Patent Application
20240148999
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 Hyperventilation 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).
Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).
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.
A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.
Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.
Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production.
Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.
Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and/or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.
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 respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.
Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient's breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).
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.
Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient breathing and/or maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, in forms such as OHS, COPD, NMD and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.
Invasive ventilation (IV) provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies may be improved.
Not all respiratory therapies aim to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume, by delivering an inspiratory flow rate profile over a targeted duration, possibly superimposed on a positive baseline pressure. In other cases, the interface to the patient's airways is ‘open’ (unsealed) and the respiratory therapy may only supplement the patient's own spontaneous breathing with a flow of conditioned or enriched gas. In one example, High Flow therapy (HFT) is the provision of a continuous, heated, humidified flow of air to an entrance to the airway through an unsealed or open patient interface at a “treatment flow rate” that is held approximately constant throughout the respiratory cycle. The treatment flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway entrance improves ventilation efficiency by flushing, or washing out, expired CO2 from the patient's anatomical deadspace. Hence, HFT is thus sometimes referred to as a deadspace therapy (DST). Other benefits may include the elevated warmth and humidification (possibly of benefit in secretion management) and the potential for modest elevation of airway pressures. As an alternative to constant flow rate, the treatment flow rate may follow a profile that varies over the respiratory cycle.
Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. Doctors may prescribe a continuous flow of oxygen enriched gas at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%) at a specified flow rate (e.g., 1 litre per minute (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient's airway.
For certain patients, oxygen therapy may be combined with a respiratory pressure therapy or HFT by adding supplementary oxygen to the pressurised flow of air. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplementary oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplementary oxygen.
These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.
A respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.
Another form of therapy 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. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.
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 fit and be 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.
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 pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.
An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.
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. Humidifiers therefore often have the capacity to heat the flow of air was well as humidifying it.
Experts in this field have recognized that exercise for respiratory failure patients provides long term benefits that slow the progression of the disease, improve quality of life and extend patient longevity. Most stationary forms of exercise like tread mills and stationary bicycles, however, are too strenuous for these patients. As a result, the need for mobility has long been recognized. Until recently, this mobility has been facilitated by the use of small compressed oxygen tanks or cylinders mounted on a cart with dolly wheels. The disadvantage of these tanks is that they contain a finite amount of oxygen and are heavy, weighing about 50 pounds when mounted.
Oxygen concentrators have been in use for about 50 years to supply oxygen for respiratory therapy. Traditional oxygen concentrators have been bulky and heavy making ordinary ambulatory activities with them difficult and impractical. Recently, companies that manufacture large stationary oxygen concentrators began developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically endless supply of oxygen. In order to make these devices small for mobility, the various systems necessary for the production of oxygen enriched gas are condensed. POCs seek to utilize their produced oxygen as efficiently as possible, in order to minimise weight, size, and power consumption. This may be achieved by delivering the oxygen as series of pulses or “boli”, each bolus timed to coincide with the start of inspiration. This therapy mode is known as pulsed or demand (oxygen) delivery (POD), in contrast with traditional continuous flow delivery more suited to stationary oxygen concentrators.
There may be clinical reasons to obtain data to determine whether the patient prescribed with respiratory therapy has been “compliant”, e.g. that the patient has used their RPT device according to one or more “compliance rules”. One example of a compliance rule for CPAP therapy is that a patient, in order to be deemed compliant, is required to use the RPT device for at least four hours a night for at least 21 of 30 consecutive days. In order to determine a patient's compliance, a provider of the RPT device, such as a health care provider, may manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period, and compare with the compliance rule. Once the health care provider has determined that the patient has used their RPT device according to the compliance rule, the health care provider may notify a third party that the patient is compliant.
There may be other aspects of a patient's therapy that would benefit from communication of therapy data to a third party or external system.
Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.
A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the lower jaw (mandible) in a forward position during sleep. The MRD is a removable device that a patient inserts into their mouth prior to going to sleep and removes following sleep. Thus, the MRD is not designed to be worn all of the time. The MRD may be custom made or produced in a standard form and includes a bite impression portion designed to allow fitting to a patient's teeth. This mechanical protrusion of the lower jaw expands the space behind the tongue, puts tension on the pharyngeal walls to reduce collapse of the airway and diminishes palate vibration.
In certain examples a mandibular advancement device may comprise an upper splint that is intended to engage with or fit over teeth on the upper jaw or maxilla and a lower splint that is intended to engage with or fit over teeth on the upper jaw or mandible. The upper and lower splints are connected together laterally via a pair of connecting rods. The pair of connecting rods are fixed symmetrically on the upper splint and on the lower splint.
In such a design the length of the connecting rods is selected such that when the MRD is placed in a patient's mouth the mandible is held in an advanced position. The length of the connecting rods may be adjusted to change the level of protrusion of the mandible. A dentist may determine a level of protrusion for the mandible that will determine the length of the connecting rods.
Some MRDs are structured to push the mandible forward relative to the maxilla while other MADs, such as the ResMed Narval CC™ MRD are designed to retain the mandible in a forward position. This device also reduces or minimises dental and temporo-mandibular joint (TMJ) side effects. Thus, it is configured to minimises or prevent any movement of one or more of the teeth.
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 focussed 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
Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular it is unsuitable for home screening/diagnosis/monitoring of sleep disordered breathing.
Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true/false result indicating whether or not a patient's SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening/diagnosis systems are suitable only for screening/diagnosis, whereas some may also be used for monitoring.
Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient's condition. In addition, a given clinical expert may apply a different standard at different times.
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 comprising:
In embodiments:
Another form of the technology comprises a patient interface comprising:
In examples:
Another form of the technology comprises a patient interface comprising:
In examples:
Another form of the technology comprises a patient interface comprising:
In examples:
Another form of the technology comprises a patient interface comprising:
In examples:
Another form of the technology comprises a frame configured to couple to the plenum chamber, the frame comprising a central portion coupled to the plenum chamber outside of the cavity and a plurality of connectors that comprises a pair of upper connector and a pair of lower connectors, the pair of lower connectors being flush with the central portion and the pair of upper connectors extend away from the central portion in a posterior direction configured to be past the plenum chamber.
In examples:
Another form of the technology comprises a frame configured to couple to the plenum chamber, the frame comprising a central portion coupled to the plenum chamber outside of the cavity and a pair of arms that extend away from the central portion in a posterior direction configured to be past the plenum chamber, the pair of arms being more flexible than the central portion.
In examples:
Another form of the technology comprises a patient interface comprising:
In examples:
Another form of the technology comprises a patient interface comprising:
Another aspect of one form of the present technology is an oro-nasal patient interface that is more compact and less obtrusive to the patient.
Another aspect of one form of the present technology is an oro-nasal patient interface that has a nasal cushion portion that provides an improved fit to the lower corners of the nose.
Another aspect of one form of the present technology is an oro-nasal patient interface that reduces occlusive contact on the nose.
Another aspect of one form of the present technology is an oro-nasal patient interface that can self adjust to accommodate patients with a wide variety of nasiolabal angles.
Another aspect of one form of the present technology is an oro-nasal patient interface that has a relatively flexible shell.
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 form of the present technology comprises a patient interface comprising:
Another form of the present technology comprises a positioning and stabilising structure configured to maintain a seal-forming structure in a therapeutically effective position, the positioning and stabilising structure comprising:
Another form of the present technology comprises a plenum chamber comprising:
Another form of the present technology comprises a frame comprising:
In examples:
Another form of the present technology comprises a patient interface comprising:
In examples:
Another form of the present technology comprises a patient interface comprises:
In examples:
Another form of the present technology comprises a patient interface comprising:
In examples:
Another form of the present technology comprises a plenum chamber comprising:
Another form of the present technology comprises a plenum chamber comprising:
Another form of the present technology comprises a system for providing pressurized air to a patient, the system comprising:
In examples:
Another form of the present technology comprises a patient interface comprising:
In examples:
Another form of the present technology comprises a patient interface comprising:
In examples:
Another form of the present technology comprises a patient interface comprising:
In examples:
In examples:
Another form of the present technology comprises an elbow configured to removably connect to a plenum chamber, the elbow comprising a button selectively engagable by the patient.
Another form of the present technology comprises an elbow configured to removably connect to a plenum chamber, the elbow comprising:
In examples:
In examples:
Another form of the present technology comprises an elbow configured to removably connect to a plenum chamber, the elbow comprising:
In examples:
Another form of the present technology comprises an elbow configured to removably connect to a plenum chamber, the elbow comprising:
In examples:
Another form of the present technology comprises vent ring configured to connect to a plenum chamber and to increase the humidity within the plenum chamber, the vent ring comprising:
In example:
Another form of the present technology is a connector member having a first side and a second side opposite to the first side. The first side and the second side each including a connector material. The connector material is configured to removably connect to a positioning and stabilizing structure of a patient interface.
In examples:
Another form of the present technology comprises a positioning and stabilizing structure comprising at least one side strap having an inner surface configured to overlay a patient's temporal bone and an outer surface opposite to the inner surface; and a connecting member removably connectable to the outer surface, the connecting member having a first side and a second side each including a connecting material; wherein the connecting member is connectable to a plurality of locations along the length of the at least one side strap.
In examples:
Another form of the present technology comprises a positioning and stabilizing structure comprising at least one side strap, at least one strap includes an elastic portion stretchable between a first length and a second length, the at least one strap includes a portion that is substantially hidden in the first position and is visible when the strap is extended in the second position.
In examples:
Another form of the present technology comprises a positioning and stabilizing structure having a rear strap configured to overlay the patient's occipital bone, a pair of lower side straps configured to removably connect to a frame, and a pair of upper straps configured to removably connect to the frame. The pair of upper side straps and the pair of lower side straps each include a connection member.
In examples:
An aspect of one form of the present technology is a method of manufacturing apparatus.
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 portable RPT device that may be carried by a person, e.g., around the home of the person.
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. An aspect of one form of the present technology is a humidifier tank that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment.
The methods, systems, devices and apparatus described may be implemented so as to improve the functionality of a processor, such as a processor of a specific purpose computer, respiratory monitor and/or a respiratory therapy apparatus. Moreover, the described methods, systems, devices and apparatus can provide improvements in the technological field of automated management, monitoring and/or treatment of respiratory conditions, including, for example, sleep disordered breathing.
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:
a is a cross-sectional view of an alternate example of the frame and plenum chamber of
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.
Where anatomical directional terms are used in describing aspects and examples of the present technology, such as “anterior”, “posterior”, “superior” and the like, the directions are to be read in the context of the present technology during use by the patient. For example, an anterior side of a patient interface refers to the side of the patient interface which is anterior with respect to the patient when the patient has donned the interface in the intended manner.
Where surfaces or portions are described as facing a direction, e.g. “superior facing”, “anterior facing” and the like, unless the context clearly requires otherwise, the surfaces or portions are to be understood as at least partially facing in the particular direction. A portion may be “superior facing” if the portion generally faces a superior direction, even if it also partially faces another direction.
In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.
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 a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000.
A non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.
In some examples of the present technology, the plenum chamber is at least partially formed by a shell 3250. In examples the shell 3250 or a portion of the shell 3250 may be somewhat flexible, as is discussed further below.
The patient interface in some examples of the technology is an oro-nasal patient interface, that is, the patient interface is configured to seal around both the patient's nasal airways and oral airway. In some examples the patient interface comprises separate seals around the each of the nasal airways and the oral airway.
In the examples 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.
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.
As is described in greater detail below, in certain forms of the invention the seal forming structure 3100 comprises a first seal forming structure 3101 connected to an oral portion 3201 of the plenum chamber and constructed and arranged to form seal with a region of the patient's face surrounding an entrance to the patient's mouth, and a second seal-forming structure 3102 connected to a nasal portion 3202 of the plenum chamber 3200 constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's nose. The phrase “connected to” is used herein to refer to portions or components which are formed as a single piece as well as to portions or components which are formed separately and subsequently joined together. In some cases components may be connected by an intermediate component.
In certain forms, the first seal forming structure 3101 seals independently against the patient's face than the second seal forming structure 3102.
In certain forms, the first seal forming structure 3101 and the second seal forming structure 3102 cooperate to form a single common seal against the patient's face.
In one form the target seal-forming region is located on an outside 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 seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.
In certain forms of the present technology, a system is provided comprising more than one 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. Limiting the occurrences of buckling may limit creases from forming in the seal-forming structure 3100, which may lead to leaks and loss of the therapeutic pressure.
In one form, the seal-forming structure 3100 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 3100 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 3100 comprises a region having a tacky or adhesive surface.
In certain forms of the present technology, a seal-forming structure 3100 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.
Referring next to
As best seen in
In embodiments provided with a ridge 3120 (as described further below), the posterior surfaces 3112 of the lateral portions 3111 may slope forward from the ridge 3120.
In some forms of the technology the posterior surfaces 3112 of the lateral portions 3111 form an angle with a mid-contact plane of the mask of between 200 and 90°. The mid-contact plane may be perpendicular to the sagittal plane, and may extend substantially along a length of the ridge 3120 and the chord 3210. This angle may be measured in the clockwise direction in
As shown in
A first angle 6056 may be measured from the mid-contact plane to a first seal axis 6060 extending along a superior boundary 3247 of the second anterior wall portion 3242 and intersecting the nasal aperture 3135. In some forms, the first angle 6056 may be between approximately 500 and approximately 150°. In some forms, the first angle 6056 may be between approximately 750 and approximately 125°. In some forms, the first angle 6056 may be between approximately 1000 and approximately 110°. For example,
A second angle 6064 may be measured from the mid-contact plane to a second seal axis 6068 extending along the surface of the second seal forming structure 3102 configured to contact the patient and intersecting the nasal aperture 3135. In some forms, the second angle 6064 may be between approximately 500 and approximately 160°. In some forms, the second angle 6064 may be between approximately 1000 and approximately 145°. In some forms, the second angle 6064 may be between approximately 1100 and approximately 130°. For example,
A difference between the first angle 6056 and the second angle 6064 may form an inclination of the second seal forming structure 3102. As described above, in some forms, this difference may be between approximately 1° and approximately 110°. In some forms, the difference may be between approximately 5° and approximately 50°. In some forms, the difference may be between approximately 100 and approximately 20°. For example,
The different angles shown in
As shown in
As shown in
Configuring the lateral portions 3111 to slope in this way results in a smaller portion of the nasal part of the interface 3000 extending over the sides of the ala than some similar interfaces of the prior art. In some forms of the technology this results in the portion of the ala which is in contact with the seal-forming structure 3100 being reduced relative to interfaces with lateral portions which slope backward, toward the patient's face, thereby reducing the proportion of the ala which can be deformed and occluded by the seal-forming structure 3100, for example when the patient sleeps on their side with the interface in contact with a pillow.
With particular reference to
In embodiments the corner or ridge 3120 forms a sharper angle than the equivalent portion or area of some oro-nasal masks of the prior art, for example those described in PCT application No. PCT/AU2019/050278.
The sharper angle reduces the likelihood of creases forming in the first and/or second seal forming structures 3101, 3102 on or adjacent the corner or ridge 3120 when the mask is donned and therapy is applied. Some oro-nasal patient interfaces which do not use such a structure may require a very thin, rounded formation in this area which may be less resistant to creasing. By contrast, the corner or ridge 3120 may be stiffer, and may hold its shape better, than such interfaces and may therefore seal better against the concavities and creases present around the patient's nose. This effect may be enhanced in embodiments which are provided with support portions, for example support portions 3260 as described herein, which resist or oppose compression of this region.
In some forms of the technology the radius of the corner or ridge 3120 may be less than 2 mm, for example around 1.75 mm. In one form of the technology the radius may vary from approximately 1.75 mm in the centre of the ridge to approximately 0.75 mm at the lateral portions.
The angle formed by the first and second sealing structures may be between 20 degrees and 90 degrees, for example 36 degrees.
In some forms of the technology, the corner or ridge 3120 may extend across substantially an entire boundary 3103 between the first seal forming structure 3101 and the second seal forming structure 3102. In embodiments the corner or ridge 3120 may engage the patient's face at least approximate the entrances to the nares, for example where the ala meets the face above the lip superior, as indicated by areas 1010 in
As is described above, in one form the non-invasive patient interface 3000 comprises a first seal-forming structure 3101 that forms a seal in use around the patient's mouth. The first seal forming structure 3101 may form a seal 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.
The seal forming structure 3100 comprises a lip inferior portion 3130 which forms a seal against the chin region of the patient and/or the lip inferior and/or supramenton of the patient. The lip inferior portion 3130 may be connected to (e.g. contiguous with) a lip superior portion 3131 via an oral hole peripheral portion 3132, as shown in
The seal forming structure 3100 comprises a relatively low wall thickness (compared to other portions of the interface), for example less than 0.7 mm, at the oral hole peripheral portion 3132, the lip inferior portion 3130 of the seal forming structure which lies against the chin region, and at least the centre of the lip inferior portion 3130. The low wall thickness in these locations assists in achieving an effective, comfortable seal. The seal forming structure in these regions is able to readily conform to any complex geometry.
In some forms of the technology the oral hole 3133 is substantially trapezoidal rather than oval or elliptical, in order to more accurately correspond to a shape of the patient's nose. This shape of oral hole may allow the interface 3000 to be particularly compact, and not be substantially wider than a width of the patient's nares.
As shown in
Also or in addition as illustrated in
In one form the seal-forming structure 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 some forms, the plenum chamber 3200 (or at least a portion of the plenum chamber 3200) and the seal-forming structure 3100 are formed from a single homogeneous piece of material (e.g., molded silicone). A combination of the seal-forming structure 3100 and the plenum chamber 3200 may be considered a cushion.
With particular reference to
In some forms of the technology a second anterior wall portion 3242 is less flexible than the immediately adjacent portions of the anterior wall. In some embodiments the second anterior wall portion 3242 is immediately adjacent the first anterior wall portion 3240 on an opposite side to the boundary 3241 of the nasal and oral portions of the plenum chamber. In embodiments the second anterior wall portion 3242 may be symmetrical about the mid-sagittal plane and may extend across at least 50% of the width of the nasal portion 3202 of the plenum chamber, for instance at least 80%. In some embodiments the second anterior wall portion 3242 may extend across substantially the entire width of the nasal portion 3202 of the plenum chamber.
The flexible first anterior wall portion 3240 may allow the patient contacting portions 3110 of the second seal forming structure 3102 to pivot or hinge about a region on the posterior side of the interface 3000. This may assist in allowing the interface to accommodate patients with a variety of angles between the bottom of the nose and the top lip (i.e. nasolabial angles).
In embodiments featuring a corner or ridge 3120 between the first and second seal forming structures 3101, 3102, such as have been described above, the patient contacting portions 3110 may pivot or hinge about an area at or adjacent the corner or ridge 3120. In embodiments provided with one or more support portions 3260 (described further below), the hinging or pivoting region may be immediately superior to the support portions 3260.
As shown in
Similarly, the second anterior wall portion 3242 may have a superior boundary 3247 and an inferior boundary 3248. In some forms of the technology the inferior boundary 3248 of the second anterior wall portion 3242 is the same as the superior boundary 3243 of the first anterior wall portion 3240. Both the superior and inferior boundaries 3247, 3248 of the second anterior wall portion 3242 may be curved, for example such that a central portion of the boundary is inferior to the lateral portions. The second anterior wall portion 3242 may be substantially the same height across its width (i.e., the superior and inferior boundaries may be substantially parallel) or the height may vary across the width, for example such that the height of a central portion of the second anterior wall portion 3242 is less than the height of the lateral portions.
In some forms of the technology other ways of configuring the first anterior wall portion 3240 to have a required stiffness may be used, in addition to or alternatively to curved boundaries. For example, the thickness of the first anterior wall portion 3240 may be selected to provide a required stiffness. In examples the first anterior wall portion 3240 may be thinner than the immediately adjacent portions of the plenum chamber wall. Additionally and/or alternatively, the first anterior wall portion 3240 may extend in a superior direction around a lateral edge of the second anterior wall portion 3242, as shown in
The second anterior wall portion 3242 (e.g., the band 3270) may assist in preventing collapse of the nasal portion 3202, and may provide support for the patient-contacting portions 3110 of the second seal forming structure 3102, which are typically relatively thin. Insufficiently supported patient contacting portions may suffer from blowout of the sealing engagement with the patient's face. In one form the second anterior wall portion 3242 is thicker than the immediately adjacent portions of the plenum chamber wall. In certain forms the second anterior wall portion 3242 is provided as a thickened band of material 3270, as shown in
In some forms, the first and second anterior wall portions 3240, 3242 may include different thicknesses. For example, the thickness of the second anterior wall portion 3242 may be greater than the thickness of the first anterior wall portion 3240, which may provide the increased stiffness in the second anterior wall portion 3242 (e.g., as compared to the first anterior wall portion 3240). Specifically, the second anterior wall portion 3242 may be a band 3270 that may extend into the cavity 3272 of the plenum chamber 3200. For example, the band 3270 may extend past the first anterior wall portion 3240, and extend toward a patient wearing the patient interface 3000. An exterior surface of the nasal portion 3202 may be substantially smooth, while an interior surface of the nasal portion (e.g., within the cavity 3272) may be stepped (or otherwise include a discontinuity).
As shown in
As shown in
As shown in
In some forms of the technology the shell 3250 may be made from a rigid material such as polycarbonate. However, in other forms of the technology the shell 3250, or portions of the shell 3250, may be somewhat flexible. For example, in examples the shell 3250 may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the shell 3250 may be made from a material having Young's modulus of 0.1 GPa or lower, for example rubber. In other forms of the technology the shell 3250 may be made from a material having a Young's modulus of 0.7 MPa or less, for example between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.
In examples, the shell 3250 and one or both of the first and second seal forming structures 3101, 3102 may be formed from the same material (e.g., silicone, textile, etc.).
In some forms of the technology (see e.g.,
In some forms of the technology the shell 3250 may be generally flexible but may comprise stiffening portions having greater thickness than immediately adjacent portions of the shell 3250. Such stiffening portions may be configured as ribs or bands, for example extending laterally across the shell and/or extending in a superior-inferior direction, although many other configurations are possible. In some forms the shell may comprise a substantially rigid portion, for example manufactured from polycarbonate, as well as a somewhat flexible portion.
In some forms of the technology it may be preferable for a central portion 3251 of the anterior side of the oral portion 3201 of the plenum chamber to have a greater stiffness than the remainder of the plenum chamber 3200. In some forms of the technology the area of increased stiffness may be immediately inferior to the nasal portion 3202, as shown in
As shown in
In one form of the technology the rigid portion 3263 extends laterally across the anterior of the plenum chamber near a superior boundary of the first anterior wall portion 3240, for example immediately below the second anterior wall portion 3242. The rigid portion 3263 may extend continuously between the connection ports 3600, and may provide an airflow path for the flow of pressurized air entering the plenum chamber 3200 through the connection ports 3600.
In some forms of the technology the connection ports 3600 may have a substantially elliptical shape in cross-section. The connection ports 3600 may be orientated such that a centreline of each port is substantially parallel to an exterior surface of the plenum chamber adjacent the port.
In some forms of the technology the rigid portion 3263 may protrude in an anterior direction relative to an adjacent face of the first anterior wall portion 3240, and may be shaped to increase resistance to bending.
In some forms of the technology (see e.g.,
In some forms of the technology (see e.g.,
In the embodiment shown in
The embodiment shown in
While inlet or connection ports are not shown in the drawings of the plenum chamber shown in
As shown in
As shown in
In some forms, the lip 3608 is approximately perpendicular to the periphery of the circumference of the inlet port such that the diameter of the inlet port 3604 is approximately equivalent to a diameter of an opening formed by the lip 3608 within the cavity 3272. In other words, the lip 3608 may extend substantially parallel to a port axis 3612 that extends through the inlet port 3604.
In other forms, the lip 3608 is inclined between approximately 1° and approximately 600 with respect to the port axis 3612. In some forms, the lip 3608 is inclined between approximately 2° and approximately 50° with respect to the port axis 3612. In some forms, the lip 3608 is inclined between approximately 5° and approximately 300 with respect to the port axis 3612. In some forms, the lip 3608 is inclined between approximately 100 and approximately 150 with respect to the port axis 3612.
In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.
In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, e.g. translucent silicone. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.
In certain forms of the present technology, dedicated stiffening members or rigidising members (e.g., with no other function) may be included on the plenum chamber 3200. These members may be formed from a material more rigid than the plenum chamber 3200 (e.g., than the silicone). The dedicated stiffening members may be overmolded to the plenum chamber 3200 to provide more stiffness than the rigid portion 3263 of the shell 3250 or the arms 3320.
As best seen in
The support portions 3260 do not act as undercushions and are instead configured to resist or hinder compression in the anterior-posterior direction. The support portions 3260 thereby support and/or stiffen portions of the second seal forming structure 3102 which engages the patient's lip superior. In particular, the support portions 3260 may support and/or stiffen regions of the second seal forming structure 3102 that may contact an area 1010 of the patient's face proximate the entrances to the nares where the ala meets the area above the lip superior, as shown in
The support portions 3260 assist in ensuring that creases do not form in the seal forming structure 3100. Creases in a seal forming structure may form as a result of a very flexible seal forming structure, with a large radius of curvature, conforming to a patient's face. The seal forming structure may fold over itself, or crease, as a result of being too flexible, and lead to leaks in the seal forming structure. Creasing may be particularly of concern where the seal forming structure seals against the area 1010 of the patient's face. The support portions 3260 may be particularly advantageous when the seal forming structure is configured to create a corner and/or ridge 3120 as described herein. The corner and/or ridge 3120 may be a sharper curve (e.g., a curve with a lower radius of curvature) as compared to seal forming structures without the support portions 3260. The support and/or stiffness added by the support portions 3260 decreases the ability of the second seal forming structure 3102 from conforming to the patient's face. In order to retain comfort for the patient, the corner and/or ridge 3120 is selected and/or sized to substantially match the geometry (e.g., contours) of the patient's face. For example, the seal forming structure 3100 for a particular patient may be selected from a variety of sizes in order to substantially conform to the nasal alar region (i.e., proximate to the area 1010). The sharper curvature permits the second seal forming structure 3102 to seal against the various crevices around the patient's nose with reduced likelihood that creases will form.
As seen in
Support portions 3260 with different geometries may be used for different patients. For example, patient's that require more support and/or stiffness in the second seal forming structure 3102 may use a seal forming structure 3100 with a thicker (e.g., proximate to the first end 3261 and/or at any location along the length) and/or more curved (e.g., lower radius of curvature) support portion 3260. For example, patients that want a more flexible second seal forming structure 3102 may use a seal forming structure 3100 with a thinner (e.g., proximate to the first end 3261 and/or at any location along the length) and/or less curved (e.g., greater radius of curvature) support portion 3260.
As seen in particular in
In some forms of the technology, the support portions 3260 are shaped to provide a substantially clear flow path from the oral portion 3201 of the plenum chamber to the nasal aperture(s) 3135 during inspiration. In some forms of the technology no part of either support portion 3260 is directly inferior to the nasal aperture(s) 3135.
As shown in
As shown in
With continued reference to
As shown in
In use, the patient's face contacts the seal-forming structure 3100 and pushes the first seal forming structure 3101 in the anterior direction. Because each patient may individually tighten the headgear straps 3354 (described in more detail below), patient's may overtighten the headgear straps 3354 and cause the seal-forming structure 3100 to press too firmly against the patient's face. This could result in patient discomfort and/or may degrade the quality of the seal if the overtightened seal-forming structure 3100 folds or wrinkles and allows pressurized air to escape the plenum chamber 3200. To limit the occurrence of overtightening, the stopper ribs 6040 are spaced apart from the first seal forming structure 3101 to allow only a predetermined amount of movement in the anterior direction. For example, the first seal forming structure 3101 contacts each stopper rib 6040 at the edge 6042 along its width (e.g., narrow width, measured substantially parallel to the first seal-forming structure 3101). Because the stopper ribs 6040 are longer than they are wide, the stopper ribs 6040 act as stiffening members and limit the total distance that the first seal forming structure 3101 can move. The stopper ribs 6040 may also be thicker in any direction than the first seal forming structure 3101. This may allow the stopper ribs 6040 to be sized so that a patient may tighten the headgear straps 3354 to an intended point to form a desired seal, but not beyond in order to minimize discomfort and/or seal degradation. The inclination of the edge 6042 may allow the patient's face enough room to fit comfortably within the plenum chamber 3200, while also limiting excess room (e.g., which can lead to overtightening), and provide support for the patient's face. The stopper ribs 6040 may also include a curvature along the surface of the width (see e.g.,
Additionally, each stopper rib 6040 may extend more than half way (e.g., two-thirds, three-quarters, etc.) along the length of the first seal forming structure 3101. This may help to ensure that movement is limited across substantially all of the first seal forming structure 3101.
As shown in
The stiffened regions 6044 may be formed on an anterior surface 6046 of the plenum chamber 3200 within the cavity 3272, and proximate the lateral sides of the oral portion 3201. The stiffened regions 6044 may be positioned directly across from the patient while wearing the patient interface 3000. The stiffened regions 6044 may be substantially symmetrical on either side of the oral portion 3201 and may extend around a side region 6048 of the plenum chamber 3200.
As shown in
As shown in
As shown in
Some forms of the stiffened regions 6044 of
As shown in
While using the patient interfaces 3000 of
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.
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 an example the strap may be configured as a tie.
In one form of the present technology, the positioning and stabilising structure 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 without overlaying the occipital bone.
In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure 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.
In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure 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.
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.
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,
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, the straps of the positioning and stabilizing structure 3300 may be constructed from an extensible (e.g., elastic) material. The positioning and stabilizing structure 3300 may stretch in order to accommodate patients with different head sizes.
In some forms, the straps of the positioning and stabilizing structure 3300 may be constructed from an at least partially inextensible material. This may limit the ability of the straps to stretch. Different sized straps may be used with different sized patients in order to accommodate different sized heads. The straps of the positioning and stabilizing structure 3300 may also be length adjustable.
As illustrated in
As shown in
In some forms, the frame 3350 is constructed from a rigid or semi-rigid material, and provides support to the seal-forming structure 3100 and/or the plenum chamber 3200. For example, the frame 3350 may assist in maintaining the shape of the seal-forming structure 3100 and/or the plenum chamber 3200 in order to reduce leaks of pressurized air as a result of folding and/or creasing as the seal-forming structure 3100 engages the patient's face.
In some forms, the frame 3350 provides at least one connection point 3352, which may assist in indirectly connecting the headgear straps 3354 to the plenum chamber 3200 and/or seal-forming structure 3100. The connection point 3352 may be a loop (e.g., with a fully formed perimeter) that receives a portion of the headgear straps 3354. For example, a length of a left superior headgear strap 3356 may be threaded through a first loop 3352a, and pulled away from the plenum chamber 3200 in order to apply tension through the left superior headgear strap 3356. The left superior headgear strap 3356 may be folded against itself and retained in the selected length (e.g., using Velcro, magnets, adhesives, etc.) in order to maintain the applied tension. Similar steps may be performed regarding adjusting the tension in the right superior headgear strap 3358 in a second loop 3352b. In other forms, the connection point 3352 may include an open perimeter (e.g., a U-shape or a C-shape).
In some forms, each loop 3352a, 3352b may be oriented so that a force vector applied by the respective superior headgear strap 3356, 3358 is substantially perpendicular to a loop inner surface 3351, against which the superior headgear straps 3356, 3358 contact. As shown in
As shown in
Although not illustrated, the inferior headgear straps 3366, 3368 may also include different widths (e.g., and include a tapered shape) similar to the description of the superior headgear straps 3356, 3358. Thus, any description related to the superior headgear straps 3356, 3358 may be applicable to the inferior headgear straps 3366, 3368.
In the illustrated example, each superior headgear strap 3356, 3358 may taper between the first width 3359 and the second width 3361. The superior headgear straps 3356, 3358 may include substantially linear sides 3363 between the first width 3359 and the second width 3361. In other examples, the superior headgear straps 3356, 3358 may be curved between the first width 3359 and the second width 3361. In still other examples, the superior headgear straps 3356, 3358 may include no transition between the first width 3359 and the second width 3361, and may instead be stepped between the first and second widths 3359, 3361.
As illustrated in
As illustrated in
In some forms, the dots 6128 may be raised from the surface of the straps 3356, 3358 in order to contact the loops 3352a, 3352b and provide the tactile response to the patient.
In the illustrated form, the dots 6128 are used with a strap that is substantially uniform in width. The width may be about the width of the respective loops 3352a, 3352b (e.g., at least a portion of the strap width may be slightly larger than the width of the loops 3352a, 3352b). If the patient attempts to pull either superior strap 3356, 3358 through the respective loop 3352a, 3352b, the dots 6128 will provide further resistance to movement through the loops 3352a, 3352b. For example, the patient may feel the vibrations of the dots 6128 contacting the loops 3352a, 3352b.
In an alternate form, the dots 6128 are used in addition to the tapered shape of the superior straps 3356, 3358. The dots 6128, therefore, may act as an additional signal to the patient that the superior strap 3356, 3358 is overtightened. In other words, the dots 6128 may be positioned on the portion of each superior strap 3356, 3358 having the second width 3361. If the patient attempts to pull the second width 3361 of either superior strap 3356, 3358 through the respective loop 3352a, 3352b, the dots 6128 will provide further resistance to movement through the loops 3352a, 3352b.
In some forms, the dots 6128 may be evenly distributed on the superior straps 3356, 3358. In other forms, the dots 6128 may be unevenly distributed. For example, the concentration of dots 6128 may increase in a direction away from the free end of the respective strap 3356, 3358. This may provide the patient with an initial warning that overtightening is possible and may transition into a greater number of dots 6128 in order to alert the patient that overtightening has occurred.
In other examples (see e.g.,
In certain forms, this may assist in providing a more tailored adjustment for the patient's head. Instead of simply alerting to overtightening, the dots 6128 may alert the patient to the particular strap length beneficial to their head.
In certain forms, the shape, size, and/or density of the dots 6128 may change along the length of the strap 3356, 3358. For example, the dots 6128 may be evenly (or substantially evenly) spaced prior to overstretch in order to help the patient chose the appropriate length, as described above, The configuration of the dots 6128 may change (e.g., become more dense) at a position of the strap that would result in the patient overtightening the strap 3356, 3358. The change in the configuration of the dots 6128 may create a different tactile response, which may alert the patient to the overtightening.
In certain forms, the dots 6128 may extend through substantially the entire length of the respective strap 3356, 3358. This may provide tactile cues to patients with a large range of head sizes. In this example, the dots 6128 may be substantially evenly spaced (although there may be changes in configuration as described above). Instead of alerting to a particular overtightening positon, the dots 6128 may allow the patient to consistently select a desired position.
Although the description above relates to “dots”, any suitable shape may be used. For example, the silicone glue (or other similar material) may include a triangular shape, a rectangular shape, or any other similar shape.
As illustrated in
In the illustrated form, the cut edges 6132 are used with a strap that is substantially uniform in width. The width may be about the width of the respective loops 3352a, 3352b (e.g., at least a portion of the strap width may be slightly larger than the width of the loops 3352a, 3352b). If the patient attempts to pull either superior strap 3356, 3358 through the respective loop 3352a, 3352b, the changes between the full width and the discontinuity of the cut edges 6132 will provide further indication to the patient to stop tightening the superior straps 3356, 3358 through the loops 3352a, 3352b.
In other forms, the cut edges 6132 are used in addition to the tapered shape of the superior straps 3356, 3358. The cut edges 6132, therefore, may act as an additional signal to the patient that the superior strap 3356, 3358 is overtightened. In other words, the cut edges 6132 may be positioned on the portion of each superior strap 3356, 3358 having the second width 3361. If the patient attempts to pull the second width 3361 of either superior strap 3356, 3358 through the respective loop 3352a, 3352b, the changes between the full second width 3361 and the discontinuity of the cut edges 6132 will provide further indication to the patient to stop tightening the superior straps 3356, 3358 through the loops 3352a, 3352b.
In some forms, the cut edges 6132 may be evenly distributed along a portion of the superior straps 3356, 3358. In other words, the distance between each adjacent cut on the respective cut edge 6132 may be equal. In other forms, the cut edges 6132 may be unevenly distributed. For example, the distance between each of the cuts and/or the size of the cuts on the cut edges 6132 may decrease in a direction away from the free end of each superior strap 3356, 3358.
In other examples, the cut edges 6132 may be used to assist in guiding the patient to the correct position. For example, the cut edges 6132 may be arranged in a linear pattern, evenly spaced apart. As the patient threads the strap 3356, 3358 through the respective loop 3352a, 3352b, the cut edges 6132 may provide feedback at each interval in order to communicate to the how far the strap has been threaded (e.g., similar to holes on a belt). In other words, the patient may adjust the strap to a particular position based on the number of discrete feedback signals that they receive.
In certain forms, this may assist in providing a more tailored adjustment for the patient's head. Instead of simply alerting to overtightening, the cut edges 6132 may alert the patient to the particular strap length beneficial to their head.
In certain forms, the shape, size, and/or density of the cut edges 6132 may change along the length of the strap 3356, 3358. For example, the cut edges 6132 may be evenly (or substantially evenly) spaced prior to overstretch in order to help the patient chose the appropriate length, as described above, The configuration of the cut edges 6132 may change (e.g., become smaller and/or closer together) at a position of the strap that would result in the patient overtightening the strap 3356, 3358. The change in the configuration of the cut edges 6132 may create a different tactile response, which may alert the patient to the overtightening.
In certain forms, the cut edges 6132 may extend through substantially the entire length of the respective strap 3356, 3358. This may provide tactile cues to patients with a large range of head sizes. In this example, the cut edges 6132 may be substantially evenly spaced (although there may be changes in configuration as described above). Instead of alerting to a particular overtightening positon, the cut edges 6132 may allow the patient to consistently select a desired position.
In use, each superior headgear strap 3356, 3358 is threaded through the respective loop 3352a, 3352b as described above. The first width 3359 may be selectively inserted through the opening of the respective loop 3352a, 3352b because the first width is less than the width of the loops 3352a, 3352b. At least some of the transition may also have a width less than the width of the loops 3352a, 3352b, so that the transition may also be received through the openings. However, the second width 3361 may be greater than the width of the loops 3352a, 3352b, and may be unable to slide through either opening. The larger second width 3361 may provide a stop, and limit the total length that may be threaded through the respective loop 3352a, 3352b. This may reduce patient overtightening because the second width 3361. In some forms, the length of the superior headgear straps 3356, 3358 with the first width 3359 (or the length of the first width 3359 plus the transition 3363) may be designed for a patient with a larger head. Thus, the superior headgear straps 3356, 3358 may be adjusted for ideal tightness at or before the second width reaches the respective loop 3352a, 3352b. The superior headgear straps 3356, 3358 may be under more tension if they are adjusted to the second width 3361 in patients with smaller heads. However, the second width 3361 may still prevent the patient from overly tightening the superior headgear straps 3356, 3358, and limit the seal-forming structure 3100 from deforming and creating leaks. Alternatively, different sized positioning and stabilizing structure 3300 may be constructed for patients with different sized heads (i.e., so that the second width 3361 acts as a stop to limit overtightening for patients with a variety of head sizes).
In other examples, strap extenders may be connected to the superior headgear straps 3356, 3358 to provide a greater length of the first width 3359. This may allow a single positioning and stabilizing structure 3300 designed for a smaller patient's head to be used with a larger patient's head.
In some forms, the strap extenders may have double-sided connectors. The illustrated example shows the same type of connector on either side, although the connector could be different on each side. For example, the strap extender may include hook and loop material. In some forms, loop material is formed on both sides while in other forms hook material is formed on both sides. In still other forms, hook material is formed on one side and loop material is formed on the other.
In some forms, the strap extenders may be used to provide extra length so that a patient does not overstretch the straps (e.g., either the superior straps 3356, 3358 and/or the inferior straps 3366, 3368).
In certain forms, the strap extenders may include similar features to the straps shown in
Any of the features described in
In certain forms, straps of the headgear 3354 (e.g., the superior straps 3356, 3358 and/or the inferior straps 3366, 3368) may include an extended length of a connector configured to interface with a connector on the strap extender. For example, the superior straps 3356, 3358 may include hook or loop material along at least a portion of the first width 3359 and a/or a portion of the second width 3361.
The patient may adjust the position of the strap extender along the length of the respective strap in order to select the proper usable length for the patient (e.g., so that there is a sufficient sealing force without overextending the strap).
In certain forms, there may be different sized strap extenders (e.g., small, medium, large) so that a patient may make more tailored adjustments to their specific head and reduce the change of overstretching the strap extender.
Also, or in addition, the superior headgear straps 3356, 3358 may be constructed from an elastic material. The elastic material may change in visual appearance (e.g., may change in color) as a result of stretching under tension. The expansion of the headgear straps 3356, 3358 could also provide a tactile response to the patient that the straps 3356, 3358 are overstretched. This change in visual appearance may alert the patient (or a third party like a bed partner) that the superior headgear straps 3356, 3358 are over tensioned. This may be beneficial when the patient has fully tightened the superior headgear straps 3356, 3358 prior to the second width reaching the respective loop 3352a, 3352b.
For example,
In
In
In some forms, the hidden portion 3365 may be luminescent and may glow when exposed. In a dark room, the glow from the hidden portion 3365 may be observable so that the patient is alerted to the overstretch condition of the headgear straps 3354.
In some forms, the hidden portion 3365 may include a noise output device (e.g., a speaker) that outputs a sound when the hidden portion 3365 is exposed in order to alert the patient.
In some forms, the hidden portion 3365 may include an electrical component (e.g., a light emitting element) that outputs light when the hidden portion 3365 is exposed. The output of light may alert the patient that the headgear strap 3354 is overstretched. In certain forms, the headgear strap 3354 may include a battery (not shown) and/or an electrical wire for providing power to the electrical component.
In some forms, the patient may be unable to see that the strap has exceeded the threshold tension and that the hidden portion 3365 is exposed (e.g., when donned by the patient, the straps may no longer be visible to the patient). As illustrated in
In certain forms, the tactile response element 3367 are a pair of magnets. The magnets 3367 are connected to one another when the strap is in the first position. When the tension in the strap exceeds the magnetic force, the magnets 3367 separate and the hidden portion 3365 is exposed. Thus, the strap may be under tension and may stretch (e.g., if elastic) prior to the magnets 3367 separating.
When the magnets 3367 separate, the patient may receive a disenable response. This could be in the form of vibrations along the strap from the magnets 3367 disconnecting and/or in an auditory signal. Either or both of these may alert the patient that the strap is too tight. Removing the excess tension in the strap allows the magnets 3367 to reconnect to one another.
In other forms, the tactile response element 3367 may be an alternate connector (e.g., a mechanical connector). For example, the tactile response element 3367 may be constructed from plastic and/or silicone. Instead of a magnetic force, the tactile response element 3367 may be connected with a mechanical connection (e.g., a snap-fit), or a similar connection (e.g., hook and loop connectors). These alternate tactile response elements 3367 can have a retention force that allows for some extension below a separation threshold before the tactile response elements 3367. Like the magnets 3367, the separation of the tactile response element 3367 may create vibrations that the patient can detect and determine that the strap is overstretched.
In some forms, the tactile response element 3367 may be wider than the strap. This may provide additional visual cues for the patient to determine that the strap tension has exceeded the threshold.
Although not illustrated, the overstretch feature shown and described in
As shown in
Because the double-sided connecting members 6136 may include the same connecting material on either side, the patient may connect either side to the headgear straps 3354.
In some forms, the double-sided connecting member 6136 may be used with headgear straps 3354 that otherwise lack affixed connectors.
As illustrated in
In the first position, a person with a smaller head may overtighten the headgear straps 3354 in order to achieve an appropriate fit. Thus, the patient may move the double-sided connecting members 6136 to the second position (i.e., away from the free ends of the various straps as illustrated in
In certain forms, the patient may cut the free ends of the straps beyond where the double-sided connecting members 6136 are located. In other forms, the excess free ends may remain so that a different patient (e.g., with a different sized head) may readjust the double-sided connecting members 6136 to fit their head.
In certain forms, the double-sided connecting member may have hook material on one side and loop material on the other so that the two sides are not functionally the same.
As shown in
In one form, at least one of the loops 3352a, 3352b may not be completely formed around an outer perimeter. In other words, the loops 3352a, 3352b may be C-shaped and/or U-shaped. The left and/or right superior headgear straps 3356, 3358 may be individually folded against themselves, and then inserted through into the respective loop 3352a, 3352b. This may allow the patient to maintain the same length adjustment in the respective superior headgear strap 3356, 3358, when the seal-forming structure 3100 is being removed from the therapeutically effective position.
As shown in
The raised portion 3390 may include a rounded (e.g., semi-circular shape). In some forms, the raised portion 3390 may protrude about 0.01 mm to about 1 cm. In some forms, the raised portion 3390 may protrude about 0.05 mm to about 5 mm. In some forms, the raised portion 3390 may protrude about 0.1 mm to about 3 mm. In some forms, the raised portion 3390 may protrude about 0.5 mm to about 1.5 mm. In some forms, the raised portion 3390 may protrude about 1.2 mm.
As shown in
As shown in
With continued reference to
As shown in
The superior headgear straps 3356, 3358 may also decrease in tension as a result of moving from the first loop section 6080-1 to the second loop section 6080-2 because the superior headgear straps 3356, 3358 do not need to be stretched as much while in the second loop section 6080-2. This may momentarily reduce the tension in the respective superior headgear strap 3356, 3358. However, there may be nothing to prevent further increases in tensioning.
As shown in
As shown in
As shown in
In one form, a single size of the central portion 3360 may be used with a variety of sizes of plenum chambers 3200 and/or seal-forming structures 3100. For example, the seal-forming structure 3100 may come in multiple sizes (e.g., small, medium, large, etc.) and/or shapes (e.g., narrow, wide, etc.) in order to better seal against patients with a variety of facial shapes. An engagement region of the central portion 3360 may remain substantially the same regardless of the size of the plenum chamber 3200 and/or seal-forming structure 3100. Thus, the central portion 3360 may be coupled to a variety of shaped and/or sized cushions, and provide substantially the same support.
In one form, the central portion 3360 may be removable coupled to the plenum chamber 3200. A patient may use the same frame 3350 with multiple plenum chambers 3200. This may be useful when the patient is first beginning the therapy, and is trying different sized plenum chambers 3200, in order to find an appropriate fit. Removing the frame 3350 may also be helpful when cleaning the patient interface 3000, as the different elements of the patient interface 3000 may be cleaned separately, to help ensure a more thorough clean.
In other forms, different frames, with different sized and/or shaped central portions, may be used with different sized plenum chambers 3200 and/or with different sized patients in order to provide a comfortable fit for a wide variety of patients. As shown in
As shown in
As shown in
In some forms, the superior bar 26036 may still provide support to the patient in use. For example, the patient may deform the nasal portion 3202 of the plenum chamber 3200 as a result of wearing the patient interface 3000 so that the nasal portion 3202 contacts the superior bar 26036. The superior bar 26036 may be far enough away in the neutral (i.e., unworn) position in order to allow the nasal portion 3202 to comfortably expand when worn by the patient, but contact the superior bar 26036, which provides support and limits over-bending of the nasal portion 3202. This may simulate the frame 3350, but in a size conducive for patients with larger noses.
In some forms, the frame 3350 includes arms 3362 that extend away from the central portion 3360. The loops 3352a, 3352b are formed at ends of the arms 3362. In use, the arms 3362 may extend at least partially in the posterior direction, which may position the loops 3352a, 3352b more posterior than the plenum chamber 3200 and/or the seal-forming structure 3100. The arms 3362 may also extend in the lateral direction (e.g., left or right respectively) so as to generally extend along contours of the patient's face.
In some forms, the arms 3362 engage a portion of the patient's face while the patient interface 3000 is worn by the patient. For example, the arms 3362 may contact the patient's cheeks. The arms 3362 may be shaped in order to correspond to the curvatures of a patient's face (e.g., extend in posterior and lateral directions).
In some forms, the arms 3362 may not substantially stretch as a result of the tension applied by the respective headgear strap 3356, 3358 via the respective loop 3352a, 3352b (e.g., the arms 3362 may be rigidizers and/or may be inextensible). Tension may be transferred along the arm 3362 to the plenum chamber 3200 and/or seal-forming structure 3100 in order to maintain the therapeutically effective pressure and limit leaks from occurring.
In one form, the arms 3362 are constructed from a material that is more flexible than the material used to construct the central portion 3360. The two materials may be molded together so that the frame 3350 is constructed in an integral, one-piece construction. The arms 3362 may have some rigidity in order to assist in maintaining their shape. However, the arms 3362 may be bendable so that a patient may adjust the shape in order to correspond to their facial structure. Allowing a patient to adjust the shape of the arms 3362 may increase the comfort experienced by the patient, which may increase patient compliance with the therapy. In this way, the arms 3362 may bend or flex relative to the central portion 3360 (e.g., because of a cantilevered configuration), but may be unable to stretch further in the posterior direction (e.g., because of its inextensibility). Additionally, the relatively flexible material used to construct each of the arms 3362 may assist in reducing facial markings, and increase patient comfort.
In one form, the arms 3362 and the central portion 3360 are constructed from the same material. This material provides enough flexibility in order to permit shape adjustment, and also provides enough rigidity in order to maintain the adjusted shape. The central portion 3360 may be more rigid than the arms 3362 as a result of being coupled to the plenum chamber 3200. In addition or instead of, the central portion 3360 may be thicker than the arms 3362, which may also cause an increased rigidity of the central portion 3360. Each arm 3362 is formed as a cantilevered shape, so that the ends proximate to the respective loop 3352a, 3352b are unsupported. Additionally, the thickness of the frame 3350 may decrease along the length of each arm 3362 in the direction of the respective loop 3352a, 3352b (see e.g.,
In one form, a sleeve 6124 may be used with the arms 3362 to provide additional comfort to the patient. As shown in
In the illustrated example, the sleeves 6124 may not cover the central portion 3360 of the frame 3350 or the loops 3352 (or 6080). In this way, the sleeves 6124 may not obscure straps from being connected to the loops 3352, and/or may not obscure the central portion 3360 from being connected to the plenum chamber 3200. In other examples, a sleeve could be used with central portion 3360 (e.g., so that the patient interface 3000 had the appearance of bedclothes).
In some forms, the sleeves 6124 may be constructed from a comfortable material, which may be flexible and/or soft to the touch. As described above, the arms 3362 may be bent and/or shaped in order to conform to the shape of the patient's face (e.g., the patient's cheeks). As a result, the at least a portion of the arms 3362 are in close contact with the patient's skin. By including the sleeves 6124, the patient's skin may be contact with material that is comfortable to wear for long periods of time. The material may be a textile and/or a foam, or any similar material.
In certain forms, the sleeves 6124 may be constructed from an elastomeric material. This may allow the sleeves to stretch over the loops 3352 so that the sleeves 6124 can be removed from the arms 3362 (e.g., to be cleaned). In other examples, the sleeves 6124 may wrap around the arms 3362 with a hook and loop, magnetic, or mechanical connection. The connection may be disconnected in order to remove the sleeves 6124 from the arms 3362.
In one form, each loop 3352 may include a raised portion 3390 with a rounded shape. The raised portion 3390 may include a smooth surface in the direction from the loop 3352 and toward the arm 3362, which may allow the sleeve 6124 to slide past the loop 3352 without snagging. An end 3392 of the raised portion 3390 proximate to the arm 3362 may be formed as a projection or overhang. This may limit the sleeve from sliding in the reverse direction (i.e., disconnecting from the loop frame 3350 by sliding over the loop 3352).
In other forms (not shown), the arms 3362 may include a comfortable material only on inner surfaces (e.g., surfaces include the scallop 3373 (see e.g.,
In some forms, the fixed end of each arm 3362 may have a thickness of between approximately 2 mm and approximately 7 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between approximately 2.5 mm and approximately 6 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between approximately 3 mm and approximately 5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of approximately 4 mm.
In some forms, the free end of each arm 3362 may have a thickness of between approximately 0 mm and approximately 4 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between approximately 0.5 mm and approximately 3 mm. In some forms, the fixed end of each arm 3362 may have a thickness of between approximately 1 mm and approximately 2.5 mm. In some forms, the fixed end of each arm 3362 may have a thickness of approximately 2 mm.
As shown in
In some forms, the height of each arm 3362 may be between approximately 5 mm and approximately 15 mm. In some forms, the height of each arm 3362 may be between approximately 6.5 mm and approximately 13.5 mm. In some forms, the height of each arm 3362 may be between approximately 8 mm and approximately 12 mm. In some forms, the height of each arm 3362 may be between approximately 9.5 mm and approximately 10.5 mm. In some forms, the height of each arm 3362 may be approximately 10 mm.
As illustrated in
In some forms, each rib 3394 may include a rounded profile (e.g., having a semi-circular shape). The rounded profile may reduce or limit discomfort caused by a sharp or angular shape.
As described above, a sleeve 6124 may be positioned around each arm 3362 in order to provide additional comfort to the patient. The dimensions of the arm 3362 (e.g., the thickness, height, and cross-section described above) provide a surface for the sleeve 6124 to extend around. However, in some examples, the sleeve 6124 may be larger than the arm 3362 (e.g., as a result of passing over the loop 3352) and may sag on the respective arm 3362. For example, a height of the arm 3362 may be greater proximate to the loop 3352. This may look and/or feel unpleasant to a patient wearing the patient interface 3000. The rib(s) 3394 on each arm 3362 may provide additional height (and/or thickness depending on the positioning of the ribs 3394) to the respective arm 3362 in order to stretch out the sleeve 6124 and minimize slack (e.g., in order to match the height of the arm 3362 proximate to the loop 3352).
The smooth profile of the ribs 3394 may limit the sleeve 6124 from snagging and/or ripping on the ribs 3394. It may also allow the sleeve 6124 to be connected or removed from the arm 3362 without damaging the sleeve 6124.
As shown in
In one form, the pivot points 6012 are disposed in approximately the same position on either side of the frame 3350. In other words, each arm 3362 may be connected to the central portion 3360 at substantially the same height, and each arm 3362 may extend approximately the same length past the pivot point 6012. This may allow the patient to make mirrored adjustments to the arms 3362. The patient may then flex or bend each arm individually in order to make adjustments specific to one side.
In one form, each pivot point 6012 is a living hinge. In other words, the frame 3350 may be constructed from a substantially uniform material (or a transition between each arm 3362 and the central portion 3360 may be constructed from a substantially uniform material). The thickness at each hinge 6012 may be significantly less than the thicknesses of the arm 3362 and the central portion 3360 immediately adjacent to the hinge 6012. For example, the hinge 6012 may be formed as a groove on a surface of the frame 3350 that faces away from the patient while in use. Uniformly and integrally constructing the hinge 6012 out of substantially the same material as the arms 3362 and the central portion 3360 may assist in reducing manufacturing costs (e.g., as compared to including a hinge constructed of a different material).
Each arm 3362 may be pivotable about the respective hinge 6012 between a first position and a second position. The loops 3352a, 3352b may be spaced closer together in the second position than in the first position.
In one form, the first position may be a relaxed position, and the second position may be a biased position. The arms 3362 may move to the second position when an external force is applied, and may return to the first position when the external force is removed.
In one form, the arms 3362 may also be positioned in either the first positon or the second position without continued application of an external force. The arms 3362 may be moved into the second position so that the arms 3362 overlap one another (e.g., like eyeglasses). This may assist in providing a small footprint for packaging and/or storage.
In other forms (not shown), each arm 3362 may be separate from the central portion 3360, and may be coupled to the central portion 3360 with a rotational hinge (e.g., a pin joint). In still other forms, each arm 3362 may be coupled to the central portion 3360 by overmolding a flexible in between, which may allow for some pivotable movement.
In some forms, the frame 3350 further includes at least one secondary connection point 3364 that is spaced apart from the loops 3352a, 3352b. The secondary connection point(s) 3364 provides an additional connection location, which may further assist in indirectly connecting the headgear straps 3354 to the plenum chamber 3200 and/or seal-forming structure 3100.
In certain forms, the frame 3350 includes two secondary connection points 3364 (e.g., a left secondary connection point 3364a, and a right secondary connection point 3364b). The secondary connection points 3364a, 3364b may be inferior to the loops 3352a, 3352b while the patient interface 3000 is worn by the patient. The headgear straps 3354 may further include a left inferior headgear straps 3366 and a right inferior headgear strap 3368, each configured to couple to the respective secondary connection point 3364a, 3364b. The headgear 3354 as a whole may then be able to provide a force to the superior and inferior regions of the seal-forming structure 3100 and/or the plenum chamber 3200.
In certain forms, the secondary connection points 3364a, 3364b are formed directly on the central portion 3360. The secondary connection points 3364a, 3364b may be more anterior than the loops 3352a, 3352b while the patient interface 3000 is worn by the patient.
In certain forms, the secondary connection points 3364a, 3364b may be constructed from a single component, which may assist in reducing tooling and/or manufacturing costs.
In certain forms, the left and/or right inferior headgear straps 3366, 3368 are removably coupled to the respective secondary connection point 3364a, 3364b. The secondary connection points 3364a, 3364b may be magnetic, and a left and/or right inferior headgear straps 3366, 3368 may be threaded through a housing 3371 that includes a magnet 3370 with an opposite polarity as the secondary connection points 3364a, 3364b. The housing 3371 may be flexible or semi-rigid to assist with coupling and better retaining the magnet in a connected position. The length of the left and/or right inferior headgear straps 3366, 3368 may be adjusted by folding the respective strap 3366, 3368 on itself around a crossbar 3386 (e.g., as done with the left and/or right superior headgear straps 3356, 3358). Additionally, the inferior headgear straps 3366, 3368 may include a first width 3359 and a second width 3361. The illustrated strap in
Alternatively, or in addition, the left and/or right inferior headgear straps 3366, 3368 may include the dots 6128 and/or the cut edges 6132 as illustrated on the superior headgear straps 3356, 3358 (see e.g.,
In other examples, the ladder locks 6092 and/or the stoppers 6096 may be connected to the frame 3350 in order to provide adjustment for the inferior headgear straps 3366, 3368.
Each magnet 3370 may be removed from the respective secondary connection point 3364a, 3364b, without changing the length adjustment of the left and/or right inferior headgear straps 3366, 3368. A patient may be able to don and/or doff the patient interface 3000 while only removing the magnets 3370 from the respective secondary connection points 3364a, 3364b (e.g., without having to remove the left and/or right superior headgear straps 3356, 3358 from the respective loops 3352a, 3352b).
As shown in
In the illustrated example, the outer casing 3376 may have a substantially elliptical shape, and the lip 3380 may extend proximate to a vertex of the planar surface 3378. The lip 3380 may also extend around only a portion of the planar surface 3378 (e.g., less than 360°). In some examples, the lip 3380 may extend less than 1800 around the planar surface 3378 (e.g., the lip 3380 may not extend to either co-vertex of the substantially elliptical planar surface 3378).
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The magnet 3370 includes a substantially planar surface that may engage the substantially planar surface 3378 of the outer casing 3376. While engaging the planar surface 3378, the magnet 3370 may be magnetically coupled to the magnetic element 3382 of the secondary connection point 3364a, 3364b. An overhang 3384 may be spaced apart from the magnet 3370. As illustrated, the overhang 3384 may be positioned on one side of the lip 3380 (e.g., an inner side) and the magnet 3370 may be positioned on the other side of the lip 3380 (e.g., an outer side). In use, the patient may adjust the length of a respective inferior headgear strap 3366, 3368. Tightening one of the inferior headgear straps 3366, 3368 may apply a force directed away from the center of the frame 3350 (e.g., in a laterally outward direction). This force may be greater than a magnetic force between the magnet 3370 and the magnetic element 3382, and may cause the magnet 3370 to move relative to the planar surface 3378.
The overhang 3384 may prevent the magnet 3370 from becoming disengaged from the magnetic material 3382 as a result of tightening the respective inferior headgear strap 3366, 3368. As the magnet 3370 begins to move, the overhang 3384 may contact the lip 3380, limiting further movement away from the center of the frame 3350. Engagement between the lip 3380 and the overhang 3384 therefore assist in reducing accidental disconnection of the magnet 3370 from the respective secondary connection point 3364a, 3364b when tightening the respective inferior headgear strap 3366, 3368, but does not limit the ability of the patient to move the magnet 3370 substantially perpendicular to the frame 3350 (e.g., in order to doff the positioning and stabilizing structure 3300).
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In some forms, the clip supports 6016 may also be curved or extend along an arcuate path. As shown in
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In some forms, a height of the clip support 6016 from the oral portion 3201 may be less than the distance between the crossbar 3386 and the oral portion 3201. Thus, the crossbar 3386 and the clip support 6016 may be slightly spaced apart in a neutral position. This spacing may provide clearance for the respective inferior strap 3366, 3368 to extend around the crossbar 3386. Once the respective inferior strap 3366, 3368 is connected to the respective connection member 3371, the connection member 3371 may be substantially close or touching the clip support 6016. This may limit or prevent the connection member 3371 from rocking and/or pivoting toward the surface of the oral portion 3201. The rocking or pivoting may occur if the lip 3380 and the overhang 3384 (see e.g.,
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In some forms, the clip support 6020 may be at least partially flush with the central portion 3360 of the frame 3350. For example, an interface between a proximate end of the clip support 6020 and the central portion 3360 may be substantially flush so that the central portion 3360 and the clip support 6020 each have the same thickness. In other forms, the clip support 6020 may have a thickness that is less than the central portion 3360. In this case, the clip support 6020 may be flush with only a portion of the central portion 3360 (e.g., the clip support 6020 may be flush with either the upper or lower edge of the central portion 3360).
In some forms, a distal end 6021 of the clip support 6020 opposite the proximate end may be curved or bent, and extend away from the surface of the oral portion 3201. The curve or bend at the distal end 6021 may form the similarly shaped projection in the clip support 6016 of
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In the illustrated example, the ribs 6024 may be substantially rectangular in shape, although any similar shape (e.g., elliptical, circular, triangular, etc.) may be used. The ribs 6024 may project from the surface of the central portion 3360. In some forms, the ribs 6024 may extend to a height substantially equal to the height of the connection member 3371, although the ribs 6024 may extend to a position below an upper surface of the connection member 3371.
When connected, each connection member 3371 fits between the respective pair of ribs 6024. Each rib 6024 may be in contact with the respective connection member 3371, or may be substantially close to the respective connection member 3371. This limits or prevents the connection members 3371 from rotating about a perpendicular axis through each respective connection point 3364a, 3364b. This may assist in maintaining the desired orientation of the force vector of each inferior strap 3366, 3368, and also help to minimize accidental disengagement of the magnet 3370 from the respective connection point 3364a, 3364b.
As shown in
The connection member 3371 may include a cut-out 6028 between the overhang 3384 and the crossbar 3386. The cut-out 6028 may be shaped to substantially correspond to the shape of the rib 6024. When the connection member 3371 engages the respective connection point 3364a, 3364b, the cut-out 6028 receives the rib 6024. The rib 6024 may contact the cut-out 6028, or be substantially close to the cut-out 6028 in order to prevent or limit rotational movement of the respective connection member 3371. Thus, the single rib 6024 may achieve substantially the same benefit as the multiple ribs 6024.
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Positioning the connection point 3364a, 3364b at an end of the arm 6032 may move the connection point 3364a, 3364b in the lateral and/or rearward direction. In some forms, the connection point 3364a, 3364b on either arm 6032 may be spaced apart from the central portion 3360 (e.g., measured along the surface of the arm 6032) between approximately 5 mm to approximately 50 mm. In some forms, the connection point 3364a, 3364b on either arm 6032 may be spaced apart from the central portion 3360 between approximately 10 mm to approximately 40 mm. In some forms, the connection point 3364a, 3364b on either arm 6032 may be spaced apart from the central portion 3360 between approximately 20 mm to approximately 30 mm. In some forms, the connection point 3364a, 3364b on either arm 6032 may be spaced apart from the central portion 3360 by approximately 29 mm. In some forms, the connection point 3364a, 3364b on either arm 6032 may be spaced apart from the central portion 3360 by approximately 21 mm.
In some forms, the arms 6032 may be integrally formed with the central portion 3360 with a one-piece construction. In this example, the central portion 3360 and the arms 6032 may be constructed from substantially the same materials. In other examples, the arms 6032 may be constructed from a different material, but integrally formed with the central portion 3360 (e.g., multiple materials are introduced during an injection molding process). In other examples, the arms 6032 may be formed using a separate process than the central portion 3360, and may be connected to the frame 3350 using an attachment means (e.g., an adhesive, a magnet, a mechanical fastener). In this example, the arms 6032 may be permanently connected, or may be removable.
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The arms 6032 in
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In use, the patient may connect the connection members 3371 to the respective connection point 3364a, 3364b in a similar manner than when the connection points 3364a, 3364b are directly connected to the central portion 3360. Thus, there may be no impact on the patient's ability to connect the magnets 3370 and the connection points 3364a, 3364b. Additionally, creating a wider connection point 3364a, 3364b (i.e., spaced further apart from the central portion 3360 of the frame 3350) may limit the occurrence of the magnet 3370 unintentionally disengaging from the respective connection point 3364a, 3364b. For example, the at least partially flexible nature of the arms 6032 may allow for bending in the posterior direction, which may limit rocking of the connection member 3371 on the respective connection point 3364a, 3364b. Thus, the magnets 3370 are less likely to become accidentally disengaged, and the seal between the patient's face and the seal-forming structure 3100 may be better maintained.
In some forms, the arms 6032 may bend or flex relative to the central portion 3360. For example, the arms 6032 may bend inwardly toward the plenum chamber 3200 (and toward the patient's face when the patient interface 3000 is worn). The bending or flexing may be the result of the force of the positioning and stabilizing structure 3300 (e.g., tightening the straps 3366, 3368 may cause bending motion in the arms 6032). As a result of the bending, the arms 6032 may be disposed in close proximity to or in contact with the plenum chamber 3200 and/or the patient's face. This may help to reduce the occurrence of rocking or accidental disengagement of the magnets 3370.
In some forms, the connection points 3364a, 3364b on the arms 6032 may not include the lip 3380. Instead, the connection points 3364a, 3364b may be substantially planar. The displacement of the connection points 3364a, 3364b away from the central portion 3360 combined with the bendability of the arms 6032 may reduce the likelihood of the of the magnet accidentally disengaging during use. Specifically, the rearward positioning of the connection points 3364a, 3364b may reduce torque on the housing 3371 and magnets 3370, which may cause the decoupling.
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The length of the bendable section 6116 may determine the total amount of bending allowed in the bendable housing 6104. Longer bendable sections 6116 may permit more bending than shorter bendable sections 6116. In some forms, the bendable section 6116 is between approximately 0.1 mm and approximately 20 mm. In some forms, the bendable section 6116 is between approximately 1 mm and approximately 10 mm. In some forms, the bendable section 6116 is approximately 5 mm.
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In some forms, the groove 3280 may have a completely formed perimeter with a substantially annular shape. The perimeter may have substantially the same length in any sized cushion.
In some forms, the groove 3280 is recessed relative to a remainder of the outer surface of the plenum chamber 3200. The recessed groove 3280 may not extend substantially into the plenum chamber 3200 and obstruct the patient's face. The groove 3280 may have substantially the same depth throughout its perimeter.
In some forms, a width of the groove 3280 may be less than a width of central portion 3360 of the frame 3350. The compliant nature of the cushion may allow the wider central portion 3360 to be received within the groove 3280. This may allow the central portion 3360 to couple to the groove 3280 via a press fit, friction fit, and/or snap-fit. The engagement between the groove 3280 and the central portion 3360 may assist in providing rigidity to the plenum chamber 3200 and/or the seal-forming structure 3100, because the rigidity of the frame 3350 (e.g., as compared to the plenum chamber 3200) may limit some flexibility of the plenum chamber 3200 alone.
In some forms, the cushion may be molded to the frame 3350 so that the groove 3280 may be created during a molding process. The material of the plenum chamber 3200 (e.g., silicone) may be molded at least partially around the central portion 3360 of the frame 3350, and may limit the central portion 3360 from being removed from the groove 3280.
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In some forms, the central portion 3360 includes slots 3372, which may be formed on either lateral side of the central portion 3360. The slots 3372 may have a generally elongated shape (e.g., rectangular, elliptical, etc.), and may be completely formed within the boundary of the central portion 3360.
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In some forms, the groove 3280 may also be asymmetrical. The groove 3280 may include an undercut 6004 on one side of the projection 3284, and an inclined surface 6008. The overhang 6000 may extend further over the undercut 6004 than over the inclined surface 6008. The length of the overhang 6000 extending over the undercut 6004 may limit the ability of the frame 3350 to be removed in a perpendicular direction from the plenum chamber 3200. The angle of the inclined surface 6008 may be directed toward the overhang 6000, and limit the ability of the frame 3350 to be removed in an oblique direction.
When the frame 3350 is being assembled to the plenum chamber 3200 (e.g., via a press fit, friction fit, snap-fit, etc.), the patient may align the projections 3284 with the slots 3372, so that the projections 3284 are received within the slots 3372 in use. The wider openings of the slots 3372 proximate to the posterior surface may assist the patient in aligning each projection 3284 within the respective slot 3372. The projections 3284 may be slightly wider than the anterior opening of each slot 3372, but are able to be received within the slot 3372 because of the flexible properties of the plenum chamber 3200 (e.g., being constructed from a resilient material like silicone). The projections 3284 may slightly deform as they enter the respective slot 3372 (e.g., as a result of the slot 3372 narrowing).
Once the projections 3284 are through the slot 3372, the projections 3284 may substantially return to their original shape. For example, the overhang 6000 may deform (e.g., elastically deform) as the slot 3372 receives the projection 3284, and may return to its initial position once the central portion 3360 is received within the groove 3280. The patient may experience this deformation as a tactile response, in order to more easily observe proper connection between the frame 3350 and the plenum chamber 3200. The overhangs 6000 of the projections 3284 may be wider than the anterior opening of the respective slot 3372 in a relaxed or initial position.
Additionally, the width of the undercut 6004 may be substantially the same as the central portion 3360 so that the frame 3350 is snuggly received within the groove 3280. The flexible material of the plenum chamber 3200 may allow the undercut 6004 to be slightly smaller than the central portion 3360, so that the undercut 6004 may flex and receive the frame 3350 via the press-fit, friction fit, snap-fit, etc.
Thus, the frame 3350 may not be easily removed from the plenum chamber 3200. The patient may have to apply a force to the frame 3350 in order to remove it from the groove 3280. This user applied force may allow the frame 3350 to be moved in either the perpendicular or oblique direction, and overcome the retention provided by the overhang 6000. For example, the patient may lift the frame 3350 from the region of the central portion 3360 that contacts the inclined surface 6008 in order to provide a force for disengaging the frame 3350 from the plenum chamber 3200.
This force may exceed a force produced by normal movements of the plenum chamber 3200 and/or seal forming structure 3100. In other words, the seal-forming structure 3100 and/or plenum chamber 3200 may move relative to the frame 3350 while the projections 3284 are received within the respective slot 3372. This may allow the seal-forming structure 3100 and/or the plenum chamber 3200 to flex and conform to a patient's face without coming loose from the frame 3350, and inadvertently causing the slots 3372 to disengage from the projections 3284.
In other forms, the plenum chamber 3200 may be molded to the frame 3350, and the projections 3284 may result from the molding process in order to permanently retain the position of the frame 3350 relative to the plenum chamber 3200.
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Additionally, each arm 3362 contacting the plenum chamber 3200 proximate to the elbow, and therefore distal to the posterior surface 3112, may produce less support at the lateral portions 3111 of the plenum chamber 3200 (e.g., because the rigid or semi-rigid arm engages less of the lateral portion 3111). The lateral portions 3111 may therefore have a greater degree of flexibility, and may be able to better conform to the shape of a patient's nose and create an effective seal.
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In some forms, the patient may move the arms 3362 into the second position in order to provide a better fit. For example, the distance between the loops 3352a, 3352b in the first position may be larger than the size of an average patient's head. Accordingly, the patient may move the arms 3362 toward the second position in order to provide an appropriate fit (e.g., contact between the arms 3362 and the patient's head). The arms 3362 may be retained in the second position by adjustment of the superior headgear straps 3356, 3358 (i.e., the superior headgear straps 3356, 3358 may provide the external force).
Similarly to the arms 3362, the plenum chamber 3200 and/or the seal-forming structure 3100 may be larger than the size of the average patient's face. For example, the seal-forming structure 3100 may not snuggly engage the patient's mouth and/or nose. The plenum chamber 3200 and/or the seal-forming structure 3100 may also move toward a more compact position in order to better engage an individual patient's face.
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Pivoting movement of each arm 3362 about the hinge 6012 may provide an inwardly directed force to the plenum chamber 3200. This may reduce a distance between the lateral portions 3111 of the second seal-forming structure 3102, and snuggly position the second seal-forming structure 3102 against the patient's nose. Compressing the seal-forming structure 3100 and/or the plenum chamber 3200 may provide a better seal against the patient's face (e.g., by limiting the occurrence of leaks). Additionally, applying the inwardly directed force proximate to the center of the plenum chamber 3200 (e.g., as described with respect to
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In some forms, the central portion 3360 of the frame 3350 may be substantially solid throughout, and may not include slots 3372, and the plenum chamber 3200 may not include projections 3284 within the groove 3280. Instead, the plenum chamber 3200 may include protrusions 3288 disposed radially inside of the groove 3280. The protrusions 3288 may be raised from the rest of the anterior surface of the plenum chamber 3200. The protrusions 3288 may also extend at least partially in a radially outward direction. In other words, the protrusions 3288 may extend at least partially over the groove 3280 (e.g., the protrusions 3288 are spaced apart from the groove 3280).
While assembling a removable frame 3350 to the plenum chamber 3200, a patient may be required to position the frame 3350 so that it extends into the groove 3280, and underneath of the protrusions 3288. Once the central portion 3260 is positioned, the protrusions 3288 may assist in retaining the central portion 3360 in place. To decouple the frame 3350 from the plenum chamber 3200, the patient may push on at least one of the protrusions 3288 (e.g., in a lateral direction toward the other protrusion 3288) so that the protrusion no longer extends over the groove 3280. In other forms, the plenum chamber 3200 may be molded to the frame 3350, the protrusions 3288 may prevent the central portion 3360 from being removed.
In some forms, the frame 3350 of any of the examples described above may be substantially flush with the outer surface of the plenum chamber 3200 when positioned within the groove 3280. The depth of the groove 3280 substantially corresponds to a thickness of the central portion 3360. Similarly, the shape of the central portion may substantially approximate the shape of the cushion as described above. The resulting assembly may have a substantially uniform surface. This assists in maintaining a low profile look of the patient interface 3000, because the frame 3350 is not projecting in front of the cushion where it may obstruct the patient's line of sight.
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.
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.
While no vent structures are shown in
In one form the patient interface 3000 includes at least one decoupling structure 3500, for example, a swivel or a ball and socket. In some examples, the decoupling structure may be an elbow 3500 that is connected (e.g., removably connected, permanently connected, etc.) to the plenum chamber 3200 (e.g., a plenum chamber inlet port).
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While not explicitly shown in the drawings of the plenum chamber shown in
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In some forms, the posterior surface 3508 has a larger diameter than the anterior surface 3512 (although these may be reversed). In some forms, the diameter of the posterior surface 3508 may be between approximately 1 mm and approximately 100 mm. In some forms, the diameter of the posterior surface 3508 may be between approximately 10 mm and approximately 75 mm. In some forms, the diameter of the posterior surface 3508 may be between approximately 20 mm and approximately 50 mm. In some forms, the diameter of the posterior surface 3508 may be between approximately 30 mm and approximately 40 mm. In some forms, the diameter of the posterior surface 3508 may be approximately 39 mm.
In some forms, the ring body 3516 may extend in an inclined manner between the posterior surface 3508 and the anterior surface 3512. For example, the diameter of ring body 3516 may be greater proximate to the anterior surface 3512 than proximate the posterior surface 3508 (or vice versa). In some forms, the angle between the posterior surface 3508 and the ring body 3516 may be approximately the same as the inclination of the lip 3608. This may allow the vent ring 3504 to engage the lip 3608 in a sealing configuration.
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In some examples, the diameter of the posterior surface 3508 may extend proximate to or adjacent to the inner surface of the plenum chamber 3200 within the cavity 3272. For example, the diameter of the posterior surface 3508 may substantially match the profile of the plenum chamber 3200. The close proximity between the posterior surface 3508 and the wall of the plenum chamber 3200, or may create two simultaneous areas of contact (i.e., the lip 3608 and the wall of the plenum chamber 3200). The multiple areas of contact may increase the total retention force of the vent ring 3504, thus making accidental removal more difficult.
In some forms, the combination of the vent ring 3504 and the lip 3608 may create a retention force between approximately 1 N and approximately 50 N. In some forms, the combination of the vent ring 3504 and the lip 3608 may create a retention force between approximately 20 N and approximately 45 N. In some forms, the combination of the vent ring 3504 and the lip 3608 may create a retention force between approximately 25 N and approximately 40 N. In some forms, the combination of the vent ring 3504 and the lip 3608 may create a retention force between approximately 30 N and approximately 35 N. In some forms, the combination of the vent ring 3504 and the lip 3608 may create a retention force of approximately 33 N. In some forms, the combination of the vent ring 3504 and the lip 3608 may create a retention force greater than approximately 20 N. The greater retention forces may limit accidental disengagement of vent ring 3504 during use (and maintain the flow of pressurized breathable gas to the patient).
In some forms, the vent ring 3504 may include openings or vent holes 3520, which may allow air (e.g., exhaled carbon dioxide) to exit the cavity 3272 of the plenum chamber 3200. In some forms, there may be at least two vent holes 3520. In other forms, there may be four or five vent holes 3520. As shown in
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In some forms, a ring seal 3536 may be positioned within the groove 3532. The ring seal 3536 may extend around an outer surface of the inner wall 3524 of the ring body 3516. In certain forms, the ring seal 3536 may not completely fill the groove 3532, and may leave space for air to escape the plenum chamber 3200 and exit to the ambient through the vent holes 3520.
In certain forms, a washer 3540 may be positioned in the groove 3532 and may contact the ring seal 3536. The washer 3540 may include an outer diameter greater than or equal to the outer diameter of the ring seal 3536 in order to obscure the ring seal 3536 from view (e.g., from a bed partner). The washer 3540 may appear visually similar (e.g., color, texture, etc.) in order to provide an appearance that the anterior surface 3512 is substantially continuous between the inner and outer walls 3524, 3528.
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As described above, in some forms, the elbow 3500 may extend beyond the posterior surface 3508 when fully connected to the vent ring 3504 (e.g., the elbow 3500 contacts the posterior surface 3508 in order to form the snap-fit). In this position, the elbow may (slightly) extend into the distance 6076 (
In some forms, the force required to remove the elbow 3500 from the vent ring 3504 may be less than the force required to remove the vent ring 3504 from the inlet port 3604. Said another way, the elbow 3500 may be easier to remove than the vent ring 3504. However, the force require to disconnect the elbow 3500 may be large enough in order to limit accidental disengagement.
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The offset 3506 may cause the elbow 3500 to extend further from the posterior surface 3508 when connected to the vent ring 3504. In the illustrated example, an extension 3507 may further extend from the anterior surface 3512 and further space the elbow from the posterior surface 3508. With or without the extension 3507, the offset 3506 may limit the elbow from extending closer to the patient's lips than the posterior surface 3508. This may keep the distance 6076 as the largest distance anterior to the patient's lips, and limit feeling of uncomfortableness while wearing the patient interface 3000.
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In some forms, the elbow 3550 may include an outer lip 3552 and an inner lip 3554. In the illustrated example, the outer lip 3552 extends substantially around the perimeter of the elbow 3550. The inner lip 3554 may be spaced apart from the outer lip 3552 and may extend around only a portion of the perimeter of the elbow 3550.
In some forms, the elbow 3550 may include at least one button 3556 that is selectively engagable by the patient. The illustrated example includes a pair of buttons 3556 spaced approximately 1800 that can be simultaneously engaged by the patient (e.g., using their thumb and index finger).
In some forms, the buttons 3556 may be formed as a cantilever structure. For example, the buttons 3556 may be fixed proximate to a first end 3558 of the elbow (e.g., the end proximate to the plenum chamber 3200). The elbow 3550 may also include a channel 3560 that extends substantially around the perimeter of each respective button 3556. Each channel 3560 may create a free end of each button 3556 opposite of the fixed end.
In certain forms, the outer lip 3552 may intersect each button 3556 along the perimeter of the elbow 3550. The channels 3560 may create discontinuities so that the outer lip 3552 does not extend continuously around the perimeter of the elbow 3550.
In certain forms, the inner lip 3554 may be disposed only on the button 3556. For example, the inner lip 3554 may include two segments, each spaced approximately 1800 apart. Additionally, the length of each segment of the inner lip 3554 may be approximately the width of each button 3556 (e.g., the distance across the button 3556 between the channel 3560).
In some forms, the cantilever structure of each button 3556 may allow each button to flex or bend when the patient applies a force. For example, each channel 3560 may allow the free end of the button 3556 to move relative to the remainder of the elbow 3550. The free end of each button 3556 may be able to move toward a center of the elbow 3550 (i.e., toward the opposite button 3556) as a result of the patient's applied force. The buttons 3556 (or the elbow 3550 in general) may be constructed from a resilient material so that the buttons 3556 return to their original position after application of the force.
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In some forms, the central column 3564 may include a groove 3566, which may extend at least partially around the inner perimeter of the central column 3564. In the illustrated example, the groove 3566 may extend entirely around the central column 3564. In other examples, the groove 3566 may extend around only a portion of the central column 3564, or a projection may replace the groove 3566. The projection may similarly extend around at least a portion of the inner perimeter (e.g., the entire inner perimeter) of the central column 3564.
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In the illustrated example, the button 3572 may form a portion of the outer surface of the elbow 3568. For example, the shape of the button may substantially match the surrounding shape of the elbow 3568. This means that the button 3572 may be curved in order to substantially match the shape of the elbow 3568. When the button 3572 is in a relaxed position, the curvature of the button 3572 may be substantially aligned with the curvature of the elbow 3568. However, when the patient applies the external force to the button 3572, the button 3572 moves inwardly and the curvature of the button 3572 is moved out of alignment with the curvature of the elbow 3568.
Unlike the button 3556, the button 3572 may not include a lip. Instead, the button 3572 may include a finger 3574. The finger 3574 may be hook shaped and may be connected proximate to the fixed end of the button 3572. In the illustrated example, the finger 3574 may extend past the fixed end of the button 3572 and away from the free end. For example, the button 3572 may be cantilevered relative to a first end 3558, and the finger 3574 may be cantilevered relative to the button 3572. The first end 3558 may therefore be a fulcrum point disposed between the button 3572 and the finger 3574.
In some forms, each button 3572 may include a finger 3574 spaced part on opposite sides of the elbow 3568 (e.g., about 1800 apart). The fingers 3574 may be wider than the remainder of the button 3572, and may be spaced apart by a first distance. In other words, the fingers 3574 may not form a portion of the perimeter of the surface of the elbow 3568. When actuating the buttons 3572, the patient pushes the free ends of the buttons 3572 toward one another. When this occurs, the fingers 3574 move further apart from one another (i.e., spaced apart by a second distance).
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In some forms, an arm 3581 may extend from the surface of the elbow 3576 (e.g., perpendicularly) in order to connect the button 3578 and the finger 3580 to the surface of the elbow 3576. The arm 3581 is disposed between the finger 3580 and the button 3578 (e.g., halfway) and forms a pivot point or fulcrum. Engaging the button 3578 in order to move the finger 3580 causes pivoting movement about the arm 3581.
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As illustrated in
In some forms, the central column 3584 may include a lip 3586, which may extend at least partially around the outer perimeter of the central column 3584. In the illustrated example, the lip 3586 may extend entirely around the central column 3584. In other examples, the lip 3586 may extend around only a portion of the central column 3584, or a groove may replace the lip 3586. The groove may similarly extend around at least a portion of the outer perimeter (e.g., the entire outer perimeter) of the central column 3584.
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In some forms, either example of the elbow 3568, 3576 may be unable to translate while connected to the vent ring 3582. For example, a washer 3540 may be spaced apart from the lip 3586 so that the respective fingers 3574, 3580 can fit there between. The space may be just large enough for the respective finger 3574, 3580 such that the fingers 3574, 3580 cannot move while in between the lip 3586 and the washer 3540. Limiting transition of the elbow 3568, 3576 may limit disturbances in flow or irritations to the patient that could be caused by the translational movement of the elbow 3568, 3576 during use.
In certain forms, the washer 3540 may be formed as an integral piece of the central column 3584 and may not be a separate piece that can be removed. In this example, the washer 3540 (or support surface) would still limit the translation of the elbow 3568, 3576 while connected to the vent ring 3582.
As shown in
As shown in
With continued reference to
In some forms, an arm 3591 may extend from the surface of the elbow 3588 (e.g., perpendicularly) in order to connect the button 3590 and the finger 3592 to the surface of the elbow 3588. The arm 3591 is disposed between the finger 3592 and the button 3590 (e.g., halfway) and forms a pivot point or fulcrum. Engaging the button 3590 in order to move the finger 3592 causes pivoting movement about the arm 3591.
In certain forms, the arm 3591 may include a curved shape, which may be an S shape. The curved shape of the arm 3591 may reduce stress points caused when engaging the button 3590.
As shown in
As illustrated in
In some forms, the central column 3596 may include a lip 3598, which may extend at least partially around the outer perimeter of the central column 3596. In the illustrated example, the lip 3598 may extend entirely around the central column 3596. In other examples, the lip 3598 may extend around only a portion of the central column 3596, or a groove may replace the lip 3598. The groove may similarly extend around at least a portion of the outer perimeter (e.g., the entire outer perimeter) of the central column 3596.
As shown in
In some forms, the elbow 3588 may be unable to translate while connected to the vent ring 3594. For example, a washer 3540 may be spaced apart from the lip 3598 so that the fingers 3592 can fit there between. The space may be just large enough for the finger 3592 such that the fingers 3592 cannot move while in between the lip 3598 and the washer 3540. Limiting transition of the elbow 3588 may limit disturbances in flow or irritations to the patient that could be caused by the translational movement of the elbow 3588 during use.
In certain forms, the washer 3540 may be formed as an integral piece of the central column 3596 and may not be a separate piece that can be removed. In this example, the washer 3540 (or support surface) would still limit the translation of the elbow 3588 while connected to the vent ring 3594.
In some forms, the elbow 3588 may be connected to the vent ring 3582 of
As shown in
Connection port 3600 allows for connection (e.g., a removable connection via a snap-fit, a permanent connection, etc.) to the air circuit 4170. The patient interface 3000 may include two connection ports 3600, one on either side of the plenum chamber 3200. Conduits may connect to the connection ports 3600 in order to convey pressurized breathable gas to the patient. In some forms, the conduits may be conduit headgear, and may contact the patient's head. The conduits may extend toward the crown of the patient's head, where the decoupling structure 3500 is located.
As described above, the inlet port 3604 of the plenum chamber 3200 may include a lip 3608 that extends into the cavity 3272 and assists in securing the vent ring 3504 and/or the elbow 3500 to the plenum chamber 3200. In the illustrated example, the vent ring 3504 may engage the lip 3608 with a snap-fit, or any other similar engagement technique.
In one form, the patient interface 3000 includes a forehead support 3700.
In one form, the patient interface 3000 includes an anti-asphyxia valve. For example, the elbow 3550 may include the anti-asphyxia valve 3800 that may be selectively closed as a result of the flow of pressurized air. When the flow of pressurized air stops, the patient may be able to breathe through the anti-asphyxia valve 3800.
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 supplementary 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 4300, 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 cm120, or at least 10 cm1120, 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.
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 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducers 4270, data communication interface 4280 and one or more output devices 4290. 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 or 3800.
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 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 when delivering respiratory pressure therapy. 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 may be under the control of the therapy device controller 4240.
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.
In one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144.
As mentioned above, in some forms of the present technology, the central controller may be configured to implement one or more algorithms expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory. The algorithms are generally grouped into groups referred to as modules.
In other forms of the present technology, some portion or all of the algorithms may be implemented by a controller of an external device such as the local external device or the remote external device. In such forms, data representing the input signals and/or intermediate algorithm outputs necessary for the portion of the algorithms to be executed at the external device may be communicated to the external device via the local external communication network or the remote external communication network. In such forms, the portion of the algorithms to be executed at the external device may be expressed as computer programs stored in a non-transitory computer readable storage medium accessible to the controller of the external device. Such programs configure the controller of the external device to execute the portion of the algorithms.
In such forms, the therapy parameters generated by the external device via the therapy engine module (if such forms part of the portion of the algorithms executed by the external device) may be communicated to the central controller to be passed to the therapy control module.
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 4230. 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.
As shown in
In some forms, the quick-release connector 4176 may be a swivel cuff. For example, the quick-release connector 4176 of the air circuit 4170 may attach to a complementary connector 4178 (e.g., either of the RPT device 4000 or of an intermediate conduit). The quick-release connector 4176 and the complementary connector 4178 may each be rotatable relative to one another. This may allow for increased movement between the RPT device 4000 and the patient interface 3000, and may allow the patient to move while asleep without disturbing the connection between the air circuit 4170 and the RPT device 4000.
In certain forms, connection between the quick-release connector 4176 and the complementary connector 4178 may be formed with a rotational snap. For example, the complementary connector 4178 may receive the quick-release connector 4176 (or vice versa), and a locking mechanism (not shown) may rotate in order to lock the two pieces together. The locking mechanism may rotate (e.g., in the clockwise direction) with a quarter turn (or a half turn, a full turn, etc.) in order to form the locking connection, and may be released with a quarter turn in the opposite rotational direction (e.g., the counter clockwise direction). Rotation of the locking mechanism to facilitate the connection between the quick-release connector 4176 and the complementary connector 4178 may not affect the relative rotation between the two connectors 4176, 4178. Rotation in the disengagement direction (e.g., the counter clockwise direction) may push the complementary connector 4178 away from the quick-release connector 4176 in order to facilitate rapid disengagement.
In certain forms, the connection between the quick-release connector 4176 and the complementary connector 4178 may be formed with catches (not shown). In other examples, this may be reversed. For example, the quick-release connector 4176 may include movable latches that are receivable within the complementary connector 4178. The movable latches may be biased toward a locked position in order to secure the two connectors 4176, 4178 together. Once secured, the movable latches may be able to move (e.g., slide) around the perimeter of the complementary connector 4178 so that the connectors 4176, 4178 are still rotatable relative to one another. To disconnect the air circuit 4170 from the RPT device 4000, the patient may engage a button 4179 on the quick-release connector 4176, which may move the latches into an unlocked position and allow the air circuit 4170 to freely translate and disengage from the complementary connector 4178. In some forms, the quick-release connector 4176 may be detachable from the complementary connector 4178 with one hand. For example, the patient may be able to disconnect the quick-release connector 4176 and the complementary connector 4178 using only his thumb and index finger. This may allow a patient to more easily disconnect the quick-release connector 4176 and the complementary connector 4178.
As shown in
In one form of the present technology, supplementary gas, e.g. 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
As shown in
In some forms, the passive humidification may occur solely through the shape and/or geometry of a plenum chamber, vent ring, conduit, and/or elbow. In other words, the shape and/or size of the structures alone may influence the airflow so that humidity within a cavity of the plenum chamber may be greater than the surrounding environment. A heat and moisture exchanger (HME) may not be needed to achieve the passive humidification.
In certain forms, an HME and/or a humidifier 5000 may be used with the passive humidification described below in order to allow for more humid environments within the cavity.
As shown in
In other forms, the extension 5316 may be connected to the plenum chamber 3200 as part of the connection port 3600 (e.g., the extension 5316 may be permanently connected to the plenum chamber 3200). The vent ring 5304 may be removably connected to the extension 5316 (e.g., in the same manner that the vent ring 3504 is connected to the connection port 3600 described above).
In some forms, the distance 5312 may be between approximately 1 mm and approximately 50 mm. In some forms, the distance 5312 may be between approximately 5 mm and approximately 30 mm. In some forms, the distance 5312 may be between approximately 15 mm and approximately 25 mm. In some forms, the distance 5312 may be approximately 20 mm. The distance may be optimized in order to balance an increase in humidity (i.e., maximize) with an increase of carbon dioxide (i.e., minimize).
In use, the flow of pressurized breathable gas is delivered to the patient through the elbow 5300 and the extension 5316. This air may be actively humidified (e.g., using a humidifier 5000) or may have the humidity of the ambient air. The patient inhales this breathable air and exhales a mixture of gas (e.g., carbon dioxide) and water vapor. As described above, this air is allowed to escape through the vent holes 5308 so that the plenum chamber 3200 can be replenished with the pressurized breathable gas and so that the patient is not inhaling exhaled gases. However, the escaping gas carries the water vapor into the ambient environment. Particularly when the patient is not using a humidifier, the loss of water vapor during a period of use (e.g., one night) can lead the patient to wake up with dry mouth and feel uncomfortable (e.g., which may discourage future use). By spacing the vent holes 5308 further from the connection port 3600 (and therefore further from the patient's nose or mouth) the exhaled air has further to travel in order to vent to ambient. This impedance may make it more difficult for the air and the water vapor to escape, which may retain more moisture (e.g., from the exhaled water vapor) in the plenum chamber 3200. During the course of a use, the patient's mouth may therefore be less likely to dry out. By spacing the vent holes 5308 apart by a distance 5312, a sufficient amount of exhaled gas may still be able to escape the plenum chamber 3200 (e.g., so that the patient is not breathing recycled air) but enough water vapor may remain to help passively humidify the flow of pressurized breathable gas.
In certain forms, the vent holes 5308 are not blocked or otherwise obstructed by a physical barrier that redirects or prevents fluid flow through the vent holes 5308. Instead, the impedance may be generated by the distance 5312, which causes the exhaled air to travel further while flowing against the oppositely directed pressurized flow of air.
In certain forms, and HME may be placed within the extension 5316 in order to further increase the humidity that may be retained within the plenum chamber 3200. The HME may further increase the impedance for the exhaled air to exit the patient interface and is designed to trap at least some exhaled water vapor so that the flow of pressurized air picks up and allows the patient to re-inhale the water. The material of the HME may be designed so that CO2 accumulation within the plenum chamber 3200 does not substantially increase.
As shown in
As shown in
In some forms, the mount 5324 may be connected to the posterior surface 5328 radially inside of the vent openings 5332 and may not substantially occlude the holes of the vent openings 5332.
As shown in
In some forms, the perimeter of the opening for the inner wall 3524 may be larger than the mount 5324. For example, there may be space radially outside the mount 5324. This may allow fluid flow between perimeter of the inner wall 3524 and the mount 5324.
In some forms, the posterior surface 5328 may abut the mount 5324. For example, there may be substantially no space between the posterior surface 5328 and the mount 5324 for fluid flow. Instead, the space 5340 may include an opening 5342 that may communicate with the opening of the inner wall 3524. For example, there may be an air path through the vent ring 5304 by way of the space 5340.
In some forms, the posterior surface 5328 may be ring shaped and an inner perimeter of the posterior surface 5328 may be spaced apart from the mount 5324. For example, there may be space radially outside the mount 5324 and inside of an inner perimeter of the posterior surface 5328. This may allow fluid flow between perimeter of the posterior surface 5328 and the mount 5324. In some forms, the mount 5324 may not include the opening 5342.
As shown in
In some forms, different shaped disks 5344 may be used in order to retain different amounts of moisture within the plenum chamber 3200. For example, the disk 5344 with a smaller radius of curvature may extend closer to a patient's nose and/or mouth than a disk 5344 with a larger radius of curvature. In other words, if both the smaller curvature and larger curvature disks 5344 include the same end-to-end distance (e.g., equal to or exceeding the diameter between the vent openings 5332), an edge of the smaller curvature disk 5344 will extend closer to the patient's face. This may cause more exhaled air to be redirected (i.e., increase the impedance) so that more water vapor is retained within the plenum chamber 3200.
In certain forms, a smaller radius of curvature may assist the flow of pressurized breathable gas in flowing around the disk 5344 because the smaller radius of curvature directs more airflow around the disk 5344 and not back toward the elbow 5300.
In certain forms, the larger radius of curvature may be more comfortable for a patient because the disk 5344 is spaced further from the patient's face. For example, the patient may desire a maximized second distance 6076 (see e.g.,
In other forms, the disk 5344 may have substantially no curvature and may be substantially planar with respect to the patient. For example, the disk 5344 may be substantially parallel to the posterior surface 5328.
In some forms, the disk 5344 may be constructed from an air impermeable material and may act as a barrier to increase the impedance for exhaled to reach the vent openings 5332. The disk 5344 may block or obstruct direct (e.g., straight line) flow paths between the patient's airways (e.g., nose or mouth) and the vent openings 5332.
In some forms, the disk 5344 may be constructed from a semi-permeable material that may allow some airflow to pass through. For example, the disk 5344 may include an HME (or may be constructed from HME material) so that some exhaled air may pass through the disk 5344 but water vapor may be trapped. Alternatively, the disk 5344 may be constructed from another semi-permeable material that does not retain moisture but still increases the impedance of the airflow exiting the plenum chamber 3200. Because the disk 5344 may be semi-permeable, some exhale air may still be directed back toward the patient (and not exhaust through the vent openings 5332).
As described above, patients lose moisture as they exhale and may experience an uncomfortable dry mouth as a result of losing too much moisture (especially if the patient interface 3000 is used without a humidifier 5000). Like the vent ring 5304, the vent ring 5320 works to retain moisture that the patient exhales within the plenum chamber in order to reduce the occurrence of dry mouth.
As shown in
Exhaled air may still be able to pass around the disk 5344 in order to exhaust out through the vent openings 5332. However, the disk 5344 may make this harder (i.e., increase an impedance) and may cause more exhausted air to remain in the plenum chamber 3200 than if the disk 5344 was not present. As described above, the radius of curvature of the disk 5344 may influence an impedance of the exhausted air 1600 leaving the plenum chamber 3200 (e.g., smaller radius of curvature creates more impedance). The disk 5344 acts similar to the distance 5312 described above in that the disk 5344 prevents some water vapor from leaving the plenum chamber 3200 by directing exhaled air back into the plenum chamber 3200. Exhaled air 1600 that is not redirected toward the patient's mouth has a further distance to travel to reach the vent openings 5332 (e.g., as compared to
As shown in
As shown in
In use, vent openings 5356 may operate like the previously described vent openings and allow exhaled air to escape the plenum chamber 3200. In this example, creating fewer vent openings 5356 reduces the flow rate of exhaust gas venting from the plenum chamber 3200. Because less gas can vent through the vent openings 5356 as a whole, more exhaust gas, and therefore more water vapor, remains in the plenum chamber 3200, which can help limit the patient's mouth from drying out.
Because less venting occurs in the plenum chamber 3200, venting may need to occur elsewhere so that the system does not become over pressurized. The vent openings 5360 of the connector 5364 may allow pressurized gas to vent to ambient prior to reaching the patient. While the pressure reaching the patient may be slightly less, more air remains in the plenum chamber 3200 so the net pressure is substantially the same (e.g., as with the vent ring 3504).
In some forms, any combination of the examples described above may be used in combination with one another. For example, a vent ring could include a fewer number of vent openings could also include either a disk or be spaced apart a distance from the connection port. Including any two (or all three) of these features together may increase the amount of water vapor that is retained within the plenum chamber 3200 that the patient may inhale on their next breath in order to help limit their mouth from drying out.
Various respiratory therapy modes may be implemented by the disclosed respiratory therapy system including CPAP therapy and bi-level therapy.
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. Device flow rate, Qd, is the flow rate of air leaving the RPT device. Total flow rate, Qt, is the flow rate of air and any supplementary gas reaching the patient interface via the air circuit. 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.
Flow therapy: Respiratory therapy comprising the delivery of a flow of air to an entrance to the airways at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient's breathing cycle.
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 (1 hectopascal=100 Pa=100 N/m2=1 millibar˜0.001 atm). 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 interface 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. The inverse of stiffness is flexibility.
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.
Breathing rate: The rate of spontaneous respiration of a patient, usually measured in breaths per minute.
Duty cycle: The ratio of inhalation time, Ti to total breath time, Ttot.
Effort (breathing): The work done by a spontaneously breathing person attempting to breathe.
Expiratory portion of a breathing cycle: The period from the start of expiratory flow to the start of inspiratory flow.
Flow limitation: Flow limitation will be taken to be the state of affairs in a patient's respiration where an increase in effort by the patient does not give rise to a corresponding increase in flow. Where flow limitation occurs during an inspiratory portion of the breathing cycle it may be described as inspiratory flow limitation. Where flow limitation occurs during an expiratory portion of the breathing cycle it may be described as expiratory flow limitation.
Types of flow limited inspiratory waveforms:
Hypopnea: According to some definitions, a hypopnea is taken to be a reduction in flow, but not a cessation of flow. In one form, a hypopnea may be said to have occurred when there is a reduction in flow below a threshold rate for a duration. A central hypopnea will be said to have occurred when a hypopnea is detected that is due to a reduction in breathing effort. In one form in adults, either of the following may be regarded as being hypopneas:
Hyperpnea: An increase in flow to a level higher than normal.
Inspiratory portion of a breathing cycle: The period from the start of inspiratory flow to the start of expiratory flow will be taken to be the inspiratory portion of a breathing cycle.
Patency (airway): The degree of the airway being open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example with a value of one (1) being patent, and a value of zero (0), being closed (obstructed).
Positive End-Expiratory Pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.
Peakflow rate (Qpeak): The maximum value of flow rate during the inspiratory portion of the respiratory flow waveform.
Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory flow rate, as opposed to “true respiratory flow rate” or “true respiratory flow rate”, which is the actual respiratory flow rate experienced by the patient, usually expressed in litres per minute.
Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing, when extra effort is not applied. In principle the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), and therefore a single tidal volume Vt may be defined as equal to either quantity. In practice the tidal volume Vt is estimated as some combination, e.g. the mean, of the inspiratory volume Vi and the expiratory volume Ve.
(inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow rate waveform.
(exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow rate waveform.
(total) Time (Ttot): The total duration between the start of one inspiratory portion of a respiratory flow rate waveform and the start of the following inspiratory portion of the respiratory flow rate waveform.
Typical recent ventilation: The value of ventilation around which recent values of ventilation Vent over some predetermined timescale tend to cluster, that is, a measure of the central tendency of the recent values of ventilation.
Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, in which the flow rate increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behaviour).
Ventilation (Vent): A measure of a rate of gas being exchanged by the patient's respiratory system. Measures of ventilation may include one or both of inspiratory and expiratory flow, per unit time. When expressed as a volume per minute, this quantity is often referred to as “minute ventilation”. Minute ventilation is sometimes given simply as a volume, understood to be the volume per minute.
Adaptive Servo-Ventilator (ASV): A servo-ventilator that has a changeable, rather than fixed target ventilation. The changeable target ventilation may be learned from some characteristic of the patient, for example, a respiratory characteristic of the patient.
Backup rate: A parameter of a ventilator that establishes the minimum breathing rate (typically in number of breaths per minute) that the ventilator will deliver to the patient, if not triggered by spontaneous respiratory effort.
Cycled: The termination of a ventilator's inspiratory phase. When a ventilator delivers a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering the breath.
Expiratory positive airway pressure (EPAP): a base pressure, to which a pressure varying within the breath is added to produce the desired interface pressure which the ventilator will attempt to achieve at a given time.
End expiratory pressure (EEP): Desired interface pressure which the ventilator will attempt to achieve at the end of the expiratory portion of the breath. If the pressure waveform template II((D) is zero-valued at the end of expiration, i.e. Π(Φ)=0 when Φ=1, the EEP is equal to the EPAP.
Inspiratory positive airway pressure (IPAP): Maximum desired interface pressure which the ventilator will attempt to achieve during the inspiratory portion of the breath.
Pressure support: A number that is indicative of the increase in pressure during ventilator inspiration over that during ventilator expiration, and generally means the difference in pressure between the maximum value during inspiration and the base pressure (e.g., PS=IPAP−EPAP). In some contexts pressure support means the difference which the ventilator aims to achieve, rather than what it actually achieves.
Servo-ventilator: A ventilator that measures patient ventilation, has a target ventilation, and which adjusts the level of pressure support to bring the patient ventilation towards the target ventilation.
Spontaneous/Timed (SIT): A mode of a ventilator or other device that attempts to detect the initiation of a breath of a spontaneously breathing patient. If however, the device is unable to detect a breath within a predetermined period of time, the device will automatically initiate delivery of the breath.
Swing: Equivalent term to pressure support.
Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be triggered to do so at the initiation of the respiratory portion of the breathing cycle by the patient's efforts.
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) Bonyframework: 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) Cartilaginousframework: 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.
Lip, lower (labrale inferius): A point on the face between the mouth and supramenton, lying in the median sagittal plane.
Lip, upper (labrale superius): A point on the face between the mouth and nose, lying in the median sagittal plane.
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-labialfold: 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 squamafrontalis, 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, theforamen 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 some bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms a shell or portions of a shell, may not be rigid. 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 fromf(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 |
|---|---|---|---|
| 10202102386Q | Mar 2021 | SG | national |
| 10202105065S | May 2021 | SG | national |
This application claims the benefit of S.G. Provisional Patent Application No. 10202105065S, filed May 14, 2021, and S.G. Provisional Patent Application No. 10202102386Q, filed Mar. 9, 2021, each of which is incorporated herein by reference in its entirety. International Application No. PCT/AU2020/050953, filed Sep. 9, 2020, which claims priority to U.S. Provisional Patent Application No. 63/058,001, filed Jul. 29, 2020, are each incorporated herein by reference in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/SG2022/050119 | 3/9/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63058001 | Jul 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/AU20/50953 | Sep 2020 | US |
| Child | 18549574 | US |
