Customized patient interface and method of making the same

Abstract

A method of manufacturing a patient interface for sealingly delivering a flow of air to an entrance of a patient's airways at a continuous positive pressure relative to ambient air pressure includes collecting anthropometric data of a patient's face. An anticipated consideration is identified from the anthropometric data collected during use of the patient interface. The collected anthropometric data is processed to provide a transformation data set based on the anticipated consideration, the transformation data set corresponding to at least one custom patient interface component. At least one patient interface component is modeled based on the transformation data set.

Description

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 020,147, filed July 2, 2014, the contents of which are incorporated by reference in their entirety as if fully set forth herein. 2 BACKGROUND 2.1 TECHNICAL FIELD

[0005] The present technology relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related disorders. In particular, the present technology relates to medical devices or apparatus, and their use.

[0006] 2.2 DESCRIPTION OF RELATED ART

[0007] 2.2.1 The human respiratory system and its disorders

[0008] The respiratory system of the body facilitates gas exchange. The nose and mouth form entry points to the respiratory tract.

[0009] The respiratory tract includes a sequence of branching tubes that, as they penetrate more deeply into the lung, become successively narrower, shorter and more numerous. The primary function of the lung is gas exchange, allowing oxygen to move from air in the lung into venous blood and carbon dioxide from the blood into the exhaled air. The trachea divides into the right and left bronchus, which in turn divide further eventually into terminal bronchioles. The bronchi constitute the conducting airways but do not participate in gas exchange. Further division of the airways leads to the respiratory bronchioles and eventually the pulmonary alveolar region. It is in the pulmonary alveolar region of the lung that gas exchange occurs, and this region is known as the respiratory zone. See "Respiratory Physiology", John B. West, Lippincott Williams & Wilkins, 9thedition published 2011.

[0010] There is a range of respiratory disorders. Certain disorders can be characterised by particular events, such as apneas, hypopneas, and hyperpneas.

[0011] One form of sleep disordered breathing (SDB), obstructive sleep apnea (OSA), is characterised by events comprising occlusion, or obstruction, of the upper respiratory tract during sleep. This is caused by a combination of abnormally small upper airways and normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The disorder results in the affected patient stopping breathing for periods of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This typically results in excessive daytime somnolence, and it can cause cardiovascular complications and brain damage. The condition is a common disorder, particularly in middle aged males, but the sufferers can be unaware of the problem. See US Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory control, characterized by alternating periods of crescendo and decrescendo ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to the repeated hypoxia, CSR can be detrimental. In some patients, CSR is associated with repeated awakenings from sleep, which can lead to severe sleep breakdown, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath during exercise, chronic cough, and sputum production.

[0015] Neuromuscular diseases (NMD) are a broad term encompassing many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair dependence, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by worsening muscle damage over several months and leading to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases: characterized by worsening muscle damage over several years and only moderately shortening life expectancy (e.g., limb-girdle muscular dystrophy, facioscapulobrachial muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0016] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling of the respiratory muscles to the thoracic cage. The disorders are usually characterised by a restrictive defect and share the possibility of long term hypoxemic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnoea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.

[0017] A range of therapies have been used to treat or ameliorate such disorders. In addition, other healthy individuals can take advantage of such therapies to prevent the development of respiratory disorders. However, these therapies have a number of shortcomings.

[0018] 2.2.2 Therapies

[0019] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnoea (OSA). It is postulated that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by nasal CPAP can be voluntary and therefore patients can elect not to comply with therapy if they find the device used to provide this therapy uncomfortable or difficult to use, expensive or aesthetically unappealing.

[0020] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways. The ventilatory support assists the patient in performing the work of breathing and / or maintaining adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a patient interface. NIV has been used to treat CSR, OHS, COPD, MD, and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0021] Invasive ventilation (IV) provides ventilatory support to a patient who is no longer able to maintain adequate gas exchange on their own and can be provided using an incision made in the trachea and a tube inserted into the trachea. In some forms, the comfort and effectiveness of these therapies can be improved.

[0022] 2.2.3 Diagnosis and Treatment Systems

[0023] These therapies can be provided by a treatment system or device. Systems and devices can also be used to diagnose a disorder without treating it.

[0024] A treatment system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0025] 2.2.3.1 Patient Interface

[0026] A patient interface can be used, for example, to interface a respiratory treatment apparatus to its user, by providing a flow of air to the user. The flow of air can be provided via a mask to the nose or mouth, a mouthpiece to the mouth, or a tracheal tube to the trachea of a user. Depending on the therapy being applied, the patient interface can form a seal with the user's face, e.g. a facial region of the user, to facilitate the delivery of gas pressure at a sufficiently different pressure to ambient pressure to effect therapy, e.g. positive pressure of around 10 cmH20 relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface can not include a seal sufficient to facilitate supply of gas at a positive pressure of around 10 cmH20 to the airways.

[0027] The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses varies considerably between individuals. As the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The mandible, or lower jaw, can move relative to other bones of the skull. The whole head can move during respiratory therapy.

[0028] Due to these challenges, some masks suffer from one or more of the following problems: conspicuous, unaesthetic, expensive, poor fit, difficult to use, and uncomfortable, particularly when worn for long periods or by patients unfamiliar with the system. For example, masks designed specifically for pilots, masks designed as part of personal protection equipment (e.g. filtering masks), SCUBA masks, or masks for the administration of anaesthetics can be tolerable for their original application, but such masks can be undesirably uncomfortable for long periods, e.g. hours. This discomfort can lead to reduced compliance by the patient with therapy. This is particularly true if the mask is worn during sleep.

[0029] Nasal CPAP therapy is very effective in treating certain respiratory disorders if a patient complies with the therapy. If a mask is uncomfortable or difficult to use, patients can not comply with the therapy. As patients are typically recommended to wash their masks on a regular basis, if a mask is difficult to clean (e.g. difficult to assemble or disassemble), patients can not clean their masks, which can affect patient compliance.

[0030] While masks for other applications (e.g. pilots) can not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing can be suitable for other applications.

[0031] For these reasons, patient interfaces for delivering nasal CAPA during sleep form a distinct field.

[0032] 2.2.3.1.1 Seal-forming portion

[0033] The patient interface can include a seal-forming portion (also referred to herein as a sealing element). The shape and configuration of the seal-forming portion can have a direct impact on the effectiveness and comfort of the patient interface due to its direct contact with the patient’s face.

[0034] The patient interface can be characterized in part by the design intent of the seal-forming portion to interface with the face in use. In one form of the patient interface, the seal-forming portion can include two sub-portions to interface with respective left and right nares. In one form of the patient interface, the seal-forming portion can include a single element that surrounds both nares in use. This single element can be designed to cover, for example, the upper lip region and the bridge of the nose region of the face. In one form of the patient interface, the seal-forming portion can include an element that surrounds the mouth region in use, for example by forming a seal over the lower lip region of the face. In one form of the patient interface, the seal-forming portion can include a single element that surrounds both the nares and the mouth region in use. The manufacturer of these different types of patient interfaces can refer to them by various names, including nasal masks, full face masks, nasal pillows, nasal puffs, and mouth-nose masks.

[0035] Due to, for example, the different shapes, structures, variability, and sensitive areas of patient faces, a seal-forming portion that is effective in one area of a patient’s face can not be suitable for use in another area. For example, a seal on a swimmer’s mask that covers the forehead of a patient can not be suitable for use on the nose of the patient.

[0036] Certain seal-forming portions can be designed for mass production, such that one design fits a wide range of different face shapes and sizes and is comfortable and effective for them. To the extent there is a mismatch between the shape of a patient’s face and the seal-forming portion of a mass-produced patient interface, one or the other must accommodate to form a seal.

[0037] One type of seal-forming portion extends around the periphery of the patient interface and is intended to seal against the face of the user when the seal-forming portion is brought into face-to-face engagement with the face of the user while a force is applied to the patient interface. The seal-forming portion can include a cushion filled with a gas or fluid, or a molded or shaped surface of an elastomeric seal element made of an elastomer such as rubber. With this type of seal-forming portion, if the fit is not adequate, there will be a gap between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0038] Another type of seal-forming portion includes a thin material flap seal positioned around the periphery of the mask to provide a self-seal against the user's face when positive pressure is applied within the mask. Similar to the previous style of seal-forming portion, additional force is required to achieve a seal if the face and mask do not mate well, otherwise the mask can inadvertently leak. Furthermore, if the shape of the seal-forming portion does not match the shape of the patient, it can wrinkle or buckle in use, leading to inadvertent leaks.

[0039] Another type of seal-forming portion can include a friction fitting element, for example for insertion into the nostrils, however, some patients find these uncomfortable.

[0040] Another form of seal-forming portion can use adhesive to achieve a seal. Some patients can find it inconvenient to constantly apply and remove adhesive to their face.

[0041] A range of patient interface seal-forming portion technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0042] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal prong is the subject of US Patent 4,782,832 (Trimble et al) assigned to Puritan-Bennett Corporation.

[0043] ResMed Limited has manufactured the following products which include nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II Nasal pillow mask, SWIFT TM LT Nasal pillow mask, SWIFT TM FX Nasal pillow mask and LIBERTY TM Full face mask. The following patent applications assigned to ResMed Limited describe nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes the ResMed SWIFT TM Nasal pillow) ; US Patent Application 2009 / 0044808 (which describes the ResMed SWIFT TM LT Nasal pillow) ; International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe the ResMed LIBERTY TMfull face mask); International Patent Application WO 2009 / 052,560 (which describes the ResMed SWIFT TM FX nasal pillow).

[0044] 2.2.3.1.2 Positioning and stabilisation

[0045] The seal-forming portion of a patient interface for positive air pressure therapy is subject to corresponding forces to break the seal from air pressure. Various techniques have therefore been used to position the seal-forming portion and maintain it in a sealing relationship with appropriate portions of the face.

[0046] One technique is to use adhesive. See, for example, US Patent Application No. US 2010 / 0000534. However, the use of adhesive can be uncomfortable for some people.

[0047] Another technique is to use one or more straps and stabilising bands. Many such straps suffer from one or more of poor fit, bulkiness, discomfort and difficulty of use.

[0048] 2.2.3.1.3 Ventilation techniques

[0049] Some forms of patient interface systems can include a vent to allow the washout of exhaled carbon dioxide. The vent can allow gas to flow from an interior space of the patient interface, for example a plenum chamber, to an exterior of the patient interface, for example to ambient. The vent can include an orifice, and gas can flow through the orifice when a mask is in use. Many such vents are noisy. In use, other vents can be occluded, providing insufficient washout. Some vents can disrupt the sleep of a bed partner 1100 of the patient 1000, for example by noise or focussed air flow.

[0050] ResMed Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. 2000 / 078,381; US Patent No. 6,581,594; US Patent Application Publication No. US 2009 / 0050156; US Patent Application Publication No. 2009 / 0044808.

[0051] Existing mask noise chart (ISO 17510-2:2007, 10 cm H20 pressure at 1 m)

[0052]

[0053] (* only one sample, measured at 10 cm H20 in CPAP mode using test method specified in ISO 3744), the sound pressure values for various objects are listed below:

[0054]

[0055]

[0056] 2.2.3.1.1 Respiratory pressure therapy (RPT) devices

[0057] Air pressure generators are known in a range of applications, such as industrial grade ventilation systems. However, air pressure generators for medical applications have specific requirements not met by more general air pressure generators, such as reliability, size and weight requirements of medical devices. Furthermore, even devices designed for medical therapy can suffer from drawbacks relating to one or more of comfort, noise, ease of convenience, effectiveness, size, weight, manufacturability, cost and reliability.

[0058] An example of a particular requirement of some RPT devices is acoustic noise.

[0059] Noise output levels of existing RPT devices (one sample only, measured at 10 cm H20 in CPAP mode using test methods specified in ISO 3744).

[0060]

[0061] One known RPT device for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators such as the ResMed Stellar™ Series of Adult and Paediatric Ventilators can provide invasive or non-invasive non- dependent ventilation support for a range of patients for treating a number of conditions such as, but not limited to, NMD, OHS and COPD. TM The ResMed Stellar™ Series of Adult and Paediatric Ventilators can provide invasive or non-invasive non-dependent ventilation support for a range of patients for treating a number of conditions such as, but not limited to, NMD, OHS and COPD.

[0062] ResMed Elisée TM 150 Ventilator and ResMed VS III TM Ventilators can provide invasive and non-invasive dependent ventilation support suitable for adult or paediatric patients for treating a number of conditions. These ventilators provide volume and pressure ventilation modes with single limb or dual limb circuits. RPT devices generally comprise a pressure generator such as a motor-driven blower or a compressed gas reservoir, and which is configured to supply a flow of air to the patient’s airway. In some cases, the flow of air can be supplied at a positive pressure to the patient’s airway. The outlet of the RPT device is connected to a patient interface, such as those described above, via an air circuit.

[0063] 2.2.3.1.5 Humidifier

[0064] Delivery of an air flow without humidification can result in drying of the airways. The use of a humidifier with an RPT device and patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Furthermore, in cooler climates, warm air applied into and around the facial region of the patient interface is generally more comfortable than cold air. A range of artificial humidification devices and systems are known, however, they can not meet the specialised requirements of a medical humidifier.

[0065] Medical humidifiers are typically used when required to increase the humidity and / or temperature of an air flow relative to ambient air, usually when the patient is sleeping or resting, for example in a hospital. Medical humidifiers for bedside placement can be small in size. Medical humidifiers can be configured to humidify and / or heat only the air flow delivered to the patient, without humidifying and / or heating the patient's surroundings. For example, room-based systems such as saunas, air conditioners or evaporative coolers can also humidify air breathed by a patient, however those systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. Furthermore, medical humidifiers can have more stringent safety limitations than industrial grade humidifiers.

[0066] While a number of medical humidifiers are known, they can suffer from one or more shortcomings. Some medical humidifiers can provide insufficient humidification, some are difficult or inconvenient for patients to use.

[0067] 2.2.3.1.6 Mandibular repositioning

[0068] Mandibular repositioning devices (MRDs) or mandibular advancement devices (MADs) are one of the treatment options for sleep apnoea and snoring. They are adjustable oral appliances available from dentists or other suppliers that hold the lower jaw (mandible) in a forward position during sleep. MRDs are removable devices that the patient inserts into the mouth before going to sleep and removes after sleeping. MRDs are therefore not designed to be worn all the time. MRDs can be custom made or produced in standard form and include bite impression sections designed to allow fitting to the patient's teeth. This mechanical protrusion of the lower jaw enlarges the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway, and reduces palate vibration.

[0069] In certain examples, a mandibular advancement device can include an upper splint intended to engage or fit with teeth on the upper jaw or maxilla, and a lower splint intended to engage or fit with teeth on the lower jaw or mandible. The upper splint and the lower splint are laterally connected together via a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0070] In this design, the length of the connecting rod is chosen so that when the MRD is placed in the patient's mouth, the mandible is held in a forward position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of mandibular protrusion, which will determine the length of the connecting rod.

[0071] Some MRDs are configured to push the mandible forward relative to the maxilla, while others such as the ResMed Narval CC TM The MRD is designed to hold the mandible in a forward position. The device also reduces or minimizes the side effects of the teeth and the temporomandibular joint (TMJ). Thus, it is configured to minimize or prevent any movement of one or more of the teeth.

[0072] 2.2.3.1.7 Monitoring system

[0073] Polysomnography (PSG) is a conventional system for diagnosing and predicting cardiopulmonary disorders. PSG typically involves placing 15 to 20 contact sensors on a person in order to record various body signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), etc. However, while they can be suitable for their common application in a clinical setting, such systems are complex and potentially expensive, and / or can be uncomfortable or impractical for a patient trying to sleep at home.

[0074] Designers of devices can be presented with an infinite number of choices to design a product or system. Design criteria often conflict, meaning that certain design choices are far from conventional or inevitable. Furthermore, the comfort and effectiveness of certain aspects can be highly sensitive to small, subtle changes in one or more parameters. 3. SUMMARY

[0076] The present technology relates to providing a medical device for diagnosing, ameliorating, treating or preventing a respiratory disorder, with one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0077] A first aspect of the present technology concerns apparatus for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0078] Another aspect of the present technology concerns methods for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0079] An aspect of certain forms of the present technology is to provide methods and / or apparatuses that improve respiratory therapy compliance.

[0080] One form of the present technology includes customizing certain elements of a patient interface.

[0081] Another aspect of one form of the present technology is to optimize a patient interface based on data collected from a patient.

[0082] Another aspect of one form of the technology is to modify at least one of the frame, the intermediate structure, the sealing element, or the headgear of the patient interface.

[0083] Another aspect of one form of the technology is to make a comfortable patient interface with superior sealing that is more likely to be worn by a user to follow a prescribed therapy regime.

[0084] Another aspect of one form of the technology is a molded or otherwise constructed patient interface whose perimeter shape is intended to complement that of an intended wearer.

[0085] An aspect of one form of the technology is a method of manufacturing equipment.

[0086] An aspect of one form of the technology is a portable RPT device that can be carried by a person, for example, around the person's home.

[0087] An aspect of one form of the technology is a patient interface that can be cleaned in a patient's home, for example, with soapy water, without requiring specialized cleaning equipment. An aspect of one form of the technology is a humidifier tank that can be cleaned in a patient's home, for example, with soapy water, without requiring specialized cleaning equipment.

[0088] Of course, parts of these aspects can form sub-aspects of the technology. Also, sub-aspects and / or aspects of the aspects can be combined in various ways and can also form additional aspects or sub-aspects of the technology.

[0089] Other features of the technology will be apparent from consideration of the following detailed description, abstract, drawings and claims. 4BRIEF DESCRIPTION OF DRAWINGS

[0091] The technology is illustrated in the drawings in which like reference numbers refer to like elements throughout the several views, and which draw include:

[0092] FIG. 1A A system is shown including a patient wearing a patient interface in the form of a nasal pillow;

[0093] FIG. 1B A system is shown including a patient wearing a patient interface in the form of a nasal mask;

[0094] FIG. 1C A system is shown including a patient wearing a patient interface in the form of a full face mask;

[0095] Figure Id shows a patient 1000 undergoing polysomnography (PSG);

[0096] FIG. 2A An overview of the human respiratory system is shown;

[0097] FIG. 2B Schematic view of the upper airway of a human;

[0098] FIG. 2C Frontal view of a face with several features identified, including upper lip, upper vermilion, lower vermilion, lower lip, mouth width, endocanthion, alar base, nasolabial sulcus, and cheilion. It also indicates superior, inferior, radially-inward, and radially-outward directions;

[0099] FIG. 2D Lateral view of a head with several features identified, including glabella, sellion, pronasale, subnasale, upper lip, lower lip, supramenton, nasion, alar crest, otobasion superior, and otobasion inferior. It also indicates superior & inferior, and anterior & posterior directions;

[0100] FIG. 2E Further lateral view of a head. It indicates the approximate location of the Frankfort horizontal and nasolabial angle. It also indicates the coronal plane;

[0101] FIG. 2F Base view of a nose with several features identified, including nasolabial sulcus, lower lip, upper vermilion, nostril, subnasale, columella, pronasale, nostril principal axis, and sagittal plane;

[0102] FIG. 2G Lateral view of the surface features of a nose;

[0103] FIG. 2H Subsurface structure of a nose, including lateral cartilages, septal cartilage, alar major cartilage, alar minor cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of maxilla, and fibrofatty tissue;

[0104] FIG. 2I Medial anatomy of a nose, approximately a few millimeters from the sagittal plane, where the medial crura of the septal cartilage and alar major cartilage are shown;

[0105] FIG. 2J Skeletal frontal view of a skull, including the forehead, nose, and zygomatic bones. It indicates the concha, and also indicates the maxilla and mandible;

[0106] FIG. 2K Lateral view of a skull with the surface contours of the head, and several muscles. It shows the following bones: forehead, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. It indicates the mental protuberance. It shows the following muscles: digastric, masseter, sternocleidomastoid, and trapezius;

[0107] FIG. 2L Anterolateral view of a nose;

[0108] FIG. 3A A patient interface in the form of a nasal mask is shown, in accordance with one form of the present technology;

[0109] FIG. 3B An RPT device in accordance with one form of the present technology is shown;

[0110] FIG. 3C A schematic of a pneumatic path for an RPT device in accordance with one form of the present technology. It also indicates upstream and downstream directions;

[0111] FIG. 3D A schematic of electrical components for an RPT device in accordance with one form of the present technology;

[0112] FIG. 3E A schematic of an algorithm implemented in an RPT device in accordance with one form of the present technology;

[0113] FIG. 3F A flow chart showing a method carried out by a therapy engine module of FIG. 3E in accordance with one form of the present technology;

[0114] FIG. 3G An isometric view of a humidifier in accordance with one form of the present technology is shown;

[0115] FIG. 3H An isometric view of a humidifier in accordance with one form of the present technology is shown, showing a humidifier reservoir 5110 removed from a humidifier reservoir base 5130;

[0116] FIG. 3I A typical respiratory waveform model of a person while sleeping is shown;

[0117] FIG. 3J A patient during non-REM sleep respiration over a period of typically about 90 seconds is shown;

[0118] FIG. 3K A polysomnogram of a patient prior to therapy is shown;

[0119] FIG. 3L Patient flow data is shown, where the patient is experiencing a series of total obstructive apneas;

[0120] FIG. 3M A scaled inspiration portion of respiration is shown, where the patient is experiencing low frequency inspiratory snoring;

[0121] FIG. 3N A scaled inspiration portion of respiration is shown, where the patient is experiencing an example of flat inspiratory flow limitation;

[0122] FIG. 3OThis shows a scaling inspiratory portion of breathing, where a patient is experiencing an example of "top flat wave" flat inspiratory flow limitation.

[0123] FIG. 3P This shows a scaling inspiratory portion of breathing, with an example of a patient experiencing “double-edge surge” inspiratory flow limitation.

[0124] FIG. 3Q This shows a scaling inspiratory portion of breathing, where a patient is experiencing an example of "rising edge surge" inspiratory flow limitation;

[0125] FIG. 3R This shows a scaling inspiratory portion of breathing, where a patient is experiencing an example of "falling edge surge" inspiratory flow limitation;

[0126] FIG. 3S This shows a scaling portion of breathing during inspiratory phase, where a patient is experiencing an example of “M-wave” inspiratory flow restriction.

[0127] FIG. 3T This shows a scaling portion of breathing during inspiratory phase, with an example of a patient experiencing severe “M-wave” inspiratory flow limitation.

[0128] FIG. 3U Patient data from patients with Cheyne-Stokes respiration are shown;

[0129] FIG. 3V Showing the use of and FIG. 3U Patient data from another example of a patient with Cheyne-Stokes respiration, using the same three channels;

[0130] FIG. 4 A flowchart outlining the steps to create a customized patient interface;

[0131] FIG. 5 , FIG. 6 and FIG. 7A to FIG. 7B This illustrates various methods for acquiring patient data;

[0132] FIG. 8A to FIG. 8B Additional methods for obtaining additional patient data related to deformity status are shown;

[0133] FIG. 8C to FIG. 8D This illustrates a method for acquiring patient data via pressure mapping;

[0134] FIG. 9A A detailed flowchart outlining the steps for acquiring and processing data for a customized patient interface;

[0135] FIG. 9B and FIG. 9C Various facial regions of interest are shown, where tissue characteristics can be useful;

[0136] FIG. 10AOne example showing a nasal mask that has been modified in response to patient feedback;

[0137] FIG. 10B One example showing differences in head shape;

[0138] FIG. 10C One example showing a system that acquires patient data and provides several mask options to the patient;

[0139] FIG. 11 One example showing a schematic of the three components of a mask;

[0140] FIG. 12A to FIG. 12F One example showing several examples of a frame and methods for forming the frame;

[0141] FIG. 13A to FIG. 13D One example showing an intermediate layer that can be attached to a frame and a sealing layer that can be attached to the intermediate layer;

[0142] FIG. 14A One example showing a cross-sectional view of a mask cushion embodiment along line 2—2 of the mask cushion of the present technology; FIG. 14B

[0143] FIG. 14B One example showing an example embodiment of a mask cushion for a nasal mask;

[0144] FIG. 14C to FIG. 14E One example showing a cross-sectional view of several embodiments of a removable mask cushion having a local chamber for a frame assembly;

[0145] FIG. 14F One example showing a cross-sectional view of further embodiments of portions or parts of a mask cushion of the present technology showing various fill materials;

[0146] FIG. 14G to FIG. 14H One example showing another embodiment of a removable mask cushion and an example frame assembly having a channel for holding the mask cushion;

[0147] FIG. 14I to FIG. 14J One example showing a cross-sectional schematic of an example mask cushion in an uncompressed state and a compressed state, respectively;

[0148] FIG. 14K to FIG. 14L One example showing a cross-sectional view of two cushions having multiple materials disposed in the inner cushion component;

[0149] FIG. 14M to FIG. 14N One example showing a cushion having multiple materials arranged in layers in the inner cushion component;

[0150] FIG. 14O One example showing a cushion having multiple materials arranged in layers in the inner cushion component and ribs for providing additional rigidity;

[0151] ​FIG. 14P Example of a cushion having multiple materials arranged in layers in an inner liner component separated by a frangible seal;

[0152] FIG. 15A to FIG. 15B Example of a headgear associated with a patient's mask shown;

[0153] FIG. 16A Example of an anchor point associated with a patient's mask shown;

[0154] FIG. 16B Example of motion transmission throughout a patient mask component shown;

[0155] FIG. 16C to FIG. 16D Example of a patient interface position relative to a patient's head in different sleep positions shown;

[0156] FIG. 16E and FIG. 16F Example of some possible facial deformations that a patient interface can compensate for shown;

[0157] FIG. 16G Top view to show the effect of applying external forces to a positioning and stabilizing structure worn by a patient;

[0158] FIG. 16H to FIG. 16J Several embodiments of positioning and stabilizing structures to compensate for skin changes shown;

[0159] FIG. 17A Example of a nare cover shown;

[0160] FIG. 17B Diagram to show the coverage of a nare cover of FIG. 17A ;

[0161] FIG. 17C to FIG. 17E Image capture and geometric modeling to form a custom nare cover shown;

[0162] FIG. 17F , FIG. 17G-1 , FIG. 17H and FIG. 17I Frame defining a plenum chamber of a nare cover shown;

[0163] FIG. 17G-2 Frustocones to approximate dead space of a plenum chamber shown;

[0164] FIG. 17J Addition of headgear to frame of FIG. 17F to FIG. 17I shown;

[0165] FIG. 17K Example of a sealing interface comprising two laminated layers shown;

[0166] FIG. 17L to FIG. 17N Manufacture and use of a sealing interface shown;

[0167] FIG. 17O to FIG. 17Q A nostril cover is shown;

[0168] FIG. 17R to FIG. 17T Use of a nostril cover is shown;

[0169] FIG. 18A to FIG. 18B Examples of manufacturing processes for different components of a patient mask are shown;

[0170] FIG. 18C to FIG. 18D Additional examples of manufacturing processes for different components of a patient mask are shown; and

[0171] FIG. 19A to FIG. 19K Numerous embodiments of customised masks are shown.

[0172] 5. Embodiments

[0173] Before this technology is further detailed, it is to be understood that this technology is not limited to particular examples described herein, which can vary. It is also to be understood that the terminology used in the 5 present disclosure is for the purpose of describing particular examples discussed herein and is not intended to be limiting.

[0174] 5.1 Treatment system

[0175] In one form, the technology comprises an apparatus or device for treating a respiratory disorder. The apparatus or device can comprise an RPT device 1500 for supplying pressurised breathing gas, such as air, to a patient 1000 via an air circuit 1600 to a patient interface 3000.

[0176] FIG. 1A A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow is shown, the patient 1000 receiving air at positive pressure from an RPT device 1500. Air from the RPT device is humidified in a humidifier 1700 and passes along an air circuit 1600 to the patient 1000. A bed partner 1100 is also shown.

[0177] FIG. 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, the patient 1000 receiving air at positive pressure from an RPT device 1500. Air from the RPT device is humidified in a humidifier 1700 and passes along an air circuit 1600 to the patient 1000.

[0178] FIG. 1C A system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask is shown, the patient 1000 receiving air at positive pressure from an RPT device 1500. Air from the RPT device is humidified in a humidifier 1700 and passes along an air circuit 1600 to the patient 1000.

[0179] In one form, the present technology comprises a method of treating a respiratory disorder, the method including the step of applying positive pressure to the entrance of the airways of a patient 1000.

[0180] In certain embodiments of the present technology, the supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0181] In certain embodiments of the present technology, breathing with the mouth is defined, limited or prevented.

[0182] 5.2 Respiratory system and facial anatomy

[0183] FIG. 2A An overview of the human respiratory system is shown, including the nasal and oral cavities, larynx, vocal folds, oesophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm.

[0184] FIG. 2B A view of the human upper airways is shown, including the nasal cavity, nasal bone, lateral nasal cartilage, alar certilage, naris, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0185] FIG. 2C A front view of a face with several identified features of surface anatomy, including the upper lip, vermilion of the upper lip, vermilion of the lower lip, lower lip, mouth width, endocanthion, alar point, nasolabial sulcus and corner of the mouth. It also indicates superior, inferior, radially inward and radially outward directions.

[0186] FIG. 2D A side view of a head with several identified features of surface anatomy, including the glabella, sellion, pronasale, subnasale, upper lip, lower lip, supramenton, nasion, alar crest, root of ear superior point and root of ear inferior point. It also indicates superior & inferior and anterior & posterior directions.

[0187] FIG. 2E A further side view of a head. It indicates the approximate location of the Frankfort horizontal and nasolabial angle. It also indicates the coronal plane.

[0188] FIG. 2F A base view of a nose with several identified features, including the nasolabial sulcus, lower lip, vermilion of the upper lip, naris, subnasale, columella, pronasale, naris principal axis and sagittal plane.

[0189] FIG. 2G A side view of surface features of a nose is shown.

[0190] FIG. 2HSubcutaneous structures of the nose are shown, including lateral cartilages, nasal septum cartilage, alar cartilages, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla and fibrofatty tissue.

[0191] FIG. 2I Medial side anatomy of the nose is shown, about a few millimeters from the sagittal plane, where the medial crura of the alar cartilages and the nasal septum cartilage are shown;

[0192] FIG. 2J Skeletal frontal view of the skull is shown, including frontal bone, nasal bone and zygomatic bone. It indicates the concha, and also the maxilla and the mandible.

[0193] FIG. 2K Lateral view of the skull is shown, with the surface contours of the head, and several muscles. It shows the following bones: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone and occipital bone. It indicates the mental protuberance. It shows the following muscles: digastric muscle, masseter muscle, sternocleidomastoid muscle and trapezius muscle.

[0194] FIG. 2L Anterolateral view of the nose is shown.

[0195] 5.3 Patient interface

[0196] FIG. 3A A patient interface according to an aspect of the present technology in the form of a nasal mask is shown. Non-invasive patient interface 3000 according to an aspect of the present technology includes the following functional aspects: a seal-forming structure 3100 (also referred to as a sealing element), a plenum chamber 3200, a positioning and stabilising structure 3300, and a connection port 3600 in one form for connection to a supply hose 1600. In some forms, a functional aspect can be provided by one or more physical components. In some forms, one physical component can provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the airways of the patient so as to facilitate the supply of air at positive pressure to the airways.

[0197] 5.3.1 Seal-forming structure 3100

[0198] In one form of the present technology, the seal-forming structure 3100 provides a seal-forming surface, and additionally provides a cushioning function.

[0199] A seal-forming structure 3100 according to the present technology can be constructed from a soft, flexible, resilient material such as silicone.

[0200] In one form, the seal-forming portion of the non-invasive patient interface 3000 includes a pair of nasal prongs or pillows, each nasal prong or pillow being constructed and arranged to form a seal with a respective naris of the patient's nose.

[0201] A nasal pillow according to an aspect of the present technology comprises: a frusto-cone that forms a seal on at least a portion of the underside of a patient's nose; a stem; a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stem. Further, the structure to which the nasal pillow of the present technology is connected comprises a flexible region adjacent to the base of the stem. The flexible regions can act in concert to facilitate a universal joint structure that accommodates relative movement (both displacement and angle) of the frusto-cone and the structure to which the nasal pillow is connected. For example, the frusto-cone can be displaced axially towards the structure to which the stem is connected.

[0202] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal on the upper lip region of the patient's face (i.e. the lip superior) in use.

[0203] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal on the chin region of the patient's face in use.

[0204] 5.3.2 Plenum chamber 3200

[0205] Preferably, the plenum chamber 3200 has a periphery that is shaped to complement the surface contours of an average human face within the region that will form a seal in use. In use, the marginal edge of the plenum chamber 3200 is positioned in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 preferably extends around the entire periphery of the plenum chamber 3200 in use.

[0206] 5.3.3 Positioning and stabilising structure 3300

[0207] Preferably, in use, the seal-forming structure 3100 of the patient interface 3000 of the present technology is held in a sealing position by the positioning and stabilising structure 3300 (often referred to as a headgear).

[0208] 5.3.4 Vent 3400

[0209] In one form, the patient interface 3000 includes a vent 3400 structured and arranged to allow the expulsion of exhaled carbon dioxide.

[0210] One form of vent 3400 according to the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes. In some examples, the vent 3400 is located in the plenum chamber 3200.

[0211] 5.3.5 Forehead support 3500

[0212] In one form, the patient interface 3000 includes a forehead support 3500.

[0213] 5.3.6 Decoupling structure(s)

[0214] In one form, the patient interface 3000 includes at least one decoupling structure, for example, a swivel 3510 or a ball joint 3520.

[0215] 5.3.7 Connection port 3600

[0216] The connection port 3600 allows connection to the air circuit 1600.

[0217] 5.3.8 Anti-asphyxia valve

[0218] In one form, the patient interface 3000 includes an anti-asphyxia valve 3800.

[0219] 5.3.9 Port

[0220] In one form of the 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 supply supplemental oxygen. In one form, this allows direct measurement of gas properties within the plenum chamber 3200, such as pressure.

[0221] 5.4 RPT device

[0222] An RPT device 40000 according to an aspect of the technology includes mechanical and pneumatic components 41000, electrical components 42000, and is configured to execute one or more algorithms 43000. The RPT device can have a housing 40100 formed in two parts, an upper part 40120 and a lower part 40140. Further, the housing 40100 can include one or more panels 40150. The RPT device 40000 includes a base 40160 which supports one or more of the internal components of the RPT device 40000. The RPT device 40000 can include a handle 40180.

[0223] The pneumatic path of the RPT device 40000 can include one or more air path items, for example, an inlet air filter 41120, an inlet muffler 41220, a pressure generator 41400 (e.g., a blower 41420) capable of supplying positive pressure gas, an outlet muffler 41240, and one or more transducers 42700, such as a pressure sensor 42720 and a flow rate sensor 42740.

[0224] One or more of the air path items can be located within a removable unitary structure referred to as a pneatics block 40200. The pneatics block 40200 can be located within the housing 40100. In one form, the pneatics block 40200 is supported by or formed as part of the base 40160.

[0225] The RPT device 40000 can have a power supply 42100, one or more input devices 42200, a central controller 42300, a therapy device controller 42400, a pressure generator 41400, one or more protection circuits 42500, a memory 42600, a transducer 42700, a data communication interface 42800, and one or more output devices 42900. The electrical components 42000 can be mounted on a single printed circuit board assembly (PCBA) 42020. In alternative forms, the RPT device 40000 can include more than one PCBA 42020.

[0226] 5.4.1 Mechanical & pneumatic components of the RPT device

[0227] The RPT device can include one or more of the following components in an integral unit. In alternative forms, one or more of the following components can be located as respective standalone units.

[0228] 5.4.1.1 Air filter(s)

[0229] An RPT device according to one form of the present technology can include one or more air filters 41100.

[0230] In one form, an inlet air filter 41120 is located at the start of the pneumatic path upstream of the pressure generator 41400. See FIG. 3C .

[0231] In one form, an outlet air filter 41140, for example an anti-bacterial filter, is located between the outlet of the pneatics block 40200 and the patient interface 3000. See FIG. 3C .

[0232] 5.4.1.2 Silencer(s)

[0233] In one form of the present technology, an inlet silencer 41220 is located in the pneumatic path upstream of the pressure generator 41400. See FIG. 3C .

[0234] In one form of the present technology, an outlet silencer 41240 is located in the pneumatic path between the pressure generator 41400 and the patient interface 3000. See FIG. 3C .

[0235] 5.4.1.3 Pressure generator 41400

[0236] In one form of the present technology, the pressure generator 41400 for generating a positive pressure flow of air or supply of air is a controllable blower 41420. For example, the blower 41420 can include a brushless DC motor 41440 having one or more impellers encased in a volute. The blower can be capable of delivering a supply of air at positive pressures ranging from about 4 cm H20 to about 20 cm H20, or in other forms up to about 30 cm H20, at rates of up to about 120 litres / minute, for example. The blower can be as described in any one of the following patents or patent applications, which are incorporated by reference herein in their entirety: US Patent No. 7,866,944; US Patent No. 8,638,014; US Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167.

[0237] The pressure generator 41400 is under the control of the therapy device controller 42400.

[0238] In other forms, the pressure generator 41400 can be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g., a compressed air reservoir), or a bellows.

[0239] 5.4.1.4 Transducer(s)

[0240] The transducer can be internal to the RPT device or external thereto. An external transducer can be located on or form part of the air circuit, for example the patient interface. The external transducer can be in the form of a non-contact sensor such as a Doppler radar motion sensor which emits or transmits data to the RPT device.

[0241] In one form of the present technology, one or more transducers 42700 are located upstream and / or downstream of the pressure generator 41400. The one or more transducers 42700 can be constructed and arranged to measure a property at a point in the pneumatic path, such as flow rate, pressure, or temperature.

[0242] In one form of the present technology, the one or more transducers 42700 can be located at a position proximate to the patient interface 3000.

[0243] In one form, the signals from the sensor 42700 can be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0244] 5.4.1.4.1 Flow rate transducer

[0245] The flow rate transducer 42740 according to the present technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION.

[0246] In one form, a signal indicative of flow rate from the flow rate transducer 42740 is received by the central controller 42300, such as the total flow rate Qt.

[0247] 5.4.1.4.2 Pressure transducer 42720

[0248] The pressure transducer 42720 according to the present technology is located at a location in fluid communication with the pneumatic path. An example of a suitable pressure transducer is a sensor from the HONEYWELL ASDX series. An alternative suitable pressure transducer is a sensor from the NPA series from GENERAL ELECTRIC.

[0249] In one form, a signal from the pressure transducer 42720 is received by the central controller 42300.

[0250] 5.4.1.4.3 Motor speed transducer

[0251] In one form of the present technology, a motor speed transducer 42760 is used to determine the rate of rotation of the motor 41440 and / or the blower 41420. The motor speed signal from the motor speed transducer 42760 can be provided to the therapy device controller 42400. The motor speed transducer 42760 can be, for example, a speed sensor such as a Hall effect sensor.

[0252] 5.4.1.5 Anti-overflow check valve

[0253] In one form of the present technology, an anti-overflow check valve is located between the humidifier 50000 and the pneumatic block 40200. The anti-overflow check valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 50000 to, for example, the motor 41440.

[0254] 5.4.1.6 Air circuit

[0255] The air circuit 41700 according to an aspect of the present technology is a conduit or tube constructed and arranged to allow, in use, a flow of air to travel between two components, such as the pneumatic block 40200 and the patient interface 3000.

[0256] In particular, the air circuit 41700 can be in fluid communication with the pneumatic block outlet and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there are separate legs of the circuit for inhalation and exhalation. In other cases, a single leg is used.

[0257] In some forms, the air circuit 41700 can comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the air temperature. The heating elements can be in the form of a heating wire circuit, and can comprise one or more transducers, such as temperature sensors. In one form, the heating wire circuit can be helically wound around the axis of the air circuit 41700. The heating elements can be in communication with a controller, such as the central controller 42300 or the humidifier controller. One example of an air circuit 41700 comprising a heating wire circuit is described in US Patent Application No. US / 2011 / 0023874, which is incorporated herein by reference in its entirety.

[0258] 5.4.1.7 Oxygen delivery

[0259] In one form of the technology, supplemental oxygen 41800 is delivered to one or more points of the pneumatic path, such as upstream of the pneumatic block 40200, to the air circuit 41700 and / or to the patient interface 3000.

[0260] 5.4.2 Electrical components of the RPT device

[0261] 5.4.2.1 Power supply

[0262] The power supply 42100 can be located internal or external to the housing 40100 of the RPT device 40000.

[0263] In one form of the technology, the power supply 42100 provides power to the RPT device 40000 only. In another form of the technology, the power supply 42100 provides power to both the RPT device 40000 and the humidifier 50000.

[0264] 5.4.2.2 Input devices

[0265] In one form of the technology, the RPT device 40000 comprises one or more input devices 42200 in the form of buttons, switches or dials to allow a human to interact with the device. The buttons, switches or dials can be physical devices or software devices accessible via a touchscreen. In one form, the buttons, switches or dials can be physically connected to the housing 40100, or in another form they can be in wireless communication with a receiver electrically connected to the central controller 42300.

[0266] In one form, the input devices 42200 can be constructed and arranged to allow a human to select values and / or menu options.

[0267] 5.4.2.3 Central controller

[0268] In one form of the technology, the central controller 42300 is one or more processors adapted to control the RPT device 40000.

[0269] Suitable processors can include x86 INTEL processors, ARM-based processors from ARM Holdings International plc, or processors based on the POWER Architecture from IBM, Motorola, or Freescale. In some alternative forms of the technology, a processor of the RISC CPU such as the STR9 series microcontroller from ST MICROELECTRONICS, or a 16-bit RISC CPU such as a processor from the MSP430 series microcontroller manufactured by TEXAS INSTRUMENTS can be suitable. In one form of the technology, the central controller 42300 is a dedicated electronic circuit.

[0270] In one form of the technology, the central controller 42300 is a dedicated integrated circuit. In other forms, the central controller 42300 comprises discrete electronic components.

[0271] In one form, the central controller 42300 is a dedicated integrated circuit. In other forms, the central controller 42300 comprises discrete electronic components.

[0272] The central controller 42300 can be configured to receive input signals from one or more transducers 42700 and one or more input devices 42200.

[0273] The central controller 42300 can be configured to provide output signal(s) to one or more of the input devices 42900, the therapy device controller 42400, the data communication interface 42800, and the humidifier controller.

[0274] In some forms of the technology, the central controller 42300 is configured to implement one or more methods described herein, such as one or more algorithms 43000 represented as computer programs stored in a non-transitory computer readable storage medium such as the memory 42600. In some forms of the technology, the central controller 42300 can be integrated with the RPT device 40000. However, in some forms of the technology, some algorithms can be performed by a remotely located device. For example, a remotely located device can determine a control setting for a ventilator or detect a breathing-related event by analyzing stored data such as from any of the sensors described herein.

[0275] 5.4.2.4 Clock

[0276] The RPT device 40000 can include a clock 42320 connected to the central controller 42300.

[0277] 5.4.2.5 Therapy device controller

[0278] In one form of the technology, the therapy device controller 42400 is a control module 43300 that forms part of the algorithm 43000 executed by the central controller 42300.

[0279] In one form of the technology, the therapy device controller 42400 is a dedicated motor control integrated circuit. For example, in one form, an MC33035 brushless DC motor controller produced by ONSEMI is used.

[0280] 5.4.2.6 Protection circuitry

[0281] One or more protection circuits 42500 according to the technology can include electrical protection circuitry, temperature and / or pressure safety circuitry.

[0282] 5.4.2.7 Memory

[0283] In one form of the technology, the RPT device 40000 includes a memory 42600, for example a non-volatile memory. In some forms, the memory 42600 can include a battery backed-up static RAM. In some forms, the memory 42600 can include a volatile RAM.

[0284] The memory 42600 can be located on the PCBA 42020. The memory 42600 can be in the form of an EEPROM or a NAND flash memory.

[0285] Additionally or alternatively, the RPT device 40000 includes a memory 42600 in removable form, for example a memory card made according to the Secure Digital (SD) standard.

[0286] In one form of the technology, the memory 42600 is used as a non-transitory computer readable storage medium on which is stored computer program instructions expressing one or more algorithms described herein, such as one or more algorithms 43000.

[0287] 5.4.2.8 Data communication system

[0288] In one form of the technology, a data communication interface 42800 is provided and is connected to the central controller 42300. The data communication interface 42800 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0289] In one form, the data communication interface 42800 is part of the central controller 42300. In other forms, the data communication interface 42800 can be separate from the central controller 42300 and can comprise an integrated circuit or processor.

[0290] In one form, the remote external communication network 4282 is the Internet. The data communication interface 42800 can connect to the Internet using wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0291] In one form, the local external communication network 4284 employs one or more communication standards, such as Bluetooth or the Consumer Infrared protocol.

[0292] In one form, the remote external device 4286 is one or more computers, e.g., a networked cluster of computers. In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessible to a suitably authorized person, such as a clinician.

[0293] The local external device 4288 can be a personal computer, mobile phone, tablet, or remote control device.

[0294] 5.4.2.9 Output devices including optional display, alarm

[0295] Output devices 42900 according to the present technology can take the form of one or more of visual, audio, and haptic units. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0296] 5.4.2.9.1 Display driver

[0297] The display driver 4292 receives as input characters, symbols, or images intended to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0298] 5.4.2.9.2 Display

[0299] The display 4294 can be configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an 8-segment display, in which case the display driver 4292 converts each character or symbol, such as the numeral "0", into 8 logic signals that indicate whether the 8 respective segments are activated to display the particular character or symbol.

[0300] 5.4.3 RPT device algorithms

[0301] 5.4.3.1 Pre-processing module

[0302] A pre-processing module 4310 in accordance with one form of the present technology receives signals as input from a transducer 42700, such as a flow rate transducer 42740 or a pressure transducer 42720, and performs one or more processing steps to calculate one or more output values that will be used as input to another module, such as a therapy engine module 43200.

[0303] In one form of the present technology, the output values include an interface or mask pressure Pm, a respiratory flow rate Qr, and a leak flow rate Ql.

[0304] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: pressure compensation 4312, vent flow rate 4314, leak flow rate 4316, and respiratory flow rate 4318.

[0305] 5.4.3.1.1 Pressure compensation

[0306] In one form of the present technology, the pressure compensation algorithm 4312 receives as input a signal indicative of the pressure in the pneumatic path proximal of the outlet of the pneumatic block. The pressure compensation algorithm 4312 estimates the pressure drop through the air circuit 41700 and provides as output an estimated pressure Pm in the patient interface 3000.

[0307] 5.4.3.1.2 Vent flow rate estimation

[0308] In one form of the present technology, the vent flow rate calculation algorithm 4314 receives as input the estimated pressure Pm in the patient interface 3000 and estimates the vent flow rate Qv of air from the vent 3400 in the patient interface 3000.

[0309] 5.4.3.1.3 Leak flow rate estimation

[0310] In one form of the present technology, the leak flow rate algorithm 4316 receives as input the total flow rate Qt and the vent flow rate Qv and provides as output a leak estimate, i.e. a leak flow rate Ql, by calculating the average of the difference between the total flow rate Qt and the vent flow rate Qv over a period of time that is sufficiently long to include several respiratory cycles, e.g. approximately 10 seconds.

[0311] In one form, the leak flow rate algorithm 4316 receives as inputs the total flow rate Qt, the vent flow rate Qv, and an estimated pressure Pm in the patient interface 3000, and provides as an output a leak flow rate Ql by calculating a leak conductance and determining the leak flow rate Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of a low pass filtered non-vent flow rate equal to the difference between the total flow rate Qt and the vent flow rate Qv, and the square root of a low pass filtered pressure Pm, where the low pass filter time constant has a value sufficiently long to include several breaths, for example about 10 seconds. The leak flow rate Ql can be calculated as the product of the leak conductance and the pressure Pm function.

[0312] 5.4.3.1.4 Breathing flow rate estimation

[0313] In one form of the present technology, the breathing flow rate algorithm 4318 receives as inputs the total flow rate Qt, the vent flow rate Qv, and the leak flow rate Ql, and estimates the breathing air flow rate Qr to the patient by subtracting the vent flow rate Qv and the leak flow rate Ql from the total flow rate Qt.

[0314] 5.4.3.2 Therapy engine module

[0315] In one form of the present technology, the therapy engine module 43200 receives as inputs one or more of the pressure Pm in the patient interface 3000 and the breathing air flow rate Qr to the patient, and provides as an output one or more therapy parameters.

[0316] In one form of the present technology, the therapy parameter is a treatment pressure Pt.

[0317] In one form of the present technology, the therapy parameter is one or more of a pressure support level and a target ventilation volume.

[0318] In various forms, the therapy engine module 432000 includes one or more of the following algorithms: phase determination 43210, waveform determination 43220, ventilation determination 43230, inspiratory flow limitation determination 43240, apnea / hypopnea determination 43250, snoring determination 43260, airway patency determination 43270, target ventilation determination 43280, and therapy parameter determination 43290.

[0319] 5.4.3.2.1 Phase determination

[0320] In one form of the present technology, the RPT device 40000 does not determine a phase.

[0321] In one form of the present technology, the phase determination algorithm 43210 receives as an input a signal indicative of the breathing flow rate Qr, and provides as an output the phase Ф of the current respiratory cycle of the patient 1000.

[0322] In some forms, known as discrete phase determination, the phase output Φ is a discrete variable. One embodiment of discrete phase determination provides a bivalued phase output Φ having values of inhalation or exhalation, for example, values of 0 turns and 0.5 turns respectively representing the onset of an autonomous inhalation and exhalation as detected. The "trigger" and "cycle" RPT devices 40000 effectively perform discrete phase determination because the trigger and cycle points are the times of phase change from exhalation to inhalation and from inhalation to exhalation respectively. In one embodiment of bivalued phase determination, the phase output Φ is determined to have a discrete value of 0 (thereby "triggering" the RPT device 40000) when the respiratory flow rate Qr has a value that exceeds a positive threshold, and the phase output Φ is determined to have a discrete value of 0.5 turns (thereby causing the RPT device 40000 to "cycle") when the respiratory flow rate Qr has a value that is more negative than a negative threshold.

[0323] Another embodiment of discrete phase determination provides a trivalued phase output Φ having values of inhalation, mid-inhalation pause, and exhalation.

[0324] In other forms, known as continuous phase determination, the phase output Φ is a continuous variable, for example, varying from 0 turns to 1 turn, or from 0 π to 2 π radians. The rate of change of the continuous-valued phase (in turns per second) with respect to time is equal to the instantaneous respiratory rate in breaths per second. An RPT device 40000 performing continuous phase determination can trigger and cycle when the continuous phase reaches 0 turns and 0.5 turns respectively. In one embodiment of continuous phase determination, a fuzzy logic analysis of the respiratory flow rate Qr is used to determine the continuous value of the phase Φ. The continuous value of the phase determined in this embodiment is often referred to as the "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules apply to the respiratory flow rate Qr:

[0325] 1. If the respiratory flow rate is 0 and rapidly increasing, then the phase is 0 turns.

[0326] 2. If the respiratory flow rate is a large positive value and stable, then the phase is 0.25 turns.

[0327] 3. If the respiratory flow rate is 0 and rapidly decreasing, then the phase is 0.5 turns.

[0328] 4. If the respiratory flow rate is a large negative value and stable, then the phase is 0.75 turns.

[0329] 5. If the respiratory flow rate is 0 and stable and the absolute value of the 5 second low pass filtered respiratory flow is large, then the phase is 0.9 turns.

[0330] 6. If the respiratory flow rate is positive and in the exhalation phase, then the phase is 0 turns.

[0331] 7. If the respiratory flow rate is negative and in the inspiration phase, the phase is 0.5 turns.

[0332] 8. If the absolute value of the 5 second low pass filtered respiratory flow rate is large, the phase is increased at a steady rate equal to the patient's respiratory rate low pass filtered with a time constant of 20 seconds.

[0333] The output of each rule can be represented as a vector, the phase of the vector is the result of the rule, and the magnitude of the vector is the degree of fuzziness for which the rule is true. The fuzzy range for respiratory flow rate being "large", "steady", etc. is determined with a suitable membership function. These rule results, represented as vectors, are then combined by some function such as, for example, taking the center combination. In this combination, the rules can be weighted equally or differently.

[0334] In another implementation of continuous phase determination independent of respiratory flow rate Qr, the phase Φ is determined as half the proportion of inspiration time Ti elapsed since the last trigger time, or as 0.5 turns plus half the proportion of expiration time Te elapsed since the last cycle time, whichever is more recent.

[0335] 5.4.3.2.2 Waveform Determination

[0336] In one form of the technology, the therapy parameter determination algorithm 43290 provides a treatment pressure that is approximately constant throughout the patient's respiratory cycle.

[0337] In other forms of the technology, the therapy parameter determination algorithm 43290 controls the pressure generator 41400 to provide a treatment parameter Pt that varies throughout the patient's respiratory cycle according to a waveform template.

[0338] In one form of the technology, the waveform determination algorithm 43220 provides a waveform template Π(Φ) that has values in the range [0, 1] over the domain of phase values Φ provided by the phase determination algorithm 43210, which are used by the therapy parameter determination algorithm 43290.

[0339] In one form, the waveform template Π(Φ) suitable for discrete or continuous value phase is a square wave template having a value of 1 for phase values up to and including 0.5 turns, and a value of 0 for phase values exceeding 0.5 turns. In one form, the waveform template Π(Φ) suitable for continuous value phase comprises two smoothly curved portions, namely, a smoothly curved (e.g., rising cosine) rise from 0 to 1 for phase values up to 0.5 turns, and a smoothly curved (e.g., exponential) decay from 0 to 1 for phase values exceeding 0.5 turns.

[0340] In some forms of the technology, the waveform determination algorithm 43220 selects a waveform template Π(Φ) from a library of waveform templates according to the settings of the RPT device. In other forms, the waveform determination algorithm 43220 instantiates a waveform template Π(Φ) from a generic waveform template using one or more parameters that depend on the current state of the patient 1000 (e.g. the time constant of the exponentially decaying portion).

[0341] The predetermined waveform templates Π(Φ) can be provided as a look-up table of values Π as a function of phase values Φ. This approach is particularly suitable when the phase determination algorithm 43210 returns discrete values of phase, such as 0 for inspiration and 0.5 for expiration. This approach can also be used when the phase determination algorithm 43210 returns a continuous value of phase Φ

[0342] 5.4.3.2.3 Determination of tidal volume

[0343] In one form of the technology, the tidal volume determination algorithm 43230 receives the respiratory flow rate Qr as an input and determines a measure indicative of the current patient tidal volume Vent.

[0344] In some embodiments, the tidal volume determination algorithm 43230 determines a measure of tidal volume Vent that is an estimate of the actual patient tidal volume. One such embodiment takes half the absolute value of the respiratory flow rate Qr, optionally filtered via a low-pass filter such as a second order Bessel low-pass filter with a corner frequency of 0.11 Hz.

[0345] In other embodiments, the tidal volume determination algorithm 43230 determines a measure of tidal volume Vent that is approximately proportional to the actual patient tidal volume. One such embodiment estimates the peak respiratory flow rate Qpeak over the inspiratory portion of the cycle. This and many other procedures involving sampling of the respiratory flow rate Qr produce measures that are approximately proportional to tidal volume, provided that the flow rate waveform shape does not vary much (in which case, the shape of two breaths is considered similar when the flow rate waveforms of the two breaths, when normalised in time and amplitude, are similar). Some simple examples include the median of the positive respiratory flow rate, the median of the absolute value of the respiratory flow rate, and the standard deviation of the flow rate. Any linear combination of arbitrary order statistics of the absolute value of the respiratory flow rate, using positive coefficients and some even using positive and negative coefficients, is approximately proportional to tidal volume. Another example is the average of the respiratory flow rate in the middle K proportion (in time) of the inspiratory portion, where 0 < K < 1. If the flow rate shape is constant, there is an infinite number of measures that are exactly proportional to tidal volume.

[0346] 5.4.3.2.4 Determination of inspiratory flow limitation

[0347] In one form of the present technology, the central controller 42300 executes one or more algorithms 43240 to detect inspiratory flow limitation.

[0348] In one form, the algorithm 43240 receives as input a respiratory flow rate signal Qr and provides as output a measure of the extent to which the inspiratory portion of the breath exhibits inspiratory flow limitation.

[0349] In one form of the present technology, the inspiratory portion of each breath is identified by a zero-crossing detector. A number of evenly spaced points (e.g. 65) representing time points are interpolated along the inspiratory flow rate-time curve of each breath by means of an interpolator. The curve described by these points is then scaled by a scaler to have unit length (duration / period) and unit area, thereby eliminating the effects of varying respiratory rate and depth. The scaled breath is then compared in a comparator to a pre-stored template representing a normal unobstructed breath, similar to FIG. 3I breaths that deviate from this template by more than a specified threshold (typically 1 scaled unit) at any time during inspiration, such as those caused by coughing, sighing, swallowing and belching, are rejected as determined by a test element. For data that is not rejected, a moving average of the first such scaled point is calculated by the central controller 42300 over previous breath events. This is repeated for the same inspiratory time for the second such point, and so on. Thus, for example, 65 scaled data points are generated by the central controller 42300 and these points represent a moving average over previous breath events, for example three events. The average moving value of the continuously updated values of these (e.g. 65) points is hereinafter referred to as the "scaled flow rate", denoted Qs(t). Alternatively, a single breath event can be employed rather than a moving average.

[0350] From the scaled flow rate two shape factors can be calculated that are relevant to determining partial obstruction.

[0351] Shape factor 1 is the ratio of the average of the middle (e.g. 32) scaled flow rate points to the average of the overall (e.g. 65) scaled flow rate points. In the case where this ratio exceeds 1, the breath will be considered normal. In the case where this ratio is 1 or less, the breath will be considered obstructed. A ratio of about 1.17 is considered to be the threshold between partially obstructed and unobstructed breaths, and it is equal to the degree of obstruction that can be tolerated in a typical patient to maintain adequate oxygenation.

[0352] Shape factor 2 is calculated as the RMS deviation from unit scaled flow rate taken over the middle (e.g. 32) points. An RMS deviation of about 0.2 units is considered normal. An RMS deviation of 0 is considered to be a fully flow-limited breath. The closer the RMS deviation is to 0, the more flow-limited the breath will be considered to be.

[0353] Shape factor 1 and shape factor 2 can be used in the alternative or in combination. In other forms of the technology, the number of sampling points, breaths, and intermediate points can be different from those described above. Furthermore, the threshold values can be different from those described.

[0354] 5.4.3.2.5 Apnea and hypopnea determination

[0355] In one form of the technology, the central controller 42300 executes one or more algorithms 43250 to determine the presence of apnea and / or hypopnea.

[0356] The one or more algorithms 43250 receive as input the respiratory flow rate signal Qr and provide as output a flag indicating that an apnea or hypopnea has been detected.

[0357] In one form, an apnea will be considered to have been detected when a function of the respiratory flow rate Qr falls below a flow rate threshold for a predetermined time. The function can determine the peak flow rate, the relatively short-term average flow rate, or the flow rate intermediate between the relatively short-term average and the peak flow rate, such as the RMS flow rate. The flow rate threshold can be a relatively long-term measure of the flow rate.

[0358] In one form, a hypopnea will be considered to have been detected when a function of the respiratory flow rate Qr falls below a second flow rate threshold for a predetermined time. The function can determine the peak flow rate, the relatively short-term average flow rate, or the flow rate intermediate between the relatively short-term average and the peak flow rate, such as the RMS flow rate. The second flow rate threshold can be a relatively long-term measure of the flow rate. The second flow rate threshold is greater than the flow rate threshold used to detect apnea.

[0359] 5.4.3.2.6 Snore determination

[0360] In one form of the technology, the central controller 42300 executes one or more algorithms 43260 for detecting snore.

[0361] In one form, the snore algorithm 43260 receives as input the respiratory flow rate signal Qr and provides as output a measure of the extent to which snore is present.

[0362] The algorithm 43260 can include a step of determining the strength of the flow rate signal in the range 30 Hz to 300 Hz. Furthermore, the algorithm 43260 can include a step of filtering the flow rate signal Qr to reduce background noise, for example, the sound of the air flow in the system from the blower.

[0363] 5.4.3.2.7 Airway patency determination

[0364] In one form of the technology, the central controller 42300 executes one or more algorithms 43270 for determining airway patency.

[0365] In one form, the airway patency algorithm 43270 receives as input the respiratory flow rate signal Qr and determines the signal power in a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak in this frequency range is taken to indicate an open airway. The absence of a peak is taken to indicate a closed airway.

[0366] In one form, the frequency range in which a peak is sought is the frequency of a small forced oscillation in the treatment pressure Pt. In one embodiment, the forced oscillation has a frequency of 2 Hz and an amplitude of approximately 1 cm H20.

[0367] In one form, the airway patency algorithm 43270 receives as input the respiratory flow rate signal Qr and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is taken to indicate a closed airway.

[0368] 5.4.3.2.8 Determination of target ventilation

[0369] In one form of the technology, the central controller 42300 receives as input a measure of the current ventilation Vent and executes one or more algorithms 43280 to determine a target value Vtgt for the measure of ventilation.

[0370] In some forms of the technology, there is no target ventilation determination algorithm 4328 and the target value Vtgt is predetermined, for example by hard coding during configuration of the RPT device 40000 or by manual input via the input device 42200.

[0371] In other forms of the technology, such as adaptive servo-ventilation (ASV), the target ventilation determination algorithm 43280 calculates the target value Vtgt from a value Vtyp indicative of a typical recent ventilation of the patient.

[0372] In certain forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as a high proportion of the typical recent ventilation Vtyp, but less than Vtyp. The high proportion in this form can be in the range of (80%, 100%) or (85%, 95%) or (87%, 92%).

[0373] In other forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as a unit multiple of the typical recent ventilation Vtyp, slightly greater than Vtyp.

[0374] The typical recent ventilation Vtyp is a measure of the tendency of the measurements of the current ventilation Vent at a plurality of times over some predetermined measure of time to cluster around a value, i.e., a measure of the tendency of the measurements of the current ventilation over a recent history to cluster. In one embodiment of the target ventilation determination algorithm 4328, the recent history is on the order of a few minutes, but in any case it should be greater than the measure of time of the tidal ramp-up and ramp-down period. The target ventilation determination algorithm 43280 can use any of a variety of known measures of tendency to determine the typical recent ventilation Vtyp from the measurements of the current ventilation Vent. One such measure is the output of a low-pass filter at the time the current ventilation Vent is measured, with a time constant equal to 100 seconds.

[0375] 5.4.3.2.9 Determination of therapy parameters

[0376] In some forms of the technology, the central controller 42300 executes one or more algorithms 43290 for determining one or more therapy parameters using values returned by one or more of the other algorithms in the therapy engine module 43200.

[0377] In one form of the technology, the therapy parameter is the instantaneous treatment pressure Pt. In one embodiment of this form, the therapy parameter determination algorithm 43290 determines the treatment pressure using the following equation:

[0378] Pt = A Π(Φ) + P0 (1)

[0379] where:

[0380] A is a pressure support;

[0381] Π(Φ) is a waveform template value at the current value of the phase Φ (in the range 0 to 1), and

[0382] P0 is a base pressure.

[0383] By determining the treatment pressure Pt using equation (1), the therapy parameter determination algorithm 43290 causes the treatment pressure Pt to oscillate in synchrony with the spontaneous breathing effort of the patient 1000. That is, based on the typical waveform template Π(Φ) described above, the therapy parameter determination algorithm 43290 increases the treatment pressure Pt at or during inspiration and decreases the treatment pressure Pt at or during expiration. The (non-negative) pressure support A is the amplitude of the oscillation.

[0384] If the waveform determination algorithm 43220 provides the waveform template Π(Φ) as a lookup table, then the therapy parameter determination algorithm 43290 applies equation (1) by locating the most recent lookup table entry to the current value of the phase Φ returned by the phase determination algorithm 4321, or by interpolating between two entries that span the current value of the phase Φ.

[0385] The values of pressure support A and base pressure P0may be set by therapy parameter determination algorithm 43290 in dependence on the selected positive pressure therapy mode in the manner described below.

[0386] 5.4.3.3 Therapy Control Module

[0387] A therapy control module 43300 according to one aspect of the technology receives as input therapy parameters from therapy parameter determination algorithm 43290 of therapy engine module 43200 and controls pressure generator 41400 to deliver a flow of air in accordance with the therapy parameters.

[0388] In one form of the technology, the therapy parameters are treatment pressure Ptand the therapy control module 43300 controls pressure generator 41400 to deliver a flow of air at a mask pressure Pmat the patient interface 3000 equal to the treatment pressure Pt.

[0389] 5.4.3.4 Fault Condition Detection

[0390] In one form of the technology, central controller 42300 implements one or more methods for detecting fault conditions. Fault conditions detected by the one or more methods can include at least one of:

[0391] Power failure (no power or insufficient power)

[0392] Converter failure detection

[0393] Failure to detect presence of component

[0394] Operation parameter outside recommended range (e.g. pressure, flow rate, temperature, PaO2)

[0395] Test alarm fails to generate a detectable alarm signal.

[0396] On detection of a fault condition, the corresponding algorithm signals the presence of a fault by one or more of:

[0397] Initiating an audible, visual and / or motion (e.g. vibration) alarm

[0398] Sending a message to an external device

[0399] Logging an event

[0400] 5.5 Humidifier

[0401] 5.5.1 Humidifier Overview

[0402] In one form of the technology, a humidifier 50000 (e.g. as shown in FIG. 3GThe humidifier 50000 is configured to alter the absolute humidity of the air or gas stream delivered to the patient relative to the surrounding air. Typically, the humidifier 50000 is used to increase the absolute humidity of the air stream and to raise the temperature of the air stream (relative to the surrounding air) prior to delivery of the air stream to the airway of the patient.

[0403] The humidifier 50000 can include a humidifier reservoir, a humidifier inlet to receive the air stream, and a humidifier outlet to deliver the humidified air stream. In certain forms, the inlet and outlet of the humidifier reservoir can be the humidifier inlet and the humidifier outlet, respectively. The humidifier 50000 can further include a humidifier base which can be adapted to receive the humidifier reservoir and include a heating element.

[0404] 5.5.2 Humidifier mechanical components

[0405] 5.5.2.1 Water reservoir

[0406] According to one arrangement, the humidifier 50000 can include a water reservoir configured to contain or hold a volume of liquid (e.g. water) to be vaporised for humidifying the air stream. The water reservoir can be configured to contain a predetermined maximum volume of water so as to provide sufficient humidification for at least the duration of a respiratory therapy session, such as a night of sleep. Typically, the water reservoir is configured to contain a few hundred millilitres of water, for example, 300 millilitres (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 50000 can be configured to receive a water supply from an external water source, such as a building's water supply system.

[0407] According to one aspect, the water reservoir is configured to increase the humidity of the air stream from the RPT device 40000 as it travels therethrough. In one form, the water reservoir can be configured to facilitate the air stream to travel through the water reservoir in a tortuous path while in contact with the volume of water therein.

[0408] According to one form, the reservoir can be removable from the humidifier 50000, for example, in a transverse direction.

[0409] The reservoir can also be configured to prevent the liquid from escaping therefrom between sub-components such as any orifices and / or the like, such as when the reservoir is displaced and / or rotated from its normal working orientation. As the air stream to be humidified by the humidifier 50000 is typically pressurised, the reservoir can also be configured to prevent loss of pneumatic pressure through leakage and / or flow impedance.

[0410] 5.5.2.2 Conductive portion

[0411] According to one arrangement, the reservoir includes a conductive portion 51200 configured to allow efficient transfer of heat from the heating element 52400 into a volume of liquid in the reservoir 51100. In one form, the conductive portion 51200 can be arranged as a plate, although other shapes can be suitable. All or part of the conductive portion 51200 can be made of a thermally conductive material, such as aluminum (e.g., approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), other thermally conductive metals, or some plastics. In some cases, suitable thermal conductivity can be achieved using a low-conductivity material with a suitable geometry.

[0412] 5.5.2.3 Humidifier Reservoir Base

[0413] In one form, the humidifier 50000 can include a humidifier reservoir base 51300 (as FIG. 3H shown) configured to receive the humidifier reservoir 51100. In some arrangements, the humidifier reservoir base 51300 can include a locking feature, such as a locking bar, configured to hold the reservoir 51100 in the reservoir base 51300.

[0414] 5.5.2.4 Water Level Indicator

[0415] The humidifier reservoir 51100 can include a water level indicator 51500, as FIG. 3G to FIG. 3H shown. In some forms, the water level indicator 51500 can provide one or more indications to a user, such as the patient 1000 or a caregiver, regarding the volume of water in the humidifier reservoir 51100. The one or more indications provided by the water level indicator 51500 can include an indication of a maximum predetermined volume of water, any portion thereof, such as 25%, 50%, or 75%, or any volume, such as 200 ml, 300 ml, or 400 ml.

[0416] 5.5.3 Humidifier Electrical & Thermal Components

[0417] The humidifier 50000 can include a number of electrical and / or thermal components, such as those listed below.

[0418] 5.5.3.1 Humidifier Transducer(s)

[0419] Instead of or in addition to the transducer 42700 described above, the humidifier 50000 can comprise one or more humidifier transducers (sensors) 52100. The humidifier transducers 52100 can comprise one or more of an air pressure sensor 52120, an air flow rate transducer 52140, a temperature sensor 52160, or a humidity sensor 52180. The humidifier transducers 52100 can generate one or more output signals which can be communicated to a controller such as the central controller 42300 and / or the humidifier controller 52500. In some forms, the humidifier sensors can be located externally of the humidifier 50000, such as in the air circuit 41700, while communicating output signals to the controller.

[0420] 5.5.3.1.1 Pressure transducer

[0421] In addition to or instead of the pressure transducer 42720 provided in the RPT device 40000, the humidifier 50000 can be provided with one or more pressure transducers 52120.

[0422] 5.5.3.1.2 Flow rate transducer

[0423] In addition to or instead of the flow rate transducer 42740 provided in the RPT device 40000, the humidifier 50000 can be provided with one or more flow rate transducers 52140.

[0424] 5.5.3.1.3 Temperature transducer

[0425] The humidifier 50000 can comprise one or more temperature transducers 52160. The one or more temperature transducers 52160 can be configured to measure one or more temperatures such as the temperature of the heating element 52400 and / or the air flow downstream of the humidifier outlet 50040. In some forms, the humidifier 50000 can further comprise a temperature sensor 5216 to detect the temperature of the ambient air.

[0426] 5.5.3.1.4 Humidity transducer

[0427] In one form, the humidifier 50000 can comprise one or more humidity sensors 52180 to detect the humidity of a gas such as the ambient air. In some forms, the humidity sensor 52180 can be placed towards the humidifier outlet 50040 to measure the humidity of the gas delivered from the humidifier 50000. The humidity sensor can be an absolute humidity sensor or a relative humidity sensor.

[0428] 5.5.3.2 Heating element

[0429] In some cases, humidifier 50000 can be provided with a heating element 52400 to provide a heat input to one or a quantity of a volume of water in humidifier reservoir 51100 and / or air flow. Heating element 52400 can include a heat-generating component, such as an electrically resistive heating track. One suitable example of a heating element 52400 is a laminar heating element, such as one described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0430] In some forms, a heating element 52400 can be provided in humidifier base 50060, where heat is supplied to humidifier reservoir 51100 primarily through electrical conduction, as shown. FIG. 3H

[0431] 5.5.3.3 Humidifier Controller

[0432] According to one arrangement of the present technology, humidifier 50000 can include a humidifier controller 52500. In one form, humidifier controller 52500 can be part of central controller 42300. In another form, humidifier controller 52500 can be a standalone controller, which can communicate with central controller 42300.

[0433] In one form, humidifier controller 52500 can receive, as input, for example, air flow, water in reservoir 51100, and / or measured characteristics of humidifier 50000, such as temperature, humidity, pressure, and / or flow rate. Humidifier controller 52500 can also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0434] The humidifier controller can include one or more controllers, such as a central humidifier controller 52510; a heated air circuit controller 52540 configured to control the temperature of heated air circuit 41710; and / or a heating element controller 52520 configured to control the temperature of heating element 52400.

[0435] 5.6 Breathing Waveform

[0436] FIG. 3I ​A typical respiratory waveform model for a human while sleeping is shown. The horizontal axis is time, and the vertical axis is respiratory flow rate. While the parameter values can vary, a typical breath can have the following approximate values: tidal volume, Vt, 0.5 L; inspiration time, Ti, 1.6 s; peak respiratory flow rate, Qpeak, 0.4 L / s; expiration time, Te, 2.4 s; peak expiratory flow rate, Qpeak, -0.5 L / s. The total duration of the breath, Ttot, is approximately 4 seconds. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM), and their ventilation, Vent, is approximately 7.5 L / min. The typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0437] FIG. 3J A patient during non-REM sleep respiration with 34 breaths over a period of typically about 90 seconds is shown, using auto-PAP therapy, and with mask pressure of about 11 cm H2O. The top channel shows blood oxygen saturation (Sp02), with a scale in the vertical direction having a range of saturation from 90% to 99%. The patient maintains a saturation of about 95% throughout the period shown. The second channel shows quantitative respiratory airflow, with a scale in the vertical direction ranging from -1 LPS to +1 LPS. Chest and abdominal motion are shown in the third and fourth channels.

[0438] FIG. 3K A polysomnogram of a patient prior to therapy is shown. There are 11 signal channels of 6 minute horizontal span from top to bottom. The first two channels are both EEG (electroencephalogram) from different scalp locations. The periodic spikes in the second EEG indicate cortical arousal and associated activity. The third channel down is submental EMG (electromyogram). The increased activity around the time of arousal indicates the recovery of the genioglossus muscle to health. The fourth & fifth channels are EOG (electrooculogram). The sixth channel is an electrocardiogram. The seventh channel shows pulse oximetry (Sp02) with repetitive desaturations from about 90% to below 70%. The eighth channel is respiratory air flow using a nasal cannula connected to a differential pressure transducer. The repetitive apneas from 25 to 35 seconds alternate with recovery breath bursts from 10 to 15 seconds, which coincide with EEG arousal and increased EMG activity. The ninth channel shows chest motion, and the tenth channel shows abdominal motion. The abdomen shows increasing motion during the length of the apnea that leads to arousal. Both become ragged during arousal due to the overall motion during the recovery breath burst. The apnea is therefore obstructive, and the case is serious. The lowest channel is posture, and in this example it shows no change

[0439] FIG. 3LPatient flow rate data is shown in which the patient is experiencing a series of complete obstructive apneas. The duration of the recording is approximately 160 seconds. The flow rate range is from approximately +1 L / s to approximately -1.5 L / s. Each apnea lasts approximately 10 to 15 seconds.

[0440] FIG. 3M A scaled inspiration portion of a breath is shown in which the patient is experiencing low frequency inspiratory snoring.

[0441] FIG. 3N A scaled inspiration portion of a breath is shown in which the patient is experiencing an example of flat inspiratory flow limitation.

[0442] FIG. 3O A scaled inspiration portion of a breath is shown in which the patient is experiencing an example of "top flat wave" flat inspiratory flow limitation.

[0443] FIG. 3P A scaled inspiration portion of a breath is shown in which the patient is experiencing an example of "double hump wave" inspiratory flow limitation.

[0444] FIG. 3Q A scaled inspiration portion of a breath is shown in which the patient is experiencing an example of "rising hump wave" inspiratory flow limitation.

[0445] FIG. 3R A scaled inspiration portion of a breath is shown in which the patient is experiencing an example of "falling hump wave" inspiratory flow limitation.

[0446] FIG. 3S A scaled inspiration portion of a breath is shown in which the patient is experiencing an example of "M-wave" inspiratory flow limitation.

[0447] FIG. 3T A scaled inspiration portion of a breath is shown in which the patient is experiencing an example of severe "M-wave" inspiratory flow limitation.

[0448] FIG. 3U Patient data from a patient with Cheyne-Stokes breathing is shown. There are three channels: oxygen saturation (Sp02); a signal indicative of flow rate; and chest movement. The data spans 6 minutes. The signal indicative of flow rate was measured using a pressure sensor connected to a nasal cannula. The patient exhibits an approximately 22 second apnea and an approximately 38 second hyperpnea. The higher frequency, low amplitude oscillations during the apnea are cardiogenic.

[0449] FIG. 3V Patient data from another example patient with Cheyne-Stokes breathing is shown using the same three channels as in FIG. 3U

[0450] 5.7 Pressure therapy modes​

[0451] In one form of the technology, various modes of respiratory pressure therapy can be implemented by the RPT device 40000 depending on the values of the parameters A and P0 in the treatment pressure equation (1) used by the therapy parameter determination algorithm 43290.

[0452] 5.7.1 CPAP therapy

[0453] In some embodiments of this form of the technology, the pressure support A is identically zero, so the treatment pressure Pt is identically equal to the base pressure P0 throughout the respiratory cycle. Such embodiments are generally grouped under the heading of CPAP therapy. In such embodiments, the therapy engine module 43200 is not required to determine the phase Φ of the waveform template Π(Φ).

[0454] In the CPAP therapy mode, the base pressure P0 can be a constant value specified or determined during titration and hard-coded or manually entered to the RPT device 40000. This alternative is sometimes referred to as constant CPAP therapy. Alternatively, the therapy parameter determination algorithm 43290 can continuously calculate the base pressure P0 as a function of an index or measure of sleep disordered breathing returned by a corresponding algorithm in the therapy engine module 43200, such as one or more of flow limitation, apneas, hypopneas, airway patency, and snoring. This alternative is sometimes referred to as APAP therapy.

[0455] FIG. 3F To illustrate the flowchart of the method 45000 by the central controller 42300, when the pressure support A is identically A, the method 45000 continuously calculates the base pressure P0 as part of the APAP therapy embodiment of the therapy parameter determination algorithm 43290.

[0456] The method 45000 starts at step 45200 in which the central controller 42300 compares the measure of apnea / hypopnea presence to a first threshold and determines whether the measure of apnea / hypopnea presence has exceeded the first threshold for a predetermined period of time, indicating the occurrence of an apnea / hypopnea. If so, the method 45000 proceeds to step 45400; otherwise, the method 45000 proceeds to step 45300. At step 45400, the central controller 423000 compares the measure of airway patency to a second threshold. If the measure of airway patency exceeds the second threshold, the detected apnea / hypopnea is deemed to be central in origin and the method 45000 proceeds to step 45600; otherwise, the apnea and / or hypopnea is deemed to be obstructive and the method 45000 proceeds to step 45500.

[0457] At step 45300, the central controller 423000 compares the measure of flow limitation to a third threshold value. If the measure of flow limitation exceeds the third threshold value, indicating that inhalation flow is limited, the method 45000 proceeds to step 45500; otherwise, the method 45000 proceeds to step 45600.

[0458] At step 45500, the central controller 423000 increases the base pressure P0 by a predetermined pressure increment AP, provided that the resulting treatment pressure Pt does not exceed a maximum treatment pressure Pmax. In one embodiment, the predetermined pressure increment AP and the maximum treatment pressure Pmax are 1 cm H2O and 25 cm H2O, respectively. In other embodiments, the pressure increment AP can be as low as 0.1 cm H2O and as high as 3 cm H2O, or as low as 0.5 cm H2O and as high as 2 cm H2O. In other embodiments, the maximum treatment pressure Pmax can be as low as 15 cm H2O and as high as 35 cm H2O, or as low as 20 cm H2O and as high as 30 cm H2O. The method 45000 then returns to step 45200.

[0459] At step 45600, the central controller 423000 decreases the base pressure P0 by an increment, provided that the decreased base pressure P0 does not fall below a minimum treatment pressure Pmin. The method 45000 then returns to step 45200. In one embodiment, the increment is proportional to the value of P0 - Pmin, such that the decrease of P0 to the minimum treatment pressure Pmin is exponential in the absence of any detected event. In one embodiment, the proportional constant is set such that the time constant τ of the exponential decrease of P0 is 60 minutes, and the minimum treatment pressure Pmin is 4 cm H2O. In other embodiments, the time constant τ can be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other embodiments, the minimum treatment pressure Pmin can be as low as 0 cm H2O and as high as 8 cm H2O, or as low as 2 cm H2O and as high as 6 cm H2O. Alternatively, the decrease of P0 can be predetermined, such that the decrease of P0 to the minimum treatment pressure Pmin is linear in the absence of any detected event.

[0460] 5.7.2 Pressure support ventilation therapy

[0461] In other embodiments of this form of the technology, the value of pressure support A in equation (1) can be positive. Such embodiments are referred to as pressure support ventilation therapy, and can be used to treat CSR. In some embodiments of pressure support ventilation therapy, referred to as servo- ventilation, therapy parameter determination algorithm 43290 takes as input the current measured value of ventilation Vent and the target value of ventilation Vtgt provided by target ventilation determination algorithm 43280, and continuously adjusts the parameters of equation (1) to bring the current measured value of ventilation Vent to the target value of ventilation Vtgt. In adaptive servo- ventilation (ASV), the target ventilation Vtgt is computed from the typical recent ventilation Vtyp, as described above.

[0462] In some forms of servo- ventilation, therapy parameter determination algorithm 43290 applies a control method to continuously compute pressure support A so as to bring the current measured Vent to the target ventilation Vtgt. One such control method is proportional-integral (PI) control. In one embodiment of PI control applicable to the ASV mode, in which the target ventilation Vtgt is set to be slightly less than the typical recent ventilation Vtyp, the pressure support is computed as:

[0463] A = G ∫ (Vent - Vtgt) dt (2)

[0464] where G is the gain of the PI control. Larger values of gain G can result in positive feedback in therapy engine module 43200. Smaller values of gain G can allow some residual untreated CSR or central sleep apnea. In some embodiments, the gain G is fixed at a predetermined value, such as 0.4 cm H20 / (L / min) / sec. Alternatively, the gain G can vary from therapy session to therapy session, starting small and increasing from session to session until a value is reached that almost eliminates CSR. In such embodiments, conventional means for retrospectively analyzing parameters of therapy sessions to assess the severity of CSR during therapy sessions can be employed.

[0465] The value of pressure support A computed via equation (2) can be limited to a range defined as [Amin, Amax]. In this embodiment, pressure support A defaults at the minimum pressure support Amin until the measured value of current measured ventilation Vent falls below the target ventilation Vtgt, at which point A begins to increase, falling back to Amin only when Vent again exceeds Vtgt.

[0466] 3 cm H2O minimum pressure support Amin is approximately 50% of the pressure support required to perform all the work of breathing of a typical patient in steady state. 12 cm H2O maximum pressure support Amax is approximately twice the pressure support required to perform all the work of breathing of a typical patient, and thus is sufficient to support their breathing in the event that the patient ceases to make any efforts, but is less than a value that would be uncomfortable or dangerous.

[0467] Other servo-ventilation control methods that can be applied by the therapy parameter determination algorithm 43290 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0468] In a pressure support ventilation therapy mode, the base pressure P0 is sometimes referred to as EPAP. The EPAP can be a constant value specified or determined during titration, and is hard-coded or manually entered to the RPT device 40000. This alternative is sometimes referred to as fixed EPAP pressure support ventilation therapy. Alternatively, the therapy parameter determination algorithm 43290 can continuously calculate the base pressure P0 as a function of an index or measure of sleep disordered breathing returned by a corresponding algorithm in the therapy engine module 43200, such as one or more of flow limitation, apnea, hypopnea, apnea-hypopnea, and snoring. This alternative is sometimes referred to as auto-EPAP pressure support ventilation therapy.

[0469] 5.8 Glossary

[0470] For the purposes of the present technology disclosure, one or more of the following definitions can apply in certain forms of the present technology. In other forms of the present technology, alternative definitions can apply.

[0471] 5.8.1 General

[0472] Air: In certain forms of the present technology, air can be taken to mean atmospheric air, while in other forms of the present technology, air can be taken to mean some other combination of breathable gases, e.g. atmospheric air enriched with oxygen.

[0473] Ambience: In certain forms of the present technology, the term ambience will be taken to mean (i) the exterior of the therapy system or patient, and (ii) the immediate surroundings of the therapy system or patient.

[0474] For example, the ambience pressure relative to a humidifier can be the pressure of the air immediately surrounding the humidifier, e.g. the pressure of the room in which the patient is sleeping. This ambience pressure can be different to the pressure outside the room in which the patient is sleeping.

[0475] In another example, the ambience pressure can be the pressure immediately surrounding or outside of the body.

[0476] In certain forms, environmental (e.g. acoustic) noise can be considered to be the background noise level in the room in which the patient is located, rather than noise generated by the RPT device, for example, or emanating from the mask or patient interface. Environmental noise can be generated by sources outside the room.

[0477] Continuous positive airway pressure (CPAP) therapy: CPAP therapy is taken to mean the supply of air to the airway entrance at a pressure that is continuously positive with respect to atmosphere. The pressure can be approximately constant through the patient’s breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detection of an indication of partial airway obstruction, and decreasing in the absence of an indication of partial airway obstruction.

[0478] Patient: a person, whether or not they suffer from a respiratory disease.

[0479] Auto-titration positive airway pressure (APAP) therapy: CPAP therapy where the treatment pressure is automatically adjusted, for example, adjusted between a minimum limit and a maximum limit with each breath, as a function of the presence or absence of indications of SDB events.

[0480] 5.8.2 Aspects of the breathing cycle

[0481] Apnoea: According to some definitions, an apnoea will be said to have occurred when the flow drops below a predetermined threshold for a duration of, for example, 10 seconds. An obstructive apnoea will be said to have occurred when some obstruction of the airway does not allow airflow despite the patient’s efforts. A central apnoea will be said to have occurred when a respiratory pause is detected due to a reduction in or absence of respiratory effort despite an unobstructed airway. A mixed apnoea occurs when a reduction in respiratory effort or absence of respiratory effort coincides with an obstructed airway.

[0482] Respiratory rate: the rate of the patient’s spontaneous breathing, usually measured in breaths per minute.

[0483] Duty cycle: the ratio of the inspiration time, Ti, to the total breath time, Ttot.

[0484] Effort (breathing): breathing effort will be taken to mean the work done by a spontaneously breathing person trying to breathe.

[0485] Exhalation portion of the breathing cycle: the period from the start of exhalation flow to the start of inhalation flow.

[0486] Flow limitation: Flow limitation will be considered to be a state of the patient's respiratory affairs in which an increase in the patient's effort does not cause a corresponding increase in the flow. Flow limitation can be described as inspiratory flow limitation in the case where it occurs during the inspiratory portion of the respiratory cycle. Flow limitation can be described as expiratory flow limitation in the case where it occurs during the expiratory portion of the respiratory cycle.

[0487] Types of flow-limited inspiratory waveforms:

[0488] (i) Flat: which has a rise, followed by a relatively flat portion, followed by a fall.

[0489] (ii) M-shaped: which has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

[0490] (iii) Leading-edge spike: which has a single local peak at the leading edge, followed by a relatively flat portion.

[0491] (iv) Trailing-edge spike: which has a relatively flat portion, followed by a single local peak at the trailing edge.

[0492] Hypopnea: Preferably, a hypopnea will be considered to be a reduction in flow, but flow is not stopped. In one form, a hypopnea will be considered to have occurred when the flow is reduced below a threshold rate for a duration. A central hypopnea will be considered to have occurred when a hypopnea is detected due to a reduction in respiratory effort. In one form for an adult, any one of the following can be considered to be a hypopnea:

[0493] (i) a 30% reduction in patient breathing for at least 10 seconds, plus an associated 4% desaturation; or

[0494] (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds, with at least a 3% associated desaturation or arousal.

[0495] Hyperpnea: An increase in flow to a level above normal flow rate.

[0496] Inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow will be considered to be the inspiratory portion of the respiratory cycle.

[0497] Patency (airway): The degree to which an airway is open, or the degree to which an airway is unobstructed. A patent airway is unobstructed. Airway patency can be quantified, for example, with a value of one (1) indicating patency, and a value of zero (0) indicating closure (obstruction).

[0498] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure in the lungs that exists at the end of expiration.

[0499] Peak flow rate (Qpeak): The maximum flow rate value during the inspiratory portion of the breath flow waveform.

[0500] Breath flow rate, air flow rate, patient air flow rate, respiratory air flow rate (Qr): These synonymous terms can be understood to refer to an estimate of the respiratory air flow rate of the RPT device, as opposed to the "true breath flow" or "true respiratory air flow" experienced by the patient, which is typically expressed in litres / minute.

[0501] Tidal volume (Vt): The amount of air inhaled or exhaled during a normal breath when no extra effort is applied.

[0502] (Inspiratory) time (Ti): The duration of the inspiratory portion of the breath flow waveform.

[0503] (Expiratory) time (Te): The duration of the expiratory portion of the breath flow waveform.

[0504] (Overall) time (Ttot): The total duration between the start of the inspiratory portion of one breath flow waveform and the start of the inspiratory portion of the next breath flow waveform.

[0505] Typical recent ventilation: The ventilation value around which the most recent values tend to cluster, i.e. a measure of the central tendency of the most recent values of ventilation.

[0506] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. This can be associated with a state of flow limitation in which the level of flow increases only slightly or can even decrease as the pressure difference across the upper airway increases (Starling resistor behaviour).

[0507] Ventilation (Vent): A measure of the total amount of gas exchanged by the respiratory system of a patient. The measurement of ventilation can include one or both of the inspiratory and expiratory flow rates per unit time. When expressed in volume / minute, this quantity is often referred to as "minute ventilation". Sometimes, minute ventilation is simply referred to as volume, with the understanding that it is volume per minute.

[0508] 5.8.3 PRT device parameters

[0509] Flow rate: Instantaneous volume (or mass) of air delivered per unit of time. While flow rate and ventilation have the same volume or mass per unit of time, flow rate is measured over a shorter time period. In some cases, a reference to flow rate will be to a scalar quantity, i.e. a quantity with only a magnitude. In other cases, a reference to flow rate will be to a vector quantity, i.e. a quantity with both a magnitude and a direction. Where it is referred to as a signed quantity, flow rate can be nominally positive for the inspiration portion of the patient's breathing cycle and therefore negative for the expiration portion of the patient's breathing cycle. Flow rate will be given the symbol Q. "Flow rate" is sometimes abbreviated to simply "flow". Total flow rate Qt is the rate of air leaving the RPT device. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow for the clearance of exhaled gases. Leak flow rate Ql is the flow rate of air leaking from the patient interface system. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0510] Leak: The word leak will be taken to mean an unintended flow of air. In one example, a leak can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak to the environment can occur in a swivel elbow.

[0511] Conducted noise (acoustics): Conducted noise in this document refers to noise brought to the patient by air through pneumatic pathways such as the air circuit and patient interface and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0512] Radiated noise (acoustics): Radiated noise in this document refers to noise brought to the patient by the ambient air. In one form, radiated noise can be quantified by measuring the sound power level / sound pressure level of the object in question according to ISO 3744.

[0513] Ventilation noise (acoustics): Ventilation noise in this document refers to noise generated by the flow of air through any vent such as a vent hole in a patient interface.

[0514] Pressure: Force per unit area. Pressure can be measured in a range of units including cm H2O, g-f / cm2, hectopascal. 1 cm H2O is equivalent to 1 g-f / cm2and is approximately 0.98 hectopascal. In this specification, pressure is given in units of cm H2O unless otherwise stated. Pressure in the patient interface is given the symbol Pm, while therapy pressure is given the symbol Pt, therapy pressure representing the target value achieved by the mask pressure Pm at the current instant.

[0515] Sound power: Energy carried by a sound wave per unit of time. Sound power is proportional to the square of the sound pressure multiplied by the area of the wave front. Sound power is typically given in decibels SWL, i.e. decibels relative to a reference power, usually taken as 10 to 12 Watts.

[0516] Sound pressure: The local deviation from ambient pressure at a given instant due to the passage of a sound wave through a medium. Sound pressure is usually given in decibels SPL, i.e., decibels relative to a reference pressure, usually taken as 20 x 10"6Pascals (Pa), which is considered the threshold of human hearing.

[0517] 5.8.4 Ventilator Terminology

[0518] Adaptive Servo Ventilation (ASV): A servo-ventilator with a variable, rather than a fixed, target ventilation. The variable target ventilation can be derived from some characteristic of the patient, such as the patient's breathing characteristics.

[0519] Backup rate: A parameter of the ventilator that establishes the minimum respiratory rate (usually breaths per minute) that the ventilator will deliver to the patient if not triggered by an autonomous breathing effort.

[0520] Cycle: The termination of the inspiratory phase of the ventilator. When the ventilator is delivering breaths to an autonomous breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to cycle to stop delivering breaths.

[0521] EPAP: The base pressure to which a pressure that varies within a breath is added to produce a desired mask pressure that the ventilator will attempt to achieve at a given time.

[0522] IPAP: The desired mask pressure that the ventilator will attempt to achieve during the inspiratory portion of a breath.

[0523] Pressure support: A number that indicates the increase in pressure during inspiration of the ventilator relative to the pressure during expiration of the ventilator, and usually means the difference in pressure between the maximum during inspiration and the minimum during expiration (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator aims to achieve, not the difference that it actually achieves.

[0524] Servo-ventilator: A ventilator that measures the patient's ventilation, has a target ventilation, and adjusts the pressure support level to bring the patient's ventilation to the target ventilation.

[0525] Spontaneous / timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath of an autonomous breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically begin the delivery of breaths.

[0526] Swing: An equivalent term for pressure support.

[0527] Trigger: When the ventilator delivers breathing air to an autonomous breathing patient, it is considered to be triggered by the patient effort at the beginning of the breathing portion of the breathing cycle.

[0528] Typical recent tidal volume: The typical recent tidal volume Vtyp is a value around which the recent measured tidal volumes tend to cluster over some predetermined measure of time. For example, a measure of the central tendency of the measured values of the tidal volumes over a recent history can be a suitable value for the typical recent tidal volume.

[0529] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0530] 5.9 Related human anatomy

[0531] 5.9.1 Facial anatomy

[0532] Ala: The outer, lateral wall or "wing" of each nostril (plural: alar)

[0533] Alar base: The most lateral point on the ala.

[0534] Alar crest (or alar crest peak) point: The last point in the curved base of each ala, found in the crease formed by the junction of the ala with the cheek.

[0535] Auricle: The entire externally visible part of the ear.

[0536] Cartilaginous skeleton of the nose: The cartilaginous skeleton of the nose includes the septal cartilage, the lateral cartilages, the major cartilages, and the minor cartilages.

[0537] Cartilaginous skeleton of the nose: The cartilaginous skeleton of the nose includes the septal cartilage, the lateral cartilages, the major cartilages, and the minor cartilages.

[0538] Columella: The skin strip separating the nostrils and extending from the tip of the nose to the upper lip.

[0539] Columellar angle: The angle between a line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfort horizontal, intersecting at the subnasal point.

[0540] Frankfort horizontal: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the depression above the tragus of the auricle.

[0541] Glabella: The most prominent point in the median sagittal plane of the forehead, located on the soft tissue.

[0542] Lateral nasal cartilage: A generally triangular cartilaginous plate. Its superior border is attached to the nasal bone and frontal process of the maxilla, and its inferior border is connected to the greater alar cartilage.

[0543] Alar cartilage: A cartilaginous plate located inferior to the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a firm fibrous membrane containing three or four alar secondary cartilages.

[0544] Nares (Nostrils): The approximately elliptical orifices that form the entrance to the nasal cavity. The singular form of the nares is naris (nostril). The nares are separated by the nasal septum.

[0545] Nasolabial sulcus or fold: The skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheeks from the upper lip.

[0546] Nasolabial angle: The angle between the columella and the upper lip, intersecting at the subnasal point.

[0547] Epiotic point: The lowest point at which the auricle attaches to the facial skin.

[0548] Infratic point: The highest point at which the auricle attaches to the facial skin.

[0549] Nasal tip point: The most protruding point or end of the nose, which can be identified in a lateral view of the rest of the head.

[0550] Philtrum: The midline groove that extends from the inferior border of the nasal septum to the vermilion of the upper lip.

[0551] Prementale point: The most forward midpoint of the chin, located on the soft tissue.

[0552] Dorsum (nasal bone): The nasal ridge is the midline protrusion of the nose, extending from the sellion to the tip of the nose.

[0553] Sagittal plane: A vertical plane that passes from front (anterior) to back (posterior), dividing the human body into right and left halves.

[0554] Sellion: The most concave point, located on the soft tissue, overlying the frontonasal suture region.

[0555] Septal cartilage (nasal bone): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0556] Alar base point: The point at the inferior border of the alar base where the alar base meets the skin of the upper (superior) lip.

[0557] Subnasale point: The point, located on the soft tissue, where the columella meets the upper lip in the median sagittal plane.

[0558] Supramentale point: The point in the midline of the lower lip with the greatest concavity between the midpoint of the lower lip and the soft tissue prementale point.

[0559] 5.9.2 Skull anatomy

[0560] Frontal bone: The frontal bone includes a large vertical part, the frontal squama, which corresponds to the area known as the forehead.

[0561] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0562] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of its lateral boundary.

[0563] Nasal bone: The nasal bone is a small, rectangular bone of varying size and form in different individuals; it is placed side by side in the middle and upper part of the face and, by its junction, forms the "bridge" of the nose.

[0564] Nasal root: The junction of the frontal bone with the two nasal bones, in the depressed area just between the eyes and above the bridge of the nose.

[0565] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes the oval foramen, the foramen magnum, through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0566] Orbit: The bony cavity in the skull that contains the eyeball.

[0567] Parietal bone: The parietal bone is the bone that, when joined together, forms the top and sides of the skull.

[0568] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0569] Zygomatic bone: The face includes two zygomatic bones, located in the upper and lateral part of the face and forming the prominence of the cheeks.

[0570] 5.9.3 Respiratory system anatomy

[0571] Diaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases, and air is drawn into the lungs. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases, and air is drawn into the lungs.

[0572] Larynx: The larynx, or voice box, covers the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

[0573] Lungs: The respiratory organs of humans. The conducting region of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes respiratory bronchioles, alveolar ducts, and alveoli.

[0574] Nasal cavity: The large air-filled space in the middle of the face above and behind the nose. The nasal cavity is divided into two parts by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal growths called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back merges into the nasopharynx through the choanae.

[0575] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity, and superior to the esophagus and larynx. The pharynx is usually divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (middle pharynx) (oral part of the pharynx), and the laryngopharynx (lower pharynx).

[0576] 5.10 General terminology

[0577] 5.10.1 Materials

[0578] Silicone or silicone elastomer: A synthetic rubber. In this specification, reference to silicone is reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of LSR that is commercially available is SILASTIC manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless specified to the contrary, the preferred form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0579] Polycarbonate: A generally transparent thermoplastic polymer of bisphenol A carbonate.

[0580] 5.10.2 Aspects of the patient interface

[0581] Anti-asphyxia valve (AAV): A component or subassembly of a mask system that opens to atmosphere in a fail-safe manner, reducing the risk of excessive C02 rebreathing by the patient.

[0582] Elbow: A conduit that directs the axis of the air flow to change direction at an angle. In one form, the angle can be about 90 degrees. In another form, the angle can be less than 90 degrees. The conduit can have an approximately circular cross-section. In another form, the conduit can have an elliptical or rectangular cross-section.

[0583] Frame: A frame will be taken to mean a mask structure that bears the tensile load between two or more connection points to a headgear. The mask frame can be a non-airtight load bearing structure in the mask. However, some forms of mask frame can also be airtight.

[0584] Headgear: Headgear will be taken to mean a form of positioning and stabilising structure designed to be used on the head. Preferably, headgear comprises a set of one or more stays, ties and stiffeners configured to position and hold a patient interface in place on a patient's face for the delivery of respiratory therapy. Some ties are formed from soft, flexible, elastic materials such as laminates of foam and fabric.

[0585] Membrane: Membrane will be taken to mean a typically thin element which preferably has substantially no resistance to bending but has resistance to stretching.

[0586] Plenum chamber: A mask plenum chamber will be taken to mean a part of a patient interface which has walls enclosing a volume which, in use, has air pressurised to above atmospheric pressure within it. A shell can form part of the walls of a mask plenum chamber.

[0587] Seal: The noun form ("seal") will be taken to mean a structure or barrier which is intended to stop the flow of air through the interface of two surfaces. The verb form ("sealing") will be taken to mean stopping the flow of air.

[0588] Shell: A shell will be taken to mean a curved two-dimensional structure which preferably has bending, tensile and compressive stiffness, for example, a part of a curved structure wall of a mask forming a mask. Preferably, it is relatively thin compared to its overall dimensions. In some forms, the shell can be multi-faceted. Preferably, such walls are air-tight, but in some forms they can not be.

[0589] Stiffener: A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0590] Stay: A stay will be taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0591] Swivel: Preferably a sub-assembly of components configured to rotate independently (noun) about a common axis, preferably at low torque. In one form, the swivel can be configured to swivel through an angle of at least 360 degrees. In another form, the swivel can be configured to swivel through an angle of less than 360 degrees. When used in the case of an air delivery conduit, the sub-assembly of components preferably comprises a pair of mating cylindrical conduits. Preferably, there is little or no leakage air flow from the swivel in use.

[0592] Tie: A tie will be taken to mean a structural component designed to be resistant to tension.

[0593] Vent: (Noun) A structure which allows air to flow intentionally from inside a mask or conduit to ambient air, for example, to allow for the clearance of exhaled gases.

[0594] 5.10.3 Terms used in association with the patient interface

[0595] Curvature (of a surface): A surface area that has a saddle shape, bending upwards in one direction and downwards in a different direction, will be considered to have negative curvature. A surface area that has a dome shape, bending in the same way in two main directions, will be considered to have positive curvature. A flat surface will be considered to have zero curvature.

[0596] Floppy: A quality of a material, structure or composite that has one or more of the following:

[0597] • easily compliant to finger pressure.

[0598] • unable to maintain its shape when supporting its own weight.

[0599] • no rigidity.

[0600] Elastically stretchable or bendable with little effort.

[0601] The quality of floppy can have an associated direction, so a particular material, structure or composite can be floppy in a first direction, but hard or rigid in a second direction, for example orthogonal to the first direction.

[0602] Elastic: Capable of substantially elastically deforming within a relatively short period of time, such as 1 second, and substantially releasing all energy upon unloading.

[0603] Rigid: Not easily deformed by finger pressure and / or tension or loads typically encountered when setting and maintaining a patient interface in a sealing relationship with an entrance of a patient's airways.

[0604] Semi-rigid: Intended to mean having sufficient rigidity to not substantially distort under mechanical forces typically exerted during positive airway pressure therapy.

[0605] 5.11 Patient interface customization

[0606] 5.11.1 Customization overview

[0607] A customized patient interface can be manufactured using rapid prototyping techniques (e.g., 3D printing). In the following embodiments, the customization can be the entire patient interface system, or can be at least one patient interface component (e.g., the seal-forming structure 3100, the frame 11001, the positioning and stabilizing structure 3300, etc.).

[0608] This customization can provide a personalized experience by forming a patient interface that specifically fits the patient. Better fit can include superior seal, more comfort during wear, and / or optimized performance, e.g., by avoiding seal breaches, compared to a conventionally mass-produced injection molded patient interface.

[0609] FIG. 4 A flowchart outlining the general steps of forming a customized patient interface. Each of these steps will be discussed in more detail below. It should be understood that not every step in the flowchart is necessary, and steps can be eliminated or repeated as desired. Additionally, certain steps indicate alternatives to one another.

[0610] The patient interface customization method 4000 generally includes the following steps: data collection 4300, data processing 4400, patient interface design 4500, and patient interface manufacturing 4600. As shown, data collection can include several data collection techniques 4301, 4302, 4303, 4304, which can be used in conjunction or as alternatives. Several outputs are generated after the various steps, including: output data package 4450, complete patient interface design package 4550, and final product 4700.

[0611] 5.11.2 Data Collection 4300

[0612] A customized patient interface is one that has been visually optimized according to the patient's preferences or geometrically optimized to fit the patient's unique facial structure or a combination of both. To form a customized patient interface for each unique individual patient, a collection of data can be collected, as shown in FIG. 4 Relaxed state data collection 4301 refers to data obtained in a relaxed, un-deformed state or data of the face such as three-dimensional data. Deformed state data collection 4302 refers to data collected from the patient's face to indicate areas of deflection under the load of a patient interface or other deflections due to different patient sleep positions (e.g., supine, lateral, prone, etc.). In addition to patient data related to geometry, pressure data can also be acquired via pressure mapping techniques 4303 to ensure proper seal of the patient interface during use. User input 4304 can also be collected, such as changes in user preferences for aesthetics, comfort, or functionality. Each of these data collection techniques is discussed in more detail independently below.

[0613] 5.11.2.1 Relaxed State Data Collection 4301

[0614] FIG. 5Various methods of acquiring patient data are shown in FIG. 7. The data collected can include facial data, head data, and / or facial bone data of the patient, and can be collected by a 3D scanner or any type of scanning device (non-contact method) or by a contact method (memory material, mechanical bar, etc.).

[0615] FIG. 5 One data collection method is shown that includes laser scanning. Generally, in this method, a 3D surface of an object is scanned using time-of-flight and triangulation methods. As shown, a laser scanning system 5000 can include a laser 5001 that directs a laser or light wave onto an object 5050 (e.g., the head of a patient). The reflected light is then collected by a lens 5002 and by a sensor 5003, which can include a position-sensing detector or a charge-coupled device. As shown, a change in distance da corresponds to a distance db at the sensor 5003. Thus, after proper calibration, the laser scanning system 5000 can be used to capture a 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) and the general shape of the head. A sample point cloud from the surface of the subject’s face and head can then be created, which can be reconstructed to regenerate the relevant 3D surface (e.g., a surface representing the patient’s forehead). In some examples, the patient can use the laser scanning system 5000 and access the laser scanner at a sleep clinic, pharmacy, or other location, and the collected data can be passed to a patient interface designer or patient interface manufacturer. FIG. 5

[0616] FIG. 6 Another data collection method is shown that includes passive stereophotogrammetry. In this method, multiple linked cameras 6001, 6002 capture multiple still images of a subject 6050 and estimate the three-dimensional coordinates of points on the object. The estimated coordinates can be determined by measurements made in two or more photographic images taken from different positions of the cameras 6001, 6002. Common points can then be identified on each image, and lines of sight (or rays) can be constructed from the camera positions to the points on the object. The intersection of these rays (triangulation) can help determine the three-dimensional position of the points. Thus, key features on the image are determined, and a 3D point cloud can be generated on a display 6003. In use, a patient 6050 can take multiple photographs or segments of video of their head and face (nose, cheeks, mouth, eyes, teeth, ears, etc.) from different angles. These images are then processed to generate a 3D model of the patient’s head and face. In some forms, one or more “targets” of predetermined shape or pattern can be used as a reference for the photogrammetry system, for example, by temporarily placing them on the patient while the measurements are being taken.

[0617] ​Another method of data collection can include white light interferometry, also known as white light scanning. In this method, white light is projected onto the surface of the object to be measured, such as a face. A measurement of the resulting interference pattern is obtained by a measurement system, such as a camera, and processed to obtain a three-dimensional profile of the object, such as the head and face of a patient.

[0618] In some examples, remote data collection is possible. For example, the patient 6050 can take a photograph of himself and send a hard copy and / or soft copy to the designer and / or manufacturer for processing. With proper calibration, the resolution and accuracy of this method is sufficient for designing a custom fit patient interface. Thus, a quick and efficient collection from the patient 6050 via passive stereophotogrammetry is possible.

[0619] Additionally, existing technology can be used to provide proper calibration. For example, certain entertainment systems, such as the Xbox Kinect, include the ability to use this technology to take precise facial scans without further calibration. Thus, software can be provided to enable a patient to plug and play the Xbox Kinect into their computer or other processor, follow simple steps to take a scan, and then send the software to the designer and / or manufacturer for further analysis and design.

[0620] The previous two methods can be classified as non-contact measurement methods. Contact methods can also be used for data collection, either alone or in combination with non-contact methods. A contact method of data collection can involve physically placing the patient's face against a device that plastically deforms to capture the surface. The type of data collected can be a cloud of point data sets.

[0621] FIG. 7A One example of a contact or haptic data collection system 7000 for data collection is shown. The data collection system 7000 can include a fine rod 7001 similar to a mechanical pin map. The rod 7001 can be coupled to a linear encoder and / or force sensor 7002 capable of measuring the distance each rod 7001 travels and passing the collected data to a processor 7003. Also, the encoder or force sensor 7002 can be capable of measuring the resistance to motion of the rod 7001. Variations are possible, including replacing the rod 7001 with a deformable or deflectable fabric. In further examples, the rod 7001 can be configured to measure the pressure applied between the rod 7001 and the face. Further, the rod 7001 can be configured to deform according to the force or pressure between the rod 7001 and the face.

[0622] In one form, the rods 7001 can be biased towards the surface of the patient's face, for example, by springs. The bias can assist in maintaining engagement between the patient's face and the rods 7001, while preferably the force of the bias is small enough that it does not affect the measurements. For example, the bias force can be set such that it is typically overcome after the face is deflected by the rods 7001 by 0.1 mm. In one form, the bias force of each rod 7001 can be approximately 0.5 N, however, the bias force can be varied to suit the particular data collection system 7000, such as the density of the rods 7001, the diameter of each rod 7001, or the shape of each rod 7001.

[0623] The resistance to movement of the rods 7001 can assist in determining whether the shape of the face is "relaxed" or "deformed". That is, a high resistance can indicate that a point on the face has reached a deformed state, while a low resistance can indicate a relaxed state. The resistance information can assist in predicting the thickness of the underlying soft tissue and / or the maximum surface deflection in that region. This gives the ability to characterise the properties of the soft tissue, and thus can be an input value for customising the production of a patient interface. Additionally, the rods 7001 can be controlled to resist plastic deformation by mechanical and electrical methods. Mechanical methods can include increasing and decreasing the friction experienced on the rods 7001 via contact or encasing the rods as they move in a viscous fluid. Electrical methods can include software controlling a magnetic field or piezoelectric material that resists movement of the metal rods. Conversely, the force of the rods 7001 can be supplied and controlled such that when the rods 7001 are placed on the face, the rods 7001 deform the surface of the face, and thus data of the deformed state can be collected.

[0624] The rods 7001 can additionally or alternatively characterise the mechanical properties of the patient's face, such as the modulus of elasticity. For example, the rods 7001 can measure the force (or pressure) between the rods 7001 and the face, and the magnitude of the deflection of the face in the direction of travel of the rods 7001. Using this method, the rods 7001 can characterise the modulus of the face in the direction of travel of the rods 7001, which can not be a constant value. For example, the modulus of elasticity of the face at zero deformation can be different to the case where the face has been depressed by 1 mm by the rods 7001, and again different to the case where the face has been depressed by 2 mm by the rods 7001. In some forms, a set of relationships (e.g. functions, tables, or curves) can be generated using the above method to characterise the potentially non-linear modulus of the face in one or more directions as required. Such a set of relationships can then be used to model the behaviour of the face under load (e.g. using finite element modelling software), as will be described in further detail below.

[0625] Each stem 7001 can include a shape configured to accurately measure a feature of a patient's face as needed, while not being so uncomfortable that the patient can forego use of the patient end of the data collection system 7000. In one form, the patient end of the stem 7001 can include a dome shape or a flat disc shape. The force or pressure measured by each stem 7001 can vary depending on the particular shape of the patient end of the stem 7001. For example, in the case of using a dome shape, when the stem 7001 comes into contact with the patient's face, the area of contact with the face (contact area) will effectively be a very small point at the top of the dome. As the stem 7001 continues to travel and deform the surface of the face, the size of the contact area can increase until the entire surface of the dome is in contact with the face. Conversely, in the case of using a flat shape (e.g., a disc), any curvature present on the patient's face can result in a point contact.

[0626] Preferably, the shape of the patient end of the stem 7001 (e.g., the curvature and radius in the case of a dome, or the radius if a flat disc) is such that the size of the contact area is known or can be determined, so that any effects due to changes in the size of the contact area can be accounted for.

[0627] In some cases, it can be desirable to simplify the plurality of stems 7001, for example to reduce the cost of producing the data collection system 7000. In one example, the stems 7001 can be placed in an array with varying density to reduce the number thereof. The data collection system 7000 can include a higher density of stems 7001 where a higher resolution of measurements to be obtained is required, such as in areas of the face where the curvature is expected to be greater than other areas. For example, the stems 7001 can be placed in a higher density in areas of the data collection system 7000 to be placed on the patient's cheek, and the stems 7001 can be placed in a lower density around areas of the data collection system 7000 to be placed on the patient's upper lip.

[0628] In one form, the data collection system 7000 can be arranged to characterize the face and head in a single direction, such as by arranging the stems 7001 in a single direction. However, in other forms, the stems 7001 can be arranged in the data collection system 7000 in varying directions to characterize the face and head in multiple directions, such as in the expected direction of engagement between the face and the patient interface cushion in each area. For example, the direction of the stems 7001 around areas of the data collection system 7000 for the patient's lower cheek can be different than the direction of the stems 7001 for the patient's upper cheek or nasal bridge. In some forms, the data collection system 7000 can include a plurality of stems 7001 configured to characterize the same area of the face in different directions. For example, one stem 7001 can characterize the modulus along an anterior / posterior direction, while another stem 7001 characterizes the modulus in the same location along a left / right direction.

[0629] In one example, the supplied resistance can mimic the patient interface contact pressure and CPAP pressure (e.g., 2 cm H2O to 40 cm H2O) within the patient interface. Therefore, the deformation state of the patient's face and head can also be captured. Furthermore, by characterizing the behavior of the face and head under deformation under load (i.e., pressure / force), customization of the patient interface can allow for variations in the pressure supplied within the patient interface. In some cases, measurements of the patient's face or head can be performed prior to titration to determine the appropriate therapeutic pressure (or pressure range). In such cases, characterization of the face and head (e.g., elastic modulus) within a certain range of conditions (e.g., degree of deformation) better allows for the creation of an appropriately customized patient interface when titrating the patient. Non-contact methods can be performed in sleep clinics or pharmacies. Alternatively, the device can be transported to the patient to collect data and returned to the designer after use.

[0630] Additional medical imaging techniques can also be used to capture 3D images of the patient's facial and head structures. These medical imaging techniques may include, but are not limited to, CT scans, ultrasound, and MRI. Therefore, the same set of images already generated during diagnosis can be used to calculate and provide a 3D surface model of the patient's head and face (nose, cheeks, mouth, eyes, teeth, ears, etc.). This approach can also include the added benefit of capturing not only the surface but also the underlying soft tissue and bone structures, which can be used to further improve the design of the patient interface.

[0631] like FIG. 7B As shown, another embodiment of data collection involves casting or forming a mold of the patient's face 7050 to capture their individual facial features as an imprint within the casting material. This embodiment may use casting materials such as plaster, thermosetting plastics, or room temperature vulcanizing silicone resins. The casting material 7060 may initially be malleable, allowing it to be applied to the patient's face 7050 to form an imprint, and then cured to permanently store the individual facial geometry of the patient's face in the mold 7065. The process of casting the patient's face to form the mold 7065 is considered a preliminary process.

[0632] Once the mold 7065 of the patient's face 7050 has been formed, it is scanned using either the non-contact method or the contact method described previously. If the non-contact method is used, a digital image of the patient's face 7050 from the mold 7065 is captured and recorded using the scanner 7070. Alternatively, the mold 7065 can be used directly in the patient interface manufacturing process as a means of transferring / molding the unique facial features to aspects of the patient interface design. The mold 7065 can be assembled with other tools 7075 used to form common components of the patient interface to give a customized nature to a new or existing patient interface design. A portion of the mold 7065 can be extracted or cut from the overall face mold, for example, the portion corresponding to the patient's nose. This portion is then placed in the tool used to manufacture the customized patient interface.

[0633] 5.11.2.2 Strain state data collection 4302

[0634] As discussed above with reference to the contact or haptics imaging system, in some cases, the same method or technique as the relaxed state data collection can be used to perform the strain state data collection 4302. The facial straining device 8001 can be used to collect data for the strain state data collection 4302. The force applied to the face can be adjustable.

[0635] The method includes placing a rigid or semi-rigid straining device 8001 on the patient's skin 8050 which mimics the straining of the facial surface during CPAP therapy at a given headgear tension and CPAP pressure. Once the straining device 8001 is worn, the surface is captured using any of the methods described above for relaxed state data collection. Optionally, the straining device 8001 can be constructed of a transparent material to allow a visual surface capture method (illustratively shown by camera 8002) to capture the "strained" surface of the patient's face.

[0636] The straining device 8001 can further include a material that is easily identifiable on medical images or contrasts with human tissue (e.g., radiopaque material). Thus, on medical images, the boundary between the skin and the device can be quickly identified and the strained 3D surface on the patient's skin can be calculated. The straining device 8001 can be available at the sleep clinic or sent out to the patient to collect data and return the device.

[0637] The straining device 8001 can include materials ranging from rigid materials to silicone soft cushions. The stiffness of the material can vary over a range of different grades to simulate the patient interface on the patient at headgear forces of 1 N to 10 N and also at CPAP pressures between 5 cm H20 to 45 cm H20 (optimally 10 cm H20 to 20 cm H20).

[0638] As FIG. 8BAs shown in the example in FIG. 8, the deformation device 8010 can be in the form of a pusher or deflector designed to push onto the face at a predetermined location (e.g., the nasal bridge 8051) to deform the skin surface to mimic the patient interface and / or air pressure. Once the deflector is on the face, the deformed surface 8055 is captured using any of the methods described above for relaxed state data collection.

[0639] A patient intended to wear a custom patient interface will likely lie down in a supine position to wear the patient interface. Given that the effect of gravity on the face varies depending on the alignment of the face with the universal force of gravity, it can be desirable to indicate the geometry of the facial surface in the supine position. This can be achieved by scanning the patient while lying down using any of the techniques described. Alternatively, the expected geometry of the face can be determined by applying an algorithm to an upright scan of the patient’s face, which can take into account factors such as the patient’s age, gender, BMI, ethnicity, and / or other factors that affect the expected size of passive facial movements. This predictive algorithm can be performed using physiological modeling software such as ANSYS, as will be described in greater detail below.

[0640] 5.11.2.3 Pressure mapping 4303

[0641] The pressure of the patient interface seal-forming structure 3100 on the patient can also be measured via pressure mapping 4303 for optimal fit and comfort. In one example, a patient interface blank or virtual patient interface 8020 is worn, and a tactile pressure film sensor 8021 is disposed between the virtual patient interface 8020 and the patient’s skin 8050. The pressure film 8021 can be a universal shape that fits a given patient population (e.g., adults, children, ethnicity, etc.). The film 8021 can measure a grid of pressure values experienced on the patient’s face when the virtual patient interface 8020 is worn. To ensure a sufficient seal around the perimeter of the patient interface, pressure values within a predetermined range can be prescribed. The data captured in this process can include the known geometry of the virtual patient interface 8020 and the grid of pressure measurements on the patient contact surface. Such data can be sent to a computer with a processor 8022 and can be used to generate a chart, table, or graph from the pressure values collected from this technique, such as a pressure map 8030.

[0642] In some examples, the virtual patient interface 8020 can include a population-based universal nasal patient interface shape, making it relatively easy to form a seal on the patient. The virtual patient interface 8020 can further have a soft cushion to mimic a real patient interface on the face. In some examples, the soft cushion can include silicone, foam, gel, and other suitable materials.

[0643] User preferences and inputs can also be collected at user input 4304. This can include various data related to form, function, aesthetics, comfort, or other preferences, and will be discussed in further detail below after processing data from relaxed state data collection 4301, deformation state data collection 4302, and pressure mapping 4303.

[0644] 5.11.3 Data Processing 4400

[0645] Prior to manufacturing a patient interface for the patient, the collected patient data from step 4300 can be transformed or processed in a data processing step 4400. Without data processing 4400, a mirror image of the scanned face (surface topography) can be used to form a patient interface. However, this patient interface can not be ideal, as certain areas of the sealing region on the face can require different levels of sealing force, or be more sensitive to tight headgear pressure, or be more likely to leak in that location due to complex facial geometry. These finer details related to performance and comfort are taken into account in data processing 4400.

[0646] FIG. 9A Detailed flowcharts of data collection 4300, data processing 4400, and output data package 4450 of the patient interface customization method 4000.

[0647] In one example, relaxed state geometry data from relaxed state data collection 4301 can be used to attempt and provide an indication of the deformation state geometry if it cannot be directly measured or is not available. Simulation software can be used in relaxed data post-processing 4401 to simulate the deformation state. An example of suitable simulation software can include, but is not limited to, ANSYS, which performs the transformation from “relaxed” to “deformation” state geometry data in relaxed data post-processing step 4401.

[0648] Using the “relaxed” and “deformation” state geometry data, when the pressure experienced is simulated 4402, finite element software such as ANSYS can be used to calculate approximate pressure values experienced between the patient interface contact region and the patient face. Alternatively, pressure data can be collected separately via pressure mapping 4303, as discussed above. Thus, the deformed geometry and the pressure experienced can be estimated from relaxed state data collection 4301, and the system is able to provide a customized patient interface even if one or more of the data collection steps are not available.

[0649] Using the measured data, geometric or pressure data, regions, or features on a patient's face requiring special consideration can be identified and addressed in specific feature processing 4403. Optionally, data from any combination of measurement sources can provide a comprehensive model including geometric and pressure datasets to further achieve the goals of providing design comfort, effectiveness, and compliance.

[0650] Furthermore, to enhance user experience and increase patient interaction, the patient interface customization method 4000 proposes a platform through which users have design inputs leading to the final product. The system can provide user inputs ranging from secondary to primary design controls, with or without design inputs from designers and / or manufacturers, including but not limited to aesthetic, mechanical considerations, therapy-dependent variables, comfort, and sealing features. This data is collected in data input 4304 and processed in patient preferences 4404 within the application data processing 4400.

[0651] 5.11.3.1 Post-processing of relaxation data 4401

[0652] The face is not a static surface. Instead, it adapts to and modulates its interaction with external conditions, such as forces from the patient interface, air pressure on the face, and gravity. Taking these interactions into account provides additional benefits in providing optimal seal and comfort to the patient. Three examples illustrate this process.

[0653] First, since patients wearing these patient interfaces will experience CPAP pressure, this knowledge can be used to improve the comfort and seal of the patient interfaces. Simulation software, along with known characteristics (e.g., soft tissue properties or elastic modulus), can help predict the deformation of the facial surface that will occur within the patient interface under specific air pressures.

[0654] For groups associated with any of the following facial locations, tissue characteristics may be known and collected: glabella, glabella, nasal root, nasal tip, philtrum, upper lip margin, lower lip margin, chin-lip fold, chin protuberance, chin, frontal protuberance, supraorbital, glabellar side, nasal side, infraorbital, lower zygomatic bone, nasal side, nasolabial ridge, maxilla, mandible, mental tubercle sinus, mid-lateral orbit, superior glabella, zygomatic bone, lateral aspect, superior-M2, masseter muscle, occlusal line, inferior-M2, angle of mandible, and mid-mandibular angle.

[0655] FIG. 9B An exemplary embodiment is shown, wherein the soft tissue thickness is known from an anthropometric database for at least one of the following locations for the patient 9000: nasal root 9003, nasal tip 9004, philtrum 9005, chin-lip fold 9008, chin protuberance 9009, infraorbital region 9015, lower zygomatic bone 9016, lateral nasal cavity 9017, nasolabial ridge 9018, maxilla 9019, mandible 9020. FIG. 9BAs shown, certain locations such as infraorbital 9015, subcondylar 9016, alar 9017, nasolabial crease 9018, maxilla 9019, and mandible 9020 are disposed on both sides of the face (e.g., infraorbital 9015 has a mirrored location on the opposite side of the face across the nose).

[0656] Known tissue properties at any one or more of these locations can include any one or more of: soft tissue thickness, modulus data based on force, deflection, modulus, and thickness, soft tissue thickness ratio information, and body mass index (BMI).

[0657] Second, the skin surface on the patient's face is significantly deformed when the CPAP patient interface is strapped on the face. Using initial 3D measurements of the geometry of the head and face in a relaxed state, the knowledge of the skin / soft tissue properties discussed above, and simulation software can be used to predict the changes in the surface. This technique can be an iterative optimization process in conjunction with the design process.

[0658] Third, the skin surface can move due to gravity, taking into account the patient's sleep position. By utilizing the knowledge of the skin and soft tissue properties, and simulation software to predict these changes, it can help to design a patient interface that is more robustly comfortable and high performing in various sleep positions. As FIG. 9C As shown, data related to upright to supine geometry changes can be collected and used from one or more regions of interest such as nasal root 9003, nasal tip 9004, philtrum 9005, chin-labial crease 9008, infraorbital 9015, alar 9017, nasolabial crease 9018, maxilla 9019, and mandible 9020.

[0659] 5.11.3.2 Simulated experienced pressure 4402

[0660] Finite element analysis (FEA) software, such as ANSYS, can be used to calculate approximate pressure values experienced between the patient interface contact areas and the patient’s face. In one form, inputs can include the geometry of the face in the “relaxed” and “deformed” states, features of the face at its various locations (e.g., measured modulus of elasticity, or substructures with known characteristics such as stiffness). Using such inputs, a finite element (FE) model of the face can be constructed, and then the model can be used to predict one or more responses of the face to inputs such as deformations or loads. For example, the FE model of the face can be used to predict the deformed shape of the face for a given pressure level in the patient interface (e.g., 15 cm H2O). In some forms, the FE model can further include a patient interface model or a portion thereof such as a cushion, including the geometry of the cushion and its features (e.g., mechanical properties such as modulus of elasticity). Such a model can predict the deformation of the cushion when an internal load is applied to the cushion, such as from the application of CPAP pressure, and the resulting interaction of the cushion with the face, including the loads / pressures therebetween and the deformation of the face. In particular, the pressure experienced at a given point (e.g., at the cheekbone) can be predicted using the change in distance at each point between the relaxed state and the deformed state, and the corresponding tissue properties.

[0661] 5.11.3.3 Special feature processing 4403

[0662] Certain areas or features on the patient’s face can require special consideration. Identifying and adjusting these features can improve the overall comfort of the patient interface. Suitable features can be applied to the custom patient interface according to the data collection and estimation techniques discussed above.

[0663] In particular, different areas on the face can have different requirements. The following table lists one example of areas of interest:

[0664] Region on face Pressure sensitivity Pressure compliance Shear sensitivity Shear compliance Nose bridge High Low High Medium Nose side High Low Not applicable Medium Nose corner (upper cheek) Medium Medium Not applicable High Mouth side Low High Not applicable High Lower nose corner Low / Medium Medium Not applicable Medium Lower lip Low / Medium Low Not applicable High Upper lip High Low / Medium Not applicable Medium

[0665] In addition to the pressure sensitivity, pressure compliance, shear sensitivity, and shear compliance indicators described above, special consideration can be given to facial hair, hairstyle, and extreme facial landmarks such as a prominent nasal bridge, sunken cheeks, etc. As used herein, “shear sensitivity” refers to the patient’s sensitivity to shear, and “shear compliance” refers to how willing the patient’s skin is to follow or conform to shear.

[0666] 5.11.3.4 Apply patient preferences 4404

[0667] In addition to areas of interest, collaboration between the user and the designer can provide a more enjoyable experience and better patient interface for the patient’s needs. This patient input can be applied in apply patient preferences 4404.

[0668] In one example, an online portal is created to allow the patient to participate in the design process. To provide the best comfort and performance for a custom patient interface, it is advantageous to create a dialogue between the patient, designer, and / or manufacturer. One option is to create an environment in which the patient can provide input to their patient interface design, and the designer and / or manufacturer can also provide suggestions via the online portal.

[0669] Within the online portal or smartphone application, the patient can create their own personal online profile in which they can perform various tasks such as tracking therapy progress, uploading 3D data, or designing a custom patient interface through aesthetic and / or functional features. In some examples, aesthetic input can include selecting colors, schemes, and / or patterns to be presented on their patient interface system. The user can also upload patterns or colors to their patient interface, select material finishes (e.g., contact, frame, or headgear materials) for comfort, touch, or temperature preferences, and / or select between various headgear styles. In some examples, functional input can include headgear elasticity (e.g., stretch strength characteristics), patient interface type (e.g., full face, nasal, etc.), headgear attachment points (e.g., number of desired points, tradeoff between stability and bulk, or attachment type such as magnets), patient interface volume (bulk vs. breathing comfort), additional sensors in the patient interface, elbow / rotary piece selection, vent location and direction, whether the user wears glasses, skin type such as oily or dry. The user can also order a patient interface or other products and participate in social networking forums in which patients can share their CPAP experience or patient interface design.

[0670] FIG. 10A One example of a nasal patient interface 10000 that has been adjusted to accommodate patient inputs 10010, 10020, 10030 is shown. In response to a first input 10010 regarding glasses, a corresponding padding 10012 is added in the desired location. In response to a second input 10020 regarding gel addition, a corresponding gel portion 10022 is added proximate the nares. In response to a third input 10030 regarding a beard, a beard patch 10032 is added to increase comfort. Thus, these additional patient-specific criteria are taken into account when designing and manufacturing the patient interface.

[0671] Information can flow between the patient and the designer in two ways. That is, in addition to patient input, the designer can suggest certain features to the patient. For example, the designer can provide the patient with a range of product options and recommendations. This recommendation can be based on queries to the patient, device usage data such as data related to leaks, usage time, or data from collected data (e.g., geometric surfaces or pressure maps) such as skin tone and color to generate an aesthetically pleasing patient interface, patient interface size and type according to head shape, and / or headgear structure. The type and orientation of elbow / tube and recommendations communicated to the patient regarding the same can also be considered.

[0672] Thus, the designer and / or manufacturer can recommend different headgear for FIG. 10B patient 10100 and patient 10200 based on their differences in head shape to increase the stability of the patient interface. Additionally, a particular headgear that can not be suitable for patient 10200 can be indicated as a poor choice due to, for example, anticipated discomfort.

[0673] The proposed system can also provide a feedback tool by which a person can see their custom design placed on a 3D rendering of their face to form FIG. 10C a virtual rehearsal as shown. Thus, in one example, the head 10300 of a patient is scanned and the data is sent to a virtual portal 1400 where the data is rendered on a plurality of patient interfaces 10401. The user can select a particular type of patient interface or headgear type, as well as adjust a plurality of parameters such as style, color, etc. Then, upon completion, the patient can print a picture of the design rendered on the face (or just the design) and send the selected design for further processing and / or manufacturing.

[0674] 5.11.4 Output Data Package 4450

[0675] As used herein, "data package" refers to a data package used as input for the process of designing a patient interface. Within the data package are several subsets of data, including data that has been captured at patient data collection 4300, enhanced versions of the data after specific feature processing 4403 and user input 4304.

[0676] These data packages contain all of the input information needed for the design of a patient interface in patient interface design 4500. Patient interface design 4500 can include an algorithm that takes the data packages as input to create a custom patient interface design that is directly responsive to the information within the data packages. Alternatively, the data packages can be used directly by a designer to create a custom patient interface design, which is a highly labor intensive but completely manual approach. If desired, the data packages can be stored for future use. Two data packages have been briefly discussed. These data packages include a geometric surface model design package 4451 and a pressure map design package 4452.

[0677] 5.11.4.1 3D geometric surface model design package 4451

[0678] The three-dimensional geometric surface model design package 4451 can be comprised of a 3D geometric surface model of the patient's face and head after the capture data has been processed in data processing 4400. In addition to this 3D model, the package can also contain patient preferences and inputs that they have specified.

[0679] 5.11.4.2 Pressure map design package 4452

[0680] The pressure map design package 4452 can include a pressure map of the patient's face after the capture data has been processed in data processing 4400. In addition to this pressure map, the package can also contain patient preferences and inputs that they have specified.

[0681] 5.11.5 Patient interface design 4500

[0682] Patient interface design 4500 can include a system of algorithms that processes the data packages 4451, 4452. Patient interface design 4500 acts as an intelligent system that is responsive to the input as data packages and calculates an output as a custom patient interface design based on that particular data package. Thus, patient interface design 4500 will take an incoming data package and use the data (3D geometric surface and / or 2D pressure map) as well as patient preference inputs and calculate at least one custom component.

[0683] FIG. 11 A schematic view of the basic elements of a patient interface 11000 is shown. The basic patient interface structure 11000 can be divided into three main sections, each of which can be standardized or customized individually, simultaneously, or in any combination as desired. As shown, the patient interface structure 11000 includes a frame 11001, a mid-structure 11002, and a sealing element 11003.

[0684] Frame 11001 is generally considered to be the component that provides the offset distance from the patient's face and the associated functional dead space; it is also the component most likely to form a pneumatic connection with the flow source. Intermediate structure 11002 has several functions. First, intermediate structure 11002 facilitates the offset of frame 11001 from the face. It also provides a method for attaching frame 11001 and sealing element 11003. It can provide a geometric transition between a standardized frame and a customized sealing element 11003, and vice versa. Intermediate structure 11002 can also be customized through geometry or material properties to provide improved user comfort / treatment effectiveness. Sealing element 11003 consists of a geometry designed as an elastomer to achieve a seal (e.g., a membrane, similar to current patient interface designs) or a material with appropriate properties to achieve a seal, such as a soft elastomer, foam, gel, textile, and / or adhesive / glue material.

[0685] 5.11.5.1 Framework Customization

[0686] To enhance functionality and comfort, the 11001 framework can be customized in various ways. (Refer to...) FIG. 12A to FIG. 12C Three such methods are described. However, it should be understood that customization is not limited to these three examples, and variations of each example are possible.

[0687] In the first example ( FIG. 12A In this process, a patient's face 12050 is scanned using any of the techniques discussed in the data collection 4300 above. The algorithm can then offset and trim surfaces, such as, for example, the unsealed surface of the patient's face 12050, to produce a patient interface frame 12010, which is a transformed copy of the patient's face, offset by a predetermined offset value O1. In some examples, the offset value O1 is between approximately 0 mm and approximately 20.0 mm. In at least some other examples, the offset value O1 is between approximately 5.0 mm and approximately 10.0 mm. The offset value O1 can vary around the face or be constant. Thus, in some examples, a constant offset value O1 of 5.0 mm is applied to each point of the patient interface. Alternatively, the offset value O1 can be varied, such that an initial offset value O1 of 5.0 mm is applied near the nose, and a different offset value O1 of 6.0 mm is applied near the cheekbone. In this example, functional dead space and ventilation flow requirements can be controlled (e.g., functional dead space and ventilation flow requirements can be reduced or increased). The resulting patient interface can also be manufactured compactly to limit visual obstruction. The contact pressure can be evenly distributed, and stability can be increased. Headband tension can also be reduced in this way. The increased contact area can also improve the seal, as will be discussed in more detail below.

[0688] If the offset value Oi is set to 0 mm, the frame 12010 of the patient interface can be in full contact with the patient's skin. In this contact, to increase comfort, the patient interface can be integrally formed from one piece. By this, the frame 12010 can be made from a soft or elastic material, unlike a "traditional" frame. In this example, the nostril or nose hole can act as a fixation point.

[0689] In a second example ( FIG. 12B ), the patient's face 12050 is scanned and an algorithm copies and offsets the relevant surfaces to form a custom frame assembly 12020 shaped in the sagittal plane that blends these surfaces into a standardized cushion interface surface. This technique can reduce functional dead space and ventilation flow requirements. The resulting patient interface can also be manufactured to be compact, limiting visual obstruction. This example can also provide a more standardized lock / key interface between the frame 12020 and the corresponding intermediate structure or sealing element 11003, resulting in improved manufacturing economy, as only certain inserts need to be customized as opposed to customizing the entire device.

[0690] In a third example ( FIG. 12C ), the patient's face 12050 is scanned and an algorithm copies and offsets the relevant surfaces to form a custom frame assembly 12030 shaped in the coronal plane that blends these surfaces into a standardized tube / elbow attachment point. This technique can distribute contact pressure evenly, increase stability, reduce headgear tension and allow for standardization similar to frame 12020. Thus, the frame 12030 can provide a lock / key interface to various elbow / short tube interfaces, or use an existing elbow array (e.g., select one of three or more elbows). If desired, custom elbows can also be formed.

[0691] Existing frame / headgear combinations can also be used without customization. In these examples, the intermediate structure and / or sealing element 11003 can be customized and coupled to a standardized frame or array of standardized frames. In the following examples, a smaller component is customized, resulting in a lower price and improved manufacturability.

[0692] As FIG. 12D to FIG. 12F shown, the user is presented with three standardized frames 12040, 12041, 12042. Based on the data collection 4300, the algorithm can decide which standardized frame 12040, 12041, 12042 is best suited for the patient. Then, a custom intermediate structure and / or sealing element 11003 can be formed separately and configured to interlock with the standardized frame. The appropriate frame can be selected based on the face size, and the appropriate frame can include a keyed interlocking system 12060 for mating with other custom components 12070 of the patient interface.

[0693] 5.11.5.2 Intermediate structure customization

[0694] Like the frame, the intermediate structure 11002 can also be standardized or customized. To achieve optimal comfort and sealing, the intermediate structure can be customized according to patient data to provide macro- and / or micro-adjustment to the patient. As used herein, micro-adjustment is a relatively small adjustment by a sealing surface or material to accommodate deformations less than or equal to 2 mm. An example of an intermediate structure 11002 capable of performing this function is one made of foam or soft durometer silicone. Additionally, macro-adjustment is a relatively larger adjustment by a sealing surface or other patient interface component to accommodate deformations greater than 2 mm. An example of an intermediate structure 11002 capable of performing this function is a higher durometer silicone (or thicker) or foam displacement. Thus, in one example FIG. 13A ) the intermediate structure 13010 can include two components that are adjustable for macro- and / or micro-adjustment. The first component 13012 can be formed of a rigid or semi-rigid material to provide proper macro-adjustment. In some examples, the material of the first component 13012 can include plastic, thermoset or thermoplastic elastomers, or any other suitable polymer, or combinations thereof. For finer adjustment (e.g., micro-adjustment), a second component 13014 can be manufactured and coupled to the first component 13012 to form a soft and compliant surface. The material for the second component 13014 can include silicone, foam, soft thermoplastic elastomers, tacky silicone, fabric, or suitable combinations thereof. When the patient 13050 wears a patient interface having an intermediate structure 13010 with two components 13012, 13014 that are adjusted for proper macro- and micro-adjustment, superior comfort and sealing are possible.

[0695] A customized intermediate structure 13010 can provide optimal sealing around the patient interface, increased patient comfort, and evenly distributed contact pressure. Additionally, different portions of the intermediate structure can be selected for materials as needed. For example, the nasal bridge region can include a softer grade of silicone, foam, or thermoplastic elastomer than other regions, which include a single grade of silicone or other harder materials. Patient preferences can also be included in the material selection. Thus, materials can be selected to relieve pressure points, provide better sealing, and increase comfort and / or stability.

[0696] The intermediate structure 13010 can also act as a custom component for securing the frame and the sealing element together. Additional benefits include the ability to provide a smooth transition from a custom frame assembly to a standard sealing element, and vice versa; enhance aesthetics; and allow decoupling of components for replacement of at least one component. Predetermined locking / geometry can further be used to prevent components from being accidentally coupled to inappropriate components of other devices or competitor products with incompatible functionality.

[0697] As FIG. 13B shown, a given intermediate structure 13010 can be coupled to more than one size and / or shape of frame 13040, 13042. In at least some examples, a single intermediate structure can be coupled to a class of frames in various sizes, shapes, and / or variations. Thus, the intermediate structure 13010 can act as an adapter for custom sealing components. Using this capability, a patient can retain a patient interface while correspondingly improving the seal and / or comfort.

[0698] 5.11.5.3 Sealing Element Customization

[0699] A third component that can be customized is the sealing element 13510, which can provide superior sealing and comfort through customization. Reference is made to FIG. 11 and user input to briefly discuss one example of this customization. By selecting and placing appropriate materials at predetermined locations, optimal comfort and sealing can be achieved. For example, for the nasal bridge region, a softer grade of silicone, foam, or soft thermoplastic elastomer can be used. The selection of materials can also be based on patient preference and can include silicone gaskets, foam, fabric, textiles, tacky silicone, thermoplastic elastomers, gel, polyurethane, and other suitable polymers, as well as combinations of any of these materials. With appropriate material selection, relief of pressure points can be achieved. Furthermore, pressure and shear sensitive areas on the patient’s skin (e.g., facial hair, scars, etc.) can also be adequately addressed. In some examples, the appropriate material can be flexible to help improve the patient interface’s interaction with the face at the circumferential level.

[0700] The geometry of the sealing element 13510 can be customized to match the patient data collected to achieve comfort and sealing. Such geometric modifications can affect the macrofit and microfit of the device. To provide adequate sealing, three-dimensional geometric data and two-dimensional pressure data of the patient’s face 13550 can determine the sealing element 13510 FIG. 13Cgeometry of the seal element 13510. For example, the thickness of the seal element 13510 can be based in part on the two-dimensional pressure map or the deformed three-dimensional surface data. By analyzing both the relaxed surface data (e.g., shown in solid lines) and the deformed three-dimensional surface data (e.g., shown in dashed lines) as well as the pressure map, an improved seal element 13510 can be customized for the patient 13550. Thus, the seal element 13510 can be modified to the shape of the seal element 13511 in view of the deformed three-dimensional surface data or the pressure map.

[0701] Additionally, the sealing surface area (the total area of the patient interface contact on the patient's skin) can be selected from the range of 1 cm 2 to 30 cm 2 to improve patient interface sealing or distribute contact pressure for better comfort. FIG. 13D Two possible patient interfaces 13500, 13502 for the patient 13550 are shown, each having a seal element 13520, 13522. The seal element 13520 can provide a sealing area of approximately 15 cm 2 while the seal element 13522 can provide a sealing area of approximately 7 cm 2 To achieve proper sealing of the patient interface, there must exist a continuous line within the contact area where the sealing force in units of grams per square centimeter exceeds the air pressure in the patient interface. This condition can be met in many portions of the contact area, but there must exist a continuous line where this condition is met. By analyzing the pressure data and the relaxed / deformed state, an appropriate sealing area can be selected to provide adequate sealing while reducing unnecessary volume of the patient interface 3000.

[0702] The thickness and material of the seal element 13510 can contribute to patient interface comfort. In some examples, the thickness of the seal element 13510 can be in the range of 0 mm to 50 mm to match the patient's comfort preference. Thus, the optimal seal element 13510 will effectively distribute contact pressure, provide optimal sealing based on the sealing surface area, improve the stability of the patient interface 3000 with respect to facial structure and / or sleep position, and enhance comfort and sealing based on any of the techniques discussed herein.

[0703] 5.11.5.3.1 Cushion Filler

[0704] In embodiments having a cushion, the cushion can include a filler to provide a patient mask with comfortable fit and effective sealing for therapy with a respiratory therapy device. In typical embodiments (e.g., as shown in FIG. 14A to FIG. 14BIn the illustrated embodiment, the mask cushion 14102 can employ an inner cushion component 14104. An outer barrier layer 14106, which can optionally be a film, can be applied to the inner cushion to form a chamber 14108 or cell relative to the inner cushion component 14104. The chamber can optionally be flexible. The outer barrier layer 14106 and the chamber 14108 can act as the patient contact side of the mask cushion 14102 relative to the inner cushion component. Thus, in some embodiments, the inner properties of the cushion component can be located more distally relative to the point of contact of the mask with the patient's face when compared to the more proximal outer properties of the barrier layer or barrier layer film that can at least partially contact the facial features of the patient. Further, the inner cushion component can be completely or partially encased by the outer barrier layer. In this case, the chamber can be a chamber formed by the outer barrier layer and the inner cushion component. Additionally, it should be appreciated that one or more of the components can be omitted. For example, the chamber 14108 and / or the outer barrier layer 14106 can be omitted, resulting in the inner cushion component 14104 being in direct contact with the skin.

[0705] Generally, the inner cushion component can be soft and / or elastic, while the outer barrier layer can be a pliable and / or elastic layer of natural or synthetic material. However, in some embodiments, it can be formed at least partially of a rigid or semi-rigid material. Optionally, the inner cushion component can act as at least partial padding for the outer barrier layer.

[0706] In some embodiments, each barrier layer or film can be formed of silicone, polyurethane, and / or polyethylene. The barrier layer can even be formed of a viscoelastic material. The pliable and / or elastic properties of either or both of the components and / or films of the mask cushion can be used to provide the chamber with flexible characteristics. In some embodiments, the barrier layer can be thin, such as in the range of approximately 0.2 millimeters to 5 millimeters. Preferably, the barrier layer can be approximately 0.2 millimeters to 0.6 millimeters. However, in some embodiments, it can even exceed this range, and can also be pliable enough to allow for sealing with the specific areas or contours of the patient's face, allowing for a comfortable and effective seal, while also maintaining the internal substances of the chamber.

[0707] Further, an outer barrier layer can be used to retain a chamber material 14110, such as a gas or liquid, within a chamber between the inner liner component and the outer barrier layer or outer barrier film or within an area substantially confined by the barrier layer. The chamber material can fill or only partially fill the chamber according to the desired response characteristics of the mask liner. Preferably, the chamber material can move, flow, permeate, or otherwise deform within the chamber in response to patient contact pressure exerted on the flexible or elastic component of the liner, such as the outer barrier layer or outer barrier film. For example, an outer layer liquid can reside and flow within the chamber formed between the outer barrier layer and the inner liner component. Thus, in some embodiments, the structure and flexibility provided by the inner liner component enables the mask to conform to the macro facial features of the patient (e.g., nose and / or mouth) with this liner component, while the outer layer of the chamber can accommodate the micro facial topography. Similarly, depending on the selected viscosity or deformability of the chamber material of the chamber, the outer barrier layer can respond more quickly than the inner liner with respect to changes in facial contours resulting from motion during use (e.g., facial expressions) in order to maintain a more effective seal against respiratory therapy leaks.

[0708] As FIG. 14C and FIG. 14D embodiments show, the outer barrier layer 14106 can form a chamber that can surround the perimeter of the inner liner component 14104 (shown as line P) in addition to extending along the length of the inner liner component (shown as line L). However, the chamber and inner liner can be formed in various configurations. The chamber can be formed from one or more discrete units, each unit containing the same chamber material or different chamber materials according to the desired flexibility achieved by different segments or units of the chamber. FIG. 14C to FIG. 14E Cross-sectional schematic views show additional example embodiments, which illustrate various chamber configurations.

[0709] In FIG. 14C , the chamber 14108 extends along a portion of the perimeter of the inner liner component 14104. In this example, the chamber 14108 extends substantially along the bounds of the inner side wall portion (shown as “ISW” in FIG. 14C and FIG. 14D ) of the mask liner and along the bounds of the facial contact top side portion (shown as “FCS” in FIG. 14C and FIG. 14D ) rather than substantially along the outer side wall portion (shown as “ESW” in FIG. 14C and FIG. 14D ). In FIG. 14C , the chamber 14108 extends substantially along the bounds of the facial contact top side portion of the mask liner rather than substantially along either of the inner side wall portion or the outer side wall portion. In FIG. 14EIn the example, the chamber is formed along a portion of the face contact top side of the mask liner to form a chamber wing F that can be flexible. Although FIG. 14E The wing portion F is shown extending from the face-contact top side portion near the outer wall portion, but alternative or additional wing portions (not shown) may optionally extend from the face-contact top side portion near the inner wall portion. Optionally, although each of these embodiments is generally shown as a substantially continuous closed chamber, in some embodiments, the inner wall portion, outer wall portion, and face-contact top side portion may each be formed from discrete units of the chamber, and may be adjacent to one or more other discrete units of the chamber.

[0710] Advantageously, when used as a liner in a breathing mask, different materials or material properties of the liner components can be combined to produce synergistic performance. Therefore, as... FIG. 14F As shown, the liner component in any of the embodiments can be a soft, elastic foam 14560, such as open-cell or closed-cell foam. The component can optionally be formed from polyether, urethane, or other elastomers 14562. It can also be formed from gel 14566 or from this gel having bubbles, beads, pellets, polyester, and / or foam balls 14564. In this case, the beads, pellets, and / or foam balls can be soft and / or flexible. Optionally, such beads, pellets, and / or foam balls can be in a liquid or any other liner component or chamber material. The liner component can even be formed from open-cell foam impregnated or soaked in gel. By way of further examples, the liner component can be formed from a three-dimensional spacer fabric, such as in a matrix structure or other three-dimensional structure or pattern.

[0711] One or more of the benefits discussed herein can be achieved when the chamber material is a flowable substance or other material with sufficiently low viscosity to facilitate its movement throughout the chamber. For example, the material can be a gas such as air or a liquid such as water, a liquid gel, a saline solution, or oil. The material can also be sterile. With such low viscosity, the chamber material 14110 can not only move through the chamber but can also optionally flow to permeate through or within the material or structure of the liner component. Thus, in some embodiments, the chamber material can impregnate or move through the porous or open structure of the liner component to the extent that portion of the liner component is encapsulated or retained within the encapsulation of the chamber. This permeation of fluid within, for example, a foam liner component can provide a liner with a greater density than in the absence of fluid, and it can then provide a different sensation to the patient upon contact or under pressure.

[0712] You can refer to this. FIG. 14I and FIG. 14JConsider an example of migration of a chamber material, such as a fluid or gas, between the chamber and the inner cushion component. In this example, the mask cushion 14102 has a chamber material 14110 within the chamber 14108, which is represented by the "+" signs in these figures. When an external force FC, such as the patient contact on the outer barrier 14106 as shown FIG. 14J When the mask cushion is compressed, the chamber material 14110 can flow (indicated by the arrows of FIG. 14J ) across the boundary between the inner cushion 14104 and the chamber 14108. Thus, under load, the material of the outer chamber 10 can migrate to the inner cushion component or its orifices at a rate that is essentially viscoelastic. Then, release of the load or force FC can allow the mask cushion 14102 to return to its uncompressed state as shown FIG. 14I . In this case, the chamber material 14110 can return to the chamber 14108 upon withdrawal of the force FC.

[0713] However, in some embodiments, such as the cushion shown FIG. 14F , can include an optional inner barrier film 14512 to block or prevent the chamber material from permeating through or within the material or structure of the inner cushion component. In this way, the inner barrier film can encapsulate the inner cushion component on the inside and prevent material from accumulating between the chamber and the inner cushion component. Thus, the inner and outer barrier films can act as a double-sealed bladder for the chamber material to separate the chamber from the inner cushion component. Thus, for example, different viscosities of gel can be used for the inner cushion component and the chamber material. For example, a gel with a higher viscosity can be used for the material of the inner cushion component (within the inner barrier film), while a lower viscosity gel can be used for the chamber material in the chamber. Similarly, the flow of a fluid such as water in the chamber can be prevented from mixing with, for example, a gel inner cushion component and the inner barrier film therebetween. By way of further example, by preventing the permeation of a fluid such as water within, for example, a foam inner cushion component, a lighter feel can be provided for the patient using the mask cushion. Further, by varying the ratio of the amount of foam of the inner cushion component to the amount of liquid in the chamber, the firmness or comfort of the mask cushion as perceived by the patient can be adjusted. Similarly, by otherwise varying the degree of flexibility or pliability of the inner cushion component relative to the flexibility or pliability of the chamber and / or outer barrier, unique mask performance qualities can be provided.

[0714] As FIG. 14FFurther shown, components of the mask cushion of the present technology can include a unitary or separate mask interconnect component 14516 that can optionally be adhered to another portion of the mask cushion with adhesive 14518 or other fastening compounds or components. The mask interconnect component can act as an attachment device to join the cushion with a mask frame for a mask assembly. In this example, the mask interconnect component 14516 includes an optional clip 14520 for temporarily affixing the interconnect component to a mask frame. The mask interconnect component 14516 can also act as a cap to assist in retaining the chamber material within the outer barrier film. Thus, the interconnect component can be adhered together with the outer barrier film. If implemented in this embodiment, it can also optionally be adhered to the inner cushion component and the inner barrier film.

[0715] In FIG. 14G to FIG. 14H Further implementations of a removable mask cushion 14102 for a mask frame 14690 are shown in the embodiments of FIGS. 15A and 15B. In this version, the flexible nature of the material used for the cap portion 14672 of the inner cushion component 14104 allows the cap portion 14672 of the inner cushion component to act as an interconnect to the mask frame. In this example, the mask frame includes a channel 14692 sized to fit with the cap portion. As FIG. 14H shown, the mask cushion can then be pushed into fit or otherwise inserted into and retained by the channel 14692. The compression fit created by the ridge 14694 of the channel 14692, along with the flexibility of the cap portion 14672, the outer barrier film, and / or the inner cushion component create a pressure seal to prevent leakage of therapeutic gas pressure between the mask frame and the mask cushion when gas is supplied to the mask via a gas port 14696 of the mask frame.

[0716] 5.11.5.3.2 Customized gel cushions

[0717] The filler composition itself can be selected based on the patient data collected, such as for insertion into the previously described chamber, or one or more compartments of the cushion, or the bladder of the mask cushion, to optimize comfort and / or performance. Such compositions can include the use of one or more gels or other flowable materials. Different types of gels or materials provide different structural properties when disposed in the cushion, allowing for customization for each patient.

[0718] In one example (see FIG. 14K and FIG. 14L), the face mask cushion 14102 can employ an inner cushion component 14104 and an outer barrier 14106 applied to the inner cushion to form a chamber 14108 or cell relative to the inner cushion component 14104. The properties of the cushion 14102 can be varied by, for example, tailoring the amount, shape, alignment, and / or other properties (e.g., thickness, shape, flexibility, directional bend) of each material added to each compartment and its configuration in the inner cushion component 14104. Thus, in FIG. 14K In the example shown, a first layer 14802, a second layer 14804, and a third layer 14806 are stacked in the inner cushion component 14104. As shown, each of the layers contains a different material. Further, while three layers of three materials are shown, any number of layers or materials can be used, and variations are possible, as will be described in more detail below. In this example, the three layers contain three different materials. However, one or more of the layers can contain the same material as another layer. It should be understood that references to different "materials" in this document are not limited to materials having varying chemical compositions. For example, references to different materials can include the use of one substance (e.g., a single chemical compound of a mixture) in different configurations to achieve different material properties (e.g., for the various layers described above). For example, changes in material properties can be caused by varying the density of a compressible substance, or by varying the porosity of a foam-like substance, effectively creating different "materials."

[0719] The materials disposed in the layers 14802, 14804, 14806 can be flowable, such as silicone or gel having different properties, such as, for example, gels having different hardness or porosity. Having materials with different properties can allow for the use of layers of flowable material having different shapes and thicknesses formed in the inner cushion component 14104 to achieve desired properties of the cushion 14102. In some cases, different types of materials can be used in a single cushion (e.g., a cushion can include both gel and pre-determined grade silicone). In at least some examples, the layers use different grades of silicone. Further, a porous foam-like silicone can be used, in which case the porosity / density of the foam can be varied to adjust the resulting mechanical properties of the substance in the layer, and thus the cushion itself. Additionally, "hollow" layers (e.g., air layers or other suitable gas layers) can be used. In cases where compressible materials are used, the pressure at which the material is contained (e.g., in the inner cushion component 14104) can be varied to change the resulting properties.

[0720] In some cases, the foamed silicone resin can be produced by a chemical reaction that generates gaseous byproducts. The manufacturing process for the patient interface (or liner component 14104) can be configured such that the gaseous byproducts can be directed to a predetermined location within the patient interface, or retained in a chamber from which the gaseous byproducts may have been generated. At least some of the hollow layers can be configured to receive the gaseous byproducts to fill the hollow layers and / or pressurize them. Alternatively or additionally, the gaseous byproducts can be used to pressurize any chamber containing the foamed silicone resin from which the gaseous byproducts have been generated. In some cases, the patient interface (or liner component 14104) can be oriented such that a predetermined target location of the gaseous byproducts is above the source of the gaseous byproducts, allowing the gaseous byproducts to rise to said target location.

[0721] Other suitable materials for placement in the liner component 14104 may be configured to sense and respond to external variables, such as temperature. For example, the liner component 14104 may include a layer configured to change color according to temperature (i.e., thermochromic). This layer may provide a visual feedback mechanism for the patient (or clinician) to determine where the liner component 14104 can make close contact with the face.

[0722] Layering of each material can be achieved by sequentially providing materials and / or changing the amount of each material introduced to form each layer. The shape and structure of each layer can also be achieved by using compartments of different sizes in the inner liner component 14104 to inject materials (see, for example...). FIG. 14A to FIG. 14C Alternatively, the orientation of the liner 14102 can be altered during material injection. Each layer can be clearly distinguished from the others, for example, by applying different colors to each layer, thus providing designers with visual confirmation of the layers. This also provides users with customized visual confirmation of the layers used in the mask and allows for improved feedback on obtaining data for the next iteration of the mask. For example, a patient might simply say that the “red” component is too rigid, allowing designers to quickly identify the problem and provide possible solutions. Additionally, by coloring the material or layers, aesthetics can be improved or customized to meet the patient's needs. In some cases, such as according to the patient's preference, one or more layers may contain one or more fragrances for layer identification. Furthermore, one or more layers may include medications that can be configured to be released, such as for absorption through the skin or for inhalation via the airway.

[0723] Thus, the number of layers and materials can be selected for a patient, as well as the shape and relative position of the selected layers. Using information from the data phone 4300, a first cushion for patient A can be manufactured, with material X injected into the first compartment, and material Y injected into the second compartment (or as first and second layers in one compartment, respectively). For a second patient, patient B, data collection can show that material Y is preferably injected into the first compartment, and material Z is injected into the second compartment (or as first and second layers in one compartment, respectively).

[0724] It will be appreciated that the layers or compartments need not have the same size or shape. For example, in a cross-section of the cushion 14102, the layer 14802 is larger than the layer 14804, and substantially the same size as the layer 14806. However, the shape of the three layers 14802, 14804, 14806 is completely different. For a different patient, the same cushion 14102 and the same materials can be selected, but the size and shape of the layers can be varied as shown in FIG. 14K FIG. 14L In this example, the layer 14806 is smallest, and the layer 14804 is largest. Thus, by varying the size and shape of the layers or compartments, greater or lesser rigidity can be achieved at different locations.

[0725] One or more of the compartments can be configured to be customizable on an ongoing basis. For example, one or more of the compartments can include a port through which a flowable material can be introduced or removed. In particular, it can be advantageous to include a port that communicates with a chamber to be placed on a relatively sensitive area of a patient's face (e.g., the nasal bones or the upper lip). Thus, for example, if a patient finds that a "standard" configuration of a patient interface purchased for a lady patient exerts too much pressure on the patient's nasal bones, the patient can remove a portion of the flowable material in the appropriate chamber through the port.

[0726] FIG. 14M and FIG. 14N One example of a layered gel cushion 14102 is shown. In this example, the layers have been arranged in a vertical direction, such that the properties of the cushion can vary in a vertical direction from a bottom end 14902 of the cushion 14102 (e.g., proximal to the user's mouth) to a top end 14904 of the cushion 14102 (e.g., proximal to the user's nasal bridge). Thus, near the bottom end 14902, a first layer 14912 formed of a first gel, for example, is used, followed by a second layer 14914 formed of a second gel, a third layer 14916 formed of silicone, and a fourth "hollow" layer 14918 having air disposed therein.

[0727] ​As briefly discussed, the number of layers used can vary such that any number of layers from one layer to any number of layers can be used. If a single layer is used, it is still possible to customize the patient interface for each patient by varying the type of flowable material introduced into the shell or the amount of flowable material introduced. Relatedly, using this process, the stiffness of the selected portions of the cushion 14102 can also vary at each point or different regions (e.g., via varying the wall thickness or wall material properties such as the modulus of elasticity) as the cushion 14102 is able to flex outward as the material is loaded into the inner cushion component 14104. Thus, a first amount of material can be loaded into the cushion 14102 in a first region, while a second amount of material (or an entire second material) can be loaded into the cushion 14102 in a second region, thereby changing the amount of flexing of the cushion that occurs in the second region as compared to the flexing that occurs in the first region. For example, the second region of the cushion can include a reduced outer wall thickness as compared to the first region, thereby causing the second region to assume a more flexed shape. This also allows for the production of customized cushions using standard tools. Additionally, it should be appreciated that while the cushion 14102 is shown as being symmetrical, it need not be so in practice.

[0728] In some cases, the inner cushion component 14104 can be configured such that its stiffness can vary, such as for customization. In one form, the inner cushion component 14104 can initially be configured to be relatively flexible such that it can be placed on a patient's face to deform according to the patient's face and then "set" to a higher stiffness. For example, the inner cushion component 14104 can include a plurality of chambers that are not in fluid communication with one another (see FIG. 14P ), and configured to be relatively flexible such that it can deform when placed on a patient's face. The plurality of chambers can contain a flowable material that will increase in stiffness when mixed with one another. The plurality of chambers can be separated at least in part by one or more frangible seals 14922 that are configured to be broken by the patient, such as by flexing of the inner cushion component 14104, and / or by applying a force to a tab 14924 that is connected to any of the frangible seals 14922. The tab can be in the form of a plate that protrudes from an outer surface of the cushion. In one form, the tab can be connected to the inner cushion component 14104 by a perforation such that it can be removed therefrom. In this arrangement, the inner cushion component 14104 can be configured such that the application of a force to remove the tab can also break the frangible seal 14922.

[0729] In addition, the inner cushion component 14104 can be configured so that the patient has sufficient time to begin the reaction to increase the rigidity of the inner cushion component 14104 and place the inner cushion component on the face before permanent setting occurs. In other cases, the inner cushion component 14104 can be configured to have a short setting reaction time so that the reaction to increase its rigidity can begin as soon as the inner cushion component is placed on the patient's face.

[0730] The inner cushion component 14104 can include a repositionable material to allow multiple transitions between the set and flexible configurations. In one form, the inner cushion component 14104 can include a thermoplastic material that can be flexible when heated to allow the patient to place it on their face. Advantageously, the use of a repositionable material can allow the patient to reconfigure the patient interface according to any changes in the shape of their face, or to allow for any mistakes (e.g., discarding the inner cushion component 14104, or incorrect placement) that occur during the setting process.

[0731] In yet another example, the inner cushion component 14104 can include a material that can be "set" to a higher rigidity in some portions. For example, the inner cushion component 14104 can include a photopolymer liquid that can set (i.e., cure) when exposed to ultraviolet light. In this form, the patient can place the inner cushion component 14104 on their face and subject the inner cushion component 14104 to ultraviolet light to cure. Additionally or alternatively, the patient can subject only the portions of the inner cushion component 14104 that are desired to cure to ultraviolet light. In some examples, a laser can be used as the source of ultraviolet light in order to accurately and precisely cure the desired areas while allowing other areas to remain flowable.

[0732] In addition to varying the number of layers and the number or amount of material used in each layer, the cushion 14102 itself can be modified in several ways to improve customization. For example, the cushion 14102 can be formed in a number of standard sizes (e.g., small, medium, large, extra large) or can include inner cushion components 14104 having different sizes. Additionally, the cushion 14102 itself can be formed from materials or constructions that vary in rigidity and / or size to accept a certain amount of material within specific areas of the inner cushion component 14104. Thus, the range of the cushion 14102 can vary from substantially rigid when no material is disposed therein to a thin membrane having substantially no structural rigidity in at least some directions, to instead serving as a receptacle that accepts material, such as a gel, therein, where the gel then provides the rigidity. Additional structural elements can also be added to the cushion 14102 to reinforce this structure at predetermined locations. For example, as FIG. 14OAs shown, ribs 14112 are added across the chamber 14108 to increase stiffness at four locations. The ribs 14112 can be formed from thin metal strips or co-molded plastic or polymeric material. It will be appreciated that the inclusion, location, amount, and / or orientation of the ribs 14112 can vary based on the data collection 4300 to stiffen the structure as needed.

[0733] Accordingly, information from the data collection 4300 can be used to produce a custom-made cushion. This information can include laser scan data, passive stereophotogrammetry data, contact collection data, deformation device data, pressure mapping data, and any other type of data discussed above, including information related to topography, facial structure data (e.g., stiffness in various directions), and / or underlying facial structure (e.g., skin, muscle, and / or bone thickness to predict and / or derive facial stiffness data).

[0734] This information from the data collection 4300 can be used to form a custom-made cushion. In one example, a system can be configured to receive anthropometric data or other information from the data collection 4300 and select an appropriate cushion or cushion component (such as a chamber). The system can then direct an injector to introduce one or more materials in at least one layer into the chamber of the cushion based on the anthropometric data received.

[0735] Feedback from the patient can also be used to improve the fit of the cushion 14102. For example, an image of the patient's face can be obtained shortly after use of the cushion 14102. This image can indicate areas where the pressure between the patient interface and the patient can be too high (e.g., by looking for redness indicating high pressure). The patient can also provide feedback regarding areas where there can be leakage (i.e., insufficient contact with the skin). This feedback can be sent to the manufacturer or designer via the internet or a smartphone APP. Using this data, the cushion 14102 can be refined to include increased stiffness in the areas of leakage and / or decreased stiffness in situations where there is excessive pressure between the patient and the patient interface.

[0736] 5.11.5.4 Volume Scaling

[0737] With contact comfort, seal, and stability in mind, attention is now turned to physical dead space and breathability comfort. Physical dead space and breathability comfort correspond to the patient interface volume. Thus, with the overall shape of the patient interface and components already produced, a scaling step can be performed to change the volume of the patient interface in a range from about 1% to about 50%. The scaling can be up or down. That is, in some examples, a preferred volume is first determined, and the patient interface shape is enlarged or reduced as needed to control the physical dead space to match the preferred volume. This scaling can take into account comfort and seal, such that important points are not changed during the scaling process. For example, the contact area can remain the same, while the patient interface is offset outward from the patient's nose and / or mouth as needed. It will be appreciated that scaling the patient interface volume can also assist in adjusting ventilation flow requirements.

[0738] 5.11.5.5 Headgear and Anchoring Components

[0739] In addition to the three elements of the patient interface discussed above, the headgear can also be customized for the patient. Proper headgear performance can impact various properties including seal, comfort, and aesthetics, and can be achieved by modifying components and locations of components.

[0740] FIG. 15A to FIG. 15B One example of a headgear associated with a patient interface for a patient is shown. Patient 15050 wears patient interface 15002 secured by headgear 15004. In this example, headgear 15004 includes first strap 15010 and second strap 15012 attached at first ends to patient interface 15002. Second strap 15012 can include a rigid piece capable of forming a predetermined shape. First strap 15010 and second strap 15012 extend toward the back of the patient's head (see FIG. 15B ), and are attached to third strap 1514 at neck attachment 15040 and crown attachment 15042, respectively. As best shown in FIG. 15B , vectors formed by first strap 15010 and second strap 15012 are labeled V15010 and V15012, respectively.

[0741] Headgear 15004 can be modified in several ways. First, strap vectors V15010 and V15012 can be adjusted. By analyzing collected patient data, such as distances of the ears, mouth, and eyes, as well as head shape, neck shape, and facial profile, modifications can be made to the vectors. In some examples, vectors V15010 and V15012 can be adjusted from about 0 degrees to about 90 degrees from the horizontal plane x, depending on the number of attachment points and avoidance of sensitive features on the face (eyes, ears, etc.).

[0742] Second, the rigidity of the second strap 15012 can also be modified. In some examples, by knowing the location of the eye and cheek contours, the strap 15012 can be formed to follow the contours of the patient's face and also to avoid the patient's eyes, thereby reducing irritation and vision obstruction caused by the patient interface.

[0743] Third, the length of any of the straps 15010, 15012, 15014 can be modified based on the collected head and / or neck shape and / or size. For example, knowing the circumference of the head at different latitudes (e.g., CI), the length of the strap can be predicted and recommended to the patient. In some examples, the straps 15010, 15012, 15014 can be elastic. In this case, the length and / or rigidity of the elastic material can be adjusted based on the collected data.

[0744] Finally, the neck attachment 15040 and crown attachment 15042 can be adjusted based on the collected data regarding the head and / or neck shape and size. In this example, the geometry of the head and neck shape can dictate the location (latitude) of the neck attachment 15040 and crown attachment 15042. The length of the third strap 15014 can also be adjusted based on the neck attachment 15040 and crown attachment 15042.

[0745] Furthermore, to improve the stability of the patient interface when worn by the patient, anchor points can be selected based on the collected data. Like eyeglasses, where the anchor point is the nose bridge; the nose bridge, mouth, ear, and teeth can act as anchor points for a respiratory patient interface. Thus, by knowing the location of these features, the patient interface can be designed to perform with greater stability. FIG. 16A An example of anchor points associated with a patient interface of a patient is shown. An algorithm can be used to analyze the collected data to determine the optimal location of the anchor points. In FIG. 16A In the example shown in FIG. 16, certain potential anchor points have been identified, including a nose bridge anchor point 16002, mouth anchor points 16004, 16006, and ear anchor points 16008. Collecting data and analyzing the location of the anchor points from the collected data can be used to form a patient interface and headgear with optimal performance and stability.

[0746] Turning now to FIG. 16BDuring CPAP therapy, unwanted motion from the positioning and stabilising structure 16070 (e.g. a headgear) or from the patient 16050 can be decoupled or separated from the patient interface 16060, in particular from the sealing element 16062, via a component of the positioning and stabilising structure 16070 or the patient interface itself that prevents the transmission of such a seal breaking force. This can be achieved by a resilient or compliant joint feature 16080 within the connection between the positioning and stabilising structure 16070 and the patient interface frame or sealing element 16062. As the patient interface is customised, the sealing element 16062 can be sensitive to small physical disturbances, so the positioning and stabilising structure 16070 and the patient interface and sealing element 16062 can be decoupled from each other to reduce the impact of such disturbances. A customised patient interface enables a less bulky patient interface that can not have a sealing element 16062 of traditional thickness to deal with seal breaking forces. A sleek, customised patient interface with a thinner sealing element 16062 can maintain a very reliable static seal by decoupling the seal breaking force caused by, for example, tube torque or patient head movement to gain stability.

[0747] 5.11.6 Dynamic stabilisation techniques

[0748] In addition to the techniques and examples disclosed above for providing customisation of different parts of the patient interface 16110, techniques for dynamic stabilisation can also be employed. As previously discussed, the facial features and skin of a patient are not static elements and deform and move frequently during therapy. Accordingly, techniques can involve stabilising the patient interface 16110 and providing it with sufficient seal during movement and / or deformation of the patient's skin and / or facial features. To assist in illustrating these techniques, FIG. 16C and FIG. 16D Patient head movement is shown to have certain effects on the patient interface 16110 in different sleep positions.

[0749] As FIG. 16C shown, a schematic view of a patient's head 16100 is shown lying on its side on a bed pillow 16120. The head 16100 includes a skull 16102, skin 16104 and a nose 16106, and the head 16100 further wears a patient interface 16110. When the patient's head 16100 is lying on its side as FIG. 16C shown, the skull 16102, skin 16104 and patient interface 16110 are all generally aligned with the axis "Y1", and the patient interface 16110 is aligned with and centred around the nose 16106, such that there is sufficient seal between the patient's skin 16104 and the patient interface 16110 around the nasal region.

[0750] Turning to FIG. 16DIf the patient 16100 starts to move his head, alignment difficulties start to occur. In particular, as shown in FIG. 16D Fig. 16B, as the skull 16102 is turned toward the pillow 16120, the patient interface 16110 does not move as much as the skin 16104 and skull 16102 due to the friction between the headgear 16108 associated with the patient interface and the pillow 16120. Thus, axis "Y2" generally represents the skin alignment, and axis "Y3" represents the patient interface alignment, Y2 and Y3 being different from each other. In at least some examples, the difference between Y2 and Y3 can be in the range of about 1 degree and about 60 degrees or about 10 degrees and about 75 degrees. The patient interface can be configured to compensate for this misalignment.

[0751] Skin movement and / or deformation can be characterized as shear and deflection properties relative to certain facial features. Features of the patient interface can be configured to compensate for this movement and / or deformation at certain locations on the skin. For example, skin shear can occur at the infraorbital 16205 (as shown in FIG. 16E Fig. 16C). The patient interface can be formed to compensate for skin shear, for example, between about 1 mm to about 50 mm, and preferably about 40 mm, and longitudinal movement (e.g., up and down) between about 1 mm to about 50 mm, and preferably about 28 mm. In other words, movement can occur in any direction in the range of about 50 mm.

[0752] A patient interface 16110 can also be manufactured that can compensate for an up-twitch / nose twitch, such as when the patient twitches the upper lip upwards. In particular, the patient interface 16110 can be configured to compensate for a change in the alar angle 16210 of between about 1 degree and 30 degrees, and preferably about 27 degrees, when the nasal angle 16215 is moved upwards due to a nose twitch and laterally due to a side twitch, during therapy. This compensation is used to design and configure the shape and profile of the sealing element 16062 and / or the frame 12020. Tolerances are introduced in the sealing element 16062 and / or the frame 12020 based on this compensation. For example, if the patient's nose twitch causes less movement, a more precise sealing element 16062 and / or frame 12020 can be provided. On the other hand, if the patient's nose twitch has a greater distance of movement, a greater tolerance can be provided for the sealing element 16062 and / or frame 12020 to minimize or avoid seal breaches. The patient interface 16110 can additionally or alternatively compensate for the upward movement of the nasal angle 16215 and the middle of the nose 16220, which can rise up to a height of 9 mm and 4 mm, respectively. The patient interface can further compensate for an increase in the width of the nose 16225 of between about 1 mm to about 4 mm. The patient interface can also be configured to accommodate a cheek bulge from a first state 16300 to a second state 16305, which can be caused by all types of nose twitch movements (e.g., laterally and / or up and down), the first state 16300 and the second state 16305 are spaced between about 1 mm and 10 mm apart.

[0753] FIG. 16G A top view is shown to illustrate the effect of applying a force to a headgear 16352 (which can also be referred to herein as a positioning and stabilizing structure) worn by a patient 16350. As shown, a first diagonal force Tl is applied to the headgear 16352 at a location 16A proximate to the patient's ear. The force Tl creates a second force T2 at a location 16B at the junction between the headgear 16352 and the frame 16354, and a third force T3 at a location 16C. In some configurations, the patient interface can be configured to roll outwards at location 16C to isolate the frame from movement, and decouple the nare frame from movement caused by tube resistance, and maintain the seal. In at least some examples, the headgear 16352 is configured to compensate for a force of between about 1 Newton and about 10 Newton without reducing the sealing contact with the patient or breaking the seal with the patient or causing discomfort to the patient, which can cause red marks on the patient's face. Several examples are shown below for compensating for this force, but it should be understood that these examples are merely exemplary, and other methods and techniques are possible.

[0754] In FIG. 16HIn the illustrated second embodiment, the patient interface 16400 includes a conduit 16401 connected to a sealing element 16402, which in turn is attached to a headgear 16403 having a first portion 16404 and a second portion 16406. As shown, the first portion 16404 and the second portion 16406 can be formed of different materials. In particular, the first portion 16404 and the second portion 16406 can be formed of materials having different material properties. For example, the first portion 16404, which is disposed around the back of the patient's head, can be formed of a substantially inelastic material (e.g., less elastic than the second portion 16406), while the second portion 16406, which is disposed on the cheeks and extends to the sealing element 16402, can be formed of an elastic material, i.e., the second portion 16406 is more elastic than the first portion 16404. Alternatively, the first portion 16404 can be formed of a tacky or adhesive material that does not readily slide on or against the patient's skin, while the second portion 16406 can be formed of a different material that readily slides on the skin. The first portion 16404 and the second portion 16406 can be formed of materials having different coefficients of friction relative to the skin (e.g., the first portion 16404 has a higher coefficient of friction than the second portion 16406), such that when similar forces are applied to both portions 16404, 16406, the second portion 16406 slides much more than the first portion 16404.

[0755] The first portion 16404 can be formed of a relatively inextensible material, while the second portion 16406 is formed of an extensible material. A textile cover or wrap can be disposed on the second portion 16406. The face-contacting surface of the second portion 16406 can be provided with features (e.g., silicone nubs) or made of a material that increases friction to prevent / minimize relative movement between the second portion 16406 and the patient's skin. The outward-facing surface of the second portion 16406 can be smooth to prevent forces from patient movement against a bed pillow or bed linens from being transferred to the patient interface 16400. With the patient interface 16400, the sealing element 16402 is decoupled from most perturbations acting on the headgear because the properties of the second portion 16406 allow it to compensate for stretching forces and movement. Moreover, forces at the first portion 16404 are not fully transmitted to the sealing element 16402 via the second portion 16406. Thus, the headgear 16403 of the patient interface 16400 provides a stable and secure hold on the patient's head and is easy to put on and take off.

[0756] In the illustrated second embodiment, the patient interface 16400 includes a conduit 16401 connected to a sealing element 16402, which in turn is attached to a headgear 16403 having a first portion 16404 and a second portion 16406. As shown, the first portion 16404 and the second portion 16406 can be formed of different materials. In particular, the first portion 16404 and the second portion 16406 can be formed of materials having different material properties. For example, the first portion 16404, which is disposed around the back of the patient's head, can be formed of a substantially inelastic material (e.g., less elastic than the second portion 16406), while the second portion 16406, which is disposed on the cheeks and extends to the sealing element 16402, can be formed of an elastic material, i.e., the second portion 16406 is more elastic than the first portion 16404. Alternatively, the first portion 16404 can be formed of a tacky or adhesive material that does not readily slide on or against the patient's skin, while the second portion 16406 can be formed of a different material that readily slides on the skin. The first portion 16404 and the second portion 16406 can be formed of materials having different coefficients of friction relative to the skin (e.g., the first portion 16404 has a higher coefficient of friction than the second portion 16406), such that when similar forces are applied to both portions 16404, 16406, the second portion 16406 slides much more than the first portion 16404. FIG. 16IIn the third embodiment shown, the patient interface 16410 includes a conduit 16411 connected to a sealing element 16412, which in turn is attached to a headgear 16413 having a first portion 16414 (e.g., crown strap) and a second portion 16416 (e.g., side strap). The second portion 16416 has an inner layer 16417a that contacts the patient's skin and is more elastic than the first portion 16414. The first portion 16414 can be relatively inelastic and not stretchable, for example, it can be made of neoprene material. As shown, the first portion 16414 and the second portion 16416 can be formed with a double layer configuration of layers 16417a, 16417b for the second portion 16416. The inner layer 16417a (e.g., patient contacting layer) of the second portion 16406 is a material that is rigid under tension and relatively collapsible under compression, such as a strap. The side strap 16416 can be length adjusted by a buckle 16419. Reducing the length of the side strap 16416 increases the elastic tension of the side strap 16416. In a resting state with no tension on the side strap 16416, there is a length mismatch between the inner layer 16417a and the outer layer 16417b of the side strap 16416, and the inner layer 16417a is slightly curved. When tension is applied, for example, by tube torque, the side strap 16416 directly transfers the tension to the crown strap 16414. Since the operative portion of the headgear 16413 is relatively inelastic in this condition, the headgear 16413 does not stretch, which can result in seal failure. With the patient interface 16410, the sealing element 16412 is decoupled from forces other than extreme forces acting on the headgear 16413, since the layers of the second portion 16416 allow it to compensate for stretching forces and movement. Additionally, the headgear of the patient interface 16410 includes the first portion 16414 and the second portion 16416 that collapse when a compressive force is applied, such that the elastic material maintains tension.

[0757] In FIG. 16JIn the fourth embodiment shown, the patient interface 16420 includes a conduit 16421 connected to a sealing element 16422 that is in turn attached to a headgear 16423 having a first portion 16424, a second portion 16426, and a string 16428 that extends through the second portion 16426 and couples the first portion 16424 to the sealing element 16422. The second portion 16426, which can be in the form of a cheek pad, is configured to move laterally along the string 16428, such as by sliding (e.g., a headgear slide), so that facial friction against the second portion 16426 does not translate into movement of the sealing element 16422. In one example, the second portion 16426 is slidable between the patient’s ear and the patient’s upper lip. In other words, the second portion 16426 is slidable between distal ends of the string 16428. As shown, the string 16428 includes an upper string and a lower string, although it should be understood that the string 16428 can include only a single string or more than two strings or other suitable material or structure that connects the first portion 16424 and the sealing element 16422. As shown, the first portion 16424 is formed of silicone or Breath-O-Prene, while the second portion 16426 can be formed of a textile material that can be knitted or woven. With the patient interface 16420, the sealing element 16422 can be held in place at the patient’s nose with sufficient seal even in the presence of movement or application of external forces to the second portion 16426. For example, without a substantial force applied to the sealing element 16422, friction between the pillow and the second portion 16426 can cause movement of the second portion. For example, the maximum amount of force that can be tolerated before the sealing element 16422 is breached is 10 Newtons. The facial contact surface of the second portion 16246 can be provided with features (e.g., silicone tabs) or made of a material that increases friction to prevent / minimize relative movement between the second portion 16246 and the patient’s skin. The outward-facing surface of the second portion 16246 can be smooth to prevent forces from patient movement against the pillow or bedding from being transferred to the patient interface 16420.

[0758] It should be understood that combinations of the above embodiments are possible in some examples. For example, a cheek pad can be combined with other portions having different materials or stiffness to further minimize movement of the patient interface 16400.

[0759] 5.11.7 Customized nasal masks

[0760] Previous embodiments have attempted to provide additional structures to compensate for forces on the headband. Examples of stabilizing the patient interface while minimizing its size are described below, specifically the size of the sealing element and the surface area of ​​the sealing element in contact with the patient's face. In another example, the thickness of the sealing element and the depth of the patient interface are minimized. FIG. 17A This example illustrates a patient interface designed to provide both stability and maximum simplicity. In this example, the patient interface includes a frame assembly in the form of a nasal mask 17000, which is attached to an air delivery conduit or tube 17005 and a headband 17010. Details of each of these components will be described individually in more detail with reference to the accompanying drawings below.

[0761] FIG. 17B This diagram illustrates the structure of the base of the nose, including the locations of the nostrils, the lower nasal septum, the nasal protuberance, the columella, the vermilion border of the upper lip, the lower lip, and the nasolabial fold. A sealing element can be configured to form a seal around the periphery indicated by the dashed line P1, which extends along the outer periphery of the nasal protuberance, the two nostrils, and the lower nasal septum, essentially surrounding or enclosing the two nostrils therein. This periphery can be minimized by ensuring it does not extend beyond the vermilion border of the upper lip, the nasolabial fold, or the lip itself.

[0762] The size and shape of each component, including the nasal mask 17000, can be customized for each patient to provide appropriate fitting. By obtaining measurements as described in Data Collection 4300, a 3D model of the desired nasal mask can be calculated and generated, partially or entirely, for each patient. For example, as... FIG. 17C As shown, in the image capture step, multiple markers 17100 (in this case, sixteen points of interest) are selected on the patient's nose and upper lip, and a model of the nasal mask 17000 is designed based on these markers 17100. In other examples, markers 17100 can be selected at different locations on the patient's face, including the eyes, ears, forehead, chin, cheeks, etc. Markers 17100 can be placed at more or fewer locations, but ideally around the periphery of each nostril, the columella (i.e., the intermediate segment between nostrils), the base of the nostrils, the nasal angle, the nasofacial groove on the affected side, and the lower contour of the nose. In at least some examples, the number of points varies based on the necessary resolution (e.g., the distance between adjacent markers). In at least some examples, the resolution around the nose is between approximately 0.1 mm and approximately 0.75 mm. The resolution around the nose can also be approximately 0.5 mm and can be greater than the resolution in other areas of the face, where the resolution can be only 0.75 mm. Selected markers 17100 can be chosen to define a plane parallel to the nasolabial angle. Then, a wavy surface, as shown by shaded surface 17102, can be defined by markings 17100 corresponding to the surface of the nose around the nostrils and a portion of the upper lip, the periphery of which corresponds to...FIG. 17B the perimeter PI of the patient's face.

[0763] As previously described with reference to FIG. 17A The delivery conduit 17005 will be connected to the custom nasal mask 17000 such that air or other gases can flow therethrough. Movement of the delivery conduit 17005 can affect the stability of the nasal mask 17000. As such, the nasal mask 17000 can be configured to receive the tube 17005 at a predetermined position, angle, and orientation to reduce the effect of the assumed or expected forces from the tube 17005 on the nasal mask 17000. In one example, during the data collection phase, an elliptical position 17120 can be defined in the free space under the surface 17102, the elliptical position 17120 defining a plane pz2 that is parallel to the plane pz1 of the nasolabial angle FIG. 17D To minimize tube torque and expected forces created on the custom nasal mask, the angle, position, and orientation of the tube can be selected to reduce the moment arm of the tube-nasal mask connection (e.g., the tube connection / tube port of the nasal mask 17000) by having the connection as close as possible to the patient's face along the axis Z1 without physical contact with the patient's face and allowing sufficient volume for the dead space defined by the plenum chamber 17200 formed in part by the frame assembly 17000. This minimizes the seal breakage caused by tube torque during therapy and reduces the volume of the mask by reducing the depth of the mask.

[0764] In some examples, the nasal mask 17000 can be positioned relative to the patient via a headgear 17010, as shown in FIG. 17A As shown in FIG. 17E To manufacture the nasal mask 17000 with the appropriate fittings, a headgear vector 17130 for the rigid arm 17250 of the headgear 17010 can also be defined. The headgear vector 17130 is an imaginary line that can preferably intersect the midpoint between the patient's eyes and ears and a point on the nasal mask 17000, such as the lateral side of the nasal mask 17000. A slot 17135 or groove or socket is then defined in the nasal mask 17000, for example at the earlier mentioned point. The angle, orientation, and position of the slot 17135 are discussed in more detail below. With the image capture and modeling complete, the components of the patient interface can be manufactured and assembled. It will be appreciated that each component can be customized for a particular patient. Customization can include creating a plurality of fittings (e.g., twenty fittings) for each mask component, and the patient matches with one of the fittings. Alternatively, customization can include custom-made components manufactured individually for a given patient.

[0765] 5.11.7.1 Custom frame defining a plenum chamber

[0766] As shown in Figures 17F-17IAs shown, the custom nasal mask 17000 forms a portion of the surface of the frame assembly 17000. The frame 17000 defines a portion of the plenum 17200. The frame 17000 can be formed of a rigid or semi-flexible material, and can define a generally hemispherical or dome-shaped structure. As seen from the interior of the frame 17000 (FIG. 17B), the frame 10200 can include an inner wall 17210 and a seal receiver surface 17220. The frame 17000 can define a portion of the plenum 17200, dead space, or chamber between its inner wall 17210 and the patient's skin, while the seal receiver surface 17220 can provide an interface for accepting a sealing element 17300, as described with reference to FIGS. 17A and 17B. Figure 17F Figures 17K-17N

[0767] The frame 17000 imparts a 3D shape to the sealing element 17300 to form an airtight enclosure around both nares. The frame 17000 and the sealing element 17300 form a portion of the plenum 17200, which defines a small chamber defined by the perimeter of both nares and a small distance dl (see FIG. 17B) away from the nares. The distance dl is typically less than 30 mm, and ideally as small as possible without physically contacting the patient's face, and allowing sufficient volume for dead space in the plenum 17200. In some examples, the dead space or chamber defined to be enclosed within the plenum 17200 and the patient's skin is defined by an estimate of the space within a frustum of a cone (FIG. 17B) approximating the plenum 17200 within the frame 17000. Thus, the volume within the plenum 17200 can be estimated as follows: Figure 17G-1 Figure 17G-2

[0768]

[0769] where ED1 and ED2 are the estimated diameters of the tube inlet, ED3 and ED4 are the approximate diameters of the perimeter of the nose marking, and EH is the estimated distance of the tube inlet / connection port to the nose. In at least some examples, the dimensions of the frame 17000 are a function of the size of the person's nose, approximating 1 to 2 times the patient's nose. The height of the frustum (i.e., the depth of the frame 17000, distance dl) is controllable and adjustable. In one example, the distance dl is selected to minimize the dead space in the plenum 17200 to the smallest possible distance. In another example, the patient's ventilation preferences can be considered, and the distance dl is selected to achieve a user-defined level of breathing comfort, and thus dl can not be the smallest possible distance.

[0770] 5.11.7.2 Custom vent

[0771] ​​​​As previously described, the frame 17000 can include a plurality of slots 17135, in this example two slots, for accepting a headgear. An approximately elliptical or circular aperture 17230 is located between the slots 17135 for accepting a delivery conduit (not shown). The frame 17000 can also include on its outer surface above the aperture 17230 vent holes 17240. The location of the vent holes 17240 on the frame 17000 can be such that they more assist in the removal of carbon dioxide and improve respiratory comfort. For example, the vent holes 17240 can be located only at positions adjacent to the nasal columella as shown. Although the vent holes 17240 are shown on the frame 17000, it should be understood that the vent holes can also be located in a bend site located on an elbow disposed between the aperture 17230 of the frame 17000 and the delivery conduit 17005. The elbow can be a quick release elbow such that the elbow can be removed from the frame 17000 by the patient along with the delivery conduit 17005.

[0772] The number of vent holes 17240 can be selected based on the dead space defined by the plenum chamber 17200 (e.g., the volume enclosed within the plenum chamber 17200 and the patient’s face). The dead space can be calculated and the number of vent holes required to more assist in the removal of carbon dioxide and improve respiratory comfort can be selected. In some examples, a computer algorithm or look-up table can be used to determine the number of vent holes 17240. The number of vent holes 17240, the location of the vent holes 17240 on the complex surface of the frame 17000, the geometry / profile of the vent holes 17240, and the inlet / outlet direction of the vent holes 17240 can be selected based on the expected therapy pressure, the expected noise level, the expected carbon dioxide removal, and the expected diffusion rate. These features of the vent holes can also be selected based on a function of the volume of the dead space. These features of the vent holes can also be selected based on a desired humidity level, for example, to prevent rainout effects. In another example, baffles or diffusers can be customized and provided to achieve the expected noise level and the expected diffusion rate. The customization of the vent holes 17240 can include automated computational fluid dynamics (CFD) for each patient and / or comparison to a look-up table based on the volume and geometry of the dead space when it has been calculated.

[0773] Figure 17JThe frame 17000 is shown after coupling the delivery conduit 17005 to the orifice 17230 and the headgear 17010 to the slot 17135 via rigid arms 17250. In one example, the rigid arms 17250 can be substantially L-shaped and can include a first end 17252 that extends generally in the coronal plane for insertion and coupling to the slot 17135 and a second end 17254 that extends generally in the sagittal plane for coupling to the headgear 17010 (e.g., to any of the straps described above). The rigid arms 17250 can be substantially rigid and stiff and can be formed of metal or other rigid polymers such as polypropylene, Hytrel, or the like. Additionally, the L-shaped rigid arms 17250 can provide a stable fixation and seal of the frame against the patient's skin to receive the headgear force, e.g., force Fl, and generate a force F2 on the frame 17000 to push the frame 17000 toward the patient's nares. Additional customization of the headgear 17010 will be discussed in greater detail below.

[0774] 5.11.7.3 Customized Sealing Element

[0775] To provide comfort and excellent sealing, the nasal mask can include a customized sealing element 17300 coupled to the sealing receiving surface 17220 of the frame 17000. The sealing element 17300 can be in the form of a cushion that is attachable to the frame 17000 and can have an adhesive or tacky member to maintain a seal against the patient's skin during patient movement or in the presence of external forces (e.g., forces of a bed pillow against a portion of the headgear). This sealing element 17300 can compensate for the minimization of the frame 17000 and can provide a patient-friendly solution to movement, resulting in a more comfortable and less cumbersome patient interface.

[0776] The sealing element 17300 can be configured to be fastened to a portion of the patient's nose via an adhesive. As Figure 17KAs shown, the sealing element 17300 can be in the form of a cushion that includes multiple layers. The exposed layers can be adhesive layers. Between the adhesive layers can be low density (more compliant) foam layers and high density (less compliant) foam layers. These layers are sandwiched together. The foam layers can together form a thin foam layer 17302. Suitable foam materials are disclosed in PCT Publication No. WO 2014 / 117227, which is incorporated by reference herein in its entirety. In use, the low density foam layer is closer to the patient’s face than the high density foam layer. The low density foam layer can have a thickness of 4 mm and the high density foam layer can have a thickness of 3 mm. In other examples, the high density foam layer can be closer to the patient’s face in use. In further examples, there can be a single layer of foam with a uniform density. One of the adhesive layers is a pressure sensitive adhesive (PSA) backing 17304 laminated to or applied to the foam layer 17302. As used herein, the terms sealing element and cushion can be used interchangeably, but it will be appreciated that the materials described for the sealing element 17300 are merely exemplary and other suitable materials can be used. Other suitable adhesives and / or tacky materials can include silicone adhesives, acrylic adhesives, and adhesives disclosed in U.S. Patent 8,291,906, which is incorporated by reference herein in its entirety. The adhesive can be laminated to the foam material. Silicone-based adhesives can provide some compliance compared to acrylic-based adhesives. Silicone-based adhesives can be reusable and washed to restore adhesion compared to acrylic-based adhesives that are typically used once or twice. In some examples, the foam layer 17302 can include a tacky foam. The sealing element 17300 can be capable of being comfortably stuck to a patient’s skin on one side and attachable to the frame 17000 on a second side. For example, adhesive can be provided on both the patient-contacting side and the non-patient-contacting side of the sealing element 17300 such that the sealing element holds the frame 17000 coupled to the patient’s skin. Alternatively, the sealing element 17300 can be mechanically and releasably engaged to the frame 17000 and include only one adhesive side for coupling to the patient’s skin. In other examples, the sealing element 17300 can be engaged with the frame 17000 via hook-and-loop fasteners. In some examples, the sealing element 17300 has one perimeter corresponding to the perimeter PI of the frame 17000 and can be customized based on data acquired in the data collection 4300 to form a desired shape. The same data collected to form the frame 17000 can also be used to form a sealing element 17300 that has excellent fit to the patient. Figure 17B

[0777] During manufacturing, the three-dimensional model 17310 of the computer-generated sealing element 17300 for a particular patient can be converted to a two-dimensional flat profile 17300( Figure 17L ​). The three-dimensional model 17310 of the sealing element 17300 is unfolded and flattened by a software program to obtain a two-dimensional flat profile of the sealing element 17300. The sealing element 17300 can be laser cut from a flat sheet, bagged and labeled with the patient's name, thereby creating a custom sealing element 17300 and a tailored or customized fit for each patient. The conversion of the three-dimensional model 17310 to the two-dimensional flat profile results in faster manufacturing, optimized storage and easier shipping of the sealing element to the patient.

[0778] In some examples, several patients with similar sizes of sealing elements 17300 can be grouped to provide an optimal fit that more closely fits the patient's anthropometric features compared to conventional mask cushions, which are typically only offered in 1 to 3 standard sizes corresponding to the patient's nose width. The grouping can for example include twenty sizes of sealing elements 17300 with a given length, width, thickness and curvature, each size having built-in tolerances. For each group, a single flat profile 17310 can be manufactured that fits within the given tolerances for the given group of several patients. For example, the tolerances for the single profile can be + / - 2.5 mm for the length dimension and + / - 2.5 mm for the width dimension.

[0779] As Figure 17M and Figure 17NAs shown, the sealing element 17300 can be coupled to the frame 17000. In particular, a first surface 17350 of the sealing element 17300 can be adhered or coupled to the sealing receiving surface 17220 of the frame 17000, while a second surface 17355 can provide a seal against the patient's skin. The sealing element 17300 can also be decoupled from the sealing receiving surface 17220 as needed. For example, if the adhesive on the second surface 17355 of the sealing element 17300 begins to wear out to the end of its life, or if the sealing element 17300 needs to be replaced, it can simply be discarded and another sealing element 17300 can be installed in its place. In at least some examples, the sealing element 17300 includes a dual layer foam construction with adhesive. A first foam layer can be disposed on the surface proximal to the frame during use, and its stiffness can be greater than a second foam layer disposed proximal to the user's face during use. This dual layer construction can allow for both macro and micro adjustments and ensure a reliable and comfortable seal for the patient. As previously mentioned, adhesive can be disposed on both sides of the sealing element 17300. In some examples, the adhesive on the first foam layer (e.g., the layer proximal to the frame 17000) has a greater adhesive strength than the adhesive on the second foam layer (e.g., the layer proximal to the patient's skin). This configuration can allow the patient to adjust the position of the frame 17000 without dislodging the sealing element 17300 from the frame 17000. It will be appreciated that the use of adhesive is merely optional, and other methods of coupling the sealing element 17300 to the frame 17000 can be envisioned, such as mechanical or magnetic engagement.

[0780] 5.11.7.4 Custom headgear

[0781] The headgear 17010 of the patient interface can also be custom made. Using measurements of the circumference of the patient's head, the length, elasticity, and thickness of the headgear straps can be adjusted for a particular patient to provide a safe, stable, and comfortable patient interface that is not too tight or too loose and requires little to no manual adjustment by the patient. Additionally, the texture or surface treatment such as smoothness or roughness of the headgear straps can be selected to be specific to the patient, for example, if they have facial hair or hair. The profile, shape, arc length, and flexibility of the rigid arms 17250 can be selected to be specific to the patient. For example, if the patient's face is wide or narrow, the rigid arms 17250 are customized to exert minimal pinch pressure against the patient's face and closely follow the profile of the patient's face and also direct the headgear straps optimally through the patient's eyes and ears.

[0782] In some examples, the optimization of the length, elasticity, and thickness of the headgear straps allows the headgear straps to be tightened or loosened (e.g., if the length is adjustable) or tightened or loosened via elasticity (if it is an elastic headgear) to control the headgear tension in the Frankfort horizontal for securely holding the mask against the patient’s face. The headgear tension can be adjusted according to the patient’s level of comfort while ensuring that the minimum amount of headgear tension required to maintain the seal is maintained. Some patients can prefer a higher headgear tension than is necessary to maintain the seal because the tightness of the headgear is reassuring and provides greater confidence for such patients.

[0783] Additionally, the angle, position, and orientation of the corresponding tabs that receive the headgear rigid arms 17250 or the slotted 17135 can be selected to create a custom headgear fit and custom headgear vector for each patient. As previously referenced Figure 17E with respect to the change in the angle, position, and orientation of the slotted 17135 changes the headgear vector 17130 of the headgear rigid arms 17250 and allows for customization of the headgear for superior fit. In some examples, the rigid arms 17250 are customized to sit below the cheekbones of each patient and optimally pass between the patient’s eyes and ears. Thus, by knowing the anthropometric features of the patient from the data collection 4300, the angle of the headgear vector can be adjusted to achieve better performance. The angle of the headgear vector relative to the Frankfort horizontal can be determined. The optimal angle of the headgear vector can improve the comfort and stability of the patient interface because the angle of the headgear vector provides uniform pressure against the patient’s face by the sealing surface / sealing perimeter of the sealing element 17300 (e.g., the patient’s nose and the patient’s upper lip). Without this optimization of the headgear vector, tightening the headgear straps can cause the mask to arch up and thus not achieve the optimal seal because the force by which the seal is achieved by the sealing element 17300 is not uniformly distributed.

[0784] In another example, to account for tube torque in the downward direction, the optimal angle of the headgear vector can include a bias for preloading (typically a slightly higher angle). In other words, if the tube 17005 is pulled downward by an amount of force, the preloading of the angle for the headgear vector is able to accommodate that amount of force before affecting the stability of the mask.

[0785] 5.11.7.5 Assembled nasal mask

[0786] The fully assembled nasal mask 17000 including the frame 17000, the rigid arms 17250, the sealing element 17300, the headgear 17010, and the delivery conduit 17005 is shown in Figures 17O-17Q itself, and as Figures 17R-17TThe seal element 17300 can be coupled to the frame 17000 and the custom nasal mask 17000 can be donned by the patient using the headgear 17010. As previously discussed, the rigid arms 17250 act as a transition from the frame 17000 to the headgear 17010 and redirect the forces from the headgear such that the frame 17000 and the seal element 17300 are pushed towards the patient’s face resulting in the desirable seal of the seal 17300 to the patient’s face. By using the data acquired during the data collection 4300, the angle, position, and orientation of the slots 17135 can be carefully selected to ensure that the rigid arms 17250 are received between the midpoints between the patient’s eyes and ears, or other desired angle / position / orientation, thereby providing the optimal, stable, and comfortable seal for the small nasal mask assembly.

[0787] Accordingly, the result of having this nasal mask is a custom mask that is as small as possible while being stable. In particular, the superior contact of the seal element 17300 to the patient’s face, the interfacing of the seal element 17300 with the frame 17000, the use of the L-shaped rigid arms 17250, and the customization according to the data collection combine to produce a small mask that is stable despite the tube resistance and body movements that occur during therapy. It will be appreciated that customization has been discussed herein with reference to the frame 17000, the vent 17240, the seal element 17300, and the headgear 17010. In some examples, the fully assembled custom nasal mask 17000 includes one or more custom elements. Additionally, custom components and standard components can be combined in various combinations to reduce costs (e.g., custom frame 17000 and standard size seal element 17300) and also to provide various options for the patient.

[0788] 5.11.8 Complete Patient Interface Design Package 4550

[0789] Using the custom patient interface and / or headgear, the complete patient interface design package 4550 is a set of files including files for each of the individually designed patient interface components, thereby preparing for manufacturing. The complete patient interface design package 4550 can include data or information related to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structure, seal element, headgear, and / or any additional accessories such as elbow, tube, headgear clips, etc.), a CAD or data file for each component, manufacturing techniques for each component, material(s) required for each component and designer, and / or user comments. The patient’s CAD file and / or photos, if any, can be retained to support the selection of visual aesthetic features to customize the patient interface according to the patient’s preferences and tastes.

[0790] 5.11.9 Manufacturing 4600

[0791] The complete patient interface design package 4550 can be sent to manufacturing 4600. There are many different manufacturing techniques that can be used to manufacture any of the components discussed above. Additionally, it should be appreciated that a combination of the techniques discussed herein can be used to form different components for a respiratory patient interface.

[0792] The first set of techniques can be referred to as ablation techniques. In ablation techniques, data can be collected and analyzed from the patient skin 18050 and the complete patient interface design package sent for manufacturing Figure 18A The large blank component 18010 can be modified to remove excess material 18012 so that the remaining portion 18014 forms the desired custom component. In some examples, the large blank component 18010 is large enough to contain the vast majority of possible variations of the custom component 18014. Several exemplary methods under the ablation techniques include machining using a CNC machine to form the component from a large block or generic patient interface shape of material. In some examples, the material such as silicone or thermoplastic elastomer can be frozen into a rigid structure before machining. A laser etching machine can also be used to remove material from a larger block of material to form the component. This can be used to form rigid components or to cut thin materials (foam, fabric, silicone sheet, etc.). An abrasive chemical can also be used to remove material to form different treatments on the component. Some examples include using acetone on plastic. Cutting tools such as knives, saws, and drills can also be used to remove material to form the component. Figure 18B The cutting tool 18060 shown punches out components 18072, 18074, and 18076 from a sheet of material 18070. Thus, the gel component 18072, the silicone component 1804, and the foam component 18076 can all be formed by changing the type of sheet. This technique can be used, for example, to form headgear and sealing elements. Furthermore, the cutting tool 18060 can have a curved cutting edge 18062 to form a three-dimensional shape.

[0793] The second set of techniques can be referred to as additive techniques. These techniques can include SLS / SLA / FDM. Printing includes direct printing of plastic or silicone parts, reducing waste from subtractive manufacturing. Parts can be printed using high quality 3D printers. Silicone parts can also be manufactured via additive manufacturing by using a fast-curing silicone grade. Silicone and elastomer printing machines can also be used. When available, patients are also able to print their own patient interface at home or at a local 3D printer boutique. This method is efficient and sustainable, as there is little waste or waste residue from the blank. Textile spraying is also possible, which includes spraying a first material onto a second material. For example, a flocked material (felt, silk, textile mixture, etc.) can be sprayed onto an intermediate part, effectively producing a sealing element. In some examples, the material can be sprayed through a multi-axis CNC nozzle, mixed with glue / binder. Thus, different numbers of layers can be applied to all or part of the sealing surface, creating a customized sealing element.

[0794] Additionally, different manufacturing techniques can be used for the components of the mask assembly. For example, when forming a custom nasal mask, the frame and the sealing element can be formed by the same or different techniques. Additionally, multiple techniques can be used to shape one component of the custom nasal mask.

[0795] The frame 17000 can be formed, for example, by machining a molded blank of different sizes. In at least some examples, a plurality of blanks of different sizes are molded to cover a wide range of sizes. After data acquisition, the blank closest to the intended mask design can be selected, and this blank can be machined from the blank. Alternatively, a size probability can be used to form a plurality of frames of different sizes to mold a given volume for each size, and the frame closest to the size can be selected for the patient.

[0796] Non-traditional machining techniques can also be applied to mold or cut a blank to form a frame and / or a sealing element. These techniques can include electrical discharge machining, chemical etching, water jet cutting, and / or laser cutting. In electrical discharge machining, complex geometries of a component such as a frame or a sealing element can be processed to a high degree of resolution. By using electrical discharge machining, a clean surface finish can be formed in a delicate element because there is no direct contact with the workpiece. In some examples, electrical discharge machining can be used to form a vent hole or a rigidizer receiving slot in a frame. Chemical etching can also be used to subtract material and form custom geometries with high resolution in a frame and / or a sealing element. In some examples, chemical etching is desirable when manufacturing delicate elements of a frame and / or a sealing element because high heat that can damage a heat affected zone of a component is not required. Water jet cutting can also be used to shape a frame and / or a sealing element through a simple process that has no heat affected zone to produce complex geometries with high resolution. Laser cutting can also be used to form precise edges and cuts through a variety of materials suitable for a frame and / or a sealing element.

[0797] Additionally, a sealing element can be milled with a high speed abrasive cutting tool to shape the sealing element into a desired shape. In at least some examples, the sealing element is frozen prior to the milling process. Subsequently, the sealing element is thawed or warmed to room temperature if desired. It will be appreciated that multiple techniques can be used in series or sequentially.

[0798] 5.11.10 Tooling

[0799] For methods of manufacturing custom components that are more efficient than additive manufacturing, a molding tool can be rapid prototyped (e.g., 3D printed). In some examples, rapid three-dimensional printing tooling can provide a cost effective method of manufacturing small volumes. Soft tools of aluminum and / or thermoplastics are also possible. Soft tools provide a smaller number of molded components and are cost effective compared to steel tools. As shown in FIG. 18, a soft tool 18502 can be created using a machine 18500 to mold a component 18504. After use, the soft tool 18502 can be melted, recycled, and made into a different shape for manufacturing a different custom patient interface. Figure 18C

[0800] ​Hard tooling can also be used during the manufacture of custom components. Hard tooling can be required in the production of advantageous volumes. Hard tools can be made from various grades of steel or other materials for use in the molding / machining process. The manufacturing process can also include the use of any combination of rapid-prototyped tools, soft tools, and hard tools to make any of the patient interface components. The construction of the tools can also vary within the tool itself, such that any or all types of tooling are used, for example: one half of the mold that defines more generic features of the portions can be made from hard tooling, while the other half of the tool that defines the custom component can be made from rapid-prototyping or soft tooling. Combinations of hard tooling or soft tooling are also possible.

[0801] Figure 18D Additional examples of manufacturing using interchangeable tool inserts are shown. In this method, a hard steel (or other suitable hard material for injection molding) tool base is formed. In this example, the tool base is formed from two parts 18510 and 18520. The tool base is formed from a hard material, such as steel, and is designed to be used with interchangeable tool inserts. The tool base can be designed to be used with a variety of interchangeable tool inserts, or can be designed to be used with a single tool insert. Figure 18D As shown, two parts 18510 and 18520 form the hard tool base. Interchangeable tool inserts 18522, 18524, 18526 are formed using, for example, aluminum or 3D printed plastic material, each insert corresponding to the needs of a different patient. The inserts 18522, 18524, 18526 can be custom made for each individual patient. Alternatively, multiple inserts can be coupled to the same tool, such that different inserts can control different segments of the patient interface, such as the nasal bridge, mouth width, patient interface depth, etc.

[0802] Other manufacturing techniques can also include multi-shot injection molding for patient interfaces having different materials within the same component. For example, a patient interface cushion can include different materials or different levels of softness of material at different regions of the patient interface. Thermoforming (e.g., vacuum forming) can also be used, which includes heating a plastic sheet and vacuum suctioning the sheet onto a tooling mold, and then cooling the sheet until it has the shape of the mold. This is a viable option for molding a custom nasal mask component. In another form, a custom patient interface frame (or any other suitable component, such as a headgear or a portion thereof, such as a rigidizer) can be produced using a material that is initially malleable. A “male” mold of the patient can be made using one or more of the techniques described herein, on which a malleable “template” component can be placed to shape the component to fit the patient. The custom component can then be “cured” to set the component so that it will no longer be in a malleable state. One example of such a material can be a thermoset polymer, which is initially malleable until it reaches a certain temperature (after which it irreversibly cures); or a heat-softening plastic (also known as a thermoplastic), which becomes malleable above a certain temperature. Custom fabric weaving / knitting / forming can also be used. This technique is similar to a three-dimensional printing process, except with yarn instead of plastic. The structure of the fabric component can be woven into any three-dimensional shape, which is ideal for manufacturing a custom headgear.

[0803] Table A below shows some potential components and manufacturing components. It will be appreciated that these combinations are merely exemplary, and variations of these combinations are possible.

[0804]

[0805]

[0806] 5.11.11 Exemplary Embodiments

[0807] Table B below shows some exemplary examples of custom respiratory patient interfaces. Again, it will be appreciated that these combinations are merely exemplary, and variations of these combinations are possible.

[0808]

[0809] Examples A to K of Table B correspond to the examples of patient interfaces 1900A to 1900K shown in Figures 19A-19K . In Figure 19AThe patient interface 19000A includes three custom components, a frame 19001, an intermediate structure 19002, and a sealing element 19003, as shown. In this example, the frame 19001 is customised based on the patient facial topography and modified to maximise comfort and stability while minimising the size of this part. This geometry will be driven primarily by the acquired 3D surface data. Further inputs into the frame design can come from user preference inputs such as: tube / elbow type and location, vent location / type, colour, etc. The intermediate structure 19002 is also customised to provide a customised geometry or material composition that provides some finer adjustments geometrically and gasketing to the patient facial topography. The customisation of the intermediate structure 19002 can be driven by the 3D surface model and 2D pressure map. The sealing element 19003 is also customised to provide the fine adjustments needed to achieve a reliable and comfortable seal. Such finer adjustments can attempt to address the difference between the relaxed state and the deformed state (e.g. thicker regions of soft material in areas that consider larger deflections / movements in use or in areas of discomfort). The patient interface 19000A can be formed using the data collection techniques and modification algorithms discussed above.

[0810] Figure 19B The patient interface 19000B is substantially the same as the patient interface 19000A, except for the use of a standard sealing element 19003S. In this embodiment, the sealing element 19003S is a standard thin layer of elastomer, foam, gel and / or adhesive material that is easily attached to the intermediate component in a way that does not wrinkle / deform in an undesirable way and can be easily cut into every custom shape.

[0811] Figure 19C The patient interface 19000C is substantially the same as the patient interface 19000B, except for the use of a standard intermediate structure 19002S. In this embodiment, several sizes of standard intermediate components are used that fit different anthropometric ranges to provide offset and compliance regions similar to those seen in conventional patient interfaces. The patient interface 19000D includes a standard intermediate structure 19002S with a custom frame 19001 and sealing element 19003. Figure 19D In the patient interface 19000E, only the sealing element 19003 is customised, while the frame 19001S and intermediate structure 19002S are standard. Figure 19E In this embodiment, the standard frame 19001S can consist of one of several available sizes that can interface with one or all of several sizes of intermediate components 19002S. However, this embodiment primarily relates to a standard frame geometry where the user can still provide inputs for vent or colour or tube type / location.

[0812] In Figure 19F patient interface 1900F, only the intermediate structure 19002 is customized, while a standard frame 19001S and a standard sealing element 19003S are provided. The intermediate structure 19002 can provide a region that provides the proper offset function, a region of compliance, and customized macro- and micro-adjustments to fit the individual facial geometry, resulting in a stable and comfortable customized platform to which a sealing layer can be attached. In this example, the intermediate structure 19002 and the sealing element 19003 can be provided to the patient as a single piece, but composed of two different materials. The surface of the intermediate structure 19002 that interfaces with the standard frame can have to be provided with geometry that can be secured to the frame. This can be achieved by surface fusion from the patient data driven customized surface to the required standard surface. In one variant, the patient interface 19000G is similar to the patient interface 19000F, except that the sealing element 19003S is not customized in this embodiment Figure 19G ). In another variant, the patient interface 1900H includes an integrated intermediate structure and sealing element 19012 Figure 19H ). The integrated intermediate structure and sealing element 19012 can be molded from a single material, or formed by a multi- shot mold of different materials, or by additive manufacturing using a single or multiple materials. Thus, the integrated intermediate structure and sealing element 19012 is formed as a single part that is designed and manufactured as an integral unit, which is then attached to a standard or pre-existing frame 19001S. The patient interface 19000I provides a customized integrated frame / intermediate structure 19011 with a standard sealing element 19003S Figure 19I

[0813] In Figure 19J a patient interface 19000J is formed with a customized frame 19001 and a standardized sealing element 19003S. This embodiment eliminates the intermediate structure. Instead, the customized frame 19001 acts as both the frame and the intermediate structure. Finally, a fully customized single part 19100 patient interface 19000K is shown in Figure 19K . The single part 19100 can be formed from a single material (e.g., Mirage FX, Nano) or a combination of any of the materials discussed above. In some examples, the patient interface 19000K is formed from a single shot of a single material in a custom tool. Alternatively, the patient interface 19000K can be produced using multiple materials, using multi-shot injection molding in a custom tool, or directly via rapid manufacturing techniques including 3D printing with multiple materials of different properties using multi-head FDM or multi-material photopolymer printing, etc.

[0814] 5.11.12 Distribution 4700​

[0815] To provide the best benefit to the patient and to ensure that adequate seal is achieved, for example, between the frame and the sealing element described with respect to the custom nasal mask, information related to the mask can be recorded and stored on a central server. Such information can be entered at the time the patient opens an online account and creates a patient profile and includes data related to the initial face geometry scan, the geometry of the designed custom mask, personal aesthetic preferences, or flow generator parameter selections, among others. The online account can hold the patient's custom mask information and thus can serve as a platform that can update the custom mask details such as the geometry of the current patient face and also as a platform through which the patient can order more of their custom mask and thus optimize the benefit of their custom mask, thereby maintaining the patient's compliance with the desired therapy.

[0816] With the online account, the patient can be assigned a patient ID number or sequence (e.g., a barcode). The patient ID number can be marked on the custom mask to give product identification so that each mask can be traced back to their respective owner for returns, optimization, etc. For patients who purchase the mask product on their own, they can scan the ID number or sequence and can order mask components through traditional retail locations or online. In at least some examples, the ID number or sequence can include at least one of a barcode sequence or symbols (numbers, letters, etc.) that are pad printed, 3D color printed, or geometrically printed onto the mask components. A radio frequency ID chip can also be embedded in the mask, which can be embedded or inserted by a 3D printer after manufacturing. Additionally, a physical copy of the custom mask components (e.g., frame) can be stored and can be scanned later if replenishment is needed.

[0817] 5.12 Other Notes

[0818] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0819] Unless the context clearly dictates otherwise and where numerical ranges are provided, it is to be understood that every intermediate value within the range is to be considered as to be included in the technology. The upper and lower limits of these intermediate ranges can be independently included in the stated intermediate range and are also included in the technology, subject to any explicitly excluded limits in the stated ranges. Where the stated range includes one or both of the limits, ranges excluding either or both of the included limits are also included in the technology.

[0820] Further, where one or more values are described herein as being part of a process, unless otherwise stated the process can be performed with more than or less than this number of values. Further, any and all ranges recited herein are intended to include all sub-ranges of the same numbers.

[0821] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0822] When a particular material is named as preferred for the construction of a component, obvious alternative materials with similar properties can be used as a substitute. Further, any and all components described herein are to be understood that they can be made, and likewise, can be used, in combination or in isolation, unless otherwise specified.

[0823] It must be noted that, as used herein and in the appended claims, the singular form "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0824] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior application. Further, the dates of publication provided can be different from the actual publication dates, which can need to be independently confirmed.

[0825] Further, in interpreting this disclosure, all terms should be interpreted in the broadest possible way consistent with the context. Specifically, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, referring to the elements, components, or steps without excluding other possible elements, components, or steps.

[0826] The subject matter headings are included for ease of reference only and are not to be construed as limiting the scope of the application as described in the body of the specification or as limiting the claims attached. The headings are not intended to be limiting.

[0827] While the technology has been described herein with reference to specific embodiments, it is understood that these embodiments are merely illustrative of the principles and applications of the present technology. In some instances, special

[0828] It is therefore to be understood that numerous modifications can be made to the illustrative embodiments, and that other arrangements can be devised without departing from the spirit and scope of the present technology.

[0829] 6Reference numerals

[0830] Outer chamber 10

[0831] Patient 1000

[0832] Bed partner 1100

[0833] Virtual portal 1400

[0834] RPT device 1500

[0835] Third strap 1514

[0836] Air circuit 1600

[0837] Humidifier 1700

[0838] Nasal mask 1700

[0839] Silicone component 1804

[0840] Published version 2011

[0841] Patient interface 3000

[0842] Patient interface sealing surface 3100

[0843] Plenum chamber 3200

[0844] Headgear system 3300

[0845] Vent 3400

[0846] Forehead support 3500

[0847] Swivel 3510

[0848] Socket 3520

[0849] Connection port 3600

[0850] International Organization for Standardization 3744

[0851] Anti-asphyxia valve 3800

[0852] Patient interface customization method 4000

[0853] Remote external communication network 4282

[0854] Local external communication network 4284

[0855] Remote external device 4286

[0856] Local external device 4288

[0857] Display driver 4292

[0858] Display 4294

[0859] Patient data collection 4300

[0860] Step 4300

[0861] Relaxation state data collection 4301

[0862] Relaxation state data collection 4302

[0863] Pressure mapping 4303

[0864] User input 4304

[0865] Processing module 4310

[0866] Pressure compensation algorithm 4312

[0867] Vent flow calculation algorithm 4314

[0868] Leak flow algorithm 4316

[0869] Breath flow algorithm 4318

[0870] Phase determination algorithm 4321

[0871] Target ventilation determination algorithm 4328

[0872] Data processing step 4400

[0873] Post-processing step 4401

[0874] Experienced pressure 4402

[0875] Specific feature processing 4403

[0876] patient preferences 4404

[0877] output data packet 4450

[0878] geometric surface model design package 4451

[0879] pressure map design package 4452

[0880] patient interface design 4500

[0881] patient interface design package 4550

[0882] manufacturing 4600

[0883] dispensing 4700

[0884] final product 4700

[0885] laser scanning system 5000

[0886] laser 5001

[0887] lens 5002

[0888] sensor 5003

[0889] object 5050

[0890] humidifier reservoir 5110

[0891] humidifier reservoir base 5130

[0892] temperature sensor 5216

[0893] camera 6001

[0894] camera 6002

[0895] display 6003

[0896] patient 6050

[0897] data collection system 7000

[0898] rod 7001

[0899] force sensor 7002

[0900] handler 7003

[0901] patient face 7050

[0902] casting material 7060

[0903] mold 7065

[0904] scanner 7070

[0905] tool 7075

[0906] rigid deformation device 8001

[0907] facial deformation device 8001

[0908] camera 8002

[0909] device 8010

[0910] virtual patient interface 8020

[0911] pressure film 8021

[0912] tactile pressure film sensor 8021

[0913] processor 8022

[0914] pressure map 8030

[0915] patient skin 8050

[0916] nose bridge 8051

[0917] surface 8055

[0918] patient 9000

[0919] nose root 9003

[0920] nose bone 9004

[0921] philtrum 9005

[0922] lip wrinkle 9008

[0923] chin 9009

[0924] suborbicular 9015

[0925] lower cheek bone 9016

[0926] nostril side 9017

[0927] lip ridge 9018

[0928] jaw 9019

[0929] lower jaw 9020

[0930] nose patient interface 10000

[0931] first input 10010

[0932] corresponding filler 10012

[0933] second input 10020

[0934] corresponding gel portion 10022

[0935] third input 10030

[0936] beard patch 10032

[0937] patient 10100

[0938] patient 10200

[0939] patient head 10300

[0940] patient interface 10401

[0941] patient interface 11000

[0942] frame 11001

[0943] intermediate structure 11002

[0944] sealing element 11003

[0945] customized sealing element 11003

[0946] patient interface frame 12010

[0947] customized frame assembly 12020

[0948] frame 12030

[0949] standard frame 12040

[0950] frame 12041

[0951] standard frame 12042

[0952] patient face 12050

[0953] interlocking system 12060

[0954] customized component 12070

[0955] intermediate structure 13010

[0956] first component 13012

[0957] second component 13014

[0958] frame 13040

[0959] frame 13042

[0960] patient 13050

[0961] sealing element 13510

[0962] Optimal sealing element 13510

[0963] Sealing element 13511

[0964] Sealing element 13520

[0965] Sealing element 13522

[0966] Patient face 13550

[0967] Patient interface 13552

[0968] Cushion 14102

[0969] Inner cushion component 14104

[0970] Outer barrier layer 14106

[0971] Chamber 14108

[0972] Chamber material 14110

[0973] Ribs 14112

[0974] Optional inner barrier film 14512

[0975] Mask interconnect component 14516

[0976] Adhesive 14518

[0977] Optional clip 14520

[0978] Soft elastic foam 14560

[0979] Elastomer 14562

[0980] Foam ball 14564

[0981] Gel 14566

[0982] Cap portion 14672

[0983] Mask frame 14690

[0984] Passage 14692

[0985] Ridge 14694

[0986] Air port 14696

[0987] First layer 14802

[0988] Second layer 14804

[0989] Layer 14806

[0990] bottom end 14902

[0991] top end 14904

[0992] first layer 14912

[0993] second layer 14914

[0994] third layer 14916

[0995] fourth “hollow” layer 14918

[0996] frangible seal 14922

[0997] tab 14924

[0998] patient interface 15002

[0999] headgear 15004

[1000] first strap 15010

[1001] second strap 15012

[1002] third strap 15014

[1003] neck attachment 15040

[1004] crown attachment 15042

[1005] patient 15050

[1006] nose bridge anchor point 16002

[1007] mouth anchor point 16004

[1008] mouth anchor point 16006

[1009] ear anchor point 16008

[1010] patient 16050

[1011] patient interface 16060

[1012] sealing element 16062

[1013] precision sealing element 16062

[1014] structure 16070

[1015] compliant joint feature 16080

[1016] patient head 16100

[1017] skull 16102

[1018] patient skin 16104

[1019] nose 16106

[1020] headgear associated with the patient interface 16108

[1021] patient interface 16110

[1022] bed pillow 16120

[1023] infraorbital 16205

[1024] nasal alar corner 16210

[1025] nasal corner 16215

[1026] mid-nose 16220

[1027] width 16225

[1028] second portion 16246

[1029] first state 16300

[1030] second state 16305

[1031] patient 16350

[1032] headgear 16352

[1033] patient interface 16400

[1034] cannula 16401

[1035] sealing element 16402

[1036] headgear 16403

[1037] first portion 16404

[1038] second portion 16406

[1039] patient interface 16410

[1040] tubing 16411

[1041] sealing element 16412

[1042] headgear 16413

[1043] crown strap 16414

[1044] second portion 16416

[1045] belt buckle 16419

[1046] Patient Interface 16420

[1047] Catheter 16421

[1048] Sealing element 16422

[1049] Headband 16423

[1050] Part 1 16424

[1051] Part Two 16426

[1052] Wire component 16428

[1053] 17,000 nose mask or frame or frame assembly

[1054] Delivery catheter 17005

[1055] Headband 17010

[1056] Mark 17100

[1057] Surface 17102

[1058] Ellipse position 17120

[1059] Headband Vector 17130

[1060] Slot 17135

[1061] 17200 pressurization chamber

[1062] Inner wall 17210

[1063] Sealed receiving surface 17220

[1064] Orifice 17230

[1065] Vent 17240

[1066] Rigid arm 17250

[1067] First end 17252

[1068] Second end 17254

[1069] Sealing element 17300

[1070] Foam layer 17302

[1071] Adhesive PSA backing 17304

[1072] Single flat profile 17310

[1073] 3D model 17310

[1074] First surface 17350

[1075] Second surface 17355

[1076] Large blank component 18010

[1077] Excess material 18012

[1078] Custom part 18014

[1079] Patient 18050

[1080] Tool 18060

[1081] 18062 curved cut edge

[1082] Material 18070

[1083] Component 18072

[1084] Component 18074

[1085] Component 18076

[1086] Third floor 18106

[1087] Machine 18500

[1088] Soft tool 18502

[1089] Component 18504

[1090] Part 18510

[1091] Part 18520

[1092] Interchangeable tool insert 18522

[1093] Interchangeable tool insert 18524

[1094] Interchangeable tool insert 18526

[1095] Frame 19001

[1096] Intermediate structure 19002 [...

Claims

1. A patient interface for sealingly delivering a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance of a patient’s airways, the patient interface comprising: a mask assembly including a frame member having an opening to a delivery tube and having a plurality of vent holes in a row along a surface of the frame member; a sealing element couplable to the mask assembly and configured to be in contact with the patient’s face in use, wherein the frame member and the sealing element form a plenum chamber that defines a cavity through a periphery of the patient’s nares; and a positioning and stabilising structure coupled to the mask assembly, the positioning and stabilising structure being configured to maintain the sealing element in sealing contact with an area surrounding an entrance of the patient’s nares while maintaining a therapy pressure at the entrance of the patient’s nares; wherein at least one of the mask assembly, the sealing element, and the positioning and stabilising structure is configured to compensate for movement and deformation of the skin.

2. The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for a lateral skin excursion of between 1 mm to 30 mm relative to a longitudinal axis of the patient’s face.

3. The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for a naris angle deflection of between 1 degree to 30 degrees.

4. The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for an upward movement of a corner of the patient’s nose of up to 9 mm, and an upward movement of a middle of the patient’s nose of up to 4 mm, respectively.

5. The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for an increase in a width of the patient’s nose of between 1 mm and 4 mm.

6. The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for a cheek bulge from a first state to a second state, the first state and the second state being spaced apart by 1 mm to 10 mm.

7. The patient interface of any one of claims 1 to 6, wherein the positioning and stabilising structure includes a first portion and a second portion, the first portion and the second portion being configured to compensate for perturbations such that the sealing element remains in contact with the patient’s face when a force of up to 10 Newtons is applied to a portion of the positioning and stabilising structure.

8. The patient interface of claim 7, wherein the first portion is formed of a non-elastic material and the second portion is formed of an elastic material.

9. The patient interface of any one of claims 1 to 6, wherein the positioning and stabilising structure includes a first portion and a second portion, at least one of the first portion and the second portion having an elastic material configured to compensate for perturbations such that the sealing element remains in contact with the patient’s face when a force of up to 10 Newtons is applied to the positioning and stabilising structure.

10. The patient interface of any one of claims 1 to 6, wherein the positioning and stabilising structure comprises a first portion, a second portion, and a path portion coupled to the first portion and coextensive with the second portion, the second portion being translatable along the path portion.

11. The patient interface of claim 10, wherein the path portion comprises a wire frame.

12. The patient interface of any one of claims 1 to 6, wherein at least one of the mask assembly, the sealing element, and the positioning and stabilising structure is configured to compensate for a longitudinal skin offset relative to a longitudinal axis of the patient’s face of between 1 mm and 50 mm.

13. The patient interface of any one of claims 1 to 6, wherein the frame component further comprises a coupling portion that attaches the positioning and stabilising structure to the frame component.

14. The patient interface of claim 13, wherein the coupling portion comprises a slot with a rigid arm.

15. The patient interface of claim 13, wherein the patient interface is configured to compensate for a nose twitch.

16. A patient interface for sealingly delivering a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance of a patient’s nares, the patient interface comprising: a mask assembly comprising a frame component having an opening to a delivery tube and having a plurality of vent holes in a row along a surface of the frame component; a sealing element couplable to the mask assembly and configured to be in contact with the patient’s face in use, wherein the frame component and the sealing element form a plenum that defines a cavity through a perimeter of the patient’s nares, the sealing element being in the form of a cushion configured to compensate for nasal deformations; and a positioning and stabilising structure coupled to the mask assembly, the positioning and stabilising structure being configured to maintain the sealing element in sealing contact with an area surrounding an entrance of the patient’s nares while maintaining a therapy pressure at the entrance of the patient’s nares, the positioning and stabilising structure comprising a left side portion, a right side portion, and a crown portion, wherein the positioning and stabilising structure comprises a relatively inextensible material and a relatively extensible material, and wherein the left side portion and the right side portion each comprise a textile cover.

17. The patient interface of claim 16, wherein the sealing element comprises silicone.

18. The patient interface of claim 16, wherein the positioning and stabilising structure is configured to compensate for a nares angle deflection of between 1 degree and 30 degrees.

19. The patient interface of claim 16, wherein the left side portion is length adjustable by a buckle.

20. The patient interface of claim 16, wherein the right side portion is length adjustable by a buckle.

21. The patient interface of claim 16, wherein the positioning and stabilising structure is configured to compensate for a cheek bulge from a first state to a second state, the first state and the second state being separated by 1 mm to 10 mm.

22. The patient interface of claim 16, wherein the right side portion and the left side portion are each configured with a length that extends from the mask assembly, in use, to a position above the patient’s ears.

23. The patient interface of claim 22, wherein a first strap portion of the positioning and stabilising structure is formed from a non-elastic material, and a second strap portion of the positioning and stabilising structure is formed from an elastic material.

24. The patient interface of any one of claims 16 to 23, wherein the positioning and stabilising structure comprises a first portion and a second portion, at least one of the first portion and the second portion having an elastic material configured to compensate for perturbations such that the sealing element maintains contact with the patient’s face when a force of up to 10 Newtons is applied to the positioning and stabilising structure.

25. The patient interface of any one of claims 16 to 23, wherein at least one of the left side portion and the right side portion is rigidly configured to transfer tension of movement of the delivery tube to the crown portion.

26. The patient interface of claim 25, wherein the tension of movement of the delivery tube comprises tube torque.

27. The patient interface of claim 25, wherein the sealing element forms a seal extending along the patient’s pronasale, the outer perimeter of the nostrils, and the subnasale.

28. The patient interface of claim 27, wherein the frame component comprises a first rigid arm coupled with the left side portion and a second rigid arm coupled with the right side portion.

29. The patient interface of claim 28, wherein the sealing element is configured to be coupled with the frame component by mechanical engagement.

30. The patient interface of claim 28, wherein the first rigid arm and the second rigid arm are each detachably coupled to the frame component via a slot in the frame component.

31. The patient interface of claim 28, wherein a nose deformation comprises a nose twitch.

32. The patient interface of any one of claims 16 to 23, wherein at least one of the mask assembly, the sealing element, and the positioning and stabilising structure is configured to compensate for a lateral skin excursion of between 1 mm to 30 mm relative to a longitudinal axis of the patient’s face.

33. The patient interface of any one of claims 16 to 23, wherein the frame component further comprises a coupling portion that attaches the positioning and stabilising structure to the frame component.

34. A patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance of a patient’s nares, the patient interface comprising: a mask assembly comprising a frame component having an opening to a delivery tube and having a plurality of vent holes in a row along a surface of the frame component; A sealing element, which is connectable to the mask assembly and configured to contact the patient's face during use, wherein the frame component and the sealing element form a pressure chamber that defines a cavity through the periphery of the patient's nostrils, and the sealing element is in the form of a pad configured to compensate for nasal deformities; and A positioning and stabilizing structure, coupled to the mask assembly, is configured to maintain a sealing contact between the sealing element and an area surrounding the entrance to the patient's nostrils while maintaining therapeutic pressure at the entrance to the patient's nostrils. The positioning and stabilizing structure includes a left portion, a right portion, and a coronal portion. The positioning and stabilizing structure comprises relatively non-stretchable and relatively stretchable materials. The left and right portions each include a textile cover. The sealing element comprises silicone. At least one of the left and right strips is rigidly constructed to transfer tension from the movement of the delivery tube to the coronal strip.

35. The patient interface of claim 34, wherein the frame component includes a first rigid arm and a second rigid arm, the first rigid arm being connected to the left side portion and the second rigid arm being connected to the right side portion.

Images