. The patient interface also includes a plenum configured to receive a flow of pressurized breathable gas. The patient interface also includes a positioning and stabilizing structure configured to maintain the seal-forming structure in an operable position.

[0047] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0048] One aspect of some forms of the present technology is for providing methods and / or apparatus for improving patient compliance with respiratory therapy.

[0049] One form of the present technology includes packaging for a patient interface.

[0050] One form of the present technology includes a foldable package having removable panels to form open and closed positions.

[0051] One form of the present technology includes a faceplate of a housing including at least one retaining structure configured to retain a patient interface in a desired position.

[0052] One form of the present technology includes a package having a panel and a panel retaining structure. The panel can be moved from an outwardly collapsed state to an in-use state. The panel retaining structure selectively maintains the position of the panel in the in-use state.

[0053] In some forms, the panel retaining structure can be disposed on one panel. For example, the panel retaining structure can be a fastener (e.g., magnet, hook and loop material, mechanical fastener, etc.) on one panel that is removably connected to a fastener on another panel.

[0054] One form of the present technology includes a package for a patient interface, the package comprising a plurality of panels arranged to fold inwardly to define a shell for the patient interface, the plurality of panels including a pair of opposing side panels and a pair of opposing end panels, and a panel retaining structure arranged to prevent the panels from collapsing outwardly so that the patient interface remains in a compressed state; wherein at least one of the panels includes at least one patient interface retaining feature that can be attached to the patient interface; and wherein the panel retaining structure is releasable to enable a patient interface in a compressed state to push one or more of the panels outwardly, thereby enabling the patient interface to be displayed in a substantially in-use configuration.

[0055] Another aspect of one form of the present technology is that at least one patient interface retaining feature includes one or more of: a lace; a clip; a snap; a strap; a hook and loop fastener; a button; and a magnet.

[0056] Another aspect of one form of the present technology is that when at least one patient interface retaining feature comprises a magnet, one of the end panels comprises at least two patient interface retaining features arranged to be magnetically attractable to each other.

[0057] Another aspect of one form of the present technology is that at least one patient interface retaining feature includes a magnet for attracting to a magnet on the patient interface.

[0058] Another form of the present technology includes a package comprising a plurality of panels arranged to move from an open position to a closed position, the closed position at least partially forming a volume for receiving a patient interface, the plurality of panels comprising a pair of opposing side panels and a pair of opposing end panels, wherein each of the plurality of panels can be moved independently of the other panels of the plurality of panels; and a panel retaining structure, the panel retaining structure being removably connected to at least one of the plurality of panels, the panel retaining structure being arranged to prevent the panel in the connected position from collapsing outward; at least one patient interface retaining feature connected to at least one of the plurality of panels, the at least one patient interface retaining feature being configured to be removably connected to a patient interface and to retain the patient interface in a desired position; and wherein the plurality of panels are biased toward an open position and are configured to move toward the open position when the panel retaining structure is released from at least one of the plurality of panels.

[0059] In some forms, a) the at least one patient interface retaining feature includes one or more of: a lace; a clip; a snap; a strap; a hook and loop fastener; a button; and a magnet; b) the at least one patient interface retaining feature includes a plurality of patient interface retaining features; and / or c) one of the plurality of patient interface retaining features is connected to each of the plurality of panels.

[0060] In some forms, a) a pair of side flaps and an end flap extend from at least one of the pair of opposing end panels; b) the pair of side flaps and the end flaps are oriented substantially perpendicular to the at least one end panel in the open position and the closed position; c) each of the pair of side flaps contacts one of the pair of opposing side panels in the closed position; d) the at least one end panel is a pair of end panels, and each of the pair of end panels includes a pair of side flaps and an end flap; e) each of the pair of side flaps of the pair of end panels contacts one of the pair of opposing side panels in the closed position; f) the pair of side flaps of one of the at least one end panels are spaced apart from the pair of side flaps of the other of the at least one end panel; g) a sleeve is removably positioned around an exterior surface of the at least one end panel; h) the sleeve is configured to selectively retain the at least one end panel in the closed position; and / or i) the sleeve contacts the end flaps.

[0061] In some forms, a) the hook is connected to a top panel extending from at least one end panel; b) the hook is connected to the top panel as a cantilever structure; c) a bottom wall is configured to support multiple panels in an upright position; d) each of the multiple panels is connected to the bottom wall via a hinge; and / or e) each of the multiple panels is configured to be pivotally movable relative to the bottom wall.

[0062] In some forms, a packaging system may include a patient interface and any of the aforementioned forms of packaging.

[0063] Another form of the present technology includes a storage system comprising a patient interface; and a package configured to selectively accommodate the patient interface, the package comprising: a plurality of panels arranged to move from an open position to a closed position, the closed position at least partially forming a volume for receiving the patient interface, the plurality of panels comprising a pair of opposing side panels and a pair of opposing end panels, wherein each of the plurality of panels can be moved independently of other panels of the plurality of panels; at least one patient interface retaining feature connected to at least one of the panels of the plurality of panels, the at least one patient interface retaining feature configured to be removably connected to the patient interface and to retain the patient interface in a desired position, the at least one patient interface retaining feature comprising a convex portion and a concave portion configured to be selectively connected to each other, wherein the patient interface retaining feature forms a loop when the convex portion and the concave portion are connected to each other, and wherein the loop is configured to wrap around a portion of the patient interface.

[0064] In some forms, a) the package also includes a panel retaining structure that is arranged to prevent the panels from collapsing outward so that the patient interface remains in a compressed state; b) the panel retaining structure includes a cover having at least one flap arranged to engage an outer surface of a first end panel of the pair of opposing end panels; c) the cover extends from a second end panel of the pair of opposing end panels and / or includes at least a portion of a second end panel of the pair of opposing end panels; d) the cover has a hinge that is connected to or is part of the second end panel; and / or e) a portion of the second end panel forms a top wall of the cover.

[0065] In some forms, a) the panels are connected by a foldable connecting plate; b) the cover includes a first cover portion and a second cover portion, each of which includes a pair of opposing side wings arranged to engage with corresponding side panels; c) the panel retaining structure includes opposing side wings of the first cover portion and the second cover portion; and / or d) each cover portion includes a top wall and a corresponding one of the end panels extending transversely to its opposing side wings.

[0066] In some forms, a) the at least one patient interface retaining feature comprises a strip; b) the strip is formed from cut portions of a material layer that is laminated to a panel; c) the strip includes a male portion and a female portion, the male portion being formed on one of the plurality of panels and the female portion being formed on another of the plurality of panels that is adjacent to the one of the plurality of panels; d) the male portion and the female portion selectively form a mechanical connection therebetween to form a loop for retaining the patient interface; e) the male portion includes an undercut that can be selectively received within a groove in the female portion; and / or f) the male portion and the female portion are selectively connected to each other using magnetic force.

[0067] In some forms, a) the at least one patient interface retaining feature comprises a strap; b) a convex portion and a concave portion, the convex portion formed on the strap or at least one panel and the concave portion formed on the other of the strap or at least one panel; c) the convex portion and the concave portion comprise one or more of: snaps; hook and loop fasteners; buttons; and magnets; d) one of the end panels comprises at least two patient interface retaining features arranged to attach to the patient interface on either side of a seal-forming structure of the patient interface or at opposite ends of a rear strap of a positioning and stabilizing structure of the patient interface; and / or e) at least one patient interface retaining feature comprises a magnet for attracting to a magnet on the patient interface.

[0068] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

[0069] One aspect of one form of the present technology is a method of making a device.

[0070] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity and vision, or by a person with limited experience in using medical devices of this type.

[0071] One aspect of one form of the present technology is a portable RPT device that can be carried by a person, such as within the person's home.

[0072] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, such as in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier water tank that can be cleaned at the patient's home, such as in soapy water, without the need for specialized cleaning equipment.

[0073] The described methods, systems, devices, and apparatus may be implemented to improve the functionality of a processor, such as a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. In addition, the described methods, systems, devices, and apparatus may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0074] Of course, parts of these aspects may form sub-aspects of the present technology. In addition, each aspect in the sub-aspects and / or aspects may be combined in various ways, and also constitute additional aspects or sub-aspects of the present technology.

[0075] Other features of the technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to similar elements, including:

[0077] Respiratory therapy systems

[0078] Figure 1 A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask, receiving a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0079] Patient Interface

[0080] Figure 2 A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0081] Figure 3A Shown is a side view of a patient interface in accordance with one form of the present technology.

[0082] Figure 3B Shows Figure 3A Close-up side perspective view of the patient interface.

[0083] Figure 3C Shows Figure 3A A portion of a patient interface in a partially disassembled form, wherein rigid components of the patient interface are exposed.

[0084] Figure 3D A portion of a patient interface is shown with the rigidizer inserted into the strap.

[0085] Packaging for patient interfaces

[0086] Figure 4A

[0013] Packaging for a patient interface in accordance with one form of the present technology is shown in an open configuration.

[0087] Figure 4B A package is shown with a patient interface that is displayed when the package is opened.

[0088] Figure 4C An opened package is shown with patient interface retaining features.

[0089] Figure 4D The opened package is shown with the patient interface retaining features attached to the patient interface.

[0090] Figure 5A Shows FIG. 4A to FIG. 4D A top view of the package at the beginning of the opening sequence.

[0091] Figure 5B A top view of the package is shown in the middle of an opening sequence.

[0092] Figure 5C A top view of the package is shown at the end of the opening sequence.

[0093] Fig. 6A

[0013] Another form of packaging for a patient interface in accordance with the present technology is shown in an open configuration.

[0094] Figure 6B Shown is a patient interface Fig. 6A packaging that displays the patient interface when the packaging is opened.

[0095] Figure 6C A patient interface with a retention feature is shown. Fig. 6A opened packaging.

[0096] Fig.6D Shows Fig. 6A An opened package wherein a patient interface retaining feature is attached to the patient interface.

[0097] Fig. 7A Shows when the opening sequence begins FIG. 6A to FIG. 6D Top view of the packaging.

[0098] Figure 7B A top view of a package is shown partially through an opening sequence, with the sleeve of the package partially removed.

[0099] Figure 7C A top view of the package is shown partially through the opening sequence, with the sleeve completely removed.

[0100] Fig.7D A top view of the package is shown at the end of the opening sequence.

[0101] Fig. 8A A top view of a package with one example of patient interface retaining features is shown.

[0102] Figure 8B A top view of a package with another example of a patient interface retaining feature is shown.

[0103] Figure 8C A top view of a package having yet another example of a patient interface retaining feature is shown.

[0104] Fig.8D and Fig. 8E A top view of a package having yet another example of a patient interface retaining feature is shown.

[0105] Figure 8F is a close-up top perspective view of a package having yet another example of a patient interface retaining feature.

[0106] Figure 8G A top view of a package having yet another example of a patient interface retaining feature is shown.

[0107] Fig.9A A front perspective view of a package for a patient interface in accordance with an example of the present technology is shown in a closed configuration.

[0108] Fig. 9B Shows a partially opened Fig.9A Front perspective view of the packaging.

[0109] Fig. 9C Shown fully open and without patient interface Fig.9A Front perspective view of the packaging.

[0110] Fig.9D Shows Fig.9A Patient interface retention features of the packaging. DETAILED DESCRIPTION

[0111] Before describing the present technology in more detail, it should be understood that the technology is not limited to the specific examples described herein which may vary. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0112] The following description is provided about various examples that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any one example can constitute another example.

[0113] therapy

[0114] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0115] In certain examples of the present technology, a positive pressure air supply is provided to the patient's nasal passages via one or both nostrils.

[0116] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0117] Respiratory therapy systems

[0118] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 .

[0119] Patient Interface

[0120] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the patient's airway entrance so as to maintain a positive pressure at the airway entrance of the patient 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0121] If a 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.

[0122] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0123] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH20 relative to ambient.

[0124] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH20 relative to ambient.

[0125] Sealing structure

[0126] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal is likely to occur. The area where a seal actually occurs—the actual sealing surface—may vary over time and from patient to patient within a given course of treatment, depending on a number of factors including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0127] Nasal pillows

[0128] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal flutters or pillows, each nasal flutter or pillow being constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0129] Inflatable room

[0130] The plenum chamber 3200 has a perimeter shaped to complement the surface contour of an average human face in the area where a seal will be formed in use. In use, the boundary edge of the plenum chamber 3200 is positioned to abut against the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0131] Positioning and stabilizing structures

[0132] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed position by a positioning and stabilising structure 3300 during use.

[0133] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a breakaway coupling portion located between a front portion of the positioning and stabilising structure 3300 and a rear portion of the positioning and stabilising structure 3300. The breakaway coupling portion does not resist compression and may be, for example, a flexible or soft strip. The breakaway coupling portion is constructed and arranged such that when the patient lies with their head on the pillow, the presence of the breakaway coupling portion prevents forces on the rear portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0134] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer comprises a loop material that is partially engaged with a hook material.

[0135] In some forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable strap, such as a resiliently extendable strap. For example, the strap can be configured to be in tension during use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0136] In one form of the present technology, the positioning and stabilizing structure includes a first strap (e.g., Figure 3A and Figure 3C The first strap 3304 is constructed and arranged so that in use at least a portion of its lower edge passes above the supra-auricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0137] In one form of the present technology applicable to a pure nasal mask or a full-face mask, the positioning and stabilizing structure includes a second strap (e.g., Figure 3A and Figure 3C The second strap 3306 is constructed and arranged so that in use at least a portion of its upper edge passes below the subauricular base point of the patient's head and covers the occipital bone of the patient's head or is located below the occipital bone of the patient's head.

[0138] In one form of the present technology applicable to a pure nasal mask or a full-face mask, the positioning and stabilizing structure includes a third strap (e.g., Figure 3A and Figure 3C The third strap is constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

[0139] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a bendable and, for example, non-rigid strap. An advantage of this aspect is that the strap is more comfortable for the patient when the patient is sleeping.

[0140] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a strip configured to be breathable to allow moisture vapor to pass through the strip.

[0141] exist FIG. 3A to FIG. 3D An example of a strap 3302 is shown in FIG. Strap 3302 includes a fabric outer layer 3314 that forms a sleeve for a rigidizer 3316. "Rigidizer" means and includes any reinforcing element that increases the stiffness of another object, and may include objects that increase stiffness in one or more axes. Rigidizer 3316 may be elastically flexible along at least a portion of its length.

[0142] In some forms of this technology, see FIG. 3A to FIG. 3D, the strap 3302 can be connected to the plenum 3200 directly or indirectly via an accordion section 3322. For example, the accordion section 3322 can extend directly from the plenum 3200 itself, or can extend from a rigid housing 3320 that is connected to a soft and / or elastic plenum 3200. For example, the strap 3302 can be connected to the accordion section 3322 via one end 3310 of the rigid member 3316.

[0143] In some forms, the strap 3302 may include a tab 3309 including a connector 3307 for connecting the strap 3302 to the second strap 3306. For example, the connector 3307 may include a button or a snap.

[0144] In some forms of the present technology, the positioning and stabilizing structure 3300 may include a pair of straps 3302 connected by an overhead strap 3303. The length of the overhead strap 3303 may be adjusted to better fit the positioning and stabilizing structure 3300 to the patient's head.

[0145] In some forms, each of the pair of straps 3302 can be connected to the first strap 3304 via a tab 3305. The tab 3305 can include a loop that allows the first strap 3304 to be passed through and removably connected in an adjustably manner to adjust the length of the strap 3304.

[0146] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure 3300 being configured to provide a holding force to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form of positioning and stabilizing structure that is suitable for small sized heads but not for large sized heads.

[0147] Vent

[0148] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases (eg, carbon dioxide).

[0149] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, such as a swivel.

[0150] Disconnection structure

[0151] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0152] Connection Ports

[0153] The connection port 3600 allows connection to the air circuit 4170 .

[0154] Forehead support

[0155] In one form, the patient interface 3000 includes a forehead support 3700 .

[0156] port

[0157] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of gas properties within the plenum chamber 3200, such as pressure.

[0158] Packaging for patient interfaces

[0159] One form of the present technology includes packaging for a patient interface. The patient interface may be Figure 2 and FIG. 3A to FIG. 3D The package is shown with a patient interface 3000 of the type depicted in FIG. 1 , but it will be appreciated that the package may be used with many other types of patient interfaces with appropriate modification.

[0160] In one form, such as FIG. 4A to FIG. 4D As shown, the packaging 6000 for the patient interface 3000 includes a plurality of panels 6004a, 6004b, 6006. The plurality of panels are arranged to fold inwardly to define a housing for the patient interface 3000.

[0161] In this example, the plurality of panels includes a first end panel 6004a including a first panel portion 6034 and a second panel portion 6036 joined at a fold line 6040. The first panel portion 6034 can be folded inwardly about the fold line 6040 (i.e., in the direction of the second panel portion 6036) to a generally upright position to form a first end wall of a housing for a patient interface. Thus, the second panel portion 6036 forms a bottom wall of the housing. In some forms, the upright position can be a position in which the first panel portion 6034 is substantially perpendicular to the second panel portion 6036.

[0162] The plurality of panels also includes a second end panel 6004b including a first panel portion 6021 and a second panel portion 6022 joined at a fold line 6030 at one end of the first panel portion 6021. The first panel portion 6021 is joined to the first end panel 6004a at its other end via another fold line 6032. The first panel portion 6021 can be folded inwardly (i.e., in the direction of the first end panel 6004a) about the fold line 6032 to form a second end wall of a housing for the patient interface 3000. In some forms, the upright position can be a position in which the first panel portion 6021 is substantially perpendicular to the second panel portion 6036. In this position, the first panel portion 6034 and the first panel portion 6021 can be substantially parallel to each other.

[0163] The plurality of panels also includes a pair of opposing side panels 6006. Each side panel 6006 can be connected to the first end panel 6004a via a fold line 6007, for example at the second panel portion 6036 of the first end panel 6004a. Each side panel 6006 is folded inwardly (i.e., in the direction of the first end panel 6004a) about its corresponding fold line 6007 to a generally upright position to form a side wall of a housing for the patient interface 3000. In some forms, the upright position can be a position in which at least one of the side panels 6006 is substantially perpendicular to the second panel portion 6036. In this position, the side panels 6006 can be substantially parallel to each other. However, other examples can include one or more side panels 6006 that are tilted relative to the second panel portion 6036 and / or other side panels 6006 that are in an upright position.

[0164] The second panel portion 6022 of the second end panel 6004b can not only be folded about the fold line 6032, but can also be folded inwardly about the fold line 6030 (i.e., in the direction of the first panel portion 6021) so that the second panel portion 6022 forms a top wall of the housing for the patient interface 3000. Thus, the top wall 6022 forms part of the cover 6020 of the package 6000.

[0165] The cover 6020 may also include an end flap 6024 extending generally perpendicular to the top wall 6022. The end flap 6024 of the cover 6020 may engage an outer surface of a first panel portion 6034 of the first end panel 6004a when the first end panel 6004a is folded inwardly about the fold line 6040 and the second end panel 6004b is folded inwardly about the fold lines 6032 and 6030. The end flap 6024 serves as a panel retaining structure to prevent the first end panel 6004a (specifically, in this case, the first panel portion 6034 of the first end panel 6004a) from collapsing outwardly.

[0166] In some forms, the end fins 6024 can be held relative to the top wall 6022. Figure 4A This can allow the end flap 6024 to act as a stop and not move (eg, pivot) when in contact with the first end panel portion 6034, which enables the end flap 6024 to act as a panel retaining structure.

[0167] As shown, the height of the end tab 6024 is substantially equal to the height of the end wall defined by the first panel portion 6034 of the first end panel 6004a. However, it should be understood that in some forms, the tab 6024 may be smaller than this and still function as a panel retaining structure or a portion thereof.

[0168] The cover 6020 may also include a pair of opposing side flaps 6026 extending perpendicularly to the top wall 6022 and the end flaps 6024. The side flaps 6026 may be connected to both the top wall 6022 and the end flaps 6024. Thus, when the side panels 6006, the first end panel 6004a, and the second end panel 6004b are all folded inwardly, each side flap 6026 of the cover 6020 may be arranged to engage with an outer surface of a corresponding side panel 6006 in an upright position and thus serve as part of a panel retaining structure that also includes the end flaps 6024. The side flaps 6026 may (but need not) each have a height substantially equal to the height of the side panels 6006.

[0169] As shown, the cover 6020 has flaps 6024, 6026 connected to each other so that they do not move relative to each other. Additionally, the end flaps 6024 and / or the side flaps 6026 may not move relative to the top wall 6022. Therefore, when the cover 6020 is folded up and its inner surface is engaged with the outer surface of the first end panel 6004a and the side panel 6006, the cover 6020 acts as a panel retaining structure that surrounds and prevents the first end panel 6004a and the side panel 6006 from collapsing outward.

[0170] Alternatively, the flaps 6024 and 6026 can be separated from each other so that they can move relative to each other. When the cover 6020 is folded up and its inner surface is engaged with the outer surface of the first end panel 6004a and the side panel 6006, additional retaining means such as magnets can be provided between the inner surface and the outer surface so that the cover 6020 can act as a panel retaining structure that surrounds and prevents the first end panel 6004a and the side panel 6006 from collapsing outwardly. This configuration allows the package to be substantially flattened when opened.

[0171] In some forms, each pair of panels 6004a, 6004b, 6006 may be connected by a foldable connecting plate 6010. Figure 4A As shown, each foldable connecting panel 6010 can include a pair of substantially triangular portions 6012 joined at a fold line 6014. When the panels 6004a, 6004b, 6006 are folded inwardly, the connecting panels 6010 can fold inwardly about the fold line 6014 so that the substantially triangular portions 6012 are flattened relative to each other when the package 6000 is closed. By providing the connecting panels 6010 between the panels, folding the panels to form a housing for the patient interface 3000 becomes easier.

[0172] In some forms, the inwardly folded connection panel 6010 may extend at least partially across the second panel portion 6036, thereby reducing the internal volume of the package 6000. This may advantageously create less space for the patient interface to move within the package 6000.

[0173] At least one panel of the package 6000 also includes at least one patient interface retaining feature that can be attached to the patient interface 3000. Various examples of such retaining features are described in FIG. 8A to FIG. 8G , and will be described in further detail below. In some forms, each end panel and side panel may include one or more patient interface retention features.

[0174] For example, the second panel portion 6036 of the first end panel 6004a may include one or more patient interface retaining features 8004a, 8004b ( Figure 4C , Figure 4D , Figure 8G ), the one or more patient interface retaining features 8004a, 8004b are arranged to be attached to the patient interface 3000 at or near the inflatable chamber 3200. In some examples, the one or more patient interface retaining features are arranged at or near the inflatable chamber 3200 ( Figure 4D ) on either side. For example, the accordion section 3322 of the patient interface 3000 (see, e.g. Figure 3C and Figure 3D ) and / or near the connection point 3310 of the strip 3302 to the inflatable chamber 3200. Figure 4C and Figure 4D As shown, the patient interface retaining features 8004a and 8004b are configured to be engageable with each other so as to retain the patient interface 3000 within the package. In other words, the patient interface retaining features 8004a and 8004b do not cooperate with the patient interface 3000.

[0175] Alternatively, the patient interface retaining features 8004a and 8004b may engage with themselves to retain the patient interface 3000 within the package. Each retaining feature 8004a, 8004b may not mate with the patient interface 3000. Instead, each retaining feature 8004, 8004b wraps around a portion of the patient interface 3000 and folds against itself.

[0176] Alternatively, the patient interface 3000 may include complementary mating means for engaging with the patient interface retaining features 8004a, 8004b. The complementary mating means may be defined by the patient interface 3000, or may be attached to the patient interface 3000.

[0177] For hygienic purposes, the one or more patient interface retaining features 8004a, 8004b preferably do not contact the seal-forming structure 3100.

[0178] In some forms, the one or more patient interface retaining features 8004a, 8004b are arranged on the first end panel 6004a to provide a gap between the patient interface 3000 and the panels 6004a, 6006 when the patient interface 3000 is attached. For example, the one or more patient interface retaining features 8004a, 8004b may be arranged such that there is sufficient gap between the plenum 3200 and the first panel portion 6034 to prevent any ink or other material from being transferred from the interior surface of the first panel portion 6034 to the plenum 3200.

[0179] The one or more patient interface retaining features 8004a, 8004b ( Figure 4C , Figure 4D , Figure 8G ) can be magnetic and arranged to form a loop around the patient interface 3000 at or near the plenum chamber 3200. For example, the retaining feature 8004a can include a magnet and the retaining feature 8004b can include another magnet so that their different poles face each other and are configured for magnetic attraction. Thus, the retaining features 8004a and 8004b secure the patient interface 3000 in a loop formed when the magnets attract each other. Alternatively, the magnetic patient interface retaining feature can engage a complementary mating device on the patient interface 3000. The complementary mating device can be defined by the patient interface 3000, or can be attached to the patient interface 3000.

[0180] In some forms, the engageable nature of the patient interface retaining features 8004a, 8004b can allow them to be mechanically connected to each other. This can replace or be in addition to the magnetic connection described above. For example, the magnetic attraction between the patient interface retaining features 8004a, 8004b can provide additional retention to better ensure that the patient interface retaining features 8004a, 8004b remain connected to each other.

[0181] In certain forms, the patient interface retention feature 8004a may include a free end having a pair of arms 8005 configured to form a groove 8006. The patient interface retention feature 8004b may include an overhanging portion 8007 having a narrow portion proximate the free end. The groove 8006 may be a concave portion that receives the narrow portion (e.g., a convex portion) such that the pair of arms 8005 wrap around the patient interface retention feature 8004b and selectively lock the two features together. The patient interface retention feature 8004b may be slightly rotated (e.g., bent, rotated, flexed, etc.) relative to the patient interface retention feature 8004a to disengage the two features from each other.

[0182] In some forms, each side panel 6006 may include at least one patient interface retaining feature 8004a arranged to attach to a respective side of the patient interface 3000. For example, the at least one patient interface retaining structure may be attached to the second strap 3306 at a point intermediate the connector 3307 and the third strap 3308. In some forms, the at least one patient interface retaining feature 8004a may be attached to the second strap 3306 at a point at or near the connector 3307. In some forms, one patient interface retaining feature 8004a may be attached to the second strap 3306 at a point at or near the connector 3307 and another patient interface retaining feature 8004a may be attached to the second strap 3306 at a point at or near the third strap 3308. In some forms, the second strap 3306 , the connector 3307 , the third strap 3308 , and / or any point intermediate these entities can each independently include a magnet so as to be respectively attracted to the magnetic retaining features 8004a on each side panel 6006 .

[0183] In some forms, the first panel portion 6021 and / or the second panel portion 6022 of the second end panel 6004b may include one or more patient interface retention features arranged to attach to the patient interface 3000 at or near the third strap 3308. In some examples, the one or more patient interface retention features are arranged to attach on either side of the third strap 3308. For example, attachment to the second strap 3306 may be on either side of the third strap 3308. In some forms, the third strap 3308 or any point near the third strap 3308 may include a magnet so as to be attracted to the magnetic retention structure on the first panel portion 6021 and / or the second panel portion 6022, respectively.

[0184] In some forms, the one or more patient interface retaining features are arranged on the second end panel 6004b to provide clearance between the patient interface 3000 and the second end panel 6004b when the patient interface 3000 is attached. For example, the one or more patient interface retaining features 8004a, 8004b may be arranged such that there is sufficient clearance between the third and second ties 3308, 3306 and the end flap 6024 so that when the cover 6020 is closed over the side panel 6006 and the first end panel 6004a, the second and third ties 3306, 3308 do not interfere with closure.

[0185] In some forms, the second panel portion 6036 may include at least one patient interface retaining feature 8004b arranged to attach to a respective side of the patient interface 3000. For example, the at least one patient interface retaining structure may attach to the second strap 3306 at a point intermediate the connector 3307 and the third strap 3308. In some forms, the at least one patient interface retaining structure may attach to the second strap 3306 at a point at or near the connector 3307. In some forms, one patient interface retaining structure may attach to the second strap 3306 at a point at or near the connector 3307 and the other patient interface retaining structure may attach to the second strap 3306 at a point at or near the third strap 3308. In some forms, the second strap 3306, the connector 3307, the third strap 3308 and / or any point intermediate these entities can each independently include a magnet so as to be correspondingly attracted to the magnetic retaining feature 8004b on the second panel portion 6036.

[0186] In some forms, the package 6000 may be manufactured with patient interface retention features 8004a and 8004b that are substantially flush with the remainder of the surface of the corresponding panel. Figure 4C As shown, the patient interface retaining features 8004a and 8004b can be pulled away from the surface and leave a space 8009 in the surface corresponding to the shape of the respective retaining features 8004a, 8004b. The space 8009 can be a cutout or depression in the surface of the respective panel in the shape of the respective retaining features 8004a, 8004b.

[0187] In some forms, the outer surface 8008 of the patient interface retaining features 8004a, 8004b and / or the surface of the space 8009 formed in the surface of the corresponding panel can be attached with an adhesive or other connecting material (e.g., hook and loop material, magnets, mechanical fasteners, etc.). For example, the outer surface 8008 and the space 8009 can face each other (see, e.g., Figure 8G). When the retaining feature 8004a is separated from the retaining feature 8004b, the retaining feature 8004a can move toward the space 8009 in the layer 8002a so that the connecting material can retain the retaining feature 8004a relative to the corresponding panel. The same description can also apply to the retaining feature 8004b relative to the space 8009 in the layer 8002b. The use of the connecting material can allow the patient interface retaining features 8004a and 8004b to return to their substantially flush positions when not in use (e.g., forming a more compact appearance). The connecting material can also allow repeated connection and disconnection between the outer surface 8008 and the space 8009, so that the retaining features 8004a, 8004b can be stored when not in use and connected to each other when in use.

[0188] In some forms, prior to first use, the patient interface retaining features 8004a and 8004b may be at least partially outlined with perforations, which may indicate to the patient where the patient interface retaining features 8004a and 8004b are located.

[0189] In some forms, each patient interface retaining feature 8004a may be connected to a patient interface retaining structure 8004b located on a separate panel of the package 6000. The panels including the corresponding patient interface retaining features 8004a and 8004b may be adjacent to each other and separated by a fold line.

[0190] In some forms (not shown), a single panel may include two of the patient interface retention features 8004a, 8004b. In other words, a connected pair of patient interface retention features 8004a, 8004b may be included on the same panel rather than on adjacent panels, such as Figure 4C As shown in the picture.

[0191] The order of opening the package 6000 is FIG. 5A to FIG. 5C As depicted in Figure 5A As shown, the user grasps the exterior surface of the cover 6020 of the package 6000, such as at the end flap 6024 and the first panel portion 6021.

[0192] Then, if Figure 5BAs shown, the cover 6020 is pulled away from the first end wall defined by the first end panel portion 6034 of the first end panel 6004a. The illustrated example shows the cover 6020 moving in a first direction 6035 (e.g., counterclockwise as illustrated). This movement of the cover 6020 releases the first end panel 6004a to allow it to begin to collapse outward. In the illustrated example, the first end panel 6004a moves in a second direction 6037 (e.g., clockwise as illustrated), which is generally opposite to the first direction 6035. For example, the first end panel 6004a can be biased toward a collapsed position (e.g., where the first end panel portion 6034 moves toward being coplanar or coplanar with the second panel portion 6036, as shown). Figure 4B ) and can move toward the collapsed position when no longer constrained by the cover 6020. In the depicted example, since a gap is provided between the patient interface 3000 and the first end panel portion 6034, the patient interface 3000 does not apply any force to the first end panel portion 6034, but it will be appreciated that in other examples, the patient interface 3000 can push the first end panel portion 6034 outward to promote collapse.

[0193] exist Figure 5B In the intermediate position shown, the side flaps 6026 of the cover 6020 maintain partial contact with the side panels 6006. Figure 5C When fully removed as shown, the side panel 6006 is released and may begin to collapse outward. The side panel 6006 can be biased toward a collapsed position (e.g., wherein the side panel 6006 moves toward being coplanar or coplanar with the second panel portion 6036, such as Figure 4B 6020) and can move toward the collapsed position when no longer constrained by the cover 6020. The collapse can also be assisted by the weight of the strap 3302 and / or the first and second straps 3304, 3306 of the patient interface 3000, which can contact the interior surface of the side panels 6006 to push them outward. In the case where the strap 3302 includes a rigidizer 3316, if the rigidizer 3316 is elastic along at least a portion of its length, they can be stored in the package 6000 under tension and pop outward to contact the side panels 6006. In addition, when the cover 6020 is fully opened, the weight of the rear portion of the patient interface 3000 (including the third strap 3308 and portions of the first and second straps 3304, 3306) can be used to push the second end panel 6004b outward to cause it to collapse.

[0194] Thus, when the cover 6020 is fully open and the panels 6004a, 6004b, 6006 are fully released, the patient interface 3000 can be displayed in a configuration substantially corresponding to the manner in which it is worn by a patient in use, such as Figure 4B shown.

[0195] To further assist the patient, one or more interior surfaces of the packaging 6000 may carry printed indicia that may include graphics and / or text providing instructions for use of the patient interface 3000 .

[0196] Now go to FIG. 6A to FIG. 6D and FIG. 7A to FIG. 7D , showing another form of packaging of the present technology.

[0197] The package 7000 includes a plurality of panels 7004a, 7004b and 7006. The plurality of panels are arranged to fold inwardly to define a housing for the patient interface 3000.

[0198] In this example, the plurality of panels includes a first end panel 7004a and a second end panel 7004b, each joined to the bottom wall 7002 at respective fold lines 7022a, 7022b. The plurality of panels also includes a pair of opposing side panels 7006 joined to the bottom wall 7002 at fold lines 7020.

[0199] The first end panel 7004a has a pair of side flaps 7008a extending therefrom. A top flap 7009a extends from the first end panel 7004a and spans between the side flaps 7008a. The side flaps 7008a and the top flap 7009a together form a first cover portion 7010a extending from the first end panel 7004a.

[0200] In some forms, each side wing panel 7008a may be disposed substantially perpendicularly relative to the first end panel 7004a. In some forms, the top wing panel 7009a may be disposed substantially perpendicularly relative to the first end panel 7004a.

[0201] In some forms, this position can be maintained regardless of whether the package 7000 is in the open position or the closed position.

[0202] Similarly, the second end panel 7004b has a pair of side flaps 7008b extending therefrom. A top flap 7009b extends from the second end panel 7004b and spans between the side flaps 7008b. The side flaps 7008b and the top flap 7009b together form a second cover portion 7010b extending from the second end panel 7004b.

[0203] In some forms, each side wing panel 7008b may be disposed substantially perpendicularly relative to the second end panel 7004b. In some forms, the top wing panel 7009b may be disposed substantially perpendicularly relative to the second end panel 7004b.

[0204] In some forms, this position can be maintained regardless of whether the package 7000 is in the open position or the closed position.

[0205] In use, the two cover portions 7010a, 7010b cooperate with the end panels 7004a, 7004b and the side panels 7006 to close the patient interface 3000. To this end, the side panels 7006 are folded inwardly (towards the bottom wall 7002) about the fold lines 7020 to a substantially upright position, and then the end panels 7004a and 7004b are folded inwardly (towards the bottom wall 7002) so that the respective side flaps 7008a and 7008b pass over the side panels 7006 in the upright position, and the inner edges of the top panels 7009a, 7009b meet or nearly meet so that the top panels 7009a and 7009b together form a top wall covering the space defined by the end panels 7004a and 7004b and the side panels 7006. The side flaps 7008a and 7008b are used to prevent the side panels 7006 from collapsing outward when the covers 7010a, 7010b are in place. The sleeve 7030 ( Figure 7B ) is attached to the end panels 7004a, 7004b to prevent them from collapsing outwards. Therefore, the covers 7010a, 7010b and the sleeve 7030 serve as a panel retaining structure that closes and prevents the first and second end panels 7004a, 7004b and the side panels 7006 from collapsing outwards.

[0206] At least one panel of the package 7000 also includes at least one patient interface retaining feature that can be attached to the patient interface 3000 .

[0207] For example, Fig.7D As best shown, the first end panel 7004a can include one or more patient interface retention features 8014 arranged to be attached to the patient interface 3000 at or near the plenum 3200. In some examples, the one or more patient interface retention features 8014 are arranged to be attached on either side of the plenum 3200. For example, attachment can be made on either side at the accordion portion 3322, and / or near the connection point 3310 of the strap 3302 to the plenum 3200.

[0208] For hygienic purposes, one or more patient interface retaining features preferably do not contact the seal-forming structure 3100 .

[0209] In some forms, the one or more patient interface retaining features 8014 are arranged on the first end panel 7004a to provide a gap between the patient interface 3000 and the side wing piece 7008a when the patient interface 3000 is attached. For example, the one or more patient interface retaining features 8014 may be arranged so that there is sufficient gap between the patient interface 3000 and the side wing piece 7008a to enable the side panel 7006 to fit between the patient interface 3000 and the side wing piece 7008a.

[0210] The one or more patient interface retention features 8014 can be magnetic and arranged to form a loop around the patient interface 3000 at or near the plenum 3200. In some examples, the retention features 8014 include a magnet that is attracted to another magnet on the first end panel 7004a. Thus, the patient interface retention features 8014 secure the patient interface 3000 in a loop formed when the magnets attract each other.

[0211] In some forms, each side panel 7006 may include at least one patient interface retaining structure 8010 arranged to attach to a respective side of the patient interface 3000. For example, the at least one patient interface retaining structure 8010 may be attached to the second strap 3306 at a point intermediate the connector 3307 and the plenum 3200. In some forms, the at least one patient interface retaining structure 8010 may be attached to the second strap 3306 at a point at or near the connector 3307. In some forms, one patient interface retaining structure 8010 may be attached to the second strap 3306 at a point at or near the connector 3307 on one side of the connector 3307, and another patient interface retaining structure 8010 may be attached to the second strap 3306 at a point at or near the connector 3307 on the other side of the connector 3307. In some forms, each side panel 7006 may include at least one magnetic patient interface retaining structure 8010 arranged to attach to a respective side of the patient interface 3000. The respective sides of the patient interface 3000 may include magnets having different poles facing the magnetic patient interface retaining structure 8010. For example, the second strap 3306, the connector 3307, and / or any point intermediate these entities may each independently include a magnet so as to be attracted to the magnetic retaining feature 8014 on each side panel 7006, respectively.

[0212] In some forms, the patient interface retaining structure 8010 can be formed of a material separate from the panel (e.g., the side panel 7006). The patient interface retaining structure 8010 can be connected (e.g., using adhesives, sutures, mechanical connectors, etc.) to the panel. The patient interface retaining structure 8010 can be constructed of fabric, although other materials can also be used.

[0213] In some forms, the second end panel 7004b may include one or more patient interface retention features 8012 arranged to be attached to the patient interface 3000 at or near the third strap 3308. In some examples, the one or more patient interface retention features 8012 are arranged to be attached on either side of the third strap 3308. For example, Fig.7D As shown, the second strap 3306 may be attached on either side of the third strap 3308. In some forms, the second end panel 7004b may include at least one magnetic patient interface retaining feature 8012 arranged to be attached to a respective side of the patient interface 3000. The respective side of the patient interface 3000 may include a magnet having different magnetic poles facing the magnetic patient interface retaining feature 8012. For example, the third strap 3308 or any point in between the third strap 3308 may include a magnet so as to be correspondingly attracted to the magnetic retaining feature 8012 on the second end panel 7004b.

[0214] In some forms, the one or more patient interface retaining features 8012 are arranged on the second end panel 7004b to provide a gap 7042 between the patient interface 3000 and the side wing flap 7008b when the patient interface 3000 is attached. For example, the one or more patient interface retaining features 8012 may be arranged such that there is sufficient gap 7042 between the patient interface 3000 and the side wing flap 7008b so that when the cover portion 7010b is closed over the side panel 7006, the side panel 7006 may fit within the gap region 7042 so that the patient interface 3000 does not interfere with the closure of the cover portion 7010b.

[0215] The order of opening the package 7000 is FIG. 7A to FIG. 7D As depicted in Fig. 7A As shown, the user grasps the sleeve 7030 of the package 7000 and as Figure 7B As shown, begin to pull it apart to begin to expose the cover portions 7010a, 7010b.

[0216] In some forms, the user may first apply a force to one of the side panels 7006 (or the other panel, depending on the orientation of the sleeve 7030). Fig. 7AThe force 7100 can cause relative motion between the sleeve 7030 and the rest of the package 7000. In other words, the force 7100 can cause the package to move toward Figure 7B The orientation moves in Figure 7B In the embodiment, at least a portion of the cover portions 7010a, 7010b are exposed.

[0217] Once cover parts 7010a, 7010b (or a part thereof) are exposed, the user can continue to apply force to separate sleeve 7030 and fully expose packaging 7000. For example, the user can grab sleeve 7030 and pull in direction 7104. This direction 7104 can be oriented to be opposite to the direction of force 7100, so as to further expose cover parts 7010a, 7010b. Additionally, the user can pull packaging 7000 in direction 7108, and direction 7108 can be opposite to direction 7104. Pulling sleeve 7030 and packaging 7000 separately in opposite directions can help to fully expose cover parts 7010a, 7010b.

[0218] Then, if Figure 7C As shown, sleeve 7030 is completely removed from packaging 7000. This releases cover parts 7010a, 7010b, and therefore releases the end panels 7004a and 7004b to which they are attached, to allow them to collapse outwardly. For example, cover parts 7010a, 7010b can move in opposite directions while moving toward the open position. As illustrated, cover part 7010a can move in approximately counterclockwise direction "A", and cover part 7010b can move in approximately clockwise direction "B". The weight of the components of the patient interface 3000 attached to corresponding end panels 7004a and 7004b tends to push end panels 7004a, 7004b outwardly (away from bottom wall 7002) to promote collapse.

[0219] Finally, if Fig.7D As shown, after the end panels 7004a, 7004b collapse and the side flaps 7008a, 7008b leave the side panels 7006, the side panels 7006 also collapse under the weight of the straps 3302 and / or the first and second ties 3304, 3306 to which the side panels 7006 are attached. The collapse may be aided by the rigidizers 3316 because, as previously described, if the rigidizers 3316 are elastic along at least a portion of their length, they may be stored in the package 6000 under tension and spring outward to contact the side panels 7006.

[0220] Thus, when the covers 7010a, 7010b are fully open and the panels 7004a, 7004b, 7006 are fully released, the patient interface 3000 may be displayed in a configuration substantially corresponding to the manner in which it would be worn by a patient in use, such as Figure 4B shown.

[0221] Several non-limiting examples of patient interface retention structures are described in FIG. 8A to FIG. 8G Shown in.

[0222] exist Fig. 8A , Figure 8F and Figure 8G In an example of the present invention, the patient interface retaining structure 8004 can include a strip or band of material, such as cardboard, which is looped around a portion of the patient interface and secured to itself, or to another portion of the package (such as the bottom wall of the package), or to a layer of material 8002 attached to the bottom wall. The strip or band can be secured by any suitable means, such as an adhesive, tape, etc.

[0223] For example, in Fig. 8A In the embodiment of the present invention, each of the opposite ends of the strip of material 8004 can be inserted into a hole in the layer 8002. Figure 8F In another example shown, one end of the strip 8004 can be fixed to the surface of the layer 8002 and the other end (the free end) can be inserted into the hole 8003 in the layer 8002.

[0224] In some instances, such as Figure 8G As shown, the strip of material may be a cut portion of layer 8002 or otherwise extend from layer 8002 (e.g., this may be similar to Figure 4C ). For example, a strip 8004a cut from region 8002a may be looped around a portion of the patient interface 3000 and then secured to a surface of layer 8002. In other examples, a strip 8004a cut from region 8002a may be connected to a second strip 8004b cut from another region 8002b of layer 8002. In some forms, a head portion of a first strip 8004a may have a shape that is complementary to a head portion of a second strip 8004b such that the head portions interlock to secure the patient interface 3000 to the package.

[0225] Such as Fig. 8A , Figure 8F and Figure 8G The arrangement shown in may be useful where the package is designed to be disposable and preferably recyclable.

[0226] exist Figure 8B In the example of , the patient interface retaining feature 8012 includes a fabric or ribbon 8020 wrapped around a button 8022. One end of the ribbon 8020 can be secured to the package (e.g., the end panel 7004b), and the button 8022 can also be secured to the package so that the other end of the ribbon can be wrapped around the package.

[0227] exist Figure 8C In the example of , the patient interface retaining feature 8014 includes an elastic band 8030 having an aperture at the free end to receive a button 8032. The elastic band 8030 can be made of any material that provides elastic extensibility. One end of the elastic band 8030 can be fixed to the package (e.g., the end panel 7004a), and the button 8032 can also be fixed to the package so that the free end of the elastic band 8030 can be fixed to the button 8032. In this example, the button 8032 can be considered as a male portion that is selectively received in the opening of the elastic band 8030 (e.g., a female portion).

[0228] exist Fig.8D and Fig. 8E In the example of , the patient interface retaining structure 8010 includes an elastic band having a first end 8040 fixed to the package (such as the fixed side panel 7006), and a second free end 8042 carrying a male portion 8044 of a snap. The female portion 8046 of the snap is fixed to the package so that the free end 8042 of the elastic band can be stretched over a portion of the patient interface, and the male portion 8044 can be pressed into the female portion 8046 to fix the patient interface. It will be appreciated that the male and female portions can be interchanged.

[0229] As described above, the patient interface retaining feature can be magnetic. The magnetic patient interface retaining feature can have a first end secured to the package and a second free end that carries a magnet. The magnetic patient interface retaining feature is attracted to another magnetic patient interface retaining feature having an opposite magnetic polarity to secure the patient interface within the formed loop. Alternatively, the magnetic patient interface retaining feature can be attracted to another magnet on the first panel, second panel, and / or side panel of the package to secure the patient interface within the formed loop. Alternatively, the magnetic patient interface retaining feature can be attracted to another magnet on the patient interface to secure the patient interface.

[0230] For example, Fig.8D The convex portion 8044 and the concave portion 8046 in the embodiment may be connected to each other using magnetic attraction instead of and / or in addition to the mechanical interaction described above.

[0231] It has been found that retention features (and in particular magnetic retention features) better secure the patient interface in the package so that squeezing of the patient interface can be avoided. The retention features are used as retention features in the package so that the patient interface is presented in a fixed position when the package is opened. This can additionally be paired with instructions in the package to help the user understand how to wear the patient interface for the first time. If the patient interface has some rigidity, the retention features can also facilitate display of the patient interface when the package is opened.

[0232] FIG. 8A to FIG. 8G Any combination of the patient interface retention features and magnetic patient interface retention features in may be used with package 6000 or package 7000 .

[0233] Now refer to 9A to 9D Describes another form of packaging. Fig. 9C As best shown in the open view of FIG. 9000 , the package 9000 includes a plurality of panels 9004a, 9004b, 9006. The plurality of panels are arranged to fold inwardly to define a housing ( Fig. 9B ).

[0234] In this example, the plurality of panels includes a first end panel 9004a and a second end panel 9004b opposite the first end panel 9004a. The first end panel 9004a and the second end panel 9004b are each connected to a bottom panel 9002 defining a bottom wall of the package. Each of the first end panel 9004a and the second end panel 9004b can be folded inwardly (i.e., toward the bottom panel 9002) to a generally upright position to form a corresponding end wall of the housing for the patient interface 3000.

[0235] The plurality of panels also includes a top panel 9010 extending from the second end panel 9004b. The top panel 9010 can be folded inwardly to form a cover for the package 9000.

[0236] The plurality of panels also includes a pair of opposing side panels 9006. Each side panel 9006 can be folded inwardly (ie, toward the bottom panel 9002) into a generally upright position to form a side wall of a housing for the patient interface 3000.

[0237] The top panel 9010 includes one or more panel retaining structures for preventing the side panels 9006 and the first end panel 9004a from collapsing outwardly. For example, the top panel 9010 may include an end wing 9024 extending substantially perpendicular to the top panel 9010. The end wing 9024 may engage with an outer surface of the first end panel 9004a. The end wing 9024 serves as a panel retaining structure to prevent the first end panel 9004a from collapsing outwardly.

[0238] The top panel 9010 may also include a pair of opposing side flaps 9026 that extend perpendicularly to the top panel 9010 and the end flaps 9024. The side flaps 9026 may be connected to both the top panel 9010 and the end flaps 9024. Thus, when the side panels 9006, the first end panel 9004a, and the second end panel 9004b are all folded inwardly, each side flap 9026 of the top panel 9010 may be arranged to engage with an outer surface of a corresponding side panel 9006 in an upright position and thus function as part of a panel retaining structure that also includes the end flaps 9024.

[0239] In some forms, the top panel 9010 may include one or more magnetic connectors that releasably secure the top panel 9010 to the side panels 9006 and the first end panel 9004a. For example, the first end panel 9004a and the side panel 9006 may each include a first magnetic portion (e.g., located at a flat top portion of the first end panel 9004a and the side panel 9006) that magnetically attaches to a corresponding second magnetic portion on the top panel 9010.

[0240] At least one panel of the package 9000 also includes at least one patient interface retaining feature (as described above) that can be attached to the patient interface 3000. For example, a hook 9030 or other member (such as a clip, snap, or hook and loop fastener) can be provided on the lower surface of the top panel 9010 that is suitable for attachment to an upper portion of a patient interface (such as at a location along the overhead strap 3303).

[0241] In some forms, the hook 9030 can be comprised of a different material than the top panel 9010. For example, the hook 9030 can be comprised of a more rigid material than the top panel 9010.

[0242] like Fig.9D As shown, the hook 9030 can be positioned on the interior surface of the top panel 9010. The hook 9030 can be hung directly on the bottom panel 9002.

[0243] In some forms, hook 9030 may have a substantially angled shape. For example, Fig.9D The hook 9030 is illustrated as comprising a plurality of segments formed at angles relative to each other. These angles may be right angles, although other angles are also contemplated.

[0244] In other forms, the hook 9030 can be at least partially smooth. For example, the hook 9030 can be at least partially curved between its free end and the fixed end.

[0245] In some forms, at least one of the side panel 9006, the first end panel 9004a, and the second end panel 9004b may also include a patient interface retaining feature, such as FIG. 8A to FIG. 8G Any of the features shown in .

[0246] The top panel 9010 may also include tabs or other graspable members 9020 protruding from its exterior surface to enable a user to pick up the package without having to hold onto the sides of the package 9000. In some forms of the present technology, this causes one or more panel retaining structures to release due to the weight of the patient interface 3000, thereby allowing the side panels 9006 and first end panel 9004a to collapse.

[0247] In some forms, the top panel 9010 can be hinged at its mid-section to define a first top panel portion 9010a and a second top panel portion 9010b such that when panels 9006 and 9004a are released from the top panel 9010 under the weight of the patient interface 3000, the package 9000 is lifted by the tabs 9020 causing the top panel 9010 to collapse outward (away from the bottom panel 9002).

[0248] Packages 6000, 7000, 9000 may be partially or completely formed of paperboard. In some examples, the package may be formed of two or more layers of paperboard of different types. For example, the outer layer of the package may be 300gsm solid fiberboard, and the inner layer may be corrugated E-corrugated paperboard with a thickness of 1.5mm.

[0249] RPT Device

[0250] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electronic components and is configured to execute one or more algorithms, such as all or part of the methods described herein. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0251] Air circuit

[0252] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to travel between two components (such as the RPT device 4000 and the patient interface 3000) in use.

[0253] humidifier

[0254] Humidifier Overview

[0255] In one form of the present technology, a humidifier 5000 is provided to change the absolute humidity of air or gas delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0256] Glossary

[0257] For purposes of this technology disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0258] General

[0259] Air: In some forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology, air may be taken to mean some other combination of breathable gases, such as oxygen-enriched air.

[0260] Ambient: In certain forms of the present technology, the term ambient will be taken to mean (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0261] For example, relative to the surrounding environment of the humidifier humidity It may be the humidity of the air directly surrounding the humidifier, such as the humidity in the room that the patient is sleeping in. Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0262] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0263] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, rather than, for example, noise generated by the RPT device or noise emanating from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0264] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjusted between minimum and maximum limits, such as between each breath, depending on the presence or absence of an indication of an SDB event.

[0265] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0266] Flow rate: The amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate will be references to a scalar quantity, i.e., a quantity having only magnitude. In other cases, references to flow rate will be references to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate may be represented by the symbol Q. "Flow rate" is sometimes simply abbreviated to "flow" or "airflow".

[0267] In the example of a patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The device flow rate, Qd, is the flow rate of air leaving the RPT device. The total flow rate, Qt, is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. The ventilation flow rate, Qv, is the flow rate of air leaving the vent to allow flushing of exhaled gases. The leakage flow rate, Ql, is the leakage flow rate from the patient interface system or elsewhere. The respiratory flow rate, Qr, is the flow rate of air received into the patient's respiratory system.

[0268] Flow Therapy: Respiratory therapy that involves delivering a flow of air to the airway entrance at a controlled flow rate known as the therapeutic flow rate, which is usually positive throughout the patient's respiratory cycle.

[0269] Humidifier: The term humidifier will be taken to mean a humidifying device constructed and arranged or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0270] Leakage: The term leakage is to be considered as unintended air flow. In one example, a leak may occur due to an incomplete seal between the mask and the patient's face. In another example, a leak may occur in the swivel elbow leading to the ambient environment.

[0271] Conducted noise (acoustics): Conducted noise in this document refers to the noise transmitted to the patient through the pneumatic path (such as the air circuit and patient interface 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.

[0272] Radiated noise (acoustics): Radiated noise in this document is the noise transmitted to the patient by the surrounding ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0273] Ventilation noise (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any vent, such as the vent holes of a patient interface.

[0274] Oxygen-enriched air: air having an oxygen concentration greater than that of atmospheric air (21%), such as 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 referred to simply as "oxygen."

[0275] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.

[0276] Patient: A person, whether or not they have a respiratory condition.

[0277] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascals. 1 cmH2O is equal to 1 g-f / cm 2 And about 0.98 hPa (1 hPa = 100 Pa = 100 N / m 2 =1 mbar to 0.001 atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0278] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the interface pressure Pm at the current moment.

[0279] Respiratory Pressure Therapy: The application of a supply of air to the entrance of the airways at a therapeutic pressure that is usually positive relative to atmosphere.

[0280] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0281] Material

[0282] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness ranging from about 35 to about 45 measured using ASTM D2240.

[0283] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0284] Mechanical properties

[0285] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0286] Rebound: Will release substantially all of its energy when unloaded. Includes, for example, some silicones and thermoplastic elastomers.

[0287] Hardness: The ability of a material to resist deformation (described, for example, by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0288] "Soft" materials may include silicone or thermoplastic elastomers (TPE), and may deform easily, for example, under finger pressure.

[0289] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily under finger pressure, for example.

[0290] 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 a moment, such as compression, tension, bending or torsion. A structure or component may offer different resistance in different directions. The antonym of stiffness is flexibility.

[0291] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, such as 1 second.

[0292] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads normally encountered in use. Examples of such use may be, for example, placing and maintaining a patient interface in sealing relationship with a patient's airway entrance at a pressure of about 20 to 30 cmH2O.

[0293] For example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0294] Patient Interface

[0295] Anti-Asphyxia Valve (AAV): A component or subassembly of a mask system that reduces the risk of the patient rebreathing too much CO2 by opening to the atmosphere in a safe manner.

[0296] Elbow: An elbow is an example of a structure that directs the axis of air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater or less than 90 degrees. The elbow may have a generally circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotatable relative to a mating component, such as approximately 360 degrees. In some forms, the elbow may be removable from a mating component, such as via a snap connection. In some forms, the elbow may be assembled to a mating component via a one-time snap during manufacturing, but may not be removed by the patient.

[0297] Frame: A frame will be considered to refer to a mask structure that carries a tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0298] Headgear: Headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, headgear may include a collection of one or more supports, straps, and reinforcements configured to position and hold a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed of a soft, flexible, resilient material, such as a laminate composite of foam and fabric.

[0299] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0300] Plenum: A mask plenum will be taken to mean that part of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The shell may form part of the walls of the mask plenum.

[0301] Seal: can be a noun form referring to a structure ("seal") or a verb form referring to the effect ("seal"). Two elements can be constructed and / or arranged to "seal" or achieve a "seal" between them without requiring a separate "seal" element itself.

[0302] Shell: Shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0303] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0304] Braces: Braces will be considered to be structural components designed to increase the compression resistance of another component in at least one direction.

[0305] Rotator (n): A subassembly of components configured to rotate preferably independently about a common axis, preferably under low torque. In one form, the rotator may be configured to rotate through an angle of at least 360 degrees. In another form, the rotator may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. In use, there may be little or no air flow leakage from the rotator.

[0306] Tie (noun): A structure designed to resist tension.

[0307] Vent: (noun): A structure that allows air to flow from the interior or conduit of a mask to the ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the treatment pressure.

[0308] Other notes

[0309] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0310] Unless the context clearly indicates and where a numerical range is provided, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, and any other stated or intervening value in that stated range, is encompassed within the technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges and are also encompassed within the technology, subject to any specifically excluded limits in the stated range. Where the stated range includes one or both limits, ranges excluding one or both of those included limits are also encompassed within the technology.

[0311] Furthermore, where a value or values ​​are set forth herein as implemented as part of the technology, it should be understood that such values ​​may be approximate unless otherwise indicated, and that such values ​​may be used to any appropriate number of significant digits to the extent that practical technical implementation may allow or require it.

[0312] 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 the invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

[0313] When a specific material is identified as being used to construct a component, obvious alternative materials having similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

[0314] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0315] All publications mentioned herein are incorporated herein by reference in their entirety, to disclose and describe methods and / or materials as the subject of those publications. The publications discussed herein are provided only for their disclosures before the filing date of the present application. This article should not be construed as admitting that due to previous inventions, the present technology has no right to precede such publications. In addition, the publication date provided may be different from the actual publication date, which may need to be confirmed independently.

[0316] The terms “comprises” and “comprising” should be understood to refer to elements, components or steps in a non-exclusive manner, indicating that the mentioned elements, components or steps may be present or utilized or combined with other elements, components or steps not explicitly mentioned.

[0317] The subject headings used in the detailed description are included only for the convenience of the reader's reference and should not be used to limit the subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0318] Although the technology of this article has been described with reference to specific examples, it should be understood that these examples are merely illustrations of the principles and applications of the technology. In some cases, terms and symbols may imply specific details that are not required for practicing this technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but can be used to distinguish different elements. In addition, although the process steps in the method can be described or illustrated in order, this order is not necessary. Those skilled in the art will recognize that this order can be modified and / or its various aspects can be performed simultaneously or even synchronously.

[0319] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

Claims

1. A package for a patient interface, the package comprising: a plurality of panels arranged to move from an open position to a closed position, the closed position at least partially defining a volume for receiving the patient interface, the plurality of panels comprising a pair of opposing side panels and a pair of opposing end panels, wherein each of the plurality of panels is movable independently of other panels of the plurality of panels; a panel retaining structure removably connected to at least one of the panels of the plurality of panels, the panel retaining structure being arranged to prevent the panel from collapsing outwardly in a connected position; as well as at least one patient interface retaining feature connected to at least one of the panels of the plurality of panels, the at least one patient interface retaining feature configured to removably connect to the patient interface and retain the patient interface in a desired position; and Wherein the plurality of panels are biased toward the open position and are configured to move toward the open position when the panel retaining structure is released from at least one panel of the plurality of panels.

2. The package of claim 1, wherein the at least one patient interface retaining feature comprises one or more of: a tie; a clip; a snap; a strap; a hook and loop fastener; a button; and a magnet.

3. A package according to any one of claims 1 to 2, wherein the at least one patient interface retaining feature includes a plurality of patient interface retaining features, and wherein one patient interface retaining feature of the plurality of patient interface retaining features is connected to each panel of the plurality of panels.

4. A package according to any one of claims 1 to 2, wherein a pair of side flaps and an end flap extend from at least one of the pair of opposing end panels.

5. The package of claim 4, wherein the pair of side flaps and the end flap are oriented substantially perpendicular to the at least one end panel in the open position and in the closed position.

6. The package of claim 4, wherein each of the pair of side flaps contacts one of the pair of opposing side panels in the closed position.

7. The package of claim 6, wherein the at least one end panel is a pair of end panels, and each of the pair of end panels comprises a pair of side flaps and an end flap, wherein each of the pair of side flaps of the pair of end panels contacts one of the pair of opposing side panels in the closed position.

8. The package of claim 7, wherein the pair of side flaps of one of the at least one end panel are spaced apart from the pair of side flaps of the other of the at least one end panel.

9. The package of claim 6, wherein the panel retaining structure is a sleeve removably positionable about an exterior surface of the at least one end panel, wherein the sleeve is configured to selectively retain the at least one end panel in the closed position.

10. The package of claim 9, wherein in the closed position, the sleeve is in contact with the end flap.

11. The package of claim 4, further comprising a hook connected to a top panel extending from the at least one end panel.

12. The package of claim 11, wherein the hook is connected to the top panel as a cantilever structure.

13. The package according to any one of claims 1 to 2 further comprises a bottom wall configured to support the plurality of panels in an upright position, wherein each of the plurality of panels is connected to the bottom wall via a hinge, and wherein each of the plurality of panels is configured to be pivotally movable relative to the bottom wall.

14. A packaging system comprising: Patient interface; as well as A package according to any one of claims 1 to 13.

15. A storage system comprising: Patient interface; as well as A package configured to selectively receive the patient interface, the package comprising: a plurality of panels arranged to move from an open position to a closed position, the closed position at least partially defining a volume for receiving the patient interface, the plurality of panels comprising a pair of opposing side panels and a pair of opposing end panels, wherein each of the plurality of panels is movable independently of other panels of the plurality of panels; At least one patient interface retaining feature connected to at least one of the panels among the plurality of panels, the at least one patient interface retaining feature being configured to be removably connected to the patient interface and to retain the patient interface in a desired position, the at least one patient interface retaining feature comprising a convex portion and a concave portion configured to be selectively connected to each other, wherein the patient interface retaining feature forms a loop when the convex portion and the concave portion are connected to each other, and wherein the loop is configured to wrap around a portion of the patient interface.

16. The storage system of claim 15, wherein the package further comprises a panel retaining structure arranged to prevent the panels from collapsing outwardly such that the patient interface remains in a compressed state.

17. The storage system of claim 16, wherein the panel retaining structure comprises a cover having at least one flap arranged to engage an exterior surface of a first end panel of the pair of opposing end panels.

18. The storage system of claim 17, wherein the cover extends from and / or includes at least a portion of a second of the pair of opposing end panels.

19. The storage system of claim 18, wherein the lid has a hinge connected to or as part of the second end panel.

20. The storage system of claim 19, wherein a portion of the second end panel forms a top wall of the cover.

21. A storage system according to claim 17, wherein the cover includes a first cover portion and a second cover portion, the first cover portion and the second cover portion each including a pair of opposite side wing pieces, the pair of opposite side wing pieces are arranged to engage with corresponding side panels, and wherein the panel retaining structure includes the opposite side wing pieces of the first cover portion and the second cover portion.

22. The storage system of claim 21, wherein each cover portion includes a top wall extending transversely to its opposed side flaps and a respective one of the end panels.

23. A storage system as claimed in any one of claims 15 to 22, wherein the panels are joined by foldable connecting panels.

24. The storage system of any one of claims 15 to 22, wherein the at least one patient interface retaining feature comprises a strap, and wherein the strap is formed from a cut portion of a layer of material laminated to one of the panels.

25. A storage system according to claim 24, wherein the strip includes a convex portion and a concave portion, wherein the convex portion is formed on one of the plurality of panels and the concave portion is formed on another of the plurality of panels adjacent to the one of the plurality of panels.

26. The storage system of claim 25, wherein the male portion and the female portion selectively form a mechanical connection therebetween to form the loop for retaining the patient interface.

27. The storage system of claim 26, wherein the male portion includes an undercut selectively receivable within a recess of the female portion.

28. The storage system of any one of claims 25 to 27, wherein the male portion and the female portion are selectively connected to each other using magnetic force.

29. A storage system according to any one of claims 15 to 22, wherein the at least one patient interface retaining feature comprises a strip, wherein the convex portion is formed on the strip or at least one panel, and the concave portion is formed on the other of the strip or at least one panel.

30. The storage system of claim 29, wherein the male portion and the female portion comprise one or more of: a snap; a hook and loop fastener; a button; and a magnet.

31. A storage system according to any one of claims 15 to 22, wherein one of the end panels comprises at least two patient interface retaining features arranged to be attached to the patient interface on either side of a sealing forming structure of the patient interface or at opposite ends of a rear strip of a positioning and stabilizing structure of the patient interface.

32. The storage system of any one of claims 15 to 22, wherein the at least one patient interface retaining feature comprises a magnet for attracting to a magnet on the patient interface.

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