CN117794601A - Patient interface with adhesive surface - Google Patents

Abstract

A patient interface including a seal-forming structure having one or more adhesive surfaces is provided. The seal-forming structure is configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. The patient interface may also include a plenum chamber, which may be addedIs pressed to at least 6cmH above the ambient air pressure ₂ Therapeutic pressure of O. A flow of breathable gas at therapeutic pressure is provided through the air circuit. The seal-forming structure may be configured to adhere to a downwardly facing surface of the patient's nose, such as a flange region. In certain forms, the patient interface includes a decoupling structure configured to at least partially decouple the seal-forming structure from the air circuit.

Description

Patient interface with adhesive surface

Technical Field

The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof. The present technology relates specifically to seal-forming structures for patient interfaces that form a seal with the airway of a patient via an adhesive surface.

Background

Human respiratory system and disorders thereof

The respiratory system of the body promotes gas exchange. The nose and mouth form the entrance to the airway of the patient.

The airway includes a series of branches that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from inhaled air into venous blood and carbon dioxide to move in the opposite direction. The trachea is divided into right and left main bronchi, which eventually further divide into peripheral bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lung is where gas exchange occurs and is referred to as the respiratory region. See respiratory physiology (Respiratory Physiology), 9 th edition published by John b.west, lippincott Williams & Wilkins in 2012.

There are a range of respiratory disorders. Certain disorders may be characterized by specific events such as apneas, hypopneas, and hyperbreaths.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), tidal breathing (CSR), respiratory insufficiency, obese Hyperventilation Syndrome (OHS), chronic Obstructive Pulmonary Disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

A range of therapies have been used to treat or ameliorate such disorders. In addition, other healthy individuals may utilize such therapies to prevent the occurrence of respiratory disorders. However, these therapies have a number of drawbacks.

One of the major problems in respiratory therapy is adherence, which is also known as compliance. Typically, as part of respiratory therapy, the patient may be required to wear the patient interface for an extended period of time. Cumbersome and/or obtrusive patient interfaces often cause the patient to interrupt respiratory therapy due to discomfort, inconvenience, or disturbance to sleep. In particular, it is difficult to ensure that infants and children do not remove the patient interface during respiratory therapy.

Therapy method

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 respiratory disorders described above.

Respiratory pressure therapy

Respiratory pressure therapy is the application of air supplied to the entrance of the airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the respiratory cycle of a patient (as opposed to negative pressure therapy such as a canister or chest-shell ventilator).

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 thus, if the patient finds that the means for providing such therapy is present in one or more of the following conditions, they may choose a non-compliant therapy: uncomfortable, difficult to use, expensive, and aesthetically undesirable.

Non-invasive ventilation (NIV) provides ventilation support to a patient through the upper airway to assist the patient in breathing and/or to maintain proper oxygen levels within the body by accomplishing some or all of the respiratory effort. Ventilation 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 ventilation support for patients that are no longer able to breathe spontaneously effectively, and may be provided using tracheostomy tubes or endotracheal tubes. In some forms, the comfort and effectiveness of these therapies may be improved.

Respiratory therapy system

These respiratory therapies may be provided by a respiratory therapy system or apparatus. Such systems and devices may also be used to screen, diagnose, or monitor conditions without treatment thereof.

The respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

Patient interface

The patient interface may be used to engage the respiratory equipment to its wearer, for example by providing an air flow to the airway inlet. The air flow may be provided to the nose and/or mouth of the patient, through a tube to the mouth or through an aero-cut tube into the patient's trachea. Depending on the therapy to be applied, the patient interface may form a seal with an area, such as the patient's face, to facilitate a pressure that is sufficiently different from ambient pressure (e.g., about 10cmH relative to ambient pressure ₂ Positive pressure of O) to deliver the gas to effect the therapy.

Typically, the mask system is used as a patient interface to deliver a flow of air. These mask systems typically include a plenum chamber that protects the patient's face through a headgear. The plenum chamber encloses a volume of space with the patient's face and protrudes from the patient's face to accommodate facial features of the patient, such as their nose and/or mouth. In general, the plenum may be made of a rigid material. These aspects of the design of some conventional patient interfaces can make the patient inconvenient, uncomfortable to sleep and may claustrophobic when wearing the patient interface.

Mask systems other than those commonly used for respiratory therapy may not be functionally suitable in the art. For example, a purely decorative mask may not be able to maintain proper pressure. Mask systems for underwater swimming or diving may be configured to prevent ingress of water from the outside at higher pressures, but not to maintain the internal air at a pressure above ambient.

Certain masks may be clinically disadvantageous to the present technology, for example, where they block airflow through the nose and only allow airflow through the mouth.

If some masks require a patient to insert a portion of the mask structure into their mouth to form and maintain a seal via their lips, these masks may be uncomfortable or impractical for the present technology.

Some masks may not be suitable for use while sleeping, for example, while sleeping on the head on a bed on its side.

The design of patient interfaces presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from individual to individual. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may be moved relative to the other bones of the skull. The entire head may be moved during respiratory therapy.

Because of these challenges, some masks present one or more problems of being obtrusive, unsightly, expensive, non-conforming, difficult to use, and uncomfortable, especially when worn for extended periods of time or when the patient is unfamiliar with the system. Wrong-sized masks may result in reduced compliance, reduced comfort, and poorer patient prognosis. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetic agents are acceptable for their original application, but such masks may be uncomfortable to wear for extended periods of time (e.g., hours). As previously mentioned, such discomfort may lead to reduced patient compliance with the therapy. This is especially the case if the mask is worn during sleep.

CPAP therapy is very effective in treating certain respiratory disorders, provided that the patient is compliant with the therapy. If the mask is uncomfortable or difficult to use, the patient may not be in compliance with the therapy.

Patients are often advised to regularly clean their masks, if they need to clean the masks, or if the masks are difficult to clean (e.g., difficult to assemble or disassemble), the patients may not be able to clean their masks, and this may affect patient compliance.

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

For these reasons, patient interfaces for delivering CPAP during sleep form a unique field.

Seal forming structure

The patient interface may include a seal-forming structure. Because the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

The patient interface may be characterized in part by the design intent of where the seal-forming structure engages the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left naris and a second sub-portion that forms a seal around the right naris. In one form of the patient interface, the seal-forming structure may comprise a single element which in use encloses both nostrils. Such a single element may be designed to cover, for example, the upper lip region and the nasal bridge region of the face. These different types of patient interfaces may be variously named by their manufacturers, including nasal cushions, nasal pillows, and nasal puffs.

In one form of patient interface, the seal-forming structure may comprise an element that in use surrounds the mouth region, for example by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure may comprise a single element which in use encloses both nostrils and mouth regions. These patient interfaces may be referred to in the art as mouthpads, mouth-nose pads, or full face pads.

For example, seal-forming structures that may be effective in one region of a patient's face may not be suitable in another region due to the different shapes, structures, variability, and sensitive regions of the patient's face. For example, a seal on swimming goggles covering the forehead of a patient may not be suitable for use over the nose of a patient.

Some seal-forming structures may be designed for mass production so that one design can fit and be comfortably and effectively used for a variety of different facial shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be accommodated to form a seal.

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 a force is applied to the patient interface, with the seal-forming structure engaging the face-facing of the patient. The seal-forming structure may comprise an air or fluid filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inadequate, there will be a gap 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 the seal.

Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery of the mask to provide self-sealing against the patient's face when positive pressure is applied within the mask. Similar to the seal-forming portions of the previous versions, additional force may be required to effect the seal if there is poor fit between the face and the mask, otherwise the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may buckle or flex during use, thereby causing leakage.

Another type of seal-forming structure may include friction-fit elements, for example, for insertion into nostrils, however some patients find these elements uncomfortable.

Another form of seal-forming structure may use an adhesive to effect the seal. For typical therapeutic pressures (e.g., up to 20cmH ₂ O), the seal formed by the adhesive is generally efficient with little or no leakage.

Periodic application and removal of adhesive-based seal-forming structures may result in skin trauma or irritation. In addition, conventional adhesive-based seal-forming structures require cleaning of the area of skin to which the seal-forming structure will adhere prior to attachment of the seal-forming structure. Repeated cleansing (which may include alcohol wiping) may result in skin damage.

Furthermore, securing the adhesive-based seal-forming structure in or around the nose region may result in reduced adhesion due to moisture from the patient's breath. In other areas of the face, the skin may also release moisture, which may loosen adhesion, resulting in leakage, which may lead to ineffective respiratory therapy. In addition, leakage may result in unnecessary loss of oxygen when the patient is subjected to oxygen therapy. Such oxygen leakage may be particularly disadvantageous in developed countries where medical oxygen is a scarce and expensive resource.

The adhesive-based seal-forming structure may also leave residue, odor, or color on the patient's skin, sometimes even after removal of the seal-forming structure.

A series of patient interface seal formation construction techniques are disclosed in the following patent applications assigned to rismel limited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in Adam circuit (AdamCicircuit) manufactured by Tascow, puritan Bennett. Another nasal pillow or nose puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al) assigned to Tascoot corporation (Puritan-Bennett Corporation).

The following products in combination with nasal pillows have been manufactured by rismai limited: SWIFT ^TM Nasal pillow cover, SWIFT ^TM II nasal pillows mask, SWIFT ^TM LT nasal pillow cover, SWIFT ^TM FX nasal pillows mask and MIRAGE LIBERTY ^TM A full face mask. The following patent applications assigned to rismel limited describe examples of nasal pillows masks: international patent application WO2004/073,778 (especially describing SWIFT from Russian Mich., ltd.) ^TM Various aspects of nasal pillows), U.S. patent application 2009/0044808 (particularly describing SWIFT from ruisimei limited) ^TM Various aspects of LT nasal pillows); international patent applications WO 2005/063,328 and WO 2006/130,903 (in particular describing MIRAGE LIBERTY, of Ruisha Mich., ltd.) ^TM Various aspects of the full face mask); international patent application WO 2009/052,560 (in particular describes SWIFT from Ruisimai Co., ltd.) ^TM Various aspects of FX nasal pillows).

Positioning and stabilization

The seal-forming structure of a patient interface for positive air pressure therapy is subject to a corresponding force of air pressure that breaks the seal. Thus, various techniques have been used to position the seal-forming structure and maintain it in sealing relation with the appropriate portion of the face.

One technique is to use an adhesive. See, for example, U.S. patent application publication No. US 2010/0000534. One advantage of using an adhesive to locate and stabilize the seal-forming structure on the patient's face is that it avoids the need for a headgear (discussed below), which may be uncomfortable, claustrophobic, and increase manufacturing costs and complexity. However, as previously mentioned, the use of adhesives known in the art has some drawbacks.

Another technique is to use one or more straps and/or stabilizing straps. Many such belts suffer from one or more of poor fit, bulkiness, discomfort, and inconvenience in use. They tend to be less airtight than adhesive-based seal-forming structures. Furthermore, straps and/or stabilizing straps tend to leave marks on the face when used overnight.

Pressurized air conduit

In one type of therapy system, a flow of pressurized air is provided to a patient interface through a conduit in an air circuit that is fluidly connected to the patient interface such that the conduit extends forward from the patient's face when the patient interface is positioned on the patient's face during use. This may sometimes be referred to as a "tube down" configuration.

Catheters connected to the anterior interface of the patient's face can sometimes become easily entangled with bedding.

Respiratory Pressure Therapy (RPT) device

Respiratory Pressure Therapy (RPT) devices may be used alone or as part of a system to deliver one or more of the above-described therapies, such as by operating the device to generate an air stream for delivery to an airway interface. The air flow may be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, the RPT device may also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

Air circuit

An air circuit is a conduit or tube constructed and arranged to allow air flow to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface, in use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single branched air circuit is used for inhalation and exhalation.

Humidifier

Delivering a non-humidified air flow may result in airway dryness. A humidifier with RPT device and patient interface is used to generate humidified gas to minimize dryness of nasal mucosa and increase patient airway comfort. In addition, in colder climates, warm air, which is typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

Vent technology

Some forms of treatment systems may include vents to allow for flushing of expired carbon dioxide. The vent may allow gas to flow from an interior space (e.g., plenum) of the patient interface to an exterior of the patient interface (e.g., to the ambient environment).

Disclosure of Invention

The present technology aims to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, which devices have one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to an apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

One aspect of certain forms of the present technology is a method and/or apparatus for providing improved patient compliance with respiratory therapy.

One aspect of one form of the present technology is a patient interface that includes a seal-forming structure configured to form a seal with an area of a patient's face surrounding an entrance to an airway of a patient.

Another aspect of one form of the present technique is a patient interface that includes a seal-forming structure having an opening such that a flow of breathable gas is delivered to at least an inlet of a nostril of a patient.

Another aspect of one form of the present technology is a patient interface that includes a seal-forming structure that further includes at least one adhesive surface configured to adhere, in use, to an area of a patient's face surrounding an entrance to an airway of a patient to form a seal.

One aspect of one form of the present technology is a patient interface that includes a plenum chamber that is pressurizable to at least 6cmH above ambient air pressure ₂ Therapeutic pressure of O, the plenum comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for respiration by a patient.

In one form of the present technique, the seal-forming structure is configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.

In one form, the seal-forming structure may include an opening through which breathable gas is delivered to the airway of the patient.

Another aspect of one form of the present technique is a patient interface having a peripheral shape that is complementary to the peripheral shape of the intended wearer.

In one form, the seal-forming structure is configured to have a perimeter shape that complements a patient's facial area surrounding the entrance to the patient's airway to form a seal.

The area to which the seal-forming structure will adhere may be referred to as the target seal area.

In one form, the seal-forming structure is configured such that the region of the patient's face includes a region of the patient's face adjacent the nostrils.

In one form, the seal-forming structure is configured such that the region of the patient's face includes a downwardly facing surface of the nose and an upper region of the upper lip. For example, the region may include a downwardly facing surface of the patient's nasal ala. For example, the region may include an uppermost region of the upper lip of the patient. In one form, the region of the patient's face may include a forward region of the nose immediately below the patient's nasal bump.

In one form, the seal-forming structure is configured such that the region of the patient's face includes a lateral region of the nasal ala, such as a lower region of the lateral region of the nasal ala.

In one form, the seal-forming structure is configured such that when the seal-forming structure is adhered to the patient's face, an uppermost portion of the seal-forming structure adheres to the patient's nasal alar fold.

In some forms, the seal-forming structure may be configured such that the region of the patient's face includes a region between the patient's nasal wings and the patient's nasolabial folds.

In some forms, the seal-forming structure is configured such that the shape of the at least one adhesive surface is substantially similar to an area of the patient's face.

One aspect of one form of the present technique is a patient interface that includes a seal-forming structure, which may be a substantially D-shaped band.

In one form, the D-shaped form may include one or more of a stem portion, two corner portions, two shoulder portions, and an apex portion. In one form, the corner portions may be located at either end of the stem portion. In another form, the shoulder portion may connect each corner portion to the apex portion. In one form, the seal-forming structure may have a reflective symmetry about an axis that lies in a sagittal plane of the patient and passes through the apex portion and the intermediate portion of the stem portion. In one form, the stem portion may be substantially straight. In another form, the stem portion may be arcuate radially inwardly to form a concave recess in its radially outer intermediate section and a convex protrusion in its radially inner intermediate section. In one form, the recess and the protrusion may be generally circular in shape. In one form, the corner portions may be generally triangular in shape and may each include an edge on a radially outer side of the seal-forming structure on the same side as the recess of the stem portion. In one form, the edge may be angled to create an obtuse angle between the angled edge and the recess of the stem portion. In one form, the apex portion may include a concave recess on a radially inner side thereof and a convex protrusion on a radially inner side thereof. The recess and the protrusion may be generally circular in shape. In one form, the apex portion is configured to adhere to an anterior region of the nose, the anterior region being below the nasal projection. In one form, the shoulder portion is configured to adhere to a lower region of the alar. In one form, the corner portion is configured to adhere to a region of a alar fold, including but not limited to, a alar fold and/or a laterally outer region of the alar and/or a cheek region adjacent the alar fold. In one form, the stem portion is configured to adhere to an upper region of the upper lip.

In one form, the seal-forming structure includes a recess in an edge of a region of the seal-forming structure, the recess being configured to adhere, in use, to a region of a patient's nose, the region being substantially below a nasal projection of the patient.

One aspect of one form of the present technology is a patient interface system that includes a plurality of seal-forming structures having a plurality of shapes and sizes.

In one form, the seal-forming structure is interchangeably connected to a plenum chamber of the patient interface. Any of a number of seal-forming structures can be used as part of the patient interface so that the patient can select a seal-forming structure that is shaped and sized to their needs. For example, the patient may select a seal-forming structure that has a shape that most corresponds to its facial features in the region of the patient's face to which the seal-forming structure is to be attached. In addition, the patient may also choose a seal-forming structure that provides maximum comfort.

A patient interface system for delivering breathable gas to a patient. The patient interface system may include a plenum chamber that may be pressurized to at least 6cmH above ambient air pressure ₂ Therapeutic pressure of O. The plenum may include a plenum inlet port configured to receive a flow of breathable gas at a therapeutic pressure for respiration by the patient. The patient interface system may also include a vent structure to allow continuous flow of exhaled gases from the patient from the interior of the plenum to the ambient environment. The vent structure may be configured to maintain a therapeutic pressure in the plenum in use. The patient interface system may further include a first seal-forming structure and a second seal-forming structure. The first seal-forming structure and the second seal-forming structure may be interchangeably connected to the plenum. The first seal-forming structure may have a different size and/or shape than the second seal-forming structure. Each of the first seal-forming structure and the second seal-forming structure may be configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. Each of the first seal-forming structure and the second seal-forming structure may have an opening therein such that the flow of breathable gas is delivered to at least an inlet of a nostril of the patient. Each of the first seal-forming structure and the second seal-forming structure may be configured to be integral to a patient in use The therapeutic pressure in the inflatable chamber is maintained during each breathing cycle. Each of the first seal-forming structure and the second seal-forming structure may comprise at least one adhesive surface configured to adhere to an area of the patient's face in use to form a seal.

In one form, the shapes of the seal-forming structures are configured such that at least one of the shapes is capable of fitting a majority of patients in a given patient population. This means that the patient interface can be configured to provide a good level of fit with only a discrete number of common shapes and sizes of seal-forming structures. Producing only a discrete number of seal-forming structures may provide cost efficiencies in manufacturing and supply.

In another form, a different number of seal-forming structures of different shapes and sizes may be provided. The greater the number of seal-forming structures provided, the more likely any individual patient will find a seal-forming structure that fits them very effectively.

In yet another alternative, the seal-forming structure may be customized to an individual patient. Customization may take into account facial features of the patient, particularly in and around the target seal area.

In one form, the shape and size of the seal-forming structure may be based on one or more principal components of the seal-forming structure, as determined by Principal Component Analysis (PCA) with respect to the shape and size of the nose region of different members of the population.

In one form, one of the primary components may be related to the size of the target sealing area. If the target seal area is the nose area, the size of the nose is relevant.

In another form, one of the principal components may be related to the degree of curvature of the target sealing region. If the target seal area is the nose area, the primary component relates to the degree of curvature of the nostrils.

In another form, one of the principal components may be related to the overall shape and/or proportion of facial features in the sealing region. If the target seal area is the nose area, the principal component is related to the shape and/or proportion of the nose, which may include the length and/or width of the nose.

In one form, the patient interface further comprises a connection port configured to connect, in use, to an air circuit and to convey the flow of breathable gas from the air circuit to the plenum chamber through the plenum chamber inlet port.

One aspect of one form of the present technology is a patient interface that includes a seal-forming structure that also includes at least one adhesive surface having areas of different adhesive strength magnitudes. In one form, the first region of the at least one adhesive surface may adhere to the patient's face with greater adhesive strength during use than the second region of the at least one adhesive surface.

In one form, the region of the seal-forming structure configured to seal with the sensitive region of the target seal region may have a lower adhesive strength magnitude. Sensitive areas may include, but are not limited to, areas that are more likely to experience skin trauma when the seal-forming structure is repeatedly applied and removed.

In another form, the regions of the seal-forming structure configured to seal with those regions of the target seal region that are difficult to seal may have a higher adhesive strength magnitude.

In another form, the region of the seal-forming structure configured to seal with the sensitive and difficult-to-seal region of the target seal region may have a balanced adhesive strength magnitude.

In one aspect, a patient interface is provided that includes a seal-forming structure having a thickness in a range of about 0.2mm to 0.3mm when the patient interface is worn by a patient.

In one aspect, a patient interface is provided that includes a seal-forming structure including an adhesive surface provided with an adhesive adapted to reapply the seal-forming structure to a patient's face at least once.

One aspect of one form of the present technique is a patient interface that further includes a decoupling structure configured to at least partially decouple the seal-forming structure from the air circuit.

One aspect of the present technology provides a patient interface for delivering breathable gas to a patient. The patient interface may include a plenum chamber that may be pressurized to a therapeutic pressure of at least 6cmH2O above ambient air pressure. The plenum may include a plenum inlet port configured to receive a flow of breathable gas at a therapeutic pressure for respiration by the patient. The patient interface may further include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may have an opening therein such that the flow of breathable gas is delivered to at least an inlet of the patient's nostrils. The seal-forming structure may be configured to maintain said therapeutic pressure in the plenum chamber throughout a patient's respiratory cycle in use. The seal-forming structure may include at least one adhesive surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal. The patient interface may further include a vent structure configured to allow continuous flow of gas exhaled by the patient from the internal ventilation of the plenum chamber to the ambient environment. The vent structure may be configured to maintain a therapeutic pressure in the plenum in use. The patient interface may also include a connection port configured to connect to an air circuit and transmit the flow of breathable gas from the air circuit to the plenum chamber through the plenum chamber inlet port in use. The patient interface may also include a decoupling structure configured to at least partially decouple the seal-forming structure from the air circuit.

In one form, the decoupling structure includes a deformable member configured to deform when an end of an air circuit connected to the connection port is tilted relative to the plenum.

The deformable member may isolate the patient interface from forces incident on the air circuit, particularly if the forces are greater than a predetermined magnitude. By isolating the patient interface from excessive forces, it is ensured that the seal-forming structure does not forcefully fall off the patient's face.

In one form, the deformable member is a plenum chamber.

In one form, the plenum may have one or more regions made of a flexible material such as, but not limited to, a thermoplastic elastomer (TPE) or silicone.

In one form, the patient interface includes a tube having a first end and a second end, wherein the first end is fluidly connected to the plenum chamber inlet port and the second end includes a connection port, and wherein the tube includes a deformable member.

In one form, the tube includes a flexible section configured to be more flexible than another section of the tube, wherein the deformable member includes the flexible section.

In one form, the flexible section of tube has a narrower diameter than the other section of tube.

In one form, the decoupling structure comprises a ball joint provided between the air circuit and the plenum.

In one form, the ball joint may be a quick release ball joint including a ball and socket. The ball and socket may be configured to disengage when a force greater than a predetermined magnitude is applied to the air circuit.

In one form, the decoupling structure includes a first magnetic member provided to the connection port, the first magnetic member configured to magnetically couple to a second magnetic member provided to the air circuit when the air circuit is connected to the connection port.

In one form, the first magnetic member is separated from the second magnetic member when the air circuit is pulled away from the patient interface with a magnetic force that is greater than an attractive force between the first magnetic member and the second magnetic member.

In one form, the first magnetic member is a magnet. In another form the first magnetic member is a non-magnetized ferromagnetic material.

In one form, the first magnetic member is annular and surrounds the connection port.

In some forms, the patient interface includes an adapter having a central bore to allow gas to pass from the first end to the second end. The first end may be configured to be directly or indirectly fluidly connected to the air circuit, and the second end may be configured to be removably inserted into the plenum inlet port. In an alternative form, the second end may be configured to be connected to a front surface of the plenum in use. The first end may be configured to magnetically couple with the air circuit (or a component that is itself coupled to the air circuit).

In some forms, the adapter may include a heat and humidity exchanger.

One aspect of one form of the present technique is a patient interface that further includes a seal-forming structure having a flange with an outer surface and an inner surface, wherein the outer surface is on a side of the flange opposite the inner surface, and wherein the adhesive surface is provided on the outer surface of the flange.

In one form, the flange may form a curved shape and pressure from the gas in the plenum is incident on the inner surface.

One aspect of one form of the present technique is a patient interface that further includes a heat and humidity exchanger configured to capture moisture from gas exhaled by the patient and deliver the moisture to the flow of breathable gas for respiration by the patient.

In one form, the heat and humidity exchanger includes a body of heat and humidity exchange material disposed on an inner surface of the plenum.

In one form, the patient interface includes a tube having a first end and a second end, wherein the first end is fluidly connected to the plenum inlet port and the second end includes a connection port, and wherein the heat and humidity exchanger includes a body of heat and humidity exchange material provided within the tube.

In one form, the patient interface includes a heat and humidity exchanger that is remote from a plenum chamber of the patient interface in use. For example, the patient interface may include a conduit fluidly connecting the heat and humidity exchanger with the plenum. In some forms, the patient interface may include a heat and humidity exchange module that includes a heat and humidity exchanger. The heat and moisture exchange module may also include a vent.

One aspect of one form of the present technique is a patient interface that includes a seal-forming structure and a plenum chamber integrally formed as a single component.

In one form, the seal-forming structure and the plenum may be formed of the same material.

In another form, the seal-forming structure and the plenum may be formed of different materials.

One aspect of one form of the present technology is a patient interface that also includes one or more adhesive tape sections that are provided to the seal-forming structure to form the at least one adhesive surface.

One aspect of one form of the present technique is a patient interface that further includes a nasal prongs configured to engage with and deliver a flow of breathable gas into the nostrils of a patient.

In one form, the nasal prongs may include a pair of nasal pillows, each of which is configured to engage one nostril of the patient.

One aspect of one form of the present technique is a patient interface comprising a seal-forming structure, the seal-forming structure further comprising at least one adhesive surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal, wherein the patient interface further comprises a positioning guide member configured to facilitate positioning of the patient interface against the patient's face, in use.

In one form, the positioning guide member may comprise a member having a concave portion facing the patient's face. For example, the member may include a V-shaped member configured to engage the nasal septum when the patient interface is properly positioned against the patient's face.

In one form, the positioning guide member may form part of the plenum. The positioning guide member may be formed of a soft and pliable material, which allows the patient to continuously wear the patient interface with the positioning guide member for a long period of time with little discomfort.

In another form, the positioning guide member may be removably provided to the plenum. The positioning guide member may be removable from the patient interface after positioning the patient interface.

One aspect of one form of the present technique is a patient interface that further includes an applicator.

In one form, the applicator may be removably attached to the front surface of the seal-forming structure and/or the plenum. The applicator may be configured to assist in positioning the patient interface in a therapeutically effective position on the patient's face prior to removal.

In one form, the applicator may be adhered to the seal-forming structure and/or the front surface of the plenum.

In one form, the surface of the applicator may be removably attached to the front surface of the seal-forming structure and/or the plenum.

In another form, the applicator may be shaped to complement an area of the patient's face with which the seal-forming structure is configured to form a seal.

One aspect of one form of the present technique is a patient interface that further includes a removable layer removably attached to and covering the adhesive surface.

In one form, the removable layer may be configured to be removed prior to the patient interface being positioned in sealing contact with the patient's face.

In one form, the removable layer includes a tab that extends beyond the perimeter of the seal-forming structure when the removable layer is attached to the adhesive surface.

One aspect of one form of the present technology is a patient interface comprising a seal-forming structure further comprising at least one adhesive surface configured to adhere in use to an area of the patient's face surrounding an entrance to the patient's airway to form a seal, and one or more tabs for grasping the seal-forming structure, wherein the one or more tabs do not have an adhesive surface facing the patient.

In some forms, one or more tabs are located at the periphery of the seal-forming structure. For example, the one or more tabs may include a first tab located on a first side of the opening and a second tab located on a second side of the opening, the first side being opposite the second side.

One aspect of another form of the present technology is a patient interface comprising a seal-forming structure, the seal-forming structure further comprising at least one adhesive surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal, wherein the adhesive surface is configured such that the adhesive strength of the adhesive surface is reduced by deformation of the adhesive surface, for example when the adhesive surface is stretched.

In some forms, the seal-forming structure may include one or more tabs for grasping the seal-forming structure, wherein the one or more tabs do not have an adhesive surface facing the patient, and wherein the tabs are configured to be pulled to deform (e.g., stretch) the seal-forming structure and reduce the adhesive strength of the adhesive surface, e.g., to remove the seal-forming structure from the patient's face.

One aspect of one form of the present technique is a patient interface that further includes one or more shape retainers. The shape retainer may be configured to facilitate retention of the shape of the seal-forming structure and/or the plenum chamber before the seal-forming structure is made to adhere to the patient's face and optionally during use, i.e., after the seal-forming structure is made to adhere to the patient's face. For example, the shape retainer may help maintain the shape of the seal-forming structure and/or the plenum chamber to a sufficient extent to prevent the seal-forming structure and/or the plenum chamber from wrinkling, folding, or sagging in a manner that makes it difficult for a patient to secure the patient interface to their face.

In some forms, the one or more shape retainers may be configured to substantially maintain the shape of the seal-forming structure after the seal-forming structure is made to adhere to the patient's face.

In some forms, the seal-forming structure includes one or more shape retainers.

In one form, the shape retainer may be located on a side that faces away from the patient's face in use.

In certain forms, the one or more shape retainers comprise an elongate member.

In one form, the shape retainer may be made of the same material as the seal forming structure and/or the plenum. For example, the shape retainer may be integrally formed with the seal forming structure and/or the plenum.

In another form, the shape retainer may include one or more tabs.

In one form, the shape retainer may be configured to separate from the seal-forming structure/plenum chamber, e.g., be removed, once the patient interface is positioned on the patient's face. In some forms, the shape retainer may adhere relatively weakly to the seal forming structure/plenum. In another form, the shape retainer may be disconnected (e.g., delaminated) from the seal forming structure/plenum when a force is applied to the seal forming structure/plenum in a certain direction.

In one form, the shape retainer may be configured such that the seal-forming structure may stretch more easily in one direction than it may stretch in a different direction.

One aspect of one form of the present technology is a patient interface system for delivering breathable gas to a patient. The patient interface system may include a patient interface. The patient interface may include a plenum chamber that may be pressurized to at least 6cmH above ambient air pressure ₂ Therapeutic pressure of O. The plenum may include a plenum inlet port configured to receive a fluid in a positionThe flow of breathable gas at therapeutic pressure is provided for patient respiration. The patient interface may also include at least one seal-forming structure configured to be provided to the plenum chamber in use. Each of the at least one seal-forming structure may be configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. Each of the at least one seal-forming structures may have an opening therein such that the flow of breathable gas is delivered to at least an inlet of a nostril of the patient. Each of the at least one seal-forming structures may be configured to maintain the therapeutic pressure in the plenum chamber throughout a patient's respiratory cycle in use. Each of the at least one seal-forming structures may include at least one sealing surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal. The patient interface may further include a vent structure configured to allow continuous flow of gas exhaled by the patient from the internal ventilation of the plenum chamber to the ambient environment. The vent structure may be configured to maintain a therapeutic pressure in the plenum in use. The patient interface system may further include an adhesive for application to at least one sealing surface of at least one seal-forming structure of the patient interface.

In some forms, the patient interface may further include a diffuser configured to diffuse the flow of exhaust gas from the interior of the plenum to the ambient environment.

One aspect of one form of the present technology is the patient interface of any one or more of the other aspects of the present technology, and further comprising a second vent configured to vent the received air prior to supplying the air to the patient interface. The second vent may be located in a different location in the patient interface than the first vent.

In one form, the patient interface includes a tube including a first end configured to connect to the patient interface and a second end configured to connect to the air circuit. In one form, the first vent may be located at or near the first end of the tube. In one form, the second vent may be located at or near the second end of the tube.

In one form, the adhesive may be a fluid.

One aspect of one form of the present technology is a patient interface system that further includes one or more sections of adhesive tape configured to be provided to at least one sealing surface of the at least one seal-forming structure.

One aspect of one form of the present technique is a patient interface system that further includes a first seal-forming structure including a first sealing surface. The first sealing surface may be configured to adhere to a first region of a patient's face. The patient interface system may further include a second seal-forming structure including a second sealing surface. The second sealing surface may be configured to adhere to a second region of the patient's face, the first region being different from the second region.

In one form, the first seal-forming structure and the second seal-forming structure are configured to be selectively interchangeably provided to the plenum.

In one form, the first and second sealing surfaces are configured such that the second region of the patient's face surrounds the first region of the patient's face.

In one form, the first region includes a flange of the patient's face, an upper region of the upper lip, and optionally a columella.

In one form, the second region includes the nasal wings, an area of the upper lip below the upper region, and a nasal projection.

One aspect of one form of the present technique is a patient interface system that further includes an applicator that may be configured to assist in positioning the patient interface in a therapeutically effective position on a patient's face.

In one form, the applicator includes a body including a recess configured to receive and retain the patient interface when the patient interface is placed in a therapeutically effective position on the patient's face.

In one form, the body of the applicator includes a surface shaped to complement an area of the patient's face with which the seal-forming structure is configured to form a seal, wherein the surface is provided around the recess to support the seal-forming structure when the patient interface is placed in a therapeutically effective position on the patient's face.

In one form, the applicator includes a grip portion provided to the body that is configured to be held by the patient or another user when the patient interface is placed in a therapeutically effective position on the patient's face.

In one form, the applicator is configured to be removably attached to the front surface of the patient interface to facilitate positioning the patient interface in a therapeutically effective position on the patient's face prior to removal.

In one form, the applicator is removably attached to the front surface by an adhesive.

In another form, the applicator may be magnetically coupled to the front surface.

In one form, the body includes two prongs extending out of the recess, the prongs configured to be inserted into the nostrils of the patient when the patient interface is placed in a therapeutically effective position on the patient's face.

One aspect of one form of the present technology is a method of customizing a patient interface for delivering breathable gas to a patient. The method may include receiving data indicative of a shape and/or size of an area of a patient's face surrounding an entrance to an airway of the patient with which the patient interface is to form a seal. The method may further include selecting a preformed patient interface assembly. The preformed patient interface assembly may include a plenum chamber that may be pressurized to at least 6cmH above ambient air pressure ₂ Therapeutic pressure of O. The plenum may include a plenum inlet port configured to receive a flow of breathable gas at a therapeutic pressure for respiration by the patient. The preformed patient interface assembly may also include seal-forming structures provided to the plenum chamber. The seal-forming structure may be configured to form a seal with a facial region of a patient, the seal-forming structure having an opening therein such thatSuch that the flow of breathable gas is delivered to at least the entrance to the nostrils of the patient, the seal-forming structure being configured to maintain said therapeutic pressure in the plenum throughout the respiratory cycle of the patient in use. The seal-forming structure may include at least one adhesive surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal. The method may further include shaping and/or sizing the seal-forming structure to complement an area of the patient's face, the shaping and/or sizing being performed based on data indicative of a shape and/or size of the area of the patient's face.

In one form, selecting the preformed patient interface assembly includes selecting the selected preformed patient interface from a plurality of preformed patient interfaces, wherein each of the plurality of preformed patient interfaces has a different shape and/or size.

In one form, shaping the seal-forming structure includes inserting the seal-forming structure into a molding device.

In one form, the molding device is a thermoforming device and shaping the seal-forming structure includes thermoforming the seal-forming structure.

In one form, the method further includes forming a mold section of the molding apparatus using the data.

In one form, the method further includes scanning an area of the patient's face to generate data.

One aspect of one form of the present technique is a molding apparatus configured to manufacture a plurality of patient interfaces.

In one form, the molding device may be configured to receive a sheet of material, such as tape, from which one or more seal-forming structures for the patient interfaces are configured to be cut.

In one form, the molding apparatus may include a cavity member configured to interact with the core member to shape the tape into a shape required for the seal-forming structure.

In one form, the cavity member and the core member are configured to have a gap therebetween when they are brought together during the forming process. In one form, a molten overmold material may be injected into the gap to overmold the plenum onto the seal-forming structure.

In one form, the molding machine may include a cutting device to separate each patient interface from the tape.

In accordance with one aspect of the present technique, a patient interface is provided. The patient interface may include a plenum chamber that may be pressurized to a therapeutic pressure that is higher than the ambient pressure. The patient interface may further include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may be configured to maintain said therapeutic pressure in the plenum chamber throughout a patient's respiratory cycle in use. The seal-forming structure may include at least one adhesive surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal. The patient interface may also include a vent structure to allow gas to flow from the ambient environment to the interior of the plenum chamber for patient breathing and to allow gas exhaled by the patient to flow from the interior of the plenum chamber to the ambient environment. The vent structure may be configured to maintain a therapeutic pressure in the plenum in use.

In some forms, the vent structure may be configured to generate and maintain a therapeutic pressure in the plenum from a flow of gas exhaled by the patient. Such vents may be referred to as exhalation resistance valves, and therapies using such vents may be referred to as Expiratory Positive Airway Pressure (EPAP).

In accordance with one aspect of the present technique, a patient interface is provided. The patient interface may include a plenum chamber. The patient interface may further include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may include at least one adhesive surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal. The patient interface may also include a vent structure to allow gas to flow from the ambient environment to the interior of the plenum chamber for patient breathing and to allow gas exhaled by the patient to flow from the interior of the plenum chamber to the ambient environment. The patient interface may also include a sensor module configured to detect characteristics of patient respiration and/or other characteristics of patient health and/or physiology.

In some forms, the characteristics of the patient's breath detected by the sensor module may be used to determine a medical condition of the patient, such as diagnosing a respiratory condition, such as Obstructive Sleep Apnea (OSA).

In accordance with one aspect of the present technique, a respiratory diagnostic system is provided that includes a patient interface. The patient interface may include a plenum chamber. The patient interface may further include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may include at least one adhesive surface configured to adhere, in use, to an area of the patient's face surrounding an entrance to the patient's airway to form a seal. The patient interface may also include a vent structure to allow gas to flow from the ambient environment to the interior of the plenum chamber for patient breathing and to allow gas exhaled by the patient to flow from the interior of the plenum chamber to the ambient environment. The patient interface may also include a sensor module configured to detect characteristics of patient respiration and/or other characteristics of patient health and/or physiology.

One aspect of certain forms of the present technology is an easy-to-use medical device, for example, easy-to-use by non-medical trained persons, by persons with limited dexterity and vision, or by persons with limited experience in using this type of medical device.

Of course, portions of these aspects may form sub-aspects of the present technique. Furthermore, sub-aspects and/or aspects may be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

Other features of the technology will become apparent from consideration of the following detailed description, abstract, drawings, and claims.

Drawings

The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

fig. 1 shows a system comprising a patient 1000, the patient 1000 wearing a patient interface 3000, the patient interface 3000 receiving a supply of positive pressure air from an RPT device 4000. The patient sleeps on his side.

Fig. 2A shows a schematic diagram of the human respiratory system including nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveoli, heart and diaphragm.

Fig. 2B shows a view of the upper airway of a human including the nasal cavity, nasal bone, lateral nasal cartilage, alar cartilage, nostrils, upper labia, lower labia, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea.

Fig. 2C is a front view of a face with several surface anatomical features identified, including an upper lip, an upper lip red, a lower lip, a mouth width, a medial canthus, a nasal wing, a nasolabial sulcus, and a labial corner. Upper, lower, radially inward and radially outward directions are also indicated.

Fig. 2D is a side view of a head with several surface anatomical features identified, including an inter-eyebrow, a nasal bridge point, a nasal protrusion point, a sub-nasal point, an upper lip, a lower lip, an upper chin point, a nasal ridge point, an upper ear base point, and a sub-ear base point. The up-down direction and the front-back direction are also indicated.

Fig. 2E is another side view of the head. The approximate location of frankfurt (Frankfort) level and nose lip angle are indicated. Coronal planes are also indicated.

Figure 2F shows a bottom view of a nose with several features identified, including the nasolabial folds, the lower labia, the upper labial reddish, the nostrils, the subnasal points, the columella, the nasomentum points, the long axis of the nostrils, and the mid-sagittal plane.

Fig. 2G shows a side view of a nasal surface feature.

Fig. 2H shows subcutaneous structures of the nose including lateral cartilage, septal cartilage, alar cartilage, seedlike cartilage, nasal bone, epidermis, adipose tissue, frontal processes of the maxilla, and fibrous adipose tissue.

Fig. 2I shows a medial anatomic view of the nose, in particular the medial foot of the septal cartilage and the alar cartilage, about a few millimeters from the median sagittal plane.

Fig. 2J shows a front view of the skull including frontal, nasal and zygomatic bones. Turbinates, maxilla and mandible are also indicated.

Figure 2K shows an outside view of the skull with the head surface profile and several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone and occipital bone. The chin protuberance is indicated. The following muscles are shown: two abdominal muscles, a chewing muscle, a sternocleidomastoid muscle and a trapezius muscle.

Fig. 2L shows a front lateral view of the nose.

Fig. 3A illustrates a patient interface in one form configured to adhere to a flange region of a patient's face in accordance with the present technique.

Fig. 3B shows a side perspective view (left) of the seal-forming structure of the patient interface of fig. 3A and shows a side perspective view (right) of the nose of the facial region to which the seal-forming structure of fig. 3A is adhered in use.

Fig. 3C illustrates a front perspective view of the seal-forming structure of the patient interface of fig. 3A.

Fig. 4A illustrates a perspective view of a patient interface secured to a patient's face in accordance with one form of the present technique.

Fig. 4B shows a side view of the patient interface of fig. 4A.

Fig. 4C shows a front view of the patient interface of fig. 4A.

Fig. 4D shows a side perspective view of the nose showing the facial area to which the seal-forming structure of fig. 4A is adhered in use.

Fig. 5A is a perspective view of a patient interface secured to a alar fold region of a patient's face in accordance with one form of the present technique.

Fig. 5B illustrates a front view of the seal-forming structure of the patient interface of fig. 5A.

Fig. 5C shows a rear view of the patient interface of fig. 5A.

Fig. 6 illustrates a cross-sectional view of another form of seal-forming structure in accordance with the present technique.

Fig. 7 illustrates an area to which a first seal-forming structure and a second seal-forming structure of a patient interface system in accordance with one form of the present technique may be adhered.

Fig. 8 is a perspective illustration of another form of patient interface in accordance with the present technique.

Fig. 9A is a perspective illustration of another form of patient interface in accordance with the present technique.

Fig. 9B is an exploded view illustration of the patient interface of fig. 9A.

Fig. 9C shows a front view of the patient interface of fig. 9A positioned on a patient's face.

Fig. 9D shows a front view of the patient interface of fig. 9A when the seal-forming structure is adhered to the patient's face.

Fig. 10A shows an exploded view of the patient interface system.

Fig. 10B illustrates an exploded view of a patient interface system having a magnetic coupling structure in accordance with another form of the present technique.

Fig. 10C shows an exploded view of the tubing and air circuit of the patient interface system of fig. 10B.

Fig. 10D shows a cross-sectional view of the tube and air circuit of the patient interface system of fig. 10B when assembled.

Fig. 10E shows a front view of a patient wearing a patient interface, with the air circuit of the patient interface system of fig. 10B separated from the patient interface.

Fig. 10F shows a side view of a patient lying on his side when wearing a form of patient interface in accordance with the present technique.

Fig. 11 illustrates a cross-sectional view of a patient interface with a heat and humidity exchanger in accordance with one form of the present technique.

Fig. 12A illustrates a molding tool and patient interface in accordance with one form of the present technique.

Fig. 12B shows the patient interface of fig. 12A.

Fig. 12C illustrates a plurality of preformed patient interfaces in accordance with another form of the present technique.

Fig. 13A illustrates a patient interface system in accordance with one form of the present technique. The patient interface system includes a patient interface having a seal-forming structure, and an applicator configured to deliver the seal-forming structure to a patient's face.

Fig. 13B shows the arrangement of the seal-forming structure and the applicator prior to transfer of the seal-forming structure to the patient's face.

Fig. 13C shows the arrangement of the seal-forming structure and the applicator when the seal-forming structure is transferred to the patient's face and the applicator is released from the seal-forming structure.

Fig. 14A illustrates a patient interface system in accordance with one form of the present technique. The patient interface system includes a patient interface having a seal-forming structure, a removable layer, and a front layer.

Fig. 14B shows an arrangement of components of the patient interface system of fig. 14A when the patient interface is transferred to the patient's face.

Fig. 14C shows the arrangement of components of the patient interface system of fig. 14A after transferring the patient interface to the patient's face.

Fig. 15A shows a back view, a side view, and a front view of a patient interface including a removable layer.

Fig. 15B illustrates an exploded view of a patient interface including a front layer with an extension in accordance with one form of the present technique.

Fig. 15C shows a perspective view of the patient interface of fig. 15B when assembled.

Fig. 16A-16F are plan views of some forms of seal-forming structures in accordance with the present technique.

Fig. 17 is an exploded view illustration of a patient interface and applicator in accordance with one form of the present technique.

Fig. 18A-18C are illustrations of other forms of applicators according to the present technique.

Fig. 19A is a perspective illustration of a patient interface including a positioning guide member in accordance with one form of the present technique.

Fig. 19B is a front view of a patient positioning the patient interface illustrated in fig. 19A.

Fig. 19C is a front view illustration of a patient interface including a positioning guide member in accordance with another form of the present technique.

Fig. 19D is a perspective view of the patient interface illustrated in fig. 19C.

Fig. 19E is a cross-sectional view illustration of a patient interface including a positioning guide member in accordance with another form of the present technique.

Fig. 20A is an exploded cross-sectional view of a patient interface and air circuit in accordance with one form of the present technique.

Fig. 20B is a partial perspective view of a seal-forming structure in accordance with one form of the present technique.

Fig. 20C is a partially exploded view of a patient interface and air circuit in accordance with one form of the present technique.

Fig. 20D is a cross-sectional view of an adapter in accordance with one form of the present technique.

Fig. 20E is a rear perspective view of an adapter in accordance with one form of the present technique.

Fig. 20F is a front perspective view of an adapter in accordance with one form of the present technique.

Fig. 21A is a perspective view of an adhesive tape in accordance with one form of the present technique.

Fig. 21B illustrates an injection molding tool and patient interface blank in accordance with one form of the present technique.

Fig. 21C illustrates the injection tool of fig. 21B molding a patient interface blank.

Fig. 21D illustrates a cross-sectional view of fig. 21C.

Fig. 22A illustrates a perspective view of a patient interface with a shape retainer in accordance with one form of the present technique.

Fig. 22B illustrates a bottom perspective view of the patient interface of fig. 22A.

Fig. 22C illustrates a top view of the patient interface of fig. 22A when a force is exerted on an end of the patient interface.

Fig. 23A illustrates a perspective view of a molding machine in accordance with one form of the present technique.

Fig. 23B illustrates an enlarged perspective view of the tape when using the molding machine of fig. 23A, in accordance with one form of the present technique.

Fig. 24A illustrates an exploded view of a tape in one form in accordance with the present technique.

Fig. 24B illustrates a perspective view of a portion of the tape of fig. 24A.

Fig. 25A illustrates one step of a manufacturing process for forming a patient interface in accordance with one form of the present technique.

Fig. 25B illustrates another step of a manufacturing process for forming a patient interface in accordance with one form of the present technique.

Fig. 25C illustrates another step of a manufacturing process for forming a patient interface in accordance with one form of the present technique.

Fig. 25D illustrates another step of a manufacturing process for forming a patient interface in accordance with one form of the present technique.

Fig. 25E illustrates another step of a manufacturing process for forming a patient interface in accordance with one form of the present technique.

Fig. 26 illustrates a front view of a patient interface in one form in accordance with the present technique.

Fig. 27 illustrates an exploded cross-sectional view of a portion of an adhesive seal forming structure in accordance with one form of the present technique.

Fig. 28 illustrates a perspective view of a respiratory therapy system including a split vent in accordance with one form of the present technique.

Fig. 29 illustrates a perspective view of a patient interface system in accordance with one form of the present technology.

Fig. 30 illustrates a perspective view of a patient interface and exhalation resistance module in accordance with one form of the present technique.

Fig. 31 illustrates a perspective view of a patient interface and sensor module in accordance with one form of the present technique.

Fig. 32 illustrates a perspective view of a respiratory therapy system in accordance with one form of the present technique.

Detailed Description

Before the present technology is described in more detail, it is to be understood that this technology is not limited to particular examples described herein that may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing the particular examples discussed herein only and is not intended to be limiting.

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

Therapy method

In one form, the present technique includes a method for treating a respiratory disorder that includes applying positive pressure to an airway inlet of a patient 1000.

In some examples of the present technology, a positive pressure air supply is provided to the nasal passages of the patient via one or both nostrils.

In some examples of the present technology, mouth breathing is restricted, constrained, or prevented.

Respiratory therapy system

In one form, as shown in fig. 1, the present technique includes a respiratory therapy system 2000 for treating respiratory disorders. The respiratory therapy system 2000 may include an RPT device 4000 for supplying an air flow to the patient 1000 via an air circuit 4170 and a patient interface 3000.

In the technical form shown in fig. 1, RPT device 4000 is portable and may be carried by patient 1000, for example attached to the patient's clothing. In an alternative form of the present technology (not shown in the figures), the RPT device may be a conventional RPT device configured to rest on a nearby surface, such as a bedside table, during use.

In addition, respiratory therapy system 2000 may include a humidifier (not shown) to vary the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Typically, humidifiers are used to increase the absolute humidity of the air stream and increase the temperature of the air stream (relative to ambient air) prior to delivery to the airway of a patient.

In some forms of the technology, the patient interface 3000 may include a heat and humidity exchanger 3700, as explained in more detail below.

Patient interface

Fig. 3A-8, 10A-18C, 20A-22C, and 26-32 illustrate forms of techniques for providing a patient interface 3000 (or portion thereof) in which the patient interface 3000 does not extend into the nostrils of the patient 1000. In the technical form shown in fig. 9A-9D, the patient interface 3000 includes nasal prongs that engage with and/or extend into the nostrils. These types of patient interfaces will be described in more detail in the following paragraphs.

In accordance with one aspect of the present technique, a patient interface 3000, such as that shown in fig. 3A, includes the following functional aspects: the seal forming structure 3100, the plenum chamber 3200, and the connection port 3600 for connection to the air circuit 4170.

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 airway inlet of a patient so as to maintain a positive pressure at the airway inlet of the patient 1000. Thus, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

The plenum chamber 3200 may be formed from one or more modular components in the sense that it or they may be replaced by different components (e.g., components of different sizes and/or shapes).

If the patient interface is unable to comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of at least 6cmH relative to the surrounding environment ₂ The positive pressure of O supplies air.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of at least 10cmH relative to the surrounding environment ₂ Positive pressure supply of OAir.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of at least 20cmH relative to the surrounding environment ₂ The positive pressure of O supplies air.

Seal forming structure

In one form of the present technique, the patient interface 3000 includes a seal-forming structure 3100, the seal-forming structure 3100 being configured to form a seal with an area of the patient's face. The seal forming structure 3100 is thus configured to secure the plenum chamber 3200 in sealing engagement with respect to the patient's face. The seal-forming structure 3100 may form openings 3110 to allow the flow of breathable gas to be delivered to at least the entrance to the nostrils of the patient.

In one form of the present technique, the seal-forming structure 3100 provides a target seal-forming region. The target seal forming area is an area on the seal forming structure 3100 where sealing may occur. The area where the seal actually occurs-the actual sealing surface-may vary over time and from patient to patient within a given treatment session, depending on a number of factors including, for example, the location where the patient interface is placed on the face and the shape of the patient's face.

Some forms of seal-forming structure 3100 of the present technology are configured to adhere to one or more regions of a patient's face by an adhesive to form a seal with regions of the patient's face surrounding one or more of the patient's airway inlets. For example, the seal-forming structures 3100 in fig. 3A-32 are each configured to seal around the nasal airways of the patient 1000. However, in an alternative form of the present technique (not shown in the figures), the seal-forming structure may be configured to seal around the mouth of the patient 1000. The seal-forming structure may also be configured to seal with the nasal airway and mouth of the patient 1000.

The adhesive-based attachment of the seal-forming structure 3100 to the patient's face allows for the formation of a highly airtight seal. It has been found that adhesive-based seals allow for much less leakage than can be achieved by conventional compression seals held to the face by a headgear. One reason for this is that in a form where the seal-forming structure 3100 attached to the patient's face is flexible enough that it can dynamically distort with the patient's face, the seal is maintained even if the patient's face or skin moves. Such movement can cause leakage in conventional compression seals. The shape of the face may particularly change when the patient moves from an upright position to a lying down position, and also between lying down positions (e.g. on the back (supine), on the front (prone), or on the side).

The high quality seal improves the effectiveness of positive pressure respiratory therapy because the desired pressure can be maintained in the patient interface. Furthermore, the high quality seal reduces the total power that RPT device 4000 consumes to maintain the pressure of the breathable gas in patient interface 3000. This reduced power requirement means that RPT devices that operate at relatively low power, such as portable RPT devices, may be used. This makes it easier for the patient to receive therapy outside his home, for example while traveling. Moreover, the reduced power requirements may reduce the cost and complexity of the RPT device 4000.

For conventional compression seals, there is a tradeoff between comfort and leakage. The greater retention force (typically exerted by the tension of the headgear straps) that holds the patient interface on the face reduces the risk of leakage, but makes the patient interface less comfortable to wear and more likely to create mark marks on the patient's face. In the case of infants and children, prolonged use of headgear can lead to deformities in the face and/or skull, which can have very significant consequences.

On the other hand, if the holding force is too low, leakage will occur, especially at high therapeutic pressures. Furthermore, for any given patient interface, the interference levels that properly balance these considerations may vary around the perimeter of the seal, and may also vary from patient to patient due to variations in the shape of the individual face. Adhesive-based seals can avoid these difficulties because the seal can more effectively follow the shape of the patient's face, particularly if the seal-forming structure is sufficiently flexible and can adhere to the skin with consistent retention around the perimeter of the seal-forming structure.

Prevention of leakage is advantageous in oxygen therapy, particularly in countries, regions or periods where oxygen availability is very scarce.

Furthermore, the absence of headgear significantly improves patient comfort. This improves the overall efficacy of the respiratory therapy, as the patient 1000 will tend to not adjust or otherwise move the comfortable patient interface 3000.

In particular, children and infants generally have lower tolerance to discomfort than adults. As a result, they tend to remove or repeatedly attempt to remove the headgear during use. If the patient interface with headgear breaks away or repeatedly interferes during use, the efficacy of the treatment or therapy may be significantly affected. The seal forming structure 3100 in the technical form described in this specification provides a more comfortable and thus more effective seal than a headgear. In addition, the patient interface 3000 with the seal forming structure 3100 provides a safer means of administering respiratory therapy to children and infants because the use of headgear may be eliminated, thereby eliminating the forces exerted by the headgear on the skull.

It was also observed that the adhesive-based attachment of the seal-forming structure 3100 to the patient's face resulted in less occlusion of the patient's nostrils than some other types of patient interfaces. As will be described, the seal-forming structure 3100 of the exemplary form of the present technology is configured to adhere around the flange of the patient's nose. This means that substantially the entire nostril area is available for receiving the incoming gases. Furthermore, in a technical form in which the seal-forming structure 3100 is able to flex with the patient's face, the nose is slightly free to expand due to the incoming pressurized gas, which further increases the area of the nostrils. These effects make it easier for the patient to breathe when using patient interface 3000 in the form of techniques according to the description herein, as compared to some conventional patient interfaces. For example, patient interfaces using compression seals may be pushed inwardly over the nostrils making them more difficult to expand outwardly, and some patient interfaces are configured such that the inner and outer surfaces of the nose are contained within the pressurized inflation chamber. This means that there is no pressure difference between the inner and outer surfaces of the nose and thus no ballooning effect occurs. Rather, some forms of the techniques described herein create a seal around the flange such that there is a pressure differential between the inner and outer surfaces of the nostrils, thereby achieving this ballooning effect. This benefit may be particularly pronounced for patients with narrow nostrils.

Adhesive surface

The seal-forming structure 3100 is configured to be secured in a therapeutically effective position against the patient's face by an adhesive. In some forms of the present technology, the seal-forming structure may be configured to adhere to the patient's face through vacuum-induced attachment in addition to one or more adhesives.

In one form, the seal-forming structure 3100 includes a region having at least one adhesive surface 3102. An exemplary adhesive surface 3102 is illustrated in one form of this technique in fig. 5C.

Adhesive is applied to the adhesive surface 3102, and in use, the adhesive surface 3102 contacts the patient's face such that the adhesive adheres the adhesive surface 3102 of the seal-forming structure 3100 to the patient's face.

In some forms of the present technology, the seal-forming structure 3100 is configured such that the shape of the adhesive surface 3102 substantially matches or resembles the shape of the region of the patient's face to which the seal-forming structure 3100 is attached in use. As will be explained in more detail later, in some forms, the seal-forming structure 3100 may be configured to substantially match/resemble the shape of an area of a particular patient's face, i.e., the seal-forming structure 3100 may be customized for an individual patient. Customizing the seal-forming structure 3100 in a patient interface 3000 of the type described herein may be more commercially viable than with other types of patient interfaces because the small footprint of the seal-forming structure 3100 makes it a relatively small component, and the seal-forming structure 3100 may be able to be cut from a flat sheet of material (such as adhesive tape), thereby reducing the relative manufacturing costs of an individual patient. Alternatively, the seal-forming structure 3100 may be configured to have a shape that substantially complements the shape of the appropriate target area of the general face, or the shape of the general face of a subset of the population (e.g., based on the size or type of face shape). Alternatively, the seal-forming structure 3100 may be formed of a material and in a form such that the seal-forming structure 3100 is sufficiently flexible that it can take the shape of the region of the patient's face to which it is attached in use.

One advantage of the seal-forming structure 3100 and/or the adhesive surface 3102 being shaped to substantially match/resemble the region of the patient's face to which the seal-forming structure 3100 is adhered, or being shaped to be flexible enough so that it can deform to do so is that this avoids the adhesive surface 3102 pulling on the underlying skin when the patient interface 3000 is in use. This significantly improves patient comfort by eliminating uneven stress created by the adhesive exerting shear stress on the skin.

In addition, a smaller amount of adhesive may also be allowed to provide the adhesive force required to secure the seal-forming structure 3100 against the patient's face, rather than the adhesive force required in other cases, as the adhesive does not exert a force when pulling the skin laterally across the face.

The area of the seal-forming structure 3100 to which the adhesive is applied may be considered a target seal-forming area. In one form, the adhesive is located on an annular region around the outer edge of the seal forming structure 3100 that completely surrounds the opening 3110. This may minimize the footprint of the seal-forming structure 3100 on the patient's face, thereby reducing the volume of the patient interface 3000 and its inconvenience to the patient 1000.

The close proximity of the seal-forming structure 3100 and the presence of adhesive on the skin surface may cause sweat from the underlying skin to accumulate and/or interact with the adhesive. Accumulation of sweat may be inconvenient when patient interface 3000 is to be worn for an extended period of time, such as during sleep. Thus, the smaller the area of the target seal-forming area and/or the area covered by the seal-forming structure 3100, the less inconvenience is caused to the patient 1000.

Patient facial region

The seal-forming structure forms a seal with an area of the patient's face surrounding the entrance to the patient's airway, such as around the nostrils and/or mouth, in use.

There are several considerations in determining which region of the patient's face, some forms of seal-forming structure 3100 according to this technique may be configured to attach in use.

One factor is that it may be desirable for the seal-forming structure 3100 to have a small footprint on the patient's face. The larger the footprint, the more prominent the patient interface 3000. Patient interface 3000 occupying a larger footprint may cause claustrophobia and discomfort. A small footprint also typically means a smaller patient interface 3000 that uses less material and is therefore cheaper to manufacture.

Similarly, the smaller the attachment area between the adhesive surface 3102 and the underlying skin, the better the patient's comfort, because the smaller the skin area to which the seal-forming structure 3100 attached may function and the smaller the skin area the adhesive may pull in different directions.

Further, since a smaller footprint of the seal forming structure 3100 generally means a smaller patient interface and thus a smaller plenum chamber, this corresponds to a smaller area on which the air pressure in the plenum chamber 3200 acts. For any given pressure, the smaller area thus results in a reduced force for pushing patient interface 3000 away from the patient's face. Thus, a smaller footprint means that the adhesive need not be too strong to hold the patient interface 3000 on the patient's face.

Another advantage of the relatively small footprint of the seal-forming structure 3100 is that the patient interface 3000 does not protrude too far from the patient's face, again since this generally means a smaller patient interface 3000. This eliminates or reduces the possibility of frictional interaction between the patient interface 3000 and surrounding objects (such as pillowcases, sheets, etc.). When the patient 1000 is asleep, certain areas of the patient's face are more likely to contact surrounding objects. Such areas include cheeks, chin, nose points and other such protruding features of the patient's face. If the patient interface 3000 protrudes significantly from those areas of the patient's face, the seal-forming structure 3100 is highly likely to peel slightly or completely from the skin. Especially when the patient interface 3000 is worn for extended periods of time to sleep.

When the patient 1000 changes his body position, for example from sitting to lying down or between any of the following lying down positions, certain areas of the face tend to change in shape more: supination; prone position; lying on the side. This is because, in different positions, gravity acts differently on the patient's skin and muscles, which causes them to move in different ways relative to the underlying bone structure. A seal-forming structure 3100 provides greater comfort, the seal-forming structure 3100 avoiding areas of greater change in shape with changes in patient body position, because changes in shape of the underlying facial area will cause the adhesive surface 3102 to stretch to accommodate changes in shape or to disengage from the underlying skin when the patient interface 3000 is worn. If the adhesive surface 3102 and/or the seal-forming structure stretches, a restoring force is exerted on the underlying skin, causing discomfort to the patient 1000. If the seal forming structure 3100 is disengaged from the patient's face, the seal may be rendered ineffective and thus the respiratory therapy rendered ineffective.

Some facial regions have more facial hair than others, particularly in men. The seal-forming structure 3100, the adhesive surface 3102 of which is configured to be primarily attached to the hairless portion, allows application and removal of the seal-forming structure without causing pain due to hair removal. Pain caused by jerking facial hair may prevent the patient from adhering to respiratory therapy. Thus, a seal-forming structure that adheres to the hairless or low-haired area of the patient's face is advantageous.

In addition to the factors described above, when considering the shape of the seal-forming structure 3100, the area of the patient's face to which the seal-forming structure 3100 is attached is also a factor, and the seal-forming structure 3100 can be adapted to many members of the population, rather than being customized for an individual patient. Forming a patient interface that can be effectively used by multiple members of a population can reduce manufacturing costs by achieving economies of scale.

Based on this consideration, extensive analysis has been performed to understand the degree of variation in different regions of the face among population members. In particular, principal Component Analysis (PCA) of 3D facial scans was performed on the airway surrounding areas of many members of the population. This identified analysis finds that certain regions of the face surrounding the airway vary less throughout the population than others.

In some forms of the technology, the shape of the seal-forming structure 3100 is configured in such a way that it can be attached to these facial regions with relatively little change in shape in use. The following section describes the shape of the facial regions that have been identified as suitable for this analysis, and the particular form of seal-forming structures according to this technique, which are particularly suitable for sealing with these regions.

Generally, based on the considerations described above, the area of the face to which the seal-forming structure 3100 of some form identified as suitable for the present technique is adhered is the area adjacent to the nostril, e.g., the area immediately adjacent to the nostril. Such areas are typically the downwardly facing surface of the nose wing and the upper region of the upper lip, such as the uppermost region of the upper lip.

In one form of the technique, as shown in fig. 3A-3C, the seal-forming structure 3100 is configured to adhere to an area of the patient's face immediately surrounding the nostrils. These areas are indicated by the unshaded areas on the right hand side of fig. 3B and include: flange region 3141 (i.e., the region where the nose wings are immediately adjacent to the nostrils and generally face downward); the uppermost region of the upper lip 3142, which may include the subnasal point and/or the region just below the subnasal point; and a nose anterior region that is inferior, e.g., directly inferior, to the nose point 3143. In the lateral direction, the seal-forming structure 3100 extends to a region 3144 slightly below the nasal alar ridge point, for example, a region immediately midway between the junction between the nasal alar ridge point and the nasal labial sulcus. In the form of the illustrated technique, the seal-forming structure 3100 does not adhere to a significant portion of the lateral regions of the nasal wings, although in some forms, or for some faces, it may adhere to lower regions of the lateral regions of the nasal wings. In addition, the seal forming structure 3100 of fig. 3A to 3C does not adhere to the nasal protrusions.

In the technical form shown in fig. 3A-3C, the area of the patient's face to which the seal-forming structure 3100 is adhered is a band that completely surrounds the patient's nostrils. The width of the band may be approximately constant around the circumference of the band.

It has been found that when the patient 1000 changes its position, the facial area covered by the seal-forming structure 3100 of the technical form shown in fig. 3A-3C does not substantially change shape, because it mainly comprises cartilage and bone and has relatively less adipose tissue than the cheek or chin area. In addition, the facial region typically has no facial hair or very little facial hair (e.g., some facial hair may be present in the uppermost region of the upper lip 3142). The seal-forming structure 3100 adhered to this region is particularly advantageous for patients 1000 having upper lip hair.

It has also been found that the facial area covered by the seal-forming structure 3100 of the technical form shown in fig. 3A-3C has relatively little shape variation on patients in a representative population sample that includes various families of patients.

In addition, the area (which may be referred to as a flange area) is smaller in size because it directly surrounds the nostrils.

In another exemplary form, as shown in fig. 4A-4D, the seal-forming structure 3100 is configured to adhere to a facial region that extends further up than the region shown in fig. 3B and includes lateral regions of the nose wings. In some forms, the seal-forming structure 3100 is configured to adhere to a lateral region of the alar, and may also extend radially outward far enough to adhere in use to cheek regions adjacent the alar ridge point 3145, such as the region between the alar and the nasolabial folds. The seal forming structure 3100 may also be adhered to the area of the face to which the seal forming structure of fig. 3A-3C is adhered. The larger bonding area of the seal-forming structures in fig. 4A-4D may improve the amount of bonding and result in less leakage than the seal-forming structures of fig. 3A-3C, but may result in less discomfort to the patient.

In another exemplary form, as shown in fig. 5A-5C, the seal-forming structure 3100 is configured to adhere to a larger area of the patient's face than the area to which the seal-forming structure of fig. 3A-3C and 4A-4D is adhered. In this form, the seal-forming structure is adhered to an area that extends in an upward direction to the region of the alar fold, i.e., when the seal-forming structure is adhered to the patient's face, the uppermost portion of the seal-forming structure is adhered to the patient's alar fold. This form of seal-forming structure 3100 may additionally or alternatively be adhered to a major portion of the upper lip. Furthermore, this form of seal-forming structure 3100 may additionally or alternatively be adhered to a nasal punctum region, which may include points directly above the nasal punctum. In the lateral direction, this form of seal-forming structure 3100 adheres to the area of the patient's cheek adjacent the alar, including the area between the alar and the nasolabial folds, and the seal-forming structure 3100 may completely cover the alar in use. The seal forming structure 3100 may also be adhered to the region of the face to which the seal forming structure of fig. 3A-3C and/or fig. 4A-4D is adhered. Alternatively, the seal-forming structures of fig. 5A-5C may be configured to adhere to areas located radially outward from the nostrils, as compared to areas to which the seal-forming structures of fig. 3A-3C and/or 4A-4D are adhered.

In some forms of this technique, such as the form of the technique shown in fig. 7, the seal-forming structure 3100 may be configured to adhere to the columella. For example, the seal-forming structure 3100 may include a septum region 3132 extending between two diametrically opposed regions of the seal-forming structure 3100, the septum region 3132 being configured to adhere to a nasal post in use.

Adhesive strength based on patient's facial area

When the seal-forming structure 3100 is removed, certain areas of the face may be more sensitive to adhesive and/or trauma caused by the pulled skin than other areas. In some forms, a seal-forming structure 3100 is provided having adhesive surface areas of different adhesive strength depending on the particular area of the face to which a particular portion of the seal-forming structure 3100 is configured to adhere.

It is not possible to achieve an airtight seal while avoiding all or most of the sensitive areas of the patient's face. The seal-forming structure 3100 having different adhesive strengths across the adhesive surface 3102 allows the seal-forming structure 3100 to adhere relatively firmly to relatively less sensitive areas of the patient's face and to have relatively lower adhesive strengths to more sensitive areas of the face. The advantage of this arrangement is that the load to create an effective seal can be borne by the relatively less sensitive areas of the patient's face while avoiding acute skin trauma in the more sensitive areas.

Similarly, certain areas of the face are more difficult to achieve an effective seal than others. For example, the upper lip-like region is more difficult for the seal forming structure 3100 to form an effective seal due to contours in the person and the tendency of facial hair to grow there compared to relatively flat, less hair-like regions such as cheeks. Thus, it may be beneficial to more effectively seal a greater amount of adhesive strength in areas that are more difficult to seal. Accordingly, in one form, the adhesive surface of the seal-forming structure 3100 that is configured to adhere to those portions that are relatively difficult to seal with areas may have greater adhesive strength than the adhesive of other portions of the seal-forming structure 3100.

Nose folds are areas of the patient's face that are both tricky to form an effective seal with (due to contours in the area) and sensitive. Accordingly, the adhesive strength of the portion of the seal forming structure 3100 that seals against the nasal alar folds may be selected to balance the formation of an effective seal, but reduce trauma to the skin due to repeated application and removal of the seal forming structure 3100.

Certain areas of the patient's face may be better suited for forming an effective seal, and the portions of the seal-forming structure 3100 that contact these areas may therefore require less adhesive strength. Examples of such regions include the region of the patient's face on the nasal side and the cheek region. The adhesive strength of the portion of the seal-forming structure 3100 configured to seal to these regions may be at a magnitude sufficient to create an effective seal, or it may be at a magnitude higher than that required to compensate for the lower adhesive strength in other regions.

In some forms, an area of the adhesive surface 3102 of the seal-forming structure 3100 may provide greater adhesive strength by using stronger adhesive in that area than another area. Alternatively or additionally, in other forms, greater adhesive strength of the region of the seal-forming structure 3100 may be provided by applying a greater amount of adhesive (e.g., the same adhesive). In other forms, other ways of varying the adhesive strength between different regions of the seal-forming structure 3100 are provided.

Exemplary shape of seal Forming Structure

Fig. 16A-16F illustrate some forms of exemplary seal-forming structures 3100 of the technology that are shaped to adhere to the protruding regions shown in fig. 4D and described above.

General shape of seal formation Structure

The seal forming structure 3100 shown in fig. 16A to 16F is formed of a sheet of material having an opening 3110 in the middle. The seal forming structure 3100 is in the form of a stem portion 3178, two corner portions 3176, two shoulder portions 3174 and a peak portion 3172. As shown in fig. 16A to 16F, corner portions 3176 are located at either end of the stem portion 3178, and shoulder portions 3174 connect each corner portion 3176 to the apex portion 3172. Each of the seal forming structures 3100 shown in fig. 16A to 16F has reflection symmetry about an axis passing through the intermediate section of the apex portion 3172 and the stem portion 3178. The axis is intended to be positioned in use on the median sagittal plane of the patient.

The stem portion 3178 may be substantially straight in some forms, and may be radially inward arcuate in other forms, such that the stem portion 3178 includes a concave recess 3180 in a radially outer intermediate section thereof and a convex protrusion 3182 in a radially inner intermediate section thereof. The shape of recess 3180 and protrusion 3182 may be generally circular.

The corner portions 3176 may be generally triangular in shape and may each include an edge 3184 on a radially outer side of the seal forming structure 3100 on the same side as the recess 3180 in the stem portion 3178. The edge 3184 may be angled to form an obtuse angle 3186 between the angled edge 3184 and the recess 3180 of the stem portion 3178.

The apex portion 3172 may include a concave recess 3188 on a radially inner side thereof and a convex protrusion 3190 on a radially outer side thereof. The shape of the recess 3188 and the protrusion 3190 may be substantially circular.

The shoulder portion 3174 may have a radially outer edge and/or a radially inner edge that is radially outwardly curved such that the shoulder portion 3174 includes a male protrusion on the radially outer edge and a female recess on the radially inner edge.

In the technical form shown in fig. 16A to 16F, the seal forming structure 3100 generally has the form of a D-shaped band. In other forms of the technology, the seal-forming structure 3100 formed from sheet material may differ in shape, although one or more of the above-described portions may still be included.

The seal-forming structure shown in fig. 16A to 16F is configured to adhere, in use, to a facial region such as indicated by the outline region in fig. 4D. For example, in use, the apex portion 3172 is configured to adhere to the anterior region of the nose below the nasogastric point, the shoulder portion 3174 is configured to adhere to the lower region of the nasogastric flap, the corner portion 3176 is configured to adhere to the nasogastric fold region, e.g., the nasogastric fold and/or the laterally outer region of the nasogastric flap and/or the cheek region adjacent the nasogastric fold, and the stem portion 3178 is configured to adhere to the upper region of the upper lip.

Shape change of seal forming structure

Fig. 16A-16F illustrate various shapes and/or sizes of seal forming structures 3100. A patient interface 3000 of the type described herein may be configured such that any one of the plurality of seal-forming structures 3100 can be used as part of the patient interface, wherein the seal-forming structures 3100 may be interchangeably connected to the plenum chamber 3200 of the patient interface 3000. In this way, the patient is able to select a seal forming structure 3100, the shape and size of the seal forming structure 3100 being adapted to optimally suit their needs, for example from a fit and comfort standpoint.

The range of shapes of the seal-forming structure 3100 shown in fig. 16A-16F may be selected such that at least one shape is capable of fitting a majority of patients in a given patient population. This means that the patient interface can be configured to provide a good level of fit using only a discrete number of common shapes and sizes of seal forming structures 3100, such as six of the exemplary forms shown in fig. 16A-16F. Producing only a discrete number of seal-forming structures 3100 (as opposed to customizing the seal-forming structures to fit an individual patient) may provide cost efficiencies in manufacturing and supply. It is appreciated that in other forms of the present technology, a different number of seal-forming structures 3100 of different shapes and sizes may be provided. The greater the number of seal-forming structures 3100 provided, the more likely any individual patient will find a seal-forming structure that fits them very effectively, but the more differently shaped the structure is made and supplied. In other forms of the technology, the seal-forming structure 3100 may be customized to an individual patient.

The shape of the seal-forming structure 3100 shown in fig. 16A-16F is identified by employing a particular shape and size of the seal-forming structure 3100, which seal-forming structure 3100 is believed to be suitable for fitting a target region of a patient's face of a general shape and size, and changing shape and size based on changes to one or more principal components of the seal-forming structure determined from PCA performed on the shape and size of the nose region for different members of the population. For example, in the PCA for generating the seal forming structure 3100 shown in fig. 16A to 16F, three main components of the target seal area (such as shown in fig. 4D) are determined to vary among members of the population, and different shapes/sizes of the seal forming structure 3100 shown in fig. 16A to 16F are generated by independently changing each of the three main components. More specifically, fig. 16A and 16B are generated by changing the first principal component by negative three standard deviations (fig. 16A) and positive three standard deviations (fig. 16B). Fig. 16C and 16D are generated by changing the second principal component by negative three standard deviations (fig. 16C) and positive three standard deviations (fig. 16D). Fig. 16E and 16F are generated by changing the third principal component by negative three standard deviations (fig. 16E) and positive three standard deviations (fig. 16F).

It should be appreciated that the principal component identified in PCA is not necessarily equal to any particular characteristic or property of the size/shape of the region. However, it can be widely seen that the first principal component generally relates to the size of the target sealing area, and thus to the size of the nose, the second principal component generally relates to the degree of curvature of the nostrils, and the third principal component generally relates to the overall shape and/or proportion of the nose, e.g., whether the nose is long and thin or short and wide. In other forms of the present technology, the scope of the seal-forming structure 3100 adapted to adhere to the patient's face may vary based on different principal components or by varying multiple principal components between versions of the seal-forming structure.

In the exemplary form of the seal-forming structure 3100 shown in fig. 16A and 16B, it can be seen that changing the first major component changes the overall size of the seal-forming structure 3100, i.e., the seal-forming structure shown in fig. 16B is a scaled-up version of the seal-forming structure shown in fig. 16C. Further, the seal forming structure shown in fig. 16B has a wider obtuse angle 3186 as compared to the seal forming structure shown in fig. 16A, i.e., the edge 3184 of the seal forming structure shown in fig. 16B is oriented more parallel to the outer edge of the stem portion 3178 as compared to the case of the seal forming structure shown in fig. 16A. Further, in the seal forming structure 3100 for a smaller nose (as shown in fig. 16A), the concave protrusion 3190 in the apex portion 3172 is more pronounced than in the seal forming structure 3100 for a larger nose (as shown in fig. 16B).

In the exemplary form of the seal forming structure 3100 shown in fig. 16C and 16D, changing the second principal component results in a change in concavity and convexity of the concave 3180 and convex 3182, respectively, of the stem portion 3178. In the seal forming structure shown in fig. 16D, the amounts of concavity and convexity are larger in both cases than those of the seal forming structure shown in fig. 16C, and therefore, the shoulder portion 3174 is longer and the corner portion 3176 is located farther from the apex portion 3172 than in the case of the seal forming structure shown in fig. 16C. For the seal-forming structure shown in fig. 16C, the stem portion 3178 is substantially straight and the edge 3184 is angled relative to a line joining the two corner portions 3176. In contrast, the edge 3184 of the seal-forming structure shown in fig. 16D is parallel to the line joining the two corner portions 3176. The seal-forming structure shown in fig. 16C may be better suited for faces having relatively flat nostrils, while the seal-forming structure shown in fig. 16D may be better suited for faces having relatively curved nostrils.

In the exemplary form of the seal forming structure 3100 shown in fig. 16E and 16F, changing the third principal component results in a change in the length of the seal forming structure 3100 in a direction perpendicular to a line joining the two corner portions 3176, i.e., the distance separating the stem portion 3178 and the apex portion 3172. The seal-forming structure shown in fig. 16E is generally more suitable for patients with longer and/or thinner noses, while the seal-forming structure shown in fig. 16F is generally more suitable for patients with shorter and/or wider noses. In the seal forming structure shown in fig. 16E, the apex portion 3172 is closer to the stem portion 3178 than the seal forming structure shown in fig. 16F, i.e., the seal forming structure 3100 of fig. 16E stretches more in a direction parallel to its reflection symmetry axis than the seal forming structure shown in fig. 16F.

Other exemplary shapes of seal-forming structures

Fig. 26 illustrates another form of a patient interface 3000 including a seal-forming structure 3100 and a plenum chamber 3200 in accordance with the present technique. Similar to the seal forming structure of fig. 16A to 16F, the seal forming structure 3100 of fig. 26 includes a vertex portion 3172, first and second corner portions 3176, and a stem portion 3178. The seal forming structure 3100 further includes a shoulder portion 3174 between the apex portion 3172 and the corresponding corner portion 3176.

When the patient interface 3000 of fig. 26 is worn by a patient, the apex portion 3172 is configured to adhere to an area of the patient's nose substantially below the nasal projection of the patient 1000. In some forms, the apex portion 3172 may also adhere to the nasal protrusions of the patient 1000. In some forms, the apex portion 3172 includes a notch 3160 at its radially outer edge. The recess 3160 is an area of the apex portion 3172 where the radial distance from the outside of the apex portion 3172 to the central opening in the seal forming structure 3100 is smaller than the adjacent portions. The outer side of the apex portion 3172 may be curved inwardly to form a notch 3160. When the seal forming structure 3100 is secured to the patient's face, the region of the seal forming structure 3100 proximate the nasal prongs may pucker due to excess material of the seal forming structure 3100 converging in that region. As illustrated in fig. 26, the notch 3160 of the seal forming structure 3100 may help to avoid such wrinkling. Wrinkles in any portion of the seal-forming structure 3100 may cause discomfort and/or line formation on the patient's face, especially if the seal-forming structure 3100 is worn for a long period of time, such as overnight. Wrinkles in the seal forming structure 3100 may also allow leakage, rendering the seal partially or fully ineffective and airtight, which may affect the effectiveness of the therapy. In other forms, the apex portion 3172 may not provide the notch 3160.

It should also be appreciated that similar notches may be provided in other forms of seal-forming structure 3100, such as in the apex portion 3172 of the seal-forming structure 3100 having a different shape, or in a portion of any seal-forming structure 3100, the seal-forming structure 3100 being configured to be proximate or adhered to a nasal projection in use.

The shoulder portion 3176 of the seal forming structure 3100 of fig. 26 may be configured to substantially adhere to the flange region 3141 of the patient 1000.

The stem portion 3178 may be configured to adhere to an upper lip 3142 of the patient's face, such as an upper portion of the upper lip.

The corner portion 3176 of the seal forming structure 1000 in fig. 26 is larger than the corner portions of the technical forms shown in fig. 16A to 16F. The corner portion 3176 in the form of fig. 26 may be described as a wing of the seal forming structure 3100. The corner portion 3176 may be configured to adhere to the patient's nasal wings on each side of the nose in use. In one form, the corner portion 3176 may be configured to extend in an upward direction substantially to the alar fold region on each side of the patient's face and in a lateral direction to a middle region immediately adjacent to the junction between the alar ridge point and the nasolabial folds when worn. In other forms, corner portion 3176 may also be adhered to the patient's face in areas adjacent the alar wings, for example, areas above the alar folds and/or areas of the patient's cheeks adjacent the alar wings. For example, in one form, corner portion 3176 may extend in a lateral direction to a lateral region immediately adjacent to the junction between the alar ridge point and the nasolabial folds when worn. It should be appreciated that the sealing area for any given patient will depend on the size of the seal-forming structure 3100 relative to the patient's face, as well as the positioning of the seal-forming structure 3100 on the face.

An opening

The seal forming structure 3100 includes at least one opening 3110 through which breathable gas is delivered to the airway of the patient. In one form, the opening 3110 may be a hole, as shown in fig. 3B, 3C, 5C, and 16A. The aperture may be generally D-shaped (e.g., as shown in fig. 16A-16F) such that the seal-forming structure 3100 with the aperture formed therein may adhere to an area around the nostrils of the patient's face. In other forms, the aperture may be of a different shape, such as substantially circular, oval or crescent.

Flange

The peripheral region of the seal-forming structure 3100 may be considered a flange, the seal-forming structure 3100 being configured to adhere to a patient's face in use. The flange may have an inner surface and an outer surface, wherein the outer surface is on a side of the flange opposite the inner surface. The inner surface is on the side of the flange that abuts the inner surface of the plenum chamber 3200 and the outer surface is on the side of the flange that abuts the outer surface of the plenum chamber 3200.

For example, in the technical forms shown in fig. 3A to 5C and fig. 8 to 11, an adhesive surface is provided on the inner surface of the flange. That is, in use, the inner surface of the flange adheres to the patient's face.

In the technical form shown in fig. 6, the seal forming structure 3100 includes a flange 3112. Flange 3112 includes an inner surface 3114 and an outer surface 3116. This form of adhesive surface 3102 is provided on the outer surface 3116 of flange 3112. The outer surface 3116 may be part of an outer surface of the seal-forming structure 3100. Flange 3112 is formed in such a way that it turns inwardly toward the interior volume within plenum chamber 3200 and has its outer surface 3116 facing toward patient 1000 for adhesion to the patient's face.

The form of the technique shown in fig. 6 may benefit from the use of a pressure assisted sealing mechanism. In use, positive pressure gas within the plenum chamber 3200 acts on the inner surface 3114 of the flange 3112, forcing the outer surface 3116 into tight sealing engagement with the face. Thus, in this form, the gas pressure within the plenum chamber 3200 may be used to enhance adhesion, rather than to push the seal-forming structure 3100 away from the skin. This, in turn, may reduce the amount of adhesion required to maintain a seal between the patient's face and the seal-forming structure 3100. Despite repeated application and removal of the seal-forming structure 3100, the reduction in adhesion required may result in less skin cell removal and less skin trauma. Additionally or alternatively, this means that the reduced strength adhesive or less adhesive is applied in some form to the adhesive surface of the seal forming structure 3100.

Non-adhesive tab

In some forms of the technology, for example as illustrated in fig. 21A-21D, the seal-forming structure 3100 includes one or more tabs 3108 for the patient 1000 or any other user to grasp the seal-forming structure 3100. Tab 3108 is the area of seal-forming structure 3100 that does not have an adhesive surface facing the patient.

The tab 3108 may be located at the periphery of the seal-forming structure 3100. For example, in the example illustrated in fig. 21A-21D, the seal-forming structure 3100 includes two tabs 3108, each tab 3108 located on a lateral periphery of the seal-forming structure 3100, and the two tabs 3108 are located opposite one another on either side of an opening 3110 in the seal-forming structure 3100, which opening 3110 allows gas to pass through the nostrils of the patient.

The tab 3108 may provide a gripping portion for the patient 1000 to grasp the seal-forming structure 3100 and transfer the seal-forming structure 3100 to their face without having to contact the adhesive or adhesive surface 3102 and/or grasp the seal-forming structure 3100 with their fingers in order to remove the seal-forming structure 3100 from the face. This ensures that the adhesive strength of the adhesive is not lost during the process of securing the seal-forming structure 3100 to the patient's face.

In some forms, the tab 3108 may facilitate the patient 1000 to pull and stretch the seal-forming structure 3100. This is particularly useful in the form of techniques using stretch releasing adhesives, which are discussed in detail in the following paragraphs. In this form, by stretching the adhesive surface 3102 of the seal-forming structure 3100, the adhesive strength of the stretch releasing adhesive can be reduced so that the seal-forming structure 3100 can be easily removed from the patient's face.

In some forms of this technique, the tab 3108 may be formed as part of a non-adhesive material that is attached to the adhesive surface 3102. For example, portions of non-adhesive material may adhere to edges of adhesive surface 3102. In other forms, the tab 3108 may be formed as a portion of non-adhesive material that covers a portion of the adhesive surface 3102. In other forms, the tab 3108 may be formed as a portion of the seal-forming structure 3100 to which no adhesive is applied.

Shape retainer

In some forms of the technology, the patient interface 1000 may include one or more shape retainers 3140. The shape retainer may be configured to facilitate retention of the shape of the seal forming structure 3100 before the seal forming structure is made to adhere to the patient's face, for example, to a sufficient extent to prevent the seal forming structure 3100 from wrinkling, folding, or sagging in a manner that makes it difficult for the patient 1000 to secure the seal forming structure 3100 to his face.

The one or more shape retainers 3140 may be one or more components, assemblies, or structures formed with shapes and/or made of materials to provide a predetermined level of stiffness suitable to facilitate a desired level of shape retention of the seal forming structure 3100. In some forms, one or more shape retainers 3140 are included as part of the seal forming structure 3100. In other forms, a shape retainer 3140 may be attached to the seal forming structure 3100 to facilitate retention of the shape of the seal forming structure 3100, for example by hardening one or more regions of the seal forming structure 3100.

Seal forming structure including shape retainer

In some forms, the seal forming structure 3100 includes one or more shape retainers 3140. One such form is illustrated in fig. 22A-22C, which will be described below, as well as other forms of the present technology in which the seal-forming structure 3100 includes one or more shape retainers 3140.

In some forms, the shape retainer 3140 may be provided on a side of the seal forming structure 3100 that faces away from the patient when the patient interface 3000 is worn, for example as shown in fig. 22A. The shape retainer 3140 may be configured to retain the shape of the main portion of the seal forming structure 3100. For example, the shape retainer 3140 may cover a majority of the side of the seal forming structure 3100 facing away from the patient.

In the exemplary form illustrated in fig. 22A-22C, the shape retainer 3140 includes an elongate member extending across a forward-facing surface of the seal forming structure 3100. In this particular example, the shape retainers 3140 are curved members that wrap around the surface of the seal forming structure 3100 in a path that ensures that any portion of the seal forming structure 3100 is sufficiently close to the shape retainers 3140 so that they have the desired effect of helping maintain the shape of the seal forming structure 3100. Accordingly, the shape retainer 3140 provides skeletal support for the seal forming structure 3100.

In other examples, the shape retainer 3140 may have another shape, such as other configurations of one or more elongated members, or the shape retainer may be a shape other than elongated. In one form, the shape retainer 3140 is formed from a plurality of elongate members arranged in a grid on a side of the seal forming structure 3100 that faces away from the patient when the patient interface 3000 is worn. The members may be arranged with holes in a grid in the shape of a parallelogram. Other shaped grids may also be formed in other forms of the present technology, such as with triangular holes or holes of another shape. The holes in the mesh are not necessarily all the same shape.

When using the patient interface 3000, the weight and amount of shape retainer material may not be so great as to cause discomfort to the patient 1000, for example, due to excessive rigidity of the seal-forming structure 3100, which may make it difficult to securely attach the seal-forming structure 3100 to the patient's face, particularly in the crevices of the patient's face. On the other hand, the shape retainer 3140 preferably has a sufficient size and/or extent to adequately retain the shape of the seal forming structure 3100 to help adhere the patient interface 3000 to the face. The amount of shape retainer material and the amount of area covered by the shape retainer material may be selected to achieve a desired balance of these considerations.

In some forms, the shape retainer 3140 includes one or more shape retaining members, such as elongate members, disposed about a peripheral region of the seal forming structure 3100. The central region of the seal forming structure 3100 located inside the peripheral member may have no shape-retaining member or little shape-retaining member provided in the central region of the seal forming structure 3100. This may provide sufficient flexibility to the central region of the seal-forming structure 3100 to be able to match the contours of the patient's face while the peripheral shape-retaining member provides a sufficient level of overall shape retention to the seal-forming structure 3100. In some forms, one or more shape retention members may span a central region of the seal forming structure 3100.

Similar to the balance to be achieved in terms of the amount of material from which the shape holder is made, a balance can also be found for the stiffness of the shape holder. In some forms, the shape retainers 3140 may be flexible enough so that they can comfortably conform to the contours of the patient's face, but yet stiff enough so that they adequately maintain the shape of the seal forming structure 3100. It will be appreciated that the desired flexibility/stiffness may be obtained by appropriate selection of the hardness of the material used to form the shape holder, and/or by appropriate selection of the material used to form the shape holder. In addition, if the patient takes the position where the shape holder is pushed into his skin, a degree of compliance in the shape holder can be used to avoid marking the patient's skin.

In the form illustrated in fig. 22A and 22B, the shape retainer 3140 is arranged to extend in a lateral direction relative to the body when worn, for example between the lateral edges of the plenum chamber 3200 and the seal forming structure 3100, wherein the non-adhesive tabs 3108 may be positioned in some fashion. In other forms, the shape retainers 3140 may extend in substantially different directions between the plenum chamber 3200 and one or more portions of the edge of the seal forming structure 3100.

In some forms, the shape retainer 3140 may be formed as a single component with the seal forming structure 3100 and/or the plenum chamber 3200. For example, in one form, the seal-forming structure 3100, which may include a shape retainer 3140, and the plenum chamber 3200 may be molded together. For example, the shape retainer 3140 may be a relatively thicker region of the seal forming structure 3100. In another example, the shape retainer 3140 and the plenum chamber 3200 may be overmolded onto a surface (e.g., the outer surface 3116) of the seal forming structure 3100. Alternatively, the shape retainer 3140 and/or the plenum chamber 3200 may be laminated to the seal forming structure 3100.

In other forms, the shape retainer 3140 and the seal forming structure 3100 and/or the remainder of the plenum chamber 3200 may be separately formed and connected together, such as by adhesive. In such forms, the shape retainers may be formed of a different material than the seal forming structure 3100 and/or the rest of the plenum chamber 3200. Alternatively, the seal forming structure 3100 and the shape retainer 3140 may be formed of the same material, for example, they may be integrally formed.

Example materials that may be used to form shape retainer 3140 include silicones, such as low duro silicone and TPE.

In some forms, the shape retainer 3140 is provided on a surface of the seal forming structure 3100 that faces away from the patient in use, and does not protrude outwardly from the patient facing surface of the inner surface of the seal forming structure 3100. Regardless of how the shape retainer is configured as part of the seal forming structure, the shape retainer 3140 may be configured to be substantially flush with the inner surface 3114. This may help avoid the shape holder marking the face when wearing the patient interface 3000.

In one form, the shape retainer 3140 may be configured such that the seal forming structure 3100 may stretch more easily in one direction than it may stretch in a different direction. That is, the shape retainer 3140 may be stress-strain anisotropic, or may provide stress-strain anisotropy to the seal forming structure 3100. For example, the bending member of fig. 22A to 22C is more easily stretched in the direction indicated by the letter F in fig. 22C than in the vertical direction.

In some forms, the shape retainer 3140 may be further configured to change a characteristic of deformation of the seal forming structure 3100 in different directions, e.g., the shape retainer 3140 may be configured such that deformation of the seal forming structure in one direction is plastic deformation and deformation of the seal forming structure in the other direction is elastic deformation. Alternatively, the transition between elastic deformation and plastic deformation may vary in different directions.

In some forms of the technology, the adhesive surface 3102 of the seal-forming structure 3100 may be provided with or formed from a stretch releasing adhesive. These forms of the technique will be described in more detail later, but aspects of these forms relating to the shape retainer 3140 will now be described.

In some forms of the technology, the shape retainer 3140 is configured such that the direction in which the seal-forming structure 3100 can be relatively easily stretched is aligned or substantially aligned with the direction in which the seal-forming structure 3100 can be stretched in order to peel the stretch release adhesive. For example, in the technical forms shown in fig. 22A to 22C, the bending member is arranged such that the member is mainly oriented in a direction perpendicular to a direction indicated by F in fig. 22C, with the bending portion connecting a portion oriented in the direction. This arrangement means that the curved shaped holder is wound outwards in the direction of arrow F. In this configuration, the shape retainer 3140 may be more easily deformed when a force is applied in the direction F. In the case of the form shown in fig. 22A-22C, this direction is a lateral direction when the patient interface 3000 is worn. Where non-adhesive tabs 3108 are used, this direction may be consistent with the direction of non-adhesive tabs 3108 as compared to plenum chamber 3200. In contrast, the seal forming structure 3100 is not easily stretched by applying a force in a direction perpendicular to F.

This form of technique may be used to achieve the use of stretch releasing adhesives while still benefiting from the shape retention of the shape retainer 3140.

In another form, the shape retainer 3140 may be configured to delaminate or otherwise separate from the seal forming structure 3100 when a force F is applied in a certain direction. For example, the shape retainer 3140 may be configured to separate from the seal forming structure 3100 when the patient 100 pulls the tab 3108 to separate the seal forming structure 3100 from the patient's face by reducing the adhesive strength of the stretch releasing adhesive.

In one form, a silicon bead material may be used to form the shape retainer 3140. The silicon beads may have a tendency to adhere less strongly to the seal-forming structure 3100 than to adhere internally between the silicon beads. When a force is applied in a direction on the seal forming structure 3100, this may cause the shape retainer 3140 to delaminate and/or separate from the seal forming structure 3100. In another form, the shape retainer 3140 may be formed as a TPE overmold over the rest of the seal forming structure 3100, and it has been found that this results in delamination of the shape retainer when the seal forming structure 3140 is stretched.

By separating from the seal forming structure 3100, the shape retainer 3140, once separated, does not increase the force required to separate the stretch releasing adhesive from the seal forming structure 3100. This may reduce the amount of stretch required to peel the stretch-release adhesive compared to other situations, avoiding excessive force to peel the adhesive, which may be uncomfortable for the patient 1000.

Front layer shape retainer

As described above, in some forms of the technology, a shape retainer 3140 may be attached to the seal forming structure 3100 to facilitate retention of the shape of the seal forming structure 3100, for example by reinforcing one or more regions of the seal forming structure 3100.

In some forms of the technique, as shown in fig. 15B and 15C, for example, the patient interface 3000 may further include a shape retainer 3140 in the form of an anterior layer 3230, the shape retainer 3140 being configured to retain the shape of the seal-forming structure 3100 and thereby assist in positioning the patient interface 3000 in a therapeutically effective position on the patient's face prior to removal of the anterior layer. The front layer 3230 may be removably attached to the front surface of the seal forming structure 3100 and optionally to the plenum chamber 3200. For example, the front layer 3230 may be adhered to the front surfaces of the seal-forming structure 3100 and the plenum chamber 3200 by a weak bond adhesive such that the front layer 3230 may be easily removed by the patient once the patient interface 3000 is in place. The adhesive may be provided on a surface of the front layer such that little or no adhesive may be perceived on the front surface of the patient interface 3000 when the front layer is removed.

In some forms, the front layer 3230 may be configured to maintain the seal forming structure 3100 in some shape prior to removal. This feature has several advantages. For example, the front layer 3230 may prevent the seal-forming structure 3100 and/or the plenum chamber 3200 from changing their shape prior to being secured to the patient's face. Further, the front layer 3230 may allow for easier handling of the material forming the seal forming structure 3100, such as winding and handling, during manufacturing without deforming or otherwise damaging the material used to form the seal forming structure 3100.

In one form, the front layer 3230 may be made of a material and formed into a shape such that the front layer is relatively rigid compared to the seal forming structure 3100 (which may be flexible, as explained above).

As explained above, once the seal-forming structure 3100 is adhered to the patient's face, the anterior layer 3230 can be removed from the seal-forming structure 3100. The front layer 3230 may be provided with an extension 3232 (which may alternatively be referred to as a tab), the extension 3232 being configured to extend beyond the periphery of the seal forming structure 3100 and/or the plenum chamber 3200 when the front layer is attached to the seal forming structure 3100 and/or the plenum chamber 3200. Once the seal forming structure 3100 is secured to the face, the extensions 3232 are used for the patient 1000 to grasp with their fingers and remove the anterior layer 3230.

In some forms, the front layer 3230 may be attached to the seal forming structure 3100 by adhesive. In one form, the adhesive used may be applied such that the surface of the seal-forming structure 3100 that contacts the front layer 3230 is not tacky when the seal-forming structure 3100 is separated from the front layer 3230.

In an alternative form, the front layer 3230 may remain attached to the seal forming structure 3100 throughout the time that the patient interface 3000 is in use.

In some forms, the anterior layer 3230 may be shaped to closely mimic or substantially resemble the features of a patient's face in the region to which the seal-forming structure 3100 is to be attached in use. In the form illustrated in fig. 15B and 15C, for example, the anterior layer 3230 includes two folds 3232 positioned and shaped to be inserted into the patient's nasal alar folds when the patient interface 3000 is in contact with the face. When the patient pushes the anterior layer 3230 towards their face, the seal-forming structure 3100 is thus pushed into the nasal alar folds, facilitating adhesion of the seal-forming structure 3100, which otherwise may be a region where adhesion is difficult to obtain due to the contours of that region. Similar features may be provided for other features of the target sealing region.

In some forms, the shape and size of the anterior layer 3230 can be customized to the individual patient's face. Alternatively, the anterior layer 3230 may be one of a plurality of different anterior layers 3230 having different shapes and sizes such that the patient may select the anterior layer 3230 that most closely resembles their facial shape and/or size. This may help the patient properly position patient interface 3000 on their face.

In the technical form shown in fig. 15B and 15C, the front layer 3230 has a ring shape with a hole in a central region. The aperture may be configured to receive a plenum chamber 3200, wherein the front layer 3230 contacts a surface of the seal forming structure 3100 facing away from the patient in use. The front layer may include one or more slits to facilitate removal of the front layer.

In some forms (not shown), the front layer 3230 may include a plurality of panels. For example, the front layer 3230 can be formed in two pieces, or preferably three pieces. The different panels of the front layer 3230 can vary in orientation relative to one another. In the case of the front layer 3230 being relatively rigid, this may allow the different sections of the seal forming structure 3100 to be oriented to allow them to adhere well to the patient's face, e.g., to be pressed into crevices and corners of the patient's face. In one form, the front layer 3230 can include three panels-a center panel, a left panel, and a right panel. The left and right panels may be configured to be located on either side of the center panel. The centerpiece may have a generally oval shape. The left and right panels may correspondingly have a concave shape configured to engage with the center panel.

In one form, the front layer 3230 can be made of plastic.

Front layer 3230 may be considered a form of applicator to help position patient interface 3000 in a therapeutically effective position on the patient's face. In the form of the technique described in this section and illustrated in fig. 15B and 15C, the applicator forms part of the patient interface 3000 in the sense that the applicator may be attached to the patient interface 3000 prior to donning the patient interface. In other forms of the technique, an applicator 3800 separate from the patient interface 3000 may be provided, such as described in more detail below.

Multiple seal forming structures

In some forms of the technology, the patient interface system 5000 may include a plenum chamber 3200, the plenum chamber 3200 being configured to interchangeably attach to each of a set of multiple seal-forming structures to form a patient interface. Each of the plurality of seal-forming structures may be configured to adhere to a different facial region.

Conventional use of patient interface 3000 in the form of the present technique involves repeated application and removal of seal-forming structure 3100. Each time the seal-forming structure 3100 is removed, it may remove some skin cells that are stuck to the adhesive and detached from the skin. Over time, such removal of skin cells may cause trauma to the facial area of the patient to which the seal-forming structure 3100 is adhered.

To alleviate this problem, forms of the present technology provide a patient interface system 5000 that includes multiple seal-forming structures that cover different areas of the facial skin 5000. This allows the patient to change the adhesion location of the facial regions so that the same facial regions are not traumatized in a sequential therapy session and allows the facial regions to recover for a period of time therebetween.

In one form, for example as shown in fig. 7, the patient interface system 5000 may include a first seal-forming structure 3120, a second seal-forming structure 3130, and a plenum chamber 3200. The first seal-forming structure 3120 includes a first sealing surface configured to adhere to a first region of the patient's face. The second seal-forming structure 3130 includes a second sealing surface configured to adhere to a second region of the patient's face. The first region may be different from the second region.

In some forms, the second region 3130 of the patient's face may surround the first region 3120. That is, portions of the second region 3130 may be positioned radially outward from radially adjacent portions of the first region 3120. Furthermore, in some forms there may be no overlap between the first region and the second region.

In one form, the first region may include, but is not limited to, one or more of a flange, an upper region of the upper lip (e.g., a subnasal spot region, which may include a portion of the upper lip just below the subnasal spot), and a columella.

In one form, the second region may include, but is not limited to, one or more of a nasal wing, a nasal wing fold, an upper lip, and a nasal projection.

In other forms of the present technology, the area of the patient's face to which the first seal-forming structure 3120 and the second seal-forming structure 3130 are configured to adhere may be different than the above-described areas.

Whenever a therapy session exists, the patient is able to select the same type of seal-forming structure as either of the first seal-forming structure 3120 and the second seal-forming structure 3130 and connect it to the plenum chamber 3200 to form the patient interface 3000. The patient 1000 may be interchanged between the first seal-forming structure 3120 and the second seal-forming structure 3130 to allow skin in each facial region to recover, for example, by alternating between a first seal-forming structure type and a second seal-forming structure type for a continuous session. This is particularly useful when respiratory therapy requires daily or periodic use of patient interface 3000.

Composition of seal forming structure

Material-seal forming structure

In some forms of the present technology, the seal-forming structure 3100 is constructed from a material having one or more of the following characteristics: biocompatibility; softening; flexibility; stretchable and optionally elastic. In an exemplary form of the present technology, the seal forming structure 3100 is formed of silicone or thermoplastic elastomer (TPE).

TPE can be a particularly advantageous material for forming seal-forming structures in this certain form of technology because it is inexpensive, recyclable, flexible and can be used with a variety of adhesives such as acrylate-based adhesives. In addition, TPE may be molded as thin sections that are stretchable and remain stretched. This may allow the TPE-based seal forming structure 3100 to form a very tight seal with facial areas such as nasal alar folds. The plastic deformability of TPE means that the seal forming structure 3100, which seals with the patient's facial area, does not attempt to spring back to its original shape. This in turn means that no pulling force is exerted on this area, thereby reducing the discomfort caused by wearing the patient interface. This may be a particularly important consideration for sealing against sensitive areas of the patient's face, such as the region of the nasal alar fold.

The ability of TPE to be cut into thin sections may allow the seal-forming structure to adhere tightly to the skin surface. This has two advantages. First, the thin sections allow for a highly compact configuration with the underlying skin and facial features. Second, the thinner sections are more likely to remain flush with and not protrude from the skin surface. This may reduce the likelihood that the seal forming structure 3100 will partially or completely loosen due to friction between the patient's face and surrounding objects (such as pillowcases, sheets, etc.).

One advantage of forming the seal-forming structure 3100 from a soft material (such as TPE) and in a configuration that enables the seal-forming structure 3100 to flex is that the seal-forming structure 3100 can conform to the shape of the patient's face and the seal-forming structure 3100 continues to do so when the shape of the patient's face changes, for example if the shape of the patient's face changes position. The reason why this is advantageous has been explained above.

In some forms, it may be advantageous to use a material for the seal forming structure 3100 that undergoes plastic deformation as it bends and/or stretches, i.e., it does not rebound to its original shape or size, or at least does not rebound completely. This prevents the seal forming structure 3100 from exerting shear forces on the patient's skin when attempting to return to its original shape/size.

In some forms, the material used to form the seal-forming structure 3100 may be stretchable. The material may be elastically deformable or plastically deformable upon stretching. When a stretch releasing adhesive is used, the stretch capability may be used to easily remove the seal-forming structure 3100 from the patient's face. These adhesives are discussed in further detail in the next section. An example of a stretchable material suitable for use in the stretch releasing adhesive is silicone rubber.

In some forms of the present technology, an example of a material suitable for use as a seal-forming structure is 3M ^TM Nexcare ^TM Tape and Leukoplast tape. These tapes also have an adhesive surface. In some forms, the material may include a rayon substrate with an adhesive applied thereto. In one form, the seal-forming structure may be formed from 3M ^TM Product number 2484, 3M ^TM Medical tape 9833, or similar type of product or product having similar structure, or may include 3M ^TM Product number 2484, 3M ^TM Medical tape 9833, or similar types of products or products having similar structures. A multi-layer tape or product may be used to form the seal-forming structure 3100.

Fig. 27 illustrates an exploded cross-sectional view of a portion of an adhesive seal forming structure 3100 in accordance with one form of the present technique. The seal forming structure 3100 includes a plurality of layers: a first layer component 6532, a second layer component 6534, and a removable layer 3104. Although in the form shown in fig. 27, the seal forming structure 3100 includes two layer components 6532 and 6534, in other forms, the seal forming structure 3100 may include only one layer component. In other forms, the seal forming structure 3100 may include three or more layer assemblies.

The first layer assembly 6532 includes a backing layer 6532A and an adhesive layer 6532B. The second layer assembly includes a backing layer 6534A and an adhesive layer 6534B. Each of the additional layer assemblies may also include a backing layer and an adhesive layer, if other forms of additional layer assemblies are present.

As shown in fig. 27, the layers may be arranged such that a backing layer (e.g., the second backing layer 6534A) forms one side of the seal-forming structure 3100 and the removable layer 3104 forms the opposite side of the seal-forming structure 3100. The adhesive layer 6534B is sandwiched between the second backing layer 6534A and the first backing layer 6532A. The first adhesive layer 6532B is sandwiched between the first backing layer 6532A and the removable layer 3104.

The removable layer 3104 is used to protect the second adhesive layer 6532B until the seal forming structure 3100 is attached to the patient's face. The function and characteristics of the exemplary removable layer 3104 are explained in more detail in later portions of this specification. Alternatively, the removable layer 3104 may be referred to as a liner.

In some forms, each backing layer may be formed from a thin layer of plastic, such as a polyurethane film. Each adhesive layer may be formed of a suitable adhesive, such as a medical silicone adhesive. In some forms, each adhesive layer may be formed of a highly tacky 3M ^TM Medical silicon adhesives are formed. Removable layer 3104 may be formed of a thin plastic or polymer, such as a polypropylene film. In one form, the removable layer 3104 is formed from a polypropylene film with a non-silicone release on one side. In one exemplary form of the technology, the seal forming structure 3100 is formed from two layers of 3M ^TM Product number 2484 was formed.

In some forms, the patient interface 3000 may be formed with a plenum chamber 3200 attached to an outer backing layer 6534A of the seal forming structure 3100.

Thickness-seal forming structure

If the seal-forming structure 3100 is too thin, it may make it difficult to remove and reapply the patient interface 3000 to the patient's face in the event that the patient interface 3000 is applied to an incorrect region of the patient's face. Too thin a seal forming structure 3100 tends to easily lose its shape and can fold onto itself, stick to itself and be difficult to manipulate when removed. Too thin a seal forming structure 3100 may also be prone to tearing.

On the other hand, if the seal-forming structure 3100 is too thick, the seal-forming structure 3100 may feel quite stiff when it is attached to the patient's face, and may cause discomfort when in use. Furthermore, stiff and/or thick seal forming structures 3100 may be difficult to press into corners and/or crevices of a patient's face, thereby affecting the quality of the seal to the face that can be achieved. The thickness of the seal-forming structure 3100 may also prevent the seal-forming structure from changing its shape to accommodate facial movement of the underlying facial region.

The appropriate thickness will depend on the choice of materials used for the seal forming structure 3100 and also on the shape and structure of the seal forming structure.

In some forms, the seal-forming structure 3100 may have a thickness substantially in the range of about 0.2mm to 0.3mm, excluding the thickness of the removable layer 3104, or about 0.3mm to 0.45mm including the removable layer. For example, in the case of the seal forming structure 3100 of fig. 27, in which two layers of 3M are used ^TM Product number 2484, without removable layer 3104, may be substantially 0.24mm thick, while with removable layer 3104, the thickness may be 0.33mm. In this exemplary form, the backing layer 6532A and the backing layer 6534A may each have a thickness of about 0.02mm, and the adhesive layer 6532B and the adhesive layer 6534B may each have a thickness of about 0.1 mm. In other forms, the seal forming structure 3100 may have different thicknesses. The appropriate thickness to provide the appropriate balance of shape retention and comfort may depend on several factors including, for example, the choice of materials used and the number of layers.

Other Properties-seal formation Structure

In some forms, it may be advantageous for the seal-forming structure 3100 to be able to transfer moisture through it. This may allow moisture from the patient's skin to pass through the seal forming structure 3100. Since the patient interface 3000 may generally be worn for a long period of time, this may be desirable to avoid moisture accumulation under the seal forming structure 3100 and discomfort. In some forms, the material used to form the seal-forming structure 3100 may have a thickness of approximately 50gm/m ² Day to 1000gm/m ² Moisture Vapor Transmission Rate (MVTR) in the range of/day, e.g., at 3M ^TM Product number 2484In the case of approximately 700gm/m ² Day. Higher MVTR values may be more desirable when patient interface 3000 is worn for extended periods of time. When the patient interface 3000 is designed for a relatively short period of time, the seal-forming structure 3100 may have a low MVTR value.

It has been described that it is advantageous to form the seal forming structure 3100 from a deformable material.

In some forms, it may be desirable for the seal-forming structure 3100 to be transparent or translucent. This may reduce the visual footprint of patient interface 3000 on the patient's face and help make the patient interface more desirable to wear for extended periods of time.

Adhesive form

The form of the technology provides a patient interface 3000, the patient interface 3000 comprising a seal-forming structure 3100, the seal-forming structure 3100 comprising at least one adhesive surface configured to adhere, in use, to a region of a patient's face surrounding an entrance to an airway of a patient to form a seal.

Any suitable adhesive may be used and suitable properties of adhesives used in some forms of the technology are described in the following paragraphs. It should be understood that the form of the present technology is not limited to certain adhesives unless explicitly stated otherwise. Further, in some forms, the adhesive may include one or more constituent adhesive materials.

In some forms, the adhesive applied to the adhesive surface of the seal-forming structure 3100 is an adhesive that adheres to the skin with an adhesive strength that maintains adhesion when forces of the direction and magnitude typically encountered when the patient interface 3000 is in use are applied so that the seal-forming structure 3100 does not become too easily detached during normal use. Similarly, the adhesive strength should not be too great to remove the patient interface 3000 after cessation of therapy without causing trauma to the skin. In some forms, the seal-forming structure may have an adhesive strength substantially in the range of about 2N to 3.5N per 25.4mm width.

In some forms, the adhesive may be configured to maintain a desired level of adhesion to facial skin despite the presence of moisture (e.g., sweat) on the patient's skin and/or heat from the skin.

It is desirable that the adhesive be able to adhere to the skin regardless of the contour of the patient's skin to which it is adhered, such as whether wrinkles or peaks or flat areas are present.

It is desirable that the adhesive be odorless (as long as it is generally perceived by the patient) and colorless or have an aesthetically attractive color. Furthermore, certain forms of the present technology use adhesives where no or little residue remains after removal from the skin. Adhesives that do not have these characteristics may be used in some forms of the present technology and may operate effectively, but may be undesirable to the patient.

Some adhesives require steps to be taken to prepare the surface to which the adhesive is to adhere in order to form an effective bond. For example, some adhesives require wiping the patient's skin with a cleaning fluid such as alcohol prior to use. The need for such preparations may be undesirable because it requires additional steps from the patient, and they may not be effective in preparing skin, particularly when tired. Thus, some forms of the present technology use adhesives that do not require such surface treatments.

It is desirable to use adhesives that adhere effectively to the skin but not well to the hair. This avoids discomfort experienced by the patient when the seal forming structure is removed and hair is removed therewith.

Desirably, the adhesive is adapted to adhere the seal-forming structure 3100 to the skin and, if desired, remove it and then adhere to the patient's skin. When the patient interface 3000 is first donned, the patient may not always be able to properly position the seal-forming structure 3100. For example, it may be located in an uncomfortable or undesirable location. In some forms of the technique, the adhesive surface of the seal-forming structure 3100 is provided with an adhesive adapted to reapply the seal-forming structure 3100 to the patient's face at least once.

At 3M ^TM Product number 2484, 3M ^TM Nexcare ^TM Adhesive tape and Leukoplast adhesive tapeThe adhesives used above are examples of suitable materials that carry adhesives that have one or more of the above-described properties and are used in some forms of the technology. For example, a rubber zinc oxide adhesive may be used. In other forms, other adhesive tapes are used, such as acrylic or acrylate adhesives, or silicone adhesives. The adhesive on the adhesive tape has been provided on a substrate (i.e., tape) which may be advantageously used as the seal forming structure 3100 or a portion thereof, or may be easily attached to the seal forming structure 3100. At 3M ^TM In the case of product number 2484, the adhesive is a silicone adhesive ("high tack 3M) ^TM Medical silicone adhesive "). 3M ^TM Product number 2484 had an adhesive strength of 2.8N per 25.4mm width. At 3M ^TM In the case of medical tape 9833, the adhesive is an acrylic/acrylate adhesive.

In other forms of this technique, the adhesive used to seal the forming structure 3100 may be deposited directly on the adhesive surface 3102, for example as described below. As part of the manufacturing process, the adhesive may be deposited on the adhesive surface. Alternatively, in some forms, the patient interface 3000 may be supplied in a form in which adhesive has not yet been applied to an adhesive surface, and the patient (or clinician) applies the adhesive to the surface prior to use.

Fluid adhesive

In some forms of the present technology, the patient interface 3000 includes a seal-forming structure 3100, the seal-forming structure 3100 having at least one surface to which a fluid adhesive can be applied to form an adhesive surface.

Spray adhesive

In an alternative form of the present technique, the patient interface 3000 includes a seal-forming structure 3100, the seal-forming structure 3100 having at least one surface onto which a sprayable adhesive can be sprayed to form an adhesive surface.

Functional release adhesive

In some forms, the seal-forming structure 3100 may be attached to the patient's face using one or more action-release adhesives. The effect-release adhesive may be configured such that its adhesive strength decreases when an "effect" is achieved. The decrease in adhesive strength may be sufficient to allow the seal-forming structure 3100 to be easily removed from the patient's face while causing an acceptable level of discomfort. Examples of the effect are provided below. In some forms, the effect may be some variation or effect of a component applied to the adhesive or applied to the adhesive (such as seal forming structure 3100).

In some forms of the present technology, the patient interface 3000 includes a seal-forming structure 3100 having an adhesive surface 3102, wherein the adhesive strength of the adhesive surface 3102 can be reduced by deformation of the adhesive surface 3102. When deformed, the adhesive surface 3102 may be configured to substantially or completely lose or alter its adhesive properties, thereby reducing or losing its adhesive strength. This allows the patient 1000 to easily remove the seal forming structure 3100 by deforming.

In some forms, the adhesive surface 3102 may be provided with or formed from a stretch-release adhesive. Stretch-release adhesives may have certain adhesive properties only when the adhesive surface 3102 is substantially unstretched. When the adhesive surface 3102 is stretched, the adhesive surface 3102 may be configured to have reduced and/or no adhesive properties. In some forms, acrylate-based adhesives may be used as stretch-release adhesives for adhesive surface 3102, such as Fixomul ^TM Or 3M ^TM Stretching the release tape.

In some forms, the adhesive surface 3102 may be formed from a carrier material to which a stretch releasing adhesive may be applied. In some examples, the carrier material may be polyurethane. Polyurethane may be suitable because it is lightweight, flexible, malleable, safe to use on the skin, breathable, can carry adhesive, and other components of the patient interface may be overmolded onto it (such as explained elsewhere in this specification). In other forms, other suitable carrier materials may be used.

In some forms, the adhesive surface 3102 provided with a stretch-release adhesive may include a polyurethane removable layer 3104, such as a stretchable polyurethane layer. In this specification, a layer that is removable from an adhesive layer to enable the adhesive to adhere to a patient may be referred to as a liner. The use of stretch-release adhesive may allow the seal-forming structure 3100 to be easily removed from the patient's face by stretching the adhesive surface 3102.

In other examples, the effect-releasing adhesive may include a heat-releasing adhesive that loses adhesive strength when heated or when exposed to temperatures greater than a predetermined level. In another example, the effect-release adhesive may be a water-release adhesive that separates the seal-forming structure 3100 when the adhesive (and/or the seal-forming structure 3100 carrying the adhesive) becomes wet and/or damp. In yet another example, the effect-release adhesive may be configured to lose adhesion when exposed to radiation of a particular frequency (such as ultraviolet light).

Adhesive tape section

In an alternative form of the technique, patient interface 3000 includes one or more adhesive tape segments configured to provide at least one sealing surface of the at least one seal-forming structure. Each adhesive tape section may include a first adhesive on one side and a second adhesive on the other side. The first adhesive may be configured to secure the adhesive tape segment to the seal-forming structure 3100. The second adhesive may be configured to secure the seal-forming structure 3100 against the skin of the patient 1000. Thus, the second side of the adhesive tape section provides an adhesive surface.

The adhesive tape section may be provided with a removable layer to protect the first adhesive and the second adhesive from contamination and/or adhesive loss prior to assembly of the seal-forming structure 3100.

In some forms (not shown in any of the figures), the adhesive tape sections may be provided with one or more shape retainers, which may improve the shape retention of the adhesive tape sections. The shape holder may be provided only to the adhesive tape section and not to the removable layer.

The shape retainer provides structural support to the section of adhesive tape when the removable layer is removed, thereby preventing the section of adhesive tape from wrinkling or substantially changing shape or orientation. If the shape and/or orientation of the adhesive tape sections is sufficiently altered, several disadvantages may result.

First, the seal forming structure 3100 may adhere to incorrect locations on the patient's face. For example, if the seal-forming structure 3100 is designed to attach to the flange region of the nose, the altered shape of the adhesive surface may result in other areas of the nose or face outside of the flange region, such as septum 3132, nasal post, or nostril regions, coming into contact with the adhesive surface. This may result in poor sealing, inconvenience, discomfort, and/or pain to patient 1000.

Second, if the sections of adhesive tape are wrinkled or deformed when the removable layer is peeled off, one or more portions of the sections of adhesive tape may be folded over one another. This may result in a reduced surface area of exposed adhesive, which may result in ineffective sealing between the patient's face and the seal forming structure 3100.

Third, if one or more portions of the adhesive tape sections are folded over one another, an uneven adhesive surface 3102 may result, which may leave marks on the patient's face.

The shape retainer of the adhesive tape section may have the same properties, configurations and/or advantages as the shape retainer 3140 described previously herein. Further, the shape retainer of the adhesive tape section may be formed in the same manner as the shape retainer 3140.

Removable layer

In some forms, patient interface 3000 may further include a removable layer 3104 that is removably attached to adhesive surface 3102 and covers adhesive surface 3102. Removable layer 3104 may be removed before patient interface 3000 is positioned in sealing contact with the patient's face. As described above, the removable layer 3104 may be referred to as a liner. Removable layer 3104 may be made of any suitable material including paper, such as waxed paper, or plastic, such as polypropylene.

Removable layer 3104 may be used to protect the adhesive on adhesive surface 3102 from contamination, inadvertently adhering to other surfaces and/or losing adhesion when patient interface 3000 is not in use. Removable layer 3104 may be attached to adhesive surface 3102 by an adhesive when patient interface 3000 is transported, stored, or otherwise not in use, but may be configured to form a generally weak attachment with adhesive surface 3102, for example by having a smooth surface that contacts adhesive surface 3102. Removable layer 3104 may be removed by patient 1000 before patient interface 3000 is donned. Fig. 14A, 14B, 15A, 15B, and 17 illustrate exemplary forms of techniques in which patient interface 3000 includes a removable layer 3104. In one form, the removable layer 3104 may include a tab 3104T that extends beyond the footprint and/or perimeter of the seal-forming structure 3100. The patient 1000 may peel the removable layer 3104 by grasping the tab 3104T (as shown in fig. 14B) and pulling the removable layer 3104 away from the seal-forming structure 3100.

In one form, the removable layer 3104 includes two portions-a first portion 3105 and a second portion 3106, as shown in fig. 15A and 15B. The first portion 3105 of the removable layer 3104 may be configured to be peeled away toward a first side of the patient's face, and the second portion 3106 of the removable layer 3104 may be configured to be peeled away toward a second side (which may be opposite the first side). The first portion 3105 may have a first tab 3105T and the second portion 3106 may have a second tab 3106T. When the first portion 3105 and the second portion 3106 are attached to the adhesive surface 3102, the first tab 3105T and the second tab 3106T may extend in different, e.g., opposite, directions. The patient 1000 may peel the first portion 3105 by grasping the first tab 3105T and pulling in the relevant direction. Similarly, the patient 1000 may peel the second portion 3016 by grasping the second tab 3106T and pulling in the relevant direction.

The tabs 3104T, 3105T, and 3106T allow the respective removable layers 3104, 3105, 3106 to be peeled apart after the patient interface 3000 is properly positioned against the patient's face. The ability to position the patient interface 3000 against the face without adhesive attachment (i.e., when the removable layer is in place) allows the patient to try different positions of the patient interface 3000 before it is adhered. This enables the patient to identify a comfortable and efficient position for securing the seal-forming structure 3100 to the patient's face. This is particularly important when the seal-forming structure 3100 is shaped to match/resemble a particular region of the patient's face to which the seal-forming structure 3100 is adhered.

In a first step, a patient interface 3000 with removable layers 3104, 3105, 3106 is placed against the patient's face until a suitable location is identified. In a second step, the patient 1000 may slide a finger under the tab 3104T, 3105T, or 3106T and/or move the patient interface 3000 slightly forward to provide clearance for the patient 1000 to grasp the tab 3104T, 3105T, or 3106T. In a third step, tab 3104T, 3105T or 3106T is peeled away to expose underlying adhesive surface 3102. In a fourth step, the seal-forming structure 3100 is secured to the patient's face by pressing the adhesive surface against the patient's face.

In one form, the tabs 3104T, 3105T, or 3106T may be configured to clear facial features of the patient when the patient interface 3000 is in a predetermined position. For example, if patient interface 3000 is configured to be attached in or around the nose region, tabs 3104T, 3105T, or 3106T may be positioned away from the nose such that the patient may grasp tabs 3104T, 3105T, or 3106T without being blocked by the nose.

Alternatively, when the patient interface is in the desired position, the tab 3104T, 3105T, or 3106T may be configured to rest against soft tissue, which may deform when a finger slides under the tab 3104T, 3105T, or 3106T for grasping. For example, if patient interface 3000 is configured to be attached in or around a mouth region, tabs 3104T, 3105T, or 3106T may be positioned against the cheeks, which may be slightly deformed to accommodate the patient's fingers when grasping tabs 3104T, 3105T, or 3106T.

Plenum chamber

Some forms of the plenum chamber 3200 of the present technique are configured to receive a flow of breathable gas from the air circuit 4170 at a therapeutic pressure for patient breathing. The plenum may be formed to be pressurizable to at least 6cmH above ambient air pressure ₂ Therapeutic pressure of O, and in some forms up to about 20cmH ₂ O or 30cmH ₂ O pressure.

In one form, the plenum chamber 3200 has a perimeter shaped to complement the surface contour of an average human face in the area where the seal will be formed in use. The complementary shape of the perimeter of the plenum chamber 3200 may be configured to facilitate proper positioning of the patient interface 3000 against the patient's face in use.

Alternatively, in some forms, the plenum chamber 3200 may be shaped in a customized manner for an individual patient. Alternatively, the plenum chamber 3200 of the patient interface 3000 may be selected from one of many possible forms of the plenum chamber 3200, with the appropriate plenum chamber for the individual patient being selected as best suited for them.

In use, the boundary edge of the plenum chamber 3200 is positioned against the adjacent surface of the face. The seal forming structure 3100 may provide the actual contact with the face. The seal forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200 in use.

In some forms, the plenum chamber 3200 and seal forming structure 3100 are formed from a single sheet of homogeneous material, such as silicone or TPE.

In certain forms of the technology, such as shown in fig. 4A-4C, 5A, 8, 9A-9D, 10B, 26, and 28-32, the plenum chamber 3200 may be generally frustum-shaped. These forms of inflatable chambers 3200 have a first end that is, in use, proximate to the patient and a second end that is, in use, distal from the patient, wherein the open area at the first end is greater than the open area at the second end. In some forms, the plenum chamber 3200 may taper from the first end to the second end, or portions of the plenum chamber 3200 may taper in that direction, e.g., an area of the plenum chamber 3200 surrounding the plenum chamber inlet port 3202 may taper. The cross-section of the plenum chamber 3200 at the first end and/or the second end may be substantially circular. Alternatively, the cross-section may be another shape, such as an oval.

The first and second ends of the plenum chamber 3200 may be substantially open. The first end may be configured to be fluidly connected to the seal-forming structure 3100 to provide pressurized gas to the airway of the patient. The second end may be substantially opposite the opening 3110 and may form a plenum inlet port 3202, as described further below.

The first end of the plenum chamber 3200 may have an area wide enough to cover the patient's airway (e.g., across the nose or over the nose and mouth) to allow air to flow into and out of the nostrils to be directed through the patient interface 3000.

The second end of the plenum chamber 3200 may be configured to connect to the air circuit 4170 and, thus, may have a smaller area to connect to the air circuit 4170. This facilitates a substantially airtight connection between the air circuit 4170 and the plenum inlet port 3202.

In some forms, the walls of the plenum chamber 3200 may form a tapered surface, or they may curve away from a truly tapered surface, e.g., bulge outwardly.

In alternative forms, the plenum chamber 3200 may have a generally hemispherical or other cup-like shape.

Plenum alignment

A plenum chamber 3200 having a perimeter shaped to complement the surface contour of a typical human face in the area where a seal will be formed in use has been described, the plenum chamber 3200 may assist in correctly positioning the patient interface 3000 against a patient's face in use.

Alternatively or additionally, the positioning guide member may be used to facilitate proper positioning of the patient interface 3000 against the patient's face when donned, which may enable the patient interface 3000 to be properly positioned prior to the seal forming structure 3100 being adhered to the patient's face.

In some forms, as shown in fig. 19A-19E, a positioning guide member 3220 extends from an interior portion of the plenum chamber 3200 toward the patient. Positioning guide member 3220 may be advantageous because it allows patient 1000 to properly position patient interface 3000 and in some forms does not need to see itself. This may be useful when positioning the patient interface 3000 in the dark or without a mirror or device with a front camera.

In addition, positioning guide members 3220 may allow patient 1000 to reposition and/or adjust patient interface 3000 prior to adhesive surface 3102 contacting the patient's skin. If the adhesive surface 3102 contacts the patient's face before the patient 1000 is satisfied with the position of the patient interface 3000 against its face, there may be contamination and/or loss of adhesion when the patient 1000 removes the patient interface 3000 and repositions it. In addition, repeated application and removal of the seal-forming structure 1000 may inadvertently cause skin trauma and/or skin cell sloughing.

In some forms, as shown in fig. 19A-19E, the positioning guide member 3220 may include a member having a concave portion facing the patient's face. The concave portion may be configured to receive a portion of the patient's face when the patient interface 3000 is worn, in order to assist the patient in properly positioning the patient interface 3000 on their face.

In some forms, as shown in fig. 19A, 19B, and 19E, the positioning guide members 3220 may comprise V-shaped members forming a portion of the plenum chamber 3200 or protruding outwardly from the plenum chamber 3200. In use, the V-shaped member may be configured to receive the septum of the patient 1000 in contact with the inner vertex of the V-shape. The V-shaped member may be formed of a soft material such that the V-shaped member may deform and not cause discomfort to the patient 1000 when the patient interface 3000 is worn. The V-shape of the V-shaped member may be circular. The positioning guide member 3200 may also comprise a U-shaped member for similar purposes.

In another form, as shown in fig. 19C and 19D, the positioning guide member 3220 includes a member having a concave portion with a side smoothly curved along an edge containing concavity.

The positioning guide member 3220 may be sized such that it does not occlude the airway of the patient in use. The positioning guide member 3220 may be made of a soft material such as TPE.

In the technical form shown in fig. 19A to 19D, the positioning guide member 3220 forms a part of the plenum chamber 3200, while in other forms, the positioning guide member 3220 is provided as a part of the plenum chamber 3200.

In some forms of the technique, after the patient interface 3000 has been donned and properly positioned, the positioning guide member 3220 may be removed from the patient interface 3000. In some forms, it may be desirable to remove the positioning guide member 3220 before the patient interface 3000 is connected to the air circuit 4170 to ensure an unobstructed flow of the supply of breathable gas.

In some forms of the present technique, the positioning guide member 3220 may include an elongated body and a patient contacting end. The patient contacting end may be concave, such as V-shaped or U-shaped, to engage a portion of the patient's face, such as a septum, as explained above. The elongate body may be configured to extend through a plenum inlet port 3202, with the patient contacting end extending through a first end of the plenum chamber 3200 (the end that is proximal to the patient in use). When the patient interface 3000 is donned, the positioning guide members 3220 are in this position, and once the patient is satisfied with the positioning of the patient interface 3000, the positioning guide members 3220 may be removed through the plenum portal port 3202.

In some forms of the present technique, prior to removal, the positioning guide members 3220 may be connected to the plenum chamber 3200 in a manner that maintains the position of the positioning guide members 3220 relative to the plenum chamber 3200 prior to use and during donning of the patient interface 3000, but allows for easy removal of the positioning guide members 3220 after the patient interface 3000 is properly positioned. For example, in one form, the positioning guide 3220 may be lightly adhered to the plenum chamber 3200. In another form, the positioning guide members 3220 may be configured to be magnetically attached to the plenum chamber 3200. For example, the body of the positioning guide member 3220 may have a magnetic member that may be magnetically attached to another magnetic member of the plenum chamber 3200.

It should be appreciated that the force required to be applied by the patient 1000 to remove the positioning guide 3220 should preferably be of a magnitude that is substantially insufficient to disengage the adhesion of the seal-forming structure 3100 to the patient's face.

In some forms of the present technique, the magnetic members of the plenum chamber 3200 may be configured to magnetically connect to the air circuit 4170 once the positioning guide members 3220 have been removed. For example, the magnetic member of the plenum chamber 3200 may be the magnetic member 3510 described in further detail below.

In the illustrated form of the present technique, the positioning guide member 3220 may be located in a lower portion of the opening in the first end of the plenum chamber 3200 (i.e., the end of the plenum chamber 3200 that is connected to the seal forming structure 3100 and that is proximate to the patient when the patient interface 3000 is worn in use).

For example, the positioning guide 3220 may be included as part of a rim around an opening in the plenum chamber 3200, or may be detachably or inseparably provided to the rim around an opening in the plenum chamber 3200 through which airflow is delivered to the nostrils of the patient. The positioning guide member 3220 may be included as part of a rim, or may be provided to a portion of a rim, such as a portion of a rim on an underside of the opening when the patient interface 3000 is worn. Alternatively, the positioning guide members 3220 may form a major portion of the rim of the plenum chamber 3200 surrounding the opening. The rim may be configured to interface with one or more of the subnasal points, the nasal posts, the septum 3132, and/or the nasal alar ridge region and/or the upper lip.

In some forms of the present technique, as shown in fig. 19E, positioning guide member 3220 (which may be V-shaped or U-shaped) may include a prongs configured to expand when patient interface 3000 is donned and positioning guide member 3220 is engaged with patient septum 3132. For example, the prongs may be long enough to have such flexibility, and/or the material used to form the positioning guide members 3220 may be flexible enough. In the illustrated form, the prongs may extend substantially into the nostrils of the patient 1000. In a technical form in which the positioning guide member 3220 is configured to be removed once the patient interface 3000 is donned, when the positioning guide member 3220 is removed through the plenum inlet port 3202, the prongs come together, allowing the positioning guide member 3220 to be removed.

In some forms of the present technology, for example as shown in fig. 19B, the adhesive surface 3102 of the seal-forming structure 3100 may be configured in such a way that: prior to application of the seal-forming structure 3100 to the face, the adhesive surface is positioned such that when the seal-forming structure 3100 is in contact with the face, the adhesive surface is not in contact with the face prior to positioning the guide member 3220. For example, adhesive surface 3102 may be oriented at an angle offset, or it may curl away from the patient's face, e.g., under its own weight. One advantage of this arrangement is that using positioning guide members 3220 as guides, patient interface 3000 can be positioned by adjusting patient interface 3000 until the correct position is achieved, and in the process adhesive surface 3102 does not contact any portion of the face. This configuration may also allow the patient 1000 to use only one hand to properly position the seal-forming structure 3100 on his face, for example by supporting the positioning guide member 3220 against the face with one hand, and then firmly pressing the seal-forming structure 3100 against the skin of the face with the same hand.

In some forms, the plenum chamber 3200 may generally be formed in a shape complementary to the shape of the patient's nose, in use the plenum chamber 3200 will be positioned adjacent the patient's nose. In such forms, the portion of the plenum chamber 3200 proximate to the patient 1000 may be considered a positioning guide member 3220 when the patient interface 3000 is worn.

Plenum material

In some forms of the present technique, the plenum chamber 3200 is constructed of a relatively hard material, such as polycarbonate.

In some forms, the plenum chamber 3200 is formed from one material and has a structure that makes the plenum chamber 3200 relatively rigid and capable of maintaining its shape when pressurized with typical therapeutic pressures. The plenum chamber 3200 may provide strength and structure to the patient interface 3000.

In other forms, the plenum chamber 3200 is formed from a softer and/or more flexible material, such as silicone or thermoplastic elastomer (TPE). Some of the advantages of TPE described above over its use for the seal forming structure 3100 may also be applied to plenums 3200 formed by some forms of TPE of this technology. In addition, forming the plenum chamber 3200 from a flexible material such as TPE allows the walls of the plenum chamber 3200 to deform. Another advantage of the deformable inflatable chamber will be explained in the following description.

Plenum inlet port

In some forms of the technology, the plenum chamber 3200 includes a plenum chamber inlet port 3202, for example as shown in fig. 4A, 4B, 4C, 5A, 10A, and 10E. Other forms of the technology illustrated in the figures also have plenum inlet ports 3202, but are not labeled in each figure. The flow of breathable gas may be configured to be delivered to the plenum 3200 through the plenum inlet port 3202. In some forms, the plenum inlet port 3202 is configured to be directly or indirectly attached to the air circuit 4170. In an exemplary form of the present technology, the plenum inlet port 3202 is preferably located at a second end of the plenum chamber 3200. The plenum inlet port 3202 may be formed as an opening in the body of the plenum chamber 3200.

Integral seal forming structure and plenum

In some forms of the present technology, the plenum chamber 3200 and the seal forming structure 3100 are integrally formed as a single component 3300. An exemplary such form is shown in fig. 8.

Advantages of integrally forming the plenum chamber 3200 and seal forming structure 3100 as a single component 3300 may include reduced part count, ease of manufacture, and reduced packaging.

Connection port

In some forms of the present technique, such as those shown in fig. 10B, 10C, and 10D, patient interface 3000 further includes a connection port 3600, which connection port 3600 may be connected to air circuit 4170 in use to deliver a flow of breathable gas from air circuit 4170 to inflatable chamber 3200 through inflatable chamber inlet port 3202. In other forms of the present technology, the connection port 3600 is the same opening as the plenum inlet port 3202. Connection port 3600 is not labeled in each figure.

In some forms, such as shown in fig. 10B-10D, the patient interface 3000 includes a tube 3502 having a first end and a second end, wherein the first end of the tube is fluidly connected to the plenum chamber inlet port 3202 and the second end of the tube includes the connection port 3600. The first and second ends of the tube 3502 are opposite one another. The first end is configured to connect with an inlet port 3202 of the plenum chamber 3200. The second end forms a connection port 3600.

In one form, a first end of the air circuit 4170 may be connected to a second end of the tube 3502 (i.e., the connection port 3600) by a fastener. In the embodiment illustrated in fig. 10C, for example, the fastener is a twist lock or bayonet fastener, wherein the air circuit 4170 has a fork tube 3520 inserted into the receiver 3522 of the tube 3502. Alternatively, the tube 3502 and the air circuit 4170 may be formed together.

Vent opening

In some forms of the present technology, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide. The vent 3400 may be implemented by a vent structure that may be formed or provided in any one or more components of the patient interface 3000.

In some forms, the vent 3400 is configured to allow a continuous flow of vent gas from the interior of the plenum chamber 3200 to the ambient environment while the pressure within the plenum chamber is positive relative to the ambient environment. The vent 3400 is configured such that the vent flow rate is sufficient to reduce patient-to-exhale CO ₂ While maintaining the magnitude of the therapeutic pressure in the plenum chamber in use.

One form of vent 3400 in accordance with the present technology includes a plurality of holes, for example, about 5 to about 80 holes, or about 10 to about 40 holes, or about 20 to about 25 holes.

In some forms of the present technology, for example as shown in fig. 5A, a vent 3400 may be located in the plenum chamber 3200.

Alternatively, as described above, the vent 3400 may be located in a tube 3502 that is fluidly connected with the plenum chamber 3200. In other forms, the vent 3400 may be located in a decoupling structure (as described in further detail below), such as a swivel. In other forms, such as the forms of fig. 10B and 10C, vents may be provided in the heat and moisture exchanger 3700, as described in more detail below.

In some forms, such as illustrated in fig. 20D, the patient interface 3000 further includes a diffuser 3410, the diffuser 3410 being configured to diffuse the flow of exhaust gas from the interior of the plenum chamber 3200 to the ambient environment. The diffuser may be located in a channel in the vent 3400. For example, in the form illustrated in fig. 20D, the diffuser 3410 includes a body of diffuser material located in the chamber along the channels of the vent 3400.

The diffuser 3410 has the advantage that it reduces noise generated by the exhaust stream and prevents injection. As the air jets exit through the vents, the jets may be directed to a sleep partner or create noise by contact with nearby surfaces. Noise and emissions may interfere with the sleep of the patient 1000 and/or sleep partner, thereby reducing their sleep quality, or causing other discomfort.

Port (port)

In some forms of the present technique, patient interface 3000 includes one or more ports that allow access to the volume within plenum chamber 3200. In some forms, this allows the clinician to supply supplemental oxygen. In one form, this allows for direct measurement of gas properties, such as pressure, within the plenum chamber 3200.

Breathing-atmosphere vent

In some forms of the present technology, the patient interface 3000 may include a vent 3400, the vent 3400 being configured to be capable of adopting at least two configurations. In one configuration, which may be referred to as an open configuration, the vent 3400 allows the patient to inhale and exhale through the vent 3400 without significant impedance, or with an impedance level that is largely unnoticeable to the patient. In another configuration, which may be referred to as a closed configuration, the vent 3400 is more occluded than in an open configuration. In some forms, in the closed configuration, the vent 3400 allows exhaled air to be flushed from the interior of the plenum chamber 3200 to the ambient environment while substantially maintaining the pressure within the plenum chamber positive relative to the ambient environment. In other forms, in the closed configuration, the vent may block substantially all gas washout through the vent, and instead, exhaled gas is exhausted through a separate vent structure. Such a vent 3400 may be referred to as a "breath-to-atmosphere" vent (BTA vent).

Whether the BTA air port is in an open or closed configuration may be based on being provided to the patient from the RPT device 4000Pressure of the supply of breathable gas to port 3000. When no breathable gas is supplied, or when below a certain threshold, for example below such as 6cmH ₂ The BTA vent may be configured to adopt an open configuration when the flow of breathable gas is supplied at a pressure that is at the therapeutic pressure level of O. When above a certain threshold (e.g. above a threshold such as 6cmH ₂ O therapeutic pressure level) and the BTA vent may be configured to adopt a closed configuration.

A further explanation of a patient interface system that includes a vent that may be considered to function in the manner of a BTA vent as described above is provided in PCT application No. PCT/US2012/055148, the contents of which are incorporated herein by reference.

In one application, a BTA vent may be used in a patient interface system, wherein the BTA vent is configured to adopt an open configuration when the patient is first wearing the patient interface 3000 and when the RPT device 4000 detects that the patient is awake. In such a configuration, the RPT device may not supply a flow of breathable gas, or may be configured to provide a small flow of breathable gas to help flush exhaled CO from the plenum chamber 3200 ₂ . Once the RPT device 4000 detects that the patient has fallen asleep, a flow of breathable gas may be supplied at therapeutic pressure, which causes the BTA vent to adopt a closed configuration.

The patient interface 3000 with the seal-forming structure 3100 adhered to the patient's face has several advantages over conventional patient interfaces 3000 in BTA vents.

In an exemplary form of such a patient interface 3000, the volume within the plenum chamber 3200 may be relatively small compared to some patient interfaces that are secured to the face by other means, such as headgear straps. This volume or related volumes may be referred to as "dead spaces" within the patient interface. The small volume of the plenum chamber 3200 means that when the patient breathes through the BTA vent in the open configuration, the breath may not be perceived as unsmooth. Furthermore, if the RPT device 4000 supplies a small flow of breathable gas to assist CO when the BTA vent is in an open configuration and the patient is awake ₂ Flushing, a small volume means if the plenum chamber3200, the flow rate may be lower than that to achieve the same level of CO ₂ The flow rate required for flushing. These factors can help minimize or reduce flow rate, reduce discomfort and help the patient fall asleep while the patient wears the mask and is still awake.

One challenge of a patient interface for use with a BTA vent is that, once sleep of the patient is detected, the RPT device increases the pressure of the supply of breathable gas, and as the pressure within the inflation chamber increases, the desired tension of the headgear strap changes. The higher the pressure within the plenum, the greater the force used to push the patient interface away from the patient's face. The positioning and stabilizing structure counteracts this force, which is typically performed by a headgear strap having the necessary tension. In such systems, the patient sometimes places the patient interface mask under headgear tension while awake that is sufficient to maintain the patient interface in sealing contact with the face when the breathable gas is supplied at low pressure or not supplied at all, but may not be sufficient to maintain the patient interface in sealing contact with the face when the breathable gas is supplied at a higher pressure (e.g., therapeutic pressure). A patient interface 3000 such as described in the technical form herein avoids this problem because the seal-forming structure 3100 is adhered to the patient's face with an adhesive. If a sufficiently strong adhesive is selected to hold patient interface 3000 in place while the gas is supplied at therapeutic pressure, patient interface 3000 will remain in place with a good quality seal even if the pressure of the gas increases while the patient is sleeping.

In addition, it has been observed that seal-forming structure 3100, which adheres to the area around the patient's nostrils, may be less likely to block the patient's nostrils than some conventional patient interfaces that supply a flow of gas to the nostrils and are maintained on the face using headgear strap tension that may be used to close the nostrils. This means that the patient may breathe more easily when wearing the patient interface 3000 with the seal-forming structure 3100 when no supply of breathable gas or supply is at low pressure than some conventional patient interfaces, the seal-forming structure 3100 adheres to the patient's face.

Anti-asphyxia valve

One form of BTA vent is an anti-asphyxia valve (AAV), which is commonly used in patient interfaces that cover the nose and mouth as a means of mitigating the risk of asphyxia. In the event that the supply of breathable gas to the plenum chamber 3200 and/or the airway of the patient 1000 is discontinued, the AAV ensures ventilation to the airway of the patient 1000. In some forms of the present technique, the patient interface 3000 may comprise a conventional design of an AAV that serves as a BTA vent, as described above.

For example, in the technical form illustrated in fig. 29, the patient interface 3000 includes a vent 3400 that, in use, functions as a BTA vent in the manner described above. The BTA vent may be in the form of an anti-asphyxia valve 3402. In the illustrated form of the present technology, the anti-asphyxia valve 3402 is located on or near an end of the air circuit 4170, the air circuit 4170 being connected to the inlet port 3202 of the plenum chamber 3200. In other forms, the AAV may be located at another location, such as in the plenum chamber 3200, or in a tube connected between the air circuit 4170 and the plenum chamber 3200.

The anti-asphyxia valve 3402 may include a flap configured to cover an opening in a wall of the air circuit 4170 and prevent or limit leakage of gas contained in the plenum chamber 3200 in use when the valve 3402 is in a closed configuration. When the valve is in the open configuration, such as in the event that the flow of breathable gas to the plenum chamber 3200 is interrupted or reduced, or if the pressure of the breathable gas supplied by the RPT device 4000 has not increased (e.g., if the patient is detected to be still awake), the flap is in a position with less blockage of the opening to allow the patient 1000 to breathe directly to and from the ambient atmosphere.

Exhalation resistance valve

In some forms of the present technology, the positive pressure within the plenum chamber 3200 may be generated in a manner different from by supplying air from the RPT device 4000 into the plenum chamber 3200. For example, in one form of respiratory therapy system 2000, the flow of gas exhaled by the patient creates a positive pressure in the plenum chamber 3200. Such a system may be referred to as an Expiratory Positive Airway Pressure (EPAP) system. Certain forms of EPAP systems according to the present technology may not include the RPT devices or air circuits described herein. Alternatively, the EPAP system may include a vent configured to generate and maintain a therapeutic pressure in the plenum from a flow of gas exhaled by the patient.

An exemplary form of a patient interface 3000 for use in an EPAP system is shown in fig. 30. The patient interface 3000 of fig. 30 includes a plenum chamber 3200 and a seal-forming structure 3100 in any of the forms of the techniques described elsewhere herein.

In the illustrated form, the patient interface 3000 also includes a vent 3400 in the form of an exhalation resistance valve 3404. The exhalation resistance valve 3404 is configured to allow gas to flow through the valve in both directions. The gas may flow in one direction through the exhalation resistance valve 3404 and from the ambient atmosphere into the plenum chamber 3200 for patient breathing. The exhalation resistance valve 3404 is configured such that the flow of gas in this direction is sufficient to breathe the patient. Gas may also flow in opposite directions from the interior volume of the plenum chamber 3200 through the exhalation resistance valve 3404 to the ambient environment to allow for flushing of the patient's exhaled gas. The exhalation resistance valve 3404 is configured such that the gas flow rate allowed in this direction creates and maintains a positive pressure in the plenum chamber 3200 compared to the ambient pressure that is sufficient to provide a therapeutic effect to the patient.

In some forms of the present technique, the exhalation resistance valve 3404 is attached, e.g., permanently attached, to the plenum chamber 3200.

In other forms, the exhalation resistance valve 3404 is removably provided to the plenum chamber 3200. This may allow replacement and/or cleaning of the exhalation resistance valve 3404. For example, in the form shown in fig. 30, an exhalation resistance valve 3404 is configured to provide to an inlet port 3202 of a plenum chamber 3200. Such a configuration may allow the same components of the plenum chamber 3200 and seal forming structure 3100 to be interchangeably used with the exhalation resistance valve 3404 and connected to the air circuit 4170 and receiving a flow of gas from the RPT device 4000 to administer respiratory therapy (e.g., CPAP) according to the patient's preference.

The exhalation resistance valve 3404 may include a tube 3406 and a cap 3408. The tube 3406 may be configured to be inserted into the inlet port 3202 of the plenum chamber 3200, and the cover 3408 may be configured to substantially span the inlet port 3202 when the tube 3406 of the exhalation resistance valve 3404 is inserted into the inlet port 3202 to prevent over-insertion. The cover 3408 may include a valve component 3409, as shown in fig. 30, that operates to allow gas to flow into and out of the plenum chamber 3200 in use and to control the pressure in the plenum chamber 3200 when the patient interface 3000 is in use, as described above.

While patient interface 3000 of fig. 30 may be used as a stand-alone device for EPAP therapy, in an alternative form of the present technology, respiratory pressure therapy system 2000 may include patient interface 3000 and an exhalation resistance valve 3404, the patient interface 3000 receiving a flow of breathable gas under positive pressure from RPT device 4000, the exhalation resistance valve 3404 increasing and helping to maintain therapeutic pressure in plenum chamber 3200. This may provide some of the benefits of the CPAP and EPAP systems while reducing the power level and/or size required by the RPT device 4000. For example, the air circuit 4170 may be attached to the inlet port 3202 with the exhalation resistance module 3404 connected between the inlet port 3202 and the air circuit 4170.

Split type vent

In some forms of the present technology, in addition to a vent 3400 (which may be referred to as a first vent 3422) constructed and arranged to allow flushing of exhaled gases, there may be a second vent 3424, the second vent 3424 being configured to vent air received from the RPT device 4000 before the air is supplied to the patient interface 3000. The second vent 3424 may be configured and arranged to reduce the flow rate of air from the RPT device 4000 received by the patient interface 3000 while maintaining the pressure of the air flow to the patient 1000. The second vent 3424 may be located in a different location in the respiratory therapy system than the first vent 3422.

For example, in the technical form illustrated in fig. 28, patient interface system 5000 includes patient interface 3000 and tube 3420. In use, breathable gas is supplied from air circuit 4170 to patient interface 3000 via tubing 3420. The tube 3420 includes a first end 3426 and a second end 3428. The first end 3426 is connected to an inlet port 3202 of the plenum chamber 3200. The second end 3428 is configured to be connected to an air circuit 4170. In some forms, the tube 3420 may be about 200 to 400mm long, such as about 300mm.

The first vent 3422 may be located at or near the first end 3426 of the tube 3420, such as on an annular cuff at the first end 3426 or on the patient interface 3000, such as on the plenum chamber 3200. The second vent 3424 may be located at or near the second end 3428 of the tube 3420. For example, the tube 3420 may include a cuff at its second end 3428 that is configured to be connected to the air circuit 3170, and the second vent 3424 may be included as part of the cuff, or may be connected to the cuff.

For example, the second vent 3428 may take the form of any vent described elsewhere in this specification.

One advantage provided by a "split vent" configuration (such as the form shown in fig. 28) is that the diameter of the tube 3420 required to deliver the same pressure or flow to the patient interface 3000 can be reduced as compared to a system in which the second vent 3424 is not present. For comfort and ease of use, a narrower tube 3420 located near the patient in use is desirable.

Nasal prongs/nasal pillows

In one form of the technique shown in fig. 9A-9D, the patient interface 3000 includes a pair of nasal puffs, nasal prongs, or pillows 3250. Each nasal pillow 3250 is constructed and arranged to form a seal with a corresponding nostril of the patient 1000's nose.

The nasal pillow 3250 according to one aspect of the present technology comprises: a frustoconical 3252, at least a portion of the frustoconical 3252 forming a seal on an underside of the patient's nose; a handle 3254; a flexible region on the underside of the truncated cone 3252 and connecting the truncated cone 3252 to the stem 3254.

In one form, the nasal pillow 3250 of the present technology is formed from a nasal pillow body positioned within a plenum chamber 3200, as shown in fig. 9A and 9B. A frustoconical 3252 of the nasal pillow 3250 is formed at one end of the nasal pillow body and is configured to align with a first end of the plenum chamber 3200. An end of the stem 3254 is formed at an opposite end of the nasal pillow body and includes an opening configured to align with an inlet port 3202 of the plenum chamber 3200 on the second end. The nasal pillow body is positioned such that, in use, breathable gas flows from the opening of the handle 3254 to the frustoconical 3252 and from there to the nostril 1000 of the patient.

In one form, the plenum chamber 3200 and the nasal pillows 3250 are separate components that can be assembled by the patient 1000 by positioning the nasal pillow body within the plenum chamber 3200. The nasal pillow body may be sized and shaped to fit snugly within the plenum chamber 3200 to avoid cavities other than airflow paths within the nasal pillow body. The nasal pillows 3250 may easily slide out of the plenum chamber 3200, and this facilitates easy cleaning of the plenum chamber 3200 and/or nasal pillows 3250.

In some forms, the nasal pillows 3250 can be flexible. This improves patient comfort, particularly when patient interface 3000 is worn for extended periods of time.

The form of patient interface 3000 shown in fig. 9A-9D includes a seal-forming structure 3100, which seal-forming structure 3100 includes an adhesive surface 3102 in addition to a nasal pillow 3250. The seal forming structure 3100 can be similar to seal forming structures described with respect to other forms of the present technology and can include an adhesive surface 3102 surrounding a nasal pillow 3250. The seal formed by the seal forming structure 3100 may be in addition to the seal formed by the nasal pillows and nostrils of the patient. This may improve the quality of the seal and may reduce the adhesive strength of the desired adhesive because the nasal pillow 3250 may act as a backup seal in the event of loss of adhesion. In an alternative form, the nasal pillows 3250 are configured to provide little or no seal with the nostrils. In such forms, the nasal pillows still serve to help position the patient interface 3000 in the correct position on the patient's face. This advantage is also provided in the form of the nasal pillow 3250 forming a seal with the nostril.

Decoupling structure

In some forms of the technology, the patient interface 3000 includes one or more decoupling structures 3500, which decoupling structures 3500 may be configured to at least partially decouple the seal-forming structure 3100 from the air circuit 4170.

The decoupling structure 3500 may be configured to completely or partially decouple (or isolate) the adhesive attachment between the seal-forming structure 3100 and the patient's face to prevent transmission of forces incident on the air circuit 4170 or another portion of the respiratory therapy system during use. Such forces may include unintended drag or pulling on the air circuit 4170, for example, by the patient, a bed partner, or via contact with objects in the patient's surroundings. If these forces are transferred directly to the seal-forming structure 3100, they may cause the seal-forming structure 3100 to fall off the patient's face or the seal-forming structure to be hard pulled at the patient's face skin. Both of these conditions can cause a significant amount of discomfort, pain, and/or skin trauma.

The decoupling structure 3500 of the present technology is configured to reduce the amount of force transferred to the seal forming structure 3100. In some forms, the decoupling structure is capable of disconnecting the air circuit 4170 from the plenum chamber 3200 when a force greater than a predetermined magnitude is incident on the air circuit 4170. It may also be useful to easily disconnect the air circuit 4170 and the plenum chamber 3200 if the patient 1000 wants to be temporarily disconnected from the respiratory therapy system 2000, such as to go to a bathroom.

In this context, decoupling may be understood as isolating or reducing the effect of a force transmitted on a first component on a second component that is somehow attached to the first component. For example, these components may be the seal forming structure 3100 and the air circuit 4170.

In some forms of the present technology, the decoupling structure 3500 may form part of the plenum chamber 3200 or the air circuit 4170. Alternatively, as in the example of fig. 10B, the air circuit 4170 and the plenum chamber 3200 may be connected by a decoupling structure 3500 located therebetween. An exemplary decoupling structure 3500 will now be described. It will be appreciated that while the technical forms described with respect to some exemplary forms may include only one form of decoupling structure, in other forms, patient interface 3000 may include a combination of one or more of the exemplary forms of decoupling structure 3500.

Deformable part

In some forms, the decoupling structure 3500 may include a deformable member configured to deform when tilting the first end of the air circuit 4170 relative to its neutral position relative to the plenum chamber 3200 (i.e., the position adopted in the absence of a force acting on the air circuit 4170). As previously described, the first end of the air circuit 4170 may be configured to connect to the plenum inlet port 3202 and/or the connection port 3600.

When the first end of the air circuit 4170 is tilted in this manner, the deformable member eliminates or reduces the amount of force transferred to the seal forming structure 3100. The deformable member is particularly useful for isolating the seal forming structure 3100 from forces acting on the air circuit 4170 in a direction perpendicular to the longitudinal axis of the air circuit 4170.

Deformable plenum

In one form, the deformable member is a plenum chamber 3200. In this form, the plenum may be formed in such a way that the plenum is substantially flexible, for example the plenum 3200 may be formed from a soft material and/or have a thin wall. For example, the plenum chamber 3200 may be formed from a relatively thin layer of silicone or TPE.

In this form, the flexible plenum chamber 3200 may be configured to twist (i.e., the first end of the air circuit 4170 is inclined relative to its neutral position) when a force urges the first end of the air circuit 4170 in a direction perpendicular to its longitudinal axis. For example, portions of the plenum chamber 3200 may be configured to pucker, fold, and/or stretch when the position of the air circuit 4170 is disturbed.

In one form, the plenum chamber 3200 may be configured such that when a force causes the air circuit 4170 to tilt, a side of the plenum chamber 3200 on a side of the air circuit 4170 may compress or collapse and a side of the plenum chamber 3200 on a side opposite the first side of the air circuit 4170 may stretch.

Pipe

In some forms of the technology, such as the exemplary forms shown in fig. 10B-10D, the decoupling structure 3500 includes a tube 3502, the tube 3502 further including a flexible section 3504 formed to be substantially flexible. For example, flexible section 3504 may be more flexible than tube 3502 and/or other sections of patient interface 3000.

The flexible section 3504 may be formed of a softer material than the material used to form the other portions of the tube 3502. Additionally or alternatively, the flexible section 3504 may be formed of a thinner material than that used to form the other portions of the tube 3502.

In the illustrated exemplary form, the flexible section 3504 is in the form of a deformable neck having a cross-sectional diameter that is narrower than the cross-sectional diameter of other sections of the tube 3502. This makes the flexible section 3504 more flexible than other areas of the tube 3502.

When a force is applied to the air circuit 4170 to move its proximal end laterally, the flexible section 3504 acts to flex, and such flexing occurs prior to the transfer of the lateral force to the seal-forming structure 3100, thereby acting to at least partially decouple the seal-forming structure 3100 from the air circuit 4170.

Spherical joint

In one form (not shown in the figures), the decoupling structure may include a swivel or ball joint configured to allow rotational movement of the air circuit 4170 relative to the plenum chamber 3200 in order to reduce the amount of force transferred from the air circuit 4170 to the seal forming structure 3100 in a direction perpendicular to the longitudinal axis of the air circuit 4170.

In one form (not shown), the ball joint may be a quick-release ball joint configured to separate the air circuit 4170 from the plenum chamber 3200 when a force greater than a predetermined value (having a force component in any direction) is applied to the air circuit 4170. The ball joints may separate when a force greater than a predetermined value is applied in a direction perpendicular to the longitudinal axis of the air circuit 4170 and/or in a direction parallel to the longitudinal axis of the air circuit 4170.

Magnetic coupling

In some forms of the present technology, the decoupling structure 3500 includes a first magnetic member 3510 provided to the connection port 3600. The first magnetic member 3510 is configured to magnetically couple to the second magnetic member 3512, the second magnetic member 3512 being provided to the air circuit 4170 when the air circuit 4170 is connected to the connection port 3600. First magnetic member 3510 may be configured to separate from second magnetic member 3512 when air circuit 4170 is pulled away from patient interface 3000 with a force that is greater than the magnetic attraction between first magnetic member 3510 and second magnetic member 3512.

An exemplary form of such a decoupling structure 3500 is shown in fig. 10A, 10E, and 10F. The decoupling structure 3500 provides a connection between the connection port 3600 and the first end of the air circuit 4170 through magnetic coupling between the first magnetic member 3510 (not shown) and the second magnetic member 3512. In this form of the present technique, the plenum inlet port 3202 forms a connection port 3600.

In a second exemplary form, as shown in fig. 10B, 10C, and 10D, the decoupling structure 3500 includes a magnetic coupling between the first end of the tube 3502 and the plenum inlet port 3202, which is connected by a magnetic coupling between a first magnetic member 3510 provided to the plenum inlet port 3202 and a second magnetic member 3512 provided to the first end of the tube 3502. In this form, the plenum inlet port 3202 may be considered to form the connection port 3600.

In another exemplary form, as shown in fig. 11, the decoupling structure 3500 includes a magnetic coupling between an end of the air circuit 4170 and the plenum inlet port 3202, which is connected by a magnetic coupling between a first magnetic member 3510 provided to the plenum inlet port 3202 and a second magnetic member 3512 provided to the end of the air circuit 4170.

The first and second magnetic members 3510, 3512 are configured to magnetically couple to each other in use. For example, the first and second magnetic members may both be magnets, such as ferromagnets, with the polarities of the first and second magnetic members 3510, 3512 similarly aligned such that they attract each other. Alternatively, one of the first magnetic member or the second magnetic member may be a magnet, and the other of the first magnetic member or the second magnetic member may be a non-magnetic material that is attracted to the magnet, such as a metal that is capable of being attracted to the magnet.

The magnetic member may be of any suitable shape. In some forms, first magnetic member 3510 and second magnetic member 3512 are annular and positioned around openings in respective components of which they form a portion. This shape helps to ensure magnetic attraction around the periphery of the connecting member and helps to reduce gas leakage. In other forms, either or both of first magnetic member 3510 and second magnetic member 3512 can include a plurality of individual magnetic members arranged in an array, for example, to surround respective openings. In other forms, one or both of first magnetic member 3510 and second magnetic member 3512 can comprise a plurality of separate magnets. A plurality of magnets may be disposed around the perimeter of connection port 3600 and/or the ends of air circuit 4170.

The magnetic coupling between the first and second magnetic members 3510, 3512, respectively, allows the patient 1000 to easily connect and/or disconnect the air circuit 4170 with the patient interface 3000, such as by directly disconnecting the air circuit 4170 and/or the tube 3502 in the presence of the tube 3502. This ease of use is illustrated in fig. 10E and 10F.

In some forms, the strength of the magnetic attractive force between first magnetic member 3510 and second magnetic member 3512, respectively, is selected such that they only break when a force greater than a predetermined magnitude is applied to air circuit 4170. The force may be selected such that the air circuit 4170 does not break too easily when subjected to typical forces that may be encountered during use, but if broken when subjected to forces that may cause significant discomfort to the patient. The predetermined amount of force may be selected such that the force is less than the amount of force required to pull the seal-forming structure 3100 away from the patient's face when the seal-forming structure 3100 is adhered to the patient's face.

In some exemplary forms of the present technology, some parts of patient interface 3000 are intended to be disposable and used only a limited number of times before being replaced. For example, in an exemplary form of the technique shown in fig. 10B, the seal-forming structure 3100 and the plenum chamber 3200 may form a single disposable component. If the part intended for single use comprises a magnetic member, such as a metal part, there may be excessive manufacturing costs.

Fig. 20A-20F illustrate an exemplary form of patient interface 3000 according to a technique to address this issue. In this form, the patient interface includes a plenum chamber 3200 and a seal forming structure 3100, which are formed of a material that is inexpensive to manufacture and may also be recycled, such as a thermoplastic elastomer (TPE). The adhesive is applied to the adhesive surface 3102 of the seal-forming structure 3100, for example by spraying.

The air circuit 4170 is connected to the tube 3502, and at the end of the tube 3502 is a magnetic member 3512. The tube 3502 may also include a flexible section 3502 as previously described.

In this form of the technique, the magnetic coupling between the air circuit 4170 and the patient interface 3000 is achieved by an adapter 3514, which adapter 3514 is shown in perspective view in fig. 20E and 20F and in cross-section view in fig. 20D. The adapter 3514 is configured to be removably inserted into the plenum inlet port 3202 and retained within the plenum inlet port 3202, and is configured to magnetically couple to the air circuit 4170 in order to retain the patient interface 3000 in connection with the air circuit 4170.

The adapter 3514 may be generally tubular in shape with a central aperture 3515 to allow gas to pass therethrough. The adapter 3514 can include a first flange 3712 and a second flange 3714 at each end. Between the first flange 3712 and the second flange 3714 is a neck 3710 having a narrower diameter than the first flange and the second flange. The second flange 3714 may have a cross-sectional diameter that continuously narrows from the end of the flange toward the neck 3710 such that the second flange 3714 has a frustoconical shape as best seen in fig. 20D.

The adapter 3514 is sized such that the adapter 3514 can be inserted into the plenum inlet port 3202. When inserted, the flanges 3712, 3714 engage the plenum inlet port 3202 in a retained sealing arrangement, such as by a friction fit. In the illustrated form, the plenum rim surrounding the plenum inlet port 3202 is sandwiched between flanges 3712 and 3714.

As described above, in some forms, the plenum chamber 3200 may taper toward the plenum chamber inlet port 3202, e.g., such that a portion of the plenum chamber 3200 proximate the patient is wide enough to cover the airway of the patient, and a portion of the plenum chamber 3200 distal from the patient is narrow enough to connect to the air circuit 4170. Thus, the plenum chamber 3200 may have sloped sides that taper away from the patient.

Correspondingly, the adapter 3514 may have an angled side complementary to the angled side of the plenum chamber 3200, the angled side resulting from the tapering. In the form illustrated in fig. 20A-20F, the second flange 3714 may have sloped sides that taper from a larger width away from the air circuit 4170 (in use, proximal to the patient) and a narrower width proximal to the air circuit 4170 (in use, distal to the patient). In addition to providing a substantially positive fit with the plenum chamber 3200, the angle of the angled second flange 3714 may enable the adapter 3514 to easily slide into the plenum chamber inlet port 3202. The angled second flange 3714 may also prevent the adapter 3514 from easily sliding out of the plenum.

The plenum inlet port 3202 can twist to allow one of the flanges 3712, 3714 of the adapter 3514 to be inserted therethrough. In some forms, the plenum inlet port 3202 may be provided with one or more small slits around its circumference to facilitate such twisting. Where a slit is present, the size of the slit may be insufficient to create a leak path for the pressurized air within the plenum chamber 3200.

In one form, as shown in fig. 20E, the neck 3710 of the adapter 3514 takes the form of a groove extending between two ends around some or all of the perimeter of the middle section of the adapter 3514. The neck 3710 is configured to receive a portion of the plenum chamber 3200 forming a plenum inlet port 3202 to secure, in use, the adapter 3514 to the seal forming structure 3100.

In certain exemplary forms, such as shown in fig. 20E, the neck 3710 of the adapter 3514 forms an annular (i.e., circular) groove extending around the entire circumference of the middle section of the adapter 3514 between the two ends. This form of plenum chamber 3200 may include an annular ring 3216 forming a plenum chamber inlet port 3202.

The adapter 3514 may be pushed into the plenum chamber 3200 such that the annular ring 3216 of the plenum chamber 3200 interlocks with the neck 3710. The annular ring 3216 and neck 3710 may be configured such that the interlock is substantially airtight, i.e., the passage of gas from the air circuit 4170 through the adapter 3514 and seal forming structure 3100 does not leak through the region where the annular ring 3216 and neck 3710 interlock.

In alternative forms, the neck 3710 of the adapter 3514 can be non-circular, such as oval, or other geometric shapes, including shapes with rounded corners, and the plenum inlet portion 3202 can be correspondingly shaped. The non-circular shape may be used to ensure that the adapter 3514 and the plenum chamber 3200 are connected with the components in a particular relative orientation. This may help orient the vent holes to avoid venting exhaled air to the patient, for example. In alternative forms, the orientation between the adapter 3514 and the plenum chamber 3200 may be achieved by alternative structural features.

For example, in some forms, the adapter 3514 may include one or more protrusions, and the plenum chamber 3200 may include one or more recesses configured to be received by the protrusions (or vice versa). These arrangements may also prevent relative rotation between the adapter 3514 and the plenum chamber 3200. By preventing relative rotation, the air circuit 4170 may be more difficult to twist and thereby clog and/or break during use.

In an alternative form (not illustrated in any of the figures), the adapter 3514 may comprise a protrusion configured to be received by an indentation in the plenum chamber 3200 to secure, in use, the adapter 3514 to the seal forming structure 3100. When the protrusions are received in the indentations, the adapter 3514 may be mounted to the plenum chamber 3200 such that the assembly of the adapter 3514 and the plenum chamber 3200 is airtight.

A magnetic member 3510 may be provided at one end of the adapter 3514. For example, the magnetic member 3510 may be provided on an end face of the first flange 3712. This end of the adapter 3514 protrudes from the front side of the plenum inlet port 3202 in use so that the magnetic member 3512 on the tube 3502 can connect to the magnetic member 3510 on the adapter 3514 to couple the air circuit 4170 to the patient interface 3000.

The magnetic members 3510 and 3512 on the adapter 3514 and tube 3502, respectively, may be annular and positioned around respective openings that allow breathable gas to flow from the air circuit 3170 into the plenum chamber 3200.

In some forms, the connection surfaces of the magnetic members may be substantially orthogonal to the longitudinal axes of the adapter 3514 and the tube 3502, respectively.

In other forms, as shown in fig. 20A-20F, for example, the connection surfaces of the magnetic members may be at non-orthogonal angles to the longitudinal axes of the adapter 3514 and tube 3502, respectively. For example, the magnetic member 3510 in fig. 20A-20F has a beveled surface 3510A, and the magnetic member 3512 has a correspondingly shaped surface 3512a. This shape of the magnetic connection surface helps to provide the desired alignment of the magnetic connection between the adapter 3514 and the tube 3502.

In some forms, one of the beveled surfaces 3510a and 3512a of the magnetic members 3510 and 3512 can be convex, while the other of the beveled surfaces can be correspondingly concave so as to mate with the convex surface of the other magnetic member. In one form, the convex surface may be the beveled surface 3510a of the adapter 3514 and the concave surface may be the beveled surface 3512a of the tube 3502. In another form, the concave surface may be the beveled surface 3510a of the adapter 3514 and the convex surface may be the beveled surface 3512a of the tube 3502.

In other forms, the surfaces of the magnetic members 3510 and 3512 can have contours of other shapes.

When the component comprising the plenum chamber 3200 and seal forming structure 3100 is ready to be discarded (e.g., because it is dirty), it may be discarded or recycled, while the adapter 3514 may be removed, retained, and used with a replacement plenum chamber/seal forming structure component. However, if the adapter 3514 becomes dirty and difficult to clean, replacement is still required.

In one form, the magnetic member 3510 can be made of a non-magnetized ferromagnetic material and the magnetic member 3512 can be a permanent magnet. This may be advantageous if the adapter 3514 needs to be replaced. In an alternative form, the magnetic member 3510 may be a permanent magnet and the magnetic member 3512 may be a non-magnetized piece of ferrous metal. In another alternative, both magnetic members 3510 and 3512 may be permanent magnets.

In one exemplary form, the vent 3400 may be located on the adapter 3514. For example, the adapter 3514 may be provided with a vent hole through its wall to fluidly connect the central bore 3515 with the ambient environment in use, allowing the exhaled gas to be vented.

In the form illustrated in fig. 20A-20F, the vent is located in the first flange 3712. This is a flange that protrudes from the front side of the plenum inlet port 3202 in use. In this form, the vent holes are arranged in a radial direction relative to the cylindrical geometry of the adapter 3514 of the illustrated form. A diffuser 3410 may be located in each vent to diffuse the flow of venting gas.

In one form, the adapter 3514 can include a frame 3518 best shown in fig. 20D and 20E. The frame 3518 can form the body of the adapter 3514 and provide structure and rigidity to the adapter 3514. The frame 3518 may also form a recess or cavity configured to receive the heat and humidity exchanger 3700, as will be described in more detail below.

In one form, the frame 3518 may be an integrally formed component. Alternatively, the frame 3518 may include a plurality of frame parts that are assembled together to form the frame 3518.

The adapter 3514 may also include a heat and humidity exchanger 3700, which will be described in more detail below.

In an alternative form (not shown in any of the figures), the adapter 3514 may be configured such that it, or a substantial portion thereof, is located outside the plenum chamber 3200. For example, the adapter may be similar to the adapter 3514 shown in fig. 20D and 20E, but configured such that the end of the adapter opposite the end coupled to the tube 3502 is connected to the front surface of the plenum, e.g., it may be connected to a ring surrounding the plenum inlet port. In this form, the adapter 3514 may not be formed by two flanges and a neck therebetween. One advantage of locating the adapter 3514 outside of the plenum chamber 3200 is that no portion of the adapter 3514 extends into the space within the plenum chamber 3200 where the adapter 3514 is at risk of contact with the nose of a patient. Components that contact the nose, particularly hard components such as adapter 3514, can be uncomfortable and undesirable. Alternatively, the plenum chamber 3200 may need to be made larger to ensure that such contact does not occur between the adapter 3514 and the nose, which is also undesirable. Further, positioning a portion of the adapter 3514 within the plenum chamber 3200 may stiffen the plenum chamber 3200 and prevent deformation thereof. As noted above, a deformable plenum chamber 3200 may be desirable in some forms.

Hook and loop fastening

In some forms of the present technology (not shown in the figures), the connection between the plenum inlet port 3202 and the first end of the air circuit 4170 and/or the first end of the tube 3502 may be provided by hook and loop fasteners. In an alternative form of the present technology, the seal-forming structure 3100 may be attached to the components forming the plenum chamber 3200 by hook and loop fasteners. For example, the non-patient contact side of the seal forming structure 3100 may be provided with a hook or loop material, and the perimeter of the plenum chamber 3200 may be provided with a complementary material (i.e., a loop or hook) such that the components attach together in use.

As with the magnetic coupling described above, a hook and loop fastener such as described above may be configured to separate when a force exceeding a predetermined magnitude is applied to the air circuit 4170, and the nature of the hook and loop fastener material (e.g., the density of hooks) may be selected accordingly.

Tether rope

In some forms of the technology, the patient interface 3000 may include a tether for tethering the air circuit 4170 relative to the patient 1000, or be configured for use with the tether. For example, the tether may include a strap that is secured around a portion of the patient's body (e.g., their neck or arm), and the tether may further include a clip on the strap that is configured to connect to a section of the air circuit 4170. The tether may be positioned in use such that the air circuit 4170 is not tensioned when the tether is pulled away from the patient to its maximum extent. This means that any excessive force applied to the air circuit 4170 to pull it away from the patient will be limited by the tension in the tether when the patient's body is pulled taut.

Heat-moisture exchanger

In certain forms of the present technology, patient interface 3000 may include a heat-moisture exchanger 3700 configured to capture moisture and/or heat from gas exhaled by patient 1000 and deliver the moisture to the flow of breathable gas for respiration by patient 1000.

The heat and moisture exchanger 3700 can include a body of heat and moisture exchange material that absorbs heat and/or moisture from the exhaled gas and releases the absorbed heat and moisture from the air circuit 4170 to the incoming fresh breathable gas.

In one form, heat-moisture exchanger 3700 can include a heat-moisture exchange material deposited at points along the flow of breathable gas. For example, in the technical forms shown in fig. 10B, 10C, 10D, the heat and moisture exchange material is positioned within the tube 3502. The heat and moisture exchange material may occupy the entire cross-section of a section of the tube 3502 such that gas cannot flow through the tube 3502 without passing through the heat and moisture exchange material. The heat moisture exchange material 3700 can be uniformly deposited within a portion of the volume within the tube 3502.

In another form, as shown in fig. 11, a heat and moisture exchange material 3700 is located on an inner wall of the plenum chamber 3200. For example, the heat and moisture exchange material 3700 may be located in a cavity formed on an inner wall of the plenum chamber 3200.

It is appreciated that the heat and moisture exchange material may be positioned between the patient airway and the vent 3400 such that gas is not expelled from the respiratory system without passing through the heat and moisture exchange material 3700. For example, in the case of the technical forms shown in fig. 10B, 10C, and 10D, when considering the flow direction of the exhaled gas, the heat moisture exchange material is positioned in a portion of the tube 3502, which portion of the tube 3502 is located upstream compared to the holes in the tube forming the vent 3400. In the case of the technical form shown in fig. 11, where the vent 3400 is formed by a hole in the plenum chamber 3200, the heat and moisture exchange material is positioned against the inner wall of the plenum chamber 3200 so as to cover the hole of the vent 3400.

In the exemplary form of the technology shown in fig. 20A-20F, a heat and humidity exchanger 3700 is included as part of the adapter 3514. For example, the heat and moisture exchange material may be located within the central bore 3515 of the adapter 3514. In the illustrated form, the heat and moisture exchange material is located in a second flange 3714 in the end of the adapter 3514, the adapter 3514 protruding inwardly into the plenum chamber 3200 in use.

In an alternative form (not shown in any of the figures), the adapter 3514 may be configured such that the heat and humidity exchanger 3700 is located outside of the plenum 3200, but still positioned in the path of the flow of gas into the plenum 3200. For example, the heat and humidity exchanger 3700 can be included as part of an adapter that is located outside of the plenum chamber 3200 in the manner explained above.

In certain forms of the present technology, the heat and moisture exchange material may comprise foam (e.g., non-salted or salted foam), paper, or nonwoven material. Other materials may be used in other forms of technology, including any of the materials commonly known for heat and humidity exchangers in respiratory systems.

Separate HME module

In some forms (not shown in any of the figures), the heat and humidity exchanger 3700 can be spaced apart from some other components of the patient interface, such as the plenum chamber 3200 and the seal forming structure 3100. In this form, patient interface 3000 may include a heat and humidity exchange (HME) module that includes a heat and humidity exchanger 3700. The HME module may include a housing that is physically separate from the plenum chamber 3200.

In this form, a conduit may fluidly connect the plenum chamber 3200 with the HME module. The conduit may be connected to the plenum chamber 3200 and/or HME module using any suitable connection mechanism, such as a magnetic coupling mechanism, including those previously described. The HME module may also be fluidly connected to the RPT device through an air circuit 4170 by a similar or different mechanism.

In some forms, the HME module may also include a vent 3400.

In some forms, the HME module may include an engagement mechanism for retaining the HME module to the structure. An advantage of this arrangement is that the weight of the heat and moisture exchanger 3700 can be removed from the impact on the adhesive strength of the adhesive surface 3102. In some forms, the structure may be a patient's clothing, for example a clothing worn by the upper body, such as a shirt. This allows for the use of relatively short conduits connecting the HME module and the plenum chamber 3200, thereby reducing the risk of entanglement.

Sensor module

In some forms, as illustrated in fig. 31, the patient interface 3000 may be connected to the sensor module 2100 at an inlet port 3202. This allows the sensor module 2100 to detect characteristics of the patient's breath and/or other characteristics of the patient's health and/or physiology. For example, the sensor module 2100 may include a pulse oximeter to measure the oxygen level in the patient's blood. The sensor module 2100 may additionally or alternatively be configured to measure the flow rate of air inhaled or exhaled by the patient over time.

In some forms, the sensor module 2100 may be configured to detect characteristics that may be used to determine a medical condition of a patient, such as diagnosing a respiratory condition, such as obstructive sleep apnea. The sensor module 2100 may include any sensor suitable for determining characteristics of the patient's breath and/or the conditions required to make such a determination.

In the illustrated form, one or more electrodes 2112 may be provided on the seal-forming structure 3100 at a location where the electrodes contact the patient's skin when the patient interface 3000 is worn. The electrode 2112 may be combined with a pulse oximeter, the electrode 2112 being configured to detect the oxygen level of the patient's blood and communicate information to the sensor module 2100. For example, electrode 2112 may be a hydrogel contact or other suitable pad.

In other forms, the sensor module 2100 is removably provided to the plenum chamber 3200. This may allow for replacement and/or cleaning of the sensor module 2100. For example, in the form shown in fig. 31, the sensor module 2100 is configured to be provided to an inlet port 3202 of a plenum chamber 3200. Such a configuration may allow the same components of the plenum chamber 3200 and seal forming structure 3100 to be used interchangeably with the sensor module 2100, and to connect to the air circuit 4170 and receive a flow of gas from the RPT device 4000 for administration of respiratory therapy (e.g., CPAP). In one form, the sensor module 2100 may include a tube 2110 and a cap 2114. The tube 2110 may be configured to be inserted into the inlet port 3202 of the plenum chamber 3200, and the cover 2114 may be configured to substantially span the inlet port 3202 when the tube 2110 of the sensor module 2100 is inserted into the inlet port 3202 to prevent over-insertion. The cover 2114 may include sensor components necessary to detect certain characteristics and/or conditions of the patient's breath in order to perform its function.

The sensor module 2100 may also include a vent 3400. For example, a vent 3400 may be provided in the lid 2114. In the technical form of fig. 31, the vent 3400 includes a vent structure configured to allow gas to flow through the vent in two directions. Gas may flow in one direction through the vents 3400 and from the ambient atmosphere into the plenum chamber 3200 for patient breathing. The vent 3400 is configured such that the flow of gas in this direction is sufficient to breathe the patient. Gas may also flow in opposite directions from the interior volume of the plenum chamber 3200 through the vents 3400 to the ambient environment to allow for flushing of the patient's exhaled gas.

Patient interface 3000 according to a form of technology that includes a sensor module such as that shown in fig. 31 may not be used as part of a respiratory therapy system. Instead, it may be used as part of a respiratory diagnostic system. Such respiratory diagnostic systems may not include the RPT devices or air circuits described herein.

In some forms, the sensor module 2100 may include one or more processors configured to process characteristics detected by its sensors. For example, the processor may be configured to analyze the detected characteristics and/or diagnose a medical condition of the patient, such as OSA. In other forms, the sensor module 2100 may include a transmitter configured to communicate information detected by the sensor to a processor remote from the patient interface 3000. Any suitable wired or wireless communication protocol may be used, such as RF communication, bluetooth, RFID, NFC, etc. In some forms, the sensor module 2100 may include a data storage device configured to store data indicative of characteristics detected by the sensor. The data storage device may store data for later processing or transmission. Additionally or alternatively, the data storage device can be removed from the sensor module 2100 and brought to a processor where the data stored thereon can be transferred for processing. For example, the data storage device may be an SD card or the like.

Air circuit

In one form, the patient interface system 5000 includes an air circuit 4170. The air circuit 4170 is configured to deliver breathable gas to the patient interface 3000 for delivery to the airway of the patient 1000. For example, an air circuit 4170 in the form of the technique shown in fig. 1 delivers breathable gas from the RPT device 4000 to the plenum chamber 3200.

A first end of the air circuit 4170 may be connected to the plenum inlet port 3202 and/or the connection port 3600. A second end of the air circuit 4170, which may be opposite the first end, may be connected to the RPT device 4000.

In an exemplary form of the present technique, the air circuit 4170 is flexible.

In some forms, the air circuit 4170 may additionally include a conduit connecting the HME module to the plenum chamber 3200.

In some forms, the geometry of the air circuit 4170 may depend on the flow parameters of the breathable gas supplied to the patient from the RPT device 4000. For example, in the case of an RPT device 4000, the diameter of the air circuit 4170 may be relatively small, the RPT device 4000 being configured to provide a relatively low pressure (e.g., 2 to 6cmH ₂ O), i.e. low pressure therapy. The diameter of the air circuit 4170 may be relatively large for use with the RPT device 4000, the RPT device 4000 being configured to operate at relatively high pressures (e.g., 6 to 20cmH ₂ O) supplying a breathable gas.

Additional pipe

In some forms, as illustrated in fig. 27, the breathable gas is delivered by an air circuit 4170 to a tube 3420, which tube 3420 itself delivers the breathable gas to a plenum chamber 3200. The diameter of the tube 3420 may be smaller than the diameter of the air circuit 4170.

In one form, patient interface 3000 may include tubing 3420. For example, the tube 3420 may be removably or permanently attached to the air inlet port 3202. In an alternative form, the air circuit 4170 may include a tube 3420 integrally formed together or attached together (either removably or permanently) to form a single assembly.

Positioning of air circuits

The patient interface 3000 described with respect to the various forms of the present technology herein may accommodate the positioning of the air circuit 4170 in various arrangements with respect to the patient.

In some forms, the air circuit 4170 may be configured to route to the patient interface 3000 from substantially above a transverse plane configured to pass through a nasal and/or mouth region of a patient, such as a frankfurt level (see fig. 2E). In this form, the patient interface 3000 may include a positioning structure configured to maintain a portion of the air circuit 4170 in a desired position relative to the patient's head, e.g., the portion of the air circuit 4170 may be maintained in a position above the on-ear base of the patient. For example, the positioning structure may include one or more straps configured to be worn on the patient's head and engage the air circuit 4170. In one form, the air circuit 4170 may be configured to pass over the top and/or rear of the patient's head. Alternatively or additionally, the air circuit 4170 may be configured to pass behind and/or near the back of the patient's neck when the patient interface system 5000 is in use.

In another form, the air circuit 4170 may be configured to reach the patient interface 3000 from substantially below a transverse plane configured to pass through a nasal and/or mouth region of a patient, such as a frankfurt level. Such an arrangement is shown, for example, in fig. 3A, 4B, and 10F. In this form, the patient interface 3000 may not require any locating structure to secure the air circuit 4170 in place.

In one form, the air circuit 4170 may be disposed around one or both ears of the patient 1000 and/or proximate one or both ears of the patient 1000. For example, the air circuit 4170 may branch into two conduits before being connected to the end of the air circuit 4170 of the patient interface 3000. Each of the conduits may be configured to be capable of passing behind a respective ear of the patient 1000 in use.

Applicator

In certain forms of the present technology, as shown, for example, in fig. 13A-14C, 17, and 18A-18C, the patient interface system 5000 includes an applicator 3800 configured to assist the patient 1000 in positioning the patient interface 3000 in a therapeutically effective position on the patient's face.

One of the advantages of the applicator 3800 is that it helps maintain the shape of the seal-forming structure 3200 from the time the removable layer (or liner) 3104 is removed until the seal-forming structure 3100 is secured to the patient's face. The applicator 3800 may be used as an alternative or in addition to the shape retainer 3140.

In some forms, the applicator 3800 includes a body 3810, the body 3810 including a recess 3802, a surface 3808, and a grip portion 3804, the recess 3802 configured to receive and retain the patient interface when the patient interface is placed in a therapeutically effective position on a patient's face, the surface 3808 provided around the recess 3802.

Main body

In an exemplary form of the present technology, the applicator 3800 includes a body 3810. The body 3810 may be formed from a material and have a structure such that the body 3810 is substantially rigid. For example, the body 3810 may be formed of a plastic material, such as polycarbonate. The body 3810 may be formed in a molded manner, such as injection molding.

In an exemplary form of the present technology, the body 3810 includes a recess 3802 and a surface 3808, which will now be described.

In some forms, the body 3810 may take the form of a front layer 3230, as previously described in this specification, for example as shown in fig. 15B and 15C.

Similar to the shape retainer 3140 or the anterior layer 3230, the body 3810 may be used to maintain the shape of the seal-forming structure 3100 and prevent it from wrinkling, folding, sagging, or otherwise changing its shape before the seal-forming structure 3100 is secured to the patient's face.

In one form, the body 3810 may be formed as or include a frame, such as a skeletal-like structure, to provide shape-retaining support for the seal-forming structure 3100 when in use.

Concave part

In an exemplary form, such as the one illustrated, the body 3810 of the applicator 3800 includes a recess 3802. A recess 3802 is formed on one side of the body 3810. Recess 3802 is configured to receive and retain patient interface 3000 when patient interface 3000 is placed in a therapeutically effective position on a patient's face. In the exemplary form shown in fig. 13A, the recess 3802 is configured to house a plenum chamber 3200 of the patient interface 3000, with the seal-forming structure 3100 positioned outside of the recess 3802. Recess 3802 is configured to receive patient interface 3000 with adhesive surface 3102 of seal-forming structure 3100 facing away from body 3810 of applicator 3800. In some forms, the recess 3802 may also at least partially house the seal-forming structure 3100 when the patient interface 3000 is received and retained.

It will be appreciated that the recess 3802 may be shaped to match the shape of the component intended to receive and retain, but with the recess on the opposite side, i.e. where the component has a protrusion, and vice versa.

In the technical form shown in fig. 13A, the body 3810 of the applicator 3800 includes two prongs 3806 extending from the recess 3802. The prongs 3806 are sized and spaced apart such that they can be inserted into the nostrils of the patient 1000 while the patient interface 3000 is placed in a therapeutically effective position on the patient's face. This assists the patient in properly positioning patient interface 3000 on his face.

Maintaining the patient interface 3000 within the recess 3802 until the seal forming structure 3100 adheres to the patient's face may be accomplished by a friction fit, i.e., the recess 3802 may be sized to hold the patient interface 3000 in place by a friction fit. The strength of the friction fit should not be stronger than the adhesive bond between the seal forming structure 3100 and the patient's face. In this way, as shown in fig. 13C and 14C, after the seal-forming structure is adhered to the patient's face and the applicator 3800 has been pulled away, the applicator 3800 may be detached from the patient interface 3000. Alternatively, the patient interface 3000 may sit in the recess 3802 under the influence of gravity while retaining the applicator 3800 such that the recess 3802 opens upwardly.

In another form, temporary retention between the patient interface 3000 and the applicator 3800 may be achieved by magnetic attraction. For example, as illustrated in the exemplary form shown in fig. 17, a magnetic member 3812 may be provided within the recess 3802, or alternatively within the body 3810 proximate to the recess 3802, in which position the magnetic member 3812 may magnetically couple with a magnetic member positioned on the patient interface 3000 (e.g., the first magnetic member 3510 of the inlet port 3202 of the plenum chamber 3200). After the seal forming structure 3100 is adhered to the patient's face, the magnetic coupling between the magnetic members can be easily broken by flipping the applicator 3800 up or down.

In some forms, the applicator 3800 may be removably attached to the front surface of the seal forming structure 3100 and/or the plenum chamber 3200. In some forms, the front surface of the seal-forming structure 3100 and/or a plenum chamber 3200 removably attached to the applicator 3800 may be opposite the adhesive surface 3102. In some forms, the applicator 3800 may be configured to adhere to a front surface of the seal-forming structure 3100 and/or the plenum chamber 3200. For example, the applicator 3800 may be adhered to the front surface of the seal-forming structure 3100 and/or the plenum chamber 3200 by a weak bond adhesive such that the applicator 3800 may be easily removed by the patient once the patient interface 3000 is in place. The adhesive may be provided on a surface 3808 of the applicator 3800 such that little or no adhesive may be perceived on the front surface of the patient interface 3000 when the applicator 3800 is removed. This may help to maintain the patient interface 3000 on the applicator 3800, making it easier for the patient to install the interface in a desired location.

In an alternative form, the applicator 3800 may be partially removably attached to the adhesive surface 3102 of the seal forming structure 3100.

Surface of the body

In some forms, the body 3810 of the applicator 3800 further includes a surface 3808. A surface 3808 is provided around the recess 3802 to support the seal-forming structure 3100 when the patient interface 3000 is placed in a therapeutically effective position on the patient's face. In some forms, the surface 3808 can form a side or end of the body 3810 of the applicator 3800. The width of the body 3810 of the applicator 3800 can be substantially similar to the width and/or length of the surface 3808. Alternatively, the surface 3808 may be a surface of a flange provided at one end of the body 3810.

Surface 3808 may be shaped to complement an area of the patient's face with which the patient interface is configured to form a seal. For example, surface 3808 may be shaped to match or resemble an area of a patient's face. Surface 3808 may be custom shaped to complement the shape of an individual patient's face. Alternatively, surface 3808 may be generally facial-shaped. Alternatively, multiple applicators 3800 may be provided to fit different facial shapes and sizes, and each individual patient may select the applicator 3800 having a surface 3808 that most closely resembles their facial shape/size.

For example, where the seal forming structure 3100 is configured to be attached to a flange region of a nose, the surface 3808 may be shaped to include a portion that complements the flange shape or general flange shape of the patient 1000. The surface 3808 may include a shape complementary to the corners and folds of the flange region such that when the applicator 3800 is positioned toward the patient's face and the seal-forming structure is in a desired position, the contour of the surface 3808 causes the seal-forming structure 3100 to tightly engage the flange region. This causes the seal forming structure 3100 to adhere to the patient's face and once the seal forming structure is securely adhered to the flange region, the applicator 3800 may be withdrawn. The surface 3808 may include surface features shaped to complement other portions of the patient's face to which the seal-forming structure 3100 is configured to adhere, including, for example, pleats 3232 to aid in adhering the seal-forming structure 3100 into the nasal wing pleats, as previously described with respect to the technical forms shown in fig. 15B and 15C.

Facial features, particularly those surrounding the wings, flanges, nasal folds, and nasolabial folds, include folds and corners, whose concavity may be greater than the convexity of the fingertip. As a result, it may be difficult for the patient 1000 to adhere to the adhesive surface of the seal-forming structure 3100 to closely conform to the wrinkled areas of the face. In some forms, the applicator 3800 may be configured to accurately position the seal-forming structure 3100 and push the seal-forming structure 3100 into contact with the patient's face in a manner that allows it to follow facial features more closely than a person's fingers. Further, the applicator 3800 helps the patient avoid touching the adhesive surface of the seal forming structure 3100 when positioning the patient interface 3000, which can help avoid particulate contamination of the adhesive surface that can lead to a loss of adhesive efficacy. This may occur when the patient 1000 manipulates the seal with his fingers to form a structure.

In the illustrated exemplary form of the present technology, surface 3808 completely surrounds recess 3802. In an alternative form of the technique, the surface 3808 may extend outwardly from the recess 3802 on only some sides of the recess 3802. In some forms, the body 3810 may include a plurality of surfaces 3808, each surface 3808 extending outwardly from the recess 3802 on a different side.

In some forms, the applicator 3800 can include one or more guides 3814 for positioning the patient interface 3000 in a desired position relative to the applicator 3800. More specifically, one or more guides 3814 may be positioned around the periphery of the surface 3808 so as to contain the periphery of the seal-forming structure 3100.

In the exemplary form of the technique shown in fig. 17, applicator 3800 includes a guide 3814 in the form of a ridge extending upwardly from surface 3808 (i.e., in a direction generally perpendicular to the general plane of surface 3808) around a portion of the periphery of surface 3808. In an alternative exemplary form of the technique shown in fig. 18A-18C, the applicator 3800 includes a plurality of guides 3814. Each guide 3814 includes a tab extending generally perpendicularly outwardly from surface 3808. Guides 3814 are arranged in a spaced arrangement around the periphery of surface 3808. In the illustrated form, the tabs are provided on slots and each tab is movable along their respective slot to change the size of the area defined by the tab within which the seal forming structure 3100 is to be retained. In use, the patient may change the position of the tabs to most effectively hold the seal-forming structure 3100 of the patient interface 3000 being used in place. The tabs may be held in place by friction fit within their respective slots.

Gripping portion

In some forms of the technique, the applicator 3800 further includes a grip portion 3804, the grip portion 3804 being configured to be held by the patient 1000 or another user when the patient interface 3000 is placed in a therapeutically effective position on the patient's face. The grip portion 3804 may be provided on the body 3810. In some forms, the grip portion 3804 and the body 3810 are separate components that are connected together. Alternatively, the grip portion 3804 and the body 3810 may be integrally formed together, such as molded as a single piece as a single component. The grip portion 3804 may be provided on a side of the body 3810 opposite to a side of the body 3810 in which the recess 3802 is formed.

In the technical form shown in fig. 13A, 13B, and 13C, the grip portion 3804 is a handle having a length suitable for being gripped by a human hand. In the embodiment of fig. 14A, 14B and 14C, the grip portion 3804 is smaller in size and includes a protrusion on a side of the body 3810 opposite the recess 3802 that is adapted to be gripped in a patient's finger when positioning the patient interface 3000 for use. The grip portion 3804 may include a high friction surface finish.

Manufacturing and/or shaping patient interfaces

The form of the technique provides a method of manufacturing and/or shaping the patient interface 3000 according to the form of the technique using different methods.

Patient interface manufacturing method

An exemplary method of manufacturing patient interface 3000 according to the forms of the techniques described elsewhere herein will now be described with reference to fig. 21A-21D, 23A, 23B, 24A, 24B, and 25A-25E.

In fig. 21A, a sheet of material is provided, for example in the form of an adhesive tape 6500, from which a plurality of seal-forming structures 3100 are formed. The tape 6500 may be an adhesive tape sheet or it may be a multi-layered laminate including an adhesive layer 6530. Other examples of the adhesive tape 6500 are illustrated in fig. 24A and 25A.

The adhesive layer 6530 may be formed of a backing to which an adhesive is applied. In some forms, the backing may be formed of polyurethane. This can be useful in technical forms using stretch releasing adhesives because polyurethanes are flexible and resilient.

In an exemplary form of the present technology, the tape 6500 may be formed as a strip having non-adhesive strips 6540 on one or both sides of the tape 6500. When the seal-forming structure 3100 is cut out of the strip, the cut may be positioned to form a majority of the seal-forming structure 3100 from a central section of the tape 6500 including the adhesive layer 6530 and form a peripheral section of the seal-forming structure 3100 from the non-adhesive strip 6540. This process may be used to form a seal-forming structure 3100 having non-adhesive tabs 3108 (formed from non-adhesive strips 6540) on one or both sides of the seal-forming structure 3100, as previously described. The non-adhesive stripes 6540 may be attached to the adhesive layer 6530 or integrally formed with the adhesive layer 6530, and may be areas where no adhesive is applied.

As previously described, the tab 3108 may allow a user to grasp the seal-forming structure 3100 to facilitate easy application and/or removal of the seal-forming structure 3100 in use. Additionally, if the adhesive (such as an acrylate-based adhesive) is a stretch release adhesive, the tab 3108 may be used to grasp the seal-forming structure 3100 and pull to stretch it and thereby remove the patient interface from the patient.

In other forms, the non-adhesive stripes 6540 may not be present.

The tape 6500 can also include a removable layer (liner) 6550, as shown in fig. 24A and 25A. The removable layer 6550 covers the adhesive surface of the adhesive layer 6530 to avoid its adhesion to any object prior to use and to mitigate adhesive loss. In addition, the removable layer 6550 may add sufficient strength to the tape 6500 to enable the tape 6500 to be rolled or otherwise manipulated during manufacturing with less chance of damaging the tape 6500 than would otherwise be the case.

In the technical form illustrated in fig. 25A, a non-adhesive strip 6540 is sandwiched between an adhesive layer 6530 and a removable layer 6550. Once the removable layer 3104 is removed by the patient, the non-adhesive strips 6540 and the adhesive surface 3102 are exposed. The exposed side of the non-adhesive strip 6540, along with the non-adhesive side of the peripheral region of the adhesive layer 6530, form a tab 3108 that allows the patient 1000 to grasp the patient interface 3000 without contacting the adhesive surface 3100.

In some forms, the tape 6500 may be wound onto the first spool 6510. During manufacture, the tape 6500 may be wound onto the second spool 6520, as shown in fig. 23A.

Cutting

The blank 3158 for the seal forming structure 3100 may be cut from a sheet of material (e.g., tape 6500). In an exemplary form, the blank 3158 may be cut into a form suitable for shaping into any of the forms of the aforementioned seal forming structure 3100, for example as illustrated by the lines indicating the shape of the seal forming structure in fig. 21A. In some forms, the blank 3158 may be die cut or laser cut.

In some forms of the present technology, the initial cutting step may involve partial cutting, which may alternatively be referred to as pre-cutting. In the pre-cutting step, the blank 3158 is not completely cut from the tape 6500. Instead, portions of the blank 3158 remain attached to the tape 6500. In accordance with an exemplary form of the present technique, the results of the pre-cutting step are shown in fig. 23B and 24B. In these figures, the tape 6500 is cut to form a blank 3158 that is still connected to the remainder of the tape 6500. The pre-cut holes 6560 may be cut entirely from the middle of each blank 3158. The pre-cut edge 6570 may cut around the outside of the blank 3158 in one or more arcs that do not intersect at the ends so that the blank 3158 remains attached to the tape 6500. Alternatively, the tape 6500 may be creased or otherwise marked prior to the cutting step, the advantages of which will be explained below.

In certain exemplary forms, as will now be described, cutting the remainder of the blank 3158 from the tape 6500 may occur in a subsequent manufacturing step, for example, concurrent with or subsequent to a molding process for applying the plenum chamber 3200 to the seal-forming structural blank.

Molding

The slit or partially slit blank 3158 may then be molded into the desired shape of the seal forming structure 3100.

Fig. 21B illustrates the blank 3158 positioned between two portions of the molding device 6000. These two parts may be a cavity part 6002, the cavity part 6002 comprising a cavity 6012 and a core part 6004, during the forming process, a blank 3158 may be inserted into the cavity 6012, the core part 6004 comprising a protrusion 6014, the protrusion 6014 being configured to be inserted into the cavity 6012 in the cavity part 6002, and the blank 3158 being positioned between the cavity and the core part. A similar arrangement is illustrated in fig. 25A.

In the technical form shown in fig. 23A and 23B, the partially cut blanks are positioned relative to the cavity member 6002 and the core member 6004 by the reels 6510 and 6520. For example, the reel is arranged to supply the adhesive tape 6500 between the cavity member 6002 and the core member 6004, the cavity member 6002 and the core member 6004 being arranged to face each other with a gap therebetween. The cavity member 6002 may include a plurality of cavities 6012, and the core member 6004 may correspondingly include a plurality of protrusions 6014. Each of the plurality of projections 6014 is received by the cavity 6014 of the cavity member 6002. The spools may be controlled so that they stop winding so that pre-cut blanks 3158 are positioned in line with cavities 6012 and protrusions 6014 on cavity member 6002 and core member 6004, respectively. Another advantage of pre-cutting (or alternatively pre-scoring or pre-marking) the tape 6500 is that the cuts, indentations and/or markings allow the digital sensor to detect the position of the tape 6500 as the tape 6500 moves between the core member 6004 and the cavity member 6002. The digital sensor may be configured to provide data to a processor that controls the first spool 6510 and/or the second spool 6520 to operate and/or stop. This allows the tape 6500 to be positioned in such a way that: when the core member 6004 is received by the cavity member 6002, the aperture 6560 is aligned with the projection 6014 and cavity 6012.

Next, the cavity and the core member are put together. This is illustrated in fig. 21C and 25B. This step sandwiches the blank 3158 between the cavity and the core member, forming it into a desired shape dictated by the shape of the cavity 6012 and the projection 6014. In some forms, a thermoforming step may be used in which heat is applied to the blank 3158 to aid in some forms of molding process. For example, the cavity and the core member may conduct heat and there may be a heating element in thermal contact with them. In other forms, no thermoforming is applied. For example, if the adhesive is affected by the application of heat, it may be desirable not to use thermoforming.

In some forms, such as shown in fig. 21C, some peripheral portions of the blank 3158 may protrude outwardly from between the cavity and the core member, such as peripheral portions including tabs 3108.

In some forms, the moulding device may include or have been provided with a cutter. The cutter may include a cutting blade 6210 having a cutting end 6200. Cutting blades 6210 may be provided on either side of each cavity 6012 on cavity member 6002. In another form, cutting end 6200 may be configured to completely or partially surround cavity member 6002. In another form, the cut ends may be arranged to align with those portions of the blank 3158 that remain attached to the tape 6500. Alternatively, the cutting blade 6210 may instead be provided to the core member 6004. This form is illustrated in fig. 25A to 25E. In this form, the cutting blade 6210 may be positioned within a channel in the cavity member 6002 (or core member 6004) and configured to move longitudinally within the channel toward the core member 6004 (or cavity member 6002).

In use, as shown in fig. 25C, the cut end 6200 can be moved toward the blank 3158 to completely cut the blank 3158 from the tape 6500. This may occur before, simultaneously with, or after the overmolding process that will now be described. Alternatively or additionally, a similar cutting step may trim excess tap material from the blank 3158 to form the seal forming structure 3100.

In some forms of the present technology, the plenum chamber 3200 is provided to the seal forming structure 3100 by an over-molding process while the blank 3158 for the seal forming structure 3100 is held in a molding device. Such process steps are illustrated in fig. 21D and 25C. The cavity member 6002 may include a channel 3908 through which molten overmolding material (e.g., TPE or silicon) may be injected into contact with the blank 3158. Molten overmold material may be injected from channel 3908 into the gap between cavity 6012 and blank 3158. The gap may be shaped into a desired shape of the plenum chamber 3200 such that the plenum chamber 3200 is formed as an overmold over the seal-forming structure 3100.

As illustrated in fig. 23A, the molding apparatus 6000 may include a hopper 6100, the hopper 6100 being a reservoir of molten overmolding material. The molten overmold material is flowed into the gap 6020 through the conduit 6110 and the channel 3908.

When the cavity member 6002 and core member 6004 are pulled apart, a shaped, overmolded plenum chamber 3200 and seal forming structure 3100 are formed, and the molding device 6000 can be formed such that the members fall into the collector 6300.

In some forms of the present technique, the shape retainer 3140 may be overmolded onto the blank 3158 in a manner similar to that described above for the plenum chamber 3200, wherein the cavity member 6002 forms one or more gaps with the blank 3158 that are adapted to receive the overmolding material to form the shape retainer 3140.

Patient interface customization

In one form, patient interface 3000 is customized to fit an individual patient 1000. In another form, patient interface 3000 is manufactured that is generally shaped and designed to fit a general facial shape. In yet another form, patient interface 3000 is manufactured in a limited number of different shapes and sizes such that there is a limited number of preformed patient interfaces 3152, and any given patient 1000 selects preformed patient interface 3150 from the number of preformed patient interfaces 3152 that best suits its needs.

As previously described, the pre-formed patient interface 3150, which is generally shaped and sized, may be cheaper to manufacture, supply, and distribute on a large scale than the custom-made seal-forming structure 3100 to correspond to the precise facial features of each individual patient 1000. However, as previously described, the seal-forming structure 3100, which mimics facial features, has many advantages. Shaping the preformed patient interface 3150 into a variety of different shapes and sizes may provide a useful tradeoff to take advantage of economies of scale while still providing a seal shaping structure 3100 that may fit an individual patient to a sufficient extent. The larger the variety of shapes and sizes provided, the greater the prospect that a patient can select a patient interface that will mate with. The fewer the number of shapes and sizes, the greater the economies of scale.

A method of customizing patient interface 3000 for delivering breathable gas to a patient in accordance with an exemplary form of the present technology will now be described in more detail.

Receiving patient data

In one exemplary form, a method of customizing patient interface 3000 includes a first step of receiving data indicative of a shape and size of an area of a patient's face surrounding an entrance to a patient's airway. The method may further comprise the step of scanning the patient's facial region to generate data indicative of the shape and size of the patient's facial region.

Selecting a preformed patient interface assembly

Further, the method may include a second step of selecting a preformed patient interface 3150 from a plurality of preformed patient interfaces 3152, as shown in fig. 12C. Each preformed patient interface 3150/3152 includes a plenum chamber 3200 and a seal-forming structure 3100 according to any of the forms of the techniques described elsewhere herein.

In one form of the present technique, each of the plurality of preformed patient interfaces 3152 may have a different shape and/or size. For example, the plurality of preformed patient interfaces 3152 may be a series, wherein each preformed patient interface 3150 differs in size from the next preformed patient interface 3150 in the series. The shape of the plurality of preformed patient interfaces 3152 may also vary depending on the typical facial type in the population. For example, there may be preformed patient interfaces 3152 corresponding to different sexes, ages, ethnicities, nasal types, etc.

A preformed patient interface 3150 is selected from a plurality of preformed patient interfaces 3152, the patient interface 3150 most closely conforming to the region of the patient's face to which the seal forming structure 3100 is adhered.

In an alternative form of the present technique, each of the plurality of preformed patient interfaces 3152 is the same, or there are very few different preformed patient interfaces 3152. This reduces the cost of manufacturing the preformed patient interface 3152 (e.g., the cost of manufacturing the mold), but it means that for some patients it may be more difficult to find a precisely identified preformed patient interface.

Molding

In a subsequent step of the exemplary form, the selected preformed patient interface 3152 (e.g., its seal-forming structure) is shaped to more closely match/resemble the facial area of the individual patient 1000 to which the seal-forming structure 3100 adheres when shaped from the preformed patient interface 3150.

In one exemplary form, the step of shaping the selected preformed patient interface 3152 includes molding the preformed patient interface 3152 into a desired shape.

For example, in the form of the technique shown in fig. 12A and 12B, a two-part molding device 3900 is used to shape a selected preformed patient interface 3152. Molding apparatus 3900 includes a first portion 3902 and a second portion 3904. As shown in fig. 12A, a selected preformed patient interface 3152 is placed between first portion 3902 and second portion 3904. The two portions 3902, 3904 of the molding apparatus 3900 are pressed together to form the selected preformed patient interface 3152. More specifically, the molding device 3900 may be used to form the seal-forming structure 3100 of a selected preformed patient interface 3152. This may be the most important part of the shaping, as the seal forming structure 3100 is the portion of the patient interface 3000 that contacts the patient's face in use. In one form, as shown in fig. 12A and 12B, the second portion 3904 of the molding device 3900 includes a recess 3906 to receive the plenum 3200 such that the plenum 3200 remains unchanged during the molding process. The inflation chamber 3200 of the selected preformed patient interface 3152 may additionally or alternatively be formed in some technical form by the molding device 3900.

The first portion 3902 and the second portion 3904 of the molding device 3900 may be shaped to create a seal-forming structure 3100, the seal-forming structure 3100 being substantially proximate to a facial region to which the seal-forming structure 3100 is attached. To achieve this, the first portion 3902 and/or the second portion 3904 are shaped according to the facial region using data indicative of the shape and size of the patient's facial region.

In one form, the relevant facial area of the patient 1000 is a scanned 3-D image, and the first portion 3902 and the second portion 3904 are formed from scanned virtual images. The first portion 3902 and the second portion 3904 may be 3-D printed.

In some forms, the molding device 3900 may be a thermoforming device that thermoforms a selected preformed patient interface 3152 or a portion thereof (e.g., seal forming structure 3100) into a desired shape.

In an alternative form, the molding apparatus 3900 may be an injection molding apparatus that shapes the preformed patient interface 3512 and retains its shape by pouring an injection molded substrate over the shaped preformed patient interface 3152. In some forms, the substrate is overmolded onto the shaped preformed patient interface 3152.

In one form of the present technique, the preformed patient interface 3152 may be formed by cutting, shaping, and optionally over-molding the blank 3158 in a manner as explained above and, for example, in connection with fig. 21A-21D or 23A-25E.

Laser bending

In one form (not shown), the selected preformed patient interface 3152 may be shaped by laser bending.

3-D printing

In one form (not shown), patient interface 3152 may be produced by 3-D printing.

RPT device

The RPT device 4000 in accordance with one aspect of the present technology includes mechanical, pneumatic, and/or electronic components and is configured to perform one or more algorithms, such as all or part of the methods described herein. The RPT device 4000 may be configured to generate an air flow for delivery to the airway of a patient, such as to treat one or more of the respiratory conditions described elsewhere in this document.

In some forms, RPT device 4000 may be configured to deliver air flow to patient interface 3000 at a positive pressure relative to the ambient environment. The RPT device 4000 may be configured to deliver air at therapeutic pressure, e.g., at least 6cmH relative to the surrounding environment ₂ O. Conventional RPT device 4000 mayFor this purpose.

In other forms, the RPT device 4000 may be configured to operate at a lower pressure (but still at a positive pressure relative to the ambient environment), for example, 2 to 6cmH relative to the ambient environment ₂ O, delivering fluid or air to patient interface 3000. Respiratory therapy systems incorporating RPT devices 4000 delivering air flow at such pressure may be used to provide low level therapy. For example, such systems may be used to treat or ameliorate snoring or other mild respiratory conditions. Such systems may be less expensive to manufacture, use less power, and be more compact in size than RPT devices capable of delivering air at higher pressures, such as RPT devices suitable for treating obstructive sleep apnea.

Fig. 32 illustrates a respiratory therapy system 2000 in conjunction with an RPT device 4000 of the type just described. In the form shown in fig. 32, breathable gas is delivered to patient interface 3000RPT device 4000, which patient interface 3000RPT device 4000 is compact in size and may therefore be portable, i.e. capable of being carried by a patient during use, e.g. mounted on the patient's person or clothing. For example, in use, the RPT device 4000 may be strapped around the neck or arm of a patient or carried in a pocket.

Breathable gas from RPT device 4000 may be delivered to patient interface 3000 through air circuit 4170. The inlet port 3202 of the plenum chamber 3200 may be connected to an end of the air circuit 4170, with the other end of the air circuit 4170 connected to the RPT device. Because the flow rate and/or pressure of the air supply may be lower than the flow rate and/or pressure of a conventional RPT device 4000 (e.g., a CPAP device), the air circuit 4170 may have a reduced diameter as compared to conventional air circuits. For example, in some forms, the air circuit 4170 may have a diameter in the range of 5 to 15mm, such as 10mm. Smaller diameter tubes provide more resistance to air flow than larger diameter tubes, but this is acceptable if the flow rate and/or pressure to be delivered is also lower. Smaller diameter tubes may be desirable because they are smaller and less obtrusive, easier to store or package, and cheaper to manufacture.

Glossary of terms

For the purposes of this technical disclosure, in certain forms of the present technology, one or more of the following definitions may be applied. In other forms of the present technology, alternative definitions may be applied.

General rule

Air: in certain forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as oxygen enriched air.

Ambient environment: in certain forms of the present technology, the term ambient environment will be considered to mean (i) outside of the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

For example, the ambient humidity relative to the humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity in a room in which the patient is sleeping. Such ambient humidity may be different from the humidity outside the room in which the patient is sleeping.

In another example, the ambient pressure may be pressure directly around the body or outside the body.

In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room in which the patient is located, rather than noise generated by the RPT device or noise emanating from a mask or patient interface, for example. Ambient noise may be generated by sound sources outside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy, in which the treatment pressure is automatically adjustable between a minimum and maximum level, for example, varies with each breath, depending on whether an indication of an SBD (sleep disordered breathing) event is present.

Continuous Positive Airway Pressure (CPAP) therapy: respiratory pressure therapy, in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, e.g., increase in response to detecting an indication of partial upper airway obstruction, and decrease in the absence of an indication of partial upper airway obstruction.

Flow rate: air volume (or mass) delivered per unit time. The flow rate may refer to an instantaneous quantity. In some cases, the reference to flow rate will be a reference to a scalar, i.e., an amount having only a magnitude. In other cases, the reference to flow rate will be a reference to a vector, i.e., a quantity having a magnitude and a direction. The flow rate may be represented by the symbol Q. "flow rate" is sometimes abbreviated simply as "flow" or "gas flow".

In the example of patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's breathing cycle and thus negative for the expiratory portion of the patient's breathing cycle. The device flow rate Qd is the flow rate of air leaving the RPT device. The total flow rate Qt is the flow rate of air and any supplemental gas to the patient interface via the air circuit. The ventilation flow rate Qv is the flow rate of air exiting the vent to allow flushing of the exhaled air. The leak flow rate Ql is the leak flow rate from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air received into the respiratory system of the patient.

Flow therapy: respiratory therapy involves delivering a flow of air to the entrance of the airway at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the respiratory cycle of the patient.

A humidifier: the word humidifier will be understood to refer to a humidification device constructed and arranged or configured to have a device that is capable of providing a therapeutically beneficial amount of water (H) to an air stream ₂ O) vapor to improve the physical structure of the patient's medical respiratory condition.

Leakage: the word leakage will be considered as an unintended air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow that leads to the surrounding environment.

Conductive noise (acoustic): conduction noise in this document refers to noise transmitted to the patient through pneumatic paths such as the air circuit and patient interface and air therein. In one form, the conducted noise may be quantified by measuring the sound pressure level at one end of the air circuit.

Radiated noise (acoustic): radiation noise in this document refers to noise transmitted to the patient by the surrounding ambient air. In one form, the radiated noise may be quantified by measuring the acoustic power/pressure level of the object in question according to ISO 3744.

Ventilation noise (acoustic): ventilation noise in this document refers to noise generated by air flow through any vent, such as a vent hole of a patient interface.

Oxygen enriched air: air having an oxygen concentration greater than the oxygen concentration of atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "oxygen-enriched air" is sometimes referred to simply as "oxygen".

Medical oxygen: medical oxygen is defined as oxygen-enriched air having an oxygen concentration of 80% or more.

Patient: a person, whether or not they have a respiratory condition.

Pressure: force per unit area. The pressure can be expressed as a unit range including cmH ₂ O, g-f/cm2, hPa. 1cmH ₂ O is equal to 1g-f/cm2 and is approximately 0.98 hPa (1 hPa=100 Pa=100N/m2=1 mbar-0.001 atm). In the present specification, unless otherwise indicated, pressure is in cmH ₂ O is given in units.

The pressure in the patient interface is given by the symbol Pm and the therapeutic pressure, which represents the target value obtained by the interface pressure Pm at the current moment, is given by the symbol Pt.

Respiratory pressure therapy: the air supply is applied to the inlet of the airway at a therapeutic pressure that is generally positive relative to the atmosphere.

Breathing machine: mechanical means to provide pressure support to the patient to perform some or all of the work of breathing.

Material

Silicone or silicone elastomer: synthetic rubber. In the present specification, reference to silicone refers to Liquid Silicone (LSR) or Compression Molded 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 corporation (Dow Corning). Another manufacturer of LSR is the Wacker group (Wacker). Unless specified to the contrary, exemplary forms of LSR have a shore a (or type a) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: a thermoplastic polymer of bisphenol A carbonate.

Mechanical properties

Rebound resilience: the ability of a material to absorb energy when elastically deformed and release energy when unloaded.

Elasticity: substantially all of the energy will be released upon unloading. Including, for example, certain silicones and thermoplastic elastomers.

Hardness: the ability of the material itself to resist deformation (e.g., described by Young's modulus or indentation hardness scale measured on a normalized sample size).

The "soft" material may comprise silicone or thermoplastic elastomer (TPE) and may be easily deformed, for example, under finger pressure.

"hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and may not readily deform, for example, under finger pressure.

Hardness (or stiffness) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load may be a force or moment, such as compression, tension, bending or torsion. The structure or component may provide different resistances in different directions. The inverse of stiffness is the compliance.

Flexible structures or components: when allowed to support its own weight for a relatively short period of time, for example, within 1 second, the structure or component will change shape (e.g., bend).

Rigid structures or components: a structure or component that does not substantially change shape when subjected to loads typically encountered in use. Examples of such uses may be, for example, in the range of about 20 to 30cmH ₂ Under the pressure of OThe patient interface is disposed and maintained in sealing relationship with the entrance to the patient airway.

For example, an i-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction. In another example, the structure or component may be flexible in a first direction and rigid in a second direction.

Anatomies of

Facial anatomy

Nose wing (Ala): the outer walls or "wings" of each naris (plural: alar)

Nose wing end: the outermost point on the nose wing.

Nasal alar curvature (or nasal alar ridge) points: the last point in the curved baseline of each wing is found in the crease formed by the connection of the wing to the cheek.

Auricle: the entire outer visible portion of the ear.

(nasal) skeletal frame: the skeletal frame of the nose includes the nasal bones, the frontal processes of the maxilla, and the nasal portion of the frontal bone.

(nasal) cartilage scaffold: the nasal cartilage frame includes septum, lateral side, large and small cartilage.

Nose post: skin strips that separate the nostrils and extend from the nasal prongs to the upper lip.

Nose columella angle: an angle between a line drawn through the midpoint of the nostril cavity and a line drawn perpendicular to the frankfurt horizontal plane while intersecting the subnasal point.

Frankfurt level: a line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the recess above the tragus of the pinna.

Intereyebrow: is positioned on the soft tissue, and is the most prominent point of the mid-forehead sagittal plane.

Extranasal cartilage: a generally triangular cartilage plate. The upper edge of which is attached to the nasal bone and the frontal process of the maxilla, and the lower edge of which is connected to the alar cartilage of the nose.

Lip, lower (lower lip midpoint):

lip, upper (upper lip midpoint):

nasal alar cartilage: a cartilage plate located under the lateral nasal cartilage. It curves around the anterior portion of the nostril. The posterior end of which is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the nasal wings.

Nostrils (Nares/Nostrils): forming an approximately oval lumen of the nasal cavity entrance. The singular form of nostrils (nares) is nostrils (naris). The nostrils are separated by the nasal septum.

Nasolabial folds or folds: extending from each side of the nose to the corners of the mouth, skin folds or furrows separating the cheeks from the upper lip.

Nose lip angle: the angle between the columella and the upper lip (while intersecting at the point below the nose).

Sub-aural base point: the lowest point of attachment of the pinna to facial skin.

Base point on ear: the highest point of attachment of the pinna to facial skin.

Nose point: the most prominent point or tip of the nose, which may be identified in the lateral view of the rest of the head.

In humans: a midline groove extending from the lower boundary of the nasal septum to the top of the lip in the upper lip region.

Anterior chin point: is located at the midpoint of the forefront of the chin, above the soft tissue.

Ridge (nose): the nasal ridge is a midline protrusion of the nose extending from the nasal bridge point to the nasal protrusion point.

Sagittal plane: a vertical plane from front (front) to back (rear). The median sagittal plane is the sagittal plane that divides the body into right and left halves.

Nose bridge point: is positioned on the soft tissue and is the most concave point covering the forehead suture.

Septal cartilage (nose): the septum cartilage forms a portion of the septum and separates the anterior portions of the nasal cavity.

Rear upper side sheet: at the point at the lower edge of the base of the nose, where the base of the nose is attached to the skin of the upper (upper) lip.

Subnasal point: is positioned on the soft tissue, and the point where the columella nasi meets the upper lip in the median sagittal plane.

Chin upper point: the point of maximum concavity in the midline of the lower lip between the midpoint of the lower lip and the anterior genitalia of the soft tissue

Skull anatomy

Frontal bone: frontal bone comprises a large vertical portion (frontal scale), which corresponds to an area called forehead.

Mandible: the mandible forms the mandible. The geniog is the bone bulge of the mandible forming the chin.

Maxilla: the maxilla forms the upper jaw and is located above the lower jaw and below the orbit. The frontal process of the maxilla protrudes upward from one side of the nose and forms part of the outer boundary.

Nasal bone: nasal bone is two small oval bones that vary in size and form among individuals; they are located side by side in the middle and upper part of the face and form a nasal "beam" by their junction.

Root of nose: the intersection of the frontal bone and the two nasal bones is located directly between the eyes and in the recessed area above the bridge of the nose.

Occipital bone: occiput is located in the dorsal and inferior parts of the cranium. It includes oval cavity, i.e. occipital macropore, through which cranial cavity communicates with vertebral canal. The curved plate behind the occipital macropores is occipital scale.

Orbit of eye: including the bone cavity in the skull of the eyeball.

Parietal bone: parietal bones are bones that when joined together form the top cover and both sides of the cranium.

Temporal bone: the temporal bone is located on the base and sides of the skull and supports that portion of the face called the temple.

Cheekbones: the face includes two cheekbones that are located in the upper and outer portions of the face and form a bulge of the cheek.

Anatomy of respiratory system

A diaphragm: muscle pieces extending across the bottom of the rib cage. The diaphragm separates the chest cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the chest cavity increases and air is drawn into the lungs.

Throat: the larynx or voice box accommodates the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

Lung: the respiratory organs of humans. The conducting areas of the lung contain the trachea, bronchi, bronchioles and terminal bronchioles. The respiratory region contains respiratory bronchioles, alveolar ducts, and alveoli.

Nasal cavity: the nasal cavity (or nasal fossa) is a larger air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by vertical fins called nasal septum. There are three horizontal branches on the sides of the nasal cavity, which are called nasal concha (singular "turbinates") or turbinates. The front of the nasal cavity is the nose, while the back is incorporated into the nasopharynx via the posterior nasal orifice.

Pharynx: is located immediately below the nasal cavity and in a portion of the throat above the esophagus and larynx. The pharynx is conventionally divided into three sections: nasopharynx (upper pharynx) (nasal part of pharynx), oropharynx (middle pharynx) (oral part of pharynx), laryngopharynx (lower pharynx).

Patient interface

Anti-asphyxia valve (AAV): by opening to the atmosphere in a safe manner, the components or subassemblies of the mask system reduce the risk of the patient re-breathing excessive CO 2.

Bending pipe: an elbow is an example of a structure that directs the axis of air flow traveling therethrough through an angle to change direction. In one form, the angle may be about 90 degrees. In another form, the angle may be greater or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotated, for example about 360 degrees, relative to the mating component. In some forms, the elbow may be removed from the mating component, for example, via a snap-fit connection. In some forms, the elbow may be assembled to the mating component via a single snap during manufacture, but not removable by the patient.

A frame: the frame will be considered to mean a mask structure that is subject to tension loads between two or more connection points with the headgear. The mask frame may be a non-airtight load carrying structure in the mask. However, some forms of mask frames may also be airtight.

Functional dead zone: (description to be inserted here)

Film: the film will be considered to mean a typically thin element, which preferably has substantially no resistance to bending but resistance to stretching.

A plenum chamber: mask plenum chamber will be considered to mean that portion of the patient interface having a wall that at least partially encloses a volume of space having air pressurized therein to above atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

And (3) sealing: may refer to the noun form of the structure (seal) or the verb form of the effect (seal). The two elements may be constructed and/or arranged to 'seal' or to achieve a 'seal' therebetween without the need for a separate 'seal' element itself.

And (3) a shell: the shell will be considered to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, the curved structural wall of the mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

Reinforcement: the reinforcement will be considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

And (3) supporting: the support will be considered as a structural component designed to increase the resistance to compression of another component in at least one direction.

Swivel (noun): a subassembly of components configured to rotate, preferably independently, about a common axis, preferably at low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a pair of mating cylindrical conduits. In use, little or no air flow may leak from the swivel.

Lacing (noun): is designed to resist tensile forces.

Vent port: (noun): structure that allows air to flow from the interior of the mask or conduit to the ambient air for clinically effective flushing of exhaled air. For example, depending on mask design and therapeutic pressure, clinically effective irrigation may involve a flow rate of about 10 liters per minute to about 100 liters per minute.

Other remarks

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 the patent office patent document or the records, but otherwise reserves all copyright rights whatsoever.

Unless the context clearly dictates otherwise and provides a range of values, it is understood that each intermediate value between the upper and lower limits of that range, to one tenth of the unit of the lower limit, and any other stated or intermediate value within that range, is encompassed within the technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges, and 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 recited herein are implemented as part of the technology, it should be understood that such values can be approximate unless otherwise stated, and that such values can be used for any suitable significant digit to the extent that a practical technical implementation can 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 exemplary methods and materials are described herein.

Obvious replacement materials with similar properties may be used as alternatives when a particular material is identified for use in constructing a component. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus 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 matter 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 technology is not entitled to antedate such publication by virtue of prior invention. Further, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

The terms "include" and "comprising" are to be interpreted as: refer to an element, component, or step in a non-exclusive manner, indicating that a marked element, component, or step may be present or utilized, or combined with other elements, components, or steps that are not marked.

The topic headings used in the detailed description are included for ease of reference to the reader only and are not to be used to limit the topics found throughout the disclosure or claims. The subject matter headings are not to be used to interpret the scope of the claims or the claims 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 present technology. In some instances, terminology and symbols may imply specific details that are not required to practice the present technology. For example, although the terms "first" and "second" may be used, they are not intended to identify any order, unless otherwise specified, but rather may be used to distinguish between different elements. Furthermore, while process steps in a method may be described or illustrated in a sequential order, such order is not required. Those skilled in the art will recognize that such sequences may be modified and/or aspects thereof may be performed simultaneously 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 present technology.

List of reference numerals

1000. Patient(s)

3132. Septum region

3141. Flange area

3142. Uppermost region of upper lip

3143. Anterior region of the nose below the point of nasal protrusion

3144. The region below the nasal alar crest point

3145. Cheek region adjacent to nasal alar ridge point

2000. Respiratory therapy system

2100. Sensor module

2110. Tube of sensor module

2112. Electrode of sensor module

2114. Cover for a sensor module

3000. Patient interface

3100. Seal forming structure

3102. Adhesive surface

3104. Removable layer

3104T tab

3105. First part

3106. Second part

3105T first tab

3106T second tab

3108. Tabs

3110. Sealing the opening of the forming structure

3112. Flange

3114. Inner surface of flange

3116. Outer surface of flange

3120. First seal forming structure

3130. Second seal forming structure

3140. Shape retainer

3150. Preformed patient interface

3152. Multiple preformed patient interfaces

3158. Blank material

3160. Recess (es)

3172. Apex portion of seal forming structure

3174. Shoulder portion of seal forming structure

3176. Corner portion of seal forming structure

3178. Rod portion of seal forming structure

3180. Recess of seal forming structure

3182. Convex protrusion of seal forming structure

3184. Edge of seal forming structure

3186. Obtuse angle of seal forming structure

3188. Concave recess of seal forming structure

3190. Concave protrusion of seal forming structure

3200. Plenum chamber

3202. Plenum inlet port

3216. Annular ring

3230. Front layer

3232. Fold

3250. Nose pillow

3252. Truncated cone

3254. Handle

3300. Integral/single component

3400. Vent opening

3402. Anti-asphyxia valve

3404. Exhalation resistance valve

3406. Tube of exhalation resistance valve

3408. Cover of expiration resistance valve

3409. Valve element of exhalation resistance valve

3410. Diffuser

3420. Pipe

3422. First air vent

3424. Second ventilation port

3426. First end of tube

3428. Second end of tube

3500. Decoupling structure

3502. Pipe

3504. Flexible section

3510. First magnetic member

3512. Second magnetic member

3514. Adapter device

3518. Frame

3520. Fork tube of air loop

3522. Receiver for a tube

4170. Air circuit

3600. Connection port

3700. Heat-moisture exchanger

3710. Adapter neck

3712. First flange of adapter

3714. Second flange of adapter

3800. Applicator

3802. Recess of applicator

3804. Gripping portion

3806. Fork tube of applicator

3808. Surface of applicator

3810. Main body of applicator

3812. Magnetic component

3814. Guide for an applicator

3908. Channel

4000 RPT device

5000. Patient interface system

6000. Molding apparatus

6002. Cavity component

6004. Core component

6012. Cavity (or cavities)

6014. Protrusions

6020. Gap of

6100. Hopper

6110. Catheter tube

6200. Cutting end

6210. Cutting blade

6300. Collector device

6500. Adhesive tape

6510. First scroll

6520. Second reel

6530. Adhesive layer

6532. First layer assembly

Backing layer of 6532A first layer assembly

6532B adhesive layer of first layer assembly

6534. Second layer assembly

6534A backing layer of a second layer assembly

6534B adhesive layer of second layer assembly

6540. Non-adhesive strip

6550. Removable layer

6560. Pre-cut hole

6570. Precut edge

Claims (46)

1. A patient interface for delivering breathable gas to a patient, the patient interface comprising:

A plenum chamber capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure of O, the plenum comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for respiration by the patient;

providing a seal-forming structure to the plenum chamber, wherein the seal-forming structure is configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an opening therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nostrils, the seal-forming structure being configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

a vent structure allowing continuous flow of exhaled gas from the patient from the interior of the plenum to the ambient environment, the vent structure being configured to maintain the therapeutic pressure in the plenum in use,

wherein the seal-forming structure comprises at least one adhesive surface configured to adhere to an area of the patient's face in use to form the seal, and

Wherein the region of the patient's face surrounds the patient's nostrils and the region comprises a downwardly facing surface of the patient's nasal wings and an upper region of the patient's upper lip.

2. The patient interface of claim 1, wherein the region of the patient's face comprises a forward region of the nose immediately below the patient's nasal endpoint.

3. A patient interface according to any one of claims 1-2, wherein the region of the patient's face comprises a lateral region of the nasal wings.

4. A patient interface according to any one of claims 1-3, wherein the seal-forming structure is configured such that an uppermost portion of the seal-forming structure adheres to a nasal alar fold of the patient when the seal-forming structure is adhered to the patient's face.

5. A patient interface according to any one of claims 1-4, wherein the region of the patient's face comprises a region between the patient's nasal wings and the patient's nasolabial folds.

6. A patient interface according to any one of claims 1-5, wherein the seal-forming structure is configured such that the at least one adhesive surface is substantially similar in shape to the region of the patient's face.

7. A patient interface according to any one of claims 1-6, wherein the seal-forming structure is a generally D-shaped band.

8. A patient interface according to any one of claims 1-7, wherein the seal-forming structure comprises a recess in an edge of a region of the seal-forming structure, the recess being configured to adhere, in use, to a region of the patient's nose, the region being substantially inferior to the patient's nasal projection.

9. A patient interface according to any one of claims 1-8, wherein the first region of the at least one adhesive surface adheres to the patient's face with a greater adhesive strength than the second region of the at least one adhesive surface during use.

10. A patient interface according to any one of claims 1-9, wherein the seal-forming structure has a thickness in the range of about 0.2mm to 0.3mm when the patient interface is worn by the patient.

11. The patient interface according to any one of claims 1 to 10, wherein the seal-forming structure and the plenum chamber are integrally formed as a single component.

12. A patient interface according to any one of claims 1-11, wherein the adhesive surface of the seal-forming structure is provided with an adhesive adapted to reapply the seal-forming structure to the patient's face at least once.

13. A patient interface system for delivering breathable gas to a patient, the patient interface system comprising:

a plenum chamber capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure of O, the plenum comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for respiration by the patient;

a vent structure allowing continuous flow of exhaled gas from the patient from the interior of the plenum to the ambient environment, the vent structure being configured to maintain the therapeutic pressure in the plenum in use; and

a first seal-forming structure and a second seal-forming structure,

wherein the first seal forming structure and the second seal forming structure are interchangeably connectable to the plenum,

wherein the first seal-forming structure has a different size and/or shape than the second seal-forming structure,

wherein each of the first and second seal-forming structures is configured to form a seal with an area of the patient's face surrounding an inlet of the patient's airway, each of the first and second seal-forming structures having an opening therein such that the flow of breathable gas is delivered to at least the inlet of the patient's nostril, each of the first and second seal-forming structures being configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, and

Wherein each of the first seal-forming structure and the second seal-forming structure comprises at least one adhesive surface configured to adhere to an area of the patient's face in use to form the seal.

14. A patient interface for delivering breathable gas to a patient, the patient interface comprising:

a plenum chamber capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure of O, the plenum comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for respiration by the patient;

providing a seal-forming structure to the plenum chamber, wherein the seal-forming structure is configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an opening therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nostril, the seal-forming structure being configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, wherein the seal-forming structure comprises at least one adhesive surface configured to adhere to the area of the patient's face surrounding the entrance to the patient's airway in use to form the seal;

A vent structure allowing continuous flow of exhaled gas from the patient from the interior of the plenum to the ambient environment, the vent structure being configured to maintain the therapeutic pressure in the plenum in use;

a connection port configured to connect, in use, to an air circuit and to transmit the flow of breathable gas from the air circuit to the plenum through the plenum inlet port; and

a decoupling structure configured to at least partially decouple the seal-forming structure from the air circuit.

15. A patient interface according to claim 14, wherein the decoupling structure comprises a first magnetic member provided to the connection port, the first magnetic member configured to magnetically couple to a second magnetic member provided to the air circuit when the air circuit is connected to the connection port.

16. A patient interface according to claim 15, wherein the first magnetic member is a magnet.

17. A patient interface according to claim 15, wherein the first magnetic member is a non-magnetized ferromagnetic material.

18. A patient interface according to any one of claims 15-17, wherein the first magnetic member is annular and surrounds the connection port.

19. The patient interface according to any one of claims 15 to 18, wherein the patient interface comprises an adapter having a central aperture to allow gas to pass from a first end to a second end, wherein the first end is configured to be directly or indirectly fluidly connected to the air circuit and the second end is configured to be removably inserted into the plenum inlet port, and wherein the first end forms the connection port.

20. The patient interface according to any one of claims 14 to 19, wherein the decoupling structure comprises a ball joint provided between the air circuit and the plenum chamber.

21. The patient interface according to any one of claims 14 to 20, wherein the decoupling structure comprises a deformable member configured to deform when an end of the air circuit connected to the connection port is tilted relative to the plenum chamber.

22. A patient interface according to claim 21, wherein the deformable member is the plenum chamber.

23. The patient interface of any one of claims 21 to 22, wherein the patient interface comprises a tube having a first end and a second end, wherein the first end is fluidly connected to the plenum chamber inlet port and the second end comprises the connection port, and wherein the tube comprises the deformable member.

24. A patient interface according to claim 23, wherein the tube comprises a flexible section configured to be more flexible than another section of the tube, wherein the deformable member comprises the flexible section.

25. A patient interface according to claim 24, wherein the flexible section of the tube has a narrower diameter than another section of the tube.

26. A patient interface for delivering breathable gas to a patient, the patient interface comprising:

a plenum chamber capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure of O, the plenum comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for respiration by the patient;

providing a seal-forming structure to the plenum chamber, wherein the seal-forming structure is configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an opening therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nostrils, the seal-forming structure being configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

A vent structure allowing continuous flow of exhaled gas from the patient from the interior of the plenum to the ambient environment, the vent structure being configured to maintain the therapeutic pressure in the plenum in use,

wherein the seal-forming structure comprises at least one adhesive surface configured to adhere, in use, to the region of the patient's face surrounding the entrance to the patient's airway to form the seal,

wherein the seal-forming structure further comprises one or more tabs for grasping the seal-forming structure, wherein the one or more tabs do not have an adhesive surface facing the patient.

27. A patient interface according to claim 26, wherein the one or more tabs are located at a periphery of the seal-forming structure.

28. A patient interface according to any one of claims 26 or 27, wherein the one or more tabs comprise a first tab on a first side of the opening and a second tab on a second side of the opening, the first side being opposite the second side.

29. A patient interface according to any one of claims 26-28, wherein the at least one adhesive surface is configured such that an adhesive strength of the adhesive surface is reduced by deformation of the at least one adhesive surface.

30. A patient interface according to claim 29, wherein the at least one adhesive surface is configured such that an adhesive strength of the adhesive surface is reduced by stretching the at least one adhesive surface.

31. A patient interface according to any one of claims 29 or 30, wherein the one or more tabs are configured to be pulled to deform the at least one adhesive surface.

32. A patient interface for delivering breathable gas to a patient, the patient interface comprising:

a plenum chamber capable of being pressurized to at least 6cmH above ambient air pressure ₂ A therapeutic pressure of O, the plenum comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for respiration by the patient;

providing a seal-forming structure to the plenum chamber, wherein the seal-forming structure is configured to form a seal with an area of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an opening therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nostrils, the seal-forming structure being configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; and

A vent structure allowing continuous flow of exhaled gas from the patient from the interior of the plenum to the ambient environment, the vent structure being configured to maintain the therapeutic pressure in the plenum in use,

wherein the seal-forming structure comprises at least one adhesive surface configured to adhere, in use, to the region of the patient's face surrounding the entrance to the patient's airway to form the seal,

wherein the patient interface further comprises one or more shape retainers configured to facilitate retention of the shape of the seal-forming structure before the seal-forming structure is made to adhere to the patient's face.

33. A patient interface according to claim 32, wherein the one or more shape retainers are configured to substantially maintain the shape of the seal-forming structure after the seal-forming structure is made to adhere to the patient's face.

34. A patient interface according to any one of claims 32-33, wherein the seal-forming structure comprises the one or more shape retainers.

35. A patient interface according to any one of claims 32-34, wherein the one or more shape retainers are located on a side of the seal-forming structure that faces away from the patient's face in use.

36. A patient interface according to any one of claims 32-35, wherein the one or more shape retainers comprise an elongate member.

37. A patient interface according to any one of claims 32-36, wherein the one or more shape retainers and the seal-forming structure are made of one material.

38. A patient interface according to claim 37, wherein the one or more shape retainers and the seal-forming structure are integrally formed together.

39. The patient interface according to any one of claims 32 to 38, wherein the one or more shape retainers and the plenum chamber are made of one material.

40. The patient interface of claim 39, wherein the one or more shape retainers and the plenum chamber are integrally formed together.

41. The patient interface according to any one of claims 32 to 40, wherein the one or more shape retainers are configured to separate from the seal-forming structure and/or the plenum chamber once the seal-forming structure is made to adhere to the patient's face.

42. A patient interface according to any one of claims 32-41, wherein one or more shape retainers are configured to allow the seal-forming structure to stretch more easily in one direction than in another direction.

43. A patient interface according to any one of claims 32-42, wherein the at least one adhesive surface is configured such that an adhesive strength of the adhesive surface is reduced by deformation of the at least one adhesive surface.

44. A patient interface according to claim 43, wherein the at least one adhesive surface is configured such that an adhesive strength of the adhesive surface is reduced by stretching the at least one adhesive surface.

45. A patient interface according to claim 44, wherein the seal-forming structure further comprises one or more tabs for grasping the seal-forming structure, wherein the one or more tabs do not have an adhesive surface facing the patient.

46. A patient interface according to claim 45, wherein the one or more tabs are configured to be pulled to deform the at least one adhesive surface.