Patent Application
20220296837
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.
This application claims the benefit of Australian Patent Application No. 2019902580 filed 22 Jul. 2019, Australian Patent Application No. 2019904852 filed 20 Dec. 2019, Singaporean Patent Application No. 10202001774V filed 27 Feb. 2020, Australian Patent Application No. 2020901769 filed 29 May 2020 and Australian Patent Application No. 2020901770 filed 29 May 2020, the entire contents of each of which are hereby incorporated by reference in their entirety.
The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use.
The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.
The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.
A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.
Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.
Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem. See U.S. Pat. No. 4,944,310 (Sullivan).
Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders: Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and chest wall disorders.
A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.
A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings.
Various therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV) and Invasive ventilation (IV) have been used to treat one or more of the above respiratory disorders.
Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.
These therapies may be provided by a treatment system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.
A treatment system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, and data management.
Another form of treatment system is a mandibular repositioning device.
A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and/or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmH2O.
Certain other mask systems may be functionally unsuitable for the present field. For example, purely ornamental masks may be unable to maintain a suitable pressure. Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient.
Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth.
Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips.
Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one's side in bed with a head on a pillow.
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 and heads varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.
As a consequence of these challenges, some masks suffer from being one or more of obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and uncomfortable especially when worn for long periods of time or when a patient is unfamiliar with a system. Wrongly sized masks can give rise to reduced compliance, reduced comfort and poorer patient outcomes. Masks designed solely for aviators, masks designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless such masks may be undesirably uncomfortable to be worn for extended periods of time, e.g., several hours. This discomfort may lead to a reduction in patient compliance with therapy. This is even more so if the mask is to be worn during sleep.
CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.
While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.
For these reasons, patient interfaces for delivery of CPAP during sleep form a distinct field.
Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure can have a direct impact the effectiveness and comfort of the patient interface.
A patient interface may be partly characterised according to the design intent of where the seal-forming structure is to engage with the face in use. In one form of patient interface, a seal-forming structure may comprise a first sub-portion to form a seal around the left naris and a second sub-portion to form a seal around the right naris. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal-forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.
A seal-forming structure that may be effective in one region of a patient's face may be inappropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient's face. For example, a seal on swimming goggles that overlays a patient's forehead may not be appropriate to use on a patient's nose.
Certain seal-forming structures may be designed for mass manufacture such that one design fits and is comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient's face, and the seal-forming structure of the mass-manufactured patient interface, one or both must adapt in order for a seal to form.
One type of seal-forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.
Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.
Another type of seal-forming structure may comprise a friction-fit element, e.g. for insertion into a naris, however some patients find these uncomfortable.
Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.
A range of patient interface seal-forming structure technologies are disclosed in the following patent applications, assigned to ResMed Limited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.
One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.
ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask, SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGE LIBERTY™ full-face mask. The following patent applications, assigned to ResMed Limited, describe examples of nasal pillows masks: International Patent Application WO2004/073,778 (describing amongst other things aspects of the ResMed Limited SWIFT™ nasal pillows), US Patent Application 2009/0044808 (describing amongst other things aspects of the ResMed Limited SWIFT™ LT nasal pillows); International Patent Applications WO 2005/063,328 and WO 2006/130,903 (describing amongst other things aspects of the ResMed Limited MIRAGE LIBERTY™ full-face mask); International Patent Application WO 2009/052,560 (describing amongst other things aspects of the ResMed Limited SWIFT™ FX nasal pillows).
A seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face.
One technique is the use of adhesives. See for example US Patent Application Publication No. US 2010/0000534. However, the use of adhesives may be uncomfortable for some.
Another technique is the use of one or more straps and/or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.
In one type of treatment system, a flow of pressurised air is provided to a patient interface through a conduit in an air circuit that fluidly connects to the patient interface so that, when the patient interface is positioned on the patient's face during use, the conduit extends out of the patient interface forwards away from the patient's face. This may sometimes be referred to as an “elephant trunk” style of interface.
Some patients find such interfaces to be unsightly and are consequently deterred from wearing them, reducing patient compliance. Additionally, conduits connecting to an interface at the front of a patient's face may sometimes be vulnerable to becoming tangled up in bed clothes.
An alternative type of treatment system which seeks to address these problems comprises a patient interface in which a tube that delivers pressurised air to the patient's airways also functions as part of the headgear to position and stabilise the seal-forming portion of the patient interface to the appropriate part of the patient's face. This type of patient interface may be referred to as incorporating ‘headgear tubing’ or ‘conduit headgear’. Such patient interfaces allow the conduit in the air circuit providing the flow of pressurised air from a respiratory pressure therapy device to connect to the patient interface in a position other than in front of the patient's face. One example of such a treatment system is disclosed in US Patent Publication No. US 2007/0246043, the contents of which are incorporated herein by reference, in which the conduit connects to a tube in the patient interface through a port positioned in use on top of the patient's head.
Patient interfaces incorporating headgear tubing may provide some advantages, for example avoiding a conduit connecting to the patient interface at the front of a patient's face, which may be unsightly and obtrusive. However, it is desirable for patient interfaces incorporating headgear tubing to be comfortable for a patient to wear over a prolonged duration when the patient is asleep while forming an effective seal with the patient's face.
A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressurised. Examples of RPT devices include a CPAP device and a ventilator.
Air pressure generators are known in a range of applications, e.g. industrial-scale ventilation systems. However, air pressure generators for medical applications have particular requirements not fulfilled by more generalised air pressure generators, such as the reliability, size and weight requirements of medical devices. In addition, even devices designed for medical treatment may suffer from shortcomings, pertaining to one or more of: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.
An example of the special requirements of certain RPT devices is acoustic noise.
The designer of a device may be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, the comfort and efficacy of certain aspects may be highly sensitive to small, subtle changes in one or more parameters.
Delivery of a flow of air without humidification may cause drying of airways. The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. In addition, in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.
A range of artificial humidification devices and systems are known, however they may not fulfil the specialised requirements of a medical humidifier.
Medical humidifiers are used to increase humidity and/or temperature of the flow of air in relation to ambient air when required, typically where the patient may be asleep or resting (e.g. at a hospital). A medical humidifier for bedside placement may be small. A medical humidifier may be configured to only humidify and/or heat the flow of air delivered to the patient without humidifying and/or heating the patient's surroundings. Room-based systems (e.g. a sauna, an air conditioner, or an evaporative cooler), for example, may also humidify air that is breathed in by the patient, however those systems would also humidify and/or heat the entire room, which may cause discomfort to the occupants. Furthermore medical humidifiers may have more stringent safety constraints than industrial humidifiers
While a number of medical humidifiers are known, they can suffer from one or more shortcomings. Some medical humidifiers may provide inadequate humidification, some are difficult or inconvenient to use by patients.
Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide. The vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.
The vent may comprise an orifice and gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become blocked in use and thus provide insufficient washout. Some vents may be disruptive of the sleep of a bed partner 1100 of the patient 1000, e.g. through noise or focused airflow.
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. WO 2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application Publication No. US 2009/0050156; US Patent Application Publication No. 2009/0044808.
Table of noise of prior masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m)
Sound pressure values of a variety of objects are listed below
The present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.
A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.
Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.
An aspect of certain forms of the present technology is to provide methods and/or apparatus that improve the compliance of patients with respiratory therapy.
One form of the present technology comprises a patient interface for delivery of a supply of pressurised breathable gas to an entrance of a patient's airways.
One aspect of the present technology comprises a patient interface having a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may be at least partially formed by a chassis portion and a seal-forming structure of the patient interface.
One aspect of the present technology is a cushion module for a patient interface, the cushion module comprising a chassis portion and a seal-forming structure.
One aspect of one form of the present technology is a patient interface, or a cushion module for a patient interface, comprising a chassis portion and a seal-forming structure together forming a plenum chamber. The chassis portion may comprise laterally projecting connection portions configured for connection to gas delivery tubes. The seal-forming structure may comprise a central portion configured to seal in use against an inferior periphery of the patient's nose surrounding the patient's nares. The seal-forming structure may comprise decoupling portions each configured to at least partially decouple the central portion from a respective one of the laterally projecting connection portions. The seal-forming structure may further comprise peripheral portions adjacent the decoupling portions and being stiffer and/or thicker than the decoupling portions.
One aspect of one form of the present technology is a patient interface comprising:
a chassis portion partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion comprising a pair of laterally projecting connection portions configured to connect to gas delivery tubes and being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal forming structure comprises:
In examples: (a) the stiffness of each peripheral portion is greater than a stiffness of the central portion of the seal-forming structure; (b) the stiffness of the decoupling portion of each lateral posterior region is greater than the stiffness of the central portion of the seal-forming structure; (c) a wall thickness of the peripheral portion of each lateral posterior region is greater than a wall thickness of the central portion of the seal-forming structure; (d) the wall thickness of the peripheral portion of each lateral posterior region is greater than a wall thickness of the decoupling portion of each lateral posterior region; (e) the wall thickness of the decoupling portion of each lateral posterior region is greater than the wall thickness of the central portion of the seal-forming structure; (f) the decoupling portion of each lateral posterior region is C-shaped when viewed from a lateral side of the seal-forming structure; (g) each of the peripheral portions partially or fully surrounds a respective decoupling portion; (h) each decoupling portion is formed by a recess in an internal surface of the seal-forming structure within the respective lateral posterior region; (i) the patient interface further comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; (j) the patient interface further comprises the gas delivery tubes, and the gas delivery tubes form part of the positioning and stabilising structure, each gas delivery tube being configured to convey the flow of air from a location atop the patient's head to the interior of the chassis portion in use; (k) the central portion of the seal-forming structure is formed from a textile material; (l) the central portion of the seal-forming structure is formed from silicone or another elastomeric material; (m) the lateral posterior regions are formed from silicone or another elastomeric material; (n) the chassis portion is formed from a flexible material; (o) the chassis portion is formed from silicone; (p) the patient interface comprises a removable cushion module, the removable cushion module comprising the chassis portion and the seal-forming structure; and/or (q) the chassis portion is formed from an elastomeric material.
One aspect of one form of the present technology is a patient interface comprising a chassis portion and a seal-forming structure together at least partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The chassis portion may comprise a pair of laterally projecting connection portions configured to connect to gas delivery tubes and being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The seal-forming structure may be supported by the chassis portion and may have at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
The seal forming structure may comprise a central portion configured to form a seal in use against the patient's face surrounding the patient's nares and without contacting the bridge of the patient's nose. The seal-forming structure may further comprise a pair of lateral posterior regions provided on respective lateral posterior sides of the seal-forming structure. Each lateral posterior region may comprise a decoupling portion configured to at least partially decouple the central portion of the seal-forming structure from a respective one of the laterally projecting connection portions. Each lateral posterior region may comprise a peripheral portion at least partially surrounding the respective decoupling portion. At least part of the peripheral portion may be located posterior to the respective decoupling portion. The decoupling portions may be thicker than the peripheral portions.
One aspect of one form of the present technology is a patient interface, or a cushion module for a patient interface, comprising a chassis portion and a seal-forming structure together forming a plenum chamber. The seal-forming structure may comprise a central portion configured to seal in use against an inferior periphery of the patient's nose surrounding the patient's nares. The seal-forming structure may further comprise mid-lateral portions on either side of the central portion and being configured to lie alongside the patient's nasal ala. The seal-forming structure may further comprise rigidising portions located on at least a posterior side of the seal-forming structure. The rigidising portions may be stiffer and/or thicker than the mid-lateral portions. The mid-lateral portions may be stiffer and/or thicker than the central portion.
One aspect of one form of the present technology is a patient interface comprising:
a chassis portion partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; and
a seal-forming structure provided to the chassis portion, the seal-forming structure partially forming the plenum chamber and being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal forming structure comprises:
In examples: (a) each rigidising portion has negative curvature along a first path from the posterior side of the seal-forming structure to the anterior side of the seal-forming structure; (b) each rigidising portion has zero curvature or negative curvature along a second path that is perpendicular to the first path; (c) each rigidising portion comprises an anterior portion provided to the anterior side of the seal-forming structure and a posterior portion provided to the posterior side of the seal-forming structure, wherein the anterior portion has a stiffness greater than a stiffness of the posterior portion; (d) the anterior portion of each rigidising portion comprises a thickness greater than a thickness of the posterior portion of the rigidising portion; (e) each rigidising portion comprises a tapered increase in thickness between the posterior portion of the rigidising portion and the anterior portion of the rigidising portion; (f) the stiffness of the anterior portion of the rigidising portion is greater than a stiffness of an adjacent portion of the seal-forming structure on the anterior side thereof; (g) the thickness of the anterior portion of the rigidising portion is greater than a thickness of the adjacent portion of the seal-forming structure on the anterior side thereof; (h) the stiffness of the posterior portion of the rigidising portion is greater than a stiffness of an adjacent portion of the posterior side of the seal-forming structure; (i) the thickness of the posterior portion of the rigidising portion is greater than a thickness of the adjacent portion on the posterior side of the seal-forming structure; (j) each rigidising portion comprises a greater wall thickness than adjacent regions, the greater wall thickness being formed by extra thickness of an internal surface of the seal-forming structure; (k) each rigidising portion is located in use proximate a respective one of the patient's nasal ala; (l) the chassis portion comprises a pair of laterally projecting connection portions configured to connect to gas delivery tubes each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; (m) the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion; (n) each rigidising portion is located proximate a respective one of the laterally projecting connection portions; (o) the chassis portion is formed from a flexible material; (p) the chassis portion is formed from silicone or another elastomeric material; (q) the central portion of the seal-forming structure is formed from a textile material; (r) the central portion of the seal-forming structure is formed from silicone or another elastomeric material; and/or (s) the rigidising portions are formed from silicone or another elastomeric material.
One aspect of one form of the present technology is a patient interface comprising a chassis portion and a seal-forming structure together at least partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure may be supported by the chassis portion and may have at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
The seal forming structure may comprise a central portion on a posterior side of the seal-forming structure and configured to form a seal in use against the patient's face surrounding the patient's nares and without contacting the bridge of the patient's nose. The seal-forming structure may comprise a pair of rigidising portions, each rigidising portion located on a respective lateral side of the seal-forming structure. Each rigidising portion may have an anterior portion on non-patient contacting side of the seal-forming structure and a posterior portion on a patient-contacting side of the seal-forming structure. The anterior portion may be thicker than the posterior portion.
One aspect of one form of the present technology is a patient interface, or a cushion module for a patient interface, comprising a chassis portion and a seal-forming structure together forming a plenum chamber. The seal-forming structure may comprise a central portion configured to seal in use against an inferior periphery of the patient's nose surrounding the patient's nares. The seal-forming structure may further comprise mid-lateral portions on either side of the central portion and configured to lie alongside the patient's nasal ala. The seal-forming structure may further comprise a pair of mid-lateral posterior support portions each located proximate a junction between the central portion and a respective mid-lateral portion. Each mid-lateral posterior support portion may have a stiffness and/or thickness greater than the stiffness of the central portion and less than the stiffness of each mid-lateral portion.
One aspect of one form of the present technology is a patient interface comprising:
a chassis portion partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient
a seal-forming structure provided to the chassis portion, the seal-forming structure partially forming the plenum chamber and being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal forming structure comprises:
In examples: (a) the seal-forming structure comprises a pair of posterior corner portions configured to engage with the patient's face proximate the patient's nasolabial sulci in use, the stiffness of each mid-lateral posterior support portion being less than a stiffness of each posterior corner portions; (b) the stiffness of each posterior corner portion is greater than the stiffness of each mid-lateral portion; (c) each mid-lateral portion comprises a thickness greater than a thickness of the central portion; (d) the thickness of each mid-lateral posterior support portion is greater than the thickness of the central portion; (e) the thickness of each mid-lateral posterior support portion is less than the thickness of each mid-lateral portion; (f) the thickness of each mid-lateral posterior support portion is less than a thickness of each posterior corner portion; (g) the thickness of each posterior corner portion is greater than the thickness of the mid-lateral portions; (h) the thickness of each mid-lateral posterior support portion is tapered and increases towards the respective adjacent mid-lateral portion; (i) the tapered thickness of each mid-lateral posterior support portion increases to the thickness of the respective adjacent mid-lateral portion; (j) the thickness of each mid-lateral support portion may be in the range of 0.3-0.7 mm; and/or (k) the thickness of each mid-lateral support portion may be in the range of 0.4-0.6 mm.
In further examples: (a) the chassis portion comprises a pair of laterally projecting connection portions each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; (b) wherein the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion; (c) the central portion of the seal-forming structure is formed from a textile material; (d) the central portion of the seal-forming structure is formed from silicone or another elastomeric material; (e) the laterally posterior regions are formed from silicone or another elastomeric material; (f) the chassis portion is flexible; and/or (g) the chassis portion is formed from silicone or another elastomeric material.
One aspect of one form of the present technology is a patient interface, or a cushion module for a patient interface, comprising a chassis portion and a seal-forming structure together forming a plenum chamber. The chassis portion may comprise laterally projecting connection portions configured for connection to gas delivery tubes. The seal-forming structure may comprise a central portion configured to seal in use against an inferior periphery of the patient's nose surrounding the patient's nares. The chassis portion may be formed from a flexible material and may be stiffened by a rigidiser. The rigidiser may comprise a vent module.
One aspect of one form of the present technology is a patient interface comprising:
a chassis portion partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion comprising a pair of laterally projecting connection portions sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion, the seal-forming structure partially forming the plenum chamber and being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a pair of gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the chassis portion and the seal-forming structure are formed from a flexible material, and
wherein the patient interface further comprises a rigidiser provided to the chassis portion, the rigidiser configured to resist deformation of the chassis portion.
In examples: (a) the rigidiser is provided to an anterior side of the chassis portion; (b) the chassis portion comprises an anterior hole configured to receive the rigidiser; (c) the rigidiser comprises a vent module comprising the vent; (d) the vent comprises a plurality of vent holes through which the continuous flow of gases exhaled by the patient passes from the interior of the plenum chamber to ambient; (e) the plurality of vent holes comprises upstream vent holes and downstream vent holes; (f) the plurality of downstream vent holes comprises one or more superior vent holes and one or more inferior vent holes; (g) the one or more superior vent holes are configured to direct exhaust gas in a direction at an angle towards the superior with respect to an axis normal to an anterior face of the vent module; (h) the one or more inferior vent holes are configured to direct exhaust gas in a direction at an angle towards the inferior with respect to the axis normal to the anterior face of the vent module; (i) the angle towards the superior is greater than the angle towards the inferior; (j) a sum of the angle towards the superior and the angle towards the inferior is within the range of 60-100 degrees; (k) the sum of the angle towards the superior and the angle towards the inferior is within the range of 70-90 degrees; (l) the sum of the angle towards the superior and the angle towards the inferior is substantially 80 degrees; (m) the plurality of downstream vent holes comprises a pair of superior vent holes; (n) the plurality of downstream vent holes comprises a pair of inferior vent holes; (o) the vent module is configured to support a diffuser through which the continuous flow of gases exhaled by the patient is able to pass when flowing to ambient; (p) the vent module is configured to allow the continuous flow of gases exhaled by the patient from the interior of the plenum chamber to ambient to pass into and out of the diffuser after passing through the upstream vent holes; (q) the vent module is configured to allow the continuous flow of gases exhaled by the patient from the interior of the plenum chamber to ambient to pass into and out of the diffuser before passing through the downstream vent holes; and/or (r) the vent module is configured to allow the continuous flow of gases exhaled by the patient from the interior of the plenum chamber to ambient to pass by the diffuser without flowing through the diffuser.
In further examples: (a) the vent module comprises a peripheral channel configured to receive a portion of the chassis portion of the plenum chamber; (b) the chassis portion comprises a lip configured to be received within the peripheral channel of the vent module; (c) the lip defines the anterior hole of the plenum chamber; (d) the lip is thicker than adjacent portions of the chassis portion of the plenum chamber; (e) the lip is the thickest portion of the chassis portion; (f) the lip comprises a thickness in the range of 3-5 mm; and/or (g) the thickness of the lip is within the range of 3.5-4.5 mm; (h) thickness of the lip is substantially 4 mm.
In further examples: (a) the chassis portion is formed from an elastomeric material; (b) the chassis portion is formed from silicone; (c) the seal-forming structure is formed at least partially from silicone; (d) the seal-forming structure is formed at least partially from a textile material; and/or (e) the rigidiser is formed at least partially from a substantially rigid material.
In further examples: (a) the seal-forming structure comprises a central portion on a posterior side of the seal-forming structure, the central portion being configured to seal in use against at least the patient's pronasale, nasal alae and lip superior; (b) the seal-forming structure does not enter the patient's nares; (c) the patient interface is configured to leave the patient's mouth uncovered.
One aspect of one form of the present technology is a patient interface comprising a chassis portion and a seal-forming structure together at least partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The chassis portion may comprise a pair of laterally projecting connection portions configured to connect to gas delivery tubes and being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The seal-forming structure may be supported by the chassis portion and may have at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
The patient interface may comprise a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use. The vent may comprise a plurality of vent holes through which the flow of gases exhaled by the patient passes from the interior of the plenum chamber to ambient, including one or more superior vent holes and one or more inferior vent holes. The one or more superior vent holes may be configured to direct exhaust gas in a direction at an angle towards the superior with respect to an axis normal to an anterior face of the vent module and the one or more inferior vent holes are configured to direct exhaust gas in a direction at an angle towards the inferior with respect to the axis normal to the anterior face of the vent module. The angle towards the superior may be greater than the angle towards the inferior.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal-forming structure comprises:
In examples: (a) the inferior portion of the central anterior portion has a wall thickness greater than a wall thickness of the superior portion of the central anterior portion; (b) the superior portion of the central anterior portion has substantially the same wall thickness as the central portion of the seal-forming structure; (c) the seal-forming structure comprises a pair of mid-lateral portions on the posterior side of the seal-forming structure, each mid-lateral portion provided on a respective lateral side of the central portion, each mid-lateral portion having a stiffness greater than a stiffness of the central portion; (d) the mid-lateral portions have a wall thickness greater than the superior portion of the central anterior portion; (e) the seal-forming structure comprises a pair of mid-lateral anterior portions on the anterior side of the seal-forming structure and located on respective lateral sides of the central anterior portion, each of the pair or mid-lateral anterior portions having a wall thickness greater than a wall thickness of the central anterior portion; (f) the chassis portion comprises a pair of laterally projecting connection portions each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; and/or (g) the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion.
In further examples: (a) the chassis portion is formed from an elastomeric material; (b) the chassis portion is formed from silicone; (c) the seal-forming structure is formed at least partially from silicone; and/or (d) the seal-forming structure is formed at least partially from a textile material.
One aspect of one form of the present technology is a patient interface comprising a chassis portion and a seal-forming structure together at least partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure may be supported by the chassis portion and may have at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
The seal forming structure may comprise a central portion on a posterior side of the seal-forming structure and configured to form a seal in use against the patient's face surrounding the patient's nares and without contacting the bridge of the patient's nose. The seal-forming structure may comprise a central anterior portion on a non-patient contacting side of the seal-forming and a pair of mid-lateral anterior portions provided on either lateral side of the central anterior portion. The central anterior portion may comprise a superior portion and an inferior portion, the inferior portion of the central anterior portion being thicker than the superior portion of the central anterior portion. The mid-lateral anterior portions may each have a superior portion and an inferior portion, the inferior portion of each mid-lateral anterior portion being thicker than the superior portion of each mid-lateral anterior portion.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal-forming structure comprises:
In examples: (a) the inferior portion of each mid-lateral anterior portion has a wall thickness greater than a wall thickness of the respective superior portion of the mid-lateral anterior portion; (b) the wall thickness of the inferior portion of each mid-lateral anterior portion is greater than a wall thickness of the central anterior portion of the seal-forming structure; (c) the wall thickness of the inferior portion of each mid-lateral anterior portion is greater than a wall thickness of the central portion of the posterior side of the seal-forming structure; (d) the superior portion of each mid-lateral anterior portion has a wall thickness greater than a wall thickness of the central anterior portion of the seal-forming structure; (e) the wall thickness of the superior portion of each mid-lateral anterior portion is greater than a wall thickness of the central portion of the posterior side of the seal-forming structure; (f) the seal-forming structure comprises a pair of mid-lateral portions on the posterior side of the seal-forming structure, each mid-lateral portion provided on a respective lateral side of the central portion, each mid-lateral portion having a wall thickness greater than a wall thickness of the central portion; (g) the inferior portion of each mid-lateral anterior portion has a greater wall thickness than a wall thickness of the mid-lateral portions of the posterior side of the seal-forming structure; (h) the superior portion of each mid-lateral anterior portion has a greater wall thickness than the wall thickness of the mid-lateral portions of the posterior side of the seal-forming structure; (i) the chassis portion comprises a pair of laterally projecting connection portions each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; and/or (j) the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion.
In further examples: (a) the chassis portion is formed from an elastomeric material; (b) the chassis portion is formed from silicone; (c) the seal-forming structure is formed at least partially from silicone; and/or (d) the seal-forming structure is formed at least partially from a textile material.
One aspect of one form of the present technology is a patient interface comprising a chassis portion and a seal-forming structure together at least partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure may be supported by the chassis portion and may have at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
The seal forming structure may comprise a central portion on a posterior side of the seal-forming structure and configured to form a seal in use against the patient's face surrounding the patient's nares and without contacting the bridge of the patient's nose. The seal-forming structure may comprise a central anterior portion on a non-patient contacting side of the seal-forming and a pair of mid-lateral anterior portions provided on either lateral side of the central anterior portion. The mid-lateral anterior portions each having a superior portion and an inferior portion, the inferior portion of each mid-lateral anterior portion being thicker than the superior portion of each mid-lateral anterior portion. The seal-forming structure may further comprise a pair of mid-lateral portions on the posterior side of the seal-forming structure, each provided on a respective lateral side of the central portion and having a wall thickness greater than a wall thickness of the central portion.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion formed from a flexible material and partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion comprising a pair of laterally projecting connection portions sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a pair of gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion;
wherein the seal-forming structure comprises a central portion on a posterior side of the seal-forming structure, the central portion being configured to seal in use against at least the patient's pronasale, nasal alae and lip superior;
wherein the chassis portion comprises a pair of chassis superior reinforcing portions each provided to a respective lateral and anterior side of the chassis portion, the chassis superior reinforcing portions each having a greater stiffness than one or more adjacent portions of the chassis portions.
In examples: (a) the chassis superior reinforcing portions are located adjacent the seal-forming structure; (b) each chassis superior reinforcing portion is located at a respective superior corner of an anterior hole of the chassis portion; (c) the seal-forming structure comprises: a central anterior portion on an anterior side of the seal-forming structure and located in use proximate and inferior to the patient's pronasale; and a pair of mid-lateral anterior portions on the anterior side of the seal-forming structure each located on a respective lateral side of the central anterior portion, wherein each of the chassis superior reinforcing portions is located adjacent a respective one of the mid-lateral anterior portions of the seal-forming structure; (d) each one of the mid-lateral anterior portions of the seal-forming structure comprises a superior portion and an inferior portion, the chassis superior reinforcing portions each being located adjacent a respective one of the inferior portions; (e) the chassis superior reinforcing portions has a wall thickness that is the same as the wall thickness of the inferior portions of the mid-lateral anterior portions; (f) the chassis superior reinforcing portions have a wall thickness of between 1 mm and 3 mm; (g) the chassis superior reinforcing portions have a wall thickness of between 1.5 mm and 2 mm; (h) the chassis superior reinforcing portions have a wall thickness of 1.7 mm; (i) the seal-forming structure is formed from the flexible material; (j) the seal-forming structure does not enter the patient's nares; (k) the patient interface is configured to leave the patient's mouth uncovered; and/or (l) the chassis superior reinforcing portions have a wall thickness greater than the one or more adjacent portions of the chassis portion.
In further examples: (a) the chassis portion is formed from an elastomeric material; (b) the chassis portion is formed from silicone; (c) the seal-forming structure is formed at least partially from silicone; and/or (d) the seal-forming structure is formed at least partially from a textile material.
One aspect of one form of the present technology is a patient interface comprising a chassis portion and a seal-forming structure together at least partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure may be supported by the chassis portion and may have at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. The chassis portion may be formed from a flexible material and may comprise a pair of chassis superior reinforcing portions each provided to a respective lateral and anterior side of the chassis portion. The chassis superior reinforcing portions may each have a greater stiffness than one or more adjacent portions of the chassis portions.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion formed from a flexible material and partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion comprising a pair of laterally projecting connection portions sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure formed from the flexible material, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a pair of gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion;
wherein the seal-forming structure and at least a majority of the chassis portion are formed together from a single homogenous piece of the flexible material;
wherein the seal-forming structure comprises:
In examples: (a) the anterior portion of the lip superior portion has a thickness greater than a thickness of the posterior portion of the lip superior portion; (b) the thickness of the posterior portion of the lip superior portion is the same as a thickness of a portion of the central portion of the seal-forming structure adjacent to the lip superior portion; (c) the thickness of the posterior portion of the lip superior portion is in the range of 0.1 mm to 0.5 mm; (d) the thickness of the posterior portion of the lip superior portion is in the range of 0.2 mm to 0.3 mm; (e) the thickness of the posterior portion of the lip superior portion is 0.25 mm; (f) the thickness of the anterior portion of the lip superior portion is in the range of 1.2 mm to 1.8 mm; (g) the thickness of the anterior portion of the lip superior portion is in the range of 1.4 to 1.6 mm; (h) the thickness of the anterior portion of the lip superior portion is 1.5 mm; (i) the seal-forming structure comprises a pair of lateral posterior regions on respective lateral posterior sides of the lip superior portion, the thickness of the posterior portion of the lip superior portion is less than a thickness of the lateral posterior regions; and/or (j) the thickness of the anterior portion of the lip superior portion is the same as the thickness of the lateral posterior regions.
In further examples: (a) the chassis portion is formed from an elastomeric material; (b) the chassis portion is formed from silicone; (c) the seal-forming structure is formed at least partially from silicone; and/or (d) the seal-forming structure is formed at least partially from a textile material.
One aspect of one form of the present technology is a patient interface comprising a chassis portion and a seal-forming structure together at least partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The seal-forming structure may be supported by the chassis portion and may have at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. The seal-forming structure may comprise a central portion on the posterior side of the seal-forming structure configured to seal against the patient's face surrounding the patient's airways, the central portion comprising a lip superior portion configured to seal against the patient's lip superior, the lip superior portion comprising an anterior portion adjacent the chassis portion and a posterior portion configured to contact the patient's lip superior, the anterior portion being thicker than the posterior portion. The chassis portion may be formed from a flexible material.
Another aspect of one form of the present technology is a patient interface comprising:
a cushion module comprising:
a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a pair of gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion; and
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use,
wherein each gas delivery tube of the positioning and stabilising structure comprises a tube end connector proximate a tube end of the gas delivery tube, each tube end connector having at least one clip projection; and
wherein the cushion module comprises a pair of connectors, each connector configured to fluidly connect a respective one of the laterally projecting connection portions of the chassis portion to a respective one of the gas delivery tubes, each connector comprising:
In examples: (a) the length of the clip base portion is greater than the length of the clip arm between the clip base portion and the recess; (b) a ratio of the length of the clip base portion to the length of the clip arm between the clip base portion and the recess is equal to or greater than 1.5:1; (c) the ratio is equal to or greater than 1.7:1; (d) the ratio is equal to or greater than 1.9:1; (e) the ratio is equal to or greater than 2:1; (f) a force required to disconnect each connector of the cushion module from the tube end connector of the respective gas delivery tube is greater than 12N; (g) the force required is greater than 20N; (h) the force required is greater than 25N; (i) the force required is greater than 30N; (j) the force required is in the range of 12N-50N; the force required is in the range of 20N-40N; (k) the force required is in the range 25N-35N; (l) the connector of the cushion module comprises a pair of clip arms projecting away from the clip base portion; (m) each one of the pair of clip arms comprises a respective recess configured to receive a respective clip projection; and/or (n) the chassis portion of the cushion module is formed from a flexible material.
Another aspect of one form of the present technology comprises a patient interface comprising:
a chassis portion formed from a flexible material and partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal-forming structure comprises:
In examples: (a) the stiffness of each of the medial portions of the mid-lateral anterior portions is greater than a stiffness of the central anterior portion; (b) each of the medial portions of the mid-lateral anterior portions comprises a wall thickness greater than a wall thickness of the central anterior portion; (c) each of the lateral portions of the mid-lateral anterior portions comprises a superior portion and an inferior portion, the inferior portion having a stiffness greater than a stiffness of the superior portion; (d) the inferior portion of the lateral portion of each mid-lateral anterior portion has a wall thickness greater than a wall thickness of the superior portion; (e) the wall thickness of the medial portion of the mid-lateral anterior portion is greater than a wall thickness of the superior portion of the lateral portion of each mid-lateral anterior portion; (f) the wall thickness of the medial portion of the mid-lateral anterior portion is less than a wall thickness of the inferior portion of each mid-lateral anterior portion; (g) the chassis portion comprises a pair of chassis superior reinforcing portions each provided to a respective lateral and anterior side of the chassis portion, the chassis superior reinforcing portions each having a greater stiffness than one or more adjacent portions of the chassis portion; (h) the chassis superior reinforcing portions are located adjacent the seal-forming structure; (i) each chassis superior reinforcing portion is located adjacent a respective one of the mid-lateral anterior portions; (j) each chassis superior reinforcing portion is located adjacent a respective one of the inferior portions of the mid-lateral anterior portions; (k) each chassis superior reinforcing portion comprises a greater wall thickness than a wall thickness of the mid-lateral anterior portions; and/or (l) each chassis superior reinforcing portion comprises a greater wall thickness than the wall thickness of the medial portion of the mid-lateral anterior portions.
In further examples: (a) the chassis portion comprises a pair of laterally projecting connection portions each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; (b) the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is formed at least partially from silicone; and/or (f) the seal-forming structure is formed at least partially from a textile material.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion formed from a flexible material and partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal-forming structure comprises:
In examples: (a) the superior portion of the anterior portion of each lateral posterior region has a wall thickness greater than a wall thickness of the posterior portion; (b) the superior portion of the anterior portion of each lateral posterior region has a wall thickness greater than a wall thickness of the inferior portion of the anterior portion of each lateral posterior region; (c) the seal-forming structure comprises a pair of mid-lateral anterior portions on the anterior side of the seal-forming structure each located on a respective lateral side of the seal-forming structure, the mid-lateral anterior portions having a stiffness greater than a stiffness of the central portion; (d) each of the anterior portions of the lateral posterior regions has a wall thickness greater than a wall thickness of each of the mid-lateral anterior portions; (e) the superior portion of the anterior portion of each lateral posterior region has a wall thickness greater than the wall thickness of each mid-lateral anterior portion; (f) each mid-lateral anterior portion comprises a superior portion and an inferior portion, the inferior portion being stiffer than the superior portion; (g) the inferior portion of each mid-lateral anterior portion has a wall thickness greater than a wall thickness of the superior portion of the mid-lateral anterior portion; and/or (h) a boundary between the superior portion and the inferior portion of the anterior portion of each lateral posterior region is located at a longest portion of the lateral posterior region in an anterior-posterior direction.
In further examples: (a) the chassis portion comprises a pair of laterally projecting connection portions each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; (b) the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is formed at least partially from silicone; and/or (f) the seal-forming structure is formed at least partially from a textile material.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion formed from a flexible material and partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
wherein the seal-forming structure comprises:
In examples: (a) the lip superior portion comprises an anterior portion adjacent the chassis portion and a posterior portion configured to seal in use against the patient's lip superior; (b) the anterior portion of the lip superior portion is stiffer than the posterior portion of the lip superior portion; (c) the anterior portions of the mid-lateral inferior portions are stiffer than the anterior portion of the lip superior portion; (d) the anterior portions of the mid-lateral inferior portions are stiffer than the posterior portion of the lip superior portion; (e) the posterior portions of the mid-lateral inferior portions are stiffer than the posterior portion of the lip superior portion; (f) the anterior portions of the mid-lateral inferior portions each have a thickness that is greater than a thickness of the posterior portions of the mid-lateral inferior portions; (g) the anterior portion of the lip superior portion has a thickness greater than a thickness of the posterior portion of the lip superior portion; (h) the thickness of the anterior portions of the mid-lateral inferior portions is greater than the thickness of the anterior portion of the lip superior portion; (i) the thickness of the anterior portions of the mid-lateral inferior portions is greater than the thickness of the posterior portion of the lip superior portion; (j) the thickness of the posterior portions of the mid-lateral inferior portions is substantially the same as the thickness of the anterior portion of the lip superior portion; (k) the thickness of the posterior portions of the mid-lateral inferior portions is greater than the posterior portion of the lip superior portion; (l) the chassis portion comprises a pair of chassis inferior reinforcing portions each located adjacent a respective one of the mid-lateral inferior portions, the chassis inferior reinforcing portions each having a greater stiffness than an adjacent portion of the chassis portion; and/or (m) the chassis inferior reinforcing portions each have a thickness greater than a thickness of the adjacent portion of the chassis portion.
In further examples: (a) the chassis portion comprises a pair of laterally projecting connection portions each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; (b) the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is formed at least partially from silicone; and/or (f) the seal-forming structure is formed at least partially from a textile material.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion formed from a flexible material and partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion comprising a pair of laterally projecting connection portions sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a pair of gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion;
wherein the seal-forming structure comprises a central portion on a posterior side of the seal-forming structure, the central portion being configured to seal in use against at least the patient's pronasale, nasal alae and lip superior;
wherein the chassis portion comprises a pair of chassis inferior reinforcing portions each provided to a respective lateral and inferior side of the chassis portion, the chassis inferior reinforcing portions each having a greater stiffness than one or more adjacent portions of the chassis portions.
In examples: (a) the chassis inferior reinforcing portions each have a thickness greater than a thickness of the adjacent portion of the chassis portion; (b) the chassis inferior reinforcing portions are provided adjacent the seal-forming structure; (c) the chassis inferior reinforcing portions may have spaced apart medial boundaries; (d) the chassis inferior reinforcing portions may each have a medial boundary proximate a central region on the inferior side of the chassis portion; (e) the chassis inferior reinforcing portions may each have a lateral boundary proximate a respective lateral posterior region of the seal-forming structure; (f) the chassis inferior reinforcing portions are shaped to follow a boundary between the chassis portion and the seal-forming structure; and/or (g) the central portion comprising a lip superior portion configured to seal in use against the patient's lip superior and a pair of mid-lateral inferior portions located on either lateral side of the lip superior portion and having a greater stiffness than the lip superior portion, the chassis inferior reinforcing portions each located adjacent a respective one of the mid-lateral inferior portions.
In further examples: (a) the chassis portion comprises a pair of laterally projecting connection portions each configured to connect to and receive the flow of gas from a respective one of a pair of gas delivery tubes; (b) the patient interface comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising the gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion; (c) the chassis portion is formed from an elastomeric material; (d) the chassis portion is formed from silicone; (e) the seal-forming structure is formed at least partially from silicone; and/or (f) the seal-forming structure is formed at least partially from a textile material.
Another aspect of one form of the present technology is a patient interface comprising:
a chassis portion partially forming a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the chassis portion being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient, and the chassis portion comprising a pair of laterally projecting connection portions configured to connect to gas delivery tubes;
a seal-forming structure provided to the chassis portion and partially forming the plenum chamber, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having at least one hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use;
a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;
a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a pair of gas delivery tubes, each gas delivery tube configured to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to a respective one of the laterally projecting connection portions of the chassis portion;
wherein the seal-forming structure comprises a central portion on a posterior side of the seal-forming structure, the central portion being configured to seal in use against at least the patient's pronasale, nasal alae and lip superior;
wherein the chassis portion comprises a pair of decoupling portions each provided to a respective lateral side of the chassis portion and each having a lesser stiffness than one or more adjacent portions of the chassis portion, the decoupling portions configured to at least partially decouple the central portion from forces applied to the chassis portion.
In examples: (a) each decoupling portion has a lesser thickness than one or more adjacent portions of the chassis portion; (b) each decoupling portion has a thickness of 0.5 mm; (c) the chassis portion has a thickness of 0.9 mm; (d) each decoupling portion is provided to an anterior side of the chassis portion; and/or (e) each decoupling portion extends from a superior side of the chassis portion to an inferior side of the chassis portion.
In further examples: (a) each decoupling portion is at least partially surrounded by a peripheral portion of the chassis portion having a greater stiffness than both the decoupling portion and an adjacent portion of the chassis portion to the peripheral portion; (b) each peripheral portion has a greater thickness than both the decoupling portion and an adjacent portion of the chassis portion to the peripheral portion; (c) each peripheral portion has a thickness within the range of 1.5 mm to 2 mm; and/or (d) each peripheral portion has a thickness of 1.75 mm.
In further examples: (a) the chassis portion comprises two decoupling portions on each lateral side of the chassis portion; (b) on each lateral side of the chassis portion, the chassis portion comprises a medial decoupling portion and a lateral decoupling portion, the lateral decoupling portion located laterally of the medial decoupling portion; (c) the lateral decoupling portions are configured to at least partially decouple the seal-forming structure from forces applied to the laterally projecting connection portions; (d) the medial decoupling portions are configured to at least partially decouple the seal-forming structure from forces applied to a central region of the anterior side of the chassis portion; (e) the cushion module comprises a vent module comprising the vent, the vent module located in the central region of the anterior side of the chassis portion, the medial decoupling portions being configured to at least partially decouple the seal-forming structure from forces applied to the vent module.
In further examples: (a) the lateral decoupling portions are D-shaped; (b) the medial decoupling portions are crescent shaped; (c) each lateral decoupling portion has a lateral side proximate a distal end of the respective laterally projecting connection portion and a medial side opposite the lateral side, the medial side having greater curvature than the lateral side; (d) the lateral side of each lateral decoupling portion is shaped to match a shape of the respective distal end of the laterally projecting connection portion; (e) each medial decoupling portion has a medial side proximate the vent module and a lateral side opposite the medial side, the lateral side having a greater curvature than the medial side; (f) the medial side of each medial decoupling portion is curved to follow a curvature of the vent module; (g) each decoupling portion is at least partially surrounded by a peripheral portion of the chassis portion having a greater thickness than both the decoupling portion and an adjacent portion of the chassis portion to the peripheral portion; (h) on each lateral side of the chassis portion, the chassis portion comprises a first peripheral portion located medially adjacent to the lateral decoupling portion and a second peripheral portion located laterally adjacent to the medial decoupling portion; (i) on each lateral side of the chassis portion, the first peripheral portion is curved to follow the curvature of the medial side of the lateral decoupling portion; (j) on each lateral side of the chassis portion, the second peripheral portion is curved to follow the curvature of the lateral side of the medial decoupling portion; and/or (k) on each lateral side of the chassis portion, the first peripheral portion and the second peripheral portion are closest at a midpoint of the anterior side of the chassis portion and are spaced further apart at superior and/or inferior sides of the chassis portion.
Another aspect of certain forms of the present technology is a system for treating a respiratory disorder comprising a patient interface according to any one or more of the other aspects of the present technology, an air circuit and a source of air at positive pressure.
Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed with a perimeter shape which is complementary to that of an intended wearer.
Another aspect of certain forms of the present technology is a patient interface that is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port.
Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured to leave the patient's mouth uncovered in use.
Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured so that no part of the seal-forming structure enters the mouth in use.
Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured so that the seal-forming structure does not extend internally of the patient's airways.
Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured so that the seal-forming structure does not extend below a mental protuberance region in use.
Another aspect of certain forms of the present technology is a patient interface constructed and arranged to leave a patient's eyes uncovered in use.
Another aspect of certain forms of the present technology is a patient interface constructed and arranged to allow a patient to breathe ambient air in the event of a power failure.
Another aspect of certain forms of the present technology is a patient interface comprising a seal forming structure configured to form a seal on an underside of a patient's nose without contacting a nasal bridge region of the patient's nose.
Another aspect of certain forms of the present technology is a patient interface comprising a vent and a plenum chamber, wherein the patient interface is constructed and arranged so that gases from an interior of the plenum chamber may pass to ambient via the vent.
Another aspect of certain forms of the present technology is a patient interface comprising a vent to allow a flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use. Another aspect of certain forms of a present technology is a patient interface comprising a vent to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use.
Another aspect of certain forms of the present technology is a patient interface constructed and arranged so that a patient may lie comfortably in a side or lateral sleeping position, in use of the patient interface.
Another aspect of certain forms of the present technology is a patient interface constructed and arranged so that a patient may lie comfortably in a supine sleeping position, in use of the patient interface.
Another aspect of certain forms of the present technology is a patient interface constructed and arranged so that a patient may lie comfortably in a prone sleeping position, in use of the patient interface.
An aspect of certain forms of the present technology is a medical device that is easy to use, e.g. by a person who does not have medical training, by a person who has limited dexterity, vision or by a person with limited experience in using this type of medical device.
An aspect of one form of the present technology is a patient interface that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment.
Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and/or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.
Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.
The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:
Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.
The following description is provided in relation to various examples which may share one or more common characteristics and/or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.
In one form as shown in
In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.
In certain examples of the present technology, mouth breathing is limited, restricted or prevented.
In one form, the present technology comprises an apparatus or device for treating a respiratory disorder. The apparatus or device may comprise an RPT device 4000 for supplying pressurised air to the patient 1000 via an air circuit 4170 to a patient interface 3000.
With reference to
As shown in
The cushion module 3150 may be modular in the sense that it can be replaced in the patient interface 3000 with another cushion module 3150. In some examples a first cushion module 3150 of the patient interface may be able to be replaced by a second cushion module 3150, the second cushion module 3150 being a different type of cushion module from the first cushion module 3150. For example, the second cushion module 3150 may have a different size, shape and/or structure from the first cushion module. In particular examples, a patient interface 3000 having the cushion module 3150 shown in
In other forms of the present technology, the plenum chamber 3200 and seal-forming structure 3100 may be inseparable from components of the positioning and stabilising structure 3300. For example, a cushion module 3150 fully or partially forming the plenum chamber 3200 may permanently connected to one or more other components of the patient interface 3000. The cushion module 3150 in such an example of the present technology may be modular in the sense that is a sub-part of a larger assembly.
In some examples of the present technology the component(s) forming the plenum chamber 3200 and/or seal-forming structure 3100 may be permanently attached to one or more headgear conduits. In some examples, the patient interface 3000 may comprise a non-removable cushion module 3150 located proximate an entrance of the patient's airways in use forming the plenum chamber 3200 and comprising a seal-forming structure 3100. The cushion module 3150 may be permanently attached to one or more gas delivery tubes configured to lie against the patient's head in use and convey a flow of air from a location on top of the patient's head to the plenum chamber 3200 for breathing by the patient. A non-removable cushion module 3150 may have a similar shape and size to the removable cushion module 3150 shown in
If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.
The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 6 cmH2O with respect to ambient.
The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 10 cmH2O with respect to ambient.
The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 20 cmH2O with respect to ambient.
A patient interface 3000 according to some examples of the present technology comprises a plenum chamber 3200 pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber 3200 may receive a flow of air at the therapeutic pressure for breathing by a patient.
The plenum chamber 3200 in some forms of the present technology is at least partially provided by a cushion module 3150 of the patient interface 3000. The cushion module 3150 according to some examples (such as those shown in
In particular, the chassis portion 3210 may at least partially form a plenum chamber 3200 pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The chassis portion 3210 may comprise one or more laterally projecting connection portions 3212 configured to connect to gas delivery tubes 3350 and being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The laterally projecting connection portions 3212 may also partially form the plenum chamber 3200 along with other portions of the cushion module 3150. The seal-forming structure 3100 may be provided to the chassis portion 3210 and may at least partially form the plenum chamber 3200. The seal-forming structure 3100 may be connected to the chassis portion 3210, either permanently connected or removably connected. The seal-forming structure 3100 may be supported by the chassis portion 3210.
In some forms, the plenum chamber 3200 is formed from a single homogeneous piece of material. In some forms, the plenum chamber 3200 may be formed from a homogenous piece of material fitted with connectors formed from another material.
In some examples, the cushion module 3150 may be formed from a single homogenous piece of material. In some forms, the cushion module 3150 may be formed from a homogenous piece of material fitted with connectors formed from another material.
In further examples, the chassis portion 3210 may be formed from a single homogenous piece of material. In some forms, the chassis portion 3210 may be formed from a homogenous piece of material fitted with connectors formed from another material.
In certain forms of the present technology, such as in the patient interface 3000 of
In certain forms of the present technology, the cushion module 3150 is constructed from an at least partially transparent material, e.g. silicone, a thermoplastic elastomer, a transparent polycarbonate or the like. For example, the majority of the cushion module 3150 is formed from silicone in the examples shown in
In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface 3000, and help improve compliance with therapy.
In some forms of the present technology, the patient interface 3000 does not include a frame formed from a rigid or substantially rigid material (e.g. polycarbonate or the like). In some examples, the patient interface 3000 does not include a rigid frame located anterior to the patient's face in use.
In the exemplary forms of the technology shown in
The wall thickness of the chassis portion 3210 may be in the range of 0.7 mm to 5 mm. In some examples the wall thickness of the majority of the chassis portion may be in the range of 0.7 mm to 1.5 mm, such as 0.9 mm to 1.4 mm, 0.7 mm-1.2 mm, 1.2 mm-1.5 mm, 0.9 mm, or 1.25 mm, as examples. In the examples shown in
It is also described below that the chassis portion 3210 may comprise chassis superior reinforcing portions 3220, which may have a greater thickness (e.g. 1.7 mm as described below with reference to
In a further example of a method of manufacturing a cushion module 3150, the posterior side portion of the seal-forming structure 3100 may be produced and then the chassis portion 3210 and anterior side portion of the seal-forming structure 3100 may be overmoulded to the posterior side portion of the seal-forming structure. The posterior side of the seal-forming structure 3100 may comprise a textile material and, in some forms, may comprise a laminate formed from one or more textile and one or more non-textile layers. A cushion module 3150 produced by one such method is shown in
In other examples of the technology the seal-forming structure 3100 may be removably connected to the chassis portion 3210. The seal-forming structure 3100 may be connected to the chassis portion 3210 by a soft-to-soft, soft-to-hard or a hard-to-hard connection.
The chassis portion 3210, as shown in
In this example, the cushion module 3150 comprises a pair of connectors 3214 configured to connect with gas delivery tubes 3350 of a positioning and stabilising structure 3300. The connectors 3214 are provided to either lateral side of the chassis portion 3210 in this example. Each connector 3214 in this example is provided to a respective laterally projecting connection portion 3212 of the chassis portion 3210. The connectors 3214, in this example, are provided at the inlets of the laterally projecting connection portions 3212.
The flexible nature of the chassis portion 3210 allows the cushion module 3150 to deform to fit to a wide range of patients. The flexible chassis portion 3210 may enable the cushion module 3150 to fit a wider range of patients than a cushion module 3150 with a rigid chassis portion. For example, the cushion module 3150 may be able to splay out to an extent to fit to a patient with a relatively wide nose, yet allow the sides to be wrapped inward to an extent to fit to a patient with a relatively narrower nose. While the chassis portion 3210 of the cushion module 3150 is flexible to provide these advantageous effects, a certain level of rigidity in the chassis portion 3210 is advantageous for providing stability and support to the seal-forming structure 3100. Accordingly, in some examples a rigidiser is provided to the chassis portion 3210 to make it more rigid (while still being flexible). In some examples, the chassis portion 3210 and the seal-forming structure 3100 are formed from a flexible material (e.g. silicone, TPE or the like) and the chassis portion 3210 comprises a rigidiser. In particular, the patient interface 3000 or cushion module 3150 may comprise a rigidiser. The rigidiser may be provided to the chassis portion 3210. The rigidiser may be configured to rigidise the chassis portion 3210. The rigidisider may be configured to resist deformation of the chassis portion 3210. The rigidiser may be configured to provide support to the chassis portion 3210.
In some examples the rigidiser is a member having a stiffness greater than a stiffness of the chassis portion 3210 of the plenum chamber 3200. The rigidiser may be formed from a different material to the chassis portion 3210. The ridigiser may be formed from a harder and/or stiffer material than a material forming the chassis portion 3210. The rigidiser may be substantially rigid. The rigidiser may be sufficiently rigid that it is not deformable by finger pressure alone. The rigidier may be formed from polycarbonate, polypropylene or nylon for example. The rigidiser may be adhered to the chassis portion 3210 in some examples. In certain examples the rigidiser may be overmoulded to the chassis portion 3210 or the chassis portion 3210 may be overmoulded to the rigidiser. The rigidiser may be removable from the chassis portion 3210. The rigidiser may be provided to one or more sides of the chassis portion 3210. In some examples the rigidiser is provided to an inferior side of the chassis portion 3210. In other examples the rigidiser is provided to an anterior side of the chassis portion 3210. In certain examples the rigidiser is provided externally to the plenum chamber 3200. In other examples the rigidiser is provided internally to the plenum chamber 3200. In some examples the rigidiser partially defines the plenum chamber 3200.
As shown in
As will be described, the chassis portion 3210 and the seal-forming structure 3100, or more generally the cushion module 3150, may comprise a plurality of regions, one or more regions having a greater stiffness than another region. In general, a greater stiffness of a portion of the cushion module 3150 with respect to another portion of the cushion module 3150 may be provided by one or more of a greater material thickness, a stiffer material (e.g. greater Young's modulus), the presence of a rigidiser, and a shape that provides a greater stiffness. Unless the context requires otherwise, where a first portion of the cushion module 3150 is described as having a greater stiffness than a second portion, each of the above ways in which a portion may be stiffened is to be understood to be disclosed as an option for how the first portion may be stiffer than the second portion. In addition, forms of the technology may combine any one or more of the above ways to render the first portion thicker than the second portion.
Unless the context clearly requires otherwise, references to stiffness of a component or portion/region thereof are to be understood to be references to the stiffness of a structure including the effects on stiffness of both the material from which the component or portion thereof is formed, and the shape (including thickness) of the component or portion thereof. However, unless the context clearly requires otherwise, references to the stiffness of a material, a material having a stiffness, or the like, are to be understood to be references to stiffness as a material property independent of a shape/size (e.g. Young's modulus or the like).
As shown in
With reference to
In some examples, such as the example illustrated in
In some examples, such as the example illustrated in
In some examples, such as the example shown in
In some examples, such as the example shown in
To remove the vent module 3410 the patient or clinician may push or pull the vent module 3410 out of the anterior hole 3215. The chassis portion 3210 may deform to allow the vent module 3410 to be removed from the anterior hole 3215. The chassis portion 3210 may be configured to allow the user to peel the lip 3230 away from the vent module 3410 to allow the vent module 3410 to be removed. The chassis portion 3210 may be able to be squeezed to aid in the removal of the vent module 3410. In some examples, the patient may be able to squeeze the chassis portion 3210 to at least partially release the lip 3230 from the peripheral channel 3430 of the vent module 3410.
In this example, the cross-sectional profile of the lip 3230 substantially matches the space available within the cross-sectional profile of the peripheral channel 3430 to facilitate a secure fit. The shape of the lip 3230 is complimentary to the shape of the peripheral channel 3430.
In this example of the present technology, the lip 3230 is thicker than adjacent portions of the chassis portion 3210 of the plenum chamber 3200, for example the lip 3230 may be the thickest portion of the chassis portion 3210. The lip 3230 may also be the thickest portion of the cushion module 3150. The lip 3230 may comprise a thickness in the range of 3-5 mm. In some examples of the present technology the thickness of the lip 3230 is within 3.5-4.5 mm. In the illustrated example, the thickness of the lip 3230 is substantially 4 mm.
The lip 3230 may be thick to create a robust connection to the vent module 3410. Additionally, the lip 3230 may be thick to provide rigidity to the chassis portion 3210. A thick lip 3230 may advantageously increase the resistance of the cushion module 3150 to torsion. The cushion module 3150 may receive torsional forces particularly during side sleeping or when the patient moves while sleeping, for example if they turn over. The added stiffness provided by the thickness of the lip 3230 provides resistance to excessive deformation as a result of torsional forces or other forces which could disturb the seal between the seal-forming structure 3100 and the patient's face. Accordingly, in this example the cushion module 3150 comprises a reinforced portion on its anterior side. The reinforced portion resists twisting.
In the illustrated example of the present technology, the lip 3230 is a thick portion of cushion module 3150. The lip 3230 and the remainder of the chassis portion 3210 of the cushion module 3150 are integrally formed in this example. They are formed from a homogenous piece of material. The chassis portion 3210 and the lip 3230 thereof may be moulded together. The lip 3230 may be formed from an elastomeric material, such as silicone, TPE or the like, along with other portions of the chassis portion 3210 in the same moulding process.
In other examples, the lip 3230 may be formed separately from one or more other portions of the chassis portion 3210. In some examples, the lip 3230 is formed from a different material from the remainder of the chassis portions 3210, i.e. the lip 3230 is formed from a first material and the remainder of the chassis portion 3210 may be formed from a second material. In some examples the lip 3230 is overmoulded to the remainder of the chassis portion 3210. In other examples the chassis portion 3210 is overmoulded to the lip 3230.
In some examples, portions of the chassis portion 3210 excluding the lip 3230 are formed from a first silicone material and the lip 3230 is formed from a second silicone material. The second silicone material may have one or more different properties to the first silicone material. The second silicone material may have a greater stiffness than the first silicone material. The second silicone material may have a greater Durometer hardness than the first silicone material.
In some examples the chassis portion 3210 excluding the lip 3230 is formed from an elastomeric material such as silicone, TPE or the like, and the lip 3230 is formed from a more rigid material such as polycarbonate, polypropylene, nylon or the like.
In some examples, the chassis portion 3210 comprises a female feature such as a groove, peripheral channel or the like about the anterior hole 3215, which is configured to receive a complimentary male feature of the vent module 3410, such as a lip, flange or the like. In some examples the vent module 3410 comprises a flange about its periphery, configured to be received within a complementary channel about the periphery of the anterior hole 3215 of the cushion module 3150.
In other forms of the present technology, the chassis portion 3210 of the cushion module 3150 may comprise a rigidising portion (in addition to the rigidising vent module 3410) in the form of a thickened portion spaced from the anterior hole 3215. In one example the chassis portion 3210 may comprise a rigidising portion that spans across an anterior side portion of the cushion module 3150. In other examples, the chassis portion 3210 may comprise a rigidising member. The rigidising member may be formed from a material having a greater stiffness than the material forming the chassis portion 3210 (e.g. silicone). The chassis portion 3210 may be overmoulded to the rigidising member (or vice versa). Alternatively, the rigidising member may be inserted into the chassis portion 3210, snap-fitted to the chassis portion 3210 or otherwise secured to an anterior side portion of the chassis portion 3210.
Sufficient resistance to excessive deformation, especially resulting from torsion, is advantageous. However, some independence between the sides of the cushion module 3150 is advantageous for providing a decoupling effect in which the cushion module 3150 can tolerate forces received at one lateral side without transmitting the forces to the other lateral side. As described above, the chassis portion 3210 may be formed from a flexible material to partially decouple one lateral side of the cushion module 3150 from the other lateral side. For example, the chassis portion 3210 may at least partially decouple movement of one of the laterally projecting connection portions 3212 from the other of the laterally projecting connection portions 3212.
The cushion module 3150 may comprise one or more features configured to enable easy locating of the vent module 3410 and prevent misalignment thereof. In particular, the cushion module 3150 may comprise one or more locating features 3216 structured and/or arranged to make correct orientation of the vent module 3410 apparent to the user. The chassis portion 3210 may comprise the locating features 3216. The chassis portion 3210 may comprise one or more locating features 3216 which engage or fit with corresponding features of the vent module 3410.
In some examples, such as the example illustrated in
The one or more locating features 3216 may prevent the vent module 3410 from being inserted into the anterior hole 3215 incorrectly. The one or more locating features 3216 may prevent the vent module 3410 from being inserted at an incorrect orientation (e.g. upside down or back-to-front). For example, the locating features 3216 may be positioned asymmetrically with respect to the anterior hole 3215.
The shape of the anterior hole 3215 and vent module 3410 in the example illustrated in
In some examples, cushion module 3150 and/or the vent module 3410 comprise guides to indicate the correct orientation of the vent module 3410, such as matching markings, indents or other visual or tactile features to indicate the correct orientation of the vent module 3410.
In some examples of the present technology, the chassis portion 3210 of the cushion module 3150 comprises a pair of chassis superior reinforcing portions 3220. The cushion modules 3150 shown in
Each chassis superior reinforcing portion 3220 is provided to a respective lateral and anterior side of the chassis portion 3210. Each chassis superior reinforcing portion 3220 may be spaced medially from a distal end of a respective laterally projecting connection portion 3212. For example, the chassis superior reinforcing portions 3220 may each be spaced medially of a respective one of the laterally projecting connection portions 3212. Each chassis superior reinforcing portion 3220 may have a lateral boundary spaced apart from a distal end of a respective one of the laterally projecting connection portions 3212.
As described above, the chassis portion 3210 may formed from a flexible material, which may be an elastomeric material. The chassis superior reinforcing portions 3220 may be formed from the flexible material forming the chassis portion 3210. The seal-forming structure 3100 may also be formed from the flexible material. The chassis superior reinforcing portions 3220 may be integrally formed with the chassis portion 3210. For example, the chassis superior reinforcing portions 3220 may be moulded together with adjacent portions of the chassis portion 3210 in a single moulding step. The chassis superior reinforcing portions 3220 may partially define the plenum chamber 3200 together with other portions of the chassis portion 3210.
In the illustrated example, the chassis superior reinforcing portions 3220 are each provided at a superior location on the chassis portion 3210, e.g. generally superior to anterior hole 3215. Each chassis superior reinforcing portion 3220 may be stiffer than one or more adjacent portions of the chassis portion 3210. The greater stiffness may result from the chassis superior reinforcing portions 3220 having a wall thickness greater than a wall thickness of one or more adjacent portions of the chassis portion 3210. In some examples the chassis superior reinforcing portions 3220 have a wall thickness between 1 mm and 3 mm. In some examples the wall thickness is between 1.2 mm and 2.5 mm or between 1.5 mm and 2.3 mm. In the examples shown in
The chassis superior reinforcing portions 3220 may help increase the stability of the cushion module 3150 and the seal it makes to the patient's face during dynamic movements, for example when the patient moves while sleeping or in bed. The chassis superior reinforcing portions 3220 may also provide greater resistance to excessive flaring out of the seal-forming structure 3100 when the seal-forming structure 3100 is brought into contact with a patient's face having slightly different contours from the seal-forming surface of the seal-forming structure 3100. This flaring may result in leak paths forming where the seal-forming structure 3100 loses contact with the patient's face, due to the otherwise flexible nature of the chassis portion 3210, in examples of the present technology in which the chassis portion 3210 is flexible. The chassis superior reinforcing portions 3220 may also provide added torsion resistance. The chassis superior reinforcing portions 3220 may prevent one side of the cushion module 3150 from twisting away from or with respect to the other side of the cushion module 3150, which could result in loss of contact with the patient's nose and leak paths.
As shown in
Each chassis superior reinforcing portion 3220 may be located on the chassis portion 3210 adjacent and anterior to the seal-forming structure 3100. The chassis superior reinforcing portions 3220 may share a boundary with the seal-forming structure 3100. Each chassis superior reinforcing portion 3220 may comprise a superior boundary that meets a portion of an inferior boundary of an anterior portion of the seal-forming structure 3100. As illustrated in
In some examples, each chassis superior reinforcing portion 3220 may extend laterally outward to a lateral portion of each connection portion 3212 of the chassis portion 3210, show by of example in
As discussed below in more detail, the seal-forming structure 3100 may comprise mid-lateral anterior portions 3125 each located on a respective lateral side of a central anterior portion 3115, shown in
In some examples of the present technology, each chassis superior reinforcing portion 3220 has a wall thickness that is the same as the wall thickness of the inferior portion 3127 of the mid-lateral anterior portion 3125 of the seal-forming structure 3100.
In other examples of the present technology, the chassis superior reinforcing portions 3220 may be formed by rigidisers formed by a material stiffer than the material forming the rest of the chassis portion 3210.
In some examples of the present technology, the cushion module 3150 may comprise chassis inferior reinforcing portions 3221. A cushion module 3150 may comprise chassis inferior reinforcing portions 3221 in addition, or as an alternative, to chassis superior reinforcing portions 3220. In other examples of the present technology the cushion module 3150 may comprise neither chassis superior reinforcing portions 3220 nor chassis inferior reinforcing portions 3221.
As shown in particular in
Each chassis inferior reinforcing portion 3221 may be spaced medially from a distal end of a respective laterally projecting connection portion 3212. For example, the chassis inferior reinforcing portions 3221 may each be spaced medially of a respective one of the laterally projecting connection portions 3212. Each chassis inferior reinforcing portion 3221 may have a lateral boundary spaced apart from a distal end of a respective one of the laterally projecting connection portions 3212.
As described above, the chassis portion 3210 may formed from a flexible material, which may be an elastomeric material. The chassis inferior reinforcing portions 3221 may be formed from the flexible material forming the chassis portion 3210. The chassis inferior reinforcing portions 3221 may be integrally formed with the chassis portion 3210. For example, the chassis inferior reinforcing portions 3221 may be moulded together with adjacent portions of the chassis portion 3210 in a single moulding step. The chassis inferior reinforcing portions 3221 may partially define the plenum chamber 3200 together with other portions of the chassis portion 3210.
The chassis inferior reinforcing portions 3221 may be elongate. As shown in
The chassis inferior reinforcing portions 3221 may each have a greater stiffness than an adjacent portion of the chassis portion 3210. In the example shown in
Each chassis inferior reinforcing portion 3221 comprises a thickness of 3 mm in the example shown in
As discussed above, the chassis portion 3210 may comprise a pair of laterally projecting connection portions 3212. Each of the laterally projecting connection portions 3212 may be configured to connect to and receive a flow of gas from a respective gas delivery tube 3350. Each laterally projecting connection portion 3212 may comprise an inlet to an interior of the chassis portion 3210.
In some examples of the present technology, each laterally projecting connection portion 3212 may define a plenum chamber inlet port.
The angles at which the laterally projecting connection portions 3212 project advantageously orient the seal-forming structure 3100 at an angle which allows the seal-forming structure 3100 to form a stable seal with the patient's face without occluding the patient's nose.
In some examples of the present technology, the angle A may be between 10 degrees and 30 degrees, such as between 15 degrees and 25 degrees or between 18 degrees and 23 degrees. In one example, the angle A is 21 degrees. In another example, the angle A is 21.5 degrees.
In other examples of the present technology, the angle A may be between 15 degrees and 35 degrees, such as between 20 degrees and 30 degrees or between 23 degrees and 29 degrees. In one example, the angle A is 25 degrees. In another example, the angle A is 27 degrees.
In some examples of the present technology, the angle B may be between 25 degrees and 45 degrees, such as between 30 degrees and 40 degrees or between 32 degrees and 37 degrees. In one example, the angle B is 34.5 degrees. In another example the angle B is 33 degrees.
In some examples of the present technology, the angle B may be between 20 degrees and 40 degrees, such as between 25 degrees and 35 degrees or between 26 degrees and 30 degrees. In one example, the angle B is 28 degrees.
These particular angles may result in the connection portions 3212, when connected to gas delivery tubes 3350 of a positioning and stabilising structure 3300, holding the seal-forming structure 3100 in a sufficiently splayed out state that it does not squeeze the patient's nose to an excessive extent that results in occlusion of the patient's nasal airways. In examples of the present technology in which the chassis portion 3210 is flexible, the seal-forming structure 3100 may be more likely to fold medially than if the chassis portion 3210 was rigid. Accordingly, connection portion 3212 angles which hold the seal-forming structure 3100 sufficiently open are advantageous for avoiding excessive medial force on the sides of the patient's nose.
The line L shown in
In some particular examples of the present technology, the presentation angle may be between 20 degrees and 40 degrees, such as between 24 and 36 degrees, within the range of 25-32 degrees or within the range of 32-38 degrees. In some examples the seal-forming structure 3100 of a patient interface 3000 may have a presentation angle as defined above within the range of 22-30 degrees. In other examples the seal-forming structure 3100 may have a presentation angle as defined above within the range of 31-39 degrees. The cushion module 3150 shown in
The presentation angle of the cushion module 3150 shown in
In the illustrated examples, the connectors 3214 are rigid. While the chassis portion 3210 may advantageously be formed from a flexible material, the connectors 3214 may be formed from a rigid material. Rigid connectors 3214 may enable a snap fit connection between the cushion module 3150 and the gas delivery tubes 3350. In some examples, the connectors 3214 are formed from polypropylene, nylon, polycarbonate or a similar material.
As illustrated in
Each connector 3214 may be joined to the chassis portion 3210 by an overmoulding process. The overmoulding process may involve forming the connectors 3214, and then moulding the chassis portion 3210 to the connectors 3214. An outwardly facing surface 3181a of the chassis connection portion 3181 of each connector 3214 may be bonded to the material forming the chassis portion 3210. The outwardly facing surface 3181a may be known as a bonding surface in some examples. The chassis connection portion 3181 of each connector 3214 is, in this example, at a downstream end of the connectors 3214. In other examples the chassis connection portion 3181 may be glued to the chassis portion 3210 or may be mechanically connected, such as by a press fit, snap fit or the like.
In cross-section, such as is shown in
As shown in
Between the outwardly facing surface 3181a and the inwardly facing surface 3181b of the chassis connection portion 3181 of each connector 3214 on a downstream side of the connector 3214 (e.g. the side of the connector 3214 interior to the chassis portion 3210) is a substantially flat downstream end surface. The downstream end surface connects the downstream sides of the outwardly facing surface 3181a and the inwardly facing surface 3181b of the chassis connection portion 3181.
The connectors 3214 each comprise a projecting connector portion 3182. The projecting connector portion 3182 extends away from the chassis portion 3210, in this form of the present technology. The projecting connector portions 3182 each extend in an upstream direction. The projecting connector portions 3182 each extend from the chassis connection portion 3181 from an inward side with respect to the chassis connection portion 3181. In particular, the projecting connector portion 3182 may project away from the chassis connection portion 3181 along a length of the connector 3214. As shown in
Each projecting connector portion 3182 is configured to engage with a corresponding connector provided to a gas delivery tube 3350. The projecting connector portions 3182, in this example of the present technology, engage with corresponding female connectors provided to respective gas delivery tubes 3350 of the patient interface 3000. In the illustrated examples, with reference to
Between the chassis connection portion 3181 and the projecting connector portion 3182 of each connector 3214 is a bend in cross section, in the examples of the present technology illustrated in
On either side of the chassis connection portion 3181 and the projecting connector portion 3182, as an outside shoulder 3183 and an inside shoulder 3184. The outside shoulder 3183 and is provided to the outwardly facing side of the connector 3214. The inside shoulder 3184 is provided to the inwardly facing side of the connector 3214.
The outside shoulder 3183 comprises a substantially flat wall 3183a perpendicular to the length of the connector 3214, as shown in
The outside shoulder 3183 may be configured to form a seal in use with the end of a gas delivery tube 3350. Each gas delivery tube 3350 may comprise a substantially flat surface at the downstream end thereof configured to engage with the outside shoulder 3183 of a respective connector 3214 and form a seal therewith. The outside shoulder 3183 extends around the periphery of the connector 3214 and may be configured to engage a sealing surface around a periphery of a corresponding connector of a respective gas delivery tube 3350. The flat wall 3183a may be configured to mate with a flat surface of the respective gas delivery tube 3350. The recesses 3185 may be spaced with respect to the outside shoulder 3183 such that when a snap fit is formed between recesses 3185 and corresponding portions of the connectors on the gas delivery tubes 3350, a compliant portion of the gas delivery tube 3350 is held tightly against the outside shoulder 3183.
In some examples, a portion of the projecting connector portion 3182 proximate the outside shoulder 3183 may also form a seal in use with the end of the gas delivery tube 3350. The gas delivery tube 3350 in some examples comprises a radially inwardly projecting lip at the end thereof, which may form a seal with one or more of the projecting connector portion 3182, the chassis connection portion 3181 (e.g. the flat wall 3183a) and the outside shoulder 3183.
The gas delivery tubes 3350 may also seal against portions of the chassis portion 3210, such as the ends of the laterally projecting connection portions 3212. Advantageously, the chassis portion 3210 may be formed from a soft material (e.g. silicone, TPE or the like). The gas delivery tubes 3350 may also be formed from a soft material (e.g. silicone, TPE or the like), resulting in a soft-to-soft connection between the gas delivery tubes 3350 and the chassis portion 3210. In other examples, the connection may be a soft-to-hard connection (e.g. if the ends of the gas delivery tubes 3350 are formed by a hard component or the ends of the gas delivery tubes 3350 are soft but they engage with hard portions of the chassis portion 3210, such as hard connectors 3214). In further examples, the connection may be a hard-to-hard connection (e.g. the ends of the gas delivery tubes 3350 are formed by hard components and they connect to hard portions of the chassis portion 3210, such as hard connectors 3214).
The inside shoulder 3184 comprises a gradual curve in cross-section. The inside shoulder 3184 comprises a gradual curved transition between the inwardly facing wall of the chassis connection portion 3181 and an inwardly facing wall of the projecting connector portion 3182. The inwardly facing wall of the projecting connector portion 3182 may be substantially parallel to the inwardly facing wall of the chassis connection portion 3181. The inwardly facing wall of the projecting connector portion 3182 may also be parallel to an outwardly facing wall of the projecting connector portion 3182. The inwardly facing wall of the projecting connector portion 3182 may be perpendicular to the downstream end surface of the chassis connection portion 3181 and/or the flat wall 3183a of the outside shoulder 3183. Each recess 3185 of the projecting connector portion 3182 may be recessed relative to the outwardly facing wall of the projecting connector portion 3182.
As shown in
The clip base portion 3186 is adjacent to the chassis connection portion 3181 of the connector 3214. The clip base portion 3186 may extend from an internal periphery of the chassis connection portion 3181 as shown in
The projecting connector portion 3182 may comprise a pair of clip arms 3187 projecting away from the clip base portion 3186. In contrast to clip base portion 3186, each of the clip arms 3187 may only partly surround the hole through the connector 3214 through which breathable gas passes in use. In the examples shown in
When a snap fit connection is made between a connector 3214 and a corresponding tube end connector 3302 provided to the tube end 3314 of a gas delivery tube 3350, the clip arms 3187 in these examples deform to allow clip projections 3304 of the tube end connector 3302 to slide over the outwardly facing surfaces of the clip arms 3187 and then fit into the recesses 3185 to form the snap fit connection. In order to facilitate the snap fit connection, the clip arms 3187 may each bend inwardly towards a central axis of the connector 3214. In some examples of the present technology the tube end connector 3302 may also deform during the snap-fit connection to the connector 3214. The tube end 3314 also comprises a lip 3324 to form a seal with the connector 3214. The lip 3324 may seal to one or more of the projecting connector portions 3182, the outside shoulder 3183, the flat wall 3183a of the outside shoulder 3183 and the connection portion 3212 of the chassis portion 3210.
The location of the recess 3185 within the connector 3214 corresponds with the location of the clip projection 3304 of the tube end connector 3302, as the recess 3185 receives the clip projection 3304 when the tube end 3314 is connected to the connector 3214. The distance C1 labelled in
With reference to
With reference to
The applicant has found that, without modifying the spacing between the recess 3185 and the chassis connection portion 3181 (e.g. distances C1 and C2), the lengths of the clip base portion 3186 and clip arms 3187 can be tailored to achieve an advantageous retention force of the connector 3214 when connected to the gas delivery tube 3350. In use of the patient interface 3000 the gas delivery tubes 3350 hold the cushion module 3150 in a sealing position. It is advantageous for the force required to disconnect the gas delivery tubes 3350 to be sufficiently high that the gas delivery tubes 3350 are not disconnected inadvertently, for example during setup when the patient pulls on the gas delivery tubes 3350 to don or adjust the patient interface 3000, or during use when the patient moves while sleeping. Additionally, it is advantageous that the force required to connect and disconnect the gas delivery tubes 3350 is not so high that it is difficult for a patient to disassemble and reassemble the patient interface 3000, for example for cleaning or replacement of the cushion module 3150.
The length of the clip arms 3187 is a factor in the force required to sufficiently deflect the clip arms 3187 during the snap-fit connection to the tube end connector 3302. Longer clip arms 3187 will result in a lower force being required to be applied to the free ends of the clip arms 3187 to deflect the free ends by a particular amount. During connection and disconnection of a gas delivery tube 3350 to/from a connector 3214, the tube end connector 3302 will apply a force on each clip arm 3187 inwardly with respect to the connector 3214. A particular amount of deflection of each clip arm 3187 is required to allow connection and disconnection of the gas delivery tubes 3350 from the connectors 3214. Accordingly, a longer clip arm 3187 will result in a lower force required to connect or disconnect the gas delivery tubes 3350 to/from the connectors 3214. Similarly, a shorter clip arm 3187 will result in a greater force required to connect or disconnect the gas delivery tubes 3350 to/from the connectors 3214.
Accordingly, for a given spacing between the recess 3185 and chassis connection portion 3181 (e.g. C1 in
In one form of the present technology, such as in the connector 3214 shown in
In another form of the present technology, such as in the connector 3214 shown in
The applicant has found that a length of the clip base portion 3186 along the length of the connector 3214 which is equal to or greater than the length of the clip arms 3187 between the clip base portion 3186 and the recess 3185 along the length of the connector 3214 results in a particularly advantageous retention force. The retention force (e.g. the separation force that the connection can withstand before separating) is sufficiently high that there is a low chance of unintentional disconnection during setup or use, but not excessively high that it is too difficult for patients to intentionally disconnect the cushion module 3150 from the gas delivery tubes 3350.
Accordingly, in some examples of the present technology, the length of the clip base portion 3186 is greater than the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185. The relationship between the length of the clip base portion 3186 and the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185 may also be expressed as a ratio. In some examples, the ratio of the length of the clip base portion 3186 to the length of the clip arm 3187 between the clip base portion 3186 and the recess 3185 is equal to or greater than 1.2:1 or 1.3:1. In further examples, the ratio is greater than about 1.5:1, 1.7:1 or 1.9:1. In the example shown in
In some examples of the present technology, a force required to disconnect each connector 3214 of the cushion module 3150 from the tube end connector 3302 of a respective gas delivery tube 3350 may be greater than 12N. In further examples the force required may be greater than 20N, 25N or greater than 30N. In some examples the force required is within the range of 12N-50N. In further examples the force required is within the range of 20N-40N, such as within the range of 20N-30N or within the range of 30N-40N. In some examples the force required is in the range of 25N-35N. In some examples of a patient interface 3000 according to the present technology, a cushion module 3150 may be separable from a gas delivery tube 3350 of the patient interface 3000 upon application of a force as specified above or within a range specified above, yet may comprise one or more connectors 3214 of a design other than those shown in
With reference to
The transverse dimension CR1 of the arc of the clip arm corners 3188 of the anterior clip arm 3187 may be within the range of 2-5 mm, for example within the range or 2.5-4 mm. In the example shown in
The transverse dimension CR3 of the arc of the clip arm corners 3188 of the posterior clip arm 3187 may be within the range of 1-4 mm, for example within the range or 1.5-3 mm. In the example shown in
As illustrated in
As illustrated in
The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 3300. Positioning and stabilising structure 3300 may comprise and function as “headgear” since it engages the patient's head in order to hold the patient interface 3000 in a sealing position. In some examples of the present technology, the positioning and stabilising structure 3300 may comprise any one or more of the features described in International Application No. PCT/AU2019/050874, the entire contents of which are hereby incorporated herein by reference.
In one form the positioning and stabilising structure 3300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.
In one form the positioning and stabilising structure 3300 provides a retention force to overcome the effect of the gravitational force on the patient interface 3000.
In one form the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.
In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure 3300 comprises at least one strap having a rectangular cross-section. In one example the positioning and stabilising structure 3300 comprises at least one flat strap.
In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient's head on a pillow.
In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient's head on a pillow.
In one form of the present technology, a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap. The decoupling portion is constructed and arranged so that when the patient lies with their head on a pillow, the presence of the decoupling portion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.
In one form of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap. In one form, the fabric outer layer comprises loop material to engage with a hook material portion.
In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is extensible, e.g. resiliently extensible. For example the strap may be configured in use to be in tension, and to direct a force to draw a seal-forming structure into sealing contact with a portion of a patient's face, in some examples in combination with other straps or other structures. In an example the strap may be configured as a tie.
A tie will be understood to be a structure designed to resist tension. In use, a tie is part of the positioning and stabilising structure 3300 that is under tension. Some ties will impart an elastic force as a result of this tension, as will be described. A tie may act to maintain the seal-forming structure 3100 in a therapeutically effective position on the patient's head.
In one form of the present technology, the positioning and stabilising structure 3300 comprises a first tie, the first tie being constructed and arranged so that in use at least a portion of an inferior edge thereof passes superior to an otobasion superior of the patient's head and overlays a portion of a parietal bone and/or frontal bone. The first tie may be provided, for example, as part of a patient interface that comprises a cradle cushion, nasal pillows, nasal cushion or full-face cushion (either an under-the-nose full-face cushion or a full-face cushion that seals to the patient's nose superior to the pronasale).
In some examples of the present technology, the first tie of the positioning and stabilising structure 3300 comprises a superior first tie portion and an inferior first tie portion. The superior first tie portion may overlay a portion of a parietal bone and/or the frontal bone. The inferior first tie portion may overlay or lie inferior to the occipital bone of the patient's head. The first tie may be bifurcated. The first tie may bifurcate into the superior first tie portion and the inferior first tie portion. The first tie may comprise an anterior portion configured to overlay the side of the patient's head/face and a bifurcated portion configured to overlay the lateral, superior to and/or posterior sides to the patient's head. The anterior portion may be formed integrally with the superior first tie portion. The inferior first tie portion may connect to a junction between the anterior portion and the superior first tie portion.
For example, as shown in
In one form of the present technology, the positioning and stabilising structure 3300 includes a second tie, the second tie being constructed and arranged so that in use at least a portion of a superior edge thereof passes inferior to an otobasion inferior of the patient's head and overlays or lies inferior to the occipital bone of the patient's head. The second tie may pass below the patient's ears. The second tie may be provided, for example, as part of a patient interface that comprises a full-face cushion (which may or may not leave the patient's pronasale uncovered) or a nasal cushion. In other examples the second tie may be provided as part of a patient interface that comprises a cradle cushion or nasal pillows cushion. The second tie may overlay the lateral and/or posterior sides of the patient's neck in use and connect to an inferior portion of a frame of the positioning and stabilising structure 3300, to an inferior portion of a cushion module 3150 or to an inferior portion of a plenum chamber 3200.
In one form of the present technology, the positioning and stabilising structure 3300 includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce a tendency of the first tie and the second tie to move apart from one another. The third tie may be provided as part of a patient interface that comprises a full-face cushion (which may or may not leave the patient's pronasale uncovered) or a nasal cushion. In other examples the third tie may be provided as part of a patient interface that comprises a cradle cushion or nasal pillows cushion.
In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is bendable and e.g. non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping. As shown in
As shown in
In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap. The strap 3310 of the positioning and stabilising structure 3300 of the exemplary patient interface 3000 shown in
In certain forms of the present technology, a system is provided comprising more than one positioning and stabilizing structure 3300, each being configured to provide a retaining force to correspond to a different size and/or shape range. For example, the system may comprise one form of positioning and stabilizing structure 3300 suitable for a large sized head, but not a small sized head, and another. suitable for a small sized head, but not a large sized head.
In some forms of the present technology, the positioning and stabilising structure 3300 comprises one or more tubes 3350 that deliver pressurised air received from the air circuit 4170 to the plenum chamber 3200 and then the patient's airways, for example through the cushion module 3150 and seal-forming structure 3100. The tubes 3350 may receive a pressurised flow of gas from a conduit forming part of the air circuit 4170. The conduit may be connected to an RPT device 4000.
In the form of the present technology illustrated in
Since air can be contained and passed through headgear tubing 3350 in order to deliver pressurised air from the air circuit 4170 to the patient's airways, the positioning and stabilising structure 3300 may be described as being inflatable. It will be understood that an inflatable positioning and stabilising structure 3300 does not require all components of the positioning and stabilising structure 3300 to be inflatable. For example, in the example shown in
In certain forms of the present technology, the patient interface 3000 may comprise a connection port 3600 located proximal a top, side or rear portion of a patient's head. For example, in the form of the present technology illustrated in
Patient interfaces in which the connection port is not positioned in front of the patient's face may be advantageous as some patients find a conduit that connects to a patient interface in front of the face to be unsightly and obtrusive. For example, a conduit connecting to a patient interface in front of the face may be prone to being tangled up in bedclothes or bed linen, particularly if the conduit extends downwardly from the patient interface in use. Forms of the technology with a patient interface with a connection port positioned proximate the top of the patient's head in use may make it easier or more comfortable, compared to other types of patient interface, for a patient to lie or sleep in one or more of the following positions: in a side or lateral position; in a supine position (i.e. on their back, facing generally upwards); and in a prone position (i.e. on their front, facing generally downwards). Moreover, connecting a conduit to the anterior side of a patient interface may exacerbate a problem known as tube drag, wherein the conduit may provide an undesired drag force upon the patient interface thereby causing dislodgement away from the face.
In some examples, at least one tube 3350 extends between the plenum chamber 3200 and the connection port 3600 across the patient's cheek region and above the patient's ear. A portion of the tube 3350 that connects to cushion module 3150 overlays a maxilla region of the patient's head in use and a portion of the tube 3350 overlays a region of the patient's head superior to the otobasion superior on the patient's head. Each of the one or more tubes 3350 may also lie over the patient's sphenoid bone and/or temporal bone and either or both of the patient's frontal bone and parietal bone. The elbow 3610 may be located in use over the patient's parietal bone, frontal bone or the junction therebetween.
In the form of the present technology illustrated in
In the form of the technology shown in
The tubes 3350 may be formed of a semi-rigid material such as an elastomeric material, e.g. silicone. The tubes 3350 may have a natural, preformed shape and be able to be bent or moved into another shape if a force is applied to the tubes. For example, the tubes may be generally arcuate or curved in a shape approximating the contours of a patient's head between the top of the head and the nasal or oral region.
As described in U.S. Pat. No. 6,044,844, the contents of which are incorporated herein, the tubes 3350 may be crush resistant to avoid the flow of breathable gas through the tubes if either is crushed during use, for example if it is squashed between a patient's face and pillow. Crush resistant tubes may not be necessary in all cases as the pressurised gas in the tubes may act as a splint to prevent or at least restrict crushing of the tubes 3350 during use. A crush resistant tube may be advantageous where only a single tube 3350 is present as if the single tube becomes blocked during use the flow of gas would be restricted and therapy will stop or reduce in efficacy.
More features of positioning and stabilising structures 3300 according to some examples of the present technology are described in U.S. Provisional Patent Application No. 62/764,995, the entire contents of which are hereby incorporated by reference herein.
In certain forms of the present technology the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient's head so that the patient interface 3000 can be positioned as appropriate for the comfort or fit of an individual patient. Movement of an upper portion of the patient interface 3000 may be decoupled from a lower portion of the patient interface 3000. This may enable the cushion module 3150 to form an effective seal with the patient's face irrespective of the position of the connection port 3600 on the patient's head. Such de-coupling can be achieved using, for example, mechanisms that allow parts of the headgear tubes 3350 to easily move or flex relative to other parts of the patient interface 3000. Examples of such mechanisms will be described below.
In a certain form of the present technology, the patient interface 3000 is configured such that the connection port 3600 is positioned approximately at a top point of the patient's head in use. The connection port 3600 may be positioned in the sagittal plane and aligned with the otobasion superior points in a plane parallel to the coronal plane.
As described above, in some examples of the present technology the patient interface 3000 comprises a seal-forming structure 3100 in the form of a cradle cushion which lies generally under the nose and seals to an inferior periphery of the nose. The positioning and stabilising structure 3300 may be structured and arranged to pull the seal-forming structure 3100 into the patient's face under the nose with a sealing force vector that has a posterior and superior direction (e.g. a posterosuperior direction). A sealing force vector with a posterosuperior direction may facilitate the seal-forming structure 3100 forming a good seal to both the inferior periphery of the patient's nose and the anterior-facing surfaces of the patient's face on either side of the patient's nose and the upper lip.
The two tubes 3350 are fluidly connected at their inferior ends to the plenum chamber 3200.
Examples of laterally projecting connection portions of the cushion module 3150 to which gas delivery tubes 3350 connect in certain forms of the technology have been described above. In these forms, the gas delivery tubes 3350 are configured to engage with such connection portions of the cushion module 3150.
In certain forms of the technology, the connection between the tubes 3350 and the cushion module 3150 is achieved by connection of two rigid components so that the patient can easily connect the two components together in a reliable manner. The tactile feedback of a ‘re-assuring click’ or like sound may be easy for a patient to use or for a patient to know that the tube has been correctly connected to the cushion module 3150. In one form, the tubes 3350 are formed from silicone and the lower end of each of the silicone tubes 3350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like. The rigid connector may comprise a female mating feature configured to connect with a male mating feature on the cushion module 3150. Alternatively, the rigid connector may comprise a male mating feature configured to connect to a female mating feature on the cushion module 3150.
In another embodiment a compression seal is used to connect each tube 3350 to the cushion module 3150. For example, a resiliently flexible (e.g. silicone) tube 3350 without the rigid connector may need to be squeezed slightly to reduce its diameter so that it can be jammed into a port in the cushion module 3150 and the inherent resilience of the silicone pushes the tube 3350 outwards to seal the tube 3350 in the port in an air-tight manner. In a hard-to-hard type engagement between the tube 3350 and port, a pressure activated seal such as a peripheral sealing flange may be used. When pressurised gas is supplied through the tubes 3350 the sealing flange is urged against the join between the tubes and the inner circumferential surface of the port of the cushion module 3150 to enhance the seal between them. If the port is soft and a rigid connector is provided to the tube 3350, the pressure activated seal as described earlier may also be used to ensure the connection is air-tight. In another example, each tube 3350 is formed from a resiliently flexible (e.g. silicone) material which is over moulded to a rigid connector such that the resiliently flexible material fits over the rigid connector and itself functions as a gasket to seal the connection between the tube 3350 and the cushion module 3150 around a periphery of an air flow passage from the tube 3350 into the cushion module 3150.
The patient interface 3000 may comprise one or more extendable tube sections. In some examples, an extendable tube section comprises an extendable concertina structure. The patient interface 3000 may comprise a positioning and stabilising structure 3300 including at least one gas delivery tube comprising a tube wall having an extendable concertina structure. For example, the patient interface 3000 shown in
Each extendable concertina structure 3362 may comprise a portion of the tube 3350 having one or more folding portions, pleats, corrugations or bellows to form an extendable portion of the tube 3350. In the example shown in
The patient interface 3000 may comprise one or more non-extendable tube sections 3363. For example, the patient interface 3000 shown in
The cross-sectional shape of the non-extendable tube sections 3363 of the tubes 3350 may be circular, elliptical, oval, D-shaped or a rounded rectangle, for example as described in U.S. Pat. No. 6,044,844. A cross-sectional shape that presents a flattened surface of tube on the side that faces and contacts the patient's face or other part of the head may be more comfortable to wear than, for example a tube with a circular cross-section.
In some examples of the present technology, the non-extendable tube sections 3363 connect to the plenum chamber 3200 from a low angle. The headgear tubes 3350 may extend inferiorly down the sides of the patient's head and then curve anteriorly and medially to connect to the plenum chamber 3200 in front of the patient's face. The tubes 3350, before connecting to the plenum chamber 3200, may extend to a location at the same vertical position as or, in some examples, inferior to the connection with the plenum chamber 3200. That is, the tubes 3350 may project in an at least partially superior direction before connecting with the plenum chamber 3200. A portion of the tubes 3350 may be located inferior to the plenum chamber 3200 and/or the seal forming structure 3100. The low position of the tubes 3350 in front of the patient's face facilitates contact with the patient's face below the patient's cheekbones.
Each non-extendable tube portion 3363 may permanently or removably connect to a cushion module 3150 of the patient interface at least partially forming the plenum chamber 3200.
In certain forms of the present technology, the positioning and stabilising structure 3300 comprises at least one headgear strap acting in addition to the tubes 3350 to position and stabilise the seal-forming structure 3100 to the entrance to the patient's airways. As shown in
In the example shown in
In one form of the present technology, a seal-forming structure 3100 provides a target seal-forming region, and may additionally provide a cushioning function. The target seal-forming region is a region on the seal-forming structure 3100 where sealing may occur. The region where sealing actually occurs—the actual sealing surface—may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient's face.
In one form the target seal-forming region is located on an exterior surface of the seal-forming structure 3100.
In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber, a textile material or a combination of such materials.
A seal-forming structure 3100 in accordance with some examples of the present technology may be constructed from a soft, flexible, resilient material such as silicone.
A seal-forming structure 3100 in accordance with some examples of the present technology may comprise non-patient contacting portions and patient contacting portions. In some examples, a seal-forming structure 3100 may comprise anterior-facing, lateral-facing, superior-facing and/or inferior-facing portions which may not be in contact with the patient's face.
A seal-forming structure 3100 in accordance with further examples of the present technology may be constructed from a textile material. In some examples an anterior side of the seal-forming structure 3100 may be formed form an elastomeric material such as silicone of TPE while a posterior side may formed from a textile material.
Where the seal-forming structure 3100 comprises a textile or textile portion, the textile may comprise a material formed of a network of fibres and being adapted such that it is air impermeable. For example, the textile can have an air impermeable film on at least one surface thereof.
In some forms, the seal-forming structure 3100 is constructed so as to stretch elastically in at least one dimension. For example, when a textile seal-forming structure is constructed from a network of fibres, the seal-forming structure may be capable of elongating in either, or both of, a longitudinal warp direction or a lateral weft direction across the textile. In some forms, a textile seal-forming structure 3100 is constructed so as to elongate elastically to an extent greater than that achievable by conventional silicone seal-forming structure.
In some forms, the seal-forming structure 3100 is constructed so as to be substantially inelastic in at least one dimension. For example, when a textile seal-forming structure is constructed from a woven textile, the seal-forming structure may be capable of substantially resisting elongation in either, or both of, a longitudinal warp direction or a lateral weft direction across the textile.
The seal-forming structure 3100 can be made from either a single layer or a plurality of layers. In forms where a plurality of layers are utilised, the individual layers can be formed using the same material, or a variety of different materials, each with unique material properties.
In some forms, the textile seal-forming structure 3100 can comprise at least one layer that exhibits substantially air-impermeable characteristics, whilst maintaining the material characteristics necessary for comfort and minimal pressure points. In some forms a textile seal-forming structure 3100 may comprise an air impermeable material formed on an inner surface of the textile material. The air impermeable material can in some forms be laminated onto the textile material. The air impermeable material and textile material can in some forms be selected such that the resulting textile material can exhibit a predetermined overall elasticity, or a resistance to elasticity, as required.
In some forms, the textile seal-forming structure 3100 can exhibit a low spring constant (i.e. high compliance) in both warp and weft. In such forms, unlike conventional designs where a fixed cushion may cause the skin of a patient's face to distort to form an effective seal, the textile material of the seal-forming structure 3100 can have a material spring constant and spring length such that the textile seal-forming structure 3100 is more compliant than the patient's skin that engages the seal-forming structure 3100. This may advantageously improve the comfort of the mask, and reduce the formation of localized pressure “hot spots”.
In some forms, the surface of the textile material of the seal-forming structure 3100 that contacts the patient's face can have low friction characteristics. This may advantageously improve the comfort of the surface texture of the textile seal-forming structure 3100 and reduce friction relative to the patient's face. In some forms, higher friction textiles may cause the seal-forming structure 3100 to grip or rub against contacted regions of the patient's face 1300, in use. Such rubbing or gripping may cause the seal-forming structure to be distorted or deformed thereby reducing the effectiveness of the seal and allowing air to leak undesirably from the device.
In some forms, the textile material of the seal-forming structure 3100 has an overall thickness of 0.275 mm or less.
The textile seal-forming structure 3100 shown in
In certain forms of the present technology, a system is provided comprising more than one a seal-forming structure 3100, each being configured to correspond to a different size and/or shape range. For example the system may comprise one form of a seal-forming structure 3100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head.
In one form, the seal-forming structure 3100 includes a sealing flange utilizing a pressure assisted sealing mechanism. In use, the sealing flange can readily respond to a system positive pressure in the interior of the plenum chamber 3200 acting on its underside to urge it into tight sealing engagement with the face. The pressure assisted mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.
In one form, the seal-forming structure 3100 comprises a sealing flange and a support flange. The sealing flange comprises a relatively thin member with a thickness of less than about 1 mm, for example about 0.25 mm to about 0.45 mm, which extends around the perimeter of the plenum chamber 3200. Support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge of the plenum chamber 3200, and extends at least part of the way around the perimeter. The support flange is or includes a spring-like element and functions to support the sealing flange from buckling in use.
In one form, the seal-forming structure may comprise a compression sealing portion or a gasket sealing portion. In use the compression sealing portion, or the gasket sealing portion is constructed and arranged to be in compression, e.g. as a result of elastic tension in the positioning and stabilising structure.
In one form, the seal-forming structure comprises a tension portion. In use, the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.
In one form, the seal-forming structure comprises a region having a tacky or adhesive surface, and/or having a higher coefficient of friction compared to other surfaces.
In certain forms of the present technology, a seal-forming structure may comprise one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a tacky or adhesive surface.
In some forms of the present technology, a seal-forming structure 3100 may comprise a low-friction surface in one or more regions. The low friction surface may enable the seal-forming structure 3100 to slide over the patient's skin to fit to surfaces of the patient's face comprising complex geometry, such as proximate the nasolabial sulcus and the concavities often present at the location where the ala of the patient's nose meets the patient's face.
In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.
In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.
In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.
In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on an upper lip region of the patient's face.
In one form the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal in use on a chin-region of the patient's face.
In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a chin-region of the patient's face.
In one form the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient.
Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose, a stalk, a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stalk. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk. The flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement both displacement and angular of the frusto-cone and the structure to which the nasal pillow is connected. For example, the frusto-cone may be axially displaced towards the structure to which the stalk is connected.
In one form, the non-invasive patient interface 3000 comprises a seal-forming portion that forms a seal in use on an upper lip region (that is, the lip superior), a nasal bridge region and a cheek region of the patient's face. This is the case, for example, with the patient interface 3000 shown in
In one form the patient interface 3000 comprises a seal-forming portion that forms a seal in use on a chin-region, a cheek region and either a nasal bridge region or an under the nose region of the patient's face. This is the case, for example, with the patient interface 3000 shown in
In one form of the present technology, for example as shown in
In certain forms of the present technology, the seal-forming structure 3100 comprises a central portion configured to form a seal to inferior surfaces of the patient's nose. The central portion may seal to an inferior periphery of the patient's nose (e.g., surrounding the patient's nares and to the patient's lip superior). In examples, the seal-forming structure 3100 may be configured to contact the patient's face below the bridge of the nose or below the pronasale.
The seal-forming structure 3100 may be configured to not enter the patient's nares in use. For example, the seal-forming structure 3100 may seal to the patient's face without entering the patient's nares. The seal-forming structure 3100 may be configured to form a seal with a region of the patient's face surrounding the patient's nares without entering the patient's nares. In some examples, the seal-forming structure 3100 is configured to form a seal which surrounds the patient's nares and columella. The seal-forming structure 3100 may form a single contiguous seal that surrounds both nares.
The seal-forming structure 3100 may be configured to seal to anterior and/or inferior surfaces of the patient's nose tip in use. The seal-forming structure 3100 may seal against lateral and/or inferior surfaces of the patient's nasal alae in use. The seal-forming structure 3100 may be configured to seal to any one or more of the patient's subnasale, inferior surfaces of the patient's nose between the patient's nares and upper lip and/or the patient's upper lip.
In some examples the seal-forming structure 3100 is configured to leave the patient's nose tip uncovered in use. The seal-forming structure 3100 may be configured to leave the patient's nasal bridge uncovered in use. In some forms the seal-forming structure 3100 may not seal to any surfaces of the patient's face superior to the lateral cartilage of the patient's nose (identified in
The seal-forming structure 3100 comprises a central portion 3111 configured to seal in use to the patient's face at inferior portions of the patient's nose. In some examples of the present technology, the central portion 3111 is configured to seal in use against at least the patient's pronasale, nasal alae and lip superior. The central portion 3111 may be configured to seal to an inferior periphery of the patient's nose in use surrounding the patient's nares and against the patient's lip superior. The central portion 3111 is provided to a posterior side of the seal-forming structure 3100. The central portion 3111 may be bisected by a plane that is parallel to the patient's sagittal plane in use.
Most of the contact with the patient's nose may be made by the central portion 3111. Some contact may also be made by mid-lateral portions 3121, which are described below. In some examples, a majority of the seal formed by the seal-forming structure 3100 to the inferior periphery of the patient's nose may be made by the central portion 3111.
It will be appreciated that the actual amount of contact made by the seal-forming structure 3100 to the patient's face will depend on the particular implementation of the present technology and the anatomy of a particular patient, among other things, such as the way the patient has setup the patient interface.
The cushion module 3150 comprises two holes 3272 configured to allow a flow of air at therapeutic pressure to be delivered to the patient's nares. The holes 3272 are identified in
In some examples, the central portion 3111 may comprise a wall thickness of between 0.15 mm and 0.4 mm. In some examples, the wall thickness of the central portion 3111 may be between 0.2 mm and 0.35 mm. In some examples the wall thickness of the central portion 3111 may be substantially 0.25 mm.
In one form, the patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face. In one form, the seal-forming structure 3100 includes a saddle-shaped region constructed to form a seal in use on an upper lip region of the patient's face.
In the examples shown in
In some examples the lip superior portion 3116 has the same stiffness as the rest of the central portion 3111. The cushion module 3150 shown in
The central portion 3111 and the lip superior portion 3116 thereof may have a lower stiffness than most or all other portions of the seal forming structure 3100. In some examples of the present technology the lower stiffness is provided by a lower wall thickness than other portions of the seal forming structure 3100. The pronasale, the inferior surfaces of the patient's nose and the lip superior, can have complex geometry and can also be very sensitive to pressure. Accordingly, it is advantageous for the areas of the plenum chamber 3200 that will contact or seal against these locations to be flexible and compliant, to avoid exerting excessive pressure on the face at these regions.
A low stiffness of certain portions of the seal-forming structure 3100, which may be provided by a low wall thickness, enables the seal-forming structure 3100 to readily deform to seal against the surfaces on the underside of the patient's nose, e.g., against the pronasale towards the anterior direction, the nasal ala on either lateral side and the lip superior.
In some examples of the present technology, the central portion 3111 may have a greater stiffness in the lip superior portion 3116 than in other regions of the central portion 3111. For example, the lip superior portion 3116 may be stiffer than the portion of the central portion 3111 surrounding the holes 3272.
The cushion module 3150 shown in
In some examples of the present technology, such as the example shown in
The anterior portion 3133 of the lip superior portion 3116 may have a stiffness greater than a stiffness of the posterior portion 3134 of the lip superior portion 3116. In the examples shown in
The thickness of the posterior portion 3134 of the lip superior portion 3116 may the same thickness as that of one or more portions of the central portion 3111 adjacent to the lip superior portion 3116. In the examples shown in
In other examples, the thickness of the posterior portion 3134 of the lip superior portion 3116 may be greater than the thickness of one or more portions of the central portion 3111 adjacent to the lip superior portion 3116. In the example shown in 25A-25I, the thickness of the posterior portion 3134 is greater than other portions of the central portion 3111.
The thickness of the posterior portion 3134 of the lip superior portion 3116 may be in the range of 0.1 mm to 1 mm, such as between 0.2 mm-0.8 mm, 0.3 mm-0.7 mm, 0.4 mm-0.6 mm, 0.15 mm-0.35 mm or 0.2 mm-0.3 mm. In particular examples the thickness of the posterior portion 3134 may be 0.25 mm or 0.5 mm. In the examples illustrated in
The thickness of the anterior portion 3133 of the lip superior portion 3116 may be in the range of 0.4 mm-2 mm, such as between 0.5 mm-1.6 mm, 0.9 mm-1.3 mm, or 1.4 mm-1.6 mm. In particular examples the thickness of the anterior portion 3133 may be 1.5 mm, 1.2 mm, 1.15 mm or 0.5 mm. In the example illustrated in
As described below in more detail, the seal-forming structure 3100 may comprise a pair of lateral posterior regions 3141 on respective lateral posterior sides of the lip superior portion 3116. In the example illustrated in
In the example illustrated in
In the examples illustrated in
As shown in
The difference in thickness between the anterior portion 3133 and the posterior portion 3134 of the lip superior portion 3116 may be produced by a sharp or stepped change in thickness. The change in thickness may be produced by a step formed in the material forming the seal-forming structure 3100, the step being formed in an internal surface of the seal-forming structure 3100.
The greater thickness in the anterior portion 3133 with respect to the posterior portion 3134 of the lip superior portion 3116 may advantageously provide additional crease resistance to the seal-forming structure 3100 than if these portions had the same thickness as each other and/or the rest of the central portion 3111. The anterior portion 3133 may prevent or at least resist creasing and the seal-forming structure 3100 proximate the junction between the seal-forming structure 3100 and the chassis portion 3210. The increased thickness of the anterior portion 3133 may also stiffen the chassis portion 3210 proximate the lip superior portion 3116 and may improve dynamic seal at the upper lip (e.g. improve the stability of the seal formed with the patient's upper lip during movement of the patient's head).
The central portion 3111 is contiguous with a central anterior portion 3115 in this example. The central anterior portion 3115 is an anterior-facing portion of the seal-forming structure 3100. In use the central anterior portion 3115 may be located proximate and inferior to the patient's pronasale.
In the examples shown in
The central portion 3111 of the seal-forming structure 3100 may be configured to inflate to conform to inferior surfaces and periphery of the patient's nose. The thin wall of the seal-forming structure 3100 in the superior-facing central portion 3111 is advantageous in creating a good seal to the complex geometry under and around the nose. The thin wall can deform and inflate under pressure from breathable gas in the plenum chamber 3200, conforming to the surfaces of the patient's face to create an effective and yet comfortable seal.
While there is an advantage for comfort in keeping the wall thickness low in the regions configured to contact the sensitive pronasale and lip superior regions, in examples of the present technology the wall thickness in these regions is not reduced to the extent that the seal-forming structure 3100 is no longer able to maintain a stable seal to the patient's face. If the wall thickness is too low in these regions, the seal-forming structure 3100 could be prone to creasing, which can break the seal and create a leak path through which air can flow to the surroundings between the patient's face and the cushion.
In some examples of the present technology, the central anterior portion 3115 comprises a superior portion 3114 and an inferior portion 3113, as shown in
The central anterior portion 3115 is on an anterior side of the seal-forming structure 3100, which may be a non-patient contact side. It is located proximate and inferior to the patient's pronasale in use. The central anterior portion 3115 may be at least partially anterior facing. For example, the central anterior portion 3115 may comprise an at least partially anterior-facing surface. At least a majority of the central anterior portion 3115 may be on an anterior side of the seal-forming structure 3100. A portion of the central anterior portion 3115 may be configured not to contact the patient's face in use. The inferior portion 3113 of the central anterior portion 3115 may be configured not to contact the patient's face in use. In some examples the superior portion 3114 may be configured not to contact the patient's face in use.
In the examples of the present technology shown in
The central anterior portion 3115 is an otherwise thin and relatively flexible portion of the seal-forming structure 3100 in comparison to other portions of the seal-forming structure. For example, in the examples shown in
In the examples shown in
In the examples shown in
In other examples of the present technology, the inferior portion 3113 of the central anterior portion 3115 may comprise a rigidising member, a portion of the seal-forming structure formed from a stiffer material or another appropriate stiffening means.
As shown in
More generally, any difference in thickness between two portions of the seal-forming structure 3100 or chassis portion 3210 exemplified herein by a step change in thickness may in other examples comprise a taper in thickness. Likewise any difference in thickness exemplified by a taper in thickness may in other examples comprise a step change in thickness.
In some examples of the present technology, an inferior portion 3113 having a greater stiffness and/or thickness than a superior portion 3114 may be provided to the central anterior portions 3115 of the cushion modules 3150 shown in
As shown in
As shown in
As a result of the curvature of the boundaries of the mid-lateral portions 3121, each mid-lateral portions 3121 as a whole may comprise a curved shape which, from a perspective of moving generally anteriorly, curves towards a medial direction proximate the anterior side of the seal-forming structure 3100.
The curves of the mid-lateral portions 3121 and their boundaries may result in the mid-lateral portions 3121 following the shape of the inferior periphery of the patient's nose. The mid-lateral portions 3121 may be concave with respect to the patient's nose proximate the widest portion of the patient's nose (e.g. proximate the alar wings). Each mid-lateral portion 3121 may curve towards an inferior and/or medial direction proximate the posterior corner portions 3131 (described below) and/or lip superior portion 3116, from a perspective of moving along the curve of the mid-lateral portion in a generally posterior direction.
Each of the mid-lateral portions 3121 may extend such that one end is proximate the lip superior portion 3116 and the other end is proximate an anterior-most portion of the central portion 3111. In the examples shown in
In this example, the lateral boundary of each mid-lateral portion is located between a medial-facing side portion of the seal-forming structure 3100 and a lateral-facing side-portion of the seal-forming structure 3100. The seal-forming structure 3100 may comprise a superior ridge 3117 (shown in
In the examples shown in
The mid-lateral portions 3121 may be located around some or all of the inferior periphery of the patient's nose in use. For example, the mid-lateral portions 3121 may be configured to lie just outside of a patient's nose at the base of the nose, e.g., proximate or in contact with the ala.
The mid-lateral portions 3121 of the seal-forming structure 3100 may comprise a pair of exterior walls facing towards partially medial and partially superior directions (e.g., having external or exterior surfaces facing in medial and superior directions) and in some examples also partially posteriorly.
Each mid-lateral portion 3121 may have a stiffness greater than a stiffness of the central portion 3111. The seal-forming structure 3100 may comprise a greater wall thickness in the mid-lateral portions 3121 than in the central portion 3111. The greater wall thickness in the mid-lateral portions 3121 in comparison to the central portion 3111 may provide the greater stiffness of the mid-lateral portions 3121.
In some examples, the mid-lateral portions 3121 of the seal-forming structure 3100 reinforce the central portion 3111 of the seal-forming structure 3100. In further examples, the mid-lateral portions 3121 are configured to resist creasing in the seal-forming structure. This crease resistance is provided in the illustrated examples due to an increased thickness of the seal-forming structure 3100 in the mid-lateral portions. In some forms, the mid-lateral portions provide a barrier to creases and prevent leak paths forming in the seal-forming structure 3100. The mid-lateral portions 3121 may be configured to prevent creases in the central portion 3111 of the seal-forming structure 3100 from forming leak paths through which gas can leak through the crease from the interior of the plenum chamber 3200 to ambient.
Accordingly, the mid-lateral portions 3121 may act as a barrier to creases that closely follow the shape of the patient's nose, by being configured to lie at or proximate the edges of the patient's ala around the base of the nose.
Additionally, the mid-lateral portions 3121 may provide for flexible support against sideward loading on the plenum chamber 3200 to help prevent breaking the seal under lateral forces. The mid-lateral portions 3121 may be flexible to deform under lateral forces while being thicker than the central portion 3111 to support the central portion 3111 in sealed contact against the underside of the patient's nose.
On either side of the central anterior portion 3115 (discussed above) is a mid-lateral anterior portion 3125, in some examples of the present technology, such as in the cushion module 3150 shown in
In other examples, the mid-lateral anterior portions 3125 have substantially the same wall thickness as the mid-lateral portions 3121 on the patient-contacting side of the seal-forming structure 3100.
The mid-lateral anterior portions 3125 may each comprise a superior portion 3126 and an inferior portion 3127. The mid-lateral anterior portions 3125 may be at least partially anterior facing and at least partially laterally facing. For example, the mid-lateral anterior portions 3125 may each comprise a surface facing at least partially anteriorly and at least partially laterally. At least a majority of the mid-lateral anterior portions 3125 may be on an anterior side of the seal-forming structure 3100. A portion of each mid-lateral anterior portion 3125 may be configured not to contact the patient's face in use. The inferior portions 3127 of each mid-lateral anterior portion 3125 may be configured not to contact the patient's face in use. In some examples the superior portion 3126 may be configured not to contact the patient's face in use.
The inferior portions 3127 of each mid-lateral anterior portion 3125 may have a stiffness greater than a stiffness of the superior portions 3126 of the mid-lateral anterior portion 3125. As shown in
The stiffness of the inferior portions 3127 of the mid-lateral anterior portions 3125 may help increase the stability of the cushion module 3150 and the seal it makes to the patient's face during dynamic movements, for example when the patient moves while sleeping or in bed. The stiffness and thickness of the inferior portions 3127 may also provide greater resistance to excessive flaring out of the seal-forming structure 3100 resulting in leak paths through loss of contact with the patient's nose, due to the otherwise flexible nature of the seal-forming structure 3100. Finally, the stiffness of the inferior portions 3127 of the mid-lateral anterior portions 3125 may provide added torsion resistance. The inferior portions 3127 may prevent one side of the cushion module 3150 from twisting away from or with respect to the other side of the cushion module 3150, which could result in loss of contact with the patient's nose and leak paths. The inferior portions 3127 of the mid-lateral anterior portions 3125 and the chassis superior reinforcing portions 3220 may together provide the above advantages, in cushion modules 3150 in which both the stiffer inferior portions 3127 and the chassis superior reinforcing portions 3220 are provided.
In the example shown in
Each superior portion 3126 of the mid-lateral anterior portions 3125, in the example shown in
In the example shown in
In the example shown in
In some examples the inferior portions 3127 have a wall thickness between 1 mm and 3 mm. In some examples the wall thickness is between 1.2 mm and 2.5 mm or between 1.5 mm and 2 mm. In the example shown in
In the example illustrated in
In some examples of the present technology, the seal-forming structure may comprise mid-lateral anterior portions 3125 having a tapering thickness from a greater thickness in an inferior portion to a lesser thickness in a superior portion of each mid-lateral anterior portion 3125. More generally, in examples of the present technology, any non-patient contacting portion of the seal-forming structure 3100 may have a thickness that tapers from a greater thickness in a region proximate the chassis portion 3210 to a lesser thickness proximate the central portion 3111.
In some examples of the present technology, the seal-forming structure 3100 of a cushion module 3150 may comprise mid-lateral anterior portions 3125 comprising medial portions 3128 and lateral portions 3129. In the cushion modules 3150 shown in
The stiffness of each of the medial portions 3128 of the mid-lateral anterior portions 3125 may be greater than a stiffness of the central anterior portion 3115. In these examples, the wall thickness of each medial portion 3128 is greater than the wall thickness of the central anterior portion 3115. The greater stiffness is provided by the greater thickness in this example. In other examples a greater stiffness may be provided by a rigidiser or by forming the medial portion 3128 from a stiffer material.
The medial portions 3128 may also have a greater stiffness than the mid-lateral portions 3121 on the patient-contacting side of the seal-forming structure 3100, or at least a greater stiffness than the central portion 3111. In the examples shown in
In some examples of the present technology, the mid-lateral anterior portions 3125 may each comprise a superior portion 3126 and an inferior portion 3127. The lateral portions 3129 of the mid-lateral anterior portions 3125 may comprise the superior portion 3126 and the inferior portion 3127. In the examples shown in
Additionally, the wall thickness of the medial portion 3128 is greater than the wall thickness of the superior portion 3126 of the lateral portion 3129 of each mid-lateral anterior portion 3125. In this example, the wall thickness of the medial portion 3128 is less than the wall thickness of the inferior portion 3127 of the lateral portion 3129 each mid-lateral anterior portion 3125. The differences in wall thickness may provide corresponding differences in stiffnesses.
The additional stiffness and/or thickness provided to the medial portion 3128 may resist creasing in the central and/or mid-lateral portions of the anterior side of the seal-forming structure. Additionally, the additional stiffness and/or thickness may help provide structure to the seal-forming structure 3100 to maintain its overall shape in use, allowing patient-contacting surfaces of the seal-forming structure 3100 to be thin to conform to the surfaces of the patient's face and create a good seal in use. The additional stiffness and/or thickness in the medial portion 3128 may be particularly advantageous in cushion modules 3150 of the present technology in which the chassis portion 3210 is formed from a flexible material, such as from silicone. The inferior portion 3127 of the lateral portion 3129 of each mid-lateral anterior portion 3125 may provide similar advantages to the cushion module 3150.
Also as illustrated in
In these examples the chassis superior reinforcing portions 3220 are located adjacent the seal-forming structure 3100 and, in this particular example, are each located adjacent a respective one of the mid-lateral anterior portions 3125. Each chassis superior reinforcing portion 3220 in the cushion modules 3150 shown in
Each chassis superior reinforcing portion 3220 may comprise a greater wall thickness than a wall thickness of the mid-lateral anterior portions 3125. The greater wall thickness provides the greater stiffness in this particular example. Additionally, each chassis superior reinforcing portion 3220 may comprise a greater wall thickness than the wall thickness of the medial portions 3128 of the mid-lateral anterior portions 3125.
In the example shown in
It is to be understood that the cushion module 3150 may comprise gradual changes in thickness between adjacent portions, such as a tapering thickness rather than a stepped change in thickness. A smooth transition may help prevent creases and leak paths forming when a load is applied. Sudden changes in geometry may also be more likely to be felt by the patient while a smoother change is more comfortable. Smooth changes may also make the cushion module 3150 easier to mould and demould.
In some examples of the present technology the seal-forming structure 3100 may comprise a pair of mid-lateral inferior portions 3122. As illustrated in particular in
Also as shown in
5.3.3.8.2.3.1 Anterior Portions of Mid-Lateral Inferior Portions Stiffer than Posterior Portions of Mid-Lateral Inferior Portions
In the examples of the present technology shown in
5.3.3.8.2.3.2 Anterior Portion of Lip Superior Portion Stiffer than Posterior Portion of Lip Superior Portion
As described above, the lip superior portion 3116 of the cushion module 3150 shown in
5.3.3.8.2.3.3 Anterior Portions of Mid-Lateral Inferior Portions Stiffer than Anterior Portion of Lip Superior Portion
The anterior portions 3123 of the mid-lateral inferior portions 3122 may be stiffer than the anterior portion 3133 of the lip superior portion 3116. In the examples shown in
5.3.3.8.2.3.4 Anterior Portions of Mid-Lateral Inferior Portions Stiffer than Posterior Portion of Lip Superior Portion
The anterior portions 3123 of the mid-lateral inferior portions 3122 may be stiffer than the posterior portion 3134 of the lip superior portion 3116. In the examples shown in
5.3.3.8.2.3.5 Posterior Portions of Mid-Lateral Inferior Portions Stiffer than Posterior Portion of Lip Superior Portion
The posterior portions 3124 of the mid-lateral inferior portions 3122 may be stiffer than the posterior portion 3134 of the lip superior portion 3116. In the examples shown in
In some examples of the present technology, the thickness of the posterior portions 3124 of the mid-lateral inferior portions 3122 is substantially the same as the thickness of the anterior portion 3133 of the lip superior portion 3116.
The greater stiffness and/or thickness of the anterior portions 3123 of the mid-lateral inferior portions 3122, relative to the posterior portions 3124 of the mid-lateral inferior portions 3122, has been found to facilitate a cushion module 3150 which may form a particularly robust seal to the patient's face in use. Likewise the applicant has found that the greater stiffness and/or thickness of the anterior portions 3123 of the mid-lateral inferior portions, relative to the posterior portion 3134 of the lip superior portion 3116, may facilitate a particularly robust seal in use. Cushion modules 3150 according to other examples of the present technology which do not incorporate the above described relative stiffnesses/thicknesses, may also provide an acceptably robust seal in use.
In the example illustrated in
It is to be understood that the cushion module 3150 may comprise gradual changes in thickness between adjacent portions, such as a tapering thickness rather than a stepped change in thickness. A smooth transition may help prevent creases and leak paths forming when a load is applied. Sudden changes in geometry may also be more likely to be felt by the patient while a smoother change is more comfortable. Smooth changes may also make the cushion module 3150 easier to mould and demould.
For example, the seal-forming structure 3100 may comprise a gradual transition in thickness (e.g. a taper) between the anterior portion 3133 and the posterior portion 3134 of the lip superior portion 3116. The seal-forming structure 3100 may comprise a gradual change in thickness, rather than a stepped change, between any two or more of the anterior portion 3133 of the lip superior portion 3116, the posterior portion 3134 of the lip superior portion 3116, the anterior portions 3123 of the mid-lateral inferior portions 3122, the posterior portions 3124 of the mid-lateral inferior portions 3122, the chassis inferior reinforcing portions 3221 and the lateral posterior portion 3141.
In the example shown in
In some examples, such as those shown in
The posterior corner portions 3131 may be configured to resist creasing in the seal-forming structure 3100. The crease resistance may be provided by a greater stiffness and/or thickness of the posterior corner portions 3131 than adjacent portions of the seal-forming structure 3100. For example, if a crease occurs in the central portion 3111 of the seal-forming structure 3100, the posterior corner portions 3131 may limit the size of the crease to prevent it from continuing past the seal forming surface (e.g. past the periphery of the patient's nose).
In examples of the present technology, a greater stiffness in regions of the seal-forming structure 3100 compared to other regions of the seal-forming structure 3100 may be provided by a greater wall thickness, a stiffer material (e.g., higher durometer silicone or other material), a reinforcing structure such as a tie or a rib, an undercushion, portion of a chassis, or the like, across various examples of the present technology.
The seal-forming structures 3100 of the plenum chambers 3200 shown in
In some examples, the lateral posterior regions 3141 may also comprise sub-regions which face in one or more of an at least partially inferior, an at least partially posterior, an at least partially superior, an at least partially anterior and an at least partially medial direction, in addition to facing in a lateral direction. In the examples illustrated in
The lateral posterior regions 3141 may comprise a stiffness greater than a stiffness of the central portion 3111. The thickness of the lateral posterior regions 3141 may be greater than the thickness of the central portion 3111. The greater thickness of the lateral posterior regions 3141 may provide the greater stiffness. The lateral posterior regions 3141 may comprise sufficient stiffness to provide form to the seal forming structure 3100 and support the more flexible portions of the seal forming structure 3100, such as the central portion 3111.
As shown in
Each of the lateral posterior regions 3141 may partially encircle a respective one of the laterally projecting connection portions 3212, for example having a shape that follows the curvature of the laterally projecting connection portion 3212. Each of the lateral posterior regions 3141 may comprise an anterior boundary matching the posterior shape of a respective laterally projecting connection portion 3212. Each of the lateral posterior regions 3141 may be located in the seal-forming structure 3100 at a junction between the seal-forming structure 3100 and a respective laterally projecting connection portion 3212. Each of the lateral posterior regions 3141 may be provided at least partially around a respective one of the laterally projecting connection portions 3212.
Each lateral posterior region 3141 may be approximately C- or crescent-shaped when viewed from the side, as shown in
As shown in
With reference to the examples shown in
In some examples, such as those shown in
In some examples of the present technology, the lateral posterior regions 3141 may comprise a plurality of portions comprising differing properties. In the examples shown in
Each lateral posterior portion 3141 in this example comprises an anterior portion 3147 and a posterior portion 3146. The anterior portion 3147 has a greater stiffness than the posterior portion 3146. In this example, the anterior portion 3147 has a wall thickness greater than a wall thickness of the posterior portion 3146. The greater wall thickness provides the anterior portion 3147 with a greater stiffness than the posterior portion 3146.
The additional stiffness and/or thickness in the anterior portion 3147 may help provide structure to the seal-forming structure 3100 to maintain the shape of the non-patient contacting side of the seal-forming structure 3100 in use, allowing the patient-contacting surfaces of the seal-forming structure 3100 to be thin to conform to the surfaces of the patient's face and create a good seal in use. The additional stiffness and/or thickness in the anterior portions 3147 of the lateral posterior regions 3141 may be particularly advantageous in cushion modules 3150 of the present technology in which the chassis portion 3210 is formed from a flexible material, such as from silicone.
The anterior portion 3147 of each lateral posterior region 3141 itself may comprise sub-portions having differing properties. In some examples of the present technology, the anterior portion 3147 of each lateral posterior region 3141 comprises a superior portion 3148 and an inferior portion 3149. The superior portion 3148 may have a greater stiffness than the inferior portion 3149. In the examples shown in
In the example shown in
It is to be understood that the cushion module 3150 may comprise gradual changes in thickness between adjacent portions, such as a tapering thickness rather than a stepped change in thickness. A smooth transition may help prevent creases and leak paths forming when a load is applied. Sudden changes in geometry may also be more likely to be felt by the patient while a smoother change is more comfortable. Smooth changes may also make the cushion module 3150 easier to mould and demould.
As discussed above, the seal-forming structure 3100 in the examples shown in
In these examples, each of the anterior portions 3147 of the lateral posterior regions 3141 have a greater wall thickness than a wall thickness of the mid-lateral anterior portions 3125. In other examples, the anterior portions 3147 may have substantially the same wall thickness as a thickness within the mid-lateral anterior portions 3125.
In these examples, the superior portion 3148 of the anterior portion 3147 of each of the lateral posterior regions 3141 has a wall thickness greater than a wall thickness of each mid-lateral anterior portion 3125. In other examples the superior portion 3148 may have substantially the same thickness as some or all of the mid-lateral anterior portion 3125.
As discussed above, each mid-lateral anterior portion 3125 comprises a superior portion 3126 and an inferior portion 3127 in the cushion module 3150 shown in
Additionally, the stiffness of the inferior portion 3127 of each mid-lateral anterior portion 3125 may be substantially the same as the stiffness of the superior portion 3148 of the anterior portion 3147. In the examples shown in
As shown in
Accordingly, as shown in
In some examples of the present technology, the cushion module 3150 comprises one or more decoupling portions 3142. The decoupling portions 3142 may be configured to at least partially decouple seal-forming surfaces of the seal-forming structure 3100 from movement of, or forces receive by, other portions of the cushion module 3150. In some examples, the seal-forming structure 3100 comprises decoupling portions 3142. In other examples the chassis portion 3210 comprises decoupling portions 3142.
As described above, the seal-forming structure 3100 comprises a pair of lateral posterior regions 3141 provided on respective lateral posterior sides of the seal-forming structure 3100. As shown in
Each decoupling portion 3142 is configured to at least partially decouple the posterior side of the seal-forming structure 3100 from the chassis portion 3210 so that forces applied to one component are not wholly transmitted to the other component. Additionally or alternatively, movement of one component does not result in the same movement to the other component. In particular, each decoupling portion 3142 is configured to at least partially decouple the central portion 3111 of the seal-forming structure 3100 from a respective one of the laterally projecting connection portions 3212. The decoupling portions 3142 may at least partially decouple the central portion 3111 from movement of the laterally projecting connection portions 3212 and/or forces applied to the laterally projecting connection portions 3212.
As illustrated, the decoupling portions 3142 are provided to the non-patient-contacting side of the seal-forming structure 3100. In this example they are located proximate the connections to the headgear conduits made by the laterally projecting connection portions 3212.
The decoupling portion 3142 may have a decoupling property due to having a lower stiffness and/or thickness in comparison to adjacent portions of the seal-forming structure 3100 to allow at least some relative movement between the adjacent portions.
The stiffness of each decoupling portion 3142 is less than a stiffness of each peripheral portion 3143. In this example, the stiffness of the peripheral portion 3143 is greater than a stiffness of the central portion 3111 of the seal-forming structure 3100. Additionally, the stiffness of each decoupling portion 3142 is greater than the stiffness of the central portion 3111 of the seal-forming structure 3100. The lateral-facing posterior portions 3141 are therefore stiffer than the central portion 3111.
The decoupling portions 3142 may be regions having a low wall thickness and may also be known as thin wall zones. As discussed above, a portion of the seal-forming structure 3100 may have a greater stiffness due to having a greater material thickness. The wall thickness of the peripheral portion 3143 of each lateral posterior region 3141 may be greater than a wall thickness of the central portion 3111 of the seal-forming structure 3100. Additionally, the wall thickness of the peripheral portion 3143 of each lateral posterior region 3141 may be greater than a wall thickness of the decoupling portion 3142 of each lateral posterior region 3141. Furthermore, the wall thickness of the decoupling portion 3142 of each lateral posterior region 3141 may be greater than the wall thickness of the central portion 3111 of the seal-forming structure 3100.
In some examples of the present technology, the decoupling portions 3142 each comprise a wall thickness of between 0.3 mm and 0.7 mm, and in some examples the wall thickness is between 0.4 mm and 0.6 mm. In some examples, the peripheral portions 3143 each comprise a wall thickness of between 1.2 mm and 1.6 mm, and in some examples the wall thickness is between 1.3 mm and 1.5 mm. In the example illustrated in
The decoupling portions 3142 may each be C-shaped, U-shaped or the like when viewed from a lateral side of the seal-forming structure. The decoupling portions 3142 are provided between the connection portions 3212 and the patient-contacting side of the seal-forming structure 3100. Each decoupling portion 3142 may have a curvature that follows the curvature of the posterior-most portions of the seal-forming structure 3100. Each decoupling portion 3142 may have a curvature corresponding to curvature of the seal-forming structure 3100 at the posterior corner portions 3131 when viewed from the side.
As described above, the peripheral portions 3143 may each be provided adjacent to, posterior to and/or surrounding, a respective one of the decoupling portions 3142 and may have a greater stiffness and/or thickness than the decoupling portions 3142. Each peripheral portion 3143 may partially or fully surround a respective decoupling portion 3142. Each peripheral portion 3143 may be located between a respective decoupling portion 3142 and posterior-most portion of the seal-forming structure 3100. The peripheral portions 3143 may each have a shape that matches the shape of a respective one of the decoupling portions 3142. The peripheral portions 3143 may each be C-shaped, U-shaped or the like when viewed from the side. The peripheral portions 3143 may comprise a curvature that follows the curvature of the decoupling portions 3142, the posterior-most portions of the seal-forming structure 3100 and/or the posterior corner portions 3131.
The decoupling portions 3142 may each have a posterior boundary and an anterior boundary. The posterior boundary of each decoupling portion 3142 may be curved. As shown in
Each peripheral portion 3143 or a portion thereof may comprise an anterior boundary matching a posterior boundary of a respective one of the decoupling portions 3142. As shown in
In the examples shown in
The seal-forming structure 3100 is flexible in general due to the use of thin walls and/or flexible materials, however the decoupling portions 3142 allow extra movement of the connection portions 3212 with respect to the patient-contacting side of the seal-forming structure 3100 and in particular with respect to the central portion 3111. This further decouples the connection portions 3212 from the sealing surfaces, enabling the cushion module 3150 to tolerate some force received at the connection portions 3212 without transferring that force to the sealing surfaces, or at least without transferring as much force as would be transferred without the decoupling portions 3142.
Decoupling of the connection portions 3212 from the sealing surface may be particularly advantageous because the connectors 3214 and the corresponding connectors on the tubes 3350 are substantially rigid, meaning they may have minimal inherent decoupling effect and are efficient at transferring forces to the chassis portion 3210 and seal-forming structure 3100. Additionally, as the laterally projecting connection portions 3212 are connections between the headgear conduits and the cushion module 3150, some forces may be received by the headgear conduits and passed on to the connection portions 3212. For example, the connection portions 3212 may be particularly susceptible to receiving external forces during side sleeping, since the seal-forming structure 3100 and/or the tubes 3350 of the positioning and stabilising structure 3300 may be in contact with the patient's pillow. Sleeping movements, such as the patient turning over or onto their side, may result in forces being received at the connection portions 3212. The decoupling portions 3142 may reduce the extent to which these forces are transmitted to the posterior side of the seal-forming structure 3100.
Additionally, the decoupling portions 3142 add flexibility to the non-patient contacting side of the seal forming structure 3100, helping it to expand to accommodate wider noses. This may enable the patient interface 3000 to fit comfortably and securely to a wider range of the population.
In the example shown in
In some examples of the present technology, the chassis portion 3210 may comprise one or more decoupling portions 3142 in addition or as an alternative to one or more decoupling portions 3142 of the seal-forming structure 3100. In some examples the laterally projecting connection portions 3212 may comprise decoupling portions. Decoupling portions may be provided to an anterior side of the chassis portion 3210. In one example, the cushion module 3150 comprises a decoupling portion provided to an anterior side of each one of the pair of laterally projecting connection portions 3212.
As described above, the decoupling portions 3142 may comprise a lower stiffness in comparison to other portions of the cushion module 3150, such as the peripheral portions 3143 and the laterally projecting connection portions 3212. In other examples of the present technology, the decoupling portions 3142 may comprise a shape that allows flexibility, such as a fold or concertina structure.
In general, a cushion module 3150 according to the present technology may comprise a chassis portion 3210 comprising a pair of decoupling portions 3142 each provided to a respective lateral side of the chassis portion 3210 and each having a lesser stiffness than one or more adjacent portions of the chassis portion 3210. The decoupling portions 3142 may be configured to at least partially decouple the central portion 3111 of the seal-forming structure 3100 from forces applied to the chassis portion 3210. The decoupling portions 3142 may be configured to at least partially decouple the posterior (e.g. patient-contacting) side of the seal-forming structure 3100 from forces applied to the chassis portion 3210.
In the
The medial decoupling portions 3142b and the lateral decoupling portions 3142a may not be features of a cushion module 3150 that are inextricably linked to each other. In some examples, the cushion module 3150 comprises a pair of medial decoupling portions 3142b and no lateral decoupling portions. In other examples, the cushion module 3150 comprises a pair of lateral decoupling portions 3142a and no medial decoupling portions. While features of the medial decoupling portions 3142b and lateral decoupling portions 3142a may be described herein in the context of a cushion module 3150 having both pairs of decoupling portions 3142a and 3142b, it is to be understood that a cushion module 3150 may have only a single pair of decoupling portions 3142. It is to be understood that the single pair of decoupling portions 3142 may have some or all of the features described with reference to the medial decoupling portions 3142b. Alternatively, or additionally, the single pair of decoupling portions 3142 may have some or all of the features described with reference to the lateral decoupling portions 3142a.
As shown in
Each decoupling portion 3142 of the cushion module 3150 shown in
The lesser stiffness/thickness may allow the decoupling portions 3142 to deform more readily than adjacent portions of the chassis portion 3210, which may allow the decoupling portions 3142 to absorb forces applied to the chassis portion 3210. The chassis portion 3210 is sufficiently stiff that is able to support the seal-forming structure 3100 and hold its shape while transferring force from the positioning and stabilising structure 3300 to the seal-forming structure 3100 to hold the seal-forming structure 3100 in sealing engagement with the patient's face. While the chassis portion 3210 may transfer a force from the positioning and stabilising structure 3300 to the seal-forming structure 3100 for sealing purposes, the decoupling portions 3142 may prevent other forces applied to the chassis portion 3210 from being transmitted to the seal-forming structure 3100 and disrupting the seal, for example forces from the patient's pillow or bed sheets. The decoupling portions 3142 (e.g medial decoupling portions 3142b and/or lateral decoupling portions 3142a) may allow localised controlled deformation of the chassis portion 3210 to partially or fully absorb disruptive forces received by the chassis portion 3210. Advantageously, absorption by the chassis portion 3210 of force applied to the chassis portion 3210 may prevent disruptive forces from being transferred to the seal-forming structure 3100 and disrupting the seal.
It is to be understood that a decoupling portion 3142 configured to at least partially decouple the seal-forming structure 3100 or the central portion 3111 thereof from forces applied to the chassis portion 3210 may not decouple the seal-forming structure 3100 from all force applied to the chassis portion 3210. For example, the positioning and stabilising structure 3300 may apply a force to the chassis portion 3210 to hold the cushion module 3150 in place on the patient's face and may apply force sufficient to hold the seal-forming structure 3100 in sealing engagement with the patient's face while the plenum chamber 3200 is pressurised. The decoupling portions 3142 may not decouple the seal-forming structure 3100 from those forces, but may decouple the seal-forming structure 3100 from additional unwanted forces.
The decoupling portions 3142 may also advantageously deform to stabilise the cushion module during movement of the patient's head during sleep. When the patient moves, forces could disrupt the seal formed by the seal-forming structure 3100. The decoupling portions 3142 may provide for deformation of the cushion module 3150 in the chassis portion 3210 rather than in the seal-forming structure 3100, which may prevent some or all of the disruptive forces from affecting the seal formed by the seal-forming structure 3100 with the patient's face.
In some examples of the present technology, each decoupling portion 3142 may have a thickness within the range of 0.25 mm-1 mm, for example between 0.35 mm-0.8 mm or 0.4 mm-0.6 mm. In the
As shown in
In some examples, such as the example shown in
In some examples, a pair of decoupling portions 3142 may each be located medially adjacent a distal end of a respective laterally projecting connection portion 3212. In other examples, each one of a pair of decoupling portions 3142 may be spaced from a distal end of a respective laterally projecting connection portion 3212. For example, each one of a pair of decoupling portions 3142 may comprise a lateral boundary spaced apart from a distal end of a respective laterally projecting connection portion 3212.
As described above, the chassis portion 3210 shown in
In this example, on each lateral side of the chassis portion 3210, the chassis portion 3210 comprises a medial decoupling portion 3142b and a lateral decoupling portion 3142a. On each lateral side, the lateral decoupling portion 3142a is located laterally of the medial decoupling portion 3142b.
The lateral decoupling portion 3142a and the medial decoupling portion 3142b may decouple the seal-forming structure 3100 from different types of forces.
In this example, the lateral decoupling portions 3142a are configured to at least partially decouple the seal-forming structure 3100 from forces applied to the laterally projecting connection portions 3212. For example, the lateral decoupling portions 3142a may be configured to decouple the seal-forming structure 3100 from forces applied to the laterally projecting connection portions 3212 and/or gas delivery tubes 3350 when the patient turns their head on to its side while lying on a pillow. The lateral decoupling portions 3142a may deform to absorb such forces and prevent the forces from disrupting the seal between the seal-forming structure 3100 and the patient's face, or at least reduce the magnitude of force that reaches the seal-forming structure 3100. The lateral decoupling portions 3142a may be proximate or adjacent to the connectors 3214. In the illustrated example, the decoupling effects provided by the lateral decoupling portions 3142a may be provided by proximity to the distal ends of the laterally projecting connection portions 3212 and a lesser stiffness than adjacent portions of the chassis portion 3210.
The medial decoupling portions 3142b are configured to at least partially decouple the seal-forming structure 3100 from forces applied to a central region of the anterior side of the chassis portion 3210 (e.g. a medial region of the anterior/non-patient facing side of the chassis portion 3210). For example, the medial decoupling portions 3142b may be configured to decouple the seal-forming structure 3100 from forces applied to the central region of the anterior side of the chassis portion 3210 when the patient turns their face towards a pillow or if the central region of the chassis portion 3210 contacts bedsheets, a mattress, the patient's hand/arm/shoulder or the like. The medial decoupling portions 3142b may deform to absorb such forces and prevent the forces from disrupting the seal between the seal-forming structure 3100 and the patient's face, or at least reduce the magnitude of force that reaches the seal-forming structure 3100.
In the example illustrated in
The medial decoupling portions 3142b may be proximate or adjacent to the vent module 3410. In the illustrated example, the decoupling effects provided by the medial decoupling portions 3142b may be provided by proximity to the vent module 3410 or centre of the chassis portion 3210 and a lesser stiffness than adjacent portions of the chassis portion 3210.
As shown in
As shown in
In some examples, each decoupling portion 3142 may be at least partially surrounded by a peripheral portion 3143 having a greater stiffness than both the decoupling portion 3142 and an adjacent portion of the chassis portion 3210. In the example shown in
The decoupling portions 3142 are more flexible than other portions of the chassis portion 3210 and the peripheral portions 3143, having less flexibility, advantageously compensate for any overall strength of the chassis portion 3210 that may be lost in the flexible decoupling portions 3142. Advantageously the decoupling portions 3142 may readily deform in a localised controlled manner, decoupling the seal-forming structure 3100 from disruptive forces, while the peripheral portions 3143 together with other portions of the chassis portion 3210 provide sufficient strength to the overall structure of the chassis portion 3210 that the chassis portion 3210 is able to support the seal-forming structure 3100 in sealing position.
As shown in
In this example, on each lateral side of the chassis portion 3210, the first peripheral portion 3143a is curved to follow the curvature of the medial side of the lateral decoupling portion 3142a. Also on each lateral side of the chassis portion 3210, the second peripheral portion 3143b is curved to follow the curvature of the lateral side of the medial decoupling portion 3142b. The first peripheral portion 3143a and the second peripheral portion 3143b may share respective boundaries with the lateral decoupling portion 3142a and the medial decoupling portion 3142b. The first peripheral portion 3143a and the second peripheral portion 3143b may each have a shape that matches a shape of a side of a respective one of the lateral decoupling portion 3142a and the medial decoupling portion 3142b. In other examples of the present technology, either of the first peripheral portion 3143a and the second peripheral portion 3143b may have a different shape, such as a straight shape. As shown in
In the example shown in
More generally, a cushion module 3150 may comprise one or more decoupling portions 3142, each decoupling portion 3142 being at least partially surrounded by a peripheral portion 3143 of the chassis portion 3210. The peripheral portion 3143 may have a greater stiffness than both the decoupling portion 3142 and an adjacent portion of the chassis portion 3210 to the peripheral portion 3143. Each peripheral portion 3143 may have a greater thickness than both an adjacent portion of the chassis portion 3210 to the peripheral portion 3143.
Each peripheral portion may have a thickness within the range of 1 mm-5 mm, for example 1.2 mm-3.5 mm, 1.4 mm-2.5 mm, 1.5 mm-2 mm. In some examples each peripheral portion 3143 has a thickness of 1.75 mm.
The cushion modules 3150 illustrated in
In some examples of the present technology, the seal-forming structure 3100 may comprise a decoupling portion in the form of a bridge 3118 between holes 3272 which supply a flow of gas to the patient's nares. With reference to
The cushion module 3150, and in some examples the seal-forming structure 3100, may comprise one or more rigidising portions 3161.
The seal-forming structure 3100 shown in
In some examples, each rigidising portion 3161 is provided to only the posterior side of the seal-forming structure 3100. In other examples, each rigidising portion 3161 is provided to only the anterior side of the seal-forming structure 3100. In some examples the rigidising portions 3161 are provided at a superior side of the seal-forming structure 3100, on either or both of an anterior and posterior side of the seal-forming structure. In some examples, the seal-forming structure 3100 comprises two rigidising portions 3161 on each lateral side thereof, one rigidising portion 3161 on an anterior side and one on a posterior side of the seal-forming structure 3100. In some examples the seal-forming structure 3100 comprises a single rigidising portion 3161 on each lateral side of the seal-forming structure 3100, each rigidising portion 3161 having an anterior portion and a posterior portion integrated to form a single rigidising portion 3161.
As shown in
Each rigidising portion 3161 may have a stiffness greater than the stiffness of the mid-lateral portions 3121 of the seal-forming structure 3100. The rigidising portions 3161 add stiffness to the seal-forming structure 3100, enhancing stability. The rigidising portions 3161 may help the seal-forming structure 3100 remain sealed to the sides of the inferior periphery of the patient's nose. The rigidising portions 3161 may help prevent leaks occurring, particularly when the seal-forming structure 3100 receives external forces, for example when the patient moves. In use, each rigidising portion 3161 may lie proximate and/or in contact with the nasal ala of the patient's nose.
As shown in
In this example, the stiffness of the anterior portion 3162 of each rigidising portion 3161 is greater than a stiffness of an adjacent portion of the seal-forming structure 3100 on the anterior side thereof. More particularly, the thickness of the anterior portion 3162 of each rigidising portion 3161 is greater than a thickness of adjacent portions of the seal-forming structure 3100 on the anterior side thereof.
Additionally, the stiffness of the posterior portion 3163 of each rigidising portion 3161 is greater than a stiffness of an adjacent portion of the posterior side of the seal forming structure 3100. More particularly, the thickness of the posterior portion 3163 of each rigidising portion 3161 is greater than a thickness of adjacent portions of the posterior side of the seal-forming structure 3100.
In other examples, the seal-forming structure 3100 may comprise a stiffer material forming the rigidising portions 3161 than forming adjacent portions. Further still, the rigidising portions 3161 may be rigidised with a rigidising part, such as an insert or a relatively rigid member moulded into or otherwise provided to the seal-forming structure 3100. In the example shown in
While each rigidising portion 3161 comprises a greater wall thickness than adjacent portions of the seal-forming structure 3100, the exterior surface on the posterior side of the seal-forming structure 3100 may comprise a smooth surface. The exterior surface on the anterior side of the seal-forming structure 3100 also comprises a smooth surface. The greater wall thickness is provided to an internal surface of the seal-forming structure 3100. This enables a smooth exterior surface of the seal-forming structure 3100, which may be more comfortable, easy to wash and/or aesthetically pleasing for a patient compared to a non-smooth exterior surface.
As described above, in use, each rigidising portion 3161 is located proximate a respective one of the patient's nasal ala. The rigidising portions 3161 stiffen the seal-forming structure 3100 in the areas which are proximate to, or in contact with, the patient's nasal ala. Additionally, each rigidising portion 3161 is located proximate a respective one of the laterally projecting connection portions 3212 of the plenum chamber 3200.
With reference to
In the example illustrated in
The cushion modules 3150 illustrated in
With reference to
The mid-lateral posterior support portions 3171 may be located laterally with respect to the central portion 3111. For example, each mid-lateral posterior support portion 3171 may be located on a respect lateral side of the central portion 3111. The mid-lateral posterior support portions 3171 may be located medially to the posterior corner portions 3131 and/or lateral posterior regions 3141. In some examples the mid-lateral posterior support portions 3171 may be located superior to the posterior corner portions 3131 and/or lateral posterior regions 3141. The mid-lateral posterior support portions 3171 may be located at posterior and/or inferior ends of the mid-lateral portions 3121. The mid-lateral posterior support portions 3171 may be located inferior to a majority of the central portion 3111. The mid-lateral posterior support portions 3171 may be located anterior and/or superior to the lip superior portion 3116.
Each mid-lateral posterior support portion 3171 has a stiffness greater than the stiffness of the central portion 3111. Due to the higher stiffness of the mid-lateral posterior support portions 3171, the mid-lateral posterior support portions 3171 provide crease-resistance to the seal-forming structure 3100. Similarly to the way that the mid-lateral portions 3121 provide crease resistance (as described above), the mid-lateral posterior support portions 3171 also resist the formation of creases in the seal-forming structure 3100, which could result in the leak paths forming. The mid-lateral posterior support portions 3171 may limit the size of creases forming the seal-forming structure 3100.
In some forms of the present technology, the stiffness of each mid-lateral posterior support portion 3171 is less than the stiffness of the mid-lateral portions 3121. In the illustrated examples, each mid-lateral portion 3121 has a greater thickness than the thickness of the mid-lateral posterior support portions 3171.
As described above, the seal-forming structure 3100 may comprise a pair of posterior corner portions 3131 configured to engage with the patient's face proximate and/or medially of the patient's nasolabial sulci, such as between the nasolabial sulci and the nasal ala. In some forms, the stiffness of each mid-lateral posterior support portion 3171 is less than the stiffness of the posterior corner portions 3131.
As described above, each mid-lateral portion 3121 may comprise a thickness greater than the thickness of the central portion 3111. In the illustrated examples, the thickness of each mid-lateral posterior support portion 3171 is also greater than the thickness of the central portion 3111. However, in these examples the thickness of each mid-lateral posterior support portion 3171 is less than the thickness of the mid-lateral portions 3121. Additionally, the thickness of each posterior corner portion 3131 is greater than the thickness of the mid-lateral portions 3121.
The thickness of each mid-lateral posterior support portion 3171 may be tapered. In some forms, the thickness of each mid-lateral posterior support portion 3171 is tapered and increases in thickness towards the respective adjacent mid-lateral portion 3121. In this example, the tapered thickness of each mid-lateral posterior support portion 3171 increases to the thickness of the respective adjacent mid-lateral portion 3121.
In some forms of the present technology, the thickness of each mid-lateral posterior support portion 3171 may be between 0.3-0.7 mm. In particular examples, the thickness may be between 0.4-0.6 mm.
In other examples of the present technology, the additional stiffness of the mid-lateral posterior support portions 3171 is provided by another means. For example, the mid-lateral posterior support portions 3171 may comprise a different material to adjacent portions of the seal-forming structure 3100, such as a silicone material with a higher durometer hardness value or another material stiffer than the central portion 3111.
In some examples of the present technology, the mid-lateral posterior support portions 3171 are wedge-shaped. As shown in
The mid-lateral posterior support portions 3171 may be wedge-shaped, triangular, tear-drop-shaped, circular or another suitable shape.
The cushion modules 3150 illustrated in
In the example cushion modules 3150 illustrated in
The textile material may comprise a laminate formed by one or more layers of non-textile material and a textile layer. In some examples the laminate may comprise an air-impermeable layer, which may be formed from silicone, TPE, TPU or the like, and a textile layer for contacting the patient's face. The textile material may be formed from a microfibre or polyurethane, for example. The textile material and textile seal may be as described in Australian Patent Application No. 2018903752 or Australian Patent Application No. 2018904886, for example, the entire contents of each of which are incorporated by reference.
In some forms, the textile may comprise a material formed of a network of fibres and being adapted such that it is air impermeable. For example, the textile can have an air impermeable film on at least one surface thereof.
In use, the textile portion of the seal-forming structure 3100 may be maintained in sealing contact with the patient's face by 1) a resilient stretch characteristic of the material; 2) a reactive stress of the support structure; and/or 3) air pressure within the plenum chamber 3200 against an inside surface of the textile portion. Each of these factors may contribute to the textile portion being under constant tension such that the textile portion complies to the anthropometric contours of the patient's face, thereby minimizing wrinkles or blow-out and maximizing the contact area of the textile portion.
In some examples, the textile portion of the seal-forming structure 3100 may be a thin, compliant, stretchable, elastic material (e.g., microfiber or polyurethane). The textile portion may be held taut and in tension by the support structure prior to and during use. The textile portion may be molded or otherwise attached (e.g., adhered, glued) to the support structure so that the textile portion is pre-tensioned (slightly stretched) so that there are no wrinkles in the material of the textile portion. This may be advantageous in ensuring that the textile portion forms a smooth and continuous seal on the patient's face without any folded sections through which air may leak. Further, the textile portion may be shaped or have curvature imparted thereto, e.g., by thermoforming, so that the textile portion holds its own shape.
The textile portion of the seal-forming structure 3100 may be constructed from a single or a plurality of layers of material (e.g., textile and non-textile materials). The material of the textile portion may exhibit a low spring constant (i.e., highly compliant) in both warp and weft. Unlike conventional masks (e.g., silicone sealing membrane), where a fixed cushion may cause a patient's skin to distort to form an effective seal, the material of the textile portion may have a material spring constant and spring length (i.e., the amount of material available to stretch) such that the material is more compliant than the patient's skin so as to more readily conform to the patient's facial features. This may improve comfort of the mask and reduce formation of localized pressure “hot spots” on the patient's face.
Compared to conventional silicone membranes and compression foam seals, the textile portion of the seal-forming structure 3100 of the present technology has a more flexible structural stiffness and therefore has a dynamic spring back characteristic that enables the textile portion to recover more quickly when disturbed by an external force. Further, due to the lower structural stiffness a smaller seal force is required allowing the sealing portion to be more comfortable and create less facial marks during use.
The material of the textile portion may exhibit variable tension forces across the material (e.g., less tension forces proximal to holes or in wider stretches of material). In some forms, the surface of the material of the textile portion that contacts the patient's face may have low friction characteristics (e.g., a low friction finish), which may advantageously improve compliance of the material with the patient's face while also improving patient comfort.
The material of the textile portion of the seal-forming structure 3100 may also comprise at least one layer that exhibits substantially air-impermeable characteristics, while maintaining the resilient stretch characteristics necessary for comfort and minimal pressure points. That is, a membrane layer or laminate film layer (e.g., a polymer such as silicone, polyurethane, polyester, nylon, etc.) may be applied to the textile material to provide a substantially air-tight material. In an alternative example, the fibers of a textile may be tightly weaved to create a substantially air impermeable material.
In some forms, the material of the sealing portion may have a thickness of 0.275 or less (e.g., 0.275 to 0.075 mm, 0.275 to 0.175 mm, 0.25 mm or less, 0.225 mm or less, 0.225 to 0.09 mm, 0.225 to 0.095 mm, 0.225 mm, or 0.25 mm). The membrane layer may have a thickness of 0.03 to 0.01 mm (e.g., 0.015, 0.02 mm, or 0.025 mm). The material of the sealing portion with the membrane layer may have an overall thickness of 0.305 mm or less (e.g., 0.305 to 0.085 mm, 0.305 to 0.185 mm, 0.28 mm or less, 0.255 mm or less, 0.255 to 0.10 mm, 0.255 to 0.105 mm, 0.25 mm, or 0.275).
Tensile forces may also be transferred to the textile portion as a result of the stiffness and resilient properties of the support structure provided by the anterior and lateral side portions of the seal-forming structure 3100. The support structure in various forms may be formed from a variety of materials, including silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomers (TPE) (e.g., thermoplastic polyurethane (TPU)), and suitable plastic materials. The support structure may be configured so as to create a number of different cushion configurations, including a single air assisted sealing portion (e.g., textile membrane) and a sealing portion with underlying cushion support layer(s) such as a double air assisted sealing portion (e.g., dual textile membranes), a sealing portion with compression support (e.g., open cell foam, polyurethane foam, gel), a sealing portion with TPU, TPE or silicone support, or a double air assisted sealing portion with additional support (e.g., dual textile membranes wherein the inner membrane has a foam laminate layer (e.g., open cell, polyurethane) or a TPU, TPE, polyurethane or silicone moulded layer thereon).
The underlying cushion layer(s) may assist in optimizing the textile portion contact surface area with the patient's face. Further, in examples where the sealing portion is constructed from a breathable material (e.g., a breathable textile), the underlying cushion layer(s) may provide sufficient contact area behind the sealing portion to adequately seal the sealing portion against the patient's face and prevent leakage.
In some forms of the present technology, in use, engagement of the patient's face with the textile portion may create a temporary strain force that tends to pull the lateral side walls of the support structure toward one another. The support structure will respond to the strain force with an outwardly pulling reaction force. The reaction force transfers more tension to the sealing portion by preferentially stretching the more compliant textile portion which creates a resultant spring force in the textile portion that is exerted on the patient's face. This may increase the ability for the textile portion to conform to, and form a good seal with, the patient's face.
In some examples, the support structure may comprise a gusset that utilizes the internal air pressure to dynamically support the support structure and sealing portion. A gusset in this context may be a portion of the support structure which is deformable either in response to external forces such as resulting from tube drag, the patient putting their face partially into their pillow or movement of the patient's head during sleep, and/or forces resulting from air pressure within the plenum chamber 3200. This type of gusset may comprise a folded portion configured to be at least partially unfolded by air pressure acting on the interior of the folded portion. This may advantageously provide further support of the sealing portion when under dynamic loads (e.g., tube drag).
The air pressure within the plenum chamber 3200 and acting against the inside surface of the textile portion of the seal-forming structure 3100 may also create tension in the textile portion such that the central portion 3111 may substantially fill depressed contours of a patient's face (e.g., around the sides of the nose). This may enable the compliant central portion 3111 to form a larger seal contact area on the patient's face. The tension in the textile portion created by the plenum chamber 3200 air pressure may also be advantageous in providing a continuous seal even when the mask is partially displaced from an optimal positioning on the patient's face, as the textile portion may partially inflate (i.e., a “hovercraft effect”) due to the counter-force from the internal air pressure.
In examples where the material of the textile portion of the seal-forming structure 3100 is not under constant tension and is non-elastic, the sealing portion may still be maintained in sealing contact with the patient's face by the air pressure within the plenum chamber 3200 and form an improved air assisted seal with the patient's face that conforms dynamically to alterations/movements (i.e., “hovercraft effect”) due to the sealing portion being thinner and having a lower structural stiffness than the support structure formed by the anterior and lateral sides of the seal-forming structure 3100.
The textile portion of the seal-forming structure 3100 may be integrated with the support structure of the seal-forming structure 3100 by molding or otherwise attaching the textile portion to the inner edge of the support structure. Thus, for example, an outer perimeter of the textile portion may be attached to the inner edge of the support structure such that the textile portion extends radially inwardly of the seal-forming structure beyond or to a further extent than the support structure. The inner edge of the support structure may be curved such that the textile portion may be slightly angled inwardly toward the mask interior. By attaching the sealing portion along the inner edge of the support structure, the sealing portion does not need to be folded or cut to blend around the corners of the support structure. This may advantageously reduce the occurrence of protruding folds or wrinkles in the textile portion, which may cause leakage, thereby improving the performance of the seal.
In some forms, the textile portion may have a removable or modular structure. For example, the textile portion may be attached to a more rigid supporting frame structure along its perimeter. The supporting frame may be removably attached as a module to a support structure formed by the seal-forming structure 3100 or chassis portion 3210. The textile portion may be attached to the supporting frame so as to reduce the occurrence of protruding folds or wrinkles in the textile surface. The modular arrangement may also substantially simplify the manufacturing of the sealing portion (e.g., textile sealing portion) as complex bonding can be done in a simple unstressed state. While the textile portion may be treated to have substantially self-cleaning properties, the use of a modular sealing portion may also provide a cheaper and more hygienic alternative.
The textile portion of the seal-forming structure 3100 may have underlying cushion support layer(s) (e.g., second, third or more cushion layers) incorporated therein. The underlying cushion layer(s) may provide additional flexibility and allow the cushion to be suitable for use by most patient faces (e.g., one size fits most). For example, the textile portion may be structured as a double air assisted sealing portion (e.g., dual textile membranes), a textile portion with compression support layer(s) (e.g., open cell foam, polyurethane foam, gel), a textile portion with TPU, TPE or silicone support layer(s), or a double air assisted textile portion with additional support layer(s) (e.g., dual textile membranes wherein the inner membrane has a foam laminate layer (e.g., open cell, polyurethane) or a TPU, TPE, polyurethane or silicone molded layer thereon).
In some examples, the support layers may be supported by a rigid structure such as plastic, e.g., polypropylene (PP), polycarbonate (PC), polyamide (PA), or polyethylene terephthalate (PET).
In some forms, the seal-forming structure 3100 is constructed so as to stretch elastically in at least one dimension. For example, when a textile seal-forming structure is constructed from a network of fibres, the seal-forming structure may be capable of elongating in either, or both of, a longitudinal warp direction or a lateral weft direction across the textile. In some forms, a textile seal-forming structure 3100 is constructed so as to elongate elastically to an extent greater than that achievable by conventional silicone seal-forming structure.
In some forms, the seal-forming structure 3100 is constructed so as to be substantially inelastic in at least one dimension. For example, when a textile seal-forming structure is constructed from a woven textile, the seal-forming structure may be capable of substantially resisting elongation in either, or both of, a longitudinal warp direction or a lateral weft direction across the textile.
Illustrated in
The silicone portions of the cushion module 3150 shown in
In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.
In certain forms the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use. The vent 3400 may provide a continuous vent flow of gas from the interior of the plenum chamber 3200 to ambient throughout the patient's respiratory cycle.
One form of vent 3400 in accordance with 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.
The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, e.g., a swivel such as elbow 3610. In the example shown in
As discussed above, the chassis portion 3210 may be rigidised with a vent module 3410 which comprises a vent 3400. A vent module may be a part of the patient interface 3000 that acts to vent exhaled gases to atmosphere. The vent module may be removable from the other parts of the patient interface 3000 for cleaning, replacement, storage and/or inspection or for any other reason the patient or clinician may need to separate a part of the patient interface 3000 comprising a vent 3400 from the rest of the patient interface 3000.
In some examples, the patient interface 3000 may comprise multiple vents 3400, each provided by a separate vent module 3410. In other examples of the present technology, the patient interface 3000 may comprise a single vent 3400 provided in a single vent module 3410. In further examples, the patient interface 3000 may comprise at least two vents 3400, one of which is provided in a vent module 3410 and another of which is not. For example, the patient interface 3000 may comprise a vent module 3410 comprising a first vent 3400, and the patient interface 3000 may comprise a second vent 3400 elsewhere on the patient interface 3000.
In some examples of the present technology, a vent module 3410 may serve more than one function. In some examples a vent module 3410 may allow gas washout, and may also function as a rigidiser. In some examples a vent module 3410 may comprise multiple parts. The multiple parts may or may not be separable. In other examples, a vent module 3410 may be formed from a single part.
In some examples of the present technology, the vent module 3410 of the patient interface 3000 may be configured to diffuse the flow of exhaust gas through the vent 3400. The vent module 3410 may comprise a diffuser.
As shown in
As shown in
The superior vent holes 3412 may be configured to direct exhaust gas in a direction 3416 at an angle towards the superior with respect to an axis 3415, as shown in
The sum of the angle towards the superior and the angle towards the inferior may be within the range of 60-100 degrees. In some forms, the sum of the angle towards the superior and the angle towards the inferior is within the range of 70-90 degrees. For the vent module 3014 shown in
A large angle between the direction at which the superior vent holes 3412 discharge exhaust gas and the direction at which the inferior vent holes 3414 discharge exhaust gas may advantageously allow for good dispersion of the exhaust gas, avoid all of the exhaust gas being discharged in the same direction and reduce noise. The larger angle towards the superior between the direction 3416 and the axis 3415 in comparison to the angle towards the inferior between the direction 3417 and the axis 3415 minimises the amount of exhaust gas impinging on the patient's lips, which could be irritating.
As shown in
The vent module 3410 may comprise a diffuser configured to diffuse the exhaust flow of gas and/or muffle the vent 3400. As shown in
The diffuser 3420 may be formed from felt, foam or any suitable network of fibres configured to allow gas to flow therethrough but force the gas to flow through a torturous path.
As described above, the vent module 3410 is configured to be fitted to the chassis portion 3210 of the cushion module 3150.
In other examples of the present technology the vent module 3410 may comprise a plurality of vent holes but no diffuser material. In further examples the vent module 3410 may comprise a meshed structure through which the exhaust gas is able to flow, with or without diffuser material.
In one form the patient interface 3000 includes at least one conduit decoupling structure, for example, a swivel or a ball and socket to decouple a conduit connected to the patient interface 3000 from components of the patient interface 3000. In one example, the conduit decoupling structure decouples a conduit from the positioning and stabilising structure 3300. The conduit decoupling structure may advantageously at least partially decouple the patient interface 3000 from tube drag forces during use. This may result in greater comfort and stability than if no conduit decoupling structure is provided.
For example, the patient interface 3000 shown in
Connection port 3600 allows for connection to the air circuit 4170. In the exemplary patient interface 3000 shown in
In one form, the patient interface 3000 includes a forehead support 3700. In other forms, the patient interface 3000 does not include a forehead support. Advantageously, the exemplary patient interface 3000 shown in
In one form, the patient interface 3000 includes an anti-asphyxia valve. In some examples, the patient interface 3000 includes a plurality of anti-asphyxia valves.
In one form of the present technology, a 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 for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.
An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and/or electrical components and is configured to execute one or more algorithms, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient's airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.
In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in a range of −20 L/min to +150 L/min while maintaining a positive pressure of at least 6 cmH2O, or at least 10cmH2O, or at least 20 cmH2O.
The RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015. The RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.
The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.
One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.
The RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, memory, transducers 4270, data communication interface and one or more output devices. Electrical components 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.
An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.
An RPT device in accordance with one form of the present technology may include an air filter 4110, or a plurality of air filters 4110.
In one form, an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.
In one form, an outlet air filter 4114, for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000.
An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.
In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.
In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000.
In one form of the present technology, a pressure generator 4140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 4142. For example the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be located in a volute. The blower 4142 may be supported in a blower housing 4100. The blower may be capable of delivering a supply of air, for example at a rate of up to about 120 litres/minute, at a positive pressure in a range from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be as described in any one of the following patents or patent applications the contents of which are incorporated herein by reference in their entirety: U.S. Pat. Nos. 7,866,944; 8,638,014; 8,636,479; and PCT Patent Application Publication No. WO 2013/020167.
The pressure generator 4140 is under the control of the therapy device controller.
In other forms, a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows.
Air Circuit
An air circuit 4170 in accordance with an aspect of the present technology is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components such as RPT device 4000 and the patient interface 3000.
In particular, the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases there may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used.
In some forms, the air circuit 4170 may comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air. The heating element may be in a form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors. In one form, the heated wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller. One example of an air circuit 4170 comprising a heated wire circuit is described in U.S. Pat. No. 8,733,349, which is incorporated herewithin in its entirety by reference.
In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020, to the air circuit 4170 and/or to the patient interface 3000.
In one form of the present technology there is provided a humidifier 5000 (e.g. as shown in
The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air. In some forms, as shown in
According to one arrangement, the humidifier 5000 may comprise a water reservoir 5110 configured to hold, or retain, a volume of liquid (e.g. water) to be evaporated for humidification of the flow of air. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water in order to provide adequate humidification for at least the duration of a respiratory therapy session, such as one evening of sleep. Typically, the reservoir 5110 is configured to hold several hundred millilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400 ml. In other forms, the humidifier 5000 may be configured to receive a supply of water from an external water source such as a building's water supply system.
According to one aspect, the water reservoir 5110 is configured to add humidity to a flow of air from the RPT device 4000 as the flow of air travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the flow of air to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.
According to one form, the reservoir 5110 may be removable from the humidifier 5000, for example in a lateral direction as shown in
The reservoir 5110 may also be configured to discourage egress of liquid therefrom, such as when the reservoir 5110 is displaced and/or rotated from its normal, working orientation, such as through any apertures and/or in between its sub-components. As the flow of air to be humidified by the humidifier 5000 is typically pressurised, the reservoir 5110 may also be configured to prevent losses in pneumatic pressure through leak and/or flow impedance.
According to one arrangement, the reservoir 5110 comprises a conductive portion 5120 configured to allow efficient transfer of heat from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may also be suitable. All or a part of the conductive portion 5120 may be made of a thermally conductive material such as aluminium (e.g. approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm or 3 mm), another heat conducting metal or some plastics. In some cases, suitable heat conductivity may be achieved with less conductive materials of suitable geometry.
In one form, the humidifier 5000 may comprise a humidifier reservoir dock 5130 (as shown in
The humidifier reservoir 5110 may comprise a water level indicator 5150 as shown in
In one form of the present technology, an anti-spillback valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144.
For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.
Air: In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. atmospheric air enriched with oxygen.
Ambient: In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.
For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.
In another example, ambient pressure may be the pressure immediately surrounding or external to the body.
In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.
Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.
Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.
Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.
In the example of patient respiration, a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient. Total flow rate, Qt, is the flow rate of air leaving the RPT device. Vent flow rate, Qv, is the flow rate of air leaving a vent to allow washout of exhaled gases. Leak flow rate, Ql, is the flow rate of leak from a patient interface system or elsewhere. Respiratory flow rate, Qr, is the flow rate of air that is received into the patient's respiratory system.
Humidifier: The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapour to a flow of air to ameliorate a medical respiratory condition of a patient.
Leak: The word leak will be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient's face. In another example leak may occur in a swivel elbow to the ambient.
Noise, conducted (acoustic): Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as well as the air therein. In one form, conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.
Noise, radiated (acoustic): Radiated noise in the present document refers to noise which is carried to the patient by the ambient air. In one form, radiated noise may be quantified by measuring sound power/pressure levels of the object in question according to ISO 3744.
Noise, vent (acoustic): Vent noise in the present document refers to noise which is generated by the flow of air through any vents such as vent holes of the patient interface.
Patient: A person, whether or not they are suffering from a respiratory condition.
Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmH2O, g-f/cm2 and hectopascal. 1 cmH2O is equal to 1 g-f/cm2 and is approximately 0.98 hectopascal. In this specification, unless otherwise stated, pressure is given in units of cmH2O.
The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the mask pressure Pm at the current instant of time, is given the symbol Pt.
Respiratory Pressure Therapy (RPT): The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.
Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.
Silicone or Silicone Elastomer: A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, an exemplary 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.
Polycarbonate: a thermoplastic polymer of Bisphenol-A Carbonate.
Resilience: Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.
Resilient: Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.
Hardness: The ability of a material per se to resist deformation (e.g. described by a Young's Modulus, or an indentation hardness scale measured on a standardised sample size).
Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load may be a force or a moment, e.g. compression, tension, bending or torsion. The structure or component may offer different resistances in different directions.
Floppy structure or component: A structure or component that will change shape, e.g. bend, when caused to support its own weight, within a relatively short period of time such as 1 second.
Rigid structure or component: A structure or component that will not substantially change shape when subject to the loads typically encountered in use. An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient's airways, e.g. at a load of approximately 20 to 30 cmH2O pressure.
As an example, an I-beam may comprise a different bending stiffness (resistance to a bending load) in a first direction in comparison to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.
Apnea: According to some definitions, an apnea is said to have occurred when flow falls below a predetermined threshold for a duration, e.g. 10 seconds. An obstructive apnea will be said to have occurred when, despite patient effort, some obstruction of the airway does not allow air to flow. A central apnea will be said to have occurred when an apnea is detected that is due to a reduction in breathing effort, or the absence of breathing effort, despite the airway being patent. A mixed apnea occurs when a reduction or absence of breathing effort coincides with an obstructed airway.
Ala: the external outer wall or “wing” of each nostril (plural: alar)
Alare: The most lateral point on the nasal ala.
Alar curvature (or alar crest) point: The most posterior point in the curved base line of each ala, found in the crease formed by the union of the ala with the cheek.
Auricle: The whole external visible part of the ear.
(nose) Bony framework: The bony framework of the nose comprises the nasal bones, the frontal process of the maxillae and the nasal part of the frontal bone.
(nose) Cartilaginous framework: The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.
Columella: the strip of skin that separates the nares and which runs from the pronasale to the upper lip.
Columella angle: The angle between the line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfort horizontal while intersecting subnasale.
Frankfort horizontal plane: A line extending from the most inferior point of the orbital margin to the left tragion. The tragion is the deepest point in the notch superior to the tragus of the auricle.
Glabella: Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.
Lateral nasal cartilage: A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and frontal process of the maxilla, and its inferior margin is connected to the greater alar cartilage.
Greater alar cartilage: A plate of cartilage lying below the lateral nasal cartilage. It is curved around the anterior part of the naris. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four minor cartilages of the ala.
Nares (Nostrils): Approximately ellipsoidal apertures forming the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nares are separated by the nasal septum.
Naso-labial sulcus or Naso-labial fold: The skin fold or groove that runs from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.
Naso-labial angle: The angle between the columella and the upper lip, while intersecting subnasale.
Otobasion inferior: The lowest point of attachment of the auricle to the skin of the face.
Otobasion superior: The highest point of attachment of the auricle to the skin of the face.
Pronasale: the most protruded point or tip of the nose, which can be identified in lateral view of the rest of the portion of the head.
Philtrum: the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.
Pogonion: Located on the soft tissue, the most anterior midpoint of the chin.
Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.
Sagittal plane: A vertical plane that passes from anterior (front) to posterior (rear). The midsagittal plane is a sagittal plane that divides the body into right and left halves.
Sellion: Located on the soft tissue, the most concave point overlying the area of the frontonasal suture.
Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.
Subalare: The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.
Subnasal point: Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.
Supramenton: The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion
Frontal bone: The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.
Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.
Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upwards by the side of the nose, and forms part of its lateral boundary.
Nasal bones: The nasal bones are two small oblong bones, varying in size and form in different individuals; they are placed side by side at the middle and upper part of the face, and form, by their junction, the “bridge” of the nose.
Nasion: The intersection of the frontal bone and the two nasal bones, a depressed area directly between the eyes and superior to the bridge of the nose.
Occipital bone: The occipital bone is situated at the back and lower part of the cranium. It includes an oval aperture, the foramen magnum, through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.
Orbit: The bony cavity in the skull to contain the eyeball.
Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.
Temporal bones: The temporal bones are situated on the bases and sides of the skull, and support that part of the face known as the temple.
Zygomatic bones: The face includes two zygomatic bones, located in the upper and lateral parts of the face and forming the prominence of the cheek.
Diaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, containing 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.
Larynx: The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.
Lungs: The organs of respiration in humans. The conducting zone of the lungs contains the trachea, the bronchi, the bronchioles, and the terminal bronchioles. The respiratory zone contains the respiratory bronchioles, the alveolar ducts, and the alveoli.
Nasal cavity: The nasal cavity (or nasal fossa) is a large air filled space above and behind the nose in the middle of the face. The nasal cavity is divided in two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal outgrowths called nasal conchae (singular “concha”) or turbinates. To the front of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.
Pharynx: The part of the throat situated immediately inferior to (below) the nasal cavity, and superior to the oesophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).
Anti-asphyxia valve (AAV): The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.
Elbow: An elbow is an example of a structure that directs an axis of flow of air travelling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be more, or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form the elbow may have an oval or a rectangular cross-section. In certain forms an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees. In certain forms an elbow may be removable from a mating component, e.g. via a snap connection. In certain forms, an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.
Frame: Frame will be taken to mean a mask structure that bears the load of tension between two or more points of connection with a headgear. A mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frame may also be air-tight.
Headgear: Headgear will be taken to mean a form of positioning and stabilizing structure designed for use on a head. For example the headgear may comprise a collection of one or more struts, ties and stiffeners configured to locate and retain a patient interface in position on a patient's face for delivery of respiratory therapy. Some ties are formed of a soft, flexible, elastic material such as a laminated composite of foam and fabric.
Membrane: Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.
Plenum chamber: a mask plenum chamber will be taken to mean a portion of a patient interface having walls at least partially enclosing a volume of space, the volume having air therein pressurised above atmospheric pressure in use. A shell may form part of the walls of a mask plenum chamber.
Seal: May be a noun form (“a seal”) which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and/or arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.
Shell: A shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, a shell may be faceted. In some forms a shell may be airtight. In some forms a shell may not be airtight.
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.
Strut: A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.
Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. There may be little or no leak flow of air from the swivel in use.
Tie (noun): A structure designed to resist tension.
Vent: (noun): A structure that allows a flow of air from an interior of the mask, or conduit, to ambient air for clinically effective washout of exhaled gases. For example, a clinically effective washout may involve a flow rate of about 10 litres per minute to about 100 litres per minute, depending on the mask design and treatment pressure.
Products in accordance with the present technology may comprise one or more three-dimensional mechanical structures, for example a mask cushion or an impeller. The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using a label to describe an associated surface orientation, location, function, or some other characteristic. For example a structure may comprise one or more of an anterior surface, a posterior surface, an interior surface and an exterior surface. In another example, a seal-forming structure may comprise a face-contacting (e.g. outer) surface, and a separate non-face-contacting (e.g. underside or inner) surface. In another example, a structure may comprise a first surface and a second surface.
To facilitate describing the shape of the three-dimensional structures and the surfaces, we first consider a cross-section through a surface of the structure at a point, p. See
The curvature of a plane curve at p may be described as having a sign (e.g. positive, negative) and a magnitude (e.g. 1/radius of a circle that just touches the curve at p).
Positive curvature: If the curve at p turns towards the outward normal, the curvature at that point will be taken to be positive (if the imaginary small person leaves the point p they must walk uphill). See
Zero curvature: If the curve at p is a straight line, the curvature will be taken to be zero (if the imaginary small person leaves the point p, they can walk on a level, neither up nor down). See
Negative curvature: If the curve at p turns away from the outward normal, the curvature in that direction at that point will be taken to be negative (if the imaginary small person leaves the point p they must walk downhill). See
A description of the shape at a given point on a two-dimensional surface in accordance with the present technology may include multiple normal cross-sections. The multiple cross-sections may cut the surface in a plane that includes the outward normal (a “normal plane”), and each cross-section may be taken in a different direction. Each cross-section results in a plane curve with a corresponding curvature. The different curvatures at that point may have the same sign, or a different sign. Each of the curvatures at that point has a magnitude, e.g. relatively small. The plane curves in
Principal curvatures and directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values are called the principal directions. In the examples of
Region of a surface: A connected set of points on a surface. The set of points in a region may have similar characteristics, e.g. curvatures or signs.
Saddle region: A region where at each point, the principal curvatures have opposite signs, that is, one is positive, and the other is negative (depending on the direction to which the imaginary person turns, they may walk uphill or downhill).
Dome region: A region where at each point the principal curvatures have the same sign, e.g. both positive (a “concave dome”) or both negative (a “convex dome”).
Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.
Planar region: A region of a surface where both of the principal curvatures are zero (or, for example, zero within manufacturing tolerances).
Edge of a surface: A boundary or limit of a surface or region.
Path: In certain forms of the present technology, ‘path’ will be taken to mean a path in the mathematical-topological sense, e.g. a continuous space curve from f(0) to f(1) on a surface. In certain forms of the present technology, a ‘path’ may be described as a route or course, including e.g. a set of points on a surface. (The path for the imaginary person is where they walk on the surface, and is analogous to a garden path).
Path length: In certain forms of the present technology, ‘path length’ will be taken to mean the distance along the surface from f(0) to f(1), that is, the distance along the path on the surface. There may be more than one path between two points on a surface and such paths may have different path lengths. (The path length for the imaginary person would be the distance they have to walk on the surface along the path).
Straight-line distance: The straight-line distance is the distance between two points on a surface, but without regard to the surface. On planar regions, there would be a path on the surface having the same path length as the straight-line distance between two points on the surface. On non-planar surfaces, there may be no paths having the same path length as the straight-line distance between two points. (For the imaginary person, the straight-line distance would correspond to the distance ‘as the crow flies’.)
Space curves: Unlike a plane curve, a space curve does not necessarily lie in any particular plane. A space curve may be closed, that is, having no endpoints. A space curve may be considered to be a one-dimensional piece of three-dimensional space. An imaginary person walking on a strand of the DNA helix walks along a space curve. A typical human left ear comprises a helix, which is a left-hand helix, see
Tangent unit vector (or unit tangent vector): For each point on a curve, a vector at the point specifies a direction from that point, as well as a magnitude. A tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell off her vehicle at a particular point, the direction of the tangent vector is the direction she would be travelling.
Unit normal vector: As the imaginary person moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction that the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.
Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction may be determined by a right-hand rule (see e.g.
Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. See
Torsion of a space curve: The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve which lies in a plane has zero torsion. A space curve which deviates a relatively small amount from the osculating plane will have a relatively small magnitude of torsion (e.g. a gently sloping helical path). A space curve which deviates a relatively large amount from the osculating plane will have a relatively large magnitude of torsion (e.g. a steeply sloping helical path). With reference to
With reference to the right-hand rule of
Equivalently, and with reference to a left-hand rule (see
A surface may have a one-dimensional hole, e.g. a hole bounded by a plane curve or by a space curve. Thin structures (e.g. a membrane) with a hole, may be described as having a one-dimensional hole. See for example the one dimensional hole in the surface of structure shown in
A structure may have a two-dimensional hole, e.g. a hole bounded by a surface. For example, an inflatable tyre has a two dimensional hole bounded by the interior surface of the tyre. In another example, a bladder with a cavity for air or gel could have a two-dimensional hole. See for example the cushion of
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.
Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.
Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.
Unless defined otherwise, 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 also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.
When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include their plural equivalents, unless the context clearly dictates otherwise.
All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and/or materials which are the subject of those publications. 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 invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.
The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.
The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.
Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms “first” and “second” may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and/or aspects thereof may be conducted concurrently or even synchronously.
It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2019902580 | Jul 2019 | AU | national |
| 2019904852 | Dec 2019 | AU | national |
| 10202001774V | Feb 2020 | SG | national |
| 2020901769 | May 2020 | AU | national |
| 2020901770 | May 2020 | AU | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/AU2020/050749 | 7/22/2020 | WO |
