CN220327766U

CN220327766U - Patient interface for delivering breathable gas to a patient

Info

Publication number: CN220327766U
Application number: CN202320185578.3U
Authority: CN
Inventors: L·R·戈尔德斯品克; M·C·霍格; S·J·瓦格纳
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2022-04-11
Filing date: 2023-02-08
Publication date: 2024-01-12
Anticipated expiration: 2033-02-08
Also published as: CN117794601A

Abstract

The present utility model provides a patient interface for delivering breathable gas to a patient. 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 pneumatic chamber that may be pressurized to at least 6cmH above 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, e.g., the nasal wingsAn end edge 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 for delivering breathable gas to a patient

1 background Art

1.1 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 a seal-forming structure for a patient interface that forms a seal with an airway of a patient via an adhesive surface.

1.2 description of related Art

1.2.1 human respiratory System and disorders thereof

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

The airways include a series of branches that become narrower, shorter and more numerous as the branch airways penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into end bronchioles. The bronchi constitute the conducting airways, but 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 the region 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 hyperapneas.

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 treatments have been used to treat or ameliorate such conditions. In addition, other healthy individuals can utilize such treatments to prevent the occurrence of respiratory disorders. However, these treatments have a number of drawbacks.

One of the major problems in respiratory therapy is compliance, 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 overhanging 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.

1.2.2 treatment

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.

1.2.2.1 respiratory pressure treatment

Respiratory pressure therapy is the supply of air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank ventilator or a ducted 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, so if the patient finds the means for providing such treatment to be: any one or more of discomfort, difficult to use, expensive, and unsightly, the patient may choose to not follow the treatment. Uncomfortable, difficult to use, expensive, and aesthetically unattractive.

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 performing some or all of the work of breathing. 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 treatments may be improved.

Invasive Ventilation (IV) provides ventilation support for patients that are no longer able to effectively breathe themselves, and may be provided using tracheostomy tubes or endotracheal tubes. In some forms, the comfort and effectiveness of these treatments may be improved.

1.2.3 respiratory therapy System

These respiratory treatments may be provided by respiratory treatment systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

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.

1.2.3.1 patient interface

The patient interface may be used to couple the breathing apparatus to its wearer, for example by providing an air flow to the inlet of the airway. The air flow may be provided to the nose and/or mouth of the patient, the tube to the mouth or the tracheostomy tube to the trachea. Depending on the treatment to be applied, the patient interface may form a seal with an area, such as the patient's face, facilitating the gas to be at a pressure that is sufficiently different from ambient pressure (e.g., about 10cmH relative to ambient pressure ₂ Positive pressure of O) to effect treatment.

Typically, the mask system is used as a patient interface to deliver a flow of air. These mask systems typically include a pneumatic chamber that is secured to the patient's face by headgear. The pneumatic 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. Typically, the pneumatic chamber may be made of a rigidized 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 cosmetic mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from an external high pressure, rather than air that is maintained at a higher pressure than ambient internally.

Certain masks may be clinically detrimental to the present technique, for example, if they block airflow through the nose and only allow airflow through the mouth.

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

Some masks may not be practical for use while sleeping, such as when the head is lying on the side on a pillow and sleeping in a bed.

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 varies significantly from person to person. Since the head includes bone, cartilage, and soft tissue, different regions of the face react differently to mechanical forces. The mandible or mandible may be movable relative to the other bones of the skull. The entire head may be moved during the respiratory treatment session.

Because of these challenges, some masks face one or more of the following problems: abrupt, unsightly, expensive, incompatible, difficult to use, especially when worn for extended periods of time or uncomfortable when the patient is unfamiliar with the system. Errors in mask size can lead to reduced compliance, reduced comfort, and poor patient prognosis. Masks designed for pilots only, 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 are not ideal as comfortable for wearing for long periods of time (e.g., several hours). As previously mentioned, such discomfort may lead to reduced patient compliance with the treatment. This is especially true if the mask is worn during sleep.

CPAP therapy is very effective in treating certain respiratory disorders, assuming patient compliance with the therapy. Patients may not be compliant with treatment if the mask is uncomfortable or difficult to use.

Patients are often advised to regularly clean their masks, if they need to be cleaned, or if it is difficult to clean (e.g., difficult to assemble or disassemble), they may not clean their masks, which 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 different field.

1.2.3.1.1 seal forming structure

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

The patient interface is characterized in part by the design intent of the seal-forming structure to engage the face during use. In one form of 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 patient interface, the seal-forming structure may comprise a single element that surrounds both nostrils in use. Such a single element may be designed to cover, for example, the upper lip region and/or the nasal bridge region of the face. These different types of patient interfaces are known by various names of their manufacturers, including nasal cushions, nasal pillows, and nasal sprays.

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 that in use surrounds both nostrils and the mouth region. These patient interfaces may be referred to in the art as mouthpads, mouth-nose pads, or full-face pads.

A seal-forming structure that is effective in one region of a patient's face may not fit in another region, for example, because of the different shape, structure, variation, 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 on the nose of a patient.

Certain seal-forming structures may be designed for mass production so that one design can be suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must be accommodated to form a seal.

One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in face-to-face engagement with the patient's face. 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. For this type of seal-forming structure, if there is insufficient fit, 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 to effect a seal.

Another type of seal-forming structure incorporates a sheet-like seal of thin material around the perimeter of the mask to provide self-sealing against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal forming portions, if the fit between the face and mask is not good, additional force may be required to achieve the seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may buckle or bend during use, resulting in leakage.

Another type of seal-forming structure may include friction-fit elements, for example, for insertion into nostrils, however some patients find these 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 skin area to which the seal-forming structure is to be adhered prior to adhering 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 nasal 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 the adhesion, resulting in leakage, which may lead to ineffective respiratory therapy. In addition, leakage can result in unnecessary loss of oxygen when the patient is undergoing 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 structures may also leave residue, odor, or color on the patient's skin, sometimes even after removal of the seal-forming structures.

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, which is manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Pat. No. 4,782,832 (Trimble et al) assigned to Puritan-Bennett corporation.

The following nasal pillow-combined products were manufactured by risma limited: SWIFTTM nasal pillow face masks, SWIFTTMII nasal pillow face masks, SWIFTTMLT nasal pillow face masks, swiftmfx nasal pillow face masks, and miragelisttytm full face masks. The following patent applications assigned to rismel limited describe examples of nasal pillow masks: international patent application WO 2004/073,778 (which describes other aspects of the SWIFTTM nasal pillow of Russian Mich Co., ltd.); U.S. patent application 2009/0044808 (which describes other aspects of a nasal pillow of rismel limited SWIFTTM LT); international patent applications WO 2005/063228 and WO 2006/130,903 (which describe other aspects of the MIRAGE LIBERTYTM full face mask of Ruisimai Co., ltd.); international patent application WO 2009/052,560 (wherein other aspects of SWIFTTM FX nasal pillows from rismel limited are described).

1.2.3.1.2 positioning and stabilization

The seal-forming structure of a patient interface for positive air pressure therapy is subjected to a corresponding force of air pressure to break the seal. Accordingly, 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. US2010/0000534. 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 the harness. Many such harnesses are subject to one or more of discomfort, bulk, discomfort, and use. They tend to be less airtight than adhesive-based seal-forming structures. Furthermore, straps and/or stabilizing harnesses often leave marks on the face when used overnight.

1.2.3.1.3 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 interfaces in front of the patient's face can sometimes become prone to entanglement in bedding.

1.2.3.2 Respiratory Pressure Treatment (RPT) devices

Respiratory Pressure Therapy (RPT) devices may be used alone or as part of a system to deliver one or more of the above-described multiple therapies, such as by operating the device to generate an air stream for delivery to an airway interface. The airflow 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.

1.2.3.3 air Loop

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

1.2.3.4 humidifier

Delivering an air flow without humidification may result in airway dryness. The use of a humidifier with an RPT device and patient interface generates humidified gases, minimizing nasal mucosa desiccation and increasing patient airway comfort. Furthermore, 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.

1.2.3.5 vent technique

Some forms of treatment systems may include vents to allow removal of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (e.g., pneumatic chamber) of the patient interface to an exterior space of the patient interface, such as into the environment.

2 summary of the utility model

The present technology relates to providing medical devices for diagnosing, ameliorating, treating or preventing respiratory disorders with 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 to provide methods and/or devices that improve 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 one 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 pneumatic chamber that is pressurizable to at least 6cmH above ambient air pressure ₂ O, the pneumatic chamber comprising a pneumatic chamber inlet port configured to receive a flow of breathable gas at the therapeutic pressure for patient respiration.

In one form of the present technique, the seal-forming structure is configured to maintain the therapeutic pressure in the pneumatic 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 region of the patient's face surrounding the entrance to the patient's airway to form the 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 the downwardly facing surface of the nose and the uppermost region of the upper lip.

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

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-end folds.

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

In one form, the D-shaped form may include one or more of a stem portion, two corners, two shoulder portions, and an apex portion.

In one form, the corners 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 reflective symmetry about an axis that lies in a sagittal plane of the patient and passes through the apex portion and the intermediate section of the shaft 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 projection are 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 so as 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 are 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 alar end fold region, including but not limited to, the alar end fold and/or a laterally outer region of the alar and/or a cheek region adjacent the alar end fold.

In one form, the stem portion is configured to adhere to an upper region of the upper lip.

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

In one form, the seal-forming structure is interchangeably connected to the pneumatic chamber of the patient interface. Any of a plurality 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 whose shape corresponds to the closest facial feature to 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.

In one form, the shape of the seal-forming structure is configured such that at least one shape can fit 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 commonly shaped and sized 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 seal-forming structures that are very effectively suited for them.

In yet another alternative, the seal-forming structure may be customized to a single patient. The 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 nasal regions 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 primary components may be related to the degree of curvature of the target sealing region. If the target sealing area is the nasal area, the primary component relates to the degree of curvature of the nostrils.

In another form, one of the primary components may be in general shape and/or proportion to the facial features in the sealing region. If the target sealing area is a nose area, the primary component relates 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 be connected, in use, to an air circuit and to communicate the flow of breathable gas from the air circuit to the pneumatic chamber through the pneumatic 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 region of the seal-forming structure configured to seal with the sensitive region of the target seal region may have a lower adhesive strength. 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.

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.

One aspect of one form of the present technology is a patient interface that further includes 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 one end of an air circuit connected to the connection port is tilted relative to the pneumatic chamber.

The deformable member may isolate the patient interface from forces 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 delaminate strongly from the patient's face.

In one form, the deformable member is the pneumatic chamber.

In one form, the pneumatic chamber 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 pneumatic 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 another portion of the tube.

In one form, the decoupling structure includes a ball joint disposed between the air circuit and the pneumatic chamber.

In one form, the ball joint may be a quick release ball joint comprising a ball and a 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 disposed to the connection port, the first magnetic member configured to magnetically couple to a second magnetic member disposed to the air circuit when the air circuit is coupled 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 some forms, the patient interface includes an adapter having a central bore to allow passage of gas 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 inserted into the pneumatic chamber inlet port. In an alternative form, the second end is configured to be connected to the front surface of the pneumatic chamber 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 comprise 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 pneumatic chamber 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 pneumatic chamber.

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 pneumatic chamber inlet port, the second end includes a connection port, and wherein the heat and humidity exchanger includes a body of heat and humidity exchange material disposed within the tube.

In one form, the patient interface includes a heat and humidity exchanger that is remote from the pneumatic 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 pneumatic chamber. In some forms, the patient interface may include a heat and humidity exchange module including 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 pneumatic chamber integrally formed as a single component.

In one form, the seal-forming structure and the pneumatic chamber may be formed from the same material.

In another form, the seal-forming structure and the pneumatic chamber 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 oxygen cannula configured to engage a nostril of a patient and deliver a flow of breathable gas into the nostril of the patient.

In one form, the nasal oxygen cannula may include a pair of nasal pillows, each configured to engage one nostril of the patient.

Another aspect of one 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 a patient's face surrounding an entrance to a 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 pneumatic chamber. 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 is removably disposed to the pneumatic chamber. The positioning guide member is 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 is removably attached to the front surface of the seal-forming structure and/or the pneumatic chamber. 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 bonded to the seal-forming structure and/or the front surface of the pneumatic chamber.

In one form, the surface of the applicator is removably attached to the front surface of the seal-forming structure and/or the pneumatic chamber.

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.

Another aspect of one 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 a patient's face surrounding an entrance to a patient's airway to form a seal, and the one or more tabs for grasping the seal-forming structure, wherein the one or more tabs do not have an adhesive surface.

Another aspect of one 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 a region of a patient's face surrounding an entrance to a patient's airway to form a seal, wherein the adhesive surface is configured such that an adhesive strength of the adhesive surface is reduced due to 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, 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, such as removing the seal-forming structure from the patient's face.

One aspect of one form of the present technology is a patient interface that further includes one or more shape retainers. The shape retainer may be configured to facilitate retention of the seal-forming structure and/or the shape of the pneumatic chamber prior to and optionally during use. For example, the shape retainer may help maintain the shape of the seal-forming structure and/or pneumatic chamber to a sufficient extent to prevent the seal-forming structure and/or pneumatic 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 one form, the shape retainer may be located on a side that faces away from the patient's face in use.

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

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

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

In one form, the shape retainer may be configured such that the seal forming structure may be stretched more easily in one direction than it may be stretched 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 pneumatic chamber that may be pressurized to at least 6cmH above ambient air pressure ₂ Therapeutic pressure of O. The pneumatic chamber may include a pneumatic chamber inlet port configured to receive a flow of breathable gas at a therapeutic pressure for respiration by the patient. The patient interface may further comprise at least one seal-forming structure configured to be provided to the pneumatic chamber in use. Each of the at least one seal-forming structures 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 structure may have an opening such that a flow of breathable gas is delivered to an inlet of a naris of the patient. Each at least one seal-forming structure may be configured to maintain the therapeutic pressure in the pneumatic chamber throughout a patient's respiratory cycle in use. Each at least one seal-forming structure may comprise 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 also include a vent structure to allow continuous flow of exhaled gas from the patient from the interior of the pneumatic chamber to the ambient environment. The vent structure may be configured to maintain a therapeutic pressure in the pneumatic chamber 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 vent flow from the interior of the pneumatic chamber to the ambient environment.

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 adhesive tape sections configured to be provided to the 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 than the second region.

In one form, the first seal-forming structure and the second seal-forming structure are configured to be selectively interchangeably disposed to the pneumatic chamber.

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 comprises a nasal wing edge of the patient's face, an upper region of the upper lip, and optionally a nasal post.

In one form, the second region includes the alar, the region of the upper lip below the upper region, and the nasal projection.

One aspect of one form of the present technique is a patient interface system that further includes an applicator that can 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, the seal-forming structure configured to form a seal with the area, wherein the surface is disposed about 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 gripped by a 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 nasal oxygen cannulas extending out of the recess, the nasal oxygen cannulas configured to be inserted into 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 that the patient interface is to use to form a seal. The method may further include selecting a preformed patient interface assembly. The preformed patient interface assembly may include a pneumatic chamber that may be pressurized to at least 6cmH above ambient air pressure ₂ Therapeutic pressure of O. The pneumatic chamber may include a pneumatic chamber 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 pneumatic chamber. The seal-forming structure may be configured to be in communication withThe patient's facial region forms a seal, the seal-forming structure having an opening therein such that a flow of breathable gas is delivered to at least one inlet of the patient's nostrils, the seal-forming structure being configured to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle in use. The seal-forming structure may comprise 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, 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 pneumatic chamber onto the seal-forming structure.

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

One aspect of certain forms of the present technology is an easy-to-use medical device, such as for people without medical training, people with clumsiness, limited vision, or people with limited experience in using this type of medical device.

Of course, portions of the various aspects may form sub-aspects of the present techniques. Various aspects of the sub-aspects and/or aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

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

Description of the 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 including a patient 1000, the patient 1000 wearing a patient interface 3000, receiving a supply of air at positive pressure from an RPT device 4000. The patient sleeps on his side.

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

Fig. 2B shows a view of the upper airway of a human including the nasal cavity, nasal bone, extra-nasal cartilage, alar cartilage, nostrils, upper lip, lower lip, 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 upper lip, upper lip red, lower lip, mouth width, inner canthus, nose wings, nasolabial folds, and corners of the mouth. 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, a mandibular socket point, a nasal ridge, a nasal wing apex, an above-the-ear base point, and a sub-the-ear base point. The up-down and front-back directions are also indicated.

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

Figure 2F shows a bottom view of a nose with several features identified, including the nasolabial folds, lower lips, upper lip reds, nostrils, subnasal points, small columns of nose, protruding nasal points, long axis of nostrils, and mid-sagittal plane.

Fig. 2G shows a side view of the surface features of the nose.

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, about a few millimeters from the median sagittal plane, showing, among other things, the medial foot of the septal cartilage and the alar cartilage.

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

Fig. 2K shows a side view of a skull with a head surface profile and several muscles. The following bone portions are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone and occipital bone. The chin bulge is also indicated. The following muscles are shown: two abdominal muscles, a chewing muscle, a sternocleidomastoid muscle and a trapezius muscle.

Fig. 2L shows a front-to-outside view of the nose.

Fig. 3A illustrates a patient interface in one form configured to be adhered to a nose-wing edge 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 a side perspective view (right) of the nose showing the face 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 illustrates a front view of the patient interface of fig. 4A.

Fig. 4D shows a side perspective view of the nose showing the face region 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-end 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 a patient interface in another form in accordance with the present technique.

Fig. 9A is a perspective illustration of a patient interface in another form 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 their side while wearing one 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 the seal-forming structure being transferred 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 view illustrations 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 shown 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 illustration of the patient interface shown 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 molding 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.

Description of the preferred embodiments

Before the present technology is described in more detail, it is to be understood that this technology is not limited to the particular examples described herein that may vary. It is also to be understood that the terminology used herein is for the purpose of describing 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, in any of the examples, any single feature or combination of features may constitute further examples.

4.1 treatment

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, the air supply under positive pressure 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.

4.2 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.

Furthermore, 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 ambient air. Generally, 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 technology, the patient interface 3000 may include a heat and humidity exchanger 3700, as explained in more detail below.

4.3 patient interface

Figures 2A through 8 and 10A through 16F 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 a nasal oxygen cannula that engages and/or extends into the nostril. 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 pneumatic chamber 3200, and the connection port 3600 for connection to the air circuit 4170.

In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround an entrance to the patient's airway in order to maintain a positive pressure at the airway entrance of the patient 1000. The sealed patient interface 3000 is thus suitable for delivery of positive pressure therapy.

Pneumatic chamber 3200 may be formed from one or more modular components, or they may be replaced with different components, such as 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.

Patient interface 3000, in accordance with one form of the present technique, is constructed and arranged to provide at least 6cmH relative to the environment ₂ O positive pressure air supply.

A patient interface 3000 according to one form of the present technique is constructed and arranged to be able to be positioned relative toAn environment of at least 20cmH ₂ The positive pressure of O supplies air.

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

4.3.1 seal formation Structure

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

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 from day to day 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 be adhered 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 the entrance of one or more patient airways. The seal-forming structures 3100 in fig. 3A-15B 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 airways 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. Adhesive-based seals have been found to allow for much less leakage than can be achieved with conventional compression seals that are held to the face by the headgear. One reason for this is that in a form in which the seal-forming structure 3100 adhered 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 of conventional compression seals. The shape of the face may particularly change when the patient moves from an upright posture to a lying down posture, and also between lying down positions (e.g. on the back (supine), on the front (prone), or on the sides).

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 needs to consume 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 treatment 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 mark the patient's face. For infants and children, prolonged use of headgear may result in deformities in the face and/or skull, which may have very serious 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 very advantageous in oxygen therapy, especially 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 patient 1000 will tend to move patient interface 3000 unadjusted or otherwise comfortably.

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 headband during use. If the patient's interface with the headgear breaks away or repeatedly interferes during use, the efficacy of the treatment or therapy may be significantly affected. The seal forming structure 3100 provides a more comfortable and thus more effective seal than the headband. In addition, the patient interface 3000 with the seal forming structure 3100 provides a safer means of respiratory therapy for children and infants because the use of headgear may be eliminated, thereby eliminating forces exerted by the headgear on the skull.

It has also been observed that the adhesive-based attachment of the seal-forming structure 3100 to the patient's face results 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 nose wing end edges 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 bulge 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 a patient interface 3000 according to aspects of the techniques described 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 in a pressurized pneumatic chamber. This means that there is no pressure difference between the inner and outer surfaces of the nose and therefore no bulge effect occurs. Rather, the forms of the techniques described herein create a seal around the nose wing edges such that there is a pressure differential between the inner and outer surfaces of the nostrils, thereby achieving this bulging effect. This benefit may be particularly pronounced for patients with narrow nostrils.

4.3.1.1 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 by 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.

An 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 a preferred form of the present technique, 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 patient interfaces 3000 of the type described herein may be more commercially viable than 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 the individual patient. Alternatively, the seal-forming structure 3100 may be configured in a manner that substantially complements the shape of the appropriate region 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 from one material and in a form such that the seal-forming structure 3100 is sufficiently flexible such that it can take the shape of the patient's facial region 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 area 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 needed to secure the seal-forming structure 3100 to the patient's face, rather than the adhesive force needed in other cases, as the adhesive does not exert a force when pulling the skin laterally across the face.

The region of the seal-forming structure 3100 to which the adhesive is applied may be considered a target seal-forming region. In one form, the adhesive is located on an annular region around the outer edge of the seal-forming structure 3100. 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 worn for extended periods 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.

4.3.1.2 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 a patient's face, the seal-forming structure 3100 according to some form of technology 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 coverage area, the more prominent the patient interface 3000. Patient interface 3000 occupying a large 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 that may be pulled in different directions by the adhesive.

Further, since the smaller footprint of the seal forming structure 3100 generally means a smaller patient interface and thus a smaller pneumatic chamber, this corresponds to a smaller area on which the air pressure in the pneumatic 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.

Another advantage of having a relatively small footprint seal-forming structure 3100 is that, also because this generally means a smaller patient interface 3000, the patient interface 3000 does not tend to protrude too far from the patient's face. This eliminates or reduces the possibility of frictional interaction between the patient interface 3000 and surrounding objects (such as pillowcases, duvets, 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, nasal protrusions and other such prominent 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. This is especially true when patient interface 3000 is worn for extended periods of time.

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. The seal-forming structure 3100 avoids areas of greater shape change with patient body position, which provides greater comfort because the shape change of the underlying facial area will cause the adhesive surface 3102 to stretch to accommodate the shape change or disengage from the underlying skin when the patient interface 3000 is worn. If the adhesive surface 3102 and/or the seal-forming structure stretch, 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, resulting in ineffective respiratory therapy.

Some facial regions have more facial hair than others, particularly in men. The adhesive surface 3102 of the seal-forming structure 3100 is configured to attach primarily to non-hair portions, allowing the seal-forming structure to be applied and removed without causing pain due to hair removal. Pain caused by lifting of facial hair may prevent the patient from adhering to respiratory therapy. Thus, a seal-forming structure that adheres to the hairless or less 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 a single 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 a 3D facial scan of the area around the airways of many members of the population was performed. The analysis determines that certain regions of the face surrounding the airway are found to vary less throughout the population than others.

In some forms of technology, the shape of the seal-forming structure 3100 is configured such that it can be attached to regions of the face where these shapes are relatively less variable in use. The following sections describe the facial regions identified as suitable in the analysis, as well as the shape of seal-forming structures in accordance with a particular technology form, which are particularly suited for sealing with these regions.

Generally, based on consideration of the above factors, the area of the face to which the seal-forming structure 3100 identified as suitable for certain forms of the present technology adheres is the area adjacent the nostril, e.g., the area immediately adjacent the nostril. These areas are typically the downwardly facing surface of the nose and the uppermost area 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 directly surrounding the nostrils. These areas are highlighted on the right hand side of fig. 3B and include: the nose wing edge region 3141 (i.e., the region of the wing immediately adjacent the nostril and generally facing downward); the uppermost region of the upper lip region 3142, which may include the subnasal point and/or immediately below the subnasal point; and a nose front region that is below the nose point 3143. In the lateral direction, the seal-forming structure 3100 extends to a region 3144 slightly below the alar roof of the nose, such as a region immediately midway between the junction between the alar roof and the nasolabial folds. In the form of the illustrated technique, the seal-forming structure 3100 is not bonded to a significant portion of the side regions of the nasal wings, although in some forms, or for some faces, it may be bonded to lower regions of the side regions of the nasal wings. In addition, the seal forming structure 3100 is not adhered 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 belt is substantially constant around the circumference of the belt.

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 to 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. The facial region is also typically free of facial hair or has very little facial hair (e.g., some facial hair may be present on the uppermost region of the upper lip 3142). The seal-forming structure 3100 bonded to this region is particularly advantageous for patients 1000 having upper lip hair.

It was also found that in representative population samples, including patients of various ethnicities, the facial area covered by the seal-forming structure 3100 in the form of the technique illustrated in fig. 3A-3C had relatively little variation in shape.

Furthermore, this region (which may be referred to as the nose flange region) 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 side regions of the nasal wings. In some forms, the seal forming structure 3100 is configured to adhere to side regions of the wing of the nose, and may also extend radially outward far enough to adhere to cheek regions adjacent the wing apex 3145 in use. The seal forming structure 3100 may also be bonded to the area of the face to which the seal forming structure of fig. 3A-3C is bonded. The larger bonding area of the seal-forming structures in fig. 4A-4D may increase the amount of bonding and result in less leakage, but may result in more discomfort to the patient, as compared to the seal-forming structures of fig. 3A-3C.

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 structures of fig. 3A-3C and 4A-4D adhere. In this form, the seal-forming structure is bonded to an area that extends in an upward direction to the region of the alar-end fold, i.e., when the seal-forming structure is bonded to the patient's face, the uppermost portion of the seal-forming structure is bonded to the alar-end fold of the patient. This form of seal-forming structure 3100 may additionally or alternatively be bonded to a major portion of the upper lip. Furthermore, this form of seal-forming structure 3100 may additionally or alternatively be bonded to the nasal punctum region, which may include a point directly above the nasal punctum. In the lateral direction, this form of seal-forming structure 3100 is adhered to the region of the patient's cheek adjacent the alar, and the seal-forming structure 3100 may completely cover the alar in use. The seal forming structure 3100 may also be bonded to the area of the face to which the seal forming structure of fig. 3A-3C and/or fig. 4A-4D is bonded. 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 fig. 4A-4D are adhered.

In some forms of technology, such as the form of technology 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 the nasal post in use.

4.3.1.3 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 skin being pulled than other areas. In some forms, a seal-forming structure 3100 is provided, the seal-forming structure 3100 having regions of adhesive surface with different adhesive strengths depending on the particular region 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. An advantage of such an 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 surface are more difficult to achieve an effective seal than others. For example, an area like the upper lip is more difficult for the seal forming structure 3100 to form an effective seal because of contours in the person and the tendency of facial hair to grow there compared to relatively flat, less hair areas such as the cheeks. Thus, it may be beneficial to more effectively seal a greater magnitude 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.

The alar fold is an area of the patient's face that is both tricky to form an effective seal with (due to the contours in the area) and sensitive. Accordingly, the adhesive strength of the portion of the seal-forming structure 3100 that is sealed with the nose-end folds may be selected to balance the formation of an effective seal and 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 more suitable for forming an effective seal therewith, 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 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 necessary 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 a 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.

4.3.1.4 exemplary shape of seal-forming structures

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

4.3.1.4.1 seal forming structure general shape

The seal forming structure 3100 shown in fig. 16A to 16F is formed from a generally D-shaped strip of material having an opening 3110 in the middle. The D-shaped form of the seal forming structure 3100 includes 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 seal forming structure 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. This axis is intended to lie in the sagittal plane of the patient in use.

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 recess 3180 and the protrusion 3182 may be generally circular in shape.

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 so as to create 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 recess 3188 and the protrusion 3190 may be generally circular in shape.

The seal-forming structures shown in fig. 16A to 16F are configured to adhere, in use, to facial regions such as those protruding on the right hand side of fig. 4D. For example, in use, the apex portion 3172 is configured to adhere to an anterior region of the nose below the point of the nose, the shoulder portion 3174 is configured to adhere to an inferior region of the wing of the nose, the corner portion 3176 is configured to adhere to a region of the wing end folds of the nose, such as the wing end folds and/or laterally outer regions of the wing of the nose and/or cheek regions adjacent the wing end folds, and the stem portion 3178 is configured to adhere to an upper region of the upper lip.

Shape change of 4.3.1.4.2 seal forming structure

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

The shapes of the seal-forming structure 3100 shown in fig. 16A-16F are configured such that at least one of these shapes can fit most 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 commonly shaped and sized 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 should be appreciated that in other versions 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. In other forms of this technique, the seal-forming structure 3100 may be customized to a single patient.

The shape of the seal-forming structure 3100 shown in fig. 16A-16F is identified by taking the particular shape and size of the seal-forming structure 3100 that is deemed suitable for fitting the target area of the patient's face of the general shape and size, and changing the shape and size based on changes in one or more major components of the seal-forming structure determined from PCA with respect to the shape and size of the nasal area of different members of the population.

For example, in a PCA for producing the seal forming structure 3100 shown in fig. 16A to 16F, three main components of the target seal area are determined to vary among members of the population (such as shown in fig. 4D), and different shapes/sizes of the seal forming structure 3100 shown in fig. 16A to 16F are produced by independently varying each of the three main components.

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 equivalent to any particular feature or characteristic of the size/shape of the region. However, it can be seen broadly that the first primary component generally relates to the size of the target seal area and thus to the size of the nose, the second primary component generally relates to the degree of curvature of the nostrils, and the third primary component generally relates to the overall shape and/or proportion of the nose, e.g., whether the nose is long, thin or short, wide. In other forms of the present technology, the scope of the seal-forming structure 3100 suitable for adhering to the patient's face may vary based on different primary components or by varying multiple primary components between each version 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 dimensions of the seal-forming structure 3100, i.e., the seal-forming structure shown in fig. 16B is an enlarged form 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, the concave protrusion 3190 in the apex portion 3172 may be more pronounced in the seal forming structure 3100 for smaller noses (as shown in fig. 16A) than for larger noses (as shown in fig. 16B).

In the exemplary form of the seal forming structure 3100 shown in fig. 16C and 16D, changing the second primary causes a change in concavity and convexity of the concave portion 3180 and convex portion 3182, respectively, of the stem portion 3178. In the seal forming structure shown in fig. 16D, the amounts of concavity and convexity are larger than those of the seal forming structure shown in fig. 16C in both cases, 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 connecting the two corner portions 3176. In contrast, the edge 3184 of the seal-forming structure shown in fig. 16D is parallel to the line connecting 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 connecting the two corner portions 3176, i.e., the distance between 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 narrower 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 is more stretched in a direction parallel to its reflection symmetry axis than the seal forming structure shown in fig. 16F.

4.3.1.5 openings

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) to adhere to the area of the patient's face surrounding the nostrils. In other forms, the holes may be of different shapes, such as oval, crescent and bone shapes.

4.3.1.6 Flange

The peripheral region of the seal-forming structure 3100 configured to adhere to the patient's face in use may be considered a flange. 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 pneumatic chamber 3200 and the outer surface is on the side of the flange that abuts the outer surface of the pneumatic chamber 3200.

For example, in the technical forms shown in fig. 3A to 5C and 8 to 11, the adhesive surface is provided on the inner surface of the flange. That is, in use, the inner surface of the flange is adhered 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. In this form, the adhesive surface 3102 is disposed on the outer surface 3116 of the 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 pneumatic 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, the positive pressure of the gas in the interior of the pneumatic chamber 3200 acts on the inner surface 3114 of the flange 3112, forcing the outer surface 3116 into tighter sealing engagement with that surface. Thus, in this form, the gas pressure within the pneumatic chamber 3200 may be used to improve adhesion, rather than to push the seal-forming structure 3100 away from the skin. This, in turn, may reduce the amount of adhesive force 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 the required adhesion force 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.

4.3.1.7 non-adhesive tabs

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

The tab 3108 may be located at the perimeter of the seal-forming structure 3100. For example, in the example shown in fig. 21A-21D, the seal-forming structure 3100 includes two tabs 3108, each tab located on a lateral perimeter of the seal-forming structure 3100, and the two tabs 3108 are located opposite each other on either side of an opening 3110 in the seal-forming structure 3100 that allows gas to pass to 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 their fingers having to contact the adhesive or bonding surface 3102 and/or grasp the seal-forming structure 3100 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 assist the patient 1000 in pulling and stretching 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 subsequent paragraphs. In this form, by stretching the adhesive surface 3102 of the seal-forming structure 3100, the adhesive strength of the stretch releasing adhesive may be reduced, making the seal-forming structure 3100 easy to remove from the patient's face.

In some forms of technology, the tab 3108 may be formed as multiple portions of non-adhesive material attached to the adhesive surface 3102. For example, portions of non-adhesive material may be attached to the edges of adhesive surface 3102. In other forms, tab 3108 may be formed as a portion of non-adhesive material that covers a portion of 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.

4.3.1.8 shaped retainer

In some forms of 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, e.g., 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 their face.

The one or more shape retainers 3140 may be components or structures formed of a shape and/or material to provide a predetermined level of rigidity suitable to facilitate a desired level of retention of the shape 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.

4.3.1.8.1 seal forming structure comprising a shape retainer

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

In some forms, the shape retainer 3140 may be disposed 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 shown in fig. 22A-22C, the shape retainer 3140 includes an elongate member extending through a forward facing surface of the seal forming structure 3100. In this particular example, the shape retainers 3140 are wave-shaped 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 to 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 other shapes, 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 the lattice in the shape of a parallelogram. Other shaped lattices may also be formed in other forms of technology.

When using the patient interface 3000, for example, by the excessive rigidity of the seal-forming structure 3100, the weight and amount of shape retainer material used may not be so great as to cause discomfort to the patient 1000, 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 sufficiently retain the shape of the seal forming structure 3100 to facilitate adhering the patient interface 3000 to the face. The amount of shape retainer material and the amount of area covered by 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 be devoid of the shape-retaining member, or the central region of the structure 3100 may be formed at 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 balancing to be impacted in terms of the amount of material from which the shape holder is made, a balancing of the rigidity of the shape holder can also be found. In some forms, the shape retainers 3140 may be flexible enough so that they can comfortably fit contours on the patient's face, but yet stiff enough so that they adequately retain the shape of the seal forming structure 3100. It will be appreciated that the desired flexibility/rigidity may be obtained by appropriate selection of the harness of material used to form the shape holder, and/or by appropriate selection of the material used to form the shape holder. Furthermore, 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 shown 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 pneumatic chamber 3200 and the seal forming structure 3100, wherein the non-adhesive tab 3108 may be positioned in some fashion. In other forms, the shape retainer 3140 may extend in substantially different directions between the pneumatic 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 pneumatic chamber 3200. For example, in one form, the seal forming structure 3100, which may include a shape retainer 3140, and the pneumatic chamber 3200 may be molded together. For example, the shape retainer 3140 may be a relatively thick region of the seal forming structure 3100. In another example, the shape retainer 3140 and the pneumatic 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 pneumatic 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 rest of the pneumatic chamber 3200 may be separately formed and connected together components, such as by adhesive. In this form, the shape retainer may be formed of a different material than the seal forming structure 3100 and/or the rest of the pneumatic chamber 3200.

Example materials that may be used to form shape retainer 3140 include silicones, such as low durometer silicones and TPEs.

In some forms, the shape retainer 3140 is disposed on a surface of the seal forming structure 3100 that faces away from the patient in use, and does not protrude outward 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 helps to avoid the shape holder marking the face when the patient interface 3000 is worn.

In one form, the shape retainer 3140 may be configured such that the seal forming structure 3100 may be more easily stretched in one direction than it may be stretched 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.

In some forms, the shape retainer 3140 may also be configured to change the deformation characteristics of the seal forming structure 3100 in different directions, e.g., the shape retainer 3140 may be configured such that the deformation of the seal forming structure in one direction is plastic deformation and the 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 technology, the adhesive surface 3102 of the seal-forming structure 3100 can have or be 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 technology, the shape retainer 3140 is configured such that the direction in which the seal-forming structure 3100 can be stretched relatively easily is aligned or substantially aligned with the direction in which the seal-forming structure 3100 can be stretched in order to release the stretch releasing adhesive. For example, in the technical form shown in fig. 22A to 22C, the wavy members are arranged such that the members are mainly oriented in a direction perpendicular to the direction indicated by F in fig. 22C, with the bent portions connecting the portions oriented in the direction. This arrangement means that the curved shape retainer is wound outwardly in the direction of arrow F, in which configuration the shape retainer 3140 may be more easily deformed when a force is applied in the direction F, which direction is a lateral direction when the patient interface 3000 is worn in the case of the form shown in fig. 22A to 22C. Where non-adhesive tabs 3108 are used, this direction may be consistent with the direction of non-adhesive tabs 3108 as compared to pneumatic chamber 3200. Conversely, by applying a force in a direction perpendicular to F, the seal forming structure 3100 is not easily stretched.

This form of technique can 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, one or more shape retainers 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 on the one or more tabs 3108 to cause the seal forming structure 3100 to separate 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 bond less strongly with the seal forming structure 3100 than the internal bonds between the silicon beads. When a force is applied in a certain 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 when the seal forming structure 3140 is stretched, this results in delamination of the shape retainer.

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 release the stretch-release adhesive compared to other situations, avoiding excessive force of the release adhesive that may cause discomfort to the patient 1000.

4.3.1.8.2 front layer shape retainer

As described above, in certain forms of the present 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 hardening one or more regions of the seal forming structure 3100.

In some forms of technology, for example as shown in fig. 15B and 15C, the patient interface 3000 may further include a shape retainer 3140 in the form of an anterior layer 3230 configured to retain the shape of the seal forming structure 3100 and thereby facilitate 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 a front surface of the seal forming structure 3100 and/or the pneumatic chamber 3200. For example, the front layer 3230 may be adhered to the front surface of the seal-forming structure 3100 and/or the pneumatic chamber 3200 by a weakly-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 a certain shape before it is removed. This feature has several advantages. For example, the front layer 3230 may prevent the seal-forming structure 3100 and/or the pneumatic 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 one 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 described above, once the seal forming structure 3100 is adhered to the patient's face, the front 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) configured to extend beyond the perimeter of the seal forming structure 3100 and/or the pneumatic chamber 3200 when the front layer is attached to the seal forming structure 3100 and/or the pneumatic chamber 3200. The extension 3232 is useful for the patient 1000 to grasp and remove the anterior layer 3230 with their fingers once the seal forming structure 3100 is attached to the face.

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 when the seal-forming structure 3100 is separated from the front layer 3230, the surface of the seal-forming structure 3100 that is in contact with the front layer 3230 is not tacky.

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

In some forms, the anterior layer 3230 may be shaped to closely mimic or generally 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 shown 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-end 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 alar-end folds, assisting in the adhesion of the seal-forming structure 3100, which otherwise may be a region where adhesion is difficult to obtain due to the contour 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 face of an individual patient. 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 form of the technique shown in fig. 15B and 15C, the front layer 3230 has a ring shape with holes in a central region. The aperture may be configured to receive the pneumatic chamber 3200, wherein the front layer 3230 contacts a patient facing surface of the seal forming structure 3100 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 can comprise multiple pieces. For example, the front layer 3230 can be formed in two pieces, or preferably three pieces. Different portions of the front layer 3230 can change orientation relative to one another. In the case of the relatively rigid anterior layer 3230, 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., pressed into crevices and corners of the patient's face. In one form, the front layer 3230 can include three pieces-a center piece, a left piece, and a right piece. The left and right pieces may be configured to be located on either side of the center piece. The centerpiece may have a generally oval shape. The left and right pieces may correspondingly have a concave shape configured to engage with the center piece.

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

Front layer 3230 may be considered to be in the form of an applicator that helps 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 shown 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 wearing the patient interface. In other forms of this technique, an applicator 3800 separate from the patient interface 3000 may be provided, such as described in more detail below.

4.3.1.9 multiple seal forming structures

In certain forms of technology, the patient interface system 5000 may include a pneumatic chamber 3200 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 this form of technology 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 adhere to the adhesive and detach from the skin. Over time, such removal of skin cells may cause trauma to the facial area of the patient to which 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. This allows the patient to change which facial region to adhere to so that the same facial region is not damaged in a sequential treatment session and allows the facial region 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 pneumatic 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 of the patient's face may surround the first region. 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 nasal wing edges, an upper region of an upper lip (e.g., a subnasal spot region, which may include an upper lip immediately below a subnasal spot) and a columella.

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

In other forms of the present technology, the areas 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 those described above.

Whenever a treatment session is present, the patient is able to select a seal-forming structure of the same type as either of the first seal-forming structure 3120 and the second seal-forming structure 3130 and connect it to the pneumatic 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 recovery in each facial region, for example by alternating between a first seal-forming structure type and a second seal-forming structure type for successive courses of treatment. This is particularly useful when respiratory therapy requires daily or periodic use of patient interface 3000.

4.3.1.10 material-seal forming structure

In some forms of the present technology, the seal forming structure 3100 is composed of 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 some forms 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 into 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 the alar-nose 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 with sensitive areas of the patient's face, such as the nose-end fold area.

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 the skin surface than to protrude from the skin surface. This may reduce the likelihood that the seal forming structure 3100 will partially or fully loosen due to friction between the patient's face and surrounding objects (such as a pillow case, counter plate, etc.).

An advantage of forming the seal forming structure 3100 from a soft material (such as TPE) is that the seal forming structure 3100 can conform to the shape of the patient's face and the seal forming structure 3100 can continue to do so when the shape of the patient's face changes, for example when the shape of the patient's face changes. 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 of the present technology, an example of a material suitable for use as a seal-forming structure is 3M 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 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 can 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.

4.3.1.11 adhesive form

The form of the technique provides a 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 an area of a patient's face surrounding an entrance to an airway of the patient to form a seal.

Any suitable adhesive may be used and suitable properties of adhesives used in certain forms of 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 be comprised of one or more component 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 is capable of remaining adhesive when applied to forces of the direction and magnitude typically experienced when using the patient interface 3000, such that the seal-forming structure 3100 does not become too easily detached during normal use. Similarly, the adhesive strength should not be so great that the patient interface 3000 cannot be removed after treatment ceases without causing trauma to the skin.

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. In addition, some forms of technology use adhesives where little or no residue remains after removal from the skin. Adhesives that do not have these characteristics may be used in some forms of 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 cleansing fluid such as alcohol prior to use. Such preparations may be undesirable because it requires additional steps for the patient and they may not be effectively prepared for application to the skin, particularly when tired. Thus, some forms of 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.

In 3M Nexcare ^TM The adhesives used on tapes and Leukoplast tapes are examples of suitable adhesives having one or more of the above-described features and are used in some forms of technology. For example, a rubber zinc oxide adhesive may be used. In other forms, other adhesive tapes are used. 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.

In other forms of this technique, the adhesive used to seal the forming structure 3100 can be deposited directly on the adhesive surface 3102, for example, as described below. As part of the manufacturing process, an adhesive may be deposited on the adhesive surface. Alternatively, in some forms, the patient interface 3000 may be provided in a form in which adhesive is also applied to the adhesive surface, and the patient (or clinician) applies the adhesive to the surface prior to use.

4.3.1.11.1 fluid adhesive

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

4.3.1.11.2 spray adhesive

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

4.3.1.11.3 action Release adhesive

In some forms, the seal-forming structure 3100 may be attached to the patient's face using one or more active release adhesives. The one or more action release adhesives may be configured such that their adhesive strength decreases when an "action" 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 actions 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 technique, 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 so as to reduce or lose its adhesive strength. This allows the patient 1000 to easily remove the seal forming structure 3100 by deforming it.

In some forms, the adhesive surface 3102 may have or be formed from a stretch releasing adhesive. Stretch releasing adhesives may have certain adhesive properties only when the adhesive surface 3102 is substantially unstretched. The adhesive surface 3102 may be configured to have reduced and/or no adhesive properties when the adhesive surface 3102 is stretched. In some forms, an acrylate-based adhesive may be used as a stretch release adhesive for adhesive surface 3102, such as a fixomultm or 3M stretch 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 an adhesive, and other components of the patient interface may be over-molded thereto (such as explained elsewhere in this specification). In other forms, other suitable carrier materials may be used.

In some forms, the adhesive surface 3102 with the stretch releasing adhesive may include a polyurethane removable layer, 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 releasing adhesive may enable the seal-forming structure 3100 to be easily removed from the patient's face by stretching the adhesive surface 3102.

In other examples, the one or more active release adhesives may include a heat release adhesive that loses adhesive strength when heated or when exposed to temperatures greater than a predetermined level. In another example, the active 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 active release adhesive may be configured to lose adhesion when exposed to radiation of a particular frequency (such as ultraviolet light).

4.3.1.11.4 adhesive tape section

In an alternative form of the technique, patient interface 3000 includes one or more adhesive tape segments configured to provide the 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 and second adhesives from contamination and/or adhesive loss before the seal-forming structure 3100 is assembled.

In some forms (not shown in the figures), the adhesive tape sections may be provided with one or more shape retainers that 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 adhesive tape section when the removable layer is removed, thereby preventing the adhesive tape section 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 nasal alar edge region of the nose, the altered shape of the adhesive surface may result in other regions of the nose or mouth beyond the nasal alar edge region, such as the septum 3132, nasal post, or nostril region, coming into contact with the adhesive surface. This may cause poor sealing, inconvenience, discomfort and/or pain to the patient 1000.

Second, if the adhesive tape section is wrinkled or deformed when the removable layer is released, one or more portions of the adhesive tape section may fold over one another. This may result in a reduced surface area of exposed adhesive, which may result in an ineffective seal between the patient's face and the seal forming structure 3100.

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

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

4.3.1.11.5 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.

Removable layer 3104 may be used to protect the adhesive on adhesive surface 3102 from contamination, inadvertently adhere to other surfaces, and/or lose 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 prior to wearing patient interface 3000. An exemplary form of a technique for patient interface 3000 to include removable layer 3104 is shown in fig. 14A, 14B, 15A, 15B and 17. In one form, the removable layer 3104 may include tabs 3104T that extend beyond the footprint and/or perimeter of the seal-forming structure 3100. The removable layer 3104 may be peeled away by the patient 1000 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 on 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 the patient 1000 with clearance for grasping 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, tabs 3104T, 3105T, or 3106T may be configured to clear facial features of a patient when patient interface 3000 is in a desired position. For example, if patient interface 3000 is configured to be attached in or around the nasal 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 the nose coming out of the way.

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 be deformed as the finger slides under the tab 3104T, 3105T, or 3106T. 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 cheeks, which may be slightly deformed to accommodate a patient's fingers when grasping tabs 3104T, 3105T, or 3106T.

4.3.2 pneumatic Chamber

Some forms of the present technique of pneumatic chamber 3200 are configured to receive a flow of breathable gas from air circuit 4170 at a therapeutic pressure of the patient's breath. The pneumatic chamber 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 pneumatic chamber 3200 has a perimeter shaped to complement the surface contour of a face of a typical person in the area where the seal will be formed in use. The complementary shape of the perimeter of pneumatic chamber 3200 may be configured to facilitate proper positioning of patient interface 3000 against the patient's face in use.

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

In use, the boundary edge of the pneumatic chamber 3200 is positioned in close proximity to 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 pneumatic chamber 3200 in use.

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

In certain forms of technology, such as shown in fig. 4A-4C, 5A, 8, 9A-9D, and 10B, the pneumatic chamber 3200 may be substantially frustum-shaped. These forms of pneumatic chamber 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 pneumatic chamber 3200 may taper from the first end to the second end, or some portion of the pneumatic chamber 3200 may taper in that direction, e.g., a region of the pneumatic chamber 3200 surrounding the pneumatic chamber inlet port 3202 may taper.

The first and second ends of the pneumatic 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 pneumatic chamber inlet port 3202, as described further below.

The first end of the pneumatic 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 pneumatic 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 pneumatic chamber inlet port 3202.

In some forms, the walls of the pneumatic chamber 3200 may form tapered surfaces, or they may curve away from the true tapered surfaces, e.g., bulge outwardly.

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

4.3.2.1 pneumatic chamber alignment

It has been described that a pneumatic chamber 3200 having a perimeter shaped to complement the surface contour of a face of a typical person in the area where the seal will be formed in use may assist in correctly positioning the patient interface 3000 against the face of the patient 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 worn, 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, positioning guide members 3220 extend from an interior portion of pneumatic chamber 3200 toward a 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 to do so. 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 member 3220 may allow patient 1000 to reposition and/or adjust patient interface 3000 before adhesive surface 3102 contacts 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 the patient's face, there may be contamination and/or loss of adhesion when the patient 1000 removes and repositions the patient interface 3000. Furthermore, repeated application and removal of the seal-forming structure 1000 may inadvertently result in skin trauma and/or peeling of skin cells.

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 patient interface 3000 is donned in order to assist the patient in properly positioning patient interface 3000 on their face.

In some forms, as shown in fig. 19A, 19B, and 19E, the positioning guide member 3220 may comprise a V-shaped member forming a portion of the pneumatic chamber 3200 or protruding outwardly from the pneumatic 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 it is deformable and does 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. For similar purposes, the positioning guide member 3200 includes 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 so that it does not obstruct 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 pneumatic chamber 3200, while in other forms, the positioning guide member 3220 is provided to a part of the pneumatic chamber 3200.

In some forms of technology, positioning guide member 3220 may be removed from patient interface 3000 after patient interface 3000 has been worn and properly positioned. 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 elongate 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 described above. The elongate body may be configured to extend through the pneumatic chamber inlet port 3202, with the patient contacting end extending through a first end of the pneumatic chamber 3200 (the end that is proximal to the patient in use). When patient interface 3000 is worn, positioning guide member 3220 is in this position, and positioning guide member 3220 may be removed through pneumatic chamber inlet port 3202 once the patient is satisfied with the positioning of patient interface 3000.

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

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

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

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

For example, the positioning guide 3220 may be included as part of an edge around an opening in the pneumatic chamber 3200, or may be detachably or inseparably provided to an edge around an opening in the pneumatic chamber 3200 through which airflow is delivered to the nostrils of the patient. The positioning guide member 3220 may be included as part of the rim, or may be provided to part of the rim, for example on the underside of the opening when the patient interface 3000 is worn. Alternatively, the positioning guide members 3220 may form a substantial portion of the edge of the pneumatic chamber 3200 around the opening. The edge may be configured to interface with one or more of the subnasal point, the columella, the septum 3132 and/or the top of the nose wing region, and/or the upper lip.

In some forms of technology, as shown in fig. 19E, positioning guide member 3220 (which may be V-shaped or U-shaped) may include a plurality of nasal oxygen cannulas configured to expand when patient interface 3000 is worn and positioning guide member 3220 is engaged with patient's septum 3132. For example, the nasal oxygen cannula may be long enough to have such flexibility, and/or the material used to form the positioning guide member 3220 may be flexible enough. In the form shown, the nasal oxygen cannula may extend substantially into the nostrils of the patient 1000. In a technical form in which positioning guide member 3220 is configured to be removed once patient interface 3000 is worn, when positioning guide member 3220 is removed through pneumatic chamber inlet port 3202, the nasal oxygen cannulas come together, allowing positioning guide member 3220 to be removed.

In some forms of technology, for example as shown in fig. 19B, the adhesive surface 3102 of the seal-forming structure 3100 may be configured such 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, it is not in contact with the face prior to positioning the guide member 3220. For example, the adhesive surface 3102 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 may be positioned by adjusting patient interface 3000 until the correct position is achieved, and during this 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 on 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 pneumatic chamber 3200 may generally be formed in a shape complementary to the shape of the patient's nose, in use the pneumatic chamber 3200 will be positioned adjacent the patient's nose. In this form, the portion of pneumatic chamber 3200 proximate to patient 1000 may be considered to be positioning guide member 3220 when patient interface 3000 is worn.

4.3.2.2 material

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

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

In other forms, the pneumatic 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 with respect to its use in the seal forming structure 3100 may also be applied to pneumatic chambers 3200 formed from TPE of some form of technology. In addition, forming the pneumatic chamber 3200 from a flexible material such as TPE allows the walls of the pneumatic chamber 3200 to deform. Another advantage of the deformable pneumatic chamber will be explained in the following description.

4.3.2.3 pneumatic chamber inlet port

In some forms of technology, for example as shown in fig. 4A, 4B, 4C, 5A, 10A, and 10E, the pneumatic chamber 3200 includes a pneumatic chamber inlet port 3202. The flow of breathable gas may be configured to be delivered to pneumatic chamber 3200 through pneumatic chamber inlet port 3202. In some forms, the pneumatic chamber inlet port 3202 is configured to be directly or indirectly attached to the air circuit 4170. In an exemplary form of the present technique, the pneumatic chamber inlet port 3202 is preferably located at a second end of the pneumatic chamber 3200. The pneumatic chamber inlet port 3202 may be formed as an opening in the body of the pneumatic chamber 3200.

4.3.3 integral seal Forming Structure and pneumatic Chamber

In some forms of technology, the pneumatic chamber 3200 and 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 pneumatic chamber 3200 and seal forming structure 3100 as a single component 3300 may include a reduced number of components, ease of manufacture, and reduced packaging.

4.3.4 connection port

In some forms of technology, such as the forms shown in fig. 10B, 10C, and 10D, the patient interface 3000 further includes a connection port 3600, the connection port 3600 being connectable, in use, to the air circuit 4170 to deliver a flow of breathable gas from the air circuit 4170 to the pneumatic chamber 3200 through the pneumatic chamber inlet port 3202. In other forms of this technique, the connection port 3600 is the same opening as the pneumatic chamber inlet port 3202.

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 pneumatic 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 pneumatic 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 shown in fig. 10C, for example, the fastener is a twist lock or bayonet fastener, wherein the air circuit 4170 has a nasal oxygen cannula 3520 inserted into the receiver 3522 of the tube 3502. Alternatively, the tube 3502 and the air circuit 4170 may be formed together.

4.3.5 vents

In some forms of technology, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the purging of exhaled gases, such as carbon dioxide.

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

One form of vent 3400 in accordance with the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

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

Alternatively, the vent 3400 may be located in a tube 3502 fluidly connected to the pneumatic chamber 3200, as described above. In yet another form, the vent 3400 may be located in a decoupling structure (e.g., 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, as shown for example in fig. 20D, patient interface 3000 further includes a diffuser 3410 configured to diffuse vent flow from inside pneumatic chamber 3200 to the ambient environment. The diffuser may be located in a channel in the vent 3400. For example, in the form shown in fig. 20D, the diffuser 3410 includes a diffuser material body located in the chamber along the channel of the vent 3400.

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

4.3.5.1 port

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

4.3.5.1.1 anti-asphyxia valve

In some forms of technology, the patient interface 3000 may include an anti-asphyxia valve. An anti-asphyxia valve may be required in the patient interface 3000 covering the nose and mouth as a means of mitigating the risk of asphyxia. The valve ensures ventilation of the airway of patient 1000 in the event of interruption of the supply of breathable gas to pneumatic chamber 3200 and/or the airway of patient 1000.

4.3.6 nasal oxygen cannula/pillow

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

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

In one form, the nasal pillow 3250 of the present technique is formed from a nasal pillow body positioned within the pneumatic chamber 3200, as shown in fig. 9A and 9B. A frustoconical body 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 pneumatic 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 pneumatic chamber 3200 on the second end. The nasal pillow body is positioned such that, in use, breathable gas flows from the opening of the stem 3254 to the frustoconical 3252 and from there to the nostrils of the patient 1000.

In one form, the pneumatic chamber 3200 and the nasal pillow 3250 are separate components that can be assembled by the patient 1000 by positioning the nasal pillow body within the pneumatic chamber 3200. The nasal pillows may be sized and shaped to fit snugly within the pneumatic chamber 3200 to avoid cavities other than airflow paths within the nasal pillows. The nasal pillows 3250 can easily slide out of the pneumatic chamber 3200, which facilitates easy cleaning of the pneumatic 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 over an extended period 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 the seal forming structure described with respect to other forms of this technology and can include an adhesive surface 3102 surrounding the 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 serve as a backup seal in the event of loss of adhesion. In alternative forms, the nasal pillows 3250 are configured to provide little or no seal with the nostrils. In this form, 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.

4.3.7 decoupling structure

In some forms of technology, the patient interface 3000 includes one or more decoupling structures 3500 that 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 tear from the patient's face or the seal forming structure to be pulled hard at the skin of the patient's face. Both of these conditions can cause a significant amount of discomfort, pain, and/or skin trauma.

One or more decoupling structures 3500 of such forms of the present technology are 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 pneumatic chamber 3200 when a force greater than a predetermined magnitude is incident on the air circuit 4170. The easy disconnection of the air circuit 4170 and the pneumatic chamber 3200 is also useful if the patient 1000 desires to be temporarily disconnected from the respiratory therapy system 2000, such as to a bathroom.

In this context, decoupling may be understood as isolating or reducing the force transferred to a first component to 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 technology, the decoupling structure 3500 may form part of the pneumatic chamber 3200 or the air circuit 4170. Alternatively, as in the example of fig. 10B, the air circuit 4170 and the pneumatic 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, the patient interface 3000 may include a combination of one or more exemplary forms of decoupling structures 3500.

4.3.7.1 deformable parts

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 pneumatic chamber 3200 (i.e., the position it adopts when no force is acting on the air circuit 4170). As previously described, the first end of the air circuit 4170 is configured to connect to the pneumatic chamber inlet port 3202 and/or the connection port 3600.

When the first end of the air circuit 4170 is tilted in such a 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.

4.3.7.1.1 deformable pneumatic chamber

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

In this form, the flexible pneumatic chamber 3200 may be configured to deform (i.e., the first end of the air circuit 4170 is inclined relative to its neutral position) when a force pushes the first end of the air circuit 4170 in a direction perpendicular to the longitudinal axis of the air circuit 4170. For example, portions of the pneumatic 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 pneumatic chamber 3200 may be configured such that when a force causes the air circuit 4170 to tilt, a side of the pneumatic chamber 3200 on a side of the air circuit 4170 may compress or collapse and a side of the pneumatic chamber 3200 on a side of the air circuit 4170 opposite the first side may stretch.

4.3.7.1.2 pipe

In some forms of 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 from a thinner material than that used to form 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 as a flex, and such flex occurs before the lateral force is transferred to the seal-forming structure 3100, acting to at least partially separate the seal-forming structure 3100 from the air circuit 4170.

4.3.7.2 ball joint

In one form (not shown in the figures), the decoupling structure may include a rotary joint or ball-and-socket joint configured to allow rotational movement of the air circuit 4170 relative to the pneumatic 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-and-socket joint may be a quick release ball-and-socket joint configured to separate the air circuit 4170 from the pneumatic chamber 3200 when a force greater than a predetermined value (with force components in either direction) is applied to the air circuit 4170. The ball joint may disengage 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.

4.3.7.3 magnetic coupling

In some forms of technology, the decoupling structure 3500 includes a first magnetic member 3510 disposed to the connection port 3600. The first magnetic member 3510 is configured to magnetically couple to the second magnetic member 3512 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 a magnetic coupling between the first magnetic member 3510 (not shown) and the second magnetic member 3512. In this form of technology, the pneumatic chamber inlet port 3202 forms the 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 pneumatic chamber inlet port 3202, which are connected by a magnetic coupling between a first magnetic member 3510 disposed to the pneumatic chamber inlet port 3202 and a second magnetic member 3512 disposed to the first end of the tube 3502. In such forms, the pneumatic chamber 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 pneumatic chamber inlet port 3202, which are connected by a magnetic coupling between a first magnetic member 3510 disposed to the pneumatic chamber inlet port 3202 and a second magnetic member 3512 disposed 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, wherein the polarity of the first magnetic member 3510 is opposite to the polarity of the second magnetic member 3512 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 material that is attracted to the magnet, such as a metal that is capable of being attracted to the magnet.

In some forms, the first and second magnetic members 3510 and 3512 are annular and positioned around openings in corresponding parts of which they form a portion. This shape helps to ensure magnetic attraction around the periphery of the connection 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, so as to surround corresponding openings.

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 open too easily when subjected to typical forces that may be encountered during use, but opens when subjected to forces that may cause significant discomfort to the patient.

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

Fig. 20A-20F illustrate a patient interface 3000 in one exemplary form according to a technique to address this issue. In this form, the patient interface includes a pneumatic chamber 3200 and a seal forming structure 3100, the seal forming structure 3100 being formed of a material that is inexpensive to manufacture and yet recyclable, 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 technology, the magnetic coupling between the air circuit 4170 and the patient interface 3000 is achieved by an adapter 3514, which is shown in perspective view in fig. 20E and 20F and in cross-section in fig. 20D. The adapter 3514 is configured to be inserted into the pneumatic chamber inlet port 3202 and retained within the pneumatic chamber inlet port 3202, and is configured to magnetically couple to the air circuit 4170 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, as best seen in fig. 20D, the second flange 3714 has a frustoconical shape.

The adapter 3514 is sized such that the adapter 3514 can be inserted into the pneumatic chamber inlet port 3202. When inserted, flanges 3712, 3714 engage pneumatic chamber inlet port 3202, e.g., by a friction fit, in a retained sealing arrangement. In the form shown, the pneumatic chamber edge surrounding pneumatic chamber inlet port 3202 is sandwiched between flanges 3712 and 3714.

As described above, in some forms, the pneumatic chamber 3200 may taper toward the pneumatic chamber inlet port 3202, for example, such that a portion of the pneumatic chamber 3200 proximate to the patient is wide enough to cover the airway of the patient and a portion of the pneumatic chamber 3200 distal from the patient is narrow enough to connect to the air circuit 4170. Thus, the pneumatic chamber 3200 may have an inclined side that tapers away from the patient.

Accordingly, the adapter 3514 may have an angled side that is complementary to the angled side of the pneumatic chamber 3200, the angled side being caused by the taper. In the form shown 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, closer to the patient) and a narrower width closer to the air circuit 4170 (in use, further from the patient). In addition to providing a substantially positive fit with the pneumatic chamber 3200, the angle of the angled second flange 3714 may enable the adapter 3514 to easily slide into the pneumatic chamber inlet port 3202. The angled second flange 3714 may also prevent the adapter 3514 from easily sliding out of the pneumatic chamber.

The pneumatic chamber inlet port 3202 is deformable to allow one of the flanges 3712, 3714 of the adapter 3514 to be inserted therethrough. In some forms, the pneumatic chamber inlet port 3202 may be provided with one or more small slits around its circumference in order to facilitate such deformation. Where present, these slits may not be of sufficient size to create a leak path for the pressurized air inside pneumatic 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 pneumatic chamber 3200 forming a pneumatic chamber 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 pneumatic chamber 3200 may include an annular ring 3216 forming a pneumatic chamber inlet port 3202.

The adapter 3514 may be pushed into the pneumatic chamber 3200 such that the annular ring 3216 of the pneumatic 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 area 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 another geometric shape, including a shape with rounded corners, and the pneumatic chamber inlet portion 3202 can be correspondingly shaped. The non-circular shape may be used to ensure that the adapter 3514 and the pneumatic 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 pneumatic chamber 3200 can be achieved by alternative structural features.

For example, in some forms, the adapter 3514 can include one or more protrusions, and the pneumatic chamber 3200 can 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 pneumatic chamber 3200 during use. By preventing relative rotation, the air circuit 4170 may be more difficult to twist during use and thereby snag and/or break.

In an alternative form (not shown in any of the figures), the adapter 3514 may comprise a tab configured to be received by an indent in the pneumatic chamber 3200 in order to secure the adapter 3514 to the seal forming structure 3100 in use. When the tab is received in the indent, the adapter 3514 can be mounted to the pneumatic chamber 3200 such that the assembly of the adapter 3514 and the pneumatic chamber 3200 is airtight.

A magnetic member 3510 is disposed at one end of the adapter 3514. For example, the magnetic member 3510 may be disposed at an end face of the first flange 3712. This end of the adapter 3514 protrudes from the front side of the pneumatic chamber inlet port 3202 in use such that the magnetic member 3512 on the tube 3502 can be connected 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 pneumatic chamber 3200.

In some forms, the connection surfaces of the magnetic members may be oriented substantially perpendicular 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, magnetic member 3510 in fig. 20A-20F has beveled surface 3510A and magnetic member 3512 has 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 beveled surfaces 3510a and 3512a of 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 beveled surface 3510a of adapter 3514 and the convex surface may be beveled surface 3512a of 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 pneumatic 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 retained and used with the replacement pneumatic 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 aperture 3515 with the ambient environment in use, allowing the exhaled air to be vented.

In the form shown 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 pneumatic chamber 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 form shown. A diffuser 3410 may be located in each vent hole to diffuse the vent flow of gas.

In one form, the adapter 3514 can include a frame 3518 best seen in fig. 20D and 20E. The frame 3518 may form the body of the adapter 3514 and provide structural 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 portions that are assembled together to form the frame 3518.

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

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

4.3.7.4 hook and loop fastening

In some forms of technology (not shown), the connection between the pneumatic chamber 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 technique, the seal forming structure 3100 may be attached to the components forming the pneumatic chamber 3200 by hook and loop fastening. For example, the non-patient contacting side of the seal forming structure 3100 may be provided with a hook or loop material and the perimeter of the pneumatic chamber 3200 may be provided with a complementary material (i.e., a loop or hook) such that the components are attached together in use.

As with the magnetic coupling described above, a hook-and-loop fastening 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 fastening material (e.g., the density of hooks) may be selected accordingly.

4.3.7.5 tether

In some forms of technology, the patient interface 3000 may include a tether for tethering the air circuit 4170 relative to a patient, 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 also 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 as the patient's body is pulled taut.

4.3.8 heat-moisture exchanger

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

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

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

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

It is appreciated that the heat and moisture exchange material may be located between the patient's airway and the vent 3400 such that gas is not vented from the respiratory system without passing through the heat and moisture exchange material 3700. For example, in the case of the technical form shown in fig. 10B, 10C and 10D, the heat and moisture exchange material is located in a portion of the tube 3502, which tube 3502 is closer to the patient's airway than the holes in the tube that form the vents 3400. In the case of the technical form shown in fig. 11, in which the vent 3400 is formed by a hole in the pneumatic chamber 3200, the heat and moisture exchanging material is positioned against the inner wall of the pneumatic 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 can be located within the central bore 3515 of the adapter 3514. In the form shown, the heat and moisture exchange material is located in a second flange 3714 in the end of the adapter 3514 which projects inwardly into the pneumatic 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 pneumatic chamber 3200, but still in the path of the airflow into the pneumatic chamber 3200. For example, the heat and humidity exchanger 3700 can be included as part of an adapter located outside of the pneumatic chamber 3200 in the manner described above.

In some forms of technology, the heat and moisture exchange material may include 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.

4.3.8.1 separated 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 pneumatic chamber 3200 and the seal forming structure 3100. In this form, the 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 pneumatic chamber 3200.

In such forms, a conduit may fluidly connect the pneumatic chamber 3200 with the HME module. The conduit may be connected to the pneumatic 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 support in the adhesive strength of the adhesive surface 3102, and in some forms the structure can be a patient's clothing, such as clothing worn on the upper body, such as a shirt. This allows for the use of a relatively short conduit connecting the HME module and the pneumatic chamber 3200, thereby reducing the risk of entanglement.

4.4 air Loop

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 RPT device 4000 to pneumatic chamber 3200.

A first end of the air circuit 4170 may be connected to the pneumatic chamber 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 certain forms, the air circuit 4170 may additionally include a conduit connecting the HME module to the pneumatic chamber 3200.

4.5 applicators

In some forms of 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 advantage 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 alternatively or additionally function as a 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 a patient interface when the patient interface is placed in a therapeutically effective position on a patient's face.

4.5.1 body

In an exemplary form of the present technology, the applicator 3800 includes a body 3810. The body 3810 may be formed from one material and have a structure such that the body 3810 is substantially rigid. For example, the body 3810 may be formed from 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 certain forms, the body 3810 may take the form of a front layer 3230, as described earlier 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 retain 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.

4.5.2 recesses

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, recess 3802 is configured to receive pneumatic chamber 3200 of patient interface 3000, with seal-forming structure 3100 positioned outside of recess 3802. The recess 3802 is configured to receive the patient interface 3000 with the adhesive surface 3102 of the seal-forming structure 3100 facing away from the body 3810 of the 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 is shaped to match the shape of the component intended to receive and retain but on the reverse side, i.e. having a recess in which 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 nasal oxygen cannulae 3806 extending out of the recess 3802. The nasal oxygen cannula 3806 is arranged in a size and spacing such that the nasal oxygen cannula 3806 can be inserted into the nostril of the patient 1000 when the patient interface 3000 is placed in a therapeutically effective position on the patient's face. This helps the patient to properly position the patient interface 3000 on their face.

Retaining the patient interface 3000 within the recess 3802 until the seal forming structure 3100 is adhered 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 with a friction fit. The strength of the friction fit should not be stronger than the bond between the seal forming structure 3100 and the patient's face. Thus, 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 apart, 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, with the applicator 3800 held such that the recess 3802 opens upwardly.

In another form, temporary retention between patient interface 3000 and applicator 3800 may be achieved by magnetic attraction. For example, as shown in the exemplary form shown in fig. 17, a magnetic member 3812 may be provided within the recess 3802, or alternatively to the body 3810 adjacent the recess 3802, in a position where it 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 pneumatic 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 pneumatic chamber 3200. In some forms, the front surface of the seal-forming structure 3100 and/or the pneumatic 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 the front surface of the seal forming structure 3100 and/or the pneumatic chamber 3200. For example, the applicator 3800 may be adhered to the front surface of the seal-forming structure 3100 and/or the pneumatic chamber 3200 by a weakly-adhesive such that the applicator 3800 may be easily removed by the patient once the patient interface 3000 is in place. Adhesive may be provided on surface 3808 of applicator 3800 such that little or no adhesive may be perceived on the front surface of patient interface 3000 when applicator 3800 is removed. This may help to keep the patient interface 3000 still on the applicator 3800 to make it easier for the patient to install the interface in a desired location.

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

4.5.3 surface

In some forms, the body 3810 of the applicator 3800 further includes a surface 3808. A surface 3808 is disposed about 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, the 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 the nose's nose wing edge region, the surface 3808 may be shaped to include a portion that complements the nose wing edge shape or general nose wing edge shape of the patient 1000. The surface 3808 can include a shape that is complementary to corners and folds of the nose wing end edge 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 nose wing end edge region. This allows the seal forming structure 3100 to adhere to the patient's face and once the seal forming structure is securely adhered to the nose wing edge region, the applicator 3800 can 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 be adhered, including, for example, pleats 3232 to assist in adhering the seal-forming structure 3100 in the nose-end pleats, as previously described with respect to the form of the technique shown in fig. 15B and 15C.

Facial features, particularly those surrounding the alar, alar border, alar folds and nasolabial folds, include folds and corners, which may have a concavity greater than the convexity of the fingertip. As a result, it may be difficult for the patient 1000 to adhere 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 urge the seal-forming structure 3100 into contact with the patient's face in a manner that allows the seal-forming structure 3100 to more closely follow facial features than can be achieved by a human finger. Further, when positioning the patient interface 3000, the applicator 3800 helps the patient avoid touching the adhesive surface of the seal forming structure 3100, which can help avoid particulate contamination of the adhesive surface that can lead to loss of adhesive efficacy. This may occur when the patient 1000 is treating the seal-forming structure with their fingers.

In the illustrated exemplary form of the 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 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, the one or more guides 3814 may be positioned around the perimeter of the surface 3808 so as to include the perimeter 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. These guides 3814 are arranged in a spaced apart arrangement around the periphery of the surface 3808. In the form shown, the tabs are disposed on the 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 these tabs in order to most effectively hold the seal-forming structure 3100 of the patient interface 3000 in place in use. The tabs may be held in place by friction fit within their respective slots.

4.5.4 gripping portion

In some forms of technology, the applicator 3800 further includes a grip portion 3804, the grip portion 3804 configured to be gripped 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 to 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 being molded as a single piece. The grip portion 3804 may be provided to the body 3810 on a side opposite to the 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 of 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 tab 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.

4.6 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 a form of the technique using different methods.

4.6.1 patient interface manufacturing method

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

In fig. 21A, a sheet 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 a sheet of adhesive tape or it may be a multi-layered laminate including an adhesive layer 6530. Other examples of the tape 6500 are shown 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 is useful in technical forms using a stretch releasable adhesive because polyurethane is flexible and stretchable.

In an exemplary form of the technique, the tape 6500 can be formed as a tape with a non-adhesive tape 6540 on one or both sides of the tape 6500. When the seal-forming structure 3100 is cut from the tape, these cuts may be positioned to form a majority of the seal-forming structure 3100 from a central section of the tape 6500 comprising the adhesive layer, and to form a peripheral section of the seal-forming structure 3100 from the non-adhesive tape 6540. This process may be used to form a seal-forming structure 3100 having non-adhesive tabs 3108 (formed by non-adhesive tape 6540) such as described previously on one or both sides. The non-adhesive tape 6540 may be attached to the adhesive layer 6540 or may be integral with the adhesive layer 6540 and may be a region 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 releasing adhesive, the tab 3108 may be used to grasp the seal-forming structure 3100 and pull to stretch it, thereby removing the patient interface from the patient.

In other forms, the non-adhesive tape 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 adhesion 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 shown in fig. 25A, a non-adhesive tape 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 tape 6540 and the adhesive surface 3102 are exposed. The exposed side of the non-adhesive tape 6540, along with the non-adhesive side of the peripheral region of the adhesive layer 6530, form a tab 3108, which allows the patient 1000 to grasp the patient interface 3000 without touching the adhesive surface 3100.

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

4.6.1.1 cutting

The blank 3158 for sealing the forming structure 3100 may be cut from a sheet of material, such as 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 shown by the lines in fig. 21A that indicate the shape of the seal forming structure. In some forms, the blank 3158 may be die cut or laser cut.

In some forms of technology, the initial cutting step may involve partial cutting, which may alternatively be referred to as pre-cutting. In the pre-cut step, the blank 3158 is not completely cut from the tape 6500. Instead, portions of the blank 3158 remain connected 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 be 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 scored or otherwise marked prior to the cutting step, the advantages of which will be described 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, simultaneously with or subsequent to a molding process for applying the pneumatic chamber 3200 to the seal-forming structure blank.

4.6.1.2 molding

The slit or partially slit blank 3158 may then be molded into the shape required to seal the 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 comprising a cavity 6012 into which a blank 3158 may be inserted during moulding, and a core part 6004 comprising a protrusion 6014 configured to be inserted into the cavity 6012 in the cavity part 6002, wherein the blank 3158 is 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 blank is positioned relative to the cavity member 6002 and the core member 6004 by reels 6510 and 652010 and 6520. For example, the reel is configured to feed 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 can include a plurality of cavities 6012, and the core member 6004 can correspondingly include a plurality of protrusions 6014. Each of the plurality of projections 6014 is received by a cavity 6014 of the cavity member 6002. The spools may be controlled so that they stop winding so that the pre-cut blanks 3158 are positioned in line with the cavities 6012 and projections 6014 on the cavity member 6002 and core member 6004, respectively. Another advantage of pre-cutting (or pre-scoring or pre-marking) the tape 6500 is that the cuts, scores, 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 tape 6500 to be positioned in such a way that when core member 6004 is received by cavity member 6002, aperture 6560 aligns with tab 6014 and cavity 6012.

Next, the cavity and the core member are put together. This is shown in fig. 21C and 25B. This step sandwiches the blank 3158 between the cavity and core member and molds it into the 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 core member may conduct heat and may have heating elements 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 disposed in alignment with those portions of the blank 3158 that remain connected to the tape 6500. The cutting blade 6210 may alternatively be provided to the core member 6004. Such forms are shown 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, thereby completely cutting 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 technology, the pneumatic 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 apparatus. Such process steps are shown in fig. 21D and 25C. The cavity member 6002 can include a channel 3908 through which molten overmolding material (e.g., TPE or silicon) can 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 to the desired shape of the pneumatic chamber 3200 such that the pneumatic chamber 3200 is formed as an overmold on the seal forming structure 3100.

As shown in fig. 23A, the molding apparatus 6000 may include a hopper 6100 that is 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, the shaped overmolded pneumatic chamber 3200 and seal forming structure 3100 are formed and the molding apparatus 6000 can be formed such that the members fall into the collector 6300.

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

4.6.2 patient interface customization

In one form, patient interface 3000 is customized to fit an individual patient 1000. In another form, a patient interface 3000 is manufactured that is generally shaped and designed to fit the 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 plurality of preformed patient interfaces 3152 that best suit its needs.

As previously described, the mass manufacturing, supply, and distribution of preformed patient interfaces 3150 of general shape and size may be less expensive than customizing the seal-forming structure 3100 to correspond to the exact 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 plurality of different shapes and sizes may provide a useful tradeoff to balance some of the advantages of economies of scale while still providing a seal forming structure 3100 that may fit an individual patient to a sufficient degree. The larger the variety of shapes and sizes provided, the greater the prospect that the 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.

4.6.2.1 receive 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 a region 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.

4.6.2.2 selection of 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 pneumatic chamber 3200 and a seal-forming structure 3100 according to any of the techniques described elsewhere herein.

In one form of the 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, nose types, and the like.

The preformed patient interface 3150 that most closely conforms to the region of the patient's face to which the seal-forming structure 3100 is adhered is selected from a plurality of preformed patient interfaces 3152.

In an alternative form of the technique, each of the plurality of preformed patient interfaces 3152 is the same or there are a very small number of 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 means that for some patients it may be more difficult to find a precisely confirmed preformed patient interface.

4.6.2.3 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 regions of the individual patient 1000, which are those facial regions to which the seal-forming structure 3100 will adhere 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 a selected preformed patient interface 3152. More specifically, the molding device 3900 may be used to shape the seal-forming structure 3100 of the 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 pneumatic chamber 3200 such that the pneumatic chamber 3200 remains unchanged during the molding process. The pneumatic chamber 3200 of the selected preformed patient interface 3152 may additionally or alternatively be shaped by the molding device 3900 in some form of the technique.

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, a 3-D image scan is performed of the relevant facial area of the patient 1000, and the first portion 3902 and the second portion 3904 may be formed from virtual images of the scan. The first portion 3902 and the second portion 3904 may be 3D 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 device 3900 may be an injection molding device 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 technique, the preformed patient interface 3152 may be formed by cutting, shaping, and optionally over-molding the blanks 3158 in the manner explained above and, for example, with respect to fig. 21A-21D or 23A-25E.

4.6.2.4 laser bending

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

4.6.2.5 3-D printing

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

4.7RPT device

An RPT device 4000 in accordance with one aspect of the present technology includes mechanical, pneumatic, and/or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described in whole or in part herein. RPT device 4000 may be configured to generate an air flow for delivery to an airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

4.8 glossary of terms

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

4.8.1 overview

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.

Environment: in certain forms of the present technology, the term environment may have the meaning of (i) external to 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 sleeps. 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, in addition to noise generated by, for example, an RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy, in which the therapeutic pressure is automatically adjusted between a minimum and maximum, e.g., from breath to breath, depending on the presence or absence of an indication of an SDB (sleep disordered breathing) event.

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

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

In an example of patient breathing, the flow 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 Qd is the air flow leaving the RPT device. The total flow Qt is the flow of air and any supplemental gas to the patient interface via the air circuit. The vent flow Qv is the air flow leaving the vent to allow flushing of the exhaled air. Leakage flow rate Ql is leakage 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 an air flow to the entrance of the airway at a controlled flow rate, referred to as the therapeutic flow rate, which is typically positive throughout the patient's respiratory cycle.

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

Leakage: word leakage will be considered an undesirable 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 to the surrounding environment.

Noise, conductive (acoustic): conduction noise in this document refers to noise that is carried 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 the end of the air circuit.

Noise, radiated (acoustic): the radiation noise in this document refers to noise brought to the patient by 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.

Noise, aerated (acoustic): ventilation noise in this document refers to noise generated by the flow of air through any ventilation aperture, such as the ventilation aperture of a patient interface.

Oxygen enriched air: air having an oxygen concentration greater than 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 higher.

Patient: people, whether they have respiratory disease or not.

Pressure: force per unit area. Pressure can be expressed in units of range, including cmH ₂ O、g-f/cm ² And hPa. 1cmH ₂ O is equal to 1g-f/cm ² And about 0.98 hPa (1 hPa=100 Pa=100N/m) ² =1 mbar to 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 is indicated by the symbol Pt, which therapeutic pressure indicates the target value reached by the mask pressure Pm at the present moment.

Respiratory Pressure Therapy (RPT): the air supply is applied to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

Breathing machine: mechanical means for providing pressure support to the patient to perform part or all of the respiratory effort.

4.8.1.1 material

Silicone or silicone elastomer: synthetic rubber. In the present specification, reference to silicone refers to Liquid Silicone Rubber (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 LSRs have a shore a (or type a) dent hardness in the range of about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: thermoplastic polymers of bisphenol a carbonate.

4.8.1.2 mechanical Properties

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

Is resilient: when empty, will release substantially all of the energy. 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 dent hardness scale measured on a standardized 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.

Stiffness (or rigidity) of a structure or component: the ability of the structure or component to resist deformation in response to an applied load. The load may be a force or 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.

A floppy structure or component: a structure or component that will change shape (e.g., bend) in a relatively short period of time (such as 1 second) when caused to support its own weight.

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, at about 20 to 30cmH ₂ The patient interface is disposed and maintained in sealing relationship with the entrance to the patient airway under the pressure of O.

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

4.8.2 anatomy of the patient

4.8.2.1 facial anatomy

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

Wing angle:

nose wing end: the outermost points on the nose wings.

Nose wing bending (or nose wing top) point: the rearmost point in the curved baseline of each wing is found in the folds formed by the combination of the wing and cheek.

Auricle: the entire outer visible portion of the ear.

(nasal) skeleton: the framework of the nose comprises nasal bones, frontal processes of the maxilla and the nose of the frontal bones.

(nasal) cartilage scaffold: the cartilage matrix of the nose includes the septum cartilage, the lateral cartilage, the large cartilage and the small cartilage.

Nose post: skin strips separating the nostrils and extending from the nasal projection to the upper lip.

Nose columella angle: the angle between the line drawn through the midpoint of the nostril and the line drawn perpendicular to the frankfurt plane (with both lines intersecting at the point under the nose).

Frankfurt level: a line extending from the lowest point of the rail edge to the left sloped region. The cochlea is the deepest point in the notch in the upper part of the tragus of the auricle.

Intereyebrow: is located on the soft tissue, the most prominent point in the mid-forehead sagittal plane.

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

Lower lip (lower lip midpoint):

upper lip (upper lip midpoint):

Nasal alar cartilage: a subchondral plate located under 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 (nose-eyes): forming an approximately oval aperture of the nasal cavity entrance. The singular form of a nostril (nare) is a nostril (nares) (nose-eye). The nostrils are separated by the nasal septum.

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

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

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

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

Nose point: the most protruding point or tip of the nose, which can be identified in a side 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 positioned on the soft tissue and is positioned at the foremost midpoint of the chin.

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

Sagittal plane: a vertical plane from front (front) to back (back). 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 covers the most concave point of the frontal nasal suture area.

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

The lower part of the nose wing: at the point at the lower edge of the base of the nose, where the base of the nose engages the skin of the upper (superior) 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.

Mandibular socket point: the midline of the lower lip is at the point of greatest concavity between the midpoint of the lower lip and the anterior genitalia of the soft tissue.

Anatomical structure of bone

Frontal bone: frontal bone comprises a large vertical portion (frontal scale), which corresponds to an area called the 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 maxillary frontal process protrudes upward from the side of the nose and forms part of the lateral border.

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 parts of the face and form the "beam" of the nose through 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 concave region above the bridge of the nose.

Occipital bone: occiput is located in the posterior and inferior parts of the cranium. It includes oval holes (occipital macropores) through which the cranial cavity communicates with the spinal canal. The curved plate behind the occipital macropores is occipital scale.

Orbit of eye: the skull accommodates the bone cavity of the eyeball.

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

Temporal bone: the temporal bones are located at the bottom and sides of the skull and support the portion of the face called the temple.

Cheekbones: the face includes two cheekbones that are located on the upper and lateral portions of the face and form the protruding portions of the cheeks.

4.8.2.2 anatomy of the respiratory system

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

Throat: the larynx or larynx 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 turbinates (singular "turbinates") or turbinates. The front of the nasal cavity is the nose, while the back is incorporated into the nasopharynx via the inner nostril.

Pharynx: located immediately below the nasal cavity and 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).

4.8.3 patient interface

Anti-asphyxia valve (AAV): by opening to the atmosphere in a fail-safe manner, patient excess CO is reduced ₂ Components or sub-components of the mask system that are at risk of rebreathing.

Bending pipe: an elbow is an example of a structure that directs the axis of an air flow traveling therethrough to change direction at an angle. In one form, the angle may be about 90 degrees. In another form, the angle may be greater than 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 rotatable relative to the mating component, for example about 360 degrees. In some forms, the elbow may be removable 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 cannot be removed by the patient.

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

Functional dead space.

Film: a film will be considered to mean a typically thin element that is preferably substantially free of bending resistance but stretch resistant.

Pneumatic chamber: the mask pneumatic chamber will be considered to mean that portion of the patient interface having a wall at least partially surrounding a volume of air that, in use, has been pressurized therein to above atmospheric pressure. The housing may form part of the wall of the mask pneumatic chamber.

And (3) sealing: but 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.

A shell: the housing will be considered to mean a curved and relatively thin structure having a bendable, stretchable and compressible stiffness. For example, the curved structural wall of the mask may be the shell. In some forms, the housing may be multi-faceted. In some forms, the housing may be airtight. In some forms, the housing may not be airtight.

Reinforcement: a 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) a supporting piece: a support will be considered to mean 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 about a common axis, preferably independently, 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. There may be little or no air flow leaking from the swivel during use.

Lacing (noun): a structure designed to resist tension.

Vent port: (noun): allowing air flow from the mask interior or conduit to ambient air, such as structures for effective removal of exhaled air. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on mask design and treatment pressure.

4.9 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 document or the record, but otherwise reserves any copyright rights whatsoever.

Unless the context clearly indicates and provides a range of values, it is understood that each intermediate value between the upper and lower limits of the range, to one of the tenth of the unit of the lower limit, and any other stated or intermediate value within the range, is broadly 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 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 described herein are implemented as part of the present technology, it is to be understood that such value or values may be approximate unless otherwise stated, and that such value or values may be practical for any suitable significance to the extent that the technical implementation may allow 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 substitute materials with similar properties may be used as substitutes 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 plural equivalents thereof 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 present technology is not entitled to antedate such disclosure by virtue of prior invention. Furthermore, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, that may be presented, utilized, or combined with other elements, components, or steps that are not expressly referenced.

The topic headings used in the detailed description are for convenience only to the reader and should not be used to limit the topics that can be found throughout the present utility model or claims. The subject matter headings are not to be used to interpret the claims or the scope of the claims.

Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, they are not intended to represent any order, unless otherwise indicated, 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 concurrently or even synchronously.

Accordingly, it should be understood that many 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.

4.10 reference symbol list

1000. Patient(s)

3132. Septum region

3141. Nose wing end edge region

3142. Uppermost region of upper lip

3143. Anterior region of the nose below the nose point

3144. The region below the apex of the alar nose

3145. Cheek region adjacent to the apex of the alar nose

2000. Respiratory therapy system

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 member

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. Recess of seal forming structure

3190. Concave protrusion of seal forming structure

3200. Pneumatic chamber

3202. Pneumatic chamber inlet port

3216. Annular ring

3230. Front layer

3232. Fold

3250. Nose pillow

3252. Truncated cone

3254. Rod

3300. Integral/single component

3400. Vent opening

3410. Diffuser

3500. Decoupling structure

3502. Pipe

3504. Flexible section

3510. First magnetic member

3512. Second magnetic member

3514. Adapter device

3518. Frame

3520. Nasal oxygen cannula of air circuit

3522. Tube receiver

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. Applicator recess

3804. Gripping portion

3806. Nasal oxygen cannula of applicator

3808. Applicator surface

3810. Applicator body

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. Protrusion

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

6540. Non-adhesive tape

6550. Removable layer

6560. Pre-cut hole

6570. Precut edge

Claims

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

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

a seal-forming structure disposed to the pneumatic chamber, wherein the seal-forming structure is configured to form a seal with a region of the patient's face surrounding an inlet of the patient's airway, the seal-forming structure having an opening therein such that a flow of breathable gas is delivered to at least one inlet of the patient's nostrils, the seal-forming structure configured to maintain the therapeutic pressure in the pneumatic chamber during the patient's respiratory cycle in use; and

a vent structure allowing continuous flow of exhaled gas from the interior of the pneumatic chamber to the environment, the vent structure being sized and shaped for maintaining the therapeutic pressure in the pneumatic chamber in use,

wherein the seal-forming structure comprises at least one adhesive surface configured to adhere, in use, to a region of the patient's face surrounding an entrance to the patient's airway to form the seal,

Wherein the seal-forming structure is integrally formed with 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.

2. The patient interface of claim 1, wherein the one or more shape retainers are configured to retain a shape of the seal-forming structure after the seal-forming structure is made to adhere to the patient's face.

3. A patient interface according to any one of claims 1-2, 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.

4. A patient interface according to any one of claims 1-3, wherein the one or more shape retainers comprise an elongate member.

5. The patient interface according to any one of claims 1 to 4, wherein the one or more shape retainers and the seal-forming structure are made of one material.

6. The patient interface according to any one of claims 1 to 5, wherein the one or more shape retainers and the pneumatic chamber are made of one material.

7. The patient interface of claim 6, wherein the one or more shape retainers and the pneumatic chamber are integrally formed together.

8. The patient interface according to any one of claims 1 to 7, wherein the one or more shape retainers are configured to be separated from the seal-forming structure and/or the pneumatic chamber once the seal-forming structure is made to adhere to the patient's face.

9. The patient interface according to any one of claims 1 to 8, 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.

10. The patient interface according to any one of claims 1 to 9, 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.

11. The patient interface of claim 10, 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.

12. The patient interface of claim 11, 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.

13. The patient interface of claim 12, wherein the one or more tabs are configured to be pulled to deform the at least one adhesive surface.