Systems and methods for manufacture of patient interface and components thereof

Abstract

To provide systems and methods for producing a customized patient respiratory interface.SOLUTION: Data representative of one or more landmark features of a head of a human is obtained. One or more landmark feature locations of the landmark features are identified based on the data. A set of manufacturing specifications for production of the patient respiratory interface component is determined based on the one or more landmark feature locations. The patient respiratory interface component is produced based on a set of manufacturing specifications.SELECTED DRAWING: Figure 18

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to AU Provisional Application No. 2019903290, filed September 6, 2019, the entirety of which is incorporated herein by reference. [Background technology]

[0003] 2. Technology Background

[0004] 2.1 Technology field

[0005] The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

[0006] 2.2 Description of Related Art

[0007] 2.2.1 The human respiratory system and its diseases

[0008] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0009] These airways contain a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0010] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0011] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD) and chest wall diseases.

[0012] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.

[0013] 2.2.2 Treatment

[0014] A variety of therapies are used to treat one or more of the above-mentioned respiratory disorders, including continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and invasive ventilation (IV).

[0015] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0016] 2.2.3 Treatment system

[0017] These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0018] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0019] Another form of treatment system is a mandibular repositioning device.

[0020] 2.2.3.1 Patient Interface

[0021] The patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example by providing airflow to an airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheotomy tube to the patient's trachea. Depending on the treatment being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby providing a pressure at which there is sufficient dispersion with ambient pressure for treatment to take place (e.g., approximately 10 cmH above ambient pressure). 2 In other forms of therapy, such as oxygen delivery, the patient interface provides a pressure of approximately 10 cmH 2They may not contain a sufficient seal to facilitate delivery of the gas supply to the airways at positive O pressures.

[0022] Certain other mask systems may be functionally inadequate in the field, for example masks that are purely decorative may not be able to maintain adequate pressure, mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0023] Certain masks may be clinically unsuitable for use with this technology (eg, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0024] In certain masks, where the patient must insert part of the mask structure into their mouth and create and maintain a seal via the lips, this may be uncomfortable or impractical in the art.

[0025] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with head on a pillow).

[0026] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0027] These challenges may result in one or more of the following: some masks may be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if the wear time is long or the patient is unfamiliar with the system. If the wrong size mask is used, this may lead to poor compliance, poor comfort, and poor patient outcomes. While masks designed specifically for aviators, as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may be tolerable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods of time (e.g., several hours). Such discomfort may result in poor patient compliance with the treatment. This is especially true if the mask must be worn while sleeping.

[0028] CPAP therapy is highly effective in treating certain respiratory diseases if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0029] Masks for other uses (e.g., for aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0030] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0031] 2.2.3.1.1 Seal formation structure

[0032] The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0033] The patient interface may be characterized in part according to the design intent of where the seal-forming structure engages the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that encloses the mouth region in use, for example by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that encloses both nostrils and the mouth region in use. These different types of patient interfaces may be known by various names by their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0034] A seal-forming structure that may be effective in one area of ​​a patient's face may be inadequate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swim goggles that rest on the patient's forehead may be inadequate for use on the patient's nose.

[0035] A particular seal-forming structure may be designed for mass production so that one design will fit, be comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both may need to be adapted in order to form a seal.

[0036] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaging against the patient's face. The seal-forming structure may include an air or fluid filled cushion, or may include a molded or formed surface of a resilient sealing element comprised of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will develop between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0037] Another type of seal-forming structure uses a thin flap seal located around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, if the fit between the face and the mask is poor, additional force may be required to achieve a seal or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, folds or buckles may occur during use, causing leakage.

[0038] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these uncomfortable.

[0039] Another form of seal-forming structure may use adhesives to achieve a seal. Some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0040] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0041] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to the Puritan-Bennett Corporation.

[0042] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask and MIRAGELIBERTY® Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® nasal pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full face mask); and International Patent Application WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX nasal pillows).

[0043] 2.2.3.1.2 Positioning and stabilization

[0044] Seal-forming structures in patient interfaces used in positive air therapy experience corresponding forces from the air pressure that disrupt a seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0045] In one technique, adhesives are used, see, for example, US Patent Application Publication US2010 / 0000534, but adhesives can be uncomfortable.

[0046] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulkiness, discomfort and awkwardness.

[0047] 2.2.3.1.3 Patient Interface Sizing and Customization

[0048] As noted above, patient interfaces may be provided to a patient in a variety of forms (e.g., nasal mask or full face mask / oral nasal mask (FFM) or nasal pillow mask). Such patient interfaces are manufactured with a variety of dimensions to accommodate the anatomical features of a particular patient, for example, to facilitate a comfortable interface that functions to provide positive pressure therapy. This is particularly important where, for example, application of positive pressure therapy requires a seal against the patient's face to provide effective respiratory therapy. Additionally, comfort increases patient compliance with the therapy.

[0049] To improve user compliance with treatment or delivery of the most effective treatment, a patient interface customized for a particular user is expected. However, to perform such an evaluation, the user may need to make an appointment and travel to a facility that has the equipment and personnel. Such scheduling and travel may be inconvenient for the user and may discourage the user from obtaining a patient interface that is suitable for them.

[0050] The above deficiencies are described in the specific context of customized patient interfaces and masks for individuals with, for example, respiratory conditions. However, similar deficiencies and problems may apply to the design and manufacture of any article, device, or other article of apparel that may be worn on a person's head or face. For example, if a user wanted to order custom-fit sunglasses, goggles, face masks, or costumes, the user would have to pay and / or travel to be evaluated, which may be an inconvenience. Summary of the Invention [Means for solving the problem]

[0051] 3. Brief description of the technology

[0052] The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0053] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0054] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0055] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0056] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0057] One aspect of one form of the present technology is a method of manufacturing system and apparatus.

[0058] Another form of the present technology involves an apparatus or device, or components thereof, for the treatment of respiratory disorders that is customized to the intended user.

[0059] Another form of the present technology involves a patient interface, or components thereof, that is customized to the intended wearer.

[0060] Another form of the present technology involves a method of making a patient interface, or components thereof, customized for the intended wearer.

[0061] One aspect of one form of the present technology is a processor-implemented method for creating a customized patient respiratory interface component, the method including: receiving, using communications circuitry, data indicative of one or more landmark features of a human head; identifying, with at least one processor, one or more landmark feature locations of the landmark feature based on the data; determining, with at least one processor, a set of manufacturing specifications for fabrication of the patient respiratory interface components based on the one or more landmark feature locations; and Controlling one or more manufacturing machines to produce patient respiratory interface components based on a set of manufacturing specifications.

[0062] One aspect of one form of the present technology is a processor-implemented method for creating a customized patient respiratory interface component, the method including: receiving, using communications circuitry, data indicative of one or more landmark features of a human head; identifying, with at least one processor, one or more landmark feature locations of the landmark feature based on the data; determining, with at least one processor, a set of manufacturing specifications for fabrication of the patient respiratory interface components based on the one or more landmark feature locations; and Causing one or more manufacturing machines to produce patient respiratory interface components based on a set of manufacturing specifications.

[0063] In examples: the data is indicative of one or more landmark features of the head of an intended user of the patient interface; (b) the data includes image data; (c) at least a portion of the image data is captured by an image sensor; (d) the method includes capturing at least a portion of the image data by the image sensor; (e) the data includes two-dimensional image data; and / or (e) the data includes three-dimensional image data.

[0064] In one example, causing one or more manufacturing machines to produce the patient respiratory interface components includes controlling the one or more manufacturing machines to produce the patient respiratory interface components based on a set of manufacturing specifications.

[0065] In one example, the method is performed by a manufacturing system including at least one processor and communications circuitry.

[0066] In an example, the method includes: (a) capturing at least a portion of the data with an image sensor; and / or (b) identifying at least one relationship between two or more of the landmark feature locations (wherein determining a set of manufacturing specifications is based at least in part on the at least one relationship between two or more of the landmark feature locations).

[0067] In an example, identifying at least one relationship between two or more of the landmark feature locations includes determining a distance between two or more of the subnasal point, the cerion, the ear point, the posteriormost point of the head, the anteriormost point of the head, the lateralmost point of the orbital rim, the inferiormost point of the orbital rim, the Frankfurt horizontal plane, and a coronal plane aligned with the ear point.

[0068] In an example, identifying at least one relationship between two or more of the landmark feature locations includes: (a) determining a distance between a subnasal point and an aural point in a sagittal plane; (b) determining a perpendicular distance between a subnasal point and therion in a sagittal plane; (c) determining a distance between a coronal plane aligned with an aural point and a subnasal point, the distance being perpendicular to said coronal plane; (d) determining a distance between a coronal plane aligned with an aural point and a lateral-most point of the orbital rim, the distance being perpendicular to said coronal plane; (e) determining a perpendicular distance between a subnasal point and an anterior-most point of the head; (f) determining a perpendicular distance between an anterior-most point of the head and a Frankfurt horizontal plane; and / or (g) determining a distance between a coronal plane aligned with an aural point and a posterior-most point of the head, the distance being perpendicular to said coronal plane.

[0069] In examples: (a) the method includes determining at least one required performance of the patient respiratory interface component based on one or more landmark feature locations; (b) the at least one required performance includes one or more of force to be applied by or to the component, elasticity, size, tactile feel, breathability, and positioning on the head; (c) the patient respiratory interface component includes a plurality of regions, and the at least one required performance is determined for each region; (d) the at least one required performance is determined based at least in part on a characteristic of another component of a patient interface intended to be used with the customized patient respiratory interface component; and / or (e) determining a set of manufacturing specifications is based at least in part on the at least one required performance.

[0070] In an example, the set of manufacturing specifications includes: (a) at least one material specification; (b) at least one construction engineering specification; and / or (c) at least one dimensional specification.

[0071] In examples, determining the set of manufacturing specifications includes: (a) selecting the set of manufacturing specifications from a plurality of sets of existing manufacturing specifications; (b) selecting the plurality of sets of existing manufacturing specifications (wherein the selecting is based on a comparison between one or more landmark feature locations determined for the human and one or more landmark feature locations associated with the plurality of sets of existing manufacturing specifications); and / or (c) selecting the plurality of manufacturing specifications to form the set of manufacturing specifications from the plurality of existing manufacturing specifications.

[0072] In an example, the method further includes generating manufacturing machine programming instructions for producing the patient interface or a component thereof based on the set of manufacturing specifications. In an example, producing the patient respiratory interface component includes programming at least one manufacturing machine with the manufacturing machine programming instructions and operating the at least one manufacturing machine in accordance with the manufacturing machine programming instructions.

[0073] In examples: (a) generating the manufacturing machine programming instructions includes generating a map indicative of a set of manufacturing specifications and generating the manufacturing machine programming instructions based on the map; and / or (b) generating the manufacturing machine programming instructions includes generating a model of the patient respiratory interface component based on the set of manufacturing specifications and generating the manufacturing machine programming instructions based on the model.

[0074] In examples, producing the patient respiratory interface components includes: (a) mechanical manipulation of yarns to produce the components; (b) knitting the components; (c) weft knitting the components; (d) circular knitting the components; (e) forming the components from textiles; (e) additive manufacturing of the components; (f) three dimensional printing of the components; and / or (g) laser cutting of the components, and / or generating instructions for one or more manufacturing devices configured to produce the components and controlling the one or more manufacturing devices based on the generated instructions to produce the components.

[0075] In an example, the patient respiratory interface component includes a headgear strap of a positioning and stabilizing structure for the patient interface. In an example, the set of manufacturing specifications includes: (a) headgear strap dimensions; (b) at least one dimension of a rear strap portion for the headgear strap, the rear strap portion configured to be positioned against at least a rear surface of the head in use; (c) a length of each one of a pair of top strap portions for the headgear strap, each top strap portion configured to be positioned on each side of the head in use; (d) top strap locations on the rear strap portions for the headgear strap, from which extend a respective one of the pair of top strap portions for the headgear strap; (e) a length of each one of the pair of top strap portions for the headgear strap, the length of each one of the pair of top strap portions for the headgear strap, and the length of each one of the pair of top strap portions for the headgear strap. (f) the length of each one of a pair of lower strap portions for the headgear straps, each lower strap portion configured to be positioned on each side of the head in use; (g) the lower strap positions on the rear strap portions for the headgear straps, each lower strap portion configured to be positioned from each one of the pair of lower strap portions; and / or (h) the length of a ring strap portion for the headgear straps, the ring strap portion having an upper portion configured to rest on the parietal bone of the head in use and a lower portion configured to rest on or below the occipital bone of the head in use.

[0076] In an example, a set of manufacturing specifications is determined such that, in use, a predetermined force is applied from the headgear straps to the seal-forming structure of the patient interface when the patient interface is worn by a human. In an example, the predetermined force is (a) between 3N and 5N; (b) approximately 4N.

[0077] In an example, the patient respiratory interface component includes a patient interface frame. In an example, the set of manufacturing specifications includes: (a) frame dimensions; (b) a length of each one of a pair of upper arms of the frame (each upper arm is configured to connect to a respective upper strap portion of the positioning and stabilizing structure in use); (c) a direction in which each one of the pair of upper arms of the frame extends from a central portion of the frame; (d) a length of each one of a pair of lower arms of the frame (each lower arm is configured to connect to a respective lower strap portion of the positioning and stabilizing structure in use); (e) a direction in which each one of the pair of lower arms of the frame extends from a central portion of the frame.

[0078] In examples, the patient respiratory interface components include: (a) a plenum chamber of the patient interface; (b) a seal-forming structure of the patient interface; and / or (c) a cushion of the patient interface.

[0079] In an example, a set of manufacturing specifications specifies specifications for headgear straps of a positioning and stabilizing structure for a patient interface, including at least one of knit construction, material composition, yarn denier, and / or machine gauge for fabrication of the headgear straps, and one or more of the manufacturing specifications dictate stretch characteristics of the positioning and stabilizing structure.

[0080] One aspect of one form of the present technology is a system for creation of customized patient respiratory interface components, the system including: one or more processors that receive data indicative of one or more landmark features of a human; one or more processors further configured to identify one or more landmark feature locations of the landmark feature based on the data; one or more processors further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and At least one manufacturing machine configured to produce patient respiratory interface components based on a set of manufacturing specifications.

[0081] One aspect of one form of the present technology is a processor-implemented method performed by a processing system including at least one processor and communications circuitry for creating a patient respiratory interface component, the method including: receiving, using communications circuitry, data indicative of one or more landmark features of a human head; identifying, using a processing system, one or more landmark feature locations of the landmark feature based on the data; determining, with the processing system, a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and Communicating the set of manufacturing specifications to a manufacturing system, the manufacturing system including at least one manufacturing machine configured to produce patient respiratory interface components based on the set of manufacturing specifications, using the communications circuitry.

[0082] One aspect of one form of the present technology is a system for creation of customized patient respiratory interface components, the system including: one or more processors receiving data indicative of one or more landmark features of a human head; one or more processors further configured to identify one or more landmark feature locations of the landmark feature based on the data; one or more processors further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and The one or more processors further configured to communicate the set of manufacturing specifications to a manufacturing system including at least one manufacturing machine configured to produce patient respiratory interface components based on the set of manufacturing specifications.

[0083] One aspect of one form of the present technology is a processor-implemented method performed by a processing system including at least one processor and communications circuitry for creating a patient respiratory interface component, the method including: receiving, using communications circuitry, data indicative of one or more landmark feature locations of the landmark feature of the human head; determining, with the processing system, a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and Communicating the set of manufacturing specifications to a manufacturing system, the manufacturing system including at least one manufacturing machine configured to produce patient respiratory interface components based on the set of manufacturing specifications, using the communications circuitry.

[0084] One aspect of one form of the present technology is a system for creation of customized patient respiratory interface components, the system including: one or more processors receiving one or more landmark feature locations of a landmark feature of the human head, the one or more landmark feature locations identified from data indicative of the one or more landmark features of the head; one or more processors further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and The one or more processors further configured to communicate the set of manufacturing specifications to a manufacturing system including at least one manufacturing machine configured to produce patient respiratory interface components based on the set of manufacturing specifications.

[0085] One aspect of one form of the present technology is a processor-implemented method for fabricating a patient respiratory interface component, the method including: receiving, using the communications circuitry, a set of manufacturing specifications for fabrication of the patient respiratory interface component, the set of manufacturing specifications being determined based on one or more landmark feature locations identified from the data indicative of one or more landmark features of a human head; and Controlling one or more manufacturing machines to produce patient respiratory interface components based on a set of manufacturing specifications.

[0086] One aspect of one form of the present technology is a processor-implemented method for fabricating a patient respiratory interface component, the method including: receiving, using the communications circuitry, a set of manufacturing specifications for fabrication of the patient respiratory interface component, the set of manufacturing specifications being determined based on one or more landmark feature locations identified from the data indicative of one or more landmark features of a human head; and Causing one or more manufacturing machines to produce patient respiratory interface components based on a set of manufacturing specifications.

[0087] In one example, causing one or more manufacturing machines to produce the patient respiratory interface components includes controlling one or more manufacturing machines to produce the patient respiratory interface components.

[0088] One aspect of one form of the present technology is a system for creation of customized patient respiratory interface components, the system including: one or more processors receiving a set of manufacturing specifications for fabrication of a patient respiratory interface component, the set of manufacturing specifications being determined based on one or more landmark feature locations identified from data indicative of one or more landmark features of a human head; and At least one manufacturing machine configured to produce patient respiratory interface components based on a set of manufacturing specifications.

[0089] One aspect of one form of the present technology is a processor-implemented method for fabricating a patient respiratory interface component, the method including: obtaining information indicative of one or more landmark feature positions of the human head based on data received from the device using the communications circuitry; determining, with at least one processor, a set of manufacturing specifications for fabrication of the patient respiratory interface components based on the one or more landmark feature locations; and Causing one or more manufacturing machines to produce patient respiratory interface components based on a set of manufacturing specifications.

[0090] One aspect of one form of the present technology is a system for fabrication of a patient respiratory interface component, the system including: one or more processors that obtain information indicative of one or more landmark feature locations of a human head; one or more processors further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and The one or more processors are further configured to fabricate the patient respiratory interface components based on a set of manufacturing specifications.

[0091] One aspect of one form of the present technology is an apparatus for production of a patient respiratory interface component, the apparatus including: means for obtaining information indicative of the location of one or more landmark features of the human head; means for determining a set of manufacturing specifications for fabrication of a patient respiratory interface component based on the one or more landmark feature locations; and A means for producing patient respiratory interface components according to a set of manufacturing specifications.

[0092] In examples, the component includes: (a) a sensor that is fabricated based on a set of manufacturing specifications; (b) features configured to receive and / or position the sensor relative to the component; and (c) a sensor element configured to interface with a sensing device.

[0093] Another form of the present technology includes a positioning and stabilizing structure for a patient interface made by any one of the above methods and / or systems.

[0094] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure formed from weave based on instructions generated based on identification of facial landmarks and / or distances between said landmarks.

[0095] One form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure including an integrally formed strap formed by knitting, the strap may connect to a frame or plenum chamber of the patient interface via four connection points.

[0096] Another form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure including an integrally formed knitted strap including a plurality of knitted structures, each knitted structure including different mechanical properties. The strap may be formed by knitting.

[0097] Another form of the present technology includes a positioning and stabilizing structure for a patient interface. The positioning and stabilizing structure includes an integrally formed knitted strap including at least a first section and a second section, the first section having a different elasticity than the second section. The first section may include a ring strap portion configured to be positioned against a rear and top surface of a patient's head. The second section may include an upper strap portion. The upper strap portion is configured to be positioned along the patient's face in use and to connect between the ring strap portion and a plenum chamber of the patient interface. The strap may be formed by knitting.

[0098] Another form of the present technology includes a positioning and stabilizing structure for a patient interface. The positioning and stabilizing structure includes an integrally formed knitted strap having multiple ventilation portions that form areas of greater breathability. The ventilation portions may include a first knitted structure and other portions of the strap may include a second knitted structure that is different from the first knitted structure. The ventilation portions may be formed with a pique mesh knitted structure while other portions of the strap may be formed with a single jersey or double jersey knitted structure. The strap may be formed by knitting.

[0099] Another form of the present technology includes a positioning and stabilizing structure for a patient interface. The positioning and stabilizing structure includes a strap including a ring strap portion. The ring strap portion is configured to be positioned against the posterior and superior surfaces of the patient's head and define a loop having an inner circumference. The ring strap portion includes a stiffening portion at or near the inner circumference of the loop. The stiffening portion may include a first knit structure and another portion of the ring strap portion may include a second knit structure. The stiffening portion may include a pique knit structure while another portion of the strap may include a single jersey or double jersey knit structure. The strap may be formed by knitting.

[0100] Another form of the present technology includes a positioning and stabilizing structure for a patient interface. The positioning and stabilizing structure includes a strap including a fastener. The fastener is configured to loop back on itself and secure to itself to secure the strap to a frame or plenum chamber of the patient interface. The strap includes a blind guide configured to provide a tactile indication of the location of the fastener of the strap. The strap may be integrally formed with the blind guide. The strap may be formed by knitting.

[0101] Another form of the present technology includes a patient interface. The patient interface includes: At least 6cmH above ambient air pressure 2 a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby an air flow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that, in use, at least a portion of the tie rests on a region of the patient's head above a superior ear-base point of the patient's head; a vent structure that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; the patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's mouth exposed; A positioning and stabilizing structure comprising: a ring strap portion having an upper portion configured to rest on the parietal bone of the patient's head in use and a lower portion configured to rest on or be positioned below the occipital bone of the patient's head in use, the ring strap portion defining a loop; a pair of upper strap portions respectively configured to provide a connection between the ring strap portion and the plenum chamber in use on each side of the patient's head above the base of the upper ear; The ring strap portion includes a stiffening portion disposed along the length of the loop defined by the ring strap portion.

[0102] In an example: a) the stiffening portion is disposed substantially along the entire length of the loop defined by the ring strap portion; b) the stiffening portion is disposed on the ring strap portion adjacent an inner circumference of the ring strap portion; c) the stiffening portion defines at least a portion of the inner circumference of the ring strap portion; d) the stiffening portion forms substantially the entire inner circumference of the ring strap portion; e) the stiffening portion is substantially centrally disposed between the inner circumference of the ring strap portion and the outer circumference of the ring strap portion; f) the upper strap portion is stretchable; g) the stiffening portion is substantially non-stretchable; h) the ring strap portion includes a circular edge; i) the material of the stiffening portion is j) the patient contacting side of the ring strap portion is substantially flat with a greater thickness of material being applied to the non-patient contacting side of the ring strap portion; k) the thickness of the ring strap portion is 4mm at the stiffening portion; l) the thickness of the ring strap portion is 2.5mm in areas of the ring strap portion other than the stiffening portion; m) the stiffening portion is greater in areas of the ring strap portion adjacent the upper strap portion than in other areas of the ring strap portion; and / or n) the stiffening portion is wider in the upper strap portion than in other areas of the ring strap portion.

[0103] In further examples: a) the ring strap portion includes at least one ventilation portion constructed and / or arranged to provide greater breathability through the ring strap portion at the ventilation portion; b) the ventilation portion includes a knit fabric having a pique mesh knit fabric structure; c) the ventilation portion is less stretchable than other portions of the ring strap portion; d) the stiffening portion surrounds the ventilation portion; e) the ring strap portion includes a pair of upper ventilation portions, each upper ventilation portion disposed adjacent a respective upper strap portion; f) the stiffening portion surrounds each of the upper ventilation portions. g) a material thickness of the stiffening portion is greater at a rear side of each upper ventilation portion than at a front side of each upper ventilation portion; h) the positioning and stabilizing structure includes a pair of lower strap portions, each lower strap portion configured to connect, in use, between the ring strap portion and the plenum chamber at each side of the patient's head below the upper ear base; i) the ring strap portion includes a lower ventilation portion disposed between the pair of lower strap portions; j) the lower ventilation portion includes a lower edge spaced apart from a lower edge of the ring strap portion; k ) a lower edge of the lower ventilation portion has a higher curvature than a lower edge of the ring strap portion such that, in use, a maximum spacing is achieved between the lower edge of the lower ventilation portion and the lower edge of the ring strap portion at or near the sagittal plane of the patient's head; l) the lower strap portion is stretchable; m) the ring strap portion comprises a knitted construction; n) the ring strap portion is formed by weft knitting; o) the ring strap portion comprises a single jersey knit construction; p) the ring strap portion comprises a double jersey loop forming knit construction; q) the stiffening portion is a pique knit. r) an upper portion of the ring strap portion includes a pair of overhead strap portions adjustably connected to each other adjacent a sagittal plane of the patient's head; s) the overhead strap portions are adjustably connected to the buckle; t) the overhead strap portions include a hook-and-loop material that enables each of the overhead strap portions to be routed through a portion of the buckle and secured thereon; u) the positioning and stabilizing structure includes a frame connected to the plenum chamber, the upper strap portions configured to connect to the frame;and / or v) the positioning and stabilizing structure further includes a lower strap portion configured for connection to the frame;

[0104] Another form of the present technology includes a patient interface. The patient interface includes: At least 6cmH above ambient air pressure 2 a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby an air flow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that, in use, at least a portion of the tie rests on a region of the patient's head above a superior ear-base point of the patient's head; a vent structure that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; the patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's mouth exposed; the positioning and stabilizing structure includes at least one strap configured to connect to the plenum chamber, the strap being formed from a knitted fabric and including a fastener portion adjacent an end of the strap, the fastener portion being constructed and / or arranged to allow the strap to loop back on itself and fasten to itself to connect to the plenum chamber; The strap includes at least one blind guide formed from the knitted fabric and configured to provide a tactile indication of the location of the fastener on the strap.

[0105] In examples: a) the strap is formed by weft knitting; b) the strap includes a non-patient contacting surface, and the at least one blind guide includes at least one of a ridge and a recess that is (optionally) raised and / or recessed relative to the non-patient contacting surface; c) the ridge / recess surrounds at least a portion of the fastening portion of the strap; d) the ridge includes an elongated raised profile on the non-patient contacting surface of the strap; e) the elongated raised profile is provided on one or more edges of the fastening portion; f) the elongated raised profile is configured to be in a position such that, in use, the ridge is in a position such that the at least one blind guide ... g) the elongated raised profile comprises a circular raised surface; h) the ridge / recess is formed by the strap having a thickness less / greater than adjacent areas of the strap; i) the fastening portion of the strap comprises hook-and-loop fastener material; j) the fastening portion comprises end portions having one of hook material and loop material on the non-patient contacting surface and a middle portion having the other of hook material and loop material on the non-patient contacting surface; k) the middle portion is longer than the end portions. the middle portion is several times longer than the end portions; l) the strap and the blind guide are formed during a single knitting process; m) the blind guide comprises a pique knit construction; n) the strap comprises a single jersey knit construction; o) the strap comprises a double jersey loop formation; p) the strap connects to the plenum chamber via the frame of the patient interface; q) the strap comprises a ring strap portion having an upper portion configured to rest against the patient's head on the parietal bone of the patient's head in use and a lower portion configured to rest against the patient's head on or below the occipital bone of the patient's head in use, and a pair of upper strap portions each configured to connect between the ring strap portion and the plenum chamber in use on each side of the patient's head above the upper ear base point; r) the strap comprises a pair of lower strap portions each configured to connect between the ring strap portion and the plenum chamber in use on each side of the patient's head below the upper ear base; and / or s) the strap and the blind guide are formed integrally.

[0106] Another form of the present technology includes a patient interface. The patient interface includes: At least 6cmH above ambient air pressure 2 a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby an air flow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle, in use; a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that, in use, at least a portion of the tie rests on a region of the patient's head above a superior ear-base point of the patient's head; a vent structure that allows a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, said vent structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; the patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's mouth exposed; The positioning and stabilizing structure comprises: a pair of headgear conduits for receiving airflow from a connection port on the patient's head and delivering the airflow through a seal-forming structure to an entrance to the patient's airway, each headgear conduit constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear base point on each side of the patient's head; and a strap integrally formed by weft knitting, the headgear strap comprising: a neck strap portion configured to rest on the occipital bone of the patient's head and / or be positioned against the patient's neck in use; a pair of upper strap portions, each configured to connect between a neck strap portion and a respective headgear conduit on each side of the patient's head; and A pair of lower strap portions, each configured to connect between the neck strap portion and a respective headgear conduit.

[0107] In examples: a) the strap is formed by a single weft knitting process; b) the strap includes a stiffening portion; c) the stiffening portion includes a pique knit construction; d) the neck strap portion includes a stiffening portion; e) the neck strap portion includes one or more stretchable portions; f) the neck strap portion includes an upper stretchable portion and a lower stretchable portion; g) the upper stretchable portion is located along an upper edge of the neck strap portion; h) the lower stretchable portion is located along a lower edge of the neck strap portion; i) the strap includes a ventilation portion constructed and / or arranged to provide greater breathability through the strap at the ventilation portion; j) the ventilation portion is disposed within the neck strap portion; k) the ventilation portion includes a knit fabric having a pique mesh knit construction; l) the ventilation portion is less stretchable than other portions of the ring strap portion; and / or m) the stiffening portion surrounds the ventilation portion.

[0108] In further examples: a) the strap includes a fastening portion adjacent an end of the strap, the fastening portion constructed and / or arranged to connect to the plenum chamber by looping the strap over itself and fastening to itself, the strap includes at least one blind guide, the at least one blind guide being formed by a knit fabric forming an integrally formed strap and configured to provide a tactile indication of the location of the fastening portion on the strap; b) the strap includes a non-patient contacting surface, the at least one blind guide including a raised portion, the raised portion being raised relative to the non-patient contacting surface; c) the raised portion includes an elongated raised profile on the non-patient contacting surface of the strap; d) the fastening portion of the strap includes a hook and loop fastener material; and / or e) the upper strap portion and the lower strap portion each include a respective blind guide.

[0109] One aspect of one form of the present technology is a processor-implemented method for creating a customized component of an apparatus or device for treating respiratory disorders, the method including: receiving, using the communications circuitry, data indicative of one or more feature requests; determining, with at least one processor, a set of manufacturing specifications for fabrication of the components based on the one or more functional requirements; and Having one or more manufacturing machines produce components based on a set of manufacturing specifications.

[0110] In an example: (a) the data indicative of the functional demand includes at least one physiological characteristic of an intended user of the device; (b) the data indicative of the at least one physiological characteristic is obtained using at least one sensor; (c) the physiological characteristic is a respiratory characteristic; and (d) the physiological characteristic is a carbon dioxide (CO 2) saturation and moisture content; (e) the functional requirements include one or more of a heat and moisture exchanger characteristic associated with absorption of heat and / or moisture from a volume of air exhaled during a patient's exhalation; breathability; heat dissipation, tactile feel (e.g., softness and / or smoothness); (f) causing one or more manufacturing devices to produce the components includes controlling the one or more manufacturing devices to produce the components based on a set of manufacturing specifications; and / or (g) the method is performed by a manufacturing system including at least one processor and communications circuitry.

[0111] The described methods, systems, devices and apparatus may be implemented to improve the comfort, cost, effectiveness, ease of use and manufacturability of customized patient interfaces and / or their components.

[0112] The described methods, systems, devices and apparatus may be implemented to increase the functionality of a processor (e.g., a processor of a special purpose computer used to identify landmark features and / or their locations, identify relationships between landmark features, determine functional requirements (e.g., for a patient interface and / or one or more components thereof), determine manufacturing specifications, and / or create or generate programmable instructions for a manufacturing machine). Additionally, the described methods, systems, devices and apparatus may enable advancements in the art of automated generation of machine programming instructions for the creation of customized patient interfaces and / or components thereof. Additionally, the described methods, systems, devices and apparatus may enable increased flexibility in the creation of customized patient interfaces and / or components thereof that properly fit and provide maximum comfort to a user, and / or enable faster creation of customized patient interfaces and / or components thereof. Examples of the present technology enable the provision of a customized patient interface and / or components thereof more quickly (e.g., from the time of request) and / or with precision not possible with conventional methods, due at least in part to the inability of a patient, clinician and / or manufacturer to precisely consider and execute all of the elements involved in providing a customized patient interface and / or components thereof (with increased precision and comfort and / or without significant cost and / or time).

[0113] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

[0114] One aspect of one form of the present technology is a portable RPT device that a person can carry with them (eg, around the home).

[0115] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a humidifier tank that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0116] The described methods, systems, devices and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory treatment device). Additionally, the described methods, systems, devices and apparatus enable advances in the art of automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0117] Of course, some of the aspects may form sub-aspects of the technology, and various ones of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the technology.

[0118] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief description of the drawings]

[0119] 4. Brief Description of the Drawings

[0120] The present technology is illustrated by way of example and not by way of limitation in the accompanying drawings in which like reference symbols include like elements:

[0121] 4.1 Treatment system

[0122] [Figure 1A]The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position.

[0123] 4.2 Respiratory System and Facial Anatomy

[0124] [Figure 2A] An outline of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] FIG. 1 is a diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face including several features of the surface anatomy including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The directions of superior, inferior, radially inward, and radially outward are also given. [Figure 2D]FIG. 1 is a lateral view of the head including several features of the surface anatomy including the glabella, serion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior temporal points. The directions of superior and inferior, and anterior and posterior are also given. [Figure 2E] FIG. 1 is a further lateral view of the head, with the approximate locations of the Frankfort horizontal and nasolabial angle noted. The coronal plane is also noted. [Figure 2F] A bottom view of the nose including several features including nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, nostril axis and midsagittal plane. [Figure 2G] FIG. 2 is a side view of the superficial features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention to the nasal septal cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull including the frontal, nasal and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] Side view of the skull with the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius. [Figure 2L] Shows the anterior lateral aspect of the nose.

[0125] 4.3 Patient Interface

[0126] [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B]3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] 1 is a schematic cross-sectional view of a structure cut at a point, where the outward normal is shown and the curvature value at this point is zero. [Figure 3E] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of curvature shown in FIG. [Figure 3F] 3C is a schematic cross-sectional view of the structure cut at a point, where the outward normal is shown, and the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The straight line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into it. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] FIGURE 3D is a cross-sectional view through the structure of Figure 3I.The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] 1 shows the right ear including the right ear helix. [Figure 3S] Shown is a right-handed spiral. [Figure 3T] FIG. 13 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left hand side and a right hand side. [Figure 3W] FIG. 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the midsagittal plane shown in FIG. The "mid-contact" plane is illustrated. The mid-sagittal plane is perpendicular to the mid-sagittal plane. The orientation of the mid-sagittal plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the mid-sagittal plane and only contacts the cushion of the plenum chamber at two points on the mid-sagittal plane (i.e., superior point 3220 and inferior point 3230). Depending on the geometry of the cushion in this region, the mid-contact plane may contact both the superior and inferior points. [Figure 3X]The plenum chamber 3200 of FIG. 3U is shown in a use position on the face. The midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in the use position. The central contact surface generally corresponds to the "face of the face" when the plenum chamber is in the use position. In FIG. 3X, the plenum chamber 3200 is of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3230 resting on the upper lip.

[0127] 4.4 RPT Devices

[0128] [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 1 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. The upstream and downstream directions are shown relative to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0129] 4.5 Humidifier

[0130] [Figure 5A] FIG. 13 is an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] Shown is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.

[0131] 4.6 Respiratory waveform

[0132] [Figure 6] 1 shows a model of a typical human breathing waveform during sleep.

[0133] 4.7 Specific Examples of the Technology

[0134] [Figure 7] FIG. 11 is a perspective view of a positioning and stabilizing structure 3300 being worn by a patient 1000 according to an example of the present technology. [Figure 8] FIG. 8 is a view of the non-patient contacting side of the strap portion of the positioning and stabilizing structure 3300 of FIG. 7 in a flat state. [Figure 9] FIG. 8 is a view of the patient-contacting side of the strap portion of the positioning and stabilizing structure 3300 of FIG. 7 in a flattened state. [Figure 10] FIG. 8 is a view of the non-patient contacting side of the positioning and stabilizing structure 3300 of FIG. 7 in a flattened state, shown in cross section. [Figure 11] FIG. 8 is an exploded view of the strap fastening portion of the positioning and stabilizing structure 3300 of FIG. [Figure 12] FIG. 8 is a view of the patient-contacting side of the positioning and stabilizing structure 3300 of FIG. 7 in a partially flattened state, shown in cross section. [Figure 13] 13 shows a portion of a positioning and stabilizing portion 3300 being worn by a patient 1000 in accordance with another example of the present technology. [Figure 14] The upper ventilated portion of the positioning and stabilizing structure of FIG. 13 is shown worn by a patient 1000. [Figure 15] The lower ventilated portion of the positioning and stabilizing structure of FIG. 13 is shown worn by a patient 1000. [Figure 16] A view of the non-patient contacting side of a headgear strap 3301 of a positioning and stabilizing structure according to another example of the present technology. [Figure 17] FIG. 17 is a perspective view of a patient interface 3000 according to another example of the present technology, including the headgear straps 3301 of FIG. [Figure 18] FIG. 3 is a schematic diagram of a system 300 in accordance with another example of the present technology. [Figure 19A] 7 shows a flowchart of a method 7000 and aspects thereof according to another example of the present technology. [Figure 19B]7 shows a flowchart of a method 7000 and aspects thereof according to another example of the present technology. [Figure 19C] 7 shows a flowchart of a method 7000 and aspects thereof according to another example of the present technology. [Figure 19D] 7 shows a flowchart of a method 7000 and aspects thereof according to another example of the present technology. [Figure 19E] 7 shows a flowchart of a method 7000 and aspects thereof according to another example of the present technology. [Figure 19F] 7 shows a flowchart of a method 7000 and aspects thereof according to another example of the present technology. [Figure 20] 7 is a side view of a patient's head with multiple distances identified, shown in relation to method 7000. [Figure 21] This is a top view of a headgear strap 3301 in a flat position according to another example of the present technology. [Figure 22] This is a top view of a headgear strap 3301 in a flat position according to another example of the present technology. [Diagram 23] This is a top view of a headgear strap 3301 in a flat position according to another example of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0135] 5 Detailed description of examples of the present technology

[0136] Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific examples described herein, and are not limiting.

[0137] The following description is provided in conjunction with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or the other examples. In addition, any single feature or combination of features in any of these examples may constitute an additional example.

[0138] 5.1 Treatment

[0139] In one form, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to an entrance to the airways of a patient 1000.

[0140] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0141] In certain instances of the present technology, mouth breathing is restricted, limited or prevented.

[0142] 5.2 Treatment system

[0143] In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0144] 5.3 Patient Interface

[0145] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functionalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a ventilation structure 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functionalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functionalities. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's airways to facilitate the supply of air at positive pressure to the airways.

[0146] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0147] A patient interface 3000 in accordance with one form of the present technology may have a circumferential 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0148] A patient interface 3000 in accordance with one form of the present technology may be configured to provide at least 10 cmH 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0149] A patient interface 3000 in accordance with one form of the present technology may be configured to provide at least 20cmH 2 Constructed and arranged to provide an air supply at positive pressure of O.

[0150] 5.3.1 Seal formation structure

[0151] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session from day to day depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0152] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0153] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0154] A seal-forming structure 3100 in accordance with the present technology may be constructed from a material that is soft, flexible and resilient (eg, silicone).

[0155] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 suitable for large head sizes but not small head sizes, and another suitable for small head sizes but not large head sizes.

[0156] 5.3.1.1 Sealing mechanism

[0157] In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 to act on its underside to form a tight sealing engagement with a surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0158] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the edge length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the edge length. The support flange is or includes a spring-like element and functions to support the sealing flange against buckling in use.

[0159] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged such that, in use, it is in a compressed state due to, for example, elastic tension in the positioning and stabilizing structure.

[0160] In one form the seal-forming structure includes a tension part which, in use, is held taut, for example by an adjacent region of a sealing flange.

[0161] In one form the seal-forming structure includes an area having a sticky or adhesive surface.

[0162] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0163] 5.3.1.2 Nasal bridge or nasal ridge area

[0164] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0165] In one form, the seal-forming structure includes a saddle-like region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0166] 5.3.1.3 Upper lip area

[0167] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip area (ie, upper lip) of the patient's face.

[0168] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0169] 5.3.1.4 Jaw area

[0170] In one form, the non-invasive patient interface 3000 includes a seal-forming structure which, in use, forms a seal over the chin area of ​​the patient's face.

[0171] In one form, the seal-forming structure includes a saddle-like region constructed to form a seal over the chin region of the patient's face in use.

[0172] 5.3.1.5 Frontal area

[0173] In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, hi such a form, the plenum chamber may cover the eye when in use.

[0174] 5.3.1.6 Nasal pillow

[0175] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0176] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum forms a seal over the underside of the patient's nose, the stalk, and a flexible region on the underside of the frustum, connecting the frustum to the stalk. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the stalk. The flexible region may function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the frustum of the cone and the relative movement of the structure to which the nasal pillows are connected. For example, the frustum of the cone may be displaced axially towards the structure to which the stalk is connected.

[0177] 5.3.2 Plenum chamber

[0178] The plenum chamber 3200 has a perimeter with a shape that is complementary to the surface contour of an average human face in the area where a seal is formed in use. In use, the peripheral edge of the plenum chamber 3200 is positioned proximate to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogenous piece of material.

[0179] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized volume defined by the plenum chamber. Such forms may improve treatment compliance because they are often less intrusive and / or more comfortable for the wearer.

[0180] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and aid in improved compliance with treatment. The use of a transparent material may aid the clinician in seeing the placement and function of the patient interface.

[0181] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can make the patient interface less intrusive and can help improve compliance with treatment.

[0182] 5.3.3 Positioning and stabilizing structures

[0183] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0184] In one form, the positioning and stabilizing structure 3300 provides at least enough retention force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0185] In one form, the positioning and stabilising structure 3300 provides a retaining force sufficient to overcome the attractive force on the patient interface 3000.

[0186] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0187] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0188] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0189] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleep position with the side region of the patient's head resting on a pillow.

[0190] In one form of the present technology, the positioning and stabilizing structure 3300 includes a decoupling site located between the front of the positioning and stabilizing structure 3300 and the rear of the positioning and stabilizing structure 3300. The decoupling site does not resist compression and can be, for example, a flexible or flimsy strap. The decoupling site is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling site does not send a rearward force along the positioning and stabilizing structure 3300, disrupting the seal.

[0191] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0192] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap may be configured to be tensioned in use to direct a force that causes the seal-forming structure to seal against a portion of the patient's face. In one example, the strap may be configured as a tie.

[0193] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-temporal point on the patient's head to cover a portion of the parietal bone without covering the occipital bone.

[0194] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes under the lower ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0195] In one form of the present technology, suitable for a nasal only or full face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart relative to one another.

[0196] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0197] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0198] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, a system may include one form of positioning and stabilizing structure 3300 that is suitable for a large sized head but not a small sized head and another that is suitable for a small sized head but not a large sized head.

[0199] 7 shows a patient 1000 wearing a patient interface 3000 in accordance with an example of the present technology. The patient interface 3000 is configured to provide at least 6 cmH2O above ambient air pressure. 2 The patient interface 3000 in this example includes a connection port 3600 connected to an air delivery conduit from which air is delivered to the plenum chamber 3200. The patient interface 3000 in this example includes a plenum chamber inlet port 3600 that is pressurizable to a therapeutic pressure of O. The plenum chamber includes a plenum chamber inlet port that is sized and configured to receive an air flow at the therapeutic pressure for breathing by the patient 1000. The patient interface 3000 in this example includes a connection port 3600 that is connected to an air delivery conduit from which air is delivered to the plenum chamber 3200.

[0200] The patient interface 3000 may also include a seal-forming structure 3100 constructed and arranged to form a seal against the patient's facial area surrounding the entrance to the patient's airways. The seal-forming structure 3100 has holes therein such that airflow at said therapeutic pressure is delivered to at least the entrance to the patient's nares. In this example, the patient interface 3000 includes a seal-forming structure 3100 that seals around both the nose and mouth. This type of patient interface is commonly known as a full face mask. In another example, the seal-forming structure 3100 may seal around the patient's nares, leaving the patient's mouth exposed. The seal-forming structure 3100 is constructed and arranged to maintain said therapeutic pressure within the plenum chamber 3200 throughout the patient's breathing cycle in use.

[0201] The patient interface 3000 further includes a vent structure 3400. The vent structure 3400 allows for a continuous flow of gases exhaled by the patient from within the plenum chamber 3200 to the surroundings. The vent structure 3400 is sized and shaped to maintain a therapeutic pressure within the plenum chamber in use.

[0202] The patient interface 3000 also includes a positioning and stabilizing structure 3300 that provides a force to hold the seal-forming structure 3100 in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes a tie constructed and arranged such that at least a portion of the tie covers an area of ​​the patient's head above the superior ear base point of the patient's head in use. In one example of the present technology, the positioning and stabilizing structure 3300 includes a frame 3500 to which the plenum chamber 3200 is connected. The frame 3500 is held in place by a number of strap portions of the positioning and stabilizing structure 3300.

[0203] 5.3.3.1 One-piece knitted headgear straps

[0204] In one example of the present technology, the positioning and stabilizing structure 3300 includes an integrally formed headgear strap 3301, shown worn by a patient in FIG. 7 and separated in FIG. 8 and FIG. 9. The headgear strap 3301 has a unitary structure. The headgear strap 3301 is formed as a single, one-piece knitted strap, as opposed to forming a combination of multiple strap pieces separately and connecting them together, or cutting a one-piece strap from a sheet of material. Forming the strap portions separately and attaching them to each other can slow down manufacturing and / or increase costs. Cutting the headgear strap can result in significant waste of material. However, in some examples of the present technology, multiple headgear strap portions that may be included in the positioning and stabilizing structure 3300 are formed separately and connected together, while including other features of the present technology described herein. As used herein, the term "strap" may be used to describe a structure that includes multiple strap portions. Each of the multiple strap portions may also take the form and function of a strap in that it is a strip of material used in conjunction with the other strap portions to hold an item in place.

[0205] The headgear straps 3301 may be knitted as a single piece of material by weft knitting. Weft knitting the headgear straps 3301 allows the entire headgear straps 3301 to be sewn in a single weft knitting process. The knit-to-shape capabilities allowed by weft knitting provide 3D shapes without requiring secondary processes for certain components (e.g., cutting and / or combining multiple components). In some examples of the present technology, the headgear straps 3301 do not include seams or joins. Seams and joins, if present, may cause some users to feel uncomfortable pressure on the skin in some situations.

[0206] One advantage of weft knitting is that it allows the headgear straps 3301 to be knitted directly from fibers in the form of threads, yarns, etc., to directly achieve a shape (rather than cutting the headgear straps 3301 directly from a sheet). Cutting multiple complex shapes from a sheet can result in large scraps, resulting in waste. Additionally, cutting headgear straps from a laminated sheet can also reduce the flexibility to cost-effectively customize the headgear fabric or color. Lamination of new sheets may be required to achieve new fabric and / or color options.

[0207] Another advantage of the knitted headgear straps 3301 is that the headgear can be knitted to closely conform to the shape of the patient's head, leading to improved comfort and stability. In some examples of the present technology, the headgear straps 3301 can be knitted to conform to the shape of a particular patient's head based on a three-dimensional model of the particular patient's head generated using imaging or scanning of the particular patient's head.

[0208] Some existing headgears are made by double-needle crochet knitting. Headgear straps made by this method may be limited to a single strap-like configuration and cannot be applied to complete headgear for nasal masks or full-face masks (e.g., patient interface with four-point headgear connection) due to the complex shape of the four-point connection headgear straps.

[0209] In some examples of the present technology, the headgear straps 3301 are formed using advanced knitting techniques to form a knit structure that is highly breathable, elastic and / or aesthetically appealing. Such a knit structure may be similar to that found in sports jerseys.

[0210] In some examples of the present technology, the headgear straps 3301 may include multiple different colors and / or patterns. Mixing colors and patterns with weft knitting allows for a wider variety of designs without additional aesthetic costs.

[0211] In some examples of the present technology, the headgear strap 3301 includes one or more regions of localized stiffness and / or elasticity. These localized regions of stiffness and / or elasticity can be formed in the headgear strap 3301 by a weft knitting process that is performed while knitting the entire headgear strap 3301. The elastic properties can be tailored to meet the different requirements of each region of the headgear strap 3301.

[0212] In some examples of the present technology, the headgear straps 3301 are formed by weft knitting, but include a non-flat shape even before being worn by the patient. The non-flat shape can be created by knitting the headgear straps 3301 with different knitting densities in different regions. Different properties can be imparted to different regions of the headgear straps 3301 to meet certain specifications. In some examples, providing such properties to the headgear straps 3301 during weft knitting can result in the headgear straps 3301 including a non-flat shape. In some forms of the present technology, the non-flat shape can impart to the headgear straps 3301 a certain property (e.g., a certain elasticity in a certain location and / or direction) or a certain force vector applied by the headgear straps 3301 to the plenum chamber 3200 and / or the seal-forming structure 3100 during use.

[0213] In some examples of the present technology, the headgear straps 3301 are customized and tailored to a particular patient's anatomy and / or preferences. Weft knitting is advantageous because it allows manufacturers flexibility in using a range of yarns, applying different design patterns, applying different colors and surface geometry features. In some examples, the headgear straps 3301 are knitted by a programmable knitting machine. Headgear straps formed by weft knitting can also be extremely comfortable. If high gauge and fine yarn woven fabrics are used, the surface finish of the straps can be smooth and the risk of marking the face can be reduced.

[0214] In some examples, the headgear strap 3301 may have one or more text, graphics, trademarks, logos, etc. knitted into it during a single knitting operation performed to form the headgear strap 3301.

[0215] In another example, the positioning and stabilizing structure 3300 may include one or more headgear straps. In some other examples, one or more headgear strap portions are formed by a circular knitting process.

[0216] In some examples, the maximum force that the headgear straps 3301 can withstand without damage is 10N-100N, more preferably 15-80N, 20-60N, or 25-40N. In some examples, the headgear straps 3301 can include one or more sections having a pique knit construction formed with 100% nylon and can be configured to withstand a maximum load of 5-8N (in some examples 6-7N) in the wales and 2.5-5.5N (in some examples 3.5N-4.5N) in the courses. In some examples, the headgear straps 3301 can include one or more sections having a pique knit construction formed with a combination of nylon and spandex and can be configured to withstand a maximum load of 3-6N (in some examples 4-5N) in the wales and 2-4N (in some examples 2.5-3.5N) in the courses. In some examples, the headgear straps 3301 may include one or more sections having a single jersey knit construction formed with a combination of nylon and spandex and may be configured to withstand a maximum load of 2.5-5N (in some examples, 3-4N) in the wales and 1-3N (in some examples, 1.5-2.5N) in the courses.

[0217] In some examples, the headgear straps 3301 are constructed to dry in a short time after washing or getting wet from body moisture. The headgear straps 3301 may be highly breathable and may keep the patient's skin relatively dry. The headgear straps 3301 may be configured to cause little or substantially no marking on the face. The headgear straps 3301 may be machine washable and hand washable.

[0218] The headgear strap 3301 shown in FIG. 8 is configured to create a four-point connection (more specifically, have four strap portions) to the frame 3500 or plenum chamber 3200 of the patient interface 3000. These four strap portions connect to four points on the frame 3500 or plenum chamber 3200, respectively. In other examples of the present technology, the headgear strap 3301 may be configured to create a two-point connection to the frame 3500 or plenum chamber 3200 (e.g., when incorporated into a nasal pillows or nasal cradle type patient interface 3000). The headgear strap 3301 may connect at one or two points to the frame 3500 or plenum chamber 3200 of a patient interface 3000 having a full-face configuration (e.g., a configuration in which the seal-forming structure 3100 seals around the lower periphery of the patient's nose, leaving most or all of the patient's nasal bridge exposed). In some examples, the headgear straps 3301 may be configured as back straps for the positioning and stabilizing structure for a conduit headgear system 3300. In such examples, the headgear straps 3301 may rest or be positioned under the patient's occipital bone in use and connect between a pair of headgear conduits that are positioned against the lateral sides of the patient's head.

[0219] 5.3.3.2 Headgear strap section

[0220] As shown in Figures 7-9, the positioning and stabilizing structure 3300 may include multiple strap portions. The multiple strap portions may be provided within a single headgear strap 3301, for example, as in the positioning and stabilizing structure 3300 of Figures 7-9. In this example of the present technology, the positioning and stabilizing structure 3300 includes a ring strap portion 3340. When worn, the ring strap portion 3340 encircles the back of the patient's head, providing a strong anchor for the other strap portions that connect to the plenum chamber 3200. The ring strap portion 3340 may also be known as a crown portion, a crown strap, a posterior / rear portion, or a halo.

[0221] In this example of the present technology, the ring strap portion 3340 of the positioning and stabilizing structure 3300 includes an upper portion 3302 and a lower portion 3304. In use, the upper portion 3302 is positioned against the patient's head across the parietal bone of the patient's head. The lower portion 3304 is configured to be positioned against the patient's head across or below the occipital bone of the patient's head in use. As shown, the ring strap portion 3340 defines a loop.

[0222] The positioning and stabilizing structure 3300 includes a pair of upper strap portions 3310. Each of the upper strap portions 3310 is configured to connect between the ring strap portion 3340 and the plenum chamber 3200. In use, each of the upper strap portions 3310 is positioned on each side along the patient's head from the top of the head to the base of the upper ear.

[0223] 7-9, the positioning and stabilizing structure 3300 also includes a pair of lower strap portions 3320. Each of the lower strap portions 3320 is configured to connect between the ring strap portion 3340 and the plenum chamber 3200. In use, each of the lower strap portions 3320 is positioned on each side along the patient's head from the underside of the head to the base of the upper ear.

[0224] The upper strap portion 3310 and the lower strap portion 3320 may each connect to the plenum chamber 3200 directly or through a frame 3500 of the positioning and stabilizing structure 3300. In the example shown in Figure 7, the upper strap portion 3310 and the lower strap portion 3320 connect to the plenum chamber 3200 (through a frame 3350 to which the plenum chamber 3200 connects).

[0225] One or more of the headgear strap portions of the positioning and stabilizing structure 3330 (e.g., upper strap portion 3310, lower strap portion 3320, and overhead strap portion 3330 described below) may include a fastening portion 3360. The fastening portion 3360 may be constructed and / or arranged to allow the strap to be looped back on itself and fastened to itself. In one example, the fastening portion 3360 may include hook and loop material. In another example, the fastening portion 3360 may include magnets configured to attach to each other when the strap is looped back on itself.

[0226] In some examples of the present technology, the positioning and stabilizing structure 3300 may include an upper strap portion 3310 but may not include a lower strap portion 3320. In some examples of the present technology, the patient interface 3000 may include a positioning and stabilizing structure 3300 that includes an upper strap portion 3310. The upper strap portion 3310 connects a rear portion of the positioning and stabilizing structure 3300 (e.g., ring strap portion 3340) to a plenum chamber 3200 that includes the nasal pillows or cradle cushion seal forming structure 3100.

[0227] In this example, the ring strap portion 3340 includes a stiffening portion 3345. The stiffening portion 3345 is stiffer than other portions of the ring strap portion 3340. The stiffening portion 3345 may not be entirely stiff, but may be "stiffened" in that it is stiffer than some or all of the other portions of the ring strap portion 3340. The stiffening portion 3345 and other portions of the ring strap portion 3340 may all be flexible to a certain extent, but the stiffening portion 3345 may be stiffer. The stiffening portion 3345 may be less stretchable and / or less flexible than other portions of the ring strap portion 3340. In this example, the stiffening portion 3345 is provided along the length of the loop defined by the ring strap portion 3345. The stiffening portion 3345 of the ring strap portion 3340 may provide reinforcement to the ring strap portion 3340. Reinforcing the ring strap portion 3340 may improve the stability of the patient interface 3000 during use, since its purpose is to anchor the other strap portions that connect to the plenum chamber 3200 (under tension to pull the plenum chamber 3200 into the patient's face). The stiffening portion 3345 may be substantially non-stretchable, but may still bend to accommodate the curvature of the patient's head. The non-stretchability of the stiffening portion 3345 allows for the reinforcement of the ring strap portion 3340, making the positioning and stabilizing structure 3300 more firmly anchored and more stable. The upper strap portion 3310 may be stretchable. In some examples of the present technology, the stiffening portion 3345 may be stretchable, but less stretchable than other portions of the ring strap portion 3340. In some examples, the ring strap portion 3340 may include a first section disposed along the length of the loop defined by the ring strap portion 3345 and a second section disposed along the length of the loop. The second section may include a high stiffness section 3345. The second section may be more stiff than the first section. The second section may be less flexible than the first section. The second section may be less stretchable than the first section.

[0228] In this example of the present technology, the stiffening portion 3345 is provided along substantially the entire length of the loop defined by the ring strap portion 3340. As shown, the ring strap portion 3340 includes an inner circumference 3341 and an outer circumference 3342. In some examples, the ring strap portion 3340 is stiffer proximate the inner circumference 3341 than proximate the outer circumference 3342. In one example, the stiffening portion 3345 is provided in the ring strap portion 3340 proximate the inner circumference 3341 of the ring strap portion 3340. The stiffening portion 3345 may define the inner circumference 3341 of the ring strap portion 3340 or may be located proximate an edge of the ring strap portion 3340 that defines the inner circumference 3341. The stiffening portion 3345 may form substantially the entire inner circumference 3341 of the ring strap portion 3340. In another example, the stiffening portion 3345 may be substantially centrally located between the inner circumference 3341 of the ring strap portion 3340 and the outer circumference 3342 of the ring strap portion 3340.

[0229] Reinforcing the inner circumference 3341 around the ring strap portion 3340 may be advantageous in that it may allow for the outer circumference 3342 (more forward) of the ring strap portion 3340 to be formed in close proximity to any other strap portions connecting the ring strap portion 3340 to the plenum chamber 3200 of the patient interface 3000. Locating the stiffening portion 3345 centrally between the inner circumference 3341 and the outer circumference 3342 may be advantageous in that it evens out the distribution of pressure loads on the patient's skin. The inner circumference 3341 of the ring strap portion 3340 may also not need to deform as much as the outer circumference 3342, because additional strap portions extend from the outer circumference 3342 to connect to the plenum chamber 3200 in front of the patient's face.

[0230] The ring strap portion 3340 and / or any other strap portion of the positioning and stabilizing structure 3300 may include rounded edges, which may be less likely to cause skin marks and may be more comfortable for the patient's skin.

[0231] In some examples of the present technology, the strap portion of the positioning and stabilizing structure 3300 may be formed by knitting. That is, one or more of the upper strap portion 3310, the lower strap portion 3320, and the ring strap portion 3340 may include a knitted fabric structure. In some examples, one or more of these strap portions of the positioning and stabilizing structure 3300 may be formed by weft knitting. For example, the ring strap portion 3340, the upper strap portion 3310, and / or the lower strap portion 3320 may include a single jersey knit structure and may be formed from a combination of nylon and spandex. The single jersey knit structure advantageously allows the strap portion to obtain the necessary flexibility and elasticity without excessive thickness. Alternatively, the ring strap portion 3340 may include a double jersey loop formation. The stiffening portion 3345 of the ring strap portion 3340 may include a pique knit structure and may be formed from nylon or a combination of nylon and spandex. The use of a pique knit structure in forming the stiffening portion 3345 may be advantageous because this type of structure is highly suitable for producing ridges that have a sufficiently high level of stiffness (while still having rounded edges).

[0232] The headgear straps of the positioning and stabilizing structure 3300 may be stretchable. Advantageously, the upper strap portion 3310, the lower strap portion 3320, and the ring strap portion 3340 are stretchable. The stretchability of the ring strap portion 3340 of the positioning and stabilizing structure 3300 allows the ring strap portion 3340 to conform and fit snugly to the back, sides, and top of the patient's head when in use. The upper strap portion 3310 and the lower strap portion 3320 are stretchable, allowing them to expand slightly in length to provide some relief when the plenum chamber 3200 is pressurized. In some instances, the upper strap portion 3310 may be less elastic than the lower strap portion 3320 due to the dynamic movement of the lower temporal circumference (head up and down) which continues to change. The portion of the headgear adjacent to the neck region (e.g., the lower strap portion 3320) may be less stretchable but not necessarily stiff, as it primarily functions as a pivot point. Near the cheekbone area (eg, in part of the upper strap portion 3310), stiffness may be necessary to ensure that headgear does not interfere with the eyes.

[0233] In use, when the plenum chamber 3200 is under pressure, the amount of pressurized air in the plenum chamber 3200 will cause the plenum chamber 3200 and frame 3500 to be pushed forward, away from the patient's face. The force from this pressure must be countered by tension in the headgear straps to maintain sealed contact between the plenum chamber 3200 and the seal-forming structure 3100 and the patient's face. Allowing the upper strap portion 3310 and the lower strap portion 3320 to expand in length by at least a small amount allows the patient interface 3000 to be more comfortable to wear when this occurs.

[0234] Advantageously, the upper strap portion 3310, the lower strap portion 3320 and the ring strap portion 3340 are all breathable due to the knitted construction of the material they are made from. Breathability is advantageous because it helps keep the headgear straps and the patient's skin dry (while maintaining a manageable temperature of the patient's skin underneath the headgear straps).

[0235] The stiffening portion 3345 may be a rounded thickened portion of the headgear strap material. The stiffening portion 3345 may include a greater material thickness compared to adjacent portions of the ring strap portion 3340. In some examples of the present technology, the patient contacting side of the ring strap portion 3340 is substantially flat and a greater material thickness is provided to the non-patient contacting side of the ring strap portion 3340. Advantageously, the extra thickness achieved by providing extra material forming the stiffening portion 3345 on the non-patient contacting side of the ring strap portion 3340 keeps the patient contacting side of the ring strap portion 3340 substantially flat. A flat surface may be more comfortable against the patient's skin than a non-flat surface, which may be advantageous. In the example shown in FIG. 7, the stiffening portion 3345 is provided on the inner periphery 3341 of the ring strap portion 3340, so that the inner periphery 3341 may be thicker than the outer periphery 3342. In use, the rear edge of ring strap portion 3340 is thicker than the front edge of ring strap portion 3340. Making inner periphery 3341 thicker than outer periphery 3342 makes the inner edge of ring strap portion 3340 stiffer and allows ring strap portion 3340 to be reinforced.

[0236] The stiffening of the stiffening portion 3345 may be imperceptible on the patient contacting side of the ring strap portion 3340. In use, the patient may not be able to see and / or feel any features of the stiffening portion 3345. In FIG. 10, a cross section of the ring strap portion 3340 at two locations is shown. As shown, the extra thickness in the stiffening portion 3345 is only on one side (non-patient contacting side) of the ring strap portion 3340. The other side of the ring strap portion 3340 is substantially flat. Additionally, the stiffening portion 3345 is circular, as are the inner edge of the ring strap portion 3340 (at the inner circumference 3341) and the outer edge of the ring strap portion 3340 (at the outer circumference 3342). This may be particularly useful in maintaining comfort when the headgear straps are over-tightened, as the smooth / circular edges allow for less pressure to be exerted on the user's face.

[0237] In some examples of the present technology, the ring strap portion 3340 includes a thickness of the stiffening portion 3345 in the range of 3-5 mm (e.g., in the range of 3.5-4.5 mm). In some examples, the thickness of the stiffening portion 3345 can be 4 mm. The thickness of the ring strap portion 3340 can be in the range of 1.5-3.5 mm (e.g., in the range of 2-3 mm) (e.g., 2 mm) in areas of the ring strap portion 3340 other than the stiffening portion 3345. The thickness of the upper strap portion 3310 and the lower strap portion 3320 can also be in the range of 1.5-3.5 mm (e.g., in the range of 2-3 mm) (e.g., 2 mm).

[0238] In some examples, the stiffening portion 3345 may have a non-uniform stiffness along the length of the ring strap portion 3340. The stiffening portion 3345 may be less stretchable and / or more flexible in some locations compared to other locations around the ring strap portion 3340. In some examples, the stiffening portion 3345 may be larger in certain locations (compared to other locations), which increases the stiffness and / or stiffness in those specific locations. As shown in FIGS. 7-8, the stiffening portion 3345 is larger near the junction of the top strap portion 3310 and the ring strap portion 3340. In this example, the stiffening portion 3345 is wider near the top strap portion 3310 (but not elsewhere along the ring strap portion 3340). In other examples of the present technology, the stiffening portion 3345 may be stiffer in certain locations due to a greater material thickness and / or the use of a different knit construction (in examples where the ring strap portion 3340 is formed by weaving).

[0239] Varying the width and / or material thickness along the length of the ring strap portion 3340 provides stiffness where stiffness / stability is needed and flexibility and / or comfort where less stiffness is needed. The extra stiffness near the junction of the upper strap portion 3310 and the ring strap portion 3340 may be particularly advantageous because in use the upper strap portion 3310 is under tension and there is a relatively large area of ​​strap material at the junction. Strengthening this junction may assist in a high level of stability of the patient interface 3000.

[0240] The upper portion 3302 of the ring strap portion 3340 may include one or more overhead strap portions 3330. As shown in Figs. 8, 9 and 13, in one example, the ring strap portion 3340 includes a pair of overhead strap portions 3330. The overhead strap portions 3330 may be configured to adjust and connect to one another. In one example, the overhead strap portions 3330 are configured to adjustably connect to one another near the sagittal plane of the patient's head. The adjustable connection between the two overhead strap portions 3330 may advantageously allow the positioning and stabilizing structure 3300 to fit patients with a range of head shapes and sizes. In other examples of the present technology, the positioning and stabilizing structure 3330 may include a single overhead strap portion 3330. If only a single overhead strap portion 3330 is provided, it may be capable of elastically expanding in length, so as to fit patients with a range of head sizes.

[0241] The two overhead strap portions 3330 may be adjustably connected together with a buckle 3335. The buckle 3335 may include a pair of slots, eyelets, or other openings through which the overhead strap portions 3330 may pass, allowing each overhead strap portion 3330 to be routed through a portion 3335 of the buckle and secured to itself. Each overhead strap portion 3330 may include a hook and loop fastener material that allows an end of each overhead strap portion 3330 to be fastened to a middle portion of each overhead strap portion 3330. In other examples of the present technology, clips, elastic bands, magnets, or other suitable fastening means may be used to fasten each overhead strap portion 3330 to itself. In another example, the two overhead strap portions are formed separately during manufacture of the positioning and stabilizing structure 3300 and then welded or sewn together to complete the loop formed by the ring strap portion 3340.

[0242] 16 shows a headgear strap 3301 of a positioning and stabilizing structure 3300 according to another example of the present technology. The headgear strap 3301 may be integrally formed by knitting and may be formed in a single weft knitting process. The headgear strap 3301 of FIG. 16 may include any of the headgear strap 3301 features and / or characteristics described with reference to FIGS. 7-15.

[0243] The headgear strap 3301 shown in FIG. 16 includes a pair of upper headgear strap portions 3310. Each of the upper headgear strap portions 3310 is configured to connect to a plenum chamber 3200 of the patient interface 3000 in use. In this example, each of the upper headgear strap portions 3310 is configured to connect to a respective headgear conduit of the positioning and stabilizing structure 3330 (located on each lateral side of the patient's head in use). Each of the headgear conduits may be configured to extend from a medial location on an upper portion of the patient's head to a lower lateral side of the patient's head in a lateral direction, and then extend forward and medial to connect to the plenum chamber 3200 proximate an entrance to the patient's airway. Thus, the upper headgear strap portions 3310 are configured to connect to the plenum chamber 3200 via the headgear conduit. The headgear strap 3301 also includes a pair of lower headgear strap portions 3320. Each of these lower headgear strap portions 3320 is configured to connect to the plenum chamber 3200. The lower headgear strap portions 3320 may connect directly to the plenum chamber 3200 or to the frame 3500 of the positioning and stabilizing structure.

[0244] FIG. 17 shows a patient interface 3000 including a positioning and stabilizing structure 3300 with headgear straps 3301 according to another example of the present technology. The headgear straps 3301 are configured into a patient interface 3000 including conduit headgear for use. The headgear straps 3301 shown in FIG. 17 connect to headgear conduits 3900 in the same manner as the headgear straps shown in FIG. 16. As shown, the headgear conduits are joined at joints 3903 at the upper part of the patient's head. From the connection ports 3600, a pressurized flow of breathable gas is provided to the headgear conduits 3900. Each headgear conduit 3900 includes a lateral portion 3901 along the patient's head. The lateral portion 3901 connects via connectors 3800 to a plenum chamber 3200 located at the entrance to the patient's airway in use. More generally, each headgear conduit 3900 can receive airflow from a connection port 3600 on the patient's head and deliver the airflow via a seal-forming structure 3100 to an entrance to the patient's airway, with each headgear conduit 3900 constructed and arranged to contact at least an area of ​​the patient's head above the upper ear base point on each side of the patient's head in use.

[0245] 17, the positioning and stabilizing structure 3300 includes a pair of upper strap portions 3320. These upper strap portions 3310 connect between the neck strap portion 3334 and each headgear conduit 3900. In this example, the upper strap portions connect to eyelets on tabs 3902 of the headgear conduits 3900. In this example, the lower strap portion 3320 connects between the neck strap portion 3334 and the plenum chamber 3200 via a headgear clip 3322.

[0246] 16 and 17, the reason why the headgear strap 3301 does not include a ring strap portion or an overhead strap portion is that the headgear conduit provides the functions of the ring strap portion and the overhead strap portion in the examples shown in Fig. 7 to 15 in the positioning and stabilizing structure 3300 as a constituent part of the headgear strap 3301. However, in some examples of the present technology, a positioning and stabilizing structure 3300 is provided that includes a headgear conduit and a headgear strap 3301 including a ring strap portion 3340 and / or an overhead strap portion 3330.

[0247] The headgear strap 3301 shown in Figures 16 and 17 includes a neck strap portion 3334. The neck strap portion 3334 connects to the upper headgear strap 3310 and the lower headgear strap 3320, respectively. The neck strap portion 3334 is configured to be placed against the rear of the patient's neck and / or a surface of the patient's head that rests on the occipital bone of the patient's skull in use. The neck strap portion 3334 may be configured to rest on the occipital bone of the patient's head and / or to be placed against the patient's neck in use.

[0248] The neck strap portion 3334, the upper headgear strap portion 3310 and the lower headgear strap portion 3320 may be integrally formed. The headgear strap 3301 and its upper headgear strap portion 3310, lower headgear strap portion 3320 and neck strap portion 3334 may be formed by a single weft knitting process.

[0249] The headgear strap 3301 shown in FIG. 16 includes a stiffening portion 3345. In this example, the stiffening portion 3345 is provided on the neck strap portion 3334. The stiffening portion 3345 may be formed in any of the manners similar to those described above in connection with the stiffening portion 3345 of the positioning and stabilizing structure 3300 shown in FIGS. 7-15, e.g., using a greater thickness and / or stiffer knit construction. In this example, the stiffening portion 3345 may be substantially non-stretchable.

[0250] The stiffening section 3345 may reinforce the neck strap section 3334. This reinforcement may provide a high level of stability to the patient interface 3000 during use since the purpose of the neck strap section 3334 is to provide an anchor for the other strap sections connecting to the plenum chamber 3200 while pulling the plenum chamber 3200 to the patient's face under tension. The stiffening section 3345 may be substantially non-stretchable or at least less stretchable than the other strap sections, but may still bendable to accommodate the curvature of the patient's head. The non-stretchable or low stretchable stiffening section 3345 may reinforce the neck strap section 3334, providing a firmer anchor and resulting in a more stable positioning and stabilizing structure 3300. The upper strap section 3310 and the lower strap section 3320 may be stretchable.

[0251] The neck strap portion 3334 may include stretchable sections in addition to the stiffening section 3345. In the example shown in FIG. 16, the neck strap portion 3334 includes stretchable sections above and below the stiffening section 3345. In this example, the neck strap portion 3334 includes an upper stretchable section 3346 and a lower stretchable section 3347. The stretchable sections may be located at the upper and / or lower edges of the neck strap portion 3334. In this example, the upper stretchable section 3346 is located along the upper edge of the neck strap portion 3334 and the lower stretchable section 3347 is located along the lower edge of the neck strap portion 3334. Providing stretchable sections at the upper and lower edges of the neck strap portion 3334 may be advantageous for patient comfort. Making the upper and lower edges of the neck strap portion 3334 substantially rigid allows the force from headgear tension to be concentrated on the patient's skin in this configuration. Providing stretchable sections at the upper and lower edges may allow some relief, leading to improved patient comfort. The stretchable sections may also allow the neck strap portion 3334 to conform to the curvature of the patient's neck.

[0252] 5.3.3.3 Headgear ventilation

[0253] In some forms of the present technology, the positioning and stabilizing structure includes a headgear strap having one or more ventilation portions. The one or more ventilation portions are constructed and / or arranged to allow for greater ventilation through the headgear strap. As shown in Figs. 7-10, the positioning and stabilizing structure 3300 includes three ventilation portions 3350. In this example, the ventilation portions 3350 are each provided within the ring strap portion 3340 to provide an area of ​​greater ventilation through the ring strap portion 3340. In the ring strap portion 3340, a ventilation portion 3350 is provided adjacent each of the upper strap portions 3310 (e.g., at each junction between the upper strap portion 3310 and the ring strap portion 3340). Additionally, in the ring strap portion 3340, a single ventilation portion 3350 is provided adjacent a junction between each of the lower strap portions 3320 and the ring strap portion 3340.

[0254] In this example, both bottom strap portions 3320 extend from the ring strap portion 3340 at similar locations. In examples of the present technology where the bottom strap portion 3320 extends from more individualized locations around the ring strap portion 3340, two separate ventilation portions 3350 may be provided, one at each of the junctions between the bottom strap portion 3320 and the ring strap portion 3340. These ventilation portions 3350 may be provided in locations where the headgear straps include a relatively large area / footprint on the patient's head. These areas may be most susceptible to increased skin temperature and / or moisture buildup. Because the junctions between the ring strap portion 3340 and the top strap portion 3310 and bottom strap portion 3320 may cover a relatively large surface area on the patient's skin, additional ventilation may be desired in these locations to provide a high level of patient comfort. These ventilation portions 3350 may advantageously allow for the avoidance of moisture buildup in the headgear material and / or on the patient's skin. These ventilation portions 3350 are localized regions of breathability. Although the knitting of the other headgear strap portions of the positioning and stabilizing structure 3300 may also be highly breathable, the ventilation portions 3350 may be particularly breathable due to the mesh-like knitting structure used to form the ventilation portions 3350. These ventilation portions 3350 also keep the patient's skin cooler, at least under the ventilation portions 3350, by promoting the exchange of fresh air through the material forming the headgear straps 3301.

[0255] These ventilation portions 3350 may include a knitted structure. The knitted structure may be formed during the same knitting process as the ring strap portion 3340, the stiffening portion 3345, the upper strap portion 3310, and / or the lower strap portion 3320. In one example, the ventilation portion 3350 includes a pique mesh knit structure. The ventilation portion 3350 may be stretchable. However, in some examples, the ventilation portion 3350 may be less stretchable than other headgear strap portions. Making the ventilation portion 3350 relatively less elastic may prevent the mesh structure from stretching to an extent that the openings forming the mesh structure may be blocked by the fabric, causing reduced breathability. These ventilation portions 3350 may be formed from nylon or a combination of nylon and spandex, for example.

[0256] In some examples, as shown in Figures 7, 8 and 10, the stiffening portion 3345 of the ring strap portion 3340 surrounds the ventilation portion 3350. This can advantageously provide additional stiffness in areas of the headgear strap portion that have a large surface area and may otherwise be overstretched. Each ventilation portion 3350 does not necessarily have to be surrounded by a stiffening portion 3345. In the examples shown in Figures 7, 8 and 10, the ventilation portion 3350 adjacent the patient's neck is not surrounded by the stiffening portion 3345. However, the ventilation portion 3350 adjacent the upper strap portion 3310 is surrounded by the stiffening portion 3345.

[0257] The ring strap portion 3340 includes a pair of upper ventilation portions 3350, each disposed adjacent a respective upper strap portion 3310. As discussed above, a stiffening portion 3345 surrounds each of the upper ventilation portions 3350. In this example, the material thickness of the stiffening portion 3345 is greater at the rear side of each of the upper ventilation portions 3350 than at the front side of each of the upper ventilation portions 3350. As discussed above, the stiffening portion 3345 may be formed to be stiffer adjacent the inner circumference 3341 of the ring strap portion 3340.

[0258] The ring strap portion 3340 also includes a lower ventilation portion 3350 disposed between the pair of lower strap portions 3320. As shown in Figures 8 and 9, the lower ventilation portion 3350 includes a lower edge 3351 spaced apart from the lower edge 3343 of the ring strap portion 3340. Both the lower edge 3351 of the lower ventilation portion 3350 and the lower edge 3343 of the ring strap portion 3340 are arcuate in this example of the technology.

[0259] The curvature of the lower edge 3351 of the ventilation portion 3350 is greater than the curvature of the lower edge 3343 of the ring strap portion 3340. This greater curvature of the lower edge 3351 of the ventilation portion 3350 provides maximum spacing between the lower edge 3351 of the ventilation portion 3350 and the lower edge 3343 of the ring strap portion 3340 that is at or adjacent to the sagittal plane of the patient's head in use. The ventilation portion 3350 and / or the ring strap portion 3340 adjacent the ventilation portion 3350 may contact the patient's neck or be located very close to the patient's neck. Additionally, the mesh structure of the ventilation portion 3350 may be coarser than the non-mesh surface of the ring strap portion 3340. Thus, spacing between the lower edge 3351 and the lower edge 3343 of the ventilation portion 3350 may result in a reduced amount of contact between the mesh fabric and the patient's skin. This may be particularly advantageous where contact between the ring strap portion 3340 and the patient's skin occurs in a state where the ring strap portion 3340 is under tension for extended periods of time (such as when the patient interface 3000 is in use).

[0260] The headgear straps 3301 of the positioning and stabilizing structure 3300 shown in Figure 16 also include a ventilation portion 3350. In this example, the ventilation portion 3350 is provided in the neck strap portion 3334. The ventilation portion 3350 may have the same form and characteristics as described above in relation to the ventilation portion 3350 and headgear straps 3301 of the positioning and stabilizing structure 3300 shown in Figures 7-15. In this example, the stiffening portion 3345 surrounds the ventilation portion 3350.

[0261] 5.3.3.4 Fastenings

[0262] As noted above, some or all of the headgear strap portions of the positioning and stabilizing structure 3300 may be provided with fastening portions 3360. As shown in Figures 7, 8 and 16, the upper strap portion 3310 and the lower strap portion 3320 each include a fastening portion 3360 adjacent an end of each strap portion. Each of these fastening portions 3360 is constructed and / or arranged to allow each strap portion to loop back on itself and fasten to itself.

[0263] In an example, the fasteners 3360 may include hook and loop material and / or magnets, which allows each of the upper strap portion 3310 and the lower strap portion 3320 to be connected to other components of the patient interface 3000 (e.g., the frame 3500) or directly to the plenum chamber 3200 in other examples. The upper strap portion 3310 and the lower strap portion 3320 may be connected directly to the frame 3500 through slots or other openings, or may be connected to a headgear clip which is then connected to the frame 3500. In one example, as shown in FIG. 7, each of the upper strap portions 3310 connects to an upper strap connection point 3510 on the frame 3500. Each upper strap connection point 3510 includes a slot through which the fasteners 3360 of the upper strap portion 3310 can pass, allowing the ends of the upper strap portion 3310 to be secured onto the middle / center of the upper strap portion 3310. In this example, the lower strap portion 3320 connects to the headgear clip 3322. Each lower strap portion 3320 passes through a slot formed in the headgear clip 3322, then loops back on itself and secures to itself. The headgear clip 3322 is then connected to the frame 3500. In this example, magnets included in each of the headgear clip 3322 and the frame 3500 allow the headgear clip 3322 to be quickly released or secured to a predetermined portion of the frame 3500 under magnetic force. In the example shown in FIG. 16, the fastener 3360 of the upper headgear strap portion 3310 may be looped through an eyelet on the headgear conduit of the positioning and stabilizing structure 3300. The fastener 3360 of the lower headgear strap 3320 may be looped through a slot on the plenum chamber 3200 of the patient interface 3000, or may be looped through a headgear clip that connects to the plenum chamber 3200, similar to the manner shown in FIG. 7.

[0264] One or more of the strap portions of the positioning and stabilizing structure 3300 may include at least one blind guide 3370. In examples of the present technology where the headgear strap portion includes a knitted fabric, the blind guide 3370 may also be formed by the knitted fabric. In some examples, the headgear strap is formed by weft knitting and the blind guide is also formed by weft knitting during the same process. The blind guide 3370 may provide a tactile indication of the location of the fastener 3360 on the strap. The blind guide 3370 may be a feature that the patient can feel on the surface of the headgear strap and is configured to assist the user in manipulating the headgear strap (e.g., fitting and adjusting the strap) (especially when the patient is wearing a mask and the patient cannot see the headgear strap). The blind guide 3370 may be a raised bump, a raised profile, or other tactile feature that guides the user in fastening the strap to themselves after looping the strap through a slot or eyelet on the mask frame or headgear clip. In another example of the present technology, the blind guide 3370 may include a recess.

[0265] 7, 8 and 16, the upper strap portion 3310 and the lower strap portion 3320 each include a blind guide 3370 in the fastening portion 3360 of each strap. Each blind guide 3370 provides a tactile indication of the location of the fastening portion 3360 on the upper strap portion 3310 and the lower strap portion 3320, respectively. In some examples, the blind guides 3370 may also be provided on the overhead strap portions of the positioning and stabilizing structure 3300.

[0266] FIG. 11 shows an exploded view of the fastening portion 3360 of the strap of the positioning and stabilizing structure 3300. In the illustrated example, the strap is the upper strap portion 3310 of the positioning and stabilizing structure 3300, however, the features of the fastening portion 3360 and blind guide 3370 may be applied to the lower strap portion 3320 or other straps / strap portions of the positioning and stabilizing structure 3300 according to examples of the present technology. In the upper strap portion 3310, a non-patient contacting surface is included on which the blind guide 3370 is provided. The blind guide 3370 may include a raised portion relative to the non-patient contacting surface of the upper strap portion 3310. The raised portion may surround at least a portion of the fastening portion 3360. As shown in FIG. 10 and FIG. 11, the raised portion includes an elongated raised profile on the non-patient contacting surface of the strap. In this example, the elongated raised profile of the blind guide 3370 is provided on one or more edges of the fastening portion 3360. The elongated raised contours may be provided on the edges 3360 of the fastener portion (which in use are the top, back and bottom edges). The blind guides 3370 may be provided around the periphery of the fastener portion 3360 (e.g., on one side, two sides or more sides).

[0267] In other examples of the present technology, the strap of the positioning and stabilizing structure 3300 may include a concave profile that is concave with respect to the non-patient contacting surface. The concave may surround at least a portion of the fastener 3360 on the strap. Any suitable features of the shape and location of the raised blind guide described herein may be applied to the recessed blind guide according to other examples of the present technology. Similarly, in other examples of the present technology, a recessed blind guide may be provided instead of a raised blind guide in any of the illustrated examples of the positioning and stabilizing structure according to the present technology. For example, the recessed blind guide may be formed by an elongated concave profile and may surround three or more sides of the fastener 3360. The concave profile may be formed by a strap of a thinner thickness. In the present technology, blind guides formed by other features are included, such areas being stiffer and having a different surface finish / texture in the area of ​​the headgear strap than adjacent areas of the strap. By varying the knitting pattern, knitting density and / or yarn material / thickness, it is possible to provide a tactile indication to the user as to the location of the fastening point on the strap.

[0268] In some examples of the present technology, the elongated raised profile of the blind guide 3370 is circular, which may make the blind guide 3370 more comfortable to the patient, may be more aesthetically pleasing, and may also increase the durability of the positioning and stabilizing structure 3300 due to the smooth transition between the raised portion and the non-patient contacting surface on which it is provided.

[0269] The ridges of the blind guide 3370 may be formed by the strap being thicker than the adjacent areas of the strap. The extra material forming the thicker thickness may be provided on the non-patient contacting surface.

[0270] The fastening portion 3360 of the strap may include a hook and loop fastener material (e.g., Velcro®). The fastening portion 3360 may include an end portion 3361 including one of a hook material and a loop material disposed on the non-patient contacting surface, and a middle portion 3363 including the other of a hook material and a loop material disposed on the non-patient contacting surface. The middle portion 3363 may be disposed adjacent the end portion 3361 of the strap. In the example shown in FIG. 11 , the fastening portion 3360 includes a hook portion 3362 and a loop portion 3364. The hook portion 3362 is disposed on the end portion 3361 of the upper strap portion 3310. The loop portion 3364 is disposed on the middle portion 3363 of the upper strap portion 3310. In other examples, the hook portion 3362 may be disposed on the middle portion 3363 of the strap and the loop portion 3364 may be disposed on the end portion 3361 of the strap. The hook portion 3362 can be releasably attached to the loop portion 3364. That is, after the upper strap portion 3310 is sewn through an opening in another component (e.g., a slot formed in the frame 3500), the end portion 3361 can be looped back to the middle portion 3363 and the hook portion 3362 can be releasably attached to the loop portion 3364. The blind guide 3370 can surround only one of the end portion 3361 and the middle portion 3363. In the example shown in FIG. 11, the blind guide 3370 is provided only around the middle portion 3363 and the loop portion 3364. As shown, the blind guide 3370 is provided around three sides of the loop portion 3364.

[0271] The middle portion 3363 can be longer than the end portions 3361. This can allow the end portions 3361 to be fastened at a range of locations along the middle portion 3363, increasing the length adjustability of the strap. In some examples, the middle portion 3363 is several times longer than the end portions 3361.

[0272] The strap portion including the blind guide 3370 (e.g., in other examples of the present technology, the upper strap portion 3310, the lower strap portion 3320, or any other strap portion) and the blind guide 3370 itself may be formed together in a single knitting process. The blind guide 3370 may include a pique knit construction. The strap may include a single jersey knit construction. In another example of the present technology, the strap may include a double jersey loop formation. The strap and blind guide 3370 may be integrally formed.

[0273] The hook portion 3362 and the loop portion 3364 may be formed separately and then assembled with the respective strap portion. They may be glued or sewn to the strap portion of the positioning and stabilizing structure 3300. Alternatively, one or both of the hook portion 3362 and the loop portion 3364 may be ultrasonically welded to the headgear strap. In another example of the present technology, one or both of the hook portion 3362 and the loop portion 3364 are knitted. The hook portion 3362 and / or the loop portion 3364 may be formed in the same knitting process used to form the strap portion to which the hook portion 3362 and / or the loop portion 3364 is provided. The knitting process may include weft knitting. The hook portion 3362 and the loop portion 3364 may be formed from nylon. This may reduce skin irritation through good breathability and provide a soft loop to avoid abrasion to the patient's skin. The hook portion 3362 and the loop portion 3364 may be die cut.

[0274] The top strap portion 3310 and / or other strap portions may include a visual guide 3366 that indicates the end of the strap. The visual guide 3366 may surround the hook portion 3362. The visual guide 3366 may not be raised above the surface of the strap portion and may be a visual guide in the form of a colored fabric. Alternatively, the visual guide 3366 may also facilitate assembly of the hook portion 3362 with the strap portion to which it is secured during manufacture.

[0275] As shown in FIG. 8 and FIG. 16, each of the upper strap portion 3310 and the lower strap portion 3320 includes a fastening portion 3360. Each of the fastening portions 3360 includes a hook portion 3362 at an end 3361 of each strap portion and a loop portion 3364 at a middle portion 3363 of each strap portion. In other examples of the present technology, this configuration is provided only on the upper strap portion 3310, only on the lower strap portion 3320, or on neither of these strap portions. In some examples, the knitting process used to form the headgear strap portions is configured to provide a predetermined stiffness level to the strap portions with high precision, thereby eliminating the need for adjustability and blind guides. In some examples, this predetermined level of stiffness can be determined based on the particular shape and size of the patient's head (as determined by a scan).

[0276] In some examples, the positioning and stabilizing structure 3300 may only have an upper strap portion 3310 without a lower strap portion 3320. Such an arrangement may be suitable for an "under the nose" type patient interface 3000 (e.g., one having a seal-forming structure 3100 in the form of a nasal pillow or nasal cradle). In such examples, the upper strap portion 3310 may have the fastener portion 3360 and blind guide 3370 described above. If the positioning and stabilizing structure 3300 has an upper strap portion 3310 but not a lower strap portion 3320, the positioning and stabilizing structure 3300 may have a ring strap portion 3340 having an upper portion 3302 and a lower portion 3304. One or both of the upper portion 3302 and the lower portion 3304 may be adjustable by the patient. In such an example, the upper portion 3302 and / or the lower portion 3304 may be split into two strap portions connected by a buckle (or similar component having an opening through which a strap can be routed). The two strap portions forming the upper portion 3302 and / or the lower portion 3304 may each include fastener 3360 and / or blind guide 3370 features as described above with reference to FIG.

[0277] The blind guide 3370 may be stretchable in some examples of the present technology and non-stretchable in other examples. The strap portion in which the blind guide 3370 is provided may be entirely stretchable to provide some extensibility under tension, but in some examples, only selected regions of the strap portion may be stretched in length. If the strap portion in which the blind guide 3370 is provided is stretchable, the blind guide 3370 may also be made to be stretchable (e.g., by utilizing a knitting process that allows the blind guide to elastically stretch along with the strap on which it rests). In some examples, the blind guide 3370 may be provided on a portion of the strap that is non-stretchable (e.g., if the strap has a stretchable portion somewhere along its length). In such examples, the blind guide 3370 may be non-stretchable.

[0278] 12, an end blind guide 3371 may be provided on the patient-contacting side of the headgear strap 3301 to provide a tactile indication of the end 3361 of the strap portion. In use, as the strap portion is fed through the slot in the frame 3500, the surface on which the blind guide 3371 is formed is looped over the patient-contacting side of the headgear strap 3301.

[0279] 5.3.4 Ventilation

[0280] In one form, the patient interface 3000 includes a vent structure 3400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide).

[0281] In certain configurations, the vent structure 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to the surroundings when the pressure in the plenum chamber is positive with respect to the surroundings. The vent structure 3400 is configured to allow a vent flow rate that is equal to or greater than the amount of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber in use. 2 The ventilator is configured to be large enough to reduce rebreathing by the patient.

[0282] A ventilation structure 3400 in one embodiment according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0283] The vent structure 3400 may be disposed within the plenum chamber 3200. Alternatively, the vent structure 3400 is disposed within a decoupling structure (e.g., a swivel).

[0284] 5.3.5 Decoupling structure(s)

[0285] In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or ball socket).

[0286] 5.3.6 Connection Ports

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

[0288] 5.3.7 Forehead support

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

[0290] 5.3.8 Anti-asphyxiation valves

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

[0292] 5.3.9 Ports

[0293] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a characteristic of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0294] 5.4 System Architecture

[0295] Examples of the system(s) outlined herein may include one or more computing devices together with one or more processor(s) programmed or configured to perform various functions described herein. In the examples, it may be described that certain information is stored and / or processing tasks are performed by particular devices, but it will be understood that alternative embodiments are contemplated in which such information and / or processing tasks are shared.

[0296] FIG. 18 is a schematic diagram of an exemplary system 100 that may be used to perform various aspects of the technology as described herein. It is understood that the system 100 may send and receive data to external systems and control the operation of components external to the system 100. The system 100 may primarily include a customization server 102 that manages the collection and processing of data related to the design and creation of customized components for the patient interface 3000. The customization server 102 has processing facilities. These processing facilities are illustrated by one or more processors 104, memory 106, and other components typically present in such computing devices. It should be noted that the server 102, processor 104, and memory 106 may take any suitable form known in the art (e.g., a "cloud-based" distributed server architecture or a dedicated server architecture). In the exemplary embodiment described, the memory 106 stores information accessible to the processor 104. This information includes instructions 108 that may be executed by the processor 104, and data 110 that may be retrieved, manipulated, or stored by the processor 104. Memory 106 may be any suitable means known in the art capable of storing information in a manner accessible to processor 104 (e.g., a computer-readable medium or other medium that stores data that can be read with the aid of an electronic device).

[0297] The processor 104 may be any suitable device known to those skilled in the art. Although the processor 104 and memory 106 are illustrated as being provided in a single unit, this should not be intended as limiting, and it should be understood that each function as described herein may be performed by multiple processors and memories, which may or may not be remote from each other and from other components of the system 100. The instructions 108 may include any set of instructions suitable for execution by the processor 104. For example, the instructions 108 may be stored as computer code on a computer-readable medium. These instructions may be stored in any suitable computer language or format. The data 110 may be retrieved, stored, or modified by the processor 104 according to the instructions 110. The data 110 may be formatted into any suitable computer-readable format. The data 110 may also include records 112 of control routines or algorithms for the execution of aspects of the system 100.

[0298] Although the server 102 in FIG. 18 is shown including only memory 106, the server 102 may further have access to other external memories, data stores, or databases (not shown). For example, information processed in the server 102 may be sent to the external data store (or database) for storage or may be accessed by the server 102 from the external data store (or database) for further processing. Furthermore, the system 100 may include multiple such data stores and / or databases. In some cases, the data stores or databases may be separately accessible (e.g., each accessible to a different server). In other cases, the data stores or databases described herein may not necessarily be separate, but may be stored together, for example, as part of separate files, folders, or columns in a table of a common file.

[0299] The server 102 may communicate with operator workstations 114 to provide access to a variety of functions and information to the operators. Such communication may occur over a network 120. The network 120 may include a variety of configurations and protocols (e.g., the Internet, an intranet, a virtual private network, a wide area network, a local network, a private network using one or more corporate proprietary communication protocols (wired or wireless), or a combination thereof).

[0300] The server 102 performing one or more operations may include the use of artificial intelligence and / or machine learning algorithms. The server 102 may be configured to generate training data sets and / or use trained data sets (by the server 102 or external to the server 102) to make some determinations.

[0301] The exemplary system 100 includes one or more user devices 130 equipped to obtain data related to the shape and / or size of a user's head or features thereof, as described further below. By way of example, the user devices 130 may include mobile computing devices (e.g., smartphone 130A or tablet computer 130B) or personal computing devices (e.g., laptop or desktop computer 130C), each equipped with an image sensor such as a camera. Although the present technology is described herein as image data obtained using a camera, alternative embodiments are contemplated in which other sensors are used to obtain data related to the shape and / or size of a user's head or features thereof. For example, such sensors may include a stereo camera that captures three-dimensional images or a photodetector capable of detecting light reflections from a laser or strobe / structure light source.

[0302] One or more manufacturing systems 140 may be included in the exemplary system 100 and configured to manufacture customized patient interfaces or components thereof. One or more manufacturing devices 142 may be included in the manufacturing system 140 and configured to physically create the components of the patient interface 3000. In some examples, the manufacturing device 142 is a knitting machine (e.g., a flat knitting machine or a circular knitting machine). In other examples, the manufacturing device 142 is an additive manufacturing device (e.g., a 3D printer). In examples, the manufacturing system 140 may include multiple types of manufacturing devices 142 for the manufacture of different components of the patient interface 3300. The manufacturing devices 142 may include one or more controllers 144 for control of the operating hardware 146 (e.g., knitting hardware or 3D printing hardware) and specialized user interfaces for operator input / monitoring of the manufacturing devices 142. The manufacturing devices 142 may also communicate with other components of the manufacturing system (e.g., a manufacturing server 150 that manages the manufacture of the custom patient interface in communication with the customization server 102 and / or a manufacturing operator workstation 152).

[0303] In some examples, one or more of the manufacturing devices 142 is a laser cutter and is configured to cut out one or more components of the patient interface and / or modify one or more produced components (e.g., components produced by another manufacturing device 142). Laser cutters may provide flexibility to allow complex shapes with high precision, repeatability, speed and / or automation. The use of laser cutters may also allow for rapid customization of mass produced components by modifying the length and / or shape of the components based on patient analysis.

[0304] In some examples, one or more of the manufacturing devices may be located in a manufacturing plant, a clinician's office, and / or a patient's home. In some examples, a component may be created by one or more of the manufacturing devices at one location and then further modified at another location by one or more of the manufacturing devices. In some examples, one or more manufacturing devices located at different locations may receive instructions from the same manufacturing server 150, the same customization server 102, and / or the same manufacturing operator workstation 152. In some examples, one or more manufacturing devices located at different locations may report results of component creation and / or modification to the manufacturing server 150, the customization server 102, and / or the manufacturing operator workstation 152.

[0305] In some examples, one or more of the devices in the example system 100 may include communications circuitry configured to communicate with one or more other devices in the system 100 directly and / or via the network 120.

[0306] 5.1 Methods for Customized Manufacturing of Patient Interfaces

[0307] As shown in the flow diagrams of Figures 19A-19E, one aspect of the present technology is a method 7000 of fabrication of at least one customized component of a patient interface 3000 for treatment of sleep disorder breathing. The customized component may be, for example, a component of the positioning and stabilizing structure 3300, the plenum chamber 3200 or the seal-forming structure 3100. The customized component may be customized in one or more ways (e.g., by shape, size or another characteristic) for an individual patient.

[0308] With reference to FIG. 19A, an example method 7000 may be generally characterized as including three phases: a user data capture phase 7100, a specification phase 7200, and a production phase 7300.

[0309] 5.1.1.1 User Data Capture Phase

[0310] In order to create a patient interface that provides effective therapy and is comfortable for the user to wear, it is desirable to customize the patient interface, or at least components thereof, to fit the size and / or shape of the user's head (and more particularly, facial features). To enable such customization, it is often necessary to collect information about the size and / or shape of the user's head in multiple instances, such as the user's facial features.

[0311] In an example of the present technology, the user data capture phase 7100 includes obtaining information indicative of one or more landmark feature positions of the user's head. As used herein, the term "landmark" refers to a particular point, area, or feature on a human head that is associated with an element of the head, such as a facial feature. The location of the landmark may be defined, for example, relative to other landmarks or fixed reference points. Non-limiting examples of head landmarks include: subnasal point, cerion, ear point, posteriormost point of the patient's head, anteriormost point of the patient's head, lateralmost point of the orbital rim, inferiormost point of the orbital rim, Frankfurt horizontal plane, and coronal plane aligned with the ear point. Other examples of landmarks may be the features shown in any one of Figures 2C-2F.

[0312] 5.1.1.1.1 Capturing Image Data

[0313] In an example, obtaining relevant information in user capture phase 7100 may include capturing image data of at least a portion of the user's head at 7102 of FIG. 19B and identifying landmark feature locations based on the image data at 7104. By way of example, capturing the image data may be performed using a camera of smartphone 130A, tablet 130B, or computer 130C.

[0314] Exemplary methods and systems for capturing data (e.g., image data) of at least a portion of a user's head, determining patient characteristics, and / or fitting mask features to a patient are described in U.S. Patent Publication No. 2018 / 0117272, U.S. Patent Publication No. 2019 / 0167934, U.S. Patent No. 7,827,038, U.S. Patent No. 8,254,637, and U.S. Patent No. 10,157,477, all of which are incorporated herein by reference in their entirety. Other exemplary software tools for creating a three-dimensional model of a user's head or a portion thereof may include: "Capture" application (available from Standard Cyborg), "Scandy Pro" application (available from Scandy, LLC); "Beauty3D" (available from Guangzhou ZhimeiCo., Ltd); "Unre3D FaceApp" (available from UNREAILIMITED); and "Bellus3D FaceApp" (available from Bellus3D,Inc.).

[0315] In another example, relevant information may be obtained by a user or clinician taking a series of measurements of the user's head and having a record of these measurements generated and entered into the system 100 (i.e., avoiding the need to capture image data).

[0316] 5.1.1.1.2 Identifying Landmark Features

[0317] In an example, the identification of the user's landmark features in 7104 may be based on two-dimensional image data. Exemplary methods and systems for determining a user's landmark features and their locations based on two-dimensional image data are described in U.S. Patent Publication No. 2018 / 0117272.

[0318] In an example, identifying landmark features based on the image data at 7104 may include creating (at 7110 in FIG. 19C ) a three-dimensional model of the user's face and / or head. By analyzing the three-dimensional model, the user's landmark features may be identified at 7112 and the locations of the landmark features may be determined. Exemplary methods and systems for identifying landmark features and landmark locations from a three-dimensional model are described in U.S. Patent Publication No. 2019 / 0167934. As an example, the three-dimensional model may be generated based on data received from a 3D scanner, a stereo camera, and / or multiple captured images of the user's face and / or head from different positions and / or orientations of the capturing device and / or the patient.

[0319] In an example, local processing facilities at the capture point of the image data (e.g., smartphone 130A, tablet 130B, or computer 130C) may be used to identify landmark features (including, in an example, generating a three-dimensional model). In another example, the image data may be communicated to a remote processing facility (e.g., customization server 102) for further processing.

[0320] 5.1.1.1.3 Relationships between landmark features

[0321] In some forms of the present technology, the method 7000 may include identifying relationships between landmark features. Such relationships may provide information about the anthropometric measurements of the user and may inform customization of the patient interface or components thereof for the user. By way of example, relationships between landmark features may include distances (i.e., spacing between features) and relative angles.

[0322] In an example, identifying the relationship between the landmark features may include determining the distance between two or more of the subnasal point, the cerion, the ear point, the posteriormost point of the patient's head, the anteriormost point of the patient's head, the lateralmost point of the orbital rim, the inferiormost point of the orbital rim, the Frankfurt horizontal plane, and a coronal plane aligned with the ear point.

[0323] It is understood that the landmark features (and associated relationships) to be identified may be influenced by the design or configuration of the patient interface or components thereof to be manufactured (i.e., some landmark features are associated with particular designs or components but not others). In an example, only selected landmark features and their relationships may be accessed. In another example, an entire set of landmark features from a list of possible identifiable landmark features may be evaluated to enable use of a data set across a range of patient interfaces or components thereof.

[0324] 20 is a lateral view of a patient's head with a number of landmark feature intervals identified, as follows: Each feature interval is between a pair of landmark feature locations.

[0325] In an example, a distance D1 between the subnasal point and a coronal plane aligned with the ear point may be determined, the distance D1 being perpendicular to said coronal plane. This landmark feature spacing may allow the spacing in the anterior-posterior axis between the patient's upper lip and the patient's ear to be taken into account in the design of customized components for the patient interface 3000. In particular, this spacing may be useful in the design of, for example, the customized frame 3500 and / or the customized headgear straps 3301.

[0326] In an example, a distance D2 in the sagittal plane between the subnasal point and the ear point can be determined. The distance D2 can be a linear distance in the sagittal plane that includes both vertical and horizontal components (e.g., a diagonal distance in the sagittal plane between the subnasal point and the vertically superior ear point). This distance D2, together with the horizontal distance D1 between the subnasal point and the ear point, can allow the height of the patient's ears relative to the lower circumference of the nose to be taken into account in the design of customized components for the patient interface 3000. This spacing can be useful, for example, in the design of the customized frame 3500 and / or the customized headgear straps 3301.

[0327] In an example, a vertical distance D3 in the sagittal plane between the subnasal point and the serion may be determined. This distance D3 may allow the height of the patient's nose and / or the spacing between the lower circumference of the patient's nose and the patient's eyes to be taken into account in the design of customized components for the patient interface 3000. In particular, this spacing may be useful in determining the shape and / or size of, for example, the customized plenum chamber 3200 and / or the customized seal-forming structure 3100.

[0328] In an example, a distance D4 between the most lateral point of the orbital rim and a coronal plane aligned with an ear point may be determined, the distance D4 being perpendicular to said coronal plane. This spacing may allow the distance between the patient's ear and the patient's eye to be taken into account in the design of customized components for the patient interface 3000. In particular, this distance may be useful in determining, for example, the customized frame 3500 and / or the customized headgear straps 3301 shape and / or size.

[0329] In an example, the vertical distance D5 between the subnasal point and the front-most point of the patient's head may be determined. This feature spacing may allow the height of the patient's head and the spacing between the lower circumference of the patient's nose and the top of the patient's head to be taken into account in the design of customized components for the patient interface 3000. This feature spacing may be useful, for example, in determining the shape and / or size of the customized headgear straps 3301.

[0330] In an example, the vertical distance between the most anterior point of the patient's head and the Frankfurt horizontal plane may be determined. This feature spacing may allow the distance between the patient's top head and the patient's ear or lower orbital rim to be taken into account in the design of customized components for the patient interface 3000. This distance may be useful, for example, in determining the shape and / or size of the customized headgear straps 3301.

[0331] In an example, a distance D7 between the most rearmost point of the head and a coronal plane aligned with the ear point may be determined, the distance D7 being perpendicular to said coronal plane. This feature spacing may allow the patient's head size and / or the distance between the patient's ear and the rear of the patient's head to be taken into account in the design of customized components for the patient interface 3000. This distance may be useful, for example, in determining the shape and / or size of the customized headgear straps 3301.

[0332] The above relationships are merely exemplary and are not intended to be limiting to all forms of the present technology.

[0333] 5.1.1.1.4 Physiological Data Capture

[0334] In some forms of the present technology, customization of respiratory treatments or components used in the treatments may be based at least in part on functional requirements that are not derived from information associated with landmark features.

[0335] In an example, such a functional requirement may include a heat and moisture exchanger characteristic related to the absorption or ventilation capacity of heat and / or moisture from a volume of air in the exhaled air stream during patient exhalation. 2 Saturation and / or moisture may be used to determine functional demand in this regard. Measurement of such physiological characteristics may be performed, for example, using stand-alone sensors or sensors located within existing equipment used by the user.

[0336] For example, manufacturing specifications for HMEs may be based on the amount of moisture required to provide increased comfort to the user, such that if the moisture content is less than desired, the HME may be specified to allow more moisture to be introduced and used for humidification, or conversely, a HME may be specified for a higher moisture content than desired, such that the moisture content is less likely to be introduced.

[0337] As a further example, the desired ventilation characteristics may be 2 It may be determined based on saturation and / or other factors (e.g., physical nose size). In the case of a mask (more specifically a plenum chamber), the ventilation characteristics may be affected by the geometry (e.g., physical dead space) and / or structure of the vent through which the flow passes. These may be specified accordingly.

[0338] 5.1.1.2 Specification Phase

[0339] In a specification phase 7200, an example of the method 7000 includes determining a set of manufacturing specifications for production of the patient interface or one or more components thereof based on one or more landmark feature locations and / or relationships between these landmark feature locations.

[0340] In examples, such specifications are determined based on one or more desired performance of the components. Examples of such desired performance may include one or more of the following: force to be applied from or to the components, elasticity, dimensions (e.g., size and relative angles of the features of the components), feel, breathability, heat dissipation, and / or positioning on the user's head. Such performance criteria may be influenced by one or more of the following: effectiveness of delivery of therapy (e.g., sealing of the patient interface and / or reducing the likelihood of blockage during use), user comfort (e.g., feel of the components, relative positioning to avoid more sensitive areas of the user's head), and manufacturing considerations (e.g., material cost and / or manufacturing complexity). It is understood that the desired performance for the components is influenced by one or more landmark feature positions and / or relationships between landmark feature positions, examples of which are further described below. In examples, customized component specifications may be determined in part based on non-performance characteristics (e.g., color).

[0341] In examples, the required performance may be based on functional requirements that are not derived from landmark feature locations and / or relationships between landmark feature locations as described above.

[0342] These requirements and resulting manufacturing specifications depend on the particular type or model of customized component being made. In an example, the customized component may include headgear straps 3301 of the positioning and stabilizing structure 3300 of the patient interface 3000. The headgear straps 3001 may be customized for a particular patient by being formed with a particular shape and / or size based on landmark feature positions and / or relationships, resulting in a comfortable and stable fit for that particular patient. Exemplary headgear straps are described above with reference to Figs. 7-17. Further considerations for determining manufacturing specifications for the headgear straps are described below with reference to Figs. 21-23. In another example, the customized component may include a customized frame 3500 of the patient interface 3000. The frame 3500 may be customized for a particular patient by being formed with a particular shape and / or size based on landmark feature positions and / or relationships, resulting in an optimal transfer of headgear forces to sealing forces for that particular patient.

[0343] In an example, the performance requirements of one component of a patient interface may be influenced by the characteristic(s) of another component. As an example, in the case of a customized headgear strap 3001, the particular performance requirements may be determined in part by the dimensions and / or configuration of the frame 3500 with which the strap 3001 is used. For example, the positioning of the headgear strap attachment points on the frame 3500 relative to one or more landmark feature positions or relationships is a factor to consider when specifying the characteristics of the headgear and / or its straps.

[0344] In examples, manufacturing specifications may include material specifications. A particular material or mixture of materials may be selected based on performance requirements (e.g., flexibility / rigidity, stretchability, or feel). In some examples, material selection may be based on the preferences of the patient for whom the customized component is to be made.

[0345] In an example, the manufacturing specifications may include construction technology specifications. For example, the manufacture of the components is performed using mechanical manipulation of yarns - for example, interlooping (e.g., knitting, more specifically flat or circular knitting), weaving and / or twisting (e.g., braiding, knotting and crocheting) - and the manipulation technique (e.g., knitted structure or stitch) may be selected based on the required performance of the components. As an example, the use of high gauge, high density knit construction in some areas of the headgear straps may help achieve a specified strap tension to achieve a desired force on the patient's nose bridge. PCT Patent Application Publication WO2013026091A1 describes an exemplary method and system for the specification and manufacture of components of a patient interface having one or more regions constructed by knitted fabric. The entire contents of this document are incorporated herein by reference.

[0346] In an example, determining the set of manufacturing specifications may include selecting the set of manufacturing specifications from a plurality of sets of existing manufacturing specifications. In an example, determining the set of manufacturing specifications may include selecting the plurality of existing manufacturing specifications to form the set of manufacturing specifications from the plurality of existing manufacturing specifications. The selection of the existing manufacturing specifications may be based on similarities between one or more landmark feature positions and / or relationships determined for the user and similarities associated with the existing manufacturing specifications.

[0347] In an example, the manufacturing specifications may include a sensor to be provided within the component. In an example, the sensor may be produced by the manufacturing process used to produce the remainder of the component. For example, a knitted or textile component may include the formation of a textile-sensor. In an example, the component may include a feature configured to receive and / or position the sensor relative to the component (e.g., a pocket within which the sensor may be held). In another example, the component may include a sensor element configured to connect to a separate sensing device.

[0348] 5.1.1.2.1 Headgear Specifications Examples

[0349] In one form of the present technology, the customized components include headgear straps 3301 of the positioning and stabilizing structure 3300 of the patient interface 3000.

[0350] In an example, determining the performance criteria for the headgear straps 3301 may include determining customized headgear strap dimensions. FIG. 21 illustrates a customized component in the form of a headgear strap 3301 according to one form of the present technology. The headgear strap 3301 forms part of a positioning and stabilizing structure 3300 of a patient interface 3000 for treating respiratory disorders. The headgear strap 3301 is illustrated in FIG. 21 in a flat state. The headgear strap 3301 includes a rear strap portion 3305. The rear strap portion 3305 is configured to be positioned against at least the rear of the patient's head in use. In some examples, the rear strap portion 3305 is configured to rest on or below the occipital bone of the patient's skull.

[0351] In one form, determining the customized headgear strap dimensions includes determining at least one dimension of a rear strap portion 3305 for the headgear strap 3301. The at least one dimension of the rear strap portion 3305 may be a width of the rear strap portion 3305, which corresponds to a length of the rear of the patient's head in the direction in which the rear strap portion 3305 will be positioned in use. Alternatively or additionally, the at least one dimension of the rear strap portion 3305 may be a rear height or thickness.

[0352] The headgear strap 3301 shown in FIG. 21 also includes a pair of upper strap portions 3310. Each upper strap portion 3310 is configured to be positioned on each side of the patient's head in use. In some forms, at least a portion of each upper strap portion 3310 may be positioned above the upper ear in use. Each upper strap portion 3310 may connect to another component of the positioning and stabilizing structure 3300 of the patient interface 3000 (e.g., the frame 3500 or the headgear conduit 3900). Alternatively, each upper strap portion 3310 may connect directly to the plenum chamber 3200 of the patient interface 3000.

[0353] In the example shown in Figure 21, each top strap portion 3310 extends from the rear strap portion 3305 at a top strap location 3310A. Additionally, each top strap portion 3310 extends from the rear strap portion 3305 at a top strap direction 3310B. In Figure 21, each top strap location 3310A is represented by a point within the general area of ​​the rear strap portion 3305 from which the top strap portion 3310 extends. Similarly, each top strap direction 3310B is represented by a longitudinal axis that lies in the direction that each top strap portion 3310 extends.

[0354] While the headgear straps 3301 are shown in a flat state in Fig. 21, it should be understood that in use they have a three-dimensional shape that conforms to the curved surface at the back of the patient's head. In this example, the upper strap directions 3310B are substantially parallel to each other and substantially aligned with the length of the rear strap portion 3305. In other examples, the upper strap portions 3310 may not be parallel to each other or to the length of the rear strap portion 3305.

[0355] In some examples, determining the customized headgear strap dimensions includes determining a length of each of the pair of top strap portions 3310. In some examples, determining the customized headgear strap dimensions includes determining a top strap position 3310A on the rear strap portion 3305 from which each top strap portion 3310 extends. In some examples, determining the customized headgear strap dimensions includes determining a top strap direction 3310B from which each top strap portion 3310 extends from the rear strap portion 3305.

[0356] By determining one or more of the size and length of the rear strap portion 3305 and the position and orientation of each upper strap portion 3310 of the headgear strap 3301 based on the received head scan data, the headgear strap 3301 can be customized for a particular patient associated with the head scan data, thereby allowing the headgear strap 3301 to fit well (e.g., in a comfortable and stable manner) to the particular patient.

[0357] FIG. 22 illustrates another customized component of the patient interface 3000 in the form of a headgear strap 3301 of the positioning and stabilizing structure 3300. In this example, the headgear strap 3301 also has a rear strap portion 3305. The rear strap portion 3305 may be configured to be positioned against the rear of the patient's head and / or neck. For example, the rear strap portion 3305 may be configured to rest on or below the occipital bone of the patient's skull. In this example, the headgear strap 3301 includes a pair of upper strap portions 3310 extending from the rear strap portion 3305. The headgear strap illustrated in FIG. 22 is a customized component made by method 7000. As described above, determining the headgear strap dimensions includes determining at least one dimension of the rear strap portion 3305, the length of each top strap portion 3310, the top strap location 3310A which is the starting point for elongation of each top strap portion 3310, and / or the top strap direction 3310B which is the direction in which each top strap portion 3310 extends.

[0358] As shown in FIG. 22, the headgear strap 3301 also includes a pair of lower strap portions 3320. Each lower strap portion 3320 may be configured to be positioned on each side of the patient's head. In some examples, the lower strap portions 3320 are configured to be positioned at least partially below the patient's ears. In some forms, at least a portion of each lower strap portion 3320 may be positioned below the lower ear edge point in use. Each lower strap portion 3320 may connect to another component (e.g., the frame 3500) of the positioning and stabilizing structure 3300 of the patient interface 3000. Alternatively, each lower strap portion 3320 may connect directly to the plenum chamber 3200 of the patient interface 3000.

[0359] In the example shown in Figure 22, each lower strap portion 3320 extends from the rear strap portion 3305 at a lower strap location 3320A. Additionally, each lower strap portion 3320 extends from the rear strap portion 3305 in a lower strap direction 3320B. In Figure 22, each lower strap location 3320A is represented by a point within the general area of ​​the rear strap portion 3305 from which the elongation of the lower strap portion 3320 begins. Similarly, each lower strap direction 3320B is represented by the longitudinal axis along which each lower strap portion 3320 extends.

[0360] The headgear straps 3301 are shown flat in FIG. 22 and it should be understood that in use they have a three-dimensional shape that corresponds to the curved surface of the patient's head. In this example, the lower strap directions 3320B are angled to each other. In other examples, the lower strap directions 3320B may not be angled to each other, but instead run parallel to each other. In this example, the upper strap directions 3310B are angled to each other. In other examples, the upper strap directions 3310B may be parallel.

[0361] Determining the length, location and orientation of the upper strap portion 3310 is described in relation to FIG. 21. The same steps may be taken in designing the headgear strap 3301 shown in FIG. 22. Additionally, for the headgear strap 3301 shown in FIG. 22 having both an upper strap portion 3310 and a lower strap portion 3320, determining the customized headgear strap dimensions includes determining the length of each of the pair of lower strap portions 3320. In some examples, determining the customized headgear strap dimensions includes determining a lower strap position 3320A on the rear strap portion 3305 from which each lower strap portion 3320 extends. In some examples, determining the customized headgear strap dimensions includes determining a lower strap direction 3320B within which each lower strap portion 3320 extends from the rear strap portion 3305.

[0362] By determining one or more of the size and length of the rear strap portion 3305 and the position and orientation of each of the upper strap portions 3310 and lower strap portions 3320 of the headgear strap 3301 based on the received head scan data, the headgear strap 3301 can be customized for a particular patient associated with the head scan data, thereby allowing the headgear strap 3301 to fit well (e.g., in a comfortable and stable manner) to the particular patient.

[0363] FIG. 23 illustrates another customizable component in the form of a headgear strap 3301. In this example, the headgear strap 3301 includes an upper strap portion 3310, a lower strap portion 3320, and a rear portion 3305. The same methods described above with respect to determining the length, position, and orientation of the upper strap portion 3310 and the lower strap portion 3320, respectively, may be performed during the execution of the method 7000. One particular difference from the headgear strap 3301 illustrated in FIG. 21 and FIG. 22 is that the headgear strap 3301 illustrated in FIG. 23 includes a rear portion 3305 in the form of a ring strap portion 3340. The features of the ring strap portion 3340 according to examples of the present technology have been described above, for example with reference to FIG. 7 and FIG. 8, and will not be described in full below.

[0364] In some forms of the present technology, determining the customized headgear strap dimensions includes determining a length of a ring strap portion 3340 for the customized headgear strap. The ring strap portion 3340 may have an upper portion configured to rest on the parietal bone of the patient's head in use. Additionally, the ring strap portion 3340 may have a lower portion configured to rest on or below the occipital bone of the patient's head in use.

[0365] In some forms of the present technology, various features of the ring strap portion 3340 and headgear strap 3301 described in connection with Figures 7-17 are included in the headgear strap 3301 produced by method 7000 (e.g., one or more of the high stiffness portion 3345, the upper stretchable portion 3346, the lower stretchable portion 3347, the ventilation portion 3350, the fastening portion 3360, the blind guide 3370 and associated features).

[0366] An advantage of using the present technology in making customized headgear straps 3301 is that the customized headgear straps 3301 may not require a long fastening portion 3360. The headgear straps 3301 made by the method 7000 may be customized to fit a particular patient, so the patient may not need to adjust the headgear straps 3301 significantly. The middle portion 3363 of the fastening portion 3360 may not need to be particularly long because only a very small adjustment range is required. In some examples, the fastening portion 3360 may include a connection between the end 3361 of the upper or lower strap portion and the middle portion 3363 at a single point (e.g., a magnetic connection or a mechanical connection (e.g., a clip or clasp)). That is, if the headgear straps 3301 are customized within a sufficiently narrow tolerance to suit a particular patient, adjustment may not be necessary in some scenarios.

[0367] In an example, determining manufacturing specifications for the customized headgear straps 3301 may include determining a knitting structure for one or more sections of the headgear straps 3301. As described above with reference to Figures 7 and 8, the headgear straps 3301 may include different knitting structures in different regions. In an example, determining manufacturing specifications may include determining a particular knitting structure required for one or more sections of the headgear straps to meet one or more performance requirements.

[0368] As also described above, the upper strap portion 3310 and the lower strap portion 3320 may be stretchable. Determining manufacturing specifications for the customized headgear strap 3301 may include determining an knitting structure for one or more stretchable portions of the headgear strap. The determination of the knitting structure may be based on one or more landmark feature positions and / or relationships. In some examples, the determination of the knitting structure may be based on the length and / or orientation of the headgear strap portion (e.g., the upper strap portion 3310 or the lower strap portion 3320).

[0369] In some forms of the present technology, determining the manufacturing specifications may include determining a knitting configuration such that each of the stretchable portions of the headgear straps 3301 (e.g., the upper strap portion 3310 and the lower strap portion 3320) are tensioned with a respective predetermined tension when the patient interface 3000 is in use. In some examples, the method includes determining a knitting configuration such that a predetermined force is applied from the headgear straps 3301 to the seal-forming structure 3100 of the patient interface when the patient interface 3000 is worn by a patient. The predetermined force may be between about 3N and about 5N. In some examples, the predetermined force may be about 4N.

[0370] In an example, the knitting configuration is determined to provide a predetermined tension in the strap portions when the patient interface 3000 is worn by the patient, regardless of the particular strap portion length and / or orientation of the headgear straps 3301. This tension may be, for example, a tension that balances sealing performance, stability, and comfort. Determining the appropriate knitting configuration to achieve the predetermined tension may be based on the characteristics (e.g., shape and / or size) of the user's head.

[0371] In some examples, different strap portions (e.g., the upper strap portion 3310 and the lower strap portion 3320) may have different predetermined tensions in use. Determining the manufacturing specifications may include determining a knitting configuration such that each of the upper strap portions 3310 of the headgear straps 3301 is tensioned with a predetermined upper strap tension when the patient interface 3000 is worn by a patient. Determining the manufacturing specifications may include determining a knitting configuration such that each of the lower strap portions 3320 of the headgear straps 3301 is tensioned with a predetermined lower strap tension when the patient interface 3000 is worn by a patient.

[0372] Determining manufacturing specifications may include determining knitting configurations based on landmark feature locations and / or relationships to achieve predetermined upper and lower strap tensions. For example, some patients may require higher upper and lower strap tensions compared to other patients. The appropriate ratio of tensions in the upper and lower strap portions 3310 and 3320 may be based on the anatomy of a particular patient.

[0373] In some examples, the stretch and / or stiffness required for the headgear straps of the positioning and stabilizing structure 3300 of the patient interface 3000 may depend on the cushion sealing properties. For example, the stretch or stiffness of the headgear or the sealing properties of the seal-forming structure may vary depending on the positioning of the seal-forming structure on the patient's face. The sealing required for a particular seal-forming structure may require a positioning and stabilizing structure 3300 capable of angled stretch directions, while other particular seal-forming structures may require a flatter stretch direction.

[0374] Thus, the stretchability and / or stiffness of one or more straps of the headgear may be selected based on the type of plenum chamber 3200 and / or seal-forming structure 3100 that the user has been recommended by the system and / or selected by the user. Additionally, the shape of the patient's face and / or head may be taken into consideration when determining the angle at which force is applied from the headgear to the seal-forming structure 3100 and whether the force applied at the determined angle (when the plenum chamber is under pressure in use) is sufficient to obtain the required seal between the seal-forming structure 3100 and the patient's face.

[0375] In addition to other examples for providing high stiffness portions in the headgear, according to examples of the present technology, high stiffness portions may also be provided in the headgear as part of weft knitting and / or laser cutting. As part of knitting, stiffness may be customized by heat melting material interspersed in a portion of the knitted headgear, rigidizers (e.g., plastic rigidizers) inserted into knitted channels in the headgear, and / or rigid materials (e.g., plastic) laminated to the knitted portion of the headgear. In some examples, a type of rigidizer may be determined for providing the knitted headgear to the patient. In some examples, multiple rigidizers may be provided for the patient. These rigidizers may be replaceable by the patient using openings in the headgear straps. In other examples, creating the headgear may include inserting a rigidizer into the headgear as part of knitting such that the rigidizer is completely enclosed by the knitting and cannot be removed from the headgear by the patient.

[0376] As part of the laser cutting, the stiffness can be customized by laser etching and / or heating techniques to achieve stiffness effects on the fabric surface. As an example, different stiffness can be provided in different parts of the headgear by laser cutting different features (e.g., holes of different sizes or lines with different thicknesses) into the headgear. Parts of the headgear that contain laser holes can provide lower stiffness and higher stretchability compared to parts of the headgear that contain smaller holes or no holes. In some examples, different stiffness can be provided by cutting features partially into the surface of the headgear straps.

[0377] In some instances, headgear specifications may be taken into account such that the stretch properties provided by the headgear are influenced by multiple factors. For example, stretch properties may be defined by the knit construction (e.g., tubular, interlock, spacer, double jersey, or plain knit), material composition (e.g., nylon, polyethersulfone, spandex, and / or high viscosity polyethylene terephthalate), machine gauge (E14, 18, etc.), and yarn denier. Selecting headgear specifications may include defining one or more of these factors for a patient based on a 3D model determined for the patient and / or the type of patient interface the patient will be using.

[0378] 5.1.1.2.2 Frame Specification Example

[0379] In some examples of the present technology, the customized component includes a patient interface frame 3500. In such examples, determining the customized component specifications in 7200 includes determining customized frame dimensions. For example, in some examples, the frame 3500 shown in FIG. 7 can be customized for a particular patient using method 7000.

[0380] In examples, determining the customized frame dimensions may include determining a length of each one of a pair of upper arms of the frame 3500, each configured to connect to a respective upper strap portion 3310 of the positioning and stabilizing structure 3300. The upper strap portion 3310 may be part of a headgear strap 3301, for example. The headgear strap 3301 may also be a customized component. In some examples, determining the customized frame dimensions includes determining a direction in which each upper arm extends from a central portion of the frame 3500. A customized frame may be advantageous because it may be more likely to provide a stable and comfortable fit for the patient interface 3000 than a one-size-fits-all frame.

[0381] In some examples, determining the customized frame dimensions includes determining a length of each one of a pair of lower arms of the frame 3500. Each lower arm can be configured to connect with a respective lower strap portion 3320 of the positioning and stabilizing structure 3300. In some examples, determining the customized frame dimensions includes determining a direction in which each lower arm extends from a central portion of the frame 3500.

[0382] In some examples, determining the customized frame dimensions includes determining where each upper and lower arm of the frame 3500 extends from a central portion of the frame 3500.

[0383] In addition to the headgear straps 3301 and frame 3500 as described above, further components of the patient interface may have specifications developed for the above manufacturing. For example, the customized components may include the plenum chamber 3200 of the patient interface and / or the seal-forming structure 3100 of the patient interface. As an example, PCT Patent Application Publication WO2013026091A1 describes an exemplary method and system for manufacturing knitted masks. As another example, US Patent Application Publication No. 20170326320 describes a cushion with a textile material, the entire contents of which are incorporated herein by reference.

[0384] Although examples have been described with respect to manufacture using knitting techniques, it should also be understood that other manufacturing techniques may be used in embodiments of the present technology (e.g., other methods of mechanically manipulating yarns (including for making textiles), textile forming, or additive manufacturing techniques) and the manufacturing specifications will be used as appropriate for the type of manufacture.

[0385] In some examples, any mask component (e.g., nasal cradle cushion, full face cushion, frame, chassis, and / or tubes) may be customized by providing textile material in whole or in part based on the patient's analysis. In some examples, the textile material may comprise a foam material. In the case of a textile cushion, a customized foam (e.g., polyurethane foam) may be included in the mask (e.g., the undercushion of the mouth cushion and / or nasal cushion may be formed from a foam coated with a textile material). Exemplary textile patient interfaces including foam are described in U.S. Patent Publication No. 2017 / 0326320, the contents of which are incorporated herein by reference in their entirety.

[0386] In some examples, customized tooling for injection molding of customized foam cushions can be 3D printed to reduce manufacturing costs. In this example, the foam can be cast into the 3D printed mold along with the fabric in the mold (instead of laminating the fabric later in the fabrication process).

[0387] If the frame and / or chassis includes a textile material, the laser cutter may be configured to trim the fabricated frame and / or chassis to a customized size and / or shape (based on the customized cushion geometry and / or patient analysis results). In this example, to reduce fabrication time, the frame and / or chassis may be pre-manufactured in large quantities and customized to the desired size and / or shape by laser cutting.

[0388] Identifying landmark features and / or their locations (e.g., at 7104 and / or 7112), identifying relationships between landmark features, determining functional requirements (e.g., for a patient interface and / or one or more components thereof) (e.g., at 7202), and / or determining manufacturing specifications (e.g., at 7204) may include using artificial intelligence and / or machine learning algorithms. For example, a trained dataset may be used to identify the landmark features and / or their locations. In some examples, the captured image data and / or three-dimensional models used to identify the landmark features may be used to train the dataset. In another example, the trained dataset may be used to identify specific manufacturing specifications based on the landmark features, their locations, and / or functional requirements.

[0389] 5.1.1.3 Creating customized components

[0390] In an example, producing the patient interface, or component thereof, based on a set of manufacturing specifications at 7300 includes producing manufacturing machine programming instructions for producing the patient interface, or component thereof, based on the set of manufacturing specifications at 7302 (see FIG. 19E). The manufacturing machine 142 is programmed with the manufacturing machine programming instructions at 7304 and operates in accordance with the manufacturing machine programming instructions to produce the patient interface, or component thereof, at 7306.

[0391] As noted above, in some examples of the present technology, the customized component to be made is the headgear strap 3301. Making the headgear strap 3301 in 7300 may include knitting the headgear strap 3301. In some examples, the headgear strap 3301 shown in Figures 7, 8, 16 and 21-23 may be formed by knitting. In some forms of the present technology, the step 7300 of forming the headgear strap 3301 includes knitting the headgear strap 3301 by flat knitting. In other forms of the present technology, the method 7000 includes knitting the headgear strap 3301 by circular knitting. Knitting may have the advantage that further processing (if required) of the headgear strap 3301 prior to providing the headgear strap 3301 to the patient is minimal. Exemplary methods and systems for the manufacture of knitted patient interfaces or components thereof are further described in PCT Patent Application Publication WO2013026091A1.

[0392] In some examples, creating the customized component in 7300 includes additive manufacturing (e.g., 3D printing) of the customized component. The manufacturing machine 142 may include a 3D printer to print the customized component (e.g., one or more of the frame 3500, the plenum chamber 3200, or the seal-forming structure 3100). The manufacturing machine 142 may include a laser cutter to cut out and / or modify the customized component (e.g., one or more of the frame 3500, the plenum chamber 3200, or the seal-forming structure 3100).

[0393] 5.1.1.3.1 Creation of manufacturing machine programming instructions

[0394] In an example, manufacturing machine programming instructions for the production of a patient interface or a component thereof can be automatically generated based on a set of manufacturing specifications. In an example, the manufacturing machine programming instructions can be generated from a model of the patient interface or component that embodies the set of manufacturing specifications. Software tools for the creation of manufacturing machine programming instructions from two-dimensional and three-dimensional models are known (e.g., STOLL-autocreate® tools (H. STOLL AG & Co. KG.) and SDS-ONE APEX® series tools (SHIMA SEIKI MFG., LTD) for the generation of knitting machine programming instructions).

[0395] In the example of a knitted product or component, the manufacturing specifications may specify parameters (e.g., yarn type, stitch type and / or spacing) for achieving a particular performance requirement. Aspects of the programming instructions (e.g., the number of stitches required to achieve a specified dimension or the structure required to transition between different regions) may be determined automatically.

[0396] In examples, generating 7302 manufacturing machine programming instructions for production of the patient interface, or a component thereof, based on a set of manufacturing specifications includes generating 7310 a map indicative of one or more manufacturing specifications (see FIG. 19F). In such examples, generating 7302 manufacturing machine programming instructions includes generating 7312 instructions based on the map indicative of the manufacturing specifications.

[0397] In one example, the map may include a two-dimensional model (e.g., one or more two-dimensional images) of the patient interface or a component thereof. In an example, detailed manufacturing specifications may be provided by visually coding the model. That is, specific manufacturing specifications may be obtained by visual recognition of the characteristics of the map. In one example, the map may include a three-dimensional model of the patient interface or a component thereof. In such an example, detailed manufacturing specifications may be encoded into the three-dimensional model.

[0398] In examples, the map may be generated at a first processing facility (e.g., customization server 102) and communicated to an appropriate manufacturer system 140 for generation of the manufacturing machine programming instructions. In other examples, generation of the map and the manufacturing machine programming instructions may occur at a single processing facility (e.g., by generating the map using a first software application and generating the manufacturing machine programming instructions using a second software application).

[0399] In an example, the map may be converted into a model from which manufacturing machine programming instructions may be generated. In another example, a manufacturing specification may be embodied as a map configured to be directly converted into manufacturing machine programming instructions. In an example, the conversion of a set of manufacturing specifications into manufacturing machine programming instructions may occur without the creation of an intermediate model or map.

[0400] In an example, a set of manufacturing specifications may be used to modify existing templates used as a basis for generating manufacturing machine programming instructions. Such templates may have predefined criteria rules associated with them, for example, related to manufacturing constraints or general required performance for a particular component design. In an exemplary embodiment, such templates may include predefined regions of the component design, and manufacturing specifications are used to modify parameters of each predefined region.

[0401] 5.1.1.4 Distribution of Customized Components

[0402] In examples, after the customized patient interface, or components thereof, is produced, an automated dispensing system may be used to manage delivery to the user. In examples, the customized patient interface, or components thereof, may be delivered directly to the user from the manufacturing system 140 facility or directly to a designated pickup point or address.

[0403] In examples where multiple components are manufactured or supplied with at least one customized component, an assembly phase may be performed. In examples, the assembly may be performed by the patient interface vendor. If the manufacturer of the customized component is a third party, the customized component may be delivered to the vendor's facility to be assembled with other components prior to delivery to the user.

[0404] 5.1.1.5 Matching existing products with users

[0405] According to aspects of the present technology, user-specific data (e.g., measurements obtained from a user or user contour information) may be used to select a patient interface component from a group of existing component configurations having associated manufacturing specifications and programming instructions. For example, the selection may be based on a comparison between the user-specific data and data records relating to information associated with the existing component configurations.

[0406] In an example, a pre-existing component configuration may be developed based on one or more sets of data indicative of head landmark features indicative of a user base. For example, one set of data may include a model of a human head having characteristics associated with a contour category (e.g., gender, age, or bone structure). Such a model may be trained, for example, using artificial intelligence and / or machine learning algorithms. Manufacturing specifications may be developed based on an analysis of such representation models and programming instructions generated from the models.

[0407] 5.1.1.6 Using Feedback to Change Specifications and / or Update Models

[0408] According to aspects of the present technology, feedback from a user, clinician, and / or manufacturing operator may be used to update parameters and / or models for performing one or more of the above operations (e.g., identifying landmark features and / or their locations, identifying relationships between landmark features, determining functional requirements, and / or determining manufacturing specifications). This feedback may be received via a user interface displayed on the RPT device, the user device 130, the operator workstation 114, and / or the manufacturing operator workstation 152.

[0409] A user may provide feedback after receiving a customized patient interface. Use may input information indicating how well the patient interface fits upon first use of the patient interface, after a predefined period of time (e.g., after receipt or initiation of use of the patient interface) and / or after a predefined amount of use. The user may be asked predefined questions about different aspects of the patient interface and / or be required to rate different features of the mask. A clinician may input feedback based on feedback received from the user and / or observations of the user using the patient interface. A manufacturing operator may provide feedback based on a customized patient interface produced by the manufacturing device 142. For example, the manufacturing operator may inspect manufactured patient interfaces and input defects in the patient interface that result from the manufacturing process.

[0410] Feedback from users, clinicians and / or manufacturing operators may be used to identify landmark features and / or their locations, to identify relationships between landmark features and / or to identify manufacturing specifications, to change manufacturing specifications and / or to update usage models (e.g., via artificial intelligence and / or machine learning algorithms).

[0411] 5.1.1.7 Examples of the use of weft knitting for the production of components of positioning and stabilizing structures

[0412] One or more of the operations described for the use of weft knitting to create components of a positioning and stabilizing structure may be used in combination with one or more of the operations described with reference to other examples of the present technology (e.g., one or more of the operations described with reference to Figures 19A-19E). Creating a positioning and stabilizing structure may include scanning a user's face and / or head, analyzing the scan data and identifying a positioning and stabilizing structure based on the analysis (e.g., size, curvature and / or stretch characteristics), sending the design layout to a weft knitting program to refine the knitting structure (e.g., pattern, knit one or more positioning and stabilizing structures), and shipping the positioning and stabilizing structure to an end user for initial trial.

[0413] In some examples, scanning the user's face and / or head may include using a 3D scanning application (e.g., the 3D scanner application provided by ALL3DP) installed on the user's or clinician's portable device (e.g., user device 130). The 3D scanning application may provide an alternative to expensive scanning hardware and / or software and may provide an easy-to-use and portable solution.

[0414] In some examples, the positioning and stabilizing structures or another component of the patient interface can be made with features that allow further customization of the patient interface by the end user and / or clinician. The positioning and stabilizing structures can include features that allow the user to trim the straps of the patient interface to their desired length at home. In flat knitting, the knitter can program one or more divider lines onto the straps (e.g., using bind-off and cast-on techniques), which allows the straps to be shortened to the divider line location (without any fraying issues after cutting).

[0415] 5.1.1.8 Examples of the use of laser cutting for the production of components of positioning and stabilizing structures

[0416] One or more of the operations described for using laser cutting techniques to fabricate components of the positioning and stabilizing structures may be used in combination with one or more of the operations described with reference to other examples of the present technology (e.g., one or more of the operations described with reference to Figures 19A-19E). Fabricating the positioning and stabilizing structures may include scanning the face and / or head of a user (e.g., with a 3D scanning application), analyzing the scan data to identify the positioning and stabilizing structures (e.g., size, curvature, and / or stretch characteristics) based on the analysis, sending the drawing outline to a laser cutting program, controlling a laser cutter to cut out one or more positioning and stabilizing structures, and shipping the positioning and stabilizing structures to an end user for initial tryout.

[0417] Laser cutting the positioning and stabilizing structures may include adding one or more perforated regions to guide a user in trimming one or more straps of the patient interface to a desired length at home. In some examples, the positioning and stabilizing structures may be etched by a laser cutter (e.g., to a predetermined depth in the straps) to provide an indicator to the user of where to cut the straps to their desired length.

[0418] Laser cutting may include modifying the positioning and stabilizing structures to increase their elasticity by making additional cutouts (e.g., holes) or etching in the straps. Laser cutting may be used to modify other components of the patient interface. For example, the mask frame and / or chassis may be cut to a desired length and / or shape by laser cutting techniques.

[0419] 5.2 RPT Devices

[0420] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 may be configured to generate an airflow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described anywhere herein.

[0421] In one form, the RPT device 4000 has a pressure of at least 6 cmH 2 O or at least 10 cmH 2 O or at least 20cmH 2 It is constructed and arranged to deliver air flows ranging from -20 L / min to +150 L / min while maintaining a positive pressure of O.

[0422] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions, an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0423] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., pressure and flow sensors).

[0424] One or more of the pneumatic path items may be disposed within a removable unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0425] The RPT device 4000 may have an electrical power source 4210, one or more input devices 4220, a central controller (e.g., provided on or coupled to a circuit board 4202), a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 may include more than one PCBA 4202.

[0426] 5.2.1 RPT Device Mechanical and Pneumatic Components

[0427] The RPT device may include one or more of the following components in an integral unit: In one alternative, one or more of the following components may be disposed as their own separate units.

[0428] 5.2.1.1 Air filter(s)

[0429] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0430] In one form, the inlet air filter 4112 is positioned at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0431] In one form, an outlet air filter 4114 (eg, antibacterial factor) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0432] 5.2.1.2 Muffler(s)

[0433] An RPT device according to one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0434] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.

[0435] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0436] 5.2.1.3 Pressure generator

[0437] In one form of the present technology, the pressure generator 4140 that creates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower controls the delivery of the air supply, for example, at a rate of up to about 120 liters / minute, at a pressure of about 4 cmH. 2 O~about 20cmH 2 Positive pressure in the range of O2 or about 30 cmH2O2 or other forms 2 The blower may be described in any one of the following patents or patent applications, which are incorporated by reference in their entirety: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT Patent Application Publication No. WO 2013 / 020167.

[0438] The pressure generator 4140 is under the control of the treatment device controller.

[0439] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a pressurized air reservoir), or a bellows.

[0440] 5.2.1.4 Transducer(s)

[0441] The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or transfers data to the RPT device).

[0442] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure or temperature at that point in the pneumatic path).

[0443] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.

[0444] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass or band-pass filtering).

[0445] 5.2.1.4.1 Flow Sensors

[0446] A flow sensor according to the present technology may be based on a differential pressure transducer (eg, the SDP600 series differential pressure transducers from SENSIRION).

[0447] In one form, a signal indicative of flow rate from a flow sensor is received by a central controller.

[0448] 5.2.1.4.2 Pressure Sensors

[0449] A pressure sensor according to the present technology can be placed in fluid communication with the pneumatic path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[0450] In one form, the signal from the pressure sensor may be received by a central controller.

[0451] 5.2.1.4.3 Motor Speed ​​Converters

[0452] In one form of the present technology, a motor speed transducer may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer may be provided to a therapy device controller. The motor speed transducer may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0453] 5.2.1.5 Anti-spillback valves

[0454] In one form of the present technology, an anti-spillback valve 4160 may be disposed between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the motor 4144).

[0455] 5.2.2 RPT Device Electrical Components

[0456] 5.2.2.1 Power supply

[0457] The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0458] In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0459] 5.2.2.2 Input Devices

[0460] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a human to interact with the device. The buttons, switches or dials may be physical or software devices accessible via a touch screen. The buttons, switches or dials may be physically connected to the external housing 4010 in one form or may communicate wirelessly with a receiver electrically connected to a central controller in another form.

[0461] In one form, the input device 4220 may be constructed and arranged to allow a human to select values ​​and / or menu options.

[0462] 5.2.3 RPT Device Algorithm

[0463] As noted above, in some forms of the technology, the central controller may be configured to implement one or more algorithms expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., memory), the algorithms being typically grouped into groups called modules.

[0464] 5.3 Air Circuit

[0465] An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (eg, the RPT device 4000 and the patient interface 3000).

[0466] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0467] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., a central controller). An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated by reference in its entirety.

[0468] 5.3.1 Oxygen delivery

[0469] In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (eg, upstream of the pneumatic block 4020), the pneumatic circuit 4170 and / or the patient interface 3000.

[0470] 5.4 Humidifier

[0471] 5.4.1 Humidifier Overview

[0472] In one form of the present technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before it is delivered to the patient's airways.

[0473] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0474] 5.4.2 Humidifier components

[0475] 5.4.2.1 Water reservoir

[0476] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidification of the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0477] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to promote the air flow traveling a tortuous path through the reservoir 5110 while the air flow contacts a volume of water in the reservoir 5110.

[0478] According to one form, the reservoir 5110 may be removable from the humidifier 5000 laterally, for example as shown in Figures 5A and 5B.

[0479] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

[0480] 5.4.2.2 Conductive sites

[0481] According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm) thick), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0482] 5.4.2.3 Humidifier Reservoir Dock

[0483] In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0484] 5.4.2.4 Water Level Indicator

[0485] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50% or 75% or an amount (e.g., 200ml, 300ml or 400ml)).

[0486] 5.4.2.5 Heating elements

[0487] In some cases, a heating element 5240 may be provided to the humidifier 5000 that provides heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the volume of water to the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistance heating track. One suitable example of a heating element 5240 is a layered heating element, for example, as described in PCT Patent Application Publication No. WO2012 / 171072, the entirety of which is incorporated herein by reference.

[0488] In some forms, the heating element 5240 may be mounted in the humidifier base 5006. In the humidifier base 5006, heat may be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in FIG.

[0489] 5.5 Respiratory waveform

[0490] FIG. 6 shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time and the vertical axis is respiratory flow. Since parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume, Vt, 0.5L; inhalation time, Ti, 1.6 seconds; peak inhalation flow, Qpeak, 0.4L / sec; exhalation time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5L / sec. The total duration of the breath, Ttot, is about 4 seconds. Humans typically breathe about 15 times per minute (BPM) and the ventilation, Vent, is about 7.5L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.

[0491] 5.6 Glossary

[0492] For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.

[0493] 5.6.1 General

[0494] Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

[0495] Surrounding: In some forms of the present technology, the term "surrounding" is to be interpreted as meaning: (i) external to the treatment system or patient; (ii) immediately surrounding the treatment system or patient.

[0496] For example, the surroundings of the humidifier humidity The ambient humidity may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such ambient humidity may differ from the humidity outside the room in which the patient sleeps.

[0497] In another example, the ambient pressure can be pressure directly surrounding or external to the body.

[0498] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0499] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting the therapy pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0500] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0501] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate refer to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, references to flow rate refer to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the designation Q. "Flow rate" may also be called "flow" for short.

[0502] In the example of a patient breathing, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle, and therefore negative for the exhalation portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Ventilation flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0503] Humidifier: The word "humidifier" refers to a device that delivers a therapeutically beneficial amount of water (H2O) to improve the medical respiratory condition of a patient. 2 O) is construed to mean a humidification device constructed, arranged, or configured with a physical structure capable of providing steam to an air stream.

[0504] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage may occur due to an imperfect seal between the mask and the patient's face. In another example, leakage may occur at the swivel elbow to the perimeter.

[0505] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic pathway (e.g., the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0506] Noise Emission (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target according to ISO 3744.

[0507] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vents in a patient interface).

[0508] Patient: A person with or without respiratory disease.

[0509] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH 2 O, gf / cm 2 , and hectopascals). 1cmH 2 O is 1g-f / cm 2 , approximately 0.98 hectopascals. In this specification, pressure is measured in cmH2 It is awarded in units of O.

[0510] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this moment, is given the symbol Pt.

[0511] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, typically a positive pressure relative to the atmosphere.

[0512] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0513] 5.6.1.1 Materials

[0514] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (in a family of products sold under this trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45 as measured by ASTM D2240.

[0515] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0516] 5.6.1.2 Mechanical properties

[0517] Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0518] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0519] Hardness: The ability of a material to resist deformation within itself (as described, for example, by Young's Modulus or the indentation hardness scale measured over a standardized sample size).

[0520] - "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example.

[0521] • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum and do not easily deform under finger pressure, for example.

[0522] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may offer different resistance in different directions.

[0523] Floppy Structure or Component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0524] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application is a patient interface that is approximately 20-30 cmH 2 It can be set up and maintained in a sealed manner against the entrance to the patient's airway under pressure loading of O.

[0525] As an example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and stiff in a second direction.

[0526] 5.6.2 Anatomy

[0527] 5.6.2.1 Facial anatomy

[0528] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0529] Alare: The outermost point on the ala of the nose.

[0530] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each ala, found in the crease formed by the union of the ala and cheek.

[0531] Pinna: the entire visible part of the ear.

[0532] (Nasal) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0533] (Nasal) Cartilaginous folds: The nasal cartilaginous folds include the septal cartilage, lateral cartilage, greater cartilage and lesser cartilage.

[0534] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0535] Columella angle: the angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfurt horizontal intersecting the subnasal point.

[0536] Frankfort horizontal plane: A line extending from the inferiormost point of the orbital rim to the left auricular point, which is the deepest point above the notch to the tragus of the pinna.

[0537] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0538] Lateral nasal cartilage: A generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla and whose lower margin is connected to the greater alar cartilage.

[0539] Alar cartilage: a plate of cartilage located below the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0540] Nostrils (alar): roughly ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nares is naris (nose hole). These nostrils are separated by the nasal septum.

[0541] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth and separates the cheeks from the upper lip.

[0542] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0543] Inferior ear point: lowest point of attachment of the pinna to the facial skin.

[0544] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0545] Nasal tip: the most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head section.

[0546] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0547] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0548] (Nasal) ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0549] Sagittal Plane: A vertical plane running from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0550] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0551] Septal cartilage (nose): The nasal septal cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0552] Nasal Alar Lowest Point: The point on the lower margin of the alar base where it joins with the skin of the upper (top) lip.

[0553] Subnasal point: located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0554] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.

[0555] 5.6.2.2 Skull anatomy

[0556] Frontal bone: The frontal bone contains the large vertical portion, the scales frontalis, which correspond to the area known as the forehead.

[0557] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw, forming the chin.

[0558] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the eye socket. The frontal process of the maxilla projects upwards by the side of the nose and forms part of its lateral border.

[0559] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from one individual to another. They lie side by side in the middle and upper parts of the face and their junction forms the "bridge" of the nose.

[0560] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0561] Occipital bone: The occipital bone is located at the back and lower part of the skull. It contains an oval hole, the foramen magnum, through which the intracranial cavity communicates with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0562] Orbit: bony cavity in the skull that contains the eyeball.

[0563] Parietal bones: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0564] Temporal Bone: The temporal bone is located at the base and on the side of the skull and supports parts of the face known as the temples.

[0565] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0566] 5.6.2.3 Respiratory system anatomy

[0567] Diaphragm: A sheet of muscle that runs over the lower rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0568] Larynx: The larynx or voice box that contains the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0569] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchiole, and terminal bronchioles. The respiratory zone includes the respiratory bronchi, alveolar ducts, and alveoli.

[0570] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinates. At the front of the nasal cavity is the nose, and at the back it opens into the nasopharynx via the choanae.

[0571] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).

[0572] 5.6.3 Patient Interface

[0573] Antiasphyxiation valve (AAV) - A component or subassembly of a mask system that prevents excessive CO by the patient by venting to atmosphere in a fail-safe manner. 2 Reduces the risk of rebreathing.

[0574] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable, for example, about 360 degrees, relative to the mating component. In certain forms, the elbow may be removable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap at the time of manufacture, but cannot be removed by the patient.

[0575] Frame: Frame is taken to mean a mask structure that supports a tensile load between two or more points that connect the headgear. A mask frame may be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0576] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed to be used on the head. For example, the headgear may include a collection of one or more posts, ties and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0577] Membrane: Membrane is taken to mean a typically thin-walled element, preferably offering substantially no resistance to bending and resistance to stretching.

[0578] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having a wall that at least partially encloses a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0579] Seal: When used as a noun ("seal") it can refer to a structure, and when used as a verb ("seal") it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0580] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0581] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending stiffness of another component in at least one direction.

[0582] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0583] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0584] Tie (noun): A structure designed to resist tension.

[0585] Venting: (noun): A structure that allows airflow to the ambient air inside a mask or conduit, allowing clinically effective flushing of exhaled gases. For example, flow rates of about 10 liters / minute to about 100 liters / minute may be used for clinically effective flushing, depending on mask design and treatment pressure.

[0586] 5.6.4 Shape of structure

[0587] Products of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be differentiated with labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structures may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, the seal-forming structures may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In another example, the structures may include a first surface and a second surface.

[0588] To facilitate the description of the shape and surface of a three-dimensional structure, a cross section at a point p through the surface of the structure is first considered. See Figures 3B-3F. Figures 3B-3F show an example cross section at a point p on the surface and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of a fictional little person standing upright on the surface.

[0589] 5.6.4.1 Curvature in one dimension

[0590] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0591] Positive curvature: If the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (if this imaginary little person walks away from point p, he or she would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.

[0592] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, he can walk on a horizontal plane that is neither pointing up nor down). See Figure 3D.

[0593] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this imaginary little person were to walk away from point p, he would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.

[0594] 5.6.4.2 Two-dimensional surface curvature

[0595] The description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane that includes the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each of the curvatures at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0596] Principal curvature and direction: The directions of the normal plane in which the curvature of the curve has a maximum and a minimum value are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0597] Surface region: A collection of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0598] Saddle region: a region where the principal curvatures at each point have opposite signs (i.e., one side has a positive sign and the other a negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0599] Dome Area: A region where the principal curvatures at every point have the same sign: both positive ("concave dome") or both negative ("convex dome").

[0600] Cylindrical region: A region in which one principal curvature is zero (or zero, for example, within a manufacturing tolerance) and the other principal curvature is non-zero.

[0601] Planar Region: Region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0602] Surface Edge: the boundary or limit of a surface or area.

[0603] Path: In certain forms of the technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A fictional person's path is a place to walk on a surface, similar to a path in a garden.)

[0604] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along a surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on a surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along a path on the surface.)

[0605] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance "as the crow flies.")

[0606] 5.6.4.3 Space curve

[0607] Space Curve: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, i.e., it has no end point. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear includes a left-handed helix (see FIG. 3Q). A typical human right ear includes a right-handed helix (see FIG. 3R). FIG. 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) may trace a space curve. In general, a space curve may be described by the curvature and twist at each point on the space curve. Twist is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve may be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0608] 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. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character was flying along a curve and fell off his vehicle at a particular point, the direction of the tangent vector is the direction he would be traveling.

[0609] Unit normal vector: If a fictional character is moving along a curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0610] Binormal unit vector: The binormal unit vector 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, Figure 3P) or the left-hand rule (Figure 3O).

[0611] Tangent plane: the plane containing the unit tangent vector and the unit principal normal vector, see Figures 3O and 3P.

[0612] Torsion of a Space Curve: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. The torsion of a space curve that lies within the plane is zero. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). With reference to FIG. 3S, the magnitude of torsion of the neighbors of the top coil of the spiral in FIG. 3S is greater than the magnitude of torsion of the bottom coil of the spiral in FIG. 3S because T2>T1.

[0613] Referring to the right-hand rule in Figure 3P, a space curve that bends towards the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative twist in the right-hand direction (e.g., a left-hand spiral).

[0614] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve with a left-handed binormal direction can be considered as having a left-handed positive twist (e.g., a left-handed spiral), where a left-handed positive direction thus corresponds to a right-handed negative direction, see Figure 3T.

[0615] 5.6.4.4 Holes

[0616] A surface may have one-dimensional holes (e.g., holes bounded by a plane or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a plane curve.

[0617] A structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire inner surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIG. 3M and FIG. 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown.

[0618] 5.7 Other Notes

[0619] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.

[0620] Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of the range, the unit of the lower limit, and any other stated or intervening value of the stated range is encompassed by the technology. The upper and lower limits of these intervening ranges, which are independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0621] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise indicated, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0622] Unless otherwise specified, all technical and scientific terms herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0623] Although particular materials are described as being preferred for use in the construction of components, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0624] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0625] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology has not antedated such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0626] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically described.

[0627] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the limitations of the claims.

[0628] Although the technology herein has been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, the terms "first" and "second" (and the like) are used, but unless otherwise specified, these terms are not intended to indicate any order, but are used to distinguish separate elements. Furthermore, although the description or illustration of process steps in the method may be described in an order, such order is not required. Those skilled in the art will recognize that such order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.

[0629] It is therefore to be understood that numerous modifications are possible in the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0630] 5.8 List of Reference Symbols [Table 1-1] [Table 1-2] [Table 1-3] [Table 1-4] [Table 1-5]

Claims

1. 1. A processor-implemented method for creating a customized patient respiratory interface component, comprising: receiving, using a communications circuit, data indicative of one or more landmark features of a human head; identifying, with at least one processor, one or more landmark feature locations of the landmark features based on the data; determining, with the at least one processor, a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and causing one or more manufacturing machines to produce the patient respiratory interface components based on the set of manufacturing specifications.

2. The method of claim 1 , further comprising capturing at least a portion of the data with an image sensor.

3. The method of claim 1 or 2, wherein the data comprises two-dimensional image data.

4. The method of claim 1 or 2, wherein the data comprises three-dimensional image data.

5. 5. The method of claim 1, further comprising identifying, with the at least one processor, at least one relationship between two or more of the landmark feature locations, and determining the set of manufacturing specifications is based at least in part on the at least one relationship between two or more of the landmark feature locations.

6. 6. The method of claim 5, wherein identifying at least one relationship between two or more of the landmark feature locations includes determining a distance between two or more of a subnasal point, a therion, an ear point, a posteriormost point of the head, an anteriormost point of the head, a lateralmost point of the orbital rim, a inferiormost point of the orbital rim, a Frankfurt horizontal plane, and a coronal plane aligned with the ear point.

7. 7. The method of claim 6, wherein determining at least one relationship between two or more of the landmark feature locations includes determining a distance in a sagittal plane between the subnasal point and the ear point.

8. 8. The method of claim 6 or 7, wherein identifying at least one relationship between two or more of the landmark feature locations comprises determining a perpendicular distance in the sagittal plane between the subnasal point and the serion.

9. 9. The method of claim 6, wherein identifying at least one relationship between two or more of the landmark feature locations comprises determining a distance between the coronal plane aligned with the ear point and the subnasal point, the distance being perpendicular to the coronal plane.

10. 10. The method of claim 6, wherein identifying at least one relationship between two or more of the landmark feature locations comprises determining a distance between the coronal plane aligned with the ear point and a lateral-most point of the orbital rim, the distance being perpendicular to the coronal plane.

11. 11. The method of claim 6, wherein identifying at least one relationship between two or more of the landmark feature locations comprises determining a perpendicular distance between the sub-nose point and a most anterior point of the head.

12. 12. The method of claim 6, wherein identifying at least one relationship between two or more of the landmark feature locations comprises determining a vertical distance between a most forward point of the head and the Frankfurt horizontal plane.

13. 13. The method of any one of claims 6 to 12, wherein identifying at least one relationship between two or more of the landmark feature locations comprises determining a distance between a coronal plane aligned with the ear points and a posteriormost point of the head, the distance being perpendicular to the coronal plane.

14. The method of any one of claims 1 to 13, comprising determining, with the at least one processor, at least one required performance of the patient respiratory interface component based on the one or more landmark feature locations.

15. 15. The method of claim 14, wherein the at least one required performance comprises one or more of the force to be applied by or to the component, elasticity, size, feel, breathability, and positioning on the head.

16. 16. The method of claim 14 or claim 15, wherein the patient respiratory interface component includes a plurality of regions and at least one required performance is determined for each region.

17. 17. The method of claim 14, wherein the at least one required performance is determined based at least in part on a characteristic of another component of the patient interface intended for use with the customized patient respiratory interface component.

18. The method of any one of claims 14 to 17, wherein determining the set of manufacturing specifications is based at least in part on the at least one required performance.

19. The method of any one of claims 1 to 18, wherein the set of manufacturing specifications includes at least one material specification.

20. The method of any one of claims 1 to 19, wherein said set of manufacturing specifications includes at least one construction engineering specification.

21. The method of any one of claims 1 to 19, wherein the set of manufacturing specifications includes at least one dimensional specification.

22. The method of any one of claims 1 to 21, wherein determining the set of manufacturing specifications comprises selecting the set of manufacturing specifications from a plurality of sets of existing manufacturing specifications.

23. 23. The method of claim 22, wherein selecting the set of existing manufacturing specifications is based on a comparison between the one or more landmark feature locations determined for the human and one or more landmark feature locations associated with the set of existing manufacturing specifications.

24. The method of any one of claims 1 to 21, wherein determining the set of manufacturing specifications comprises selecting a plurality of manufacturing specifications to form the set of manufacturing specifications from a plurality of existing manufacturing specifications.

25. 25. The method of any one of claims 1 to 24, further comprising using the at least one processor to generate manufacturing machine programming instructions for producing the patient interface or a component thereof based on the set of manufacturing specifications, and wherein producing the patient respiratory interface component comprises programming the at least one manufacturing machine with the manufacturing machine programming instructions and operating the at least one manufacturing machine in accordance with the manufacturing machine programming instructions.

26. 26. The method of claim 25, wherein generating the manufacturing machine programming instructions comprises generating a map indicative of the set of manufacturing specifications and generating the manufacturing machine programming instructions based on the map.

27. 27. The method of claim 26, wherein creating the manufacturing machine programming instructions includes generating a model of the patient respiratory interface component based on the set of manufacturing specifications and generating the manufacturing machine programming instructions based on the model.

28. 28. The method of any one of claims 1 to 27, wherein creating the patient respiratory interface component comprises mechanical manipulation of threads to create the component.

29. 30. The method of claim 28, wherein creating the patient respiratory interface components includes knitting the components.

30. 30. The method of claim 29, wherein knitting the patient respiratory interface component comprises one of flat knitting and circular knitting.

31. The method of any one of claims 1 to 30, wherein the patient respiratory interface components include headgear straps of a positioning and stabilizing structure for a patient interface.

32. The method of claim 31 , wherein the set of manufacturing specifications includes headgear strap dimensions.

33. 32. The method of claim 31, wherein the set of manufacturing specifications includes at least one dimension of a rear strap portion for the headgear straps, the rear strap portion configured to be positioned against at least a rear surface of the head in use.

34. 32. The method of claim 31, wherein the set of manufacturing specifications includes a length of each one of a pair of upper strap portions for the headgear straps, each upper strap portion configured to be positioned on a respective side of the head in use.

35. 32. The method of claim 31, wherein the set of manufacturing specifications includes top strap locations on rear strap portions for the headgear straps from which respective ones of a pair of top strap portions for the headgear straps extend.

36. 32. The method of claim 31, wherein in an upper strap orientation included in the set of manufacturing specifications, one of a pair of upper strap portions for the headgear strap extends from a rear strap portion for the headgear strap.

37. 32. The method of claim 31, wherein the set of manufacturing specifications includes a length of each one of a pair of lower strap portions for the headgear straps, each lower strap portion configured to be positioned on a respective side of the head in use.

38. 32. The method of claim 31, wherein the set of manufacturing specifications includes lower strap locations on rear strap portions for the headgear straps from which respective ones of a pair of lower strap portions extend.

39. 32. The method of claim 31 , wherein the set of manufacturing specifications includes lengths of ring strap portions for the headgear straps, the ring strap portions having an upper portion configured to rest on the parietal bone of the head in use and a lower portion configured to rest on or be positioned below the occipital bone of the head in use.

40. 40. The method of any one of claims 31 to 39, wherein the set of manufacturing specifications is determined such that, in use, a predetermined force is applied from the headgear straps to a seal-forming structure of the patient interface when the patient interface is worn by the person.

41. The method of claim 40, wherein the predetermined force is between 3N and 5N.

42. 42. The method of claim 41, wherein the predetermined force is about 4N.

43. The method of any one of claims 1 to 27, wherein the patient respiratory interface component comprises a frame of the patient interface.

44. 44. The method of claim 43, wherein the set of manufacturing specifications includes frame dimensions.

45. 44. The method of claim 43, wherein the set of manufacturing specifications includes a length of a respective one of a pair of upper arms of the frame, each upper arm being configured to connect to a respective upper strap portion of a positioning and stabilizing structure in use.

46. 44. The method of claim 43, wherein the set of manufacturing specifications includes a direction that each one of a pair of upper arms of the frame extends from a central portion of the frame.

47. 44. The method of claim 43, wherein the set of manufacturing specifications includes a length of a respective one of a pair of lower arms of the frame, each lower arm configured to connect to a respective lower strap portion of a positioning and stabilizing structure in use.

48. 44. The method of claim 43, wherein the set of manufacturing specifications includes a direction that each one of a pair of lower arms of the frame extends from a central portion of the frame.

49. The method of any one of claims 1 to 27, wherein the patient respiratory interface component comprises a plenum chamber of the patient interface.

50. The method of any one of claims 1 to 27, wherein the patient respiratory interface component comprises a seal-forming structure of the patient interface.

51. 51. The method of any one of claims 1 to 50, wherein the set of manufacturing specifications specifies specifications for headgear straps of a positioning and stabilizing structure for a patient interface, including at least one of knit construction, material composition, yarn denier and / or machine gauge for construction of the headgear straps, and one or more of the manufacturing specifications dictate stretch characteristics of the positioning and stabilizing structure.

52. The method of any one of claims 1 to 51, wherein the method is performed by a manufacturing system including the at least one processor and the communication circuitry.

53. 1. A system for fabrication of customized patient respiratory interface components, comprising: one or more processors receiving data indicative of one or more landmark features of a human head; the one or more processors are further configured to identify one or more landmark feature locations of the landmark feature based on the data; one or more processors further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications.

54. 1. A processor-implemented method performed by a processing system including at least one processor and communications circuitry for creating a patient respiratory interface component, comprising: receiving, with the communications circuitry, data indicative of one or more landmark features of a human head; identifying one or more landmark feature locations of the landmark feature based on the data using the processing system; determining, with the processing system, a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and communicating, using the communications circuitry, the set of manufacturing specifications to a manufacturing system including at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications.

55. 1. A system for fabrication of customized patient respiratory interface components, comprising: one or more processors receiving data indicative of one or more landmark features of a human head; the one or more processors are further configured to identify one or more landmark feature locations of the landmark feature based on the data; The one or more processors are further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; the one or more processors are further configured to communicate the set of manufacturing specifications to a manufacturing system including at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications.

56. 1. A processor-implemented method performed by a processing system including at least one processor and communications circuitry for creating a patient respiratory interface component, comprising: receiving, with the communications circuitry, one or more landmark feature locations of a landmark feature of the human head, the one or more landmark feature locations identified from data indicative of the one or more landmark features of the head; determining, with the processing system, a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and communicating, using the communications circuitry, the set of manufacturing specifications to a manufacturing system including at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications.

57. 1. A system for fabrication of customized patient respiratory interface components, comprising: one or more processors that receive one or more landmark feature locations of a landmark feature of the human head, the one or more landmark feature locations identified from data indicative of the one or more landmark features of the head; The one or more processors are further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; the one or more processors are further configured to communicate the set of manufacturing specifications to a manufacturing system including at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications.

58. 1. A processor-implemented method for fabricating a patient respiratory interface component, comprising: receiving, using a communications circuitry, a set of manufacturing specifications for fabrication of the patient respiratory interface component, the set of manufacturing specifications being determined based on one or more landmark feature locations identified from data indicative of one or more landmark features of a human head; and causing one or more manufacturing machines to produce the patient respiratory interface components based on the set of manufacturing specifications.

59. 1. A system for fabrication of customized patient respiratory interface components, comprising: one or more processors receiving a set of manufacturing specifications for fabrication of the patient respiratory interface component, the set of manufacturing specifications determined based on one or more landmark feature locations identified from data indicative of one or more landmark features of a human head; and at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications.

60. 1. A processor-implemented method for fabricating a patient respiratory interface component, comprising: obtaining information indicative of one or more landmark feature positions of the human head based on data received from the device using the communications circuitry; determining, with at least one processor, a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and causing one or more manufacturing machines to produce the patient respiratory interface components based on the set of manufacturing specifications.

61. 1. A system for fabrication of a patient respiratory interface component, comprising: one or more processors for obtaining information indicative of one or more landmark feature positions of the human head; The one or more processors are further configured to determine a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; The one or more processors are further configured to fabricate the patient respiratory interface components based on the set of manufacturing specifications.

62. 1. An apparatus for making a patient respiratory interface component, comprising: means for obtaining information indicative of the location of one or more landmark features of the human head; means for determining a set of manufacturing specifications for fabrication of the patient respiratory interface component based on the one or more landmark feature locations; and means for producing said patient respiratory interface components according to said set of manufacturing specifications.

63. 1. A processor-implemented method for fabricating customized components of an apparatus or device for treating respiratory disorders, comprising: receiving, using communications circuitry, data indicative of one or more function requests; determining, with at least one processor, a set of manufacturing specifications for fabrication of the component based on the one or more functional requirements; and causing one or more manufacturing devices to produce said components based on said set of manufacturing specifications.

64. 64. The processor-implemented method of claim 63, wherein fabricating the patient respiratory interface component comprises: (a) mechanical manipulation of yarn to fabricate the component; (b) knitting the component; (c) weft knitting the component; (d) circular knitting the component; (e) forming the component from a textile; (e) additive manufacturing of the component; (f) three dimensional printing of the component; and / or (g) laser cutting of the component.

65. 64. The processor implemented method of claim 63, wherein producing the component based on the set of manufacturing specifications includes generating instructions for the one or more manufacturing devices configured to produce the component, and controlling the one or more manufacturing devices based on the generated instructions to produce the component.

66. 66. The processor implemented method of any one of claims 63 to 65, wherein the method is performed by a manufacturing system including the at least one processor and the communications circuitry.

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