Apparatus, systems, and methods for positioning and stabilizing a patient interface

Abstract

A patient contact member is disclosed. The patient contact member can be configured to releasably engage a gas delivery tube that forms part of a positioning and stabilising structure of a patient interface. The patient contact member can include an elongate sleeve portion that is engageable with the gas delivery tube and a strap configured to engage with the back of a patient's head in use. A system for positioning and stabilising a patient interface is also disclosed, which includes a plurality of patient contact members.

Description

Background Technology 1.1 Technical Field

[0002] This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0003] 1.2 Description of related technologies

[0004] 1.2.1 Human Respiratory System and Its Diseases

[0005] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0006] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0007] There are a range of respiratory diseases. Some diseases can be characterized by specific events, such as sleep apnea, hypoventilation, and hyperventilation.

[0008] 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.

[0009] 1.2.2 Treatment

[0010] Various respiratory therapies, such as continuous positive airway pressure (CPAP), noninvasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the above-mentioned respiratory disorders.

[0011] 1.2.2.1 Respiratory pressure therapy

[0012] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic brachial tubes).

[0013] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0014] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to assist breathing and / or maintain adequate oxygen levels by performing some or all of the work of breathing. Ventilation support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure forms such as OHS, COPD, NMD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.

[0015] Non-invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0016] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor 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] Another type of treatment system is the mandibular repositioning device.

[0019] 1.2.2.2 Patient Interface

[0020] Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow-based treatments such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0021] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving can be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.

[0022] Certain masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow it through the mouth.

[0023] If patients need to insert part of the mask structure into their mouths to create and maintain a seal through their lips, some masks may be uncomfortable or impractical for this technique.

[0024] Some face masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[0025] CPAP therapy is highly effective for treating certain respiratory conditions, provided the patient adheres to the treatment. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Because patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean it, and this can affect patient adherence.

[0026] While masks designed for other applications (such as navigators) may not be suitable for treating sleep-disordered breathing, masks designed for treating sleep-disordered breathing may be suitable for other applications.

[0027] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0028] 1.2.2.2.1 Sealing Formation Structure

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

[0030] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0031] One form of nasal pillow is found in the Adam circuitry manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0032] ResMed Limited manufactures the following products that combine nose pillows: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMedLimited describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (described by ResMedLimited SWIFT) TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (describes ResMed Limited SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (describe ResMed Limited MIRAGE LIBERTY) TM Other aspects of the full-face mask); International patent application WO2009 / 052,560 (describes ResMed Limited SWIFT) TM Other aspects of the FX nose pillow).

[0033] 1.2.2.2.2 Positioning and Stability

[0034] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of air pressure, which can disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain a sealing relationship with the appropriate part of the face.

[0035] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0036] Another technique involves using one or more straps and / or stabilizing shoulder straps. Many such shoulder straps suffer from one or more problems of being unsuitable, bulky, uncomfortable, and inconvenient to use.

[0037] One form of positioning and stabilization structure includes a pair of gas delivery tubes for receiving airflow from a connection port at the top of the patient's head and delivering the airflow to the inlet of the patient's airway through a sealing structure. In this example, the gas delivery tubes may be made of silicone.

[0038] It may be necessary to manufacture this type of positioning and stabilizing structure in various sizes to accommodate the full range of patient head sizes.

[0039] Some of the positioning and stabilizing structures described above can be made of silicone. Because some patients may dislike the feel of silicone against their skin, some existing positioning and stabilizing structures have been manufactured as fabric sleeves with a permanent attachment covering at least a portion of the gas delivery tubing. However, this can make it difficult to inspect the catheter to confirm its cleanliness. It may also be difficult to properly clean the gas delivery tubing while the sleeve is in place.

[0040] 1.2.2.3 Respiratory Pressure Therapy (RPT) Device

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

[0042] 1.2.2.4 Air Circuit

[0043] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiratory and expiratory breathing. In other cases, a single branch air circuit is used for both inspiratory and expiratory breathing.

[0044] 1.2.2.5 Humidifier

[0045] Delivering airflow without humidification can lead to airway dryness. The use of humidifiers with an RPT device and patient interface produces humidified gas that minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air. Therefore, humidifiers typically have the ability to both heat and humidify the airflow.

[0046] 1.2.2.6 Ventilation Technology

[0047] Some forms of therapeutic systems may include vents to allow for the flushing of exhaled carbon dioxide. Vents can allow gas to flow from the internal space of the patient interface, such as an inflation chamber, to the outside of the patient interface, such as the surrounding environment. Summary of the Invention

[0048] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0049] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0050] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0051] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0052] One form of this technology includes a patient contact component comprising an elongated sleeve portion that releasably engages with a gas delivery tube forming part of a positioning and stabilization structure for the patient interface.

[0053] Another form of the technology includes a system for positioning and stabilizing a patient interface, the system including a positioning and stabilizing structure comprising at least one gas delivery tube, and the system including a plurality of patient contact members releasably engaging with the gas delivery tube.

[0054] One form of the technology includes a patient contact member configured to releasably engage a gas delivery tube forming part of a positioning and stabilization structure for a patient interface. The patient contact member includes an elongated sleeve portion that engages with the gas delivery tube and a strap configured to engage the back of a patient's head in use.

[0055] In some examples:

[0056] a. The elongated sleeve portion has a length and a width, and the length is greater than twice the width;

[0057] b. The length is greater than four times the width;

[0058] c. The slender sleeve portion is configured to be positioned adjacent to the interface structure of the patient interface during use;

[0059] d. The patient contact component comprises two elongated sleeve sections;

[0060] e. The belt comprises two belt sections and a connector device for connecting these belt sections to each other;

[0061] f. The connector device allows adjustment of the length of the strap;

[0062] g. The belt includes an elastic, extendable portion;

[0063] h. The belt is releasably connected to the elongated sleeve portion;

[0064] i. The elongated sleeve portion includes a receiving device, which includes an opening for receiving a strip;

[0065] j. The elongated sleeve portion includes a plurality of receiving devices spaced apart along the elongated sleeve portion;

[0066] k. A receiving device or each receiving device includes a tab provided with a slot to receive the strip;

[0067] l. The slender sleeve portion includes a rigid section;

[0068] m. The rigid part is curved;

[0069] n. The patient contact component includes an additional strap or strap section configured to pass around the back of the patient's neck during use;

[0070] o. The elongated sleeve portion has a patient contact side and a non-patient contact side, wherein the patient contact side contacts at least the patient's cheek area during use;

[0071] p. The elongated sleeve portion has a window portion on the non-patient contact side;

[0072] q. The window portion includes an opening in the patient contact component;

[0073] r. The window portion includes a first side and an opposing second side, wherein an elastic line engages with the first side and the second side;

[0074] s. A first side is provided with a plurality of first rings, and a second side is provided with a plurality of second rings, wherein the elastic line extends through the plurality of first rings and the plurality of second rings;

[0075] t. A portion of the non-patient contact side includes a mesh; and / or

[0076] u. The window portion includes transparent material.

[0077] Another aspect of certain forms of this technology is a system for locating and stabilizing a patient interface, the system comprising:

[0078] Positioning and stabilizing structure, comprising at least one gas delivery pipe; and

[0079] Multiple patient contact components, each patient contact component including: an elongated sleeve portion that interchangeably engages with the gas delivery tube; and a strap configured to engage the back of the patient's head in use;

[0080] The length of the elongated sleeve portion of the first of the plurality of patient contact components is different from the length of the elongated sleeve portion of the second of the plurality of patient contact components.

[0081] Another aspect of certain forms of this technology is a system for locating and stabilizing a patient interface, the system comprising:

[0082] Positioning and stabilizing structure, comprising at least one gas delivery pipe; and

[0083] Multiple patient contact components, each patient contact component including: an elongated sleeve portion that interchangeably engages with the gas delivery tube; and a strap configured to engage the back of a patient's head in use;

[0084] Each patient contact component includes a rigid portion that bends along its length, and

[0085] The first of the plurality of patient contact components has a different arc length than the second of the patient contact components.

[0086] Another aspect of certain forms of this technology is a patient contact member configured to releasably engage a gas delivery tube for a patient interface, wherein the patient contact member includes a patient contact portion and a resilient, flexible clamping portion configured to releasably engage the gas delivery tube.

[0087] In the embodiment:

[0088] a. The resilient and flexible clamping portion extends substantially along the entire length of the patient contact portion;

[0089] b. The elastic flexible clamping portion defines a groove extending along the length of the elastic flexible clamping portion;

[0090] c. The gas delivery tubing forms part of the positioning and stabilizing structure of the patient interface;

[0091] d. The patient contact component includes a foam layer; and / or

[0092] e. The patient contact component includes a fabric layer on the patient contact side of the patient contact component.

[0093] Another aspect of certain forms of this technology is a patient contact member configured to releasably engage a gas delivery tube structure for a patient interface, wherein the patient contact member includes a patient contact portion and an engagement portion defining a groove along its length, wherein the groove is shaped and configured such that the gas delivery tube can be inserted into the patient contact member through the groove.

[0094] In the embodiment:

[0095] a. The joining portion includes an elastic flexible clamping portion;

[0096] b. The gas delivery tube forms part of the positioning and stabilizing structure of the patient interface;

[0097] c. The patient contact component includes a foam layer; and / or

[0098] d. The patient contact component includes a fabric layer on the patient contact side of the patient contact component.

[0099] Another aspect of certain forms of this technology is a system for locating and stabilizing a patient interface, the system comprising:

[0100] Positioning and stabilizing structure, comprising at least one gas delivery pipe; and

[0101] Multiple patient contact components, each configured to releasably engage the gas delivery tube, wherein each patient contact component includes a patient contact portion and an elastic flexible clamping portion configured to releasably engage the gas delivery tube;

[0102] The length of the patient contact portion of the first of the plurality of patient contact components is different from the length of the patient contact portion of the second of the plurality of patient contact components.

[0103] Another aspect of certain forms of this technology is a system for locating and stabilizing a patient interface, the system comprising:

[0104] Positioning and stabilizing structure, comprising at least one gas delivery pipe; and

[0105] Multiple patient contact components, each configured to releasably engage the gas delivery tube, wherein each patient contact component includes a patient contact portion and an elastic flexible clamping portion configured to releasably engage the gas delivery tube;

[0106] Each patient contact component includes a rigid portion that bends along its length, and

[0107] The first of the plurality of patient contact components has a different arc length than the second of the patient contact components.

[0108] Another aspect of certain forms of this technology is a gas delivery tube assembly for a patient interface, the assembly including a gas delivery tube having a patient-facing side and a non-patient-facing side, the assembly further including a patient-facing liner member releasably connectable to the gas delivery tube.

[0109] The patient-facing side of the gas delivery tube and one of the lining members include at least one complete ring material, and the other of the patient-facing side of the gas delivery tube and the lining member includes at least one hook material configured to releasably engage the complete ring material.

[0110] In the embodiment:

[0111] a. The gas delivery tube forms part of the positioning and stabilization structure of the patient interface;

[0112] b. The lining components include a foam layer;

[0113] c. The lining member includes a fabric layer on the patient contact side of the lining member;

[0114] d. One of the patient-facing sides of the gas delivery tube and the lining component includes multiple segments of complete ring material and / or hook material;

[0115] e. Both the patient-facing side of the gas delivery tube and the lining component comprise multiple segments of complete ring material and / or hook material; and / or

[0116] f. The lining components have a thickness of at least 2 mm.

[0117] One aspect of this technology is a method for manufacturing equipment.

[0118] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0119] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier canister that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment.

[0120] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0121] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0122] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0123] The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including:

[0124] 3.1 Respiratory Therapy System

[0125] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine position.

[0126] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0127] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0128] 3.2 Respiratory System and Facial Anatomy

[0129] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0130] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, supralabial and sublabial folds, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0131] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corners of the mouth. It also indicates the directions of up, down, radially inward, and radially outward.

[0132] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, supralipal, sublipal, supramental, nasal ridge, nasal alar apex, supraauricular, and subauricular points. It also indicates the vertical and horizontal directions.

[0133] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.

[0134] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, sublipus, upper vermilion border, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0135] Figure 2G A side view showing the features of the nasal surface is shown.

[0136] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0137] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0138] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0139] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0140] Figure 2L The frontal lateral view of the nose is shown.

[0141] 3.3 Patient Interface

[0142] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0143] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0144] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0145] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0146] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0147] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0148] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The dome and saddle-shaped areas are indicated.

[0149] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and a dome-shaped area are indicated.

[0150] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0151] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0152] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0153] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0154] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. The inner surface defines a two-dimensional aperture in the mask.

[0155] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0156] Figure 3O The left-hand rule is shown.

[0157] Figure 3P The right-hand rule is shown.

[0158] Figure 3Q The left ear is shown, including the left ear spiral.

[0159] Figure 3R The right ear is shown, including the right ear spiral.

[0160] Figure 3S A right-handed spiral is shown.

[0161] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0162] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0163] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts: the left-hand side and the right-hand side.

[0164] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a section taken at the sagittal plane. The "intermediate contact" plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3230). Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0165] Figure 3X It shows Figure 3UThe position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 substantially coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane substantially corresponds to the "plane of the face". Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper lip.

[0166] Figure 3Y A patient interface in the form of a nasal cannula according to the present technology is shown.

[0167] 3.4RPT device

[0168] Figure 4A An RPT device of one form according to the present technology is shown.

[0169] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0170] 3.5 Humidifier

[0171] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0172] Figure 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0173] 3.6 Examples of patient contact components of this technology

[0174] Figure 6 A perspective view of the patient interface is shown.

[0175] Figure 7 This is a perspective view of a patient contact component, an example of this technology, which engages with a patient interface.

[0176] Figure 8 This is a perspective view of a patient contact component according to the present technology, which engages with a patient interface.

[0177] Figure 9 This is a perspective view of a patient contact component according to the present technology, which engages with a patient interface.

[0178] Figure 9A It is based on Figure 9 A perspective view of a patient contact component having an optional connector disposed on a lower band.

[0179] Figure 10 This is a perspective view of a patient contact component according to the present technology, which engages with a patient interface.

[0180] Figure 11 This is a side view of a patient contact component according to this technology, which engages with a patient interface.

[0181] Figure 12 This is an enlarged side view of a window portion of a patient contact component according to another example of the present technology.

[0182] Figure 13 This is an enlarged side view of another form of the window portion of the patient contact component according to another example of this technology.

[0183] Figure 14 This is a perspective view of a patient contact component according to another example of this technology.

[0184] Figure 15 This is a side view of a patient contact component according to another example of the technology, shown as a catheter separated from the positioning and stabilizing structure.

[0185] Figure 16 yes Figure 15 A front view of the patient contact component, showing the patient contact component attached to the catheter of the positioning and stabilizing structure.

[0186] Figure 17 This is a schematic diagram of two patient contact components with the same chord length but different arc lengths.

[0187] Figure 18 A perspective view of one form of lining component according to the present technology is shown.

[0188] Figure 19 This is a side view of one form of gas delivery pipe assembly according to the present technology, the gas delivery pipe assembly including a portion that engages with a conduit portion. Figure 18 Lining components.

[0189] Figure 20 This is a side view of a patient contact component according to the present technology, seen from the non-patient contact side.

[0190] Figure 21 Viewed from the patient's contact side Figure 20 A side view of the patient contact component.

[0191] Figure 22 It is a conduit attached to the positioning and stabilizing structure. Figure 20 A magnified perspective view of the patient contact components.

[0192] Figure 23 It is a conduit attached to the positioning and stabilizing structure. Figure 20 A side view of the patient contact component. Detailed Implementation

[0193] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0194] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0195] 4.1 Treatment

[0196] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0197] In some examples of this technique, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0198] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0199] 4.2 Respiratory Therapy System

[0200] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0201] 4.3 Patient Interface

[0202] According to one aspect of the present technology, a noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an 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, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0203] The unsealed patient interface 3800 in the form of a nasal cannula includes nasal inserts 3810a and 3810b, which deliver air to the individual nostrils of a patient 1000 via corresponding orifices in their tips. These nasal inserts typically do not form a seal with the inner or outer skin surface of the nostril. Air can be delivered to the nasal inserts via one or more air supply lumens 3820a and 3820b connected to the nasal cannula 3800. The lumens 3820a and 3820b extend from the nasal cannula 3800 to a respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. A “vent” at the unsealed patient interface 3800 is a passage between the ends of the inserts 3810a and 3810b of the cannula 3800 through the patient’s nostrils to the atmosphere; excess airflow escapes into the surrounding environment through this vent.

[0204] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0205] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to the environment.

[0206] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cmH2O relative to the environment.

[0207] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0208] 4.3.1 Sealing Formation Structure

[0209] In one form of this 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 may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0210] 4.3.1.1 Sealing Mechanism

[0211] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0212] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from buckling during use.

[0213] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0214] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0215] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0216] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0217] 4.3.1.2 Nasal pillow

[0218] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0219] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0220] 4.3.2 Positioning and Stabilizing Structure

[0221] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by positioning and stabilizing structure 3300.

[0222] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away.

[0223] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0224] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0225] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.

[0226] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0227] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying on the pillow in a side-sleeping position with the side of the patient's head on the pillow.

[0228] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. This decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0229] In one form of this technology, the positioning and stabilizing structure 3300 includes a strip constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strip. In one form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0230] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, such as elastically extendable. For example, the strap may be configured to be tensioned during use and to guide a force to pull the sealing structure into a sealing contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0231] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt that is flexible and, for example, non-rigid. An advantage of this is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0232] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0233] In some forms of this technology, the positioning and stabilization structure 3300 includes one or more tubes that, for example, deliver pressurized air received from a conduit forming part of an air circuit 4170 from the RPT device to the patient's airway via an interface structure 3010, which includes an inflation chamber 3200 and a sealing formation structure 3100, such as... Figure 6As shown. In the example, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the sealing structure 3100. The tubes 3350 are integral part of the positioning and stabilizing structure 3300 of the patient interface 3000 to position and stabilize the sealing structure 3100 of the patient interface to an appropriate part of the patient's face (e.g., nose and / or mouth). This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to the connection port 3600 of the patient interface in a location other than in front of the patient's face, which may be unsightly for some. While there are some advantages to using a pair of tubes 3350 (described below), in some examples, the positioning and stabilizing structure 3300 includes only a single tube 3350 configured to cover the patient's head on one side. A strap or other stabilizing component may be provided on the other side of the patient's head between the tip of the single tube 3350 and the sealing structure 3100 to provide balanced forces on the sealing structure 3100.

[0234] In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or rear of the patient's head. For example, in Figure 6 In the illustrated form of the present technology, the connection port 3600 is located at the top of the patient's head. In this example, the patient interface 3000 includes a bend 3610 to which the connection port 3600 is disposed. The bend 3610 is rotatable relative to the positioning and stabilizing structure 3300 to disengage the movement of a catheter connected to the connection port 3600 from the positioning and stabilizing structure 3300. The bend 3610 may be connected to a fluid connection opening in or to a component connected to a head sleeve 3350. Alternatively or additionally, the catheter connected to the connection port 3600 may be rotatable relative to the bend 3610. In the illustrated example, the bend 3610 includes a rotary catheter connector that includes an air circuit 4170 to which a catheter can be connected to the connection port 3600, allowing the catheter to rotate about its longitudinal axis relative to the bend 3610. In some examples, the air circuit 4170 may be connected to a fluid connection opening. The bend 3610 can be rotatably connected to a fluid connection opening or to a ring housed in the fluid connection opening.

[0235] exist Figure 6In the example shown, two tubes 3350 are integrally formed and include a fluid connection opening, to which a swivel bend is connected. In other instances, when using separate tubes, they may be indirectly connected together, for example, each may be connected to a T-shaped catheter with two catheter arms, each catheter arm being fluidly connected to tube 3350. The coronal connector may include a third catheter arm. The connection port 3600 may include an elbow 3610 received at the center of the coronal connector 3360. The elbow 3610 may be configured to rotate.

[0236] 4.3.3 Head sleeve for connection to pipe

[0237] In some forms of this technology, for example, Figure 6 As shown, the positioning and stabilizing structure 3300 includes at least one headband 3310, which, in addition to the tube 3350, is used to position and stabilize the sealing forming structure 3100 in a sealed position at the patient's airway inlet. In one example, the patient interface 3000 includes the band 3310 forming part of the positioning and stabilizing structure 3300. For example, the band 3310 may be referred to as a back strap or rear headband. In other examples of the art, one or more additional bands may be provided. For example, a patient interface 3000 with a full face or nasal pad module according to an example of the art may have a second lower band configured to cover the back of the patient's neck.

[0238] In some examples of this technology, tube 3350 is configured to receive strap 3310 (e.g., by providing tab 3320) at a location above and near the patient's ear. If strap 3310 is connected to tube 3350 that is too high relative to the patient's head, strap 3310 may tend to drape upwards over the back of the patient's head. Additionally, strap 3310 may form too large an angle relative to the upper part of headband tube 3350, causing the patient to need to excessively tighten strap 3310, which may result in excessive tension in the positioning and stabilization structure 3300 and may make strap 3310 more likely to drape over the back of the patient's head. Therefore, it is advantageous that the connection between strap 3310 and tube 3350 is set as low as possible, but spaced sufficiently from the top of the patient's ear, so that when strap 3310 is tightened, tube 3350 is not pulled into contact with the patient's ear.

[0239] As described below, in other forms of this technology, tube 3350 is not configured to receive tape 3310. In some forms of this technology, one or more tapes may be connected to patient contact members 3370, 3380 and / or may form part of patient contact members 3370, 3380. In these forms of the technology, considerations similar to those discussed above apply to the positioning of the tapes.

[0240] 4.3.4 Patient contact components

[0241] Next reference Figure 7 , 8 In some forms of this technology, patient contact component 3370 is provided. Figures 7 to 9 In the illustrated embodiment, the patient contact member 3370 includes an elongated sleeve portion 3371 (or sleeve portion 3371) configured to releasably engage a tube 3350 (e.g., a catheter) of the positioning and stabilizing structure 3300. In one form of this technology, the elongated sleeve portion 3371 may be partially or entirely formed of fabric. The textile may be woven or nonwoven.

[0242] In the example, the elongated sleeve portion 3371 may be made of an elastic material, or may include one or more portions made of an elastic material to facilitate insertion of the tube 3350 through the elongated sleeve portion 3371. In the example, the elongated sleeve portion 3371 may be sized to allow the tube 3350 to slide through the elongated sleeve portion 3371, wherein one or more elastic portions of the elongated sleeve portion 3371 may extend, or not extend, any portion of the elongated sleeve portion 3371. The sleeve portion 3371 may be configured to allow a user (e.g., a patient) to repeatedly engage and disengage the tube 3350 (e.g., without damage), rather than being engaged and / or manufactured by the manufacturer with the tube 3350 and difficult or substantially impossible for the patient to disengage the tube 3350 (at least without damaging the patient contact member and / or the tube). Figure 6 The prior art sleeve 3364 is shown, which is the type that the manufacturer permanently engages with the head sleeve 3350.

[0243] In some forms of this technology, the patient contact component 3370 also includes a strap 3310, such as a shoulder strap 3310 as described above.

[0244] In some forms of this technology, the patient contact component 3370 includes two sleeve portions 3371, each sleeve portion 3371 being configured to connect to a corresponding tube 3350 disposed on the opposite side of the positioning and stabilizing structure 3300.

[0245] exist Figure 10 In the example shown, the two sleeve portions 3371 and the shoulder strap 3310 are integrally formed as a single piece, for example, from the same material. However, in other forms of this technology (e.g., as...) Figure 14 As shown), the shoulder strap 3310 may include two separate shoulder strap portions 3312 (in... Figure 14 (Only one is shown in the image), and the two shoulder strap sections can be connected together via a suitable connector device 3313 (e.g., an adjustable connector device 3313 that allows adjustment of the total length of the shoulder strap 3310). In the example, a hook and loop fastening system (e.g., Velcro) can be used. TMFor example, the end of the strap portion 3312 may be provided with a portion of a complete loop material 3314, and adjacent portions of each strap portion 3312 may be provided with a portion of a broken loop (e.g., hook) material 3315, such that each strap portion 3312 can pass through a suitable connector and can be attached to itself. In other examples, the positions of the broken loop material and the complete loop material may be reversed on one or both of the strap portions 3312. In other examples, one of the strap portions 3312 may be provided with a portion of a broken loop material, while the other strap portion 3312 may be provided with a portion of a complete loop material, such that the two strap portions 3312 can be connected together without the use of an intermediate connector device. Additionally or alternatively, one or more portions of the strap 3310 may be formed of a resilient, stretchable material. In the example, when the interface is put on or taken off, the strap 3310 can extend over the patient's head without requiring the patient to adjust the length of the strap 3310 or to disengage the strap 3310 from the patient contact member 3370.

[0246] like Figure 10 As shown, in one form of the technology, the carrying strap 3310 may be provided with a tag 3316, which the patient can grasp to help the patient slide the carrying strap 3310 over their head and into the proper position when putting on the interface.

[0247] exist Figure 7 In the example shown, the band 3310 is releasably connected to the band engagement portion of the sleeve portion 3371. In this example, the end of the sleeve portion 3371, away from the interface structure 3010, is provided with a ring or groove 3321 that can be engaged by the band 3310. Figure 7 , 8 In the example shown in Figure 9, each slot is provided in the tab 3320.

[0248] In one form of this technology, one or both ends of the band 3310 are provided with a portion of hook material 3315, which engages with a portion of a complete ring material 3314 disposed on an adjacent portion of the band 3310 to form an adjustable connection mechanism. In an alternative form of this technology, the end 3317 of the band 3310 is provided with a complete ring material 3314, and the hook material 3315 is disposed on the outer surface of the band 3310 for engaging the complete ring material 3314. Other forms of connectors are also possible, such as buckles, magnetic connectors, or other connectors.

[0249] like Figure 8As shown, in some forms of this technology, each elongated sleeve portion 3371 includes multiple band engaging portions, such as loops, eyes, or slots 3321. In the example, the elongated sleeve portion 3371 may include multiple slots 3321, each slot 3321 which may be selectively engaged by a band 3310. This allows the patient to select the position of the band 3310 relative to the elongated sleeve portion 3371 and / or the interface structure 3010. Loops, eyes, or slots 3321 may be provided in tabs 3320, which may all have the same length or may have two or more different lengths.

[0250] Choosing specific strap engagement portions to connect strap 3310 can affect the balance of forces within the headgear and thus the fit of the interface, as described herein. This allows a range of users of different sizes to comfortably use the same form and / or size of positioning and stabilization structure 3300. A tab 3320 extending further in the posterior direction allows the strap 3310 to engage at a more rearward position, which reduces the tendency of the strap 3310 to cross over the patient's head upwards or downwards, thus providing a more stable positioning and stabilization structure 3300 for some users.

[0251] In one form of this technology, such as Figure 9 As shown, in addition to the aforementioned shoulder strap 3310, the patient contact member 3370 also includes another strap 3318. In this example, the additional strap 3318 is provided near or at the end of the elongated sleeve portion 3371, which, in use, is closest to (e.g., adjacent to) the interface structure 3010 (or at least towards the lower part of the elongated sleeve portion). The additional strap 3318 can extend around the patient's neck in use. This example is particularly suitable for full-face masks, ultra-compact oronasal masks, and / or nasal masks. In some examples, the additional strap 3318 can engage a slot in the tab 3320 via a hook-and-loop fastening system, as described above. In other examples, the additional strap 3318 can engage the tab 3320 via an alternative connector (e.g., a magnetic connector), such as... Figure 9A As shown.

[0252] exist Figures 7 to 9 In the example shown in 9A, the elongated sleeve portion 3371 may have a patient contact side 3372 that contacts at least the patient's cheek area during use.

[0253] Next reference Figure 7In the example, the length L along the elongated sleeve portion 3371 is greater than the width W of the elongated sleeve portion 3371. In some examples, the length L (i.e., the length along the sleeve portion, such as the arc length) may be greater than twice the width W of the elongated sleeve portion 3371 (the width measured parallel to the surface of the patient's face), for example, greater than four times the width W. In one embodiment, the elongated sleeve portion 3371 is sized to substantially cover the entire portion of the patient contact side 3351 of the tube 3350 between the interface structure 3010 and the strap 3310. In other forms of the technology, the elongated sleeve portion 3371 is sized to cover the entire portion of the tube 3350 between the interface structure 3010 and the strap 3310 (excluding any provided window portions, as discussed below). In some forms of the technology, the patient contact side 3372 of the elongated sleeve portion 3371 contacts the patient's face from a point immediately adjacent to the interface structure 3010 to a point above the patient's ear.

[0254] Next, refer to Figures 11 to 13 In some forms of this technology, the non-patient contact side of the patient contact member 3370 (or sleeve 3370) may include a window portion 3373, which may be uncovered, covered by one or more fibers or threads spaced sufficiently to allow the user to see the tube 3350 through the window portion 3373, and / or covered by a transparent material. This allows the user to check that the tube 3350 is clean (e.g., when the tube itself is transparent or translucent). Additionally or alternatively, the window portion 3373 may be configured to increase the flexibility of the sleeve 3370, thereby making it easier for the sleeve 3370 to engage or disengage from the tube 3350 without damage.

[0255] exist Figure 11 In the example shown, window portion 3373 includes an open mesh 3374. In one form of this technology, the mesh 3374 may be knitted to be formed with a sleeve (e.g., integrally formed).

[0256] In another form of this technology, such as Figure 12 As shown, the opposite sides of the window portion 3373 may include spaced-apart rings 3375. A ring 3375A disposed on one side of the window portion 3373 may be offset along the length of the window portion 3373 relative to a ring 3375B on the opposite side of the window portion 3373. The opposite rings 3375A and 3375B may be interconnected by one or more suitable fibers or wires 3376.

[0257] In another form of this technology, such as Figure 13As shown, the interconnecting rings 3375 of the damping line 3377 can be disposed on opposite sides of the window portion 3373. In the example shown, the rings 3375 are provided in interconnecting pairs, wherein one ring in the pair is opposite (e.g., directly opposite) to the other ring in the pair. The damping line 3377 can be elastically extendable in length, meaning that the circumference of the elongated sleeve portion 3371 is elastically expandable in this region, in the sense that the circumference can be increased by applying an appropriate force, but biased toward the original circumference by the interconnecting damping lines 3377.

[0258] In other forms of this technology, the window portion 3373 may include a transparent material, such as a silicone sheet.

[0259] In other forms of this technology, such as Figures 14 to 16 As shown in Figures 20 to 23, the patient contact component 3380 includes a body 3381 configured to at least partially surround a tube 3350 of a positioning and stabilizing structure 3300, wherein the body 3381 includes a patient contact side 3382 and a groove 3383 on the side of the body 3381 opposite to the patient contact side.

[0260] The groove 3383 may extend generally longitudinally along the patient contact member 3380, that is, along the entire length of the patient contact member 3380. In some forms of this technology, the groove 3383 may be curved; for example, if the body 3381 is curved, the side surface 3384 of the groove 3383 may also be curved so as to be substantially parallel to the side surface 3385 of the body 3381. In other forms of this technology, the side surfaces 3384 of the groove 3383 may not be parallel to each other and / or not parallel to the side surface 3385 of the body 3381.

[0261] In some forms of this technology, the body 3381, or at least a portion thereof, may be rigid, i.e., may have greater resistance to bending than the tube 3350 to which it is intended to engage in use. The groove 3383 may be shaped and sized such that the patient contact member 3380 engages with the tube 3350 of the positioning and stabilizing structure 3300 by inserting the tube 3350 through the groove 3383 (or, alternatively, by snapping the body 3381 onto the tube). In some forms of this technology, the portion of the body 3381 adjacent to the groove 3383 and / or the portion forming the edge of the groove 3383 is elastically flexible to form a clamping portion that facilitates engagement of the patient contact member 3380 with the tube 3350. In other forms of this technology, the body 3381 may be substantially rigid and the tube 3350 may be sufficiently deformable to allow insertion through the groove 3383. In some forms of this technology, the sides 3384 of the groove 3383 may be generally parallel to each other, but one or more portions of the sides 3384 may be closer together (e.g., to reduce the width of the groove 3383). These portions ensure that the body 3381 is securely engaged with the tube 3350.

[0262] In the example, the body 3381 may be formed of a fabric laminate. The laminate may include fabric and one or more silicone, foam, or other plastic materials, such as fabric layer 3386, which is configured as the outer layer of the laminate for contact with the patient's skin. In the example, the body 3381 may be thermoformed to provide rigidity to a selected area. In embodiments with an integral band 3310, for example, as... Figure 14 As shown, the strip portion 3312 may not be thermoformed, thus maintaining its flexibility. Alternatively, the strip portion 3312 may be formed from a single sheet of material. Figure 15 , 16 As shown in Figures 20 to 23, some embodiments of the patient contact component 3380 may not have the band 3310 or the band engagement portion.

[0263] In some forms of this technology, when the patient contact member 3380 has engaged with the tube 3350 of the positioning and stabilizing structure 3300, the opposing edges of the groove 3383 may contact each other along their length, or one edge may overlap each other along its length. For example, the portion of the body 3381 adjacent to and / or forming the edge of the groove 3383 may be flexible enough to allow a user to separate the edges of the groove, thereby allowing the tube 3350 to be inserted into the patient contact member 3380, and then can be returned to a configuration in which the edges contact each other or one edge overlaps the other.

[0264] In another form of this technology, the edges of the groove 3383 may not touch or overlap each other, but when the patient contact member 3380 engages with the tube 3350, additional portions of a more flexible material (e.g., sheets) may be provided on one or both edges 3383 to cover the groove. The portions of the material or sheets may be attached to opposite edges of the groove (or to material attached to the other side of the groove) by suitable fasteners (e.g., hook-and-loop fastening systems).

[0265] exist Figures 20 to 23 In the example shown, the patient contact component 3380 may include a body 3381 formed of a fabric layer 3386, which is connected to a thermoplastic elastomer 3387, for example, by overmolding. The patient contact side 3382 of the body 3381 may be provided with a plurality of protruding rib structures 3388.

[0266] The protruding rib structure 3388 can provide areas between the rib structures where there is no contact between the patient's skin and the patient contact side 3382 of the body 3381. These areas allow the patient's skin to breathe.

[0267] The patient contact member 3380, characterized by this rib structure 3388, can also be relatively flexible in the longitudinal direction while maintaining the required stiffness in the transverse direction.

[0268] In other examples, the patient contact member 3380, which includes a fabric layer 3386 attached to a thermoplastic elastomer 3387 (e.g., by overmolding), may be formed without ribs 3388 and may have a substantially flat patient contact side 3382.

[0269] 4.3.5 Systems for Positioning and Stabilization

[0270] In some forms of this technology, a system for positioning and stabilizing the patient interface portion may include a positioning and stabilization structure 3300, which includes at least one gas delivery tube 3350 and a plurality of patient contact members 3370, 3380 as described above. Each of the patient contact members 3370, 3380 may be interchangeably engaged with the gas delivery tube 3350, i.e., each patient contact member may engage with the gas delivery tube 3350 if the others are removed first.

[0271] In one form of the present technology, at least one of the patient contact components 3370 and 3380 may include a rigid portion, or may be fully rigid, i.e., it may have greater resistance to bending in at least one plane (e.g., a surface parallel to the patient's cheek) than the corresponding tube 3350.

[0272] One or more of the partially or fully rigid patient contact components 3370, 3380 may be bent along a portion or entirely of their longest dimension (i.e., length). For example... Figure 17 As shown, patient contact components 3370 and 3380 may have a chord length LC (e.g., straight-line distance) and an arc length LA, wherein the arc length LA is the distance along the centerline CL of at least a partial bend in the patient contact component. Figure 17 As shown, patient contact components 3370 and 3380 with different curvatures can have different arc lengths LA1 and LA2, but have the same chord length LC. The less curved the patient contact component, the closer the arc length LA and chord length LC are.

[0273] Engaging these rigid patient contact components 3370, 3380 with the tube 3350 of the positioning and stabilizing structure 3300 results in the portion of the tube 3350 that contacts the patient contact component substantially adopting the curvature of the patient contact component 3370, 3380. Therefore, in one form of this technology, the positioning and stabilizing structure 3300, including the tube 3350, can be adjusted to suit a particular patient by engaging patient contact components 3370, 3380 having suitable arc lengths LA and chord lengths LC. Because multiple patient contact components 3370, 3380 can have the same chord length but different arc lengths, and multiple patient contact components 3370, 3380 can have the same arc length but different chord lengths, the patient can select patient contact components 3370, 3380 that both adjust the fit of the positioning and stabilizing structure 3300 to a particular patient's head and position the engagement portion and / or the integrated shoulder strap 3310 in an appropriate position on the patient's head. Thus, compared to similar positioning and stabilizing structures in the prior art, the single-size positioning and stabilizing structure 3300 can be applied to patients with a wide range of head shapes and sizes.

[0274] In one embodiment of the present technology, the system for positioning and stabilizing the patient interface portion may include a positioning and stabilizing structure 3300, which includes at least one gas delivery tube 3350 and a plurality of patient contact members 3370, 3380 as described above, wherein the plurality of patient contact members 3370, 3380 have the same chord length but different arc lengths. In another embodiment of the present technology, the system for positioning and stabilizing the patient interface may include a positioning and stabilizing structure 3300, which includes at least one gas delivery tube 3350 and a plurality of patient contact members 3370, 3380 as described above, wherein the plurality of patient contact members have the same arc length but different chord lengths. In another form of the present technology, the system for positioning and stabilizing the patient interface may include a positioning and stabilizing structure 3300, which includes at least one gas delivery tube 3350 and a plurality of patient contact members 3370, 3380 as described above, wherein a first group of patient contact members has the same arc length but different chord lengths, and a second group of patient contact members has the same chord length but different arc lengths, wherein each of the first and second groups includes a plurality of patient contact members.

[0275] 4.3.6 Gas delivery pipe assembly

[0276] Next reference Figure 18 and 19 In another form of the present technology, a gas delivery tube assembly 3360 used with a patient interface, such as a gas delivery tube assembly 3360 forming part of a positioning and stabilization structure 3300 of the patient interface, includes a gas delivery tube 3352 releasably connected to a liner member 3390.

[0277] The gas delivery tube 3352 has a patient-facing side 3353 and a non-patient-facing side 3354. In some examples, the patient-facing side 3353 may contact the patient, but in some examples, some or all of the patient-facing side 3353 of the gas delivery tube may not contact the patient due to the presence of the lining member 3390.

[0278] At least one of the patient-facing side 3353 of the gas delivery tube 3352 and the lining member 3390 may include at least one complete ring material, and the other of the patient-facing side 3353 of the gas delivery tube 3352 and the lining member 3390 includes at least one hooked or broken material configured to releasably engage the complete ring material. Figure 19In the example shown, the gas delivery pipe 3352 is provided with a plurality of broken ring material portions 3355 spaced apart along the length of the pipe 3352. The lining member 3390 may include a plurality of portions of complete ring material, or may include a single portion of complete ring material along substantially the entire length of the lining member 3390.

[0279] The lining member 3390 may include a laminated material, such as an outer fabric layer (patient contact layer) and at least one cushioning layer, such as a foam layer. In some forms of this technology, the laminated material may be thick enough that the portion of the gas delivery tube adjacent to the patient-facing end 3353 of the lining member 3390 remains away from the patient's skin during use. In one form of this technology, the lining is at least approximately 2 mm thick, for example, 2 mm to 10 mm, or for example, 4 mm to 5 mm.

[0280] The segments of complete and / or broken ring material provided to the gas delivery tube 3352 can be molded into the gas delivery tube 3352, or can be joined by adhesives or other suitable joining methods.

[0281] In the example, the gas delivery tube assembly 3360 described above can be used in conjunction with the patient contact components 3370 and 3380 described above.

[0282] 4.3.7 Vent

[0283] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0284] 4.3.8 Decoupling Structure

[0285] In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or a ball and a socket.

[0286] 4.3.9 Connection Port

[0287] Connection port 3600 allows connection to air circuit 4170.

[0288] 4.3.10 Forehead Stent

[0289] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0290] 4.3.11 Anti-asphyxiation valve

[0291] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0292] 4.3.12 port

[0293] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0294] 4.4RPT device

[0295] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, for example for treating one or more respiratory conditions described elsewhere in this document.

[0296] In one embodiment, the RPT device 4000 is constructed and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0297] 4.5 Humidifier

[0298] 4.5.1 Humidifier Overview

[0299] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0300] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0301] 4.6 Breathing Therapy Mode

[0302] Various respiratory therapy modes can be achieved through the disclosed respiratory therapy system.

[0303] 4.7 Glossary

[0304] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0305] 4.7.1 Overview

[0306] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0307] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0308] For example, the ambient humidity relative to a humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0309] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0310] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or transmitted from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0311] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0312] Continuous positive airway pressure (CPAP) therapy: respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In some forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of an indication of partial upper airway obstruction.

[0313] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, that is, a quantity that only has a magnitude. In other cases, the reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0314] Flow therapy: Breathing therapy involves delivering a controlled flow of air to the inlet of the airway at a rate known as the therapeutic flow, which is generally positive throughout the patient’s respiratory cycle.

[0315] Humidifier: The term humidifier will be considered to refer to a humidification device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0316] Patient: A person, regardless of whether they have a respiratory illness.

[0317] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2 And it is approximately 0.98 hPa (1 hPa = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0318] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0319] Respiratory pressure therapy (RPT): Applying an air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0320] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0321] 4.7.1.1 Materials

[0322] Silicone resin or silicone elastomer: synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0323] Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.

[0324] 4.7.1.2 Mechanical Properties

[0325] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0326] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicone resins and thermoplastic elastomers.

[0327] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or by an indentation hardness scale measured on a standardized sample size).

[0328] • "Soft" materials may include silicone resins or thermoplastic elastomers (TPEs) and may deform easily, for example, under finger pressure.

[0329] • "Hard" materials can include polycarbonate, polypropylene, steel or aluminum, and are not easily deformed, for example, under finger pressure.

[0330] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0331] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0332] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting up and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a pressure load of approximately 20 to 30 cmH2O.

[0333] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0334] 4.7.2 Anatomy

[0335] 4.7.2.1 Facial Anatomy

[0336] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0337] Alar tip: the outermost point on the ala of the nose.

[0338] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0339] Auricle: The entire visible external part of the ear.

[0340] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0341] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0342] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0343] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0344] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0345] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0346] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0347] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0348] Nostrils (Nares (Nostrils)): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal (naris) (nostril). Nostrils are separated by the nasal septum.

[0349] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0350] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0351] The lowest point on the face where the auricle attaches to the skin.

[0352] The highest point on the face where the auricle attaches to the skin.

[0353] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0354] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0355] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0356] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0357] Sagittal plane: A vertical plane running from front to back. The central sagittal plane is the sagittal plane that divides the body into the right and left halves.

[0358] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0359] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0360] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0361] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the central sagittal plane.

[0362] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue.

[0363] 4.7.2.2 Skull Anatomy

[0364] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0365] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0366] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0367] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0368] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0369] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0370] The eye socket is the bony cavity in the skull that houses the eyeball.

[0371] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0372] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0373] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the prominent part of the cheek.

[0374] 4.7.2.3 Anatomy of the Respiratory System

[0375] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0376] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0377] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0378] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0379] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0380] 4.7.3 Patient Interface

[0381] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0382] Bend: A bend is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The bend can have an approximately circular cross-section. In another form, the bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0383] Frame: The frame is generally considered to refer to the mask structure that bears tensile loads between two or more connection points to the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0384] Headgear: A headgear is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headgear may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0385] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0386] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the mask inflation chamber.

[0387] Sealing: can refer to the noun form of a structure ("seal") or the verb form of the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve 'seal' between them, without the need for a separate 'seal' element itself.

[0388] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0389] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0390] Support rod: The support rod will be considered as a structural component designed to increase the compressive strength of another component in at least one direction.

[0391] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft can be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft can be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. During use, there can be little or no airflow leakage from the rotary shaft.

[0392] Lacing (noun): A structure used to resist tension.

[0393] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0394] 4.7.4 Shape of the structure

[0395] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In another example, a structure may include a first surface and a second surface.

[0396] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure. See also Figures 3B to 3F They show examples of cross-sections at point p on the surface and the resulting planar curves. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at p points away from the surface. In some examples, we describe the surface from the viewpoint of an imaginary little person standing on the surface.

[0397] 4.7.4.1 One-dimensional curvature

[0398] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0399] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the figures in the image were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3CCompared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0400] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0401] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0402] 4.7.4.2 Curvature of Two-Dimensional Surfaces

[0403] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has, for example, a relatively small amplitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0404] Principal curvature and direction: The direction of the normal plane to which the curvature of a curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.

[0405] Surface region: A set of connected points on a surface. The points in this region can have similar properties, such as curvature or sign.

[0406] Saddle-shaped region: At each point, the region where the principal curvature has opposite signs, that is, one is positive and the other is negative (depending on the direction the imagined person is turning, they can be walking uphill or downhill).

[0407] Dome region: A region where the principal curvatures at each point have the same sign, such as both being positive ("concave dome") or both being negative ("convex dome").

[0408] Cylindrical region: A region with one principal curvature of 0 (or, for example, 0 within manufacturing tolerances) and another principal curvature of non-0.

[0409] Planar region: A surface region where both principal curvatures are 0 (or, for example, 0 within manufacturing tolerances).

[0410] Surface edge: The boundary or limit of a surface or region.

[0411] Path: In some forms of this technique, "path" will be considered a path in the mathematical topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, "path" can be described as a route or road, including, for example, a set of points on a surface. (Imagine a person's path is where they walk on the surface, and similar to a garden path).

[0412] Path length: In some forms of this technique, "path length" refers to the distance along the surface from f(0) to f(1), that is, the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of an imagined person would be the distance they must walk along the path on the surface).

[0413] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For the imaginary person, straight-line distance will correspond to the distance "in a straight line".)

[0414] 4.7.4.3 Space Curves

[0415] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3SA right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0416] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If you imagine a person flying along a curve and falling from their aircraft at a specific point, the direction of the tangent vector is the direction they would have traveled.

[0417] Unit normal vector: This is the vector that changes as an imagined person moves along the curve. The unit vector pointing in the direction of the tangent vector's change is called the principal normal vector. It is perpendicular to the tangent vector.

[0418] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0419] Occult plane: The plane containing the unit tangent vector and the unit principal normal vector. See Appendix. Figure 3O and 3P .

[0420] Space curve twist: The twist of a space curve at a point is the magnitude of the rate of change of the unit vector of the two normals at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the osculating plane has zero twist. A space curve deviating relatively small from the osculating plane will have a relatively small amount of twist (e.g., a slightly inclined spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of twist (e.g., a sharply inclined spiral path). See also Figure 3S Since T2 > T1, therefore Figure 3S The amount of twist near the top coil of the spiral is greater than Figure 3S The amount of twist of the bottom coil of the spiral.

[0421] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral is shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0422] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve oriented towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0423] 4.7.4.4 Hole

[0424] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0425] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having cavities for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, a conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Figure 3K The two-dimensional hole in the structure shown is defined by the surface shown.

[0426] 4.8 Other comments

[0427] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.

[0428] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also covered within this technique, subject to any specific exclusions within the stated range. Where the range includes one or two limitations, the range excluding any one or both of those included limitations is also included within this technique.

[0429] Furthermore, where one or more values ​​are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used with any suitable significant figure to the extent that the actual implementation of the technology may allow or require.

[0430] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0431] When a particular material is set for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein should be understood as capable of being manufactured, and therefore can be manufactured together or separately.

[0432] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0433] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0434] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0435] The subject headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. Subject headings should not be used to interpret the claims or limit their scope.

[0436] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not required for practicing the techniques described. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or shown in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0437] Therefore, it should be understood that numerous modifications can be made to the exemplary examples, and that other arrangements can be designed without departing from the spirit and scope of this technology.

[0438] 4.9 List of Reference Symbols

[0439]

[0440]

[0441]

Claims

1. A patient contact member configured to releasably engage a gas delivery tube forming part of a positioning and stabilizing structure for a patient interface, the patient contact member including an elongated sleeve portion and a strap, the elongated sleeve portion engaging the gas delivery tube, the strap being configured to engage the back of a patient's head in use. The elongated sleeve portion includes a patient contact side and a non-patient contact side, wherein the patient contact side contacts at least the patient's cheek area during use. The non-patient contact side includes a window portion, wherein the window portion includes a cover that allows the patient to view through the window portion.

2. The patient contact component according to claim 1, wherein the elongated sleeve portion has a length and a width, and the length is greater than twice the width.

3. The patient contact member according to claim 2, wherein the length is greater than four times the width.

4. The patient contact member of claim 1, wherein the elongated sleeve portion is configured to be positioned adjacent to the interface structure of the patient interface during use.

5. The patient contact component according to claim 1, wherein the strip is integrally formed with the elongated sleeve portion.

6. The patient contact component of claim 1, wherein the band is releasably connected to the elongated sleeve portion.

7. The patient contact component of claim 6, wherein the elongated sleeve portion includes a receiving device, the receiving device including an opening for receiving the strip.

8. The patient contact member of claim 6, wherein the elongated sleeve portion includes a plurality of receiving devices spaced apart along the elongated sleeve portion.

9. The patient contact member of claim 7, wherein the receiving device includes a tab provided with a groove to receive the strip.

10. The patient contact member according to any one of claims 1 to 9, wherein the patient contact member comprises two elongated sleeve portions.

11. The patient contact member according to any one of claims 1 to 9, wherein the band comprises two band portions and a connector device connecting the band portions to each other.

12. The patient contact member of claim 11, wherein the connector device allows adjustment of the length of the strap.

13. The patient contact member according to any one of claims 1 to 9, wherein the band includes an elastically extendable portion.

14. The patient contact member according to any one of claims 1 to 9, wherein the elongated sleeve portion includes a rigidified portion.

15. The patient contact member of claim 14, wherein the rigid portion is curved.

16. The patient contact member of claim 15, wherein the non-patient contact side includes a groove that extends generally longitudinally along the patient contact member.

17. The patient contact member according to any one of claims 1 to 9, wherein the patient contact member includes an additional strap or strap portion configured to pass around the back of the patient's neck in use.

18. The patient contact member according to any one of claims 1 to 9, wherein the window portion includes an opening in the elongated sleeve portion.

19. The patient contact member according to any one of claims 1 to 9, wherein the window portion includes a first side and an opposing second side, and wherein the cover includes an elastic line that engages with the first side and the second side.

20. The patient contact member of claim 19, wherein a plurality of first rings are provided on the first side, a plurality of second rings are provided on the second side, wherein the elastic line extends through the plurality of first rings and the plurality of second rings.

21. The patient contact member according to any one of claims 1 to 9, wherein the cover comprises a mesh.

22. The patient contact member according to any one of claims 1 to 9, wherein the cover comprises a transparent material.

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